CHAPTER I
SUBJECT MATTER, SCOPE AND DEFINITIONS
Article 1
Subject matter
Article 2
Scope
Article 3
Definitions: general
Article 3A
Definitions: “competent authority” and “constituent territory”
Article 4
List of groups of products for which ... MRLs shall apply
Article 5
Active substances for which no MRLs are required
CHAPTER II
PROCEDURE FOR APPLICATIONS FOR MRLS
SECTION 1
Submission of applications for MRLs
Article 6
Applications
Article 7
Requirements relating to applications for MRLs
Article 8
Evaluation of applications
Article 8A
The competent authority's opinion on applications concerning MRLs
Article 9
Notification of evaluated applications
SECTION 2
Assessment of existing MRLs by the competent authority
Article 10
The Authority's opinion on applications concerning MRLs
Article 11
Time limits for the Authority's opinion on applications concerning MRLs
Article 12
Assessment of existing MRLs by the competent authority
Article 13
Administrative review
SECTION 3
Setting, modifying or deletion of MRLs
Article 14
Decisions on applications or opinions concerning MRLs
Article 15
Setting of new MRLs
Article 16
Procedure for setting temporary MRLs in certain circumstances
Article 17
Modifications of MRLs following withdrawal of authorisations of plant protection products
Article 17A
Transitional provision for modified MRLs
CHAPTER III
MRLS APPLICABLE TO PRODUCTS OF PLANT AND ANIMAL ORIGIN
Article 18
Compliance with MRLs
Article 18A
Setting default values for active substances
Article 19
Prohibition concerning processed and/or composite products
Article 20
MRLs applicable to processed and/or composite products
CHAPTER IV
SPECIAL PROVISIONS RELATING TO THE INCORPORATION OF EXISTING MRLS INTO THIS REGULATION
Article 21
First establishment of MRLs
Article 22
First establishment of temporary MRLs
Article 23
Information to be provided by the Member States on national MRLs
Article 24
Opinion of the Authority on data underlying national MRLs
Article 25
Setting of temporary MRLs
CHAPTER V
OFFICIAL CONTROLS, REPORTS AND SANCTIONS
SECTION 1
Official controls of MRLs
Article 26
Official controls
Article 27
Sampling
Article 28
Methods of analysis
SECTION 2
Great Britain control programme
Article 29
Great Britain control programme
SECTION 3
Competent authority control programmes
Article 30
Competent authority control programmes for pesticide residues
SECTION 4
Information by the competent authorities and annual report
Article 31
Information by the competent authorities
Article 32
The Annual Report on Pesticide Residues
Article 33
Submission of the Annual Report on Pesticide Residues to the Committee
SECTION 5
Sanctions
Article 34
Sanctions
CHAPTER VI
EMERGENCY MEASURES
Article 35
Emergency measures
CHAPTER VII
SUPPORT MEASURES RELATING TO HARMONISED PESTICIDE MRLS
Article 36
Support measures relating to harmonised pesticide MRLs
Article 37
Community contribution to the support measures for harmonised pesticide MRLs
CHAPTER VIII
COORDINATION OF APPLICATIONS FOR MRLS
Article 38
Designation of national authorities
Article 39
Coordination by the Authority of information on MRLs
Article 40
Information to be submitted by the Member States
Article 41
Database of the Authority on MRLs
Article 42
Member States and fees
CHAPTER IX
IMPLEMENTATION
Article 43
Scientific advice
Article 44
Procedure for the adoption of the Authority's opinions
Article 45
Committee procedure
Article 46
Implementing measures
Article 46A
MRLs register
Article 46B
Regulations
Article 47
Report on implementation of this Regulation
CHAPTER X
FINAL PROVISIONS
Article 48
Repeal and adaptation of legislation
Article 49
Transitional measures
Article 50
Entry into force
ANNEX I
PART A
Products of plant and animal origin referred to in Article 2(1) to which MRLs apply
PART B
Other products referred to in Article 2(1)
ANNEX II
MRLs formerly defined under Directives 86/362/EEC, 86/363/EEC and 90/642/EEC, referred to in Article 21(1)
ANNEX III
Temporary MRLs referred to in Articles 16(1) and 22(1)
PART A
Temporary MRLs for substances without MRLs under Directives 86/362/EEC, 86/363/EEC and 90/642/EEC
PART B
Temporary MRLs for products not defined in Annexes I of Directives 86/362/EEC, 86/363/EEC and 90/642/EEC
ANNEX IV
List of active substances of plant protection products evaluated under Directive 91/414/EEC for which no MRLs are required, referred to in Article 5(1)
ANNEX V
List of default values, as referred to in Article 18(1)(b)
ANNEX VII
Regulation (EC) No 396/2005 of the European Parliament and of the Council
of 23 February 2005
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)
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty establishing the European Community, and in particular Articles 37 and 152(4)(b) thereof,
Having regard to the proposal from the Commission,
Having regard to the opinion of the European Economic and Social Committee ,
Having consulted the Committee of the Regions,
Acting in accordance with the procedure laid down in Article 251 of the Treaty ,
Whereas:
(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 , Council Directive 86/362/EEC of 24 July 1986 on the fixing of maximum levels for pesticide residues in and on cereals , Council Directive 86/363/EEC of 24 July 1986 on the fixing of maximum levels for pesticide residues in and on foodstuffs of animal origin , and 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 vegetables , have been substantially amended several times. In the interests of clarity and simplicity, those Directives should be repealed and replaced by a single act.
(2)
This Regulation directly concerns public health and is relevant to the functioning of the internal market. Differences in national maximum residue levels for pesticides can pose barriers to trade in products included in Annex I to the Treaty and products derived therefrom between Member States and trade between third countries and the Community. Accordingly, in the interest of free movement of goods, equal competition conditions among the Member States, as well as a high level of consumer protection, it is appropriate that maximum residue levels (MRLs) for products of plant and animal origin be set at Community level, taking into account good agricultural practice.
(3)
A Regulation establishing MRLs does not require transposition into national law in the Member States. It is therefore the most appropriate legal instrument with which to set MRLs for pesticides in products of plant and animal origin, as its precise requirements are to be applied at the same time and in the same manner throughout the Community and accordingly permit a more efficient use of national resources.
(4)
The production and consumption of plant and animal products play a very important role in the Community. The yield from plant production is continually being affected by harmful organisms. It is essential to protect plants and plant products against such organisms in order to prevent a reduction in yield or damage to them, and ensure both the quality of the products harvested and high agricultural productivity. To this end, different methods are available, including non-chemical methods, practices such as using resistant varieties, crop rotation, mechanical weeding, biological control and chemical methods such as the use of plant protection products.
(5)
One of the most common methods of protecting plants and plant products from the effects of harmful organisms is the use of active substances in plant protection products. However, a possible consequence of their use may be the presence of residues in the treated products, in animals feeding on those products and in honey produced by bees exposed to those substances. According to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market , public health should be given priority over the interests of crop protection, thus it is necessary to ensure that such residues should not be present at levels presenting an unacceptable risk to humans and, where relevant, to animals. MRLs should be set at the lowest achievable level consistent with good agricultural practice for each pesticide with a view to protecting vulnerable groups such as children and the unborn.
(6)
It is also important to carry out further work to develop a methodology to take into account cumulative and synergistic effects. In view of human exposure to combinations of active substances and their cumulative and possible aggregate and synergistic effects on human health, MRLs should be set after consultation of the European Food Safety Authority established by Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (hereinafter the Authority).
(7)
Directive 91/414/EEC provides that Member States, when issuing authorisations, are to prescribe that plant protection products be used properly. Proper use includes the application of the principles of good agricultural practice as well as the principles of integrated control. Where the MRLs arising from an authorised use of a pesticide 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 the use of amounts of pesticides at levels consistent with efficient pest control.
(8)
A number of active substances are banned under Council Directive 79/117/EEC of 21 December 1978 prohibiting the placing on the market and use of plant protection products containing certain active substances . At the same time, many other active substances are not currently authorised under Directive 91/414/EEC. The residues of active substances in products of plant and animal origin arising from unauthorised use or from environmental contamination or from use in third countries should be carefully controlled and monitored.
(9)
The basic rules with regard to food and feed law are laid down in Regulation (EC) No 178/2002.
(10)
In addition to those basic rules, more specific rules are 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 feed in which pesticide residues may be present, whilst providing the basis for securing a high level of protection for human and animal health and the interests of consumers. Such rules should include the establishment of specific MRLs for each pesticide in food and feed products and the quality of the data underlying these MRLs.
(11)
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 view of the difficulty of segregating products to be used as feed intended for animals which are not destined for food production and in order to facilitate the control and the enforcement of the provisions of this Regulation, it is appropriate to apply them also to feed which is not intended for food-producing animals. However, this Regulation should not be an obstacle to the tests which are necessary in order to assess pesticides.
(12)
Directive 91/414/EEC lays down basic rules with respect 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. Pesticide residues resulting from uses of plant protection products may have harmful effects on the health of consumers. It is therefore appropriate that rules for MRLs for products intended for human consumption be defined that are linked to the authorisation for use of plant protection products as defined under Directive 91/414/EEC. Similarly that Directive needs to be adapted in order to take into account the Community procedure for the establishment of MRLs under this Regulation. Pursuant to that Directive, a Member State may be designated as rapporteur for the evaluation of an active substance. It is appropriate to use the expertise in that Member State for the purposes of this Regulation.
(13)
It is appropriate that specific rules concerning the control of pesticide residues be introduced to complement the general Community provisions on the control of food and feed.
(14)
Whilst considering MRLs of pesticides, it should also be recognised that few consumers are aware of the risks arising from pesticides. It would be valuable to fully explain such risks to the public.
(15)
Member States should look into the possibility of publishing the names of companies whose products contain higher pesticide residues than the maximum permitted levels.
(16)
Specific rules for animal feed including marketing, storage of feed and feeding of animals are provided for in Directive 2002/32/EC of the European Parliament and of the Council of 7 May 2002 on undesirable substances in animal feed . For certain products it is not possible 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 relevant, for animal consumption. Accordingly it is appropriate that the rules set out in this Regulation also apply to those products in addition to the specific rules for animal nutrition.
(17)
It is necessary to define at Community level certain terms used for the setting, control and reporting on controls of MRLs for products of plant and animal origin. It is important that the Member States apply proper sanctions in accordance with Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules .
(18)
Directive 76/895/EEC provides that Member States may authorise higher levels of MRLs than are currently authorised at Community level. That possibility should cease to exist as, in view of the internal market, it could create obstacles to intra-Community trade.
(19)
The determination of MRLs for pesticides requires lengthy technical consideration and includes an assessment of potential risks to consumers. Therefore, MRLs cannot be set immediately for the residues of pesticides currently regulated by Directive 76/895/EEC or for pesticides for which Community MRLs have not yet been set.
(20)
It is appropriate that the minimum data requirements to be used when considering the setting of MRLs for pesticides be laid down at Community level.
(21)
In exceptional circumstances and in particular for unauthorised pesticides that may be present in the environment, it is appropriate to permit the use of monitoring data in setting MRLs.
(22)
MRLs for pesticides should be continually monitored and should be changed to take account of new information 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 an appropriately low level to protect the consumer from the intake of unauthorised or excessive levels of pesticides residues. In order to facilitate control of residues of pesticides, a default value is to be set for pesticide residues 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 is listed in Annex IV. It is appropriate to set the default value at 0,01 mg/kg and to provide for the possibility of setting it at a different level for active substances covered by Annex V, taking into account the routine analytical methods available and/or consumer protection.
(23)
Regulation (EC) No 178/2002 establishes procedures for taking emergency measures in relation to food and feed of Community origin or imported from a third country. 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 satisfactorily by measures taken by the Member State(s) concerned. It is appropriate that these measures and their effect on humans and, where relevant, animals be assessed by the Authority.
(24)
The lifetime exposure, and where appropriate the acute exposure of consumers to pesticide residues via food products should be evaluated in accordance with Community procedures and practices, taking account of guidelines published by the World Health Organisation.
(25)
Through the World Trade Organisation, the Community'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 Commission should also be considered when Community MRLs are being set, taking into account the corresponding good agricultural practices.
(26)
For food and feed produced outside the Community, different agricultural practices as regards the use of plant 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 are set for imported products that take these uses and the resulting residues into account provided that the safety of the products can be demonstrated using the same criteria as for domestic produce.
(27)
It is necessary that the Authority assess MRL applications and evaluation reports prepared by the Member States, taking into account the full range of toxicological effects such as immunotoxicity, endocrine disruption and developmental toxicity, with a view to determining the associated risks to consumers and, where relevant, to animals.
(28)
Member States should lay down rules on sanctions applicable to infringements of this Regulation and ensure that they are implemented. Those sanctions are to be effective, proportionate and dissuasive.
(29)
The development of a Community-harmonised system for MRLs entails the development of guidelines, databases and other activities with associated costs. It is appropriate for the Community in certain cases to make a contribution to those costs.
(30)
It is good administrative practice and technically desirable 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 been set, decisions are not due to be taken under that Directive before the date of entry into force of this Regulation.
(31)
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 harmonised MRLs should be based, in particular, on existing national MRLs established by the Member States and should respect the national arrangements by which they were established, provided that the MRLs do not present an unacceptable risk to consumers.
(32)
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 period of up to four years to provide for continuity of authorisations and, on completion of re-evaluation, 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 so supported.
(33)
This Regulation establishes MRLs for the control of pesticide residues in food and feed. It is therefore appropriate that Member States establish national programmes to control these residues. The results of the national control programmes are to be submitted to the Commission, the Authority and the other Member States and included in the Community annual report.
(34)
To ensure that consumers are kept adequately informed, Member States should, in accordance with Regulation (EC) No 882/2004, publish the results of national monitoring residues annually on the Internet, providing all individual data, including the place of collection and the names of retailers, traders and/or producers.
(35)
The measures necessary for the implementation of this Regulation should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission .
(36)
In accordance with the principle of proportionality, it is necessary and appropriate for the achievement of the basic objectives of facilitating trade whilst protecting the consumer to lay down rules on MRLs for products of plant and animal origin. This Regulation does not go beyond what is necessary in order to achieve the objectives pursued in accordance with the third paragraph of Article 5 of the Treaty,
HAVE ADOPTED THIS REGULATION:
OJ C 234, 30.9.2003, p. 33.
Opinion of the European Parliament of 20 April 2004 (not yet published in the Official Journal), Council Common Position of 19 July 2004 (OJ C 25 E, 1.2.2005, p. 1) and Position of the European Parliament of 15 December 2004 (not yet published in the Official Journal) and Council Decision of 24 January 2005.
OJ L 340, 9.12.1976, p. 26. Directive as last amended by Regulation (EC) No 807/2003 (OJ L 122, 16.5.2003, p. 36).
OJ L 221, 7.8.1986, p. 37. Directive as last amended by Commission Directive 2004/61/EC (OJ L 127, 29.4.2004, p. 81).
OJ L 221, 7.8.1986, p. 43. Directive as last amended by Directive 2004/61/EC.
OJ L 350, 14.12.1990, p. 71. Directive as last amended by Commission Directive 2004/95/EC (OJ L 301, 28.9.2004, p. 42).
OJ L 230, 19.8.1991, p. 1. Directive as last amended by Commission Directive 2004/99/EC (OJ L 309, 6.10.2004, p. 6).
OJ L 31, 1.2.2002, p. 1. Regulation as amended by Regulation (EC) No 1642/2003 (OJ L 245, 29.9.2003, p. 4).
OJ L 33, 8.2.1979, p. 36. Directive as last amended by Regulation (EC) No 850/2004 of the European Parliament and of the Council (OJ L 158, 30.4.2004, p. 7. Regulation as corrected in OJ L 229, 29.6.2004, p. 5).
OJ L 140, 30.5.2002, p. 10. Directive as last amended by Commission Directive 2003/100/EC (OJ L 285, 1.11.2003, p. 33).
OJ L 165, 30.4.2004, p. 1. Regulation as corrected in OJ L 191, 28.5.2004, p. 1.
OJ L 184, 17.7.1999, p. 23.
Regulation applied (with modifications) (N.I.) (1.10.2023) by The Windsor Framework (Retail Movement Scheme: Public Health, Marketing and Organic Product Standards and Miscellaneous Provisions) Regulations 2023 (S.I. 2023/959), regs. 1(2), 4(a), Sch. 1 (with regs. 7, 8)