Proposal for a Council Directive amending Council Directive 76/895/EEC of 23 November 1976 relating to the fixing of maximum levels for pesticide residues in and on fruit and vegetables, Council Directive 86/362/EEC of 24 July 1986 on the fixing of maximum levels for pesticide residues in and on cereals, Council Directive 86/363/EEC of 24 July 1986 on the fixing of maximum levels for pesticide residues in and on foodstuffs of animal origin and Council Directive 90/642/EEC of 27 November 1990 on the fixing of maximum levels for pesticide residues in and on certain products of plant origin, including fruit and vegetables

(95/C 201/07)

(Text with EEA relevance)

COM(95) 272 final - 95/0154(CNS)

(Submitted by the Commission on 20 June 1995)

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Comunity, and in particular Article 43 thereof,

Having regard to the proposal from the Commission,

Having regard to the opinion of the European Parliament,

Having regard to the opinion of the Economic and Social Committee,

Whereas Council Directives 86/362/EEC of 24 July 1986 on the fixing of maximum levels for pesticide residues in and on cereals (1), 86/363/EEC of 24 July 1986 on the fixing of maximum levels for pesticide residues in and on foodstuffs of animal origin (2) and 90/642/EEC of 27 November 1990 relating to the fixing of maximum levels for pesticide residues in and on certain products of plant origin, including fruit and vegetables (3) have established a common regime providing for mandatory residue levels applicable throughout the European Community;

Whereas this regime provides for a gradual transfer of the maximum residue levels established under Directive 76/895/EEC to Directive 90/642/EEC after technical consideration; whereas such transfer has already been realized for certain levels and is still in preparation for others;

Whereas Directive 91/414/EEC (4) concerning the placing of plant protection products on the market has provided for a mechanism linking the authorization of a plant protection product containing an active substance included in Annex I of that Directive to the obligation for the Member State having granted the authorization to establish a provisional maximum residue level of the active substance concerned in the treated crops; whereas this mechanism also provides for a mandate to the Commission to establish, on the basis of the provisional maximum residue level set by a Member State, provisional maximum residue levels applicable throughout the Community; whereas for reasons of clarity, the provisional maximum residue levels set according to this mechanism, should be integrated in an appropriate way in the Annexes to Directives 86/362/EEC, 86/363/EEC and 90/642/EEC;

Whereas rules have to be set concerning the maximum residue levels which are acceptable in dried and/or processed single agricultural products and in composite foodstuffs in order to ensure proper human health protection as well as proper functioning of the single market with regard to such products;

Whereas Member States should provide for the possibility to establish maximum residue levels for imported products in order to prevent as much as possible trade problems due to the absence of harmonized maximum residue levels for certain residue/product combinations;

Whereas a conciliation procedure is necessary in cases where in practice barriers to intracommunity trade have appeared due to the absence of harmonized maximum residue levels for certain residue/product combinations;

Whereas effective monitoring of pesticide residues should be systematically organized at both national and Community stages in order to ensure compliance with the mandatory levels set and to contribute to the highest degree of consumer confidence in the degree of protection of human health achieved;

Whereas it is necessary to update certain provisions of Directives 76/895/EEC relating to the fixing of maximum levels for pesticide residues in and on fruit and vegetables (5), 86/362/EEC and 86/363/EEC to the similar provisions in Directive 90/642/EEC to ensure coherence in the implementation of the whole regime concerning maximum residue levels;

Whereas the introduction of amendments in the Annexes as a result of developments in scientific and technical knowledge, as well as the setting of temporary maximum residue levels and the establishment of dilution or concentration factors related to certain drying or processing operations are technical measures; whereas a Regulatory Committee decision procedure seems appropriate for the adoption of such measures in order to ensure an effective and streamlined operation of the implementation measures under Directives 76/895/EEC, 86/362/EEC, 86/363/EEC and 90/642/EEC and the implementation measures under Directive 91/414/EEC and other relevant Directives;

Whereas an adequate protection of human health and a proper functioning of the single market requires that the amendments introduced in the Annexes are swiftly applied by all the Member States,

HAS ADOPTED THIS DIRECTIVE:

Article 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 is hereby amended as follows:

1. The first sentence of Article 5 is replaced by the following:

'Without prejudice to Article 4, any amendments to be made to the Annexes shall be adopted in accordance with the procedure laid down in Article 7.`

2. Paragraphs 2, 3 and 4 of Article 7 are replaced by the following:

'2. 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 called upon 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.

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

4. If the measures 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.

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.`

3. Paragraphs 2, 3 and 4 of Article 8 are replaced by the following:

'2. 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 called upon 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.

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

4. If the measures 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.

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.`

4. Article 9 is replaced by the following:

'Article 9

1. This Directive shall apply to products referred to in Article 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.

2. This Directive shall not apply to the products referred to in Article 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.`

5. After Article 10, the following Article is inserted:

'Article 10a

The Member States shall bring into force laws, regulations and administrative provisions necessary to ensure that the amendments referred to in Article 5 can be implemented in their territory within a period of a maximum four months from their adoption, and within a shorter implementation period when this is required for reasons of human health protection.`

Article 2

Council Directive 86/362/EEC of 24 July 1986 on the fixing of maximum levels for pesticide residues in and on cereals, is amended as follows:

1. Article 1 is replaced by the following:

'Article 1

1. This Directive shall apply to the cereal products listed in Annex I in so far as these products 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 74/63/EEC of 17 December 1973 on the fixing of maximum permitted levels for undesirable substances and products in feedingstuffs (*);

(b) the provisions of 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;

(c) the provisions of Council Directive 90/642/EEC of 27 November 1990 on the fixing of maximum levels for pesticide residues in and on certain products of plant origin, including fruit and vegetables.

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.

(*) OJ No L 38, 11. 2. 1974, p. 31. Directive as last amended by Directive 94/16/EC (OJ No L 104, 23. 4. 94, p. 32).`

2. In Article 2 (1) the words 'listed in Annex II` are deleted.

3. Article 4 is replaced by the following:

'Article 4

1. Notwithstanding the provisions of Article 6, the 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 12 having regard to current scientific and technical knowledge.

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. In accordance with the procedure laid down in Article 12 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.

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

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

(*) OJ No L 186, 30. 6. 1989, p. 23.

(**) OJ No L 290, 24. 11. 1993, p. 14.`

4. Article 5 is replaced by the following two Articles:

'Article 5

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

Article 5a

1. For the purposes of this Article a Member State of origin is defined as the Member State on which territory a product specified in Article 1 (1), first subparagraph is legally produced or commercialized and a destination Member State is defined as the Member State into which 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 provide for a regime to enable the establishment of maximum residue levels for products referred to in Article 1 (1), first subparagraph, introduced into their territories from a Member State of origin, and taking into account the good agricultural practice in the Member State of origin, in cases where no maximum residue levels have been established for these products in accordance with the provisions of Article 4 (1) or 5.

3. Moreover in cases where no maximum residue levels have been established in accordance with the provisions of Article 4 (1) or 5 the following shall apply:

1. Where a product specified in Article 1 (1), first subparagraph satisfying the maximum residue levels applied by its Member State of origin, has been submitted in the destination Member State to measures with the effect to prohibit or submit to special restrictions the putting into circulation of the product concerned on the grounds that such product contains pesticide residue levels exceeding the maximum residue level accepted in the destination Member State, the destination Member State shall inform thereof the other Member State concerned and the Commission. In the communication the cases on which the information is based, shall be documented.

2. On the basis of the communication referred to in subparagraph 1, the two Member States concerned shall open without delay a discussion in order to remove, whenever possible, the prohibitive or restrictive effect of the measures applied by the destination Member State by means of measures agreed between the Member States and they shall, within a period of three months from the communication, notify to the Commission and the other Member States the result of this discussion, and in particular the agreed measures if any, including the maximum residue level the destination Member State intends to set in the framework of the regime referred to in paragraph 2.

The Member States shall submit to each other all required information; in particular the producing Member State shall indicate the data, including its toxicological assessment and estimation of an ADI, its good agricultural practice and corresponding trial data it relied upon to establish its own maximum residue level; the destination Member State shall indicate the reasons justifying the measures it applies.

3. The Commission shall refer the matter to the Standing Committee on Plant Health. A temporary maximum level may be established in Annex II for a limited period of time in accordance with the procedure laid down in Article 12. For the establishment of this temporary maximum level, the Commission takes into account the state of the technical and scientific knowledge.

Moreover the Member State of origin and/or other interested Member States shall give, where relevant, a satisfactory undertaking that the necessary trial data will be submitted within a time limit set in accordance with Article 12; this time limit will not exceed four years.

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

5. The provisions of 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 (*), do not apply to the measures applied and notified by Member States in accordance with the provisions of 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 12.

(*) OJ No L 109, 26. 4. 1983, p. 8. Directive as last amended by Directive 94/10/EEC (OJ No L 110, 19. 4. 1994, p. 30).`

5. Article 7 is replaced by the following:

'Article 7

1. Member States shall designate an authority to ensure that the monitoring specified in Article 4 (4) is carried out; the designated authority may be the same as the single liaison body designated pursuant to Article 6 of Directive 93/99/EEC.

2. (a) By 30 June each year, the Member States shall send to the Commission their intended national monitoring programmes for the following calender 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 for,

- the criteria applied in drawing up these programmes.

(b) By 30 September each year, the Commission shall refer a draft Decision setting out a coordinated monitoring programme to the Standing Committee on Plant Health. The Decision will be adopted in accordance with the procedure laid down in Article 13. The basic objective of the coordinated monitoring programme will be to maximize the check sampling of cereals included in the groups listed in Annex I, produced in the Community and imported into it, in order to ensure compliance with the maximum levels for pesticide residues set out in Annex II. This coordinated monitoring programme may be subsequently adjusted as required during its implementation.

(c) By 28 February each year the Member States shall send to the Commission reports on the implementation in the preceding calendar year of their national monitoring programmes and of the coordinated monitoring programme communicated by the Commission in accordance with subparagraph (b). These reports shall include at least the following information:

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

- the pesticide residues analysed for or to be analysed for.

3. By 31 August each year, the Member States shall send to the Commission the results of the analyses of the check samples taken during the previous year under their national monitoring programmes and under the coordinated monitoring programme. The Commission shall collate and combine this information and shall communicate it to the Member States in the framework of the Standing Committee on Plant Health together with any recommendations for consequent action. In particular, the recommendations should cover:

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

- the desirability of publication of the collated and combined information,

- specific conclusions as to modifications which might be made to national monitoring programmes.

4. In accordance with the procedure laid down in Article 12 the following may be adopted:

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

(b) detailed implementation 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.`

6. Article 9 is replaced by the following:

'Article 9

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 Annex II 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 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 the 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 13, 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.`

7. Article 10 is replaced by the following:

'Article 10

Without prejudice to Article 9, amendments to the Annexes shall be adopted in accordance with the procedure laid down in Article 12, having regard to current scientific and technical knowledge.`

8. The provisions of Article 11 are deleted.

9. Paragraphs 2, 3 and 4 of Article 12 are replaced by the following:

'2. 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 called upon 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.

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

4. If the measures 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.

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.`

10. Paragraphs 2, 3 and 4 of Article 13 are replaced by the following:

'2. 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 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 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 Committee.

4. If the measures 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.

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.`

11. Article 14 is replaced by the following:

'Article 14

The Member States shall bring into force laws, regulations and administrative provisions necessary to ensure that the amendments in Annex II resulting from decisions referred to in Articles 4 (1) and (2), 5, 5a (3), 9 (3) and 10 can be implemented in their territory within a period of a maximum of four months from their adoption, and within a shorter implementation period when this was prescribed for reasons of human health protection.`

Article 3

Council Directive 86/363/EEC of 24 July 1986 on the fixing of maximum levels for pesticide residues in foodstuffs of animal origin, is amended as follows:

1. Article 1 is replaced by the following:

'Article 1

1. This Directive shall apply to the foodstuffs of animal origin listed in Annex I in so far as these products 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 the provisions of Council Directive 74/63/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.

3. This Directive shall also apply to products referred to in paragraph 1 intended for export to third countries.

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 the manufacture of products other than foodstuffs and animal feed.`

2. In Article 2 (1) the words 'listed in Annex II` are deleted.

3. Article 4 is replaced by the following:

'Article 4

1. The 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 12 having regard to current scientific and technical knowledge.

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. In accordance with the procedure laid down in Article 12 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.

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

4. Member States shall ensure, at least by monitoring and check sampling, compliance with the maximum levels referred to in paragraph 1. The necessary inspections and control measures shall be carried out in accordance with Directive 89/397/EEC, and in particular Article 4 thereof, and Directive 93/99/EEC on the subject of additional measures concerning the official control of foodstuffs and other relevant legislation concerning monitoring of residues in foodstuffs of animal origin.`

4. Article 5 is replaced by the following two Articles:

'Article 5

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

Article 5a

1. For the purposes of this Article a Member State of origin is defined as the Member State on which territory a product specified in Article 1 (1), first subparagraph, is legally produced or commercialized and a destination Member State is defined as the Member State into which territory such a product is introduced and put into circulation for operations other than transit to another Member State or third country.

2. Member States shall provide for a regime to enable the establishment of maximum residue levels for products referred to in Article 1 (1), first subparagraph, introduced into their territories from a Member State of origin, and taking into account the good agricultural practice in the Member State of origin, in cases where no maximum residue levels have been established for these products in accordance with the provisions of Article 4 (1) or 5.

3. Moreover in cases where no maximum residue levels have been established in accordance with the provisions of Article 4 (1) or 5 the following shall apply:

1. Where a product specified in Article 1 (1), first subparagraph, satisfying the maximum residue levels applied by its Member State of origin, has been submitted in the destination Member State to measures with the effect to prohibit or submit to special restrictions the putting into circulation of the product concerned on the grounds that such product contains pesticide residue levels exceeding the maximum residue level accepted in the destination Member State, the destination Member State shall inform thereof the other Member State concerned and the Commission. In the communication the cases on which the information is based, shall be documented.

2. On the basis of the communication referred to in subparagraph 1, the two Member States concerned shall open without delay a discussion in order to remove, whenever possible, the prohibitive or restrictive effect of the measures applied by the destination Member State by means of measures agreed between the Member States and they shall, within a period of three months from the communication, notify to the Commission and the other Member States the result of this discussion, and in particular the agreed measures if any, including the maximum residue level the destination Member State intends to set in the framework of the regime referred to in paragraph 2.

The Member States shall submit to each other all reguired information; in particular the producing Member State shall indicate the data, including its toxicological assessment and estimation of an ADI, its good agricultural practice and corresponding trial data it relied upon to establish its own maximum residue level; the destination Member State shall indicate the reasons justifying the measures it applies.

3. The Commission shall refer the matter to the Standing Committee on Plant Health. A temporary maximum level may be established in Annex II for a limited period of time in accordance with the procedure laid down in Article 12. For the establishment of this temporary maximum level, the Commission takes into account the state of the technical and scientific knowledge.

Moreover the Member State of origin and/or other interested Member States shall give, where relevant, a satisfactory undertaking that the necessary trial data will be submitted within a time limit set in accordance with Article 12; this time limit will not exceed four years.

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

5. The provisions of 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 do not apply to the measures applied and notified by Member States in accordance with the provisions of 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 12.`

5. Article 9 is replaced by the following:

'Article 9

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 Annex II 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 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 the 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 13, 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.`

6. Article 10 is replaced by the following:

'Article 10

Without prejudice to Article 9, amendments to the Annexes shall be adopted in accordance with the prodedure laid down in Article 12, having regard to current scientific and technical knowledge.`

7. The provisions of Article 11 are deleted.

8. Paragraphs 2, 3 and 4 of Article 12 are replaced by the following:

'2. 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 called upon 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.

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

4. If the measures 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.

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.`

9. Paragraphs 2, 3 and 4 of Article 13 are replaced by the following:

'2. 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 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 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 Committee.

4. If the measures are not in accordancee 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.

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.`

10. Article 14 is replaced by the following:

'Article 14

The Member States shall bring into force laws, regulations and administrative provisions necessary to ensure that the amendments in Annex II resulting from decisions referred to in Articles 4 (1) and (2), 5, 5a (3), 9 (3) and 10 can be implemented in their territory within a period of a maximum of four months from their adoption, and within a shorter implementation period when this was prescribed for reasons of human health protection.`

Article 4

Council Directive 90/642/EEC of 27 November 1990 on the fixing of maximum levels for pesticide residues in and on certain products of plant origin, including fruit and vegetables, is amended as follows:

1. Article 1 (1), is replaced by the following:

'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 these 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. Article 2 (a) is replaced by the following:

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

3. Article 3 is replaced by the following:

'Article 3

1. The products in the groups or, as the case may be, 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 9 having regard to current scientific and technical knowledge. A pesticide residue shall not be included on the list for as long as a maximum level is fixed for it by Directive 76/895/EEC.

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. According to the procedure laid down in Article 9 the concentration or dilution factor covering the concentration and/or the dilution caused by certain drying or processing operations may be determined with regard to certain dried or processed products.

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

4. Member States shall ensure, at least by monitoring and check sampling, compliance with the maximum levels referred to in paragraph 1. The necessary inspections and control measures shall be carried out in accordance with Directive 89/397/EEC, and in particular Article 4 thereof, and Directive 93/99/EEC on the subject of additional measures concerning the official control of foodstuffs.`

4. Article 4 is replaced by the following:

'Article 4

1. Member States shall designate an authority to ensure that the monitoring specified in Article 3 (4) is carried out; the designated authority may be the same as the single liaison body designated pursuant to Article 6 of Directive 93/99/EEC.

2. (a)

By 30 June each year, the Member States shall send to the Commission their intended national monitoring programmes for the following calender 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 for,

- the criteria applied in drawing up these programmes.

(b) By 30 September each year, the Commission shall refer a draft Decision setting out a coordination monitoring programme to the Standing Committee on Plant Health. The Decision will be adopted in accordance with the procedure laid down in Article 10. The basic objective of the coordinated monitoring programme will be to maximize the check sampling of products of plant origin included in the groups listed in Annex I, produced in the Community and imported into it, in order to ensure compliance with the maximum levels for pesticide residues set out in Annex II. This coordinated monitoring programme may be subsequently adjusted as required during its implementation.

(c) By 28 February each year the Member States shall send to the Commission reports on the implementation in the preceding calendar year of their national monitoring programmes and of the coordinated monitoring programme communicated by the Commission in accordance with subparagraph (b). These reports shall include at least the following information:

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

- the pesticide residues analysed for or to be analysed for.

3. By 31 August each year, the Member States shall send to the Commission the results of the analyses of the check samples taken during the previous year under their national monitoring programmes and under the coordinated monitoring programme. The Commission shall collate and combine this information and shall communicate it to the Member States in the framework of the Standing Committee on Plant Health together with any appropriate recommendations for consequent action, if necessary.

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

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

(b) detailed implementation 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.`

5. After Article 5, the following articles are inserted:

'Article 5a

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

Article 5b

1. For the purposes of this Article a Member State of origin is defined as the Member State on which territory a product specified in Article 1 (1), first subparagraph is legally produced or commercialized and a destination Member State is defined as the Member State into which 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 provide for a regime to enable the establishment of maximum residue levels for products referred to in Article 1 (1), first subparagraph, introduced into their territories from a Member State of origin, and taking into account the good agricultural practice in the Member State of origin, in cases where no maximum residue levels have been established for these products in accordance with the provisions of Article 3 (1) or 5a.

3. Moreover in cases where no maximum residue levels have been established in accordance with the provisions of Article 3 (1) or 5a the following shall apply:

1. Where a product specified in Article 1 (1), first subparagraph satisfying the maximum residue levels applied by its Member State of origin, has been submitted in the destination Member State to measures with the effect to prohibit or submit to special restrictions the putting into circulation of the product concerned on the grounds that such product contains pesticide residue levels exceeding the maximum residue level accepted in the destination Member State, the destination Member State shall inform thereof the other Member State concerned and the Commission. In the communication the cases on which the information is based, shall be documented.

2. On the basis of the communication referred to in subparagraph 1, the two Member States concerned shall open without delay a discussion in order to remove, whenover possible, the prohibitive or restrictive effect of the measures applied by the destination Member State by means of measures agreed between the Member States and they shall, within a period of three months from the communication, notify to the Commission and the other Member States the result of this discussion, and in particular the agreed measures if any, including the maximum residue level the destination Member State intends to set in the framework of the regime referred to in paragraph 2.

The Member States shall submit to each other all required information; in particular the producing Member State shall indicate the data, including its toxicological assessment and estimation of an ADI, its good agricultural practice and corresponding trial data it relied upon to establish its own maximum residue level; the destination Member State shall indicate the reasons justifying the measures it applies.

3. The Commission shall refer the matter to the Standing Committee on Plant Health. A temporary maximum level may be established in Annex II for a limited period of time in accordance with the procedure laid down in Article 9. For the establishment of this temporary maximum level, the Commission takes into account the state of the technical and scientific knowledge.

Moreover the Member State of origin and/or other interested Member States shall give, where relevant, a satisfactory undertaking that the necessary trial data will be submitted within a time limit set in accordance with Article 9; this time limit will not exceed four years.

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

5. The provisions of 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 do not apply to the measures applied and notified by Member States in accordance with the provisions of 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.`

6. Article 7 is replaced by the following:

'Article 7

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 9.`

7. After Article 10, the following Article is inserted:

'Article 10a

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

Article 5

Member States shall bring into force laws, regulations and administrative provisions necessary to comply with this Directive not later than 31 December 1996.

When Member States adopt these measures, 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 6

This Directive is addressed to the Member States.

(1) OJ No L 221, 7. 8. 1986, p. 37. Directive as last amended by Directive as 94/29/EC (OJ No L 189 , 23. 7. 1994, p. 67).

(2) OJ No L 221, 7. 8. 1986, p. 43. Directive as last amended by 94/29/EC (OJ No L 189, 23. 7. 1994, p. 67).

(3) OJ No L 350, 14. 12. 1990, p. 71. Directive as last amended by Directive 94/30/EC (OJ No L 189, 23. 7. 1994, p. 70).

(4) OJ No L 230, 19. 8. 1991, p. 1. Directive as last amended by Directive 94/79/EC (OJ No L 354, 31. 12. 1994, p. 16).

(5) OJ No L 340, 9. 12. 1976, p. 26. Directive as last amended by Directive 93/58/EEC (OJ No L 211, 23. 8. 1993, p. 6).