# Official Journal L 41/2018

| | ISSN 1977-0677 |
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| Official Journal
  of the European Union | L 41 |
| | |
| English edition | Legislation | Volume 6114 February 2018 |

ISSN 1977-0677

Official Journal

of the European Union

L 41

English edition

Legislation

Volume 6114 February 2018

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| Contents | | II   Non-legislative acts | page |
| --- | --- | --- | --- |
| | | REGULATIONS |
| | * | Commission Delegated Regulation (EU) 2018/211 of 21 November 2017 establishing a discard plan as regards salmon in the Baltic Sea | 1 |
| | * | Commission Delegated Regulation (EU) 2018/212 of 13 December 2017 amending Delegated Regulation (EU) 2016/1675 supplementing Directive (EU) 2015/849 of the European Parliament and of the Council, as regards adding Sri Lanka, Trinidad and Tobago, and Tunisia to the table in point I of the Annex (
  1
  ) | 4 |
| | * | Commission Regulation (EU) 2018/213 of 12 February 2018 on the use of bisphenol A in varnishes and coatings intended to come into contact with food and amending Regulation (EU) No 10/2011 as regards the use of that substance in plastic food contact materials (
  1
  ) | 6 |
| | * | Commission Implementing Regulation (EU) 2018/214 of 13 February 2018 approving an amendment to the specification for a Protected Designation of Origin or a Protected Geographical Indication (Pla i Llevant (PDO)) | 13 |
| | * | Commission Implementing Regulation (EU) 2018/215 of 13 February 2018 conferring protection under Article 99 of Regulation (EU) No 1308/2013 of the European Parliament and of the Council on the name Mergelland (PDO) | 14 |

Contents

II   Non-legislative acts

page

REGULATIONS

*

Commission Delegated Regulation (EU) 2018/211 of 21 November 2017 establishing a discard plan as regards salmon in the Baltic Sea

1

*

Commission Delegated Regulation (EU) 2018/212 of 13 December 2017 amending Delegated Regulation (EU) 2016/1675 supplementing Directive (EU) 2015/849 of the European Parliament and of the Council, as regards adding Sri Lanka, Trinidad and Tobago, and Tunisia to the table in point I of the Annex (
  1
  )

1

4

*

Commission Regulation (EU) 2018/213 of 12 February 2018 on the use of bisphenol A in varnishes and coatings intended to come into contact with food and amending Regulation (EU) No 10/2011 as regards the use of that substance in plastic food contact materials (
  1
  )

1

6

*

Commission Implementing Regulation (EU) 2018/214 of 13 February 2018 approving an amendment to the specification for a Protected Designation of Origin or a Protected Geographical Indication (Pla i Llevant (PDO))

13

*

Commission Implementing Regulation (EU) 2018/215 of 13 February 2018 conferring protection under Article 99 of Regulation (EU) No 1308/2013 of the European Parliament and of the Council on the name Mergelland (PDO)

14

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| | (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. |
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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

| 14.2.2018 | EN | Official Journal of the European Union | L 41/1 |
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14.2.2018

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Official Journal of the European Union

L 41/1

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COMMISSION DELEGATED REGULATION (EU) 2018/211

of 21 November 2017

establishing a discard plan as regards salmon in the Baltic Sea

THE EUROPEAN COMMISSION,

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

Having regard to the Regulation (EU) No 1380/2013 of the European Parliament and of the Council of 11 December 2013 on the Common Fisheries Policy, amending Council Regulations (EC) No 1954/2003 and (EC) No 1224/2009 and repealing Council Regulations (EC) No 2371/2002 and (EC) No 639/2004 and Council Decision 2004/585/EC (1), and in particular Articles 15(6),

Whereas:

| (1) | Regulation (EU) No 1380/2013 aims to progressively eliminate discards in all Union fisheries through the introduction of a landing obligation for catches of species subject to catch limits. |
| --- | --- |

(1)

Regulation (EU) No 1380/2013 aims to progressively eliminate discards in all Union fisheries through the introduction of a landing obligation for catches of species subject to catch limits.

| (2) | In accordance with Article 15(1)(a) of Regulation (EU) No 1380/2013, the landing obligation applies in fisheries for salmon from 1 January 2015. |
| --- | --- |

(2)

In accordance with Article 15(1)(a) of Regulation (EU) No 1380/2013, the landing obligation applies in fisheries for salmon from 1 January 2015.

| (3) | Article 15(6) of Regulation (EU) No 1380/2013 empowers the Commission, in the absence of multiannual plans established pursuant to Article 9 of that Regulation, to adopt a discard plan specifying details of the implementation of the landing obligation for an initial period of three years that may be renewed for another period of three years. Those discard plan are to be adopted on the basis of joint recommendations developed by Member States in consultation with the relevant Advisory Councils. |
| --- | --- |

(3)

Article 15(6) of Regulation (EU) No 1380/2013 empowers the Commission, in the absence of multiannual plans established pursuant to Article 9 of that Regulation, to adopt a discard plan specifying details of the implementation of the landing obligation for an initial period of three years that may be renewed for another period of three years. Those discard plan are to be adopted on the basis of joint recommendations developed by Member States in consultation with the relevant Advisory Councils.

| (4) | Commission Delegated Regulation (EU) No 1396/2014 (2) established a discard plan concerning fisheries for salmon, herring, sprat and cod in the Baltic Sea. That discard plan includes i.a. an exemption from the landing obligation for cod and salmon on account of high survival rates demonstrated for those species as provided for in Article 15(4)(b) of Regulation (EU) No 1380/2013. Delegated Regulation (EU) No 1396/2014 expires on 31 December 2017. |
| --- | --- |

(4)

Commission Delegated Regulation (EU) No 1396/2014 (2) established a discard plan concerning fisheries for salmon, herring, sprat and cod in the Baltic Sea. That discard plan includes i.a. an exemption from the landing obligation for cod and salmon on account of high survival rates demonstrated for those species as provided for in Article 15(4)(b) of Regulation (EU) No 1380/2013. Delegated Regulation (EU) No 1396/2014 expires on 31 December 2017.

| (5) | Regulation (EU) 2016/1139 of the European Parliament and of the Council (3) establishes a multiannual plan concerning certain Baltic Sea fisheries for cod, herring and sprat. That multiannual plan does not cover salmon stocks and Baltic Sea fisheries for that stock. |
| --- | --- |

(5)

Regulation (EU) 2016/1139 of the European Parliament and of the Council (3) establishes a multiannual plan concerning certain Baltic Sea fisheries for cod, herring and sprat. That multiannual plan does not cover salmon stocks and Baltic Sea fisheries for that stock.

| (6) | In the absence of a multiannual plan applicable to salmon stocks and Baltic Sea fisheries for that stock, details for implementing the landing obligation after the expiry of Delegated Regulation (EU) No 1396/2014 are to be adopted in the framework of a new discard plan based on a joint recommendation submitted by the Member States. |
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(6)

In the absence of a multiannual plan applicable to salmon stocks and Baltic Sea fisheries for that stock, details for implementing the landing obligation after the expiry of Delegated Regulation (EU) No 1396/2014 are to be adopted in the framework of a new discard plan based on a joint recommendation submitted by the Member States.

| (7) | Denmark, Germany, Estonia, Latvia, Lithuania, Poland, Finland and Sweden have a direct fisheries management interest in the Baltic Sea. On 31 May 2017 those Member States have submitted a joint recommendation (4) to the Commission, after consulting the Baltic Sea Advisory Council. Scientific contribution was obtained from relevant scientific bodies. |
| --- | --- |

(7)

Denmark, Germany, Estonia, Latvia, Lithuania, Poland, Finland and Sweden have a direct fisheries management interest in the Baltic Sea. On 31 May 2017 those Member States have submitted a joint recommendation (4) to the Commission, after consulting the Baltic Sea Advisory Council. Scientific contribution was obtained from relevant scientific bodies.

| (8) | The joint recommendation suggests that the exemption from the landing obligation for salmon caught with trap-nets, creels/pots, fyke-nets and pound nets, provided for by Delegated Regulation (EU) No 1396/2014, should continue to apply after 31 December 2017. |
| --- | --- |

(8)

The joint recommendation suggests that the exemption from the landing obligation for salmon caught with trap-nets, creels/pots, fyke-nets and pound nets, provided for by Delegated Regulation (EU) No 1396/2014, should continue to apply after 31 December 2017.

| (9) | The joint recommendation is based on scientific evidence of high survivability, provided by the Baltic Sea Fisheries Forum (BALTFISH) and has been reviewed by the Scientific, Technical and Economic Committee for Fisheries (STECF). STECF concluded that, based on the fact that such gears operate by trapping fish inside a static netting structure, as opposed to entangling or hooking for example, it may be reasonably assumed that mortality for these gears will be low. |
| --- | --- |

(9)

The joint recommendation is based on scientific evidence of high survivability, provided by the Baltic Sea Fisheries Forum (BALTFISH) and has been reviewed by the Scientific, Technical and Economic Committee for Fisheries (STECF). STECF concluded that, based on the fact that such gears operate by trapping fish inside a static netting structure, as opposed to entangling or hooking for example, it may be reasonably assumed that mortality for these gears will be low.

| (10) | The measures suggested by the joint recommendation comply with Article 15(6) of Regulation (EU) No 1380/2013 and therefore, in line with Article 18(3) of Regulation (EU) No 1380/2013, they should be included in this Regulation. |
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(10)

The measures suggested by the joint recommendation comply with Article 15(6) of Regulation (EU) No 1380/2013 and therefore, in line with Article 18(3) of Regulation (EU) No 1380/2013, they should be included in this Regulation.

| (11) | Since Delegated Regulation (EU) No 1396/2014 expires on 31 December 2017, this Regulation should apply from 1 January 2018, |
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(11)

Since Delegated Regulation (EU) No 1396/2014 expires on 31 December 2017, this Regulation should apply from 1 January 2018,

HAS ADOPTED THIS REGULATION:

Article 1

Subject matter and scope

This Regulation specifies details for implementing the landing obligation as regards salmon caught in the fisheries for salmon, herring, sprat and cod in the Baltic Sea.

Article 2

Definitions

For the purposes of this Regulation, the following definitions shall apply:

| (1) | ‘Baltic Sea’ means ICES divisions IIIb, IIIc and IIId, as specified in Annex III to Regulation (EC) No 218/2009 of the European Parliament and of the Council (5). |
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(1)

‘Baltic Sea’ means ICES divisions IIIb, IIIc and IIId, as specified in Annex III to Regulation (EC) No 218/2009 of the European Parliament and of the Council (5).

5

Article 3

Survivability exemption

1.   By way of derogation from Article 15(1) of Regulation (EU) No 1380/2013, the landing obligation shall not apply to salmon caught with trap-nets, creels/pots, fyke-nets and pound nets.

2.   Salmon caught without an available quota or below the minimum conservation reference size in the circumstances referred to in paragraph 1 shall be released back into the sea.

Article 4

Entry into force

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

Official Journal of the European Union

It shall apply from 1 January 2018 until 31 December 2020.

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

Done at Brussels, 21 November 2017.

For the Commission

The President

Jean-Claude JUNCKER

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(1)  
  OJ L 354, 28.1.2013, p. 22.

1

(2)  Commission Delegated Regulation (EU) No 1396/2014 of 20 October 2014 establishing a discard plan in the Baltic Sea (OJ L 370, 30.12.2014, p. 40).

2

(3)  Regulation (EU) 2016/1139 of the European Parliament and of the Council of 6 July 2016 establishing a multiannual plan for the stocks of cod, herring and sprat in the Baltic Sea and the fisheries exploiting those stocks, amending Council Regulation (EC) No 2187/2005 and repealing Council Regulation (EC) No 1098/2007 (OJ L 191, 15.7.2016, p. 1).

3

(4)  
  ‘BALTFISH High Level Group Joint Recommendation on the Outline of a Discard Plan for the Baltic Sea’, transmitted on 27 May 2014 and on 31 May 2017.

4

(5)  Regulation (EC) No 218/2009 of the European Parliament and of the Council of 11 March 2009 on the submission of nominal catch statistics by Member States fishing in the north-east Atlantic (OJ L 87, 31.3.2009, p. 70).

5

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| 14.2.2018 | EN | Official Journal of the European Union | L 41/4 |
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14.2.2018

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Official Journal of the European Union

L 41/4

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COMMISSION DELEGATED REGULATION (EU) 2018/212

of 13 December 2017

amending Delegated Regulation (EU) 2016/1675 supplementing Directive (EU) 2015/849 of the European Parliament and of the Council, as regards adding Sri Lanka, Trinidad and Tobago, and Tunisia to the table in point I of the Annex

(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 an effective protection of the integrity and proper functioning of its financial system and the internal market from money laundering and terrorist financing. Hence Directive (EU) 2015/849 provides that the Commission should identify high-risk third countries which present strategic deficiencies in their regimes on anti-money-laundering and countering terrorist financing that pose significant threats to the financial system of the Union. |
| --- | --- |

(1)

The Union must ensure an effective protection of the integrity and proper functioning of its financial system and the internal market from money laundering and terrorist financing. Hence Directive (EU) 2015/849 provides that the Commission should identify high-risk third countries which present strategic deficiencies in their regimes on anti-money-laundering and countering terrorist financing that pose significant threats to the financial system of the Union.

| (2) | The Commission should review the list of high-risk third countries listed in Delegated Regulation (EU) 2016/1675 (2) at appropriate times in light of the progress made by those high-risk third countries in removing the strategic deficiencies in their regime on anti-money-laundering and countering terrorist financing (‘AML/CFT’). The Commission should take account in its assessments of new information from international organisations and standard-setters, such as those issued by the Financial Action Task Force (FATF). In light of this information, the Commission should also identify additional high-risk third countries presenting strategic deficiencies in their AML/CFT regime. |
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(2)

The Commission should review the list of high-risk third countries listed in Delegated Regulation (EU) 2016/1675 (2) at appropriate times in light of the progress made by those high-risk third countries in removing the strategic deficiencies in their regime on anti-money-laundering and countering terrorist financing (‘AML/CFT’). The Commission should take account in its assessments of new information from international organisations and standard-setters, such as those issued by the Financial Action Task Force (FATF). In light of this information, the Commission should also identify additional high-risk third countries presenting strategic deficiencies in their AML/CFT regime.

| (3) | In line with the criteria set out in Directive (EU) 2015/849, the Commission took into account the recent available information, in particular recent FATF Public Statements and the FATF document ‘Improving Global AML/CFT Compliance: ongoing process’, and FATF reports of the International Cooperation Review Group in relation to the risks posed by individual third countries in line with Article 9(4) of Directive (EU) 2015/849. |
| --- | --- |

(3)

In line with the criteria set out in Directive (EU) 2015/849, the Commission took into account the recent available information, in particular recent FATF Public Statements and the FATF document ‘Improving Global AML/CFT Compliance: ongoing process’, and FATF reports of the International Cooperation Review Group in relation to the risks posed by individual third countries in line with Article 9(4) of Directive (EU) 2015/849.

| (4) | The FATF identified Sri Lanka, Trinidad and Tobago, and Tunisia as having strategic AML/CFT deficiencies that pose a risk to the international financial system, for which they have developed an action plan with the FATF. |
| --- | --- |

(4)

The FATF identified Sri Lanka, Trinidad and Tobago, and Tunisia as having strategic AML/CFT deficiencies that pose a risk to the international financial system, for which they have developed an action plan with the FATF.

| (5) | 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 or from the Union, as well as the degree of market opening, the Commission hence considers that any AML/CFT threat posed to the international financial system also represents a threat for the Union financial system. |
| --- | --- |

(5)

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 or from the Union, as well as the degree of market opening, the Commission hence considers that any AML/CFT threat posed to the international financial system also represents a threat for the Union financial system.

| (6) | In accordance with the latest relevant information, the Commission's analysis has concluded that Sri Lanka, Trinidad and Tobago, and Tunisia should be considered third-country jurisdictions which have strategic deficiencies in their AML/CFT regime that pose significant threats to the financial system of the Union in accordance with the criteria set out in Article 9 of Directive (EU) 2015/849. However, these 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. The Commission will reassess these countries' status in the light of the implementation of the above commitment. |
| --- | --- |

(6)

In accordance with the latest relevant information, the Commission's analysis has concluded that Sri Lanka, Trinidad and Tobago, and Tunisia should be considered third-country jurisdictions which have strategic deficiencies in their AML/CFT regime that pose significant threats to the financial system of the Union in accordance with the criteria set out in Article 9 of Directive (EU) 2015/849. However, these 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. The Commission will reassess these countries' status in the light of the implementation of the above commitment.

| (7) | Delegated Regulation (EU) 2016/1675 should therefore be amended accordingly, |
| --- | --- |

(7)

Delegated Regulation (EU) 2016/1675 should therefore be amended accordingly,

HAS ADOPTED THIS REGULATION:

Article 1

In the Annex to Delegated Regulation (EU) 2016/1675, in the table in point I the following lines are inserted:

| ‘11 | Sri Lanka |
| --- | --- |
| 12 | Trinidad and Tobago |
| 13 | Tunisia’ |

‘11

Sri Lanka

12

Trinidad and Tobago

13

Tunisia’

Article 2

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

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

Done at Brussels, 13 December 2017.

For the Commission

The President

Jean-Claude JUNCKER

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(1)  
  OJ L 141, 5.6.2015, p. 73.

1

(2)  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 (OJ L 254, 20.9.2016, p. 1).

2

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| 14.2.2018 | EN | Official Journal of the European Union | L 41/6 |
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14.2.2018

EN

Official Journal of the European Union

L 41/6

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COMMISSION REGULATION (EU) 2018/213

of 12 February 2018

on the use of bisphenol A in varnishes and coatings intended to come into contact with food and amending Regulation (EU) No 10/2011 as regards the use of that substance in plastic food contact materials

(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 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC (1), and in particular points (d), (e), (h), (i) and (j) of Article 5(1) thereof,

Whereas:

| (1) | The substance 2,2-bis(4-hydroxyphenyl)propane (CAS 0000080-05-7), commonly known as bisphenol A (BPA) is used in the manufacture of certain materials and articles intended to come into contact with food, such as polycarbonate plastic and epoxy resins used in varnishes and coatings. BPA can migrate into food from the material or article with which it is in contact, resulting in exposure to BPA for consumers of those foods. |
| --- | --- |

(1)

The substance 2,2-bis(4-hydroxyphenyl)propane (CAS 0000080-05-7), commonly known as bisphenol A (BPA) is used in the manufacture of certain materials and articles intended to come into contact with food, such as polycarbonate plastic and epoxy resins used in varnishes and coatings. BPA can migrate into food from the material or article with which it is in contact, resulting in exposure to BPA for consumers of those foods.

| (2) | The use of BPA as a monomer in the production of plastic materials and articles is authorised by Commission Regulation (EU) No 10/2011 (2). The authorisation is subject to a specific migration limit (SML) of 0,6 mg of BPA per kg of food (mg/kg) based on a previous evaluation by the Scientific Committee on Food (3). The European Food Safety Authority (the Authority) has reviewed scientific information and updated its opinion on BPA in 2006 (4), 2008 (5), 2010 (6) and 2011 (7). A prohibition is in place on its use in the manufacture of polycarbonate infant feeding bottles on the basis of the precautionary principle. |
| --- | --- |

(2)

The use of BPA as a monomer in the production of plastic materials and articles is authorised by Commission Regulation (EU) No 10/2011 (2). The authorisation is subject to a specific migration limit (SML) of 0,6 mg of BPA per kg of food (mg/kg) based on a previous evaluation by the Scientific Committee on Food (3). The European Food Safety Authority (the Authority) has reviewed scientific information and updated its opinion on BPA in 2006 (4), 2008 (5), 2010 (6) and 2011 (7). A prohibition is in place on its use in the manufacture of polycarbonate infant feeding bottles on the basis of the precautionary principle.

| (3) | After the publication of its scientific advice on BPA in 2011, the Authority noted that its exposure assessment which dated back to its 2006 opinion needed to be updated in light of new data and that the relevance of dietary exposure in the context of other routes of exposure should also be investigated. The Authority decided to undertake a full re-evaluation of BPA based on the most recent scientific evidence. In 2012, in accordance with Article 29(1)(b) of Regulation (EC) No 178/2002 of the European Parliament and of the Council (8), the Authority asked its scientific Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) to provide a scientific opinion on the risks to public health related to the presence of BPA in foodstuffs. |
| --- | --- |

(3)

After the publication of its scientific advice on BPA in 2011, the Authority noted that its exposure assessment which dated back to its 2006 opinion needed to be updated in light of new data and that the relevance of dietary exposure in the context of other routes of exposure should also be investigated. The Authority decided to undertake a full re-evaluation of BPA based on the most recent scientific evidence. In 2012, in accordance with Article 29(1)(b) of Regulation (EC) No 178/2002 of the European Parliament and of the Council (8), the Authority asked its scientific Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) to provide a scientific opinion on the risks to public health related to the presence of BPA in foodstuffs.

| (4) | The Authority adopted an opinion on 11 December 2014 (9), having reviewed the available data and scientific studies published from 2006 to 2012 as well as some studies available in 2013. In that opinion, the Authority established changes in mean relative kidney weight in a two-generation study in mice as the critical endpoint and calculated a Benchmark Dose (Lower Confidence Limit) (BMDL10) of 8 960 μg/kg bw per day. It was able to apply new toxicokinetic data to allow a more accurate substance-specific extrapolation of data from animals to humans and established a human equivalent dose (HED) of 609 μg/kg bw per day. The HED was used as a reference point for establishing a health-based guidance value for BPA. |
| --- | --- |

(4)

The Authority adopted an opinion on 11 December 2014 (9), having reviewed the available data and scientific studies published from 2006 to 2012 as well as some studies available in 2013. In that opinion, the Authority established changes in mean relative kidney weight in a two-generation study in mice as the critical endpoint and calculated a Benchmark Dose (Lower Confidence Limit) (BMDL10) of 8 960 μg/kg bw per day. It was able to apply new toxicokinetic data to allow a more accurate substance-specific extrapolation of data from animals to humans and established a human equivalent dose (HED) of 609 μg/kg bw per day. The HED was used as a reference point for establishing a health-based guidance value for BPA.

| (5) | To establish this health-based guidance value, the Authority applied an uncertainty factor of 2,5 for inter-species differences and 10 for intra-species differences. It applied an additional factor of 6 to take into account uncertainties surrounding potential health effects of BPA on the mammary gland, reproductive, metabolic, neurobehavioural and immune systems. As a result, an overall uncertainty factor of 150 was applied to establish a new Tolerable Daily Intake (TDI) of 4 μg/kg bw per day. However, the Authority designated the TDI as temporary (t-TDI) pending the anticipated outcome of a long-term toxicity study on BPA in rodents being undertaken by the National Toxicology Program/Food and Drug Administration (NTP/FDA) in the United States of America (USA). |
| --- | --- |

(5)

To establish this health-based guidance value, the Authority applied an uncertainty factor of 2,5 for inter-species differences and 10 for intra-species differences. It applied an additional factor of 6 to take into account uncertainties surrounding potential health effects of BPA on the mammary gland, reproductive, metabolic, neurobehavioural and immune systems. As a result, an overall uncertainty factor of 150 was applied to establish a new Tolerable Daily Intake (TDI) of 4 μg/kg bw per day. However, the Authority designated the TDI as temporary (t-TDI) pending the anticipated outcome of a long-term toxicity study on BPA in rodents being undertaken by the National Toxicology Program/Food and Drug Administration (NTP/FDA) in the United States of America (USA).

| (6) | The Authority noted that dietary exposure to BPA is below the t-TDI and concluded that there is no health concern at the estimated levels of exposure. In its opinion adopted on 11 December 2014, the Authority also estimated non-dietary sources of exposure as well as those from the diet. Non-dietary sources include exposure through air, ingestion of dust and uptake through the skin as a result of contact with thermal paper and cosmetics. The Panel concluded that the central estimates for aggregated exposure to BPA through dietary and non-dietary sources for the highest exposed groups including infants, children and adolescents, are below the t-TDI and that the health concern for BPA is low at the estimated levels of aggregated exposure. |
| --- | --- |

(6)

The Authority noted that dietary exposure to BPA is below the t-TDI and concluded that there is no health concern at the estimated levels of exposure. In its opinion adopted on 11 December 2014, the Authority also estimated non-dietary sources of exposure as well as those from the diet. Non-dietary sources include exposure through air, ingestion of dust and uptake through the skin as a result of contact with thermal paper and cosmetics. The Panel concluded that the central estimates for aggregated exposure to BPA through dietary and non-dietary sources for the highest exposed groups including infants, children and adolescents, are below the t-TDI and that the health concern for BPA is low at the estimated levels of aggregated exposure.

| (7) | Following the opinion published by the Authority in 2014, the current SML for plastic materials and articles should be updated to take account of the new t-TDI. The setting of the SML uses a conventional exposure assumption that 1 kg of food is consumed daily by a person of 60 kg body weight and that all exposure comes from food contact materials. Article 5(1)(e) of Regulation (EC) No 1935/2004 establishes that specific limits on the migration of certain constituents into or onto food should take due account of other possible sources of exposure to those constituents. The Authority noted that exposure from non-dietary sources of BPA may contribute a significant proportion of overall exposure for some population groups and that in addition to these non-dietary sources, non-canned meat and meat products were found to be a major contributor to BPA exposure for several population groups. In such cases where sources other than food contact materials may contribute significantly to the potential overall exposure of a substance, it is not appropriate to allocate the full TDI to food contact materials and a lower value should be used. |
| --- | --- |

(7)

Following the opinion published by the Authority in 2014, the current SML for plastic materials and articles should be updated to take account of the new t-TDI. The setting of the SML uses a conventional exposure assumption that 1 kg of food is consumed daily by a person of 60 kg body weight and that all exposure comes from food contact materials. Article 5(1)(e) of Regulation (EC) No 1935/2004 establishes that specific limits on the migration of certain constituents into or onto food should take due account of other possible sources of exposure to those constituents. The Authority noted that exposure from non-dietary sources of BPA may contribute a significant proportion of overall exposure for some population groups and that in addition to these non-dietary sources, non-canned meat and meat products were found to be a major contributor to BPA exposure for several population groups. In such cases where sources other than food contact materials may contribute significantly to the potential overall exposure of a substance, it is not appropriate to allocate the full TDI to food contact materials and a lower value should be used.

| (8) | Taking into account conventional assumptions on the use of allocation factors for food contact materials, including that the overall exposure does not exceed the t-TDI and the uncertainty factor of 150 in the derivation of the t-TDI, as well as the data in the Authority's opinion on sources of BPA other than food contact materials, an allocation factor of 20 % is considered appropriate when setting the SML. Therefore, on the basis of the t-TDI, the allocation factor and the exposure assumption, an SML of 0,05 mg of BPA per kg of food (mg/kg) should be set for plastic materials and articles to ensure that exposure to BPA remains below the t-TDI and does not endanger human health. |
| --- | --- |

(8)

Taking into account conventional assumptions on the use of allocation factors for food contact materials, including that the overall exposure does not exceed the t-TDI and the uncertainty factor of 150 in the derivation of the t-TDI, as well as the data in the Authority's opinion on sources of BPA other than food contact materials, an allocation factor of 20 % is considered appropriate when setting the SML. Therefore, on the basis of the t-TDI, the allocation factor and the exposure assumption, an SML of 0,05 mg of BPA per kg of food (mg/kg) should be set for plastic materials and articles to ensure that exposure to BPA remains below the t-TDI and does not endanger human health.

| (9) | While the SML established, which takes into account the opinion, serves as a basis for the overall management of risks posed by BPA from food contact materials, there are still uncertainties, which are identified in that opinion. With respect to two new studies on the developmental immunotoxicity of BPA, the Authority stated in 2016 (10) that the new evidence presented by those studies adds to the indications of developmental immunotoxicity of BPA. Taking into account the extent of the scientific uncertainties and the nature of the potential adverse effects, in particular developmental effects, further precautionary steps should be taken as regards more vulnerable population groups, in particular infants and young children, where developmental effects could be irreversible and would last a life-time. |
| --- | --- |

(9)

While the SML established, which takes into account the opinion, serves as a basis for the overall management of risks posed by BPA from food contact materials, there are still uncertainties, which are identified in that opinion. With respect to two new studies on the developmental immunotoxicity of BPA, the Authority stated in 2016 (10) that the new evidence presented by those studies adds to the indications of developmental immunotoxicity of BPA. Taking into account the extent of the scientific uncertainties and the nature of the potential adverse effects, in particular developmental effects, further precautionary steps should be taken as regards more vulnerable population groups, in particular infants and young children, where developmental effects could be irreversible and would last a life-time.

| (10) | The precautionary principle referred to in Article 7 of Regulation (EC) No 178/2002 authorises the adoption of provisional measures on the basis of available pertinent information, pending results related to continued uncertainties, to an additional assessment of risk and a review of the measure within a reasonable period of time. |
| --- | --- |

(10)

The precautionary principle referred to in Article 7 of Regulation (EC) No 178/2002 authorises the adoption of provisional measures on the basis of available pertinent information, pending results related to continued uncertainties, to an additional assessment of risk and a review of the measure within a reasonable period of time.

| (11) | The Commission is authorised to take preventive measures as regards the use of BPA on the basis of the precautionary principle which is applicable in a situation in which there is scientific uncertainty, even if the risk, notably to human health, has not yet been fully demonstrated. In order to do so, BPA should not be used to manufacture polycarbonate drinking cups or bottles which are intended for infants and young children as defined in Regulation (EU) No 609/2013 of the European Parliament and of the Council (11). |
| --- | --- |

(11)

The Commission is authorised to take preventive measures as regards the use of BPA on the basis of the precautionary principle which is applicable in a situation in which there is scientific uncertainty, even if the risk, notably to human health, has not yet been fully demonstrated. In order to do so, BPA should not be used to manufacture polycarbonate drinking cups or bottles which are intended for infants and young children as defined in Regulation (EU) No 609/2013 of the European Parliament and of the Council (11).

| (12) | In addition to its use in plastic food contact materials, BPA is used extensively in epoxy resins for varnishes and coatings, particularly for application on the interior of food cans. While specific measures provided for in Article 5 of Regulation (EC) No 1935/2004 have been adopted as regards BPA in plastic materials and articles, such measures have not been adopted as regards BPA in varnishes and coatings at the Union level. Therefore, in accordance with Article 6 of that Regulation, Member States have been able to maintain or adopt national provisions on BPA in varnishes and coatings provided those measures comply with the rules laid down in the Treaties. |
| --- | --- |

(12)

In addition to its use in plastic food contact materials, BPA is used extensively in epoxy resins for varnishes and coatings, particularly for application on the interior of food cans. While specific measures provided for in Article 5 of Regulation (EC) No 1935/2004 have been adopted as regards BPA in plastic materials and articles, such measures have not been adopted as regards BPA in varnishes and coatings at the Union level. Therefore, in accordance with Article 6 of that Regulation, Member States have been able to maintain or adopt national provisions on BPA in varnishes and coatings provided those measures comply with the rules laid down in the Treaties.

| (13) | In light of the introduction by Member States of divergent national measures applicable to BPA in food contact materials and the resulting technical and practical burdens reported by industry, and having regard to the contribution to dietary exposure of BPA from canned food identified in the Authority's opinion of 2014 and the extensive use of BPA in epoxy resins for varnishes and coatings applied to food cans, it is also appropriate to establish restrictions for BPA used in varnishes and coatings. |
| --- | --- |

(13)

In light of the introduction by Member States of divergent national measures applicable to BPA in food contact materials and the resulting technical and practical burdens reported by industry, and having regard to the contribution to dietary exposure of BPA from canned food identified in the Authority's opinion of 2014 and the extensive use of BPA in epoxy resins for varnishes and coatings applied to food cans, it is also appropriate to establish restrictions for BPA used in varnishes and coatings.

| (14) | The same assumption concerning exposure to BPA from plastic materials and articles applies to varnishes and coatings. In order to ensure the effective functioning of the internal market and to ensure a high level of protection for human health, the SML established for BPA from plastic materials and articles should also apply to varnishes and coatings applied to materials and articles, where that varnish or coating has been produced using BPA. As BPA may be used in food packaging containing foods for infants and young children, BPA should not migrate from varnishes and coatings applied to materials or articles specifically intended to come into contact with food intended for infants and young children as referred to in Regulation (EU) No 609/2013, namely infant formula, follow-on formula, processed cereal-based food, baby food, food for special medical purposes developed to satisfy the nutritional requirements of infants and young children or milk-based drinks and similar products specifically intended for young children. |
| --- | --- |

(14)

The same assumption concerning exposure to BPA from plastic materials and articles applies to varnishes and coatings. In order to ensure the effective functioning of the internal market and to ensure a high level of protection for human health, the SML established for BPA from plastic materials and articles should also apply to varnishes and coatings applied to materials and articles, where that varnish or coating has been produced using BPA. As BPA may be used in food packaging containing foods for infants and young children, BPA should not migrate from varnishes and coatings applied to materials or articles specifically intended to come into contact with food intended for infants and young children as referred to in Regulation (EU) No 609/2013, namely infant formula, follow-on formula, processed cereal-based food, baby food, food for special medical purposes developed to satisfy the nutritional requirements of infants and young children or milk-based drinks and similar products specifically intended for young children.

| (15) | In conjunction with the establishment of restrictions for varnishes and coatings, it is also necessary to define rules for verification of compliance with the restrictions. In particular, rules for migration testing and rules for expression of migration testing results should be established. Therefore it is appropriate to establish such rules for checking compliance with the restrictions for varnishes and coatings applied to materials and articles where those varnishes or coatings have been produced using BPA. |
| --- | --- |

(15)

In conjunction with the establishment of restrictions for varnishes and coatings, it is also necessary to define rules for verification of compliance with the restrictions. In particular, rules for migration testing and rules for expression of migration testing results should be established. Therefore it is appropriate to establish such rules for checking compliance with the restrictions for varnishes and coatings applied to materials and articles where those varnishes or coatings have been produced using BPA.

| (16) | Regulation (EU) No 10/2011 establishes a comprehensive framework for verifying compliance of plastic food contact materials with defined restrictions, including rules on the expression of migration test results. As the varnishes and coatings applied to materials and articles do not have specific characteristics that would require the establishment of different or more specific provisions, it is appropriate to extend the application of the rules laid down in Regulation (EU) No 10/2011 to the verification of compliance of varnishes and coatings applied to materials and articles with the established restrictions. |
| --- | --- |

(16)

Regulation (EU) No 10/2011 establishes a comprehensive framework for verifying compliance of plastic food contact materials with defined restrictions, including rules on the expression of migration test results. As the varnishes and coatings applied to materials and articles do not have specific characteristics that would require the establishment of different or more specific provisions, it is appropriate to extend the application of the rules laid down in Regulation (EU) No 10/2011 to the verification of compliance of varnishes and coatings applied to materials and articles with the established restrictions.

| (17) | Article 16(1) of Regulation (EC) No 1935/2004 provides that materials and articles covered by specific measures be accompanied by a written declaration of compliance stating that they comply with the rules applicable to them. On production of the varnished or coated material or article, the responsible business operator should document compliance with the applicable rules in a declaration of compliance which is made available to their customers. In order to ensure that the declaration provides sufficient information to enable verification of compliance, it is appropriate to specify the information that must be included in the declaration. In addition, competent authorities should be able to verify compliance with the applicable rules. Business operators should therefore be required to make available for the competent authorities appropriate supporting documentation, substantiating the declaration of compliance. |
| --- | --- |

(17)

Article 16(1) of Regulation (EC) No 1935/2004 provides that materials and articles covered by specific measures be accompanied by a written declaration of compliance stating that they comply with the rules applicable to them. On production of the varnished or coated material or article, the responsible business operator should document compliance with the applicable rules in a declaration of compliance which is made available to their customers. In order to ensure that the declaration provides sufficient information to enable verification of compliance, it is appropriate to specify the information that must be included in the declaration. In addition, competent authorities should be able to verify compliance with the applicable rules. Business operators should therefore be required to make available for the competent authorities appropriate supporting documentation, substantiating the declaration of compliance.

| (18) | In order to ensure that the business operators have sufficient time to adjust their manufacturing processes to comply with the restrictions and to reduce the administrative and financial burden that such adjustment may entail, it is appropriate to defer the application of this Regulation and to permit materials and articles which have been lawfully placed on the market before the date of application of this Regulation to remain on the market until the exhaustion of stocks. |
| --- | --- |

(18)

In order to ensure that the business operators have sufficient time to adjust their manufacturing processes to comply with the restrictions and to reduce the administrative and financial burden that such adjustment may entail, it is appropriate to defer the application of this Regulation and to permit materials and articles which have been lawfully placed on the market before the date of application of this Regulation to remain on the market until the exhaustion of stocks.

| (19) | Regulation (EU) No 10/2011 should therefore be amended accordingly. |
| --- | --- |

(19)

Regulation (EU) No 10/2011 should therefore be amended accordingly.

| (20) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, |
| --- | --- |

(20)

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

For the purposes of this Regulation, the following definitions shall apply:

| (1) | ‘specific migration limit’ (SML) means the maximum permitted amount of a given substance released from a material or article into food or food simulants; |
| --- | --- |

(1)

‘specific migration limit’ (SML) means the maximum permitted amount of a given substance released from a material or article into food or food simulants;

| (2) | ‘materials and articles’ means any materials or articles which fall within one of the categories laid down in Article 1(2) of Regulation (EC) No 1935/2004; |
| --- | --- |

(2)

‘materials and articles’ means any materials or articles which fall within one of the categories laid down in Article 1(2) of Regulation (EC) No 1935/2004;

| (3) | ‘varnishes’ or ‘coatings’ means materials or articles composed of one or more non-self-supporting layer or layers manufactured using 2,2-bis(4-hydroxyphenyl)propane (‘BPA’), applied on a material or article in order to impart special properties on it or to improve its technical performance. |
| --- | --- |

(3)

‘varnishes’ or ‘coatings’ means materials or articles composed of one or more non-self-supporting layer or layers manufactured using 2,2-bis(4-hydroxyphenyl)propane (‘BPA’), applied on a material or article in order to impart special properties on it or to improve its technical performance.

Article 2

1.   The migration into or onto food of 2,2-bis(4-hydroxyphenyl)propane (‘BPA’) (CAS No 0000080-05-7) from varnishes or coatings applied to materials and articles shall not exceed a specific migration limit of 0,05 mg of BPA per kg of food (mg/kg).

2.   By derogation from paragraph 1, no migration of BPA shall be permitted from varnishes or coatings applied to materials and articles specifically intended to come into contact with infant formula, follow-on formula, processed cereal-based food, baby food, food for special medical purposes developed to satisfy the nutritional requirements of infants and young children or milk-based drinks and similar products specifically intended for young children, as referred to in Regulation (EU) No 609/2013.

Article 3

1.   In order to verify compliance with Article 2 of this Regulation, rules laid down in Article 11(4), in paragraphs 1, 2, 3, 6 and 7 of Article 18, in Annex III and in Chapters 1, 2 and 4 of Annex V to Regulation (EU) No 10/2011 shall apply.

2.   Test results obtained as part of the verification procedure referred to in paragraph 1 shall be expressed in accordance with the rules laid down in paragraphs 1 to 3 of Article 17 of Regulation (EU) No 10/2011.

Article 4

1.   In accordance with Article 16(1) of Regulation (EC) No 1935/2004, business operators shall ensure that varnished or coated materials and articles are accompanied by a written declaration of compliance containing the information laid down in Annex I to this Regulation. The declaration shall be available at all stages of manufacture, processing and distribution other than the retail stage.

2.   The written declaration shall permit an easy identification of the varnished or coated materials and articles to which it applies. It shall be renewed to reflect any changes in migration levels from the varnish or coating that has been applied to materials and articles.

3.   Business operators shall, upon request of a national competent authority, make available appropriate supporting documentation to demonstrate compliance with the written declaration referred to in paragraph 1. Such supporting documentation shall be provided without delay and in any event not later than 10 days following receipt of the request. The documentation shall contain the conditions and results of the testing, calculations, including modelling, other analysis and evidence on the safety or reasoning demonstrating compliance.

Article 5

Annex I to Regulation (EU) No 10/2011 is amended in accordance with Annex II to this Regulation.

Article 6

Varnished or coated materials and articles and plastic materials and articles that were lawfully placed on the market before 6 September 2018 may remain on the market until exhaustion of stocks.

Article 7

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

It shall apply from 6 September 2018.

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

Done at Brussels, 12 February 2018.

For the Commission

The President

Jean-Claude JUNCKER

---

(1)  
  OJ L 338, 13.11.2004, p. 4.

1

(2)  Commission Regulation (EU) No 10/2011 of 14 January 2011 on plastic materials and articles intended to come into contact with food (OJ L 12, 15.1.2011, p. 1).

2

(3)  Opinion of the Scientific Committee on Food on Bisphenol A (SCF/CS/PM/3936 Final).

3

(4)  The EFSA Journal (2006) 428, 1.

4

(5)  The EFSA Journal (2008) 759, 1.

5

(6)  The EFSA Journal 2010;8(9):1829.

6

(7)  The EFSA Journal 2011;9(12):2475.

7

(8)  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).

8

(9)  The EFSA Journal 2015;13(1):3978.

9

(10)  EFSA Journal 2016;14(10):4580.

10

(11)  Regulation (EU) No 609/2013 of the European Parliament and of the Council of 12 June 2013 on food intended for infants and young children, food for special medical purposes, and total diet replacement for weight control and repealing Council Directive 92/52/EEC, Commission Directives 96/8/EC, 1999/21/EC, 2006/125/EC and 2006/141/EC, Directive 2009/39/EC of the European Parliament and of the Council and Commission Regulations (EC) No 41/2009 and (EC) No 953/2009 (OJ L 181, 29.6.2013, p. 35).

11

---

ANNEX I

The written declaration referred to in Article 4 shall contain the following information:

| (1) | the identity and address of the business operator issuing the declaration of compliance; |
| --- | --- |

(1)

the identity and address of the business operator issuing the declaration of compliance;

| (2) | the identity and address of the business operator which manufactures or imports the coated material or article; |
| --- | --- |

(2)

the identity and address of the business operator which manufactures or imports the coated material or article;

| (3) | the identity of the varnished or coated material or article; |
| --- | --- |

(3)

the identity of the varnished or coated material or article;

| (4) | the date of the declaration; |
| --- | --- |

(4)

the date of the declaration;

| (5) | confirmation that the varnish or coating applied to the material or article meets the restrictions laid down in Article 2 of this Regulation and the requirements set out in Articles 3, 15 and 17 of Regulation (EC) No 1935/2004; |
| --- | --- |

(5)

confirmation that the varnish or coating applied to the material or article meets the restrictions laid down in Article 2 of this Regulation and the requirements set out in Articles 3, 15 and 17 of Regulation (EC) No 1935/2004;

| (6) | specifications on the use of the coated material or article, such as:






  (a) | the type or types of food with which it is intended to be put into contact; |
| --- | --- | --- |

(6)

specifications on the use of the coated material or article, such as:

(a)

the type or types of food with which it is intended to be put into contact;

| (b) | the time and temperature of treatment and storage in contact with food; |
| --- | --- |

(b)

the time and temperature of treatment and storage in contact with food;

| (c) | the highest food contact surface area to volume ratio for which compliance has been verified in accordance with Articles 17 and 18 of Regulation (EU) No 10/2011 or equivalent information. |
| --- | --- |

(c)

the highest food contact surface area to volume ratio for which compliance has been verified in accordance with Articles 17 and 18 of Regulation (EU) No 10/2011 or equivalent information.

---

ANNEX II

In Table 1 of Annex I to Regulation (EU) No 10/2011, the entry concerning substance No 151 is replaced by the following:

| ‘151 | 13480 | 0000080-05-7 | 2,2-bis(4-hydroxyphenyl)propane | no | yes | no | 0,05 | | Not to be used for the manufacture of polycarbonate infant (1) feeding bottles (2).
  Not to be used for the manufacture of polycarbonate drinking cups or bottles which, due to their spill proof characteristics, are intended for infants (3) and young children (4). | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 13607 |

‘151

13480

0000080-05-7

2,2-bis(4-hydroxyphenyl)propane

no

yes

no

0,05

Not to be used for the manufacture of polycarbonate infant (1) feeding bottles (2).

Not to be used for the manufacture of polycarbonate drinking cups or bottles which, due to their spill proof characteristics, are intended for infants (3) and young children (4).

13607

---

(1)  Infant as defined in Article 2(2)(a) of Regulation (EU) No 609/2013 of the European Parliament and of the Council of 12 June 2013 on food intended for infants and young children, food for special medical purposes, and total diet replacement for weight control and repealing Council Directive 92/52/EEC, Commission Directives 96/8/EC, 1999/21/EC, 2006/125/EC and 2006/141/EC, Directive 2009/39/EC of the European Parliament and of the Council and Commission Regulations (EC) No 41/2009 and (EC) No 953/2009 (OJ L 181, 29.6.2013, p. 35).

1

(2)  This restriction is applicable from 1 May 2011 as regards the manufacture and from 1 June 2011 as regards the placing on the market and importation into the Union.

2

(3)  Infant as defined in Article 2(2)(a) of Regulation (EU) No 609/2013

3

(4)  Young children as defined in Article 2(2)(b) of Regulation (EU) No 609/2013.’

4

---

| 14.2.2018 | EN | Official Journal of the European Union | L 41/13 |
| --- | --- | --- | --- |

14.2.2018

EN

Official Journal of the European Union

L 41/13

---

COMMISSION IMPLEMENTING REGULATION (EU) 2018/214

of 13 February 2018

approving an amendment to the specification for a Protected Designation of Origin or a Protected Geographical Indication (‘Pla i Llevant’ (PDO))

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), and in particular Article 99 thereof,

Whereas:

| (1) | The Commission has examined the application for the approval of an amendment to the specification for the Protected Designation of Origin ‘Pla i Llevant’, sent by Spain in accordance with Article 105 of Regulation (EU) No 1308/2013. |
| --- | --- |

(1)

The Commission has examined the application for the approval of an amendment to the specification for the Protected Designation of Origin ‘Pla i Llevant’, sent by Spain in accordance with Article 105 of Regulation (EU) No 1308/2013.

| (2) | The Commission has published the application for the approval of an amendment to the specification in the Official Journal of the European Union, as required by Article 97(3) of Regulation (EU) No 1308/2013 (2). |
| --- | --- |

(2)

The Commission has published the application for the approval of an amendment to the specification in the Official Journal of the European Union, as required by Article 97(3) of Regulation (EU) No 1308/2013 (2).

| (3) | No statement of objection has been received by the Commission under Article 98 of Regulation (EU) No 1308/2013. |
| --- | --- |

(3)

No statement of objection has been received by the Commission under Article 98 of Regulation (EU) No 1308/2013.

| (4) | The amendment to the specification should therefore be approved in accordance with Article 99 of Regulation (EU) No 1308/2013. |
| --- | --- |

(4)

The amendment to the specification should therefore be approved in accordance with Article 99 of Regulation (EU) No 1308/2013.

| (5) | The measures provided for in this Regulation are in accordance with the opinion of the Committee for the Common Organisation of the Agricultural Markets, |
| --- | --- |

(5)

The measures provided for in this Regulation are in accordance with the opinion of the Committee for the Common Organisation of the Agricultural Markets,

HAS ADOPTED THIS REGULATION:

Article 1

The amendment to the specification published in the Official Journal of the European Union regarding the name ‘Pla i Llevant’ (PDO) is hereby approved.

Article 2

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

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

Done at Brussels, 13 February 2018.

For the Commission

The President

Jean-Claude JUNCKER

---

(1)  
  OJ L 347, 20.12.2013, p. 671.

1

(2)  
  OJ C 284, 29.8.2017, p. 5.

2

---

| 14.2.2018 | EN | Official Journal of the European Union | L 41/14 |
| --- | --- | --- | --- |

14.2.2018

EN

Official Journal of the European Union

L 41/14

---

COMMISSION IMPLEMENTING REGULATION (EU) 2018/215

of 13 February 2018

conferring protection under Article 99 of Regulation (EU) No 1308/2013 of the European Parliament and of the Council on the name ‘Mergelland’ (PDO)

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), and in particular Article 99 thereof,

Whereas:

| (1) | In accordance with Article 97(2) and (3) of Regulation (EU) No 1308/2013, the Commission has examined the application to register the name ‘Mergelland’ sent by the Netherlands and has published it in the Official Journal of the European Union (2). |
| --- | --- |

(1)

In accordance with Article 97(2) and (3) of Regulation (EU) No 1308/2013, the Commission has examined the application to register the name ‘Mergelland’ sent by the Netherlands and has published it in the Official Journal of the European Union (2).

| (2) | No statement of objection has been received by the Commission under Article 98 of Regulation (EU) No 1308/2013. |
| --- | --- |

(2)

No statement of objection has been received by the Commission under Article 98 of Regulation (EU) No 1308/2013.

| (3) | In accordance with Article 99 of Regulation (EU) No 1308/2013, the name ‘Mergelland’ should be protected and entered in the register referred to in Article 104 of that Regulation. |
| --- | --- |

(3)

In accordance with Article 99 of Regulation (EU) No 1308/2013, the name ‘Mergelland’ should be protected and entered in the register referred to in Article 104 of that Regulation.

| (4) | The measures provided for in this Regulation are in accordance with the opinion of the Committee for the Common Organisation of the Agricultural Markets, |
| --- | --- |

(4)

The measures provided for in this Regulation are in accordance with the opinion of the Committee for the Common Organisation of the Agricultural Markets,

HAS ADOPTED THIS REGULATION:

Article 1

The name ‘Mergelland’ (PDO) is hereby protected.

Article 2

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

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

Done at Brussels, 13 February 2018.

For the Commission

The President

Jean-Claude JUNCKER

---

(1)  
  OJ L 347, 20.12.2013, p. 671.

1

(2)  
  OJ C 296, 7.9.2017, p. 2.

2

---