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Council Directive 95/38/EC of 17 July 1995 amending Annexes I and II to Directive 90/642/EEC on the fixing of maximum levels for pesticide residues in and on certain products of plant origin, including fruit and vegetables, and providing for the establishment of a list of maximum levels Official Journal L 197 , 22/08/1995 P. 0014 - 0028

COUNCIL DIRECTIVE 95/38/EC of 17 July 1995 amending Annexes I and II to Directive 90/642/EEC on the fixing of maximum levels for pesticide residues in and on certain products of plant origin, including fruit and vegetables, and providing for the establishment of a list of maximum levels THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty establishing the European Community, Having regard to Council Directive 90/642/EEC of 27 November 1990 on maximum levels for pesticide residues in and on certain products of plant origin, including fruit and vegetables (1), and in particular Article 1 thereof, Having regard to the proposal from the Commission, Whereas the Commission has been instructed, within the framework of Directive 90/642/EEC, to prepare a list of pesticide residues and their maximum levels for submission to the Council for approval; Whereas pesticide residues may occur in products of plant origin, including fruit and vegetables, as a result of agricultural practices; whereas it is necessary to take into account relevant data for both authorized pesticide uses and supervised trials; Whereas in order better to estimate the maximum potential dietary intake of pesticide residues, it is prudent to establish simultaneously, where appropriate, maximum residue levels for individual pesticides in all major components of diet; whereas these levels represent the use of minimum quantities of pesticide necessary to achieve adequate control, applied in such a manner that the amount of residue is the smallest possible and is toxicologically acceptable; Whereas it is now appropriate that maximum levels be fixed for certain pesticide residues in products of plant origin, namely methidathion, methomyl thiodicarb, amitraz, pirimiphos-methyl, aldicarb, thiabendazole; whereas, however, it is not possible to do so for all pesticide residue product combinations due to insufficient data; Whereas, in the case of thiabendazole, the available data are insufficient to establish, in accordance with current rules, a maximum residue level for citrus fruit; whereas, however, thiabendazole has been included in the list of substances included in Commission Regulation (EEC) No 3600/92 (2) and is covered by the first stage of the work programme provided for in Article 8 (2) of Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (3); whereas an important element of this programme will be the establishment of maximum levels arising from use as plant protection products; Whereas certain pesticide residues may remain, in particular, in spices, which may need to be controlled; whereas it is necessary to amend Annex I to Directive 90/642/EEC to include such spices in the list of groups of product to which maximum residue levels apply; Whereas, it is only considered necessary to establish maximum pesticide residue levels in spices for certain pesticides having regard to the toxicological nature of their residues and their use pattern; Whereas, however, the available data are insufficient by current standards to establish maximum pesticide residue levels for certain pesticide residue/product combinations; whereas in such cases a period of time not exceeding four years would seem reasonable for the generation of the necessary data; whereas maximum levels should therefore be established on the basis of such data by 1 July 2000 at the latest; whereas failure to provide satisfactory data will result in the establishment of levels at the appropriate limit of determination; whereas satisfactory undertakings to generate the necessary data must be given within one year of adoption of this Directive; Whereas the maximum residue levels established in this Directive will have to be reviewed in the framework of the re-evaluation of active substances provided for in the work programme referred to in Article 8 (2) of Directive 91/414/EEC, HAS ADOPTED THIS DIRECTIVE: Article 1 Directive 90/642/EEC is hereby amended as follows: 1. Annex I shall be supplemented by the addition of the following: >TABLE> 2. Annex II shall become Annex II, Part A, and shall be supplemented by the following: >TABLE> >TABLE> >TABLE> Article 2 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 1 July 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 reference shall be laid down by Member States. Article 3 This Directive is addressed to the Member States. Done at Luxembourg, 17 July 1995. For the Council The President L. ATIENZA SERNA

COUNCIL DIRECTIVE 95/38/EC of 17 July 1995 amending Annexes I and II to Directive 90/642/EEC on the fixing of maximum levels for pesticide residues in and on certain products of plant origin, including fruit and vegetables, and providing for the establishment of a list of maximum levels

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community,

Having regard to Council Directive 90/642/EEC of 27 November 1990 on maximum levels for pesticide residues in and on certain products of plant origin, including fruit and vegetables (1), and in particular Article 1 thereof,

Having regard to the proposal from the Commission,

Whereas the Commission has been instructed, within the framework of Directive 90/642/EEC, to prepare a list of pesticide residues and their maximum levels for submission to the Council for approval;

Whereas pesticide residues may occur in products of plant origin, including fruit and vegetables, as a result of agricultural practices; whereas it is necessary to take into account relevant data for both authorized pesticide uses and supervised trials;

Whereas in order better to estimate the maximum potential dietary intake of pesticide residues, it is prudent to establish simultaneously, where appropriate, maximum residue levels for individual pesticides in all major components of diet; whereas these levels represent the use of minimum quantities of pesticide necessary to achieve adequate control, applied in such a manner that the amount of residue is the smallest possible and is toxicologically acceptable;

Whereas it is now appropriate that maximum levels be fixed for certain pesticide residues in products of plant origin, namely methidathion, methomyl thiodicarb, amitraz, pirimiphos-methyl, aldicarb, thiabendazole; whereas, however, it is not possible to do so for all pesticide residue product combinations due to insufficient data;

Whereas, in the case of thiabendazole, the available data are insufficient to establish, in accordance with current rules, a maximum residue level for citrus fruit; whereas, however, thiabendazole has been included in the list of substances included in Commission Regulation (EEC) No 3600/92 (2) and is covered by the first stage of the work programme provided for in Article 8 (2) of Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (3); whereas an important element of this programme will be the establishment of maximum levels arising from use as plant protection products;

Whereas certain pesticide residues may remain, in particular, in spices, which may need to be controlled; whereas it is necessary to amend Annex I to Directive 90/642/EEC to include such spices in the list of groups of product to which maximum residue levels apply;

Whereas, it is only considered necessary to establish maximum pesticide residue levels in spices for certain pesticides having regard to the toxicological nature of their residues and their use pattern;

Whereas, however, the available data are insufficient by current standards to establish maximum pesticide residue levels for certain pesticide residue/product combinations; whereas in such cases a period of time not exceeding four years would seem reasonable for the generation of the necessary data; whereas maximum levels should therefore be established on the basis of such data by 1 July 2000 at the latest; whereas failure to provide satisfactory data will result in the establishment of levels at the appropriate limit of determination; whereas satisfactory undertakings to generate the necessary data must be given within one year of adoption of this Directive;

Whereas the maximum residue levels established in this Directive will have to be reviewed in the framework of the re-evaluation of active substances provided for in the work programme referred to in Article 8 (2) of Directive 91/414/EEC,

HAS ADOPTED THIS DIRECTIVE:

Directive 90/642/EEC is hereby amended as follows:

1. Annex I shall be supplemented by the addition of the following:

>TABLE>

2. Annex II shall become Annex II, Part A, and shall be supplemented by the following:

>TABLE>

>TABLE>

>TABLE>

Article 2 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 1 July 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 reference shall be laid down by Member States.

Article 3

This Directive is addressed to the Member States.

Done at Luxembourg, 17 July 1995.

For the Council The President L. ATIENZA SERNA