9.7.2010   

EN

Official Journal of the European Union

L 174/51

(1)

Regulation (EC) No 178/2002 lays down the general principles governing food and feed in general, and food and feed safety in particular, at Union and national level. It provides for emergency measures where it is evident that food or feed imported from a third country is likely to constitute a serious risk to human health, animal health or the environment, and that such risk cannot be contained satisfactorily by means of measures taken by the Member State(s) concerned.

(2)

Council Directive 96/23/EC of 29 April 1996 on measures to monitor certain substances and residues thereof in live animals and animal products (2) provides that the production process of animals and primary products of animal origin is to be monitored for the purpose of detecting the presence of certain residues and substances in live animals, their excrements and body fluids and in tissue, animal products, animal feed and drinking water.

(3)

Commission Decision 2002/657/EC of 12 August 2002 implementing Council Directive 96/23/EC concerning the performance of analytical methods and the interpretation of results (3) provides rules for the analytical methods to be used in the testing of official samples taken pursuant to Directive 96/23/EC and specifies common criteria for the interpretation of analytical results of official control laboratories for such samples.

(4)

Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin (4) lays down rules and procedures for the classification of pharmacologically active substances and for establishing the maximum concentration of residues of such substances which may be permitted in food of animal origin.

(5)

In addition, Regulation (EC) No 470/2009 lays down rules and procedures in order to establish the level of residues of a pharmacologically active substance for control reasons in the case of certain substances for which a maximum residue limit has not been laid down in accordance with that Regulation.

(6)

The results of a Commission inspection to India in September 2009 have revealed shortcomings as regards the residue control system in aquaculture products and a lack of appropriate laboratory capacity for detecting certain pharmacologically active substances in such products, as required by Directive 96/23/EC and by Decision 2002/657/EC.

(7)

Following that inspection, India has submitted an action plan and guarantees addressing the recommendations in the inspection report. Pending the full implementation of that plan and of those guarantees, the risk remains that aquaculture products originating from India contain residues of certain pharmacologically active substances. Further measures are therefore required at Union level to minimise that risk.

(8)

Commission Decision 2009/727/EC of 30 September 2009 on emergency measures applicable to crustaceans imported from India and intended for human consumption or animal feed (5) already provides that consignments of crustaceans of aquaculture origin introduced from India and intended for human consumption or animal feed are to be tested for the presence of nitrofurans or their metabolites before they are imported into the Union. In addition, in aquaculture products other than crustaceans, chloramphenicol and tetracyclines are also known to be used in India.

(9)

Since the adoption of Decision 2009/727/EC, the number of positive findings of nitrofurans or their metabolites in crustaceans reported by the Member States has decreased. Therefore, it is appropriate to adopt measures similar to those laid down in that Decision in respect of all aquaculture products imported from India and intended for human consumption.

(10)

In addition a significant proportion of the aquaculture products imported from India should undergo mandatory testing by the Member States for the detection of pharmacology active substances as defined in Regulation (EC) No 470/2009 before those products are placed on the market. The results of that mandatory testing should provide more accurate information on the actual contamination of aquaculture products originating from India with those residues. The testing should also deter producers in India from misusing those substances.

(11)

It is appropriate that Member States notify the Commission of the results of the tests performed, where the presence of the concerned pharmacologically active substances not authorised for use in food producing animals, or exceeding the maximum residue limits laid down in Union law, is revealed. Member States should also regularly submit reports on all the tests carried out by them.

(12)

The scope of this Decision also includes crustaceans of aquaculture origin currently covered by Decision 2009/727/EC. Accordingly, in the interest of clarity and consistency of Union legislation, that Decision should be repealed.

(13)

The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

(a)

classified in accordance with Article 14(2)(a), (b) or (c) of Regulation (EC) No 470/2009 at a level exceeding the maximum residue limit established pursuant to that Regulation; or

(b)

not classified in accordance with Article 14(2)(a), (b) or (c) of Regulation (EC) No 470/2009; however, the Member State concerned is not required to immediately inform the Commission of the results of such tests where the level of residues is lower than: