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Plant Health / Pesticides Safety Pesticide Residues Legislation

Council Directive "90/642/EC" Pesticides MRLs - Plant origin

This is an unofficial consolidated compilation of the Articles of Council Directive 90/642 on the setting of maximum residue levels of pesticides in products of plant origin, including fruit and vegetables, as amended during 1990-2000. This text is an unofficial operational working aide-memoire with no legal status and the Commission accepts no responsibility for eventual errors. Readers wishing to have the current legal content and status of the Directive are advised to consult the original legal texts.

THE COUNCIL OF THE EUROPEAN COMMUNITIES,

HAS ADOPTED THIS DIRECTIVE:

Article 1

1. This Directive shall apply to products within the groups specified in column 1 of Annex I, examples of which are given in column 2, in so far as products in those groups, or the parts of product described in column 3, may contain certain pesticide residues. The Directive shall also apply to the same products after drying or processing or after inclusion in a composite food in so far as they may contain certain pesticide residues.

2. This Directive shall apply without prejudice to:

(a) The provisions of Council Directive 64/54/EEC of 5 November 1963 on the approximation of the laws of The Member States concerning the preservatives authorised for use in foodstuffs intended for human consumption, as last amended by Directive 85/585/EEC, relating to biphenyl (diphenyl), orthophenylphenol, sodium orthophenylphenate and 2-(4 thiazolyl)-benzimidazole (thiabendazole), which shall continue to regulate the use of those substances until they and their maximum levels are included in the list referred to in paragraph 1;

(b) The provisions of Council Directive 71/63/EEC of 17 December 1973 on the fixing of maximum permitted levels for undesirable substances and products in feedingstuffs as last amended by Directive 87/519/EEC;

(c) The provisions of Directive 76/895/EEC;

(d) The provisions of Council Directive 86/362/EEC of 24 July 1986 on the fixing of maximum levels for pesticide residues in and on cereals, as last amended by Directive 88/298/EEC;

(e) The provisions of Commission Directive 91/321/EEC of 14 May 1991 on infant formulae and follow-on formulae and Commission Directive 96/5/EC of 16 February 1996 on processed cereal-based foods and baby foods for infants and young children. However, until maximum levels have been established in accordance with Article 6 of Directive 91/321/EEC or Article 6 of Directive 96/5/EC the provisions of Article 5(A)(1) and (3) to (6) of this Directive shall apply for the products concerned.

3. This Directive shall also apply to products referred to in paragraph 1 intended for export to third countries. However, maximum pesticide residue levels set in accordance with this Directive shall not apply in the case of products treated before export where it can be satisfactorily proved that:

(a) The third country of destination requires that particular treatment in order to prevent the introduction of harmful organisms into its territory; or

(b) The treatment is necessary in order to protect the products against harmful organisms during transport to the third country of destination and storage there.

4. This Directive shall not apply to the products referred to in paragraph 1 where it can be established by appropriate evidence that they are intended for:

(a) The manufacture of products other than foodstuffs and animal feed; or

(b) Sowing or planting.

Article 2

For the purposes of this Directive

(a) 'Pesticide residues' shall mean residues of pesticides and of their metabolites, and breakdown or reaction products, which are present in or on the products referred to in Article 1;

(b) 'Putting into circulation' shall mean any post-harvest handing over, whether or not for a consideration, of the products referred to in Article 1.

Article 3

1. The products in the groups or, where applicable, the parts of products referred to in Article 1 shall not contain, from the time they are put into circulation, pesticide residue levels higher than those specified in the list referred to in Annex II.

The list of pesticide residues concerned and their maximum levels shall be established in Annex II in accordance with the procedure laid down in Article 10(A) having regard to current scientific and technical knowledge. A pesticide residue will not be included on the list for as long as Directive 76/895/EEC fixes a maximum level for that residue.

2. In the case of dried and processed products for which maximum levels are not explicitly fixed in Annex II, the maximum residue level applicable shall be that laid down in Annex II, taking into account, respectively, the concentration caused by the drying process or the concentration or dilution caused by processing. A concentration or dilution factor covering the concentration and/or dilution caused by certain drying or processing operations may be determined for certain dried or processed products in accordance with the procedure laid down in Article 10(A).

3. In the case of compound foods which contain a mixture of ingredients and for which maximum residue levels are not fixed, the maximum residue levels applied may riot exceed the levels laid down in Annex II, taking into account the relative concentrations of the ingredients in the mixture and also the provisions of paragraph 2.

4. Member States shall ensure, at least by check sampling compliance with the maximum levels referred to in paragraph 1. The necessary inspections and monitoring shall be carried out in accordance with Council Directive 89/397/EEC of 14 June 1989 on the official control of foodstuffs, except for Article 14 thereof, and Directive 93/99/EEC of 29 October 1993 or, the subject of additional measures concerning the official control of foodstuffs except for Articles 5, 6 and 8 thereof.

Article 4

1. Member States shall designate an authority to ensure that the monitoring specified in Article 3(4) is carried out.

2. (a) By 30 September each year, Member States shall send to the Commission their forward national monitoring programmes for the following calendar year. These forward programmes shall specify at least:

- the products to be inspected and the number of inspections to be carried out,

- the pesticide residues to be inspected,

- the criteria applied in drawing up these programmes.

(b) By 31 December each year, the Commission shall submit to the Standing Committee on Plant Health a draft recommendation setting out a coordinated Community monitoring programme identifying the taking of specific samples to be included in the national monitoring programmes. The recommendation shall be adopted in accordance with the procedure laid down in Article 10. The basic objective of the Community monitoring programme shall be to make optimum use at Community level of the sampling of plant products included in the groups listed in Annex I, produced in the Community or imported into it. When problems have been identified, in order to ensure compliance with the maximum levels for pesticide residues set out in Annex II.

3. By 31 August each year, Member States shall send to the Commission and the other Member States the results of the analyses of the samples taken during the previous year under their national monitoring programmes and under the coordinated Community monitoring programme. The Commission shall collate and combine this information together with the results of the checks carried out in accordance with Directives 86/362/EEC and 86/363/EEC and analyse infringements of the maximum residue levels, and the average actual levels of residues and their relative values with respect to the maximum residue levels established.

The Commission should progressively work towards a system, when preparing the coordinated monitoring programme, which could permit the estimation of actual pesticide dietary exposure.

The Commission shall forward this information to the Member States in the framework of the Standing Committee on Plant Health before 30 September for each year, for review and adoption of any necessary measure such as:

- any action to be taken at Community level in the case of reported infringements of the maximum levels,

- the desirability of publication of the collated and compiled information.

4. The following may be adopted in accordance with the procedure laid down in Article 9:

(a) amendments to paragraphs 2 and 3 of this Article in so far as these amendments concern the dates for notification;

(b) detailed implementing rules necessary for proper functioning of the provisions of paragraphs 2 and 3.

5. Not later than 31 December 1999 the Commission shall forward to the Council a report on the application of this Article, accompanied, if necessary, by any appropriate proposals.

Article 5

Member States may not prohibit or impede the putting into circulation within their territories of the products referred to in Article 1 on the grounds that they contain pesticide residues, if the quantity of such residues in and on the products or parts of products concerned does not exceed the maximum levels specified in the list referred to in Article 1.

A.

Where for a product belonging to a group referred to in Annex I, a provisional maximum residue level applicable throughout the Community is set by the Commission in accordance with the provisions of Article 4(1)(f) of Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market, this level will be indicated in Annex II with a reference to that procedure.

B.

1. For the purposes of this Article a Member State of origin shall be defined as the Member State in whose territory a product specified in Article 1(1) is either legally produced and marketed or put into free circulation and a Member State of destination as the Member State into whose territory such product is introduced and put into circulation for operations other than transit to another Member State or third country.

2. Member States shall introduce arrangements for establishing maximum residue levels, whether permanent or temporary, for products referred to in Article 1(1), brought into their territories from a Member State of origin, taking into account good agricultural practice in the Member State of origin, and without prejudice to conditions necessary to protect the health of consumers, in cases where no maximum residue levels have been established for these products in accordance with the provisions of Articles 3(1) or 5(A).

3. Where

- no maximum residue level has been established for a product referred to in Article 1(1) in accordance with Articles 3(1) or 5(A), and

- that product, which satisfies the maximum residue levels applied by its Member State of origin, has been subjected in the Member State of destination to measures whose effect is to prohibit or restrict its putting into circulation, on the grounds that the product contains pesticide residue levels in excess of the maximum residue level accepted in the Member State of destination, and

- either the Member State of destination has introduced new maximum residue levels or has altered the levels laid down in its legislation, or it has made changes to its controls which are disproportionate and/or discriminatory compared with those for its domestic production, or the maximum residue level applied by the Member State of destination differs substantially from the corresponding levels established by other Member States, or the maximum residue level applied by the Member State of destination represents a disproportionate level of protection compared with the level of protection applied by the Member State to pesticides carrying a similar risk or to similar agricultural products or foodstuffs,

the following exceptional provisions shall apply:

(a) the Member State of destination shall communicate the measures adopted to the other Member State concerned and the Commission within 20 days of their application. The notification shall document the facts involved;

(b) on the basis of the notification referred to in (a), the two Member States concerned shall contact each other without delay in order to remove, whenever possible, the prohibitive or restrictive effect of the measures adopted by the Member State of destination by means of measures agreed between them; the Member States shall submit all the requisite information to each other.

Within a period of three months of the notification referred to in (a), the Member States concerned shall inform the Commission of the result of such contracts and in particular the measures they intend to apply, if any, including the maximum residue level they have agreed. The Member State of origin shall inform the other Member States of the result of such contacts;

(c) the Commission shall immediately refer the matter to the Standing Committee on Plant Health and, if possible, submit a proposal aimed at establishing in Annex II a temporary maximum residue level, which shall be adopted in accordance with the procedure laid down in Article 10(A).

In its proposal, the Commission shall take account of existing technical and scientific knowledge on the matter and in particular data submitted by the Member States with an interest, especially the toxicological assessment and estimated ADI, good agricultural practice and the trial data which the Member State of origin used to establish the maximum residue level, together with the reasons given by the Member State of destination for deciding on the measures in question.

The period of validity of the temporary maximum level shall be laid down in the legal act adopted and may not exceed four years. That period may be linked to the supply, by the Member State of origin and/or other Member States with an interest, of the trial data required by the Commission in order to set the maximum residue level in accordance with Article 3(1). At their request the Commission and the Member States shall he kept informed regarding the programme of trials established.

4. Any measure provided for in paragraphs 2 or 3 shall be taken by a Member State with due regard for its obligations under the Treaty, in particular Articles 30 to 36 thereof.

5. Council Directive 83/189/EEC of 28 March 1983 laying down a procedure for the provision of information in the field of technical standards and regulations shall not apply to measures adopted and notified by Member States in accordance with paragraph 3 of this Article.

6. Detailed measures for the implementation of the procedure set out in this article may be adopted in accordance with the procedure laid down in Article 9.

Article 6.

1. The sampling methods necessary for carrying out the checks provided for in Article 3 on fruit and vegetables shall be those laid down by Commission Directive 79/700/EEC. The sampling methods necessary for carrying out such checks on products other than fruit and vegetables, and the methods of analysis for all products, shall be determined in accordance with the procedure laid down in Article 9.

The existence of Community methods of analysis shall not preclude Member States from using other tested and scientifically valid methods provided that this does not hinder the free movement of products recognized by virtue of Community methods as complying with the rules provided for in this Directive. In the event of differences in the interpretation of results, those obtained by the use of Community methods shall prevail.

2. The methods of analysis determined under paragraph 1 shall comply with the criteria set out in the Annex to Directive 85/591/EEC.

3. Member States shall inform the other Member States and the Commission of the other methods used pursuant to paragraph 1.

Article 7

Without prejudice to the amendments made to the Annexes in accordance with Articles 5(A), 5(B)(3) and 8, amendments to Annexes I and II as a result of developments in scientific or technical knowledge shall be adopted in accordance with the procedure laid down in Article 10(A). In particular, when establishing maximum residue levels, account shall be taken of a relevant dietary intake risk assessment and of the number and quality of the data available.

Article 8

1. Where a Member State, as a result of new information or of a reassessment of existing information, considers that a maximum level fixed in the list referred to in Article 1 endangers human or animal health, and therefore requires swift action to be taken, that Member State may temporarily reduce the level in its own territory. In that case, it shall immediately notify the other Member States and the Commission of the measures, attaching a statement of the reasons therefor.

2. The Commission shall quickly examine the grounds given by the Member State referred to in the first subparagraph and shall consult the Member States within the Standing Committee on Plant Health, hereinafter referred to as 'the Standing Committee'; it shall then deliver its opinion forthwith and take the appropriate measures. The Commission shall immediately notify the Council and the Member States of any measures taken. Any Member State may refer the Commission's measures to the Council within 15 days of such notification. The Council acting by a qualified majority may take a different decision within 15 days of the date on which the matter was referred to it.

3. If the Commission considers that maximum levels laid down in the list referred to in Article 1 should be amended to resolve the difficulties mentioned in paragraph 1 and to ensure the protection of human health, it shall initiate the procedure laid down in Article 10, with a view to adopting those amendments. In this case, the Member State which has taken measures under paragraph 1 may in that event maintain them until the Council or the Commission has taken a decision in accordance with the said procedure.

Article 9

1. Where the procedure laid down in this Article is to be followed, the matter shall be referred without delay to the Standing Committee by its chairman, either on his own initiative or at the request of a Member State.

2. The representative of the Commission shall submit to the Standing Committee a draft of the measures to be taken. The Standing Committee shall deliver its opinion on the draft within a time limit which the chairman may lay down according to the urgency of the matter. The opinion shall be delivered by the majority laid down in Article 148(2) of the Treaty in the case of decisions which the Council is called upon to adopt on a proposal from the Commission. The votes of the representatives of the Member States within the Standing Committee shall be weighted in the manner set out in that Article. The chairman shall not vote.

3. The Commission shall adopt the measures envisaged if they are in accordance with the opinion of the Standing Committee.

4. If the measures are not in accordance with the opinion of the Standing Committee, or if no opinion is delivered, the Commission shall without delay submit to the Council a proposal relating to the measures to be taken. The Council shall act by a qualified majority.

5. If, within three months following the date on which the matter was referred to the Council, the Council has not acted, the proposed measures shall be adopted by the Commission.

Article 10

1. Where the procedure laid down in this Article is to be followed, the matter shall be referred without delay to the Standing Committee by its chairman, either on his own initiative or at the request of a Member State.

2. The representative of the Commission shall submit to the Standing Committee a draft of the measures to be taken. The Standing Committee shall deliver its opinion on the draft within a time limit which the chairman may lay down according to the urgency of the matter. The opinion shall be delivered by the majority laid down in Article 148(2) of the Treaty in the case of decisions which the Council is called upon to adopt on a proposal from the Commission. The votes of the representatives of the Member States within the Standing Committee shall be weighted in the manner set out in that Article. The chairman shall not vote.

3. The Commission shall adopt the measures envisaged if they are in accordance with the opinion of the Standing Committee.

4. If the measures are not in accordance with (he opinion of the Standing Committee, or if no opinion is delivered, the Commission shall without delay submit to the Council a proposal relating to the measures to be taken. The Council shall act by a qualified majority.

5. If, within 15 days following the date on which the matter was referred to the Council, the Council has not acted, the proposed measures shall be adopted by the Commission.

A.

The Commission shall be assisted by a committee composed of the representatives of the Member States and chaired by the representative of the Commission.

The representative of the Commission shall submit to the committee a draft of the measures to be taken. The committee shall deliver its opinion on the draft within a time limit which the chairman may lay down according to the urgency of the matter. The opinion shall be delivered by the majority laid down in Article 148(2) of the Treaty in the case of Decisions which the Council is required to adopt on a proposal from the Commission. The votes of the representatives of the Member States within the committee shall be weighted in the manner set out in that Article. The chairman shall not vote.

The Commission shall adopt the measures envisaged if they are in accordance with the opinion of the committee.

If the measures envisaged are not in accordance with the opinion of the committee, or if no opinion is delivered, the Commission shall, without delay, submit to the Council a proposal relating to the measures to be taken. The Council shall act by a qualified majority.

If, on the expiry of a period of three months from the date of referral to the Council, the Council has not acted, the proposed measures shall be adopted by the Commission, save where the Council has decided against the said measures by a simple majority.

B.

Member States shall bring into force the laws, regulations and administrative provisions necessary to ensure that the amendments in Annex II resulting from decisions referred to in Articles 3(1) and (2), 5(A), 5(B) (3), 7 and 8(3) can be implemented in their territory within a maximum period of eight months from their adoption, and within a shorter implementation period when required for urgent reasons of human health protection.

In order to safeguard legitimate expectations, Community legal implementing acts may provide for transitional periods for the implementation of certain maximum residue levels allowing the normal marketing of the harvested products.

Article 11

1. Member States shall take the measures necessary to comply with this Directive not later than 31 December 1999.

2. When Member States adopt the measures referred to paragraph 1, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States.

Article 12

This Directive is addressed to the Member States.

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Plant Health / Pesticides Safety Pesticide Residues Legislation
FOOD SAFETY | PUBLIC HEALTH | CONSUMER PROTECTION | DIRECTORATE GENERAL "HEALTH & CONSUMER PROTECTION"

 

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