Explanatory Memorandum to COM(2003)117 - Maximum residue levels of pesticides in products of plant and animal origin - Main contents
Please note
This page contains a limited version of this dossier in the EU Monitor.
| dossier | COM(2003)117 - Maximum residue levels of pesticides in products of plant and animal origin. |
|---|---|
| source | COM(2003)117  |
| date | 14-03-2003 |
This proposed draft Regulation of the European Parliament and the Council replaces the four Council Directives on Maximum Residue Levels (MRLs) for plant protection products.
The consequence of this draft Regulation entering into force will be that all MRLs for plant protection products will become harmonised after a transitional phase-in period, and will thenceforth only be set at the European level. It removes all trade barriers that were the result of the current situation whereby Member States can set their own national MRLs in the absence of Community MRLs.
It provides for the role of the European Food Safety Authority (EFSA) and of the Commission in the process of setting MRLs. Risk assessment will become a responsibility of EFSA acting with its network of experts and institutes in the Member States and where EFSA will have the responsibility for giving an opinion on the safety of each MRL. The Commission will be responsible for the risk management, by deciding on the setting of MRLs based on the opinion of EFSA.
Member States authorities will provide EFSA with data on national diets, the authorisations and their agricultural practices. EFSA will base its opinions on assessments of these data, other data obtained in the process of evaluation of active substances under Directive 91/414/EEC and additional data to be supplied by applicants.
MRLs not yet harmonised both for existing and new substances, previously set at the national level will be compiled by EFSA, screened for their safety based on the data available and set as temporary MRLs. These MRLs will be revisited on a substance-by-substance basis after the final conclusions on each of the 91/414/EEC evaluations.
In all cases where there is no use of a pesticide on a commodity or when no data are available to demonstrate that residues do not endanger consumer health, no residues may be permitted at levels higher than 0.01 mg/kg which is an enforceable default for zero. Exceptions will be made for substances where a level of 0.01 is not safe for the consumer by setting MRLs at a lower level
Objectives of proposal:
The primary objectives of the proposal are to consolidate and to simplify the existing legislation in this area and to define the roles of the different actors, particularly that of the EFSA in the process. To this end, existing legislation was examined in the fifth Simpler Legislation for the Internal Market (SLIM V) exercise of the Commission during 2001, the recommendations of which are incorporated in the proposal. A secondary objective is to solve existing practical, Single Market and third-country trade problems.
Main issues addressed in proposal:
The proposal:
1. Takes into account problems encountered in the practical implementation of the existing directives.
2. Acts on the issues raised in the Report of the Commission to the Council on the implementation of Articles 7 and 4 respectively of Council Directives 86/362/EEC and 90/642/EEC, concerning the monitoring of pesticides residues (COM/2000/98 final).
3. Is in line with the conclusions of the Agriculture Council of 20 November 2001 and the Environment Council of 12 December 2001 in response to the Report of the Commission on progress in evaluating active substances under Council Directive 91/414/EEC (COM/2001/444 final), both of which call on the Commission to propose amendments the residues directives. It also responds to the resolution of the European Parliament of 30 May 2002 and also adopted in response to the Report of the Commission.
4. Sets the groundwork to prepare the Commission and the Member States to deal more effectively with the extensive workload expected in and after 2003 in the framework of Council Directive 91/414/EEC when several hundreds of active substances of plant protection products will be withdrawn from the market and where MRLs will need to be set for food commodities in the absence of the all of information required to guarantee an adequate protection of the consumer (use of default MRL of 0.01 mg/kg).
5. Uses the new comitology procedures.
6. Takes note of developments outlined in the White Paper on Food Safety including but not limited to those regarding the European Food Safety Authority established by Regulation 178/2002 of the Parliament and the Council as well as its competence in matters of risk assessment and the provision of independent scientific advice.
7. Establishes a framework within which Member States can set fees for the evaluation of dossiers. The resources needed for this area of work are expected to increase dramatically in the future and the current legislation does not provide a basis to recover the costs incurred.
8. Establishes a framework within which the Commission and the Member States can work with the European Food Safety Authority in this area - separating risk assessment from risk management.
9. Takes account of the provisions of the Commission proposal for a Regulation of the Council and the European Parliament on official feed and food controls.
10. Takes into account the recommendations of the SLIM V exercise of 2001.
11. Allows for the possibility that in some cases MRLs can be set on the basis of monitoring data.
Contents
- 12. Allows for the possibility that in some cases, the normal shelf-life of products should be considered in fixing dates of entry-into-force of MRLs
- Why choose 0.01 mg/kg as a default MRL?
- MRL status on 9/1/2003 of substances under evaluation under Directive 91/414/EEC
- Under what circumstances can and should MRLs be deleted?
- Under what circumstances can and should MRLs be set?
12. Allows for the possibility that in some cases, the normal shelf-life of products should be considered in fixing dates of entry-into-force of MRLs
13. Allows for the possibility to set import tolerances where different agricultural practices outside the European Union lead to different residue levels on imported products.
14. Repeals the original 4 Directives and replaces them with a single Regulation.
15. Establishes transitional measures for setting temporary MRLs of active substances that have not yet been evaluated in the framework of Council Directive 91/414/EEC on the placing of plant protection products on the market and in doing so, removes the competence of Member States to act unilaterally in this area of food safety.
Overview of legislation on pesticides MRLs:
Legislation on pesticide residues in food and feed includes provisions for the setting of maximum residue levels, for sampling as well as for monitoring, control and reporting. Residues in babyfood are covered by separate legislation and using a different approach.
Setting of MRLs:
Pesticides MRLs are currently set in four Council Directives: 76/895/EEC (for some crops and categorised by customs codes - not a satisfactory directive by today's standards), 86/362/EEC (cereals), 86/363/EEC (products of animal origin) and 90/642/EEC (products of plant origin other than cereals).
With about 160 crops and up to 1,000 pesticides in or out of use, then up to 160,000 MRLs are possible for raw commodities (including animal feed). The Community is gradually harmonising all of these (see status below). The directives also permit Member States to act at national level pending Community decisions on individual MRLs. The directives also allow MRLs to be set for processed and for composite foods. In practice this is not done at Community level for logistics reasons although the Community does step in where there are problems. Processing factors for individual substances are normally agreed during the evaluation of a 91/414/EEC dossier and are used in the consumer intake assessments performed to check the acceptability of a MRL.
Matters are complicated by the fact that Council Directive 91/414/EEC on the placing of plant protection products on the market also permits Member States to set MRLs when granting national authorisations of plant protection products. It includes a procedure to ensure that the residues directives take account of such MRLs. Furthermore, under WTO rules introduced late in the 1990's, Codex MRLs should be respected. Many Codex MRLs are not acceptable to the Community, particularly those set prior to the late 1990's but where the Commission did not formally object to them at the time. Therefore the Authority will have to critically examine on a case-by-case basis whether Codex MRLs ensure the same high level of sanitary protection that would be expected from Community MRLs.
1.1.1. Objective of setting an MRL:
Extract from Foreward to FAO Guidelines on Pesticide Residue Trials to provide Data for the Registration of Pesticides and the Establishment of Maximum Residue Levels
Adequate data from properly conducted trials involving agricultural plants or farm animals intended for the production of food are needed to establish the parameters of 'good agricultural practices in the use of pesticides'. The levels of residues of pesticides remaining unavoidably in food products entering trade following such practices, form the basis for setting maximum residue levels. It is important that the results of residue analysis in supervised trials relate to those chemical species in the residue which are relevant for the purpose of setting maximum residue levels. It is equally important that the food products examined, as well as portions thereof examined, be relevant to the commodity moving in trade. Other aspects should also be borne in mind during pesticide residue trials, which have a bearing on the usefulness of the residue data used in setting maximum residue levels.
MRLs for pesticides used in plant protection products have been set by the Community since 1976 to facilitate trade. Unusually by the standards of today, the 1976 Directive permits Member States to set MRLs at higher levels than the Community ones but not at lower levels. In this respect, these older pesticides MRLs differ from the more recent directives where MRLs are primarily set to protect the consumer. however, the MRL is normally set for the product moving in trade and not for the product as consumed by the consumer e.g. dried tea leaves vs. the liquid beverage.
1.1.2. How MRLs are set:
Generally, an authorisation for use of a pesticide will only be given on the basis of submitted scientific data showing that the use is safe for the user, the environment and the consumer. The consumer assessment part of the procedure relates to data on the residues in the crop from supervised trials data. If, inter alia, the proposed conditions of use result in residue levels that are safe for the consumer, then (i) an authorisation for use specifying the use conditions ('good agricultural practice' - GAP) can be issued and (ii) a MRL can be set and the product can move in trade.
The mechanisms and methods used to fix MRLs are fairly well-standardised at Community level and well-developed data requirements exist. Various authorised uses in one or more countries or regions on a given crop may give rise to various levels of residues. The GAP giving rise to the highest levels (the so-called critical GAP) is used to set the MRL as all other authorised uses should be covered by it. If the residues arising from the critical GAP are not safe for the consumer, then that use is not authorised and the next critical GAP is examined.
In a minority of cases where residues might be expected but where there are no authorised uses e.g. from environmentally persistent substances such as DDT, then MRLs can be set (provided they are safe for the consumer) using monitoring data that is regularly reviewed. There have also been calls for the Commission to set MRLs using monitoring data for substances still in use for minor commodities e.g. spices and where residues arise as adventitious contamination e.g. honey. This proposal opens up this possibility.
Since risk is a combination of hazard and exposure, then due to differences in national eating habits, an acceptable consumer assessment in one country may not be acceptable in another. In the Community, diets in all Member States are examined when setting MRLs and intakes by adults, children and toddlers are assessed. Total intake of a substance from all dietary sources is examined every time a MRL is set for a substance on a crop. Acceptable methodologies are not yet available to systematically look at aggregate exposure (from other sources such as home and workplace) or cumulative exposure (intake from all dietary sources of similarly-acting substances). These are being developed.
1.1.3. What the setting of a MRL at the Limit of Determination (LOD) signifies:
The LOD is the lower limit of analytical determination i.e. the limit below which residues cannot be detected using suitable analytical methods in accredited laboratories and following agreed quality assurance guidelines and criteria. The LOD is therefore dependent on the substance, the method and the matrix. For example, LODs for substances in oily crops such as nuts or oilseeds are often higher than those in watery crops because of analytical difficulties. The LOD needs to be carefully defined to ensure that legal enforcement measures seen to be neither arbitrary nor capricious.
Setting a MRL at the LOD is not equivalent to banning a substance and conversely, banning a substance does not mean that the MRL is set at the LOD. For many of the cases where MRLs are set at LOD, the MRLs could be increased without compromising consumer safety. There are eight cases where MRLs would normally be set at the LOD.
(a) No residue expected because obsolete: The substance is obsolete and is no longer used anywhere. This would also normally preclude that residues would be present on products but illegal uses cannot be excluded nor that contamination may occur from old stocks. No judgement needs to be made in such cases on the consumer-protection aspects of the acceptability of residues.
(b) No residue expected and no residue wanted: Following an evaluation, the use of the substance is banned in the Community because e.g. its residues are genotoxic. Residues on imported products would also be unwelcome.
(c) No residues expected because of use pattern: Following an evaluation, it has been demonstrated that the authorised uses of the substance do not leave residues in the harvested crop e.g. it is used as a soil or seed dressing or if residues degrade quickly. This could also apply to animal-origin products if a substance is used on crops that are not fed to animals.
(d) No residues expected because not (yet) used on certain crops: Particularly for new substances, in early years only a few major crops e.g. cereals would be treated. For untreated crops, no residues would be expected. As new uses are developed, the LODs for those latter crops would have to be reviewed. This will also be true in future for existing substances because, with the loss of half of all existing substances in 2003, the others will find wider uses.
(e) No residue expected because no longer authorised for use in the Community: In 2003, about 400 substances will have been withdrawn from the market and most withdrawals will have been for economical reasons (and without any prior evaluations) rather than because of concerns. They might still be used in third countries and residues could be present on imported produce.
(f) Existing high residue levels are possibly unsafe (although lower levels would be acceptable): Often new data becomes available showing that a substance is not as safe as formerly thought and that existing MRLs for some crops are too high. In these cases, the MRLs need to be reduced to safe levels. If a good agricultural practice exists giving rise to the lower safe levels then the MRL can be reduced. If not, then the MRL is set at LOD as a precautionary measure. If afterwards, a new GAP is developed giving rise to low, but safe, residue levels then the MRL can be increased again.
(g) Where a substance is banned because of environmental or worker safety considerations then MRLs would also normally be set at the LOD. However, there may be safe consumer exposure levels and residues could be accepted on (i) imported produce and (ii) domestic or imported produce where soil is contaminated and persistent residues are taken up by crops e.g. DDT. In both cases a consumer safety assessment would be required. In addition, in the former case, one cannot under WTO rules use MRLs to block trade where an assessment shows that allowing the imports would protect the consumer. In the latter case the MRLs would be set using monitoring data that is regularly reviewed.
(h) Insufficient data: Where the minimum data requirements to set a MRL are not met for a substance/crop combination, then a policy decision can be taken to set the MRL at LOD (see below). When additional data becomes available, the need to set a higher MRL can be reconsidered.
1.1.4. Use of default LOD:
Various approaches exist around the world on the use of a default MRL for non-authorised uses.
One approach e.g. U.S.A., Codex, sees MRLs being set (whether at LOD or at a higher level) only where adequate data is available. In its absence, there is no MRL and no possibility of trade. It supposes that in all cases where any residues are detected and where there is no MRL, the result will be confiscation of the consignment. In the absence of agreed certified analytical methods for each substance/matrix combination, this approach is open to capricious use and a strong risk of trade problems. A variation of this policy approach is to allow trade in the absence of a MRL with the intention of eventually setting a MRL.
A second approach e.g. Germany, sees a default MRL of 0.01 mg/kg being applied to everything unless a specific higher MRL has been established for a particular crop/substance combination. This has the advantage of protecting against the unforeseen but also gives rise to trade problems for imported produce - especially for produce treated with new pesticides that have not been used and not yet evaluated in the country of destination. Canada currently applies this approach with a default of 0.1 mg/kg but is currently considering moving to the U.S.A. approach.
The Community approach up to now has been to gradually set MRLs for every substance and once these MRLs have been set for a substance then these Community MRLs apply everywhere. This approach allows national policies and MRLs to apply for the substances not yet harmonised at Community level. A drawback of this is that it means different policies and different MRLs in each Member State for many substances and this results in continuing trade problems in the Internal Market. When setting MRLs for a substance, the current Commission approach is to explicitly set MRLs at the LOD for those crops for which there is no or insufficient data. This approach in itself requires data (on the definition of the residues, on analytical methods etc) but such data is normally available from the dossiers on the other crops for which MRLs are being set. Setting a default MRL at or near the LOD also gives Member States an additional legal instrument with which illegal uses of pesticides can be controlled.
The approach initially proposed for the future was based on the U.S.A. one. This was supported by SLIM but rejected by the Member States. The approach now proposed is similar to the Canada/Germany one. The new default approach is necessary because of the hundreds of substances being withdrawn from the market in 2003 for which we do not have the necessary residue and analytical data to set explicit MRLs. However, the use of a Community default MRL is not compatible with the practice of letting Member States set national MRLs for those substances still in use but for which Community MRLs have not yet been set. The proposal includes provisions for temporary MRLs in these cases (see Single Market Issues below).
Since many residues can be detected with modern sophisticated methods at levels lower than 0.01 mg/kg, the question is often asked as to why this level is conventionally set at 0.01 mg/kg.
Firstly, it is not possible to set MRLs at zero because there is no analytical method that is capable of detecting zero levels of residues and background analytical noise and uncertainty increase as zero is approached. Actual detection limits are dependent on the matrix, the substance and the analytical method. It is not practical to determine and to certify these individually for the more than 160,000 possible combinations. Therefore a default needs to be selected and from practical experience this is 0.01 mg/kg. A lower value may not be attainable for certain substance/matrix combinations and a higher default value is not necessary.
Secondly, for almost all cases investigated of pesticides in use, a MRL at 0.01 mg/kg is protective of the consumer. In exceptional case where this may not be true, a lower level could be explicitly set.
Thirdly, monitoring laboratories do not have the resources to routinely examine every possible crop/substance combination and they have to prioritise their efforts. They normally use certified multi-residue methods for screening levels of more than a hundred substances at a time in any one commodity and can look at e.g. up to 50 samples in any one run. Multi-residue methods are not as sensitive as targeted methods that can only detect one substance at a time but at much lower levels than the multi-residue methods which are generally able to detect levels down to 0.01 mg/kg. It is considered that screening 50 samples for more than a hundred substances each is more protective of the consumer than spending the same time analysing 10 samples for one substance. An exception is where there is a suspected infringement or a rapid alert - in which cases a more targeted sampling and analysis can be made.
Sampling:
Sampling for pesticides residues in products of plant origin was covered by Commission Directive 79/700/EEC. This was recently repealed and replaced by Commission Directive 2002/63/EC which (i) extended sampling provisions to include pesticides in products of animal origin and (ii) incorporated into EC legislation the sampling provisions of Codex that the Community agreed to in 2000. Article 33 of the proposal addresses sampling.
Monitoring, reporting and control:
The objectives of monitoring are two-fold. Firstly, monitoring is done to permit an estimation to be made of the real exposure of consumers to pesticides residues. The second objective of monitoring to ensure compliance (i) with existing Community and national MRLs and (ii) to guard against illegal use of pesticides. MRLs are set on the basis of data arising from legal authorised uses and, as a corollary, in this sense the legally permitted residues should not be considered as contaminants.
In the Community, national monitoring programmes are complemented by a co-ordinated Community monitoring programme which has as its first objective to estimate the exposure of consumers to pesticides residues. Monitoring is done at all points in the food production and distribution chain. To cover all major pesticides and crop groupings, monitoring programmes have been organised over a five-year period. The first such period has just expired and a contract is being prepared to analyse the results.
MRLs for babyfood:
The above-mentioned existing Community legislation on MRLs applies without prejudice to the babyfood directives (Directives 91/321/EEC and 96/5/EC) where MRLs are also set. It differs from them in several respects.
1. The basic intention of the legislation on Baby Food is to control the production chain in order that no pesticides are used in the manufacturing process. In absence of ways to directly control this MRLs are set at such levels that do not permit the use of pesticides.
2. Babyfood legislation applies a default MRL of 0.01 mg/kg unless other (higher or lower) MRLs are explicitly set (this is the approach proposed in the current proposal);
3. Babyfood MRLs apply to a specific sector rather than to all of the population;
4. Since babyfoods are often composite, processed foods, the MRLs are set and are applicable for the food to be eaten and calculated as the whole diet. The toxicological endpoint (acceptable daily intake) is the starting point. In the MRL directives, GAP is the starting point and the MRLs apply to the raw commodity (or part thereof). Processing/composition factors are applied for the consumer intake assessment.
This different approach is justification not to include babyfood MRLs in the current proposal.
Objectives to be attained by proposed measures:
Consolidation:
Four Council Directives and most of their provisions are being replaced with a single Regulation of the European Parliament and the Council.
Simplification:
The SLIM recommendations are taken up in the proposal which is a Regulation rather than a Directive. Many of the procedures in the existing directives have been simplified in the proposal.
Legal basis for expenditure:
The current directives do not contain any legal basis for expenditure and, in 2002, it was considered appropriate to use the veterinary model as a basis for drafting new text.
In the area of pesticides residues there are two types of Community expenditure. One relates to monitoring, enforcement and control and the second is related to the development of technical guidelines, data requirements and methods to set MRLs. Although the second type of work should be transferred to the EFSA as soon as it becomes operational, a legal basis is still required for the first category and expenditure in the second category will still be required during the transition period during which EFSA becomes operational. Therefore, the proposal covers both types, recognising that the second type could be removed in the medium-term.
Single Market issues:
The biggest Single Market problem is related to the non-harmonised substances and the different national policies and MRLs governing them. In addition, uses of 461 substances will be withdrawn in 2003 and a harmonised approach to setting their MRLs in the absence of specific data, as well as to dealing with imports from third countries will be necessary. It can be seen from the Table below (penultimate row in rightmost column) that at the end of 2003, there will be a withdrawal from the market of about 386 substances for which there are no Community MRLs. Since most will be withdrawn because of lack of data, it will be impossible to set explicit MRLs for them on a substance by substance basis. A default MRL at LOD approach together with the setting of import tolerances where appropriate, is the only realistic way to control them. This approach would also apply to 75 substances to be withdrawn for which we currently have harmonised Community MRLs.
The problem with applying the default LOD approach will lie with the 388 substances that will remain on the market but for which MRLs are not yet harmonised (middle row, rightmost column). Their uses, currently covered by national MRLs, would be blocked by the application of a default LOD. Therefore, the proposal includes an annex of temporary MRLs that will be based on the existing national MRLs. Filling this annex is not a trivial task (screening of MRLs in 15 Member States times up to 388 substances times up to 160 crops) and it could be one of the first tasks given to the EFSA. Since there are not yet any agreed Community (or even Codex in almost all cases) toxicological endpoints for the substances, then national (or JMPR or OECD) data would have to apply in the first instance. The setting of temporary Community MRLs carries a risk that some of the national MRLs upon which they are based may be unsafe. However, it should be recalled that (i) 91/414/EC dossiers will be available or forthcoming for all of them, (ii) unsafe MRLs will be identified by EFSA, the Commission or the Member States and will be reduced accordingly and (iii) since the MRLs already apply then the situation for the consumer will not be any worse than at present during the temporary transition period and (iv) this proposal includes a safeguard clause. The proposal foresees that as soon as a substance is evaluated under 91/414/EEC and Community toxicological endpoints are agreed, then the temporary national-based MRLs will be deleted from that annex and new Community MRLs will be fixed based on the agreed 91/414/EEC endpoints. Under this scheme, all Community MRLs will be harmonised in one way or the other and there should be no more trade problems in the Community due to this issue.
>TABLE POSITION>
Coherence with Directive 91/414/EEC:
Directive 91/414/EEC on the placing of plant protection products on the market is the primary piece of Community legislation for plant protection products and their active substances. It provides for a Community evaluation of the active substance and for Member States to evaluate and authorise the uses of products containing them - using agreed hazard endpoints and risk assessment criteria. The Commission cannot authorise uses (it can oblige Member States to withdraw uses however) and Member States consistently invoke the principle of subsidiarity on every occasion that they feel their competence to authorise uses is threatened. In the 1990's, the Community assessment of active substances almost ground to a halt while trying to evaluate all uses of each substance. The scope of the assessments went beyond what was foreseen in the directive but it was felt that as much as possible should be done at Community level. This view and approach has changed as a result of experience. More recently, the focus is on a limited range of representative uses when assessing active substances at Community level.
Directive 91/414/EEC allows Member States full control of all authorisations e.g. whether for use of an insecticide on an edible crop, a herbicide along railway tracks and motorways, or as a growth regulator in parks and sports arenas. In allowing any use, Member States have to ensure that users, bystanders, soil, non-target terrestrial and aquatic animals and plants, succeeding crops, water, air, and consumers are protected. In the latter case, MRLs are required and, for new active substances and for substances in its Annex I, the Directive permits Member States to set provisional MRLs pending a notification to EFSA and a later endorsement from the Commission after comitology.
The current proposal takes account of this possibility but modifies the current procedure - recognising that an amendment of Directive 91/414/EEC is also necessary. In addition, the proposal blocks the Member States from setting MRLs in future.
The proposal also recognises the need for coherent timing of decisions on substances in the two sets of legislation. Annex I inclusion decisions under Directive 91/414/EEC often include risk mitigation measures and in any case always oblige Member States to review all existing authorisations in the light of the new agreed 91/414/EEC endpoints and the uniform principles for risk assessment in Annex VI of that Directive. The proposal provides that MRLs would normally be set for active substances after their inclusion in Annex I to the Directive because full assessment reports would then be available (excluded substances would have MRLs set at the LOD after allowing for sell-out or phase-out periods).
On a related matter, the proposal also recognises that, under the current legislation, when MRLs are reduced for reasons other than health concerns, then produce on the market could become illegal from one day to the next. This is particularly problematic for produce which has a long shelf-life and the proposal provides for phase-in dates to resolve the problem in cases where there are no health concerns.
Key dates:
The key date for Directive 91/414/EEC is 2003 (withdrawal of about 400 substances from the market). Another key date is 2008 (finalisation of review programme and start of re-evaluations).
The key date for residues legislation is 2004. At this time, decisions have to be made on MRLs for about 400 substances used on crops during 2003 but that in 2004 are no longer on the market. Decisions also have to be made on MRLs for up to 388 substances still on the market but with national MRLs. Since at least one Member State has stated that it would ban, in 2004, all trade in commodities containing residues of the 388 substances, a Community solution before that time would be desirable.
Roles and procedures:
Role of the European Food Safety Authority (EFSA):
EFSA should take on those tasks related to risk assessment of plant protection products under Directive 91/414/EEC and the risk assessment of pesticides residues under the pesticides residues legislation.
Given the fact that EFSA is not yet operational, the approach taken in drafting the current proposal was to ensure that the present work continues and that the transition to EFSA be as smooth as possible. Therefore, the text is as specific as possible about the role of EFSA without always explicitly detailing the exact procedures and timelines under which EFSA should work in this area. Although these details will eventually be necessary, the proposal provides that they can be adopted as implementing measures through comitology at a later stage. The proposal foresees two additional tasks for EFSA.
Firstly, it should be recalled that one of the objectives of pesticide residue monitoring is to assess actual consumer exposure to residues. Since this exposure, coupled to the hazard profile of a substance, is what determines risk, then it is considered proper that this task be handled by the EFSA which will be well-placed to modify the design and requirements of monitoring programmes so as to improve its risk estimates. The task of compiling, analysing and publishing the monitoring data and reports, currently managed by the Commission, is proposed to be transferred to EFSA and this is also considered to be consistent with the risk communication remit of EFSA.
Secondly, risk can only be properly assessed if all the data elements are available. On the exposure side of the risk equation, detailed data on dietary intakes from all sources (all food types - including portion sizes - as well as water and other sources) are required. Therefore, the Regulation proposes that EFSA maintain a database of all uses of plant protection products in the Community to complement a second database on dietary intakes of each type of food among various population subgroups. It will be well-placed to maintain this information through its complementary activities on the assessment of plant protection products under Council Directive 91/414/EEC and on intakes of other substances in food.
Role of the Commission :
The Commission will be responsible for risk management, by deciding on the setting of MRLs taking into account the opinion of EFSA. This will not be an automatism relying fully on EFSA's judgement. The Commission has its own responsibility will have to verify the risk assessment and the opinion of EFSA. Apart from setting MRLs the Commission shall also make proposals for Monitoring Decisions and publish guidelines for submission of data, methods of sampling etc.
Normally MRLs would be deleted (i) where there are no authorised uses or (ii) where there is insufficient data on which to set a MRL, or (c) where there is evidence that a MRL is not safe for the consumer (see also the discussion on default MRLs above). Under all these circumstances, the default MRL of 0.01 mg/kg would apply. However, there may be circumstances where an assessment shows that a MRL of 0.01 mg/kg would not be protective of the consumer. In such cases, a specific, lower MRL could be set.
The proposal foresees two types of MRL - fixed and temporary. Fixed MRLs are foreseen for all existing MRLs in Directives 86/362/EEC, 86/363/EEC and 90/642/EEC - irrespective of their 91/414/EEC inclusion status and of whether the substances are considered as existing or new in the context of Directive 91/414/EEC. These MRLs can actually be modified at any time and all would be reviewed case-by-case after 91/414/EEC inclusion or exclusion decisions. To avoid continuing trade problems in the Single Market, temporary MRLs are foreseen to be created in a one-off exercise for all existing substances for which there is not yet a Community MRL as well as for substances with MRLs in Directive 76/895/EEC. These would be reviewed and either transferred to the fixed-MRL annex after a 91/414/EEC Annex I inclusion decision, or deleted after an exclusion decision. Temporary MRLs would also be set for new active substances prior to a 91/414/EEC Annex I decision where Member States have issued provisional authorisations under that directive. These would also be reviewed, and either transferred to the fixed-MRL annex after an Annex I inclusion decision, or deleted after an exclusion decision
The existing legislation provides for a number of circumstances under which the Commission or the Member States can set MRLs. That number is reduced in this proposal, as is the competence of Member States to set MRLs. Assuming that default LOD approach of the proposal is adopted, then there are five (eventually to be reduced to four) sets of circumstances under which MRLs are required and which are foreseen in the proposal. The five sets of circumstances are, as well as the proposed approaches to deal with them, illustrated graphically on the following pages in the diagrams accompanying the text. They are:
1. New or changed use for a substance (Article 22).
2. Import tolerances (Article 29).
3. One-off creation of an annex of Temporary MRLs (Article 24).
4. Cases of concern (Article 42).
1. New or changed use for a substance:
This is foreseen as the normal or standard procedure for setting MRLs. Where a new or changed use for a substance is developed (Article 22 of proposal), MRLs often need to be modified. Annex I inclusion decisions under Directive 91/414/EEC often include risk mitigation measures and in any case always oblige Member States to review all existing authorisations in the light of the newly-agreed 91/414/EEC endpoints and the uniform principles for risk assessment in Annex VI of that Directive. Hence, many such cases are foreseen. In these cases, a 91/414/EEC dossier and assessment report would be available already and the extra workload for any one individual use would normally be marginal. In addition, due to the withdrawal of so many substances, new extensions of uses of the remaining existing substances should become a very common practice - even before annex I decisions are taken. Since a default LOD will be already in place for a new use, an upwards revision of the MRL would be necessary.
For a changed use of a new or existing substance after Annex I inclusion, the MRL could need changing in either direction. Article 4.1.f of Directive 91/414/EEC already allows Member States to do this nationally but on a provisional basis. This possibility will be removed by the proposed Regulation and the normal procedure will have to be followed. It is anticipated that Member States will object strongly to this but their concerns can be allayed if there are guarantees that such MRLs can be set quickly at Community level.
Where a new use for a new substance is developed in a Member State, this procedure also applies. Most new substances are developed and assessed initially for one or two major crop types and in the first instance are only introduced into one Member State. The 91/414/EEC assessment process takes several years and during this period the substance can be introduced into other Member States with different growing conditions or pest pressures. Articles 4.1.f and 8.1 of Directive 91/414/EEC provide that Member States may issue provisional authorisations and, where appropriate, provisional MRLs (this possibility has to be removed in the amendment of Directive 91/414/EEC). In addition, as experience is gained, extension to other crops is common and even expected. Since a default LOD will be in place, an upwards revision of the MRL would be necessary - in many cases even before Annex I inclusion. In such cases, temporary MRLs would be set pending Annex I decisions under 91/414/EEC.
Currently, where there is no harmonised MRL at Community level, Article 8.2 of Directive 91/414/EEC permits Member States to authorise new or extended uses of existing active substances and to set national MRLs pending the eventual harmonisation of MRLs for the substance at Community level. This proposal will not permit this in future as the national MRLs will be replaced by temporary Community MRLs (see case 3 below). The procedure outlined here would also apply to the modification of temporary Community MRLs.
2. Import tolerances:
There are three cases where import tolerances would be required (Article 29 of proposal).
(a) Where an importer wants to import a commodity containing residues of a substance used in the Community but where the commodity is not produced in the Community e.g. papayas. In this case there would usually be expertise (Rapporteur Member State) and 91/414/EEC data in the Community and the additional workload would be slight-to-moderate.
(b) Where an importer wants to import a commodity treated with a substance no longer or not yet used in the Community. In this case, there would normally not be expertise in the Community and full toxicological and residues data would be required. A significant workload would be expected for each individual evaluation - for which there could be many due to our withdrawal of 461 substances from the market. An exception would be for substances that had been evaluated at Community level and which were withdrawn for reasons of consumer protection e.g. because they were genotoxic. For the small number of cases where this has happened, no import tolerance could be considered.
(c) Where an importer wants to import a commodity treated with a substance in use in the Community but where the foreign GAP gives higher residues than the Community critical GAP. In this case, marginal data specific to the GAP for the crop would be needed since a dossier and Rapporteur Member State would be available. The additional workload would be slight.
3. Temporary MRLs:
Temporary MRLs (Article 24 of proposal) are required for non-harmonised substances that are still in use in the Community as a pre-requisite to applying a default LOD policy for the up to 500 substances that will be withdrawn from the market. Their use is discussed more fully in the main body of the text in the context of the Single Market. It is envisaged that such MRLs be deleted after 91/414/EEC Annex I inclusion decisions are taken and that they be then replaced with fixed MRLs.
This temporary category would include MRLs that have already been set in Directive 76/895/EEC since Member States are allowed to set higher MRLs arnd therefore they are not fully harmonized MRLs. When they were set these MRLs were not always backed up by data meeting the quality standards required today.
4. Cases of concern:
In cases of concern (Article 42 of proposal), where a Member State or other party has new information indicating that an existing MRL may not be safe and needs to be revised downwards (with or without triggering a safeguard clause). For example, new toxicological data may require that the acceptable daily intake (ADI) or the acute reference dose (ARfD) be revised downwards or new dietary information may become available indicating that people are eating more of a certain commodity than was estimated during the intake assessment. As a temporary risk management measure, the MRL could be reduced downwards pending an assessment of the data and a final decision on a new MRL.