2009R1152 — EN — 18.02.2013 — 002.001

This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents

►B COMMISSION REGULATION (EC) No 1152/2009 of 27 November 2009 imposing special conditions governing the import of certain foodstuffs from certain third countries due to contamination risk by aflatoxins and repealing Decision 2006/504/EC (Text with EEA relevance) (OJ L 313, 28.11.2009, p.40)

Amended by:









▼B

COMMISSION REGULATION (EC) No 1152/2009

of 27 November 2009

imposing special conditions governing the import of certain foodstuffs from certain third countries due to contamination risk by aflatoxins and repealing Decision 2006/504/EC

(Text with EEA relevance)







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) Commission Decision 2006/504/EC of 12 July 2006 on special conditions governing certain foodstuffs imported from certain third countries due to contamination risks of these products by aflatoxins ( 2 ), has been amended substantially several times. It is necessary to amend again certain provisions substantially to take into account particularly developments as regards aflatoxin contamination of certain products covered by that Decision. At the same time, the provisions should have a direct application and be binding in their entirety, therefore Decision 2006/504/EC should be replaced by this Regulation. (2) Commission Regulation (EC) No 1881/2006 of 19 December 2006 setting maximum levels for certain contaminants in foodstuffs ( 3 ) lays down permitted maximum levels of aflatoxins in foodstuffs for the protection of public health. It can be observed that these maximum levels of aflatoxins are frequently exceeded in certain foodstuffs from certain countries. Such contamination constitutes a serious threat to public health within the Community and it is therefore appropriate to adopt special conditions at the Community level. (3) For the protection of public health it is important that compound foodstuffs containing to a significant amount the foodstuffs covered by this Regulation are also within the scope of this Regulation. To facilitate the enforcement of controls of processed and compound foodstuffs whilst maintaining a high level of effectiveness of controls, it is appropriate to increase the threshold for control of compound products. For the same reason, the limit of 5 kg for consignments falling out of scope should be increased to 20 kg. Competent authorities may control at random for the presence of aflatoxins the compound foodstuffs containing less than 20 % of foodstuffs covered by this Regulation. When monitoring data indicate that compound foodstuffs containing less than 20 % of foodstuffs covered by this Regulation have been found in several cases to be non-compliant with the Community legislation on maximum levels for aflatoxins, these thresholds should be reviewed. (4) The Combined Nomenclature (CN) code has changed for certain food categories covered by this Regulation. It is appropriate to change the CN codes in this Regulation accordingly. (5) Experience has shown that the additional conditions for non-compliant shipments of unshelled Brazil nuts imported from Brazil are no longer necessary, since such shipments can be handled in accordance with the general provisions for non-compliant shipments and those additional conditions should therefore be repealed. As regards the imports of foodstuffs from the United States of America, since the transitional provisions for non-USDA approved laboratories for aflatoxin analysis are no longer needed, those transitional provisions should be repealed. (6) Commission Regulation (EC) 669/2009 of 24 July 2009 implementing Regulation (EC) No 882/2004 of the European Parliament and of the Council as regards the increased level of official controls on imports of certain feed and food of non-animal origin and amending Decision 2006/504/EC ( 4 ) provides for the use of a Common Entry Document for prior notification of arrival of consignments and information on the official checks performed. It is appropriate to provide for the use of that document and to lay down specific guidance notes for the completion thereof in application of this Regulation. (7) In the light of the number and nature of notifications in the Rapid Alert System for Food and Feed, trade volumes, the outcome of inspections of the Food and Veterinary Office and the outcome of controls, the existing control frequencies should be reviewed. (8) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, Whereas: HAS ADOPTED THIS REGULATION:







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Article 1

Scope

1. This Regulation shall apply to the import of the following foodstuffs and of the foodstuffs processed and compound thereof:

(a) the following foodstuffs originating in or consigned 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 originating in or consigned from China: (i) groundnuts falling within CN code 1202 41 00 or 1202 42 00; (ii) groundnuts falling within CN code 2008 11 91 (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 groundnuts falling within CN code 2008 11 96 (in immediate packings of a net content not exceeding 1 kg);

(c) the following foodstuffs originating in or consigned from Egypt: (i) groundnuts falling within CN code 1202 41 00 or 1202 42 00; (ii) groundnuts falling within CN code 2008 11 91 (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 groundnuts falling within CN code 2008 11 96 (in immediate packings of a net content not exceeding 1 kg);

(d) the following foodstuffs originating in or consigned from Iran: (i) pistachios falling within CN code 0802 51 00 or 0802 52 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 originating in or consigned from Turkey: (i) dried figs falling within CN code 0804 20 90; (ii) hazelnuts (Corylus spp.) in shell or shelled falling within CN code 0802 21 00 or 0802 22 00; (iii) pistachios falling within CN code 0802 51 00 or 0802 52 00; (iv) mixtures of nuts or dried fruits falling within CN code 0813 50 and containing figs, hazelnuts or pistachios; (v) fig paste, pistachio paste and hazelnut paste falling within CN codes 2007 10 or 2007 99; (vi) hazelnuts and pistachios, prepared or preserved, including mixtures falling within CN code 2008 19 and figs, prepared or preserved, falling within CN code 2008 99, including mixtures falling within CN code 2008 97; (vii) flour, meal and powder of hazelnuts, figs and pistachios falling within CN code 1106 30 90; (viii) cut, sliced and broken hazelnuts falling within CN 0802 22 00 and 2008 19;

(f) the following foodstuffs originating in or consigned from the United States of America: (i) almonds in shell or shelled falling within CN code 0802 11 or 0802 12; (ii) roasted almonds 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); (iii) mixtures of nuts or dried fruits falling within CN code 0813 50 and containing almonds.

2. Paragraph 1 shall not apply to consignments of foodstuffs of a gross weight not exceeding 20 kg, or to processed or compound foodstuffs containing the foodstuffs referred to in points (b) to (f) of paragraph 1 in a quantity below 20 %.

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Article 2

Definitions

For the purposes of this Regulation, 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 of the European Parliament and of the Council ( 5 ) shall apply.

In addition, the following definitions shall apply:

(a) ‘designated points of import’ means any point designated by the competent authority, through which the foodstuffs referred to in Article 1 may be imported into the Community;

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(b) Designated point of entry (DPE): means the point of entry as defined in Article 3 (b) of Regulation (EC) No 669/2009.

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Article 3

Import into the Community

Consignments of foodstuffs referred to in Article 1 (hereafter referred to as foodstuffs), may only be imported into the Community in accordance with the procedures laid down in this Regulation.

Article 4

Health certificate and results of sampling and analysis

1. Foodstuffs presented for import into the Community shall be accompanied by the results of sampling and analysis and a health certificate 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;

(f) the United States Department of Agriculture (USDA) for foodstuffs from the United States of America.

2. The health certificates shall be drawn up in an official language of the exporting country and in an official language of the importing Member State.

The competent authorities concerned may decide to use any other language understandable for certifying officers or control officials concerned.

3. The health certificate provided for in paragraph 1 shall only be valid for imports of foodstuffs into the Community not later than four months from the date of issue.

4. The sampling and the analysis referred to in paragraph 1 must be performed in accordance with Commission Regulation (EC) No 401/2006 ( 6 ) or equivalent.

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

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▼B

Article 5

Prior notification of consignments

Food business operators or their representatives shall give prior notification of the estimated date and time of physical arrival of the consignment at the ►M2 DPE ◄ and of the nature of the consignment.

For that purpose, they shall complete Part I of the common entry document (CED) referred to in Article 3 (a) of Commission Regulation (EC) 669/2009 and transmit that document to the competent authority at the ►M2 DPE ◄ , at least one working day prior to the physical arrival of the consignment.

For the completion of the CED in application of this Regulation, food business operators shall take into account the notes for guidance laid down in Annex II.

Article 6

Designated points of import

1. The competent authorities in Member States shall ensure that the designated points of import 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 to 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 while awaiting the results of analysis;

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

(f) the availability of an official laboratory for aflatoxin analysis, situated at a place to which the samples can be transported within a short period of time and which is able to perform the analysis within a due time-limit.

2. The Member States shall maintain and make publicly available an up-to-date list of the designated points of import. The Member States shall communicate them to the Commission.

3. Food business operators shall ensure the unloading of the consignment of foodstuffs necessary for representative sampling to take place.

In the case of special transport or specific packaging forms, the operator shall make available to the official inspector the appropriate sampling equipment in so far as the sampling cannot be representatively performed with the usual sampling equipment.

Article 7

Official controls

1. All official controls before the acceptance for release for free circulation into the Community and completion of the common entry document shall be performed within 15 working days from the moment the consignment is offered for import and physically available for sampling at the designated point of import.

2. The competent authority at the ►M2 DPE ◄ shall ensure that the foodstuffs intended for import into the Community are subject to documentary checks to ensure that the requirements for the results of sampling and analysis and the health certificate provided for in Article 4 are complied with.

Where a consignment of foodstuffs is not accompanied by the results of sampling and analysis and the health certificate provided for in Article 4(1), the consignment may not enter the Community for import into the Community and must be re-dispatched to the country of origin or destroyed.

3. The competent authority at the ►M2 DPE ◄ shall authorise transfer of the consignment to a designated point of import after favourable completion of the checks referred to in paragraph 2. The original certificate shall accompany the consignment during transfer.

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4. The competent authority at the designated point of import shall carry out an identity check and shall take a sample for analysis of aflatoxin B1 and total aflatoxin contamination on certain consignments with a frequency indicated in paragraph 5 and in accordance with Annex I to Regulation (EC) No 401/2006 before release for free circulation into the Union.

5. The identity check and the sampling for analysis referred to in paragraph 4 shall be carried out on:

(a) approximately 50 % of the consignments of foodstuffs from Brazil;

(b) approximately 20 % of the consignments of foodstuffs from China;

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

(d) approximately 50 % of the consignments of foodstuffs from Iran;

(e) approximately 5 % of the consignments for each category of hazelnuts and derived products from Turkey referred to in Article 1(1)(e)(ii) and (iv) to (viii), approximately 20 % of the consignments for each category of dried figs and derived products from Turkey referred to in Article 1(1)(e)(i) and (iv) to (vii) and approximately 50 % of the consignments for each category of pistachios and derived products from Turkey referred to in Article 1(1)(e)(iii) to (vii);

(f) a random basis for consignments of foodstuffs from the United States of America, referred to in Article 1(1)(f).

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6. After completion of the checks, the competent authorities shall, for checks carried out by them:

(a) complete the relevant part of Part II of the common entry document (CED);

(b) join the results of sampling and analysis;

(c) stamp and sign the original of the CED;

(d) make and retain a copy of the signed and stamped CED.

For the completion of the CED in application of this Regulation, the competent authority shall take into account the notes for guidance laid down in Annex II.

7. The original of the CED shall accompany the consignment during its transfer until it is released for free circulation.

8. The release for free circulation of consignments shall be subject to the presentation by the food business operator or their representative to the custom authorities of a common entry document or its electronic equivalent duly completed by the competent authority once all official controls have been carried out and favourable results from physical checks, where such checks are required, are known.

9. Member States shall submit to the Commission every three months a report of all analytical results of official controls on consignments of foodstuffs. That report shall be submitted during the month following each quarter.

Article 8

Splitting of a consignment

Consignments shall not be split until all official controls have been completed, and the CED has been fully completed by the competent authorities as provided for in Article 7.

In the case of subsequent splitting of the consignment, an authenticated copy of the CED shall accompany each part of the consignment until it is released for free circulation.

Article 9

Additional conditions as regards imports of foodstuffs from the United States of America

1. As regards imports from the United States of America, the analysis referred to in Article 4(1) must be performed by an USDA approved laboratory for aflatoxin analysis.

2. The health certificate referred to in Article 4(1) accompanying consignments of foodstuffs referred to in Article 1(1)(f) shall make a reference to the Voluntary Aflatoxin Sampling Plan.

Article 10

Costs

All costs resulting from the official controls including sampling, analysis, storage and any measures taken following non-compliance, shall be borne by the food business operator.

Article 11

Repeal

Decision 2006/504/EC is hereby repealed.

References to the repealed Decision shall be construed as references to this Regulation.

Article 12

Transitional provisions

By way of derogation from Article 4(1), Member States shall authorise the imports of consignments of foodstuffs referred to in Article 1(1) which left the country of origin prior to 1 July 2010 accompanied by a health certificate as provided for by Decision 2006/504/EC.

Article 13

Entry into force

This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union.

It shall apply from 1 January 2010.

This Regulation shall be binding in its entirety and directly applicable in all Member States.









ANNEX I

Health Certificate for the importation into the European Community of

… ( 7 )

Consignment Code: …

Certificate Number: …

According to the provisions of Commission Regulation (EC) NNN/2009 imposing special conditions governing the import of certain foodstuffs from certain third countries due to contamination risk by aflatoxins and repealing Decision 2006/504/EC, the …

…

… (competent authority referred to in Article 4(1))

CERTIFIES that the …

… (insert foodstuffs referred to in Article 1)

of this consignment composed of: …

…

… (description of consignment, product, number and type of packages, gross or net weight)

embarked at … (embarkation place)

by … (identification of transporter)

going to … (place and country of destination)

which comes from the establishment …

… (name and address of establishment)

have been produced, sorted, handled, processed, packaged and transported in line with good hygiene practices.

From this consignment, samples were taken in accordance with Commission Regulation (EC) No 401/2006 on … (date), subjected to laboratory analysis on … (date)

in the … (name of laboratory),

to determine the level of aflatoxin B1 and level of total aflatoxin contamination. The details of sampling, methods of analysis used and all results are attached.

This certificate is valid until …

Done at: … on …

Stamp and signature of authorised representative of competent authority referred to in Article 4(1)









ANNEX II

Notes for guidance for the CED in application of this Regulation in case of imports of foodstuffs from certain third countries, due to contamination risk of these products by aflatoxins

General: For the use of the CED in application of this Regulation, whenever ‘DPE’ is mentioned, this should be read as ‘ ►M2 DPE ◄ ’ or ‘designated point of import’ as stipulated in the specific notes for each box. Whenever ‘control point’ is mentioned, this should be read as ‘designated point of import’. Complete the document in capital letters. Notes are shown against the relevant box number.

Part I This section is to be completed by the food business operator or their representative, unless otherwise indicated

Box I.1. Consignor: name and full address of the natural or legal person (food business operator) dispatching the consignment. Information on telephone and fax numbers or email address is recommended.

Box I.2. All three fields in this box are to be filled in by the authorities of the designated point of import as defined in Article 2. Attribute a CED reference number in the first box. Indicate the name of the designated point of import and its number respectively in the second and third box.

Box I.3. Consignee: indicate name and full address of the natural or legal person (food business operator) to whom the consignment is destined. Information on telephone and fax numbers or email address is recommended.

Box I.4. Person responsible for the consignment: (also agent, declarant or food business operator) indicate name and full address of the person who is in charge of the consignment when presented to the ►M2 DPE ◄ and makes the necessary declarations to the competent authorities on behalf of the importer. Information on telephone and fax numbers or email address is recommended.

Box I.5. Country of origin: indicate the country where the commodity is originating from, grown, harvested or produced.

Box I.6. Country from where consigned: indicate the country where the consignment was placed aboard the means of final transport for the journey to the Community.

Box I.7. Importer: indicate name and full address. Information on telephone and fax numbers or email address is recommended.

Box I.8. Place of destination: indicate delivery address in the Community. Information on telephone and fax numbers or email address is recommended.

Box I.9. Arrival at the DPE (estimated date): give the estimated date on which the consignment is expected to arrive at the ►M2 DPE ◄ .

Box I.10. Documents: indicate the date of issue and the number of official documents accompanying the consignment, as appropriate.

Box I.11. Means of transport: tick the box to indicate the means of arrival transport. Identification: give full details of the means of transport. For aircraft, indicate the flight number. For vessels, indicate the ship’s name. For road vehicles: indicate the registration number plate with trailer number if appropriate. For railway transport: indicate the train identity and wagon number. Documentary references: number of airway bill, bill of lading or commercial number for railway or truck.

Box I.12. Description of the commodity: provide a detailed description of the commodity using the terminology in Article 1.

Box I.13. Commodity code (HS code): use the Harmonised System of the World Customs Organisation.

Box I.14. Gross weight: specify overall weight in kg or tonnes. This is defined as the aggregate mass of the products and of the immediate containers and all their packaging, but excluding transport containers and other transport equipment. Net weight: specify weight of actual product in kg or tonnes, excluding packaging. This is defined as the mass of the products themselves without immediate containers or any packaging.

Box I.15. Number of packages: specify the number of packages in the consignment.

Box I.16. Temperature: tick the appropriate mode of transport/storage temperature.

Box I.17. Type of packaging: identify the type of packaging of products.

Box I.18. Commodity intended for: tick the appropriate box depending on whether the commodity is destined for human consumption without prior sorting or other physical treatment (in this case tick ‘human consumption’) or is intended for human consumption after such treatment (tick ‘further process’ in this case), or is intended for use as ‘feedingstuff’ (in this case tick ‘feedingstuffs’). In the latter case the provisions of this Regulation do not apply.

Box I.19. Seal number and container number: give all seal and container identification numbers where relevant.

Box I.20. For transfer to Control Point: in case the consignment is intended for import (cf. Box I.22), tick the box and identify the designated point of import.

Box I.21. Not applicable.

Box I.22. For import: tick the box in case the consignment is intended for import.

Box I.23. Not applicable.

Box I.24. Means of transport to Control Point: tick the appropriate means of transport used for transfer to the designated point of import.

Part II This section is to be completed by the competent authority

General: Box II.1 is to be completed by the competent authority of the designated point of import. Boxes II.2 till II.9 are to be completed by the authorities responsible for the documentary control. Boxes II.10. till II.21 are to be completed by the competent authorities of the designated point of import.

Box II.1. CED Reference number: use the same CED reference number as in Box I.2.

Box II.2. Customs Document Reference: for use by customs services if necessary.

Box II.3. Documentary Check: to be completed for all consignments.

Box II.4. Consignments selected for physical checks: not applicable in the framework of this Regulation.

Box II.5. ACCEPTABLE for transfer: in case the consignment is acceptable for transfer to a designated point of import following a satisfactory documentary check, the competent authority at the ►M2 DPE ◄ shall tick the box and indicate to which designated point of import the consignment shall be transferred for a possible physical check (following information given in Box I.20).

Box II.6. NOT ACCEPTABLE: in case the consignment is not acceptable for transfer to a designated point of import due to the unsatisfactory outcome of the documentary checks, the competent authority at the ►M2 DPE ◄ shall tick the box and indicate clearly the action to be carried out in case of rejection of the consignment. The address of the destination establishment in case of ‘Re-dispatching’, ‘Destruction’, ‘Transformation’ and ‘Use for other purpose’ should be entered in Box II.7.

Box II.7. Details of Controlled Destinations (II.6): indicate as appropriate approval number and address (or ship’s name and port) for all destinations where further control of the consignment is required, for example for Box II.6, ‘Re-dispatching’, ‘Destruction’, ‘Transformation’ or ‘Use for other purpose’.

Box II.8. Full identification of DPE and official stamp: indicate here the full identification of the ►M2 DPE ◄ and the official stamp of the competent authority at this point.

Box II.9. Official inspector: signature of the official responsible of the competent authority at the ►M2 DPE ◄ .

Box II.10. Not applicable.

Box II.11. Identity Check: tick the boxes to indicate whether the identity checks have been performed and with which results.

Box II.12. Physical Check: indicate here the results of the physical checks.

Box II.13. Laboratory tests: tick the box to indicate whether the consignment has been selected for sampling and analysis. Tested for: indicate for which substances (aflatoxin B1 and/or total) and by which analytical method a laboratory test is carried out. Results: indicate the results of the laboratory test and tick the appropriate box.

Box II.14. ACCEPTABLE for release for free circulation: tick the box in case the consignment is to be released for free circulation within the Community. Tick one of the boxes (‘Human consumption’, ‘Further process’, ‘Feedingstuff’ or ‘Other’) to indicate the further use.

Box II.15. Not applicable.

Box II.16. NOT ACCEPTABLE: tick the box in case of rejection of the consignment due to the unsatisfactory outcome of the identity or physical checks. Indicate clearly the action to be carried out in such case by ticking one of the boxes (‘Re-dispatching’, ‘Destruction’, ‘Transformation’ or ‘Use for other purpose’). The address of the establishment of destination shall be entered in Box II.18.

Box II.17. Reasons for refusal: tick the appropriate box. Use as appropriate to add relevant information.

Box II.18. Details of controlled destinations (II.16): give as appropriate approval number and address (or ship’s name and port) for all destinations where further control of the consignment is required following information indicated in Box II.16.

Box II.19. Consignment resealed: use this box when the original seal recorded on a consignment is destroyed on opening the container. A consolidated list of all seals that have been used for this purpose must be kept.

Box II.20. Full identification of DPE/Control Point and official stamp: put here the full identification of the designated point of import and the official stamp of the competent authority at the designated point of import.

Box II.21. Official Inspector: put name (in capital letters), date of issuing and signature of the official responsible of the competent authority at the designated point of import.

Part III This section is to be completed by the competent authority

Box III.1. Details on re-dispatching: the competent authority at the ►M2 DPE ◄ entry or at the designated point of import indicates the means of transport used, its identification, the country of destination and the date of re-dispatching, as soon as they are known.

Box III.2. Follow-up: indicate the local competent authority unit responsible, as appropriate, for the supervision in case of ‘Destruction’, ‘Transformation’ or ‘Use for other purpose’ of the consignment. This competent authority shall report here the result of the arrival of the consignment and the correspondence.

Box III.3. Official Inspector: signature of the official responsible for the competent authority at the DPI in case of ‘Re-dispatching’. Signature of the official responsible for the local competent authority in case of ‘Destruction’, ‘Transformation’ or ‘Use for other purpose’.