Annexes to COM(2007)470 - Approval of the first and the second amendments to the UN/ECE Espoo Convention on Environmental Impact Assessment in a Transboundary Context - Main contents
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| dossier | COM(2007)470 - Approval of the first and the second amendments to the UN/ECE Espoo Convention on Environmental Impact Assessment in a ... |
|---|---|
| document | COM(2007)470  |
| date | November 9, 2007 |
2. This Directive shall apply without prejudice to any other relevant Community legislation or to any national fiscal measures to encourage the use of less harmful pesticides .
3. Member States may provide subsidies or take fiscal measures to encourage the use of less harmful pesticides. This may include the introduction of a pesticides levy on all products except non-chemical products or low-risk plant protection products as defined in Article [50(1)] of Regulation (EC) No ... [concerning the placing of plant protection products on the market].
4. The provisions of this Directive shall not prevent Member States from applying the precautionary principle in restricting or prohibiting the use of pesticides.
Article 3
Definitions
For the purposes of this Directive, the following definitions shall apply:
| (1) | ‘use’: means all operations carried out with a pesticide, such as storage, handling, dilution, mixing, and application; |
| (2) | ‘ ▐ user’: means any natural or legal person who carries out the use of pesticides in the framework of his ▐ activity, whether he is self-employed , employed or recruited for a special task; regarding ‘professional users’ Member States may distinguish between those entitled to use pesticides only on their own holdings and those entitled to provide pesticide services on holdings belonging to 3rd parties; In addition, golf courses, tennis courts and other leisure facilities, local authorities with public parks, and infrastructure items such as car parks, roads, railways etc. shall be looked upon as users; |
| (3) | ‘distributor’: means any natural or legal person who makes a pesticide available on the market, including wholesalers, retailers, vendors, suppliers; |
| (4) | ‘adviser’: means any natural or legal person who has the level of instruction and training stipulated by the Member States in order to be authorised to provide advice on the use of pesticides, in the context of uses authorised by the country in which the pesticide is produced and of the maximum residue limits laid down by the Community; |
| (5) | ‘pesticide application equipment’: means any apparatus used for the application of pesticides or pesticide-containing products; |
| (6) | ‘pesticide application accessories’: means devices that can be mounted on pesticide application equipment, that are essential for its good working, such as nozzles, manometers, filters, strainers and cleaning devices for tank; |
| (7) | ‘aerial spraying’: means any application of pesticides by an air-borne vehicle; |
| (8) | ‘integrated pest management’: means integrated pest management as defined in Article [3(23)] of Regulation (EC) No ...[concerning the placing of plant protection products on the market]; |
| (9) | ‘risk indicator’: means a parameter that can be used to evaluate pesticide use impacts on human health and the environment; |
| (10) | ‘non-chemical methods of plant protection and pest and crop management’: means the use of pest control and management techniques that do not rely on chemical properties. Non-chemical methods of plant protection and pest and crop management include rotation, physical and mechanical control and natural predator management; |
| (11) | ‘application frequency’: refers to a utilisation indicator which expresses the average number of times that a piece of agricultural land can be treated with the prescribed dose, calculated on the basis of the total quantities of each pesticide sold; |
| (12) | ‘pesticide’: means a plant protection product as defined in Regulation (EC) No ... [concerning the placing of plant protection products on the market]; |
| (13) | ‘use reduction’: means reduction of applications of pesticides and is not necessarily dependent on volume; |
| (14) | ‘treatment frequency index’: is based on the fixed standard dose of active substance per hectare needed for one treatment against the pest in question. Therefore, it is not necessarily dependent on volume and can be used to evaluate use reduction. |
Article 4
National action plans to reduce risks and use of pesticides
1. Not later than ... (20), Member States shall adopt a background report in accordance with Annex III with the objective of identifying national trends in pesticide use and risks and the priority areas and crops to be addressed in the national action plan.
2. Member States shall, after consulting farmers' and winegrowers' associations, environmental protection organisations and the industrial and other sectors concerned, adopt and implement without undue delay national action plans to set up targets, measures and timetables to reduce risks, including hazards, and dependence on pesticides. The national action plans shall as a minimum include:
| (a) | for other than biological pesticides and low-risk plant protection products as defined in Article [50(1)] of Regulation (EC) No ... [concerning the placing of plant protection products on the market], quantitative use reduction targets measured as a treatment index. The treatment index will be adapted to the specific conditions of each Member State. The treatment index will have to be communicated immediately to the Commission for its approval. For active substances of very high concern the reduction target shall be a minimum 50% reduction in relation to the treatment index calculated for the year 2005 by the end of 2013, unless the Member State can prove that it has already achieved a comparable or higher target based on another year of reference from the period 1995-2004; |
| (b) | for pesticide formulations classified as toxic or very toxic pursuant to Directive 1999/45/EC of the European Parliament and of the Council of 31 May 1999 concerning the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations (21), a quantitative use reduction target measured as sold volumes. This target shall be a minimum 50% reduction calculated in relation to the year 2005 by the end of 2013, unless the Member State can prove that it has already achieved a comparable or higher reduction target based on another year of reference from the period 1995-2004. |
Member States may also choose to opt for setting the same targets for risk reduction, instead of use reduction targets. Reduction of risks shall be measured using the risk indicators as provided for in Article 15 and Member States opting for risk reduction shall select a year of reference from the period 1995-2005.
National action plans shall include integrated pest management as referred to in Article 14, priority being assigned to non-chemical crop protection measures and encouragement provided to farmers who opt to use non-chemical crop protection products.
3. The baseline year shall be the average use and risks in the last three calendar years ‘January through December’ before the entry into force of this Directive.
4. When drawing up and revising their national action plans, Member States shall give due consideration to the public health, social, economic and environmental impacts of the measures envisaged , to specific national, regional and local conditions and to all relevant stakeholder groups. Minimum requirements for the national action plans are listed in the guidance document in Annex IV .
The national action plans shall comprise, if necessary, information on the aspects listed in Articles 5 to 14. They shall take into account plans under other Community legislation on the use of pesticides, such as planned measures under Directive 2000/60/EC.
The measures contained in the national action plans may, in particular, be of a legislative, taxation or voluntary nature and should be based on the findings of relevant risk assessments.
Member States shall establish a mechanism for financing the introduction of the national action plans.
5. Not later than ... (22) , Member States shall communicate their national action plans to the Commission and to the other Member States.
The national action plans shall be reviewed at least every three years and , depending on the attainment of objectives, updated. Monitoring shall also include an analysis of whether the risks in the action plan are appropriately taken into account or if they need to be reassessed. Any changes to the national action plans and the essential findings of the monitoring shall be reported to the Commission without undue delay.
Member States shall make the information reported under this paragraph available to the public on a website.
The Commission shall make the information communicated in accordance with this paragraph available to third countries and to the public .
6. The Commission shall draw up every two years a report presenting the results of implementing the national action plans.
The Commission shall establish an Internet portal to inform the public about the national action plans, any changes and the essential results of their implementation.
7. The provisions on public participation as laid down in Article 2 of Directive 2003/35/EC shall apply to the preparation and the modification of the national action plans.
8. Member States shall step up their efforts to monitor and prevent illegal use of pesticides, in collaboration with the relevant stakeholders.
Member States shall report on a regular basis on controls in place regarding illegal use.
Chapter II
Training, Awareness programmes, and Sales of pesticides
Article 5
Training
1. Member States shall ensure that all professional users, distributors and advisers have access to appropriate and independently organised instruction and training or further training, including regular updating on new information available, on the sustainable and proper use of pesticides reflecting the level of responsibility of those concerned and their specific role with regard to integrated pest management. To this end, minimum requirements that are binding throughout the Community shall be laid down .
In the case of microbusiness-type farms or wineries, Member States shall ensure that one person working as a professional user within the meaning of Article 3(2) has access to such training.
The training or further training shall be designed so as to ensure that sufficient knowledge on the subjects listed in Annex I is acquired.
2. Member States shall ensure that professional users, distributors and advisers are aware of the existence and risks of illegal (counterfeit) pesticides, and are properly trained to identify such products.
3. Not later than ... (23) , Member States shall establish an assessment system. Appropriate certificates shall be issued to prove knowledge of the matters referred to in Annex I. The system shall incorporate rules on the preconditions for issue, the period of validity and the withdrawal of the certificates .
The certificate issued to a trainee (where that trainee is a professional user from a microbusiness-type farm or winery) shall be valid for that farm or winery, with particular reference to the provisions laid down in Article 6(2).
4. The Commission may, in accordance with the regulatory procedure with scrutiny referred to in Article 20(2) , amend Annex I for adaptation to technical and scientific progress.
Consequently, as and when deemed necessary by the national authorities responsible, holders of the certificates referred to in Annex I shall be required to undergo refresher training.
Article 6
Requirements for sales of pesticides
1. Member States shall ensure that distributors selling pesticides ▐ have at least one person in their employment, who has a certificate referred to in Article 5(3), and who shall be present and available at the place of sales to provide information to customers as regards use of pesticides as well as the health and environmental risks and potential adverse impacts associated with them. The certificate shall be not more than 7 years old .
2. Member States shall take the necessary measures to ensure that sales of authorised pesticides are restricted to use only by professional users holding a certificate referred to in Article 5(3) and in accordance with the advice of suitably qualified, competent professionals designated by the Member States .
3. Member States shall require distributors placing pesticides for non-professional use on the market to provide general information regarding the risks and potential adverse health and environmental impacts of pesticide use, in particular on hazards, exposure, proper storage, handling and application, as well as disposal. This shall apply also in the case of sale over the Internet. If the buyer holds a certificate issued pursuant to Article 5(3), it shall be sufficient to produce the certificate in order to purchase pesticides.
The measures provided for in paragraphs 1 and 2 shall be established not later than ... (24)
4. Member States shall ensure that existing inspection and enforcement measures are fully implemented to ensure that illegal (counterfeit) pesticides are not offered for sale.
Article 7
Information programmes , monitoring and research
1. Member States shall promote and facilitate information programmes and the availability of information intended for the general public relating to the use and risks of pesticides and the potential acute and chronic health and environmental effects arising from their use. In addition, information shall be provided on the role of pesticides in agriculture and food production, responsible use of pesticides, hazards and non-chemical alternatives.
2. Member States shall put in place mandatory systems for gathering information on pesticide acute and chronic poisoning incidents, especially among pesticide operators, workers, residents and any other groups that may be exposed to pesticides regularly.
3. Member States shall regularly monitor and collect information on indicator species exposed to pesticides and on pesticides in the environment, such as in fresh and marine waters, soil and air, and report on this information regularly to the Commission.
4. Member States shall carry out long-term research programmes into specific situations where pesticides have been linked to impacts on human health and the environment, including studies on high-risk groups, biological diversity and combination effects.
5. To enhance comparability of information, the Commission, in cooperation with the Member States, shall develop a strategic guidance document on monitoring and surveying of impacts of pesticide use on human health and the environment not later than ... (25) .
Chapter III
Pesticide application equipment
Article 8
Inspection of equipment in use
1. Member States shall ensure that pesticide application equipment and accessories in professional use shall be subject to mandatory inspections at regular intervals not exceeding five years .
For that purpose, they shall establish certificate systems designed to allow the verification of inspections.
2. The inspections shall verify that the pesticide application equipment and accessories are satisfying the essential health and safety and environmental requirements listed in Annex II.
Pesticide application equipment and accessories complying with harmonised standards developed according to Article 19(1) shall be presumed to comply with the essential health and safety and environmental requirements covered by such a harmonised standard.
3. Not later than ... (26) , Member States shall ensure that all pesticide application equipment and accessories for professional use have been inspected at least once, and that only pesticide application equipment and accessories having successfully passed inspection are in professional use. Compulsory inspections must subsequently take place at least every five years .
4. Member States shall designate bodies responsible for carrying out the inspections and inform the Commission thereof.
5. The Commission may, in accordance with the regulatory procedure with scrutiny referred to in Article 20(2) , amend Annex II for adaptation to technical progress.
Chapter IV
Specific Practices and Uses
Article 9
Aerial spraying
1. Member States shall prohibit aerial spraying subject to paragraphs 2-6.
2. Member States shall define and make public crops, areas and particular requirements for application, where by way of derogation from paragraph 1, aerial spraying may be authorised.
3. Member States shall designate the authorities competent for monitoring aerial spraying , and inform the Commission thereof.
4. Derogations may only be granted where the following conditions are fulfilled:
| (a) | there must be no viable alternatives, or there must be clear advantages in terms of reduced impacts on human health and the environment in comparison to land-based application of pesticides; |
| (b) | the pesticides used must be explicitly authorised for aerial spraying; substances classified as very toxic (R50) to aquatic organisms shall not be authorised for aerial spraying; |
| (c) | the pilot or operator preparing and carrying out the aerial spraying must hold a certificate referred to in Article 5(3); |
| (d) | aerial spraying must be notified in advance to the competent authority and authorised by that authority; |
| (e) | all the requisite measures must be taken in order to provide warning in good time for residents and bystanders and to protect the environment in the vicinity of the area sprayed ; |
| (f) | the area to be sprayed must not be in close proximity to public or residential areas and there must be no effects on the health of residents or bystanders; |
| (g) | the aerial craft must be equipped with the best available technology to reduce spray drift (e.g. lowdrift nozzles); where helicopters are used, the spray booms must be equipped with injection jets to reduce drift; |
| (h) | the socio-economic and environmental benefits must outweigh the potential effects on the health of residents and bystanders. |
5. A professional user wishing to apply pesticides by aerial spraying shall submit a request to the competent authority accompanied by data supporting that the conditions referred to in paragraph 4 are fulfilled. The notification shall contain information about the time of spraying and the amounts and the type of pesticides applied.
6. The competent authorities shall keep records of derogations granted and shall make them available to the public .
Article 10
Information to the public
Member States may include in their national action plans provisions on informing neighbours who could be exposed to the spray drift.
Article 11
Specific measures to protect the aquatic environment
1. Member States shall ensure that, when pesticides are used in the vicinity of water bodies, particularly bodies of drinking water, preference is given to:
| (a) | products that do not present a high risk of entering the aquatic environment; |
| (b) | most efficient application techniques, including the use of low-drift application equipment. |
2. Member States shall take the necessary action to protect bodies of water, in particular by ensuring that ▐ buffer zones, where pesticides must not be applied or stored, are established on fields adjacent to water courses, and in particular to safeguard zones for the abstraction of drinking water established in accordance with Article 7(3) of Directive 2000/60/EC.
The dimensions of the buffer zones shall be defined as a function of the risks of pollution and the agricultural and climate characteristics of the area concerned.
Furthermore Member States shall ensure that, in safeguard zones for the abstraction of drinking water in accordance with Article 7(3) of Directive 2000/60/EC, additional measures are taken to prevent contamination of water with pesticides including, where necessary, tighter restrictions on use of some high-risk products, enhanced use of buffer zones, specific training and awareness of advisers and spray operators, and strict enforcement of best practice in filling, mixing and disposal of pesticides.
Member States may establish any pesticide-free zones they deem necessary in order to safeguard drinking water resources. Such pesticide-free zones may cover the entire Member State.
3. Member States shall ensure that appropriate measures are taken to limit the aerial drift and long-range transportation of pesticides at least in vertical crops, including orchards, vineyards, and hops directly adjacent to or near a water course , by ensuring that pesticide use in such areas is reduced to the minimum and non-chemical alternatives are used .
4. Member States shall ensure that application of pesticides is reduced as far as possible or eliminated ▐ on or along roads, railway lines, ▐ surfaces made up of permeable rock, in sloping areas or other infrastructure close to surface water or groundwater, or on sealed surfaces with high risk of run-off into surface water or sewage systems. In all these areas use of non-chemical alternatives should be promoted.
Article 12
Reduction of pesticide use in sensitive areas
1. Member States shall, taking due account of the necessary hygiene and public safety requirements, ensure that the following measures are adopted:
| (a) | the use of pesticides shall be prohibited or restricted to the minimum necessary in all areas used by the general public or by sensitive population groups, at least in residential areas, parks, public gardens, sports and recreation grounds, school grounds and playgrounds and in the vicinity of public healthcare facilities (clinics, hospitals, rehabilitation centres, health resorts, hospices) as well as in substantial no-spray zones including in fields around these areas, particularly, although not exclusively, to protect sensitive groups such as babies, children, pregnant women, the elderly and those with preexisting medical conditions and who may be taking medication; |
| (b) | the use of pesticides shall be prohibited or strongly restricted in ▐ conservation areas or other areas identified for the purposes of establishing the necessary conservation measures in accordance with Articles 3 and 4 of Directive 79/409/EEC and Articles 6, 10, and 12 of Directive 92/43/EEC. |
2. The prohibition or restriction shall be based on the results of relevant risk assessments.
Article 13
Handling and storage of pesticides and their packaging and remnants
1. As part of their national action plans, Member States shall adopt the ▐ measures that prove necessary on the basis of relevant risk assessments to ensure that the following operations carried out by users do not endanger the health or safety of humans and the environment:
| (a) | safe storage, handling, dilution and mixing of pesticides before application; |
| (b) | safe handling of packaging and remnants of pesticides; |
| (c) | treatment of mixtures remaining after application; |
| (d) | preparation, handling, cleaning and storage of the equipment used for application and any accessories, including spraying equipment and chemicals . |
2. Member States shall take all necessary measures regarding pesticides authorised for non-professional use to avoid dangerous handling operations.
3. In their national action plans, Member States shall take the measures that prove necessary on the basis of appropriate risk assessments to ensure that storage areas for pesticides shall be constructed in such a way as to prevent unwanted releases.
Article 14
Integrated Pest Management
1. Member States shall take all necessary measures , including the use of economic instruments, to promote low pesticide-input farming, including integrated pest management with the prioritisation of nonchemical methods of plant protection and pest and crop management , and to ensure that professional users of pesticides switch as quickly as possible to a more environmentally-friendly use of all available crop protection measures, giving priority to low-risk alternatives wherever possible, and otherwise to the products with minimum impact on human health and the environment among the ones available for the same pest problem.
2. Member States shall encourage the use of low-risk plant protection products as defined in Article [50(1)] of Regulation (EC) No ... [concerning the placing of plant protection products on the market].
3. Member States shall establish or support the establishment of all necessary conditions for implementation of integrated pest management and non-chemical methods of plant protection and pest and crop management, and shall draw up descriptions of the best integrated crop protection practices, assigning priority to non-chemical crop protection .
4. In particular, Member States shall ensure that farmers have at their disposal systems, including training in accordance with Article 5, and tools for pest monitoring and decision making, as well as advisory services on non-chemical methods of plant protection and pest and crop management.
5. By 30 June 2011 , Member States will report to the Commission on the implementation of paragraphs 3 and 4, and in particular, whether the necessary conditions for implementation of integrated pest management are in place.
6. Minimum requirements for the development of general standards of Integrated Pest Management are defined in Annex V.
7. Member States shall ensure that, at the latest by 1 January 2014, all professional users of pesticides implement the general standards for Integrated Pest Management.
8. Amendments to Annex V shall be adopted using the regulatory procedure with scrutiny referred to in Article 20(2).
9. Member States shall establish appropriate incentives , training and financial measures to assist users to implement crop-specific or sector-specific guidelines for Integrated Pest Management which take account of the general criteria described in Annex V. In their national action plans pursuant to Article 4, Member States shall refer to the appropriate guidelines .
10. The general standards for Integrated Pest Management ▐ shall be developed in accordance with the procedure referred to in Article [58] of Regulation (EC) No ...[concerning the placing of plant protection products on the market], with public participation of interested stakeholders .
11. The crop-specific standards for Integrated Pest Management referred to in paragraph 9 may be developed in accordance with the procedure laid down in Article 6(3) of Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations and of rules on Information Society services (27) .
Chapter V
Indicators, Reporting and Information Exchange
Article 15
Indicators
1. The Commission shall, in accordance with the regulatory procedure with scrutiny referred to in Article 20(2) , develop harmonised risk and use indicators. Until those indicators are adopted, Member States may continue to use existing national indicators or adopt other appropriate indicators.
2. Member States shall use statistical data collected in accordance with Regulation (EC) No [...] [of the European Parliament and of the Council of ... concerning statistics on plant protection products] (28) for the following purposes:
| (a) | calculation of common and harmonised risk and use indicators at national level; |
| (b) | identification of trends in the use of individual active substances, in particular when use restrictions have been decided at Community level in accordance with the provisions of Regulation (EC) No [...] [statistics on plant protection products]; |
| (c) | identification of trends in the occurrence of pests and disease and development of fungi; |
| (d) | identification of priority active substances or priority crops or unsustainable practices that require particular attention, or good practices that can be set as examples in order to achieve the objectives of this Directive in preventing both health and environmental risks, including hazards, and dependency on pesticides; promoting and encouraging the adoption of non-chemical alternatives to pesticides; |
| (e) | assessment and adaptation of the national action plans. |
3. Member States shall communicate the results of the evaluations carried out pursuant to paragraph 2 to the Commission and to the other Member States and shall make this information available to the public .
The results shall be published via the Internet portal referred to in Article 4(6).
4. The Commission shall use statistical data collected in accordance with Regulation (EC) No ... [statistics on plant protection products] and the information referred to in paragraph 3 to calculate risk and use indicators at Community level, in order to estimate trends in risks from pesticide use.
This data and information shall also be used by the Commission to assess progress in the achievement of the objectives of other Community policies aimed at reducing the impact of pesticides on human and animal health and on the environment.
The results shall be made available to the general public via the Internet portal referred to in Article 4(6).
5. For the purposes of paragraph 2(a) and paragraph 3, risk and use indicators shall be calculated on the basis of data inputs concerning hazard and exposure, pesticide use records, data on characteristics of pesticides, weather data and soil data.
6. The gathering of data may not impose on Community farmers and wine producers any additional documentary requirements or any unreasonable requirements to make information available.
Article 16
Recordkeeping and reporting
1. Pesticide dealers shall maintain records showing the receipt, sale, delivery or other disposal of all pesticides or pesticide application equipment for a period of two years.
2. The Commission shall , every three years, submit to the European Parliament and the Council a report on the progress in the implementation of this Directive and an assessment of national action plans , accompanied where appropriate by proposals for amendments.
3. Member States shall report annually to the Commission on their national action plans.
Article 17
Exchange of information and best practice
The Commission shall establish a platform for the exchange of information and best practice in the field of sustainable use of pesticides and integrated pest management.
Chapter VI
Final provisions
Article 18
Penalties
1. Member States shall determine penalties applicable to infringements of the national provisions adopted pursuant to this Directive and shall take all measures necessary to ensure that they are implemented. The penalties imposed shall be effective, proportionate and dissuasive.
2. Member States shall notify those provisions to the Commission not later than ... (29) . and shall notify it without delay of any subsequent amendment affecting them.
Article 19
Standardisation
1. The standards referred to in Article 8(2) of this Directive shall be established in accordance with the procedure provided for in Article 6(3) of Directive 98/34/EC.
The request for developing these standards may be established in consultation with the Committee referred to in Article 20(1).
2. The Commission shall publish the references of the standards in the Official Journal of the European Union.
3. When a Member State or the Commission considers that a standard does not entirely satisfy the essential requirements which it covers, the Commission or the Member State concerned shall bring the matter before the Committee set up by Directive 98/34/EC giving its arguments. That Committee shall deliver its opinion without delay.
In the light of that Committee's opinion, the Commission shall decide to publish, not to publish, to publish with restriction, to maintain, to maintain with restriction or to withdraw the references to the harmonised standard concerned in the Official Journal of the European Union.
Article 20
Committee
1. The Commission shall be assisted by the Standing Committee on the Food Chain and Animal Health established by Article 58 of Regulation (EC) No 178/2002.
2. Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.
▐
Article 21
Expenditure
In order to support the establishment of a harmonised policy and systems in the field of sustainable use of pesticides, the Commission may finance:
| (a) | the development of a harmonised system including an appropriate database for gathering and storing all information relating to pesticide risk and use indicators, and for making such information available to the competent authorities, other interested parties and the general public; |
| (b) | the performance of studies necessary for the preparation and development of legislation, including the adaptation of the Annexes of this Directive to technical progress; |
| (c) | the development of guidance and best practices to facilitate the implementation of this Directive; |
| (d) | the creation of an Internet portal in line with Article 4(6). |
Article 22
Transposition
1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than ... (30) . They shall forthwith communicate to the Commission the text of those measures and a correlation table between those measures and this Directive.
When Member States adopt those measures, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.
Article 23
Entry into force
This Directive shall enter into force on the day following that of its publication in the Official Journal of the European Union.
Article 24
This Directive is addressed to the Member States.
Done at ..., on ...
For the European Parliament
The President
For the Council
The President
(1) OJ C 161, 13.7.2007, p. 48 .
(2) OJ C 146, 30.6.2007, p. 48 .
(3) Position of the European Parliament of 23 October 2007.
(4) OJ L 242, 10.9.2002, p. 1.
(5) OJ L ...
(6) OJ L 327, 22.12.2000, p. 1. Directive as amended by Decision No 2455/2001/EC (OJ L 331, 15.12.2001, p. 1).
(7) OJ L 70, 16.3.2005, p. 1. Regulation as amended by Commission Regulation (EC) No 178/2006 (OJ L 29, 2.2.2006, p. 3).
(8) OJ L 31, 1.2.2002, p. 1. Regulation as last amended by Commission Regulation (EC) No 575/2006 (OJ L 100, 8.4.2006, p. 3).
(9) OJ L 156, 25.6.2003, p. 17.
(10) OJ L 277, 21.10.2005, p. 1. Regulation as last amended by Regulation (EC) No 2012/2006 (OJ L 384, 29.12.2006, p. 8).
(11) OJ L 131, 5.5.1998, p. 11. Directive as last amended by Directive 2007/30/EC of the European Parliament and of the Council (OJ L 165, 27.6.2007, p. 21).
(12) OJ L 158, 30.4.2004, p. 50. Corrected in OJ L 204, 4.8.2007, p. 28.
(13) OJ L 157, 9.6.2006, p. 24. Corrected in OJ L 76, 16.3.2007, p. 35.
(14) OJ L 103, 25.4.1979, p. 1. Directive as last amended by Directive 2006/105/EC (OJ L 363, 20.12.2006, p. 368) .
(15) OJ L 206, 22.7.1992, p. 7. Directive as last amended by Directive 2006/105/EC.
(16) OJ L 114, 27.4.2006, p. 9.
(17) OJ L 377, 31.12.1991, p. 20. Directive as last amended by Regulation (EC) No 166/2006 of the European Parliament and of the Council (OJ L 33, 4.2.2006, p. 1).
(18) OJ L 184, 17.7.1999, p. 23. Decision as amended by Decision 2006/512/EC (OJ L 200, 22.7.2006, p. 11) .
(19) OJ L 123, 24.4.1998, p. 1. Directive as last amended by Directive 2007/47/EC (OJ L 247, 21.9.2007, p. 21).
(20) One year after the entry into force of this Directive.
(21) OJ L 200, 30.7.1999, p. 1. Directive as last amended by Regulation (EC) No 1907/2006 (OJ L 396, 30.12.2006, p. 1).
(22) Three years after the entry into force of this Directive.
(23) Five years after the entry into force of this Directive.
(24) Four years after the entry into force of this Directive.
(25) Three years after the entry into force of this Directive.
(26) Seven years after the entry into force of this Directive.
(27) OJ L 204, 21.7.1998, p. 37. Directive as last amended by Council Directive 2006/96/EC (OJ L 363, 20.12.2006, p. 81).
(28) OJ L ...
(29) Three years after the entry into force of this Directive.
(30) Two years after the entry into force of this Directive.
ANNEX I
TRAINING AND FURTHER TRAINING PROGRAMMES
Training and further training programmes shall be designed so as to ensure that sufficient knowledge on the following subjects is acquired:
| 1. | all relevant legislation regarding pesticides and their use , pesticide labels and labelling systems, pesticide terminology, pesticide safety, toxicity and eco-toxicity; |
| 2. | the hazards and risks associated with pesticides, and how to identify and control them, in particular:
|
| 3. | notions on integrated pest management strategies and techniques, ▐ integrated crop management strategies and techniques, organic farming principles and non-chemical crop protection, in particular preventive methods and biological control methods ; information on general and crop-specific standards and practices of non-chemical methods of plant protection and pest and crop management; |
| 4. | initiation to comparative assessment at user level to help professional users make the most appropriate choices among all authorised products for a given pest problem, in a given situation , choosing the least dangerous product for human health and the environment; |
| 5. | measures to minimise the risks to humans, non-target species and the environment: safe working practices for storing, handling and mixing pesticides, and disposing of empty packaging, other contaminated materials and surplus pesticides (including tank mixes), whether in concentrate or dilute form; recommended way to control operator exposure (personal protection equipment) ; knowledge of all potential exposure factors including long-term exposure to pesticides in the air, exposure to vapours after application, reactivation, precipitation, pesticides transported from outdoor applications and redistributed into an indoor air environment, exposure to mixtures, pesticide residues transported on pollen or crop dust (e.g. at harvest), spreading of contaminated soil and long-range transportation; |
| 6. | procedures for preparing application equipment for work, including its calibration, and for its operation with minimum risks to the user, other humans, non-target animal and vegetal species, biodiversity , the environment and water resources; |
| 7. | use of application equipment and its maintenance, and specific spraying techniques to reduce pesticide use, drift and risks (e.g. low-volume spraying, low-drift nozzles), as well as the objectives of the technical check of sprayers in use and ways to improve spray quality; |
| 8. | emergency action to protect human health , the environment and water resources in case of accidental spillage , contamination and extreme weather events that would result in pesticide leaching risks; |
| 9. | health monitoring and access facilities to report on any incidents or unease; |
| 10. | record keeping of any use of pesticides, in accordance with the relevant legislation; |
| 11. | special care in protection areas established under Articles 6 and 7 of Directive 2000/60/EC; |
| 12. | the specific categories in which a pesticide operator may be licensed, which may include:
|
| 13. | risk-based approaches which take into account the local catchment variables such as climate, soil and crop types, slopes. |
ANNEX II
HEALTH AND SAFETY AS WELL AS ENVIRONMENTAL REQUIREMENTS RELATING TO THE INSPECTION OF PESTICIDE APPLICATION EQUIPMENT
The inspection of pesticide application equipment shall cover all aspects important to achieve a high level of safety and protection of human health and the environment and full effectiveness of the application operation by ensuring proper performance of the following devices and functions, where appropriate:
(1) Power transmission parts
The power take-off drive shaft guard and the guard of the power input connection shall be fitted and in good condition and the protective devices and any moving or rotating power transmission parts shall not be affected in their function so as to ensure protection of the operator.
(2) Pump
The pump capacity shall be suited to the needs of the equipment and the pump must function properly in order to ensure a stable and reliable application rate. There shall be no leakages from the pump.
(3) Agitation
Agitation devices must ensure a proper recirculation in order to achieve an even concentration of the whole volume of the liquid spray mixture in the tank.
(4) Spray liquid tank
Spray tanks including indicator of tank content, filling devices, strainers and filters, emptying devices, and mixing devices shall operate in such a way as to minimise accidental spillage, uneven concentration distributions, operator exposure and residual content.
(5) Measuring systems, control and regulation systems
All devices for measuring, switching on and off and adjusting pressure and/or flow rate shall work reliably and there shall be no leakages. Control of pressure and operation of pressure adjustment devices shall be easily possible during application. Pressure adjustment devices shall maintain a constant working pressure at constant revolutions of the pump, in order to ensure that a stable volume application rate is applied.
(6) Pipes and hoses
Hoses and pipes shall be in proper condition to avoid disturbance of liquid flow or accidental spillage in case of failure. There shall be no leakages from pipes or hoses when run with the maximum obtainable pressure for the system.
(7) Filters
In order to avoid turbulence and heterogeneity in spray patterns, filters shall be in good condition and the mesh size of the filters shall correspond to the size of nozzles fitted on the sprayer. The filter blockage indication system shall operate correctly.
(8) Spray boom (for equipment spraying pesticides by means of a horizontally positioned boom, located close to the crop or the material to be treated)
The spray boom must be in good condition and stable in all directions. The fixation and adjustment systems and the devices for damping unintended movements and slope compensation must work reliably.
(9) Nozzles
Nozzles must work properly to control dripping when spraying stops. To ensure homogeneity of the spray pattern, the flow rate of each individual nozzle shall not deviate by more than 5% from the data of the flow rate tables provided by the manufacturer.
(10) Distribution
The transverse and vertical (in case of applications in vertical crops) distribution of the spray mixture and the distribution in the driving direction must be even. The adequate quantity and distribution of the spray mixture on the target area must be ensured.
(11) Blower (for equipment distributing pesticides by air assistance)
The blower must be in good condition and must ensure a stable and reliable air stream.
ANNEX III
MINIMUM ELEMENTS OF NATIONAL BACKGROUND REPORTS
Part A: Elements to be included in initial national pesticide use reduction studies
Description of current conditions:
| — | Known information on production, import, export, sales and distribution of pesticides; |
| — | Current pesticide consumption patterns (overall amounts of active ingredients used; specific amounts of pesticides used in specific applications on all major crops and in non-agricultural uses, particularly in public spaces; calculation of treatment frequency index); |
| — | Description of the impacts of current pesticide use patterns on the environment, the food chain and human health, based on data gathered via existing monitoring programmes; |
| — | Overview of current legislation and policy instruments and their effectiveness; |
| — | Evaluation of the need of pesticides; |
| — | Gaps identified in any of the information above. |
Scenarios for pesticide reductions:
| — | 30% and 50% use reduction measured by the treatment frequency index. |
Assessment of consequences of implementing the various scenarios:
| — | Effects on the environment (including energy consumption, greenhouse gases); |
| — | Effects on public health (workers, residents, bystanders, residues on food); |
| — | Effects on agricultural production; |
| — | Economic costs and benefits (including reduction in hidden costs) of the various scenarios. |
Identification and assessment of elements needed to achieve scenarios:
| — | Impact of the elements specified in the Directive in achieving reductions in use; |
| — | Additional scientific data needed and how to gather it, e. g., additional monitoring capacity, research facilities; |
| — | Additional capacity necessary for implementing pesticide use reduction, e.g. agricultural extension services, inspectors for control of use; |
| — | Possible sources of funding, including levies, for implementation of the various scenarios. |
Conclusions
| — | Achievable pesticide use reduction targets for specific crops and non-agricultural pest control situations as well as nationally, which at a minimum meet the mandatory reduction goals set in Article 4 and which aim to achieve further use reductions over time. |
Part B: Elements to be included in subsequent national pesticide use reduction studies
| — | Evaluation of the experiences of the previous three years concerning the implementation of the pesticide reduction programme. |
| — | Other elements as in Part A. |
| — | Setting of new targets for the next period. |
ANNEX IV
MINIMUM ELEMENTS IN THE NATIONAL ACTION PLANS FOR THE REDUCTION OF RISKS AND USE OF PESTICIDES
Qualitative and quantitative goals:
| — | Interim goals for reduction of risks and use reduction measured by the treatment frequency index; |
| — | Goals for specific target groups or uses, e.g. public authorities, farmers, transportation rights-of-way; |
| — | Goals for reduction of use in pesticide sensitive zones; |
| — | Goals for progressive elimination of pesticides and their residues from groundwater and other environmental media; |
| — | Goals for problematic crops and/or regions. |
Controls over uses:
| — | Measures for ensuring implementation of Integrated Pest Management practices; |
| — | Controls such as bans on applications of pesticides near drinking water well-heads or in pesticide sensitive zones, such as nature sites and in buffer zones; |
| — | Controls including bans on applications of pesticides in areas with high risk of exposure, e.g. schools, parks and other public spaces, roadsides, etc. |
Research and extension:
| — | Research into non-chemical alternatives to pesticides; |
| — | Demonstration programmes on how to reduce frequency of application by use of non-chemical pest control methods and systems; |
| — | Training of agricultural advisers in non-chemical pest control methods and systems; |
| — | Research into possible use reductions through the application of better spraying equipment, methods and techniques. |
Information, education and training:
| — | Education of all pesticide operators on health hazards posed by pesticides as well as on non-chemical pest control methods and systems; |
| — | Guidance for pesticide operators, e.g. on storage and handling of pesticides. |
Pesticide application equipment:
| — | Inspection of equipment in use. |
Financial instruments:
| — | Financial support for implementation of Integrated Pest Management standards and practices; |
| — | Financial support for other measures to reduce pesticide use; |
| — | Greater application of cross-compliance mechanisms. |
ANNEX V
ELEMENTS FOR GENERAL AND CROP-SPECIFIC INTEGRATED PEST MANAGEMENT CRITERIA
Integrated Pest Management as a minimum includes the following general criteria:
| (a) | The prevention and/or suppression of harmful organisms should be achieved or supported among other options especially by:
|
| (b) | Harmful organisms must be monitored with appropriate methods and tools. Such tools should include scientifically sound warning, forecasting and early diagnosis systems, where feasible, as well as professionally qualified advisers, such as those provided for by state and private extension services. |
| (c) | Based on the results of the monitoring the professional user has to decide whether and when to apply plant protection measures. Robust and scientifically sound threshold values are essential components for decision making. For harmful organisms threshold levels defined for the region must be taken into account before treatment, where feasible. |
| (d) | Biological, physical, mechanical and other non-chemical methods must be preferred to chemical methods whenever feasible. Against weeds, mechanical weeding or other non-chemical methods such as use of heat should be preferred. Exceptions should be allowed only in case of bad weather conditions during a prolonged period of time that makes mechanical weeding unfeasible. |
| (e) | The pesticide applied shall be as specific as possible for the target and shall have the least side effects on human health and the environment, such as plant and tree extracts, mineral substances for prevention of fungal growth. |
| (f) | The professional user should keep the use of pesticides and other forms of intervention to levels that are necessary, e.g. by reduced dosage, reduced application frequency or partial applications, bearing in mind that the level of risk in vegetation must remain acceptable and that they may not increase the risk for development of resistance in populations of harmful organisms. |
| (g) | Where the risk of resistance against a plant protection measure is known and where the level of harmful organisms requires repeated application of pesticides to crops, available anti-resistance strategies should be applied to maintain the effectiveness of the products. This may include the use of multiple pesticides with different modes of action. |
| (h) | Professional users should keep records of all pesticides used, by field. Based on the records on the use pesticides and on the monitoring of harmful organisms the professional user should check the success of the applied plant protection measures. |
P6_TA(2007)0445
The placing of plant protection products on the market ***I
European Parliament legislative resolutionof 23 October 2007 on the proposal for a regulation of the European Parliament and of the Council concerning the placing of plant protection products on the market (COM(2006)0388 — C6-0245/2006 — 2006/0136(COD))
(Codecision procedure: first reading)
The European Parliament,
| — | having regard to the Commission proposal to the European Parliament and the Council (COM(2006)0388), |
| — | having regard to Article 251(2) and Articles 37(2) and 152(4)(b) of the EC Treaty, pursuant to which the Commission submitted the proposal to Parliament (C6-0245/2006), |
| — | having regard to the opinion of the Committee on Legal Affairs on the proposed legal basis, |
| — | having regard to Rules 51 and 35 of its Rules of Procedure, |
| — | having regard to the report of the Committee on the Environment, Public Health and Food Safety and the opinions of the Committee on Industry, Research and Energy, the Committee on the Internal Market and Consumer Protection and the Committee on Agriculture and Rural Development (A6-0359/2007), |
| 1. | Approves the Commission proposal as amended; |
| 2. | Calls on the Commission to refer the matter to Parliament again if it intends to amend the proposal substantially or replace it with another text; |
| 3. | Instructs its President to forward its position to the Council and Commission. |
P6_TC1-COD(2006)0136
Position of the European Parliament adopted at first reading on 23 October 2007 with a view to the adoption of Regulation (EC) No .../2008 of the European Parliament and of the Council concerning the placing of plant protection products on the market
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty establishing the European Community, and in particular Articles ▐ 152(4)(b) and 175(1) thereof,
Having regard to the proposal from the Commission,
Having regard to the opinion of the European Economic and Social Committee (1),
Having regard to the opinion of the Committee of the Regions,
Acting in accordance with the procedure laid down in Article 251 of the Treaty (2),
Whereas:
| (1) | Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (3) provides for rules governing plant protection products and the active substances contained in those products. |
| (2) | In their conclusions on the progress report (4) presented by the Commission under Directive 91/414/EEC, the European Parliament and the Council asked the Commission to review the Directive and identified a number of issues for the Commission to address. |
| (3) | In the light of the experience gained from the application of Directive 91/414/EEC and of recent scientific and technical developments, Directive 91/414/EEC should be replaced. |
| (4) | By way of simplification, the new act should also repeal Council Directive 79/117/EEC of 21 December 1978 prohibiting the placing on the market and use of plant protection products containing certain active substances (5). However, the main principles of Directive 79/117/EEC should be maintained in the new act. |
| (5) | To simplify application of the new act and to ensure consistency throughout the Member States, it should take the form of a Regulation. |
| (6) | Plant production has a very important place in the Community. One of the most important ways of protecting plants and plant products against harmful organisms, including weeds, and of improving agricultural production is the use of plant protection products. |
| (7) | Various types of crop are of significance in the Community for both large-scale and small-scale production. These various types of production should be protected by allowing the use of different plant protection products. |
| (8) | Plant protection products can also have non-beneficial effects on plant production. Their use may involve risks and hazards for humans, animals and the environment, especially if placed on the market without having been officially tested and authorised and if incorrectly used. Therefore, harmonised rules should be adopted on the placing on the market of plant protection products. |
| (9) | The purpose of this Regulation is to ensure a high level of protection of both human and animal health and the environment , and at the same time to ensure the competitiveness of European agriculture. Particular attention should be paid to the protection of vulnerable groups of the population, including pregnant and nursing women, embryos and foetuses, infants and children. The precautionary principle should be applied and ensure that industry demonstrates that substances or products produced or placed on the market do not adversely affect human health or the environment and are not suspected of doing so . |
| (10) | In order to avoid animal testing, testing on vertebrate animals for the purposes of this Regulation should be undertaken only as a last resort. This Regulation, and the legislation establishing data requirements for active substances, plant protection products, safeners and synergists, should ensure that testing on vertebrate animals is minimised and that double-testing is avoided, and promote the use of non-animal test methods and intelligent testing strategies. Existing results from tests on vertebrate animals should be shared in the process of developing new plant protection products. In accordance with Council Directive 86/609/EEC of 24 November 1986 on the approximation of laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposes (6), tests on vertebrate animals must also be replaced, restricted or refined. Implementation of this Regulation should where possible be based on the use of appropriate alternative testing methods. Not later than ... (7), the Commission should review the rules on the data protection of results from tests on vertebrate animals and where necessary change those rules. |
| (11) | Substances should only be included in plant protection products where it has been demonstrated that they present a clear benefit for plant production and it has been established that they will not have any harmful effect on human or animal health or any unacceptable influence on the environment. In order to achieve a high and identical level of protection in all Member States, the decision on acceptability or non-acceptability of such substances should be taken at Community level. |
| (12) | To apply the ‘polluter pays’ principle, the Commission should examine how manufacturers of plant protection products or of the active substances they contain should be appropriately involved in dealing with or rectifying harm to human health or to the environment which may result from the use of plant protection products. |
| (13) | In the interest of predictability, efficiency and consistency, a detailed procedure should be laid down for assessing whether an active substance can be approved. The information to be submitted by interested parties for the purposes of approval of a substance should be specified. In view of the amount of work connected with the approval procedure, it is appropriate that the evaluation of such information be performed by a Member State acting as a rapporteur for the Community. To ensure consistency in evaluation, an independent scientific review should be performed by the European Food Safety Authority established by Article 22 of Regulation (EC) No 178/2002 of the European Parliament and the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (8) (hereinafter referred to as ‘the Authority’). It should be clarified that the Authority performs a risk assessment whilst the Commission should perform the risk management and take the ultimate decision on an active substance. Provisions should be included to ensure transparency of the evaluation process. |
| (14) | For ethical reasons, the assessment of an active substance or a plant protection product should not be based on tests or studies involving the deliberate administration of the active substance or plant protection product to humans with the purpose of determining a human No Observed Effect Level of an active substance. Similarly, toxicological studies carried out on humans should not be used to lower the safety margins for active substances or plant protection products. |
| (15) | The development of non-animal in vitro (test tube) test methods should be promoted in order to produce safety data more relevant to humans than results of animal studies currently in use. |
| (16) | To speed up the approval of active substances, strict deadlines should be established for the different procedural steps. |
| (17) | In the interest of safety, the approval period for active substances should be limited in time. The approval period should be proportional to the possible risks inherent in the use of such substances and should be limited to a maximum of 15 years for low risk substances, 5 years for candidates for substitution and 10 years for other substances. Experience gained from the actual use of plant protection products containing the substances concerned and any developments in science and technology should be taken into account when any decision regarding the renewal of an approval is taken. After the first renewal, a regular review of substances should take place . |
| (18) | The possibility of amending or withdrawing the approval of an active substance in cases where the criteria for approval are no longer satisfied or where compliance with Directive 2000/60/EC of the European Parliament and of the Council of 23 October 2000 establishing a framework for Community action in the field of water policy (9) and its daughter directives may be compromised, should be provided for. |
| (19) | The evaluation of an active substance may reveal that it presents considerably less of a risk than other substances. In order to favour the inclusion of such a substance in plant protection products, it is appropriate to identify such substances and to facilitate the placing on the market of plant protection products containing them. |
| (20) | To encourage the development of plant protection products, incentives must be incorporated for placing on the market products with a low risk profile or a risk profile that is lower than that of products already on the market. Clear and objective criteria must be laid down to define which products may claim such a profile. |
| (21) | Certain substances which are not predominantly used as a plant protection product may be of value for plant protection, but the economic interest of applying for approval may be limited. Therefore, specific provisions should ensure that such substances, as far as their risks are deemed acceptable by all relevant stakeholders, may also be approved for plant protection use. |
| (22) | Some active substances of particular concern, which are currently approved, should be identified at Community and national level as candidates for substitution . Member States should examine plant protection products containing such active substances with the aim of replacing them by plant protection products containing active substances which require significantly less or no risk mitigation or by alternative non-chemical agricultural practices and methods of crop protection. After a positive check, active substances should be replaced immediately. |
| (23) | Member States should be entitled to prohibit or not authorise plant protection products in order to take account of their specific natural, agricultural or climatic conditions, or if the use of these products would be in conflict with their national action plan to reduce the risks associated with, and dependence on, the use of pesticides, adopted in accordance with Directive 2008/.../EC of the European Parliament and of the Council of ... [establishing a framework for Community action to achieve a sustainable use of pesticides] (10). |
| (24) | In addition to active substances, plant protection products may contain safeners or synergists for which similar legislation should be provided. The provisions necessary for the review of such substances should be established on the basis of a legislative proposal from the Commission . Substances currently on the market should only be reviewed after those provisions have been established. |
| (25) | Plant protection products may also contain co-formulants. It is appropriate to adopt and make publicly available a positive list of co-formulants which may be included in plant protection products and the reasons therefor. This information should be available to the public. Details of all coformulants that are included in plant protection products must also be available to the public . |
| (26) | Plant protection products containing active substances can be formulated in many ways and used on a variety of crops, under different agricultural, ecological and climatic conditions. Authorisations for plant protection products should therefore be granted by Member States. |
| (27) | The provisions governing authorisation must ensure a high standard of protection. In particular, when granting authorisations of plant protection products, the objective of protecting human or animal health and the environment should take priority over the objective of improving plant production. Therefore, it should be demonstrated, before plant protection products are placed on the market, that they ▐ do not have any harmful effect on human health, including that of vulnerable groups, or animal health or any unacceptable influence on the environment and on water resources. Member States should be entitled to prohibit or not authorise plant protection products that do not present a clear benefit for plant production in the specific conditions of their territory. |
| (28) | In the interest of predictability, efficiency and consistency, criteria, procedures and conditions for the authorisation of plant protection products should be harmonised, account being taken of the general principles of protection of human and animal health and the environment. |
| (29) | The active substances contained in a plant protection product can be produced by different manufacturing processes, leading to differences in specifications. Such differences may have safety implications. For efficiency reasons, a harmonised procedure at Community level should be provided for the assessment of those differences. |
| (30) | To avoid unnecessary duplication of work, to reduce the administrative burden for industry and for Member States and to facilitate more harmonised availability of plant protection products, authorisations granted by one Member State should be notified to other Member States. Member States should be entitled to confirm, reject or restrict the authorisation granted by another Member State on the basis of their specific agricultural needs or to maintain a higher protection level in line with their national action plans. |
| (31) | Good administrative cooperation between Member States should be increased during all steps of the authorisation procedure and should be facilitated by a European Helpdesk. |
| (32) | The economic interest for industry to apply for an authorisation is limited in certain uses. In order to ensure that diversification of agriculture and horticulture is not jeopardised by the lack of availability of plant protection products, specific rules should be established for minor uses. |
| (33) | In exceptional cases, it should be permitted to authorise plant protection products not complying with the conditions provided for in this Regulation, where it is necessary to do so because of a danger or threat to plant production and ecosystems which cannot be contained by any other means. Such temporary authorisations should be reviewed at Community level. |
| (34) | To promote innovation, special rules should be established permitting the use of plant protection products in experiments even where they have not yet been authorised. |
| (35) | In order to ensure a high level of protection of human health and the environment, plant protection products should be used properly , according to their authorisation, having regard to the principles of integrated pest management and giving priority to non-chemical and natural alternatives wherever possible. The Council shall include in the statutory management requirement referred to in Annex III of Council Regulation (EC) No 1782/2003 of 29 September 2003 establishing common rules for direct support schemes under the common agricultural policy and establishing certain support schemes for farmers (11) the principles of integrated pest management, including good plant protection practice and nonchemical methods of plant protection and pest and crop management . A transitional period should therefore be foreseen to allow Member States to put in place the necessary structures to enable users of plant protection products to apply the principles of integrated pest management and non-chemical alternatives to plant protection and pest and crop management . |
| (36) | A system of exchange of information should be established. Member States should make available to each other, the Authority and the Commission the particulars and scientific documentation submitted in connection with applications for authorisation of plant protection products. Studies and data relevant for toxicological and ecotoxicological assessment of plant protection products should be made available to the public. |
| (37) | Adjuvants may be used to increase the efficacy of a plant protection product. Their placing on the market or use should be forbidden where they contain a co-formulant which has been prohibited. |
| (38) | Studies represent a major investment. This investment should be protected in order to stimulate research. For this reason, studies , other than those involving tests on vertebrate animals and other studies that may prevent animal testing, lodged by one applicant with a Member State should be protected against use by another applicant. This protection should, however, be limited in time in order to allow competition. It should also be limited to studies which are genuinely necessary for regulatory purposes, to avoid applicants artificially extending the period of protection by submitting new studies which are not necessary. |
| (39) | Rules should be laid down to avoid duplication of tests and studies. In particular, repetition of studies involving vertebrates should be prohibited. In this context, there should be an obligation to allow access to studies on vertebrates and other studies that may prevent animal testing. In order to allow operators to know what studies have been carried out by others, Member States should forward to the Authority all such studies even where they are not covered by the above system of compulsory access . The Authority should establish a central database for such studies . |
| (40) | As different rules are applied by Member States, the Authority or the Commission in relation to access to and confidentiality of documents, it is appropriate to clarify the provisions concerning access to information contained in the documents in the possession of these authorities and the confidentiality of these documents. |
| (41) | Directive 1999/45/EC of the European Parliament and of the Council of 31 May 1999 concerning the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations (12) applies to the classification, packaging and labelling of pesticides. However, to further improve the protection of users of plant protection products, of residents and bystanders who could be exposed to pesticides from crop-spraying, of consumers of plants and plant products and of the environment, it is appropriate to adopt specific legislation on the basis of a legislative proposal from the Commission which takes account of the specific conditions of use of plant protection products. |
| (42) | To ensure that advertisements do not mislead users of plant protection products or the public , it is appropriate to provide rules on the advertising of those products. |
| (43) | Provisions on record keeping and information about the use of plant protection products should be established in order to raise the level of protection of human and animal health and the environment by ensuring the traceability of potential exposure, to increase the efficiency of monitoring and control and to reduce the costs of monitoring water quality. |
| (44) | Member States should carry out controls and inspections with regard to the marketing and use of plant protection products to ensure compliance with the requirements laid down in this Regulation in order to achieve a high level of protection of both human and animal health and the environment. |
| (45) | Operators must have the same opportunities in respect of market access, in particular so that small and medium-sized enterprises can operate, in order to ensure that sufficient safe and effective plant protection products are available to farmers. |
| (46) | Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules (13) provides for control measures for the use of plant protection products at all stages of the production of food, including record keeping on the use of plant protection products. Similar rules should be established on the basis of a legislative proposal from the Commission for the storage and use of plant protection products not covered by Regulation (EC) No 882/2004. |
| (47) | The bureaucratic burden on farmers should be as limited as possible. |
| (48) | The measures provided for in this Regulation should apply without prejudice to existing Community legislation, in particular Directive 2008/.../EC [establishing a framework for Community action to achieve a sustainable use of pesticides], Directive 2000/60/EC, Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residues levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC (14), and Community legislation on the protection of workers and anyone concerned with the contained use and deliberate release of genetically modified organisms. |
| (49) | It is necessary to establish procedures for the adoption of emergency measures in situations where an approved active substance, a safener, a synergist or a plant protection product is likely to constitute a serious risk to human or animal health or the environment. |
| (50) | Member States should lay down rules on penalties applicable to infringements of this Regulation and should take the measures necessary to ensure that they are implemented. |
| (51) | General civil and criminal liability in the Member States of the manufacturer and, where applicable, of the person responsible for placing the plant protection product on the market or using it should remain applicable. |
| (52) | Member States should have the possibility of recovering the costs of the procedures associated with the application of the Regulation from those seeking to place, or placing, plant protection products on the market and from those applying for the approval of active substances, safeners or synergists. |
| (53) | Member States should designate the necessary national authorities. |
| (54) | The Commission should facilitate the application of this Regulation. Therefore, it is appropriate to provide for the necessary financial resources and the possibility of amending certain provisions of the Regulation in the light of experience or of developing technical notes for guidance. |
| (55) | The measures necessary for the implementation of this Regulation should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (15). It is appropriate to adopt purely technical, administrative or urgent measures using the advisory committee procedure. |
| (56) | In particular, the Commission should be empowered to approve active substances, to renew or review their approval, to approve co-formulants, to adopt harmonised methods to determine the nature and quantity of active substances, safeners and synergists, and where appropriate of relevant impurities and co-formulants, to establish rules for resolving disagreement between Member States on the assessment of equivalence, to adopt guidelines on the organisation of compliance checks at the renewal of an authorisation, to adopt detailed rules for allowing derogations from authorisation of plant protection products for research and development, implementing measures to ensure uniform application of record keeping on production, storage and use of plant protection products, technical or other guidance documents for the implementation of this Regulation and the list of approved active substances. Since those measures are of general scope and are designed to amend non-essential elements of this Regulation or to supplement it by the addition of non-essential elements, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC. |
| (57) | Certain provisions of Directive 91/414/EEC should remain applicable during the transitional period, |
HAVE ADOPTED THIS REGULATION:
Chapter I
General provisions
Article 1
Subject matter and purpose
1. This Regulation lays down rules for the authorisation of plant protection products in commercial form and for their placing on the market, use and control within the Community.
2. This Regulation lays down both rules for the approval of active substances, safeners and synergists, which plant protection products contain or consist of, and rules for adjuvants and co-formulants.
3. The purpose of this Regulation is to ensure a high level of protection of both human and animal health and the environment.
4. This Regulation is based on the precautionary principle in order to ensure that substances or products placed on the market do not adversely affect human health or the environment.
5. The purpose of this Regulation is furthermore to harmonise the rules on the placing on the market of plant protection products in order to harmonise the availability of plant protection products between farmers in different Member States.
6. Member States may not be prevented from applying the precautionary principle in restricting or prohibiting pesticides.
7. Member States may establish any pesticide-free zones they deem necessary in order to safeguard drinking water resources. Such pesticide-free zones may cover the entire Member State.
8. Member States may impose a ban on the use and marketing of EU-authorised pesticides where they are found in measurable quantities outside the root zone.
Article 2
Scope
1. This Regulation shall apply to products, in the form in which they are supplied to the user, consisting of or containing active substances, safeners or synergists, and intended for one of the following uses:
| (a) | protecting plants or plant products against all harmful organisms or preventing the action of such organisms, unless the main purpose of these products is considered to be for hygiene reasons rather than for the protection of plants or plant products; |
| (b) | influencing the life processes of plants, such as substances influencing their growth, other than as a nutrient; |
| (c) | preserving plant products, insofar as such substances or products are not subject to special Community provisions on preservatives; |
| (d) | destroying undesired plants or parts of plants, except algae; |
| (e) | checking or preventing undesired growth of plants, except algae. |
These products are referred to hereinafter as ‘plant protection products’.
2. This Regulation shall apply to substances, including micro-organisms and viruses, having general or specific action against harmful organisms or on plants, parts of plants or plant products, hereinafter ‘active substances’. It shall, however, cease to apply to micro-organisms, viruses, pheromones and biological products once a specific regulation on biological control products has been adopted.
3. This Regulation shall apply to the following:
| (a) | substances or preparations which are added to a plant protection product to eliminate or reduce phytotoxic effects of the preparation on certain plants, hereinafter ‘safeners’; |
| (b) | substances or preparations which, while showing no or only weak activity in the sense of paragraph 1, can give enhanced activity to the active substance(s) in a plant protection product, hereinafter ‘synergists’; |
| (c) | substances or preparations which are used or intended to be used in a plant protection product or adjuvant, but are neither active substances nor safeners or synergists, hereinafter ‘co-formulants’; |
| (d) | substances or preparations which consist of co-formulants or preparations containing one or more coformulants, in the form in which they are supplied to the user and placed on the market to be mixed by the user with a plant protection product for the purpose of changing its properties or effects, hereinafter ‘adjuvants’. |
Article 3
Definitions
For the purposes of this Regulation, the following definitions shall apply:
| (1) | ‘residues’: One or more substances present in or on plants or products of plant origin, edible animal products or elsewhere in the environment and resulting from the use of a plant protection product, including their metabolites, breakdown or reaction products; |
| (2) | ‘substances’: Chemical elements and their compounds, as they occur naturally or by manufacture, including any impurity inevitably resulting from the manufacturing process used ; |
| (3) | ‘active substances’: Substances, including their metabolites present in the use phase, micro-organisms and viruses, having general or specific action against target organisms or on plants, parts of plants or plant products; |
| (4) | ‘preparations’: Mixtures or solutions composed of two or more substances , at least one of which is an active substance, intended for use as a plant protection product or as an adjuvant; |
| (5) | ‘substance of concern’: Any substance which has an inherent capacity to cause an adverse effect on humans, animals or the environment ▐. Such substances include, but are not limited to, substances classified as dangerous in accordance with Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances (16), and regarded as dangerous within the meaning of Article 3 of Directive 1999/45/EC. Any substance that has or potentially has either carcinogenic, mutagenic, endocrine disrupting, neurotoxic, immunotoxic, reprotoxic or genotoxic capabilities should be regarded as a substance of concern; |
| (6) | ‘article’: An object which during production is given a special shape, surface or design which determines its function to a greater degree than does its chemical composition; |
| (7) | ‘advertisement’: A means of promoting the sale or use of plant protection products to anyone other than the authorisation holder, the person placing the plant protection product on the market and their agents by printed or electronic media; |
| (8) | ‘plants’: Live plants and live parts of plants, together with seeds for sowing, in particular: fresh fruit, vegetables , flowers, leaves, shoots, living pollen, seedlings, bulbs and roots ; |
| (9) | ‘plant products’: Products in unprocessed state or having undergone only simple preparation, such as milling, drying or pressing, derived from plants, but excluding plants as defined in point (8); |
| (10) | ‘harmful organisms’: Any species, strain or biotype belonging to the animal or plant kingdom or pathogenic agent injurious to plants or plant products; |
| (11) | ‘low risk’: Of a nature considered inherently unlikely to cause an adverse effect on humans, animals or the environment; |
| (12) | ‘animals’: Animals belonging to species normally domesticated, fed, kept or consumed by humans; |
| (13) | ‘placing on the market’: The holding of a plant protection product for the purpose of sale within the Community, including offering for sale or any other form of transfer, whether free of charge or not, and the sale, distribution, and other forms of transfer themselves. Release for free circulation of a plant protection product into the territory of the Community , as well as imports, shall be deemed to constitute placing on the market for the purposes of this Regulation; |
| (14) | ‘parallel trade’: The import of a plant protection product from a Member State where the product has been authorised under the conditions of Directive 91/414/EEC or this Regulation with the intention of placing it on the market in the importing Member State where the plant protection product or an identical reference product has been authorised under the conditions of Directive 91/414/EEC or this Regulation; |
| (15) | ‘identical’: Plant protection products shall be considered as identical when they:
|
| (16) | ‘authorisation of a plant protection product’: Administrative act by which the competent authority of a Member State authorises the placing on the market of a plant protection product in its territory; |
| (17) | ‘producer’: A person who manufactures active substances, safeners, synergists, co-formulants, plant protection products or adjuvants on his own, or who contracts this manufacturing to another party, or a person designated by the manufacturer as his sole representative for the purpose of compliance with this Regulation; |
| (18) | ‘importer’: A person importing plant protection products for commercial purposes; |
| (19) | ‘letter of access’: A document by which the owner of data protected under this Regulation agrees to the use of such data by the competent authority for the purpose of granting an authorisation of a plant protection product or an approval of an active substance, synergist or safener for the benefit of another person; |
| (20) | ‘environment’: Waters (including ground, surface, transitional and coastal), soil, air, land, wild species of fauna and flora, and any interrelationship between them, and any relationship with other living organisms; |
| (21) | ‘health’: A state of complete physical, mental and social well-being, and not merely the absence of disease or infirmity; |
| (22) | ‘vulnerable groups’: Persons needing specific consideration when assessing the acute and chronic health effects of plant protection products. These include pregnant and nursing women, embryos and foetuses, infants and children, the elderly, people who are ill and those taking medication, workers and residents subject to high pesticide exposure over the long term; |
| (23) | ‘integrated pest management’: Careful consideration of all available pest control techniques and subsequent integration of appropriate measures that discourage the development of pest populations and keep plant protection products and other forms of intervention to levels that are economically and ecologically justified and reduce or minimise risks to human health and the environment. Integrated pest management emphasises the growth of a healthy crop with the least possible disruption to agroecosystems by giving priority to preventive crop-growing measures and the use of adapted varieties and of non-chemical methods of plant protection and pest and crop management; |
| (24) | ‘non-chemical methods of plant protection and pest and crop management’: The use of pest control and management techniques that do not have chemical properties. Non-chemical methods of plant protection and pest and crop management include rotation, physical and mechanical control and natural predator management; |
| (25) | ‘micro-organisms’: Any microbiological entity, including lower fungi and viruses, cellular or non-cellular, capable of replication or of transferring genetic material; |
| (26) | ‘genetically modified micro-organisms’: Micro-organisms in which the genetic material has been altered within the meaning of Article 2(2) of Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms (17); ▐ |
| (27) | ‘Good ▐ Practice for the Use of Plant Protection Products ’: Practice whereby the treatments with plant protection products applied to a given crop, in conformity with the conditions of their authorised uses, are selected, dosed and timed to ensure that only the minimum quantity necessary is used , taking due account of local conditions , of the need to prevent the build-up of resistance and of the possibilities for cultural and biological control, and giving priority to non-chemical methods of plant protection and pest and crop management ; |
| (28) | ‘Good Environmental Practice’: Practice in plant protection which includes the handling and application of plant protection products in a way which only contaminates the environment with the smallest amount practicable; |
| (29) | ‘Good Laboratory Practice’: Practice as defined by Directive 2004/10/EC [of the European Parliament and of the Council] (18); |
| (30) | ‘Good Experimental Practice’: Practice in accordance with Directive 2004/10/EC; |
| (31) | ‘Data protection’: A test or study report , other than those involving tests on vertebrate animals and other tests or studies that may prevent animal testing, is covered by data protection where its owner has the right to prevent it being used for the benefit of another person. |
| (32) | ‘rapporteur Member State’: The Member State which agrees to assume the responsibility for assessing the active substances, or safeners, or synergists. It is required to carry out this task in a professional manner and to publish an impact assessment report within a specified period; |
| (33) | ‘tests and studies’: Investigation or experiment whose purpose is to determine the properties and behaviour of an active substance or of plant protection products, predict exposure to active substances and/or their relevant metabolites, determine safe levels of exposure and establish conditions for the safe use of plant protection products; |
| (34) | ‘unacceptable effect on the environment’: Any effect that may alter biodiversity and biotopes, inter alia via a disruption to certain species which could ultimately lead to their becoming extinct; |
| (35) | ‘minor uses of a plant protection product’: The use of that product, in a particular Member State, on a crop which is not widely grown in that Member State or on a widely grown crop in order to meet a limited or sporadic and exceptional need. |
Chapter II
Active substances, safeners, synergists and co-formulants
SECTION 1
Active substances
Subsection 1
Requirements and conditions for approval
Article 4
Approval criteria for active substances
1. An active substance shall be approved in accordance with Annex I, if it may be expected, in the light of current scientific and technical knowledge, that, taking into account the approval criteria set out in points 2 and 3 of that Annex, plant protection products containing that active substance will fulfil the conditions provided for in paragraphs 2 and 3.
2. The residues of the plant protection products, consequent on application consistent with good plant protection practice, shall meet the following requirements:
| (a) | they shall not have any harmful effects on human health, in particular that of users who are in direct contact with the products, residents, bystanders and vulnerable groups, or animal health, taking into account known cumulative and synergistic effects, ▐ or on groundwater; |
| (b) | they shall not have any unacceptable effect on the environment taking into account cumulative and synergistic effects and all relevant exposure routes to organisms in the environment; methods to assess such effects will be presented by the European Food Safety Authority (hereinafter ‘the Authority’) ; |
| (c) | for residues of all approved substances , there shall be standardised methods in general use for measuring them which are sufficiently sensitive with respect to any technically detectable levels that could be present in any environmental and biological media. The residues shall be detectable with the common multi-residue methods as applied by Community reference laboratories. |
3. The use of the plant protection products, consequent on application consistent with good plant protection practice and having regard to normal conditions of use, shall meet the following requirements:
| (a) | it shall be sufficiently effective; |
| (b) | it shall have no immediate or delayed harmful effect on human health, in particular that of residents and bystanders and vulnerable groups, or animal health, directly or through drinking water, food, feed or air, including in locations distant from its use following long-range transportation, or consequences in the workplace or through other indirect effects, taking into account cumulative and synergistic effects ▐; or on surface water and groundwater; |
| (c) | it shall not have any unacceptable effects on plants or plant products; |
| (d) | it shall not cause unnecessary suffering and pain to vertebrates to be controlled; |
| (e) | it shall have no unacceptable effects on the environment, having particular regard to the following considerations:
|
4. For approval of an active substance, paragraphs 1, 2 and 3 shall be deemed to be satisfied where this has been established with respect to one or more representative uses of at least one plant protection product containing that active substance.
5. In relation to human health, no data collected on humans shall be used to lower the safety margins resulting from tests or studies on animals.
Article 5
Animal testing
In order to avoid animal testing, testing on vertebrate animals for the purposes of this Regulation shall be undertaken only as a last resort. The use of non-animal tests and intelligent testing strategies shall be promoted, and duplicate vertebrate animal testing shall be prohibited.
Article 6
First approval
First approval shall be for a period not exceeding ten years.
Article 7
Conditions and restrictions
Approval may be subject to conditions and restrictions including:
| (a) | the minimum degree of purity of the active substance; |
| (b) | the nature and maximum content of certain impurities; |
| (c) | restrictions arising from the evaluation of the information referred to in Article 9 taking account of the agricultural, plant health and environmental, including climatic, conditions in question; |
| (d) | type of preparation; |
| (e) | manner and conditions of application; |
| (f) | submission of further confirmatory information to Member States and to the ║ Authority, ║ where new requirements are established during the evaluation process as a result of new scientific and technical knowledge; |
| (g) | designation of categories of users, such as professional and non-professional; |
| (h) | designation of places where plant protection products containing the active substance may be authorised according to specific conditions; |
| (i) | the need to impose risk mitigation measures and monitoring after use; |
| (j) | restrictions or prohibitions for uses not compatible with integrated pest management schemes, or even detrimental to these schemes such as chemical soil treatment; |
| (k) | any other particular conditions that result from the evaluation of information made available in the context of this Regulation. |
Subsection 2
Approval procedure
Article 8
Application
1. The Authority shall be responsible for coordinating the approval procedure.
In doing so, the Authority shall rely on the competent authorities of Member States.
An application for the approval of an active substance or for an amendment to the conditions of an approval shall be submitted by the producer of the active substance to the Authority together with a complete and a summary dossier, as provided for in Article 9(1) and (2), or a letter of access to such dossiers or a scientifically reasoned justification for not providing certain parts of those dossiers, demonstrating that the active substance fulfils the approval criteria provided for in Article 4. The Authority shall inform the competent authorities of the Member States of the applications it has received.
A Member State may choose an active substance for which an application for approval has been received by the Authority, with the aim of becoming the rapporteur Member State for the purposes of Articles 10 and 12.
In cases where two or more Member States have expressed an interest in becoming the rapporteur Member State and they cannot agree who should be the competent authority, the rapporteur Member State shall be determined in accordance with the regulatory procedure referred to in Article 83(3).
The decision shall be based on objective criteria such as geographic, agricultural and climatic conditions, especially with regard to the target organisms, the performance and impartiality of the competent authority and the reference laboratory, and the absence of interests linked to the producing companies.
A joint application may be submitted by an association of producers designated by the producers for the purpose of compliance with this Regulation.
2. A natural or legal person established outside the Community who submits an application shall appoint a natural or legal person established in the Community to fulfil, as his only representative, the obligations on producers under this Regulation.
3. Assessment of an application may be performed by a number of Member States together under the co-rapporteur system.
4. Within 14 days of receiving the application, the rapporteur Member State shall send the applicant a written acknowledgement, stating the date of receipt.
5. When submitting his application, the applicant may, pursuant to Article 66, request certain parts of the dossiers referred to in paragraph 1 to be kept confidential. He shall explain for each document or each part of a document why it is to be considered as confidential.
He shall at the same time submit any claims for data protection pursuant to Article 62.
After giving the applicant the possibility to submit comments on the decision it plans to adopt, the rapporteur Member State shall decide what information is to be kept confidential. It shall inform the applicant and the Authority of its decision.
Article 9
Dossiers
1. The summary dossier shall include the following:
| (a) | Data with respect to one or more representative uses on a widely grown crop in each zone of at least one plant protection product containing the active substance, demonstrating that the requirements of Article 4 are met; where the data submitted do not cover all zones or concern a crop which is not widely grown, justification for this approach; |
| (b) | for each point of the data requirements for the active substance referred to in paragraph 3 , the summaries and results of tests and studies, the name of their owner and of the person or institute that has carried out the tests and studies; |
| (c) | for each point of the data requirements for the plant protection product referred to in paragraph 3 , the summaries and results of tests and studies, the name of their owner and of the person or institute that carried out the tests and studies, relevant to the assessment of the criteria referred to in Article 4 for one or more plant protection products which are representative of the uses referred to in point (a), taking into account the fact that any data gaps in the dossier, as provided for in paragraph 2, resulting from the proposed limited range of representative uses of the active substance, shall lead to nonapproval of the active substance ; |
| (d) | for each test or study involving vertebrate animals, a justification of the steps taken to avoid animal testing and duplicative testing on vertebrate animals; |
| (e) | a checklist demonstrating that the dossier provided for in paragraph 2 is complete; |
| (f) | the reasons why the test and study reports submitted are necessary for first approval of the active substance or for amendments to the conditions of the approval; |
| (g) | an assessment of all information submitted. |
2. The complete dossier shall contain the full text of the individual test and study reports concerning all the information referred to in points (b) and (c) of paragraph 1.▐
3. The format of the summary dossier and the complete dossier shall be established in accordance with the advisory procedure referred to in Article 83(2).
The data requirements referred to in paragraph 1 shall be laid down in Regulations adopted in accordance with the advisory procedure referred to in Article 83(2), transferring the requirements for active substances and plant protection products in Annexes II and III to Directive 91/414/EEC with any ▐ modifications necessary due to the change from a directive to a regulation . Similar data requirements shall be defined for safeners and synergists in accordance with the procedure referred to in Article 251 of the Treaty.
4. All scientific peer-reviewed open literature on the active substance and its metabolites regarding negative side-effects on health, the environment and non-target species shall be added by the applicant to the dossier.
Article 10
Admissibility of the application
1. Within 30 days of receiving the application, the rapporteur Member State shall check whether the dossiers submitted with the application contain all the elements provided for in Article 9, using the checklist referred to in Article 9(1)(e).
2. Where one or more of the elements provided for in Article 9 are missing, the rapporteur Member State shall inform the applicant, setting a time period of no longer than three months for their submission. Article 8(5) shall apply .
Where at the end of that period, the applicant has not submitted the missing elements, the rapporteur Member State shall inform the applicant that the application is inadmissible.
A new application for the same substance may be submitted at any time.
3. Where the dossiers submitted with the application contain all the elements provided for in Article 9, the rapporteur Member State shall notify the applicant, the Commission, the other Member States and theAuthority of the admissibility of the application and start assessing the active substance.
After receiving that notification, the applicant shall immediately forward the summary dossier and the complete dossier to the other Member States, the Authority and the Commission.
Article 11
Access to the summary dossier
The Authority shall without delay make the summary dossier referred to in Article 9(1) available to the public, excluding any information which is confidential under Article 66.
Article 12
Draft assessment report
1. The rapporteur Member State may start the evaluation of test and study reports as soon as they are submitted by the applicant, including before the date of the notification provided for in the first subparagraph of Article 10(3). Within twelve months of the date of the notification ║ , the rapporteur Member State shall prepare and submit to the Authority a report (hereafter called ‘draft assessment report’) assessing whether the active substance can be expected to meet the requirements of Article 4.
Where the Member State needs additional information, it shall set a reasonable time period for the applicant to supply it along with any claims for data protection pursuant to Article 62 . In that case, the twelvemonth period shall be extended by the additional time period granted by the Member State. It shall inform the Commission and the Authority. When supplying additional information, the applicant shall at the same time submit any claims for data protection pursuant to Article 62. Article 8(5) shall apply.
The Member State may consult the Authority.
2. The format of the draft assessment report shall be established in accordance with the advisory procedure referred to in Article 83(2).
Article 13
Conclusion by the Authority
1. The Authority shall circulate the draft assessment report received from the rapporteur Member State to the applicant, the other Member States and the Commission.
It shall make it available to the public, after giving the applicant two weeks to request, pursuant to Article 66, that certain parts of the draft assessment report be kept confidential.
The Authority shall allow a period of sixty days for the submission of written comments.
Where appropriate, the Authority shall organise a consultation of experts, including experts from the rapporteur Member State.
2. The Authority shall adopt a conclusion on whether the active substance can be expected to meet the requirements of Article 4 within ninety days of the end of the period provided for in paragraph 1 of this Article , with due justification, including a reference to the consideration of any public comments, and communicate it to the applicant, the Member States and the Commission. The conclusion shall be published by the Authority within one week after its adoption.
Where ▐ the Authority needs additional consultations with experts as provided for in paragraph 1, it shall set a time period for concluding the consultations. In that case, the ninety-day period shall be extended by the additional period granted by the Authority. It shall inform the Commission and the Member States .
3. Where the Authority needs additional information, it shall set a time period for the applicant to supply it. In that case, the ninety-day period provided for in paragraph 2 shall be extended by the additional period granted by the Authority and by the time necessary for the evaluation of that information by the rapporteur Member State in its draft assessment report. The Authority shall inform the Commission and the Member States.
Where the Authority needs to organise consultations of experts, the ninety-day period provided for in paragraph 2 shall be extended by the time necessary for these consultations. It shall inform the Commission and the Member States.
The Authority may ask the Commission to consult a Community reference laboratory, designated pursuant to Regulation (EC) No 882/2004 for the purposes of verifying whether the analytical method for the determination of the residues proposed by the applicant is satisfactory and meets the requirements of Article 30(1)(h) of this Regulation. The applicant shall, if requested by the Community reference laboratory, provide samples and analytical standards.
4. The Authority shall establish the format for its conclusion which shall include details on the procedure of the evaluation and the properties of the active substance concerned.
Article 14
Approval Regulation
1. Within three months of receiving the conclusion provided for in Article 13(2) from the Authority, the Commission shall present a report, (herinafter referred to as ‘the review report’, to the Committee referred to in Article 83(1), taking into account the draft assessment report by the Rapporteur Member State under Article 12 and the conclusion of the Authority under Article 13.
The applicant and any others who have submitted written comments under the procedure provided for in Article 13(1) shall be given the opportunity to submit comments on the review report.
The review report shall be available to the public and forwarded to the European Parliament.
2. On the basis of the review report provided for in paragraph 1, other factors legitimate to the matter under consideration and the precautionary principle where the conditions laid down in Article 7(1) of Regulation (EC) No 178/2002 are relevant, a Regulation with due justification shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 83(4) , providing that:
| (a) | an active substance is approved, subject to conditions and restrictions, as referred to in Article 7, where appropriate, and included in Annex II; |
| (b) | an active substance is not approved; or |
| (c) | the conditions of the approval are amended. |
3. The Commission shall maintain an updated list of approved active substances in Annex II and publish this list on the Internet .
Subsection 3
Renewal and review
Article 15
Renewal of approval
1. On application the approval of an active substance shall be renewed where it is established that the criteria referred to in Article 4 are satisfied.
Article 4 shall be deemed to be satisfied where this has been established with respect to one or more representative uses of at least one plant protection product containing that active substance.
Such renewal of the approval may include conditions and restrictions, as referred to in Article 7.
2. The approval may be renewed once or repeatedly for a period not exceeding 10 years .
Article 16
Application for renewal
1. The application provided for in Article 15 shall be submitted by a producer of the active substance to the Member State concerned , with a copy to the other Member States, the Commission and the Authority, no later than three years before the expiry of the first approval.
2. When applying for renewal, the applicant shall identify new data he intends to submit and demonstrate that they are necessary, because of data requirements or criteria which were not applicable on first approval of the active substance or because his request is for an amended approval. He shall at the same time submit a timetable of any new and ongoing studies.
The applicant shall identify, giving reasons, the parts of the information submitted that are to be kept confidential in accordance with Article 66.
Article 17
Access to the application for renewal
The Authority shall, without delay, make available to the public the information provided by the applicant under Article 16, excluding any information declared confidential under Article 66.
Article 18
Extension of approval period for the duration of the procedure
Where for reasons beyond the control of the applicant it appears that the approval is likely to expire before a decision has been taken on renewal, a Regulation shall be adopted in accordance with the regulatory procedure referred to in Article 83(3), postponing the expiry for a period sufficient to examine the application. In particular, such a Regulation shall be adopted where applicants could not give the three years' notice required under Article 16(1) because the active substance was included in Annex I to Directive 91/414/EEC for a duration which expired less than three years after the date of application of this Regulation.
The length of that period shall be established on the basis of the following:
| (a) | the time needed to provide the information requested; |
| (b) | the time needed to complete the procedure; |
| (c) | the need to ensure the establishment of a coherent programme of work, as provided for in Article 19. |
Article 19
Programme of work
The Commission may establish a programme of work grouping together similar active substances. This programme may require interested parties to submit all the necessary data to the Commission, the Authority and the Member States within a period provided for in the programme.
The programme shall include the following:
| (a) | the procedures concerning the submission and assessment of applications for renewal of approvals; |
| (b) | the necessary data to be submitted including measures to minimise animal testing, in particular the use of non-animal test methods and intelligent testing strategies ; |
| (c) | the time periods for submission of such data; |
| (d) | rules on the submission of new information; |
| (e) | rules on requests for confidentiality in accordance with Article 66. |
Article 20
Implementing measures
A Regulation, adopted in accordance with the regulatory procedure with scrutiny referred to in Article 83 (4), shall set out the provisions necessary for the implementation of the renewal and review procedure, including, where relevant, the implementation of a programme of work, as provided for in Article 19.
Article 21
Renewal Regulation
1. A Regulation with due justification shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 83(4) , providing that:
| (a) | the approval of an active substance is renewed, where appropriate, subject to conditions and restrictions; or |
| (b) | the approval of an active substance is not renewed. |
2. Where the reasons for not renewing the approval do not concern the protection of health or the environment , the Regulation referred to in paragraph 1 shall provide for a grace period for using up stocks of the plant protection products concerned, which shall be not longer than one year. Past this period, producers shall ensure the removal and safe disposal of the remaining stocks .
3. In the event of a ban or the withdrawal of the approval on health or environmental grounds, the plant protection product concerned shall be disposed of immediately.
Article 22
Review of approval
1. The Commission may review the approval of an active substance at any time and shall give due consideration to requests for review from a Member State, the European Parliament and other stakeholders, based on current scientific and technical knowledge and monitoring data .
Where it considers that there are indications that the substance no longer satisfies the criteria provided for in Article 4, or further information required in accordance with point (f) of Article 7 has not been provided, it shall inform the Member States, the Authority and the producer of the active substance, setting a time period for the producer to submit its comments.
The Commission shall review the approval of an active substance where there are indications that the achievement of the objectives established in accordance with Article 4(1)(a)(iv) and (b)(i) and Article 7(2) and (3) of Directive 2000/60/EC may be compromised.
2. The Commission may ask the Authority for an opinion, or for scientific or technical assistance. The Authority shall provide its opinion or the results of its work to the Commission within 3 months of the request.
3. Where the Commission concludes that the criteria referred to in Article 4 are no longer satisfied, or the further information required in accordance with point (f) of Article 7 has not been provided, a Regulation to withdraw or amend the approval shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 83(4).
Article 21(2) shall apply.
4. Where the Commission concludes that the objectives of reducing pollution from priority substances established in accordance with Article 4(1)(a)(iv) and (b)(i) and Article 7(2) and (3) of Directive 2000/60/EC cannot be met, a Regulation to withdraw or amend the approval shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 83(4) of this Regulation.
Subsection 4
Derogations
Article 23
Low risk active substances
1. By way of derogation from Article 6, an active substance complying with the criteria provided for in Article 4 shall be approved for a period not exceeding 15 years, where it ▐ will have no adverse effect on human and animal health and the environment, as provided for in Article 50(1).
This derogation shall not apply to any active substance classified in accordance with Directive 67/548/EEC as:
| — | carcinogenic, |
| — | mutagenic, |
| — | toxic to reproduction, |
| — | sensitising chemicals, |
or to substances that are qualified as:
| — | persistent with a half-life of more than 60 days, |
| — | endocrine disrupters appearing on the EU list of suspected endocrine disrupters, |
| — | toxic, |
| — | bioaccumulative and non-readily degradable. |
Not later than ... (19), the Commission shall review and if necessary specify the criteria for treating an active substance as a low risk substance and, if appropriate, submit proposals.
2. Notwithstanding Article 6, active substances based on biological control agents which comply with the criteria of Article 4 shall be given approval for a period not exceeding 15 years where plant protection products containing such biological control agents are expected to present only a low risk to human and animal health and the environment as provided for in Article 50(1).
3. Article 4(4) and Articles 7 to 22 shall apply.
Article 24
Approval criteria for basic substances
1. Basic substances shall be approved in accordance with paragraphs 2 to 6. ▐ For the purpose of those paragraphs, a basic substance is an active substance which:
| (a) | is not predominantly used as a plant protection product but |
| (b) | nevertheless has some use as a plant protection product, either directly or in a product consisting of the substance and a simple diluent, |
| (c) | is not a substance of concern, and |
| (d) | is not directly marketed for use as a plant protection product. |
For the purpose of this Regulation, an active substance which fulfils the criteria of a ‘foodstuff’ as defined in Article 2 of Regulation (EC) No 178/2002 shall be considered as a basic substance.
2. ▐ A basic substance shall be approved in accordance with Article 4 and where any relevant evaluations carried out in accordance with other Community legislation, regulating the use of that substance for purposes other than as a plant protection product, show that the substance has neither an immediate or delayed harmful effect on human or animal health nor an unacceptable effect on the environment, provided that each point of the data requirements for active substances contained in plant protection products is given and the same decision-making procedures apply.
3. An application for the approval of a basic substance shall be submitted by any interested party or by a Member State to the Commission.
The application shall be accompanied by the following information:
| (a) | any evaluations carried out in accordance with other Community legislation regulating the use of the substance; or |
| (b) | information indicating that the substance has neither an immediate or delayed harmful effect on human or animal health nor an unacceptable effect on the environment. |
4. The Commission may ask the Authority for an opinion, or for scientific or technical assistance. The Authority shall provide its opinion or the results of its work to the Commission within 3 months of the request.
5. Articles 7 and 14 shall apply.
6. The Commission may review the approval of a basic substance at any time.
Where it considers that there are indications that the substance no longer satisfies the criteria provided for in paragraphs 1 and 2 it shall inform the Member States, the Authority and the interested party, setting a time period for their comments to be submitted.
The Commission shall ask the Authority for an opinion, or for scientific or technical assistance. The Authority shall provide its opinion or the results of its work to the Commission within 3 months of the request.
Where the Commission concludes that the criteria referred to in paragraph 1 are no longer satisfied, a Regulation to withdraw or amend the approval shall be adopted in accordance with the regulatory procedure referred to in Article 83(3). Article 21(2) shall apply.
Article 25
Approval criteria for candidates for substitution
1. By way of derogation from Article 6 and Article 15(2), an active substance complying with the criteria provided for in Article 4 shall be approved once for a period not exceeding five years , where other already approved active substances or alternative agricultural methods or practices are significantly less toxic for consumers or operators or present significantly fewer risks for the environment. The assessment shall take account of the criteria laid down in point 4 of Annex I.
Such a substance is referred to hereinafter as a ‘candidate for substitution’.
2. Article 4(4) and Articles 7 to 22 shall apply.
SECTION 2
Safeners and synergists
Article 26
Approval of safeners and synergists
1. A safener or synergist shall be approved, where it complies with Article 4.
2. For approval of a safener or synergist, paragraph 1 shall be deemed to be satisfied where compliance with Article 4 has been established with respect to one or more representative uses of at least one plant protection product for every different active substance the safener or synergist is combined with.
3. Articles 6 to 22 shall apply.
Article 27
Safeners and synergists already on the market
Not later than ... (20), a Regulation shall be adopted in accordance with the procedure referred to in Article 251 of the Treaty establishing a programme of work for the gradual review of synergists and safeners on the market when that Regulation enters into force. The regulation shall include the establishment of data requirements , including measures to minimise animal testing , notification, evaluation, assessment and decision-making procedures. It shall require interested parties to submit all the necessary data to the Commission, the Authority and the Member States within a specified time period.
SECTION 3
║ Co-formulants
Article 28
Approval of co-formulants
1. A co-formulant shall be approved where it has been established that:
| (a) | the co-formulant or its residues, consequent on application consistent with realistic conditions of use, do not have a harmful effect on human or animal health or on groundwater or an unacceptable effect on the environment; and |
| (b) | its use, consequent on application consistent with good plant protection product practice and having regard to realistic ▐ conditions of use, does not have a harmful effect on human or animal health or an unacceptable effect on plants, plant products or the environment. |
2. Co-formulants approved pursuant to paragraph 1 shall be included in Annex III in accordance with the regulatory procedure with scrutiny referred to in Article 83(4).
3. Where a co-formulant is used in a plant protection product authorised under this Regulation, its specific use in plant protection products shall be considered as being registered in accordance with Article 15(1) of Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) (21).
Chapter III
Plant protection products
SECTION 1
Authorisation
Subsection 1
Requirements and contents
Article 29
Authorisation for placing on the market and use
1. A plant protection product shall not be placed on the market or used unless it has been authorised in the Member State concerned in accordance with this Regulation.
2. By way of derogation from paragraph 1, no authorisation shall be required in the following cases:
| (a) | use of plant protection products containing exclusively one or more basic substances; |
| (b) | ▐ use of plant protection products for research or development purposes in accordance with Article 57; |
| (c) | production, storage or movement of a plant protection product intended for use in another Member State, provided that the product is authorised in that Member State and that the Member State of production, storage or movement has put in place inspection requirements to ensure that the plant protection product is not used in its territory. |
Article 30
Requirements
1. A plant protection product shall only be authorised where it complies with the following requirements:
| (a) | its active substances, safeners and synergists have been approved; |
| (b) | where its active substance, safener or synergist is produced by a person or in accordance with a manufacturing process other than that specified in the dossier on the basis of which that substance, safener or synergist was approved, the active substance, safener or synergist contained in the plant protection product does not deviate significantly from the specification included in the Regulation approving that substance, safener or synergist and has no more harmful effects within the meaning of Article 4(2) and (3), due to its impurities, than if it had been produced in accordance with the manufacturing process specified in that dossier; |
| (c) | its co-formulants have ▐ been approved under Article 28; |
| (d) | its (technical) formulation is such that user exposure or other risks are limited as much as possible without compromising the functioning of the product; |
| (e) | in the light of current scientific and technical knowledge, it complies with the requirements provided for in Article 4(3); |
| (f) | the nature and quantity of its active substances, safeners and synergists and, where appropriate, any toxicologically, ecotoxicologically or environmentally significant impurities and co-formulants can be determined by appropriate methods; |
| (g) | all metabolites of the active substance(s) present in the use-phase have been determined and comply with criteria of the uniform principles referred to in paragraph 5; |
| (h) | its residues, resulting from authorised uses, ▐ can be determined by standardised methods in general use in all Member States, which are sufficiently sensitive with respect to any technically detectable levels that could be present in any environmental and biological media. The residues shall be detectable with the common multi-residue methods as applied by Community reference laboratories; |
| (i) | its physical and chemical properties have been determined and deemed acceptable for the purposes of the appropriate use and storage of the product; |
| (j) | for feed and food crops, where appropriate, the maximum residue levels for the agricultural products affected by the use referred to in the authorisation have been set or modified in accordance with Regulation (EC) No 396/2005. |
| (k) | its authorisation does not counteract the national action plans developed under Directive 2008/.../EC [establishing a framework for Community action to achieve a sustainable use of pesticides]. |
▐
2. The applicant shall demonstrate that the requirements provided for in paragraph 1 are met.
3. Compliance with the requirements set out in point (b) and points (d) to (i) of paragraph 1 shall be established by official or officially recognised tests and analyses carried out under agricultural, plant health and environmental conditions relevant to the use of the plant protection product in question and representative of the conditions prevailing in the zone where the product is intended to be used.
4. With respect to point (f) of paragraph 1, harmonised methods may be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 83(4) .
5. Uniform principles for evaluation and authorisation of plant protection products shall be defined in a Regulation adopted in accordance with the procedure laid down in Article 251 of the Treaty, incorporating the requirements in Annex VI to Directive 91/414/EEC with any necessary modifications.
The uniform principles shall take due account of the interaction between the active substance, safeners, synergists and co-formulants.
6. By way of derogation from paragraph 1(a), Member States may pre-authorise a product evaluated by a rapporteur Member State on the basis of the criteria set out in this Regulation. A pre-authorisation may be granted for a period of not more than three years if, two and a half years after submission of the application pursuant to Article 8(1), no decision has yet been taken on the authorisation of the active substance. A Member State may start its evaluation regarding a pre-authorisation as soon as there is evidence that the deadlines for the substance authorisation will not be met. The pre-authorisation shall be restricted to specific crops:
| (a) | that have been evaluated by the rapporteur Member State, and where the rapporteur Member State considers that the use on these crops is safe, that the active substance can satisfy the requirements of Article 4(2) and (3) and that the plant protection product satisfies the requirements of points (b) to (i) of paragraph 1 of this Article; and |
| (b) | where MRLs have been set in line with Regulation (EC) No 396/2005, and included in Annex II or III to that Regulation. |
Article 31
Contents of the authorisation
1. The authorisation , which shall use a standardised form, shall define the crops on which and the purposes for which the plant protection product may be used.
2. The authorisation shall set out the requirements relating to the placing on the market and use of the plant protection product. Those requirements shall as a minimum include:
| (a) | the conditions of use necessary to comply with the conditions and requirements provided for in the Regulation approving the active substances, safeners and synergists and the requirements and conditions for plant protection products set out in Article 4(3); |
| (b) | a classification of the plant protection product pursuant to Directive 1999/45/EC ; |
| (c) | indications for proper use according to the principles of Integrated Pest Management, to apply from 2012 onwards. |
These requirements shall in any case cover:
| — | the maximum dose per hectare in each application; |
| — | the period between the last application and harvest; |
| — | the number of applications per year. |
3. The requirements referred to in paragraph 2 may include:
| (a) | a restriction of the product with respect to the distribution and use of the plant protection product to protect the health of the distributors, users , ▐ workers , residents, bystanders and consumers concerned , animal health or the environment ; |
| (b) | the obligation to inform any neighbours who could be exposed to the spray drift before the product is used and who have requested to be informed ; |
| (c) | any restrictions or prohibitions of pesticide use in and around areas used by the general public or by vulnerable groups, such as residential areas, parks, public gardens, sports grounds, school grounds, children's playgrounds etc.; |
| (d) | other restrictions or conditions relevant to the issue of an authorisation and to the use of the plant protection product, particularly where these are intended to protect the health of distributors, users, workers, residents, bystanders and consumers or animal health or the environment. |
Article 32
Duration
1. The period of authorisation shall be laid down in the authorisation. The duration of an authorisation shall be set for as long as all active substances, safeners and synergists contained in the plant protection product are approved.
2. Authorisations may be granted for shorter periods to synchronise the re-evaluation of similar products for the purposes of a comparative assessment of products containing candidates for substitution as provided for in Article 53.
3. After renewal of the approval of an active substance, safener or synergist contained in the plant protection product, an additional authorisation period of nine months shall be granted to allow the examination as provided for in Article 44 to be carried out.
Subsection 2
Procedure
Article 33
Application for authorisation
1. A person who wishes to place a plant protection product on the market shall apply for an authorisation, in person or via a representative, to each Member State where the plant protection product is intended to be placed on the market.
The person who wishes to place a plant protection product on the market shall notify the Commission. This notification shall include the information referred to in paragraph 2 and the summary dossier referred in paragraph 3(a) .
2. The application shall include the following:
| (a) | a list of ▐ the Member States where the applicant has made an application; ▐ |
| (b) | a certified copy of any authorisations already granted for that plant protection product in a Member State. |
3. The application shall be accompanied by the following:
| (a) | for the plant protection product concerned, a complete and a summary dossier for each point of the data requirements of the plant protection product; |
| (b) | for each active substance, safener and synergist, co-formulant and adjuvant contained in the plant protection product, a complete and a summary dossier for each point of the data requirements of the active substance, safener and synergist, co-formulant and adjuvant, as well as a complete and summary dossier on the combined effect of the active substance(s), safener(s) and synergist(s), co-formulant(s) and adjuvant(s) contained in the plant protection product; |
| (c) | for each test or study involving vertebrate animals, a justification of the steps taken to avoid animal testing and duplicative testing on vertebrate animals ; |
| (d) | the reasons why the test and study reports submitted are necessary for first authorisation or for amendments to the conditions of the authorisation. |
4. When submitting his application, the applicant may, pursuant to Article 66, request that certain parts of the dossiers referred to in paragraph 3 are to be kept confidential. He shall explain for each document or each part of a document why it is to be considered as confidential.
He shall at the same time submit any claims for data protection pursuant to Article 62(4).
After giving the applicant the possibility to submit comments on the decision it plans to adopt, the rapporteur Member State shall decide what information is to be kept confidential. It shall inform the applicant and the Authority of its decision.
5. Where requested by the Member State the applicant shall submit his application in the national or official languages of that Member State or one of those languages.
On request, the applicant shall provide the Member States involved in the assessment with samples of the plant protection product and analytical standards of its ingredients.
6. On request, the applicant shall provide any other Member States with the complete dossier referred to in paragraph 3(a).
7. Application forms shall be standard in all Member States.
Article 34
Exemption
1. Applicants shall be exempted from supplying the test and study reports referred to in Article 33(3) where they demonstrate that they have been granted access in accordance with Article 62, 64 or 65 or that any data protection period has expired.
2. However, applicants to whom paragraph 1 applies shall provide the following information:
| (a) | the information needed to identify the active substance, safener or synergist, where they have been approved, and to establish whether the conditions for approval are met and comply with Article 30(1) (b), where appropriate; |
| (b) | the data needed to demonstrate that the plant protection product has comparable effects to the plant protection product for which they show access to the protected data. |
Article 35
Member State examining the application
The application shall be examined by the Member State where the applicant submits the application , unless another Member State volunteers to examine it. The Member State which will examine the application shall inform the applicant.
At the request of the Member State examining the application, the other Member States ▐ shall cooperate to ensure a fair division of the workload.
The other Member States shall have the right to send their comments to the Member State examining the application.
Article 36
Database of the Authority
Upon being informed which Member State will examine the application, the applicant shall immediately forward to the Authority the complete and the summary dossiers referred to in Article 33(3)(a) and (b) and the information referred to in Article 33(3)(c).
The Authority shall without delay make available to the public the summary dossiers, excluding any information which is confidential under Article 66, and the information referred to in Article 33(3)(c).
Article 37
Examination
1. The Member State examining the application shall make an independent, objective and transparent assessment in the light of the accepted scientific and technical guidelines and requirements existing at the time of application without prejudice to Article 22.
It shall apply the uniform principles for evaluation and authorisation of plant protection products, referred to in Article 30(5), to establish whether the plant protection product meets the requirements provided for in Article 30, where used in accordance with Article 58, and under all realistic ▐ conditions of use, and the consequences of its use under the authorised conditions.
The Member State examining the application shall make available its assessment to the other Member States ▐.
2. Without prejudice to Articles 31 and 32, where a plant protection product has already been authorised in one Member State, the other Member States shall decide whether and under which conditions to authorise the plant protection product concerned within 180 days of receiving an application .
3. By way of derogation from paragraph 2 and subject to Community law:
| (a) | Member States may subject approval to specific conditions and restriction of use, if there is substantiated, scientific evidence that due to specific conditions of use, use patterns, nutritional habits or other relevant circumstances the conditions and restriction in the original authorisation are not sufficient; |
| (b) | additional conditions may be imposed with respect to the requirements referred to in Article 31(3). |
Article 38
Time period for examination
1. The Member State examining the application shall decide within twelve months of receiving it whether the requirements for authorisation are met.
Where the Member State needs additional information, it shall set a time period for the applicant to supply it. In that case, the twelve-month period shall be extended by the additional time period granted by the Member State , which may not exceed four months .
2. The time-limits provided for in paragraph 1 shall be suspended while applying the procedure set out in Article 39.
3. For an application for authorisation of a plant protection product containing an active substance not yet approved, Member States shall start the evaluation as soon as it has received the draft assessment report referred to in Article 13(1). In such case the Member State shall decide on the application at the latest within six months of the active substance being approved.
Article 39
Assessment of equivalence under Article 30(1)(b)
1. Where it is necessary to establish whether a plant protection product complies with Article 30(1)(b), this shall be assessed by the Member State which acted as rapporteur for the active substance, safener or synergist as referred to in Article 8(1). ║ . The applicant shall submit all necessary data to that Member State .
2. After giving the applicant the opportunity to submit his comments, which the applicant shall also communicate to the Member State examining the application, the rapporteur Member State shall adopt a conclusion which it shall communicate to the Commission, the other Member States and the applicant.
3. Where the Member State examining the application for authorisation does not agree with the conclusion of the rapporteur Member State, it shall inform the applicant, the other Member States and the Commission stating its reasons.
The Member State examining the application for authorisation and the rapporteur Member State shall try to reach agreement on whether Article 30(1)(b) is complied with. They shall provide the applicant with an opportunity to submit his comments.
4. Where the Member States concerned do not reach agreement within 180 days the Member State examining the application for authorisation shall submit the matter to the Commission. A decision on whether the conditions referred to in Article 30(1)(b) are complied with shall be adopted in accordance with the regulatory procedure referred to in Article 83(3). The 180-day period begins on the date on which the Member State examining the application for authorisation informed the rapporteur Member State that it does not agree with the conclusion of the latter, in accordance with paragraph 3.
Before such a decision is adopted, the Commission may ask the Authority for an opinion, or for scientific or technical assistance which shall be provided within three months of the request.
5. Detailed rules for the implementation of paragraphs 1 to 4 may be established in accordance with the regulatory procedure with scrutiny referred to in Article 83(4), after consultation of the Authority.
Article 40
Reporting and exchange of information on applications for authorisation
1. Member States shall compile a file on each application. Each file shall contain the following:
| (a) | a copy of the application; |
| (b) | a report containing information on the evaluation of and decision on the plant protection product; |
| (c) | a record of the administrative decisions taken by the Member State concerning the application and the documentation provided for in Article 33(3) together with a summary of the latter. |
Not later than ... (22), the Commission shall present a proposal introducing a standardised format for the documentation provided for in points (a), (b) and (c).
2. Member States shall, without delay, make available to the Authority a file containing the documentation provided for in points (a), (b) and (c) of paragraph 1. The Authority shall maintain a register in which all authorisations in the different Member States are registered.
3. To facilitate the decision-making process described in Article 37(2), Member States having granted an authorisation shall, without delay, make available to the other Member States ▐ and the Commission a file containing the documentation provided for in points (a), (b) and (c) of paragraph 1 of this Article .
4. Within 12 weeks of a decision on the authorisation of a plant protection product, Member States shall make available a record of the administrative decision as referred to in point (c) of paragraph 1 on a public web site.
5. On request, applicants shall provide a copy of the documentation to be submitted with an application pursuant to Article 33(2) and Article 34 to Member States, the Authority and the Commission.
Subsection 3
Mutual recognition of authorisations
Article 41
Mutual recognition
1. The holder of an authorisation may apply for an authorisation for the same plant protection product and for the same use in another Member State under the mutual recognition procedure║ provided for in this subsection.▐
▐
2. Mutual recognition shall not apply to plant protection products containing a candidate for substitution.
Article 42
Authorisation
1. The Member State to which an application under Article 41 is submitted shall examine thoroughly the assessment undertaken by the reference Member State against the circumstances in its own territory.
2. The Member State shall grant the authorisation under conditions relevant to that Member State or refuse to grant the authorisation if Article 30 is not fulfilled in that Member State.
3. The authorisation may be subject to provisions resulting from the implementation of other measures in accordance with Community law, relating to the conditions for distribution and use of plant protection products intended to protect the health of the distributors, users and workers concerned.
4. The authorisation may be subject to additional requirements when relevant agricultural, plant health and environmental (including climatic) conditions in the Member State make these requirements necessary in order to comply with Article 30.
These use conditions should in any case cover:
| — | the dose per hectare in each application; |
| — | the period between the last application and harvest; |
| — | the number of applications per year; |
| — | prescription of the need of spraying; |
| — | the level of danger/risk for human health (cumulative effects); |
| — | protection of groundwater and biodiversity. |
5. ║ Subject to Community law, additional conditions may be imposed with respect to the requirements referred to in Article 31(3).
6. Where a Member State believes a plant protection product authorised by another Member State cannot meet the requirements set out in Article 30 or would counteract the objectives of its national action plan, and consequently proposes to refuse the authorisation, it shall notify the Commission, the other Member States and the applicant.
Article 43
Procedure
1. The application shall be accompanied by:
| (a) | a certified copy of the authorisation granted by the reference Member State; |
| (b) | a formal statement that the plant protection product is identical to that authorised by the reference Member State; |
| (c) | a summary of the dossier as required in Article 33(3) ; |
| (d) | at the request of the Member State a complete dossier as required in Article 33(3). |
2. The Member State to which an application under Article 41 is submitted shall decide on the application within 180 days .
Subsection 4
Renewal , amendment and withdrawal
Article 44
Renewal of authorisation
1. An authorisation shall be renewed upon application by the authorisation holder, provided that the conditions provided for in Article 30 are still satisfied.
The application shall be submitted at the latest one year before the expiry of the authorisation except where applicants cannot comply with this deadline because the active substance in question was included in Annex I to Directive 91/414/EEC for a duration which expired less than a year after the date of application of this Regulation.
2. The application shall be accompanied by the following information:
| (a) | a copy of the authorisation of the plant protection product, |
| (b) | a report on the results of monitoring, where the authorisation was subject to monitoring. |
3. Within three months of renewal of the approval of an active substance, safener or synergist contained in the plant protection product, the applicant shall submit the following information:
| (a) | any new information referred to in the renewal Regulation, as mentioned in Article 21, or required as a result of amendments in data requirements or criteria; |
| (b) | justification that the new data submitted are the result of data requirements or criteria which were not in force when the authorisation of the plant protection product was granted or necessary to amend the conditions of the approval; |
| (c) | any information required to demonstrate that the plant protection product meets the requirements set out in the Regulation on the renewal of the approval of the active substance, safener or synergist contained in it. |
4. Member States shall check that all plant protection products containing the active substance, safener or synergist concerned comply with any conditions and restrictions provided for in the Regulation renewing the approval under Article 21.
The Member State which acted as rapporteur for the active substance, safener or synergist shall coordinate performance of the compliance check and assessment of the results. The compliance check shall be performed within the time period set in the Regulation on the renewal of the approval.
5. Guidelines on the organisation of compliance checks may be established in accordance with the regulatory procedure with scrutiny referred to in Article 83(4).
6. Member States shall decide on the renewal of the authorisation at the latest nine months after the renewal of the approval of the active substance, safener or synergist contained in it.
7. Where, for reasons beyond the control of the holder of the authorisation, no decision is taken on the renewal of the authorisation before its expiry, the Member State in question shall extend the authorisation for the period necessary to complete the examination and adopt a decision on the renewal.
Article 45
Withdrawal or amendment of an authorisation
1. Member States may review an authorisation at any time where there are indications that a requirement referred to in Article 30 is no longer satisfied.
2. Member States shall review an authorisation where there are indications that the achievement of the objectives established in accordance with Article 4(1)(a)(iv) and (b)(i) and Article 7(2) and (3) of Directive 2000/60/EC may be compromised.
3. Where a Member State intends to withdraw or amend an authorisation, it shall inform the authorisation holder and give him the possibility to submit comments.
The Member State may ask the authorisation holder to submit further information.
4. The Member State shall withdraw or amend the authorisation, as appropriate, where:
| (a) | the requirements referred to in Article 30 are not or are no longer satisfied; |
| (b) | false or misleading information was supplied concerning the facts on the basis of which the authorisation was granted; |
| (c) | a condition included in the authorisation has not been met ; |
| (d) | on the basis of developments in scientific and technical knowledge the manner of use and amounts used can be modified. |
5. Where a Member State withdraws or amends an authorisation in accordance with paragraph 4, it shall immediately inform the holder of the authorisation, the other Member States, the Authority and the Commission. ▐
Article 46
Withdrawal or amendment of an authorisation at the request of the authorisation holder
1. An authorisation may be withdrawn or amended at the request of the holder of the authorisation, who shall state the reasons for his request.
2. Amendments may only be granted where it is established that the requirements of Article 30 continue to be satisfied.
Article 47
Grace period
Where a Member State withdraws or amends an authorisation or does not renew it, it may grant a grace period for the disposal, storage, placing on the market and use of existing stocks.
Where the reasons for withdrawal, amendment or not renewing the authorisation are not related to the protection of human and animal health or the environment , grace periods for using up stocks of the plant protection products concerned shall be granted for a period not longer than one season. If the reasons for withdrawal, amendment or not renewing the authorisation are related to the protection of human and animal health or the environment then there shall be no time-period for using up stocks of the plant protection products concerned and all sales and use of such products shall cease with immediate effect once the decision of withdrawal or non-renewal has been taken .
Article 48
Disposal and destruction of unauthorised plant protection products
Notwithstanding the provisions of Article 47, stocks of unauthorised plant protection products shall be safely disposed of and destroyed under the responsibility of the former authorisation holder.
Article 49
Imports
Imported non-food materials or articles shall not contain residues of active substances that have not been approved in accordance with the provisions of this Regulation.
Subsection 5
Special cases
Article 50
Placing on the market and use of low-risk plant protection products
1. Where all the active substances contained in a plant protection product are substances as referred to in Article 23 (‘low-risk active substances’), that product shall, by way of derogation from Article 30, be authorised as a low-risk plant protection product provided it meets the following requirements:
| (a) | the low-risk active substances, safeners and synergists contained in it have been approved under Chapter II; |
| (b) | the low-risk active substances contained in it have no adverse effect on humans, animals or the environment; |
| (c) | it does not contain a substance of concern; |
| (d) | it is sufficiently effective; |
| (e) | it does not cause unnecessary pain and suffering to vertebrates to be controlled; |
| (f) | it complies with Article 30(1)(b), (c), (f) and (h) to (j). |
These products are referred to hereinafter as ‘low-risk plant protection products’.
2. An applicant for authorisation of a low-risk plant protection product shall demonstrate that the requirements set out in paragraph 1 are met and shall accompany the application with a complete and summary dossier for each point of the data requirements of the active substance and the plant protection product.
3. The Member State shall decide within 90 days on whether to approve an application for authorisation of a low-risk plant protection product.
The period shall be 60 days where an authorisation has already been granted for the same low-risk plant protection product by another Member State ▐.
Where the Member State needs additional information, it shall set a time limit for the applicant to supply it. In that case, the 90-day period shall be extended by the additional time limit granted by the Member State. The total period may not exceed four months.
4. Unless otherwise specified, all provisions relating to authorisations under this Regulation shall apply.
Article 51
Placing on the market and use of reduced risk plant protection products
1. Notwithstanding Article 30, a plant protection product shall be authorised as a reduced risk product if it satisfies the following requirements:
| (a) | at least one of the active substances that it contains is a substance as defined in Article 23 (‘Lowrisk active substances’); |
| (b) | all the active substances, safeners and synergists with a low risk that it contains are approved in accordance with Chapter II; |
| (c) | it entails, in the light of scientific or technical knowledge, considerably fewer risks to human or animal health or the environment than a comparable plant protection product that is already authorised; |
| (d) | it is sufficiently active; |
| (e) | it complies with Article 30(1)(b), (c), (f) and (h) to (j). |
2. Applicants for authorisation of a reduced risk plant protection product must demonstrate that it meets the conditions in paragraph 1 and enclose with the application a detailed and a summary dossier for each point of the details required for the active substance and the plant protection product.
3. The Member State shall decide within 120 days whether to approve an application for authorisation for a reduced risk plant protection product.
This period shall be 90 days if another Member State has already granted authorisation for the same reduced risk plant protection product.
If the Member State requires additional information, it shall set a deadline by which the applicant must provide the information. In such a case the period of 120 days shall be extended by the additional period that the Member State has granted.
4. Unless otherwise specified, all provisions relating to authorisations under this Regulation shall apply.
Article 52
Placing on the market and use of plant protection products containing a genetically modified micro-organism
1. A plant protection product which contains a micro-organism falling within the scope of Directive 2001/18/EC shall be examined in respect of the genetic modification in accordance with that Directive, in addition to the assessment under this Chapter.
An authorisation under this Regulation shall not be granted for such a plant protection product unless written consent, as referred to in Article 19 of Directive 2001/18/EC, has been granted for it.
2. Unless otherwise specified, all provisions relating to authorisations under this Regulation shall apply.
Article 53
Comparative assessment of plant protection products containing candidates for substitution
1. Member States shall not authorise for use in a given crop a plant protection product either containing a candidate for substitution or posing a higher risk where a comparative assessment weighing up the risks and benefits, as set out in Annex IV, shows that:
| (a) | for the uses specified in the application an authorised plant protection product, or a non-chemical control or prevention method, having equivalent efficacy is already authorised and is significantly safer for human or animal health or the environment; |
| (b) | the substitution by plant protection products or non-chemical control or prevention methods referred to in point (a) does not present significant economic or practical disadvantages; |
| (c) | the chemical diversity of the active substances, where relevant, or methods and practices of crop management and pest prevention are adequate to minimise the occurrence of resistance in the target organism. |
While Member States shall not authorise any plant protection product where a comparative assessment shows the existence of safer alternatives, priority in comparative assessment and substitution shall be given to candidates for substitution.
2. By way of derogation from paragraph 1, a plant protection product containing a candidate for substitution shall be authorised without comparative assessment in cases where it is necessary to acquire experience first through using that product in practice.
Such authorisations shall be granted for a period not exceeding three years.
3. Member States shall repeat the comparative assessment provided for in paragraph 1 regularly and at the latest four years after authorisation or renewal of the authorisation was granted.
Based on the results of that comparative assessment, Member States shall maintain, withdraw or amend the authorisation.
4. Where a Member State decides to withdraw or amend an authorisation pursuant to paragraph 3, that withdrawal or amendment shall take effect two years after the decision of the Member State or at the end of the approval period of the candidate for substitution where that period ends earlier.
5. Unless otherwise specified, all provisions relating to authorisations under this Regulation shall apply.
Article 54
Extension of authorisations for minor uses
1. For the purpose of this Article, minor use of a plant protection product in a particular Member State means the use of that product on a crop which is not widely grown in that Member State or on a widely grown crop to meet an exceptional need.
2. The authorisation holder, official or scientific bodies involved in agricultural activities or professional agricultural organisations and professional users may ask for the authorisation of a plant protection product already authorised in the Member State concerned to be extended to minor uses not yet covered by that authorisation.
3. Member States may, after authorisation by the Commission, adopt specific measures to facilitate the submission of applications to extend the authorisation for and the submission of applications relating to minor uses.
4. Member States shall extend the authorisation provided that:
| (a) | the intended use is minor in nature; |
| (b) | the conditions referred to in Article 4(3)(b), (d) and (e) and Article 30(1)(j) are satisfied; |
| (c) | the extension is in the public interest; |
| (d) | the documentation and information to support an extension of use has been submitted by the persons or bodies referred to in paragraph 2. The studies necessary in order to determine maximum residue levels may be carried out by scientific institutes or official bodies. |
5. The extension may take the form of an amendment to the existing authorisation or may be a separate authorisation, according to the administrative procedures of the Member State concerned.
Extensions on the basis of this Article shall be separately identified and separate reference shall be made to liability restrictions.
6. When Member States grant an extension of authorisation for a minor use, they shall inform the authorisation holder, who shall change the labelling accordingly.
Where the authorisation holder declines, the Member States shall ensure that users are fully and specifically informed as to instructions for use, by means of an official publication or an official website.
The label shall indicate that such uses have not been evaluated for efficacy or phytotoxicity. Without prejudice to Article 76, the authorisation holder shall not be liable for any losses arising from use in accordance with extensions of authorisation.
7. Member States shall establish and regularly update a list of minor uses. This list shall be made available to the public through official websites of the Member State and of the Commission .
8. Not later than ... (23), the Commission shall present a proposal to the European Parliament and the Council for establishing a European promotion fund for minor uses. The Fund shall also be entitled to finance additional residue tests for minor uses.
9. Unless otherwise specified, all provisions relating to authorisations under this Regulation shall apply.
Article 55
Parallel trade
1. A plant protection product that is authorised in one Member State (Member State of origin) may, subject to an application for a parallel trade permit, be introduced, placed on the market and used in another Member State (Member State of introduction), if that Member State determines that the plant protection product is identical in composition to a plant protection product already authorised in the Member State of introduction (reference product). The application shall be submitted to the regulatory authority in the Member State of introduction (competent authority).
2. A parallel trade permit shall be granted within 90 working days after receiving a complete application. Member States shall on request provide each other with the information necessary to assess identicality within 10 working days of receiving the request. The procedure for granting a parallel trade permit shall be interrupted from the day the request for information is sent to the competent authority of the Member State of origin until the complete information required is delivered to the competent authority.
3. Member States shall grant a parallel trade permit under a simplified procedure if the plant protection product to be introduced is identical to the reference product in specification and content of the active substances, safeners and synergists, in type of formulation and in composition of the plant protection product.
4. Active substances, safeners and synergists shall be considered as identical in terms of paragraph 3 if:
| (a) | they have been manufactured by the same company or by an associated undertaking or under licence according to the same manufacturing process; and |
| (b) | they have either the same specification, or specifications approved to be equivalent under the procedure referred to in Article 39. |
5. The plant protection product to be introduced and the reference product shall be considered as identical in composition in terms of paragraph 3 if:
| (a) | the co-formulants are identical in all respects; or |
| (b) | varying co-formulants do not have more harmful effects within the meaning of Article 4(3) with due regard, in particular, to differences which may exist in conditions relating to agriculture, plant health and the environment, in particular climatic conditions, relevant to the use of the product. |
6. The criteria and the procedures for evaluating to what extent the compositions are identical may be described in detail in accordance with the regulatory procedure referred to in Article 83(3).
7. The application for a parallel trade permit shall include the following:
| — | Member State of origin, |
| — | name and address of the applicant, |
| — | name and address of a contact person in the Member State of introduction, if the applicant is not established there, |
| — | name to be given to the plant protection product to be distributed in the Member State of introduction, |
| — | name and registration number of the plant protection product in the Member State of origin, |
| — | name and address of the authorisation holder in the Member State of origin, |
| — | original instructions for use with which the plant protection product to be introduced is distributed in the Member State of origin if it is considered as necessary for the examination by the competent authority. The competent authority may require a translation of the relevant parts of the original instructions for use, |
| — | name and registration number of the reference product, |
| — | name and address of the authorisation holder of the reference product, |
| — | a draft label for the product intended to be placed on the market, |
| — | a sample of the product which is intended to be introduced if it is considered as necessary by the competent authority. |
8. The applicant for a parallel trade permit may demonstrate by means of all available and accessible information that the plant protection product intended to be introduced is identical in terms of paragraphs 3, 4 and 5 to the reference product.
9. A plant protection product for which a parallel trade permit has been issued is to be placed on the market and used in accordance with the provisions of the authorisation of the reference product. To meet the requirements of Article 30 and to facilitate monitoring and controls in terms of Article 71 the competent authority may lay down additional requirements for the product to be introduced.
10. The parallel trade permit shall be valid for the duration of authorisation of the reference product. If the authorisation holder of the reference product applies for a withdrawal of authorisation in accordance with Article 46(1) and the requirements of Article 30 are still fulfilled, the validity of the parallel trade permit will expire by the date on which the authorisation of the reference product would normally have expired.
11. Without prejudice to specific provisions in this Article, Articles 45 to 47, 58 and 59(4) and Chapters VI to X shall apply to parallel traded plant protection products correspondingly.
12. Without prejudice to Article 45a parallel trade permit may be withdrawn if
| — | the authorisation of the introduced plant protection product is withdrawn in the Member State of origin for reasons of safety or efficacy, |
| — | the parallel trade permit is misused by the applicant to introduce or place on the market plant protection products which are not authorised in any Member State. |
13. Where, with regard to the criteria provided for in paragraphs 3, 4 and 5, the assessment carried out by the Member State of introduction shows that the product intended to be introduced is not identical in terms of paragraph 3, 4 or 5 to the reference product, the Member State of introduction may only grant the authorisation required for placing on the market and use in accordance with Article 29.
14. The provisions of this Article do not apply to plant protection products which are authorised in the Member State of origin pursuant to Article 56 or 57.
Subsection 6
Derogations
Article 56
Emergency situations
1. By way of derogation from Article 29, in special circumstances a Member State may authorise, for a period not exceeding 120 days, the placing on the market of plant protection products, for limited and controlled use, where such a measure appears necessary because of a danger to plant health which cannot be contained by any other reasonable means.
The Member State concerned shall immediately inform the other Member States and the Commission of the measure taken, providing detailed information about the situation and any measures taken to ensure consumer safety.
2. The Commission may ask the Authority for an opinion, or for scientific or technical assistance.
The Authority shall provide its opinion or the results of its work to the Commission within one month of the request.
3. If necessary, a decision shall be taken, in accordance with the regulatory procedure referred to in Article 83(3), as to
| (a) | whether the treated crop may be safely marketed, and |
| (b) | whether and under what conditions the Member State
|
4. Paragraphs 1 to 3 shall not apply to plant protection products containing or composed of genetically modified micro-organisms.
Article 57
Research and development
1. By way of derogation from Article 29, experiments or tests for research or development purposes involving the release into the environment of an unauthorised plant protection product may be carried out if the Member State in whose territory the experiment or test is to be carried out has assessed the available data and granted an authorisation for trial purposes. Any such experiments or tests must be very strictly controlled to ensure that there will be no immediate or delayed harmful effect on human health, including residents and bystanders and vulnerable groups, such as babies, children, pregnant women, the elderly, people who are ill and those taking medication, or animal health, directly or through drinking water, food, feed or air, including in locations distant from its use following long-range transportation, or consequences in the workplace or through other indirect effects, taking into account cumulative and synergistic effects; or on groundwater. The authorisation may limit the quantities to be used and the areas to be treated and may impose further conditions to prevent any harmful effects on human or animal health or any unacceptable adverse effect on the environment, such as the need to prevent entry into the food chain of feed and food containing residues unless a relevant provision has already been established under Regulation (EC) No 396/2005.
The Member State may authorise a programme of experiments or tests in advance or require an authorisation for each experiment or test.
2. An application shall be submitted to the Member State in whose territory the experiment or test is to be conducted, together with a dossier containing all the available data to permit an assessment of possible effects on human or animal health or the possible impact on the environment.
3. An authorisation for trial purposes shall not be granted for experiments or tests involving the release into environment of a genetically modified micro-organism unless such release has been accepted underDirective 2001/18/EC.
4. Detailed rules for the application of this Article, in particular the maximum quantities of plant protection products that may be released during experiments or tests and the minimum data to be submitted in accordance with paragraph 2, may be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 83(4) .
SECTION 2
Use and information
Article 58
Use of plant protection products
Plant protection products shall be used properly.
Proper use shall include compliance with the conditions established in accordance with Article 31 and specified on the labelling, and application of the principles of good plant protection practice as well as, whenever possible, the principles of integrated pest management ▐.
At the latest by 1 January 2014 proper use of plant protection products shall comply with the principles of integrated pest management, including good plant protection practice and good environmental practice.
Detailed rules for the application of this Article including minimum requirements for these principles may be adopted in accordance with the regulatory procedure referred to in Article 83(3) .
Article 59
Information on potentially harmful effects
1. The holder of an authorisation for a plant protection product shall immediately notify the Member States ▐ of any new information concerning that plant protection product, or an active substance, safener or synergist contained in the plant protection product, which suggests that the plant protection product has harmful effects which might mean that the plant protection product or the active substance, safener or synergist no longer complies with the criteria set out in Articles 30 and 4 respectively.
In particular, potentially harmful effects of that plant protection product, or of residues of an active substance, safener or synergist contained in it, on human or animal health or on surface water and groundwater, or their potentially unacceptable effects on plants or plant products and other parts of the environment shall be notified.
To this end the authorisation holder shall record and report all suspected adverse reactions in humans , in animals and the environment related to the use of the plant protection product.
The obligation to notify shall include relevant information on decisions or assessments by public bodies which authorise plant protection products or active substances in third countries.
2. The notification shall include an assessment of whether and how the new information means that the plant protection product or the active substance, safener or synergist no longer comply with the requirements set out in Article 30 and Article 4 respectively.
3. The Member State receiving such notification shall immediately pass it on to the other Member States. Without prejudice to the right of Member States to adopt interim protective measures, the ▐ Member State which granted an authorisation ▐ shall evaluate the information received and inform the other Member States, ▐ where it decides to withdraw or amend the authorisation under Article 45.
It shall inform the other Member States, the Authority and the Commission where it considers that the conditions of the approval of the active substance, safener or synergist contained in the plant protection product are no longer fulfilled and propose that the approval be withdrawn or the conditions amended.
4. The holder of an authorisation for a plant protection product shall report annually to the competent authorities of the Member States any available information relating to the lack of expected efficacy, the development of resistance and to any unexpected effect on plants, plant products or the environment.
Article 60
Obligation to keep information available
1. Member States shall forward to the Authority, who shall make electronically available to the public, information on plant protection products authorised or withdrawn in accordance with this Regulation, containing at least:
| (a) | the name or business name of the holder of the authorisation, |
| (b) | the trade name of the product, |
| (c) | the type of preparation, |
| (d) | the name and amount of each active substance, safener or synergist which it contains, |
| (e) | the use or uses for which it is intended, |
| (f) | the Member State(s) where the plant protection product has been authorised, |
| (g) | information on basic environmental and health risks, |
| (h) | where relevant, the reasons for withdrawal of an authorisation. |
2. The information referred to in paragraph 1 shall be readily accessible and updated at least once every three months.
3. In accordance with the advisory procedure referred to in Article 83(2), a standardised information system may be set up to facilitate the application of paragraphs 1 and 2 of this Article.
Chapter IV
Adjuvants
Article 61
Placing on the market and use of adjuvants
An adjuvant shall not be placed on the market or used if it contains a co-formulant which has not been approved in accordance with Article 28.
Chapter V
Data protection and data sharing
Article 62
Data protection
1. Test and study reports shall benefit from data protection under the conditions laid down in this Article.
The protection applies to test and study reports submitted to a Member State by an applicant for authorisation under this Regulation (hereinafter called ‘the first applicant’), provided that those test and study reports were
| (a) | necessary for the authorisation or an amendment of an authorisation in order to allow the use on another crop, and |
| (b) | certified as compliant with the principles of Good Laboratory Practice or Good Experimental Practice in accordance with the data requirements for plant protection products referred to in Article 9(1)(c). |
Where a report is protected, it may ▐ be used, by the Member State which received it, for the benefit of other applicants for pesticides , except as provided in paragraph 3, in Article 65 or in Article 84.
The period of data protection shall be ten years starting at the date of the first authorisation in that Member State, except as provided in paragraph 3, in Article 65 or in Article 84. That period shall be extended to 15 years for pesticides covered by Article 50 and 12 years for those covered by Article 51 .
A study submitted for the renewal or review of an authorisation shall not be protected except where required for the purposes of amending the legislation .
Data protection shall also apply to 3rd parties who submit tests and study reports for the purpose of minor uses.
2. The data protection period for the product concerned shall be extended if the first applicant applies for authorisation for derived plant protection products for restricted uses as defined in Article 54(1). The data protection period shall be extended by three months for each new product for limited use. The data protection period may be extended by a maximum of three years.
3. Paragraph 1 shall not apply:
| (a) | to test and study reports for which the applicant has submitted a letter of access; or |
| (b) | where any period of data protection granted for the test and study reports concerned in relation to another plant protection product has expired. |
4. Data protection under paragraph 1 shall only be granted where the first applicant has claimed data protection at the time of submitting the dossier or further information and has provided to the Member State concerned for each test or study report the following information:
| (a) | justification that the test and study reports submitted are necessary for the first authorisation, renewal or review, or for the amendment of the authorisation of a plant protection product; or as a result of changes to legislation ; |
| (b) | confirmation that any period of data protection granted for the test or study report has not expired. |
5. By way of derogation from paragraph 1, where tests and study reports have already been used to grant authorisation to another product and the period of protection has not yet expired, those reports shall be protected for the remaining period.
Article 63
List of test and study reports
1. For each active substance, safener and synergist, rapporteur Member States shall forward to the Authority, who shall make available to the public at the moment of publishing the draft assessment report pursuant to Article 13 , a list of the test and study reports necessary for first approval, amendment of approval conditions or renewal of the approval and a summary of the results of the tests and study reports to establish the efficacy of the substance and its harmlessness to humans, animals, plants and the environment.
2. For each plant protection product which they authorise, Member States shall forward to the Authority, who shall make available to the public, at the moment of publishing the draft assessment report pursuant to Article 13 :
| (a) | a list of the test and study reports necessary for first authorisation, amendment of the authorisation conditions or renewal of the authorisation; ▐ |
| (b) | a list of test and study reports for which protection is claimed under Article 62 and any justifications submitted in accordance with that Article ; and |
| (c) | a summary of the results of the tests and study reports to establish the efficacy of the product and its harmlessness to humans, animals, plants and the environment . |
3. The lists provided for in paragraphs 1 and 2 shall include information on whether those test and study reports were certified as compliant with the principles of Good Laboratory Practice or with the principles of Good Experimental Practice.
Article 64
General rules on avoidance of duplicative testing
1. Any persons intending to seek an authorisation for a plant protection product shall, before carrying out tests or studies, consult the database referred to in Articles 36, 60 and 63.
2. Any persons intending to seek , renew or review an authorisation for a plant protection product shall, before carrying out tests or studies, inform the competent authority of the Member State to which they intend to make an application that an authorisation has already been granted in that or another Member State for a plant protection product containing the same active substance, safener or synergist , referring to the relevant information in the database .
The prospective applicant shall submit all data regarding the identity and impurities of the active substance he proposes to use. The enquiry shall be supported by evidence that the prospective applicant intends to apply for an authorisation.
3. The competent authority of the Member State, where satisfied that the prospective applicant intends to apply for an authorisation, or the renewal or review thereof, shall provide him with the name and address of the holder or holders of previous relevant authorisations and shall at the same time inform the holders of the authorisations of the name and address of the applicant.
4. The prospective applicant for the authorisation, or the renewal or review thereof, and the holder or holders of relevant authorisations shall take all reasonable steps to reach agreement on the sharing of any test and study reports protected under Article 62 that are required by the applicant for the authorisation, or the renewal or review, of a plant protection product. Such an agreement may be replaced by submission of the matter to an arbitration board and acceptance of the arbitration order. In an endeavour to ensure that the costs of sharing the information are determined in a fair, transparent and non-discriminatory way, the Commission may, in accordance with the regulatory procedure referred to in Article 83(3), adopt cost-sharing guidelines based on those principles.
5. Where the Member State considers that a monopoly might be created, and the prospective applicant and the holder or holders of the authorisations for plant protection products containing the same active substance, safener, or synergist cannot reach agreement on the sharing of any tests and studies involving vertebrate animals, the prospective applicant shall inform the competent authority of the Member State to that effect. The two parties shall nevertheless agree which courts and tribunals have jurisdiction for the purposes of the second subparagraph of Article 65(3).
Article 65
Sharing of tests and studies involving vertebrate animals
1. Tests and studies involving vertebrate animals shall not be repeated for the purposes of this Regulation. Any person intending to perform tests and studies involving vertebrate animals shall take the necessary measures to verify that those tests and studies have not already been performed or initiated , in particular by consulting the database .
2. The prospective applicant and the holder or holders of the relevant authorisations shall make every effort to ensure that they share tests and studies involving vertebrate animals. The costs of sharing the test and study reports shall be determined in a fair, transparent and non-discriminatory way. The prospective applicant ▐ is required to share in the costs that accrue during the entire process of generating the information he is required to submit to meet the authorisation requirements.
3. Where the prospective applicant and the holder or holders of the relevant authorisations of plant protection products containing the same active substance, safener or synergist cannot reach agreement on the sharing of test and study reports involving vertebrate animals, the prospective applicant shall inform the competent authority of the Member State. The two parties shall nevertheless agree which courts have jurisdiction for the purpose of the second subparagraph.
The failure to reach agreement, as provided in paragraph 2, shall not prevent the competent authority of the Member State from using the test and study reports involving vertebrate animals for the purpose of the application of the prospective applicant. The holder or holders of the relevant authorisation shall have a claim on the prospective applicant for an equal share of the costs incurred by him, which shall be enforceable before the courts of a Member State, as designated by the parties under the first subparagraph. Those courts shall have regard to the principles in paragraph 2.
4. Not later than ... (24), the Commission shall carry out a review of the provisions in this Regulation concerning data protection for tests and studies involving vertebrate animals. The Commission shall submit this assessment, and any proposed amendments for limiting the data protection with regard to animal experiments, to the European Parliament and the Council.
Chapter VI
Public access to information
Article 66
Confidentiality
1. A person claiming under Articles 8(5), 13(1), 16(2), 17 or 33(4) that information submitted by that person under this Regulation is to be treated as confidential shall provide a verifiable justification to show that the disclosure of the information might undermine his commercial interests, as referred to in the first indent of Article 4(2) of Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents (25), or any interest protected by Article 4(1) of that Regulation.
2. An opportunity to comment shall be given to the applicant before the competent authority adopts a decision as to the confidentiality of the data, which shall be binding on all Member States, the Authority and the Commission. The decision, which must be notified to the applicant, shall contain an adequate justification. The applicant shall have the right to challenge such decision in court before it is implemented, with a view to having the assessments and decision made by the competent authority reviewed by the court and to preventing disclosure of the data in question.
3. As regards the commercial interests referred to in paragraph 1, only the following elements shall be considered confidential:
| (a) | the method of manufacture; |
| (b) | the specification of purity of the active substance except for the impurities that are considered to be toxicologically, ecotoxicologically or environmentally relevant; |
| (c) | information on the complete composition of a plant protection product; |
| (d) | names and addresses of institutions and persons involved in testing on vertebrate animals. |
4. For test data, including study reports, which have been provided by an applicant to support a decision to authorise or to amend an authorisation for a plant protection product under this Regulation, such data may be viewed by interested parties in specific locations identified by the Commission, the Authority or the Member States. Such data shall not be made public through the provision of copies or through any other means of publication (including electronic publication).
5. This Article is without prejudice to Directive 2003/4/EC of the European Parliament and of the Council of 28 January 2003 on public access to environmental information (26).
Chapter VII
Packaging, labelling and advertising of plant protection products and adjuvants
Article 67
Packaging and presentation
1. Plant protection products and adjuvants that may be mistaken for food, drink or feed shall be packaged in such a way as to minimise the likelihood of such a mistake being made.
2. Plant protection products and adjuvants available to the general public that may be mistaken for food, drink or feed shall contain components to discourage or prevent their consumption.
3. Article 9 of Directive 1999/45/EC shall also apply to plant protection products and adjuvants not covered by that Directive.
Article 68
Labelling
1. The labelling of plant protection products shall comply with the requirements set out in a Regulation adopted in accordance with the advisory procedure referred to in Article 83(2).
That Regulation shall also contain standard phrases for special risks and safety precautions which supplement the phrases provided for by Directive 1999/45/EC. It shall transfer the text of the Annexes IV and V to Directive 91/414/EEC with any ▐ modifications necessary due to the change from a directive to a regulation .
2. Member States may require samples or mock-ups of the packaging and drafts of labels and leaflets to be submitted for examination before an authorisation is granted.
3. Where a Member State considers that additional phrases are necessary to protect human or animal health or the environment, it shall notify the other Member States and the Commission forthwith and shall forward the additional phrase or phrases and the reasons for these requirements.
Such phrases shall be included in the Regulation referred to in paragraph 1.
Pending that inclusion, the Member State may require the use of the additional phrase or phrases.
4. Food products which do not comply with the provisions of Commission Directive 2006/125/EC of 5 December 2006 on processed cereal-based foods and baby foods for infants and young children (27), shall be labelled ‘not suitable for infants and young children’.
Article 69
Advertising
1. Every advertisement for a plant protection product shall be accompanied by the sentences ‘Use plant protection products safely. Always read the label and product information before use’. These sentences shall be clearly distinguishable in relation to the whole advertisement. The words ‘plant protection products’ may be replaced by a more precise description of the product-type, such as fungicide, insecticide or herbicide.
2. The advertisement shall not include information which could be misleading as regards possible risks to human or animal health or to the environment, such as the terms ‘low risk’, ‘non-toxic’ or ‘harmless’.
3. Member States may prohibit or restrict the advertising of plant protection products in certain media.
Chapter VIII
Controls
Article 70
Record keeping
1. Producers, suppliers, distributors and professional users of plant protection products shall keep records of the plant protection products they produce, store or use for at least 10 years after the end of production or use.
They shall make the ▐ information contained in these records available to the competent authority ▐. They shall also keep this information available for neighbours and residents, retailers or the drinking water industry who request direct access to it. The information on all applications of plant protection products on a given agricultural product shall be provided to retailers and wholesalers in the form of a pesticide passport.
2. Producers of plant protection products shall undertake post-registration monitoring. They shall notify the competent authorities of any relevant information and keep the information available to relevant stakeholders on request.
3. Producers of plant protection products shall inform the competent authorities about:
| — | the amounts produced of a given substance or product, |
| — | the amounts of a given substance or product delivered to processors or wholesalers within the EU, |
| — | the amounts exported of a given substance or product. |
This information shall be assessed and published by the competent authorities.
4. Implementing measures to ensure the uniform application of paragraphs 1 and 3 may be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 83(4) .
Article 71
Monitoring and controls
Member States shall carry out official controls in order to enforce compliance with this Regulation. These controls shall include controls on the farm, in order to verify compliance with use restrictions. Member States shall finalise and transmit to the Commission a report on the scope and the results of these controls within six months of the end of the year to which the reports relate.
Commission experts shall carry out general and specific audits in the Member States for purposes of verifying the official controls carried out by the Member States.
A Regulation, adopted in accordance with the procedure referred to in Article 251 of the Treaty, shall set out provisions for the controls on the production, packaging, labelling, storage, transport, marketing, formulation and use of plant protection products. That Regulation shall contain provisions equivalent to Articles 1 to 13, 26, 27(1), 27(4)(a) and (b) and 27(5) to (12), 28, 29, 32 to 45, 51, 53, 54, 66 and to Annexes I, II, III, VI, and VII to Regulation (EC) No 882/2004. It shall also contain provisions concerning the collection of information and reporting on suspected poisonings and shall detail the information to be made available in response to medical demand.
Chapter IX
Emergencies
Article 72
Emergency measures
Where it is clear that an approved substance, safener, synergist or co-formulant or a plant protection product which has been authorised in accordance with this Regulation is likely to constitute a serious risk to human or animal health or the environment, and that such risk cannot be contained satisfactorily by means of measures taken by the Member State(s) concerned, measures to restrict or prohibit the use and/or sale of that substance or product shall be taken immediately in accordance with the regulatory procedure referred to in Article 83(3), either at the own initiative of the Commission or at the request of a Member State. Before taking such measures the Commission shall examine the evidence and may request an opinion from the Authority. The Commission may set a time limit within which such an opinion shall be provided.
Article 73
Emergency measures in cases of extreme urgency
By way of derogation from Article 72, the Commission may provisionally adopt the measures referred to in Article 72 after consulting the Member State or Member States concerned and informing the other Member States.
As soon as possible, and at the latest after 10 working days, those measures shall be confirmed, amended, revoked or extended in accordance with the regulatory procedure referred to in Article 83(3).
Article 74
Other emergency measures
1. Where a Member State officially informs the Commission of the need to take emergency measures, and no action has been taken in accordance with Articles 72 or 73, the Member State may adopt interim protective measures. In this event, it shall immediately inform the other Member States and the Commission.
2. Within 30 working days, the Commission shall put the matter before the Committee referred to in Article 83(1) in accordance with the regulatory procedure referred to in Article 83(3) with a view to the extension, amendment or abrogation of the national interim protective measure.
3. The Member State may maintain its national interim protective measures until Community measures have been adopted.
Chapter X
Administrative and financial provisions
Article 75
Penalties
The Member States shall lay down the rules on penalties applicable to infringements of this Regulation and shall take the measures necessary to ensure that they are implemented. The penalties provided for must be effective, proportionate and dissuasive.
The Member States shall notify those rules and any subsequent amendment to the Commission without delay.
Article 76
Civil and criminal liability
The granting of authorisation and any other measures in conformity with this Regulation shall be without prejudice to general civil and criminal liability in the Member States of the producer and, where applicable, of the person responsible for placing the plant protection product on the market or using it.
Article 77
Fund for safe disposal of obsolete pesticides
Producers and authorisation holders shall contribute to a fund covering the costs associated with the disposal and destruction of stocks of obsolete pesticides in Member States and third countries. The contribution to the fund shall be distributed in a fair and transparent manner.
Article 78
Fees and charges
1. Member States may recover the costs associated with any work they carry out in connection with approvals or authorisations within the scope of, or arising from obligations under, this Regulation, by means of fees or charges.
2. Member States shall ensure that the fee or charge referred to in paragraph 1:
| (a) | is established in a transparent manner; and |
| (b) | corresponds to the actual cost of the work involved. |
The fee or charge may include a scale of fixed charges based on average costs for the work referred to in paragraph 1.
Article 79
Member State authority
1. Each Member State shall designate a competent authority or authorities to carry out the obligations of the Member States as defined in this Regulation.
2. Each Member State shall designate a coordinating national authority to coordinate and ensure all the necessary contacts with applicants, other Member States, the Commission and the Authority.
3. Each Member State shall give the details concerning its national competent authority or authorities to the Commission, the Authority and the coordinating national authorities of the other Member States and inform them of any modifications thereof.
4. The Commission shall publish and keep updated on its website a list of the authorities referred to in paragraphs 1 and 2.
Article 80
Expenditure by the Commission
1. The Commission may incur expenditure for activities contributing to the aims of this Regulation including the organisation of the following:
| (a) | development of a harmonised system, including an appropriate database, for gathering and storing all information concerning active substances, safeners, synergists, co-formulants, plant protection products and adjuvants and for making such information available to the Member States, producers and other interested parties; |
| (b) | performance of studies needed to prepare and develop further legislation on the placing on the market and use of plant protection products and adjuvants; |
| (c) | performance of studies needed to harmonise procedures, decision-making criteria and data requirements; |
| (d) | coordination, if necessary by electronic means, of cooperation between Member States, the Authority and the Commission and measures to facilitate work sharing; |
| (e) | development and maintenance of a coordinated electronic submission and evaluation system aimed at promoting electronic document exchange and work sharing between the applicants, the Member States, the Authority and the Commission; |
| (f) | development of guidance to facilitate the day-to-day implementation of this Regulation; |
| (g) | travel and subsistence expenses that Member States' experts incur as a result of the Commission appointing them to assist its experts in the framework of control activities laid down under Article 71; |
| (h) | training of control staff; |
| (i) | financing of other measures needed to ensure application of the Regulation adopted under Article 71. |
2. The appropriations required under paragraph 1 shall be subject to authorisation by the budgetary authority each financial year.
Article 81
Guidance documents
The Commission may, in accordance with the regulatory procedure with scrutiny referred to in Article 83 (4), adopt or amend technical and other guidance documents for the implementation of this Regulation. The Commission may ask the Authority to prepare or to contribute to such guidance documents. The Authority may initiate the preparation or revision of guidance documents for the risk assessment of active substances.
Article 82
Amendments and implementing measures
1. The measures needed to implement this Regulation shall be adopted in accordance with the regulatory procedure referred to in Article 83(3).
Not later than ... (28), the Commission shall present legislative proposals based on Article 251 of the Treaty on:
▐
| (a) | the ▐ data requirements for active substances and for plant protection products, as referred to in Article 9(1)(b) and (c), including measures to minimise animal testing, in particular the use of non-animal testing methods and intelligent testing strategies, taking into account scientific and technical knowledge; |
| (b) | ▐ uniform principles for evaluation and authorisation of plant protection products, as referred to in Article 30(5), taking into account scientific and technical knowledge; |
| (c) | ▐ requirements of the labelling of plant protection products as referred to in Article 68(1); |
▐
2. In accordance with the regulatory procedure with scrutiny referred to in Article 83(4), a Regulation shall be adopted containing the list of active substances included in Annex I to Directive 91/414/EEC. Those substances shall be deemed to have been approved under this Regulation.
Article 83
Committee
1. The Commission shall be assisted by the Standing Committee on the Food Chain and Animal Health, as established by Article 58 of Regulation (EC) No 178/2002, hereinafter referred to as ‘the Committee’.
2. Where reference is made to this paragraph, Articles 3 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.
3. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.
The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.
4. Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.
║
5. The meetings of the Committee and its Working Groups shall be open to Members of the European Parliament on request.
Chapter XI
Transitional and final provisions
Article 84
Transitional measures
1. Directive 91/414/EEC (‘the Directive’) shall continue to apply, with respect to the procedure and the conditions for approval, to active substances for which a decision has been adopted in accordance with Article 6(3) of the Directive before the date of application of this Regulation.
On the basis of the examination carried out under the Directive, a Regulation on the approval of such a substance shall be adopted in accordance with Article 14(2) of this Regulation.
2. Article 13(1) to (4) of the Directive and Annexes II and III to the Directive shall continue to apply with respect to active substances included in Annex I to the Directive and to active substances approved in accordance with paragraph 1:
| — | For a period of five years from the date of their inclusion or approval, for active substances covered by Article 8(2) of the Directive. |
| — | For a period of ten years from the date of their inclusion or approval, for active substances which were not on the market two years after the date of notification of the Directive. |
| — | For a period of five years from the date of the renewal of the inclusion or renewal of the approval, for active substances whose inclusion in Annex I to the Directive expires at the latest two years after the date of publication of this Regulation. This provision shall only apply to data necessary for the renewal of the approval and which were certified as compliant with the principles of Good Laboratory practice at the latest two years after the publication of Regulation. |
3. Where Article 13 of the Directive applies by virtue of paragraph 1 or paragraph 2 of this Article, it shall be subject to any special rules concerning the Directive laid down in the Act of Accession by which a Member State joined the Community.
4. For active substances for which the first approval expires at the latest three years after the entry into force of this Regulation, the application provided for in Article 15 of this Regulation shall be submitted by a producer of the active substance to a Member State, with a copy to the other Member States, the Commission and the Authority, no later than two years before the expiry of the first approval.
5. Applications for authorisations of plant protection products under Article 4 of the Directive which are pending in the Member States on the date of application of this Regulation shall be decided on the basis of national law in force on that date.
After that decision, this Regulation shall apply.
6. Products labelled in accordance with Article 16 of the Directive may continue to be placed on the market for four years from the date of application of this Regulation.
▐
Article 85
Repeal
Directives 79/117/EEC and 91/414/EEC, as amended by the acts listed in Annex V, are repealed with effect from the date of application of this Regulation, without prejudice to the obligations of the Member States relating to the time-limits for transposition into national law and application of the Directives set out in that Annex.
References to the repealed Directives shall be construed as references to this Regulation.
Article 86
Entry into force and application
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
The Commission shall, not later than ... (29), adopt the following Regulations:
| — | a Regulation containing the list of the active substances already approved at the moment of publication of that Regulation, |
| — | a Regulation on data requirements for active substances, as referred to in Article 9(1)(b), |
| — | a Regulation on data requirements for plant protection products, as referred to in Article 9(1)(c), ▐ |
| — | a Regulation containing the requirements of the labelling of plant protection products as referred to in Article 68(1). |
The Commission shall, not later than ... (30), adopt the following Regulation:
| — | a Regulation on uniform principles for risk assessment for plant protection products, as referred to in Article 37. |
This Regulation shall apply from ... (29)
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at ..., on ...
For the European Parliament
The President
For the Council
The President
(1) OJ C 175, 27.7.2007, p. 44.
(2) Position of the European Parliament of 23 October 2007.
(3) OJ L 230, 19.8.1991, p. 1. Directive as last amended by Commission Directive 2007/52/EC (OJ L 214, 17.8.2007, p. 3).
(4) COM(2001)0444.
(5) OJ L 33, 8.2.1979, p. 36. Directive as last amended by Regulation (EC) No 850/2004 of the European Parliament and the Council (OJ L 158, 30.4.2004, p. 7, corrected version in OJ L 229, 29.6.2004, p. 5).
(6) OJ L 358, 18.12.1986, p. 1. Directive as amended by Directive 2003/65/EC of the European Parliament and of the Council (OJ L 230, 16.9.2003, p. 32).
(7) Seven years after the entry into force of this Regulation.
(8) OJ L 31, 1.2.2002, p. 1. Regulation as last amended by Commission Regulation (EC) No 575/2006 (OJ L 100, 8.4.2006, p. 3).
(9) OJ L 327, 22.12.2000, p. 1. Directive as amended by Decision No 2455/2001/EC (OJ L 331, 15.12.2001, p. 1).
(10) OJ L ...
(11) OJ L 270, 21.10.2003, p. 1. Regulation as last amended by Commission Regulation (EC) No 1276/2007 (OJ L 284, 30.10.2007, p. 11).
(12) OJ L 200, 30.7.1999, p. 1. Directive as last amended by Regulation (EC) No 1907/2006 (OJ L 396, 30.12.2006, p. 1 , corrected by OJ L 136, 29.5.2007, p. 3).
(13) OJ L 165, 30.4.2004, p. 1. Regulation as last amended by Council Regulation (EC) No 1791/2006 (OJ L 363, 20.12.2006, p. 1).
(14) OJ L 70, 16.3.2005, p. 1. Regulation as amended by Commission Regulation (EC) No 178/2006 (OJ L 29, 2.2.2006, p. 3).
(15) OJ L 184, 17.7.1999, p. 23. Decision as amended by Decision 2006/512/EC (OJ L 200, 22.7.2006, p. 11).
(16) OJ 196, 16.8.1967, p. 1. Directive as last amended by Directive 2006/121/EC of the European Parliament and of the Council (OJ L 396, 30.12.2006, p. 850, corrected by OJ L 136, 29.5.2007, p. 281).
(17) OJ L 106, 17.4.2001, p. 1. Directive as last amended by Regulation (EC) No 1830/2003 (OJ L 268, 18.10.2003, p. 24).
(18) Directive 2004/10/EC of the European Parliament and of the Council of 11 February 2004 on the harmonisation of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances ( OJ L 50, 20.2.2004, p. 44 ).
(19) One year after the entry into force of this Regulation.
(20) Two years after the entry into force of this Regulation.
(21) OJ L 396, 30.12.2006, p. 1. Corrected in OJ L 136, 29.5.2007, p. 3.
(22) 12 months after the entry into force of this Regulation.
(23) One year after the entry into force of this Regulation.
(24) Seven years after the entry into force of this Regulation.
(25) OJ L 145, 31.5.2001, p. 43.
(26) OJ L 41, 14.2.2003, p. 26.
(27) OJ L 339, 6.12.2006, p. 16.
(28) Two years after entry into force of this Regulation.
(29) 18 months after the entry into force of this Regulation.
(30) Six months after the entry into force of this Regulation.
ANNEX I
PROCEDURE AND CRITERIA FOR THE APPROVAL OF ACTIVE SUBSTANCES, SAFENERS AND SYNERGISTS PURSUANT TO CHAPTER II
1. Evaluation
1.1. During the process of evaluation and decision-making provided for in Articles 4 to 22, the rapporteur Member State and the Authority shall cooperate with applicants to resolve any questions on the dossier quickly or to identify at an early stage any additional studies necessary for the evaluation of the dossier, including information to eliminate the need for a restriction of the approval, or to amend any proposed conditions for the use of the plant protection product or to modify its nature or its composition in order to ensure full satisfaction of the requirements of this Regulation.
1.2. The evaluation by the Authority and the rapporteur Member State must be based on scientific principles and be made with the benefit of expert advice.
1.3. During the process of evaluation and decision-making provided for in Articles 4 to 22, Member States and the Authority shall take into consideration any further guidance developed in the framework of the Standing Committee on the Food Chain and Animal Health for the purposes of refining, where relevant, the risk assessments.
2. General decision-making criteria
2.1. Article 8(1) shall only be considered as complied with, where, on the basis of the dossier submitted, authorisation in at least one Member State is expected to be possible for at least one plant protection product containing that active substance for at least one of the representative uses.
2.2. Submission of further information
In principle an active substance shall only be approved where a complete dossier is submitted.
In exceptional cases an active substance may be approved even though certain information is still to be submitted where:
| (a) | the data requirements have been amended or refined after the submission of the dossier or; |
| (b) | the information is considered to be confirmatory in nature, as required to increase the confidence in the decision. |
In such cases the additional information shall be submitted to the rapporteur Member State for evaluation within a deadline set by the Commission. The Member State shall report to the Commission on the results of the assessment.
2.3. Restrictions on approval
Restrictions on approval, where necessary, may be linked to:
| — | identification of unacceptable risks under particular conditions; |
| — | gaps in the risk assessment resulting from the limited range of representative uses and preparations notified by the applicant. |
Where the rapporteur Member State considers that the dossier provided lacks certain information, to the effect that the active substance could only be approved subject to restrictions, it shall contact the applicant at an early stage to obtain more information which may possibly enable these restrictions to be removed.
3. Criteria for the approval of an active substance
3.1. Dossier
The dossiers submitted pursuant to Article 8(1) shall contain the information needed to establish, where relevant, Acceptable Daily Intake (ADI), Acceptable Operator Exposure Level (AOEL) and Acute Reference Dose (ARfD).
In the case of an active substance for which the limited range of representative uses includes use on feed or food crops or leads indirectly to residues in food or feed, the dossier submitted pursuant to Article 8(1) shall contain the information necessary to carry out a risk assessment and for enforcement purposes.
The dossier shall in particular:
| (a) | permit any residue of concern to be defined; |
| (b) | reliably predict the residues in food and feed, including succeeding crops; |
| (c) | reliably predict, where relevant, the corresponding residue level reflecting the effects of processing and/or mixing; |
| (d) | permit a Maximum Residue Level (MRL) to be defined for the commodity and, where appropriate, for products of animal origin where the commodity or parts of it is fed to animals; |
| (e) | permit, where relevant, concentration or dilution factors due to processing and/or mixing to be defined. |
The dossier submitted pursuant to Article 8(1) shall be sufficient to permit, where relevant, an estimate of the fate and distribution of the active substance in the environment, and its impact on non-target species.
3.2. Efficacy
An active substance shall only be approved where it has been established for an extensive range of representative uses that the plant protection product, consequent on application consistent with good plant protection product practice and having regard to realistic ▐ conditions of use, is sufficiently effective. This requirement shall be evaluated in the light of the uniform principles for evaluation and authorisation of plant protection products referred to in ║ Article 30(5).
3.3. Toxic relevance of breakdown products
Where the limited range of representative uses includes use on food or feed crops, the documentation submitted shall be sufficient to permit the establishment of the toxicological relevance of breakdown products that were not present in the animals used in the test or studies performed on the active substance but which are formed in or on treated plants, as a result of processing or are found in studies performed on livestock animals.
3.4. Composition of the active substance
3.4.1. The specification shall define the minimum degree of purity, the identity and maximum content of impurities, and where relevant of isomers / diastereo-isomers and additives, and the content of impurities of toxicological, ecotoxicological or environmental concern within acceptable limits.
3.4.2. The specification shall be in compliance with the relevant FAO specification where such specification exists. However where necessary for reasons of protection of human or animal health or the environment, stricter specifications may be adopted.
3.5. Methods of analysis
3.5.1. The methods of analysis of the active substance as manufactured and of determination of impurities of toxicological, ecotoxicological or environmental concern or which are present in quantities greater than 1 g/kg in the active substance as manufactured, shall have been validated and shown to be sufficiently specific, linear, accurate and precise.
3.5.2. The method of analysis in environmental matrices, as appropriate, shall have been validated and shown to be sufficiently sensitive with respect to the levels of concern.
3.5.3. The evaluation has been carried out in accordance with the uniform principles for evaluation and authorisation of plant protection products referred to in Article 30(5).
3.6. Impact on human health
3.6.1. Where relevant, an ADI, AOEL and ARfD shall be established. When establishing such values an appropriate safety margin of at least 100 shall be ensured taking into account the type and severity of effects, possible combination effects and the vulnerability of specific groups of the population particularly at risk.
3.6.2. An active substance shall only be approved if, on the basis of assessment of higher tier genotoxicity testing carried out in accordance with the data requirements for the active substances and the plant protection products and other available data and information including a review of the scientific literature , it is not or has not to be classified, in accordance with the provisions of Directive 67/548/EEC, as a mutagen category 1 or 2. Such active substances may only be approved if the exposure of humans to that active substance in a plant protection product, under realistic ▐ conditions of use, is negligible , as the product is used in closed systems or in other conditions excluding contact with humans and where residues of the active substance concerned on food and feed do not exceed the limit of determination using the most sensitive methods .
3.6.3. An active substance shall only be approved if, on the basis of assessment of carcinogenicity testing carried out in accordance with the data requirements for the active substances and the plant protection products and other available data and information including a review of the scientific literature , it is not or has not to be classified, in accordance with the provisions of Directive 67/548/EEC, as a carcinogen category 1 or 2. Such active substances may only be approved if the exposure of humans to that active substance in a plant protection product, under realistic ▐ conditions of use, is negligible , as the product is used in closed systems or in other conditions excluding contact with humans and where residues of the active substance concerned on food and feed do not exceed the limit of determination using the most sensitive methods .
3.6.4. An active substance shall only be approved if, on the basis of assessment of reproductive toxicity testing carried out in accordance with the data requirements for the active substances and the plant protection products and other available data and information including a review of the scientific literature , it is not or has not to be classified, in accordance with the provisions of Directive 67/548/EEC, as toxic for reproduction category 1 or 2. Such active substances may only be approved if the exposure of humans to that active substance in a plant protection product, under realistic ▐ conditions of use, is negligible , as the product is used in closed systems or in other conditions excluding contact with humans and where residues of the active substance concerned on food and feed do not exceed the limit of determination using the most sensitive methods .
3.6.5. An active substance shall only be approved if, on the basis of the assessment of Community or internationally agreed test guidelines or other available data and information including a review of the scientific literature it is not considered to have endocrine disrupting properties that are suspected to be of toxicological significance in humans including when exposure is likely to happen during embryonic/foetal life and/or during childhood, taking due account of likely combination effects. Such active substances may only be approved if the exposure of humans to that active substance in a plant protection product, under realistic ▐ conditions of use, is negligible , as the product is used in closed systems or in other conditions excluding contact with humans and where residues of the active substance concerned on food and feed do not exceed the limit of determination using the most sensitive methods .
3.6.6. An active substance shall only be approved if, on the basis of the assessment or other available data and information including a review of the scientific literature, it is not considered to cause a risk of developmental neurotoxic or immunotoxic properties in humans, taking into account exposure during embryonic/foetal life and/or during childhood as well as likely combination effects. Such active substances may only be approved if the exposure of humans to that active substance in a plant protection product, under realistic conditions of use, is negligible, as the product is used in closed systems or in other conditions excluding contact with humans and where residues of the active substance concerned on food and feed do not exceed the limit of determination using the most sensitive methods.
3.7. Fate and behaviour in the environment
3.7.1. An active substance shall only be approved where it, and its transformation products or residues, are not considered to be ▐ persistent organic pollutants .
A persistent organic pollutant is defined as follows:
| (a) | Persistence:
|
| (b) | Bio-accumulation:
|
| (c) | Potential for long-range environmental transport:
|
3.7.2. An active substance shall only be approved if it, and its transformation products or residues, are not considered to be ▐ persistent, bioaccumulating and toxic (PBT) substances .
A substance that fulfils all three of the criteria of the sections below is a PBT substance.
3.7.2.1. Persistence
An active substance fulfils the persistence criterion where:
| — | the half-life in marine water is higher than 60 days, or |
| — | the half-life in fresh or estuarine water is higher than 40 days, or |
| — | the half-life in marine sediment is higher than 180 days, or |
| — | the half-life in fresh or estuarine water sediment is higher than 120 days, or |
| — | the half-life in soil is higher than 120 days. |
Assessment of persistency in the environment shall be based on available half-life data collected under appropriate conditions, which shall be described by the applicant.
It also fulfils the persistence criterion where there is evidence that the substance is otherwise sufficiently persistent to be of concern.
3.7.2.2. Bioaccumulation
An active substance fulfils the bioaccumulation criterion where the bioconcentration factor (BCF) is higher than 2000.
Assessment of bioaccumulation shall be based on measured data on bioconcentration in aquatic species. Data from both freshwater and marine water species can be used.
It also fulfils the bioaccumulation criterion when there is evidence of high bioaccumulation in other species, or monitoring data in biota indicate that the bioaccumulation potential of the substance is sufficient to be of concern .
3.7.2.3. Toxicity
An active substance fulfils the toxicity criterion where:
| — | the long-term no-observed effect concentration (NOEC) for marine or freshwater organisms is less than 0.01 mg/l, or |
| — | the substance is classified as carcinogenic (category 1, ▐ 2 or 3 ), mutagenic (category 1, ▐ 2 or 3 ), or toxic for reproduction (category 1, 2, or 3), or |
| — | there is other evidence of chronic toxicity, as identified by the classifications: T, R48 or Xn, R48 pursuant to Directive 67/548/EEC. |
3.7.3. An active substance shall not be considered as complying with Article 4 where it, or its transformation products or residues, are very persistent, very bioaccumulating (vPvB).
A substance that fulfils both of the criteria of the sections below is a vPvB substance.
3.7.3.1. Persistence
An active substance fulfils the very persistent criterion (vP-) where there is evidence that:
| — | the half-life in marine, fresh- or estuarine water is higher than 60 days, or |
| — | the half-life in marine, fresh- or estuarine water sediment is higher than 180 days, or |
| — | the half-life in soil is higher than 180 days. |
It also fulfils the very persistent criterion where there is evidence that the substance is otherwise sufficiently highly persistent to be of concern.
3.7.3.2. Bioaccumulation
An active substance fulfils the very bioaccumulative criterion where the bioconcentration factor is greater than 5000.
Assessment of bioaccumulation shall be based on measured data on bioconcentration in aquatic species. Data from both freshwater and marine water species can be used.
It also fulfils the very bioaccumulative criterion when there is evidence of very high bioaccumulation in other species, or monitoring data in biota indicate that the bioaccumulation potential of the substance is sufficient to be of concern.
3.8. Ecotoxicology
3.8.1. An active substance shall only be considered as complying with Article 4 if the risk assessment demonstrates risks to be acceptable in accordance with the criteria laid down in the uniform principles for evaluation and authorisation of plant protection products referred to in Article 37 under realistic proposed conditions of use of a plant protection product containing the active substance. The assessment must take into account the severity of effects on biodiversity , the uncertainty of the data, and the number of organism groups which the active substance is expected to affect adversely by the intended use.
3.8.2. An active substance shall only be considered as complying with Article 4 if, on the basis of the assessment of Community or internationally agreed test guidelines, it is not considered to have endocrine disrupting properties that may be of toxicological significance on nontarget organisms unless the exposure of non-target organisms to that active substance in a plant protection product, under realistic proposed conditions of use is negligible.
3.8.3. An active substance shall only be approved, if, on the basis of the assessment of Community or internationally agreed test guidelines and other available data and information including a review of the scientific literature, it is not considered to be toxic for bees and has a Hazard Quotient (HQ) lower than 50.
3.9. Residue definition
An active substance shall only be approved if ▐ a residue definition can be established and analytical methods in general use are capable of detecting them for the purposes of risk assessment and for enforcement purposes.
3.10. Food-chain effects
An active substance shall only be approved if its impact on the food chain of higher organisms is considered to be acceptable on the basis of a scientifically approved risk assessment methodology and, if approved, the assessed impact on the ecosystem is reduced through a system of mitigation and compensation.
3.11. Water policy
Substances on the list of priority hazardous substances for water policy annexed to Directive 2000/60/EC should not be approved.
4. Criteria for approval as a candidate for substitution
An active substance shall be defined as a candidate for substitution pursuant to Article 25 where any of the following conditions are met :
| — | its ADI, ARfD or AOEL is ▐ lower than those of the majority of the approved active substances , taking into account residents, bystanders and the most vulnerable population groups; |
| — | it meets one of the criteria to be considered as a PBT substance; |
| — | it is prone to leaching to groundwater; |
| — | there are reasons for concern linked to the nature of the critical effects and properties which may give rise to very restrictive risk management measures (such as extensive personal protective equipment or very large buffer zones); |
| — | it has potentially endocrine disrupting, neurotoxic or immunotoxic properties, in adults or during development, on the basis of assessment and other available data and information including a review of scientific literature; |
| — | it contains a significant proportion of non-active isomers. |
ANNEX II
LIST OF ACTIVE SUBSTANCES APPROVED FOR INCLUSION IN PLANT PROTECTION PRODUCTS
ANNEX III
LIST OF CO-FORMULANTS, SAFENERS AND SYNERGISTS APPROVED FOR INCLUSION IN PLANT PROTECTION PRODUCTS
ANNEX IV
COMPARATIVE ASSESSMENT PURSUANT TO ARTICLE 53
1. Conditions for comparative assessment
A comparative assessment shall be performed by Member States when evaluating an application for authorisation for a plant protection product. In this process, priority shall be given to plant protection products containing an active substance approved as a candidate for substitution.
Where refusal or withdrawal of an authorisation of a plant protection product in favour of an alternative plant protection product is considered (hereinafter ‘substitution’), the alternative must, in the light of scientific and technical knowledge, show significantly lower risk to health or the environment. An assessment of the alternative plant protection product shall be performed to demonstrate whether it can be used with similar effect on the target organism and without significant economic and practical disadvantages to the user or not.
Further conditions for refusal or withdrawal of an authorisation are:
| (a) | substitution shall be applied only where the ▐ diversity of the active substances and other non-chemical methods of plant protection and pest and crop management is sufficient to minimise the occurrence of resistance in the target organism; |
| (b) | substitution may be applied by Member States to all active substances which, where used in authorised plant protection products, present a ▐ higher level of risk to human health or the environment; |
▐
2. Significant difference in risk
A significant difference in risk , especially for health risks, shall be identified on a case-by-case basis by the competent authorities, taking into account known cumulative and synergistic effects . The properties of the active substance, and the possibility of exposure of different population subgroups (professional or nonprofessional users, bystanders, workers, residents, specific vulnerable groups or consumers) directly or indirectly through food, feed, water or the environment shall be taken into account. Other factors such as the stringency of imposed restrictions on use and prescribed personal protective equipment must also be considered.
For the environment, taking into account known cumulative and synergistic effects, a factor of at least 3 between the Predicted Environmental Concentration (PEC) and the Predicted No Effect Concentration (PNEC) ratios of different active substances is considered a significant difference in risk.
3. Significant practical or economic disadvantages
Significant practical or economic disadvantage to the user is defined as a major quantifiable impairment of working practices or business activity leading to inability to maintain sufficient control of the target organism. Such a major impairment might be, for example, where no technical facilities for the use of the alternative substance(s) are available or economically feasible.
Where a comparative assessment indicates that restrictions/prohibitions of use of a plant protection product could cause such disadvantage, then this will be taken into account in the decision-making process. This situation must be substantiated.
The comparative assessment shall take authorised minor uses into account.
ANNEX V
REPEALED DIRECTIVES AND THEIR SUCCESSIVE AMENDMENTS
A. Directive 91/414/EEC
| Acts amending Directive 91/414/EEC | Deadline for transposition |
| Directive 93/71/EEC | 3 August 1994 |
| Directive 94/37/EC | 31 July 1995 |
| Directive 94/79/EC | 31 January 1996 |
| Directive 95/35/EC | 30 June 1996 |
| Directive 95/36/EC | 30 April 1996 |
| Directive 96/12/EC | 31 March 1997 |
| Directive 96/46/EC | 30 April 1997 |
| Directive 96/68/EC | 30 November 1997 |
| Directive 97/57/EC | 1 October 1997 |
| Directive 2000/80/EC | 1 July 2002 |
| Directive 2001/21/EC | 1 July 2002 |
| Directive 2001/28/EC | 1 August 2001 |
| Directive 2001/36/EC | 1 May 2002 |
| Directive 2001/47/EC | 31 December 2001 |
| Directive 2001/49/EC | 31 December 2001 |
| Directive 2001/87/EC | 31 March 2002 |
| Directive 2001/99/EC | 1 January 2003 |
| Directive 2001/103/EC | 1 April 2003 |
| Directive 2002/18/EC | 30 June 2003 |
| Directive 2002/37/EC | 31 August 2003 |
| Directive 2002/48/EC | 31 December 2002 |
| Directive 2002/64/EC | 31 March 2003 |
| Directive 2002/81/EC | 30 June 2003 |
| Directive 2003/5/EC | 30 April 2004 |
| Directive 2003/23/EC | 31 December 2003 |
| Directive 2003/31/EC | 30 June 2004 |
| Directive 2003/39/EC | 30 September 2004 |
| Directive 2003/68/EC | 31 March 2004 |
| Directive 2003/70/EC | 30 November 2004 |
| Directive 2003/79/EC | 30 June 2004 |
| Directive 2003/81/EC | 31 January 2005 |
| Directive 2003/82/EC | 30 July 2004 |
| Directive 2003/84/EC | 30 June 2004 |
| Directive 2003/112/EC | 30 April 2005 |
| Directive 2003/119/EC | 30 September 2004 |
| Regulation (EC) No 806/2003 | - |
| Directive 2004/20/EC | 31 July 2005 |
| Directive 2004/30/EC | 30 November 2004 |
| Directive 2004/58/EC | 31 August 2005 |
| Directive 2004/60/EC | 28 February 2005 |
| Directive 2004/62/EC | 31 March 2005 |
| Directive 2004/66/EC | 1 May 2004 |
| Directive 2004/71/EC | 31 March 2005 |
| Directive 2004/99/EC | 30 June 2005 |
| Directive 2005/2/EC | 30 September 2005 |
| Directive 2005/3/EC | 30 September 2005 |
| Directive 2005/25/EC | 28 May 2006 |
| Directive 2005/34/EC | 30 November 2005 |
| Directive 2005/53/EC | 31 August 2006 |
| Directive 2005/54/EC | 31 August 2006 |
| Directive 2005/57/EC | 31 October 2006 |
| Directive 2005/58/EC | 31 May 2006 |
| Directive 2005/72/EC | 31 December 2006 |
| Directive 2006/5/EC | 31 March 2007 |
| Directive 2006/6/EC | 31 March 2007 |
| Directive 2006/10/EC | 30 September 2006 |
| Directive 2006/16/EC | 31 January 2007 |
| Directive 2006/19/EC | 30 September 2006 |
| Directive 2006/39/EC | 31 July 2007 |
B. Directive 79/117/EEC
| Acts amending Directive 79/117/EEC | Deadline for transposition |
| Directive 83/131/EEC | 1 October 1984 |
| Directive 85/298/EEC | 1 January 1986 |
| Directive 86/214/EEC | - |
| Directive 86/355/EEC | 1 July 1987 |
| Directive 87/181/EEC | 1 January 1988 and 1 January 1989 |
| Directive 87/477/EEC | 1 January 1988 |
| Directive 89/365/EEC | 31 December 1989 |
| Directive 90/335/EEC | 1 January 1991 |
| Directive 90/533/EEC | 31 December 1990 and 30 September 1990 |
| Directive 91/118/EEC | 31 March 1992 |
| Regulation (EC) No 807/2003 | - |
| Regulation (EC) No 850/2004 | - |