# Official Journal L 309/2015

| | ISSN 1977-0677 |
| --- | --- |
| Official Journal
  of the European Union | L 309 |
| | |
| English edition | Legislation | Volume 5826 November 2015 |

ISSN 1977-0677

Official Journal

of the European Union

L 309

English edition

Legislation

Volume 5826 November 2015

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| Contents | | II   Non-legislative acts | page |
| --- | --- | --- | --- |
| | | REGULATIONS |
| | * | Commission Implementing Regulation (EU) 2015/2178 of 25 November 2015 entering a name in the register of protected designations of origin and protected geographical indications (Saucisson de Lacaune/Saucisse de Lacaune (PGI)) | 1 |
| | * | Commission Implementing Regulation (EU) 2015/2179 of 25 November 2015 initiating a review of Council Implementing Regulation (EU) No 102/2012 imposing a definitive anti-dumping duty on imports of steel ropes and cables originating, inter alia, in the People's Republic of China, as extended to imports of steel ropes and cables consigned from the Republic of Korea, whether declared as originating in the Republic of Korea or not, for the purposes of determining the possibility of granting an exemption from those measures to one Korean exporter, repealing the anti-dumping duty with regard to imports from that exporter and making imports from that exporter subject to registration | 3 |
| | | Commission Implementing Regulation (EU) 2015/2180 of 25 November 2015 establishing the standard import values for determining the entry price of certain fruit and vegetables | 8 |
| | | DECISIONS |
| | * | Commission Implementing Decision (EU) 2015/2181 of 24 November 2015 on the publication with restriction in the Official Journal of the European Union of the reference to standard EN 795:2012 on Personal fall protection equipment — Anchor devices under Regulation (EU) No 1025/2012 of the European Parliament and of the Council (
  1
  ) | 10 |
| | * | Commission Implementing Decision (EU) 2015/2182 of 24 November 2015 on a measure taken by Germany pursuant to Directive 2006/42/EC of the European Parliament and of the Council, to prohibit the placing on the market of a type of a poultry plucking machine
  (notified under document C(2015) 8086)

   (
  1
  ) | 13 |
| | * | Commission Implementing Decision (EU) 2015/2183 of 24 November 2015 establishing a common format for the notification of electronic cigarettes and refill containers
  (notified under document C(2015) 8087)

   (
  1
  ) | 15 |

Contents

II   Non-legislative acts

page

REGULATIONS

*

Commission Implementing Regulation (EU) 2015/2178 of 25 November 2015 entering a name in the register of protected designations of origin and protected geographical indications (Saucisson de Lacaune/Saucisse de Lacaune (PGI))

1

*

Commission Implementing Regulation (EU) 2015/2179 of 25 November 2015 initiating a review of Council Implementing Regulation (EU) No 102/2012 imposing a definitive anti-dumping duty on imports of steel ropes and cables originating, inter alia, in the People's Republic of China, as extended to imports of steel ropes and cables consigned from the Republic of Korea, whether declared as originating in the Republic of Korea or not, for the purposes of determining the possibility of granting an exemption from those measures to one Korean exporter, repealing the anti-dumping duty with regard to imports from that exporter and making imports from that exporter subject to registration

inter alia

3

Commission Implementing Regulation (EU) 2015/2180 of 25 November 2015 establishing the standard import values for determining the entry price of certain fruit and vegetables

8

DECISIONS

*

Commission Implementing Decision (EU) 2015/2181 of 24 November 2015 on the publication with restriction in the Official Journal of the European Union of the reference to standard EN 795:2012 on Personal fall protection equipment — Anchor devices under Regulation (EU) No 1025/2012 of the European Parliament and of the Council (
  1
  )

Official Journal of the European Union

1

10

*

Commission Implementing Decision (EU) 2015/2182 of 24 November 2015 on a measure taken by Germany pursuant to Directive 2006/42/EC of the European Parliament and of the Council, to prohibit the placing on the market of a type of a poultry plucking machine
  (notified under document C(2015) 8086)

   (
  1
  )

(notified under document C(2015) 8086)

1

13

*

Commission Implementing Decision (EU) 2015/2183 of 24 November 2015 establishing a common format for the notification of electronic cigarettes and refill containers
  (notified under document C(2015) 8087)

   (
  1
  )

(notified under document C(2015) 8087)

1

15

| | |
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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. |
| --- | --- |

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

| 26.11.2015 | EN | Official Journal of the European Union | L 309/1 |
| --- | --- | --- | --- |

26.11.2015

EN

Official Journal of the European Union

L 309/1

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COMMISSION IMPLEMENTING REGULATION (EU) 2015/2178

of 25 November 2015

entering a name in the register of protected designations of origin and protected geographical indications (Saucisson de Lacaune/Saucisse de Lacaune (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 Articles 15(1) and 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 de Lacaune’/‘Saucisse de Lacaune’ was published in the Official Journal of the European Union (2). |
| --- | --- |

(1)

Pursuant to Article 50(2)(a) of Regulation (EU) No 1151/2012, France's application to register the name ‘Saucisson de Lacaune’/‘Saucisse de Lacaune’ 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 de Lacaune’/‘Saucisse de Lacaune’ should therefore be entered in the register. |
| --- | --- |

(2)

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

| (3) | By letter received on 27 February 2014, the French authorities notified the Commission that the companies SARL René Pujol, 11 avenue de Lattre de Tassigny, BP 52 81230 Lacaune, La Lacaunaise Escande Pistre & Cie, 7, boulevard Jean-Jaurès, 81230 Lacaune, and Maison Nègre, Charcuterie Lacaunaise, 6 avenue de Naurois, 81230 Lacaune, which are established on their territory, had been legally marketing the product sold under the name ‘Saucisson de Lacaune’/‘Saucisse de Lacaune’, using this name continuously for more than five years, and that this point had been raised during the national opposition procedure. |
| --- | --- |

(3)

By letter received on 27 February 2014, the French authorities notified the Commission that the companies SARL René Pujol, 11 avenue de Lattre de Tassigny, BP 52 81230 Lacaune, La Lacaunaise Escande Pistre & Cie, 7, boulevard Jean-Jaurès, 81230 Lacaune, and Maison Nègre, Charcuterie Lacaunaise, 6 avenue de Naurois, 81230 Lacaune, which are established on their territory, had been legally marketing the product sold under the name ‘Saucisson de Lacaune’/‘Saucisse de Lacaune’, using this name continuously for more than five years, and that this point had been raised during the national opposition procedure.

| (4) | Since the companies SARL René Pujol, La Lacaunaise Escande Pistre & Cie, and Maison Nègre referred to in recital 3 above meet the requirements laid down in Article 15(1) of Regulation (EU) No 1151/2012 for the granting of a transitional period in which to make legal use of the sales name after registration, they should be granted a transitional period of five years starting from the date on which the application for registration was lodged with the Commission, during which time they may make use of the name ‘Saucisson de Lacaune’/‘Saucisse de Lacaune’. |
| --- | --- |

(4)

Since the companies SARL René Pujol, La Lacaunaise Escande Pistre & Cie, and Maison Nègre referred to in recital 3 above meet the requirements laid down in Article 15(1) of Regulation (EU) No 1151/2012 for the granting of a transitional period in which to make legal use of the sales name after registration, they should be granted a transitional period of five years starting from the date on which the application for registration was lodged with the Commission, during which time they may make use of the name ‘Saucisson de Lacaune’/‘Saucisse de Lacaune’.

| (5) | The measures provided for in this Regulation are in accordance with the opinion of the Agricultural Product Quality Policy Committee, |
| --- | --- |

(5)

The measures provided for in this Regulation are in accordance with the opinion of the Agricultural Product Quality Policy Committee,

HAS ADOPTED THIS REGULATION:

Article 1

The name ‘Saucisson de Lacaune’/‘Saucisse de Lacaune’ (PGI) is hereby entered in the register.

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

Article 2

The companies SARL René Pujol, La Lacaunaise Escande Pistre & Cie, and Maison Nègre Charcuterie Lacaunaise are authorised to continue to use the registered name ‘Saucisson de Lacaune’/‘Saucisse de Lacaune’ (PGI) until 27 February 2019.

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, 25 November 2015.

For the Commission

The President

Jean-Claude JUNCKER

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

1

(2)  
  OJ C 142, 29.4.2015, p. 25.

2

(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).

3

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| 26.11.2015 | EN | Official Journal of the European Union | L 309/3 |
| --- | --- | --- | --- |

26.11.2015

EN

Official Journal of the European Union

L 309/3

---

COMMISSION IMPLEMENTING REGULATION (EU) 2015/2179

of 25 November 2015

initiating a review of Council Implementing Regulation (EU) No 102/2012 imposing a definitive anti-dumping duty on imports of steel ropes and cables originating, inter alia, in the People's Republic of China, as extended to imports of steel ropes and cables consigned from the Republic of Korea, whether declared as originating in the Republic of Korea or not, for the purposes of determining the possibility of granting an exemption from those measures to one Korean exporter, repealing the anti-dumping duty with regard to imports from that exporter and making imports from that exporter subject to registration

THE EUROPEAN COMMISSION,

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

Having regard to Council Regulation (EC) No 1225/2009 of 30 November 2009 on protection against dumped imports from countries not members of the European Community (1) (‘the basic Regulation’), and in particular Articles 11(4), 13(4) and 14(5) thereof,

After informing the Member States,

Whereas:

1.   REQUEST FOR A REVIEW

REQUEST FOR A REVIEW

| (1) | The European Commission (‘the Commission’) received a request for an exemption from the anti-dumping measures applicable to imports of steel ropes and cables originating in the People's Republic of China, as extended to imports consigned from the Republic of Korea, whether declared as originating in the Republic of Korea or not, pursuant to Articles 11(4) and 13(4) of the basic Regulation. |
| --- | --- |

(1)

The European Commission (‘the Commission’) received a request for an exemption from the anti-dumping measures applicable to imports of steel ropes and cables originating in the People's Republic of China, as extended to imports consigned from the Republic of Korea, whether declared as originating in the Republic of Korea or not, pursuant to Articles 11(4) and 13(4) of the basic Regulation.

| (2) | The request was lodged on 7 September 2015 by Daechang Steel Co. Ltd (‘the applicant’), an exporting producer of steel ropes and cables in the Republic of Korea (the country concerned) and it was limited to the applicant. |
| --- | --- |

(2)

The request was lodged on 7 September 2015 by Daechang Steel Co. Ltd (‘the applicant’), an exporting producer of steel ropes and cables in the Republic of Korea (the country concerned) and it was limited to the applicant.

2.   PRODUCT UNDER REVIEW

PRODUCT UNDER REVIEW

| (3) | The product under review is steel ropes and cables including locked coil ropes, excluding ropes and cables of stainless steel, with a maximum cross-sectional dimension exceeding 3 mm, consigned from the Republic of Korea, whether declared as originating in the Republic of Korea or not (‘the product under review’), currently falling within CN codes ex 7312 10 81, ex 7312 10 83, ex 7312 10 85, ex 7312 10 89 and ex 7312 10 98 (TARIC codes 7312108113, 7312108313, 7312108513, 7312108913 and 7312109813). |
| --- | --- |

(3)

The product under review is steel ropes and cables including locked coil ropes, excluding ropes and cables of stainless steel, with a maximum cross-sectional dimension exceeding 3 mm, consigned from the Republic of Korea, whether declared as originating in the Republic of Korea or not (‘the product under review’), currently falling within CN codes ex 7312 10 81, ex 7312 10 83, ex 7312 10 85, ex 7312 10 89 and ex 7312 10 98 (TARIC codes 7312108113, 7312108313, 7312108513, 7312108913 and 7312109813).

3.   EXISTING MEASURES

EXISTING MEASURES

| (4) | The Council, by Regulation (EC) No 1796/1999 (2), imposed anti-dumping measures on steel ropes and cables originating, inter alia, in the People's Republic of China (‘the original measures’). By Regulation (EC) No 1858/2005 (3), the Council maintained the original measures following an expiry review in accordance with Article 11(2) of the basic Regulation. By Implementing Regulation (EU) No 400/2010 (4), the Council extended the measures to steel ropes and cables consigned from the Republic of Korea, whether declared as originating in the Republic of Korea or not (‘the extended measures’), with the exception of those produced by companies specially mentioned in Article 1 of that Regulation. |
| --- | --- |

(4)

The Council, by Regulation (EC) No 1796/1999 (2), imposed anti-dumping measures on steel ropes and cables originating, inter alia, in the People's Republic of China (‘the original measures’). By Regulation (EC) No 1858/2005 (3), the Council maintained the original measures following an expiry review in accordance with Article 11(2) of the basic Regulation. By Implementing Regulation (EU) No 400/2010 (4), the Council extended the measures to steel ropes and cables consigned from the Republic of Korea, whether declared as originating in the Republic of Korea or not (‘the extended measures’), with the exception of those produced by companies specially mentioned in Article 1 of that Regulation.

2

inter alia

3

4

| (5) | The measures currently in force are a definitive anti-dumping duty imposed by Council Implementing Regulation (EU) No 102/2012 (5) following an expiry review pursuant to Article 11(2) of the basic Regulation, as last amended by Commission Implementing Regulation (EU) No 493/2014 (6), under which, inter alia, imports into the European Union of the product under review consigned from the Republic of Korea are subject to a definitive anti-dumping duty of 60,4 %, with the exception of the product manufactured by companies which have been exempted. |
| --- | --- |

(5)

The measures currently in force are a definitive anti-dumping duty imposed by Council Implementing Regulation (EU) No 102/2012 (5) following an expiry review pursuant to Article 11(2) of the basic Regulation, as last amended by Commission Implementing Regulation (EU) No 493/2014 (6), under which, inter alia, imports into the European Union of the product under review consigned from the Republic of Korea are subject to a definitive anti-dumping duty of 60,4 %, with the exception of the product manufactured by companies which have been exempted.

5

6

inter alia

4.   GROUNDS FOR THE REVIEW

GROUNDS FOR THE REVIEW

| (6) | The applicant provided prima facie evidence that: |
| --- | --- |

(6)

The applicant provided prima facie evidence that:

| (7) | it did not export the product under review to the Union during the investigation period used in the investigation that led to the extended measures, namely the period from 1 July 2008 to 30 June 2009; |
| --- | --- |

(7)

it did not export the product under review to the Union during the investigation period used in the investigation that led to the extended measures, namely the period from 1 July 2008 to 30 June 2009;

| (8) | it is not related to any of the exporting producers of the product under review which are subject to the anti-dumping duties in force, and that it has not circumvented the measures applicable to steel ropes and cables of Chinese origin; and |
| --- | --- |

(8)

it is not related to any of the exporting producers of the product under review which are subject to the anti-dumping duties in force, and that it has not circumvented the measures applicable to steel ropes and cables of Chinese origin; and

| (9) | it has entered into an irrevocable contractual obligation to export a significant quantity to the Union. |
| --- | --- |

(9)

it has entered into an irrevocable contractual obligation to export a significant quantity to the Union.

5.   PROCEDURE

PROCEDURE

5.1.   Initiation

Initiation

| (10) | The Commission examined the evidence available and concluded that there was sufficient evidence to justify the initiation of an investigation pursuant to Articles 11(4) and 13(4) of the basic Regulation for the purposes of determining the possibility of granting the applicant an exemption from the extended measures. Union producers known to be concerned were informed of the request for a review and were given an opportunity to comment. |
| --- | --- |

(10)

The Commission examined the evidence available and concluded that there was sufficient evidence to justify the initiation of an investigation pursuant to Articles 11(4) and 13(4) of the basic Regulation for the purposes of determining the possibility of granting the applicant an exemption from the extended measures. Union producers known to be concerned were informed of the request for a review and were given an opportunity to comment.

5.2.   Repeal of the existing measures and registration of imports

Repeal of the existing measures and registration of imports

| (11) | Pursuant to Article 11(4) of the basic Regulation, the anti-dumping duty in force should be repealed with regard to imports of the product under review which are produced and sold for export to the Union by the applicant. At the same time, such imports should be made subject to registration in accordance with Article 14(5) of the basic Regulation, in order to ensure that, should the review result in a finding of circumvention in respect of the applicant, anti-dumping duties can be levied from the date of the registration of these imports. The amount of the applicant's possible future liabilities cannot be estimated at this stage of the investigation. |
| --- | --- |

(11)

Pursuant to Article 11(4) of the basic Regulation, the anti-dumping duty in force should be repealed with regard to imports of the product under review which are produced and sold for export to the Union by the applicant. At the same time, such imports should be made subject to registration in accordance with Article 14(5) of the basic Regulation, in order to ensure that, should the review result in a finding of circumvention in respect of the applicant, anti-dumping duties can be levied from the date of the registration of these imports. The amount of the applicant's possible future liabilities cannot be estimated at this stage of the investigation.

5.3.   Investigating the applicant

Investigating the applicant

| (12) | In order to obtain information it deems necessary for its investigation, the Commission will send a questionnaire to the applicant. The applicant must submit the completed questionnaire within 37 days of the date of entry into force of this Regulation, unless otherwise specified, pursuant to Article 6(2) of the basic Regulation. |
| --- | --- |

(12)

In order to obtain information it deems necessary for its investigation, the Commission will send a questionnaire to the applicant. The applicant must submit the completed questionnaire within 37 days of the date of entry into force of this Regulation, unless otherwise specified, pursuant to Article 6(2) of the basic Regulation.

5.4.   Other written submissions

Other written submissions

| (13) | Subject to the provisions of this Regulation, all interested parties are invited to make their views known, submit information and provide supporting evidence. Unless otherwise specified, this information and supporting evidence must reach the Commission within 37 days of the date of entry into force of this Regulation. |
| --- | --- |

(13)

Subject to the provisions of this Regulation, all interested parties are invited to make their views known, submit information and provide supporting evidence. Unless otherwise specified, this information and supporting evidence must reach the Commission within 37 days of the date of entry into force of this Regulation.

5.5.   Possibility to be heard by the Commission investigation services

Possibility to be heard by the Commission investigation services

| (14) | All interested parties may request to be heard by the Commission investigation services. Any request to be heard must be made in writing and must specify the reasons for the request. For hearings on issues pertaining to the initiation stage of the investigation the request must be submitted within 15 days of the date of entry into force of this Regulation. Thereafter, a request to be heard must be submitted within the specific deadlines set by the Commission in its communication with the parties. |
| --- | --- |

(14)

All interested parties may request to be heard by the Commission investigation services. Any request to be heard must be made in writing and must specify the reasons for the request. For hearings on issues pertaining to the initiation stage of the investigation the request must be submitted within 15 days of the date of entry into force of this Regulation. Thereafter, a request to be heard must be submitted within the specific deadlines set by the Commission in its communication with the parties.

5.6.   Instructions for making written submissions and sending completed questionnaires and correspondence

Instructions for making written submissions and sending completed questionnaires and correspondence

| (15) | Information submitted to the Commission for the purpose of trade defence investigations shall be free from copyrights. Interested parties, before submitting to the Commission information and/or data which is subject to third party copyrights, must request specific permission to the copyright holder explicitly allowing: (a) the Commission to use the information and data for the purpose of this trade defence proceeding; and (b) to provide the information and/or data to interested parties to this investigation in a form that allows them to exercise their right of defence. |
| --- | --- |

(15)

Information submitted to the Commission for the purpose of trade defence investigations shall be free from copyrights. Interested parties, before submitting to the Commission information and/or data which is subject to third party copyrights, must request specific permission to the copyright holder explicitly allowing: (a) the Commission to use the information and data for the purpose of this trade defence proceeding; and (b) to provide the information and/or data to interested parties to this investigation in a form that allows them to exercise their right of defence.

| (16) | All written submissions, including the information requested in this Regulation, completed questionnaires and correspondence provided by interested parties for which confidential treatment is requested should be labelled ‘Limited’ (7). |
| --- | --- |

(16)

All written submissions, including the information requested in this Regulation, completed questionnaires and correspondence provided by interested parties for which confidential treatment is requested should be labelled ‘Limited’ (7).

7

| (17) | Interested parties providing ‘Limited’ information are required to furnish non-confidential summaries of it pursuant to Article 19(2) of the basic Regulation, which will be labelled ‘For inspection by interested parties’. These summaries should be sufficiently detailed to permit a reasonable understanding of the substance of the information submitted in confidence. If an interested party providing confidential information does not furnish a non-confidential summary of it in the requested format and quality, such information may be disregarded. |
| --- | --- |

(17)

Interested parties providing ‘Limited’ information are required to furnish non-confidential summaries of it pursuant to Article 19(2) of the basic Regulation, which will be labelled ‘For inspection by interested parties’. These summaries should be sufficiently detailed to permit a reasonable understanding of the substance of the information submitted in confidence. If an interested party providing confidential information does not furnish a non-confidential summary of it in the requested format and quality, such information may be disregarded.

| (18) | Interested parties are invited to make all submissions and requests by e-mail including scanned powers of attorney and certification sheets, with the exception of voluminous replies which should be submitted on a CD-ROM or DVD by hand or by registered mail. By using e-mail, interested parties express their agreement with the rules applicable to electronic submissions contained in the document ‘CORRESPONDENCE WITH THE EUROPEAN COMMISSION IN TRADE DEFENCE CASES’ published on the website of the Directorate-General for Trade: http://trade.ec.europa.eu/doclib/docs/2011/june/tradoc_148003.pdf. The interested parties must indicate their name, address, telephone and a valid e-mail address and they should ensure that the provided e-mail address is a functioning official business e-mail which is checked on a daily basis. Once contact details are provided, the Commission will communicate with interested parties by e-mail only, unless they explicitly request to receive all documents from the Commission by another means of communication or unless the nature of the document to be sent requires the use of a registered mail. For further rules and information concerning correspondence with the Commission including principles that apply to submissions by e-mail, interested parties should consult the communication instructions with interested parties referred to above.
  Commission address for correspondence:





  European Commission |
| --- | --- |
| Directorate-General for Trade |
| Directorate H |
| Office: CHAR 04/039 |
| 1040 Brussels |
| BELGIUM |
| E-mail: TRADE-SWR-R636-DUMP@ec.europa.eu |

(18)

Interested parties are invited to make all submissions and requests by e-mail including scanned powers of attorney and certification sheets, with the exception of voluminous replies which should be submitted on a CD-ROM or DVD by hand or by registered mail. By using e-mail, interested parties express their agreement with the rules applicable to electronic submissions contained in the document ‘CORRESPONDENCE WITH THE EUROPEAN COMMISSION IN TRADE DEFENCE CASES’ published on the website of the Directorate-General for Trade: http://trade.ec.europa.eu/doclib/docs/2011/june/tradoc_148003.pdf. The interested parties must indicate their name, address, telephone and a valid e-mail address and they should ensure that the provided e-mail address is a functioning official business e-mail which is checked on a daily basis. Once contact details are provided, the Commission will communicate with interested parties by e-mail only, unless they explicitly request to receive all documents from the Commission by another means of communication or unless the nature of the document to be sent requires the use of a registered mail. For further rules and information concerning correspondence with the Commission including principles that apply to submissions by e-mail, interested parties should consult the communication instructions with interested parties referred to above.

Commission address for correspondence:

European Commission

Directorate-General for Trade

Directorate H

Office: CHAR 04/039

1040 Brussels

BELGIUM

E-mail: TRADE-SWR-R636-DUMP@ec.europa.eu

6.   NON-COOPERATION

NON-COOPERATION

| (19) | In cases where any interested party refuses access to or does not provide the necessary information within the time limits, or significantly impedes the investigation, findings, affirmative or negative, may be made on the basis of facts available, in accordance with Article 18 of the basic Regulation. |
| --- | --- |

(19)

In cases where any interested party refuses access to or does not provide the necessary information within the time limits, or significantly impedes the investigation, findings, affirmative or negative, may be made on the basis of facts available, in accordance with Article 18 of the basic Regulation.

| (20) | Where it is found that any interested party has supplied false or misleading information, the information may be disregarded and use may be made of facts available. |
| --- | --- |

(20)

Where it is found that any interested party has supplied false or misleading information, the information may be disregarded and use may be made of facts available.

| (21) | If an interested party does not cooperate or cooperates only partially and findings are therefore based on facts available in accordance with Article 18 of the basic Regulation, the result may be less favourable to that party than if it had cooperated. |
| --- | --- |

(21)

If an interested party does not cooperate or cooperates only partially and findings are therefore based on facts available in accordance with Article 18 of the basic Regulation, the result may be less favourable to that party than if it had cooperated.

| (22) | Failure to give a computerised response will not be deemed to constitute non-cooperation, provided that the interested party shows that presenting the response as requested would result in an unreasonable extra burden or unreasonable additional cost. The interested party should immediately contact the Commission. |
| --- | --- |

(22)

Failure to give a computerised response will not be deemed to constitute non-cooperation, provided that the interested party shows that presenting the response as requested would result in an unreasonable extra burden or unreasonable additional cost. The interested party should immediately contact the Commission.

7.   HEARING OFFICER

HEARING OFFICER

| (23) | Interested parties may request the intervention of the Hearing Officer in trade proceedings. The Hearing Officer acts as an interface between the interested parties and the Commission investigation services. The Hearing Officer reviews requests for access to the file, disputes regarding the confidentiality of documents, requests for extension of time limits and requests by third parties to be heard. The Hearing Officer may organise a hearing with an individual interested party and mediate to ensure that the interested parties' rights of defence are being fully exercised. The Hearing Officer will also provide opportunities for a hearing involving parties to take place which would allow different views to be presented and rebuttal arguments offered. |
| --- | --- |

(23)

Interested parties may request the intervention of the Hearing Officer in trade proceedings. The Hearing Officer acts as an interface between the interested parties and the Commission investigation services. The Hearing Officer reviews requests for access to the file, disputes regarding the confidentiality of documents, requests for extension of time limits and requests by third parties to be heard. The Hearing Officer may organise a hearing with an individual interested party and mediate to ensure that the interested parties' rights of defence are being fully exercised. The Hearing Officer will also provide opportunities for a hearing involving parties to take place which would allow different views to be presented and rebuttal arguments offered.

| (24) | A request for a hearing with the Hearing Officer should be made in writing and should specify the reasons for the request. For hearings on issues pertaining to the initial stage of the investigation the request must be submitted within 15 days of the date of entry into force of this Regulation. Thereafter, a request to be heard must be submitted within specific deadlines set by the Commission in its communication with the parties. |
| --- | --- |

(24)

A request for a hearing with the Hearing Officer should be made in writing and should specify the reasons for the request. For hearings on issues pertaining to the initial stage of the investigation the request must be submitted within 15 days of the date of entry into force of this Regulation. Thereafter, a request to be heard must be submitted within specific deadlines set by the Commission in its communication with the parties.

| (25) | For further information and contact details interested parties may consult the Hearing Officer's web pages on DG Trade's website: http://ec.europa.eu/trade/trade-policy-and-you/contacts/hearing-officer/. |
| --- | --- |

(25)

For further information and contact details interested parties may consult the Hearing Officer's web pages on DG Trade's website: http://ec.europa.eu/trade/trade-policy-and-you/contacts/hearing-officer/.

8.   SCHEDULE OF INVESTIGATION

SCHEDULE OF INVESTIGATION

| (26) | The investigation will be concluded, pursuant to Article 11(5) of the basic Regulation, within nine months of the date of the entry into force of this Regulation. |
| --- | --- |

(26)

The investigation will be concluded, pursuant to Article 11(5) of the basic Regulation, within nine months of the date of the entry into force of this Regulation.

9.   PROCESSING OF PERSONAL DATA

PROCESSING OF PERSONAL DATA

| (27) | Any personal data collected in this investigation will be treated in accordance with Regulation (EC) No 45/2001 of the European Parliament and of the Council (8), |
| --- | --- |

(27)

Any personal data collected in this investigation will be treated in accordance with Regulation (EC) No 45/2001 of the European Parliament and of the Council (8),

8

HAS ADOPTED THIS REGULATION:

Article 1

A review of Implementing Regulation (EU) No 102/2012 as last amended by Implementing Regulation (EU) No 493/2014, is hereby initiated pursuant to Articles 11(4) and 13(4) of Regulation (EC) No 1225/2009 in order to establish whether the imports of steel ropes and cables including locked coil ropes, excluding ropes and cables of stainless steel, with a maximum cross-sectional dimension exceeding 3 mm, currently falling within CN codes ex 7312 10 81, ex 7312 10 83, ex 7312 10 85, ex 7312 10 89 and ex 7312 10 98 (TARIC codes 7312108113, 7312108313, 7312108513, 7312108913, and 7312109813), consigned from the Republic of Korea and produced and sold for export to the Union by Daechang Steel Co. Ltd, should be subject to the anti-dumping imposed by Implementing Regulation (EU) No 102/2012.

Article 2

The anti-dumping duty imposed by Implementing Regulation (EU) No 102/2012, as last amended by Implementing Regulation (EU) No 493/2014, is hereby repealed with regard to the imports identified in Article 1 of the present Regulation.

Article 3

The Customs authorities shall take the appropriate steps to register the imports into the Union identified in Article 1 of this Regulation, pursuant to Article 14(5) of Regulation (EC) No 1225/2009.

Registration shall expire nine months following the date of entry into force of this Regulation.

Article 4

This Regulation shall enter into force on the 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, 25 November 2015.

For the Commission

The President

Jean-Claude JUNCKER

---

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

1

(2)  Council Regulation (EC) No 1796/1999 of 12 August 1999 imposing a definitive anti-dumping duty, and collecting definitively the provisional duty imposed, on imports of steel ropes and cables originating in the People's Republic of China, Hungary, India, Mexico, Poland, South Africa and Ukraine and terminating the anti-dumping proceeding in respect of imports originating in the Republic of Korea (OJ L 217, 17.8.1999, p. 1).

2

(3)  Council Regulation (EC) No 1858/2005 of 8 November 2005 imposing a definitive anti-dumping duty on imports of steel ropes and cables originating in the People's Republic of China, India, South Africa and Ukraine following an expiry review pursuant to Article 11(2) of Regulation (EC) No 384/96 (OJ L 299, 16.11.2005, p. 1).

3

(4)  Implementing Regulation of the Council (EU) No 400/2010 of 26 April 2010 extending the definitive anti-dumping duty imposed by Regulation (EC) No 1858/2005 on imports of steel ropes and cables originating, inter alia, in the People's Republic of China to imports of steel ropes and cables consigned from the Republic of Korea, whether declared as originating in the Republic of Korea or not, and terminating the investigation in respect of imports consigned from Malaysia (OJ L 117, 11.5.2010, p. 1).

4

inter alia

(5)  Council Implementing Regulation (EU) No 102/2012 of 27 January 2012 imposing a definitive anti-dumping duty on imports of steel ropes and cables originating in the People's Republic of China and Ukraine as extended to imports of steel ropes and cables consigned from Morocco, Moldova and the Republic of Korea, whether declared as originating in these countries or not, following an expiry review pursuant to Article 11(2) of Regulation (EC) No 1225/2009 and terminating the expiry review proceeding concerning imports of steel ropes and cables originating in South Africa pursuant to Article 11(2) of Regulation (EC) No 1225/2009 (OJ L 36, 9.2.2012, p. 1).

5

(6)  Commission Implementing Regulation (EU) No 493/2014 of 13 May 2014 amending Council Implementing Regulation (EU) No 102/2012 imposing a definitive anti-dumping duty on imports of steel ropes and cables originating, inter alia, in the People's Republic of China, as extended to imports of steel ropes and cables consigned from, inter alia, the Republic of Korea, whether declared as originating in the Republic of Korea or not (OJ L 139, 14.5.2014, p. 7).

6

inter alia

inter alia

(7)  A ‘Limited’ document is a document which is considered confidential pursuant to Article 19 of Council Regulation (EC) No 1225/2009 (OJ L 343, 22.12.2009, p. 51) and Article 6 of the WTO Agreement on Implementation of Article VI of the GATT 1994 (Anti-Dumping Agreement). It is also a document protected pursuant to Article 4 of Regulation (EC) No 1049/2001 of the European Parliament and of the Council (OJ L 145, 31.5.2001, p. 43).

7

(8)  Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data (OJ L 8, 12.1.2001, p. 1).

8

---

| 26.11.2015 | EN | Official Journal of the European Union | L 309/8 |
| --- | --- | --- | --- |

26.11.2015

EN

Official Journal of the European Union

L 309/8

---

COMMISSION IMPLEMENTING REGULATION (EU) 2015/2180

of 25 November 2015

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

THE EUROPEAN COMMISSION,

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

Having regard to Regulation (EU) No 1308/2013 of the European Parliament and of the Council of 17 December 2013 establishing a common organisation of the markets in agricultural products and repealing Council Regulations (EEC) No 922/72, (EEC) No 234/79, (EC) No 1037/2001 and (EC) No 1234/2007 (1),

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

Whereas:

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

(1)

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

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

(2)

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

HAS ADOPTED THIS REGULATION:

Article 1

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

Article 2

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

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

Done at Brussels, 25 November 2015.

For the Commission,

On behalf of the President,

Jerzy PLEWA

Director-General for Agriculture and Rural Development

---

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

1

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

2

---

ANNEX

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

| (EUR/100 kg) |
| --- |
| CN code | Third country code (1) | Standard import value |
| 0702 00 00 | AL | 53,3 |
| MA | 75,8 |
| ZZ | 64,6 |
| 0707 00 05 | AL | 78,9 |
| MA | 96,4 |
| TR | 144,2 |
| ZZ | 106,5 |
| 0709 93 10 | AL | 83,5 |
| MA | 88,6 |
| TR | 160,6 |
| ZZ | 110,9 |
| 0805 20 10 | CL | 96,2 |
| MA | 87,3 |
| PE | 78,8 |
| ZZ | 87,4 |
| 0805 20 30 , 0805 20 50 , 0805 20 70 , 0805 20 90 | TR | 61,9 |
| ZZ | 61,9 |
| 0805 50 10 | AR | 61,0 |
| TR | 95,9 |
| ZZ | 78,5 |
| 0808 10 80 | AU | 166,8 |
| CA | 159,7 |
| CL | 85,5 |
| MK | 28,7 |
| NZ | 173,1 |
| US | 117,9 |
| ZA | 164,9 |
| ZZ | 128,1 |
| 0808 30 90 | BA | 86,2 |
| CN | 63,9 |
| TR | 128,8 |
| ZZ | 93,0 |

(EUR/100 kg)

CN code

Third country code (1)

Standard import value

0702 00 00

AL

53,3

MA

75,8

ZZ

64,6

0707 00 05

AL

78,9

MA

96,4

TR

144,2

ZZ

106,5

0709 93 10

AL

83,5

MA

88,6

TR

160,6

ZZ

110,9

0805 20 10

CL

96,2

MA

87,3

PE

78,8

ZZ

87,4

0805 20 30 , 0805 20 50 , 0805 20 70 , 0805 20 90

TR

61,9

ZZ

61,9

0805 50 10

AR

61,0

TR

95,9

ZZ

78,5

0808 10 80

AU

166,8

CA

159,7

CL

85,5

MK

28,7

NZ

173,1

US

117,9

ZA

164,9

ZZ

128,1

0808 30 90

BA

86,2

CN

63,9

TR

128,8

ZZ

93,0

---

(1)  Nomenclature of countries laid down by Commission Regulation (EU) No 1106/2012 of 27 November 2012 implementing Regulation (EC) No 471/2009 of the European Parliament and of the Council on Community statistics relating to external trade with non-member countries, as regards the update of the nomenclature of countries and territories (OJ L 328, 28.11.2012, p. 7). Code ‘ZZ’ stands for ‘of other origin’.

---

DECISIONS

| 26.11.2015 | EN | Official Journal of the European Union | L 309/10 |
| --- | --- | --- | --- |

26.11.2015

EN

Official Journal of the European Union

L 309/10

---

COMMISSION IMPLEMENTING DECISION (EU) 2015/2181

of 24 November 2015

on the publication with restriction in the Official Journal of the European Union of the reference to standard EN 795:2012 on ‘Personal fall protection equipment — Anchor devices’ under Regulation (EU) No 1025/2012 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 Council Directive 89/686/EEC of 21 December 1989 on the approximation of the laws of the Member States relating to personal protective equipment (1), and in particular Article 5(4) thereof,

Having regard to the Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 on European standardisation, amending Council Directives 89/686/EEC and 93/15/EEC and Directives 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 98/34/EC, 2004/22/EC, 2007/23/EC, 2009/23/EC and 2009/105/EC of the European Parliament and of the Council and repealing Council Decision 87/95/EEC and Decision No 1673/2006/EC of the European Parliament and of the Council (2), and in particular point (a) of Article 11(1) thereof,

Having regard to the opinion of the Committee established by Article 22 of Regulation (EU) No 1025/2012,

Whereas:

| (1) | Where a national standard transposing a harmonised standard, the reference of which has been published in the Official Journal of the European Union, covers one or more essential health and safety requirements set out in Annex II to Directive 89/686/EEC, equipment manufactured in accordance with this standard is presumed to meet the basic health and safety requirements concerned. |
| --- | --- |

(1)

Where a national standard transposing a harmonised standard, the reference of which has been published in the Official Journal of the European Union, covers one or more essential health and safety requirements set out in Annex II to Directive 89/686/EEC, equipment manufactured in accordance with this standard is presumed to meet the basic health and safety requirements concerned.

| (2) | On 12 February 2000, the European Commission, upon publication of the list of harmonised standards in the Official Journal of the European Union, issued a warning for harmonised standard EN 795:1996. It specifies that ‘this publication does not concern the equipment described in classes A, C and D [...] in respect of which there shall be no presumption of conformity with the provisions of Directive 89/686/EEC’. |
| --- | --- |

(2)

On 12 February 2000, the European Commission, upon publication of the list of harmonised standards in the Official Journal of the European Union, issued a warning for harmonised standard EN 795:1996. It specifies that ‘this publication does not concern the equipment described in classes A, C and D [...] in respect of which there shall be no presumption of conformity with the provisions of Directive 89/686/EEC’.

| (3) | In a judgment of 21 October 2010 in case C-185/08, the Court of Justice of the European Union held that the provisions of EN 795 relating to Class A 1 anchor devices are not covered by Directive 89/686/EEC. |
| --- | --- |

(3)

In a judgment of 21 October 2010 in case C-185/08, the Court of Justice of the European Union held that the provisions of EN 795 relating to Class A 1 anchor devices are not covered by Directive 89/686/EEC.

| (4) | On 3 August 2012, France lodged a formal objection in respect of standard EN 795:2012 ‘Personal fall protection equipment — Anchor devices’, harmonised under Directive 89/686/EEC. The standard was approved by the European Committee for Standardisation (CEN) on 9 June 2012 but its reference has not yet been published in the Official Journal of the European Union. |
| --- | --- |

(4)

On 3 August 2012, France lodged a formal objection in respect of standard EN 795:2012 ‘Personal fall protection equipment — Anchor devices’, harmonised under Directive 89/686/EEC. The standard was approved by the European Committee for Standardisation (CEN) on 9 June 2012 but its reference has not yet been published in the Official Journal of the European Union.

| (5) | The formal objection is based on the fact that fixed anchor devices, to which personal protective equipment (PPE) against falls from a height — such as a body harness, a lanyard with shock absorber and other connecting elements — is attached, form an integral part of a structure or rock face. Anchor devices which form an integral part of a structure are not PPE but devices external to the PPE and therefore complementary. In this case, only connecting elements should be regarded as PPE. |
| --- | --- |

(5)

The formal objection is based on the fact that fixed anchor devices, to which personal protective equipment (PPE) against falls from a height — such as a body harness, a lanyard with shock absorber and other connecting elements — is attached, form an integral part of a structure or rock face. Anchor devices which form an integral part of a structure are not PPE but devices external to the PPE and therefore complementary. In this case, only connecting elements should be regarded as PPE.

| (6) | Standard EN 795:2012 concerns both fixed and mobile anchor points. However, only mobile anchor points (that is to say transportable and temporary), not permanently secured to a structure, come under the scope of Directive 89/686/EEC. |
| --- | --- |

(6)

Standard EN 795:2012 concerns both fixed and mobile anchor points. However, only mobile anchor points (that is to say transportable and temporary), not permanently secured to a structure, come under the scope of Directive 89/686/EEC.

| (7) | The anchor devices covered by standard EN 795:2012 are of five types, according to their characteristics:

  type A: anchor devices with one or more stationary anchor points and with the need for structural anchors or fixing elements to fix to the structure;

  type B: anchor device with one or more stationary anchor points without the need for structural anchors or fixing elements to fix it to the structure;

  type C: anchor devices employing horizontal flexible anchor lines;

  type D: anchor devices employing horizontal rigid anchor lines;

  type E: anchor device for use on horizontal surfaces where the performance relies solely on mass and friction between itself and the surface (deadweight anchors). |
| --- | --- |

(7)

The anchor devices covered by standard EN 795:2012 are of five types, according to their characteristics:

type A: anchor devices with one or more stationary anchor points and with the need for structural anchors or fixing elements to fix to the structure;

type B: anchor device with one or more stationary anchor points without the need for structural anchors or fixing elements to fix it to the structure;

type C: anchor devices employing horizontal flexible anchor lines;

type D: anchor devices employing horizontal rigid anchor lines;

type E: anchor device for use on horizontal surfaces where the performance relies solely on mass and friction between itself and the surface (deadweight anchors).

| (8) | Having examined the standard EN 795:2012, the Commission has established that only types B and E anchor devices are mobile anchors not meant to remain permanently fixed to the structure, and are therefore PPE covered by Directive 89/686/EEC. |
| --- | --- |

(8)

Having examined the standard EN 795:2012, the Commission has established that only types B and E anchor devices are mobile anchors not meant to remain permanently fixed to the structure, and are therefore PPE covered by Directive 89/686/EEC.

| (9) | The European standardisation organisations, the European stakeholder organisations receiving Union financing and the personal protective equipment working group were consulted, |
| --- | --- |

(9)

The European standardisation organisations, the European stakeholder organisations receiving Union financing and the personal protective equipment working group were consulted,

HAS ADOPTED THIS DECISION:

Article 1

The reference of standard EN 795:2012 ‘Personal fall protection equipment — Anchor devices’ shall be published in the Official Journal of the European Union with restriction as set out in the Annex.

Article 2

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

Done at Brussels, 24 November 2015.

For the Commission

The President

Jean-Claude JUNCKER

---

(1)  
  OJ L 399, 30.12.1989, p. 18.

1

(2)  
  OJ L 316, 14.11.2012, p. 12.

2

---

ANNEX

PUBLICATION OF TITLES AND REFERENCES OF EUROPEAN HARMONISED STANDARDS UNDER DIRECTIVE 89/686/EEC

| ESO (1) | Reference and title of the harmonised standard
  (and reference document) | First publication OJ | Reference of superseded standard | Date of cessation of presumption of conformity of superseded standard
  Note 1 |
| --- | --- | --- | --- | --- |
| CEN | EN 795:2012
  Personal fall protection equipment — Anchor devices | This is the first publication | EN 795:1996 | |
| Warning: This publication does not concern the equipment described in:






  — | type A (anchor devices with one or more stationary anchor points and with the need for structural anchors or fixing elements to fix to the structure) referred to in clauses 3.2.1, 4.4.1, 5.3, |

ESO (1)

Reference and title of the harmonised standard

(and reference document)

First publication OJ

Reference of superseded standard

Date of cessation of presumption of conformity of superseded standard

Note 1

CEN

EN 795:2012

Personal fall protection equipment — Anchor devices

This is the first publication

EN 795:1996

Warning: This publication does not concern the equipment described in:

—

type A (anchor devices with one or more stationary anchor points and with the need for structural anchors or fixing elements to fix to the structure) referred to in clauses 3.2.1, 4.4.1, 5.3,

| — | type C (anchor devices employing horizontal flexible anchor lines) referred to in clauses 3.2.3, 4.4.3 and 5.5, |
| --- | --- |

—

type C (anchor devices employing horizontal flexible anchor lines) referred to in clauses 3.2.3, 4.4.3 and 5.5,

| — | type D (anchor devices employing horizontal rigid anchor lines) referred to in clauses 3.2.4, 4.4.4 and 5.6, |
| --- | --- |

—

type D (anchor devices employing horizontal rigid anchor lines) referred to in clauses 3.2.4, 4.4.4 and 5.6,

| — | any combination of the above. |
| --- | --- |

—

any combination of the above.

In respect of types A, C and D, this publication does not concern either clauses: 4.5, 5.2.2, 6, 7; Annex A or Annex ZA.

Accordingly, in respect of the equipment mentioned above, there shall be no presumption of conformity with the provisions of Directive 89/686/EEC because they are not considered to be PPE.

| Note: | Generally the date of cessation of presumption of conformity will be the date of withdrawal ('dow'), set by the European standardisation organisation, but attention of users of these standards is drawn to the fact that in certain exceptional cases this can be otherwise. |
| --- | --- |

Note:

---

(1)  ESO: European standardisation organisation:

| — | CEN: Avenue Marnix 17, 1000 Brussels, Belgium; tel.+32 25500811; fax +32 25500819 (http://www.cen.eu) |
| --- | --- |

—

CEN: Avenue Marnix 17, 1000 Brussels, Belgium; tel.+32 25500811; fax +32 25500819 (http://www.cen.eu)

| — | Cenelec: Avenue Marnix 17, 1000 Brussels, Belgium; tel.+32 25196871; fax +32 25196919 (http://www.cenelec.eu) |
| --- | --- |

—

Cenelec: Avenue Marnix 17, 1000 Brussels, Belgium; tel.+32 25196871; fax +32 25196919 (http://www.cenelec.eu)

| — | ETSI: 650 route des Lucioles, 06921 Sophia Antipolis, France; tel.+33 492944200; fax +33 493654716, (http://www.etsi.eu) |
| --- | --- |

—

ETSI: 650 route des Lucioles, 06921 Sophia Antipolis, France; tel.+33 492944200; fax +33 493654716, (http://www.etsi.eu)

---

| 26.11.2015 | EN | Official Journal of the European Union | L 309/13 |
| --- | --- | --- | --- |

26.11.2015

EN

Official Journal of the European Union

L 309/13

---

COMMISSION IMPLEMENTING DECISION (EU) 2015/2182

of 24 November 2015

on a measure taken by Germany pursuant to Directive 2006/42/EC of the European Parliament and of the Council, to prohibit the placing on the market of a type of a poultry plucking machine

(notified under document C(2015) 8086)

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

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

Having regard to Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery, and amending Directive 95/16/EC (1), and in particular Article 11(3) thereof,

Whereas:

| (1) | In accordance with the procedure set out in Article 11(2) of Directive 2006/42/EC, Germany informed the Commission of a measure to prohibit the placing on the market of a poultry plucking machine of type RF-169 distributed by Fringo GmbH & Co. KG, Kurfürstendamm 96, 10709 Berlin. |
| --- | --- |

(1)

In accordance with the procedure set out in Article 11(2) of Directive 2006/42/EC, Germany informed the Commission of a measure to prohibit the placing on the market of a poultry plucking machine of type RF-169 distributed by Fringo GmbH & Co. KG, Kurfürstendamm 96, 10709 Berlin.

| (2) | The reason for taking the measure was the non-conformity of the poultry plucking machine with the essential health and safety requirements set out in Annex I to Directive 2006/42/EC. |
| --- | --- |

(2)

The reason for taking the measure was the non-conformity of the poultry plucking machine with the essential health and safety requirements set out in Annex I to Directive 2006/42/EC.

| (3) | Sections 1.2.3 ‘Starting’ and 1.2.4.1 ‘Normal stop’ of Annex I to Directive 2006/42/EC require that machinery must be fitted with a control device which prevents unattended and unexpected starting and ensures that operator can stop machinery safely at all times. The plucking machine has a flexible mains cable with a plug which contains a small distribution panel with a residual current protection device (RCD). Intentional starting and normal stopping are carried out, in accordance with the operating instructions, by inserting a plug into a socket and removing it. There is no on/off switch on the machinery. |
| --- | --- |

(3)

Sections 1.2.3 ‘Starting’ and 1.2.4.1 ‘Normal stop’ of Annex I to Directive 2006/42/EC require that machinery must be fitted with a control device which prevents unattended and unexpected starting and ensures that operator can stop machinery safely at all times. The plucking machine has a flexible mains cable with a plug which contains a small distribution panel with a residual current protection device (RCD). Intentional starting and normal stopping are carried out, in accordance with the operating instructions, by inserting a plug into a socket and removing it. There is no on/off switch on the machinery.

| (4) | Section 1.2.4.3 ‘Emergency stop’ of Annex I to Directive 2006/42/EC requires that machinery must be fitted with one or more emergency stop to enable actual or impending danger to be averted. Owing to the length (3,4 m) of the flexible mains cable, the fact that there is no on/off switch and the machine can only be stopped by unplugging it from the socket, an immediate risk can only be averted by means of an emergency stop device on the machinery. |
| --- | --- |

(4)

Section 1.2.4.3 ‘Emergency stop’ of Annex I to Directive 2006/42/EC requires that machinery must be fitted with one or more emergency stop to enable actual or impending danger to be averted. Owing to the length (3,4 m) of the flexible mains cable, the fact that there is no on/off switch and the machine can only be stopped by unplugging it from the socket, an immediate risk can only be averted by means of an emergency stop device on the machinery.

| (5) | Section 1.2.6 ‘Failure of the power supply’ of Annex I to Directive 2006/42/EC requires the machinery not to lead to dangerous situation in case of interruption of the power supply, the re-establishment of the power supply after an interruption or any fluctuation of the power supply. When the power supply is restored the plucking machinery starts up immediately, which could give rise to a hazardous situation. |
| --- | --- |

(5)

Section 1.2.6 ‘Failure of the power supply’ of Annex I to Directive 2006/42/EC requires the machinery not to lead to dangerous situation in case of interruption of the power supply, the re-establishment of the power supply after an interruption or any fluctuation of the power supply. When the power supply is restored the plucking machinery starts up immediately, which could give rise to a hazardous situation.

| (6) | Section 1.3.7 ‘Risks related to moving parts’ of Annex I to Directive 2006/42/EC requires the machinery to prevent risk of contact which could lead to accidents or, where risk persist, to be fitted with guards or protective devices. The movable transmission parts of plucking machine are accessible through the feather discharge chute on side of the machine and from beneath the machine. The machine does not stop when the flap is open and therefore parts of the body of the user may come into contact with rotating parts causing injures. |
| --- | --- |

(6)

Section 1.3.7 ‘Risks related to moving parts’ of Annex I to Directive 2006/42/EC requires the machinery to prevent risk of contact which could lead to accidents or, where risk persist, to be fitted with guards or protective devices. The movable transmission parts of plucking machine are accessible through the feather discharge chute on side of the machine and from beneath the machine. The machine does not stop when the flap is open and therefore parts of the body of the user may come into contact with rotating parts causing injures.

| (7) | Section 1.5.1 ‘Electricity supply’ of Annex I to Directive 2006/42/EC requires the machinery to be designed, constructed and equipped in a way that all hazards of an electrical nature are or can be prevented. Wiring must be selected in such a way as to be suitable for all conditions of use, for external influences and mechanical stresses. The PVC cables used on the machinery (H05VV-F and 53 RVV 300/500 V) are intended for: very light, light and normal loads, when water is present — free-falling drops and for temporary outdoor use. Since, when the machinery is used for its intended purpose, inundation of the connection cable and heavy loading are to be reckoned with, the connection cable is classed as unsafe. |
| --- | --- |

(7)

Section 1.5.1 ‘Electricity supply’ of Annex I to Directive 2006/42/EC requires the machinery to be designed, constructed and equipped in a way that all hazards of an electrical nature are or can be prevented. Wiring must be selected in such a way as to be suitable for all conditions of use, for external influences and mechanical stresses. The PVC cables used on the machinery (H05VV-F and 53 RVV 300/500 V) are intended for: very light, light and normal loads, when water is present — free-falling drops and for temporary outdoor use. Since, when the machinery is used for its intended purpose, inundation of the connection cable and heavy loading are to be reckoned with, the connection cable is classed as unsafe.

| (8) | Section 1.7.3 ‘Marking of machinery’ of Annex I to Directive 2006/42/EC requires the machinery to be marked visibly, legibly and indelibly with minimum particulars. The plucking machine has no indication of the year in which it was manufactured, and the data plate is not attached to the machine in a permanent manner. On the motor, there is no manufacturer's serial number or identification symbol, strand count, standard(s) applied, temperature class/temperature limit or rated power factor(s). |
| --- | --- |

(8)

Section 1.7.3 ‘Marking of machinery’ of Annex I to Directive 2006/42/EC requires the machinery to be marked visibly, legibly and indelibly with minimum particulars. The plucking machine has no indication of the year in which it was manufactured, and the data plate is not attached to the machine in a permanent manner. On the motor, there is no manufacturer's serial number or identification symbol, strand count, standard(s) applied, temperature class/temperature limit or rated power factor(s).

| (9) | The Commission invited Fringo GmbH & Co. KG to present its observations on the measure taken by Germany. No reply was received. |
| --- | --- |

(9)

The Commission invited Fringo GmbH & Co. KG to present its observations on the measure taken by Germany. No reply was received.

| (10) | Examination of the evidence provided by the German authorities confirms that the poultry plucking machine of type RF-169 distributed by Fringo GmbH & Co. KG, Kurfürstendamm 96, 10709 Berlin, fails to comply with the essential health and safety requirements referred to in Article 5(1)(a) of Directive 2006/42/EC and that the non-conformity gives rise to serious risks of injury to users. It is therefore appropriate to consider the measure taken by Germany as justified, |
| --- | --- |

(10)

Examination of the evidence provided by the German authorities confirms that the poultry plucking machine of type RF-169 distributed by Fringo GmbH & Co. KG, Kurfürstendamm 96, 10709 Berlin, fails to comply with the essential health and safety requirements referred to in Article 5(1)(a) of Directive 2006/42/EC and that the non-conformity gives rise to serious risks of injury to users. It is therefore appropriate to consider the measure taken by Germany as justified,

HAS ADOPTED THIS DECISION:

Article 1

The measure taken by Germany to prohibit the placing on the market of a poultry plucking machine of type RF-169 distributed by Fringo GmbH & Co. KG, Kurfürstendamm 96, 10709 Berlin, is justified.

Article 2

This Decision is addressed to the Member States.

Done at Brussels, 24 November 2015.

For the Commission

Elżbieta BIEŃKOWSKA

Member of the Commission

---

(1)  
  OJ L 157, 9.6.2006, p. 24.

1

---

| 26.11.2015 | EN | Official Journal of the European Union | L 309/15 |
| --- | --- | --- | --- |

26.11.2015

EN

Official Journal of the European Union

L 309/15

---

COMMISSION IMPLEMENTING DECISION (EU) 2015/2183

of 24 November 2015

establishing a common format for the notification of electronic cigarettes and refill containers

(notified under document C(2015) 8087)

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to Directive 2014/40/EU of the European Parliament and of the Council of 3 April 2014 on the approximation of the laws, regulations and administrative provisions of the Member States concerning the manufacture, presentation and sale of tobacco and related products and repealing Directive 2001/37/EC (1), and in particular Article 20(13) thereof,

Whereas:

| (1) | Directive 2014/40/EU provides that manufacturers and importers of electronic cigarettes and refill containers are to submit to the competent authorities of the Member States concerned a notification of any such products which they intend to place on the market or which are already placed on the market on 20 May 2016. The information should be submitted 6 months before the intended placing on the market of new or substantially modified products. The format for that notification should be laid down. |
| --- | --- |

(1)

Directive 2014/40/EU provides that manufacturers and importers of electronic cigarettes and refill containers are to submit to the competent authorities of the Member States concerned a notification of any such products which they intend to place on the market or which are already placed on the market on 20 May 2016. The information should be submitted 6 months before the intended placing on the market of new or substantially modified products. The format for that notification should be laid down.

| (2) | The experience gained and the knowledge acquired with existing formats for the reporting of tobacco ingredients, where relevant, should be taken into account when developing the format. |
| --- | --- |

(2)

The experience gained and the knowledge acquired with existing formats for the reporting of tobacco ingredients, where relevant, should be taken into account when developing the format.

| (3) | A common electronic notification format for submission of information on electronic cigarettes and refill containers should allow Member States and the Commission to process, compare, analyse and draw conclusions from the information received. The data will also provide a basis for assessing health impacts associated with these products. |
| --- | --- |

(3)

A common electronic notification format for submission of information on electronic cigarettes and refill containers should allow Member States and the Commission to process, compare, analyse and draw conclusions from the information received. The data will also provide a basis for assessing health impacts associated with these products.

| (4) | A common electronic entry gate for submission of data is essential to ensure uniform application of the notification obligations set out in Directive 2014/40/EU. In particular, a common entry gate facilitates and harmonises the submission of data from the manufacturer or importer to the Member States. Streamlining the submission process also reduces administrative burden for manufacturers, importers and national regulators and facilitates comparison of data. To facilitate multiple uploads, a repository might be established at the level of the common entry gate to allow for references to non-confidential documents.
  The common entry gate should foresee tools for submission of information which are adequate both for companies which have comprehensive IT solutions in place (system to system submissions) and for companies which have no such solutions, in particular small and medium sized companies. Companies will be provided with a submitter identification number which should be used for all submissions by this company. |
| --- | --- |

(4)

A common electronic entry gate for submission of data is essential to ensure uniform application of the notification obligations set out in Directive 2014/40/EU. In particular, a common entry gate facilitates and harmonises the submission of data from the manufacturer or importer to the Member States. Streamlining the submission process also reduces administrative burden for manufacturers, importers and national regulators and facilitates comparison of data. To facilitate multiple uploads, a repository might be established at the level of the common entry gate to allow for references to non-confidential documents.

The common entry gate should foresee tools for submission of information which are adequate both for companies which have comprehensive IT solutions in place (system to system submissions) and for companies which have no such solutions, in particular small and medium sized companies. Companies will be provided with a submitter identification number which should be used for all submissions by this company.

| (5) | Member States should be free to make the tools for submission of information laid down in this Decision available for submission of information required under Article 20(7) of Directive 2014/40/EU. The tools could also facilitate submission of other information on electronic cigarettes and refill containers pursuant to Article 20. Manufacturers and importers should be encouraged to keep data provided to Member States up-to-date. To facilitate comparison within the Union, Member States should encourage manufacturers and importers to submit updates during the first half of the subsequent calendar year. When sales data is reported under this format it should relate to the calendar year. |
| --- | --- |

(5)

Member States should be free to make the tools for submission of information laid down in this Decision available for submission of information required under Article 20(7) of Directive 2014/40/EU. The tools could also facilitate submission of other information on electronic cigarettes and refill containers pursuant to Article 20. Manufacturers and importers should be encouraged to keep data provided to Member States up-to-date. To facilitate comparison within the Union, Member States should encourage manufacturers and importers to submit updates during the first half of the subsequent calendar year. When sales data is reported under this format it should relate to the calendar year.

| (6) | When resubmitting data, including correcting errors in an earlier submission, the information should be provided through the common entry gate. |
| --- | --- |

(6)

When resubmitting data, including correcting errors in an earlier submission, the information should be provided through the common entry gate.

| (7) | In order to ensure the quality and comparability of data submitted, Member States should, where applicable, encourage manufacturers and importers to use agreed standards or testing methods. In the absence of agreed Union or international standards or testing methods, manufacturers and importers should clearly describe in their notifications the measurement methods used and should ensure that they are reproducible. |
| --- | --- |

(7)

In order to ensure the quality and comparability of data submitted, Member States should, where applicable, encourage manufacturers and importers to use agreed standards or testing methods. In the absence of agreed Union or international standards or testing methods, manufacturers and importers should clearly describe in their notifications the measurement methods used and should ensure that they are reproducible.

| (8) | In order to limit the administrative burden and ensure comparability between reported data, Member States should encourage manufacturers and importers to select compatible items when testing components of electronic cigarettes and refill containers placed on the market as separate items. |
| --- | --- |

(8)

In order to limit the administrative burden and ensure comparability between reported data, Member States should encourage manufacturers and importers to select compatible items when testing components of electronic cigarettes and refill containers placed on the market as separate items.

| (9) | Whilst the full responsibility for gathering, verifying, analysing as appropriate, storing and disseminating the data collected in accordance with this Decision lies with the Member States, they should have the possibility to store the data submitted to them at Commission facilities. The service offered by the Commission should provide Member States with technical tools to facilitate compliance with their obligations under Article 20 of Directive 2014/40/EU. The Commission will develop a standard service level agreement for this purpose. The Commission should keep an off-line copy of the data submitted through the common entry gate for the purpose of applying Directive 2014/40/EU. |
| --- | --- |

(9)

Whilst the full responsibility for gathering, verifying, analysing as appropriate, storing and disseminating the data collected in accordance with this Decision lies with the Member States, they should have the possibility to store the data submitted to them at Commission facilities. The service offered by the Commission should provide Member States with technical tools to facilitate compliance with their obligations under Article 20 of Directive 2014/40/EU. The Commission will develop a standard service level agreement for this purpose. The Commission should keep an off-line copy of the data submitted through the common entry gate for the purpose of applying Directive 2014/40/EU.

| (10) | When submitting information on products with the same composition and design, manufacturers and importers should, to the extent possible, use the same product identification number, regardless of brand and subtype or whether they are placed on the market in one or more Member States. |
| --- | --- |

(10)

When submitting information on products with the same composition and design, manufacturers and importers should, to the extent possible, use the same product identification number, regardless of brand and subtype or whether they are placed on the market in one or more Member States.

| (11) | It is appropriate to lay down rules concerning the treatment of confidential data by the Commission in order to ensure the greatest possible transparency of product information for the general public, whilst ensuring that due account is taken of trade secrets. The legitimate expectation of consumers to have access to adequate information on the content of products they intend to consume should be weighed against manufacturers' interests of protecting recipes of their products. Having regard to those competing interests, data that could reveal ingredients used in small quantities in specific products should, in principle, be kept confidential. |
| --- | --- |

(11)

It is appropriate to lay down rules concerning the treatment of confidential data by the Commission in order to ensure the greatest possible transparency of product information for the general public, whilst ensuring that due account is taken of trade secrets. The legitimate expectation of consumers to have access to adequate information on the content of products they intend to consume should be weighed against manufacturers' interests of protecting recipes of their products. Having regard to those competing interests, data that could reveal ingredients used in small quantities in specific products should, in principle, be kept confidential.

| (12) | Personal data should be processed in accordance with the rules and safeguards laid down in Directive 95/46/EC of the European Parliament and of the Council (2) and of Regulation (EC) No 45/2001 of the European Parliament and of the Council (3). |
| --- | --- |

(12)

Personal data should be processed in accordance with the rules and safeguards laid down in Directive 95/46/EC of the European Parliament and of the Council (2) and of Regulation (EC) No 45/2001 of the European Parliament and of the Council (3).

| (13) | The measures provided for in this Decision are in accordance with the opinion of the Committee referred to in Article 25 of Directive 2014/40/EU, |
| --- | --- |

(13)

The measures provided for in this Decision are in accordance with the opinion of the Committee referred to in Article 25 of Directive 2014/40/EU,

HAS ADOPTED THIS DECISION:

Article 1

Subject matter

This Decision establishes a common format for the notification of information on electronic cigarettes and refill containers.

Article 2

Format for notification

1.   Member States shall ensure that manufacturers and importers of electronic cigarettes and refill containers submit information referred to in Article 20(2) of Directive 2014/40/EU, including modifications and withdrawal from the market, in accordance with the format provided for in the Annex.

2.   Member States shall ensure that manufacturers and importers of electronic cigarettes and refill containers submit the information referred to in paragraph 1 by means of a common entry gate for data submission.

Article 3

Storage of data

Member States shall be entitled to use data storage services offered by the Commission to comply with their obligations under Article 20(2) of Directive 2014/40/EU provided they have signed a service level agreement with the Commission.

Article 4

Identification number of the data submitter

Before submitting information to Member States for the first time pursuant to this Decision, the manufacturer or importer shall apply for an identification number (Submitter ID) generated by the operator of the common entry gate. The manufacturer or importer shall, upon request, submit a document providing company identification and authentication of activities in accordance with the national legislation where the company is established. The Submitter ID shall be used for all subsequent submissions and in all subsequent correspondence.

Article 5

Identification number of the product

1.   Based on the Submitter ID referred to in Article 4, the manufacturer or importer shall assign an E-Cigarette ID (EC-ID) for each product to be notified.

2.   When submitting information on products with the same composition and design, manufacturers and importers shall, to the extent possible, use the same EC-ID, in particular where data are submitted by various members of a group of companies. This shall apply regardless of brand, subtype and the number of markets on which they are placed.

3.   Where the manufacturer or importer is not able to ensure that the same EC-ID is used for products with the same composition and design, it shall at least provide, in so far as possible, the different EC-ID that were assigned to such products.

Article 6

Confidential data and disclosure of data

1.   In their submission, manufacturers and importers shall mark all information which they consider to be a trade secret or otherwise confidential and shall, upon request, duly justify their claims.

2.   In using the data transmitted for applying Directive 2014/40/EU and Regulation (EC) No 1049/2001 of the European Parliament and of the Council (4), the Commission shall, in principle, not consider the following information to be confidential or amount to a trade secret:

| (a) | ingredients used in quantities above 0,1 % of the final formulation of the liquid; |
| --- | --- |

(a)

ingredients used in quantities above 0,1 % of the final formulation of the liquid;

| (b) | studies and data submitted according to Article 20(2) of Directive 2014/40/EU, in particular on toxicity and addictiveness. Where those studies are linked to specific brands, the explicit and implicit references to the brand shall be removed and the redacted version shall be accessible. |
| --- | --- |

(b)

studies and data submitted according to Article 20(2) of Directive 2014/40/EU, in particular on toxicity and addictiveness. Where those studies are linked to specific brands, the explicit and implicit references to the brand shall be removed and the redacted version shall be accessible.

Article 7

Addressees

This Decision is addressed to the Member States.

Done at Brussels, 24 November 2015.

For the Commission

Vytenis ANDRIUKAITIS

Member of the Commission

---

(1)  
  OJ L 127, 29.4.2014, p. 1.

1

(2)  Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data (OJ L 281, 23.11.1995, p. 31).

2

(3)  Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data (OJ L 8, 12.1.2001, p. 1).

3

(4)  Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents (OJ L 145, 31.5.2001, p. 43).

4

---

ANNEX

1.   FIELD DESCRIPTIONS

All fields marked (M) in the common format are mandatory.

Filter dependent mandatory fields (F) become mandatory if a specific response is selected from a previous variable.

System generated fields (AUTO) are automatically generated by the software system.

For fields in which the response is to be selected from a list, corresponding reference tables will be provided, maintained and published on a Commission website.

2.   SUBMITTER CHARACTERISTICS

The submitter is either the manufacturer or importer responsible for the submitted data.

| Field # | Field | Description | Reporting | Submitter considers information confidential |
| --- | --- | --- | --- | --- |
| | Submitter_ID | Submitter ID is the identification number attributed pursuant to Article 4 | M | |
| | Submitter_Name | Official name of the submitter at Member State level, as linked to the VAT number | M | |
| | Submitter_SME | Indication whether the submitter, or its parent company if it exists, is an SME as defined in Commission Recommendation 2003/361/EC (1) | M | |
| | Submitter_VAT | VAT number of the submitter | M | |
| | Submitter_Type | Indication whether the submitter is a manufacturer or importer | M | |
| | Submitter_Address | Address of the submitter | M | |
| | Submitter_Country | Country in which the submitter has its seat/domicile | M | |
| | Submitter_Phone | Business phone of the submitter | M | |
| | Submitter_Email | Functional business email address of the submitter | M | |
| | Submitter_Has_Parent_Company | Tick the box if the submitter has a parent company | M | |
| | Submitter_Has_Affiliate_Company | Tick the box if the submitter has an affiliate company | M | |
| | Submitter_Appoints_Enterer | Tick the box if the submitter has appointed a third party to submit its data on its behalf (‘enterer’) | M | |

Field #

Field

Description

Reporting

Submitter considers information confidential

Submitter_ID

Submitter ID is the identification number attributed pursuant to Article 4

M

Submitter_Name

Official name of the submitter at Member State level, as linked to the VAT number

M

Submitter_SME

Indication whether the submitter, or its parent company if it exists, is an SME as defined in Commission Recommendation 2003/361/EC (1)

M

Submitter_VAT

VAT number of the submitter

M

Submitter_Type

Indication whether the submitter is a manufacturer or importer

M

Submitter_Address

Address of the submitter

M

Submitter_Country

Country in which the submitter has its seat/domicile

M

Submitter_Phone

Business phone of the submitter

M

Submitter_Email

Functional business email address of the submitter

M

Submitter_Has_Parent_Company

Tick the box if the submitter has a parent company

M

Submitter_Has_Affiliate_Company

Tick the box if the submitter has an affiliate company

M

Submitter_Appoints_Enterer

Tick the box if the submitter has appointed a third party to submit its data on its behalf (‘enterer’)

M

2.1.   Manufacturer/Importer Parent company characteristics

For the parent company, the following information must be provided: Submitter ID number if any, official name, address, country, business phone and functional business email address.

2.2.   Manufacturer/Importer affiliate company characteristics

For each affiliate, the following information must be provided: Submitter ID number if any, official name, address, country, business phone and functional business email address.

2.3.   Enterer reporting on behalf of the submitter

For the enterer, the following information must be provided: Submitter ID number if any, official name, address, country, business phone and functional business email address.

3.   PRODUCT INFORMATION SUBMISSION AND DESCRIPTION — PART A

| Field # | Field | Description | Reporting | Submitter considers information confidential |
| --- | --- | --- | --- | --- |
| | Submission_Type | Type of submission for the product | M | |
| | Submission_Start_Date | Submission date will be filled in automatically by the system when the user submits the information about the product | AUTO | |
| | Product_ID (EC-ID) | EC-ID is the identification number of the product used in the system in the format ‘submitter ID-year-product number’ (NNNNN-NN-NNNNN), where | ‘submitter ID’ is the ID number of the submitter (see above) |

Field #

Field

Description

Reporting

Submitter considers information confidential

Submission_Type

Type of submission for the product

M

Submission_Start_Date

Submission date will be filled in automatically by the system when the user submits the information about the product

AUTO

Product_ID (EC-ID)

EC-ID is the identification number of the product used in the system in the format ‘submitter ID-year-product number’ (NNNNN-NN-NNNNN), where

‘submitter ID’ is the ID number of the submitter (see above)

| | ‘year’ is the year within which data on the product were submitted for the first time (2 digits) |
| --- | --- |

‘year’ is the year within which data on the product were submitted for the first time (2 digits)

| | ‘product number’ is the number attributed by the submitter to the product when submitting data for the first time |
| --- | --- |

‘product number’ is the number attributed by the submitter to the product when submitting data for the first time

M

Product_ID_Other_Exist

Indication whether the submitter is aware of other product(s) with the same design and composition that is marketed in the EU using a different EC-ID

M

Product_ID_Other

List EC-ID of the product(s) with same design and composition. If EC-ID of the product(s) is not known to the submitter, full brand and subtype name(s) as well as Member State(s) where product(s) is placed on the market shall at least be provided

F

Product_Same_Composition_Exist

Indication whether the submitter is aware of other product(s) with the same composition of e-liquid, but different design

M

Product_Same_Composition_Other

List EC-ID of the product(s) with the same composition of e-liquid but different design. If EC-ID of the product(s) is not known to the submitter, brand and subtype name(s) as well as Member State(s) where product(s) is placed on the market shall at least be provided

F

Product_Type

Type of product concerned

M

Product_Weight_E-liquid

Total weight of e-liquid in one product unit in mg.

F

Product_Volume_E-liquid

Total volume of e-liquid in one product unit in ml.

F

Product_Manufacturer_Identification

If the submitter is not the manufacturer, the official company name(s) of the manufacturer(s) of the product including its contact details (2)

F

Product_Production_Site_Address

For each manufacturer, address(es) of the site(s) where production is completed

M

Product_CLP_Classification

Overall product classification (including labelling elements) as a mixture of substances based on Regulation (EC) No 1272/2008 of the European Parliament and of the Council (3) and as described in the ‘Guidance on the Application of the CLP Criteria’ (4)

F

3.   PRODUCT INFORMATION SUBMISSION AND DESCRIPTION — PART B.

Where the products are presented for sale in different formats or where the same product is presented for sale in different Member States, the following variables must be completed for each format and each Member State.

| Field # | Field | Description | Reporting | Submitter considers information confidential |
| --- | --- | --- | --- | --- |
| | Product_Brand_Name | Brand name under which the product is marketed in the Member State to which information is being submitted. | M | |
| | Product_Brand_Subtype_Name | Product ‘subtype name’ (if any) as marketed in the Member State to which the product information is being submitted. | M | |
| | Product_Launch_Date | The date on which the submitter plans to launch/launched the product on the market | M | |
| | Product_Withdrawal_Indication | Indication that the submitter plans to withdraw/withdrew the product from the market | M | |
| | Product_Withdrawal_Date | Date on which the submitter plans to withdraw/withdrew the product from the market | F | |
| | Product_Submitter_Number | ID number used internally by the submitter | M
  At least one of those numbers must be used consistently for all submissions made by a single submitter | |
| | Product_UPC_Number | UPC-12 (Universal Product Code) of the product | |
| | Product_EAN_Number | EAN-13 or EAN-8 (European Article Number) of the product | |
| | Product_GTIN_Number | GTIN (Global Trade Identification Number) of the product | |
| | Product_SKU_Number | SKU (Stock Keeping Unit) number of the product | |
| | Product_National_Market | Member State to which the product information is being provided | M | |
| | Product_Package_Units | Number of individual units in the unit packet | M | |

Field #

Field

Description

Reporting

Submitter considers information confidential

Product_Brand_Name

Brand name under which the product is marketed in the Member State to which information is being submitted.

M

Product_Brand_Subtype_Name

Product ‘subtype name’ (if any) as marketed in the Member State to which the product information is being submitted.

M

Product_Launch_Date

The date on which the submitter plans to launch/launched the product on the market

M

Product_Withdrawal_Indication

Indication that the submitter plans to withdraw/withdrew the product from the market

M

Product_Withdrawal_Date

Date on which the submitter plans to withdraw/withdrew the product from the market

F

Product_Submitter_Number

ID number used internally by the submitter

M

At least one of those numbers must be used consistently for all submissions made by a single submitter

Product_UPC_Number

UPC-12 (Universal Product Code) of the product

Product_EAN_Number

EAN-13 or EAN-8 (European Article Number) of the product

Product_GTIN_Number

GTIN (Global Trade Identification Number) of the product

Product_SKU_Number

SKU (Stock Keeping Unit) number of the product

Product_National_Market

Member State to which the product information is being provided

M

Product_Package_Units

Number of individual units in the unit packet

M

4.   DESCRIPTION OF INGREDIENTS CONTAINED IN THE PRODUCT

For each ingredient used in the product, variables in the following section shall be completed (5). In the case of products containing more than one item with ingredients, the following variables must be completed for each of these items.

| Field # | Field | Description | Reporting | Submitter considers information confidential |
| --- | --- | --- | --- | --- |
| | Ingredient_Name | Chemical name of the ingredient | M | |
| | Ingredient_CAS | CAS (Chemical Abstracts Service) number | M | |
| | Ingredient_CAS_Additional | Additional CAS numbers if applicable | F | |
| | Ingredient_FEMA_Number | FEMA (Flavour and Extract Manufacturers Association) number, if any | F
  If a CAS does not exist, at least one of those four numbers must be indicated. If more than one number is indicated, those numbers must be indicated in the following order of importance FEMA>Additive> FL>EC | |
| | Ingredient_Additive_Number | If the ingredient is a food additive, its food additive ‘E number’ set out in Annexes II and III to Regulation (EC) No 1333/2008 of the European Parliament and of the Council (6) | |
| | Ingredient_FL_Number | FL number (European Flavouring number as set out in Annex I to Regulation (EC) No 1334/2008 of the European Parliament and of the Council (7) | |
| | Ingredient_EC_Number | European Community (EC) number (8), if any | |
| | Ingredient_Function | Function(s) of the ingredient | M | |
| | Ingredient_Function_Other | Function of the ingredient if ‘other’ | F | |
| | Ingredient_Recipe_Quantity | Weight of the ingredient included in one product unit in mg according to recipe. | M | |
| | Ingredient_ Non_Vaporised_Status | Indication whether the ingredient in non-vaporised form is characterised by a known type of toxicity or has carcinogenic, mutagenic or toxic for reproduction properties | M | |
| | Ingredient_REACH_Registration | Registration number pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council (9), if any. | M | |
| | Ingredient_CLP_Whether_Classification | Indication whether the ingredient has been classified under Regulation (EC) No 1272/2008 of the European Parliament and of the Council (10) and is in the classification and labelling Inventory | M | |
| | Ingredient_CLP_Classification | Ingredient classification with to regard Regulation (EC) No 1272/2008 | F | |
| | Ingredient_Tox_Data | Availability of toxicological data, concerning a substance, either in isolation or as part of a mixture. In each case, specify whether the toxicological data relate to the substance in heated or unheated form. | M | |
| | Ingredient_Tox_Emission | Existence of studies that inform about the chemistry and/or toxicity of emissions. | F/M | |
| | Ingredient_Tox_CMR | Existence of any studies relating to the carcinogenicity, mutagenicity or toxicity for reproduction of the ingredient. | F/M | |
| | Ingredient_Tox_CardioPulmonary | Existence of in vitro and in vivo assays to evaluate the toxicological effects of the ingredient on the heart, blood vessels or respiratory tract | F/M | |
| | Ingredient_Tox_Addictive | Existence of an analysis of the possible addictive properties of the ingredient | F/M | |
| | Ingredient_Tox_Other | Existence of any other toxicological data not stated above. | F/M | |
| | Ingredient_Tox/Addictive_File | Upload available studies indicated in the previous six fields (Ingredient Tox Data, Emission, CMR, CardioPulmonary, Addictive, Other) | F/M | |

Field #

Field

Description

Reporting

Submitter considers information confidential

Ingredient_Name

Chemical name of the ingredient

M

Ingredient_CAS

CAS (Chemical Abstracts Service) number

M

Ingredient_CAS_Additional

Additional CAS numbers if applicable

F

Ingredient_FEMA_Number

FEMA (Flavour and Extract Manufacturers Association) number, if any

F

If a CAS does not exist, at least one of those four numbers must be indicated. If more than one number is indicated, those numbers must be indicated in the following order of importance FEMA>Additive> FL>EC

Ingredient_Additive_Number

If the ingredient is a food additive, its food additive ‘E number’ set out in Annexes II and III to Regulation (EC) No 1333/2008 of the European Parliament and of the Council (6)

Ingredient_FL_Number

FL number (European Flavouring number as set out in Annex I to Regulation (EC) No 1334/2008 of the European Parliament and of the Council (7)

Ingredient_EC_Number

European Community (EC) number (8), if any

Ingredient_Function

Function(s) of the ingredient

M

Ingredient_Function_Other

Function of the ingredient if ‘other’

F

Ingredient_Recipe_Quantity

Weight of the ingredient included in one product unit in mg according to recipe.

M

Ingredient_ Non_Vaporised_Status

Indication whether the ingredient in non-vaporised form is characterised by a known type of toxicity or has carcinogenic, mutagenic or toxic for reproduction properties

M

Ingredient_REACH_Registration

Registration number pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council (9), if any.

M

Ingredient_CLP_Whether_Classification

Indication whether the ingredient has been classified under Regulation (EC) No 1272/2008 of the European Parliament and of the Council (10) and is in the classification and labelling Inventory

M

Ingredient_CLP_Classification

Ingredient classification with to regard Regulation (EC) No 1272/2008

F

Ingredient_Tox_Data

Availability of toxicological data, concerning a substance, either in isolation or as part of a mixture. In each case, specify whether the toxicological data relate to the substance in heated or unheated form.

M

Ingredient_Tox_Emission

Existence of studies that inform about the chemistry and/or toxicity of emissions.

F/M

Ingredient_Tox_CMR

Existence of any studies relating to the carcinogenicity, mutagenicity or toxicity for reproduction of the ingredient.

F/M

Ingredient_Tox_CardioPulmonary

Existence of in vitro and in vivo assays to evaluate the toxicological effects of the ingredient on the heart, blood vessels or respiratory tract

F/M

Ingredient_Tox_Addictive

Existence of an analysis of the possible addictive properties of the ingredient

F/M

Ingredient_Tox_Other

Existence of any other toxicological data not stated above.

F/M

Ingredient_Tox/Addictive_File

Upload available studies indicated in the previous six fields (Ingredient Tox Data, Emission, CMR, CardioPulmonary, Addictive, Other)

F/M

5.   EMISSIONS

Where multiple emissions have been measured, variables in the following sections are requested for each individual emission. In the case of products containing more than one item or more than one combination of an e-cigarette or refill container, the following variables must be completed for each of these items or combinations.

| Field # | Field | Description | Reporting | Submitter considers information confidential |
| --- | --- | --- | --- | --- |
| | Emission_Test_Product_EC-ID | If the product requires an additional product(s) for use, the EC-ID of the additional product(s) used to carry out the tests must be provided. If EC_ID of the additional product(s) is not known to the submitter, brand and subtype name(s) as well as Member State(s) where product is placed on the market shall at least be provided | F | |
| | Emission_Product_Combination | If the product contains more than one item or more than one combination of an e-cigarette or refill container, specification of the item or combination used to measure the emission | F | |
| | Emission_Methods_File | Description of the measurement methods used to assess the emissions, including reference to the relevant approved standard, when available | M | |
| | Emission_Name | Name of the emission produced during the testing of the product | M | |
| | Emission_CAS | CAS (Chemical Abstracts Service) number of emissions | F | |
| | Emission_IUPAC | IUPAC (International Union of Pure and Applied Chemistry) name of emissions, should a CAS number not exist | F | |
| | Emission_Quantity | Quantity of emissions produced during the process of using the product based on the measurement method used. | M | |
| | Emission_Units | Unit in which the emission is measured | F | |

Field #

Field

Description

Reporting

Submitter considers information confidential

Emission_Test_Product_EC-ID

If the product requires an additional product(s) for use, the EC-ID of the additional product(s) used to carry out the tests must be provided. If EC_ID of the additional product(s) is not known to the submitter, brand and subtype name(s) as well as Member State(s) where product is placed on the market shall at least be provided

F

Emission_Product_Combination

If the product contains more than one item or more than one combination of an e-cigarette or refill container, specification of the item or combination used to measure the emission

F

Emission_Methods_File

Description of the measurement methods used to assess the emissions, including reference to the relevant approved standard, when available

M

Emission_Name

Name of the emission produced during the testing of the product

M

Emission_CAS

CAS (Chemical Abstracts Service) number of emissions

F

Emission_IUPAC

IUPAC (International Union of Pure and Applied Chemistry) name of emissions, should a CAS number not exist

F

Emission_Quantity

Quantity of emissions produced during the process of using the product based on the measurement method used.

M

Emission_Units

Unit in which the emission is measured

F

6.   PRODUCT DESIGN

| Field # | Field | Description | Reporting for e-cigarettes | Submitter considers information confidential | Reporting for refill container | Submitter considers information confidential |
| --- | --- | --- | --- | --- | --- | --- |
| | E-Cigarette_Description | Description of the product to facilitate unique product identification, including a description of all items and the individual parts (components/e-liquid) | M | | M | |
| | E-Cigarette_Liquid_Volume/Capacity | Volume/capacity in ml (for devices, indicate tank size, for cartridges/cartomisers or for refill container actual volume when placed on the market) | M | | M | |
| | E-cigarette_Nicotine_Concentration | Nicotine concentration in mg/ml | F | | M | |
| | E-Cigarette_Battery_Type | Description of the battery type | F | | N/A | |
| | E-Cigarette_Battery_Type_Capacity | Indication of the battery capacity in mAh | F | | N/A | |
| | E-Cigarette_Volt/Watt_Adjustable | Indication whether the e-cigarette is voltage/wattage adjustable | M | | N/A | |
| | E-Cigarette_Voltage | Nominal voltage of the e-cigarette if non-adjustable and recommended voltage if adjustable. | F | | N/A | |
| | E-Cigarette_Voltage_Lower_Range | Lowest voltage obtainable | F | | N/A | |
| | E-Cigarette_Voltage_Upper_Range | Highest voltage obtainable. | F | | N/A | |
| | E-Cigarette_Wattage | Nominal wattage output if non-adjustable and recommended wattage if adjustable. | F | | N/A | |
| | E-Cigarette_Wattage_Lower_Range | Lowest wattage obtainable | F | | N/A | |
| | E-Cigarette_Wattage_Upper_Range | Highest wattage obtainable | F | | N/A | |
| | E-Cigarette_Airflow_Adjustable | Indication whether the airflow of the e-cigarette is adjustable | M | | N/A | |
| | E-Cigarette_Wick_Changeable | Indication whether the consumer may adjust/alter/replace the wick | M | | N/A | |
| | E-Cigarette_Microprocessor | Indication whether the e-cigarette contains a microprocessor | M | | N/A | |
| | E-Cigarette_Coil_Composition | Chemical composition of the wiring (coil) in the atomiser | M | | N/A | |
| | E-Cigarette_Nicotine_Dose/Uptake_File | Description of the measurement methods used to assess consistent dosing and nicotine uptake, including reference to the relevant approved standard, when available. Description of the outcomes of the assessment | M | | M | |
| | E-Cigarette_Production _File | Description of the final production process, including series production | M | | M | |
| | E-Cigarette_Production_Conformity | Declaration that the production process ensures conformity (including but not limited to information on series production). | M | | M | |
| | E-Cigarette_Quality_Safety | Declaration that the manufacturer and importer bear full responsibility for the quality and safety of the product, when placed on the market and used under normal or reasonably foreseeable conditions. | M | | M | |
| | E_Cigarette_Opening/Refill _File | Description of the opening and refill mechanism, where applicable. | F | | M | |

Field #

Field

Description

Reporting for e-cigarettes

Submitter considers information confidential

Reporting for refill container

Submitter considers information confidential

E-Cigarette_Description

Description of the product to facilitate unique product identification, including a description of all items and the individual parts (components/e-liquid)

M

M

E-Cigarette_Liquid_Volume/Capacity

Volume/capacity in ml (for devices, indicate tank size, for cartridges/cartomisers or for refill container actual volume when placed on the market)

M

M

E-cigarette_Nicotine_Concentration

Nicotine concentration in mg/ml

F

M

E-Cigarette_Battery_Type

Description of the battery type

F

N/A

E-Cigarette_Battery_Type_Capacity

Indication of the battery capacity in mAh

F

N/A

E-Cigarette_Volt/Watt_Adjustable

Indication whether the e-cigarette is voltage/wattage adjustable

M

N/A

E-Cigarette_Voltage

Nominal voltage of the e-cigarette if non-adjustable and recommended voltage if adjustable.

F

N/A

E-Cigarette_Voltage_Lower_Range

Lowest voltage obtainable

F

N/A

E-Cigarette_Voltage_Upper_Range

Highest voltage obtainable.

F

N/A

E-Cigarette_Wattage

Nominal wattage output if non-adjustable and recommended wattage if adjustable.

F

N/A

E-Cigarette_Wattage_Lower_Range

Lowest wattage obtainable

F

N/A

E-Cigarette_Wattage_Upper_Range

Highest wattage obtainable

F

N/A

E-Cigarette_Airflow_Adjustable

Indication whether the airflow of the e-cigarette is adjustable

M

N/A

E-Cigarette_Wick_Changeable

Indication whether the consumer may adjust/alter/replace the wick

M

N/A

E-Cigarette_Microprocessor

Indication whether the e-cigarette contains a microprocessor

M

N/A

E-Cigarette_Coil_Composition

Chemical composition of the wiring (coil) in the atomiser

M

N/A

E-Cigarette_Nicotine_Dose/Uptake_File

Description of the measurement methods used to assess consistent dosing and nicotine uptake, including reference to the relevant approved standard, when available. Description of the outcomes of the assessment

M

M

E-Cigarette_Production _File

Description of the final production process, including series production

M

M

E-Cigarette_Production_Conformity

Declaration that the production process ensures conformity (including but not limited to information on series production).

M

M

E-Cigarette_Quality_Safety

Declaration that the manufacturer and importer bear full responsibility for the quality and safety of the product, when placed on the market and used under normal or reasonably foreseeable conditions.

M

M

E_Cigarette_Opening/Refill _File

Description of the opening and refill mechanism, where applicable.

F

M

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(1)  Commission Recommendation 2003/361/EC of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises (OJ L 124, 20.5.2003, p. 36).

(2)  For each manufacturer, the following information is to be provided: ID number if any, official name, address, country, business phone and functional business email.

(3)  Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1).

(4)  http://echa.europa.eu/documents/10162/13562/clp_en.pdf

(5)  M and F in this section applies only for product types where applicable.

(6)  Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives (OJ L 354, 31.12.2008, p. 16).

(7)  Regulation (EC) No 1334/2008 of the European Parliament and of the Council of 16 December 2008 on flavourings and certain food ingredients with flavouring properties for use in and on foods and amending Council Regulation (EEC) No 1601/91, Regulations (EC) No 2232/96 and (EC) No 110/2008 and Directive 2000/13/EC (OJ L 354, 31.12.2008, p. 34).

(8)  As created by the European Community Commission Decision 81/437/EEC, of 11 May 1981 laying down the criteria in accordance with which information relating to the inventory of chemical substances is supplied by the Member States to the Commission (OJ L 167, 24.6.1981, p. 31).

(9)  Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, p. 1).

(10)  Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1).

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