Amended 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 (1) (97/C 103/13) (Text with EEA relevance) COM(97) 21 final - 95/0154(CNS)

(Submitted by the Commission pursuant to Article 189a (2) of the EC Treaty on 31 January 1997)

In response to the opinion delivered by the European Parliament on the proposal for a Council Directive sent to the Council by the Commission on 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, and in accordance with Article 189a (2) of the Treaty establishing the European Community, the Commission has decided to amend the aforementioned proposal as follows.

Amendments in Article 1 of the proposal (Council Directive 76/895/EEC)

1. The following points are added after the heading of Article 1 of the proposal:

(1) Article 1 is replaced by the following:

'Article 1

1. This Directive concerns products intended for human or, in exceptional cases, animal consumption listed under the Common Customs Tariff headings set out in Annex I and in or on which are found the pesticide residues listed in Annex II.

2. This 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.

3. This Directive is without prejudice to 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 (**).

(*) OJ No L 175, 4. 7. 1991, p. 35. Directive as last amended by Directive 96/4/EC of 16 February 1996 (OJ No L 49, 28. 2. 1996, p. 12).

(**) OJ No L 49, 28. 2. 1996, p. 17.`;

(2) Article 2 is replaced by the following:

'Article 2

For the purposes of this Directive:

1. "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;

2. "putting into circulation" shall mean any post-harvest handing over, whether or not for a consideration, of the products referred to in Article 1.`;

(3) Article 4 (1) is replaced by the following:

'Article 4

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. Points 1 to 5 of the proposal become points 4 to 8 respectively.

Amendments in Article 2 of the proposal (Council Directive 86/362/EEC)

3. In point 1, the first sentence of Article 1 (1) is replaced by the following:

'This Directive shall apply to the cereal products and other grains or seeds listed in Annex I in so far as these products may contain certain pesticide residues.`

4. In point 4, 'first subparagraph` is deleted in Article 5a (1).

5. In point 4, 'first subparagraph` is deleted in Article 5a (2).

6. In point 4, Article 5a (3), subparagraph 1 is replaced by the following:

'1. Where a product specified in Article 1 (1) 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 within 20 days of their application. In the communication the cases on which the information is based, shall be documented.`

7. In point 5, Article 7 (3) is replaced by the following:

'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 together with the results of the checks carried out in accordance with Directives 86/363/EEC and 90/642/EEC and analyse:

- infringements of the maximum residue levels, and

- the average actual levels of residues and their relative value 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 to estimate the actual pesticide dietary exposure.

The Commission shall communicate this information 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.`

Amendments in Article 3 of the proposal (Council Directive 86/363/EEC)

8. In point 4, 'first subparagraph` is deleted in Article 5a (1).

9. In point 4, 'first subparagraph` is deleted in Article 5a (2).

10. In point 4, Article 5a (3), subparagraph 1 is replaced by the following:

'1. Where a product specified in Article 1 (1) 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 within 20 days of their application. In the communication the cases on which the information is based, shall be documented.`

11. The following is added between points 4 and 5:

4a. The following paragraph is added at the end of Article 7:

'The Commission shall collate and combine this information and process it, together with the results of the checks carried out in accordance with Directives 86/362/EEC and 90/642/EEC.`

Amendments in Article 4 of the proposal (Council Directive 90/642/EEC)

12. In point 4, Article 4 (3) is replaced by the following:

'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 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 value 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 to estimate the actual pesticide dietary exposure.

The Commission shall communicate this information to the Member States in the framework of the Standing Committee on Plant Health together with any recommendations for consequent action if necessary.`

13. In point 5, 'first subparagraph` is deleted in Article 5b (1).

14. In point 5, 'first subparagraph` is deleted in Article 5b (2).

15. In point 5, Article 5b (3), subparagraph 1 is replaced by the following:

'1. Where a product specified in Article 1 (1), 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 within 20 days of their application. In the communication the cases on which the information is based, shall be documented.`

16. In point 6, the text of Article 7 is replaced by the following:

'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. 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.`

17. In point 7, the following paragraph is added at the end in Article 10a:

'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.`

(1) OJ No C 201, 5. 8. 1995, p. 8.