21.7.2006

EN

Official Journal of the European Union

L 199/21

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COMMISSION DECISION

of 12 July 2006

on special conditions governing certain foodstuffs imported from certain third countries due to contamination risks of these products by aflatoxins

(notified under document number C(2006) 3113)

(Text with EEA relevance)

(2006/504/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

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)	The Scientific Committee for Food has noted that aflatoxin B1 is a potent genotoxic carcinogen and, even at extremely low levels, contributes to the risk of liver cancer.

(2)

Commission Regulation (EC) No 466/2001 of 8 March 2001 setting maximum levels for certain contaminants in foodstuffs (2) lays down maximum levels for certain contaminants and in particular aflatoxins that are permitted in foodstuffs. Those limits for aflatoxins have been regularly exceeded in certain foodstuffs from certain third countries.

(3)	Such contamination constitutes a serious threat to public health within the Community and it is therefore appropriate to adopt special conditions at Community level.

(4)

Commission Decision 2000/49/EC of 6 December 1999 repealing Decision 1999/356/EC and imposing special conditions on the import of peanuts and certain products derived from peanuts originating in or consigned from Egypt (3) lays down special conditions on the import of peanuts and certain products derived from peanuts originating in or consigned from Egypt.

(5)

Commission Decision 2002/79/EC of 4 February 2002 imposing special conditions on the import of peanuts and certain products derived from peanuts originating in or consigned from China (4) lays down special conditions on the import of peanuts and certain products derived from peanuts originating in or consigned from China.

(6)

Commission Decision 2002/80/EC of 4 February 2002 imposing special conditions on the import of figs, hazelnuts and pistachios and certain products derived thereof originating in or consigned from Turkey (5), lays down special conditions on the import of figs, hazelnuts and pistachios and certain products derived thereof originating in or consigned from Turkey.

(7)	Commission Decision 2003/493/EC of 4 July 2003 imposing special conditions on the import of Brazil nuts in shell originating in or consigned from Brazil (6) lays down special conditions on the import of Brazil nuts in shell originating in or consigned from Brazil.

(8)

Commission Decision 2005/85/EC of 26 January 2005 imposing special conditions on the import of pistachios and certain products derived from pistachios originating in or consigned from Iran (7), lays down special conditions on the import of pistachios and certain products derived from pistachios originating in or consigned from Iran

(9)

Many of the special conditions for imports of the foodstuffs covered by Decisions 2000/49/EC, 2002/79/EC, 2002/80/EC, 2003/493/EC and 2005/85/EC from Brazil, China, Egypt, Iran and Turkey are the same. Accordingly, in the interest of clarity of Community legislation, it is appropriate to set out the special conditions for the import of those foodstuffs from those third countries due to contamination of those products by aflatoxins in a single Decision.

(10)

Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules (8) establishes at Community level a harmonised framework of general rules for the organisation of official controls.

(11)	For some foodstuffs from certain third countries, specific additional measures are necessary.

(12)

The measures provided for in this Decision, in particular as regards foodstuffs from Iran and Brazil, have a significant impact on the control resources of the Member States. It is therefore appropriate to require that all costs resulting from sampling, analysis, storage and all costs resulting from official measures taken as regards non-compliant consignments related to the official controls of foodstuffs from Iran and Brazil pursuant to this Decision are to be borne by the importers or food business operators concerned.

(13)

From the findings of the Commission's Food and Veterinary Office (FVO) mission, it may be concluded that Brazil cannot currently ensure reliable analytical results or guarantee lot integrity in respect of certification of consignments of unshelled Brazil nuts. Furthermore, it may also be concluded that current official controls on returned lots are inadequate. It is therefore appropriate to restrict the analyses to the official laboratory which can provide guarantees as regards the analytical results and to impose strict conditions regarding the return of non-conforming lots. In the event that those strict conditions are not complied with, subsequent non-conforming lots should be destroyed.

(14)

In the interests of public health, Member States should keep the Commission informed through quarterly reports of all results of official controls carried out in respect of consignments of foodstuffs covered by this Decision. Such reports shall be in addition to the notification obligations under the rapid alert system for food and feed established by Regulation (EC) No 178/2002.

(15)

It is important to ensure that the sampling and analysis of consignments of foodstuffs covered by this Decision are performed in a harmonised manner throughout the Community. Accordingly the sampling and analysis to be performed under this Decision should be carried out in accordance with the provisions of Commission Regulation (EC) No 401/2006 of 23 February 2006 laying down the methods of sampling and analysis for the official control of the levels of mycotoxins in foodstuffs (9).

(16)

The operation of this Decision should be kept under review on the basis of the guarantees provided by the competent authorities of the third countries concerned and of the results of the official controls carried out by Member States in order to assess whether the special conditions provide a sufficient level of protection of public health within the Community and whether they are still needed.

(17)	Decisions 2000/49/EC, 2002/79/EC, 2002/80/EC, 2003/493/EC and 2005/85/EC should accordingly be repealed.

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

HAS ADOPTED THIS DECISION:

Article 1

Scope

This Decision shall apply to the foodstuffs referred to in points (a) to (e) and to processed and compound foodstuffs derived from or containing the foodstuffs referred to in points (a) to (e).

Foodstuffs shall be considered as containing the foodstuffs when such foodstuffs are listed as ingredients on the label or packaging in accordance with Article 6 of Directive 2000/13/EC of the European Parliament and of the Council of 20 March 2000 on the approximation of the laws of the Member States relating to labelling, presentation and advertising of foodstuffs (10):

(a)	the following foodstuffs imported from Brazil: (i) Brazil nuts in shell falling within category CN code 0801 21 00; (ii) mixtures of nuts or dried fruits falling within CN code 0813 50 and containing Brazil nuts in shell;

(b)

the following foodstuffs imported from China: (i) peanuts falling within CN code 1202 10 90 or 1202 20 00; (ii) peanuts falling within CN code 2008 11 94 (in immediate packings of a net content exceeding 1 kg) or 2008 11 98 (in immediate packings of a net content not exceeding 1 kg); (iii) roasted peanuts falling within CN codes 2008 11 92 (in immediate packings of a net content exceeding 1 kg) or 2008 11 96 (in immediate packings of a net content not exceeding 1 kg);

(c)

the following foodstuffs imported from Egypt: (i) peanuts falling within CN code 1202 10 90 or 1202 20 00; (ii) peanuts falling within CN code 2008 11 94 (in immediate packings of a net content exceeding 1 kg) or 2008 11 98 (in immediate packings of a net content not exceeding 1 kg); (iii) roasted peanuts falling within CN codes 2008 11 92 (in immediate packings of a net content exceeding 1 kg) or 2008 11 96 (in immediate packings of a net content not exceeding 1 kg);

(d)	the following foodstuffs imported from Iran: (i) pistachios falling within CN code 0802 50 00; (ii) roasted pistachios falling within CN codes 2008 19 13 (in immediate packings of a net content exceeding 1 kg) and 2008 19 93 (in immediate packings of a net content not exceeding 1 kg);

(e)

the following foodstuffs imported from Turkey: (i) dried figs falling within CN code 0804 20 90; (ii) hazelnuts (Corylus sp) in shell or shelled falling within CN code 0802 21 00 or 0802 22 00; (iii) pistachios falling within CN code 0802 50 00; (iv) mixtures of nuts or dried fruits falling within CN code 0813 50 and containing figs, hazelnuts or pistachios; (v) fig paste and hazelnut paste falling within CN code 2007 99 98; (vi) hazelnuts, figs and pistachios, prepared or preserved, including mixtures falling within CN code 2008 19; (vii) flour, meal and powder of hazelnuts, figs and pistachios falling within CN code 1106 30 90; (viii) cut, sliced and broken hazelnuts.

Article 2

Definitions

For the purposes of this Decision, the definitions laid down in Articles 2 and 3 of Regulation (EC) No 178/2002 and in Article 2 of Regulation (EC) No 882/2004 shall apply.

‘Designated points of import’ means the points through which the foodstuffs referred to in Article 1 may only be imported into the Community. An exhaustive list of designated points of import is provided in Annex II.

Article 3

Results of sampling and analysis and health certificate

1.   Member States may only permit imports of the foodstuffs referred to in Article 1 (hereafter referred to as foodstuffs), where the consignment is accompanied by the results of sampling and analysis and a health certificate (11) in accordance with the model set out in Annex I, completed, signed and verified by an authorised representative of:

(a)	the Ministério da Agricultura, Pecuária e Abastecimento (MAPA) for foodstuffs from Brazil;

(b)	the State Administration for Entry-Exit inspection and Quarantine of the People's Republic of China for foodstuffs from China;

(c)	the Egyptian Ministry of Agriculture for foodstuffs from Egypt;

(d)	the Iranian Ministry of Health for foodstuffs from Iran;

(e)	the General Directorate of protection and Control of the Ministry of Agriculture and Rural Affairs of the Republic of Turkey for foodstuffs from Turkey.

2.   The health certificate provided for in paragraph 1 shall only be valid for imports of foodstuffs into the Community no later than four months from the date of issue of the health certificate.

3.   The competent authorities in each Member State shall ensure that the foodstuffs are subject to documentary checks to ensure that the requirement of the results of sampling and analysis and the health certificate provided for in paragraph 1 are complied with. The documentary check must take place at the point of first introduction into the territory of the Community.

4.   Where a consignment of foodstuffs is not accompanied by the results of sampling and analysis and the health certificate provided for in paragraph 1, the consignment may not enter the Community for onward transit to the designated point of import nor be imported into the Community and must be re-dispatched to the country of origin or destroyed.

5.   The sampling and the analysis provided for in paragraph 1 must be performed in accordance with the provisions of Regulation (EC) No 401/2006.

6.   Each consignment of foodstuffs shall be identified with a code which corresponds to the code on the sampling results of the sampling and analysis and health certificate referred to in paragraph 1. Each individual bag, or other packaging form, of the consignment shall be identified with that code.

Article 4

Designated points of import into the Community

1.   Foodstuffs may only be imported into the Community through one of the designated points of import listed in Annex II.

2.   The competent authorities in each Member State shall ensure that the designated points of import (12) listed in Annex II comply with following requirements:

(a)	the presence of trained staff to perform official controls on consignments of foodstuffs;

(b)	the availability of detailed instructions regarding sampling and the sending of the samples to the laboratory, in accordance with provisions in Annex I of Regulation (EC) No 401/2006;

(c)

the possibility to perform the unloading and the sampling in a sheltered place at the designated point of import; it must be possible to place the consignment of the foodstuffs under the official control of the competent authority from the designated point of import onwards in cases where the consignment has to be transported in order to perform the sampling;

(d)	the availability of storage rooms, warehouses to store detained consignments of foodstuffs in good conditions during the period of detention awaiting the results of analysis;

(e)	the availability of unloading equipment and appropriate sampling equipment;

(f)

the availability of an accredited official laboratory (13) for aflatoxin analysis, situated at a place to which the samples can be transported within a short period of time; the laboratory must have the appropriate grinding equipment for homogenising 10 to 30 kg samples (14). The laboratory must be able to analyse the sample within a reasonable period of time in order to comply with the 15 working day maximum period of detention for consignments.

3.   Member States shall ensure that food business operators must make available sufficient human resources and logistics to unload the consignment of foodstuffs, thus enabling representative sampling to take place.

In the case of special transport and/or specific packaging forms, the operator/responsible food business operator must make available to the official inspector the appropriate sampling equipment insofar as the sampling cannot be representatively performed with the usual sampling equipment.

Article 5

Official control

1.   The competent authorities in each Member State shall take a sample for analysis, in accordance with the provisions of Annex I of Regulation (EC) No 401/2006 from consignments of foodstuffs for analysis of aflatoxin B1 and total aflatoxin contamination before release for free circulation from the designated point of import into the Community.

2.   The sampling for analysis referred to in paragraph 1 shall be carried out on:

(a)	each consignment of foodstuffs from Brazil;

(b)	approximately 10 % of the consignments of foodstuffs from China;

(c)	approximately 20 % of the consignments of foodstuffs from Egypt;

(d)	each consignment of foodstuffs from Iran;

(e)	approximately 5 % of the consignments for each category of hazelnuts referred to in point (e)(ii), (iv) and (vi) of Article 1 and derived products from such hazelnuts from Turkey and approximately 10 % of the consignments of other categories of foodstuffs from Turkey.

3.   Any consignment of foodstuffs which is to be subjected to sampling and analysis may be held before release for free circulation from the designated point of import into the Community for a maximum period of 15 working days from the moment the consignment is offered for import and physically available for sampling.

The competent authorities of the importing Member State shall issue an accompanying official document establishing that the consignment of foodstuffs has been subjected to sampling and analysis and indicating the results of the analysis.

4.   Member States shall submit to the Commission every three months a report of all analytical results of official controls on consignments of foodstuffs. This report shall be submitted during the month following each quarter (April, July, October, and January).

Article 6

Splitting of a consignment

If a consignment is split, copies of the health certificate provided for in Article 3(1) and the official document provided for in Article 5(3), and certified by the competent authority of the Member State on whose territory the splitting has taken place, shall accompany each part of the split consignment up to and including the wholesale stage.

Article 7

Additional conditions as regards imports of foodstuffs from Brazil

1.   The analysis provided for in Article 3(1) must be performed by the official control laboratory for the analysis of aflatoxins in foodstuffs from Brazil, the Laboratório de Controle de Qualidade de Segurança Alimentar (LACQSA) in Belo Horizonte, Brazil.

2.   Consignments of unshelled Brazil nuts not complying with the maximum levels for aflatoxin B1 and aflatoxin total, established by Regulation (EC) No 466/2001 may only be returned to the country of origin where, for each individual non-conforming consignment, the Ministério da Agricultura, Pecuária e Abastecimento (MAPA) provides the following in writing:

(a)	explicit agreement for the return of the consignment concerned, and indicating the consignment code;

(b)	a commitment to put the returned consignment under official control from the date of arrival onwards;

(c)	a concrete indication of: (i) the destination of the returned consignment; (ii) the intended treatment of the returned consignment; and (iii) the intended sampling and analysis to be performed on the returned consignment.

However, if the conditions provided for in points (a), (b) and (c) are not complied with by the Ministério da Agricultura, Pecuária e Abastecimento (MAPA), all subsequent consignments that do not comply with the maximum levels for aflatoxin B1 and aflatoxin total, established by Regulation (EC) No 466/2001 shall be destroyed by the competent authorities of the importing Member State.

Article 8

Additional conditions as regards imports of foodstuffs from Brazil and Iran

1.   All costs resulting from sampling, analysis, storage and issuing of accompanying official documents and of copies of health certificate and accompanying documents pursuant to Articles 3(1) and 5(3) for foodstuffs from Brazil and Iran as referred to in points (a) and (d) of Article 1 and to processed and compound foodstuffs derived from or containing the foodstuffs referred to in these points, shall be borne by the food business operator responsible for the consignment or its representative.

2.   All costs related to official measures taken by the competent authorities as regards non-compliance of consignments of foodstuffs from Brazil and Iran as referred to in points (a) and (d) of Article 1 and to processed and compound foodstuffs derived from or containing the foodstuffs referred to in these points shall be borne by the food business operator responsible for the consignment or its representative.

Article 9

Review

This Decision shall be reviewed on the basis of the reports provided for in Article 5(4) and guarantees provided by the competent authorities of countries exporting the foodstuffs and of the results of the sampling and analysis carried out by Member States in order to assess whether the conditions set out in Articles 3, 4, 5, 6, 7 and 8 provide a sufficient level of protection of public health within the Community and whether they are still necessary.

Article 10

Repeals

Decisions 2000/49/EC, 2002/79/EC, 2002/80/EC, 2003/493/EC and 2005/85/EC are hereby repealed.

Article 11

Applicability

This Decision shall apply from 1 October 2006.

Member States shall adopt and publish the necessary measures to comply with this Decision. They shall forthwith inform the Commission thereof.

Article 12

Addressees

This Decision is addressed to the Member States.

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(1)  OJ L 31, 1.2.2002, p. 1. Regulation as last amended by Commission Regulation (EC) No 575/2006 (OJ L 100, 8.4.2006, p. 3).

(2)  OJ L 77, 16.3.2001, p. 1. Regulation as last amended by Regulation (EC) No 199/2006 (OJ L 32, 4.2.2006, p. 34).

(3)  OJ L 19, 25.1.2000, p. 46. Decision as last amended by Decision 2004/429/EC (OJ L 154, 30.4.2004, p. 19, corrected by OJ L 189, 27.5.2004, p. 13).

(4)  OJ L 34, 5.2.2002, p. 21. Decision as last amended by Decision 2004/429/EC.

(5)  OJ L 34, 5.2.2002, p. 26. Decision as last amended by Decision 2004/429/EC.

(6)  OJ L 168, 5.7.2003, p. 33. Decision as amended by Decision 2004/428/EC (OJ L 154, 30.4.2004, p. 14, corrected by OJ L 189, 27.5.2004, p. 8).

(7)  OJ L 30, 3.2.2005, p. 12.

(8)  OJ L 165, 30.4.2004, p. 1, corrected by OJ L 191, 28.5.2004, p. 1. Regulation as amended by Commission Regulation (EC) No 776/2006 (OJ L 136, 24.5.2006, p. 3).

(9)  OJ L 70, 9.3.2006, p. 12.

(10)  OJ L 109, 6.5.2000, p. 29. Directive as last amended by Directive 2003/89/EC (OJ L 308, 25.11.2003, p. 15).

(11)  Health certificates shall be drawn up in a language understood by the certifying officer, enabling the certifying officer to be fully aware of the significance of the contents of each certificate they sign and in a language understood by the control official of the country of import.

(12)  The requirements apply to the designated points of import or to the place where the sampling effectively takes place in case where the consignment is transported from the point of import under official control to that place to perform the sampling.

(13)  Laboratory that is accredited and is an official laboratory (belonging to the competent authority structure) or a laboratory designated by the competent authority.

(14)  The grinding step for homogenisation as part of sample preparation, can be performed outside the laboratory, but the premise where the grinding is performed must have the appropriate grinding equipment, environment and protocol for homogenisation.

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