Legal provisions of COM(2002)485 - Detergents

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This page contains a limited version of this dossier in the EU Monitor.

dossier COM(2002)485 - Detergents.
document COM(2002)485 EN
date March 31, 2004


Contents

Article 1 - Objectives and scope

1. This Regulation establishes rules designed to achieve the free movement of detergents and surfactants for detergents in the internal market while, at the same time, ensuring a high degree of protection of the environment and human health.

2. For this purpose, this Regulation harmonises the following rules for the placing on the market of detergents and of surfactants for detergents:

- the biodegradability of surfactants in detergents;

- restrictions or bans on surfactants on grounds of biodegradability;

- the additional labelling of detergents, including fragrance allergens; and

- the information that manufacturers must hold at the disposal of the Member States competent authorities and medical personnel.

Article 2 - Definitions

For the purpose of this Regulation:

1. 'Detergent' means any substance or preparation containing soaps and/or other surfactants intended for washing and cleaning processes. Detergents may be in any form (liquid, powder, paste, bar, cake, moulded piece, shape, etc.) and marketed for or used in household, or institutional or industrial purposes.

Other products to be considered as detergents are:

- 'Auxiliary washing preparation', intended for soaking (pre-washing), rinsing or bleaching clothes, household linen, etc.;

- 'Laundry fabric-softener', intended to modify the feel of fabrics in processes which are to complement the washing of fabrics;

- 'Cleaning preparation', intended for domestic all purposes cleaners and/or other cleaning of surfaces (e.g.: materials, products, machinery, mechanical appliances, means of transport and associated equipment, instruments, apparatus, etc.);

- 'Other cleaning and washing preparations', intended for any other washing and cleaning processes.

2. 'Washing' means the cleaning of laundry, fabrics, dishes and other hard surfaces.

3. 'Cleaning' has the meaning defined by EN ISO 862.

4. 'Substance' means chemical elements and their compounds in the natural state or obtained by any production process, including any additive necessary to preserve the stability of the products and any impurity deriving from the process used, but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition.

5. 'Preparation' means a mixture or solution composed of two or more substances.

6. 'Surfactant' means any organic substance and/or preparation used in detergents, which has surface-active properties and which consists of one or more hydrophilic and one or more hydrophobic groups of such a nature and size that it is capable of reducing the surface tension of water, and of forming spreading or adsorption monolayers at the water-air interface, and of forming emulsions and/or microemulsions and/or micelles, and of adsorption at water-solid interfaces.

7. 'Primary biodegradation' means the structural change (transformation) of a surfactant by micro-organisms resulting in the loss of its surface-active properties due to the degradation of the parent substance and consequential loss of the surface-active property as measured by test methods listed in Annex II.

8. 'Ultimate aerobic biodegradation' means the level of biodegradation achieved when the surfactant is totally used by micro-organisms in the presence of oxygen resulting in its breakdown to carbon dioxide, water and mineral salts of any other elements present (mineralisation), as measured by test methods listed in Annex III, and new microbial cellular constituents (biomass).

9. 'Placing on the market' means introducing onto the Community market, thereby making available to third parties, whether in exchange for payment or not. Import into the Community customs territory shall be deemed to be placing on the market.

10. 'Manufacturer' means the natural or legal person responsible for placing a detergent or a surfactant for a detergent on the market; in particular, a producer, an importer, a packager working for his own account, or any person changing the characteristics of a detergent or of a surfactant for a detergent, or creating or changing the labelling thereof, shall be deemed to be a manufacturer. A distributor who does not change the characteristics, labelling or packaging of a detergent, or of a surfactant for a detergent, shall not be deemed to be a manufacturer, except where he acts as an importer.

11. 'Medical personnel' means a registered medical practitioner, or a person working under the direction of a registered medical practitioner, acting to provide patient care, make a diagnosis or administer treatment, and who is bound by professional confidentiality.

12. 'Industrial and institutional detergent' means a detergent for washing and cleaning outside the domestic sphere, carried out by specialised personnel using specific products.

Article 3 - The placing on the market

1. When placed on the market, detergents and surfactants for detergents referred to in Article 1 shall conform with the conditions, characteristics and limits laid down in this Regulation and its Annexes and, where relevant, with Directive 98/8/EC and with any other relevant Community legislation. Surfactants that are also active substances within the meaning of Directive 98/8/EC and that are used as disinfectants are exempt from the provisions of Annexes II, III, IV and VIII of this Regulation provided:

(a) they are listed in Annex I or IA of Directive 98/8/EC, or

(b) they are constituents of biocidal products authorised under Article 15(1) or 15(2) of Directive 98/8/EC, or

(c) they are constituents of biocidal products allowed under the transitional measures or subject to the 10 year work programme provided for in Article 16 of Directive 98/8/EC.

Instead, such surfactants are deemed to be disinfectants and the detergents of which they are ingredients are subject to the labelling provisions for disinfectants of Annex VII A.

2. Manufacturers of detergents and/or of surfactants for detergents shall be established within the Community.

3. Manufacturers shall be responsible for the conformity of detergents and/or of surfactants for detergents with the provisions of this Regulation and its Annexes.

Article 4 - Limitations based on the biodegradability of surfactants

1. Under this Regulation, surfactants and detergents containing surfactants that meet the criteria for ultimate aerobic biodegradation as laid down in Annex III may be placed on the market without further limitations relating to biodegradability.

2. If a detergent contains surfactants for which the level of ultimate aerobic biodegradation is lower than that stipulated in Annex III, manufacturers of industrial or institutional detergents containing surfactants, and/or of surfactants for industrial or institutional detergents, may ask for derogation. Requests for derogation shall be made and decided in accordance with Articles 5, 6 and 9.

3. The level of primary biodegradability shall be measured for all surfactants in detergents failing ultimate aerobic biodegradation tests. Detergent surfactants, for which the level of primary biodegradability is lower than that stipulated in Annex II, shall not be granted derogation.

Article 5 - Granting of derogation

1. The request by a manufacturer for derogation shall be made by sending an application to the competent authority of the Member State concerned, referred to in Article 8(1), and to the Commission, providing evidence relating to the criteria mentioned under Article 6(1). Member States can make the request for derogation dependent upon the payment to the Member State's competent authority of a fee. Such fees, if any, shall be levied in a non-discriminatory way and shall not exceed the cost of processing the application.

2. Applications shall include a technical file supplying all the information and justifications necessary for evaluating the safety aspects related to the specific use of surfactants in detergents failing to comply with the biodegradability limits, as set out in Annex III.

In addition to the results of tests stipulated in Annex III, the technical file shall include information and results of tests, as stipulated in Annexes II and IV.

The tests laid down in Annex IV, point 4 shall be carried out on the basis of a tiered approach. The tiered approach will be defined in a technical guidance document to be adopted in accordance with the procedure referred to in Article 12(2) by 8 April 2007. This guidance document will also specify, where appropriate, those tests for which the principles of good laboratory practice should be applied.

3. The competent authority of the Member State, receiving applications for derogation in accordance with paragraphs 1 and 2, shall examine the requests, evaluate their compliance with the conditions for derogation and inform the Commission about the results within six months of receiving the complete application.

If the competent authority of the Member State deems it necessary for the evaluation of the risk which may be caused by a substance and/or a preparation, it shall, within three months of receiving the application, ask for further information, verification and/or confirmatory tests concerning these substances and/or preparations or their transformation products, of which they have been notified or have received information under this Regulation. The time period for the evaluation of the dossier by the competent authority of the Member State will start only after the dossier is completed with the additional information. If the requested information is not provided within 12 months, the application shall be considered incomplete and thus invalid. In such a case Article 6(2) shall not apply.

If further information on metabolites is sought, stepwise testing strategies should be employed to ensure maximum use of in-vitro and other non-animal test methods.

4. On the basis of, in particular, the evaluation carried out by the Member State, the Commission may grant a derogation in accordance with the procedure referred to in Article 12(2). If necessary, before granting such derogation the Commission shall evaluate further the matters indicated in paragraph 3 of this Article. It shall take its decision within 12 months of receiving the evaluation from the Member State, except in the case of Article 5(4) and (6) of Decision 1999/468/EC where the period shall be 18 months.

5. Such derogations may allow, limit or severely restrict the placing on the market and the use of surfactants as ingredients in detergents, depending on the results of the complementary risk assessment, as defined in Annex IV. They may include a phase-out period for placing on the market and the use of surfactants as ingredients in detergents. The Commission may review a derogation as soon as information comes to light which would justify a significant revision of the technical file that was included in the application for derogation. For this purpose, the manufacturer shall, upon request, supply to the Commission a technical file that has been updated regarding the items mentioned in Annex IV, point 2. On the basis of this updated information, the Commission may decide to prolong, modify or terminate the derogation. Paragraphs 1 to 4 and 6 of this Article and Article 6 shall apply mutatis mutandis.

6. The Commission shall publish the list of surfactants that have obtained derogation, with the corresponding conditions or limitations of use, as provided in Annex V.

Article 6 - Conditions for granting a derogation

1. Where the Commission considers granting a derogation, it shall do so in accordance with the procedure referred to in Article 12(2), and on the basis of the following criteria:

- use in low-dispersive applications, rather than in wide-dispersive applications;

- use in specific industrial and/or institutional applications only;

- the risk to the environment or to health posed by the volume of sales and the pattern of use throughout the Community is small compared to the socio-economic benefits, including food safety and hygiene standards.

2. As long as the Commission has not decided on a request for derogation, the placing on the market and use of the surfactant in question may be maintained, provided the manufacturer can show that the surfactant was already in use on the Community market at the date of entry into force of this Regulation and that the request for derogation was made within two years from that date.

3. If the Commission refuses to grant a derogation, it shall do so within 12 months of receiving from a Member State the evaluation mentioned in Article 5(3), except in the case of Article 5(4) and (6) of Decision 1999/468/EC where the period shall be 18 months. It may set a transitional period during which the placing on the market and use of the surfactant in question shall be phased out. This transitional period shall not exceed two years from the date of the Commission's decision.

4. The Commission shall publish in Annex VI the list of surfactants that have been identified as not complying with this Regulation.

Article 7 - Testing of surfactants

All tests referred to in Articles 3 and 4 and in Annexes II, III, IV and VIII shall be conducted in compliance with the standards mentioned in Annex I.1 and in accordance with testing requirements under Article 10(5) of Regulation (EEC) No 793/93. For this purpose, it is sufficient to apply either the EN ISO/IEC standard or the principles of good laboratory practice, except for those tests for which the principles of good laboratory practice have been made mandatory. In cases where surfactants are used in detergents which were placed on the market before the entry into force of the above standard, existing tests that were performed using the best scientific knowledge available, and that were performed to a standard comparable to those of the standards mentioned in Annex I may be accepted on a case-by-case basis. The manufacturer or the Member State may submit to the Commission any case over which there is doubt or dispute. A decision shall then be taken in accordance with the procedure laid down in Article 12(2).

Article 8 - Duties of the Member States

1. Member States shall appoint the competent authority or authorities responsible for communicating and exchanging information relating to the management of this Regulation and inform the Commission of the full name and address of these authorities.

2. Each Member State shall notify to the other Member States and to the Commission the list of approved laboratories, with their full name and address, that are competent and authorised to carry out the tests required by this Regulation. Member States shall demonstrate the competence of the above laboratories according to the standard EN ISO/IEC 17025 mentioned in Annex I.1. This requirement shall be deemed to be fulfilled if the Member State has verified the compliance of laboratories with the principles of good laboratory practice in accordance with Article 2 of Directive 2004/9/EC.

3. Where the competent authority of a Member State has grounds for believing that an approved laboratory does not possess the competence referred to in paragraph 2, it shall raise the matter in the Committee referred to in Article 12. If the Commission decides that the laboratory does not possess the required competence, the name of the approved laboratory shall be removed from the list referred to in paragraph 4. Article 15(2) shall apply, except in the case of laboratories claiming compliance with the requirements of good laboratory practice, for which the non-compliance provisions of Articles 5 and 6 of Directive 2004/9/EC shall apply.

4. The Commission shall publish the lists of competent authorities, mentioned in paragraph 1, and of approved laboratories, mentioned in paragraph 2, once a year in the Official Journal of the European Union to the extent that changes have occurred.

Article 9 - Information to be provided by manufacturers

1. Without prejudice to Article 17 of Directive 1999/45/EC, manufacturers placing on the market the substances and/or preparations covered by this Regulation shall hold at the disposal of the competent authorities of the Member States:

- information on one or more results of the tests mentioned in Annex III;

- for those surfactants failing to pass tests mentioned in Annex III, and for which a request for derogation was made as referred to in Article 5:

(i) a technical file on results of the tests mentioned in Annex II,

(ii) a technical file on results of the tests and information mentioned in Annex IV.

2. Whenever substances and/or preparations covered by this Regulation are placed on the market, the manufacturer shall be responsible for the correct performance of the relevant tests mentioned above. He shall also have available documentation on the testing carried out to demonstrate compliance with this Regulation, and to show that he is allowed to benefit from the property rights concerning the test results, other than for those test results already in the public domain.

3. Manufacturers placing on the market the preparations covered by this Regulation shall, upon request, make available without delay and free of charge, to any medical personnel, an ingredient datasheet as stipulated in Annex VII C.

This is without prejudice to the right of a Member State to request that such a datasheet be made available to a specific public body to which the Member State has assigned the task of providing this information to medical personnel.

The information contained in the datasheet shall be kept confidential by the specific public body and by the medical personnel, and shall be used only for medical purposes.

Article 10 - Control measures

1. Member States' competent authorities may apply, as appropriate, all necessary control measures to detergents placed on the market which ensure the compliance of the product with the provisions of this Regulation. The reference method shall be the test and analytical methods referred to in Annex VIII. These control measures shall not oblige manufacturers to repeat tests made by laboratories fulfilling the conditions indicated in Article 8(2), or to pay for any repeat or additional test, provided the initial test has shown compliance of detergents, or surfactants used as ingredients in detergents, with this Regulation.

2. In cases of concern that a test carried out in accordance with the methods listed in Annex II, III, IV or VIII has produced false positive results, the Member States' competent authorities shall notify the Commission and the Commission shall, in accordance with the procedure laid down in Article 12(2), verify those results and take the necessary measures.

Article 11 - Labelling

1. The provisions of this Article are without prejudice to the provisions relating to the classification, packaging and labelling of dangerous substances and preparations in Directives 67/548/EEC and 1999/45/EC.

2. The following information must appear in legible, visible and indelible characters on the packaging in which the detergents are put up for sale to the consumer:

(a) the name and trade name of the product;

(b) the name or trade name or trademark and full address and telephone number of the party responsible for placing the product on the market;

(c) the address, email address, where available, and telephone number from which the datasheet referred to in Article 9(3) can be obtained.

The same information must appear on all documents accompanying detergents transported in bulk.

3. The packaging of detergents shall indicate the content, in accordance with the specifications provided for in Annex VII A. It shall also indicate instructions for use and special precautions, if required.

4. Additionally, the packaging of detergents sold to the general public intended to be used as laundry detergents shall bear the information provided for in Annex VII B.

5. In cases where a Member State has a national requirement to label in the national language(s), the manufacturer and distributor shall comply with that requirement for the information specified in paragraphs 3 and 4.

6. Paragraphs 1 to 5 are without prejudice to existing national rules according to which graphic representations of fruits which may lead the user into error as to the use of liquid products, shall not appear on the packaging in which the detergents are put up for sale to the consumer.

Article 12 - Committee procedure

1. The Commission shall be assisted by a committee.

2. 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.

3. The committee shall adopt its Rules of Procedure.

Article 13 - Adaptation of the Annexes

1. The amendments necessary for adapting the Annexes shall be adopted in accordance with the procedure referred to in Article 12(2), and shall, wherever possible, use European Standards.

2. In particular, the amendments or additions necessary for applying the rules of this Regulation to solvent-based detergents shall be adopted in accordance with the procedure referred to in Article 12(2).

Article 14 - Free movement clause

Members States shall not prohibit, restrict or impede the placing on the market of detergents, and/or of surfactants for detergents, which comply with the requirements of this Regulation, on grounds that are dealt with in this Regulation.

Pending further harmonisation, Member States may maintain or lay down national rules concerning the use of phosphates in detergents.

Article 15 - Safeguard clause

1. Where a Member State has justifiable grounds for believing that a specific detergent, although complying with the requirements of this Regulation, constitutes a risk to safety or health of humans or of animals or a risk to the environment, it may temporarily prohibit the placing on the market of that detergent in its territory or make it temporarily subject to special conditions.

It shall immediately inform the other Member States and the Commission thereof, giving the reasons for its decision.

2. After consultation of the Member States, or, if appropriate, of the relevant technical or scientific committee of the Commission, a decision shall be taken on the matter within ninety days in accordance with the procedure referred to in Article 12(2).

Article 16 - Review

1. By 8 April 2007, the Commission shall evaluate, submit a report on and, where justified, present a legislative proposal on the use of phosphates with a view to their gradual phase-out or restriction to specific applications.

2. By 8 April 2009, the Commission shall carry out a review of the application of this Regulation, paying particular regard to the biodegradability of surfactants, and shall evaluate, submit a report on, and, where justified, present legislative proposals relating to:

- anaerobic biodegradation,

- the biodegradation of main non-surfactant organic detergent ingredients.

Article 17 - Legislation to be repealed

1. The following Directives are hereby repealed with effect from 8 October 2005.

- Directive 73/404/EEC;

- Directive 73/405/EEC;

- Directive 82/242/EEC;

- Directive 82/243/EEC and

- Directive 86/94/EEC.

2. Recommendation 89/542/EEC is hereby repealed with effect from 8 October 2005.

3. References made to the repealed Directives shall be construed as being references to this Regulation.

4. On the day of entry into force of this Regulation, Member States shall repeal their laws, regulations and administrative provisions adopted pursuant to the Directives provided for in paragraph 1 or to the Recommendation referred to in paragraph 2.

Article 18 - Sanctions

1. No later than 8 October 2005.

- appropriate legal or administrative measures in order to deal with any infringment of this Regulation and;

- dissuasive, effective and proportionate sanctions for any such infringment.

This shall include measures allowing them to detain consignments of detergents that fail to comply with this Regulation.

2. They shall immediately inform the Commission thereof.

Article 19 - Entry into force

This Regulation shall enter into force 8 October 2005.


This Regulation shall be binding in its entirety and directly applicable in all Member States.