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(1),
Having consulted the Committee of the Regions,
Acting in accordance with the procedure laid down in Article 251 of the Treaty(2),
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(3), Council Directive 86/362/EEC of 24 July 1986 on the fixing of maximum levels for pesticide residues in and on cereals(4), 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(5), 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(6), 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 In the interests of clarity and simplicity, those Directives should be repealed and replaced by a single act.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(7), 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(8) (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(9). 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(10). 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(11).
(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(12).
(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:
CHAPTER ISUBJECT MATTER, SCOPE AND DEFINITIONS
Article 1Subject matter
This Regulation establishes, in accordance with the general principles laid down in Regulation (EC) No 178/2002, in particular the need to ensure a high level of consumer protection ... relating to maximum levels of pesticide residues in or on food and feed of plant and animal origin.
Article 2Scope
1.This Regulation shall apply to products of plant and animal origin or parts thereof listed in Part 1 of the MRLs register in relation to a constituent territory to be used as fresh, processed and/or composite food or feed in or on which pesticide residues may be present.
2.This Regulation shall not apply to the products listed in Part 1 of the MRLs register in relation to a constituent territory where it may be established by appropriate evidence that they are intended for:
(a)the manufacture of products other than food or feed; or
(b)sowing or planting; or
(c)activities authorised by national law for the testing of active substances.
3.Maximum residue levels for pesticides set in accordance with this Regulation shall not apply to products listed in Part 1 of the MRLs register in relation to a constituent territory intended for export ... and treated before export, where it has been established by appropriate evidence that the ... country of destination requires or agrees with that particular treatment in order to prevent the introduction of harmful organisms into its territory.
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Article 3Definitions: general
1.For the purpose of this Regulation, the definitions in Regulation (EC) No 178/2002, and the definitions in Article 2(1) and (2) of Regulation (EC) No 1107/2009 shall apply.
2.The following definitions shall also apply:
(za)‘Regulation (EC) No 1107/2009’ means Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market;
(zb)‘MRLs register’ means the register maintained in accordance with Article 46A;
(a)‘good agricultural practice’ (GAP) means the nationally recommended, authorised or registered safe use of plant protection products under actual conditions at any stage of production, storage, transport, distribution and processing of food and feed. It also implies the application of the principles of integrated pest management referred to in Article 14 of and Annex 3 to Directive 2009/128/EC of the European Parliament and of the Council establishing a framework for Community action to achieve the sustainable use of pesticides , as well as using the minimum quantity of pesticides and setting MRLs/temporary MRLs at the lowest level which allows the desired effect to be obtained , and for these purposes Directive 2009/128/EC is to be read as if—
(i)Article 3(10)(b) were omitted;
(ii)in Article 14—
obligations on Member States were obligations on the competent authorities;
paragraph 3 were omitted ;
(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 residue in a treated crop and is the basis for establishing the MRL;
(c)‘pesticide residues’ means residues, including active substances, metabolites and/or breakdown or reaction products of active substances currently or formerly used in plant protection products ..., which are present in or on the products listed in Part 1 of the MRLs register in relation to a constituent territory , including in particular those which may arise as a result of use in plant protection, in veterinary medicine and as a biocide;
(d)‘maximum residue level’ (MRL) means the upper legal level of a concentration for a pesticide residue in or on food or feed set in accordance with this Regulation, based on good agricultural practice and the lowest consumer exposure necessary to protect vulnerable consumers;
(e)‘CXL’ means an MRL set by the Codex Alimentarius Commission;
(f)‘limit of determination’ (LOD) means the validated lowest residue concentration which can be quantified and reported by routine monitoring with validated control methods;
(g)‘import tolerance’ means an MRL set for imported products to meet the needs of international trade where:
(g)the use of the active substance in a plant protection product on a given product is not authorised in a constituent territory for reasons other than public health reasons for the specific product and specific use; or
a different level is appropriate because the existing ... MRL was set for reasons other than public health reasons for the specific product and specific use;
(h)‘proficiency test’ means a comparative test in which several laboratories perform analyses on identical samples, allowing an evaluation of the quality of the analysis performed by each laboratory;
(i)‘acute reference dose’ means the estimate of the amount of substance in food, expressed on a body weight basis, that can be ingested over a short period of time, usually during one day, without appreciable risk to the consumer on the basis of the data produced by appropriate studies and taking into account sensitive groups within the population (e.g. children and the unborn);
(j)‘acceptable daily intake’ means the estimate of the amount of substances in food expressed on a body weight basis, that can be ingested daily over a lifetime, without appreciable risk to any consumer on the basis of all known facts at the time of evaluation, taking into account sensitive groups within the population (e.g. children and the unborn).
Article 3ADefinitions: “competent authority” and “constituent territory”
1.In this Regulation, a reference to a competent authority or a constituent territory is to be interpreted in accordance with the provisions of this Article.
2.The Secretary of State is the competent authority for the constituent territory of England.
3.The Welsh Ministers are the competent authority for the constituent territory of Wales.
4.The Scottish Ministers are the competent authority for the constituent territory of Scotland.
Article 4List of groups of products for which ... MRLs shall apply
1.The products, product groups and/or parts of products referred to in Article 2(1) to which MRLs apply in relation to a constituent territory must be established and maintained by the competent authority in a list in Part 1 of the MRLs register. ... A list in Part 1 of the MRLs register in relation to a constituent territory shall include all products for which MRLs are set, as well as the other products for which it is appropriate to apply ... MRLs, in particular in view of their relevance in the diet of consumers or in trade. Products shall be grouped in such a way that MRLs may as far as possible be set for a group of similar or related products.
2.A competent authority may add, amend or remove an entry from the list in Part 1 of the MRLs register accordingly as the competent authority considers appropriate.
3.The Secretary of State may exercise a function under this Article instead of the competent authority—
(a)in relation to Wales, with the consent of the Welsh Ministers;
(b)in relation to Scotland, with the consent of the Scottish Ministers.
Article 5Active substances for which no MRLs are required
1.A competent authority must establish and maintain a list in Part 4 of the MRLs register of active substances evaluated under Regulation (EC) No 1107/2009 for which MRLs are not required in relation to its constituent territory, taking into account the uses of those active substances and the matters referred to in Article 14(2)(a), (c) and (d).
2.A competent authority must update the MRLs register accordingly as soon as reasonably practicable—
(a)after first establishing a list in accordance with paragraph 1, and
(b)after adding to or removing an entry from that list.
3.The Secretary of State may exercise a function under this Article instead of the competent authority—
(a)in relation to Wales, with the consent of the Welsh Ministers;
(b)in relation to Scotland, with the consent of the Scottish Ministers.
CHAPTER IIPROCEDURE FOR APPLICATIONS FOR MRLS
SECTION 1Submission of applications for MRLs
Article 6Applications
1.Where a competent authority envisages granting an authorisation for the use of a plant protection product in accordance with Regulation (EC) No 1107/2009, the competent authority must consider whether, in relation to its constituent territory—
(a)as a result of such use an MRL listed in Part 2 or 3 of the MRLs register needs to be modified;
(b)as a result of such use it is necessary to set a new MRL;
(c)the active substance contained in the plant protection product does not require the setting of an MRL and therefore should be listed in Part 4 of the MRLs register.
1A.The competent authority referred to in paragraph 1 may require the person requesting the grant of that authorisation for the plant protection product to submit an application in accordance with Article 7.
2.All parties demonstrating, through adequate evidence, a legitimate interest in health, including civil society organisations, as well as commercially interested parties such as manufacturers, growers, importers and producers of products listed in Part 1 of the MRLs register in relation to a constituent territory may also submit an application to the competent authority for that constituent territory in accordance with Article 7.
3.Where a competent authority considers that the setting, modification or deletion of an MRL is necessary, that competent authority may also compile and evaluate an application ... in accordance with Article 7.
4.Applications for import tolerances shall be submitted to any competent authority . Such applications shall be made in accordance with Article 7 of this Regulation.
Article 7Requirements relating to applications for MRLs
1.The applicant shall include in an application for an MRL the following particulars and documents:
(a)the name and address of the applicant;
(b)a presentation of the application dossier including:
a summary of the application;
the main substantive arguments;
an index of the documentation;
a copy of the relevant GAP applying to the specific use of that active substance;
(c)a comprehensive overview of relevant concerns raised in the available scientific literature about the plant protection product and/or its residue;
(d)the data required under Article 8(4) of Regulation (EC) No 1107/2009 relating to data requirements for the setting of MRLs for pesticides in relation to the constituent territory to which the application relates including, where appropriate, toxicological data and data on routine analytical methods for use in control laboratories, as well as plant and animal metabolism data.
However, where relevant data are already publicly available, in particular when an active substance has already been evaluated under Regulation (EC) No 1107/2009 in relation to that constituent territory or when a CXL exists and such data are submitted by the applicant, a competent authority may also use such information in evaluating an application. In such cases, the evaluation report shall include a justification for using or not using such data.
2.The evaluating competent authority may, where appropriate, request the applicant to provide supplementary information in addition to information required under paragraph 1 within a time limit specified by the competent authority . In no event may this period exceed two years.
Article 8Evaluation of applications
1.A competent authority to which an application complying with Article 7 is submitted pursuant to Article 6 shall immediately notify the other competent authorities and draw up an evaluation report without undue delay.
1A.A competent authority notified in accordance with paragraph 1 may request from the notifying competent authority a copy of the application received, and where such a request is received the notifying competent authority must provide a copy as soon as reasonably practicable.
2.Applications must be evaluated in accordance with—
(a)principles set by regulations made under paragraph 2A in relation to the constituent territory, or
(b)where there are no such regulations, the uniform principles for the evaluation and authorisation of plant protection products prescribed in accordance with Article 29(6) of Regulation (EC) No 1107/2009 in relation to the constituent territory.
2A.The appropriate authority may, by regulations, set evaluation principles for applications for MRLs.
2B.In paragraph 2A, “the appropriate authority” means—
(a)for regulations applying in relation to England, the Secretary of State;
(b)for regulations applying in relation to Wales, the Welsh Ministers;
(c)for regulations applying in relation to Scotland, the Scottish Ministers.
2C.But the appropriate authority is the Secretary of State if consent is given by—
(a)for regulations applying in relation to Wales, the Welsh Ministers;
(b)for regulations applying in relation to Scotland, the Scottish Ministers.
3.A competent authority may, by agreement, transfer the evaluation of an application to another competent authority, provided the relevant principles referred to in paragraph 2 are the same in relation to the constituent territory of each of those competent authorities.
3A.A transfer in accordance with paragraph 3 does not affect anything done by a competent authority prior to transfer.
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Article 8AThe competent authority's opinion on applications concerning MRLs
1.An evaluation report under Article 8 must include the competent authority's reasoned opinion on, in particular, the risks to the consumer and where relevant to animals associated with the setting, modification or deletion of an MRL.
2.The reasoned opinion must include—
(a)an assessment of whether the analytical method for routine monitoring proposed in the application is appropriate for the intended control purposes;
(b)the anticipated LOD for the pesticide/product combination;
(c)an assessment of the risks of the acceptable daily intake or acute reference dose being exceeded as a result of the modification of the MRL;
(d)the contribution to the acceptable daily intake due to the residues in the product for which the MRL was requested;
(e)any other element relevant to the risk assessment.
3.The reasoned opinion must clearly define the basis for each conclusion reached.
4.The competent authority may request supplementary information from the applicant where necessary for the giving of a reasoned opinion.
Article 9Notification of evaluated applications
1.After completion of the evaluation report under Article 8 the competent authority must without delay—
(a)forward the application, evaluation report and supporting dossier to the other competent authorities;
(b)forward a copy of its reasoned opinion to the applicant;
(c)make a copy of the reasoned opinion public, subject to paragraphs 2 and 3.
2.The duty in paragraph 1(c) does not apply to third party confidential information received by the competent authority for which confidential treatment has been requested and justified.
3.Paragraph 2 does not apply to—
(a)information which must be made public in order to protect public health;
(b)the conclusions of the reasoned opinion relating to foreseeable health effects.
SECTION 2Assessment of existing MRLs by the competent authority
Article 10The Authority's opinion on applications concerning MRLs
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Article 11Time limits for the Authority's opinion on applications concerning MRLs
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Article 12Assessment of existing MRLs by the competent authority
1.A competent authority must produce a reasoned opinion within a period of 36 months beginning with the date on which an active substance approval decision is made in respect of an active substance in relation to its constituent territory, except where paragraph 2 applies.
2.Where at the end of the 36 month period described in paragraph 1 there are outstanding renewals of authorisations under Article 43 of Regulation (EC) No 1107/2009 relating to that active substance in relation to its constituent territory, a competent authority must instead produce a reasoned opinion before the end of the period of 6 months beginning with the date on which the last of those outstanding renewals is concluded.
3.The reasoned opinion must be based in particular on the relevant assessment report prepared under Regulation (EC) No 1107/2009, and must include—
(a)existing MRLs for that active substance set out in Part 2 or 3 of the MRLs register in relation to the competent authority's constituent territory;
(b)the necessity of setting a new MRL for that active substance, or its inclusion in Part 4 of the MRLs register;
(c)specific processing factors as referred to in Article 20(2) that may be needed for that active substance;
(d)MRLs which the competent authority may consider including in Part 2 or 3 of the MRLs register and those MRLs related to that active substance which may be deleted.
4.In paragraph 1, an “active substance approval decision” means a decision by the competent authority under Article 13(1) or 20(1) of Regulation (EC) No 1107/2009.
5.The Secretary of State may produce a reasoned opinion under this Article instead of a competent authority—
(a)in relation to Wales, with the consent of the Welsh Ministers;
(b)in relation to Scotland, with the consent of the Scottish Ministers.
6.Where the Secretary of State produces a reasoned opinion in accordance with paragraph 5—
(a)a reference in paragraphs 1 to 3 to the competent authority is to be read as a reference to the Secretary of State;
(b)the Secretary of State must send a copy of the produced reasoned opinion to the competent authority.
Article 13Administrative review
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SECTION 3Setting, modifying or deletion of MRLs
Article 14Decisions on applications or opinions concerning MRLs
1.Within 3 months of completing the evaluation of an application under Article 8 or producing or receiving a reasoned opinion under Article 12, a competent authority must decide to take one of the actions set out in paragraph 1B(a) to (c).
1A.Within 3 months of receiving an evaluation report under Article 9(1)(a), a competent authority may decide to—
(a)take the action outlined in paragraph 1B(a) or (b), or
(b)take no action.
1B.The actions are—
(a)set a new MRL in relation to its constituent territory,
(b)modify or delete an existing MRL, or
(c)reject the application, or take no further action in respect of the reasoned opinion.
1C.A new MRL set under paragraph 1B(a) applies from a date set by the competent authority.
1D.The modification or deletion of an MRL under paragraph 1B(b) applies from a date set by the competent authority in accordance with paragraph 1E.
1E.The date described in paragraph 1D must be at least 6 months after the day on which the decision under paragraph 1 or 1A is made, except where the competent authority considers that an earlier date is necessary to avoid endangering human or animal health.
2.In making a decision under paragraphs 1 or 1A, the competent authority must take account of—
(a)the scientific and technical knowledge available;
(b)the possible presence of pesticide residues arising from sources other than current plant protection uses of active substances, and their known cumulative and synergistic effects, when the methods to assess such effects are available;
(c)the results of an assessment of any potential risks to consumers with a high intake and high vulnerability and, where appropriate, to animals;
(d)the results of any evaluations and decisions to modify the uses of plant protection products;
(e)a CXL or a GAP implemented in another country for the legal use of an active substance in that country;
(f)other legitimate factors relevant to the matter under consideration.
3.The competent authority may request at any time that supplementary information be provided by the applicant or , where the Secretary of State provided the reasoned opinion to the competent authority in accordance with Article 12(6)(b), the Secretary of State . The competent authority shall make available any supplementary information received to the other competent authorities .
4.As soon as reasonably practicable after making a decision under paragraph 1 or 1A, the competent authority must—
(a)notify the other competent authorities and any applicant in writing of the decision and the reasons for it, and
(b)update the MRLs register accordingly.
5.The Secretary of State may make a decision under paragraph 1 or 1A instead of a competent authority—
(a)in relation to Wales, with the consent of the Welsh Ministers;
(b)in relation to Scotland, with the consent of the Scottish Ministers.
6.Where the Secretary of State makes a decision in accordance with paragraph 5, a reference in paragraphs 1C to 4 to the competent authority is to be read as a reference to the Secretary of State.
Article 15Setting of new MRLs
1This Article applies where the competent authority decides to set a new MRL in accordance with Article 14(1B)(a).
2The competent authority—
(a)may set a temporary MRL in relation to its constituent territory—
(i)for an active substance which is not approved under Regulation (EC) No 1107/2009 in relation to that territory, or
(ii)in the circumstances described in Article 16(1);
(b)otherwise, must set an MRL in relation to its constituent territory.
3A temporary MRL set in accordance with paragraph 2(a)(i) expires after 12 months unless—
(a)deleted in accordance with Article 14(1B)(b), or
(b)extended in accordance with paragraphs 4 or 5.
4A competent authority may extend a temporary MRL set in accordance with paragraph 2(a)(i) by a further 12 months where confirmation is pending that any scientific studies necessary for supporting an application for setting an MRL have been undertaken.
5Where the confirmation described in paragraph 4 is received, a competent authority may extend the temporary MRL by a further 24 months provided that no unacceptable safety concerns for consumers have been identified.
6Where the competent authority extends the period of the temporary MRL in accordance with paragraph 4 or 5, the competent authority must update the MRLs register accordingly.
7Where the Secretary of State makes a decision under Article 14(5) to set a new MRL in accordance with Article 14(1B)(a), a reference to the competent authority in paragraphs 1 and 2 is to be read as a reference to the Secretary of State.
8The Secretary of State may extend a temporary MRL in accordance with paragraphs 4 or 5 instead of a competent authority—
(a)in relation to Wales, with the consent of the Welsh Ministers;
(b)in relation to Scotland, with the consent of the Scottish Ministers.
9Where the Secretary of State extends a temporary MRL in accordance with paragraph 8, a reference in paragraph 6 to the competent authority is to be read as a reference to the Secretary of State.
Article 16Procedure for setting temporary MRLs in certain circumstances
1.The competent authority may set a temporary MRL in the following circumstances—
(a)in exceptional cases, in particular where pesticide residues may arise as a result of environmental or other contamination or from uses of plant protection products pursuant to Article 53 of Regulation (EC) No 1107/2009 ; or
(b)where the products concerned constitute a minor component of the diet of consumers, and do not constitute a major part of the diet of relevant subgroups, and, where relevant, of animals; or
(c)for honey; or
(d)for herbal infusions; or
(e)where essential uses of plant protection products have been identified by the competent authority in deciding to refuse approval or the renewal of approval, or to withdraw approval, for an active substance under Regulation (EC) No 1107/2009 ; or
(f)where new products, product groups and/or parts of products have been included in the list in Part 1 of the MRLs register in relation to its constituent territory , in order to allow any scientific studies necessary for supporting an MRL to be undertaken and evaluated, provided that no unacceptable safety concerns for the consumer have been identified.
2.The inclusion of temporary MRLs as referred to in paragraph 1 shall be based on the opinion of the competent authority , monitoring data and an assessment demonstrating that there are no unacceptable risks to consumers or animals.
The continued validity of the temporary MRLs referred to in paragraphs 1(a), (b), (c) and (d) shall be reassessed at least once every 10 years ....
The MRLs referred to in paragraph 1(e) shall be reassessed at the expiry of the period for which the essential use was authorised. The MRLs referred to in paragraph 1(f) shall be reassessed when the scientific studies have been completed and evaluated, but no later than four years after their inclusion in Part 3 of the MRLs register .
3.Upon reassessment of a temporary MRL in accordance with paragraph 2, the competent authority—
(a)may modify or delete the temporary MRL, and
(b)where the competent authority does so, must update the MRLs register accordingly.
4.Where the Secretary of State makes a decision in accordance with Article 15(2)(a)(ii), a reference to the competent authority in paragraphs 1 and 2 is to be read as a reference to the Secretary of State.
5.The Secretary of State may reassess a temporary MRL in accordance with the second or third subparagraph of paragraph 2 instead of a competent authority—
(a)in relation to Wales, with the consent of the Welsh Ministers;
(b)in relation to Scotland, with the consent of the Scottish Ministers.
6.Where the Secretary of State reassesses a temporary MRL in accordance with paragraph 5, a reference in paragraph 3 to the competent authority is to be read as a reference to the Secretary of State.
Article 17Modifications of MRLs following withdrawal of authorisations of plant protection products
1.Where a competent authority withdraws an authorisation for a plant protection product, the competent authority—
(a)may modify or delete a MRL, and
(b)where the competent authority does so, must update the MRLs register accordingly.
2.The Secretary of State may modify or delete an MRL in accordance with paragraph (1)(a) instead of the competent authority—
(a)in relation to Wales, with the consent of the Welsh Ministers;
(b)in relation to Scotland, with the consent of the Scottish Ministers.
3.Where the Secretary of State modifies or deletes an MRL in accordance with paragraph 2, the Secretary of State must update the MRLs register accordingly.
Article 17ATransitional provision for modified MRLs
1.Paragraph 2 applies where a competent authority modifies an MRL in relation to its constituent territory for a pesticide residue by lowering it, under Article 14(1B)(b), 16, 17 or 18(6).
2.The competent authority may exempt one or more products produced before the relevant date from the application of the modified MRL where—
(a)the competent authority considers it necessary to allow for the normal marketing, processing or consumption of each product exempted, and
(b)the competent authority is satisfied that in doing so a high level of consumer protection can be ensured.
3.Where the competent authority exempts a product from the application of a modified MRL for a pesticide residue in accordance with paragraph 2—
(a)an entry in Parts 2 to 5 of the MRLs register in relation to the competent authority's constituent territory which immediately before the relevant date applied in respect of that product and pesticide residue continues to apply in respect of that product and pesticide residue on and after the relevant date, and
(b)the competent authority must update the MRLs register accordingly.
4.Where the Secretary of State modifies an MRL for a pesticide residue by lowering it in accordance with Article 14(5), 16(6) or 17(2), a reference in paragraphs 1 to 3 to competent authority is to be read as a reference to Secretary of State.
5.In this Article, “relevant date” means the date from which the modified MRL applies in accordance with Article 14(1D).
CHAPTER IIIMRLS APPLICABLE TO PRODUCTS OF PLANT AND ANIMAL ORIGIN
Article 18Compliance with MRLs
1.A product listed in Part 1 of the MRLs register in relation to a constituent territory must not contain, from the time it is placed on the market as food or feed, or fed to animals in that constituent territory, any pesticide residue exceeding—
(a)the MRL for that product listed in Part 2 or 3 of the MRLs register in relation to that constituent territory;
(b)the level described in paragraphs 1A or 1B, where there is no MRL.
1A.Where there is no MRL for a product listed in Part 2 or 3 of the MRLs register in relation to a constituent territory, the level is the default value for an active substance as listed in Part 5 of the MRLs register in relation to that constituent territory (see Article 18A).
1B.Where in relation to a constituent territory—
(a)there is no MRL for the product in Part 2 or 3 of the MRLs register,
(b)there is no default value for an active substance listed in Part 5 of the MRLs register, and
(c)the active substance is not listed in Part 4 of the MRLs register,
the level applicable is 0.01mg/kg.
2.A competent authority may not prohibit or impede the placing on the market or the feeding to food-producing animals within its constituent territory of the products listed in Part 1 of the MRLs register in relation to its constituent territory on the grounds that they contain pesticide residues provided that:
(a)such products comply with paragraph 1 and Article 20; or
(b)the active substance is listed in Part 4 of the MRLs register in relation to that constituent territory.
3.By way of derogation from paragraph 1, a competent authority may authorise, further to a post-harvest treatment with a fumigant on its constituent territory, residue levels for an active substance which exceed the limits specified in Part 2 or 3 of the MRLs register in relation to that constituent territory where the active substance/product combinations are listed in Part 7 of the MRLs register in relation to that constituent territory, provided that—
(a)such products are not intended for immediate consumption;
(b)appropriate controls are in place to ensure that such products cannot be made available to the end user or consumer, if they are supplied directly to the latter, until the residues no longer exceed the maximum levels specified in Part 2 or 3 of the MRLs register;
(c)the other competent authorities have been informed of the measures taken.
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3A.A competent authority may, in relation to its constituent territory—
(a)define combinations of active substances and products for the purposes of paragraph 3;
(b)modify or withdraw any such combinations.
3B.As soon as reasonably practicable after defining, modifying or withdrawing a combination in accordance with paragraph 3A the competent authority must—
(a)notify the other competent authorities of the defining, modifying or withdrawing of the combination and the reason for that decision, and
(b)update the MRLs register accordingly.
4.In exceptional circumstances, and in particular further to the use of plant protection products in accordance with Article 53 of Regulation (EC) No 1107/2009 or pursuant to obligations set out in the EU-derived domestic legislation which transposedDirective 2000/29/EC(13), a competent authority may authorise the placing on the market and/or the feeding to animals within its constituent territory of treated food or feed not complying with paragraph 1, provided that such food or feed does not constitute an unacceptable risk. ....
5.Where a competent authority grants an authorisation in accordance with paragraph 4, the competent authority must—
(a)notify the other competent authorities of that authorisation;
(b)as soon as reasonably practicable, undertake an appropriate risk assessment with a view to setting a temporary MRL for a specified period, or taking any other necessary measure in relation to the products to which the authorisation relates.
6.After the completion of the risk assessment described in paragraph 5(b) the competent authority may set a temporary MRL, and Article 15(3) to (9) applies to any temporary MRL set.
7.In paragraph 4, “EU-derived domestic legislation” has the meaning given by section 2(2) of the European Union (Withdrawal) Act 2018.
Article 18ASetting default values for active substances
1.A competent authority may, in relation to its constituent territory, set a default value for an active substance where—
(a)there is no specific MRL for that active substance listed in Part 2 or 3 of the MRLs register in relation to that constituent territory, and
(b)the active substance is not listed in Part 4 of the MRLs register in relation to that constituent territory.
2.A competent authority may modify or withdraw a default value listed in Part 5 of the MRLs register in relation to its constituent territory.
3.When setting, modifying or withdrawing a default value, the competent authority must take into account the routine analytical methods available.
4.As soon as reasonably practicable after setting, modifying or withdrawing a default value the competent authority must—
(a)notify the other competent authorities of the setting, modifying or withdrawing of the default value and the reason for that decision, and
(b)update the MRLs register accordingly.
5.The Secretary of State may set, modify or withdraw a default value in accordance with paragraph 1 or 2 instead of a competent authority—
(a)in relation to Wales, with the consent of the Welsh Ministers;
(b)in relation to Scotland, with the consent of the Scottish Ministers.
6.Where the Secretary of State sets, modifies or withdraws a default value in accordance with paragraph 5, a reference in paragraph 3 or 4 to the competent authority is to be read as a reference to the Secretary of State.
Article 19Prohibition concerning processed and/or composite products
The processing, and/or mixing for dilution purposes with the same or other products, of the products listed in Part 1 of the MRLs register in relation to a constituent territory not complying with Articles 18(1) or 20 with a view to placing them on the market as food or feed or feeding them to animals in that constituent territory shall be prohibited.
Article 20MRLs applicable to processed and/or composite products
1.Where MRLs are not set out in Part 2 or 3 of the MRLs register in relation to a constituent territory for processed and/or composite food or feed, the MRLs applicable shall be those provided in Article 18(1) for the relevant product listed in Part 1 of the MRLs register in relation to that constituent territory , taking into account changes in the levels of pesticide residues caused by processing and/or mixing.
2.A competent authority may, in relation to its constituent territory—
(a)specify concentration factors or dilution factors for—
(i)specified processing or mixing operations, or
(ii)specified processed or composite products;
(b)modify or withdraw any such factors.
3.As soon as reasonably practicable after specifying, modifying or withdrawing concentration or dilution factors in accordance with paragraph 2 the competent authority must—
(a)notify the other competent authorities of the specifying, modifying or withdrawing of the factors and the reason for that decision, and
(b)update Part 6 of the MRLs register accordingly.
4.The Secretary of State may specify, modify or withdraw concentration or dilution factors in accordance with paragraph 2 instead of a competent authority—
(a)in relation to Wales, with the consent of the Welsh Ministers;
(b)in relation to Scotland, with the consent of the Scottish Ministers.
5.Where the Secretary of State specifies, modifies or withdraws concentration or dilution factors in accordance with paragraph 4, a reference in paragraph 3 to the competent authority is to be read as a reference to the Secretary of State.
CHAPTER IVSPECIAL PROVISIONS RELATING TO THE INCORPORATION OF EXISTING MRLS INTO THIS REGULATION
Article 21First establishment of MRLs
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Article 22First establishment of temporary MRLs
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Article 23Information to be provided by the Member States on national MRLs
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Article 24Opinion of the Authority on data underlying national MRLs
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Article 25Setting of temporary MRLs
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CHAPTER VOFFICIAL CONTROLS, REPORTS AND SANCTIONS
SECTION 1Official controls of MRLs
Article 26Official controls
1.Each competent authority shall carry out official controls on pesticide residues in order to enforce compliance with this Regulation, in accordance with the relevant provisions of assimilated law relating to official controls for food and feed.
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 residue levels. Such controls shall also be carried out at the point of supply to the consumer.
Article 27Sampling
1.Each competent authority shall take a sufficient number and range of samples to ensure that the results are representative of the market, taking into account the results of previous control programmes. Such sampling shall be carried out as close to the point of supply as is reasonable, to allow for any subsequent enforcement action to be taken.
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Article 28Methods of analysis
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3.All laboratories analysing samples for the official controls on pesticide residues must—
(a)have regard to any relevant guidance;
(b)participate in any proficiency tests for pesticides organised by a competent authority.
SECTION 2Great Britain control programme
Article 29Great Britain control programme
1.The competent authorities may jointly prepare a coordinated multiannual Great Britain control programme, identifying specific samples to be included in the competent authority control programmes and taking into account problems that have been identified regarding compliance with the MRLs in relation to each constituent territory , with a view to assessing consumer exposure and the application of current legislation.
2.The competent authorities must jointly publish a Great Britain control programme prepared in accordance with paragraph 1—
(a)in a manner which the competent authorities consider appropriate, and
(b)at least six months before the end of the calendar year before the first year covered by the control programme.
SECTION 3Competent authority control programmes
Article 30Competent authority control programmes for pesticide residues
1.Each competent authority must establish multiannual control programmes for pesticide residues in its constituent territory, and must update its multiannual programme every year.
Those programmes shall be risk-based and aimed in particular at assessing consumer exposure and compliance with current legislation. They shall specify at least the following:
(a)the products to be sampled;
(b)the number of samples to be taken and analyses to be carried out;
(c)the pesticides to be analysed;
(d)the criteria applied in drawing up such programmes, including:
the pesticide-product combinations to be selected;
the number of samples taken for domestic and non-domestic products respectively;
consumption of the products as a share of the national diet;
any Great Britain control programme; and
the results of previous control programmes.
2.A competent authority must submit its proposed updated control programme to the other competent authorities at least three months before the end of each calendar year.
3.Each competent authority shall participate in any Great Britain control programme as provided for in Article 29. Each competent authority shall, on an annual basis, publish all results of its residue monitoring on the Internet. Where MRLs are exceeded, a competent authority may name the retailers, traders or producers concerned.
SECTION 4Information by the competent authorities and annual report
Article 31Information by the competent authorities
1.Each competent authority shall submit the following information concerning the previous calendar year to the other competent authorities by 31 August each year:
(a)the results of the official controls provided for in Article 26(1) , and the results of the analysis of samples tested in accordance with the competent authority's control programme and any Great Britain control programme ;
(b)the LODs applied in the competent authority's control programme referred to in Article 30 and under any Great Britain control programme referred to in Article 29;
(c)details of the participation of the analytical laboratories in the ... proficiency tests referred to in Article 28(3) and other proficiency tests relevant to the pesticide-product combinations sampled in the competent authority's control programme;
(d)details of the accreditation status of the analytical laboratories involved in the controls referred to in point (a);
(e)where permitted by national legislation, details of enforcement measures taken.
2.The competent authorities may jointly issue guidance regarding the format and submission of information in accordance with paragraph 1.
3.The competent authorities must jointly publish any guidance issued under paragraph 2 in a manner which the competent authorities consider appropriate.
4.In submitting information in accordance with paragraph 1, a competent authority must have regard to any guidance issued under paragraph 2.
Article 32The Annual Report on Pesticide Residues
1.On the basis of the information provided ... under Article 31(1) the competent authorities must jointly draw up an Annual Report on pesticide residues.
2.The competent authorities shall include information on at least the following in the Annual Report:
(a)an analysis of the results of the controls provided for in Article 26(2) , and of the results of the analysis of samples tested in accordance with each competent authority's control programme and any Great Britain control programme ;
(b)a statement of the possible reasons why any MRLs were exceeded, together with any appropriate observations regarding risk management options;
(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 based on the information provided under point (a) and any other relevant available information ....
2A. For the purpose of the first annual report under paragraph 1, paragraph 2(a) is to be read as if for “in accordance with each competent authority’s control programme and any Great Britain control programme” there were substituted “by the United Kingdom as an EU member State in accordance with Commission Implementing Regulation (EU) 2019/533 concerning a coordinated multiannual control programme of the Union for 2020, 2021 and 2022 to ensure compliance with maximum residue levels of pesticides and to assess the consumer exposure to pesticide residues in and on food of plant and animal origin as it had effect immediately before IP completion day
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7.The competent authorities must jointly publish the Annual Report by the 31st October of the second year following the year to which the information in the Annual Report relates.
Article 33Submission of the Annual Report on Pesticide Residues to the Committee
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SECTION 5Sanctions
Article 34Sanctions
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CHAPTER VIEMERGENCY MEASURES
Article 35Emergency measures
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CHAPTER VIISUPPORT MEASURES RELATING TO HARMONISED PESTICIDE MRLS
Article 36Support measures relating to harmonised pesticide MRLs
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Article 37Community contribution to the support measures for harmonised pesticide MRLs
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CHAPTER VIIICOORDINATION OF APPLICATIONS FOR MRLS
Article 38Designation of national authorities
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The national authorities may delegate tasks to other bodies.
Each Member State shall inform the Commission and the Authority of the names and addresses of the designated national authorities.
Article 39Coordination by the Authority of information on MRLs
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Article 40Information to be submitted by the Member States
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Article 41Database of the Authority on MRLs
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Article 42Member States and fees
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CHAPTER IXIMPLEMENTATION
Article 43Scientific advice
1.In fulfilling any obligation or performing any function under this Regulation, a competent authority may obtain independent scientific advice, where the competent authority considers it appropriate to do so.
2.Where independent scientific advice is obtained in accordance with paragraph 1, the competent authority must take that advice into account when fulfilling the obligation or performing the function.
Article 44Procedure for the adoption of the Authority's opinions
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Article 45 Committee procedure
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Article 46 Implementing measures
1.A competent authority may issue guidance to assist in the application of this Regulation in relation to its constituent territory, including (but not limited to)—
(a)guidance on the scientific data required for the setting of MRLs;
(b)guidance regarding the sampling methods other than those described in Article 27(2) which are necessary for carrying out such controls of pesticide residues in products;
(c)guidance regarding the specific validation criteria and quality control procedure in relation to the methods of analysis referred to in Article 28(1).
1A.A competent authority must publish any guidance issued under paragraph 1 in a manner which the competent authority considers appropriate.
1B.The Secretary of State may issue guidance under paragraph 1 instead of a competent authority—
(a)in relation to Wales, with the consent of the Welsh Ministers;
(b)in relation to Scotland, with the consent of the Scottish Ministers;
1C.Where the Secretary of State issues guidance under paragraph 1B, a reference in paragraph 1A to competent authority is to be read as a reference to Secretary of State.
1D.In complying with any obligation under this Regulation, a person or competent authority must have regard to any guidance issued in accordance with paragraph 1.
2.The Secretary of State may, by regulations, amend—
(a)Article 29(2)(b) in respect of the date by which a Great Britain control programme must be published;
(b)Article 30(2) in respect of the date by which a competent authority must submit its control programme;
(c)the date in Article 31(1) by which a competent authority must submit the information described in that Article;
(d)the date in Article 32(7) by which the Annual Report must be published.
3.The Secretary of State may only make regulations under paragraph 2 with the consent of the Welsh Ministers and the Scottish Ministers.
Article 46AMRLs register
1.The competent authorities must jointly establish and maintain a register (“the MRLs register”) in accordance with this Article.
2.The MRLs register must be divided into seven Parts as follows.
3.Part 1 of the MRLs register must contain a list of products, product groups and (where appropriate) parts of products referred to in Article 4(1) in relation to each constituent territory, and each list must be divided into the following—
(a)Section A for entries relating to products of plant and animal origin;
(b)Section B for entries relating to other products.
4.An entry for a product in Section A of a list in Part 1 must contain the following information—
(a)a unique code number,
(b)the category to which the product relates,
(c)the group and (where applicable) the subgroup to which the product relates,
(d)the common name of the product,
(e)the scientific name of the product, and
(f)where applicable, the part of the product to which MRLs or temporary MRLs apply.
5.An entry for a product in Section B of a list in Part 1 must contain the following information—
(a)a unique code number,
(b)the common name of the product,
(c)the scientific name of the product, and
(d)a reference to the product in Section A of the list to which the same MRLs apply, including the information required by paragraph 4(a) to (c) in relation to that product.
6.Part 2 of the MRLs register must contain, in relation to each constituent territory, a list of MRLs set in accordance with Article 15(2)(b).
7.Part 3 of the MRLs register must contain, in relation to each constituent territory, a list of temporary MRLs set in accordance with Article 15(2)(a).
8.An entry on Part 2 or 3 of the MRLs register must contain—
(a)a maximum residue level expressed in mg/kg for each product, product group and (where appropriate) part of a product listed in a list in Part 1 of the MRLs register to which it relates;
(b)the date from which the MRL or temporary MRL applies in accordance with Article 14(1C) or (1D);
(c)where the MRL or temporary MRL continues to apply to a product produced before a certain date by virtue of an exemption under Article 17A, that date.
9.Part 4 of the MRLs register must contain the list of evaluated active substances referred to in Article 5(1) in relation to each constituent territory.
10.Part 5 of the MRLs register must contain a list of default values set in accordance with Article 18A in relation to each constituent territory.
11.An entry on the list—
(a)in Part 4 or 5 of the MRLs register which continues to apply to a product produced before a certain date by virtue of an exemption under Article 17A, must contain that date;
(b)in Part 5 of the MRLs register must contain a maximum residue level expressed in mg/kg for each product, product group and (where appropriate) part of a product listed in a list in Part 1 of the MRLs register to which the default values relate.
12.Part 6 of the MRLs register must contain a list of concentration or dilution factors set in accordance with Article 20 in relation to each constituent territory.
13.Part 7 of the MRLs register must contain a list of combinations of active substances and products set for the purposes of Article 18(3) in relation to each constituent territory.
14.An entry on the list in Part 7 of the MRLs register for a combination must contain—
(a)an active substance,
(b)each product listed in a list in Part 1 of the MRLs register relating to the combination, and
(c)for each product included in accordance with point (b), the unique code number for that product as provided in the relevant entry in a list in Part 1 of the MRLs register.
15.Where any information to be contained in a list or entry in a Part of the MRLs register in accordance with this Article is the same in relation to one or more constituent territories, a single list or entry (as the case may be) of that information may be established and maintained instead in the relevant Part.
16.A list or entry of information established and maintained in a Part of the MRLs register in accordance with paragraph 15 must—
(a)comply with any of the requirements in paragraphs 3 to 14 relevant to that Part, and
(b)indicate each of the constituent territories to which it relates.
17.The MRLs register must contain a search facility.
18.The competent authorities must make the MRLs register available for inspection by the public on a website jointly maintained by the competent authorities.
Article 46BRegulations
1.Regulations made by the Secretary of State or Welsh Ministers under this Regulation are to be made by statutory instrument.
2.For regulations made under this Regulation by the Scottish Ministers, see section 27 of the Interpretation and Legislative Reform (Scotland) Act 2010.
4.A statutory instrument containing regulations made by the Secretary of State under this Regulation is subject to annulment in pursuance of a resolution of either House of Parliament.
5.A statutory instrument containing regulations made by the Welsh Ministers under this Regulation is subject to annulment in pursuance of a resolution of the National Assembly for Wales.
6.Regulations made by the Scottish Ministers under this Regulation are subject to the negative procedure (see section 28 of the Interpretation and Legislative Reform (Scotland) Act 2010).
8.Such regulations may—
(a)contain consequential, incidental, supplementary, transitional or saving provision (including provision amending, repealing or revoking enactments);
(b)make different provision for different purposes.
Article 47Report on implementation of this Regulation
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CHAPTER XFINAL PROVISIONS
Article 48Repeal and adaptation of legislation
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Article 49 Transitional measures
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Article 50Entry into force
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ANNEX I
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ANNEX II MRLs formerly defined under Directives 86/362/EEC, 86/363/EEC and 90/642/EEC, referred to in Article 21(1)
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ANNEX III Temporary MRLs referred to in Articles 16(1) and 22(1)
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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)
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ANNEX V List of default values, as referred to in Article 18(1)(b)
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ANNEX VII
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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.
Council Directive 2000/29/EC of 8 May 2000 on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community (OJ L 169, 10.7.2000, p. 1). Directive as last amended by Commission Directive 2007/41/EC (OJ L 169, 29.6.2007, p. 51).
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.
[F19Council Directive 2000/29/EC of 8 May 2000 on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community (OJ L 169, 10.7.2000, p. 1). Directive as last amended by Commission Directive 2007/41/EC (OJ L 169, 29.6.2007, p. 51).]
Textual Amendments
F19Substituted by Regulation (EC) No 299/2008 of the European Parliament and of the Council of 11 March 2008 amending Regulation (EC) No 396/2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin, as regards the implementing powers conferred on the Commission.