ddrg/super_eurlex huggingface dataset:
EN Official Journal of the European Union L 223/58

COMMISSION REGULATION (EU) 2016/1390

of 17 August 2016

refusing to authorise a health claim made on foods and referring to children's development and health

(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 1924/2006 of the European Parliament and of the Council of 20 December 2006 on nutrition and health claims made on foods (1), and in particular Article 17(3) thereof,

Whereas:

(1) Pursuant to Regulation (EC) No 1924/2006 health claims made on foods are prohibited unless they are authorised by the Commission in accordance with that Regulation and included in a list of permitted claims.

(2) Regulation (EC) No 1924/2006 also provides that applications for authorisations of health claims may be submitted by food business operators to the national competent authority of a Member State. The national competent authority is to forward valid applications to the European Food Safety Authority (EFSA), hereinafter referred to as ‘the Authority’.

(3) Following receipt of an application the Authority is to inform without delay the other Member States and the Commission thereof, and to deliver an opinion on the health claim concerned.

(4) The Commission is to decide on the authorisation of health claims taking into account the opinion delivered by the Authority.

(5) Following an application from Vifor Ltd, submitted pursuant to Article 14(1)(b) of Regulation (EC) No 1924/2006, the Authority was required to deliver an opinion on a health claim related to Equazen eye q® and improving reading ability (Question No EFSA-Q-2014- 00462 (2)). The claim proposed by the applicant was worded as follows: ‘Equazen eye q® (composition of EPA:DHA:GLA at a 9:3:1 ratio) improves reading ability and related cognitive functions in children’.

(6) On 13 October 2015, the Commission and the Member States received the scientific opinion from the Authority, which concluded that a cause and effect relationship had not been established between the consumption of Equazen eye q®, a combination of EPA, DHA and GLA (at a weight ratio of 9:3:1), and improving reading ability in children. Accordingly, as the claim does not comply with the requirements of Regulation (EC) No 1924/2006, it should not be authorised.

(7) 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

The health claim listed in the Annex to this Regulation shall not be included in the Union list of permitted claims as provided for in Article 14(1) of Regulation (EC) No 1924/2006.

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, 17 August 2016. For the Commission The President Jean-Claude JUNCKER

(1) OJ L 404, 30.12.2006, p. 9.

(2) EFSA Journal 2015;13(10):4251.
EN Official Journal of the European Union L 254/5

COMMISSION IMPLEMENTING REGULATION (EU) 2016/1676

of 7 September 2016

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

THE EUROPEAN COMMISSION,

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

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

Whereas:

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

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

HAS ADOPTED THIS REGULATION:

Article 1

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

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

Article 2

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

This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 7 September 2016. For the Commission, On behalf of the President, Phil HOGAN Member of the Commission

(1) OJ L 343, 14.12.2012, p. 1.

(2) OJ C 160, 4.5.2016, p. 14.

(3) Commission Implementing Regulation (EU) No 668/2014 of 13 June 2014 laying down rules for the application of Regulation (EU) No 1151/2012 of the European Parliament and of the Council on quality schemes for agricultural products and foodstuffs (OJ L 179, 19.6.2014, p. 36).
EN Official Journal of the European Union L 276/1

COMMISSION IMPLEMENTING REGULATION (EU) 2016/1805

of 29 September 2016

entering a name in the register of protected designations of origin and protected geographical indications (Carmarthen Ham (PGI))

THE EUROPEAN COMMISSION,

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

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

Whereas:

(1) Pursuant to Article 50(2)(a) of Regulation (EU) No 1151/2012, the United Kingdom's application to register the name ‘Carmarthen Ham’ was published in the Official Journal of the European Union (2).

(2) As no statement of opposition under Article 51 of Regulation (EU) No 1151/2012 has been received by the Commission, the name ‘Carmarthen Ham’ should therefore be entered in the register,

HAS ADOPTED THIS REGULATION:

Article 1

The name ‘Carmarthen Ham’ (PGI) is hereby entered in the register.

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

Article 2

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

This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 29 September 2016. For the Commission, On behalf of the President, Phil HOGAN Member of the Commission

(1) OJ L 343, 14.12.2012, p. 1.

(2) OJ C 197, 3.6.2016, p. 9.

(3) Commission Implementing Regulation (EU) No 668/2014 of 13 June 2014 laying down rules for the application of Regulation (EU) No 1151/2012 of the European Parliament and of the Council on quality schemes for agricultural products and foodstuffs (OJ L 179, 19.6.2014, p. 36).
EN Official Journal of the European Union L 270/1

COMMISSION IMPLEMENTING REGULATION (EU) 2016/1766

of 26 September 2016

entering a name in the register of protected designations of origin and protected geographical indications [Korčulansko maslinovo ulje (PDO)]

THE EUROPEAN COMMISSION,

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

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

Whereas:

(1) Pursuant to Article 50(2)(a) of Regulation (EU) No 1151/2012, Croatia's application to register the name ‘Korčulansko maslinovo ulje’ was published in the Official Journal of the European Union (2).

(2) As no statement of opposition under Article 51 of Regulation (EU) No 1151/2012 has been received by the Commission, the name ‘Korčulansko maslinovo ulje’ should therefore be entered in the register,

HAS ADOPTED THIS REGULATION:

Article 1

The name ‘Korčulansko maslinovo ulje’ (PDO) is hereby entered in the register.

The name specified in the first paragraph denotes a product in Class 1.5. Oils and fats (butter, margarine, oil, etc.), as listed in Annex XI to Commission Implementing Regulation (EU) No 668/2014 (3).

Article 2

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

This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 26 September 2016. For the Commission, On behalf of the President, Phil HOGAN Member of the Commission

(1) OJ L 343, 14.12.2012, p. 1.

(2) OJ C 187, 26.5.2016, p. 21.

(3) Commission Implementing Regulation (EU) No 668/2014 of 13 June 2014 laying down rules for the application of Regulation (EU) No 1151/2012 of the European Parliament and of the Council on quality schemes for agricultural products and foodstuffs (OJ L 179, 19.6.2014, p. 36).
EN Official Journal of the European Union L 301/9

COMMISSION IMPLEMENTING REGULATION (EU) 2016/1958

of 4 November 2016

concerning the classification of certain goods in the Combined Nomenclature

THE EUROPEAN COMMISSION,

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

Having regard to Regulation (EU) No 952/2013 of the European Parliament and of the Council of 9 October 2013 laying down the Union Customs Code (1), and in particular Article 57(4) and Article 58(2) thereof,

Whereas:

(1) In order to ensure uniform application of the Combined Nomenclature annexed to Council Regulation (EEC) No 2658/87 (2), it is necessary to adopt measures concerning the classification of the goods referred to in the Annex to this Regulation.

(2) Regulation (EEC) No 2658/87 has laid down the general rules for the interpretation of the Combined Nomenclature. Those rules apply also to any other nomenclature which is wholly or partly based on it or which adds any additional subdivision to it and which is established by specific provisions of the Union, with a view to the application of tariff and other measures relating to trade in goods.

(3) Pursuant to those general rules, the goods described in column (1) of the table set out in the Annex should be classified under the CN code indicated in column (2), by virtue of the reasons set out in column (3) of that table.

(4) It is appropriate to provide that binding tariff information issued in respect of the goods concerned by this Regulation which does not conform to this Regulation may, for a certain period, continue to be invoked by the holder in accordance with Article 34(9) of Regulation (EU) No 952/2013. That period should be set at 3 months.

(5) The measures provided for in this Regulation are in accordance with the opinion of the Customs Code Committee,

HAS ADOPTED THIS REGULATION:

Article 1

The goods described in column (1) of the table set out in the Annex shall be classified within the Combined Nomenclature under the CN code indicated in column (2) of that table.

Article 2

Binding tariff information which does not conform to this Regulation may continue to be invoked in accordance with Article 34(9) of Regulation (EU) No 952/2013 for a period of 3 months from the date of entry into force of this Regulation.

Article 3

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

This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 4 November 2016. For the Commission, On behalf of the President, Stephen QUEST Director-General for Taxation and Customs Union

(1) OJ L 269, 10.10.2013, p. 1.

(2) Council Regulation (EEC) No 2658/87 of 23 July 1987 on the tariff and statistical nomenclature and on the Common Customs Tariff (OJ L 256, 7.9.1987, p. 1).
EN Official Journal of the European Union L 336/22

COMMISSION IMPLEMENTING REGULATION (EU) 2016/2224

of 5 December 2016

concerning the classification of certain goods in the Combined Nomenclature

THE EUROPEAN COMMISSION,

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

Having regard to Regulation (EU) No 952/2013 of the European Parliament and of the Council of 9 October 2013 laying down the Union Customs Code (1), and in particular Article 57(4) and Article 58(2) thereof,

Whereas:

(1) In order to ensure uniform application of the Combined Nomenclature annexed to Council Regulation (EEC) No 2658/87 (2), it is necessary to adopt measures concerning the classification of the goods referred to in the Annex to this Regulation.

(2) Regulation (EEC) No 2658/87 has laid down the general rules for the interpretation of the Combined Nomenclature. Those rules apply also to any other nomenclature which is wholly or partly based on it or which adds any additional subdivision to it and which is established by specific provisions of the Union, with a view to the application of tariff and other measures relating to trade in goods.

(3) Pursuant to those general rules, the goods described in column (1) of the table set out in the Annex should be classified under the CN code indicated in column (2), by virtue of the reasons set out in column (3) of that table.

(4) It is appropriate to provide that binding tariff information issued in respect of the goods concerned by this Regulation which does not conform to this Regulation may, for a certain period, continue to be invoked by the holder in accordance with Article 34(9) of Regulation (EU) No 952/2013. That period should be set at 3 months.

(5) The measures provided for in this Regulation are in accordance with the opinion of the Customs Code Committee,

HAS ADOPTED THIS REGULATION:

Article 1

The goods described in column (1) of the table set out in the Annex shall be classified within the Combined Nomenclature under the CN code indicated in column (2) of that table.

Article 2

Binding tariff information which does not conform to this Regulation may continue to be invoked in accordance with Article 34(9) of Regulation (EU) No 952/2013 for a period of 3 months from the date of entry into force of this Regulation.

Article 3

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

This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 5 December 2016. For the Commission Stephen QUEST Director-General Directorate-General for Taxation and Customs Union

(1) OJ L 269, 10.10.2013, p. 1.

(2) Council Regulation (EEC) No 2658/87 of 23 July 1987 on the tariff and statistical nomenclature and on the Common Customs Tariff (OJ L 256, 7.9.1987, p. 1).
EN Official Journal of the European Union L 344/68

COMMISSION IMPLEMENTING REGULATION (EU) 2016/2289

of 16 December 2016

approving epsilon-Momfluorothrin as an active substance for use in biocidal products of product-type 18

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

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

Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (1), and in particular Article 90(2) thereof,

Whereas:

(1) The United Kingdom received on 29 May 2013 an application, in accordance with Article 11(1) of Directive 98/8/EC of the European Parliament and of the Council (2), for the inclusion of the active substance epsilon-Momfluorothrin, in Annex I to that Directive for use in products of product-type 18, insecticides, acaricides and products to control other arthropods, as described in Annex V to that Directive, which correspond to product-type 18 as described in Annex V to Regulation (EU) No 528/2012.

(2) The United Kingdom submitted the assessment report together with its recommendations on 6 October 2015 in accordance with Article 90(2) of Regulation (EU) No 528/2012.

(3) The opinion of the European Chemicals Agency was formulated on 16 June 2016 by the Biocidal Products Committee, having regard to the conclusions of the evaluating competent authority.

(4) According to that opinion, biocidal products of product-type 18 and containing epsilon-Momfluorothrin may be expected to satisfy the criteria of Article 19(1)(b) of Regulation (EU) No 528/2012, provided that certain specifications and conditions concerning their use are complied with.

(5) It is therefore appropriate to approve epsilon-Momfluorothrin for use in biocidal products of product-type 18, subject to compliance with certain specifications and conditions.

(6) A reasonable period should be allowed to elapse before an active substance is approved in order to permit interested parties to take the preparatory measures necessary to meet the new requirements.

(7) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products,

HAS ADOPTED THIS REGULATION:

Article 1

epsilon-Momfluorothrin is approved as an active substance for use in biocidal products of product-type 18, subject to the specifications and conditions set out in the Annex.

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, 16 December 2016. For the Commission The President Jean-Claude JUNCKER

(1) OJ L 167, 27.6.2012, p. 1.

(2) Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market (OJ L 123, 24.4.1998, p. 1).
EN Official Journal of the European Union L 134/52

Corrigendum to Commission Implementing Regulation (EU) 2017/220 of 8 February 2017 amending Council Implementing Regulation (EU) No 1106/2013 imposing a definitive anti-dumping duty on imports of certain stainless steel wires originating in India following a partial interim review under Article 11(3) of Regulation (EU) 2016/1036 of the European Parliament and of the Council

( Official Journal of the European Union L 34 of 9 February 2017 )

On page 28, Article 1, last row in table, second column ‘Duty (%)’:

for:

‘16,2’,

read:
‘(b)

a short description of the appropriate arrangements to be in place and the date from which these arrangements will be provided in the host Member State;’,
EN Official Journal of the European Union L 38/41

Corrigendum to Commission Implementing Regulation (EU) 2017/1570 of 15 September 2017 amending Implementing Regulation (EU) 2017/366 and Implementing Regulation (EU) 2017/367 imposing definitive countervailing and anti-dumping duties on imports of crystalline silicon photovoltaic modules and key components (i.e. cells) originating in or consigned from the People's Republic of China and repealing Implementing Decision 2013/707/EU confirming the acceptance of an undertaking offered in connection with the anti-dumping and anti-subsidy proceedings concerning imports of crystalline silicon photovoltaic modules and key components (i.e. cells) originating in or consigned from the People's Republic of China for the period of application of definitive measures

( Official Journal of the European Union L 238 of 16 September 2017 )

On page 37, in the Annex:

for:

Name of the company TARIC additional code ‘Zheijiang Era Solar Co. Ltd B818 ’

read:
EN Official Journal of the European Union L 122/36

Corrigendum to Commission Delegated Regulation (EU) 2017/391 of 11 November 2016 supplementing Regulation (EU) No 909/2014 of the European Parliament and of the Council with regard to regulatory technical standards further specifying the content of the reporting on internalised settlements

( Official Journal of the European Union L 65 of 10 March 2017 )

On page 44, in recital 6:

for:

‘ESMA has conducted open public consultations on the draft regulatory technical standards on which this Regulation is based, analysed the potential related costs and benefits and requested the opinion of the Securities and Markets Stakeholder Group established in accordance with Article 10 of Regulation (EU) No 1095/2010 of the European Parliament and of the Council (2).’,

read:
Corrigendum to Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU

( Official Journal of the European Union L 117 of 5 May 2017 )

On page 242, the first subparagraph of Article 83(1):

for:

‘… referred to in Sections 1 and 5 of Annex I and which …’,

read:

‘… referred to in Sections 1 and 8 of Annex I and which …’.

On page 256, Article 110(8):

for:

‘8. By way of derogation from Article 10 and points (a) and (b) of Article 12(1) of Directive 98/79/EC, manufacturers, authorised representatives, importers and notified bodies which, during the period starting on the later of the dates referred to in point (f) of Article 113(3) and ending 18 months later, comply with Article 27(3) and Article 28(1) and Article 51(5) of this Regulation shall be considered to comply with the laws and regulations adopted by Member States in accordance with Article 10 and points (a) and (b) of Article 12(1) of Directive 98/79/EC as specified in Decision 2010/227/EU.’,

read:

‘8. By way of derogation from Article 10, points (a) and (b) of Article 12(1) and Article 15(5) of Directive 98/79/EC, manufacturers, authorised representatives, importers and notified bodies which, during the period starting on the later of the dates referred to in point (f) of Article 113(3) and ending 18 months later, comply with Articles 26(3), 28(1) and 51(5) of this Regulation shall be considered to comply with the laws and regulations adopted by Member States in accordance with Article 10, points (a) and (b) of Article 12(1) and Article 15(5) of Directive 98/79/EC as specified in Decision 2010/227/EU.’.

On page 257, point (b) of the first paragraph of Article 112:

for:

‘(b) Article 10 and points (a) and (b) of Article 12(1) of Directive 98/79/EC, and …’,

read:

‘(b) Article 10, points (a) and (b) of Article 12(1) and Article 15(5) of Directive 98/79/EC, and ...’.

On page 257, Article 113(3), point (a):

for:

‘(a) Article 27(3) and Article 51(5) shall apply from 27 November 2023;’,

read:

‘(a) Articles 26(3) and 51(5) shall apply from 18 months after the later of the dates referred to in point (f);’.

On page 277, Annex III, Section 1, point (b), fifth bullet point:

for:

‘— methods and protocols to manage the events subject to the trend report …’,

read:

‘— methods and protocols to manage the incidents subject to the trend report …’.

On page 304, Annex VIII, Section 2.2, introductory phrase:

for:

‘Devices intended to be used for blood grouping, or tissue typing to ensure the immunological compatibility of blood, …’,

read: