# Official Journal L 144/2012

| | ISSN 1977-0677
  doi:10.3000/19770677.L_2012.144.eng |
| --- | --- |
| Official Journal
  of the European Union | L 144 |
| | |
| English edition | Legislation | Volume 555 June 2012 |

ISSN 1977-0677

doi:10.3000/19770677.L_2012.144.eng

Official Journal

of the European Union

L 144

English edition

Legislation

Volume 555 June 2012

---

| Contents | | II   Non-legislative acts | page |
| --- | --- | --- | --- |
| | | REGULATIONS |
| | * | Commission Implementing Regulation (EU) No 468/2012 of 1 June 2012 amending Regulation (EU) No 28/2012 laying down requirements for the certification for imports into and transit through the Union of certain composite products (
  1
  ) | 1 |
| | * | Commission Implementing Regulation (EU) No 469/2012 of 1 June 2012 correcting Implementing Regulation (EU) No 69/2012 on the issue of licences for importing rice under the tariff quotas opened for the January 2012 subperiod by Implementing Regulation (EU) No 1273/2011 | 15 |
| | * | Commission Regulation (EU) No 470/2012 of 4 June 2012 amending Annex II to Regulation (EC) No 1333/2008 of the European Parliament and of the Council as regards the use of polydextrose (E 1200) in beer (
  1
  ) | 16 |
| | * | Commission Regulation (EU) No 471/2012 of 4 June 2012 amending Annex II to Regulation (EC) No 1333/2008 of the European Parliament and of the Council as regards the use of lysozyme (E 1105) in beer (
  1
  ) | 19 |
| | * | Commission Regulation (EU) No 472/2012 of 4 June 2012 amending Annex II to Regulation (EC) No 1333/2008 of the European Parliament and of the Council as regards the use of glycerol esters of wood rosins (E 445) for printing on hard-coated confectionery products (
  1
  ) | 22 |
| | * | Commission Regulation (EU) No 473/2012 of 4 June 2012 amending Annex III to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for spinetoram (XDE-175) in or on certain products (
  1
  ) | 25 |
| | | Commission Implementing Regulation (EU) No 474/2012 of 4 June 2012 establishing the standard import values for determining the entry price of certain fruit and vegetables | 39 |
| | | DECISIONS |
| | | 2012/288/EU |
| | * | Commission Implementing Decision of 1 June 2012 authorising the placing on the market of Gamma-Cyclodextrin as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council
  (notified under document C(2012) 3496) | 41 |
| | | 2012/289/EU |
| | * | Commission Decision of 4 June 2012 terminating the anti-dumping proceeding concerning imports of tartaric acid originating in the People’s Republic of China, limited to one Chinese exporting producer, Hangzhou Bioking Biochemical Engineering Co. Ltd | 43 |
| | | ACTS ADOPTED BY BODIES CREATED BY INTERNATIONAL AGREEMENTS |
| | | 2012/290/EU |
| | * | Decision of the US-EU Joint Customs Cooperation Committee of 4 May 2012 regarding mutual recognition of the Customs-Trade Partnership Against Terrorism program in the United States and the Authorised Economic Operators programme of the European Union | 44 |

Contents

II   Non-legislative acts

page

REGULATIONS

*

Commission Implementing Regulation (EU) No 468/2012 of 1 June 2012 amending Regulation (EU) No 28/2012 laying down requirements for the certification for imports into and transit through the Union of certain composite products (
  1
  )

1

1

*

Commission Implementing Regulation (EU) No 469/2012 of 1 June 2012 correcting Implementing Regulation (EU) No 69/2012 on the issue of licences for importing rice under the tariff quotas opened for the January 2012 subperiod by Implementing Regulation (EU) No 1273/2011

15

*

Commission Regulation (EU) No 470/2012 of 4 June 2012 amending Annex II to Regulation (EC) No 1333/2008 of the European Parliament and of the Council as regards the use of polydextrose (E 1200) in beer (
  1
  )

1

16

*

Commission Regulation (EU) No 471/2012 of 4 June 2012 amending Annex II to Regulation (EC) No 1333/2008 of the European Parliament and of the Council as regards the use of lysozyme (E 1105) in beer (
  1
  )

1

19

*

Commission Regulation (EU) No 472/2012 of 4 June 2012 amending Annex II to Regulation (EC) No 1333/2008 of the European Parliament and of the Council as regards the use of glycerol esters of wood rosins (E 445) for printing on hard-coated confectionery products (
  1
  )

1

22

*

Commission Regulation (EU) No 473/2012 of 4 June 2012 amending Annex III to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for spinetoram (XDE-175) in or on certain products (
  1
  )

1

25

Commission Implementing Regulation (EU) No 474/2012 of 4 June 2012 establishing the standard import values for determining the entry price of certain fruit and vegetables

39

DECISIONS

2012/288/EU

*

Commission Implementing Decision of 1 June 2012 authorising the placing on the market of Gamma-Cyclodextrin as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council
  (notified under document C(2012) 3496)

(notified under document C(2012) 3496)

41

2012/289/EU

*

Commission Decision of 4 June 2012 terminating the anti-dumping proceeding concerning imports of tartaric acid originating in the People’s Republic of China, limited to one Chinese exporting producer, Hangzhou Bioking Biochemical Engineering Co. Ltd

43

ACTS ADOPTED BY BODIES CREATED BY INTERNATIONAL AGREEMENTS

2012/290/EU

*

Decision of the US-EU Joint Customs Cooperation Committee of 4 May 2012 regarding mutual recognition of the Customs-Trade Partnership Against Terrorism program in the United States and the Authorised Economic Operators programme of the European Union

44

| | |
| --- | --- |
| | (1)   Text with EEA relevance |

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(1)   Text with EEA relevance

1

| EN | Acts whose titles are printed in light type are those relating to day-to-day management of agricultural matters, and are generally valid for a limited period.
  The titles of all other Acts are printed in bold type and preceded by an asterisk. |
| --- | --- |

EN

Acts whose titles are printed in light type are those relating to day-to-day management of agricultural matters, and are generally valid for a limited period.

The titles of all other Acts are printed in bold type and preceded by an asterisk.

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II Non-legislative acts

REGULATIONS

| 5.6.2012 | EN | Official Journal of the European Union | L 144/1 |
| --- | --- | --- | --- |

5.6.2012

EN

Official Journal of the European Union

L 144/1

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COMMISSION IMPLEMENTING REGULATION (EU) No 468/2012

of 1 June 2012

amending Regulation (EU) No 28/2012 laying down requirements for the certification for imports into and transit through the Union of certain composite products

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

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

Having regard to Council Directive 2002/99/EC of 16 December 2002 laying down the animal health rules governing the production, processing, distribution and introduction of products of animal origin for human consumption (1), and in particular Article 8(5) thereof,

Whereas:

| (1) | Commission Regulation (EU) No 28/2012 (2) lays down rules on the certification of consignments of certain composite products introduced into the Union from third countries, including composite products containing processed egg products. |
| --- | --- |

(1)

Commission Regulation (EU) No 28/2012 (2) lays down rules on the certification of consignments of certain composite products introduced into the Union from third countries, including composite products containing processed egg products.

| (2) | Pursuant to Regulation (EU) No 28/2012, consignments of composite products introduced into or transited through the Union are to be accompanied by a health certificate in accordance with the models set out in Annexes I and II thereto and comply with the conditions established in that certificate. |
| --- | --- |

(2)

Pursuant to Regulation (EU) No 28/2012, consignments of composite products introduced into or transited through the Union are to be accompanied by a health certificate in accordance with the models set out in Annexes I and II thereto and comply with the conditions established in that certificate.

| (3) | The model certificates set out in Annexes I and II to Regulation (EU) No 28/2012 do not currently include detailed conditions as regards processed egg products contained in composite products which are being introduced into or transited through the Union. |
| --- | --- |

(3)

The model certificates set out in Annexes I and II to Regulation (EU) No 28/2012 do not currently include detailed conditions as regards processed egg products contained in composite products which are being introduced into or transited through the Union.

| (4) | Commission Regulation (EC) No 798/2008 of 8 August 2008 laying down a list of third countries, territories, zones or compartments from which poultry and poultry products may be imported into and transit through the Community and the veterinary certification requirements (3) lays down veterinary certification requirements for imports into and transit, through the Union of certain commodities, including egg products. It provides that commodities imported into or transited through the Union are to be accompanied by a veterinary certificate for the commodity concerned and comply with the conditions set out therein. |
| --- | --- |

(4)

Commission Regulation (EC) No 798/2008 of 8 August 2008 laying down a list of third countries, territories, zones or compartments from which poultry and poultry products may be imported into and transit through the Community and the veterinary certification requirements (3) lays down veterinary certification requirements for imports into and transit, through the Union of certain commodities, including egg products. It provides that commodities imported into or transited through the Union are to be accompanied by a veterinary certificate for the commodity concerned and comply with the conditions set out therein.

| (5) | Processed egg products present a potential risk for animal health, also when they are used to manufacture certain composite products. It is therefore appropriate that the same conditions which must be complied with by egg products pursuant to Regulation (EC) No 798/2008, when those products are introduced into or transited through the Union, apply also to processed egg products used to manufacture composite products. |
| --- | --- |

(5)

Processed egg products present a potential risk for animal health, also when they are used to manufacture certain composite products. It is therefore appropriate that the same conditions which must be complied with by egg products pursuant to Regulation (EC) No 798/2008, when those products are introduced into or transited through the Union, apply also to processed egg products used to manufacture composite products.

| (6) | The model certificates set out in Annexes I and II to Regulation (EU) No 28/2012 include the condition that the country of origin of meat or milk products used to manufacture composite products imported into or transited through the Union is authorised by relevant Union legislation to export meat or milk products into the Union. In addition, those model certificates include the condition that the country of origin of the meat or milk products be the same as the country of export of the composite products. |
| --- | --- |

(6)

The model certificates set out in Annexes I and II to Regulation (EU) No 28/2012 include the condition that the country of origin of meat or milk products used to manufacture composite products imported into or transited through the Union is authorised by relevant Union legislation to export meat or milk products into the Union. In addition, those model certificates include the condition that the country of origin of the meat or milk products be the same as the country of export of the composite products.

| (7) | Those two conditions ensure that meat and milk products originating from third countries and used to manufacture composite products comply with Union rules for human and animal health. However, the condition that the country of origin and the country of export be the same does not allow for the import into and transit through the Union of composite products exported from a third country but which contain meat and milk products originating in the Union. |
| --- | --- |

(7)

Those two conditions ensure that meat and milk products originating from third countries and used to manufacture composite products comply with Union rules for human and animal health. However, the condition that the country of origin and the country of export be the same does not allow for the import into and transit through the Union of composite products exported from a third country but which contain meat and milk products originating in the Union.

| (8) | Meat and milk products originating in the Union are in compliance with the human and animal health conditions laid down in Union legislation. It is therefore appropriate to amend the conditions included in the model certificates set out in Annexes I and II to Regulation (EU) No 28/2012 to allow the use of meat and milk products originating in the Union to manufacture composite products in third countries authorised to export composite products to the Union. |
| --- | --- |

(8)

Meat and milk products originating in the Union are in compliance with the human and animal health conditions laid down in Union legislation. It is therefore appropriate to amend the conditions included in the model certificates set out in Annexes I and II to Regulation (EU) No 28/2012 to allow the use of meat and milk products originating in the Union to manufacture composite products in third countries authorised to export composite products to the Union.

| (9) | Commission Decision 2007/777/EC of 29 November 2007 laying down the animal and public health conditions and model certificates for imports of certain meat products and treated stomachs, bladders and intestines for human consumption from third countries (4) provides that Member States are to authorise imports into the Union of certain meat products that comply with the conditions concerning origin and treatment set out in Annex II thereto. That Annex sets out rules on a non-specific treatment (treatment A) to which the imported products are to be subjected when they originate in third countries where the animal health status does not present a risk for the animal health status in the Union. Since those products may be directly imported into the Union, it is appropriate to amend the conditions included in the model certificates set out in Annexes I and II to Regulation (EU) No 28/2012 to allow the use of such meat products to manufacture composite products in third countries authorised to export composite products to the Union, provided that the third country exporting the composite products ensures that those meat products comply with the health and origin requirements foreseen in Union legislation and that it is authorised to export itself the same meat products to the Union under the same conditions. |
| --- | --- |

(9)

Commission Decision 2007/777/EC of 29 November 2007 laying down the animal and public health conditions and model certificates for imports of certain meat products and treated stomachs, bladders and intestines for human consumption from third countries (4) provides that Member States are to authorise imports into the Union of certain meat products that comply with the conditions concerning origin and treatment set out in Annex II thereto. That Annex sets out rules on a non-specific treatment (treatment A) to which the imported products are to be subjected when they originate in third countries where the animal health status does not present a risk for the animal health status in the Union. Since those products may be directly imported into the Union, it is appropriate to amend the conditions included in the model certificates set out in Annexes I and II to Regulation (EU) No 28/2012 to allow the use of such meat products to manufacture composite products in third countries authorised to export composite products to the Union, provided that the third country exporting the composite products ensures that those meat products comply with the health and origin requirements foreseen in Union legislation and that it is authorised to export itself the same meat products to the Union under the same conditions.

| (10) | Commission Regulation (EU) No 605/2010 of 2 July 2010 laying down animal and public health and veterinary certification conditions for the introduction into the European Union of raw milk and dairy products intended for human consumption (5) provides that Member States are to authorise the importation of consignments of raw milk and dairy products from the third countries or parts thereof listed in column A of Annex I thereto. In addition, Regulation (EU) No 605/2010 provides that Member States are to authorise the importation of consignments of certain dairy products from the third countries or parts thereof not at risk from foot-and-mouth disease listed in column B of Annex I thereto, provided that such dairy products have undergone, or been produced from raw milk which has undergone a pasteurisation treatment involving a single heat treatment as laid down in that Regulation. Since those dairy products may be directly imported into the Union, it is appropriate to amend the conditions included in the model certificates set out in Annexes I and II to Regulation (EU) No 28/2012 to allow the use of such dairy products to manufacture composite products in third countries authorised to export composite products to the Union, provided that the third country exporting the composite products ensures that those milk products comply with the health and origin requirements foreseen in Union legislation and that it is authorised to export itself the same dairy products to the Union under the same conditions. |
| --- | --- |

(10)

Commission Regulation (EU) No 605/2010 of 2 July 2010 laying down animal and public health and veterinary certification conditions for the introduction into the European Union of raw milk and dairy products intended for human consumption (5) provides that Member States are to authorise the importation of consignments of raw milk and dairy products from the third countries or parts thereof listed in column A of Annex I thereto. In addition, Regulation (EU) No 605/2010 provides that Member States are to authorise the importation of consignments of certain dairy products from the third countries or parts thereof not at risk from foot-and-mouth disease listed in column B of Annex I thereto, provided that such dairy products have undergone, or been produced from raw milk which has undergone a pasteurisation treatment involving a single heat treatment as laid down in that Regulation. Since those dairy products may be directly imported into the Union, it is appropriate to amend the conditions included in the model certificates set out in Annexes I and II to Regulation (EU) No 28/2012 to allow the use of such dairy products to manufacture composite products in third countries authorised to export composite products to the Union, provided that the third country exporting the composite products ensures that those milk products comply with the health and origin requirements foreseen in Union legislation and that it is authorised to export itself the same dairy products to the Union under the same conditions.

| (11) | Regulation (EU) No 28/2012 should therefore be amended accordingly. |
| --- | --- |

(11)

Regulation (EU) No 28/2012 should therefore be amended accordingly.

| (12) | To avoid any disruption of trade, the use of certificates issued in accordance with Regulation (EU) No 28/2012 prior to the entry into force of this Regulation should be authorised for a transitional period. |
| --- | --- |

(12)

To avoid any disruption of trade, the use of certificates issued in accordance with Regulation (EU) No 28/2012 prior to the entry into force of this Regulation should be authorised for a transitional period.

| (13) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, |
| --- | --- |

(13)

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

Annexes I and II to Regulation (EU) No 28/2012 are replaced by the text in the Annex to this Regulation.

Article 2

For a transitional period until 31 December 2012, consignments of composite products accompanied by certificates issued before 1 October 2012 in accordance with the models set out in Annexes I and II to Regulation (EU) No 28/2012 before the amendments introduced by this Regulation may continue to be introduced into the Union.

Article 3

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

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

Done at Brussels, 1 June 2012.

For the Commission

The President

José Manuel BARROSO

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(1)  
  OJ L 18, 23.1.2003, p. 11.

1

(2)  
  OJ L 12, 14.1.2012, p. 1.

2

(3)  
  OJ L 226, 23.8.2008, p. 1.

3

(4)  
  OJ L 312, 30.11.2007, p. 49.

4

(5)  
  OJ L 175, 10.7.2010, p. 1.

5

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ANNEX

‘ANNEX I

Model Health Certificate for import into the European Union of composite products intended for human consumption

Image 1

Part I: Details of dispatched consignment

COUNTRY

Veterinary 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.

I.7. Country of origin

ISO code

I.8. Region of origin

Code

I.9. Country of destination

ISO code

I.10.

I.11. Place of origin

Name

Approval number

Address

Name

Approval number

Address

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

I.26.

I.27. For import or admission into EU

I.28. Identification of the commodities

Manufacturing plant

Number of packages

Nature of commodity

Net weight

Batch number

Image 2

Part II: Certification

COUNTRY

Composite products intended for human consumption

II. Health information

II.a. Certificate reference No

II.b.

I, the undersigned official veterinarian/official inspector hereby certify that

II.1. I am aware of the relevant provisions of Regulations (EC) No 178/2002, (EC) No 852/2004 and (EC) No 853/2004, in particular Article 6.1(b) on the origin of the products of animal origin used in the production of the composite products described above and certify that the composite products described above were produced in accordance with those requirements, in particular that they come from (an) establishment(s) implementing a programme based on the HACCP principles in accordance with Regulation (EC) No 852/2004;

II.2. the composite products described above contain:

(1) either [II.2.A Meat products, treated stomachs, bladders and intestines (2) in any quantity which meet the animal health requirements in Commission Decision 2007/777/EC and contain the following meat constituents which meet the criteria indicated below:

Species (A)

Treatment (B)

Origin (C)

Approved Establishment(s) (D)

(A) Insert the code for the relevant species of meat product, treated stomachs, bladders and intestines where BOV = domestic bovine animals (Bos taurus, Bison bison, Bubalus bubalis and their crossbreds); OVI = domestic sheep (Ovis aries) and goats (Capra hircus); EQI = domestic equine animals (Equus caballus, Equus asinus and their crossbreds), POR = domestic porcine animals (Sus scrofa); RM = domestic rabbits, PFG = domestic poultry and farmed feathered game, RUF farmed non-domestic animals other than suidae and solipeds; RUW = wild non-domestic animals other than suidae and solipeds; SUW = wild non-domestic suidae: EQW = wild non-domestic solipeds, WL = wild lagomorphs, WGB = wild game birds.

(B) Insert A, B, C, D, E or F for the required treatment as specified and defined in Parts 2, 3 and 4 of Annex II to Decision 2007/777/EC.

(C) Insert the ISO code of the country of origin of the meat product, treated stomachs, bladders and intestines as listed in Annex II, Part 2 to Decision 2007/777/EC and, in the case of regionalization by Union legislation for the relevant meat constituents, the region as indicated in Part 1 of Annex II to Decision 2007/777/EC or a Member State of the European Union. The country of origin of the meat products must be one the following:

the same as the country of export in box I.7,

a Member State of the European Union,

a third country or parts thereof authorised to export to the Union meat products treated with treatment A as set out in Annex II to Decision 2007/777/EC, where the third country where the composite product is produced is also authorised to export to the Union meat products treated with that treatment.

(D) Insert EU approval number of the establishments of origin of the meat products, treated stomachs, bladders and intestines contained in the composite product.

(E) If containing material from bovine, ovine or caprine animals, the fresh meat and/or intestines used in the preparation of the meat products and/or treated intestines shall be subject to the following conditions depending on the BSE risk category of the country of origin:

(1) (E.1) for imports from a country or a region with a negligible BSE risk as listed in Annex to Commission Decision 2007/453/EC as amended:

(1) the country or region is classified in accordance with Article 5(2) of Regulation (EC) No 999/2001 of the European Parliament and of the Council as a country or region posing a negligible BSE risk;

(2) the animals from which the products of bovine, ovine and caprine animal origin were derived were born, continuously reared and slaughtered in the country with negligible BSE risk and passed ante-mortem and post-mortem inspections;

(1) (3) if in the country or region there have been BSE indigenous cases:

(1) (a) the animals were born after the date from which the ban on the feeding of ruminants with meat-and-bone meal and greaves derived from ruminants had been enforced; or

(1) (b) the products of bovine, ovine and caprine animal origin do not contain and are not derived from specified risk material as defined in Annex V to Regulation (EC) No 999/2001, or mechanically separated meat obtained from bones of bovine, ovine or caprine animals.

Image 3

COUNTRY

Composite products intended for human consumption

II. Health information

II.a. Certificate reference No

II.b.

(1) (E.2) for imports from a country or a region with a controlled BSE risk as listed in the Annex to Commission Decision 2007/453/EC as amended:

(1) the country or region is classified in accordance with Article 5(2) of Regulation (EC) No 999/2001 as a country or region posing a controlled BSE risk;

(2) the animals from which the products of bovine, ovine and caprine animal origin were derived passed ante-mortem and post-mortem inspections;

(3) animals from which the products of bovine, ovine and caprine animal origin destined for export were derived have not been slaughtered after stunning by means of gas injected into the cranial cavity or killed by the same method or slaughtered by laceration after stunning of central nervous tissue by means of an elongated rod-shaped instrument introduced into the cranial cavity;

(1) (3) (4) the products of bovine, ovine and caprine animal origin do not contain and are not derived from specified risk material as defined in Annex V to Regulation (EC) No 999/2001, or mechanically separated meat obtained from bones of bovine, ovine or caprine animals;

(1) (4) (5) in the case of intestines originally sourced from a country or a region with a negligible BSE risk, imports of treated intestines shall be subject to the following conditions:

(a) the country or region is classified in accordance with Article 5(2) of Regulation (EC) No 999/2001 as a country or region posing a controlled BSE risk;

(b) the animals from which the products of bovine, ovine and caprine animal origin were derived were born, continuously reared and slaughtered in the country or region with a negligible BSE risk and passed ante-mortem and post-mortem inspections;

(1) (c) if the intestines are sourced from a country or region where there have been BSE indigenous cases:

(1) (i) the animals were born after the date from which the ban on the feeding of ruminants with meat-and-bone meal and greaves derived from ruminants had been enforced; or

(1) (ii) the products of bovine, ovine and caprine animal origin do not contain and are not derived from specified risk material as defined in Annex V to Regulation (EC) No 999/2001.

(1) (E.3) for imports from a country or a region with an undetermined BSE risk as listed in the Annex to Commission Decision 2007/453/EC:

(1) the animals from which the products of bovine, ovine and caprine animal origin were derived have not been fed meat-and-bone meal or greaves derived from ruminants and passed ante-mortem and post-mortem inspections;

(2) the animals from which the products of bovine, ovine and caprine animal origin were derived have not been slaughtered after stunning by means of gas injected into the cranial cavity or killed by the same method or slaughtered by laceration after stunning of central nervous tissue by means of an elongated rod-shaped instrument introduced into the cranial cavity;

(1) (5) (3) the products of bovine, ovine and caprine animal origin are not derived from:

(i) specified risk material as defined in Annex V to Regulation (EC) No 999/2001;

(ii) nervous and lymphatic tissues exposed during the deboning process;

(iii) mechanically separated meat obtained from bones of bovine, ovine or caprine animals;

(1) (4) (4) in the case of intestines originally sourced from a country or a region with a negligible BSE risk, imports of treated intestines shall be subject to the following conditions:

(a) the country or region is classified in accordance with Article 5(2) of Regulation (EC) No 999/2001 as a country or region posing an undetermined BSE risk;

(b) the animals from which the products of bovine, ovine and caprine animal origin were derived were born, continuously reared and slaughtered in the country or region with a negligible BSE risk and passed ante-mortem and post-mortem inspections;

Image 4

COUNTRY

Composite products intended for human consumption

II. Health information

II.a. Certificate reference No

II.b.

(1) (c) if the intestines are sourced from a country or region where there have been BSE indigenous cases:

(1) (i) the animals were born after the date from which the ban on the feeding of ruminants with meat-and-bone meal and greaves derived from ruminants had been enforced; or

(1) (ii) the products of bovine, ovine and caprine animal origin do not contain and are not derived from specified risk material as defined in Annex V to Regulation (EC) No 999/2001.]

(1) and/or [II.2.B Processed dairy products (6) in an amount of half or more of the substance of the composite product or not shelf stable dairy products in any quantity that:

(a) have been produced in the country ... in the establishment ...(approval number of the establishments of origin of the dairy products contained in the composite product authorised at the time of production for export of dairy products to the EU). The country of origin of the dairy products must be one of the following:

the same as the country of export in box I.7,

a Member State of the European Union,

a third country authorised to export to the Union milk and dairy products in Column A or B of Annex I to Regulation (EU) No 605/2010, where the third country where the composite product is produced is also authorised, under the same conditions, to export to the Union milk and dairy products.

The country of origin indicated in box I.7 must be listed in Annex I to Regulation (EU) No 605/2010 and the treatment applied must be conform to the treatment provided for in that list for the relevant country;

(b) have been produced from milk obtained from animals:

(i) under the control of the official veterinary service;

(ii) belonging to holdings which were not under restrictions due to foot-and-mouth disease or rinderpest; and

(iii) subject to regular veterinary inspections to ensure that they satisfy the animal health conditions laid down in Chapter I of Section IX of Annex III to Regulation (EC) No 853/2004 and in Directive 2002/99/EC;

(c) are dairy products made from raw milk obtained from:

(1) either [cows, ewes, goats or buffaloes and prior to import into the territory of the European Union have undergone or been produced from raw milk which has undergone

(1) either [a pasteurisation treatment involving a single heat treatment with a heating effect at least equivalent to that achieved by a pasteurisation process of at least 72 °C for 15 seconds and where applicable, sufficient to ensure a negative reaction to an alkaline phosphatase test applied immediately after the heat treatment;]

(1) or [a sterilisation process, to achieve an F0 value equal to or greater than three;]

(1) or [an ultra high temperature (UHT) treatment at not less than 135 °C in combination with a suitable holding time;]

(1) or [a high temperature short time pasteurisation treatment (HTST) at 72 °C for 15 seconds, or a treatment with an equivalent pasteurisation effect, applied to milk with a pH lower than 7,0 achieving, where applicable, a negative reaction to an alkaline phosphatase test

(1) or [a high temperature short time pasteurisation treatment (HTST) at 72 °C for 15 seconds, or a treatment with an equivalent pasteurisation effect, applied twice to milk with a pH equal to or greater than 7,0 achieving, where applicable, a negative reaction to an alkaline phosphatase test, immediately followed by

(1) either [lowering the pH below 6 for one hour;]

(1) or [additional heating equal to or greater than 72 °C, combined with desiccation;]]

(1) or [animals other than cows, ewes, goats or buffaloes and prior to import into the territory of the European Union have undergone or been produced from raw milk which has undergone

Image 5

COUNTRY

Composite products intended for human consumption

II. Health information

II.a. Certificate reference No

II.b.

(1) either [a sterilisation process, to achieve an F0 value equal to or greater than three;]

(1) or [an ultra high temperature (UHT) treatment at not less than 135 °C in combination with a suitable holding time;]]

(d) were produced on ... or between ... and ... (7).]

(1) and/or [II.2.C Processed fishery products that originate from the approved establishment No (8) ... situated in the country (9) ...]

(1) and/or [II.2.D Processed egg products that originate from the approved country (9) ...]

were produced from eggs coming from an establishment which satisfies the requirements of Section X of Annex III to Regulation (EC) No 853/2004 which at the date of issue of the certificate is free from highly pathogenic avian influenza as defined in Regulation (EC) No 798/2008 and

either

(1) II.2.D.1 [within a 10 km radius of which [including, where appropriate, the territory of a neighbouring country,] there has been no outbreak of highly pathogenic avian influenza or Newcastle disease for at least the previous 30 days.]

or

(1) II.2.D.2 [the egg products were processed:

(1) either [liquid egg white was treated:

(1) either [with 55,6 °C for 870 seconds.]

(1) or [with 56,7 °C for 232 seconds.]

(1) or [10 % salted yolk was treated with 62,2 °C for 138 seconds.]

(1) or [dried egg white was treated:

(1) either [with 67 °C for 20 hours.]

(1) or [with 54,4 °C for 513 hours.]

(1) or [whole eggs were at least treated:

(1) either [with 60 °C for 188 seconds.]

(1) or [completely cooked.]

[whole egg blends were at least treated]:

(1) either [with 60 °C for 188 seconds.]

(1) or [with 61,1 °C for 94 seconds.]

Notes

Part I:

Box reference I.7: Insert the ISO code of the country of origin of the composite product containing meat product, treated stomachs, bladders and intestines as listed in Annex II, Part 2 to Decision 2007/777/EC and/or for processed dairy products in Annex I to Commission Regulation (EU) No 605/2010 and/or for processed fishery products in Annex I and II to Commission Decision 2006/766/EC and/or for processed egg products in Annex I part 1 to Commission Regulation (EC) No 798/2008.

Box reference I.11: Name, address and registration/approval number if available of the establishments of production of the composite product(s). Name of the country of origin which must be the same as the country of origin in box I.7.

Box reference I.15: Registration number (railway wagons or container and road vehicles), flight number (aircraft) or name (ship). In the case of transport in containers, the total number of containers and their registration number and where there is a serial number of the seal it must be indicated in box I.23. In case of unloading and reloading, the consignor must inform the border inspection post of introduction into the European Union.

Box reference I.19: Use the appropriate Harmonised System (HS) code of the World Customs Organisation such as: 16.01; 16.02; 16.03; 16.04; 16.05; 19.01; 19.02; 19.05; 20.04; 20.05; 21.03; 21.04; 21.05; 21.06.

Box reference I.20: Indicate total gross weight and total net weight.

Image 6

COUNTRY

Composite products intended for human consumption

II. Health information

II.a. Certificate reference No

II.b.

Box reference I.23: For containers or boxes, the container number and the seal number (if applicable) must be included.

Box reference I.28: Manufacturing plant: insert the name and approval number if available of the establishments of production of the composite product(s). Nature of commodity: in case of composite products containing meat products, treated stomachs, bladders and intestines indicate “meat product”, “treated stomachs”, “bladders” or “intestines”. In case of composite product containing dairy products indicate “dairy product”. In case of composite product containing processed fishery products specify whether aquaculture or wild origin. In case of composite product containing egg products specify the egg content percentage.

Part II:

(1) Keep as appropriate.

(2) Meat products as laid down in point 7.1 of Annex I to Regulation (EC) No 853/2004 and treated stomachs, bladders and intestines as laid down in point 7.9 of Annex I to Regulation (EC) No 853/2004 that have undergone one of the treatments laid down in Annex II part 4 to Decision 2007/777/EC.

(3) By way of derogation from point 4, carcasses, half carcasses or half carcasses cut into no more than three wholesale cuts, and quarters containing no specified risk material other than the vertebral column, including dorsal root ganglia, may be imported.

When removal of the vertebral column is not required, carcasses or wholesale cuts of carcasses of bovine animals containing vertebral column shall be identified by a blue stripe on the label referred to in Regulation (EC) No 1760/2000.

The number of bovine carcasses or wholesale cuts of carcasses, from which removal of the vertebral column is required as well as the number where removal of the vertebral column is not required shall be added to the document referred to in Article 2(1) of Regulation (EC) No 136/2004 in case of imports.

(4) Only applicable to imports of treated intestines.

(5) By way of derogation from point 3, carcasses, half carcasses or half carcasses cut into no more than three wholesale cuts, and quarters containing no specified risk material other than the vertebral column, including dorsal root ganglia, may be imported.

When removal of the vertebral column is not required, carcasses or wholesale cuts of carcasses of bovine animals containing vertebral column shall be identified by a clearly visible blue stripe on the label referred to in Regulation (EC) No 1760/2000.

Specific information on the number of bovine carcasses or wholesale cuts of carcasses, from which removal of the vertebral column is required and from which removal of the vertebral column is not required shall be added to the document referred to in Article 2(1) of Regulation (EC) No 136/2004 in case of imports.

(6) Raw milk and dairy products means, raw milk and dairy products for human consumption as defined in point 7.2 of Annex I to Regulation (EC) No 853/2004.

(7) Date or dates of production. Imports of raw milk and dairy products shall not be allowed when obtained either prior to the date of authorisation for exportation to the European Union of the third country or part thereof mentioned under I.7 and I.8, or during a period where restrictive measures have been adopted by the European Union against imports of raw milk and dairy products from this third country or part thereof.

(8) Number of the fishery product establishment authorised to export to the EU.

(9) Country of origin authorised to export to the EU.

(10) In case of composite products containing only egg or fishery products the signature of an official Inspector can be accepted.

The colour of the signature shall be different to that of the printing. The same rule applies to stamps other than those embossed or watermark.

Image 7

COUNTRY

Composite products intended for human consumption

II. Health information

II.a. Certificate reference No

II.b.

Official veterinarian/Official inspector (10)

Name (in capital letters):

Qualification and title:

Date:

Signature:

Stamp:

‘ANNEX II

Model Health Certificate for transit through or storage in the European Union of composite products intended for human consumption

Image 8

Part I: Details of dispatched consignment

COUNTRY

Veterinary 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 load in EU

Name

Address

Postcode

Tel.

I.7. Country of origin

ISO code

I.8. Region of origin

Code

I.9. Country of destination

ISO code

I.10.

I.11. Place of origin

Name

Approval number

Address

Name

Approval number

Address

Name

Approval number

Address

I.12. Place of origin

Custom warehouse

Ship supplier

Name

Approval number

Address

Postcode

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

I.26. For transit through EU to third country

Third country

ISO code

I.27.

I.28. Identification of the commodities

Manufacturing plant

Number of packages

Nature of commodity

Net weight

Batch number

Image 9

Part II: Certification

COUNTRY

Composite products intended for human consumption

Transit/Storage

II. Health information

II.a. Certificate reference No

II.b.

I, the undersigned official veterinarian/official inspector hereby certify that the composite products described above contain:

(1) either II.1.A Meat products, treated stomachs, bladders and intestines (2) in any quantity and such meat products, treated stomachs, bladders and intestines have been produced according to Commission Decision 2007/777/EC and contain the following meat constituents and meet the criteria indicated below:

Species (A)

Treatment (B)

Origin (C)

(A) Insert the code for the relevant species of meat product, treated stomachs, bladders and intestines where BOV = domestic bovine animals (Bos taurus, Bison bison, Bubalus bubalis and their crossbreds); OVI = domestic sheep (Ovis aries) and goats (Capra hircus); EQI = domestic equine animals (Equus caballus, Equus asinus and their crossbreds), POR = domestic porcine animals (Sus scrofa); RM = domestic rabbits, PFG = domestic poultry and farmed feathered game, RUF farmed non-domestic animals other than suidae and solipeds; RUW = wild non-domestic animals other than suidae and solipeds; SUW = wild non-domestic suidae: EQW = wild non-domestic solipeds, WL = wild lagomorphs, WGB = wild game birds.

(B) Insert A, B, C, D, E or F for the required treatment as specified and defined in Parts 2, 3 and 4 of Annex II to Decision 2007/777/EC.

(C) Insert the ISO code of the country of origin of the meat product, treated stomachs, bladders and intestines as listed in Annex II, Part 2 to Decision 2007/777/EC and, in the case of regionalization by Union legislation for the relevant meat constituents, the region as indicated in Part 1 of Annex II to Decision 2007/777/EC or a Member State of the European Union. The country of origin of the meat products must be one the following:

the same as the country of export in box I.7,

a Member State of the European Union,

a third country or parts thereof authorised to export to the Union meat products treated with treatment A as set out in Annex II to Decision 2007/777/EC, where the third country where the composite product is produced is also authorised to export to the Union meat products treated with that treatment.

(1) and/or [II.1.B Processed dairy products (3) in an amount of half or more of the substance of the composite product or not shelf stable dairy products in any quantity that

(a) have been produced in the country ... The country of origin of the dairy products must be one of the following:

the same as the country of export in box I.7,

a Member State of the European Union,

a third country or parts thereof authorised to export to the Union meat products treated with treatment A as set out in Annex II to Decision 2007/777/EC, where the third country where the composite product is produced is also authorised to export to the Union meat products treated with that treatment.

The country of origin indicated in box I.7 must be listed in Annex I to Regulation (EU) No 605/2010 and the treatment applied must be conform to the treatment provided for in that list for the relevant country;

(b) have been produced from milk obtained from animals:

(i) under the control of the official veterinary service;

(ii) belonging to holdings which were not under restrictions due to foot-and-mouth disease or rinderpest; and

(iii) subject to regular veterinary inspections to ensure that they satisfy the animal health conditions laid down in Chapter I of Section IX of Annex III to Regulation (EC) No 853/2004 and in Directive 2002/99/EC;

(c) are dairy products made from raw milk obtained from

(1) either [cows, ewes, goats or buffaloes and prior to import into the territory of the European Union have undergone or been produced from raw milk which has undergone

(1) either [a pasteurisation treatment involving a single heat treatment with a heating effect at least equivalent to that achieved by a pasteurisation process of at least 72 °C for 15 seconds and where applicable, sufficient to ensure a negative reaction to an alkaline phosphatase test applied immediately after the heat treatment;]

Image 10

COUNTRY

Composite products intended for human consumption

Transit/Storage

II. Health information

II.a. Certificate reference number

II.b.

(1) or [a sterilisation process, to achieve an F0 value equal to or greater than three;]

(1) or [an ultra high temperature (UHT) treatment at not less than 135 °C in combination with a suitable holding time;]

(1) or [a high temperature short time pasteurisation treatment (HTST) at 72 °C for 15 seconds, or a treatment with an equivalent pasteurisation effect, applied to milk with a pH lower than 7,0 achieving, where applicable, a negative reaction to an alkaline phosphatase test];

(1) or [a high temperature short time pasteurisation treatment (HTST) at 72 °C for 15 seconds, or a treatment with an equivalent pasteurisation effect, applied twice to milk with a pH equal to or greater than 7,0 achieving, where applicable, a negative reaction to an alkaline phosphatase test, immediately followed by

(1) either [lowering the pH below 6 for one hour;]

(1) or [additional heating equal to or greater than 72 °C, combined with desiccation;]]

(1) or [animals other than cows, ewes, goats or buffaloes and prior to import into the territory of the European Union have undergone or been produced from raw milk which has undergone

(1) either [a sterilisation process, to achieve an F0 value equal to or greater than three;]

(1) or [an ultra high temperature (UHT) treatment at not less than 135 °C in combination with a suitable holding time;]]

(d) were produced on ... or between ... and ...(4).]

and/or [II.1.C Processed egg products that originate from the approved country (5)

Were produced from eggs coming from an establishment which satisfies the requirements of Section X of Annex III to Regulation (EC) No 853/2004 which at the date of issue of the certificate is free from highly pathogenic avian influenza as defined in Regulation (EC) No 798/2008 and

either

(1) [II.1.C.1 [within a 10 km radius of which [including, where appropriate, the territory of a neighbouring country,] there has been no outbreak of highly pathogenic avian influenza or Newcastle disease for at least the previous 30 days.]

or

(1) [II.1.C.2 [the egg products were processed:

(1) either [liquid egg white was treated:

(1) either [with 55,6 °C for 870 seconds.]

(1) or [with 56,7 °C for 232 seconds.]

(1) or [10 % salted yolk was treated with 62,2 °C for 138 seconds.]

(1) or [dried egg white was treated:

(1) either [with 67 °C for 20 hours.]

(1) or [with 54,4 °C for 513 hours.]

(1) or [whole eggs were at least treated:

(1) either [with 60 °C for 188 seconds.]

(1) or [completely cooked.]

[whole egg blends were at least treated]:

(1) either [with 60 °C for 188 seconds.]

(1) or [with 61,1 °C for 94 seconds.]

Image 11

COUNTRY

Composite products intended for human consumption

Transit/Storage

II. Health information

II.a. Certificate reference number

II.b.

Notes

Part I:

Box reference I.7: Insert the ISO code of the country of origin of the meat product, treated stomachs, bladders and intestines as listed in Annex II, Part 2 to Decision 2007/777/EC and/or for processed dairy product in Annex I to Commission Regulation (EU) No 605/2010.

Box reference I.11: Name, address of the establishments of production of the composite product(s). Name of the country of origin which must be the same as the country of origin in box I.7.

Approval number is not applicable.

Box reference I.15: Registration number (railway wagons or container and road vehicles), flight number (aircraft) or name (ship). In the case of transport in containers, the total number of containers and their registration number and where there is a serial number of the seal it must be indicated in box I.23. In case of unloading and reloading, the consignor must inform the border inspection post of introduction into the European Union.

Box reference I.19: Use the appropriate Harmonised System (HS) code of the World Customs Organisation such as: 16.01; 16.02; 16.03; 16.04; 16.05; 19.01; 19.02; 19.05; 20.04; 20.05; 21.03; 21.04; 21.05; 21.06.

Box reference I.20: Indicate total gross weight and total net weight.

Box reference I.23: For containers or boxes, the container number and the seal number (if applicable) must be included.

Box reference I.28: Manufacturing plant: insert the name and approval number if available of the establishments of production of the composite product(s). Nature of commodity: in case of composite products containing meat products, treated stomachs, bladders and intestines indicate “meat product”, “treated stomachs”, “bladders” or “intestines”. In case of composite product containing dairy products indicate “dairy product”.

Part II:

(1) Keep as appropriate.

(2) Meat products as laid down in point 7.1 of Annex I to Regulation (EC) No 853/2004 and treated stomachs, bladders and intestines as laid down in point 7.9 of Annex I to Regulation (EC) No 853/2004 that have undergone one of the treatments laid down in Annex II part 4 to Decision 2007/777/EC.

(3) Raw milk and dairy products means, raw milk and dairy products for human consumption as defined in point 7.2 of Annex I to Regulation (EC) No 853/2004.

(4) Date or dates of production. Imports of raw milk and dairy products shall not be allowed when obtained either prior to the date of authorisation for exportation to the European Union of the third country or part thereof mentioned under I.7 and I.8, or during a period where restrictive measures have been adopted by the European Union against imports of raw milk and dairy products from this third country or part thereof.

(5) Country of origin authorised to export to the EU.

The colour of the signature shall be different to that of the printing. The same rule applies to stamps other than those embossed or watermark.

Official veterinarian/Official inspector

Name (in capital letters):

Qualification and title:

Date:

Signature:

Stamp:

---

| 5.6.2012 | EN | Official Journal of the European Union | L 144/15 |
| --- | --- | --- | --- |

5.6.2012

EN

Official Journal of the European Union

L 144/15

---

COMMISSION IMPLEMENTING REGULATION (EU) No 469/2012

of 1 June 2012

correcting Implementing Regulation (EU) No 69/2012 on the issue of licences for importing rice under the tariff quotas opened for the January 2012 subperiod by Implementing Regulation (EU) No 1273/2011

THE EUROPEAN COMMISSION,

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

Having regard to Council Regulation (EC) No 1234/2007 of 22 October 2007 establishing a common organisation of agricultural markets and on specific provisions for certain agricultural products (Single CMO Regulation) (1),

Having regard to Commission Implementing Regulation (EU) No 1273/2011 of 7 December 2011 opening and providing for the administration of certain tariff quotas for imports of rice and broken rice (2), and in particular the first paragraph of Article 5 thereof,

Whereas:

| (1) | A check has revealed an error in the Annex to Commission Implementing Regulation (EU) No 69/2012 (3) regarding the quantity available for the July 2012 subperiod for the quota of broken rice falling within CN Code 1006 40 00 provided for in Article 1(1)(c) of Implementing Regulation (EU) No 1273/2011 and with order number 09.4149. |
| --- | --- |

(1)

A check has revealed an error in the Annex to Commission Implementing Regulation (EU) No 69/2012 (3) regarding the quantity available for the July 2012 subperiod for the quota of broken rice falling within CN Code 1006 40 00 provided for in Article 1(1)(c) of Implementing Regulation (EU) No 1273/2011 and with order number 09.4149.

| (2) | Implementing Regulation (EU) No 69/2012 should therefore be corrected accordingly. |
| --- | --- |

(2)

Implementing Regulation (EU) No 69/2012 should therefore be corrected accordingly.

| (3) | In order to ensure sound management of the procedure for issuing import licences, this Regulation should enter into force immediately after its publication, |
| --- | --- |

(3)

In order to ensure sound management of the procedure for issuing import licences, this Regulation should enter into force immediately after its publication,

HAS ADOPTED THIS REGULATION:

Article 1

In point (c) of the Annex to Implementing Regulation (EU) No 69/2012, ‧Quota of broken rice covered by CN code 1006 40 00 as provided for in Article 1(1)(c) of Implementing Regulation (EU) No 1273/2011‧, in the line concerning the quota with order number 09.4149, the quantity ‧44 047 269‧ shall be replaced by the quantity ‧44 921 269‧.

Article 2

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

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

Done at Brussels, 1 June 2012.

For the Commission, On behalf of the President,

José Manuel SILVA RODRÍGUEZ

Director-General for Agriculture and Rural Development

---

(1)  
  OJ L 299, 16.11.2007, p. 1.

1

(2)  
  OJ L 325, 8.12.2011, p. 6.

2

(3)  
  OJ L 24, 27.1.2012, p. 7.

3

---

| 5.6.2012 | EN | Official Journal of the European Union | L 144/16 |
| --- | --- | --- | --- |

5.6.2012

EN

Official Journal of the European Union

L 144/16

---

COMMISSION REGULATION (EU) No 470/2012

of 4 June 2012

amending Annex II to Regulation (EC) No 1333/2008 of the European Parliament and of the Council as regards the use of polydextrose (E 1200) in beer

(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 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives (1), and in particular Article 10(3) and Article 30(5) thereof,

Whereas:

| (1) | Annex II to Regulation (EC) No 1333/2008 lays down a Union list of food additives approved for use in foods and their conditions of use. |
| --- | --- |

(1)

Annex II to Regulation (EC) No 1333/2008 lays down a Union list of food additives approved for use in foods and their conditions of use.

| (2) | That list may be amended in accordance with the procedure referred to in Regulation (EC) No 1331/2008 of the European Parliament and of the Council of 16 December 2008 establishing a common authorisation procedure for food additives, food enzymes and food flavourings (2). |
| --- | --- |

(2)

That list may be amended in accordance with the procedure referred to in Regulation (EC) No 1331/2008 of the European Parliament and of the Council of 16 December 2008 establishing a common authorisation procedure for food additives, food enzymes and food flavourings (2).

| (3) | Pursuant to Article 3(1) of Regulation (EC) No 1331/2008, the Union list of food additives may be updated either on the initiative of the Commission or following an application. |
| --- | --- |

(3)

Pursuant to Article 3(1) of Regulation (EC) No 1331/2008, the Union list of food additives may be updated either on the initiative of the Commission or following an application.

| (4) | An application for authorisation of the use of polydextrose (E 1200) as a stabiliser in beer was submitted and has been made available to the Member States. |
| --- | --- |

(4)

An application for authorisation of the use of polydextrose (E 1200) as a stabiliser in beer was submitted and has been made available to the Member States.

| (5) | Energy-reduced and low-alcohol beers have a generally low acceptance because of their lack of body and mouthfeel. Addition of polydextrose (E 1200) can contribute to the body and mouthfeel and at the same time can provide the necessary foam stability. In addition, polydextrose (E 1200) has a low caloric value and its addition will have a limited contribution to the total calorie content of the beer. |
| --- | --- |

(5)

Energy-reduced and low-alcohol beers have a generally low acceptance because of their lack of body and mouthfeel. Addition of polydextrose (E 1200) can contribute to the body and mouthfeel and at the same time can provide the necessary foam stability. In addition, polydextrose (E 1200) has a low caloric value and its addition will have a limited contribution to the total calorie content of the beer.

| (6) | Polydextrose (E 1200) belongs to the group of additives for which no acceptable daily intake has been specified (3). This implies that it does not represent a hazard to health at the levels necessary to achieve the desired technological effect. It is therefore appropriate to allow the use of polydextrose (E 1200) in energy-reduced and low-alcohol beers. |
| --- | --- |

(6)

Polydextrose (E 1200) belongs to the group of additives for which no acceptable daily intake has been specified (3). This implies that it does not represent a hazard to health at the levels necessary to achieve the desired technological effect. It is therefore appropriate to allow the use of polydextrose (E 1200) in energy-reduced and low-alcohol beers.

| (7) | Pursuant to Article 3(2) of Regulation (EC) No 1331/2008, the Commission is to seek the opinion of the European Food Safety Authority in order to update the Union list of food additives set out in Annex II to Regulation (EC) No 1333/2008, except where the update in question is not liable to have an effect on human health. Since the authorisation of use of polydextrose (E 1200) in energy-reduced and low-alcohol beers constitutes an update of that list which is not liable to have an effect on human health, it is not necessary to seek the opinion of the European Food Safety Authority. |
| --- | --- |

(7)

Pursuant to Article 3(2) of Regulation (EC) No 1331/2008, the Commission is to seek the opinion of the European Food Safety Authority in order to update the Union list of food additives set out in Annex II to Regulation (EC) No 1333/2008, except where the update in question is not liable to have an effect on human health. Since the authorisation of use of polydextrose (E 1200) in energy-reduced and low-alcohol beers constitutes an update of that list which is not liable to have an effect on human health, it is not necessary to seek the opinion of the European Food Safety Authority.

| (8) | Pursuant to the transitional provisions of Commission Regulation (EU) No 1129/2011 of 11 November 2011 amending Annex II to Regulation (EC) No 1333/2008 of the European Parliament and of the Council by establishing a Union list of food additives (4), Annex II establishing the Union list of food additives approved for use in foods and conditions of use applies from 1 June 2013. In order to allow the use of polydextrose (E 1200) in beer before that date, it is necessary to specify an earlier date of application with regard to this use of that food additive. |
| --- | --- |

(8)

Pursuant to the transitional provisions of Commission Regulation (EU) No 1129/2011 of 11 November 2011 amending Annex II to Regulation (EC) No 1333/2008 of the European Parliament and of the Council by establishing a Union list of food additives (4), Annex II establishing the Union list of food additives approved for use in foods and conditions of use applies from 1 June 2013. In order to allow the use of polydextrose (E 1200) in beer before that date, it is necessary to specify an earlier date of application with regard to this use of that food additive.

| (9) | Therefore, Annex II to Regulation (EC) No 1333/2008 should be amended accordingly. |
| --- | --- |

(9)

Therefore, Annex II to Regulation (EC) No 1333/2008 should be amended accordingly.

| (10) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health and neither the European Parliament nor the Council has opposed them, |
| --- | --- |

(10)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health and neither the European Parliament nor the Council has opposed them,

HAS ADOPTED THIS REGULATION:

Article 1

Annex II to Regulation (EC) No 1333/2008 is amended in accordance with the Annex to this Regulation.

Article 2

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

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

Done at Brussels, 4 June 2012.

For the Commission

The President

José Manuel BARROSO

---

(1)  
  OJ L 354, 31.12.2008, p. 16.

1

(2)  
  OJ L 354, 31.12.2008, p. 1.

2

(3)  Report from the Commission on Dietary Food Additive Intake in the European Union, COM(2001) 542 final.

3

(4)  
  OJ L 295, 12.11.2011, p. 1.

4

---

ANNEX

In Part E of Annex II to Regulation (EC) No 1333/2008 the following entry is inserted in the food category 14.2.1 ‘beer and malt beverages’ after the entry for E 1105:

| | ‘E 1200 | Polydextrose | quantum satis | | Only energy-reduced and low-alcohol beers | Period of application:
  From 25 June 2012’ |
| --- | --- | --- | --- | --- | --- | --- |

‘E 1200

Polydextrose

quantum satis

Only energy-reduced and low-alcohol beers

Period of application:

From 25 June 2012’

---

| 5.6.2012 | EN | Official Journal of the European Union | L 144/19 |
| --- | --- | --- | --- |

5.6.2012

EN

Official Journal of the European Union

L 144/19

---

COMMISSION REGULATION (EU) No 471/2012

of 4 June 2012

amending Annex II to Regulation (EC) No 1333/2008 of the European Parliament and of the Council as regards the use of lysozyme (E 1105) in beer

(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 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives (1), and in particular Article 10(3) and Article 30(5) thereof,

Whereas:

| (1) | Annex II to Regulation (EC) No 1333/2008 lays down a Union list of food additives approved for use in foods and their conditions of use. |
| --- | --- |

(1)

Annex II to Regulation (EC) No 1333/2008 lays down a Union list of food additives approved for use in foods and their conditions of use.

| (2) | That list may be amended in accordance with the procedure referred to in Regulation (EC) No 1331/2008 of the European Parliament and of the Council of 16 December 2008 establishing a common authorisation procedure for food additives, food enzymes and food flavourings (2). |
| --- | --- |

(2)

That list may be amended in accordance with the procedure referred to in Regulation (EC) No 1331/2008 of the European Parliament and of the Council of 16 December 2008 establishing a common authorisation procedure for food additives, food enzymes and food flavourings (2).

| (3) | Pursuant to Article 3(1) of Regulation (EC) No 1331/2008, the Union list of food additives may be updated either on the initiative of the Commission or following an application. |
| --- | --- |

(3)

Pursuant to Article 3(1) of Regulation (EC) No 1331/2008, the Union list of food additives may be updated either on the initiative of the Commission or following an application.

| (4) | An application for authorisation of the use of lysozyme (E 1105) as a preservative in beer was submitted and has been made available to the Member States. |
| --- | --- |

(4)

An application for authorisation of the use of lysozyme (E 1105) as a preservative in beer was submitted and has been made available to the Member States.

| (5) | Most breweries use sterile filtration or pasteurisation of their beers to prevent bacterial spoilage during storage of the beer before consumption. For some specialty beers, like the top-fermenting beers with re-fermentation, for instance cask-conditioned beer and bottle-conditioned beer, such treatments are not possible because the present viable micro-organisms are part of the production process of those beers. Lysozyme (E 1105) has been proven to be a suitable antibacterial agent for brewing purposes and it is effective in inhibiting lactic acid bacteria added to finished beers. |
| --- | --- |

(5)

Most breweries use sterile filtration or pasteurisation of their beers to prevent bacterial spoilage during storage of the beer before consumption. For some specialty beers, like the top-fermenting beers with re-fermentation, for instance cask-conditioned beer and bottle-conditioned beer, such treatments are not possible because the present viable micro-organisms are part of the production process of those beers. Lysozyme (E 1105) has been proven to be a suitable antibacterial agent for brewing purposes and it is effective in inhibiting lactic acid bacteria added to finished beers.

| (6) | Lysozyme (E 1105) belongs to the group of additives for which no acceptable daily intake has been specified (3). This implies that it does not represent a hazard to health at the levels necessary to achieve the desired technological effect. It is therefore appropriate to allow the use of lysozyme (E 1105) for the preservation of beers that will not receive either pasteurisation or sterile filtration. |
| --- | --- |

(6)

Lysozyme (E 1105) belongs to the group of additives for which no acceptable daily intake has been specified (3). This implies that it does not represent a hazard to health at the levels necessary to achieve the desired technological effect. It is therefore appropriate to allow the use of lysozyme (E 1105) for the preservation of beers that will not receive either pasteurisation or sterile filtration.

| (7) | According to Commission Directive 2008/84/EC of 27 August 2008 laying down specific purity criteria on food additives other than colours and sweeteners (4), lysozyme (E 1105) is obtained from hen’s eggs whites. Eggs and products thereof are listed in Annex IIIa to 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 the labelling, presentation and advertising of foodstuffs (5). The presence of this enzyme in beers needs to be indicated on the labelling in accordance with the requirements of the said Directive. |
| --- | --- |

(7)

According to Commission Directive 2008/84/EC of 27 August 2008 laying down specific purity criteria on food additives other than colours and sweeteners (4), lysozyme (E 1105) is obtained from hen’s eggs whites. Eggs and products thereof are listed in Annex IIIa to 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 the labelling, presentation and advertising of foodstuffs (5). The presence of this enzyme in beers needs to be indicated on the labelling in accordance with the requirements of the said Directive.

| (8) | Pursuant to Article 3(2) of Regulation (EC) No 1331/2008, the Commission is to seek the opinion of the European Food Safety Authority in order to update the Union list of food additives set out in Annex II to Regulation (EC) No 1333/2008, except where the update in question is not liable to have an effect on human health. Since the authorisation of use of lysozyme (E 1105) as a preservative in beer constitutes an update of that list which is not liable to have an effect on human health, it is not necessary to seek the opinion of the European Food Safety Authority. |
| --- | --- |

(8)

Pursuant to Article 3(2) of Regulation (EC) No 1331/2008, the Commission is to seek the opinion of the European Food Safety Authority in order to update the Union list of food additives set out in Annex II to Regulation (EC) No 1333/2008, except where the update in question is not liable to have an effect on human health. Since the authorisation of use of lysozyme (E 1105) as a preservative in beer constitutes an update of that list which is not liable to have an effect on human health, it is not necessary to seek the opinion of the European Food Safety Authority.

| (9) | Pursuant to the transitional provisions of Commission Regulation (EU) No 1129/2011 of 11 November 2011 amending Annex II to Regulation (EC) No 1333/2008 of the European Parliament and of the Council by establishing a Union list of food additives (6), Annex II establishing the Union list of food additives approved for use in foods and conditions of use applies from 1 June 2013. In order to allow the use of lysozyme (E 1105) in beers before that date, it is necessary to specify an earlier date of application with regard to that food additive. |
| --- | --- |

(9)

Pursuant to the transitional provisions of Commission Regulation (EU) No 1129/2011 of 11 November 2011 amending Annex II to Regulation (EC) No 1333/2008 of the European Parliament and of the Council by establishing a Union list of food additives (6), Annex II establishing the Union list of food additives approved for use in foods and conditions of use applies from 1 June 2013. In order to allow the use of lysozyme (E 1105) in beers before that date, it is necessary to specify an earlier date of application with regard to that food additive.

| (10) | Therefore, Annex II to Regulation (EC) No 1333/2008 should be amended accordingly. |
| --- | --- |

(10)

Therefore, Annex II to Regulation (EC) No 1333/2008 should be amended accordingly.

| (11) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health and neither the European Parliament nor the Council has opposed them, |
| --- | --- |

(11)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health and neither the European Parliament nor the Council has opposed them,

HAS ADOPTED THIS REGULATION:

Article 1

Annex II to Regulation (EC) No 1333/2008 is amended in accordance with the Annex to this Regulation.

Article 2

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

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

Done at Brussels, 4 June 2012.

For the Commission

The President

José Manuel BARROSO

---

(1)  
  OJ L 354, 31.12.2008, p. 16.

1

(2)  
  OJ L 354, 31.12.2008, p. 1.

2

(3)  Report from the Commission on Dietary Food Additive Intake in the European Union, COM(2001) 542 final.

3

(4)  
  OJ L 253, 20.9.2008, p. 1.

4

(5)  
  OJ L 109, 6.5.2000, p. 29.

5

(6)  
  OJ L 295, 12.11.2011, p. 1.

6

---

ANNEX

In Part E of Annex II to Regulation (EC) No 1333/2008 the following entry is inserted in the food category 14.2.1 ‘beer and malt beverages’ after the entry for E 962:

| | ‘E 1105 | Lysozyme | quantum satis | | only in beers that will not receive either pasteurisation or sterile filtration | Period of application:
  From 25 June 2012’ |
| --- | --- | --- | --- | --- | --- | --- |

‘E 1105

Lysozyme

quantum satis

only in beers that will not receive either pasteurisation or sterile filtration

Period of application:

From 25 June 2012’

---

| 5.6.2012 | EN | Official Journal of the European Union | L 144/22 |
| --- | --- | --- | --- |

5.6.2012

EN

Official Journal of the European Union

L 144/22

---

COMMISSION REGULATION (EU) No 472/2012

of 4 June 2012

amending Annex II to Regulation (EC) No 1333/2008 of the European Parliament and of the Council as regards the use of glycerol esters of wood rosins (E 445) for printing on hard-coated confectionery products

(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 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives (1), and in particular Article 10(3) and Article 30(5) thereof,

Whereas:

| (1) | Annex II to Regulation (EC) No 1333/2008 lays down a Union list of food additives approved for use in foods and their conditions of use. |
| --- | --- |

(1)

Annex II to Regulation (EC) No 1333/2008 lays down a Union list of food additives approved for use in foods and their conditions of use.

| (2) | That list may be amended in accordance with the procedure referred to in Regulation (EC) No 1331/2008 of the European Parliament and of the Council of 16 December 2008 establishing a common authorisation procedure for food additives, food enzymes and food flavourings (2). |
| --- | --- |

(2)

That list may be amended in accordance with the procedure referred to in Regulation (EC) No 1331/2008 of the European Parliament and of the Council of 16 December 2008 establishing a common authorisation procedure for food additives, food enzymes and food flavourings (2).

| (3) | Pursuant to Article 3(1) of Regulation (EC) No 1331/2008, the Union list of food additives may be updated either on the initiative of the Commission or following an application. |
| --- | --- |

(3)

Pursuant to Article 3(1) of Regulation (EC) No 1331/2008, the Union list of food additives may be updated either on the initiative of the Commission or following an application.

| (4) | An application for authorisation of the use of glycerol esters of wood rosins (E 445) as an emulsifier for printing on hard-coated confectionery products was submitted and has been made available to the Member States. |
| --- | --- |

(4)

An application for authorisation of the use of glycerol esters of wood rosins (E 445) as an emulsifier for printing on hard-coated confectionery products was submitted and has been made available to the Member States.

| (5) | Currently available food colour preparations used for printing on hard-coated confectionery products do not allow sufficient quality for the printing of texts, logos and pictures. Research and development have identified that the use of glycerol esters of wood rosins (E 445) as an emulsifier in aqueous based food colour preparations improves the mixing and integrity of the ingredients which results in a more homogenous preparation delivering good fixing and coverage properties. This facilitates printing of high quality text and high resolution pictures to personalised and/or promotional hard-coated confectionery products intended for celebratory occasions. |
| --- | --- |

(5)

Currently available food colour preparations used for printing on hard-coated confectionery products do not allow sufficient quality for the printing of texts, logos and pictures. Research and development have identified that the use of glycerol esters of wood rosins (E 445) as an emulsifier in aqueous based food colour preparations improves the mixing and integrity of the ingredients which results in a more homogenous preparation delivering good fixing and coverage properties. This facilitates printing of high quality text and high resolution pictures to personalised and/or promotional hard-coated confectionery products intended for celebratory occasions.

| (6) | The Report from the Commission on Dietary Food Additive Intake in the European Union (3) concluded that glycerol esters of wood rosins (E 445) needed no further examination, since the theoretical intake based on conservative assumptions on food consumption and additive usage (Tier 1) did not exceed the acceptable daily intake. The acceptable daily intake value was established on 19 June 1992 by the Scientific Committee for Food (4). The additional intake based on the new use for printing on hard-coated confectionery products does not significantly contribute to the overall intake. It is therefore appropriate to allow the use of glycerol esters of wood rosins (E 445) as an emulsifier for printing on hard-coated confectionery products. |
| --- | --- |

(6)

The Report from the Commission on Dietary Food Additive Intake in the European Union (3) concluded that glycerol esters of wood rosins (E 445) needed no further examination, since the theoretical intake based on conservative assumptions on food consumption and additive usage (Tier 1) did not exceed the acceptable daily intake. The acceptable daily intake value was established on 19 June 1992 by the Scientific Committee for Food (4). The additional intake based on the new use for printing on hard-coated confectionery products does not significantly contribute to the overall intake. It is therefore appropriate to allow the use of glycerol esters of wood rosins (E 445) as an emulsifier for printing on hard-coated confectionery products.

| (7) | Pursuant to Article 3(2) of Regulation (EC) No 1331/2008, the Commission is to seek the opinion of the European Food Safety Authority in order to update the Union list of food additives set out in Annex II to Regulation (EC) No 1333/2008, except where the update in question is not liable to have an effect on human health. Since the authorisation of use of glycerol esters of wood rosins (E 445) as an emulsifier for printing on hard-coated confectionery products constitutes an update of that list which is not liable to have an effect on human health, it is not necessary to seek the opinion of the European Food Safety Authority. |
| --- | --- |

(7)

Pursuant to Article 3(2) of Regulation (EC) No 1331/2008, the Commission is to seek the opinion of the European Food Safety Authority in order to update the Union list of food additives set out in Annex II to Regulation (EC) No 1333/2008, except where the update in question is not liable to have an effect on human health. Since the authorisation of use of glycerol esters of wood rosins (E 445) as an emulsifier for printing on hard-coated confectionery products constitutes an update of that list which is not liable to have an effect on human health, it is not necessary to seek the opinion of the European Food Safety Authority.

| (8) | Pursuant to the transitional provisions of Commission Regulation (EU) No 1129/2011 of 11 November 2011 amending Annex II to Regulation (EC) No 1333/2008 of the European Parliament and of the Council by establishing a Union list of food additives (5), Annex II establishing the Union list of food additives approved for use in foods and conditions of use applies from 1 June 2013. In order to allow the use of glycerol esters of wood rosins (E 445) for printing on hard-coated confectionery products before that date, it is necessary to specify an earlier date of application with regard to this use of that food additive. |
| --- | --- |

(8)

Pursuant to the transitional provisions of Commission Regulation (EU) No 1129/2011 of 11 November 2011 amending Annex II to Regulation (EC) No 1333/2008 of the European Parliament and of the Council by establishing a Union list of food additives (5), Annex II establishing the Union list of food additives approved for use in foods and conditions of use applies from 1 June 2013. In order to allow the use of glycerol esters of wood rosins (E 445) for printing on hard-coated confectionery products before that date, it is necessary to specify an earlier date of application with regard to this use of that food additive.

| (9) | Therefore, Annex II to Regulation (EC) No 1333/2008 should be amended accordingly. |
| --- | --- |

(9)

Therefore, Annex II to Regulation (EC) No 1333/2008 should be amended accordingly.

| (10) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health and neither the European Parliament nor the Council has opposed them, |
| --- | --- |

(10)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health and neither the European Parliament nor the Council has opposed them,

HAS ADOPTED THIS REGULATION:

Article 1

Annex II to Regulation (EC) No 1333/2008 is amended in accordance with the Annex to this Regulation.

Article 2

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

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

Done at Brussels, 4 June 2012.

For the Commission

The President

José Manuel BARROSO

---

(1)  
  OJ L 354, 31.12.2008, p. 16.

1

(2)  
  OJ L 354, 31.12.2008, p. 1.

2

(3)  COM(2001) 542 final.

3

(4)  http://ec.europa.eu/food/fs/sc/scf/reports/scf_reports_32.pdf

4

(5)  
  OJ L 295, 12.11.2011, p. 1.

5

---

ANNEX

In Part E of Annex II to Regulation (EC) No 1333/2008 the following entry is inserted in the food category 05.2 ‘other confectionery including breath refreshening microsweets’ after the entry for E 442:

| | ‘E 445 | Glycerol esters of wood rosins | 320 | | Only for printing on personalised and/or promotional hard-coated confectionery products | Period of application:
  From 25 June 2012’ |
| --- | --- | --- | --- | --- | --- | --- |

‘E 445

Glycerol esters of wood rosins

320

Only for printing on personalised and/or promotional hard-coated confectionery products

Period of application:

From 25 June 2012’

---

| 5.6.2012 | EN | Official Journal of the European Union | L 144/25 |
| --- | --- | --- | --- |

5.6.2012

EN

Official Journal of the European Union

L 144/25

---

COMMISSION REGULATION (EU) No 473/2012

of 4 June 2012

amending Annex III to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for spinetoram (XDE-175) in or on certain products

(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 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC (1), and in particular Article 18(4) thereof,

Whereas:

| (1) | For spinetoram (XDE-175) MRLs are set in Part A of Annex III to Regulation (EC) No 396/2005. |
| --- | --- |

(1)

For spinetoram (XDE-175) MRLs are set in Part A of Annex III to Regulation (EC) No 396/2005.

| (2) | In accordance with Article 53 of Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (2), France notified on 11 May 2012 to the Commission the temporary authorisation of plant protection products containing the active substance spinetoram (XDE-175), due to an unexpected outbreak of Drosophila suzukii, a danger that was unforeseeable and could not be contained by any other reasonable means. Consequently, France has also notified to the other Member States, the Commission and the Authority in accordance with Article 18(4) of Regulation (EC) No 396/2005 that it has authorised the placing on the market in its territory of cherries, raspberries and blueberries containing pesticide residues higher than the MRLs. Currently, those MRLs are established at the limit of determination in Annex III to Regulation (EC) No 396/2005. |
| --- | --- |

(2)

In accordance with Article 53 of Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (2), France notified on 11 May 2012 to the Commission the temporary authorisation of plant protection products containing the active substance spinetoram (XDE-175), due to an unexpected outbreak of Drosophila suzukii, a danger that was unforeseeable and could not be contained by any other reasonable means. Consequently, France has also notified to the other Member States, the Commission and the Authority in accordance with Article 18(4) of Regulation (EC) No 396/2005 that it has authorised the placing on the market in its territory of cherries, raspberries and blueberries containing pesticide residues higher than the MRLs. Currently, those MRLs are established at the limit of determination in Annex III to Regulation (EC) No 396/2005.

| (3) | France submitted to the Commission an appropriate consumer risk assesment and proposed temporary MRLs on that basis. |
| --- | --- |

(3)

France submitted to the Commission an appropriate consumer risk assesment and proposed temporary MRLs on that basis.

| (4) | The European Food Safety Authority, hereinafter "the Authority", assessed the data provided and issued a statement (3) on the safety of the proposed temporary MRLs. |
| --- | --- |

(4)

The European Food Safety Authority, hereinafter "the Authority", assessed the data provided and issued a statement (3) on the safety of the proposed temporary MRLs.

| (5) | The Authority concluded that the emergency use of spinetoram (XDE-175) on cherries, raspberries and blueberries is not likely to result in a consumer exposure exceeding the toxicological reference value and therefore is not expected to pose a public health concern. |
| --- | --- |

(5)

The Authority concluded that the emergency use of spinetoram (XDE-175) on cherries, raspberries and blueberries is not likely to result in a consumer exposure exceeding the toxicological reference value and therefore is not expected to pose a public health concern.

| (6) | France did not report details of supervised field trials, nor complete a quality assessment of such trials. The Authority had to base its statement on the assumption that the supervised field trials are valid and confirm the proposed temporary MRLs. In order to verify the correctness of the assumption, France should update the evaluation report as soon as possible. |
| --- | --- |

(6)

France did not report details of supervised field trials, nor complete a quality assessment of such trials. The Authority had to base its statement on the assumption that the supervised field trials are valid and confirm the proposed temporary MRLs. In order to verify the correctness of the assumption, France should update the evaluation report as soon as possible.

| (7) | Based on the statement of the Authority and taking into account the factors relevant to the matter under consideration, the appropriate modifications to the MRLs fulfil the requirements of Article 18(4) of Regulation (EC) No 396/2005. |
| --- | --- |

(7)

Based on the statement of the Authority and taking into account the factors relevant to the matter under consideration, the appropriate modifications to the MRLs fulfil the requirements of Article 18(4) of Regulation (EC) No 396/2005.

| (8) | Regulation (EC) No 396/2005 should therefore be amended accordingly. |
| --- | --- |

(8)

Regulation (EC) No 396/2005 should therefore be amended accordingly.

| (9) | Given that the emergency uses of plant protection products concerning spinetoram are already authorized by France and the resulting urgent need to ensure a high level of consumer protection, it is appropriate to provide for the MRLs by applying the procedure referred to in Article 45(5) of Regulation (EC) No 396/2005. |
| --- | --- |

(9)

Given that the emergency uses of plant protection products concerning spinetoram are already authorized by France and the resulting urgent need to ensure a high level of consumer protection, it is appropriate to provide for the MRLs by applying the procedure referred to in Article 45(5) of Regulation (EC) No 396/2005.

| (10) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, |
| --- | --- |

(10)

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

Annex III to Regulation (EC) No 396/2005 is amended in accordance with the Annex to this Regulation.

Article 2

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

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

Done at Brussels, 4 June 2012.

For the Commission

The President

José Manuel BARROSO

---

(1)  
  OJ L 70, 16.3.2005, p. 1.

1

(2)  
  OJ L 309, 24.11.2009, p. 1.

2

(3)  European Food Safety Authority; Statement on the modification of the existing MRLs for spinetoram in cherries, raspberries and blueberries. EFSA Journal 2012;10(5):2708. [24 pp.] doi:10.2903/j.efsa.2012.2708. Available online: http://www.efsa.europa.eu/efsajournal.htm

3

---

ANNEX

In Part A of Annex III to Regulation (EC) No 396/2005, the column for spinetoram (XDE-175) is replaced by the following:

‘Pesticide residues and maximum residue levels (mg/kg)

| Code number | Groups and examples of individual products to which the MRLs apply (1) | Spinetoram (XDE-175) |
| --- | --- | --- |
| (1) | (2) | (3) |
| 0100000 | 1. | FRUIT FRESH OR FROZEN; NUTS |

Code number

Groups and examples of individual products to which the MRLs apply (1)

Spinetoram (XDE-175)

(1)

(2)

(3)

0100000

1.

0110000

| (i) | Citrus fruit |
| --- | --- |

(i)

0,2

0110010

Grapefruit (Shaddocks, pomelos, sweeties, tangelo (except mineola), ugli and other hybrids)

0110020

Oranges (Bergamot, bitter orange, chinotto and other hybrids)

0110030

Lemons (Citron, lemon)

0110040

Limes

0110050

Mandarins (Clementine, tangerine, mineola and other hybrids)

0110990

Others

0120000

| (ii) | Tree nuts (shelled or unshelled) |
| --- | --- |

(ii)

0,05  (*1)

0120010

Almonds

0120020

Brazil nuts

0120030

Cashew nuts

0120040

Chestnuts

0120050

Coconuts

0120060

Hazelnuts (Filbert)

0120070

Macadamia

0120080

Pecans

0120090

Pine nuts

0120100

Pistachios

0120110

Walnuts

0120990

Others

0130000

| (iii) | Pome fruit |
| --- | --- |

(iii)

0,2

0130010

Apples (Crab apple)

0130020

Pears (Oriental pear)

0130030

Quinces

0130040

Medlar

0130050

Loquat

0130990

Others

0140000

| (iv) | Stone fruit |
| --- | --- |

(iv)

0140010

Apricots

0,2

0140020

Cherries (sweet cherries, sour cherries)

0,2 (+)

0140030

Peaches (Nectarines and similar hybrids)

0,2

0140040

Plums (Damson, greengage, mirabelle, sloe)

0,05  (*1)

0140990

Others

0,05  (*1)

0150000

| (v) | Berries & small fruit |
| --- | --- |

(v)

0151000

| (a) | Table and wine grapes |
| --- | --- |

(a)

0,5

0151010

Table grapes

0151020

Wine grapes

0152000

| (b) | Strawberries |
| --- | --- |

(b)

0,2

0153000

| (c) | Cane fruit |
| --- | --- |

(c)

0153010

Blackberries

0,05  (*1)

0153020

Dewberries (Loganberries, boysenberries, and cloudberries)

0,05  (*1)

0153030

Raspberries (Wineberries, arctic bramble/raspberry, (Rubus arcticus), nectar raspberries (Rubus arcticus x idaeus))

0,8 (+)

0153990

Others

0,05  (*1)

0154000

| (d) | Other small fruit & berries |
| --- | --- |

(d)

0154010

Blueberries (Bilberries)

0,2 (+)

0154020

Cranberries (Cowberries (red bilberries))

0,05  (*1)

0154030

Currants (red, black and white)

0,05  (*1)

0154040

Gooseberries (Including hybrids with other ribes species)

0,05  (*1)

0154050

Rose hips

0,05  (*1)

0154060

Mulberries (arbutus berry)

0,05  (*1)

0154070

Azarole (mediteranean medlar) (Kiwiberry (Actinidia arguta))

0,05  (*1)

0154080

Elderberries (Black chokeberry (appleberry), mountain ash, buckthorn (sea sallowthorn), hawthorn, service berries, and other treeberries)

0,05  (*1)

0154990

Others

0,05  (*1)

0160000

| (vi) | Miscellaneous fruit |
| --- | --- |

(vi)

0,05  (*1)

0161000

| (a) | Edible peel |
| --- | --- |

(a)

0161010

Dates

0161020

Figs

0161030

Table olives

0161040

Kumquats (Marumi kumquats, nagami kumquats, limequats (Citrus aurantifolia x Fortunella spp.))

0161050

Carambola (Bilimbi)

0161060

Persimmon

0161070

Jambolan (java plum) (Java apple (water apple), pomerac, rose apple, Brazilean cherry Surinam cherry (grumichama Eugenia uniflora),)

0161990

Others

0162000

| (b) | Inedible peel, small |
| --- | --- |

(b)

0162010

Kiwi

0162020

Lychee (Litchi) (Pulasan, rambutan (hairy litchi), mangosteen)

0162030

Passion fruit

0162040

Prickly pear (cactus fruit)

0162050

Star apple

0162060

American persimmon (Virginia kaki) (Black sapote, white sapote, green sapote, canistel (yellow sapote), and mammey sapote)

0162990

Others

0163000

| (c) | Inedible peel, large |
| --- | --- |

(c)

0163010

Avocados

0163020

Bananas (Dwarf banana, plantain, apple banana)

0163030

Mangoes

0163040

Papaya

0163050

Pomegranate

0163060

Cherimoya (Custard apple, sugar apple (sweetsop), llama and other medium sized Annonaceae)

0163070

Guava (Red pitaya or dragon fruit (Hylocereus undatus))

0163080

Pineapples

0163090

Bread fruit (Jackfruit)

0163100

Durian

0163110

Soursop (guanabana)

0163990

Others

0200000

| 2. | VEGETABLES FRESH OR FROZEN |
| --- | --- |

2.

0210000

| (i) | Root and tuber vegetables |
| --- | --- |

(i)

0,05  (*1)

0211000

| (a) | Potatoes |
| --- | --- |

(a)

0212000

| (b) | Tropical root and tuber vegetables |
| --- | --- |

(b)

0212010

Cassava (Dasheen, eddoe (Japanese taro), tannia)

0212020

Sweet potatoes

0212030

Yams (Potato bean (yam bean), Mexican yam bean)

0212040

Arrowroot

0212990

Others

0213000

| (c) | Other root and tuber vegetables except sugar beet |
| --- | --- |

(c)

0213010

Beetroot

0213020

Carrots

0213030

Celeriac

0213040

Horseradish (Angelica roots, lovage roots, gentiana roots,)

0213050

Jerusalem artichokes

0213060

Parsnips

0213070

Parsley root

0213080

Radishes (Black radish, Japanese radish, small radish and similar varieties, tiger nut (Cyperus esculentus))

0213090

Salsify (Scorzonera, Spanish salsify (Spanish oysterplant))

0213100

Swedes

0213110

Turnips

0213990

Others

0220000

| (ii) | Bulb vegetables |
| --- | --- |

(ii)

0,05  (*1)

0220010

Garlic

0220020

Onions (Silverskin onions)

0220030

Shallots

0220040

Spring onions (Welsh onion and similar varieties)

0220990

Others

0230000

| (iii) | Fruiting vegetables |
| --- | --- |

(iii)

0231000

| (a) | Solanacea |
| --- | --- |

(a)

0,5

0231010

Tomatoes (Cherry tomatoes, tree tomato, Physalis, gojiberry, wolfberry (Lycium barbarum and L. chinense))

0231020

Peppers (Chilli peppers)

0231030

Aubergines (egg plants) (Pepino)

0231040

Okra, lady's fingers

0231990

Others

0232000

| (b) | Cucurbits - edible peel |
| --- | --- |

(b)

0,2

0232010

Cucumbers

0232020

Gherkins

0232030

Courgettes (Summer squash, marrow (patisson))

0232990

Others

0233000

| (c) | Cucurbits-inedible peel |
| --- | --- |

(c)

0,05  (*1)

0233010

Melons (Kiwano)

0233020

Pumpkins (Winter squash)

0233030

Watermelons

0233990

Others

0234000

| (d) | Sweet corn |
| --- | --- |

(d)

0,05  (*1)

0239000

| (e) | Other fruiting vegetables |
| --- | --- |

(e)

0,05  (*1)

0240000

| (iv) | Brassica vegetables |
| --- | --- |

(iv)

0,05  (*1)

0241000

| (a) | Flowering brassica |
| --- | --- |

(a)

0241010

Broccoli (Calabrese, Chinese broccoli, broccoli raab)

0241020

Cauliflower

0241990

Others

0242000

| (b) | Head brassica |
| --- | --- |

(b)

0242010

Brussels sprouts

0242020

Head cabbage (Pointed head cabbage, red cabbage, savoy cabbage, white cabbage)

0242990

Others

0243000

| (c) | Leafy brassica |
| --- | --- |

(c)

0243010

Chinese cabbage (Indian (Chinese) mustard, pak choi, Chinese flat cabbage (tai goo choi), choi sum, peking cabbage (pe-tsai),)

0243020

Kale (Borecole (curly kale), collards, Portuguese Kale, Portuguese cabbage, cow cabbage)

0243990

Others

0244000

| (d) | Kohlrabi |
| --- | --- |

(d)

0250000

| (v) | Leaf vegetables & fresh herbs |
| --- | --- |

(v)

0251000

| (a) | Lettuce and other salad plants including Brassicacea |
| --- | --- |

(a)

0251010

Lamb's lettuce (Italian cornsalad)

0,05  (*1)

0251020

Lettuce (Head lettuce, lollo rosso (cutting lettuce), iceberg lettuce, romaine (cos) lettuce)

10

0251030

Scarole (broad-leaf endive) (Wild chicory, red-leaved chicory, radicchio, curld leave endive, sugar loaf)

0,05  (*1)

0251040

Cress

0,05  (*1)

0251050

Land cress

0,05  (*1)

0251060

Rocket, Rucola (Wild rocket)

0,05  (*1)

0251070

Red mustard

0,05  (*1)

0251080

Leaves and sprouts of Brassica spp (Mizuna, leaves of peas and radish and other babyleaf brassica crops (crops harvested up to 8 true leaf stage))

0,05  (*1)

0251990

Others

0,05  (*1)

0252000

| (b) | Spinach & similar (leaves) |
| --- | --- |

(b)

0,05  (*1)

0252010

Spinach (New Zealand spinach, amaranthus spinach)

0252020

Purslane (Winter purslane (miner’s lettuce), garden purslane, common purslane, sorrel, glassworth, Agretti (Salsola soda))

0252030

Beet leaves (chard) (Leaves of beetroot)

0252990

Others

0253000

| (c) | Vine leaves (grape leaves) |
| --- | --- |

(c)

0,05  (*1)

0254000

| (d) | Water cress |
| --- | --- |

(d)

0,05  (*1)

0255000

| (e) | Witloof |
| --- | --- |

(e)

0,05  (*1)

0256000

| (f) | Herbs |
| --- | --- |

(f)

0,05  (*1)

0256010

Chervil

0256020

Chives

0256030

Celery leaves (Fennel leaves, Coriander leaves, dill leaves, Caraway leaves, lovage, angelica, sweet cisely and other Apiacea leaves)

0256040

Parsley

0256050

Sage (Winter savory, summer savory,)

0256060

Rosemary

0256070

Thyme (Marjoram, oregano)

0256080

Basil (Balm leaves, mint, peppermint)

0256090

Bay leaves (laurel)

0256100

Tarragon (Hyssop)

0256990

Others (Edible flowers)

0260000

| (vi) | Legume vegetables (fresh) |
| --- | --- |

(vi)

0260010

Beans (with pods) (Green bean (french beans, snap beans), scarlet runner bean, slicing bean, yardlong beans)

0,1

0260020

Beans (without pods) (Broad beans, Flageolets, jack bean, lima bean, cowpea)

0,05  (*1)

0260030

Peas (with pods) (Mangetout (sugar peas, snow peas))

0,1

0260040

Peas (without pods) (Garden pea, green pea, chickpea)

0,05  (*1)

0260050

Lentils

0,05  (*1)

0260990

Others

0,05  (*1)

0270000

| (vii) | Stem vegetables (fresh) |
| --- | --- |

(vii)

0,05  (*1)

0270010

Asparagus

0270020

Cardoons

0270030

Celery

0270040

Fennel

0270050

Globe artichokes

0270060

Leek

0270070

Rhubarb

0270080

Bamboo shoots

0270090

Palm hearts

0270990

Others

0280000

| (viii) | Fungi |
| --- | --- |

(viii)

0,05  (*1)

0280010

Cultivated (Common mushroom, Oyster mushroom, Shi-take)

0280020

Wild (Chanterelle, Truffle, Morel, Cep)

0280990

Others

0290000

| (ix) | Sea weeds |
| --- | --- |

(ix)

0,05  (*1)

0300000

| 3. | PULSES, DRY |
| --- | --- |

3.

0,05  (*1)

0300010

Beans (Broad beans, navy beans, flageolets, jack beans, lima beans, field beans, cowpeas)

0300020

Lentils

0300030

Peas (Chickpeas, field peas, chickling vetch)

0300040

Lupins

0300990

Others

0400000

| 4. | OILSEEDS AND OILFRUITS |
| --- | --- |

4.

0,05  (*1)

0401000

| (i) | Oilseeds |
| --- | --- |

(i)

0401010

Linseed

0401020

Peanuts

0401030

Poppy seed

0401040

Sesame seed

0401050

Sunflower seed

0401060

Rape seed (Bird rapeseed, turnip rape)

0401070

Soya bean

0401080

Mustard seed

0401090

Cotton seed

0401100

Pumpkin seeds (Other seeds of cucurbitacea)

0401110

Safflower

0401120

Borage

0401130

Gold of pleasure

0401140

Hempseed

0401150

Castor bean

0401990

Others

0402000

| (ii) | Oilfruits |
| --- | --- |

(ii)

0402010

Olives for oil production

0402020

Palm nuts (palmoil kernels)

0402030

Palmfruit

0402040

Kapok

0402990

Others

0500000

| 5. | CEREALS |
| --- | --- |

5.

0,05  (*1)

0500010

Barley

0500020

Buckwheat (Amaranthus, quinoa)

0500030

Maize

0500040

Millet (Foxtail millet, teff)

0500050

Oats

0500060

Rice

0500070

Rye

0500080

Sorghum

0500090

Wheat (Spelt, triticale)

0500990

Others

0600000

| 6. | TEA, COFFEE, HERBAL INFUSIONS AND COCOA |
| --- | --- |

6.

0,1  (*1)

0610000

| (i) | Tea (dried leaves and stalks, fermented or otherwise of Camellia sinensis) |
| --- | --- |

(i)

0620000

| (ii) | Coffee beans |
| --- | --- |

(ii)

0630000

| (iii) | Herbal infusions (dried) |
| --- | --- |

(iii)

0631000

| (a) | Flowers |
| --- | --- |

(a)

0631010

Camomille flowers

0631020

Hybiscus flowers

0631030

Rose petals

0631040

Jasmine flowers (Elderflowers (Sambucus nigra))

0631050

Lime (linden)

0631990

Others

0632000

| (b) | Leaves |
| --- | --- |

(b)

0632010

Strawberry leaves

0632020

Rooibos leaves (Ginkgo leaves)

0632030

Maté

0632990

Others

0633000

| (c) | Roots |
| --- | --- |

(c)

0633010

Valerian root

0633020

Ginseng root

0633990

Others

0639000

| (d) | Other herbal infusions |
| --- | --- |

(d)

0640000

| (iv) | Cocoa (fermented beans) |
| --- | --- |

(iv)

0650000

| (v) | Carob (st johns bread) |
| --- | --- |

(v)

0700000

| 7. | HOPS (dried), including hop pellets and unconcentrated powder |
| --- | --- |

7.

0,1  (*1)

0800000

| 8. | SPICES |
| --- | --- |

8.

0,1  (*1)

0810000

| (i) | Seeds |
| --- | --- |

(i)

0810010

Anise

0810020

Black caraway

0810030

Celery seed (Lovage seed)

0810040

Coriander seed

0810050

Cumin seed

0810060

Dill seed

0810070

Fennel seed

0810080

Fenugreek

0810090

Nutmeg

0810990

Others

0820000

| (ii) | Fruits and berries |
| --- | --- |

(ii)

0820010

Allspice

0820020

Anise pepper (Japan pepper)

0820030

Caraway

0820040

Cardamom

0820050

Juniper berries

0820060

Pepper, black and white (Long pepper, pink pepper)

0820070

Vanilla pods

0820080

Tamarind

0820990

Others

0830000

| (iii) | Bark |
| --- | --- |

(iii)

0830010

Cinnamon (Cassia)

0830990

Others

0840000

| (iv) | Roots or rhizome |
| --- | --- |

(iv)

0840010

Liquorice

0840020

Ginger

0840030

Turmeric (Curcuma)

0840040

Horseradish

0840990

Others

0850000

| (v) | Buds |
| --- | --- |

(v)

0850010

Cloves

0850020

Capers

0850990

Others

0860000

| (vi) | Flower stigma |
| --- | --- |

(vi)

0860010

Saffron

0860990

Others

0870000

| (vii) | Aril |
| --- | --- |

(vii)

0870010

Mace

0870990

Others

0900000

| 9. | SUGAR PLANTS |
| --- | --- |

9.

0,05  (*1)

0900010

Sugar beet (root)

0900020

Sugar cane

0900030

Chicory roots

0900990

Others

1000000

| 10. | PRODUCTS OF ANIMAL ORIGIN-TERRESTRIAL ANIMALS |
| --- | --- |

10.

1010000

| (i) | Meat, preparations of meat, offals, blood, animal fats fresh chilled or frozen, salted, in brine, dried or smoked or processed as flours or meals other processed products such as sausages and food preparations based on these |
| --- | --- |

(i)

1011000

| (a) | Swine |
| --- | --- |

(a)

1011010

Meat

0,2

1011020

Fat free of lean meat

0,01  (*1)

1011030

Liver

0,01  (*1)

1011040

Kidney

0,01  (*1)

1011050

Edible offal

0,01  (*1)

1011990

Others

0,01  (*1)

1012000

| (b) | Bovine |
| --- | --- |

(b)

1012010

Meat

0,2

1012020

Fat

0,01  (*1)

1012030

Liver

0,01  (*1)

1012040

Kidney

0,01  (*1)

1012050

Edible offal

0,01  (*1)

1012990

Others

0,01  (*1)

1013000

| (c) | Sheep |
| --- | --- |

(c)

1013010

Meat

0,2

1013020

Fat

0,01  (*1)

1013030

Liver

0,01  (*1)

1013040

Kidney

0,01  (*1)

1013050

Edible offal

0,01  (*1)

1013990

Others

0,01  (*1)

1014000

| (d) | Goat |
| --- | --- |

(d)

1014010

Meat

0,2

1014020

Fat

0,01  (*1)

1014030

Liver

0,01  (*1)

1014040

Kidney

0,01  (*1)

1014050

Edible offal

0,01  (*1)

1014990

Others

0,01  (*1)

1015000

| (e) | Horses, asses, mules or hinnies |
| --- | --- |

(e)

1015010

Meat

0,2

1015020

Fat

0,01  (*1)

1015030

Liver

0,01  (*1)

1015040

Kidney

0,01  (*1)

1015050

Edible offal

0,01  (*1)

1015990

Others

0,01  (*1)

1016000

| (f) | Poultry -chicken, geese, duck, turkey and Guinea fowl-, ostrich, pigeon |
| --- | --- |

(f)

0,01  (*1)

1016010

Meat

1016020

Fat

1016030

Liver

1016040

Kidney

1016050

Edible offal

1016990

Others

1017000

| (g) | Other farm animals (Rabbit, Kangaroo) |
| --- | --- |

(g)

1017010

Meat

0,2

1017020

Fat

0,01  (*1)

1017030

Liver

0,01  (*1)

1017040

Kidney

0,01  (*1)

1017050

Edible offal

0,01  (*1)

1017990

Others

0,01  (*1)

1020000

| (ii) | Milk and cream, not concentrated, nor containing added sugar or sweetening matter, butter and other fats derived from milk, cheese and curd |
| --- | --- |

(ii)

0,01  (*1)

1020010

Cattle

1020020

Sheep

1020030

Goat

1020040

Horse

1020990

Others

1030000

| (iii) | Birds' eggs, fresh preserved or cooked Shelled eggs and egg yolks fresh, dried, cooked by steaming or boiling in water, moulded, frozen or otherwise preserved whether or not containing added sugar or sweetening matter |
| --- | --- |

(iii)

0,01  (*1)

1030010

Chicken

1030020

Duck

1030030

Goose

1030040

Quail

1030990

Others

1040000

| (iv) | Honey (Royal jelly, pollen) |
| --- | --- |

(iv)

0,01  (*1)

1050000

| (v) | Amphibians and reptiles (Frog legs, crocodiles) |
| --- | --- |

(v)

0,01  (*1)

1060000

| (vi) | Snails |
| --- | --- |

(vi)

0,01  (*1)

1070000

| (vii) | Other terrestrial animal products |
| --- | --- |

(vii)

0,01  (*1)

Spinetoram (XDE-175)

| (+) | MRL applicable until 31 December 2014, after that date 0,05 () will be applicable unless modified by a Regulation. Detailed information on supervised field trials to be submitted to the Authority and the European Commission by 30 June 2013 at the latest. Reassessment of data may lead to modification of the MRL.









  0140020 | Cherries (sweet cherries, sour cherries) |
| --- | --- | --- |
| 0153030 | Raspberries (Wineberries, arctic bramble/raspberry, (Rubus arcticus), nectar raspberries (Rubus arcticus x idaeus)) |
| 0154010 | Blueberries (Bilberries)’ |

(+)

MRL applicable until 31 December 2014, after that date 0,05 () will be applicable unless modified by a Regulation. Detailed information on supervised field trials to be submitted to the Authority and the European Commission by 30 June 2013 at the latest. Reassessment of data may lead to modification of the MRL.

0140020

Cherries (sweet cherries, sour cherries)

0153030

Raspberries (Wineberries, arctic bramble/raspberry, (Rubus arcticus), nectar raspberries (Rubus arcticus x idaeus))

0154010

Blueberries (Bilberries)’

---

(1)  For the complete list of products of plant and animal origin to which MRLs apply, reference should be made to Annex I.

1

(*1)  Indicates lower limit of analytical determination

*1

---

| 5.6.2012 | EN | Official Journal of the European Union | L 144/39 |
| --- | --- | --- | --- |

5.6.2012

EN

Official Journal of the European Union

L 144/39

---

COMMISSION IMPLEMENTING REGULATION (EU) No 474/2012

of 4 June 2012

establishing the standard import values for determining the entry price of certain fruit and vegetables

THE EUROPEAN COMMISSION,

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

Having regard to Council Regulation (EC) No 1234/2007 of 22 October 2007 establishing a common organisation of agricultural markets and on specific provisions for certain agricultural products (Single CMO Regulation) (1),

Having regard to Commission Implementing Regulation (EU) No 543/2011 of 7 June 2011 laying down detailed rules for the application of Council Regulation (EC) No 1234/2007 in respect of the fruit and vegetables and processed fruit and vegetables sectors (2), and in particular Article 136(1) thereof,

Whereas:

| (1) | Implementing Regulation (EU) No 543/2011 lays down, pursuant to the outcome of the Uruguay Round multilateral trade negotiations, the criteria whereby the Commission fixes the standard values for imports from third countries, in respect of the products and periods stipulated in Annex XVI, Part A thereto. |
| --- | --- |

(1)

Implementing Regulation (EU) No 543/2011 lays down, pursuant to the outcome of the Uruguay Round multilateral trade negotiations, the criteria whereby the Commission fixes the standard values for imports from third countries, in respect of the products and periods stipulated in Annex XVI, Part A thereto.

| (2) | The standard import value is calculated each working day, in accordance with Article 136(1) of Implementing Regulation (EU) No 543/2011, taking into account variable daily data. Therefore this Regulation should enter into force on the day of its publication in the Official Journal of the European Union, |
| --- | --- |

(2)

The standard import value is calculated each working day, in accordance with Article 136(1) of Implementing Regulation (EU) No 543/2011, taking into account variable daily data. Therefore this Regulation should enter into force on the day of its publication in the Official Journal of the European Union,

HAS ADOPTED THIS REGULATION:

Article 1

The standard import values referred to in Article 136 of Implementing Regulation (EU) No 543/2011 are fixed in the Annex to this Regulation.

Article 2

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

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

Done at Brussels, 4 June 2012.

For the Commission, On behalf of the President,

José Manuel SILVA RODRÍGUEZ

Director-General for Agriculture and Rural Development

---

(1)  
  OJ L 299, 16.11.2007, p. 1.

1

(2)  
  OJ L 157, 15.6.2011, p. 1.

2

---

ANNEX

Standard import values for determining the entry price of certain fruit and vegetables

| (EUR/100 kg) |
| --- |
| CN code | Third country code (1) | Standard import value |
| 0702 00 00 | AL | 87,5 |
| MA | 66,7 |
| TR | 71,1 |
| ZZ | 75,1 |
| 0707 00 05 | MK | 43,6 |
| TR | 113,3 |
| ZZ | 78,5 |
| 0709 93 10 | TR | 99,6 |
| ZZ | 99,6 |
| 0805 50 10 | BO | 105,2 |
| TR | 110,6 |
| ZA | 134,9 |
| ZZ | 116,9 |
| 0808 10 80 | AR | 105,1 |
| BR | 85,9 |
| CA | 161,4 |
| CH | 86,1 |
| CL | 99,2 |
| CN | 87,3 |
| NZ | 122,7 |
| US | 189,2 |
| UY | 67,3 |
| ZA | 93,7 |
| ZZ | 109,8 |
| 0809 10 00 | TR | 230,4 |
| ZZ | 230,4 |
| 0809 29 00 | TR | 476,3 |
| US | 577,9 |
| ZZ | 527,1 |

(EUR/100 kg)

CN code

Third country code (1)

Standard import value

0702 00 00

AL

87,5

MA

66,7

TR

71,1

ZZ

75,1

0707 00 05

MK

43,6

TR

113,3

ZZ

78,5

0709 93 10

TR

99,6

ZZ

99,6

0805 50 10

BO

105,2

TR

110,6

ZA

134,9

ZZ

116,9

0808 10 80

AR

105,1

BR

85,9

CA

161,4

CH

86,1

CL

99,2

CN

87,3

NZ

122,7

US

189,2

UY

67,3

ZA

93,7

ZZ

109,8

0809 10 00

TR

230,4

ZZ

230,4

0809 29 00

TR

476,3

US

577,9

ZZ

527,1

---

(1)  Nomenclature of countries laid down by Commission Regulation (EC) No 1833/2006 (OJ L 354, 14.12.2006, p. 19). Code ‘
  ZZ
  ’ stands for ‘of other origin’.

---

DECISIONS

| 5.6.2012 | EN | Official Journal of the European Union | L 144/41 |
| --- | --- | --- | --- |

5.6.2012

EN

Official Journal of the European Union

L 144/41

---

COMMISSION IMPLEMENTING DECISION

of 1 June 2012

authorising the placing on the market of Gamma-Cyclodextrin as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council

(notified under document C(2012) 3496)

(Only the German text is authentic)

(2012/288/EU)

THE EUROPEAN COMMISSION,

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

Having regard to Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients (1), and in particular Article 7 thereof,

Whereas:

| (1) | On 26 February 2010 the company Wacker Chemie GmbH made a request to the competent authorities of Ireland to place γ-Cyclodextrin on the market as novel food ingredient. Gamma-Cyclodextrin is a digestible carbohydrate to be added to foods. |
| --- | --- |

(1)

On 26 February 2010 the company Wacker Chemie GmbH made a request to the competent authorities of Ireland to place γ-Cyclodextrin on the market as novel food ingredient. Gamma-Cyclodextrin is a digestible carbohydrate to be added to foods.

| (2) | On 9 July 2010 the competent food assessment body of Ireland issued its initial assessment report. In this report it came to the conclusion that the company Wacker Chemie GmbH had provided sufficient information to authorise the placing on the market of γ-Cyclodextrin as a novel food ingredient. |
| --- | --- |

(2)

On 9 July 2010 the competent food assessment body of Ireland issued its initial assessment report. In this report it came to the conclusion that the company Wacker Chemie GmbH had provided sufficient information to authorise the placing on the market of γ-Cyclodextrin as a novel food ingredient.

| (3) | The Commission forwarded the initial assessment report to all Member States on 19 July 2010. |
| --- | --- |

(3)

The Commission forwarded the initial assessment report to all Member States on 19 July 2010.

| (4) | Within the 60-day period laid down in Article 6(4) of Regulation (EC) No 258/97 reasoned objections were raised in accordance with that provision. In particular, objections which concerned the absorption of fat soluble vitamins were raised. In accordance with the provisions of Article 7(1) a Commission Implementing Decision is required that takes into account the objections raised. Additional explanations by the applicant alleviated these concerns to the satisfaction of Member States and the Commission. |
| --- | --- |

(4)

Within the 60-day period laid down in Article 6(4) of Regulation (EC) No 258/97 reasoned objections were raised in accordance with that provision. In particular, objections which concerned the absorption of fat soluble vitamins were raised. In accordance with the provisions of Article 7(1) a Commission Implementing Decision is required that takes into account the objections raised. Additional explanations by the applicant alleviated these concerns to the satisfaction of Member States and the Commission.

| (5) | The intentional addition of γ-Cyclodextrin to food for technological purposes falls within the scope of Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives (2) and should be authorised in accordance with that regulation. |
| --- | --- |

(5)

The intentional addition of γ-Cyclodextrin to food for technological purposes falls within the scope of Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives (2) and should be authorised in accordance with that regulation.

| (6) | The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, |
| --- | --- |

(6)

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

Gamma-Cyclodextrin as specified in the Annex may be placed on the market as a novel food ingredient.

Article 2

The designation of γ-Cyclodextrin authorised by this Decision on the labelling of the foodstuffs containing it shall be ‘Gamma-Cyclodextrin’ or ‘γ-Cyclodextrin’.

Article 3

This Decision is addressed to Wacker Chemie AG, Hanns Seidel Platz 4, 81737 München, Germany.

Done at Brussels, 1 June 2012.

For the Commission

John DALLI

Member of the Commission

---

(1)  
  OJ L 43, 14.2.1997, p. 1.

1

(2)  
  OJ L 354, 31.12.2008, p. 16.

2

---

ANNEX

SPECIFICATIONS OF γ-CYCLODEXTRIN

Synonyms

γ-cyclodextrin, γ-dextrin, cyclooctaamylose, cyclomaltooctaose, γ-cycloamylase

Definition

A non-reducing cyclic saccharide consisting of eight α-1,4-linked D-glucopyranosyl units produced by the action of cyclodextrin glucosyltransferase (CGTase, EC 2.4.1.19) on hydrolysed starch. Recovery and purification of γ-cyclodextrin may be carried out by precipitation of a complex of γ-cyclodextrin with 8-cyclohexadecen-1-one, dissolution of the complex with water and n-decane, steam-stripping of the aqueous phase and recovery of gamma-CD from the solution by crystallisation.

| Chemical name | Cyclooctaamylose |
| --- | --- |
| CAS number | 17465-86-0 |
| Chemical formula | (C6H10O5)8 |
| Structural formula | |
| Assay | Not less than 98 % (dry basis) |
| Description | Virtually odourless, white or almost white crystalline solid |

Chemical name

Cyclooctaamylose

CAS number

17465-86-0

Chemical formula

(C6H10O5)8

Structural formula

Image 12

Assay

Not less than 98 % (dry basis)

Description

Virtually odourless, white or almost white crystalline solid

Characteristics

Identification

| Melting range | Decomposes above 285 °C |
| --- | --- |
| Solubility | Freely soluble in water; very slightly soluble in ethanol |
| Specific rotation | [α]D
  25: between + 174° and + 180° (1 % solution) |

Melting range

Decomposes above 285 °C

Solubility

Freely soluble in water; very slightly soluble in ethanol

Specific rotation

[α]D
  25: between + 174° and + 180° (1 % solution)

Purity

| Water | Not more than 11 % |
| --- | --- |
| Residual complexant (8-cyclohexadecen-1-one (CHDC) | Not more than 4 mg/kg |
| Residual solvent (n-decane) | Not more than 6 mg/kg |
| Reducing substances | Not more than 0,5 % (as glucose) |
| Sulphated ash | Not more than 0,1 % |

Water

Not more than 11 %

Residual complexant (8-cyclohexadecen-1-one (CHDC)

Not more than 4 mg/kg

Residual solvent (n-decane)

Not more than 6 mg/kg

Reducing substances

Not more than 0,5 % (as glucose)

Sulphated ash

Not more than 0,1 %

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| 5.6.2012 | EN | Official Journal of the European Union | L 144/43 |
| --- | --- | --- | --- |

5.6.2012

EN

Official Journal of the European Union

L 144/43

---

COMMISSION DECISION

of 4 June 2012

terminating the anti-dumping proceeding concerning imports of tartaric acid originating in the People’s Republic of China, limited to one Chinese exporting producer, Hangzhou Bioking Biochemical Engineering Co. Ltd

(2012/289/EU)

THE EUROPEAN COMMISSION,

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

Having regard to Council Regulation (EC) No 1225/2009 of 30 November 2009 on protection against dumped imports from countries not members of the European Community (1) (‘the basic Regulation’), and in particular Article 9 thereof,

After consulting the Advisory Committee,

Whereas:

A.   PROCEDURE

PROCEDURE

| (1) | On 15 June 2011 the European Commission (‘Commission’) received a complaint concerning the alleged injurious dumping concerning imports of tartaric acid originating in the People’s Republic of China limited to one Chinese exporting producer, Hangzhou Bioking Biochemical Engineering Co. Ltd (‘the company concerned’). |
| --- | --- |

(1)

On 15 June 2011 the European Commission (‘Commission’) received a complaint concerning the alleged injurious dumping concerning imports of tartaric acid originating in the People’s Republic of China limited to one Chinese exporting producer, Hangzhou Bioking Biochemical Engineering Co. Ltd (‘the company concerned’).

| (2) | The complaint was lodged by the following producers (the complainants): Distillerie Bonollo SpA, Industria Chimica Valenzana SpA, Distillerie Mazzari SpA, Caviro Distillerie SRL and Comercial Quimica Sarasa SL representing a major proportion, in this case more than 50 % of the total Union production of tartaric acid. |
| --- | --- |

(2)

The complaint was lodged by the following producers (the complainants): Distillerie Bonollo SpA, Industria Chimica Valenzana SpA, Distillerie Mazzari SpA, Caviro Distillerie SRL and Comercial Quimica Sarasa SL representing a major proportion, in this case more than 50 % of the total Union production of tartaric acid.

| (3) | The complaint contained prima facie evidence of the existence of dumping and of material injury resulting from the dumped imports, which was considered sufficient to justify the initiation of an anti-dumping proceeding. |
| --- | --- |

(3)

The complaint contained prima facie evidence of the existence of dumping and of material injury resulting from the dumped imports, which was considered sufficient to justify the initiation of an anti-dumping proceeding.

prima facie

| (4) | The Commission, after consultation of the Advisory Committee, in a notice published in the Official Journal of the European Union (2), initiated an anti-dumping proceeding concerning imports of tartaric acid originating in the People’s Republic of China limited to one Chinese exporting producer, Hangzhou Bioking Biochemical Engineering Co. Ltd (‘the company concerned’). |
| --- | --- |

(4)

The Commission, after consultation of the Advisory Committee, in a notice published in the Official Journal of the European Union (2), initiated an anti-dumping proceeding concerning imports of tartaric acid originating in the People’s Republic of China limited to one Chinese exporting producer, Hangzhou Bioking Biochemical Engineering Co. Ltd (‘the company concerned’).

Official Journal of the European Union

2

| (5) | The Commission sent questionnaires to the Union industry, to the exporting producer in the People’s Republic of China, to the importers, and to the authorities of the People’s Republic of China. Interested parties were given the opportunity to make their views known in writing and to request a hearing within the time limit set out in the notice of initiation. |
| --- | --- |

(5)

The Commission sent questionnaires to the Union industry, to the exporting producer in the People’s Republic of China, to the importers, and to the authorities of the People’s Republic of China. Interested parties were given the opportunity to make their views known in writing and to request a hearing within the time limit set out in the notice of initiation.

| (6) | All interested parties who so requested and showed that there were particular reasons why they should be heard were granted a hearing. |
| --- | --- |

(6)

All interested parties who so requested and showed that there were particular reasons why they should be heard were granted a hearing.

B.   WITHDRAWAL OF THE COMPLAINT AND TERMINATION OF THE PROCEEDING

WITHDRAWAL OF THE COMPLAINT AND TERMINATION OF THE PROCEEDING

| (7) | By letter of 14 February 2012 to the Commission, the complainants formally withdrew their complaint. |
| --- | --- |

(7)

By letter of 14 February 2012 to the Commission, the complainants formally withdrew their complaint.

| (8) | In accordance with Article 9(1) of the basic Regulation, the proceeding may be terminated where the complaint is withdrawn, unless such termination would not be in the Union interest. |
| --- | --- |

(8)

In accordance with Article 9(1) of the basic Regulation, the proceeding may be terminated where the complaint is withdrawn, unless such termination would not be in the Union interest.

| (9) | The Commission considered that the present proceeding should be terminated since the investigation had not brought to light any reasons or considerations showing that such termination would not be in the Union interest. |
| --- | --- |

(9)

The Commission considered that the present proceeding should be terminated since the investigation had not brought to light any reasons or considerations showing that such termination would not be in the Union interest.

| (10) | Interested parties were informed accordingly and were given the opportunity to comment. No comments were received indicating that such a termination would not be in the Union interest. |
| --- | --- |

(10)

Interested parties were informed accordingly and were given the opportunity to comment. No comments were received indicating that such a termination would not be in the Union interest.

| (11) | The Commission therefore concludes that the anti-dumping proceeding concerning imports into the Union of tartaric acid originating in the People’s Republic of China should be terminated without the imposition of measures, |
| --- | --- |

(11)

The Commission therefore concludes that the anti-dumping proceeding concerning imports into the Union of tartaric acid originating in the People’s Republic of China should be terminated without the imposition of measures,

HAS ADOPTED THIS DECISION:

Article 1

The anti-dumping proceeding concerning imports of tartaric acid currently falling within CN Code ex 2918 12 00, originating in the People’s Republic of China limited to one Chinese exporting producer, Hangzhou Bioking Biochemical Engineering Co. Ltd, is hereby terminated.

Article 2

This Decision shall enter into force on the day following that of its publication in the Official Journal of the European Union.

Done at Brussels, 4 June 2012.

For the Commission

The President

José Manuel BARROSO

---

(1)  
  OJ L 343, 22.12.2009, p. 51.

1

(2)  
  OJ C 223, 29.7.2011, p. 11.

2

---

ACTS ADOPTED BY BODIES CREATED BY INTERNATIONAL AGREEMENTS

| 5.6.2012 | EN | Official Journal of the European Union | L 144/44 |
| --- | --- | --- | --- |

5.6.2012

EN

Official Journal of the European Union

L 144/44

---

DECISION OF THE US-EU JOINT CUSTOMS COOPERATION COMMITTEE

of 4 May 2012

regarding mutual recognition of the Customs-Trade Partnership Against Terrorism program in the United States and the Authorised Economic Operators programme of the European Union

(2012/290/EU)

THE US-EU JOINT CUSTOMS COOPERATION COMMITTEE (hereinafter referred to as the ‘JCCC’),

Having regard to the Agreement between the European Community and the United States of America on Customs Cooperation and Mutual Assistance in Customs Matters of 28 May 1997 (hereinafter referred to as the ‘CMAA’), and in particular Article 22(2)(c) thereof,

Considering the Agreement between the European Community and the United States of America on intensifying and broadening the CMAA to include cooperation on container security and related matters concluded on 28 April 2004,

Considering the need to further develop transatlantic cooperation and secure trade, particularly in accordance with the World Customs Organisation 2011 Framework of Standards to Secure and Facilitate Global Trade (hereinafter referred to as the ‘SAFE Framework’), as it may be amended with the concurrence of the European Union and the United States,

Recognising that the United States of America (hereinafter referred to as the ‘US’) and the European Union (hereinafter referred to as the ‘EU’) consider that customs security and safety, and the facilitation of the international trade supply chain, can be significantly enhanced through mutual recognition of their respective trade partnership programmes (hereinafter referred to as the ‘trade partnership programmes’); the Customs-Trade Partnership against Terrorism (hereinafter referred to as the ‘C-TPAT’) and Authorised Economic Operator (hereinafter referred to as the ‘AEO’),

Affirming that the C-TPAT and AEO programmes operate within the context of the SAFE Framework,

Acknowledging that mutual recognition allows the US and the EU to facilitate trade of operators who have invested in supply chain security and have been granted membership in either C-TPAT or AEO,

Recognising that examination of the C-TPAT and AEO programmes revealed that their qualification standards for membership are compatible,

Affirming that this Decision does not constitute a precedent for any future agreements or arrangements between the US and the EU, particularly with regard to the processing or use and transfer of personal data or information or data protection or privacy,

HAS DECIDED AS FOLLOWS:

Section I

Mutual recognition and responsibility for implementation

| 1. | The trade partnership programmes of the EU and the US are mutually recognised to be compatible and members of each programme are treated in a manner consistent with Section III. |
| --- | --- |

1.

| 2. | The customs authorities defined in Article 1(b) of the CMAA (hereinafter referred to as ‘customs authorities’) are responsible for the implementation of this Decision. |
| --- | --- |

2.

| 3. | The trade partnership programmes concerned are:






  (a) | the European Union Authorised Economic Operator (security and safety or customs simplifications/security and safety)
  (Council Regulation (EEC) No 2913/92 (1) and Commission Regulation (EEC) No 2454/93 (2), as amended by Regulation (EC) No 648/2005 of the European Parliament and of the Council (3) and Title IIA of Commission Regulation (EC) No 1875/2006 (4)); and |
| --- | --- | --- |

3.

(a)

the European Union Authorised Economic Operator (security and safety or customs simplifications/security and safety)

(Council Regulation (EEC) No 2913/92 (1) and Commission Regulation (EEC) No 2454/93 (2), as amended by Regulation (EC) No 648/2005 of the European Parliament and of the Council (3) and Title IIA of Commission Regulation (EC) No 1875/2006 (4)); and

| (b) | the US Customs-Trade Partnership Against Terrorism (tier two and tier three levels) (Security and Accountability for Every (‘SAFE’) Ports Act of 2006). |
| --- | --- |

(b)

the US Customs-Trade Partnership Against Terrorism (tier two and tier three levels) (Security and Accountability for Every (‘SAFE’) Ports Act of 2006).

| 4. | This Decision, as it relates to compatibility, reflects the current structure and territorial application of the C-TPAT program and the AEO programme. This Decision does not take into consideration future modifications of each programme and expansion of their respective territorial application. The customs authorities understand that any such programme modifications or expansion of territorial application may necessitate the successful completion of additional joint validations to the satisfaction of both customs authorities. |
| --- | --- |

4.

Section II

Compatibility

The customs authorities cooperate to maintain compatibility of the standards applied to each programme with respect to the following matters:

| (a) | application process for granting membership to operators; |
| --- | --- |

(a)

application process for granting membership to operators;

| (b) | assessment of applications; and |
| --- | --- |

(b)

assessment of applications; and

| (c) | granting of membership and monitoring of membership status. |
| --- | --- |

(c)

granting of membership and monitoring of membership status.

The customs authorities have completed a work programme setting out a process of joint validations.

Section III

Treatment of members

| 1. | Each customs authority treats operators holding a membership status under the other customs authority’s programme in a manner comparable to the way it treats members in its own trade partnership programme, to the extent practicable and possible and consistent with applicable law and policy. This treatment includes, in particular, taking favourably into account in its risk assessment, for the purpose of the conduct of inspections or controls, the respective membership status of an operator authorised by the other customs authority in order to facilitate EU-US trade and encourage the adoption of effective security-related measures. |
| --- | --- |

1.

| 2. | Each customs authority may suspend treatment consistent with paragraph 1 to members of the other customs authority’s programme under this Decision. Such suspension of treatment by one customs authority is to be promptly communicated to the other customs authority providing any additional information regarding the basis for suspension as appropriate. |
| --- | --- |

2.

| 3. | Each customs authority promptly informs the other customs authority in case it identifies any irregularity committed by a member authorised by the other customs authority to allow it to take an informed decision on the possible revocation or suspension of the membership of the operator concerned. |
| --- | --- |

3.

Section IV

Exchange of information and communication

| 1. | The customs authorities enhance communication in order to implement this Decision effectively. They exchange information and foster communication on their trade partnership programmes in particular by:






  (a) | providing updates on operation and development of their programmes in a timely manner; |
| --- | --- | --- |

1.

(a)

providing updates on operation and development of their programmes in a timely manner;

| (b) | engaging in mutually beneficial exchanges of information regarding supply chain security; and |
| --- | --- |

(b)

engaging in mutually beneficial exchanges of information regarding supply chain security; and

| (c) | facilitating effective inter-agency communication between the European Commission Directorate-General for Taxation and Customs Union and US Customs and Border Protection to enhance risk management practices with respect to supply chain security on the part of the members of the trade partnership programmes. |
| --- | --- |

(c)

facilitating effective inter-agency communication between the European Commission Directorate-General for Taxation and Customs Union and US Customs and Border Protection to enhance risk management practices with respect to supply chain security on the part of the members of the trade partnership programmes.

| 2. | Exchanges of information are to be conducted in electronic format and in accordance with the CMAA, in particular Article 17 thereof. |
| --- | --- |

2.

| 3. | Data to be exchanged regarding members of the trade partnership programmes, where such exchanges are otherwise authorised, include:






  (a) | name; |
| --- | --- | --- |

3.

(a)

name;

| (b) | address; |
| --- | --- |

(b)

address;

| (c) | status of membership; |
| --- | --- |

(c)

status of membership;

| (d) | validation or authorisation date; |
| --- | --- |

(d)

validation or authorisation date;

| (e) | suspensions and revocations; |
| --- | --- |

(e)

suspensions and revocations;

| (f) | the unique authorisation or identification number (in a form mutually determined by the customs authorities); and |
| --- | --- |

(f)

the unique authorisation or identification number (in a form mutually determined by the customs authorities); and

| (g) | details that may be mutually determined between the customs authorities, subject, where applicable, to any necessary safeguards. |
| --- | --- |

(g)

details that may be mutually determined between the customs authorities, subject, where applicable, to any necessary safeguards.

| 4. | The exchange of data is expected to commence when the customs authorities implement mutual recognition of membership status as described in paragraph 1 of Section III of this Decision. |
| --- | --- |

4.

Section V

Treatment of data

| 1. | Consistent with the CMAA, in particular Article 17, the data obtained by the receiving customs authority under this Decision are to be used and processed for the purposes of implementing this Decision. |
| --- | --- |

1.

| 2. | The customs authorities strive to ensure that the information exchanged is accurate and regularly updated, and that appropriate deletion procedures are in place. In the event a customs authority determines that information provided under this Decision should be amended, the customs authority providing this information is to promptly advise the receiving customs authority of such amendments. Once notified of such amendments, the receiving customs authority is to promptly record such amendment. Information may not be processed and kept longer than necessary for the purpose for which it is transferred. |
| --- | --- |

2.

| 3. | In the event information with personal data is exchanged pursuant to Section IV paragraph 3 (a) to (g), the customs authorities also take appropriate measures to ensure data protection, security, confidentiality and integrity. The customs authorities ensure in particular that:






  — | security safeguards are in place (including electronic safeguards) which control, on a need-to-know basis, access to such information obtained from the other customs authority under this Decision and that it is used only for the purposes of this Decision, |
| --- | --- | --- |

3.

—

security safeguards are in place (including electronic safeguards) which control, on a need-to-know basis, access to such information obtained from the other customs authority under this Decision and that it is used only for the purposes of this Decision,

| — | such information obtained from the other customs authority under this Decision is protected from unauthorised access, dissemination, and alteration, deletion or destruction, except to the extent appropriate to implement the provisions of paragraph 2 above, |
| --- | --- |

—

such information obtained from the other customs authority under this Decision is protected from unauthorised access, dissemination, and alteration, deletion or destruction, except to the extent appropriate to implement the provisions of paragraph 2 above,

| — | information obtained from the other customs authority under this Decision is not transmitted to any other country or international body without the prior consent of the customs authority that has provided this information and only in accordance with the conditions specified by the latter, |
| --- | --- |

—

information obtained from the other customs authority under this Decision is not transmitted to any other country or international body without the prior consent of the customs authority that has provided this information and only in accordance with the conditions specified by the latter,

| — | any such information may be used within the Contracting Parties to the CMAA to protect public security interests and supply chain security relevant to this Decision, and for customs, import/export safety and trade facilitation and enforcement, provided it is subject to safeguards equivalent or comparable to those set forth in this section, |
| --- | --- |

—

any such information may be used within the Contracting Parties to the CMAA to protect public security interests and supply chain security relevant to this Decision, and for customs, import/export safety and trade facilitation and enforcement, provided it is subject to safeguards equivalent or comparable to those set forth in this section,

| — | such information obtained from the other customs authority under this Decision is stored at all times in secure electronic and/or paper storage systems. Logs or documentation are kept on all access, as well as processing and use of such information obtained from the other customs authority. |
| --- | --- |

—

such information obtained from the other customs authority under this Decision is stored at all times in secure electronic and/or paper storage systems. Logs or documentation are kept on all access, as well as processing and use of such information obtained from the other customs authority.

| 4. | With respect to any personal data which may be exchanged pursuant to Section IV paragraph 3 (a) to (g), a programme member may request access to and/or amendment of such data relating to him or her that are processed by a customs authority. Each customs authority is to advise its programme members to make requests for access and/or amendment in the first instance via their own trade partnership programme. Where appropriate, and in accordance with its domestic legislation, the customs authority is to correct any such inaccurate or incomplete data. Each customs authority also informs programme members of the options for seeking administrative and/or judicial redress. |
| --- | --- |

4.

| 5. | At the request of the supplying customs authority, the receiving customs authority is to update, correct, block, or delete information received under this Decision that is inaccurate or incomplete or if its collection or further processing contravenes this Decision or the CMAA. Each customs authority is to notify the other if it becomes aware that material information it has transmitted to the other customs authority or received from the other customs authority under this Decision is inaccurate or unreliable or is subject to significant doubt. Where a customs authority determines that information it has received from the other customs authority under this Decision is inaccurate, it is to take all measures it deems appropriate to safeguard against erroneous reliance on such information, including supplementation, deletion, or correction of such information. |
| --- | --- |

5.

| 6. | Compliance with provisions in this Section by each customs authority is subject to the independent oversight and review by their respective relevant authority (for the US side, the Department of Homeland Security’s Chief Privacy Officer; for the EU, the European Data Protection Supervisor and the EU Member States data protection authorities). These authorities have effective powers of oversight, investigation, intervention and review, and have power to refer violations of law for prosecution or disciplinary action, where appropriate. They ensure that complaints relating to non-compliance are received, investigated, responded to, and appropriately redressed. |
| --- | --- |

6.

Section VI

Review

The JCCC reviews the implementation of this Decision regularly. The review includes, in particular:

| (a) | joint validations to identify strengths and weaknesses in implementing this Decision; |
| --- | --- |

(a)

joint validations to identify strengths and weaknesses in implementing this Decision;

| (b) | exchanges of views on data to be shared and treatment of operators, consistent with this Decision; and |
| --- | --- |

(b)

exchanges of views on data to be shared and treatment of operators, consistent with this Decision; and

| (c) | exchanges of views on security provisions such as procedures to be followed during and after a serious security incident or when conditions merit suspension of mutual recognition. |
| --- | --- |

(c)

exchanges of views on security provisions such as procedures to be followed during and after a serious security incident or when conditions merit suspension of mutual recognition.

Section VII

General acknowledgements

| 1. | This Decision aims to implement provisions of the CMAA and of the Agreement between the European Community and the United States of America on intensifying and broadening the CMAA to include cooperation on container security and related matters of 28 April 2004. |
| --- | --- |

1.

| 2. | This Decision is to be implemented consistent with the respective applicable laws, regulations, and international agreements to which the EU or the US is a party. |
| --- | --- |

2.

| 3. | This Decision does not create or confer any rights, privileges, or benefits upon any third party, person, or entity, private or public. |
| --- | --- |

3.

| 4. | Each customs authority is to be responsible for its own costs resulting from the implementation of this Decision. |
| --- | --- |

4.

Section VIII

Commencement, suspension and discontinuation

| 1. | The cooperation under this Decision commences upon signature by the JCCC Chairpersons. |
| --- | --- |

1.

| 2. | Implementation of mutual recognition between the US and EU takes place consistent with Section III(1). Either customs authority may suspend or discontinue cooperation under this Decision at any time, but should provide at least thirty (30) days’ written notice thereof. Such notice is provided to or by US Customs and Border Protection and the European Commission Directorate-General for Taxation and Customs Union, respectively. |
| --- | --- |

2.

Done at Washington, DC, 4 May 2012.

For the European Union

European Commission Director-General for Taxation and Customs Union

Heinz ZOUREK

For the United States of America

Acting Commissioner US Customs and Border Protection

David V. AGUILAR

---

(1)  
  OJ L 302, 19.10.1992, p. 1.

1

(2)  
  OJ L 253, 11.10.1993, p. 1.

2

(3)  
  OJ L 117, 4.5.2005, p. 13.

3

(4)  
  OJ L 360, 19.12.2006, p. 64.

4

---