# Official Journal L 90/2015

| | ISSN 1977-0677 |
| --- | --- |
| Official Journal
  of the European Union | L 90 |
| | |
| English edition | Legislation | Volume 582 April 2015 |

ISSN 1977-0677

Official Journal

of the European Union

L 90

English edition

Legislation

Volume 582 April 2015

---

| Contents | | II   Non-legislative acts | page |
| --- | --- | --- | --- |
| | | REGULATIONS |
| | * | Commission Implementing Regulation (EU) 2015/543 of 1 April 2015 approving the active substance COS-OGA, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 (
  1
  ) | 1 |
| | | Commission Implementing Regulation (EU) 2015/544 of 1 April 2015 establishing the standard import values for determining the entry price of certain fruit and vegetables | 5 |
| | | DECISIONS |
| | * | Commission Implementing Decision (EU) 2015/545 of 31 March 2015 authorising the placing on the market of oil from the micro-algae Schizochytrium sp. (ATCC PTA-9695) as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council
  (notified under document C(2015) 2082) | 7 |
| | * | Commission Implementing Decision (EU) 2015/546 of 31 March 2015 authorising an extension of use of DHA and EPA-rich oil from the micro-algae Schizochytrium sp. as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council
  (notified under document C(2015) 2083) | 11 |
| | * | Commission Decision (EU) 2015/547 of 1 April 2015 on the safety requirements to be met by European standards for alcohol-powered flueless fireplaces pursuant to Directive 2001/95/EC of the European Parliament and of the Council on general product safety (
  1
  ) | 14 |

Contents

II   Non-legislative acts

page

REGULATIONS

*

Commission Implementing Regulation (EU) 2015/543 of 1 April 2015 approving the active substance COS-OGA, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 (
  1
  )

1

1

Commission Implementing Regulation (EU) 2015/544 of 1 April 2015 establishing the standard import values for determining the entry price of certain fruit and vegetables

5

DECISIONS

*

Commission Implementing Decision (EU) 2015/545 of 31 March 2015 authorising the placing on the market of oil from the micro-algae Schizochytrium sp. (ATCC PTA-9695) as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council
  (notified under document C(2015) 2082)

Schizochytrium

(notified under document C(2015) 2082)

7

*

Commission Implementing Decision (EU) 2015/546 of 31 March 2015 authorising an extension of use of DHA and EPA-rich oil from the micro-algae Schizochytrium sp. as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council
  (notified under document C(2015) 2083)

Schizochytrium

(notified under document C(2015) 2083)

11

*

Commission Decision (EU) 2015/547 of 1 April 2015 on the safety requirements to be met by European standards for alcohol-powered flueless fireplaces pursuant to Directive 2001/95/EC of the European Parliament and of the Council on general product safety (
  1
  )

1

14

| | |
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| | (1)   Text with EEA relevance |

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(1)   Text with EEA relevance

1

| EN | Acts whose titles are printed in light type are those relating to day-to-day management of agricultural matters, and are generally valid for a limited period.
  The titles of all other Acts are printed in bold type and preceded by an asterisk. |
| --- | --- |

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

| 2.4.2015 | EN | Official Journal of the European Union | L 90/1 |
| --- | --- | --- | --- |

2.4.2015

EN

Official Journal of the European Union

L 90/1

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COMMISSION IMPLEMENTING REGULATION (EU) 2015/543

of 1 April 2015

approving the active substance COS-OGA, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

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

Having regard to Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (1), and in particular Article 22(1) in conjunction with Article 13(2) thereof,

Whereas:

| (1) | In accordance with Article 7(1) of Regulation (EC) No 1107/2009, Belgium received on 28 June 2012 an application from FytoFend SA for the approval of the active substance COS-OGA. In accordance with Article 9(3) of that Regulation, Belgium, as rapporteur Member State, notified the Commission on 5 December 2012 of the admissibility of the application. |
| --- | --- |

(1)

In accordance with Article 7(1) of Regulation (EC) No 1107/2009, Belgium received on 28 June 2012 an application from FytoFend SA for the approval of the active substance COS-OGA. In accordance with Article 9(3) of that Regulation, Belgium, as rapporteur Member State, notified the Commission on 5 December 2012 of the admissibility of the application.

| (2) | On 19 December 2013 the rapporteur Member State submitted a draft assessment report to the Commission with a copy to the European Food Safety Authority (hereinafter ‘the Authority’), assessing whether that active substance can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009. |
| --- | --- |

(2)

On 19 December 2013 the rapporteur Member State submitted a draft assessment report to the Commission with a copy to the European Food Safety Authority (hereinafter ‘the Authority’), assessing whether that active substance can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009.

| (3) | The Authority complied with Article 12(1) of Regulation (EC) No 1107/2009. In accordance with Article 12(3) of Regulation (EC) No 1107/2009, it requested that the applicant supply additional information to the Member States, the Commission and the Authority. The assessment of the additional information by the rapporteur Member State was submitted to the Authority in the format of an updated draft assessment report in September 2014. |
| --- | --- |

(3)

The Authority complied with Article 12(1) of Regulation (EC) No 1107/2009. In accordance with Article 12(3) of Regulation (EC) No 1107/2009, it requested that the applicant supply additional information to the Member States, the Commission and the Authority. The assessment of the additional information by the rapporteur Member State was submitted to the Authority in the format of an updated draft assessment report in September 2014.

| (4) | On 1 October 2014 the Authority communicated to the applicant, the Member States and the Commission its conclusion on whether the active substance COS-OGA can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 (2). The Authority made its conclusion available to the public. |
| --- | --- |

(4)

On 1 October 2014 the Authority communicated to the applicant, the Member States and the Commission its conclusion on whether the active substance COS-OGA can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 (2). The Authority made its conclusion available to the public.

| (5) | The applicant was given the possibility to submit comments on the review report. |
| --- | --- |

(5)

The applicant was given the possibility to submit comments on the review report.

| (6) | On 11 December 2014 the Commission presented to the Standing Committee on Plants, Animals, Food and Feed the review report for COS-OGA and a draft Regulation providing that COS-OGA is approved. |
| --- | --- |

(6)

On 11 December 2014 the Commission presented to the Standing Committee on Plants, Animals, Food and Feed the review report for COS-OGA and a draft Regulation providing that COS-OGA is approved.

| (7) | It has been established with respect to one or more representative uses of at least one plant protection product containing the active substance, and in particular the uses which were examined and detailed in the review report, that the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied. Those approval criteria are therefore deemed to be satisfied. It is therefore appropriate to approve COS-OGA. |
| --- | --- |

(7)

It has been established with respect to one or more representative uses of at least one plant protection product containing the active substance, and in particular the uses which were examined and detailed in the review report, that the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied. Those approval criteria are therefore deemed to be satisfied. It is therefore appropriate to approve COS-OGA.

| (8) | The Commission further considers that COS-OGA is a low-risk active substance pursuant to Article 22 of Regulation (EC) No 1107/2009. COS-OGA is not a substance of concern and fulfils the conditions set in point 5 of Annex II to Regulation (EC) No 1107/2009. COS-OGA consists of compounds naturally contained in plants and in some microorganisms and ubiquitous in the environment. The additional exposure of humans, animals and the environment by the uses approved under Regulation (EC) No 1107/2009 is expected to be negligible compared to exposure expected through realistic natural situations. |
| --- | --- |

(8)

The Commission further considers that COS-OGA is a low-risk active substance pursuant to Article 22 of Regulation (EC) No 1107/2009. COS-OGA is not a substance of concern and fulfils the conditions set in point 5 of Annex II to Regulation (EC) No 1107/2009. COS-OGA consists of compounds naturally contained in plants and in some microorganisms and ubiquitous in the environment. The additional exposure of humans, animals and the environment by the uses approved under Regulation (EC) No 1107/2009 is expected to be negligible compared to exposure expected through realistic natural situations.

| (9) | It is therefore appropriate to approve COS-OGA as a low risk substance. In accordance with Article 13(4) of Regulation (EC) No 1107/2009, the Annex to Commission Implementing Regulation (EU) No 540/2011 (3) should be amended accordingly. |
| --- | --- |

(9)

It is therefore appropriate to approve COS-OGA as a low risk substance. In accordance with Article 13(4) of Regulation (EC) No 1107/2009, the Annex to Commission Implementing Regulation (EU) No 540/2011 (3) should be amended accordingly.

| (10) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, |
| --- | --- |

(10)

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

HAS ADOPTED THIS REGULATION:

Article 1

Approval of active substance

The active substance COS-OGA, as specified in Annex I, is approved subject to the conditions laid down in that Annex.

Article 2

Amendments to Implementing Regulation (EU) No 540/2011

The Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with Annex II to this Regulation.

Article 3

Entry into force and date of application

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, 1 April 2015.

For the Commission

The President

Jean-Claude JUNCKER

---

(1)  OJ L 309, 24.11.2009, p. 1.

1

(2)  EFSA Journal 2014;12(10):3868.

2

EFSA Journal

(3)  Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances (OJ L 153, 11.6.2011, p. 1).

3

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ANNEX I

| Common Name, Identification Numbers | IUPAC Name | Purity (1) | Date of approval | Expiration of approval | Specific provisions |
| --- | --- | --- | --- | --- | --- |
| COS-OGA
  CAS No: not allocated
  CIPAC No: 979 | Linear copolymer of α-1,4-D-galactopyranosyluronic acids and methylesterified galactopyranosyluronic acids (9 to 20 residues) with linear copolymer β-1,4-linked 2-amino-2-deoxy-D-glucopyranose and 2-acetamido-2-deoxy-D-glucopyranose (5 to 10 residues). | ≥ 915 g/kg






  — | OGA/COS ratio comprised between 1 and 1,6 |

Common Name, Identification Numbers

IUPAC Name

Purity (1)

Date of approval

Expiration of approval

Specific provisions

COS-OGA

CAS No: not allocated

CIPAC No: 979

Linear copolymer of α-1,4-D-galactopyranosyluronic acids and methylesterified galactopyranosyluronic acids (9 to 20 residues) with linear copolymer β-1,4-linked 2-amino-2-deoxy-D-glucopyranose and 2-acetamido-2-deoxy-D-glucopyranose (5 to 10 residues).

≥ 915 g/kg

—

OGA/COS ratio comprised between 1 and 1,6

| — | Degree of polymerisation of COS comprised between 5 and 10 |
| --- | --- |

—

Degree of polymerisation of COS comprised between 5 and 10

| — | Degree of polymerisation of OGA comprised between 9 and 20 |
| --- | --- |

—

Degree of polymerisation of OGA comprised between 9 and 20

| — | Degree of methylation of OGA < 10 % |
| --- | --- |

—

Degree of methylation of OGA < 10 %

| — | Degree of acetylation of COS < 50 % |
| --- | --- |

—

Degree of acetylation of COS < 50 %

22 April 2015

22 April 2030

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on COS-OGA, and in particular Appendices I and II thereof, shall be taken into account.

---

(1)  Further details on identity and specification of active substance are provided in the review report.

---

ANNEX II

In Part D of the Annex to Implementing Regulation (EU) No 540/2011, the following entry is added:

| Number | Common Name, Identification Numbers | IUPAC Name | Purity (1) | Date of approval | Expiration of approval | Specific provisions |
| --- | --- | --- | --- | --- | --- | --- |
| ‘2 | COS-OGA
  CAS No: not allocated
  CIPAC No: 979 | Linear copolymer of α-1,4-D-galactopyranosyluronic acids and methylesterified galactopyranosyluronic acids (9 to 20 residues) with linear copolymer β-1,4-linked 2-amino-2-deoxy-D-glucopyranose and 2-acetamido-2-deoxy-D-glucopyranose (5 to 10 residues). | ≥ 915 g/kg






  — | OGA/COS ratio comprised between 1 and 1,6 |

Number

Common Name, Identification Numbers

IUPAC Name

Purity (1)

Date of approval

Expiration of approval

Specific provisions

‘2

COS-OGA

CAS No: not allocated

CIPAC No: 979

Linear copolymer of α-1,4-D-galactopyranosyluronic acids and methylesterified galactopyranosyluronic acids (9 to 20 residues) with linear copolymer β-1,4-linked 2-amino-2-deoxy-D-glucopyranose and 2-acetamido-2-deoxy-D-glucopyranose (5 to 10 residues).

≥ 915 g/kg

—

OGA/COS ratio comprised between 1 and 1,6

| — | Degree of polymerisation of COS comprised between 5 and 10 |
| --- | --- |

—

Degree of polymerisation of COS comprised between 5 and 10

| — | Degree of polymerisation of OGA comprised between 9 and 20 |
| --- | --- |

—

Degree of polymerisation of OGA comprised between 9 and 20

| — | Degree of methylation of OGA < 10 % |
| --- | --- |

—

Degree of methylation of OGA < 10 %

| — | Degree of acetylation of COS < 50 % |
| --- | --- |

—

Degree of acetylation of COS < 50 %

22 April 2015

22 April 2030

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on COS-OGA, and in particular Appendices I and II thereof, shall be taken into account.’

---

(1)  Further details on identity and specification of active substance are provided in the review report.

1

---

| 2.4.2015 | EN | Official Journal of the European Union | L 90/5 |
| --- | --- | --- | --- |

2.4.2015

EN

Official Journal of the European Union

L 90/5

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COMMISSION IMPLEMENTING REGULATION (EU) 2015/544

of 1 April 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, 1 April 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

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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 | IL | 139,9 |
| MA | 102,0 |
| TR | 121,8 |
| ZZ | 121,2 |
| 0707 00 05 | AL | 119,5 |
| MA | 176,1 |
| TR | 143,4 |
| ZZ | 146,3 |
| 0709 93 10 | MA | 104,5 |
| TR | 172,1 |
| ZZ | 138,3 |
| 0805 10 20 | EG | 44,3 |
| IL | 71,9 |
| MA | 47,2 |
| TN | 54,2 |
| TR | 66,8 |
| ZZ | 56,9 |
| 0805 50 10 | TR | 45,7 |
| ZZ | 45,7 |
| 0808 10 80 | AR | 94,0 |
| BR | 72,4 |
| CL | 94,8 |
| CN | 89,6 |
| MK | 25,2 |
| US | 167,0 |
| ZA | 118,4 |
| ZZ | 94,5 |
| 0808 30 90 | AR | 108,3 |
| CL | 125,1 |
| CN | 99,4 |
| ZA | 123,3 |
| ZZ | 114,0 |

(EUR/100 kg)

CN code

Third country code (1)

Standard import value

0702 00 00

IL

139,9

MA

102,0

TR

121,8

ZZ

121,2

0707 00 05

AL

119,5

MA

176,1

TR

143,4

ZZ

146,3

0709 93 10

MA

104,5

TR

172,1

ZZ

138,3

0805 10 20

EG

44,3

IL

71,9

MA

47,2

TN

54,2

TR

66,8

ZZ

56,9

0805 50 10

TR

45,7

ZZ

45,7

0808 10 80

AR

94,0

BR

72,4

CL

94,8

CN

89,6

MK

25,2

US

167,0

ZA

118,4

ZZ

94,5

0808 30 90

AR

108,3

CL

125,1

CN

99,4

ZA

123,3

ZZ

114,0

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(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’.

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DECISIONS

| 2.4.2015 | EN | Official Journal of the European Union | L 90/7 |
| --- | --- | --- | --- |

2.4.2015

EN

Official Journal of the European Union

L 90/7

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COMMISSION IMPLEMENTING DECISION (EU) 2015/545

of 31 March 2015

authorising the placing on the market of oil from the micro-algae Schizochytrium sp. (ATCC PTA-9695) as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council

(notified under document C(2015) 2082)

(Only the English text is authentic)

THE EUROPEAN COMMISSION,

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

Having regard to Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients (1), and in particular Article 7 thereof,

Whereas:

| (1) | On 18 September 2013, the company DSM Nutritional Products made a request to the competent authorities of the United Kingdom to place on the market oil rich in DHA (docosahexaenoic acid) from the micro-algae Schizochytrium sp. as a novel food ingredient. The strain of the micro-algae is specified as the strain American Type Culture Collection (ATCC) PTA-9695. |
| --- | --- |

(1)

On 18 September 2013, the company DSM Nutritional Products made a request to the competent authorities of the United Kingdom to place on the market oil rich in DHA (docosahexaenoic acid) from the micro-algae Schizochytrium sp. as a novel food ingredient. The strain of the micro-algae is specified as the strain American Type Culture Collection (ATCC) PTA-9695.

| (2) | On 2 April 2014, the competent food assessment body of the United Kingdom issued its initial assessment report. In that report it came to the conclusion that the use of this algal oil meets the criteria for novel food set out in Article 3(1) of Regulation (EC) No 258/97. |
| --- | --- |

(2)

On 2 April 2014, the competent food assessment body of the United Kingdom issued its initial assessment report. In that report it came to the conclusion that the use of this algal oil meets the criteria for novel food set out in Article 3(1) of Regulation (EC) No 258/97.

| (3) | On 10 April 2014, the Commission forwarded the initial assessment report to the other Member States. |
| --- | --- |

(3)

On 10 April 2014, the Commission forwarded the initial assessment report to the other Member States.

| (4) | Reasoned objections were raised within the 60-day period laid down in the first subparagraph of Article 6(4) of Regulation (EC) No 258/97. In particular, objections concerning elevated intake levels of DHA were raised. In accordance with Article 7(1) of Regulation (EC) No 258/97 a Decision should be adopted taking into account the objections raised. The applicant consequently modified the request concerning the maximum amount of DHA in food supplements. This change and additional explanations provided by the applicant alleviated the concerns to the satisfaction of Member States and the Commission. |
| --- | --- |

(4)

Reasoned objections were raised within the 60-day period laid down in the first subparagraph of Article 6(4) of Regulation (EC) No 258/97. In particular, objections concerning elevated intake levels of DHA were raised. In accordance with Article 7(1) of Regulation (EC) No 258/97 a Decision should be adopted taking into account the objections raised. The applicant consequently modified the request concerning the maximum amount of DHA in food supplements. This change and additional explanations provided by the applicant alleviated the concerns to the satisfaction of Member States and the Commission.

| (5) | Directive 2002/46/EC of the European Parliament and of the Council (2) lays down requirements on food supplements. Regulation (EC) No 1925/2006 of the European Parliament and of the Council (3) lays down requirements on the addition of vitamins and minerals and of certain other substances to foods. Directive 2009/39/EC of the European Parliament and of the Council (4) lays down requirements on foodstuffs intended for particular nutritional uses. Commission Directive 96/8/EC (5) lays down requirements on foods intended for use in energy-restricted diets for weight reduction. Commission Directive 1999/21/EC (6) lays down requirements for dietary foods for special medical purposes. Commission Directive 2006/125/EC (7) lays down requirements on processed cereal-based foods and baby foods for infants and young children. Commission Directive 2006/141/EC (8) lays down requirements on infant formulae and follow-on formulae. The use of oil from the micro-algae Schizochytrium sp. (ATCC PTA-9695) should be authorised without prejudice to the requirements of those legislations. |
| --- | --- |

(5)

Directive 2002/46/EC of the European Parliament and of the Council (2) lays down requirements on food supplements. Regulation (EC) No 1925/2006 of the European Parliament and of the Council (3) lays down requirements on the addition of vitamins and minerals and of certain other substances to foods. Directive 2009/39/EC of the European Parliament and of the Council (4) lays down requirements on foodstuffs intended for particular nutritional uses. Commission Directive 96/8/EC (5) lays down requirements on foods intended for use in energy-restricted diets for weight reduction. Commission Directive 1999/21/EC (6) lays down requirements for dietary foods for special medical purposes. Commission Directive 2006/125/EC (7) lays down requirements on processed cereal-based foods and baby foods for infants and young children. Commission Directive 2006/141/EC (8) lays down requirements on infant formulae and follow-on formulae. The use of oil from the micro-algae Schizochytrium sp. (ATCC PTA-9695) should be authorised without prejudice to the requirements of those legislations.

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

(6)

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

HAS ADOPTED THIS DECISION:

Article 1

Oil from the micro-algae Schizochytrium sp. (ATCC PTA-9695) as specified in Annex I may be placed on the market in the Union as a novel food ingredient for the uses defined and at the maximum levels established in Annex II without prejudice to the provisions of Directive 2002/46/EC, Regulation (EC) No 1925/2006, Directive 2009/39/EC, Directive 96/8/EC, Directive 1999/21/EC, Directive 2006/141/EC and Directive 2006/125/EC.

Article 2

The designation of oil from the micro-algae Schizochytrium sp. (ATCC PTA-9695) authorised by this Decision on the labelling of the foodstuffs containing it shall be ‘oil from the micro-algae Schizochytrium sp. (ATCC PTA-9695)’.

Article 3

This Decision is addressed to DSM Nutritional Products, 6480 Dobbin Road, Columbia, MD 21045, USA.

Done at Brussels, 31 March 2015.

For the Commission

Vytenis ANDRIUKAITIS

Member of the Commission

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(1)  OJ L 43, 14.2.1997, p. 1.

1

(2)  Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements (OJ L 183, 12.7.2002, p. 51).

2

(3)  Regulation (EC) No 1925/2006 of the European Parliament and of the Council of 20 December 2006 on the addition of vitamins and minerals and of certain other substances to foods (OJ L 404, 30.12.2006, p. 26).

3

(4)  Directive 2009/39/EC of the European Parliament and of the Council of 6 May 2009 on foodstuffs intended for particular nutritional uses (OJ L 124, 20.5.2009, p. 21).

4

(5)  Commission Directive 96/8/EC of 26 February 1996 on foods intended for use in energy-restricted diets for weight reduction (OJ L 55, 6.3.1996, p. 22).

5

(6)  Commission Directive 1999/21/EC of 25 March 1999 on dietary foods for special medical purposes (OJ L 91, 7.4.1999, p. 29).

6

(7)  Commission Directive 2006/125/EC of 5 December 2006 on processed cereal-based foods and baby foods for infants and young children (OJ L 339, 6.12.2006, p. 16).

7

(8)  Commission Directive 2006/141/EC of 22 December 2006 on infant formulae and follow-on formulae and amending Directive 1999/21/EC (OJ L 401, 30.12.2006, p. 1).

8

---

ANNEX I

Specification of oil from the micro-algae Schizochytrium sp. (American Type Culture Collection (ATCC) PTA-9695)

| Test | Specification |
| --- | --- |
| Free fatty acids | Not more than 0,4 % |
| Peroxide value (PV) | Not more than 5,0 meq/kg oil |
| Unsaponifiables | Not more than 3,5 % |
| DHA content | Not less than 35 % |
| Docosapentaenoic acid (DPA) n-6 | Not more than 6 % |
| Trans-fatty acids | Not more than 2,0 % |

Test

Specification

Free fatty acids

Not more than 0,4 %

Peroxide value (PV)

Not more than 5,0 meq/kg oil

Unsaponifiables

Not more than 3,5 %

DHA content

Not less than 35 %

Docosapentaenoic acid (DPA) n-6

Not more than 6 %

Trans-fatty acids

Not more than 2,0 %

---

ANNEX II

Authorised uses of oil from the micro-algae Schizochytrium sp. (American Type Culture Collection (ATCC) PTA-9695)

| Food category | Maximum use level of DHA |
| --- | --- |
| Dairy products except milk-based drinks | 200 mg/100 g or for cheese products 600 mg/100 g |
| Dairy analogues except drinks | 200 mg/100 g or for analogues to cheese products 600 mg/100 g |
| Spreadable fat and dressings | 600 mg/100 g |
| Breakfast cereals | 500 mg/100 g |
| Food supplements | 250 mg DHA per day as recommended by the manufacturer for normal population
  450 mg DHA per day as recommended by the manufacturer for pregnant and lactating women |
| Foods intended for use in energy-restricted diets for weight reduction as defined in Directive 96/8/EC | 250 mg per meal replacement |
| Other foods for particular nutritional uses as defined in Directive 2009/39/EC excluding infant and follow-on formulae | 200 mg/100 g |
| Dietary foods for special medical purposes | In accordance with the particular nutritional requirements of the persons for whom the products are intended |
| Bakery products (breads and rolls), sweet biscuits | 200 mg/100 g |
| Cereal bars | 500 mg/100 g |
| Cooking fats | 360 mg/100 g |
| Non-alcoholic beverages (including dairy analogue and milk-based drinks) | 80 mg/100 ml |
| Infant formula and follow-on formula | Used in accordance with Directive 2006/141/EC |
| Processed cereal-based foods and baby foods for infants and young children including those used in accordance with Directive 2006/125/EC | 200 mg/100 g |

Food category

Maximum use level of DHA

Dairy products except milk-based drinks

200 mg/100 g or for cheese products 600 mg/100 g

Dairy analogues except drinks

200 mg/100 g or for analogues to cheese products 600 mg/100 g

Spreadable fat and dressings

600 mg/100 g

Breakfast cereals

500 mg/100 g

Food supplements

250 mg DHA per day as recommended by the manufacturer for normal population

450 mg DHA per day as recommended by the manufacturer for pregnant and lactating women

Foods intended for use in energy-restricted diets for weight reduction as defined in Directive 96/8/EC

250 mg per meal replacement

Other foods for particular nutritional uses as defined in Directive 2009/39/EC excluding infant and follow-on formulae

200 mg/100 g

Dietary foods for special medical purposes

In accordance with the particular nutritional requirements of the persons for whom the products are intended

Bakery products (breads and rolls), sweet biscuits

200 mg/100 g

Cereal bars

500 mg/100 g

Cooking fats

360 mg/100 g

Non-alcoholic beverages (including dairy analogue and milk-based drinks)

80 mg/100 ml

Infant formula and follow-on formula

Used in accordance with Directive 2006/141/EC

Processed cereal-based foods and baby foods for infants and young children including those used in accordance with Directive 2006/125/EC

200 mg/100 g

---

| 2.4.2015 | EN | Official Journal of the European Union | L 90/11 |
| --- | --- | --- | --- |

2.4.2015

EN

Official Journal of the European Union

L 90/11

---

COMMISSION IMPLEMENTING DECISION (EU) 2015/546

of 31 March 2015

authorising an extension of use of DHA and EPA-rich oil from the micro-algae Schizochytrium sp. as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council

(notified under document C(2015) 2083)

(Only the English text is authentic)

THE EUROPEAN COMMISSION,

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

Having regard to Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients (1), and in particular Article 7 thereof,

Whereas:

| (1) | On 6 July 2012, the competent authorities of the United Kingdom authorised, in accordance with Regulation (EC) No 258/97, the placing on the market of docosahexaenoic acid (DHA) and eicosapentaenoic (EPA)-rich oil from the micro-algae Schizochytrium sp. as a novel food ingredient to be used in certain foods. |
| --- | --- |

(1)

On 6 July 2012, the competent authorities of the United Kingdom authorised, in accordance with Regulation (EC) No 258/97, the placing on the market of docosahexaenoic acid (DHA) and eicosapentaenoic (EPA)-rich oil from the micro-algae Schizochytrium sp. as a novel food ingredient to be used in certain foods.

| (2) | On 19 November 2012, the company DSM Nutritional Products made a request to the competent authorities of the United Kingdom for extension of use of DHA and EPA-rich oil from micro-algae Schizochytrium sp. as a novel food ingredient. |
| --- | --- |

(2)

On 19 November 2012, the company DSM Nutritional Products made a request to the competent authorities of the United Kingdom for extension of use of DHA and EPA-rich oil from micro-algae Schizochytrium sp. as a novel food ingredient.

| (3) | On 29 April 2013, the competent food assessment body of the United Kingdom issued its initial assessment report. In that report it came to the conclusion that the extension of use of this algal oil meets the criteria for novel food set out in Article 3(1) of Regulation (EC) No 258/97. |
| --- | --- |

(3)

On 29 April 2013, the competent food assessment body of the United Kingdom issued its initial assessment report. In that report it came to the conclusion that the extension of use of this algal oil meets the criteria for novel food set out in Article 3(1) of Regulation (EC) No 258/97.

| (4) | On 9 July 2013, the Commission forwarded the initial assessment report to the other Member States. |
| --- | --- |

(4)

On 9 July 2013, the Commission forwarded the initial assessment report to the other Member States.

| (5) | Reasoned objections were raised within the 60-day period laid down in the first subparagraph of Article 6(4) of Regulation (EC) No 258/97. |
| --- | --- |

(5)

Reasoned objections were raised within the 60-day period laid down in the first subparagraph of Article 6(4) of Regulation (EC) No 258/97.

| (6) | On 25 March 2014, the Commission consulted the European Food Safety Authority (EFSA) asking it to carry out an additional assessment of the extension of use of DHA and EPA-rich oil from the micro-algae Schizochytrium sp. as a novel food ingredient in accordance with Regulation (EC) No 258/97. |
| --- | --- |

(6)

On 25 March 2014, the Commission consulted the European Food Safety Authority (EFSA) asking it to carry out an additional assessment of the extension of use of DHA and EPA-rich oil from the micro-algae Schizochytrium sp. as a novel food ingredient in accordance with Regulation (EC) No 258/97.

| (7) | On 18 September 2014, EFSA adopted a scientific opinion on the extension of use for DHA and EPA-rich oil from the micro-algae Schizochytrium sp. as a novel food ingredient (2), concluding that it is safe under the proposed uses and use levels. |
| --- | --- |

(7)

On 18 September 2014, EFSA adopted a scientific opinion on the extension of use for DHA and EPA-rich oil from the micro-algae Schizochytrium sp. as a novel food ingredient (2), concluding that it is safe under the proposed uses and use levels.

| (8) | That opinion gives sufficient grounds to establish that DHA and EPA-rich oil from the micro-algae Schizochytrium sp. in the proposed uses and use levels complies with the criteria laid down in Article 3(1) of Regulation (EC) No 258/97. |
| --- | --- |

(8)

That opinion gives sufficient grounds to establish that DHA and EPA-rich oil from the micro-algae Schizochytrium sp. in the proposed uses and use levels complies with the criteria laid down in Article 3(1) of Regulation (EC) No 258/97.

| (9) | Directive 2002/46/EC of the European Parliament and of the Council (3) lays down requirements on food supplements. The use of DHA and EPA-rich oil from the micro-algae Schizochytrium sp. should be authorised without prejudice to the requirements of that legislation. |
| --- | --- |

(9)

Directive 2002/46/EC of the European Parliament and of the Council (3) lays down requirements on food supplements. The use of DHA and EPA-rich oil from the micro-algae Schizochytrium sp. should be authorised without prejudice to the requirements of that legislation.

| (10) | The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, |
| --- | --- |

(10)

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

HAS ADOPTED THIS DECISION:

Article 1

DHA and EPA-rich oil from the micro-algae Schizochytrium sp. as specified in Annex I may be placed on the market in the Union as a novel food ingredient for the use defined and at the maximum level established in Annex II without prejudice to the provisions of Directive 2002/46/EC.

Article 2

The designation of DHA- and EPA-rich oil from the micro-algae Schizochytrium sp. authorised by this Decision on the labelling of the foodstuffs containing it shall be ‘DHA and EPA-rich oil from the micro-algae Schizochytrium sp.’.

Article 3

This Decision is addressed to DSM Nutritional Products, 6480 Dobbin Road, Columbia, MD 21045, USA.

Done at Brussels, 31 March 2015.

For the Commission

Vytenis ANDRIUKAITIS

Member of the Commission

---

(1)  OJ L 43, 14.2.1997, p. 1.

1

(2)  EFSA Journal 2014; 12(10):3843.

2

EFSA Journal

(3)  Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements (OJ L 183, 12.7.2002, p. 51).

3

---

ANNEX I

Specification of DHA (docosahexaneoic acid) and EPA (eicosapentaenoic acid)-rich oil from the micro-algae Schizochytrium sp.

| Test | Specification |
| --- | --- |
| Acid value | Not more than 0,5 mg KOH/g |
| Peroxide value (PV) | Not more than 5,0 meq/kg oil |
| Moisture and volatiles | Not more than 0,05 % |
| Unsaponifiables | Not more than 4,5 % |
| Trans-fatty acids | Not more than 1,0 % |
| DHA content | Not less than 22,5 % |
| EPA content | Not less than 10 % |

Test

Specification

Acid value

Not more than 0,5 mg KOH/g

Peroxide value (PV)

Not more than 5,0 meq/kg oil

Moisture and volatiles

Not more than 0,05 %

Unsaponifiables

Not more than 4,5 %

Trans-fatty acids

Not more than 1,0 %

DHA content

Not less than 22,5 %

EPA content

Not less than 10 %

---

ANNEX II

Authorised uses of DHA (docosahexaenoic acid) and EPA (eicosapentaenoic acid)-rich oil from the micro-algae Schizochytrium sp.

| Food category | Maximum use level of DHA and EPA (mg/day) |
| --- | --- |
| Food supplements | 3 000 mg as recommended by the manufacturer for adult population excluding pregnant and lactating women |

Food category

Maximum use level of DHA and EPA (mg/day)

Food supplements

3 000 mg as recommended by the manufacturer for adult population excluding pregnant and lactating women

---

| 2.4.2015 | EN | Official Journal of the European Union | L 90/14 |
| --- | --- | --- | --- |

2.4.2015

EN

Official Journal of the European Union

L 90/14

---

COMMISSION DECISION (EU) 2015/547

of 1 April 2015

on the safety requirements to be met by European standards for alcohol-powered flueless fireplaces pursuant to Directive 2001/95/EC of the European Parliament and of the Council on general product safety

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

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

Having regard to Directive 2001/95/EC of the European Parliament and of the Council of 3 December 2001 on general product safety (1), and in particular Article 4(1)(a) thereof,

Whereas:

| (1) | Products which conform to national standards transposing European standards drawn up under Directive 2001/95/EC and referenced in the Official Journal of the European Union benefit from a presumption of safety. |
| --- | --- |

(1)

Products which conform to national standards transposing European standards drawn up under Directive 2001/95/EC and referenced in the Official Journal of the European Union benefit from a presumption of safety.

| (2) | European standards are to be drawn up on the basis of requirements intended to ensure that products which conform to them satisfy the general safety requirement set out in Article 3 of Directive 2001/95/EC. |
| --- | --- |

(2)

European standards are to be drawn up on the basis of requirements intended to ensure that products which conform to them satisfy the general safety requirement set out in Article 3 of Directive 2001/95/EC.

| (3) | No European standards exist for alcohol-powered flueless fireplaces, although according to the existing studies various hazards are associated with them (2)
   (3). Many models are designed with detachable fuel containers which are placed in a chamber within the fireplace, and fuel may therefore spill within the chamber. It may then evaporate, increase in temperature and deflagrate, causing sudden combustion. The rapid spread of flames puts the user at risk of burns and may ignite surrounding materials. Refuelling an ethanol fireplace while it is still hot is very dangerous, as ethanol may vaporise quickly, ignite and cause an explosion. Free-standing floor models could be placed too close to combustible materials and may consequently cause fires. Faulty installation of wall-mounted fireplaces may cause overheating, which may in turn lead to the fireplace becoming detached from the wall while still in operation (4). There is also a risk that free-standing floor models may overturn. Should this occur, the burning fuel would spill out of the fireplace, spreading fire into the surrounding room area. |
| --- | --- |

(3)

No European standards exist for alcohol-powered flueless fireplaces, although according to the existing studies various hazards are associated with them (2)
   (3). Many models are designed with detachable fuel containers which are placed in a chamber within the fireplace, and fuel may therefore spill within the chamber. It may then evaporate, increase in temperature and deflagrate, causing sudden combustion. The rapid spread of flames puts the user at risk of burns and may ignite surrounding materials. Refuelling an ethanol fireplace while it is still hot is very dangerous, as ethanol may vaporise quickly, ignite and cause an explosion. Free-standing floor models could be placed too close to combustible materials and may consequently cause fires. Faulty installation of wall-mounted fireplaces may cause overheating, which may in turn lead to the fireplace becoming detached from the wall while still in operation (4). There is also a risk that free-standing floor models may overturn. Should this occur, the burning fuel would spill out of the fireplace, spreading fire into the surrounding room area.

| (4) | The combustion of fuels in alcohol-powered flueless fireplaces may put human health at risk. If incomplete combustion occurs, carbon monoxide, a toxic compound, is formed. If complete combustion occurs, carbon dioxide is formed, which is hazardous to health and can lead to hyperventilation. |
| --- | --- |

(4)

The combustion of fuels in alcohol-powered flueless fireplaces may put human health at risk. If incomplete combustion occurs, carbon monoxide, a toxic compound, is formed. If complete combustion occurs, carbon dioxide is formed, which is hazardous to health and can lead to hyperventilation.

| (5) | Furthermore, the installation of flueless fireplaces does not require inspection by the relevant authorities. |
| --- | --- |

(5)

Furthermore, the installation of flueless fireplaces does not require inspection by the relevant authorities.

| (6) | It is therefore appropriate to determine the requirements needed to ensure that alcohol-powered flueless fireplaces satisfy the general safety requirement set out in Article 3 of Directive 2001/95/EC. |
| --- | --- |

(6)

It is therefore appropriate to determine the requirements needed to ensure that alcohol-powered flueless fireplaces satisfy the general safety requirement set out in Article 3 of Directive 2001/95/EC.

| (7) | The measures provided for in this Decision are in accordance with the opinion of the Committee on general product safety, |
| --- | --- |

(7)

The measures provided for in this Decision are in accordance with the opinion of the Committee on general product safety,

HAS ADOPTED THIS DECISION:

Article 1

Definition

For the purposes of this Decision, the following definition shall apply:

| | ‘Alcohol-powered flueless fireplace’ means an appliance which:






  (a) | is designed to produce a decorative flame by burning alcohol, but is unsuitable for primary heating purposes; and |
| --- | --- | --- |

‘Alcohol-powered flueless fireplace’ means an appliance which:

(a)

is designed to produce a decorative flame by burning alcohol, but is unsuitable for primary heating purposes; and

| (b) | is not designed to be connected to a flue. |
| --- | --- |

(b)

is not designed to be connected to a flue.

Article 2

Scope

This Decision shall apply to all domestic flueless fireplaces and their accessories where these are intended for use indoors. Fireplaces with a fuel chamber volume below 0,2 l specifically designed for cooking food or keeping it warm do not fall within the scope of this Decision.

Article 3

Safety requirements

The specific safety requirements for alcohol-powered flueless fireplaces referred to in Article 1 to be met by European standards pursuant to Article 4 of Directive 2001/95/EC are set out in the Annex to this Decision.

Article 4

Entry into force

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, 1 April 2015.

For the Commission

The President

Jean-Claude JUNCKER

---

(1)  OJ L 11, 15.1.2002, p. 4.

1

(2)  Storesund A. K, Mai T. T. & Sesseng C, 2010, ‘Ethanol-fuelled, flue-less fireplaces. An evaluation’, SINTEF. http://nbl.sintef.no/publication/lists/docs/NBL_A09127.pdf

2

(3)  http://www.sik.dk/content/download/5561/77087/version/1/file/Report+-+Bio+fireplaces+-+v5-3+(2).pdf

3

(4)  http://www.cpsc.gov/CPSCPUB/PREREL/prhtml11/11164.html

4

---

ANNEX

SPECIFIC SAFETY REQUIREMENTS RELATING TO ALCOHOL-POWERED FLUELESS FIREPLACES

1.1.   Construction and design requirements

General requirements

Alcohol-powered flueless fireplaces for domestic use shall have a maximum fuel consumption corresponding to a thermal output of 4,5 kW.

Alcohol-powered flueless fireplaces shall be made from materials that are not malleable at the maximum permissible temperatures listed in the section ‘Surface temperatures’. The materials shall display sufficient resistance to the prevalent thermal, mechanical and chemical conditions.

Where flame screens are used, their construction and attachment to the fireplace shall be such that they can withstand the temperatures to which they are exposed.

The use of decorative elements, e.g. ceramic wood or pebbles, is not permitted in the area of flame impingement.

Alcohol-powered flueless fireplaces shall be designed in such a way as to prevent accidental re-ignition and backfiring.

The combustion of fuels in alcohol-powered flueless fireplaces must not put human health at risk.

Alcohol-powered flueless fireplaces shall be designed in such a way as to prevent spilt fuel from accumulating in closed compartments inside the appliance, from where it could evaporate and cause an explosion.

The appliance shall be constructed in such a way as to avoid any leakage of fuel.

Stability

Unintentional movement or tilting of alcohol-powered flueless fireplaces during operation must not compromise safety.

Appliances on wheels shall be fitted with easy to operate lockable brakes.

Free-standing alcohol-powered flueless fireplaces shall be fitted with supports to prevent them from overturning and be subject to testing of their stability on impact. If the fireplace does not pass this test it shall be built in such a way that it remains safe at all times.

Fixed appliances shall also be subject to testing of their stability on impact. Wall hooks shall be built in such a way as to prevent the appliance being lifted off the hooks if unintentionally pushed upwards.

Fittings (e.g. wheels or handles) facilitating movement of the fireplace

Alcohol-powered flueless fireplaces with wheels and/or handles intended to allow them to be moved shall be designed in such way that the fire has to be extinguished before moving the fireplace.

Ignition

When igniting the alcohol-powered flueless fireplace the user shall be able to stay at a safe horizontal distance from the appliance. Alternatively, the alcohol-powered flueless fireplace shall be equipped with a safe built-in ignition device.

Operation when lit

The alcohol-powered flueless fireplace shall burn with a stable flame that does not produce soot. When lit, fuel consumption shall remain steady and there shall be no risk of burner runaway.

Extinguishing

The user shall be able to extinguish an alcohol-powered flueless fireplace safely at any time.

Re-ignition

The design of the alcohol-powered flueless fireplace shall make it possible to safely re-ignite the appliance even if the container is not full.

Preventing re-ignition when unsafe

It shall not be possible to reignite the alcohol-powered flueless fireplace until all parts of the appliance, including the burner, have reached a safe temperature of 60 °C or below. The instructions for use shall include information about the time it takes for the fireplace to cool down sufficiently to be safe to re-ignite, so that the user is not tempted to force re-ignition by tampering with the safety device preventing re-ignition at unsafe temperatures.

Filling and re-filling

The design of the alcohol powered flueless fireplace shall make filling and re-filling safe, and shall prevent the tank of the fireplace from being refilled while the fireplace is lit.

The instructions for use supplied with alcohol-powered flueless fireplaces shall inform users that the tank must not be filled during operation. This information shall be presented clearly and brought to users' attention. Additionally, the same information shall be conveyed by appropriate warning labels visibly displayed on the appliance itself.

Accessible surfaces

Providing the fireplace is installed according to the installation instructions given by the manufacturer, it shall not be possible for the user to accidentally come into contact with the flame, the burner or any other active or hot surface of the fireplace.

Surface temperatures

Accessible surfaces, with the exception of active surfaces, shall not reach unsafe temperatures when the alcohol-powered flueless fireplace is in operation.

The temperature increase (as measured from the starting temperature on ignition) of the surfaces that are not intended to be touched by the user when the fireplace is in use shall not exceed:

| — | 60 K for metal or metallic surfaces, |
| --- | --- |

—

60 K for metal or metallic surfaces,

| — | 65 K for metal enamel surfaces, |
| --- | --- |

—

65 K for metal enamel surfaces,

| — | 80 K for glass and ceramic surfaces, |
| --- | --- |

—

80 K for glass and ceramic surfaces,

| — | 100 K for plastic surfaces, and |
| --- | --- |

—

100 K for plastic surfaces, and

| — | 70 K for surfaces made of any other material. |
| --- | --- |

—

70 K for surfaces made of any other material.

The temperature increase (as measured from the starting temperature on ignition) of the surfaces that are intended to be touched by the user when the fireplace is in use, i.e. those that the user may need to touch in order to operate the fireplace, shall not exceed:

| — | 35 K for metal or metallic surfaces, |
| --- | --- |

—

35 K for metal or metallic surfaces,

| — | 45 K for metal enamel and ceramic surfaces, and |
| --- | --- |

—

45 K for metal enamel and ceramic surfaces, and

| — | 60 K for surfaces made of plastic or other similar material. |
| --- | --- |

—

60 K for surfaces made of plastic or other similar material.

These limits shall also apply to surfaces and the air space within 50 mm of the flame area.

Glass surfaces (e.g. screens) and their fixings which would reasonably be assumed to be hot due to their closeness to open flames are exempted from the above requirements.

At the point of contact with the floor or table, the temperature on the surface of the fireplace stand shall not exceed the room temperature by more than 65 K.

In addition to the requirement of not exceeding the room temperature by more than 65 K, the maximum temperature, which cannot be exceeded in any circumstances, is set as follows: at the point of contact with the floor or table, the temperature of the fireplace stand shall not exceed 85 °C, irrespective of the room temperature.

The surface temperature on adjacent walls shall not exceed the room temperature by more than 65 K and shall never exceed 85 °C.

Temperature limits for handles and knobs intended to be used by the owner in the normal course of operating the fireplace need to be set in accordance with suitable guidance documents, such as Cenelec Guide 29, according to the materials from which they are made. The temperature limits for these parts of the fireplace are lower than the abovementioned temperatures.

Fuel container and fuel system

The maximum fuel capacity of the appliance shall be limited according to the risk of fire and explosion.

The standard shall require that all tests are carried out with the fuel tank filled to the capacity that is potentially most dangerous in that particular situation.

The fuel container shall be constructed so as to prevent any leakage. Spillage or overfilling shall not compromise the safety of the appliance.

The fuel system, including any seals, shall have sufficient mechanical strength to withstand the strains caused by expected normal usage. It shall have sufficient resistance to corrosion to withstand the long-term effects of exposure to the fuel used. The design of the burner shall prevent corrosion occurring.

Child safety

The alcohol-powered flueless fireplace shall be designed to prevent children from coming into contact with the fuel and/or the flame.

1.2.   Equipment and fittings for installation of the fireplace

Mounting systems

Mounting systems supplied with the alcohol-powered flueless fireplace shall have sufficient mechanical strength and resistance to high temperatures to support the fireplace safely during its expected lifetime.

If the appliance is designed to be fixed to the floor, the wall or the ceiling, the system for fixing/mounting it shall be designed so as to prevent the appliance from coming loose accidentally.

Wall plugs and fittings

If supplied with the alcohol-powered flueless fireplace, wall plugs and fittings shall be of appropriate long-term mechanical strength and thermal properties.

The user manual shall warn the user to use only the supplied wall plugs and fittings or wall plugs and fittings with the appropriate mechanical strength and thermal properties.

1.3.   Auxiliary equipment

Equipment for the safe ignition and safe extinction of the fireplace shall be installed or supplied with the appliance.

1.4.   Emissions

Alcohol-powered flueless fireplaces shall be constructed in such a way as to avoid any risk to human health which may arise from combustion or other emissions through inherently safe design and construction, or where this is not possible by adequate protection measures, including alarms, or information to users.

The standard should address in particular:

| — | carbon monoxide and carbon dioxide (CO, CO2), |
| --- | --- |

—

carbon monoxide and carbon dioxide (CO, CO2),

| — | nitrogen oxides such as NO, NO2 and NOX, |
| --- | --- |

—

nitrogen oxides such as NO, NO2 and NOX,

| — | aldehydes such as formaldehyde, |
| --- | --- |

—

aldehydes such as formaldehyde,

| — | volatile organic compounds (VOCs), |
| --- | --- |

—

volatile organic compounds (VOCs),

| — | aromatic hydrocarbons such as benzene and polycyclic aromatic hydrocarbons (PAHs), |
| --- | --- |

—

aromatic hydrocarbons such as benzene and polycyclic aromatic hydrocarbons (PAHs),

| — | soot and other particle emissions, |
| --- | --- |

—

soot and other particle emissions,

| — | emissions from unburnt fuel, and |
| --- | --- |

—

emissions from unburnt fuel, and

| — | any other emissions that may be relevant. |
| --- | --- |

—

any other emissions that may be relevant.

The standard provisions regarding carbon monoxide and nitrogen oxides shall reflect the latest version of the World Health Organisation (WHO) guidelines ‘WHO guidelines for indoor air quality: selected pollutants’ (1) and Environmental Health Criteria (EHC) (2).

The standard provisions regarding carbon dioxide shall reflect Commission Directive 2006/15/EC (3).

1.5.   Safety information, user manual and identification of the manufacturer and importer

General

Safety information, together with the names of the manufacturer and the importer, shall be displayed on the alcohol-powered flueless fireplace or on its packaging, or included in the instructions for use.

The standard shall state precisely which safety instructions must be displayed on the product itself and which warnings and instructions can be included in the instructions for use or displayed on the packaging.

The information shall be given in the language(s) of the country in which the fireplace is offered for retail sale. The information shall be presented in one continuous section in each language and shall not be interrupted by other text. Additional text given in another language shall not distract from the required information.

The information appearing on the fireplace shall be visible, legible and indelible, being either written on a permanent label or imprinted directly on the appliance.

Safety information

Safety information shall be conspicuously displayed and clearly communicated in the instructions for use or on the packaging and, if indicated in the standard, on the alcohol-powered flueless fireplace. This information shall include at least the following:

| — | ‘Use only the types and quantities of fuel specified in the guidelines in the user manual.’ |
| --- | --- |

—

‘Use only the types and quantities of fuel specified in the guidelines in the user manual.’

| — | ‘Only use in a well-ventilated room.’ |
| --- | --- |

—

‘Only use in a well-ventilated room.’

| — | ‘Never pour fuel into the appliance when in operation or still hot.’ |
| --- | --- |

—

‘Never pour fuel into the appliance when in operation or still hot.’

| — | ‘Never overfill the fuel container and carefully wipe away any spilt fuel before igniting the appliance.’ |
| --- | --- |

—

‘Never overfill the fuel container and carefully wipe away any spilt fuel before igniting the appliance.’

| — | ‘Only use in a place free of draughts.’ |
| --- | --- |

—

‘Only use in a place free of draughts.’

| — | ‘Never ignite a hot appliance.’ |
| --- | --- |

—

‘Never ignite a hot appliance.’

| — | ‘Never move the appliance while it is in operation’. |
| --- | --- |

—

‘Never move the appliance while it is in operation’.

| — | ‘Never leave small children or pets unattended near a lit fireplace.’ |
| --- | --- |

—

‘Never leave small children or pets unattended near a lit fireplace.’

| — | ‘Install, use and maintain only in accordance with the manufacturer's instructions.’ |
| --- | --- |

—

‘Install, use and maintain only in accordance with the manufacturer's instructions.’

Appliances fitted with wheels shall also include the following instruction: ‘Always lock the brakes before using the fireplace.’

In addition, the minimum safe distance at which the fireplace may be placed from flammable materials shall be indicated.

Users shall also be informed of the labelling conventions for fuels, and specifically the information on the properties of the different fuels conveyed by their labelling.

The written safety information may be accompanied by suitable pictograms, where allowed for in the standard.

User manual

The alcohol-powered flueless fireplace shall be supplied with a user manual, which shall include the following information:

| — | the required (minimum) distance from the burning chamber at which a device for igniting the alcohol-powered flueless fireplace may be installed, |
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the required (minimum) distance from the burning chamber at which a device for igniting the alcohol-powered flueless fireplace may be installed,

| — | required characteristics of the wall (or other structure) for wall-mounting an alcohol-powered flueless fireplace, including instructions regarding appropriate air slots for heat ventilation, |
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required characteristics of the wall (or other structure) for wall-mounting an alcohol-powered flueless fireplace, including instructions regarding appropriate air slots for heat ventilation,

| — | requirements relating to the fixtures used for attaching wall-mounted alcohol-powered flueless fireplaces (and free-standing fireplaces where relevant), |
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requirements relating to the fixtures used for attaching wall-mounted alcohol-powered flueless fireplaces (and free-standing fireplaces where relevant),

| — | requirements relating to the positioning and structural surroundings of the free-standing alcohol-powered flueless fireplace, in particular the floor, and ceiling where relevant, and |
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requirements relating to the positioning and structural surroundings of the free-standing alcohol-powered flueless fireplace, in particular the floor, and ceiling where relevant, and

| — | requirements relating to the wall on which an alcohol-powered flueless fireplace is to be mounted, including specific mention of wall types where particular care is to be exercised, e.g. gypsum walls or wooden walls. |
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requirements relating to the wall on which an alcohol-powered flueless fireplace is to be mounted, including specific mention of wall types where particular care is to be exercised, e.g. gypsum walls or wooden walls.

Additionally, the user manual shall provide information on:

| — | the type(s) of fuel that may be used, and additives allowed in that fuel, to ensure that the alcohol-powered flueless fireplace burns safely and that the maximum emissions are not exceeded, |
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the type(s) of fuel that may be used, and additives allowed in that fuel, to ensure that the alcohol-powered flueless fireplace burns safely and that the maximum emissions are not exceeded,

| — | the required ventilation of the room, |
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the required ventilation of the room,

| — | the minimum safe distance from flammable materials at which the fireplace may be placed, and |
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the minimum safe distance from flammable materials at which the fireplace may be placed, and

| — | the minimum size of the room or minimum floor area. |
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the minimum size of the room or minimum floor area.

Furthermore, the user manual shall:

| — | explain how to introduce fuel into the alcohol-powered flueless fireplace (and warn users not to pour fuel into a hot fireplace), |
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explain how to introduce fuel into the alcohol-powered flueless fireplace (and warn users not to pour fuel into a hot fireplace),

| — | explain how to safely store fuel and indicate the indoor storage limits imposed by national and/or regional legislation in the country where the appliance is marketed, |
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explain how to safely store fuel and indicate the indoor storage limits imposed by national and/or regional legislation in the country where the appliance is marketed,

| — | explain how to extinguish an alcohol-powered flueless fireplace, |
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explain how to extinguish an alcohol-powered flueless fireplace,

| — | provide information about appropriate fire extinguishing equipment and recommend that such equipment be located near the fireplace, |
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provide information about appropriate fire extinguishing equipment and recommend that such equipment be located near the fireplace,

| — | warn against using the alcohol-powered flueless fireplace in a draughty environment, |
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warn against using the alcohol-powered flueless fireplace in a draughty environment,

| — | give instructions for safely igniting and re-igniting the fireplace, |
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give instructions for safely igniting and re-igniting the fireplace,

| — | warn against igniting a hot alcohol-powered flueless fireplace, and |
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warn against igniting a hot alcohol-powered flueless fireplace, and

| — | instruct users never to move an alcohol-powered flueless fireplace while in use, and, if the fireplace is fitted with wheels, to lock the brakes when using the appliance. |
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instruct users never to move an alcohol-powered flueless fireplace while in use, and, if the fireplace is fitted with wheels, to lock the brakes when using the appliance.

Identification of the manufacturer and importer

Manufacturers (4) shall indicate their name, registered trade name or registered trade mark and the address at which they can be contacted on the alcohol-powered flueless fireplace itself or on its packaging and in a document accompanying the fireplace.

They shall also affix information enabling identification of the product (serial or batch number) on the product itself.

Importers (5) shall indicate their name, registered trade name or registered trade mark and the address at which they can be contacted on the alcohol-powered flueless fireplace itself or on its packaging and in a document accompanying the fireplace. In cases where the importer would have to open the packaging only for the purpose of putting this required information on the product itself, it is sufficient to indicate the name, registered trade name or registered trade mark and the address at which they can be contacted on the packaging or in a document accompanying the fireplace.

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(1)  World Health Organisation, 2010: http://www.euro.who.int/en/health-topics/environment-and-health/air-quality/publications/2010/who-guidelines-for-indoor-air-quality-selected-pollutants

(2)  http://www.who.int/ipcs/publications/ehc/ehc_alphabetical/en/index.html

(3)  Commission Directive 2006/15/EC of 7 February 2006 establishing a second list of indicative occupational exposure limit values in implementation of Council Directive 98/24/EC and amending Directives 91/322/EEC and 2000/39/EC (OJ L 38, 9.2.2006, p. 36).

(4)  As defined in Article R1 of Chapter R1 of Annex I to Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the marketing of products, and repealing Council Decision 93/465/EEC (OJ L 218, 13.8.2008, p. 82).

(5)  See footnote 4.

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