1.2.2005 EN Official Journal of the European Union C 25 E/1 I (Information) COUNCIL COMMON POSITION (EC) No 1/2005 adopted by the Council on 19 July 2004 with a view to the adoption of Regulation (EC) No.../2005 of the European Parliament and of the Council of... on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC (Text with EEA relevance) (2005/C 25E/01) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EURO- residues in and on foodstuffs of animal origin (5), and PEAN UNION, Council Directive 90/642/EEC of 27 November 1990 on the fixing of maximum levels for pesticide residues in and on products of plant origin, including fruit and Having regard to the Treaty establishing the European Com- vegetables (6), have been substantially amended several munity, and in particular Articles 37 and 152(4)(b) thereof, times. In the interests of clarity and simplicity, those Directives should be repealed and replaced by a single act. Having regard to the proposal from the Commission, Having regard to the opinion of the European Economic and Social Committee (1), (2) Differences in national maximum residue levels for pesti- cides can pose barriers to trade in products included in Having consulted the Committee of the Regions, Annex I to the Treaty and products derived therefrom between Member States and trade between third coun- tries and the Community. Accordingly, in the interest of Acting in accordance with the procedure laid down in Article free movement of goods and equal competition condi- 251 of the Treaty (2), tions among the Member States, as well as consumer protection, it is appropriate that maximum residue levels (MRLs) for products of plant and animal origin be set at Whereas: Community level. (1) Council Directive 76/895/EEC of 23 November 1976 relating to the fixing of maximum levels for pesticide residues in and on fruit and vegetables (3), Council Direc- tive 86/362/EEC of 24 July 1986 on the fixing of (3) A Regulation establishing MRLs does not require trans- maximum levels for pesticide residues in and on position into national law in the Member States. It is cereals (4), Council Directive 86/363/EEC of 24 July therefore the most appropriate legal instrument with 1986 on the fixing of maximum levels for pesticide which to set MRLs for pesticides in products of plant and animal origin, as its precise requirements are to be (1) OJ C 234, 30.9.2003, p. 33. applied at the same time and in the same manner (2) Opinion of the European Parliament of 20 April 2004 (OJ C 104 E, throughout the Community and accordingly permit a 30.4.2004), Council Common Position of 19 July 2004 and posi- more efficient use of national resources. tion of the European Parliament of .......... (not yet published in the Official Journal). (3) OJ L 340, 9.12.1976, p. 26. Directive as last amended by Regu- (5) OJ L 221, 7.8.1986, p. 43. Directive as last amended by Directive lation (EC) No 807/2003, (OJ L 122, 16.5.2003, p. 36). 2004/61/EC. (4) OJ L 221, 7.8.1986, p. 37. Directive as last amended by Commis- (6) OJ L 350, 14.12.1990, p. 71. Directive as last amended by Direc- sion Directive 2004/61/EC, (OJ L 127, 29.4.2004, p. 81). tive 2004/61/EC. C 25 E/2 EN Official Journal of the European Union 1.2.2005 (4) The production and consumption of plant and animal 2002 laying down the general principles and require- products play a very important role in the Community. ments of food law, establishing the European Food The yield from plant production is continually being Safety Authority and laying down procedures in matters affected by harmful organisms. It is essential to protect of food safety (3). plants and plant products against such organisms, not only to prevent a reduction in yield or damage to them but also in order to ensure the quality of the products harvested, to increase agricultural productivity, and to protect the natural environment by limiting the surface (9) In addition to those basic rules, more specific rules are area needed for agricultural production. needed to ensure the effective functioning of the internal market and trade with third countries in relation to fresh, processed and/or composite plant and animal products intended for human consumption or animal (5) One of the most important methods of protecting plants feed in which pesticide residues may be present, whilst and plant products from the effects of harmful organ- providing the basis for securing a high level of protec- isms is the use of active substances in plant protection tion for human and animal health and the interests of products. However, a possible consequence of their use consumers. Such rules should include the establishment may be the presence of residues in the treated products, of specific MRLs for each pesticide in food and feed in animals feeding on those products and in honey products and the quality of the data underlying these produced by bees exposed to those substances. It is MRLs. necessary to ensure that such residues should not be present at levels presenting an unacceptable risk to humans and, where relevant, to animals. (10) Notwithstanding the fact that the principles of the general food law laid down in Regulation (EC) No 178/ 2002 apply only to feed for food-producing animals, in (6) Council Directive 91/414/EEC of 15 July 1991 view of the difficulty of segregating products to be used concerning the placing of plant protection products on as feed intended for animals which are not destined for the market (1) provides that Member States, when issuing food production and in order to facilitate the control authorisations, are to prescribe that plant protection and the enforcement of the provisions of this Regu- products be used properly. Proper use includes the appli- lation, it is appropriate to apply them also to feed which cation of the principles of good plant protection practice is not intended for food-producing animals. However, as well as the principles of integrated control. Where the this Regulation should not be an obstacle to the tests MRLs arising from an authorised use of a pesticide which are necessary in order to assess pesticides. under Directive 91/414/EEC present a risk to the consumer such use should be revised to decrease the levels of pesticide residues. The Community should encourage the use of methods or products favouring a reduction in risk, and a reduction in the amounts of pesticides used to levels consistent with efficient pest (11) Directive 91/414/EEC lays down basic rules with respect control. to the use and placing on the market of plant protection products. In particular the use of those products should have no harmful effects on humans or on animals. Pesti- cide residues resulting from uses of plant protection products may have harmful effects on the health of (7) A number of active substances are banned under consumers. It is therefore appropriate that rules for Council Directive 79/117/EEC of 21 December 1978 MRLs for products intended for human consumption be prohibiting the placing on the market and use of plant defined that are linked to the authorisation for use of protection products containing certain active plant protection products as defined under Directive 91/ substances (2). At the same time, many other active 414/EEC. Similarly that Directive needs to be adapted in substances are not currently authorised under Directive order to take into account the Community procedure for 91/414/EEC. The residues of active substances in the establishment of MRLs under this Regulation. products of plant and animal origin arising from Pursuant to that Directive, a Member State may be desig- unauthorised use or from environmental contamination nated as rapporteur for the evaluation of an active or from use in third countries should be carefully substance. It is appropriate to use the expertise in that controlled and monitored. Member State for the purposes of this Regulation. (8) The basic rules with regard to food and feed law are laid down in Regulation (EC) No 178/2002 of the European (12) It is appropriate that specific rules concerning the Parliament and of the Council of 28 January control of pesticide residues be introduced to comple- ment the general Community provisions on the control of food and feed. (1) OJ L 230, 19.8.1991, p. 1. Directive as last amended by Commis- sion Directive 2004/71/EC (OJ L 127, 29.4.2004, p. 14). (2) OJ L 33, 8.2.1979, p. 36. Directive as last amended by Regulation (3) OJ L 31, 1.2.2002, p. 1. Regulation as amended by Regulation (EC) (EC) No 807/2003. No 1642/2003 (OJ L 245, 29.9.2003, p. 4). 1.2.2005 EN Official Journal of the European Union C 25 E/3 (13) Specific rules for animal feed including marketing, is listed in Annex IV. It is appropriate to set the default storage of feed and feeding of animals are provided for value at 0,01 mg/kg and to provide for the possibility of in Directive 2002/32/EC of the European Parliament and setting it at a different level for active substances covered of the Council of 7 May 2002 on undesirable substances by Annex V, taking into account the routine analytical in animal feed (1). For certain products it is not possible methods available and/or consumer protection. to determine whether they will be transformed into food or animal feed. Therefore the pesticide residues in such products should be safe both for human and, where rele- vant, for animal consumption. Accordingly it is appro- priate that the rules set out in this Regulation also apply (20) For food and feed produced outside the Community, to those products in addition to the specific rules for different agricultural practices as regards the use of plant animal nutrition. protection products may be legally applied, sometimes resulting in pesticide residues differing from those resulting from uses legally applied in the Community. It is therefore appropriate that MRLs be fixed for imported (14) It is necessary to define at Community level certain products that take these uses and the resulting residues terms used for the setting and control of MRLs for into account provided that the safety of the products can products of plant and animal origin. be demonstrated using the same criteria as for domestic produce. (15) Directive 76/895/EEC provides that Member States may authorise higher levels of MRLs than are currently (21) Regulation (EC) No 178/2002 establishes procedures for authorised at Community level. That possibility should taking emergency measures in relation to food and feed cease to exist as, in view of the internal market, it could of Community origin or imported from a third country. create obstacles to intra-Community trade. Those procedures allow the Commission to adopt such measures in situations where food is likely to constitute a serious risk to human health, animal health or the environment and where such risk cannot be contained (16) The determination of MRLs for pesticides requires satisfactorily by measures taken by the Member State(s) lengthy technical consideration and includes an assess- concerned. It is appropriate that these measures and ment of potential risks to consumers. Therefore, MRLs their effect on humans and, where relevant, animals be cannot be set immediately for the residues of pesticides assessed by the European Food Safety Authority ('the currently regulated by Directive 76/895/EEC or for pesti- Authority'). cides for which Community MRLs have not yet been set. (22) The lifetime exposure, and where appropriate the acute (17) It is appropriate that the minimum data requirements to be used when considering the setting of MRLs for pesti- exposure of consumers to pesticide residues via food cides be laid down at Community level. products, should be evaluated in accordance with Com- munity procedures and practices, taking account of guidelines published by the World Health Organisation. (18) In exceptional circumstances, and in particular for unauthorised pesticides that may be present in the envir- onment, it is appropriate to permit the use of moni- (23) Through the World Trade Organisation, the Communi- toring data in setting MRLs. ty's trading partners should be consulted about the MRLs proposed, and their observations should be taken into account before the MRLs are adopted. MRLs set at the international level by the Codex Alimentarius Commis- (19) MRLs for pesticides should be continually monitored sion should also be considered when Community MRLs and should be changed to take account of new informa- are being set. tion and data. MRLs should be set at the lower level of analytical determination where authorised uses of plant protection products do not result in detectable levels of pesticide residues. Where uses of pesticides are not authorised at Community level, MRLs should be set at (24) It is necessary that the Authority assess MRL applications an appropriately low level to protect the consumer from and evaluation reports prepared by the Member States the intake of unauthorised or excessive levels of pesti- with a view to determining the associated risks to consu- cides residues. In order to facilitate control of residues of mers and, where relevant, to animals. pesticides, a default value is to be set for pesticide resi- dues present in products or groups of products covered by Annex I for which no MRLs have been established in Annexes II or III, unless the active substance in question (25) Member States should lay down rules on sanctions applicable to infringements of this Regulation and (1) OJ L 140, 30.5.2002, p. 10. Directive as last amended by Commis- ensure that they are implemented. Those sanctions are sion Directive 2003/100/EC (OJ L 285, 1.11.2003, p. 33). to be effective, proportionate and dissuasive. C 25 E/4 EN Official Journal of the European Union 1.2.2005 (26) The development of a Community-harmonised system (32) In accordance with the principle of proportionality, it is for MRLs entails the development of guidelines, data- necessary and appropriate for the achievement of the bases and other activities with associated costs. It is basic objectives of facilitating trade whilst protecting the appropriate for the Community in certain cases to make consumer to lay down rules on MRLs for products of a contribution to those costs. plant and animal origin. This Regulation does not go beyond what is necessary in order to achieve the objec- tives pursued in accordance with the third paragraph of Article 5 of the Treaty, (27) It is good administrative practice and technically desir- able to coordinate the timing of decisions on MRLs for active substances with decisions taken for those substances under Directive 91/414/EEC. For many substances for which Community MRLs have not yet HAVE ADOPTED THIS REGULATION: been set, decisions are not due to be taken under that Directive before the date of entry into force of this Regu- lation. CHAPTER I SUBJECT MATTER, SCOPE AND DEFINITIONS (28) It is therefore necessary to adopt separate rules providing for temporary but mandatory harmonised MRLs, with a view to setting MRLs progressively as decisions are taken on individual active substances as part of the evaluations under Directive 91/414/EEC. Such temporary harmo- Article 1 nised MRLs should be based, in particular, on existing national MRLs established by the Member States and Subject matter should respect the national arrangements by which they were established, provided that the MRLs do not present an unacceptable risk to consumers. This Regulation establishes, in accordance with the general principles laid down in Regulation (EC) No 178/2002, harmo- nised Community provisions relating to maximum levels of pesticide residues in or on food and feed of plant and animal origin. (29) Following the inclusion of existing active substances in Annex I to Directive 91/414/EEC, Member States are to re-evaluate each plant protection product containing those active substances within four years of the date of inclusion. The MRLs concerned should be retained for a Article 2 period of up to four years to provide for continuity of authorisations and, on completion of re-evaluation, Scope should be made definitive if they are supported by dossiers which satisfy Annex III to Directive 91/414/EEC, or be set to a default level if they are not 1. This Regulation shall apply to products of plant and so supported. animal origin or parts thereof covered by Annex I to be used as fresh, processed and/or composite food or feed in or on which pesticide residues may be present. (30) This Regulation establishes MRLs for the control of 2. This Regulation shall not apply to the products covered pesticide residues in food and feed. It is therefore appro- by Annex I where it may be established by appropriate priate that Member States establish national programmes evidence that they are intended for: to control these residues. The results of the national control programmes are to be submitted to the Commis- (a) the manufacture of products other than food or feed; or sion, the Authority and the other Member States and included in the Community annual report. (b) sowing or planting; or (c) activities authorised by national law for the testing of active substances. (31) The measures necessary for the implementation of this 3. Maximum residue levels for pesticides set in accordance Regulation should be adopted in accordance with with this Regulation shall not apply to products covered by Council Decision 1999/468/EC of 28 June 1999 laying Annex I intended for export to third countries and treated down the procedures for the exercise of implementing before export, where it has been established by appropriate powers conferred on the Commission (1). evidence that the third country of destination requires or agrees with that particular treatment in order to prevent the introduc- (1) OJ L 184, 17.7.1999, p. 23. tion of harmful organisms into its territory. 1.2.2005 EN Official Journal of the European Union C 25 E/5 4. This Regulation shall apply without prejudice to Direc- (g) `import tolerance': means an MRL set for imported products tives 98/8/EC (1) and 2002/32/EC and Regulation (EEC) No where: 2377/90 (2). - the use of the active substance in a plant protection product on a given product is not authorised in the Community; or - an existing Community MRL is not sufficient to meet Article 3 the needs of international trade; (h) `proficiency test': means a comparative test in which several laboratories perform analyses on identical samples, allowing Definitions an evaluation of the quality of the analysis performed by each laboratory; 1. For the purpose of this Regulation, the definitions in (i) `acute reference dose': means the estimate of the amount of Regulation (EC) No 178/2002 and in Article 2(1) and (4) of substance in food, expressed on a body weight basis, that Directive 91/414/EEC shall apply. can be ingested over a short period of time, usually during one meal or one day, without appreciable health risk to the consumer on the basis of all known facts at the time of evaluation; 2. The following definitions shall also apply: (j) `acceptable daily intake': means the estimate of the amount (a) `good agricultural practice' (GAP): means the nationally of substance in food expressed on a body weight basis, that recommended, authorised or registered safe use of plant can be ingested daily over a lifetime, without appreciable protection products under actual conditions at any stage of health risk to the consumer on the basis of all known facts production, storage, transport, distribution and processing at the time of evaluation. of food and feed; Article 4 (b) `critical GAP': means the GAP, where there is more than one GAP for an active substance/product combination, which gives rise to the highest acceptable level of pesticide List of groups of products for which harmonised MRLs residue in a treated crop and is the basis for establishing shall apply the MRL; 1. The products, product groups and/or parts of products (c) `pesticide residues': means residues, including active referred to in Article 2(1) to which harmonised MRLs shall substances, metabolites and/or breakdown or reaction apply shall be defined in and covered by Annex I in accordance products of active substances currently or formerly used in with the procedure referred to in Article 45(2). Annex I shall plant protection products as defined in Article 2(1) of include all products for which MRLs are set, as well as the Directive 91/414/EEC, which are present in or on the other products for which it is appropriate to apply harmonised products covered by Annex I to this Regulation, including MRLs in particular in view of their relevance in the diet of in particular those which may arise as a result of use in consumers or in trade. Products shall be grouped in such a way plant protection, in veterinary medicine and as a biocide; that MRLs may as far as possible be set for a group of similar or related products. (d) `maximum residue level' (MRL): means the upper legal level of concentration for a pesticide residue in or on food or 2. Annex I shall be first established within three months feed; from the entry into force of this Regulation and shall be revised when appropriate, in particular at the request of a Member State. (e) `CXL': means an MRL set by the Codex Alimentarius Commission; Article 5 (f) `limit of determination' (LOD): means the validated lowest residue concentration which can be quantified and reported by routine monitoring with validated control methods; Establishment of a list of active substances for which no MRLs are required (1) Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on 1. Active substances of plant protection products evaluated the market (OJ L 123, 24.4.1998, p. 1). Directive as last amended by Regulation (EC) No 1882/2003, (OJ L 284, 31.10.2003, p. 1). under Directive 91/414/EEC for which no MRLs are required (2) Council Regulation (EEC) No 2377/90 of 26 June 1990 laying shall be defined in accordance with the procedure referred to in down a Community procedure for the establishment of maximum Article 45(2) of this Regulation and listed in Annex IV hereto, residue limits of veterinary medicinal products in foodstuffs of taking into account the uses of those active substances and the animal origin (OJ L 224, 18.8.1990, p. 1). Regulation as last amended by Commission Regulation (EC) No 546/2004 (OJ L 87, matters referred to in Article 14(2), (a), (c) and (d) of this Regu- 25.3.2004, p. 13). lation. C 25 E/6 EN Official Journal of the European Union 1.2.2005 2. Annex IV shall be first established within 12 months (iv) a copy of the relevant GAP applying to the specific use from the entry into force of this Regulation. of that active substance; (c) where appropriate, scientifically substantiated reasons for CHAPTER II concern; PROCEDURE FOR APPLICATIONS FOR MRLS (d) the data listed in Annexes II and III to Directive 91/414/EEC relating to data requirements for the setting of MRLs for pesticides including, where appropriate, toxicolo- SECTION 1 gical data and data on routine analytical methods for use in control laboratories, as well as plant and animal metabo- SUBMISSION OF APPLICATIONS FOR MRLS lism data. However, where relevant data are already publicly available, Article 6 in particular when an active substance has already been evaluated under Directive 91/414/EEC or when a CXL exists and such data are submitted by the applicant, a Applications Member State may also use such information in evaluating an application. In such cases, the evaluation report shall 1. Where a Member State envisages granting an authorisa- include a justification for using or not using such data. tion or a provisional authorisation for the use of a plant protec- tion product in accordance with Directive 91/414/EEC, that 2. The evaluating Member State may, where appropriate, Member State shall consider whether, as a result of such use, request the applicant to provide supplementary information in an existing MRL set out in Annex II or III to this Regulation addition to information required under paragraph 1 within a needs to be modified, whether it is necessary to set a new MRL, time limit specified by the Member State. or whether the active substance should be included in Annex IV. If necessary it shall require the party requesting the authori- sation to submit an application in accordance with Article 7. 2. Parties demonstrating, through adequate evidence, a legiti- mate interest, including manufacturers, growers and producers Article 8 of products covered by Annex I may also submit an application to a Member State in accordance with Article 7. Evaluation of applications 3. Where a Member State considers that the setting, modifi- cation or deletion of an MRL is necessary, that Member State may also compile and evaluate an application for setting, modi- 1. A Member State to which an application complying with fying or deleting the MRL in accordance with Article 7. Article 7 is submitted pursuant to Article 6 shall immediately forward a copy to the European Food Safety Authority estab- 4. Applications for import tolerances shall be submitted to lished by Regulation (EC) No 178/2002 (hereinafter referred to rapporteur Member States designated pursuant to Directive as 'the Authority') and the Commission and draw up an evalua- 91/414/EEC or, if no such rapporteur has been designated, tion report without undue delay. applications shall be made to Member States designated by the Commission in accordance with procedure referred to in Article 45(2) of this Regulation at the request of the applicant. 2. Applications shall be evaluated in accordance with the Such applications shall be made in accordance with Article 7 relevant provisions of the Uniform Principles for the Evaluation of this Regulation. and Authorisation of Plant Protection Products set out in Annex VI to Directive 91/414/EEC or specific evaluation prin- ciples to be laid down in a Commission Regulation in accord- ance with the procedure referred to in Article 45(2) of this Article 7 Regulation. Requirements relating to applications for MRLs 3. By way of derogation from paragraph 1 and by agree- 1. The applicant shall include in an application for an MRL ment between the Member States concerned, evaluation of the the following particulars and documents: application may be carried out by the rapporteur Member State designated pursuant to Directive 91/414/EEC for that active (a) the name and address of the applicant; substance. (b) a presentation of the application dossier including: (i) a summary of the application; 4. Where a Member State encounters difficulties in evalu- ating an application or in order to avoid duplication of work, it (ii) the main substantive arguments; may be decided in accordance with the procedure referred to in Article 45(2) which Member State shall evaluate particular (iii) an index of the documentation; applications. 1.2.2005 EN Official Journal of the European Union C 25 E/7 Article 9 2. Where the Authority requests supplementary information, the time limit laid down in paragraph 1 shall be suspended Submission of evaluated applications to the Commission until that information has been provided. Such suspensions are and the Authority subject to Article 13. 1. After completion of the evaluation report, the Member State shall forward it to the Commission. The Commission shall without delay inform the Member States and forward the application, the evaluation report and the supporting dossier to Article 12 the Authority. Assessment of existing MRLs by the Authority 2. The Authority shall acknowledge in writing receipt of the application to the applicant, the evaluating Member State and the Commission without delay. The acknowledgement shall 1. The Authority shall, within a period of 12 months from state the date of receipt of the application and the accompa- the date of the inclusion or non-inclusion of an active nying documents. substance in Annex I to Directive 91/414/EEC after the entry into force of this Regulation, submit a reasoned opinion based in particular on the relevant assessment report prepared under SECTION 2 Directive 91/414/EEC to the Commission and the Member States on: CONSIDERATION OF APPLICATIONS CONCERNING MRLS BY THE AUTHORITY (a) existing MRLs for that active substance set out in Annex II or III to this Regulation; Article 10 (b) the necessity of setting new MRLs for that active substance, or its inclusion in Annex IV to this Regulation; The Authority's opinion on applications concerning MRLs (c) specific processing factors as referred to in Article 20(2) of 1. The Authority shall assess the applications and the this Regulation that may be needed for that active evaluation reports and give a reasoned opinion on, in particu- substance; lar, the risks to the consumer and where relevant to animals associated with the setting, modification or deletion of an MRL. (d) MRLs which the Commission may consider including in That opinion shall include: Annex II and/or Annex III to this Regulation and on those MRLs which may be deleted related to that active (a) an assessment of whether the analytical method for routine substance. monitoring proposed in the application is appropriate for the intended control purposes; 2. For substances included in Annex I to Directive (b) the anticipated LOD for the pesticide/product combination; 91/414/EEC before the entry into force of this Regulation, the reasoned opinion referred to in paragraph 1 of this Article (c) an assessment of the risks of the acceptable daily intake or shall be delivered within 12 months of the entry into force of acute reference dose being exceeded as a result of the modi- this Regulation. fication of the MRL; the contribution to the intake due to the residues in the product for which the MRLs was requested; (d) any other element relevant to the risk assessment. Article 13 2. The Authority shall forward its reasoned opinion to the applicant, the Commission and the Member States. The Administrative review reasoned opinion shall clearly define the basis for each conclu- sion reached. Any decision taken under, or failure to exercise, the powers 3. Without prejudice to Article 39 of Regulation (EC) No vested in the Authority by this Regulation may be reviewed by 178/2002, the Authority shall make its reasoned opinion the Commission on its own initiative or in response to a public. request from a Member State or from any person directly and individually concerned. Article 11 For that purpose, a request shall be submitted to the Commis- sion within two months after the day on which the party Time limits for the Authority's opinion on applications concerned became aware of the act or omission in question. concerning MRLs 1. The Authority shall give its reasoned opinion as provided The Commission shall take a decision within two months for in Article 10 as soon as possible and at the latest within requiring, if appropriate, the Authority to withdraw its decision three months from the date of receipt of the application. or to remedy its failure to act within a set time-limit. C 25 E/8 EN Official Journal of the European Union 1.2.2005 SECTION 3 (c) in the cases mentioned in Article 16, set temporary MRLs and list them in Annex III to this Regulation. SETTING, MODIFYING OR DELETION OF MRLS 2. Where a temporary MRL is set as provided for in para- graph 1(b), it shall be deleted from Annex III by a Regulation one year after the date of the inclusion or non-inclusion in Article 14 Annex I to Directive 91/414/EEC of the active substance concerned, in accordance with the procedure referred to in Article 45(2) of this Regulation. However, where one or more Decisions on applications concerning MRLs Member States so requests, it may be maintained for an addi- tional year pending confirmation that any scientific studies necessary for supporting an application for setting a MRL have 1. Upon receipt of the opinion of the Authority and taking been undertaken. In cases where such confirmation is provided, into account that opinion, a Regulation on the setting, modifi- the temporary MRL shall be maintained for a further two years, cation or deletion of an MRL or a Decision rejecting the appli- provided that no unacceptable safety concerns for the cation shall be prepared by the Commission without delay and consumer have been identified. at the latest within three months, and submitted for adoption in accordance with the procedure referred to in Article 45(2). 2. With regard to the acts referred to in paragraph 1, account shall be taken of: Article 16 (a) the scientific and technical knowledge available; Procedure for setting temporary MRLs in certain circum- (b) the possible presence of pesticide residues arising from stances sources other than current plant protection uses of active substances; 1. The Regulation referred to in Article 14(1) may also set a (c) the results of an assessment of any potential risks to the temporary MRL to be included in Annex III in the following consumer and, where appropriate, to animals; circumstances: (d) the results of any evaluations and decisions to modify the uses of plant protection products; (a) in exceptional cases, in particular where pesticide residues may arise as a result of environmental or other contamina- (e) a CXL or a GAP implemented in a third country for the tion or from uses of plant protection products pursuant to legal use of an active substance in that country; Article 8(4) of Directive 91/414/EEC; or (f) other legitimate factors relevant to the matter under consid- (b) where the products concerned constitute a minor compo- eration. nent of the diet of consumers and, where relevant, of animals; or 3. The Commission may request at any time that supple- mentary information be provided by the applicant or by the (c) for honey; or Authority. The Commission shall make available any supple- mentary information received to the Member States and the Authority. (d) where essential uses of plant protection products have been identified by a Decision to delete an active substance from, or not to include an active substance in, Annex I to Direc- tive 91/414/EEC. Article 15 2. The inclusion of temporary MRLs as referred to in para- graph 1 shall be based on the opinion of the Authority, moni- Inclusion of new or modified MRLs in Annexes II and III toring data and an assessment demonstrating that there are no unacceptable risks to consumers or animals. 1. The Regulation referred in Article 14(1) shall: (a) set new or modified MRLs and list them in Annex II to this The continued validity of the temporary MRLs referred to in Regulation where the active substances have been included paragraph 1(a), (b) and (c) shall be reassessed at least once in Annex I to Directive 91/414/EEC; or every 10 years and any such MRLs shall be modified or deleted as appropriate. (b) where the active substances have not been included in Annex I to Directive 91/414/EEC and where they are not included in Annex II to this Regulation, set or modify The MRLs referred to in paragraph 1(d) shall be reassessed at temporary MRLs and list them in Annex III to this Regu- the expiry of the period for which the essential use was lation; or authorised. 1.2.2005 EN Official Journal of the European Union C 25 E/9 Article 17 (c) the other Member States and the Commission have been informed of the measures taken. Modifications of MRL following revocation of authorisa- tions of plant protection products The active substance/product combinations listed in Annex VII shall be defined in accordance with the procedure referred to in Article 45(2). Amendments to Annexes II or III needed to delete an MRL following the revocation of an existing authorisation for a plant protection product may be adopted without seeking the 4. In exceptional circumstances, and in particular further to opinion of the Authority. the use of plant protection products in accordance with Article 8(4) of Directive 91/414/EEC or in pursuance of obligations in Directive 2000/29/EC (1), a Member State may authorise the placing on the market and/or the feeding to animals within its territory of treated food or feed not complying with paragraph CHAPTER III 1, provided that such food or feed does not constitute an unac- ceptable risk. Such authorisations shall immediately be notified MRLS APPLICABLE TO PRODUCTS OF PLANT AND ANIMAL to the other Member States, the Commission and the Authority, ORIGIN together with an appropriate risk assessment for consideration without undue delay in accordance with the procedure referred to in Article 45(2), with a view to setting a temporary MRL for a specified period or taking any other necessary measure in relation to such products. Article 18 Compliance with MRLs Article 19 1. The products covered by Annex I shall not contain, from the time they are placed on the market as food or feed, or fed to animals, any pesticide residue exceeding: Prohibition concerning processed and/or composite products (a) the MRLs for those products set out in Annexes II and III; (b) 0,01 mg/kg for those products for which no specific MRL The processing, and/or mixing for dilution purposes with the is set out in Annexes II or III, or for active substances not same or other products, of the products covered by Annex I listed in Annex IV unless different default values are fixed not complying with Articles 18(1) or 20 with a view to placing for an active substance in accordance with the procedure them on the market as food or feed or feeding them to animals referred to in Article 45(2) while taking into account the shall be prohibited. routine analytical methods available. Such default values shall be listed in Annex V. 2. Member States may not prohibit or impede the placing on the market or the feeding to food-producing animals within Article 20 their territories of the products covered by Annex I on the grounds that they contain pesticide residues provided that: MRLs applicable to processed and/or composite products (a) such products comply with Articles 18(1) and 20; or 1. Where MRLs are not set out in Annexes II or III for (b) the active substance is listed in Annex IV. processed and/or composite food or feed, the MRLs applicable shall be those provided in Article 18(1) for the relevant 3. By way of derogation from paragraph 1, Member States product covered by Annex I, taking into account changes in may authorise, further to a post-harvest treatment with a fumi- the levels of pesticide residues caused by processing and/or gant on their own territory, residue levels for an active mixing. substance which exceed the limits specified in Annexes II and III for a product covered by Annex I where the active substance/product combinations are listed in Annex VII 2. Specific concentration or dilution factors for certain provided that: processing and/or mixing operations or for certain processed and/or composite products may be included in the list in (a) such products are not intended for immediate consump- Annex VI in accordance with the procedure referred to in tion; Article 45(2). (b) appropriate controls are in place to ensure that such (1) Council Directive 2000/29/EC of 8 May 2000 on protective products cannot be made available to the end user or measures against the introduction into the Community of organisms consumer, if they are supplied directly to the latter, until harmful to plants or plant products and against their spread within the residues no longer exceed the maximum levels specified the Community (OJ L 169, 10.7.2000, p. 1). Directive as last amended by Commission Directive 2004/70/EC (OJ L 127, in Annexes II or III; 29.4.2004, p. 97). C 25 E/10 EN Official Journal of the European Union 1.2.2005 CHAPTER IV the date of entry into force of Annex I to this Regulation at the latest, a national MRL for that active substance for a product covered by Annex I to this Regulation, or has decided that no SPECIAL PROVISIONS RELATING TO THE INCORPORATION MRL is required for that active substance, the Member State OF EXISTING MRLS INTO THIS REGULATION concerned shall notify the Commission, in a format and by a date to be established in accordance with the procedure referred to in Article 45(2) of the national MRL, or the fact that no MRL is required for an active substance, and where relevant and at the request of the Commission: Article 21 (a) the GAP; First establishment of MRLs (b) where the critical GAP is applied in the Member State and, 1. MRLs for products covered by Annex I shall be first estab- where available, summary data on supervised trials and/or lished and listed in Annex II in accordance with the procedure monitoring data; referred to in Article 45(2), incorporating the MRLs provided for under Directives 86/362/EEC, 86/363/EEC and (c) the acceptable daily intake and, if relevant, the acute refer- 90/642/EEC, taking into account the criteria mentioned in ence dose used for the national risk assessment, as well as Article 14(2) of this Regulation. the outcome of the assessment. 2. Annex II shall be established within 12 months from the entry into force of this Regulation. Article 24 Article 22 Opinion of the Authority on data underlying national MRLs First establishment of temporary MRLs 1. At the request of the Commission, the Authority shall 1. Temporary MRLs for active substances for which a deci- provide a reasoned opinion to the Commission on potential sion on inclusion or non-inclusion in Annex I to Directive risks to consumer health arising from: 91/414/EEC has not yet been taken shall be first established and listed in Annex III to this Regulation, unless already listed in Annex II hereto, in accordance with the procedure referred (a) temporary MRLs that may be included in Annex III; to in Article 45(2), taking into account the information provided by the Member States, where relevant the reasoned opinion mentioned in Article 24, the factors referred to in (b) active substances that may be included in Annex IV. Article 14(2) and the following MRLs: 2. In preparing the reasoned opinion referred to in para- (a) remaining MRLs in the Annex to Directive 76/895/EEC; graph 1, the Authority shall take into account the scientific and and technical knowledge available, and in particular, information provided by the Member States as required by Article 23. (b) hitherto unharmonised national MRLs. 2. Annex III shall be established within 12 months from the entry into force of this Regulation in accordance with Articles 23, 24 and 25. Article 25 Article 23 Setting of temporary MRLs Information to be provided by the Member States on Taking into account the opinion of the Authority, if such national MRLs opinion is requested, temporary MRLs for active substances referred to in Article 23 may be set and listed in Annex III pursuant to Article 22(1) or, as appropriate, the active Where an active substance is not yet included in Annex I to substance may be included in Annex IV pursuant to Article Directive 91/414/EEC and where a Member State has set, by 5(1). 1.2.2005 EN Official Journal of the European Union C 25 E/11 CHAPTER V adopted in accordance with the procedure referred to in Article 45(2). OFFICIAL CONTROLS, REPORTS AND SANCTIONS 3. All laboratories analysing samples for the official controls on pesticide residues shall participate in the Community Profi- SECTION 1 ciency Tests for pesticide residues organised by the Commis- sion. OFFICIAL CONTROLS OF MRLS Article 26 SECTION 2 Official controls COMMUNITY CONTROL PROGRAMME 1. Without prejudice to Directive 96/23/EC (1), Member States shall carry out official controls on pesticide residues in order to enforce compliance with this Regulation, in accord- ance with the relevant provisions of Community law relating to Article 29 official controls for food and feed. Community Control Programme 2. Such controls on pesticide residues shall, in particular, consist of sampling and subsequent analysis of the samples and identification of the pesticides present and their respective 1. The Commission shall prepare a coordinated multiannual residue levels. Community control programme, identifying specific samples to be included in the national control programmes and taking into account problems that have been identified regarding Article 27 compliance with the MRLs set out in this Regulation, with a view to assessing consumer exposure and the application of current legislation. Sampling 1. Each Member State shall take a sufficient number and 2. The Community control programme shall be adopted and range of samples to ensure that the results are representative of updated every year in accordance with the procedure referred the market, taking into account the results of previous control to in Article 45(2). The draft Community control programme programmes. Such sampling shall be carried out as close to the shall be presented to the Committee referred to in Article 45(1) point of supply as is reasonable, to allow for any subsequent at least six months before the end of each calendar year. enforcement action to be taken. 2. The sampling methods necessary for carrying out such controls of pesticide residues in products other than those SECTION 3 provided for in Directive 2002/63/EC (2) shall be determined in accordance with the procedure referred to in Article 45(2) of this Regulation. NATIONAL CONTROL PROGRAMMES Article 28 Article 30 Methods of Analysis National control programmes for pesticide residues 1. The methods of analysis of pesticide residues shall comply with the criteria set out in the relevant provisions of Community law relating to official controls for food and feed. 1. Member States shall establish multiannual national control programmes for pesticide residues. They shall update 2. Technical guidelines dealing with the specific validation their multiannual programme every year. criteria and quality control procedures in relation to methods of analysis for the determination of pesticide residues may be Those programmes shall be risk-based and aimed in particular at assessing consumer exposure and compliance with current (1) Council Directive 96/23/EC of 29 April 1996 on measures to legislation. They shall specify at least the following: monitor certain substances and residues thereof in live animals and animal products and repealing Directives 85/358/EEC and (a) the products to be sampled; 86/469/EEC and Decisions 89/187/EEC and 91/664/EEC (OJ L 125, 23.5.1996, p. 10). Directive as last amended by Regulation (EC) No 806/2003 (OJ L 122, 16.5.2003, p. 1). (b) the number of samples to be taken and analyses to be (2) Commission Directive 2002/63/EC of 11 July 2002 establishing carried out; Community methods of sampling for the official control of pesticide residues in and on products of plant and animal origin and repealing Directive 79/700/EEC (OJ L 187, 16.7.2002, p. 30). (c) the pesticides to be analysed; C 25 E/12 EN Official Journal of the European Union 1.2.2005 (d) the criteria applied in drawing up such programmes, Article 32 including: (i) the pesticide-product combinations to be selected; The Annual Report on pesticide residues (ii) the number of samples taken for domestic and non- domestic products respectively; 1. On the basis of the information provided by the Member States under Article 31(1) the Authority shall draw up an (iii) consumption of the products as a share of the national Annual Report on pesticide residues. diet; (iv) the Community Control Programme, and 2. The Authority shall include information on at least the following in the Annual Report: (v) the results of previous control programmes. (a) an analysis of the results of the controls provided for in 2. Member States shall submit their updated national control Article 26(2); programmes for pesticide residues, as mentioned in paragraph 1, to the Commission and to the Authority at least three (b) a statement of the possible reasons why the MRLs were months before the end of each calendar year. exceeded, together with any appropriate observations regarding risk management options; 3. Member States shall participate in the Community Control Programme as provided for in Article 29. (c) an analysis of chronic and acute risks to the health of consumers from pesticide residues; (d) an assessment of consumer exposure to pesticide residues SECTION 4 based on the information provided under point (a) and any other relevant available information, including reports submitted under Directive 96/23/EC. INFORMATION BY THE MEMBER STATES AND ANNUAL REPORT 3. Where a Member State has not provided information in accordance with Article 31, the Authority may disregard the information relating to that Member State when compiling the Article 31 Annual Report. Information by the Member States 4. The format of the Annual Report may be decided in accordance with the procedure referred to in Article 45(2). 1. Member States shall submit the following information concerning the previous calendar year to the Commission, the Authority and the other Member States by 31 August each 5. The Authority shall submit the Annual Report to the year: Commission by the last day of February each year. (a) the results of the official controls provided for in Article 6. The Annual Report may include an opinion on the pesti- 26(1); cides to be covered in future programmes. (b) the LODs applied in the national control programmes referred to in Article 30 and under the Community Control 7. The Authority shall make public the Annual Report, as Programme referred to in Article 29; well as any comments by the Commission or Member States. (c) details of the participation of the analytical laboratories in the Community proficiency tests referred to in Article 28(3) and other proficiency tests relevant to the pesticide-product combinations sampled in the national control programme; Article 33 (d) details of the accreditation status of the analytical labora- tories involved in the controls referred to in point (a); Submission of the Annual Report on pesticide residues to the Committee (e) where permitted by national legislation, details of enforce- ment measures taken. The Commission shall submit the Annual Report on pesticide 2. Implementing measures relating to the submission of residues to the Committee referred to in Article 45(1) without information by the Member States may be established in delay, for review and recommendations on any necessary accordance with the procedure referred to in Article 45(2) after measures to be taken regarding reported infringements of the consultation with the Authority. MRLs set out in Annexes II and III. 1.2.2005 EN Official Journal of the European Union C 25 E/13 SECTION 5 (e) studies necessary to support control laboratories where analytical methods are not capable of controlling the MRLs SANCTIONS established. 2. Any necessary implementing provisions concerning the measures referred to in paragraph 1 may be adopted in accord- Article 34 ance with the procedure referred to in Article 45(2). Sanctions Article 37 The Member States shall lay down rules on the sanctions applicable to infringements of the provisions of this Regulation and shall take all measures necessary to ensure that they are Community contribution to the support measures for implemented. The sanctions provided for must be effective, harmonised pesticide MRLs proportionate and dissuasive. 1. The Community may make a financial contribution of up The Member States shall notify those rules and any subsequent to 100 % of the cost of the measures provided for in Article amendment to the Commission without delay. 36. 2. The appropriations shall be authorised each financial year CHAPTER VI as part of the budgetary procedure. EMERGENCY MEASURES CHAPTER VIII Article 35 COORDINATION OF APPLICATIONS FOR MRLS Emergency measures Article 38 Articles 53 and 54 of Regulation (EC) 178/2002 shall apply where, as a result of new information or of a reassessment of existing information, pesticide residues or MRLs covered by Designation of national authorities this Regulation may endanger human or animal health requiring immediate action. Each Member State shall designate one or more national autho- rities to coordinate cooperation with the Commission, the Authority, other Member States, manufacturers, producers and growers for the purposes of this Regulation. Where more than CHAPTER VII one authority is designated by a Member State, it shall indicate which of the designated authorities shall act as a contact point. SUPPORT MEASURES RELATING TO HARMONISED PESTI- CIDE MRLS The national authorities may delegate tasks to other bodies. Each Member State shall inform the Commission and the Article 36 Authority of the names and addresses of the designated national authorities. Support measures relating to harmonised pesticide MRLs 1. Support measures relating to harmonised pesticide MRLs shall be established at Community level, including: Article 39 (a) a consolidated database for Community legislation on Coordination by the Authority of information on MRLs MRLs of pesticide residues and for making such informa- tion publicly available; The Authority shall: (b) Community proficiency tests as referred to in Article 28(3); (a) coordinate with the rapporteur Member State designated in (c) studies and other measures necessary for the preparation accordance with Directive 91/414/EEC for an active and development of legislation and of technical guidelines substance; on pesticide residues; (b) coordinate with the Member States and the Commission (d) studies necessary for estimating the exposure of consumers regarding MRLs, in particular for the purpose of fulfilling and animals to pesticide residues; the requirements of Article 41. C 25 E/14 EN Official Journal of the European Union 1.2.2005 Article 40 application of well-established scientific or technical principles they may, unless the Commission or a Member State objects, Information to be submitted by the Member States be issued by the Authority without consulting the scientific committee or the scientific panels mentioned in Article 28 of Member States shall submit to the Authority, at its request, any Regulation (EC) No 178/2002. available information necessary for the assessment of the safety of MRLs. 2. The implementing rules pursuant to Article 29(6)(a) of Regulation (EC) No 178/2002 shall specify the cases in which paragraph 1 above shall apply. Article 41 Database of the Authority on MRLs Article 45 Without prejudice to the applicable provisions of Community and national law on access to documents, the Authority shall develop and maintain a database, accessible to the Commission Committee Procedure and to the competent authorities of the Member States, containing the relevant scientific information and GAPs relating 1. The Commission shall be assisted by the Standing to the MRLs, the active substances and the processing factors Committee on the Food Chain and Animal Health set up by set out in Annexes II, III, IV and VII. In particular it shall Article 58 of Regulation (EC) No 178/2002 (hereinafter contain dietary intake assessments, processing factors and toxi- referred to as `the Committee'.) cological endpoints. 2. Where reference is made to this paragraph, Articles 5 and Article 42 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. Member States and Fees The period laid down in Article 5(6) of Decision 1999/468/EC 1. Member States may recover the costs of work associated shall be set at three months. with setting, modifying or deleting MRLs, or with any other work arising from obligations under this Regulation, by means 3. The Committee shall adopt its rules of procedure. of a fee or charge. 2. Member States shall ensure that the fee or charge referred to in paragraph 1: Article 46 (a) is established in a transparent manner; and (b) corresponds to the actual cost of the work involved. Implementing measures It may include a scale of fixed charges based on average costs In accordance with the procedure referred to in Article 45(2) for the work referred to in paragraph 1. and, where appropriate, taking into account the opinion of the Authority, the following shall be established or may be amended: CHAPTER IX (a) implementing measures to ensure the uniform application IMPLEMENTATION of this Regulation; (b) the dates in Articles 23, 29(2), 30(2), 31(1) and 32(5); Article 43 (c) technical guidance documents to assist in the application of Scientific opinion of the Authority this Regulation; The Commission or the Member States may request the (d) detailed rules concerning the scientific data required for the Authority for a scientific opinion on any measure related to the setting of MRLs. assessment of risks under this Regulation. The Commission may specify the time limit within which such an opinion shall be provided. Article 47 Article 44 Report on implementation of this Regulation Procedure for the adoption of the Authority's opinions Not later than 10 years after the entry into force of this Regu- lation, the Commission shall forward to the European Parlia- 1. When the Authority's opinions pursuant to this Regu- ment and to the Council a report on its implementation and lation require only scientific or technical work involving the any appropriate proposals. 1.2.2005 EN Official Journal of the European Union C 25 E/15 CHAPTER X However, in order to ensure a high level of consumer protec- tion, appropriate measures concerning those products may be FINAL PROVISIONS taken in accordance with the procedure referred to in Article 45(2). Article 48 Repeal and adaptation of legislation 2. Where it is necessary in order to allow for the normal marketing, processing and consumption of products, further 1. Directives 76/895/EEC, 86/362/EEC, 86/363/EEC and transitional measures may be laid down for the implementation 90/642/EEC are hereby repealed with effect from the date of certain MRLs provided for in Articles 15, 16, 21, 22, and referred to in the second paragraph of Article 50. 25. 2. Article 4(1)(f) of Directive 91/414/EEC shall be replaced Those measures, which shall be without prejudice to the obliga- by the following: tion to ensure a high level of consumer protection, shall be `(f) where appropriate, the MRLs for the agricultural adopted in accordance with the procedure referred to in products affected by the use referred to in the authori- Article 45(2). sation have been set or modified in accordance with Regulation (EC) No .../2004 (*). Article 50 (*) OJ L .... .' Entry into force Article 49 This Regulation shall enter into force on the twentieth day Transitional Measures following its publication in the Official Journal of the European Union. 1. The requirements of Chapter III shall not apply to products lawfully produced or imported into the Community Chapters II, III and V shall apply as from six months from the before the date referred to in the second paragraph of publication of the last of the Regulations establishing Annexes Article 50. I, II, III and IV. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, For the European Parliament For the Council The President The President C 25 E/16 EN Official Journal of the European Union 1.2.2005 STATEMENT OF THE COUNCIL'S REASONS I. INTRODUCTION On 14 March 2003 the Council received from the Commission a proposal for a Regulation of the European Parliament and of the Council on maximum residue levels of pesticides in products of plant and animal origin. The European Parliament adopted its opinion at a first reading on 20 April 2004. The European Economic and Social Committee adopted its opinion on 16 July 2003. The Council adopted its common position on 19 July 2004, in accordance with the procedure laid down in Article 251 of the Treaty. II. OBJECTIVES The proposal overhauls and streamlines European pesticides legislation by replacing four existing Council Directives with a single Regulation. The aim of the new, harmonised provisions is twofold: to facilitate trade within the Single Market and with third countries, import tolerances being granted to exporters to the EU in certain cases, and to ensure a consistent level of consumer protection across the Community. The proposal also provides for the role of the European Food Safety Authority (EFSA) in this field. Under the new provisions, as amended by the Council, following a transitional period, MRLs would only be set at Community level through a procedure where Member States assess the need for an MRL and submit an evaluation report to the Commission. EFSA would be responsible for risk assess- ment based on the Member State evaluation report and data received from applicants, while the Commission would handle risk management by setting MRLs. III. ANALYSIS OF THE COMMON POSITION A. GENERAL OBSERVATIONS The Council's common position broadly accords with the positions taken by the Commission and the Parliament, inasmuch as it: - confirms the objectives and most of the arrangements proposed by the Commission and supported by the European Parliament; - includes a large number of the amendments adopted at first reading by the European Parlia- ment. In particular, the Council agreed with a series of parliamentary amendments aiming to ensure the smooth functioning of the new procedures and to increase consistency between the new Regulation and other Community legislation. In addition, the Council felt that it was appropriate to introduce further amendments, for example, to allow Member States the flexibility to deal with MRL excee- dences that arise in certain exceptional cases. The Council also reordered and reformatted parts of the text of the Regulation so as to clarify the roles of the Member States, EFSA and the Commission and to separate transitional provisions from the standard procedures under the new regime. A number of technical and editorial amendments were also introduced. B. SPECIFIC COMMENTS (a) Application procedure: the respective roles of the EFSA and the Member States In its proposal, the Commission had foreseen an exclusive role for EFSA in scientific evaluation work and the setting of MRLs. However, the Council agreed with the Parliament that Member States should perform a preliminary analysis of MRL applications in line with established proce- dures under Directive 91/414/EEC. In addition, the Council agreed that a copy of MRL applica- tions received by Member States should immediately be sent to the Commission and to EFSA (Article 8). 1.2.2005 EN Official Journal of the European Union C 25 E/17 (b) Procedure for routine work performed by EFSA In the light of the substantial workload foreseen for EFSA, the Council introduced a new article designed to avoid unnecessary consultation of scientific bodies on matters of routine, i.e. in cases where EFSA issues opinions purely based on well-established scientific principles (Article 44). This provision is analogous to Article 31 of Regulation 178/2002/EC. (c) Administrative review A new article was added with a view to providing a form of legal redress regarding decisions taken by EFSA and also in the event of non-action by EFSA (Article 13). (d) Time scale and transition to the new procedures To ensure a smooth transition to the new provisions, the Council followed the Parliament in setting down specific deadlines for the completion of the principal technical annexes, which will set out a list of harmonised MRLs (Annex II), a list of harmonised temporary MRLs (Annex III) and a list of active substances for which no MRLs are required (Annex IV). In the same spirit, the Council also introduced a deadline for drawing up the annex listing the products to which harmonised MRLs will apply (Annex I). Like Parliament, the Council considered that the Regulation should not apply in full until after the crucial annexes have been drawn up (Articles 4, 5, 21, 22 and 50). (e) Possibility to extend the validity of temporary MRLs In order to facilitate a smooth transition to a fully harmonised regime (e.g. where Member States indicate that extra time is required to complete scientific studies on substances that have been authorised nationally), the Council decided that it should be possible for temporary MRLs, which will normally be valid for one year, to be maintained in Annex III for up to three addi- tional years in certain cases (Article 15). (f) The use of pesticides for post-harvest treatment A derogation was introduced in order to provide for the practice of post-harvest fumigation of products (e.g. with a view to protecting them against pests during storage and transport, which can entail the temporary exceedence of MRLs while the product remains in storage or transit) (Article 18(3)). (g) The use of pesticides in exceptional circumstances In order to provide for exceptional circumstances (e.g. when an emergency use of a plant protection product is required to control pest(s) in accordance with Article 8(4) of Directive 91/414/EEC), emergency provisions were introduced allowing a Member State to authorise the placing on the market and/or the feeding to animals within its territory of food or feed that is not in compliance with the MRLs laid down in the Regulation. Such authorisations are to be notified to the other Member States, the Commission and EFSA, with a view to setting temporary MRLs and taking any other necessary actions. Such authorisations can only be granted provided that the treated food or feed does not constitute an unacceptable risk to consumers (Article 18(4)). (h) Definitions In redrafting the text to improve legal clarity, the Council added two new definitions, namely `critical GAP' (i.e. the Good Agricultural Practice that forms the basis for a harmonised MRL under the Regulation) and `CXL' (i.e. an MRL set by the Codex Alimentarius Commission), and deleted the definition of `composite foodstuffs'. In addition, the Council followed the European Parliament in clarifying the definition of `pesticide residues' (Article 3). C 25 E/18 EN Official Journal of the European Union 1.2.2005 (i) Technical and editorial amendments A large number of other changes, including technical adjustments and clarifications, were also made. (j) Amendments not accepted by Council Further discussion is needed, in particular, on issues associated with risk assessment, and on provisions concerning the use of plant protection products, where Council was unable to agree to a number of Parliament's amendments at this stage. Such items concern, in particular, approaches to exposure assessment in the context of MRL-setting, considerations surrounding the most appropriate way of providing information to the public, and the drafting of provisions concerning good agricultural practice and pest management.