20.9.2016

EN

Official Journal of the European Union

L 254/1

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COMMISSION DELEGATED REGULATION (EU) 2016/1675

of 14 July 2016

supplementing Directive (EU) 2015/849 of the European Parliament and of the Council by identifying high-risk third countries with strategic deficiencies

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

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

Having regard to Directive (EU) 2015/849 of the European Parliament and of the Council of 20 May 2015 on the prevention of the use of the financial system for the purposes of money laundering or terrorist financing, amending Regulation (EU) No 648/2012 of the European Parliament and of the Council, and repealing Directive 2005/60/EC of the European Parliament and of the Council and Commission Directive 2006/70/EC (1), and in particular Article 9(2) thereof,

Whereas:

(1)

The Union must ensure efficient protection mechanisms for the whole of the internal market, with a view to increase legal certainty for economic operators and stakeholders in general in their relationships with third-country jurisdictions. The integrity of financial markets and the proper functioning of the internal market as a whole are seriously threatened by jurisdictions with strategic deficiencies in their national anti-money-laundering and terrorism-financing frameworks. Those jurisdictions that have in place deficient legal and institutional frameworks with poor standards for controlling money flows pose significant threats to the financial system of the Union.

(2)	All Union obliged entities under Directive (EU) 2015/849 should apply enhanced due diligence measures in their relationship to natural persons or legal entities established in high-risk third countries, thereby ensuring equivalent requirements for market participants across the Union.

(3)	Article 9 of Directive (EU) 2015/849 lays down the criteria on which the Commission's assessment is to be based and empowers the Commission to identify high-risk third countries taking into account those criteria.

(4)

The identification of high-risk third countries must be based on a clear and objective assessment which focuses on a jurisdiction's compliance with the criteria laid down in Directive (EU) 2015/849 regarding its legal and institutional anti-money-laundering and countering the financing of terrorism (AML/CFT) framework, the powers and procedures of its competent authorities for the purposes of combating money laundering and terrorist financing and the effectiveness of the anti-money-laundering and countering the financing of terrorism (AML/CFT) system in addressing money laundering or terrorist financing risks of the third country.

(5)	All findings upon which the Commission's decision to include a jurisdiction in the list of high-risk third countries is to be based should be documented by robust, verifiable and up-to-date information.

(6)

It is essential that the Commission fully acknowledges relevant work already undertaken at international level for identifying high-risk third countries, in particular that of the Financial Action Task Force (‘FATF’). With a view to ensuring the integrity of the global financial system, it is of the highest importance that the list of third countries laid down at Union level is closely aligned, as appropriate, with those lists agreed internationally. By promoting a global approach at international level, the Union contributes to enhancing the financial integrity worldwide and better protecting the international financial system from high-risk countries. Such a global approach serves to achieve equivalent conditions for obliged entities and avoid any disruptive effect on the international financial system.

(7)

In line with the criteria set out in Directive (EU) 2015/849, the Commission took into account all available expert assessments of factors that contribute to making a country or jurisdiction particularly vulnerable to money laundering, terrorist financing or other illicit financial activity. In particular, the Commission took into account, as appropriate, the most recent FATF Public Statement, FATF documents (Improving Global AML/CFT Compliance: ongoing process), FATF reports on International Cooperation Review, and the mutual evaluations report carried out by FATF and FATF-Style Regional Bodies in relation to the risks posed by individual third countries in line with Article 9(4) of Directive (EU) 2015/849.

(8)

Considering the high level of integration of the international financial system, the close connection of market operators, the high volume of cross-border transactions to/from the EU, as well as the degree of market opening, it is hence considered that any AML/CFT threat posed to the international financial system also represents a threat for the EU financial system.

(9)

In accordance with the latest relevant information, the Commission's analysis has concluded that Afghanistan, Bosnia and Herzegovina, Guyana, Iraq, Lao PDR, Syria, Uganda, Vanuatu and Yemen should be considered third-country jurisdictions which have strategic deficiencies in their AML/CFT regimes that pose significant threats to the financial system of the Union. Those countries have provided a written high-level political commitment to address the identified deficiencies and have developed an action plan with FATF, which would allow the requirements laid down in Directive (EU) 2015/849 to be met.

(10)

In accordance with the latest relevant information, the Commission's analysis has similarly concluded that Iran should be considered a third-country jurisdiction which has strategic deficiencies in its AML/CFT regimes that pose significant threats to the financial system of the Union. This country, identified by FATF Public Statement, has provided a high-level political commitment to address the identified deficiencies, and has decided to seek technical assistance in the implementation of the FATF Action Plan which would allow the requirements laid down in Directive (EU) 2015/849 to be met.

(11)

In accordance with the latest relevant information, the Commission's analysis has similarly concluded that the Democratic People's Republic of Korea (DPRK) should be considered third-country jurisdiction which has strategic deficiencies in its AML/CFT regime that pose significant threats to the financial system of the Union. This country, identified by FATF Public Statement, presents ongoing and substantial money-laundering and terrorist-financing risks, having repeatedly failed to address the identified deficiencies.

(12)

It is essential that the Commission extends an invitation to third-country jurisdictions identified as high-risk to fully cooperate with the Commission and international bodies with a view to agreeing and effectively implementing measures for correcting the strategic deficiencies in their anti-money laundering and terrorism financing regimes.

(13)

It is of the utmost importance that the Commission conducts a permanent monitoring of developments in the assessment of legal and institutional frameworks in place in third countries, the powers and procedures of competent authorities, and the effectiveness of their AML/CFT regimes with a view to updating the list of high-risk third countries with strategic deficiencies,

HAS ADOPTED THIS REGULATION:

Article 1

The list of third-country jurisdictions which have strategic deficiencies in their anti-money laundering and countering the financing of terrorism regimes that pose significant threats to the financial system of the Union (‘high-risk third countries’) is laid down in the Annex.

Article 2

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

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(1)  OJ L 141, 5.6.2015, p. 73.

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20.9.2016

EN

Official Journal of the European Union

L 254/5

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COMMISSION IMPLEMENTING REGULATION (EU) 2016/1676

of 7 September 2016

entering a name in the register of protected designations of origin and protected geographical indications (Saucisson sec d'Auvergne/Saucisse sèche d'Auvergne (PGI))

THE EUROPEAN COMMISSION,

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

Having regard to Regulation (EU) No 1151/2012 of the European Parliament and of the Council of 21 November 2012 on quality schemes for agricultural products and foodstuffs (1), and in particular Article 52(2) thereof,

Whereas:

(1)	Pursuant to Article 50(2)(a) of Regulation (EU) No 1151/2012, France's application to register the name ‘Saucisson sec d'Auvergne’/‘Saucisse sèche d'Auvergne’ was published in the Official Journal of the European Union  (2).

(2)	As no statement of opposition under Article 51 of Regulation (EU) No 1151/2012 has been received by the Commission, the name ‘Saucisson sec d'Auvergne’/‘Saucisse sèche d'Auvergne’ should therefore be entered in the register,

HAS ADOPTED THIS REGULATION:

Article 1

The name ‘Saucisson sec d'Auvergne’/‘Saucisse sèche d'Auvergne’ (PGI) is hereby entered in the register.

The name specified in the first paragraph denotes a product in Class 1.2. Meat products (cooked, salted, smoked, etc.), as listed in Annex XI to Commission Implementing Regulation (EU) No 668/2014 (3).

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.

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(1)  OJ L 343, 14.12.2012, p. 1.

(2)  OJ C 160, 4.5.2016, p. 14.

(3)  Commission Implementing Regulation (EU) No 668/2014 of 13 June 2014 laying down rules for the application of Regulation (EU) No 1151/2012 of the European Parliament and of the Council on quality schemes for agricultural products and foodstuffs (OJ L 179, 19.6.2014, p. 36).

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20.9.2016

EN

Official Journal of the European Union

L 254/6

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COMMISSION REGULATION (EU) 2016/1677

of 14 September 2016

establishing a prohibition of fishing for Norway lobster in areas VIIIa, VIIIb, VIIId and VIIIe by vessels flying the flag of Belgium

THE EUROPEAN COMMISSION,

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

Having regard to Council Regulation (EC) No 1224/2009 of 20 November 2009 establishing a Community control system for ensuring compliance with the rules of the common fisheries policy (1), and in particular Article 36(2) thereof,

Whereas:

(1)	Council Regulation (EU) 2016/72 (2) lays down quotas for 2016.

(2)	According to the information received by the Commission, catches of the stock referred to in the Annex to this Regulation by vessels flying the flag of or registered in the Member State referred to therein have exhausted the quota allocated for 2016.

(3)	It is therefore necessary to prohibit fishing activities for that stock,

HAS ADOPTED THIS REGULATION:

Article 1

Quota exhaustion

The fishing quota allocated to the Member State referred to in the Annex to this Regulation for the stock referred to therein for 2016 shall be deemed to be exhausted from the date set out in that Annex.

Article 2

Prohibitions

Fishing activities for the stock referred to in the Annex to this Regulation by vessels flying the flag of or registered in the Member State referred to therein shall be prohibited from the date set out in that Annex. In particular it shall be prohibited to retain on board, relocate, tranship or land fish from that stock caught by those vessels after that date.

Article 3

Entry into force

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

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(1)  OJ L 343, 22.12.2009, p. 1.

(2)  Council Regulation (EU) 2016/72 of 22 January 2016 fixing for 2016 the fishing opportunities for certain fish stocks and groups of fish stocks, applicable in Union waters and, for Union fishing vessels, in certain non-Union waters, and amending Regulation (EU) 2015/104 (OJ L 22, 28.1.2016, p. 1).

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20.9.2016

EN

Official Journal of the European Union

L 254/8

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COMMISSION REGULATION (EU) 2016/1678

of 14 September 2016

establishing a prohibition of fishing for hake in areas VIIIa, VIIIb, VIIId and VIIIe by vessels flying the flag of Belgium

THE EUROPEAN COMMISSION,

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

Having regard to Council Regulation (EC) No 1224/2009 of 20 November 2009 establishing a Community control system for ensuring compliance with the rules of the common fisheries policy (1), and in particular Article 36(2) thereof,

Whereas:

(1)	Council Regulation (EU) 2016/72 (2) lays down quotas for 2016.

(2)	According to the information received by the Commission, catches of the stock referred to in the Annex to this Regulation by vessels flying the flag of or registered in the Member State referred to therein have exhausted the quota allocated for 2016.

(3)	It is therefore necessary to prohibit fishing activities for that stock,

HAS ADOPTED THIS REGULATION:

Article 1

Quota exhaustion

The fishing quota allocated to the Member State referred to in the Annex to this Regulation for the stock referred to therein for 2016 shall be deemed to be exhausted from the date set out in that Annex.

Article 2

Prohibitions

Fishing activities for the stock referred to in the Annex to this Regulation by vessels flying the flag of or registered in the Member State referred to therein shall be prohibited from the date set out in that Annex. In particular it shall be prohibited to retain on board, relocate, tranship or land fish from that stock caught by those vessels after that date.

Article 3

Entry into force

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

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(1)  OJ L 343, 22.12.2009, p. 1.

(2)  Council Regulation (EU) 2016/72 of 22 January 2016 fixing for 2016 the fishing opportunities for certain fish stocks and groups of fish stocks, applicable in Union waters and, for Union fishing vessels, in certain non-Union waters, and amending Regulation (EU) 2015/104 (OJ L 22, 28.1.2016, p. 1).

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20.9.2016

EN

Official Journal of the European Union

L 254/10

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COMMISSION REGULATION (EU) 2016/1679

of 14 September 2016

establishing a prohibition of fishing for plaice in VIII, IX and X; Union waters of CECAF 34.1.1 by vessels flying the flag of Belgium

THE EUROPEAN COMMISSION,

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

Having regard to Council Regulation (EC) No 1224/2009 of 20 November 2009 establishing a Community control system for ensuring compliance with the rules of the common fisheries policy (1), and in particular Article 36(2) thereof,

Whereas:

(1)	Council Regulation (EU) 2016/72 (2) lays down quotas for 2016.

(2)	According to the information received by the Commission, catches of the stock referred to in the Annex to this Regulation by vessels flying the flag of or registered in the Member State referred to therein have exhausted the quota allocated for 2016.

(3)	It is therefore necessary to prohibit fishing activities for that stock,

HAS ADOPTED THIS REGULATION:

Article 1

Quota exhaustion

The fishing quota allocated to the Member State referred to in the Annex to this Regulation for the stock referred to therein for 2016 shall be deemed to be exhausted from the date set out in that Annex.

Article 2

Prohibitions

Fishing activities for the stock referred to in the Annex to this Regulation by vessels flying the flag of or registered in the Member State referred to therein shall be prohibited from the date set out in that Annex. In particular it shall be prohibited to retain on board, relocate, tranship or land fish from that stock caught by those vessels after that date.

Article 3

Entry into force

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

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(1)  OJ L 343, 22.12.2009, p. 1.

(2)  Council Regulation (EU) 2016/72 of 22 January 2016 fixing for 2016 the fishing opportunities for certain fish stocks and groups of fish stocks, applicable in Union waters and, for Union fishing vessels, in certain non-Union waters, and amending Regulation (EU) 2015/104 (OJ L 22, 28.1.2016, p. 1).

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20.9.2016

EN

Official Journal of the European Union

L 254/12

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COMMISSION REGULATION (EU) 2016/1680

of 14 September 2016

establishing a prohibition of fishing for sole in areas VIIIa and VIIIb vessels flying the flag of Belgium

THE EUROPEAN COMMISSION,

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

Having regard to Council Regulation (EC) No 1224/2009 of 20 November 2009 establishing a Community control system for ensuring compliance with the rules of the common fisheries policy (1), and in particular Article 36(2) thereof,

Whereas:

(1)	Council Regulation (EU) 2016/72 (2) lays down quotas for 2016.

(2)	According to the information received by the Commission, catches of the stock referred to in the Annex to this Regulation by vessels flying the flag of or registered in the Member State referred to therein have exhausted the quota allocated for 2016.

(3)	It is therefore necessary to prohibit fishing activities for that stock,

HAS ADOPTED THIS REGULATION:

Article 1

Quota exhaustion

The fishing quota allocated to the Member State referred to in the Annex to this Regulation for the stock referred to therein for 2016 shall be deemed to be exhausted from the date set out in that Annex.

Article 2

Prohibitions

Fishing activities for the stock referred to in the Annex to this Regulation by vessels flying the flag of or registered in the Member State referred to therein shall be prohibited from the date set out in that Annex. In particular it shall be prohibited to retain on board, relocate, tranship or land fish from that stock caught by those vessels after that date.

Article 3

Entry into force

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

---

(1)  OJ L 343, 22.12.2009, p. 1.

(2)  Council Regulation (EU) 2016/72 of 22 January 2016 fixing for 2016 the fishing opportunities for certain fish stocks and groups of fish stocks, applicable in Union waters and, for Union fishing vessels, in certain non-Union waters, and amending Regulation (EU) 2015/104 (OJ L 22, 28.1.2016, p. 1).

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20.9.2016

EN

Official Journal of the European Union

L 254/14

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COMMISSION REGULATION (EU) 2016/1681

of 14 September 2016

establishing a prohibition of fishing for megrims in areas VIIIa, VIIIb, VIIId and VIIIe by vessels flying the flag of Belgium

THE EUROPEAN COMMISSION,

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

Having regard to Council Regulation (EC) No 1224/2009 of 20 November 2009 establishing a Community control system for ensuring compliance with the rules of the common fisheries policy (1), and in particular Article 36(2) thereof,

Whereas:

(1)	Council Regulation (EU) 2016/72 (2) lays down quotas for 2016.

(2)	According to the information received by the Commission, catches of the stock referred to in the Annex to this Regulation by vessels flying the flag of or registered in the Member State referred to therein have exhausted the quota allocated for 2016.

(3)	It is therefore necessary to prohibit fishing activities for that stock,

HAS ADOPTED THIS REGULATION:

Article 1

Quota exhaustion

The fishing quota allocated to the Member State referred to in the Annex to this Regulation for the stock referred to therein for 2016 shall be deemed to be exhausted from the date set out in that Annex.

Article 2

Prohibitions

Fishing activities for the stock referred to in the Annex to this Regulation by vessels flying the flag of or registered in the Member State referred to therein shall be prohibited from the date set out in that Annex. In particular it shall be prohibited to retain on board, relocate, tranship or land fish from that stock caught by those vessels after that date.

Article 3

Entry into force

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

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(1)  OJ L 343, 22.12.2009, p. 1.

(2)  Council Regulation (EU) 2016/72 of 22 January 2016 fixing for 2016 the fishing opportunities for certain fish stocks and groups of fish stocks, applicable in Union waters and, for Union fishing vessels, in certain non-Union waters, and amending Regulation (EU) 2015/104 (OJ L 22, 28.1.2016, p. 1).

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20.9.2016

EN

Official Journal of the European Union

L 254/16

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COMMISSION REGULATION (EU) 2016/1682

of 14 September 2016

establishing a prohibition of fishing for anglerfish in areas VIIIa, VIIIb, VIIId and VIIIe by vessels flying the flag of Belgium

THE EUROPEAN COMMISSION,

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

Having regard to Council Regulation (EC) No 1224/2009 of 20 November 2009 establishing a Community control system for ensuring compliance with the rules of the common fisheries policy (1), and in particular Article 36(2) thereof,

Whereas:

(1)	Council Regulation (EU) 2016/72 (2) lays down quotas for 2016.

(2)	According to the information received by the Commission, catches of the stock referred to in the Annex to this Regulation by vessels flying the flag of or registered in the Member State referred to therein have exhausted the quota allocated for 2016.

(3)	It is therefore necessary to prohibit fishing activities for that stock,

HAS ADOPTED THIS REGULATION:

Article 1

Quota exhaustion

The fishing quota allocated to the Member State referred to in the Annex to this Regulation for the stock referred to therein for 2016 shall be deemed to be exhausted from the date set out in that Annex.

Article 2

Prohibitions

Fishing activities for the stock referred to in the Annex to this Regulation by vessels flying the flag of or registered in the Member State referred to therein shall be prohibited from the date set out in that Annex. In particular it shall be prohibited to retain on board, relocate, tranship or land fish from that stock caught by those vessels after that date.

Article 3

Entry into force

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

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(1)  OJ L 343, 22.12.2009, p. 1.

(2)  Council Regulation (EU) 2016/72 of 22 January 2016 fixing for 2016 the fishing opportunities for certain fish stocks and groups of fish stocks, applicable in Union waters and, for Union fishing vessels, in certain non-Union waters, and amending Regulation (EU) 2015/104 (OJ L 22, 28.1.2016, p. 1).

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20.9.2016

EN

Official Journal of the European Union

L 254/18

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COMMISSION IMPLEMENTING REGULATION (EU) 2016/1683

of 19 September 2016

amending for the 253rd time Council Regulation (EC) No 881/2002 imposing certain specific restrictive measures directed against certain persons and entities associated with the ISIL (Da'esh) and Al-Qaeda organisations

THE EUROPEAN COMMISSION,

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

Having regard to Council Regulation (EC) No 881/2002 of 27 May 2002 imposing certain specific restrictive measures directed against certain persons and entities associated with the ISIL (Da'esh) and Al-Qaeda organisations (1), and in particular Article 7(1)(a) and Article 7a(5) thereof,

Whereas:

(1)	Annex I to Regulation (EC) No 881/2002 lists the persons, groups and entities covered by the freezing of funds and economic resources under that Regulation.

(2)

On 14 September 2016, the Sanctions Committee of the United Nations Security Council decided to amend two entries in its list of persons, groups and entities to whom the freezing of funds and economic resources should apply. Annex I to Regulation (EC) No 881/2002 should therefore be updated accordingly,

HAS ADOPTED THIS REGULATION:

Article 1

Annex I to Regulation (EC) No 881/2002 is amended in accordance with the Annex to this Regulation.

Article 2

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

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(1)  OJ L 139, 29.5.2002, p. 9.

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20.9.2016

EN

Official Journal of the European Union

L 254/20

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COMMISSION IMPLEMENTING REGULATION (EU) 2016/1684

of 19 September 2016

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 Regulation (EU) No 1308/2013 of the European Parliament and of the Council of 17 December 2013 establishing a common organisation of the markets in agricultural products and repealing Council Regulations (EEC) No 922/72, (EEC) No 234/79, (EC) No 1037/2001 and (EC) No 1234/2007 (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.

(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.

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(1)  OJ L 347, 20.12.2013, p. 671.

(2)  OJ L 157, 15.6.2011, p. 1.

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20.9.2016

EN

Official Journal of the European Union

L 254/22

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COMMISSION IMPLEMENTING DECISION (EU) 2016/1685

of 16 September 2016

authorising the placing on the market of products containing, consisting of, or produced from genetically modified maize Bt11 × MIR162 × MIR604 × GA21, and genetically modified maizes combining two or three of the events Bt11, MIR162, MIR604 and GA21, and repealing Decisions 2010/426/EU, 2011/892/EU, 2011/893/EU and 2011/894/EU

(notified under document C(2016) 5746)

(Only the French text is authentic)

(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 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed (1), and in particular Articles 7(3), 9(2), 19(3) and 21(2) thereof,

Whereas:

(1)

On 9 February 2009, Syngenta France SAS submitted to the competent authority of Germany an application in accordance with Articles 5 and 17 of Regulation (EC) No 1829/2003 for the placing on the market of foods, food ingredients, and feed containing, consisting of, or produced from Bt11 × MIR162 × MIR604 × GA21 maize (‘the application’).

(2)	The application also covers the placing on the market of genetically modified maize Bt11 × MIR162 × MIR604 × GA21 in products consisting of it or containing it for other uses than food and feed as any other maize, with the exception of cultivation.

(3)

In accordance with Articles 5(5) and 17(5) of Regulation (EC) No 1829/2003, the application includes the data and information required by Annexes III and IV to Directive 2001/18/EC of the European Parliament and of the Council (2) and information and conclusions about the risk assessment carried out in accordance with the principles set out in Annex II to that Directive. It also includes a monitoring plan for environmental effects conforming with Annex VII to Directive 2001/18/EC.

(4)

On 5 July 2013, Syngenta extended the scope of the application to all sub-combinations of the single genetic modification events constituting Bt11 × MIR162 × MIR604 × GA21 maize (‘sub-combinations’), including Bt11 × GA21 maize, MIR604 × GA21 maize, Bt11 × MIR604 maize, and Bt11 × MIR604 × GA21 which are already authorised respectively by Commission Decisions 2010/426/EU (3), 2011/892/EU (4), 2011/893/EU (5) and 2011/894/EU (6). Syngenta asked the Commission to repeal those four Decisions once authorisation is given to Bt11 × MIR162 × MIR604 × GA21 maize and all sub-combinations.

(5)

On 7 December 2015, the European Food Safety Authority (‘EFSA’) gave a favourable opinion in accordance with Articles 6 and 18 of Regulation (EC) No 1829/2003 (7). It concluded that genetically modified maize Bt11 × MIR162 × MIR604 × GA21, as described in the application, is as safe and as nutritious as its conventional counterpart and no safety concerns are identified for any of the sub-combinations.

(6)	In its opinion, EFSA considered all the specific questions and concerns raised by the Member States in the context of the consultation of the national competent authorities as provided for by Articles 6(4) and 18(4) of Regulation (EC) No 1829/2003.

(7)	EFSA also concluded that the monitoring plan for environmental effects, consisting of a general surveillance plan, submitted by the applicant, is in line with the intended uses of the products.

(8)

In its opinion, EFSA recommends the collection of relevant information on expression levels of the newly expressed proteins, if the sub-combinations Bt11 × MIR162 × MIR604, MIR162 × MIR604 × GA21, Bt11 × MIR162, MIR162 × MIR604 and/or MIR162 × GA21 were to be created via targeted breeding approaches and commercialised. In line with this recommendation, specific conditions should be laid down to that effect.

(9)

Taking into account those considerations, authorisation should be granted to the products containing, consisting of, or produced from genetically modified maizes Bt11 × MIR162 × MIR604 × GA21, Bt11 × MIR162 × MIR604, Bt11 × MIR162 × GA21, Bt11 × MIR604 × GA21, MIR162 × MIR604 × GA21, Bt11 × MIR162, Bt11 × MIR604, Bt11 × GA21, MIR162 × MIR604, MIR162 × GA21 and MIR604 × GA21.

(10)	Decisions 2010/426/EU, 2011/892/EU, 2011/893/EU and 2011/894/EU authorising Bt11 × GA21 maize, MIR604 × GA21 maize, Bt11 × MIR604 maize, and Bt11 × GA21 × MIR604 maize should be repealed.

(11)	A unique identifier should be assigned to each genetically modified organism (hereinafter ‘GMO’) as provided for in Commission Regulation (EC) No 65/2004 (8).

(12)

On the basis of the EFSA opinion, no specific labelling requirements, other than those provided for in Articles 13(1) and 25(2) of Regulation (EC) No 1829/2003, appear to be necessary for foods, food ingredients and feed containing, consisting of, or produced from genetically modified maize Bt11 × MIR162 × MIR604 × GA21 including all possible combinations of the single genetic modification events. However, in order to ensure the use of those products within the limits of the authorisation granted by this Decision, the labelling of the products containing or consisting of maize Bt11 × MIR162 × MIR604 × GA21 and the sub-combinations, with the exception of food products, should be complemented by a clear indication that the products in question are not intended for cultivation.

(13)

Regulation (EC) No 1830/2003 of the European Parliament and of the Council (9) lays down labelling requirements in Article 4(6) for products containing or consisting of GMOs. Traceability requirements for those products are laid down in paragraphs 1 to 5 of Article 4 and traceability requirements for food and feed produced from GMOs are laid down in Article 5 of that Regulation.

(14)

The authorisation holder should submit annual reports on the implementation and the results of the activities set out in the monitoring plan for environmental effects. Those results should be presented in accordance with Commission Decision 2009/770/EC (10). The EFSA opinion does not justify the imposition of specific conditions for the protection of particular ecosystems/environment and/or geographical areas, as provided for in point (e) of Article 6(5) and Article 18(5) of Regulation (EC) No 1829/2003.

(15)	The authorisation holder should also submit annual reports on the results of the activities set out in the specific conditions of this authorisation.

(16)	All relevant information on the authorisation of the products should be entered in the Community register of genetically modified food and feed provided for in Regulation (EC) No 1829/2003.

(17)	This Decision is to be notified through the Biosafety Clearing-House to the Parties to the Cartagena Protocol on Biosafety to the Convention on Biological Diversity, pursuant to Articles 9(1) and 15(2)(c) of Regulation (EC) No 1946/2003 of the European Parliament and of the Council (11).

(18)

The Standing Committee on the Food Chain and Animal Health has not delivered an opinion within the time-limit laid down by its Chairman. An implementing act was deemed to be necessary and the chair submitted the draft implementing act to the appeal committee for further deliberation. The appeal committee did not deliver an opinion,

HAS ADOPTED THIS DECISION:

Article 1

Genetically modified organism and unique identifier

1.   The following unique identifiers for genetically modified organisms (GMOs) are assigned in accordance with Regulation (EC) No 65/2004:

(a)	the unique identifier SYN-BTØ11-1 × SYN-IR162-4 × SYN-IR6Ø4-5 × MON-ØØØ21-9 for genetically modified maize (Zea mays L.) Bt11 × MIR162 × MIR604 × GA21;

(b)	the unique identifier SYN-BTØ11-1 × SYN-IR162-4 × SYN-IR6Ø4-5 for genetically modified maize (Zea mays L.) Bt11 × MIR162 × MIR604;

(c)	the unique identifier SYN-BTØ11-1 × SYN-IR162-4 × MON-ØØØ21-9 for genetically modified maize (Zea mays L.) Bt11 × MIR162 × GA21;

(d)	the unique identifier SYN-BTØ11-1 × SYN-IR6Ø4-5 × MON-ØØØ21-9 for genetically modified maize (Zea mays L.) Bt11 × MIR604 × GA21;

(e)	the unique identifier SYN-IR162-4 × SYN-IR6Ø4-5 × MON-ØØØ21-9 for genetically modified maize (Zea mays L.) MIR162 × MIR604 × GA21;

(f)	the unique identifier SYN-BTØ11-1 × SYN-IR162-4 for genetically modified maize (Zea mays L.) Bt11 × MIR162;

(g)	the unique identifier SYN-BTØ11-1 × SYN-IR6Ø4-5 for genetically modified maize (Zea mays L.) Bt11 × MIR604;

(h)	the unique identifier SYN-BTØ11-1 × MON-ØØØ21-9 for genetically modified maize (Zea mays L.) Bt11 × GA21;

(i)	the unique identifier SYN-IR162-4 × SYN-IR6Ø4-5 for genetically modified maize (Zea mays L.) MIR162 × MIR604;

(j)	the unique identifier SYN-IR162-4 × MON-ØØØ21-9 for genetically modified maize (Zea mays L.) MIR162 × GA21;

(k)	the unique identifier SYN-IR6Ø4-5 × MON-ØØØ21-9 for genetically modified maize (Zea mays L.) MIR604 × GA21.

2.   The genetically modified maizes referred to in paragraph 1 are specified in point (b) of the Annex.

Article 2

Authorisation

The following products are authorised for the purposes of Articles 4(2) and 16(2) of Regulation (EC) No 1829/2003 in accordance with the conditions set out in this Decision:

(a)	foods and food ingredients containing, consisting of, or produced from the GMOs referred to in Article 1;

(b)	feed containing, consisting of, or produced from the GMOs referred to in Article 1;

(c)	GMOs referred to in Article 1 in products containing them or consisting of them for any other use than those provided in points (a) and (b), with the exception of cultivation.

Article 3

Labelling

1.   For the purposes of the labelling requirements laid down in Article 13(1) and Article 25(2) of Regulation (EC) No 1829/2003 and in Article 4(6) of Regulation (EC) No 1830/2003, the ‘name of the organism’ shall be ‘maize’.

2.   The words ‘not for cultivation’ shall appear on the label of and in the documents accompanying products containing or consisting of the GMOs referred to in Article 1, with the exception of products referred to in point (a) of Article 2.

Article 4

Monitoring for environmental effects

1.   The authorisation holder shall ensure that the monitoring plan for environmental effects, as set out in point (h) of the Annex, is put in place and implemented.

2.   The authorisation holder shall submit to the Commission annual reports on the implementation and the results of the activities set out in the monitoring plan in accordance with Decision 2009/770/EC.

Article 5

Specific conditions for the placing on the market

1.   The authorisation holder shall ensure that the specific conditions, referred to in point (g) of the Annex, are implemented.

2.   The authorisation holder shall submit to the Commission annual reports on the results of the activities set out in the specific conditions of this authorisation for the duration of the authorisation.

Article 6

Community register

The information set out in the Annex to this Decision shall be entered in the Community register of genetically modified food and feed, as provided for in Article 28 of Regulation (EC) No 1829/2003.

Article 7

Authorisation holder

The authorisation holder shall be Syngenta France SAS, representing Syngenta Crop Protection AG, Switzerland.

Article 8

Repeal

Decisions 2010/426/EU, 2011/892/EU, 2011/893/EU and 2011/894/EU are repealed.

Article 9

Validity

This Decision shall apply for a period of 10 years from the date of its notification.

Article 10

Addressee

This Decision is addressed to Syngenta France SAS, 12, Chemin de l`Hobit, 31790 Saint-Sauveur, France.

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(1)  OJ L 268, 18.10.2003, p. 1.

(2)  Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC (OJ L 106, 17.4.2001, p. 1).

(3)  Commission Decision 2010/426/EU of 28 July 2010 authorising the placing on the market of products containing, consisting of, or produced from genetically modified maize Bt11 × GA21 (SYN-BTØ11-1 × MON-ØØØ21-9) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (OJ L 199, 31.7.2010, p. 36).

(4)  Commission Decision 2011/892/EU of 22 December 2011 authorising the placing on the market of products containing, consisting of, or produced from genetically modified maize MIR604 × GA21 (SYN-IR6Ø4-5 × MON-ØØØ21-9) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (OJ L 344, 28.12.2011, p. 55).

(5)  Commission Decision 2011/893/EU of 22 December 2011 authorising the placing on the market of products containing, consisting of, or produced from genetically modified maize Bt11 × MIR604 (SYN-BTØ11-1 × SYN-IR6Ø4-5) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (OJ L 344, 28.12.2011, p. 59).

(6)  Commission Decision 2011/894/EU of 22 December 2011 authorising the placing on the market of products containing, consisting of, or produced from genetically modified maize Bt11 × MIR604 × GA21 (SYN-BTØ11-1 × SYN-IR6Ø4-5 × MON-ØØØ21-9) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (OJ L 344, 28.12.2011, p. 64).

(7)  EFSA GMO Panel (EFSA Panel on Genetically Modified Organisms), 2015. Scientific Opinion on an application by Syngenta (EFSA-GMO-DE-2009-66) for placing on the market of herbicide tolerant and insect resistant maize Bt11 × MIR162 × MIR604 × GA21 and subcombinations independently of their origin for food and feed uses, import and processing under Regulation (EC) No 1829/2003. EFSA Journal 2015;13(12):4297, 34 pp. doi:10.2903/j.efsa.2015.4297

(8)  Commission Regulation (EC) No 65/2004 of 14 January 2004 establishing a system for the development and assignment of unique identifiers for genetically modified organisms (OJ L 10, 16.1.2004, p. 5).

(9)  Regulation (EC) No 1830/2003 of the European Parliament and of the Council of 22 September 2003 concerning the traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms and amending Directive 2001/18/EC (OJ L 268, 18.10.2003, p. 24).

(10)  Commission Decision 2009/770/EC of 13 October 2009 establishing standard reporting formats for presenting the monitoring results of the deliberate release into the environment of genetically modified organisms, as or in products, for the purpose of placing on the market, pursuant to Directive 2001/18/EC of the European Parliament and of the Council (OJ L 275, 21.10.2009, p. 9).

(11)  Regulation (EC) No 1946/2003 of the European Parliament and of the Council of 15 July 2003 on transboundary movements of genetically modified organisms (OJ L 287, 5.11.2003, p. 1).

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