# L_2016271EN.01000701.xml

| 6.10.2016 | EN | Official Journal of the European Union | L 271/7 |
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6.10.2016

EN

Official Journal of the European Union

L 271/7

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COMMISSION IMPLEMENTING DECISION (EU) 2016/1774

of 4 October 2016

amending Decision 2010/381/EU on emergency measures applicable to consignments of aquaculture products imported from India and intended for human consumption

(notified under document C(2016) 6280)

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (1), and in particular Article 53(1)(b)(ii) thereof,

Whereas:

| (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 States. |
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(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 States.

| (2) | Council Directive 96/23/EC (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. |
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(2)

Council Directive 96/23/EC (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 2010/381/EU (3) provides that at least 10 % of the consignments of aquaculture products from India intended for human consumption are to be tested for the presence of pharmacologically active substances as defined in Article 2(a) of Regulation (EC) No 470/2009 of the European Parliament and of the Council (4), and in particular of chloramphenicol, tetracycline, oxytetracycline and chlortetracycline and of metabolites of nitrofurans. |
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(3)

Commission Decision 2010/381/EU (3) provides that at least 10 % of the consignments of aquaculture products from India intended for human consumption are to be tested for the presence of pharmacologically active substances as defined in Article 2(a) of Regulation (EC) No 470/2009 of the European Parliament and of the Council (4), and in particular of chloramphenicol, tetracycline, oxytetracycline and chlortetracycline and of metabolites of nitrofurans.

| (4) | The results of analytical tests undertaken by offical control laboratories demonstrate that the level of compliance of aquaculture products from India intended for human consumption as regards presence of residues of chloramphenicol, tetracycline, oxytetracycline, chlortetracycline and metabolites of nitrofurans is unsatisfactory. |
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(4)

The results of analytical tests undertaken by offical control laboratories demonstrate that the level of compliance of aquaculture products from India intended for human consumption as regards presence of residues of chloramphenicol, tetracycline, oxytetracycline, chlortetracycline and metabolites of nitrofurans is unsatisfactory.

| (5) | The results of an inspection to India carried out in March 2014 by the Commission inspection service have confirmed that Indian guarantees on the residues status of aquaculture products rely to a large extent on the additional pre-harvest and pre-export testing programmes in place and these mitigate to a certain extent the long-standing deficiencies in official controls on farms, and in particular, very unsatisfactory official controls on the use of veterinary medicinal products. Nevertheless, the relatively narrow range of substances tested for in those additional programmes weakens the reliability of those guarantees. To date, the recommendations from the inspection report concerning official monitoring of aquaculture farms have not been satisfactorily addressed. |
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(5)

The results of an inspection to India carried out in March 2014 by the Commission inspection service have confirmed that Indian guarantees on the residues status of aquaculture products rely to a large extent on the additional pre-harvest and pre-export testing programmes in place and these mitigate to a certain extent the long-standing deficiencies in official controls on farms, and in particular, very unsatisfactory official controls on the use of veterinary medicinal products. Nevertheless, the relatively narrow range of substances tested for in those additional programmes weakens the reliability of those guarantees. To date, the recommendations from the inspection report concerning official monitoring of aquaculture farms have not been satisfactorily addressed.

| (6) | It is appropriate to adapt the measures of Decision 2010/381/EU in respect of all aquaculture products intended for human consumption imported from India. The obligation for a mandatory testing should be strengthened to continue to deter producers in India from misusing the relevant substances and to minimise risks to human health in the European Union. |
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(6)

It is appropriate to adapt the measures of Decision 2010/381/EU in respect of all aquaculture products intended for human consumption imported from India. The obligation for a mandatory testing should be strengthened to continue to deter producers in India from misusing the relevant substances and to minimise risks to human health in the European Union.

| (7) | Following the implementation of the integrated computerised veterinary system (‘Traces’) in accordance with Article 3 of Commission Decision 2004/292/EC (5) and the improved use of the import module in Traces as regards information on results of the laboratory tests, Member States should be relieved from the quarterly reporting obligations laid down in Article 5(2) of Decision 2010/381/EU. |
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(7)

Following the implementation of the integrated computerised veterinary system (‘Traces’) in accordance with Article 3 of Commission Decision 2004/292/EC (5) and the improved use of the import module in Traces as regards information on results of the laboratory tests, Member States should be relieved from the quarterly reporting obligations laid down in Article 5(2) of Decision 2010/381/EU.

| (8) | Decision 2010/381/EU should therefore be amended accordingly. |
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(8)

Decision 2010/381/EU should therefore be amended accordingly.

| (9) | The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, |
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(9)

The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

HAS ADOPTED THIS DECISION:

Article 1

Decision 2010/381/EU is amended as follows:

| (1) | In Article 3, paragraph 1 is replaced by the following:

  ‘1.   Member States shall, by using appropriate sampling plans, ensure that official samples are taken from at least 50 % of consignments presented for import at border inspection posts on their territory. In case a consignment consists of aquaculture products from more than one establishment of origin, samples shall be taken for each individual establishment.’ |
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(1)

In Article 3, paragraph 1 is replaced by the following:

‘1.   Member States shall, by using appropriate sampling plans, ensure that official samples are taken from at least 50 % of consignments presented for import at border inspection posts on their territory. In case a consignment consists of aquaculture products from more than one establishment of origin, samples shall be taken for each individual establishment.’

| (2) | In Article 5, paragraph 2 is deleted. |
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(2)

In Article 5, paragraph 2 is deleted.

Article 2

This Decision is addressed to the Member States.

Done at Brussels, 4 October 2016.

For the Commission

Vytenis ANDRIUKAITIS

Member of the Commission

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(1)  
  OJ L 31, 1.2.2002, p. 1.

1

(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 (OJ L 125, 23.5.1996, p. 10).

2

(3)  Commission Decision 2010/381/EU of 8 July 2010 on emergency measures applicable to consignments of aquaculture products imported from India and intended for human consumption (OJ L 174, 9.7.2010, p. 51).

3

(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, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council (OJ L 152, 16.6.2009, p. 11).

4

(5)  Commission Decision 2004/292/EC of 30 March 2004 on the introduction of the TRACES system and amending Decision 92/486/EEC (OJ L 94, 31.3.2004, p. 63).

5

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