# Official Journal L 77/2018

| | ISSN 1977-0677 |
| --- | --- |
| Official Journal
  of the European Union | L 77 |
| | |
| English edition | Legislation | Volume 6120 March 2018 |

ISSN 1977-0677

Official Journal

of the European Union

L 77

English edition

Legislation

Volume 6120 March 2018

---

| Contents | | II   Non-legislative acts | page |
| --- | --- | --- | --- |
| | | REGULATIONS |
| | * | Commission Regulation (EU) 2018/454 of 14 March 2018 establishing a prohibition of fishing for cod in areas 1 and 2B by vessels flying the flag of all Member States except Germany, Spain, France, Poland, Portugal and the United Kingdom | 1 |
| | * | Commission Regulation (EU) 2018/455 of 16 March 2018 laying down additional responsibilities and tasks for the European Union reference laboratory for fish and crustacean diseases and amending Annex VII to Regulation (EC) No 882/2004 of the European Parliament and of the Council (
  1
  ) | 4 |
| | * | Commission Implementing Regulation (EU) 2018/456 of 19 March 2018 on the procedural steps of the consultation process for determination of novel food status in accordance with Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods (
  1
  ) | 6 |
| | | DECISIONS |
| | * | Council Implementing Decision (EU) 2018/457 of 13 March 2018 authorising the Republic of Latvia to introduce a special measure derogating from Article 193 of Directive 2006/112/EC on the common system of value added tax | 14 |
| | * | Council Decision (CFSP) 2018/458 of 19 March 2018 repealing Common Position 97/193/CFSP on restrictive measures aimed at persons having perpetrated violent acts during the incidents in Mostar on 10 February 1997 | 16 |
| | * | Council Decision (CFSP) 2018/459 of 19 March 2018 amending Decision 2011/173/CFSP concerning restrictive measures in view of the situation in Bosnia and Herzegovina | 17 |

Contents

II   Non-legislative acts

page

REGULATIONS

*

Commission Regulation (EU) 2018/454 of 14 March 2018 establishing a prohibition of fishing for cod in areas 1 and 2B by vessels flying the flag of all Member States except Germany, Spain, France, Poland, Portugal and the United Kingdom

1

*

Commission Regulation (EU) 2018/455 of 16 March 2018 laying down additional responsibilities and tasks for the European Union reference laboratory for fish and crustacean diseases and amending Annex VII to Regulation (EC) No 882/2004 of the European Parliament and of the Council (
  1
  )

1

4

*

Commission Implementing Regulation (EU) 2018/456 of 19 March 2018 on the procedural steps of the consultation process for determination of novel food status in accordance with Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods (
  1
  )

1

6

DECISIONS

*

Council Implementing Decision (EU) 2018/457 of 13 March 2018 authorising the Republic of Latvia to introduce a special measure derogating from Article 193 of Directive 2006/112/EC on the common system of value added tax

14

*

Council Decision (CFSP) 2018/458 of 19 March 2018 repealing Common Position 97/193/CFSP on restrictive measures aimed at persons having perpetrated violent acts during the incidents in Mostar on 10 February 1997

16

*

Council Decision (CFSP) 2018/459 of 19 March 2018 amending Decision 2011/173/CFSP concerning restrictive measures in view of the situation in Bosnia and Herzegovina

17

| | |
| --- | --- |
| | (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

| 20.3.2018 | EN | Official Journal of the European Union | L 77/1 |
| --- | --- | --- | --- |

20.3.2018

EN

Official Journal of the European Union

L 77/1

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COMMISSION REGULATION (EU) 2018/454

of 14 March 2018

establishing a prohibition of fishing for cod in areas 1 and 2B by vessels flying the flag of all Member States except Germany, Spain, France, Poland, Portugal and the United Kingdom

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 Union 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) 2018/120 (2) lays down quotas for 2018. |
| --- | --- |

(1)

Council Regulation (EU) 2018/120 (2) lays down quotas for 2018.

| (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 2018. |
| --- | --- |

(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 2018.

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

(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 2018 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.

Official Journal of the European Union

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

Done at Brussels, 14 March 2018.

For the Commission,

On behalf of the President,

João AGUIAR MACHADO

Director-General

Directorate-General for Maritime Affairs and Fisheries

---

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

1

(2)  Council Regulation (EU) 2018/120 of 23 January 2018 fixing for 2018 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) 2017/127 (OJ L 27, 31.1.2018, p. 1).

2

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ANNEX

| No | 03/TQ120 |
| --- | --- |
| Member State | Other Member States than Germany, Spain, France, Poland, Portugal and the United Kingdom |
| Stock | COD/1/2B. |
| Species | Cod (Gadus morhua) |
| Zone | 1 and 2b |
| Closing date | 8.2.2018 |

No

03/TQ120

Member State

Other Member States than Germany, Spain, France, Poland, Portugal and the United Kingdom

Stock

COD/1/2B.

Species

Cod (Gadus morhua)

Zone

1 and 2b

Closing date

8.2.2018

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| 20.3.2018 | EN | Official Journal of the European Union | L 77/4 |
| --- | --- | --- | --- |

20.3.2018

EN

Official Journal of the European Union

L 77/4

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COMMISSION REGULATION (EU) 2018/455

of 16 March 2018

laying down additional responsibilities and tasks for the European Union reference laboratory for fish and crustacean diseases and amending Annex VII to Regulation (EC) No 882/2004 of the European Parliament and of the Council

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

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

Having regard to Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules (1), and in particular Article 32(5) and (6) thereof,

Having regard to Council Directive 2006/88/EC of 24 October 2006 on animal health requirements for aquaculture animals and products thereof, and on the prevention and control of certain diseases in aquatic animals (2), and in particular Article 55(1) thereof,

Whereas:

| (1) | Regulation (EC) No 882/2004 lays down the general tasks, duties and requirements of the European Union (EU) reference laboratories for food and feed, and for animal health. The EU reference laboratories for animal health and live animals are listed in Part II of Annex VII to Regulation (EC) No 882/2004. Point 15 of Part II of that Annex lists the Centre for Environment, Fisheries & Aquaculture Science (Cefas), Weymouth, United Kingdom, as the EU reference laboratory for crustacean diseases. |
| --- | --- |

(1)

Regulation (EC) No 882/2004 lays down the general tasks, duties and requirements of the European Union (EU) reference laboratories for food and feed, and for animal health. The EU reference laboratories for animal health and live animals are listed in Part II of Annex VII to Regulation (EC) No 882/2004. Point 15 of Part II of that Annex lists the Centre for Environment, Fisheries & Aquaculture Science (Cefas), Weymouth, United Kingdom, as the EU reference laboratory for crustacean diseases.

| (2) | Directive 2006/88/EC lays down the animal health requirements for the placing on the market, and the importation and the transit through the Union of aquaculture animals and products thereof, and certain minimum preventive and control measures for certain diseases in those animals. Article 55(1) of Directive 2006/88/EC provides for the designation of EU reference laboratories for aquatic animal diseases relevant to that Directive. |
| --- | --- |

(2)

Directive 2006/88/EC lays down the animal health requirements for the placing on the market, and the importation and the transit through the Union of aquaculture animals and products thereof, and certain minimum preventive and control measures for certain diseases in those animals. Article 55(1) of Directive 2006/88/EC provides for the designation of EU reference laboratories for aquatic animal diseases relevant to that Directive.

| (3) | Commission Regulation (EC) No 737/2008 (3) designated the Centre for Environment, Fisheries & Aquaculture Science (Cefas), Weymouth Laboratory, United Kingdom, as the EU reference laboratory for crustacean diseases for the period from 1 July 2008 until 30 June 2018. Article 55(3) of Directive 2006/88/EC provides for a review of the functions of that laboratory. |
| --- | --- |

(3)

Commission Regulation (EC) No 737/2008 (3) designated the Centre for Environment, Fisheries & Aquaculture Science (Cefas), Weymouth Laboratory, United Kingdom, as the EU reference laboratory for crustacean diseases for the period from 1 July 2008 until 30 June 2018. Article 55(3) of Directive 2006/88/EC provides for a review of the functions of that laboratory.

| (4) | As a consequence of the United Kingdom notification in accordance with Article 50 of the Treaty on European Union, the function of Cefas as EU reference laboratory for crustacean diseases cannot be continued for a further period starting on 1 July 2018. |
| --- | --- |

(4)

As a consequence of the United Kingdom notification in accordance with Article 50 of the Treaty on European Union, the function of Cefas as EU reference laboratory for crustacean diseases cannot be continued for a further period starting on 1 July 2018.

| (5) | In view of the synergies in technical expertise, laboratory capacity and networking with national reference laboratories, the EU reference laboratory for fish diseases should also take over the tasks and functions of the EU reference laboratory for crustacean diseases. |
| --- | --- |

(5)

In view of the synergies in technical expertise, laboratory capacity and networking with national reference laboratories, the EU reference laboratory for fish diseases should also take over the tasks and functions of the EU reference laboratory for crustacean diseases.

| (6) | The ‘Danmarks Tekniske Universitet, Veterinærinstituttet Afdeling for Diagnostik og Beredskab — Fiskesygdomme, 2800 Kgs. Lyngby, Danmark’ which has been designated as the EU reference laboratory for fish diseases, should therefore take over the tasks and functions of the EU reference laboratory for crustacean diseases. |
| --- | --- |

(6)

The ‘Danmarks Tekniske Universitet, Veterinærinstituttet Afdeling for Diagnostik og Beredskab — Fiskesygdomme, 2800 Kgs. Lyngby, Danmark’ which has been designated as the EU reference laboratory for fish diseases, should therefore take over the tasks and functions of the EU reference laboratory for crustacean diseases.

| (7) | The DTU Veterinærinstituttet Afdeling for Diagnostik og Beredskab — Fiskesygdomme that is assuming the responsibilities of the EU reference laboratory for fish and crustacean diseases should be indicated as the EU reference laboratory for crustacean diseases for the period from 1 July 2018 to 30 June 2023. In addition, it should be listed in Part II of Annex VII to Regulation (EC) No 882/2004. Part II of Annex VII to Regulation (EC) No 882/2004 should therefore be amended accordingly. |
| --- | --- |

(7)

The DTU Veterinærinstituttet Afdeling for Diagnostik og Beredskab — Fiskesygdomme that is assuming the responsibilities of the EU reference laboratory for fish and crustacean diseases should be indicated as the EU reference laboratory for crustacean diseases for the period from 1 July 2018 to 30 June 2023. In addition, it should be listed in Part II of Annex VII to Regulation (EC) No 882/2004. Part II of Annex VII to Regulation (EC) No 882/2004 should therefore be amended accordingly.

| (8) | In order to ensure seamless continuity of the activities of the European Union reference laboratories for crustacean diseases, it is appropriate to provide for a specific date of application for the measures provided for in this Regulation. |
| --- | --- |

(8)

In order to ensure seamless continuity of the activities of the European Union reference laboratories for crustacean diseases, it is appropriate to provide for a specific date of application for the measures provided for in this Regulation.

| (9) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, |
| --- | --- |

(9)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

HAS ADOPTED THIS REGULATION:

Article 1

Danmarks Tekniske Universitet, Veterinærinstituttet Afdeling for Diagnostik og Beredskab — Fiskesygdomme, 2800 Kgs. Lyngby, Denmark, shall have the responsibilities and tasks of the European Union reference laboratory for crustacean diseases from 1 July 2018 to 30 June 2023.

Article 2

Part II of Annex VII to Regulation (EC) No 882/2004 is amended as follows:

| (1) | point 6. is replaced by the following:






  ‘6. | EU reference laboratory for fish and crustacean diseases |
| --- | --- | --- |
| Danmarks Tekniske Universitet |
| Veterinærinstituttet |
| Afdeling for Diagnostik og Beredskab — Fiskesygdomme, Kemitorvet, Bygning 202 |
| 2800 Kgs. Lyngby |
| Denmark’; |

(1)

point 6. is replaced by the following:

‘6.

EU reference laboratory for fish and crustacean diseases

Danmarks Tekniske Universitet

Veterinærinstituttet

Afdeling for Diagnostik og Beredskab — Fiskesygdomme, Kemitorvet, Bygning 202

2800 Kgs. Lyngby

Denmark’;

| (2) | point 15 is deleted. |
| --- | --- |

(2)

point 15 is deleted.

Article 3

This Regulation shall enter into force on 1 July 2018.

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

Done at Brussels, 16 March 2018.

For the Commission

The President

Jean-Claude JUNCKER

---

(1)  
  OJ L 165, 30.4.2004, p. 1.

1

(2)  
  OJ L 328, 24.11.2006, p. 14.

2

(3)  Commission Regulation (EC) No 737/2008 of 28 July 2008 designating the Community reference laboratories for crustacean diseases, rabies and bovine tuberculosis, laying down additional responsibilities and tasks for the Community reference laboratories for rabies and bovine tuberculosis and amending Annex VII to Regulation (EC) No 882/2004 of the European Parliament and of the Council (OJ L 201, 30.7.2008, p. 29).

3

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| 20.3.2018 | EN | Official Journal of the European Union | L 77/6 |
| --- | --- | --- | --- |

20.3.2018

EN

Official Journal of the European Union

L 77/6

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COMMISSION IMPLEMENTING REGULATION (EU) 2018/456

of 19 March 2018

on the procedural steps of the consultation process for determination of novel food status in accordance with Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

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

Having regard to Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No 258/97 of the European Parliament and of the Council and Commission Regulation (EC) No 1852/2001 (1), and in particular Article 4 thereof,

Whereas:

| (1) | Regulation (EU) 2015/2283 lays down rules for the placing on the market and use of novel foods in the Union. |
| --- | --- |

(1)

Regulation (EU) 2015/2283 lays down rules for the placing on the market and use of novel foods in the Union.

| (2) | Article 4 of Regulation (EU) 2015/2283 lays down basic principles on the procedure for the determination of novel food status. Paragraph 1 of that Article requires food business operators to verify whether or not the food which they intend to place on the Union market falls within the scope of that Regulation. |
| --- | --- |

(2)

Article 4 of Regulation (EU) 2015/2283 lays down basic principles on the procedure for the determination of novel food status. Paragraph 1 of that Article requires food business operators to verify whether or not the food which they intend to place on the Union market falls within the scope of that Regulation.

| (3) | In order to determine the novel food status of a particular food, a consultation request should be submitted. The Member States should verify the validity of such requests. Therefore, it is necessary to establish rules for the verification process. |
| --- | --- |

(3)

In order to determine the novel food status of a particular food, a consultation request should be submitted. The Member States should verify the validity of such requests. Therefore, it is necessary to establish rules for the verification process.

| (4) | Rules should be established in order to ensure that the consultation request for determination of novel food status provides all the information necessary for the evaluation by the Member States. |
| --- | --- |

(4)

Rules should be established in order to ensure that the consultation request for determination of novel food status provides all the information necessary for the evaluation by the Member States.

| (5) | In order to ensure that food business operators and the public are informed of the novel food status, the information on the novel food status should be made publicly available. |
| --- | --- |

(5)

In order to ensure that food business operators and the public are informed of the novel food status, the information on the novel food status should be made publicly available.

| (6) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, |
| --- | --- |

(6)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

HAS ADOPTED THIS REGULATION:

Article 1

Scope and subject matter

This Regulation lays down rules for the implementation of Article 4 of Regulation (EU) 2015/2283 as regards the procedural steps of the consultation process to determine whether or not a food falls within the scope of that Regulation.

Article 2

Definitions

In addition to the definitions laid down in Regulation (EC) No 178/2002 of the European Parliament and of the Council (2) and Regulation (EU) 2015/2283, the following definitions shall apply:

2

| (a) | ‘consultation request’ means a request from a food business operator to a recipient Member State to determine the novel food status of a particular food; |
| --- | --- |

(a)

‘consultation request’ means a request from a food business operator to a recipient Member State to determine the novel food status of a particular food;

| (b) | ‘recipient Member State’ means a Member State where the food business operator intends to place on the market a particular food for the first time. |
| --- | --- |

(b)

‘recipient Member State’ means a Member State where the food business operator intends to place on the market a particular food for the first time.

Article 3

Submission of a consultation request

1.   The food business operator shall consult the recipient Member State as provided for in Article 4(2) of Regulation (EU) 2015/2283 by submitting a consultation request to that Member State.

2.   Where the food business operator intends to place the food on the market simultaneously in several Member States, the food business operator shall submit the consultation request only to one of those Member States.

Article 4

Content and presentation of a consultation request

1.   The consultation request shall be submitted electronically to the recipient Member State and shall consist of the following:

| (a) | a cover letter; |
| --- | --- |

(a)

a cover letter;

| (b) | a technical dossier; |
| --- | --- |

(b)

a technical dossier;

| (c) | supporting documentation; |
| --- | --- |

(c)

supporting documentation;

| (d) | an explanatory note clarifying the purpose and relevance of the submitted documentation. |
| --- | --- |

(d)

an explanatory note clarifying the purpose and relevance of the submitted documentation.

2.   The cover letter referred to in paragraph 1(a) shall be drafted in accordance with the template provided in Annex I.

3.   The technical dossier referred to in paragraph 1(b) shall contain the information necessary to enable the recipient Member State to conclude on the novel food status and shall be drafted in accordance with the template provided in Annex II.

4.   By way of derogation from paragraph 3, an applicant is not required to provide all the elements referred to in Annex II, provided that the applicant has submitted verifiable justification for the absence of each missing element.

Article 5

Procedures for verifying the validity of a consultation request

1.   The recipient Member State shall without delay verify whether the consultation request complies with the requirements of Article 4.

2.   Where the food business operator submits insufficient information in the consultation request, the recipient Member State shall request the food business operator to provide additional information or make the relevant updates to the consultation request within the time period specified by the recipient Member State.

3.   The consultation request shall be considered not valid where:

| (a) | the food business operator does not provide requested additional information or updated consultation request within the period specified by the recipient Member State; |
| --- | --- |

(a)

the food business operator does not provide requested additional information or updated consultation request within the period specified by the recipient Member State;

| (b) | the submitted additional information is insufficient to conclude that the consultation request is valid. |
| --- | --- |

(b)

the submitted additional information is insufficient to conclude that the consultation request is valid.

4.   The recipient Member State shall decide on the validity of the consultation request and without delay inform the food business operator, the other Member States and the Commission of the decision. Where the consultation request is considered not valid, the recipient Member State shall provide the reasons for that conclusion.

Article 6

Procedures for evaluating a valid consultation request

1.   The recipient Member State shall conclude on the novel food status of a food within 4 months from the date on which it decided on the validity of the consultation request.

2.   Where the recipient Member State identifies that it does not have sufficient evidence to decide on the novel food status of a food, it may request the food business operator to provide additional information. The period of that request shall be determined together with the food business operator.

The recipient Member State may consult the other Member States and the Commission.

3.   Without prejudice to paragraph 4, a request for additional information referred to in paragraph 2 shall not extend the time period referred to in paragraph 1.

4.   In duly justified cases, the recipient Member State may extend the time period referred to in paragraph 1 by a maximum of 4 months. The recipient Member State shall inform the food business operator, the other Member States and the Commission of their decision and shall provide justification.

5.   On concluding on the novel food status of a food, the recipient Member State shall without delay notify the food business operator, the other Member States and the Commission of the decision and shall provide justification in accordance with Article 7 of this Regulation.

Article 7

Information on the novel food status and publication

1.   The notification referred to in Article 6(5) of this Regulation shall include the following:

| (a) | the name and description of the food concerned; |
| --- | --- |

(a)

the name and description of the food concerned;

| (b) | a statement indicating whether the food concerned is novel, not novel or not novel only in food supplements; |
| --- | --- |

(b)

a statement indicating whether the food concerned is novel, not novel or not novel only in food supplements;

| (c) | reasons justifying the statement referred to in point (b); |
| --- | --- |

(c)

reasons justifying the statement referred to in point (b);

| (d) | where the food is novel food, the most appropriate food category under which it falls in accordance with Article 3(2) of Regulation (EU) 2015/2283. |
| --- | --- |

(d)

where the food is novel food, the most appropriate food category under which it falls in accordance with Article 3(2) of Regulation (EU) 2015/2283.

2.   The Commission shall without delay make the information on the novel food status publicly available on the Commission's website.

Article 8

Competent authorities of the Member States

Member States shall provide the Commission with the contact details of the national competent authorities and the contact details of the respective contact points designated for the purposes of this Regulation by 1 March 2018.

The Commission shall publish those contact details on the Commission's website by 1 May 2018.

Article 9

Confidentiality

1.   Food business operators may request the recipient Member State to agree that the disclosure of certain information submitted as part of the consultation request needs to benefit from confidential treatment where disclosure of such information may harm their competitive position.

2.   For the purpose of paragraph 1, food business operators shall indicate to the recipient Member State the parts of the information provided that they wish to be treated as confidential and provide all the necessary details to substantiate their request for confidentiality.

3.   The recipient Member State shall inform the food business operator of its views on which parts of the information are to remain confidential.

However, confidentiality shall not apply to the following information:

| (a) | the name and address of the applicant; |
| --- | --- |

(a)

the name and address of the applicant;

| (b) | the name and description of the food; |
| --- | --- |

(b)

the name and description of the food;

| (c) | a summary of the studies submitted by the applicant; |
| --- | --- |

(c)

a summary of the studies submitted by the applicant;

| (d) | where appropriate, the analysis method(s). |
| --- | --- |

(d)

where appropriate, the analysis method(s).

4.   In case of the consultation of other Member States pursuant to Article 6(2), second subparagraph, the recipient Member State shall inform the Commission and the Member States about its views on confidentiality of the consultation request.

5.   After being informed pursuant to paragraph 3, the food business operator may withdraw its consultation request within 3 weeks during which the confidentiality of the information provided shall be observed.

6.   The Commission and the Member States shall take necessary measures to ensure appropriate confidentiality of the information referred to in paragraphs 3 and received by them under this Regulation, except for information which is required to be made public in order to protect human health.

7.   Where a food business operator withdraws or has withdrawn its consultation request in accordance with paragraph 5, neither the Commission nor the Member States shall disclose information for which confidentiality was requested by the food business operator pursuant to paragraph 1.

8.   The application of paragraphs 1 to 7 shall not affect the exchange of information between the Commission and the Member States necessary to consider the consultation requests submitted under this Regulation.

Article 10

Entry into force and application

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

Official Journal of the European Union

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

Done at Brussels, 19 March 2018.

For the Commission

The President

Jean-Claude JUNCKER

---

(1)  
  OJ L 327, 11.12.2015, p. 1.

1

(2)  Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (OJ L 31, 1.2.2002, p. 1).

2

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ANNEX I

TEMPLATE COVER LETTER ACCOMPANYING A CONSULTATION REQUEST FOR DETERMINATION OF THE NOVEL FOOD STATUS

Competent authority of the Member State

Date: ...

Subject: Consultation request for determination of the novel food status of ...

...

The Food business operator(s)/consulting party:

Company: ...

Address: ...

Telephone: ...

Email: ...

Contact person: ...

submit(s) the present consultation request in order to determine the novel food status of ...

Yours sincerely,

Signature ...

Enclosures:

| ☐ | Technical dossier |
| --- | --- |

☐

Technical dossier

| ☐ | Documents in support of the consultation request |
| --- | --- |

☐

Documents in support of the consultation request

| ☐ | Explanatory note |
| --- | --- |

☐

Explanatory note

---

ANNEX II

TEMPLATE TECHNICAL DOSSIER

The connection between the different pieces of information shall be explained in an explanatory note. In particular, as regards the evidence presented to support a human consumption to a significant degree within the Union before 15 May 1997, where documents from a range of sources must be considered to be able to reach a conclusion.

Where only parts of the documents are relevant for the determination of the novel food status, those parts shall be highlighted.

For all foods, Section 1 must be completed.

For extracts, in addition to Section 1, Section 2 must be completed.

For foods resulting from a production process not used for food production within the Union before 15 May 1997, Section 1 (points 1 to 3, and point 7) and Section 3 must be completed.

Section 1: All foods (for foods resulting from a production process not used for food production within the Union before 15 May 1997 only points 1 to 3 and point 7)

| 1. | Description of the food |
| --- | --- |

1.

| 1.1 | Name of the food |
| --- | --- |

1.1

Name of the food

| 1.2 | Detailed description of the food, including information whether the food consists of engineered nanomaterials as referred to in points (a)(viii) and (ix) of Article 3(2) of Regulation (EU) 2015/2283 (1) |
| --- | --- |

1.2

Detailed description of the food, including information whether the food consists of engineered nanomaterials as referred to in points (a)(viii) and (ix) of Article 3(2) of Regulation (EU) 2015/2283 (1)

| 1.3 | Proposed category of the novel food in accordance with Article 3(2)(a) of Regulation (EU) 2015/2283, where applicable |
| --- | --- |

1.3

Proposed category of the novel food in accordance with Article 3(2)(a) of Regulation (EU) 2015/2283, where applicable

| 2. | Further characterisation of the food and/or source of the food (where relevant) |
| --- | --- |

2.

Organisms (microorganisms, fungi, algae, plants, animals)

| 2.1 | Taxonomic name (full Latin name with author name) |
| --- | --- |

2.1

Taxonomic name (full Latin name with author name)

| 2.2 | Synonyms, other names, where applicable |
| --- | --- |

2.2

Synonyms, other names, where applicable

| 2.3 | Specification of which part of the organism the use for human consumption before 15 May 1997 within the Union refers to, where applicable |
| --- | --- |

2.3

Specification of which part of the organism the use for human consumption before 15 May 1997 within the Union refers to, where applicable

| 2.4 | Specification about purity/concentration |
| --- | --- |

2.4

Specification about purity/concentration

Chemical substances

| 2.5 | CAS number(s) (if this has been attributed) |
| --- | --- |

2.5

CAS number(s) (if this has been attributed)

| 2.6 | Chemical name(s) according to IUPAC nomenclature rules |
| --- | --- |

2.6

Chemical name(s) according to IUPAC nomenclature rules

| 2.7 | Synonyms, trade name, common name, where applicable |
| --- | --- |

2.7

Synonyms, trade name, common name, where applicable

| 2.8 | Molecular and structural formulae |
| --- | --- |

2.8

Molecular and structural formulae

| 2.9 | Specification about purity/concentration |
| --- | --- |

2.9

Specification about purity/concentration

| 3. | Conditions of use |
| --- | --- |

3.

| 3.1 | How is the food intended to be used? |
| --- | --- |

3.1

How is the food intended to be used?

| 3.2 | Type of product(s) in which the food is intended to be used |
| --- | --- |

3.2

Type of product(s) in which the food is intended to be used

| 3.3 | Level/concentration (or range of levels) in the product(s) in which the food is intended to be used |
| --- | --- |

3.3

Level/concentration (or range of levels) in the product(s) in which the food is intended to be used

| 4. | Production process |
| --- | --- |

4.

| 4.1 | Detailed description of the production process. Include a flow process chart to describe the production process. |
| --- | --- |

4.1

Detailed description of the production process. Include a flow process chart to describe the production process.

| 5. | History of human consumption of the food within the Union before 15 May 1997 |
| --- | --- |

5.

| 5.1 | To what extent was the food consumed to a significant degree throughout the Union before 15 May 1997? Details shall be provided. |
| --- | --- |

5.1

To what extent was the food consumed to a significant degree throughout the Union before 15 May 1997? Details shall be provided.

| 5.2 | To what extent was the food consumed to a significant degree in one Member State before 15 May 1997? Details shall be provided. |
| --- | --- |

5.2

To what extent was the food consumed to a significant degree in one Member State before 15 May 1997? Details shall be provided.

| 5.3 | Was the food consumed only regionally/on a small local scale in the Union before 15 May 1997? Details shall be provided. |
| --- | --- |

5.3

Was the food consumed only regionally/on a small local scale in the Union before 15 May 1997? Details shall be provided.

| 5.4 | Was the food available before 15 May 1997 in the Union as an ingredient designed for specific target population (e.g. food for a special medical purpose)? Details shall be provided. |
| --- | --- |

5.4

Was the food available before 15 May 1997 in the Union as an ingredient designed for specific target population (e.g. food for a special medical purpose)? Details shall be provided.

| 6. | Consultations on availability in the Union
  Where food business operators are unsure whether the information in their possession is sufficient to prove that the food concerned has been used for human consumption to a significant degree within the Union before 15 May 1997, they may consult other food business operators or food business operator federations in order to gather sufficient information. |
| --- | --- |

6.

Where food business operators are unsure whether the information in their possession is sufficient to prove that the food concerned has been used for human consumption to a significant degree within the Union before 15 May 1997, they may consult other food business operators or food business operator federations in order to gather sufficient information.

| 6.1 | Have other food business operators or food business operator federations been consulted? Details should be provided. |
| --- | --- |

6.1

Have other food business operators or food business operator federations been consulted? Details should be provided.

| 6.2 | Is the food currently available on the market within the Union? Details should be provided. |
| --- | --- |

6.2

Is the food currently available on the market within the Union? Details should be provided.

| 7. | Additional information |
| --- | --- |

7.

| 7.1 | Is there any information that the product concerned is used within the Union as medicinal product in accordance with Directive 2001/83/EC (2)? |
| --- | --- |

7.1

Is there any information that the product concerned is used within the Union as medicinal product in accordance with Directive 2001/83/EC (2)?

| 7.2 | Is there any other information which would assist in determining the novel food status? Any information which is relevant even if not specifically requested shall be submitted. |
| --- | --- |

7.2

Is there any other information which would assist in determining the novel food status? Any information which is relevant even if not specifically requested shall be submitted.

Section 2: Extracts

| 8. | Extracts |
| --- | --- |

8.

| 8.1 | Any further details of the source material for the extract, if not provided in Section 1. Details shall be provided. |
| --- | --- |

8.1

Any further details of the source material for the extract, if not provided in Section 1. Details shall be provided.

| 8.2 | Specification of the extract. Details shall be provided. |
| --- | --- |

8.2

Specification of the extract. Details shall be provided.

| 8.3 | If extracted from a food source, will the intake of any extract components in the food be higher than the intake of these components in the food source? Details shall be provided. |
| --- | --- |

8.3

If extracted from a food source, will the intake of any extract components in the food be higher than the intake of these components in the food source? Details shall be provided.

Section 3: Foods resulting from a production process not used for food production within the Union before 15 May 1997

| 9. | Production process |
| --- | --- |

9.

| 9.1 | Detailed description of the production process. Include a flow process chart to describe the production process. |
| --- | --- |

9.1

Detailed description of the production process. Include a flow process chart to describe the production process.

| 9.2 | Is the structure or composition of the food affecting its nutritional value, metabolism or level of undesirable substances because of the process by which the food has been prepared? Details shall be provided. |
| --- | --- |

9.2

Is the structure or composition of the food affecting its nutritional value, metabolism or level of undesirable substances because of the process by which the food has been prepared? Details shall be provided.

| 9.3 | Is the food produced from a source that in itself is not normally consumed as part of the diet? Details shall be provided. |
| --- | --- |

9.3

Is the food produced from a source that in itself is not normally consumed as part of the diet? Details shall be provided.

| (1) | Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No 258/97 of the European Parliament and of the Council and Commission Regulation (EC) No 1852/2001 (OJ L 327, 11.12.2015, p. 1). |
| --- | --- |

(1)

| (2) | Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ L 311, 28.11.2001, p. 67). |
| --- | --- |

(2)

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DECISIONS

| 20.3.2018 | EN | Official Journal of the European Union | L 77/14 |
| --- | --- | --- | --- |

20.3.2018

EN

Official Journal of the European Union

L 77/14

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COUNCIL IMPLEMENTING DECISION (EU) 2018/457

of 13 March 2018

authorising the Republic of Latvia to introduce a special measure derogating from Article 193 of Directive 2006/112/EC on the common system of value added tax

THE COUNCIL OF THE EUROPEAN UNION,

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

Having regard to Council Directive 2006/112/EC of 28 November 2006 on the common system of value added tax (1), and in particular Article 395 thereof,

Having regard to the proposal from the European Commission,

Whereas:

| (1) | Pursuant to Article 193 of Directive 2006/112/EC any taxable person carrying out a taxable supply of goods or services, as a general rule, is liable for the payment of value added tax (VAT) to the tax authorities. |
| --- | --- |

(1)

Pursuant to Article 193 of Directive 2006/112/EC any taxable person carrying out a taxable supply of goods or services, as a general rule, is liable for the payment of value added tax (VAT) to the tax authorities.

| (2) | Pursuant to point (h) of Article 199a(1) of Directive 2006/112/EC, Member States may provide that the person liable for the payment of VAT on supplies of game consoles is the taxable person to whom the supply is made (‘reverse charge mechanism’). Latvia does not avail itself of this option, although it applies the reverse charge to supplies of tablet PCs and laptops based on point (h) of Article 199a(1) of that Directive. |
| --- | --- |

(2)

Pursuant to point (h) of Article 199a(1) of Directive 2006/112/EC, Member States may provide that the person liable for the payment of VAT on supplies of game consoles is the taxable person to whom the supply is made (‘reverse charge mechanism’). Latvia does not avail itself of this option, although it applies the reverse charge to supplies of tablet PCs and laptops based on point (h) of Article 199a(1) of that Directive.

| (3) | Due to increased fraud in the game consoles sector in Latvia, Latvia would like to introduce the reverse charge mechanism to domestic supplies of game consoles. |
| --- | --- |

(3)

Due to increased fraud in the game consoles sector in Latvia, Latvia would like to introduce the reverse charge mechanism to domestic supplies of game consoles.

| (4) | Pursuant to Article 199a(1) of Directive 2006/112/EC, the reverse charge mechanism may be applied until 31 December 2018, for a minimum period of 2 years. Because the condition of a 2-year period is not fulfilled, Latvia cannot apply the reverse charge mechanism based on point (h) of Article 199a(1) of Directive 2006/112/EC. |
| --- | --- |

(4)

Pursuant to Article 199a(1) of Directive 2006/112/EC, the reverse charge mechanism may be applied until 31 December 2018, for a minimum period of 2 years. Because the condition of a 2-year period is not fulfilled, Latvia cannot apply the reverse charge mechanism based on point (h) of Article 199a(1) of Directive 2006/112/EC.

| (5) | By letter registered with the Commission on 15 November 2017, Latvia requested authorisation to apply a special measure derogating from Article 193 of Directive 2006/112/EC in order to make the recipient of the supply of game consoles liable for the payment of VAT. |
| --- | --- |

(5)

By letter registered with the Commission on 15 November 2017, Latvia requested authorisation to apply a special measure derogating from Article 193 of Directive 2006/112/EC in order to make the recipient of the supply of game consoles liable for the payment of VAT.

| (6) | In accordance with Article 395(2) of Directive 2006/112/EC, the Commission informed the other Member States of the request made by Latvia by letter dated 23 November 2017. By letter dated 24 November 2017, the Commission notified Latvia that it had all the information necessary to consider the request. |
| --- | --- |

(6)

In accordance with Article 395(2) of Directive 2006/112/EC, the Commission informed the other Member States of the request made by Latvia by letter dated 23 November 2017. By letter dated 24 November 2017, the Commission notified Latvia that it had all the information necessary to consider the request.

| (7) | According to the information provided by Latvia, VAT fraud increased in relation to the supply of game consoles following the introduction of the reverse charge mechanism for the supply of mobile phones, tablet PCs, laptops and integrated circuit devices. Game consoles are particularly susceptible to VAT fraud as they are relatively small in size, have a relatively high value and have a well-developed market on the internet. According to the information submitted by Latvia, a number of conventional measures have been introduced by Latvia to combat the VAT fraud. Nevertheless, Latvia considers that it is necessary to introduce the reverse charge mechanism for the supply of game consoles in order to prevent the loss of VAT revenue to the public budget. |
| --- | --- |

(7)

According to the information provided by Latvia, VAT fraud increased in relation to the supply of game consoles following the introduction of the reverse charge mechanism for the supply of mobile phones, tablet PCs, laptops and integrated circuit devices. Game consoles are particularly susceptible to VAT fraud as they are relatively small in size, have a relatively high value and have a well-developed market on the internet. According to the information submitted by Latvia, a number of conventional measures have been introduced by Latvia to combat the VAT fraud. Nevertheless, Latvia considers that it is necessary to introduce the reverse charge mechanism for the supply of game consoles in order to prevent the loss of VAT revenue to the public budget.

| (8) | Therefore, in order to prevent tax evasion, Latvia should be authorised to apply the reverse charge mechanism to supplies of game consoles for a limited period. |
| --- | --- |

(8)

Therefore, in order to prevent tax evasion, Latvia should be authorised to apply the reverse charge mechanism to supplies of game consoles for a limited period.

| (9) | The special measure has no adverse impact on the Union's own resources accruing from VAT, |
| --- | --- |

(9)

The special measure has no adverse impact on the Union's own resources accruing from VAT,

HAS ADOPTED THIS DECISION:

Article 1

By way of derogation from Article 193 of Directive 2006/112/EC, in the case of the supply of game consoles, Latvia is authorised to designate the recipient of the supply as the person liable to pay VAT.

Article 2

This Decision shall take effect on the day of its notification.

This Decision shall expire on 31 December 2018.

Article 3

This Decision is addressed to the Republic of Latvia.

Done at Brussels, 13 March 2018.

For the Council

The President

V. GORANOV

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(1)  
  OJ L 347, 11.12.2006, p. 1.

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| 20.3.2018 | EN | Official Journal of the European Union | L 77/16 |
| --- | --- | --- | --- |

20.3.2018

EN

Official Journal of the European Union

L 77/16

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COUNCIL DECISION (CFSP) 2018/458

of 19 March 2018

repealing Common Position 97/193/CFSP on restrictive measures aimed at persons having perpetrated violent acts during the incidents in Mostar on 10 February 1997

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on European Union, and in particular Article 29 thereof,

Having regard to the proposal from the High Representative of the Union for Foreign Affairs and Security Policy,

Whereas:

| (1) | On 17 March 1997 the Council adopted Common Position 97/193/CFSP (1). |
| --- | --- |

(1)

On 17 March 1997 the Council adopted Common Position 97/193/CFSP (1).

| (2) | On the basis of a review of Common Position 97/193/CFSP, the measures imposed by the Common Position should be lifted. |
| --- | --- |

(2)

On the basis of a review of Common Position 97/193/CFSP, the measures imposed by the Common Position should be lifted.

| (3) | Common Position 97/193/CFSP should therefore be repealed, |
| --- | --- |

(3)

Common Position 97/193/CFSP should therefore be repealed,

HAS ADOPTED THIS DECISION:

Article 1

Common Position 97/193/CFSP is hereby repealed.

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, 19 March 2018.

For the Council

The President

F. MOGHERINI

---

(1)  Common Position 97/193/CFSP of 17 March 1997 defined by the Council on the basis of Article J.2 of the Treaty on European Union, on restrictive measures aimed at persons having perpetrated violent acts during the incidents in Mostar on 10 February 1997 (OJ L 81, 21.3.1997, p.1).

1

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| 20.3.2018 | EN | Official Journal of the European Union | L 77/17 |
| --- | --- | --- | --- |

20.3.2018

EN

Official Journal of the European Union

L 77/17

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COUNCIL DECISION (CFSP) 2018/459

of 19 March 2018

amending Decision 2011/173/CFSP concerning restrictive measures in view of the situation in Bosnia and Herzegovina

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on European Union, and in particular Article 29 thereof,

Having regard to the proposal from the High Representative of the Union for Foreign Affairs and Security Policy,

Whereas:

| (1) | On 21 March 2011, the Council adopted Decision 2011/173/CFSP (1), concerning restrictive measures in view of the situation in Bosnia and Herzegovina. |
| --- | --- |

(1)

On 21 March 2011, the Council adopted Decision 2011/173/CFSP (1), concerning restrictive measures in view of the situation in Bosnia and Herzegovina.

| (2) | On the basis of a review of Decision 2011/173/CFSP, those restrictive measures should be renewed until 31 March 2019. |
| --- | --- |

(2)

On the basis of a review of Decision 2011/173/CFSP, those restrictive measures should be renewed until 31 March 2019.

| (3) | Decision 2011/173/CFSP should therefore be amended accordingly, |
| --- | --- |

(3)

Decision 2011/173/CFSP should therefore be amended accordingly,

HAS ADOPTED THIS DECISION:

Article 1

The second paragraph of Article 6 of Decision 2011/173/CFSP is replaced by the following:

‘This Decision shall apply until 31 March 2019.’.

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, 19 March 2018.

For the Council

The President

F. MOGHERINI

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(1)  Council Decision 2011/173/CFSP of 21 March 2011 concerning restrictive measures in view of the situation in Bosnia and Herzegovina (OJ L 76, 22.3.2011, p. 68).

1

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