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Commission Implementing Regulation （EU） No 844/2011
of 23 August 2011
approving the pre-export checks carried out by Canada on wheat and wheat flour as regards the presence of ochratoxin A
（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 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 [1], and in particular Article 23 thereof,
Whereas:
（1） Commission Regulation （EC） No 1881/2006 of 19 December 2006 setting maximum levels for certain contaminants in foodstuffs [2] lays down permitted maximum levels of ochratoxin A in foodstuffs. Only foodstuffs complying with the maximum level may be placed on the Union market.
（2） Regulation （EC） No 882/2004 provides an obligation for the Member States to ensure that official controls are carried out regularly, on a risk basis and with appropriate frequency in order to achieve the objectives of the Regulation, which are inter alia preventing, eliminating or reducing to acceptable levels risks to humans and animals.
（3） Article 23 of Regulation （EC） No 882/2004 provides that specific pre-export checks that a third country carries out on feed and food immediately prior to export to the European Union with a view to verifying that the exported products satisfy Union requirements may be approved.
（4） Such an approval may only be granted to a third country if an European Union audit has shown that feed or food exported to the European Union meets Union requirements or equivalent requirements and that the controls carried out in the third country prior to dispatch are considered sufficiently effective and efficient as to replace or reduce the documentary, identity and physical checks laid down in Union law.
（5） On 8 October 2007 Canada has submitted to the Commission an application for obtaining an approval of the pre-export checks performed by the competent authorities of Canada on the ochratoxin A contamination in wheat （common and durum） and wheat flour intended for export to the European Union.
（6） The Commission has assessed in detail the information provided by the Canadian Grain Commission, the competent authority of Canada under the responsibility of which the pre-export checks will be performed, and considers that the guarantees provided are satisfactory and justify the approval of the pre-export checks on wheat and wheat flour as regards the presence of ochratoxin A.
（7） It is therefore appropriate to grant approval of pre-export checks carried out by Canada on wheat and wheat flour ensuring compliance with the maximum levels of ochratoxin A laid down in Union law.
（8） According to Article 16（2） of Regulation （EC） No 882/2004 Member States are required to adjust the frequency of physical checks on imports to the risk associated with different categories of food and taking into account, among other things, the guarantees provided by the competent authorities of the third country of origin of the food in question. Systematic pre-export checks carried out under the authority of the Canadian Grain Commission in conformity with the Union approval and in accordance with Article 23 of Regulation 882/2004 provide a satisfactory level of guarantees in relation to the ochratoxin A contamination in wheat and wheat flour and therefore allow Member States to reduce the frequency of physical checks performed on those commodities.
（9） The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,
HAS ADOPTED THIS REGULATION:
Article 1
Approval of pre-export checks
Pre-export checks as regards the presence of ochratoxin A, carried out by the Canadian Grain Commission immediately prior to export to the European Union, are approved for the following foodstuffs
（a） wheat falling within HS/CN code 1001, produced on the territory of Canada, and
（b） wheat flour falling within HS/CN code 110100, produced on the territory of Canada.
Article 2
Conditions for approval of pre-export checks
1. Each consignment of products referred to in Article 1 shall be accompanied by:
（a） a report containing the results of sampling and analysis performed 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 mycotoxins in foodstuffs [3], or with equivalent requirements, by a laboratory approved for that purpose by the Canadian Grain Commission;
（b） a certificate in accordance with the model set out in the Annex, completed, verified and signed by a representative of the Canadian Grain Commission; the certificate shall be valid for four months from the date of issuance.
2. The report and certificate referred to in paragraph 1 may be provided electronically, after the practical modalities have been agreed upon.
3. Each consignment of foodstuffs shall bear an identification code which shall be reproduced on the report and on the certificate referred to in paragraph 1. Each individual bag, or other packaging form, of the consignment shall be identified with the same code.
Article 3
Splitting of consignments
If a consignment is split, copies of the certificate provided for in Article 2 （1） （b） 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 until it is released for free circulation.
Article 4
Official controls
In accordance with the provisions of Article 16 （2） and Article 23（2） of Regulation （EC） 882/2004, the frequency of the physical checks carried out by the Member States on consignments of products referred to in Article 1 shall be reduced to a maximum of 1 % of the number of consignments presented in accordance with Article 2.
Article 5
Entry into force
This Regulation shall enter into force on the twentieth day following its publication in the Official Journal of the European Union.
It shall apply from 1 October 2011.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 23 August 2011.
For the Commission
The President
José Manuel Barroso
[1] OJ L 165, 30.4.2004, p. 1.
[2] OJ L 364, 20.12.2006, p. 5.
[3] OJ L 70, 9.3.2006, p. 12.
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ANNEX
Part I: Details of dispatched consignment
COUNTRY:
Certificate to EU
I.1. Consignor
Name
Address
Tel.
I.2. Certificate reference No
I.2.a.
I.3. Central competent authority
I.4. Local competent authority
I.5. Consignee
Name
Address
Postcode
Tel.
I.6. Person responsible for the consignment in EU
Name
Address
Postcode
Tel.
I.7. Country of origin
ISO code
I.8.
I.9. Country of destination
ISO code
I.10.
I.11. Place of origin
Name
Approval number
Address
I.12.
I.13. Place of loading
I.14. Date of departure
I.15. Means of transport
Aeroplane
Ship
Railway wagon
Road vehicle
Other
Identification
Documentation references
I.16. Entry BIP in EU
I.17.
I.18. Description of commodity
I.19. Commodity code （HS code）
I.20. Quantity
I.21. Temperature of product
Ambient
Chilled
Frozen
I.22. Number of packages
I.23. Seal/Container No
I.24. Type of packaging
I.25. Commodities certified for:
Human consumption
Animal feedingstuff
Further process
I.26.
I.27. For import or admission into EU
I.28. Identification of the commodities
Treatment type
Batch number
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Part II: Certification
COUNTRY
WHEAT - PRE-EXPORT CHECK
II. Health information
II.a. Certificate reference No
II.b.
According to the provisions of Commission Regulation （EU） No 844/2011 approving the pre-export checks carried out by Canada on wheat and wheat flour as regards the presence of ochratoxin A, I undersigned, …， authorised representative of the competent authority referred to in Article 1 certify that the commodities described in the Part I of the certificate have been produced, sorted, handled, processed, packaged and transported in line with good hygiene practices and have been subject to a pre-export check, as approved by Commission Regulation （EU） No 844/2011 and ensure that the commodities covered by this certificate will be transported to the European Union in a container, which is in line with good hygiene practices.
From this consignment samples for ochratoxin A analysis were taken on … （date）, subjected to laboratory analysis on … （date） in the … （name of laboratory）, and the details of sampling, methods of analysis used and all results are attached.
Notes
This certificate is valid for 4 months after issuance.
Part I
Box reference I.11: Approval number: only if applicable.
Box reference I.19: Use the appropriate HS code of WCO under the following headings : 1001 or 1101.
Box reference I.20: Indicate total gross weight and total net weight.
Box reference I.25: Further process means ‘subject to sorting or other physical treatment before human consumption’。
Official inspector
Name （in capital letters）:
Qualification and title:
Date:
Signature:
Stamp:
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地区：
