# Official Journal L 230/2016

| | ISSN 1977-0677 |
| --- | --- |
| Official Journal
  of the European Union | L 230 |
| | |
| English edition | Legislation | Volume 5925 August 2016 |

ISSN 1977-0677

Official Journal

of the European Union

L 230

English edition

Legislation

Volume 5925 August 2016

---

| Contents | | II   Non-legislative acts | page |
| --- | --- | --- | --- |
| | | REGULATIONS |
| | * | Commission Regulation (EU) 2016/1411 of 24 August 2016 refusing to authorise certain health claims made on foods, other than those referring to the reduction of disease risk and to children's development and health (
  1
  ) | 1 |
| | * | Commission Regulation (EU) 2016/1412 of 24 August 2016 refusing to authorise a health claim made on foods and referring to the reduction of disease risk (
  1
  ) | 6 |
| | * | Commission Regulation (EU) 2016/1413 of 24 August 2016 amending Regulation (EU) No 432/2012 establishing a list of permitted health claims made on foods other than those referring to the reduction of disease risk and to children's development and health (
  1
  ) | 8 |
| | * | Commission Implementing Regulation (EU) 2016/1414 of 24 August 2016 approving the active substance cyantraniliprole, 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
  ) | 16 |
| | * | Commission Implementing Regulation (EU) 2016/1415 of 24 August 2016 entering a name in the register of traditional specialities guaranteed (Tepertős pogácsa (TSG)) | 20 |
| | * | Commission Regulation (EU) 2016/1416 of 24 August 2016 amending and correcting Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food (
  1
  ) | 22 |
| | | Commission Implementing Regulation (EU) 2016/1417 of 24 August 2016 establishing the standard import values for determining the entry price of certain fruit and vegetables | 43 |

Contents

II   Non-legislative acts

page

REGULATIONS

*

Commission Regulation (EU) 2016/1411 of 24 August 2016 refusing to authorise certain health claims made on foods, other than those referring to the reduction of disease risk and to children's development and health (
  1
  )

1

1

*

Commission Regulation (EU) 2016/1412 of 24 August 2016 refusing to authorise a health claim made on foods and referring to the reduction of disease risk (
  1
  )

1

6

*

Commission Regulation (EU) 2016/1413 of 24 August 2016 amending Regulation (EU) No 432/2012 establishing a list of permitted health claims made on foods other than those referring to the reduction of disease risk and to children's development and health (
  1
  )

1

8

*

Commission Implementing Regulation (EU) 2016/1414 of 24 August 2016 approving the active substance cyantraniliprole, 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

16

*

Commission Implementing Regulation (EU) 2016/1415 of 24 August 2016 entering a name in the register of traditional specialities guaranteed (Tepertős pogácsa (TSG))

20

*

Commission Regulation (EU) 2016/1416 of 24 August 2016 amending and correcting Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food (
  1
  )

1

22

Commission Implementing Regulation (EU) 2016/1417 of 24 August 2016 establishing the standard import values for determining the entry price of certain fruit and vegetables

43

| | | III   Other acts |
| --- | --- | --- |
| | | EUROPEAN ECONOMIC AREA |
| | * | EFTA Surveillance Authority Decision No 83/15/COL of 18 March 2015 concerning the consistency of certain targets included in the national or functional airspace block plans submitted pursuant to Regulation (EC) No 549/2004 of the European Parliament and of the Council with the Union-wide performance targets for the second reference period [2016/1418] | 45 |
| | * | EFTA Surveillance Authority Decision No 111/15/COL of 31 March 2015 amending the list contained in point 39 of Part 1.2 of Chapter I of Annex I to the Agreement on the European Economic Area listing border inspection posts in Iceland and Norway agreed for veterinary checks on live animals and animal products from third countries and repealing EFTA Surveillance Authority Decision No 311/13/COL [2016/1419] | 51 |
| | * | EFTA Surveillance Authority Decision No 221/15/COL of 3 June 2015 amending EFTA Surveillance Authority Decision No 83/15/COL concerning the consistency of certain targets included in the national or functional airspace block plans submitted pursuant to Regulation (EC) No 549/2004 of the European Parliament and of the Council with the Union-wide performance targets for the second reference period [2016/1420] | 56 |
| | * | EFTA Surveillance Authority Decision No 293/15/COL of 14 July 2015 to approve the national programme established by Iceland for the control of salmonella in poultry and poultry products [2016/1421] | 58 |

III   Other acts

EUROPEAN ECONOMIC AREA

*

EFTA Surveillance Authority Decision No 83/15/COL of 18 March 2015 concerning the consistency of certain targets included in the national or functional airspace block plans submitted pursuant to Regulation (EC) No 549/2004 of the European Parliament and of the Council with the Union-wide performance targets for the second reference period [2016/1418]

45

*

EFTA Surveillance Authority Decision No 111/15/COL of 31 March 2015 amending the list contained in point 39 of Part 1.2 of Chapter I of Annex I to the Agreement on the European Economic Area listing border inspection posts in Iceland and Norway agreed for veterinary checks on live animals and animal products from third countries and repealing EFTA Surveillance Authority Decision No 311/13/COL [2016/1419]

51

*

EFTA Surveillance Authority Decision No 221/15/COL of 3 June 2015 amending EFTA Surveillance Authority Decision No 83/15/COL concerning the consistency of certain targets included in the national or functional airspace block plans submitted pursuant to Regulation (EC) No 549/2004 of the European Parliament and of the Council with the Union-wide performance targets for the second reference period [2016/1420]

56

*

EFTA Surveillance Authority Decision No 293/15/COL of 14 July 2015 to approve the national programme established by Iceland for the control of salmonella in poultry and poultry products [2016/1421]

58

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

---

(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.

---

II Non-legislative acts

REGULATIONS

| 25.8.2016 | EN | Official Journal of the European Union | L 230/1 |
| --- | --- | --- | --- |

25.8.2016

EN

Official Journal of the European Union

L 230/1

---

COMMISSION REGULATION (EU) 2016/1411

of 24 August 2016

refusing to authorise certain health claims made on foods, other than those referring to the reduction of disease risk and to children's development and health

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

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

Having regard to Regulation (EC) No 1924/2006 of the European Parliament and of the Council of 20 December 2006 on nutrition and health claims made on foods (1), and in particular Article 18(5) thereof,

Whereas:

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

(1)

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

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

(2)

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

| (3) | The Authority is to deliver an opinion on the health claim concerned. |
| --- | --- |

(3)

The Authority is to deliver an opinion on the health claim concerned.

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

(4)

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

| (5) | Following an application from SmithKline Beecham Limited, submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006, the Authority was required to deliver an opinion on a health claim related to caffeine and increased alertness (Question No EFSA-Q-2013-00399 (2)). The claim proposed by the applicant was worded as follows: ‘caffeine helps to increase alertness’. |
| --- | --- |

(5)

Following an application from SmithKline Beecham Limited, submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006, the Authority was required to deliver an opinion on a health claim related to caffeine and increased alertness (Question No EFSA-Q-2013-00399 (2)). The claim proposed by the applicant was worded as follows: ‘caffeine helps to increase alertness’.

| (6) | On 21 February 2014, the Commission and the Member States received the scientific opinion from the Authority. In its opinion, the Authority recalled that a claim on caffeine and increased alertness in the general adult population for products containing at least 75 mg of caffeine per serving had already been assessed by the Authority with a favourable outcome (3). In the present application, the applicant proposed that, in order to bear the claim, a product should contain a dose of caffeine of at least 40 mg per serving. The Authority considered that the scientific substantiation of this claim related to doses of caffeine between 40 mg per serving (4) and 75 mg per serving (5), and concluded that, on the basis of the data presented, a cause and effect relationship had not been established between the consumption of caffeine and increased alertness under the conditions of use proposed by the applicant. Further, the Authority reiterated its previous conclusion that, in order to bear the claim, a product should contain at least 75 mg caffeine per serving. Accordingly, as the claim, under the proposed conditions of use, does not comply with the requirements of Regulation (EC) No 1924/2006, it should not be authorised. |
| --- | --- |

(6)

On 21 February 2014, the Commission and the Member States received the scientific opinion from the Authority. In its opinion, the Authority recalled that a claim on caffeine and increased alertness in the general adult population for products containing at least 75 mg of caffeine per serving had already been assessed by the Authority with a favourable outcome (3). In the present application, the applicant proposed that, in order to bear the claim, a product should contain a dose of caffeine of at least 40 mg per serving. The Authority considered that the scientific substantiation of this claim related to doses of caffeine between 40 mg per serving (4) and 75 mg per serving (5), and concluded that, on the basis of the data presented, a cause and effect relationship had not been established between the consumption of caffeine and increased alertness under the conditions of use proposed by the applicant. Further, the Authority reiterated its previous conclusion that, in order to bear the claim, a product should contain at least 75 mg caffeine per serving. Accordingly, as the claim, under the proposed conditions of use, does not comply with the requirements of Regulation (EC) No 1924/2006, it should not be authorised.

| (7) | Following an application from BASF SE and Stepan Lipid Nutrition, submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006, the Authority was required to deliver an opinion on a health claim related to an equimolar mixture (marketed under the trade names Clarinol® and Tonalin®) of the two conjugated linoleic acid (CLA) isomers c9,t11 and t10,c12, and contribution to a reduction in body fat mass (Question No EFSA-Q-2014-00580 (6)). The claim proposed by the applicant was worded as follows: ‘Consumption of Clarinol® or Tonalin® contributes to a reduction in body fat mass’. |
| --- | --- |

(7)

Following an application from BASF SE and Stepan Lipid Nutrition, submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006, the Authority was required to deliver an opinion on a health claim related to an equimolar mixture (marketed under the trade names Clarinol® and Tonalin®) of the two conjugated linoleic acid (CLA) isomers c9,t11 and t10,c12, and contribution to a reduction in body fat mass (Question No EFSA-Q-2014-00580 (6)). The claim proposed by the applicant was worded as follows: ‘Consumption of Clarinol® or Tonalin® contributes to a reduction in body fat mass’.

| (8) | On 8 January 2015, the Commission and the Member States received the scientific opinion from the Authority, which concluded that, on the basis of the data presented, a cause and effect relationship had not been established between the consumption of an equimolar mixture of the CLA isomers c9,t11 and t10,c12, marketed under the trade names of Clarinol® and Tonalin®, and the claimed effect. Accordingly, as the claim does not comply with the requirements of Regulation (EC) No 1924/2006, it should not be authorised. |
| --- | --- |

(8)

On 8 January 2015, the Commission and the Member States received the scientific opinion from the Authority, which concluded that, on the basis of the data presented, a cause and effect relationship had not been established between the consumption of an equimolar mixture of the CLA isomers c9,t11 and t10,c12, marketed under the trade names of Clarinol® and Tonalin®, and the claimed effect. Accordingly, as the claim does not comply with the requirements of Regulation (EC) No 1924/2006, it should not be authorised.

| (9) | Following an application from Synbiotec S.r.l., submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006, the Authority was required to deliver an opinion on a health claim related to SYNBIO®, a combination of Lactobacillus rhamnosus IMC 501® and Lactobacillus paracasei IMC 502®, and maintenance of normal defecation (Question No EFSA-Q-2014-00567 (7)). The claim proposed by the applicant was worded as follows: ‘SYNBIO® persists in the intestinal tract and favours the natural regularity contributing to maintain and improve human intestinal well-being’. |
| --- | --- |

(9)

Following an application from Synbiotec S.r.l., submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006, the Authority was required to deliver an opinion on a health claim related to SYNBIO®, a combination of Lactobacillus rhamnosus IMC 501® and Lactobacillus paracasei IMC 502®, and maintenance of normal defecation (Question No EFSA-Q-2014-00567 (7)). The claim proposed by the applicant was worded as follows: ‘SYNBIO® persists in the intestinal tract and favours the natural regularity contributing to maintain and improve human intestinal well-being’.

| (10) | On 13 May 2015, the Commission and the Member States received the scientific opinion from the Authority, which concluded that, on the basis of the data presented, a cause and effect relationship had not been established between the consumption of SYNBIO® and maintenance of normal defecation. Accordingly, as the claim does not comply with the requirements of Regulation (EC) No 1924/2006, it should not be authorised. |
| --- | --- |

(10)

On 13 May 2015, the Commission and the Member States received the scientific opinion from the Authority, which concluded that, on the basis of the data presented, a cause and effect relationship had not been established between the consumption of SYNBIO® and maintenance of normal defecation. Accordingly, as the claim does not comply with the requirements of Regulation (EC) No 1924/2006, it should not be authorised.

| (11) | Following an application from WILD-Valencia SAU, submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006, the Authority was required to deliver an opinion on a health claim related to a FRUIT UP®, a carbohydrate extract from carob pods (Ceratonia siliqua L.), and a reduction of post-prandial blood glucose responses (Question No EFSA-Q-2014-00405 (8)). The claim proposed by the applicant was worded as follows: ‘FRUIT UP® reduces post-prandial blood glucose responses compared to high-glycaemic carbohydrates’. |
| --- | --- |

(11)

Following an application from WILD-Valencia SAU, submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006, the Authority was required to deliver an opinion on a health claim related to a FRUIT UP®, a carbohydrate extract from carob pods (Ceratonia siliqua L.), and a reduction of post-prandial blood glucose responses (Question No EFSA-Q-2014-00405 (8)). The claim proposed by the applicant was worded as follows: ‘FRUIT UP® reduces post-prandial blood glucose responses compared to high-glycaemic carbohydrates’.

| (12) | On 13 May 2015, the Commission and the Member States received the scientific opinion from the Authority, which concluded that, on the basis of the data presented, a cause and effect relationship had not been established between the consumption of FRUIT UP® and a reduction of post-prandial glycaemic responses over and above the well-established effect of fructose (9) on reducing post-prandial glycaemic responses when replacing glucose in foods. The Authority also stated that no effect had been observed when FRUIT UP® was compared with sucrose. Accordingly, as the claim does not comply with the requirements of Regulation (EC) No 1924/2006, it should not be authorised. |
| --- | --- |

(12)

On 13 May 2015, the Commission and the Member States received the scientific opinion from the Authority, which concluded that, on the basis of the data presented, a cause and effect relationship had not been established between the consumption of FRUIT UP® and a reduction of post-prandial glycaemic responses over and above the well-established effect of fructose (9) on reducing post-prandial glycaemic responses when replacing glucose in foods. The Authority also stated that no effect had been observed when FRUIT UP® was compared with sucrose. Accordingly, as the claim does not comply with the requirements of Regulation (EC) No 1924/2006, it should not be authorised.

| (13) | Following an application from Nerthus ApS, submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006, the Authority was required to deliver an opinion on a health claim related to a combination of pomegranate pomace extract (standardised by its content of punicalagins) and greater galangal rhizome powder (standardised by its content of acetoxychavicol acetate) and an increase in the number of motile spermatozoa in semen (Question No EFSA-Q-2014-00566 (10)). The claim proposed by the applicant was worded as follows: ‘A combination of standardised pomegranate pomace extract and greater galangal rhizome powder increases the number of motile spermatozoa in semen’. |
| --- | --- |

(13)

Following an application from Nerthus ApS, submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006, the Authority was required to deliver an opinion on a health claim related to a combination of pomegranate pomace extract (standardised by its content of punicalagins) and greater galangal rhizome powder (standardised by its content of acetoxychavicol acetate) and an increase in the number of motile spermatozoa in semen (Question No EFSA-Q-2014-00566 (10)). The claim proposed by the applicant was worded as follows: ‘A combination of standardised pomegranate pomace extract and greater galangal rhizome powder increases the number of motile spermatozoa in semen’.

| (14) | On 13 May 2015, the Commission and the Member States received the scientific opinion from the Authority, which concluded that, on the basis of the data presented, a cause and effect relationship had not been established between the consumption of the combination of pomegranate pomace extract (standardised by its content of punicalagins) and greater galangal rhizome powder (standardised by its content of acetoxychavicol acetate) and the claimed effect. Accordingly, as the claim does not comply with the requirements of Regulation (EC) No 1924/2006, it should not be authorised. |
| --- | --- |

(14)

On 13 May 2015, the Commission and the Member States received the scientific opinion from the Authority, which concluded that, on the basis of the data presented, a cause and effect relationship had not been established between the consumption of the combination of pomegranate pomace extract (standardised by its content of punicalagins) and greater galangal rhizome powder (standardised by its content of acetoxychavicol acetate) and the claimed effect. Accordingly, as the claim does not comply with the requirements of Regulation (EC) No 1924/2006, it should not be authorised.

| (15) | Following an application from Lallemand Health Solutions, submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006, the Authority was required to deliver an opinion on a health claim related to Bifidobacterium bifidum CNCM I-3426 and defence against pathogens in the upper respiratory tract (Question No EFSA-Q-2014-00673 (11)). The claim proposed by the applicant was worded as follows: ‘Bifidobacterium bifidum CNCM I-3426 increases the proportion of healthy days by maintaining normal immune function in healthy adults during everyday life events such as moderate stress’. |
| --- | --- |

(15)

Following an application from Lallemand Health Solutions, submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006, the Authority was required to deliver an opinion on a health claim related to Bifidobacterium bifidum CNCM I-3426 and defence against pathogens in the upper respiratory tract (Question No EFSA-Q-2014-00673 (11)). The claim proposed by the applicant was worded as follows: ‘Bifidobacterium bifidum CNCM I-3426 increases the proportion of healthy days by maintaining normal immune function in healthy adults during everyday life events such as moderate stress’.

| (16) | On 13 May 2015, the Commission and the Member States received the scientific opinion from the Authority, which concluded that, on the basis of the data presented, a cause and effect relationship had not been established between the consumption of B. bifidum CNCM I-3426 and defence against pathogens in the upper respiratory tract. Accordingly, as the claim does not comply with the requirements of Regulation (EC) No 1924/2006, it should not be authorised. |
| --- | --- |

(16)

On 13 May 2015, the Commission and the Member States received the scientific opinion from the Authority, which concluded that, on the basis of the data presented, a cause and effect relationship had not been established between the consumption of B. bifidum CNCM I-3426 and defence against pathogens in the upper respiratory tract. Accordingly, as the claim does not comply with the requirements of Regulation (EC) No 1924/2006, it should not be authorised.

| (17) | Following an application from Tchibo GmbH, submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006, the Authority was required to deliver an opinion on a health claim related to coffee C21, a coffee standardised by its content of caffeoylquinic acids, trigonelline and N-methylpyridinium, and reduction of DNA damage by decreasing spontaneous DNA strand breaks (Question No EFSA-Q-2014-00624 (12)). The claim proposed by the applicant was worded as follows: ‘Regular consumption of coffee C21 contributes to the maintenance of DNA integrity in cells of the body’. |
| --- | --- |

(17)

Following an application from Tchibo GmbH, submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006, the Authority was required to deliver an opinion on a health claim related to coffee C21, a coffee standardised by its content of caffeoylquinic acids, trigonelline and N-methylpyridinium, and reduction of DNA damage by decreasing spontaneous DNA strand breaks (Question No EFSA-Q-2014-00624 (12)). The claim proposed by the applicant was worded as follows: ‘Regular consumption of coffee C21 contributes to the maintenance of DNA integrity in cells of the body’.

| (18) | On 13 May 2015, the Commission and the Member States received the scientific opinion from the Authority, which concluded that, on the basis of the data presented, a cause and effect relationship had not been established between the consumption of coffee C21 and the claimed effect. Accordingly, as the claim does not comply with the requirements of Regulation (EC) No 1924/2006, it should not be authorised. |
| --- | --- |

(18)

On 13 May 2015, the Commission and the Member States received the scientific opinion from the Authority, which concluded that, on the basis of the data presented, a cause and effect relationship had not been established between the consumption of coffee C21 and the claimed effect. Accordingly, as the claim does not comply with the requirements of Regulation (EC) No 1924/2006, it should not be authorised.

| (19) | The comments from the applicants received by the Commission pursuant to Article 16(6) of Regulation (EC) No 1924/2006 have been considered when setting the measures provided for in this Regulation. |
| --- | --- |

(19)

The comments from the applicants received by the Commission pursuant to Article 16(6) of Regulation (EC) No 1924/2006 have been considered when setting the measures provided for in this Regulation.

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

(20)

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

HAS ADOPTED THIS REGULATION:

Article 1

The health claims listed in the Annex to this Regulation shall not be included in the Union list of permitted claims as provided for in Article 13(3) of Regulation (EC) No 1924/2006.

Article 2

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

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

Done at Brussels, 24 August 2016.

For the Commission

The President

Jean-Claude JUNCKER

---

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

1

(2)  
  EFSA Journal 2014; 12(2):3574.

2

EFSA Journal

(3)  
  EFSA Journal 2011; 9(4):2054.

3

EFSA Journal

(4)  Minimum effective dose proposed by the applicant.

4

(5)  Minimum effective dose proposed by EFSA.

5

(6)  
  EFSA Journal 2015; 13(1):3953.

6

EFSA Journal

(7)  
  EFSA Journal 2015; 13(5):4095.

7

EFSA Journal

(8)  
  EFSA Journal 2015; 13(5):4098.

8

EFSA Journal

(9)  
  EFSA Journal 2011; 9(6):2223. A health claim relating to fructose was authorised by Commission Regulation (EU) No 536/2013 of 11 June 2013 amending Regulation (EU) No 432/2012 establishing a list of permitted health claims made on foods other than those referring to the reduction of disease risk and to children's development and health (OJ L 160, 12.6.2013, p. 4).

9

EFSA Journal

(10)  
  EFSA Journal 2015; 13(5):4097.

10

EFSA Journal

(11)  
  EFSA Journal 2015; 13(5):4094.

11

EFSA Journal

(12)  
  EFSA Journal 2015; 13(5):4099.

12

EFSA Journal

---

ANNEX

Rejected health claims

| Application — Relevant provisions of Regulation (EC) No 1924/2006 | Nutrient, substance, food or food category | Claim | EFSA opinion reference |
| --- | --- | --- | --- |
| Article 13(5) health claim based on newly developed scientific evidence and/or including a request for the protection of proprietary data | Caffeine | Caffeine helps to increase alertness *
  - For intakes of caffeine between 40 mg per serving and 75 mg per serving. | Q-2013-00399 |
| Article 13(5) health claim based on newly developed scientific evidence and/or including a request for the protection of proprietary data | Clarinol® and Tonalin® | The consumption of Clarinol® or Tonalin® contributes to a reduction in body fat mass. | Q-2014-00580 |
| Article 13(5) health claim based on newly developed scientific evidence and/or including a request for the protection of proprietary data | SYNBIO® | SYNBIO® persists in the intestinal tract and favours the natural regularity contributing to maintain and improve human intestinal well-being'. | Q-2014-00567 |
| Article 13(5) health claim based on newly developed scientific evidence and/or including a request for the protection of proprietary data | FRUIT UP® | FRUIT UP® reduces post-prandial blood glucose responses compared to high-glycaemic carbohydrates. | Q-2014-00405 |
| Article 13(5) health claim based on newly developed scientific evidence and/or including a request for the protection of proprietary data | A combination of pomegranate pomace extract and greater galangal rhizome powder | A combination of standardised pomegranate pomace extract and greater galangal rhizome powder increases the number of motile spermatozoa in semen. | Q-2014-00566 |
| Article 13(5) health claim based on newly developed scientific evidence and/or including a request for the protection of proprietary data | Bifidobacterium bifidum CNCM I-3426 | Bifidobacterium bifidum CNCM I-3426 increases the proportion of healthy days by maintaining normal immune function in healthy adults during everyday life events such as moderate stress. | Q-2014-00673 |
| Article 13(5) health claim based on newly developed scientific evidence and/or including a request for the protection of proprietary data | Coffee C21 (coffee standardised by its content of caffeoylquinic acids, trigonelline andN-methylpyridinium) | Regular consumption of coffee C21 contributes to the maintenance of DNA integrity in cells of the body. | Q-2014-00624 |

Application — Relevant provisions of Regulation (EC) No 1924/2006

Nutrient, substance, food or food category

Claim

EFSA opinion reference

Article 13(5) health claim based on newly developed scientific evidence and/or including a request for the protection of proprietary data

Caffeine

Caffeine helps to increase alertness *

- For intakes of caffeine between 40 mg per serving and 75 mg per serving.

Q-2013-00399

Article 13(5) health claim based on newly developed scientific evidence and/or including a request for the protection of proprietary data

Clarinol® and Tonalin®

The consumption of Clarinol® or Tonalin® contributes to a reduction in body fat mass.

Q-2014-00580

Article 13(5) health claim based on newly developed scientific evidence and/or including a request for the protection of proprietary data

SYNBIO®

SYNBIO® persists in the intestinal tract and favours the natural regularity contributing to maintain and improve human intestinal well-being'.

Q-2014-00567

Article 13(5) health claim based on newly developed scientific evidence and/or including a request for the protection of proprietary data

FRUIT UP®

FRUIT UP® reduces post-prandial blood glucose responses compared to high-glycaemic carbohydrates.

Q-2014-00405

Article 13(5) health claim based on newly developed scientific evidence and/or including a request for the protection of proprietary data

A combination of pomegranate pomace extract and greater galangal rhizome powder

A combination of standardised pomegranate pomace extract and greater galangal rhizome powder increases the number of motile spermatozoa in semen.

Q-2014-00566

Article 13(5) health claim based on newly developed scientific evidence and/or including a request for the protection of proprietary data

Bifidobacterium bifidum CNCM I-3426

Bifidobacterium bifidum CNCM I-3426 increases the proportion of healthy days by maintaining normal immune function in healthy adults during everyday life events such as moderate stress.

Q-2014-00673

Article 13(5) health claim based on newly developed scientific evidence and/or including a request for the protection of proprietary data

Coffee C21 (coffee standardised by its content of caffeoylquinic acids, trigonelline andN-methylpyridinium)

Regular consumption of coffee C21 contributes to the maintenance of DNA integrity in cells of the body.

Q-2014-00624

---

| 25.8.2016 | EN | Official Journal of the European Union | L 230/6 |
| --- | --- | --- | --- |

25.8.2016

EN

Official Journal of the European Union

L 230/6

---

COMMISSION REGULATION (EU) 2016/1412

of 24 August 2016

refusing to authorise a health claim made on foods and referring to the reduction of disease risk

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

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

Having regard to Regulation (EC) No 1924/2006 of the European Parliament and of the Council of 20 December 2006 on nutrition and health claims made on foods (1), and in particular Article 17(3) thereof,

Whereas:

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

(1)

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

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

(2)

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

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

(3)

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

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

(4)

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

| (5) | Following an application from Han-Asiabiotech GmbH, submitted pursuant to Article 14(1)(a) of Regulation (EC) No 1924/2006, the Authority was required to deliver an opinion on a health claim related to Symbiosal® and lowering of blood pressure and reduced risk of hypertension (Question No EFSA-Q-2014-00366 (2)). The claim proposed by the applicant was worded as follows: ‘Symbiosal has been shown to lower the rising of blood pressure when used as a replacement of traditional table salt. The rising of blood pressure is a risk factor for high blood pressure (hypertension)’. |
| --- | --- |

(5)

Following an application from Han-Asiabiotech GmbH, submitted pursuant to Article 14(1)(a) of Regulation (EC) No 1924/2006, the Authority was required to deliver an opinion on a health claim related to Symbiosal® and lowering of blood pressure and reduced risk of hypertension (Question No EFSA-Q-2014-00366 (2)). The claim proposed by the applicant was worded as follows: ‘Symbiosal has been shown to lower the rising of blood pressure when used as a replacement of traditional table salt. The rising of blood pressure is a risk factor for high blood pressure (hypertension)’.

| (6) | On 1 July 2015, the Commission and the Member States received the scientific opinion from the Authority, which concluded that on the basis of the data presented a cause and effect relationship had not been established between the consumption of Symbiosal® instead of table salt and lowering of blood pressure. Accordingly, as the claim does not comply with the requirements of Regulation (EC) No 1924/2006, it should not be authorised. |
| --- | --- |

(6)

On 1 July 2015, the Commission and the Member States received the scientific opinion from the Authority, which concluded that on the basis of the data presented a cause and effect relationship had not been established between the consumption of Symbiosal® instead of table salt and lowering of blood pressure. Accordingly, as the claim does not comply with the requirements of Regulation (EC) No 1924/2006, it should not be authorised.

| (7) | The measure provided for in this Regulation is in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, |
| --- | --- |

(7)

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

HAS ADOPTED THIS REGULATION:

Article 1

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

Article 2

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

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

Done at Brussels, 24 August 2016.

For the Commission

The President

Jean-Claude JUNCKER

---

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

1

(2)  
  EFSA Journal 2015;13(7):4147.

2

EFSA Journal

---

ANNEX

Rejected health claim

| Application — Relevant provisions of Regulation (EC) No 1924/2006 | Nutrient, substance, food or food category | Claim | EFSA opinion reference |
| --- | --- | --- | --- |
| Article 14(1)(a) health claim referring to a reduction of a disease risk. | Symbiosal® | Symbiosal has been shown to lower the rising of blood pressure when used as a replacement of traditional table salt. The rising of blood pressure is a risk factor for high blood pressure (hypertension) | Q-2014-00366 |

Application — Relevant provisions of Regulation (EC) No 1924/2006

Nutrient, substance, food or food category

Claim

EFSA opinion reference

Article 14(1)(a) health claim referring to a reduction of a disease risk.

Symbiosal®

Symbiosal has been shown to lower the rising of blood pressure when used as a replacement of traditional table salt. The rising of blood pressure is a risk factor for high blood pressure (hypertension)

Q-2014-00366

---

| 25.8.2016 | EN | Official Journal of the European Union | L 230/8 |
| --- | --- | --- | --- |

25.8.2016

EN

Official Journal of the European Union

L 230/8

---

COMMISSION REGULATION (EU) 2016/1413

of 24 August 2016

amending Regulation (EU) No 432/2012 establishing a list of permitted health claims made on foods other than those referring to the reduction of disease risk and to children's development and health

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

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

Having regard to Regulation (EC) No 1924/2006 of the European Parliament and of the Council of 20 December 2006 on nutrition and health claims made on foods (1), and in particular Article 13(4) thereof,

Whereas:

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

(1)

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

| (2) | Pursuant to Article 13(3) of Regulation (EC) No 1924/2006 the Commission adopted Regulation (EU) No 432/2012 (2) which establishes a list of permitted health claims made on foods other than those referring to the reduction of disease risk and to children's development and health. |
| --- | --- |

(2)

Pursuant to Article 13(3) of Regulation (EC) No 1924/2006 the Commission adopted Regulation (EU) No 432/2012 (2) which establishes a list of permitted health claims made on foods other than those referring to the reduction of disease risk and to children's development and health.

| (3) | The list of permitted health claims and their conditions of use are set out in the Annex to Regulation (EU) No 432/2012. Two claims have been authorised for meal replacement for weight control. The conditions of use of those claims require that in order to bear them, the food should comply with specifications laid down in Commission Directive 96/8/EC (3). |
| --- | --- |

(3)

The list of permitted health claims and their conditions of use are set out in the Annex to Regulation (EU) No 432/2012. Two claims have been authorised for meal replacement for weight control. The conditions of use of those claims require that in order to bear them, the food should comply with specifications laid down in Commission Directive 96/8/EC (3).

| (4) | Those claims were included in the list of permitted health claims pursuant to the favourable Opinion of the European Food Safety Authority (hereinafter ‘the Authority’) of 2010 (Question EFSA-Q-2008-2154, EFSA-Q-2008-2155 (4)) which found that a cause and effect relationship had been established between the consumption of meal replacements in substitution of regular meals and the maintenance of body weight after weight loss and also between the consumption of meal replacements in substitution of regular meals in the context of energy restricted diets and reduction in body weight. It stated that in order to bear the claims a food should contain a maximum of 250 kcal per serving and comply with specifications laid down in Directive 96/8/EC. |
| --- | --- |

(4)

Those claims were included in the list of permitted health claims pursuant to the favourable Opinion of the European Food Safety Authority (hereinafter ‘the Authority’) of 2010 (Question EFSA-Q-2008-2154, EFSA-Q-2008-2155 (4)) which found that a cause and effect relationship had been established between the consumption of meal replacements in substitution of regular meals and the maintenance of body weight after weight loss and also between the consumption of meal replacements in substitution of regular meals in the context of energy restricted diets and reduction in body weight. It stated that in order to bear the claims a food should contain a maximum of 250 kcal per serving and comply with specifications laid down in Directive 96/8/EC.

| (5) | Directive 96/8/EC lays down compositional requirements for foods for use in energy-restricted diets for weight reduction which replace the whole or part of the total daily diet and specifies mandatory particulars which shall appear on the labelling of those products. It provides that as regards products which are presented as a replacement for one or more meals of the daily diet, the name under which they are sold is ‘Meal replacement for weight control’. |
| --- | --- |

(5)

Directive 96/8/EC lays down compositional requirements for foods for use in energy-restricted diets for weight reduction which replace the whole or part of the total daily diet and specifies mandatory particulars which shall appear on the labelling of those products. It provides that as regards products which are presented as a replacement for one or more meals of the daily diet, the name under which they are sold is ‘Meal replacement for weight control’.

| (6) | Regulation (EU) No 609/2013 of the European Parliament and of the Council (5) revises the legal framework applicable to foods for particular nutritional uses. It provides that Directive 96/8/EC shall not apply from 20 July 2016 to foods presented as a replacement for one or more meals of the daily diet, which should in future be regulated under Regulation (EC) No 1924/2006 and should comply with requirements set out therein. |
| --- | --- |

(6)

Regulation (EU) No 609/2013 of the European Parliament and of the Council (5) revises the legal framework applicable to foods for particular nutritional uses. It provides that Directive 96/8/EC shall not apply from 20 July 2016 to foods presented as a replacement for one or more meals of the daily diet, which should in future be regulated under Regulation (EC) No 1924/2006 and should comply with requirements set out therein.

| (7) | Therefore, the references to Directive 96/8/EC regarding health claims which may be made on meal replacement for weight control need to be replaced by setting out the conditions of use of those claims in the Annex to Regulation (EC) No 432/2012. |
| --- | --- |

(7)

Therefore, the references to Directive 96/8/EC regarding health claims which may be made on meal replacement for weight control need to be replaced by setting out the conditions of use of those claims in the Annex to Regulation (EC) No 432/2012.

| (8) | Article 13(4) of Regulation (EC) No 1924/2006 empowers the Commission, after consulting the Authority, to adopt changes to the list of permitted health claims based on generally accepted scientific evidence. |
| --- | --- |

(8)

Article 13(4) of Regulation (EC) No 1924/2006 empowers the Commission, after consulting the Authority, to adopt changes to the list of permitted health claims based on generally accepted scientific evidence.

| (9) | When introducing the necessary technical adaptations regarding the health claims for meal replacement for weight control the requirements as regards the amounts of vitamins and minerals in food set out in Directive 96/8/EC should be taken into account. |
| --- | --- |

(9)

When introducing the necessary technical adaptations regarding the health claims for meal replacement for weight control the requirements as regards the amounts of vitamins and minerals in food set out in Directive 96/8/EC should be taken into account.

| (10) | Regulation (EU) No 1169/2011 of the European Parliament and of the Council (6) lays down rules on the provision of food information to consumers. Part A of Annex XIII sets out nutrient reference values for vitamins and minerals on the basis of recent scientific advices. |
| --- | --- |

(10)

Regulation (EU) No 1169/2011 of the European Parliament and of the Council (6) lays down rules on the provision of food information to consumers. Part A of Annex XIII sets out nutrient reference values for vitamins and minerals on the basis of recent scientific advices.

| (11) | Accordingly, the Commission requested the Authority to provide scientific advice on whether a change in the conditions of use for claims on meal replacements for weight control regarding their vitamin and mineral composition (30 % of the nutrient reference values of vitamins and minerals laid down in Regulation (EU) No 1169/2011 instead of the 30 % of values of vitamins and minerals laid down in Directive 96/8/EC) would affect the conclusions reached in the Authority's Opinion of 2010 with respect to the scientific substantiation of health claims related to meal replacement for weight control. |
| --- | --- |

(11)

Accordingly, the Commission requested the Authority to provide scientific advice on whether a change in the conditions of use for claims on meal replacements for weight control regarding their vitamin and mineral composition (30 % of the nutrient reference values of vitamins and minerals laid down in Regulation (EU) No 1169/2011 instead of the 30 % of values of vitamins and minerals laid down in Directive 96/8/EC) would affect the conclusions reached in the Authority's Opinion of 2010 with respect to the scientific substantiation of health claims related to meal replacement for weight control.

| (12) | The Authority adopted an Opinion on 28 October 2015 (Question EFSA-Q-2015-00579) (7) and concluded that the differences in the micronutrient composition of meal replacements which would derive from changing the conditions of use from Directive 96/8/EC to Regulation (EU) No 1169/2011 do not affect the scientific substantiation of health claims related to meal replacements for weight control and reduction in body weight and maintenance of body weight after weight loss. |
| --- | --- |

(12)

The Authority adopted an Opinion on 28 October 2015 (Question EFSA-Q-2015-00579) (7) and concluded that the differences in the micronutrient composition of meal replacements which would derive from changing the conditions of use from Directive 96/8/EC to Regulation (EU) No 1169/2011 do not affect the scientific substantiation of health claims related to meal replacements for weight control and reduction in body weight and maintenance of body weight after weight loss.

| (13) | Nutrient reference values for fluoride, chromium, chloride and molybdenum are provided in Annex XIII to Regulation (EU) No 1169/2011. Directive 96/8/EC does not require the addition of these micronutrients to meal replacement for weight control. Taking into account that the claimed effects of meal replacement for weight control are related to the controlled energy content and the relatively high protein/low fat content, there is no need to require that meal replacement for weight control provides at least 30 % of the nutrient reference values of fluoride, chromium, chloride and molybdenum per meal as laid down in Regulation (EU) No 1169/2011. |
| --- | --- |

(13)

Nutrient reference values for fluoride, chromium, chloride and molybdenum are provided in Annex XIII to Regulation (EU) No 1169/2011. Directive 96/8/EC does not require the addition of these micronutrients to meal replacement for weight control. Taking into account that the claimed effects of meal replacement for weight control are related to the controlled energy content and the relatively high protein/low fat content, there is no need to require that meal replacement for weight control provides at least 30 % of the nutrient reference values of fluoride, chromium, chloride and molybdenum per meal as laid down in Regulation (EU) No 1169/2011.

| (14) | Annex XIII to Regulation (EU) No 1169/2011 does not set nutrient reference value for sodium. However, taking into account the intended use of meal replacement for weight control products, the requirement to provide 30 % of the sodium amount per meal as laid down in Annex I to Directive 96/8/EC should be further maintained in the conditions of use of those health claims. |
| --- | --- |

(14)

Annex XIII to Regulation (EU) No 1169/2011 does not set nutrient reference value for sodium. However, taking into account the intended use of meal replacement for weight control products, the requirement to provide 30 % of the sodium amount per meal as laid down in Annex I to Directive 96/8/EC should be further maintained in the conditions of use of those health claims.

| (15) | Nutrient reference value for potassium is set at 2000 milligrams in PART A of Annex XIII to Regulation (EU) No 1169/2011. Directive 96/8/EC does not require for meal replacement for weight control to provide 30 % of the potassium value, but sets a minimum amount at 500 milligram per meal. This value should be further maintained. |
| --- | --- |

(15)

Nutrient reference value for potassium is set at 2000 milligrams in PART A of Annex XIII to Regulation (EU) No 1169/2011. Directive 96/8/EC does not require for meal replacement for weight control to provide 30 % of the potassium value, but sets a minimum amount at 500 milligram per meal. This value should be further maintained.

| (16) | Since the Authority's Opinion of 2015 confirmed the conclusions of its Opinion of 2010 as regards the energy content of the products concerned a maximum of 250 kcal per serving should be set. The requirements set out in Directive 96/8/EC on fat, protein and amino acids should be maintained. |
| --- | --- |

(16)

Since the Authority's Opinion of 2015 confirmed the conclusions of its Opinion of 2010 as regards the energy content of the products concerned a maximum of 250 kcal per serving should be set. The requirements set out in Directive 96/8/EC on fat, protein and amino acids should be maintained.

| (17) | As regards mandatory particulars which should appear on the labelling of meal replacement for weight control food information requirements included in Directive 96/8/EC should be maintained in the conditions of use of the relevant health claims. |
| --- | --- |

(17)

As regards mandatory particulars which should appear on the labelling of meal replacement for weight control food information requirements included in Directive 96/8/EC should be maintained in the conditions of use of the relevant health claims.

| (18) | To enable food business operators to adapt to the necessary changes regarding the conditions of use of health claims for meal replacement for weight control in particular regarding the energy content and the vitamin and mineral content, a transitional period should be provided. |
| --- | --- |

(18)

To enable food business operators to adapt to the necessary changes regarding the conditions of use of health claims for meal replacement for weight control in particular regarding the energy content and the vitamin and mineral content, a transitional period should be provided.

| (19) | Regulation (EU) No 432/2012 should therefore be amended accordingly. |
| --- | --- |

(19)

Regulation (EU) No 432/2012 should therefore be amended accordingly.

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

(20)

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

HAS ADOPTED THIS REGULATION:

Article 1

The Annex to Regulation (EU) No 432/2012 is amended in accordance with the Annex to this Regulation.

Article 2

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

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

Done at Brussels, 24 August 2016.

For the Commission

The President

Jean-Claude JUNCKER

---

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

1

(2)  Commission Regulation (EU) No 432/2012 of 16 May 2012 establishing a list of permitted health claims made on foods, other than those referring to the reduction of disease risk and to children's development and health (OJ L 136, 25.5.2012, p. 1).

2

(3)  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).

3

(4)  EFSA Journal 2010; 8(2):1466.

4

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

5

(6)  Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011 on the provision of food information to consumers, amending Regulation (EC) No 1924/2006 and (EC) No 1925/2006 of the European Parliament and of the Council, and repealing Commission Directive 87/250/EEC, Council Directive 90/496/EEC, Commission Directive 1999/10/EC, directive 2000/13/EC of the European Parliament and of the Council, Commission Directives 2002/67/EC and 2008/5/EC and Commission Regulation (EC) No 608/2004 (OJ L 304, 22.11.2011, p. 18).

6

(7)  EFSA Journal 2015; 13(11): 4287.

7

---

ANNEX

In the Annex to Regulation (EU) No 432/2012 the entries for food categories ‘Meal replacement for weight control’ are replaced by the following:

| Nutrient substance, food or food category | Claim | Conditions of use of the claim | Conditions, and/or restrictions of use of the food, and/or additional statement or warning | EFSA Journal number | Relevant entry number in the Consolidated List submitted to EFSA for its assessment |
| --- | --- | --- | --- | --- | --- |
| ‘Meal replacement for weight control | Substituting one of the main daily meals of an energy restricted diet with a meal replacement contributes to the maintenance of weight after weight loss | In order to bear the claim, a food should comply with the following requirements:
  1.   Energy content

  The energy content shall not be less than 200 kcal (840 kJ) and shall not exceed 250 kcal (1 046 KJ) per meal (*1).
  2.   Fat content and composition

  The energy derived from fat shall not exceed 30 % of total available energy content of the product.
  The linoleic acid (in the form of glycerides) shall not be less than 1 g.
  3.   Protein content and composition

  The protein contained in the food shall provide not less than 25 % and not more than 50 % of the total energy content of the product.
  The chemical index of protein shall be equal to that set by the World Health Organization in “Energy and protein requirements”. Report of a Joint WHO/FAO/UNU Meeting. Geneva: World Health Organisation, 1985 (WHO Technical Report Series, 724):



  Amino acid requirement pattern (g/100 g protein)








  Cystine + methionine | 1,7 |
| Histidine | 1,6 |
| Isoleucine | 1,3 |
| Leucine | 1,9 |
| Lysine | 1,6 |
| Phenylalanine + tyrosine | 1,9 |
| Threonine | 0,9 |
| Tryptophan | 0,5 |
| Valine | 1,3 |

Nutrient substance, food or food category

Claim

Conditions of use of the claim

Conditions, and/or restrictions of use of the food, and/or additional statement or warning

EFSA Journal number

Relevant entry number in the Consolidated List submitted to EFSA for its assessment

‘Meal replacement for weight control

Substituting one of the main daily meals of an energy restricted diet with a meal replacement contributes to the maintenance of weight after weight loss

In order to bear the claim, a food should comply with the following requirements:

1.   Energy content

The energy content shall not be less than 200 kcal (840 kJ) and shall not exceed 250 kcal (1 046 KJ) per meal (*1).

2.   Fat content and composition

The energy derived from fat shall not exceed 30 % of total available energy content of the product.

The linoleic acid (in the form of glycerides) shall not be less than 1 g.

3.   Protein content and composition

The protein contained in the food shall provide not less than 25 % and not more than 50 % of the total energy content of the product.

The chemical index of protein shall be equal to that set by the World Health Organization in “Energy and protein requirements”. Report of a Joint WHO/FAO/UNU Meeting. Geneva: World Health Organisation, 1985 (WHO Technical Report Series, 724):

Amino acid requirement pattern (g/100 g protein)

Cystine + methionine

1,7

Histidine

1,6

Isoleucine

1,3

Leucine

1,9

Lysine

1,6

Phenylalanine + tyrosine

1,9

Threonine

0,9

Tryptophan

0,5

Valine

1,3

The “chemical index” shall mean the lowest of the ratios between the quantity of each essential amino acid of the test protein in and the quantity of each corresponding amino acid of the reference protein.

If the chemical index is lower than 100 % of the reference protein, the minimum protein levels shall be correspondingly increased. In any case the chemical index of the protein shall at least be equal to 80 % of that of the reference protein.

In all cases, the addition of amino acids is permitted solely for the purpose of improving the nutritional value of the proteins and only in the proportions necessary for that purpose.

4.   Vitamins and minerals

The food shall provide at least 30 % of the amounts of the nutrient reference values of vitamins and minerals per meal as laid down in Annex XIII to Regulation (EU) No 1169/2011. This requirement does not apply to fluoride, chromium, chloride and molybdenum. The amount of sodium per meal provided by the food shall be at least 172,5 mg. The amount of potassium per meal provided by the food shall be at least 500 mg (*2).

In order to bear the claim, information shall be provided to the consumer on the importance of maintaining an adequate daily fluid intake and on the fact that the products are useful for the intended use only as part of an energy-restricted diet and that other foodstuffs should be a necessary part of such diet.

In order to achieve the claimed effect, one main meal should be substituted with one meal replacement daily.

2010; 8(2):1466

2015; 13(11):4287

1418

Meal replacement for weight control

Substituting two of the main daily meals of an energy restricted diet with meal replacements contributes to weight loss

In order to bear the claim, a food should comply with the following requirements:

1.   Energy content

The energy content shall not be less than 200 kcal (840 kJ) and shall not exceed 250 kcal (1 046 KJ) per meal (*1).

2.   Fat content and composition

The energy derived from fat shall not exceed 30 % of total available energy content of the product.

The linoleic acid (in the form of glycerides) shall not be less than 1 g.

3.   Protein content and composition

The protein contained in the food shall provide not less than 25 % and not more than 50 % of the total energy content of the product.

The chemical index of protein shall be equal to that set by the World Health Organization in “Energy and protein requirements”. Report of a Joint WHO/FAO/UNU Meeting. Geneva: World Health Organisation, 1985 (WHO Technical Report Series, 724):

Amino acid requirement pattern (g/100 g protein)

| Cystine + methionine | 1,7 |
| --- | --- |
| Histidine | 1,6 |
| Isoleucine | 1,3 |
| Leucine | 1,9 |
| Lysine | 1,6 |
| Phenylalanine + tyrosine | 1,9 |
| Threonine | 0,9 |
| Tryptophan | 0,5 |
| Valine | 1,3 |

Cystine + methionine

1,7

Histidine

1,6

Isoleucine

1,3

Leucine

1,9

Lysine

1,6

Phenylalanine + tyrosine

1,9

Threonine

0,9

Tryptophan

0,5

Valine

1,3

The “chemical index” shall mean the lowest of the ratios between the quantity of each essential amino acid of the test protein in and the quantity of each corresponding amino acid of the reference protein.

If the chemical index is lower than 100 % of the reference protein, the minimum protein levels shall be correspondingly increased. In any case the chemical index of the protein shall at least be equal to 80 % of that of the reference protein.

In all cases, the addition of amino acids is permitted solely for the purpose of improving the nutritional value of the proteins, and only in the proportions necessary for that purpose.

4.   Vitamins and minerals

The food shall provide at least 30 % of the amounts of the nutrient reference values of vitamins and minerals per meal as laid down Annex XIII to Regulation (EU) No 1169/2011. This requirement does not apply to fluoride, chromium, chloride and molybdenum. The amount of sodium per meal provided by the food shall be at least 172,5 mg. The amount of potassium per meal provided by the food shall be at least 500 mg (*2).

In order to bear the claim, information shall be provided to the consumer on the importance of maintaining an adequate daily fluid intake and on the fact that the products are useful for the intended use only as part of an energy-restricted diet and that other foodstuffs should be a necessary part of such diet.

In order to achieve the claimed effect, two of the main daily meals should be substituted with meal replacements daily.

2010; 8(2):1466

2015; 13(11):4287

1417

---

(*1)  From 21 July 2016 until 14 September 2019 the energy content of the food shall not be less than 200 kcal (840 kJ) and shall not exceed 400 kcal (1 680 kJ).

*1

(*2)  From 21 July 2016 until 14 September 2019 the food shall provide at least 30 % of the amounts of vitamins and minerals specified in the below Table per meal:

*2

| Vitamin A | (μg RE) | 700 |
| --- | --- | --- |
| Vitamin D | (μg) | 5 |
| Vitamin E | (mg) | 10 |
| Vitamin C | (mg) | 45 |
| Thiamine | (mg) | 1,1 |
| Riboflavin | (mg) | 1,6 |
| Niacin | (mg-NE) | 18 |
| Vitamin B6 | (mg) | 1,5 |
| Folate | (μg) | 200 |
| Vitamin B12 | (μg) | 1,4 |
| Biotin | (μg) | 15 |
| Pantothenic acid | (mg) | 3 |
| Calcium | (mg) | 700 |
| Phosphorus | (mg) | 550 |
| Iron | (mg) | 16 |
| Zinc | (mg) | 9,5 |
| Copper | (mg) | 1,1 |
| Iodine | (μg) | 130 |
| Selenium | (μg) | 55 |
| Sodium | (mg) | 575 |
| Magnesium | (mg) | 150 |
| Manganese | (mg) | 1 |

Vitamin A

(μg RE)

700

Vitamin D

(μg)

5

Vitamin E

(mg)

10

Vitamin C

(mg)

45

Thiamine

(mg)

1,1

Riboflavin

(mg)

1,6

Niacin

(mg-NE)

18

Vitamin B6

6

(mg)

1,5

Folate

(μg)

200

Vitamin B12

12

(μg)

1,4

Biotin

(μg)

15

Pantothenic acid

(mg)

3

Calcium

(mg)

700

Phosphorus

(mg)

550

Iron

(mg)

16

Zinc

(mg)

9,5

Copper

(mg)

1,1

Iodine

(μg)

130

Selenium

(μg)

55

Sodium

(mg)

575

Magnesium

(mg)

150

Manganese

(mg)

1

From 21 July 2016 until 14 September 2019 the amount of potassium per meal provided by the food shall be at least 500 mg.’

---

| 25.8.2016 | EN | Official Journal of the European Union | L 230/16 |
| --- | --- | --- | --- |

25.8.2016

EN

Official Journal of the European Union

L 230/16

---

COMMISSION IMPLEMENTING REGULATION (EU) 2016/1414

of 24 August 2016

approving the active substance cyantraniliprole, 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 13(2) thereof,

Whereas:

| (1) | In accordance with Article 7(1) of Regulation (EC) No 1107/2009 the United Kingdom received on 29 June 2011 an application from DuPont Crop Protection and Syngenta Crop Protection for the approval of the active substance cyantraniliprole. In accordance with Article 9(3) of that Regulation, the United Kingdom, as rapporteur Member State, notified the applicant, the other Member States, the Commission and the European Food Safety Authority (hereinafter ‘the Authority’) on 10 August 2011 of the admissibility of the application. |
| --- | --- |

(1)

In accordance with Article 7(1) of Regulation (EC) No 1107/2009 the United Kingdom received on 29 June 2011 an application from DuPont Crop Protection and Syngenta Crop Protection for the approval of the active substance cyantraniliprole. In accordance with Article 9(3) of that Regulation, the United Kingdom, as rapporteur Member State, notified the applicant, the other Member States, the Commission and the European Food Safety Authority (hereinafter ‘the Authority’) on 10 August 2011 of the admissibility of the application.

| (2) | On 31 May 2013 the rapporteur Member State submitted a draft assessment report to the Commission with a copy to 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 31 May 2013 the rapporteur Member State submitted a draft assessment report to the Commission with a copy to 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 the applicant to 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 on 12 June 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 the applicant to 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 on 12 June 2014.

| (4) | On 18 August 2014 the Authority communicated to the applicant, the Member States and the Commission its conclusion on whether the active substance cyantraniliprole 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. A revised version of this conclusion was published on 11 November 2014 and 28 May 2015 (3). |
| --- | --- |

(4)

On 18 August 2014 the Authority communicated to the applicant, the Member States and the Commission its conclusion on whether the active substance cyantraniliprole 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. A revised version of this conclusion was published on 11 November 2014 and 28 May 2015 (3).

| (5) | On 13 July 2015 the Commission presented to the Standing Committee on Plants, Animals, Food and Feed the review report for cyantraniliprole and a draft Regulation providing that cyantraniliprole is approved. |
| --- | --- |

(5)

On 13 July 2015 the Commission presented to the Standing Committee on Plants, Animals, Food and Feed the review report for cyantraniliprole and a draft Regulation providing that cyantraniliprole is approved.

| (6) | The applicant was given the possibility to submit comments on the review report. |
| --- | --- |

(6)

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

| (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. It is therefore appropriate to approve cyantraniliprole. |
| --- | --- |

(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. It is therefore appropriate to approve cyantraniliprole.

| (8) | In accordance with Article 13(2) of Regulation (EC) No 1107/2009 in conjunction with Article 6 thereof and in the light of current scientific and technical knowledge, it is, however, necessary to include certain conditions and restrictions. It is, in particular, appropriate to require further confirmatory information. |
| --- | --- |

(8)

In accordance with Article 13(2) of Regulation (EC) No 1107/2009 in conjunction with Article 6 thereof and in the light of current scientific and technical knowledge, it is, however, necessary to include certain conditions and restrictions. It is, in particular, appropriate to require further confirmatory information.

| (9) | In accordance with Article 13(4) of Regulation (EC) No 1107/2009, the Annex to Commission Implementing Regulation (EU) No 540/2011 (4) should be amended accordingly. |
| --- | --- |

(9)

In accordance with Article 13(4) of Regulation (EC) No 1107/2009, the Annex to Commission Implementing Regulation (EU) No 540/2011 (4) 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 cyantraniliprole, as specified in Annex I, is approved subject to the conditions laid down in that Annex.

Article 2

Amendment 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

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

Official Journal of the European Union

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

Done at Brussels, 24 August 2016.

For the Commission

The President

Jean-Claude JUNCKER

---

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

1

(2)  
  EFSA Journal 2014;12(9):3814. Available online: www.efsa.europa.eu

2

EFSA Journal

(3)  
  EFSA Journal 2014;12(9):3814. Available online: www.efsa.europa.eu

3

EFSA Journal

(4)  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).

4

---

ANNEX I

| Common Name, Identification Numbers | IUPAC Name | Purity (1) | Date of approval | Expiration of approval | Specific provisions |
| --- | --- | --- | --- | --- | --- |
| Cyantraniliprole
  CAS No:
  736994-63-1
  CIPAC No: Not allocated. | 3-bromo-1-(3-chloro-2-pyridyl)-4′-cyano-2′-methyl-6′-(methylcarbamoyl)pyrazole-5-carboxanilide | ≥ 940 g/kg
  IN-Q6S09 max. 1 mg/kg
  IN-RYA13 max. 20 mg/kg
  methanesulfonic acid max. 2 g/kg
  acetonitrile max. 2 g/kg
  heptane max. 7 g/kg
  3-picoline max. 3 g/kg. | 14 September 2016 | 14 September 2026 | 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 cyantraniliprole, and in particular Appendices I and II thereto, shall be taken into account.
  In this overall assessment Member States shall pay particular attention to:






  (a) | the risk to operators; |

Common Name, Identification Numbers

IUPAC Name

Purity (1)

Date of approval

Expiration of approval

Specific provisions

Cyantraniliprole

CAS No:

736994-63-1

CIPAC No: Not allocated.

3-bromo-1-(3-chloro-2-pyridyl)-4′-cyano-2′-methyl-6′-(methylcarbamoyl)pyrazole-5-carboxanilide

≥ 940 g/kg

IN-Q6S09 max. 1 mg/kg

IN-RYA13 max. 20 mg/kg

methanesulfonic acid max. 2 g/kg

acetonitrile max. 2 g/kg

heptane max. 7 g/kg

3-picoline max. 3 g/kg.

14 September 2016

14 September 2026

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 cyantraniliprole, and in particular Appendices I and II thereto, shall be taken into account.

In this overall assessment Member States shall pay particular attention to:

(a)

the risk to operators;

| (b) | the risk to aquatic organisms, bees and other non-target arthropods; |
| --- | --- |

(b)

the risk to aquatic organisms, bees and other non-target arthropods;

| (c) | the risk to bees and bumble bees released for pollination, when the substance is applied in glasshouses; |
| --- | --- |

(c)

the risk to bees and bumble bees released for pollination, when the substance is applied in glasshouses;

| (d) | the protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions. |
| --- | --- |

(d)

the protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions.

Conditions of use shall include risk mitigation measures, where appropriate.

The applicant shall submit to the Commission, Member States and the Authority confirmatory information as regards the effect of water treatment processes on the nature of residues present in surface and groundwater, when surface water or groundwater are abstracted for drinking water within 2 years after adoption of a guidance document on evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater.

---

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

---

ANNEX II

In Part B 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 |
| --- | --- | --- | --- | --- | --- | --- |
| ‘99 | Cyantraniliprole
  CAS No:
  736994-63-1
  CIPAC No: Not allocated. | 3-bromo-1-(3-chloro-2-pyridyl)-4′-cyano-2′-methyl-6′-(methylcarbamoyl)pyrazole-5-carboxanilide | ≥ 940 g/kg
  IN-Q6S09 max. 1 mg/kg
  IN-RYA13 max. 20 mg/kg
  methanesulfonic acid max. 2 g/kg
  acetonitrile max. 2 g/kg
  heptane max. 7 g/kg
  3-picoline max. 3 g/kg. | 14 September 2016 | 14 September 2026 | 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 cyantraniliprole, and in particular Appendices I and II thereto, shall be taken into account.
  In this overall assessment Member States shall pay particular attention to:






  (a) | the risk to operators; |

Number

Common Name, Identification Numbers

IUPAC Name

Purity (*1)

Date of approval

Expiration of approval

Specific provisions

‘99

Cyantraniliprole

CAS No:

736994-63-1

CIPAC No: Not allocated.

3-bromo-1-(3-chloro-2-pyridyl)-4′-cyano-2′-methyl-6′-(methylcarbamoyl)pyrazole-5-carboxanilide

≥ 940 g/kg

IN-Q6S09 max. 1 mg/kg

IN-RYA13 max. 20 mg/kg

methanesulfonic acid max. 2 g/kg

acetonitrile max. 2 g/kg

heptane max. 7 g/kg

3-picoline max. 3 g/kg.

14 September 2016

14 September 2026

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 cyantraniliprole, and in particular Appendices I and II thereto, shall be taken into account.

In this overall assessment Member States shall pay particular attention to:

(a)

the risk to operators;

| (b) | the risk to aquatic organisms, bees and other non-target arthropods; |
| --- | --- |

(b)

the risk to aquatic organisms, bees and other non-target arthropods;

| (c) | the risk to bees and bumble bees released for pollination, when the substance is applied in glasshouses; |
| --- | --- |

(c)

the risk to bees and bumble bees released for pollination, when the substance is applied in glasshouses;

| (d) | the protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions. |
| --- | --- |

(d)

the protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions.

Conditions of use shall include risk mitigation measures, where appropriate.

The applicant shall submit to the Commission, Member States and the Authority confirmatory information as regards the effect of water treatment processes on the nature of residues present in surface and groundwater, when surface water or groundwater are abstracted for drinking water within 2 years after adoption of a guidance document on evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater.’

---

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

*1

---

| 25.8.2016 | EN | Official Journal of the European Union | L 230/20 |
| --- | --- | --- | --- |

25.8.2016

EN

Official Journal of the European Union

L 230/20

---

COMMISSION IMPLEMENTING REGULATION (EU) 2016/1415

of 24 August 2016

entering a name in the register of traditional specialities guaranteed (Tepertős pogácsa (TSG))

THE EUROPEAN COMMISSION,

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

Having regard to Regulation (EU) No 1151/2012 of the European Parliament and of the Council of 21 November 2012 on quality schemes for agricultural products and foodstuffs (1), and in particular Article 26 and Article 52(2) thereof,

Whereas:

| (1) | In accordance with Article 26 of Regulation (EU) No 1151/2012, Hungary submitted the name ‘Tepertős pogácsa’ in view of enabling it to be registered in the register of traditional specialities guaranteed provided for in Article 22 of Regulation (EU) No 1151/2012 with reservation of name. |
| --- | --- |

(1)

In accordance with Article 26 of Regulation (EU) No 1151/2012, Hungary submitted the name ‘Tepertős pogácsa’ in view of enabling it to be registered in the register of traditional specialities guaranteed provided for in Article 22 of Regulation (EU) No 1151/2012 with reservation of name.

| (2) | The name ‘Tepertős pogácsa’ had previously been registered (2) as traditional speciality guaranteed without reservation of name in accordance with Article 58(1) of Regulation (EU) No 1151/2012. |
| --- | --- |

(2)

The name ‘Tepertős pogácsa’ had previously been registered (2) as traditional speciality guaranteed without reservation of name in accordance with Article 58(1) of Regulation (EU) No 1151/2012.

| (3) | The submission of the name ‘Tepertős pogácsa’ was examined by the Commission and subsequently published in the Official Journal of the European Union (3). |
| --- | --- |

(3)

The submission of the name ‘Tepertős pogácsa’ was examined by the Commission and subsequently published in the Official Journal of the European Union (3).

| (4) | As no statement of opposition under Article 51 of Regulation (EU) No 1151/2012 has been received by the Commission, the name ‘Tepertős pogácsa’ should therefore be entered in the register with reservation of name, |
| --- | --- |

(4)

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

HAS ADOPTED THIS REGULATION:

Article 1

The name ‘Tepertős pogácsa’ (TSG) is hereby entered in the register with reservation of name.

The product specification of the TSG ‘Tepertős pogácsa’ shall be deemed to be the specification referred to in Article 19 of Regulation (EU) No 1151/2012 for the TSG ‘Tepertős pogácsa’ with reservation of name.

The name specified in the first paragraph denotes a product in Class 2.3. bread, pastry, cakes, confectionery, biscuits and other baker's wares, as listed in Annex XI to Commission Implementing Regulation (EU) No 668/2014 (4).

Article 2

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

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

Done at Brussels, 24 August 2016.

For the Commission

The President

Jean-Claude JUNCKER

---

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

1

(2)  Commission Regulation (EU) No 1144/2013 of 13 November 2013 entering a name in the register of traditional specialities guaranteed (Tepertős pogácsa (TSG)) (OJ L 303, 14.11.2013, p. 17).

2

(3)  
  OJ C 94, 10.3.2016, p. 8.

3

(4)  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).

4

---

| 25.8.2016 | EN | Official Journal of the European Union | L 230/22 |
| --- | --- | --- | --- |

25.8.2016

EN

Official Journal of the European Union

L 230/22

---

COMMISSION REGULATION (EU) 2016/1416

of 24 August 2016

amending and correcting Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

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

Having regard to Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC (1), and in particular Article 5(1)(a), (c), (d), (e), (h), (i) and (j), Article 11(3) and Article 12(6) thereof,

Whereas:

| (1) | Commission Regulation (EU) No 10/2011 (2) (‘the Regulation’) lays down specific rules as regards plastic materials and articles intended to come into contact with foods. In particular, it establishes a Union list of substances which may be used in the manufacture of plastic food contact materials and articles. |
| --- | --- |

(1)

Commission Regulation (EU) No 10/2011 (2) (‘the Regulation’) lays down specific rules as regards plastic materials and articles intended to come into contact with foods. In particular, it establishes a Union list of substances which may be used in the manufacture of plastic food contact materials and articles.

| (2) | Since the Regulation's adoption, the European Food Safety Authority (‘the Authority’) has published further reports on particular substances that may be used in food contact materials as well as on the permitted use of substances that have been authorised previously. In addition, certain textual errors and ambiguities were identified. In order to ensure that the Regulation reflects the most recent findings of the Authority and in order to remove any doubt as regards its correct application, the Regulation should be amended and corrected. |
| --- | --- |

(2)

Since the Regulation's adoption, the European Food Safety Authority (‘the Authority’) has published further reports on particular substances that may be used in food contact materials as well as on the permitted use of substances that have been authorised previously. In addition, certain textual errors and ambiguities were identified. In order to ensure that the Regulation reflects the most recent findings of the Authority and in order to remove any doubt as regards its correct application, the Regulation should be amended and corrected.

| (3) | The definition of ‘non-fatty foods’ in point (16) of Article 3 of the Regulation contains a reference to food simulants laid down in an annex to the Regulation. As the definition was intended to refer to food simulants listed in Table 2 of Annex III, the reference should be corrected accordingly. |
| --- | --- |

(3)

The definition of ‘non-fatty foods’ in point (16) of Article 3 of the Regulation contains a reference to food simulants laid down in an annex to the Regulation. As the definition was intended to refer to food simulants listed in Table 2 of Annex III, the reference should be corrected accordingly.

| (4) | Regulation (EU) No 10/2011 uses the term ‘hot-fill’ in the context of setting restrictions on the use of certain authorised monomers in materials and articles intended to act as a receptacle for hot food. In order to clarify the scope of such restrictions, it is appropriate to provide a definition of the term specifying the temperatures at which such restrictions apply. |
| --- | --- |

(4)

Regulation (EU) No 10/2011 uses the term ‘hot-fill’ in the context of setting restrictions on the use of certain authorised monomers in materials and articles intended to act as a receptacle for hot food. In order to clarify the scope of such restrictions, it is appropriate to provide a definition of the term specifying the temperatures at which such restrictions apply.

| (5) | Article 6(3) of Regulation (EU) No 10/2011 establishes a derogation as regards the use of salts of specified metals derived from authorised acids, phenols or alcohols, even though these salts are not included in the Union list of authorised substances. As the conclusion of the Authority on which the derogation is based was not specific to certain categories of salts (3), the qualification in point (a) of Article 6(3) that the derogation extends to ‘double salts and acid salts’ is superfluous. Since that qualification could be interpreted as supporting an a contrario interpretation according to which there could be categories of salts to which the definition does not apply, it should be clarified that the derogation applies to all salts of the listed metals, and the qualification should be deleted. |
| --- | --- |

(5)

Article 6(3) of Regulation (EU) No 10/2011 establishes a derogation as regards the use of salts of specified metals derived from authorised acids, phenols or alcohols, even though these salts are not included in the Union list of authorised substances. As the conclusion of the Authority on which the derogation is based was not specific to certain categories of salts (3), the qualification in point (a) of Article 6(3) that the derogation extends to ‘double salts and acid salts’ is superfluous. Since that qualification could be interpreted as supporting an a contrario interpretation according to which there could be categories of salts to which the definition does not apply, it should be clarified that the derogation applies to all salts of the listed metals, and the qualification should be deleted.

| (6) | Article 11(2) of the Regulation sets a generic specific migration limit for all substances for which no specific migration limit has been set. The absence of a prescribed limit for particular substances reflects the view that such specification was not necessary for the purposes of ensuring compliance with the safety criteria laid down in Article 3 of Regulation (EC) No 1935/2004. As the migration levels from all substances are already subject to compliance with an overall migration limit, the existence of a parallel generic specific limit is unnecessary and gives rises to a duplication of migration testing and development of testing methods. In order to avoid the imposition of unnecessarily burdensome testing obligations, the provision establishing generic specific migration limits should be deleted. |
| --- | --- |

(6)

Article 11(2) of the Regulation sets a generic specific migration limit for all substances for which no specific migration limit has been set. The absence of a prescribed limit for particular substances reflects the view that such specification was not necessary for the purposes of ensuring compliance with the safety criteria laid down in Article 3 of Regulation (EC) No 1935/2004. As the migration levels from all substances are already subject to compliance with an overall migration limit, the existence of a parallel generic specific limit is unnecessary and gives rises to a duplication of migration testing and development of testing methods. In order to avoid the imposition of unnecessarily burdensome testing obligations, the provision establishing generic specific migration limits should be deleted.

| (7) | Pursuant to Article 13(3), and Annex I and Annex II to the Regulation, there are certain substances in respect of which it must not be possible to detect any level of migration. The prohibition is justified on the grounds that any degree of migration of such substances could pose a risk to health. As the presence of a particular substance can only be determined in so far as it reaches a detectable threshold, its absence can also only be determined by reference to that threshold. As the rules governing the establishment and expression of detection thresholds are repeated throughout the Regulation, it is appropriate to simplify the Regulation by deleting repetitions of those rules and by consolidating such rules within a single provision in the Regulation. |
| --- | --- |

(7)

Pursuant to Article 13(3), and Annex I and Annex II to the Regulation, there are certain substances in respect of which it must not be possible to detect any level of migration. The prohibition is justified on the grounds that any degree of migration of such substances could pose a risk to health. As the presence of a particular substance can only be determined in so far as it reaches a detectable threshold, its absence can also only be determined by reference to that threshold. As the rules governing the establishment and expression of detection thresholds are repeated throughout the Regulation, it is appropriate to simplify the Regulation by deleting repetitions of those rules and by consolidating such rules within a single provision in the Regulation.

| (8) | As specific migration limits are expressed in mg/kg food, the same measurement unit should also be used for the verification of compliance of a cap or closure, as a consistent approach avoids the potential for conflicting results. It is therefore appropriate to remove the option to express the migration from caps or closures in mg/dm2. |
| --- | --- |

(8)

As specific migration limits are expressed in mg/kg food, the same measurement unit should also be used for the verification of compliance of a cap or closure, as a consistent approach avoids the potential for conflicting results. It is therefore appropriate to remove the option to express the migration from caps or closures in mg/dm2.

| (9) | Pursuant to Article 18(4) of the Regulation, the compliance of materials and articles that were not yet in contact with food is to be verified in accordance with detailed rules laid down in Section 3.1 of Chapter 3 of Annex V. As the provisions laid down in Sections 3.2, 3.3 and 3.4 of the same Chapter may also be relevant to verification of compliance, it is appropriate to amend Article 18(4) so that it refers to the Chapter 3 as a whole. |
| --- | --- |

(9)

Pursuant to Article 18(4) of the Regulation, the compliance of materials and articles that were not yet in contact with food is to be verified in accordance with detailed rules laid down in Section 3.1 of Chapter 3 of Annex V. As the provisions laid down in Sections 3.2, 3.3 and 3.4 of the same Chapter may also be relevant to verification of compliance, it is appropriate to amend Article 18(4) so that it refers to the Chapter 3 as a whole.

| (10) | Table 1 of Annex I to the Regulation contains the Union list of authorised substances which includes a reference to simulant D. Since the Regulation distinguishes between food simulants D1 and D2, the references to food simulant D should be replaced by more specific references to food simulant D1 or D2 for all substances. |
| --- | --- |

(10)

Table 1 of Annex I to the Regulation contains the Union list of authorised substances which includes a reference to simulant D. Since the Regulation distinguishes between food simulants D1 and D2, the references to food simulant D should be replaced by more specific references to food simulant D1 or D2 for all substances.

| (11) | The substance silicon dioxide, silanated (food contact material (‘FCM’) substance No 87) is currently authorised for use as an additive in all plastics. Also covered under FCM No 87 is a sub-category of this substance, synthetic amorphous silicon dioxide, silanated, which is produced using primary particles in nanoform. Under Article 9(2) of the Regulation, substances in nanoform are only to be used if explicitly authorised and mentioned in the specifications in Annex I. Taking account of the available scientific information, and the absence of migration of primary nanoparticles of this synthetic form, the Authority has concluded that that synthetic amorphous silicon dioxide, silanated, produced from primary particles in nanoform does not raise a safety concern when only aggregates larger than 100 nm and larger agglomerates are present in the final material (4). The Union list should therefore be amended to add a specification of substance FCM No 87 as regards the form in which it may be used in the final material. |
| --- | --- |

(11)

The substance silicon dioxide, silanated (food contact material (‘FCM’) substance No 87) is currently authorised for use as an additive in all plastics. Also covered under FCM No 87 is a sub-category of this substance, synthetic amorphous silicon dioxide, silanated, which is produced using primary particles in nanoform. Under Article 9(2) of the Regulation, substances in nanoform are only to be used if explicitly authorised and mentioned in the specifications in Annex I. Taking account of the available scientific information, and the absence of migration of primary nanoparticles of this synthetic form, the Authority has concluded that that synthetic amorphous silicon dioxide, silanated, produced from primary particles in nanoform does not raise a safety concern when only aggregates larger than 100 nm and larger agglomerates are present in the final material (4). The Union list should therefore be amended to add a specification of substance FCM No 87 as regards the form in which it may be used in the final material.

| (12) | The Authority has adopted a scientific opinion on the extension of the use of perfluoromethyl perfluorovinylether (MVE, FCM No 391) (5). According to that opinion the substance is not a safety concern if used as a monomer for fluoro- and perfluoropolymers intended for repeated use applications, where the contact ratio is 1 dm2 surface in contact with not less than 150 kg food such as in sealing and gaskets. It is therefore appropriate to add this application to the specifications set out in relation to substance FCM No 391. |
| --- | --- |

(12)

The Authority has adopted a scientific opinion on the extension of the use of perfluoromethyl perfluorovinylether (MVE, FCM No 391) (5). According to that opinion the substance is not a safety concern if used as a monomer for fluoro- and perfluoropolymers intended for repeated use applications, where the contact ratio is 1 dm2 surface in contact with not less than 150 kg food such as in sealing and gaskets. It is therefore appropriate to add this application to the specifications set out in relation to substance FCM No 391.

| (13) | The authorisation of the substance ‘mixture of (35-45 % w/w) 1,6-diamino-2,2,4-trimethylhexane and (55-65 % w/w)1,6-diamino-2,4,4-trimethylhexane’ (FCM No 641) refers in column 11 to note (10) in Table 3 of Annex I to the Regulation. Compliance is therefore verified by residual content per food contact surface area (QMA) in case of reaction with food or simulant. Verification of compliance by QMA is only appropriate if a migration testing method is unavailable or impractical. As adequate migration testing methods are available, and a specific migration limit has been specified, the possibility to verify compliance by residual content should be removed from the entry for this substance in the Regulation. |
| --- | --- |

(13)

The authorisation of the substance ‘mixture of (35-45 % w/w) 1,6-diamino-2,2,4-trimethylhexane and (55-65 % w/w)1,6-diamino-2,4,4-trimethylhexane’ (FCM No 641) refers in column 11 to note (10) in Table 3 of Annex I to the Regulation. Compliance is therefore verified by residual content per food contact surface area (QMA) in case of reaction with food or simulant. Verification of compliance by QMA is only appropriate if a migration testing method is unavailable or impractical. As adequate migration testing methods are available, and a specific migration limit has been specified, the possibility to verify compliance by residual content should be removed from the entry for this substance in the Regulation.

| (14) | The authorisation of the substance bis(methylbenzylidene)sorbitol (FCM No 752) refers in column 3 to four CAS numbers. These CAS numbers have been incorrectly separated in print. Therefore the authorisation of this substance should be corrected by separating the CAS numbers correctly. |
| --- | --- |

(14)

The authorisation of the substance bis(methylbenzylidene)sorbitol (FCM No 752) refers in column 3 to four CAS numbers. These CAS numbers have been incorrectly separated in print. Therefore the authorisation of this substance should be corrected by separating the CAS numbers correctly.

| (15) | The Authority adopted a scientific opinion concerning substance FCM No 779 in 2007 (6). In its opinion the Authority observed that analytical methods for the verification of compliance to the migration limits are available and well described. Nevertheless, the present authorisation of this substance contains a reference to note (1) of Table 3 of Annex I to the Regulation, which states that, pending the availability of an analytical method, compliance should be verified by residual content per food contact surface area (QMA). Verification of compliance by QMA is only appropriate if a migration testing method is unavailable or impractical. Since the Authority considers that analytical methods are available and well described, the reference to note (1) should be deleted. The Authority further notes in its opinion that a risk exists that migration levels in fatty foods may exceed the applicable migration limit, which was not referred to in the present authorisation. It is therefore appropriate to insert a reference to note (2) of Table 3 of Annex I to the Regulation so as to ensure that this risk is considered as part of the verification of compliance. |
| --- | --- |

(15)

The Authority adopted a scientific opinion concerning substance FCM No 779 in 2007 (6). In its opinion the Authority observed that analytical methods for the verification of compliance to the migration limits are available and well described. Nevertheless, the present authorisation of this substance contains a reference to note (1) of Table 3 of Annex I to the Regulation, which states that, pending the availability of an analytical method, compliance should be verified by residual content per food contact surface area (QMA). Verification of compliance by QMA is only appropriate if a migration testing method is unavailable or impractical. Since the Authority considers that analytical methods are available and well described, the reference to note (1) should be deleted. The Authority further notes in its opinion that a risk exists that migration levels in fatty foods may exceed the applicable migration limit, which was not referred to in the present authorisation. It is therefore appropriate to insert a reference to note (2) of Table 3 of Annex I to the Regulation so as to ensure that this risk is considered as part of the verification of compliance.

| (16) | At present, the substance with FCM No 974 is included in the Union list and may be used provided that the migration of its hydrolysis product 2,4-di-tert-amylphenol (CAS number 120-95-6), does not exceed 0,05 mg/kg. The migration of FCM No 974 is expressed as the sum of phosphite and phosphate forms and the hydrolysis product 4-t-amylphenol. The Authority has adopted a scientific opinion according to which the migration limit applicable to this hydrolysis product could, without giving rise to health concerns, be extended to 1 mg/kg food, provided that the migration from the product is added to the sum of the phosphite and phosphate forms and the hydrolysis product 4-t-amylphenol, and that the sum of these four substances is subject to the existing 5 mg/kg specific migration limit for FCM No 974. The specifications of FCM No 974 should therefore be amended accordingly. |
| --- | --- |

(16)

At present, the substance with FCM No 974 is included in the Union list and may be used provided that the migration of its hydrolysis product 2,4-di-tert-amylphenol (CAS number 120-95-6), does not exceed 0,05 mg/kg. The migration of FCM No 974 is expressed as the sum of phosphite and phosphate forms and the hydrolysis product 4-t-amylphenol. The Authority has adopted a scientific opinion according to which the migration limit applicable to this hydrolysis product could, without giving rise to health concerns, be extended to 1 mg/kg food, provided that the migration from the product is added to the sum of the phosphite and phosphate forms and the hydrolysis product 4-t-amylphenol, and that the sum of these four substances is subject to the existing 5 mg/kg specific migration limit for FCM No 974. The specifications of FCM No 974 should therefore be amended accordingly.

| (17) | The Authority has adopted a scientific opinion (7) on the use of the additive dodecanoic acid, 12-amino-, polymer with ethene, 2,5-furandione, α-hydro-ω-hydroxypoly (oxy-1,2-ethanediyl) and 1-propene, FCM No 871. When used as an additive in polyolefins at levels of up to 20 weight % at ambient temperature or below in contact with dry foods as represented by food simulant E, and when migration of the low molecular weight oligomeric fraction less than 1 000 Da does not in total exceed 50 μg/kg food, the use of this additive does not endanger human health. It is therefore appropriate to include this additive in the Union list and to authorise its use in accordance with those specifications. |
| --- | --- |

(17)

The Authority has adopted a scientific opinion (7) on the use of the additive dodecanoic acid, 12-amino-, polymer with ethene, 2,5-furandione, α-hydro-ω-hydroxypoly (oxy-1,2-ethanediyl) and 1-propene, FCM No 871. When used as an additive in polyolefins at levels of up to 20 weight % at ambient temperature or below in contact with dry foods as represented by food simulant E, and when migration of the low molecular weight oligomeric fraction less than 1 000 Da does not in total exceed 50 μg/kg food, the use of this additive does not endanger human health. It is therefore appropriate to include this additive in the Union list and to authorise its use in accordance with those specifications.

| (18) | The Authority has adopted a scientific opinion (8) on the use of the starting substance furan-2,5-dicarboxylic acid (FCM No 1031). When used as a monomer in the production of polyethylene furanoate (PEF) polymer this substance does not raise a safety concern for the consumer when the migration of the substance itself does not exceed 5 mg/kg food, and when migration of the oligomers less than 1 000 Da does not exceed 50 μg/kg food. It is therefore appropriate to include this starting substance in the Union list and to authorise its use in accordance with the specified migration limits. |
| --- | --- |

(18)

The Authority has adopted a scientific opinion (8) on the use of the starting substance furan-2,5-dicarboxylic acid (FCM No 1031). When used as a monomer in the production of polyethylene furanoate (PEF) polymer this substance does not raise a safety concern for the consumer when the migration of the substance itself does not exceed 5 mg/kg food, and when migration of the oligomers less than 1 000 Da does not exceed 50 μg/kg food. It is therefore appropriate to include this starting substance in the Union list and to authorise its use in accordance with the specified migration limits.

| (19) | The Authority has noted that PEF containing a substance with FCM No 1031 can safely be used in contact with non-alcoholic foods in accordance with its specified migration limits. However when the compliance of such a plastic is verified with food simulant D1 in accordance with the food simulant assignments in Table 2 of Annex III, there is a risk of interaction between this food simulant and the plastic. As this interaction would not occur in contact with the non-alcoholic foods for which this food simulant is assigned, the use of food simulant D1 for verification of compliance would give unrealistic results in such cases. According to the Authority, therefore, when verifying whether the use of this substance complies with this Regulation, food simulant C should be used for non-alcoholic foods to which Table 2 of Annex III assigns food simulant D1. It is therefore appropriate to add a note on the verification of compliance to substance with FCM No 1031 to indicate that food simulant D1 should be substituted with food simulant C in case of testing. |
| --- | --- |

(19)

The Authority has noted that PEF containing a substance with FCM No 1031 can safely be used in contact with non-alcoholic foods in accordance with its specified migration limits. However when the compliance of such a plastic is verified with food simulant D1 in accordance with the food simulant assignments in Table 2 of Annex III, there is a risk of interaction between this food simulant and the plastic. As this interaction would not occur in contact with the non-alcoholic foods for which this food simulant is assigned, the use of food simulant D1 for verification of compliance would give unrealistic results in such cases. According to the Authority, therefore, when verifying whether the use of this substance complies with this Regulation, food simulant C should be used for non-alcoholic foods to which Table 2 of Annex III assigns food simulant D1. It is therefore appropriate to add a note on the verification of compliance to substance with FCM No 1031 to indicate that food simulant D1 should be substituted with food simulant C in case of testing.

| (20) | The Authority has adopted a scientific opinion (9) on the use of the starting substance 1,7-octadiene (FCM No 1034). When used as a crosslinking co-monomer in the manufacture of polyolefins for contact with any type of foods for long term storage at room temperature, including hot-fill conditions, and the migration of the substance does not exceed 0,05 mg/kg food, the use of this substance does not endanger human health. It is therefore appropriate to include that additive in the Union list and to authorise its use in accordance with those specifications. |
| --- | --- |

(20)

The Authority has adopted a scientific opinion (9) on the use of the starting substance 1,7-octadiene (FCM No 1034). When used as a crosslinking co-monomer in the manufacture of polyolefins for contact with any type of foods for long term storage at room temperature, including hot-fill conditions, and the migration of the substance does not exceed 0,05 mg/kg food, the use of this substance does not endanger human health. It is therefore appropriate to include that additive in the Union list and to authorise its use in accordance with those specifications.

| (21) | The Authority has adopted a scientific opinion (10) on the use of the polymer production aid perfluoro{acetic acid, 2-[(5-methoxy-1,3-dioxolan-4-yl)oxy]}, ammonium salt (FCM No 1045). When used as polymer production aid during the manufacture of fluoropolymers which are produced under high temperature conditions of at least 370 C the use of this substance does not endanger human health. Therefore, it should be added to the Union list and its use authorised subject to compliance with those specifications. |
| --- | --- |

(21)

The Authority has adopted a scientific opinion (10) on the use of the polymer production aid perfluoro{acetic acid, 2-[(5-methoxy-1,3-dioxolan-4-yl)oxy]}, ammonium salt (FCM No 1045). When used as polymer production aid during the manufacture of fluoropolymers which are produced under high temperature conditions of at least 370 C the use of this substance does not endanger human health. Therefore, it should be added to the Union list and its use authorised subject to compliance with those specifications.

| (22) | The Authority has adopted a scientific opinion (11) on the use of the additive ethylene glycol dipalmitate (FCM No 1048). The Authority concluded that when the substance is produced using a fatty acid precursor conventionally obtained from edible fats or oils and the migration of ethylene glycol is limited by including it in the group SML(T) for ethylene glycol, the use of this additive does not endanger human health. Therefore, that additive should be included in the Union list subject to the requirement that it complies with those specifications. In particular, it should be added to the group to which the SML(T) applies and entry (2) of Table 2 of Annex I to Regulation (EU) No 10/2011 should be amended accordingly. |
| --- | --- |

(22)

The Authority has adopted a scientific opinion (11) on the use of the additive ethylene glycol dipalmitate (FCM No 1048). The Authority concluded that when the substance is produced using a fatty acid precursor conventionally obtained from edible fats or oils and the migration of ethylene glycol is limited by including it in the group SML(T) for ethylene glycol, the use of this additive does not endanger human health. Therefore, that additive should be included in the Union list subject to the requirement that it complies with those specifications. In particular, it should be added to the group to which the SML(T) applies and entry (2) of Table 2 of Annex I to Regulation (EU) No 10/2011 should be amended accordingly.

| (23) | The Authority has adopted a scientific opinion (12) on the use of the additive zinc oxide, nanoparticles, uncoated (FCM No 1050) and zinc oxide, nanoparticles, coated with [3-(methacryloxy)propyl] trimethoxysilane (FCM No 1046). The Authority concluded that these additives do not migrate in nanoform from polyolefins. In a further opinion the Authority extended this conclusion to the migration of zinc oxide nanoparticles to unplasticised polymers (13). It therefore stated that its safety evaluation focused on the migration of soluble ionic zinc, which should respect the specific migration limit for zinc specified in Annex II to the Regulation. For the coated form of zinc oxide, nanoparticles, the levels of migration of [3-(methacryloxy)propyl]trimethoxysilane should remain within the existing specific migration limits for this substance, namely 0,05 mg/kg. Therefore, the two additives should be included in the Union list. |
| --- | --- |

(23)

The Authority has adopted a scientific opinion (12) on the use of the additive zinc oxide, nanoparticles, uncoated (FCM No 1050) and zinc oxide, nanoparticles, coated with [3-(methacryloxy)propyl] trimethoxysilane (FCM No 1046). The Authority concluded that these additives do not migrate in nanoform from polyolefins. In a further opinion the Authority extended this conclusion to the migration of zinc oxide nanoparticles to unplasticised polymers (13). It therefore stated that its safety evaluation focused on the migration of soluble ionic zinc, which should respect the specific migration limit for zinc specified in Annex II to the Regulation. For the coated form of zinc oxide, nanoparticles, the levels of migration of [3-(methacryloxy)propyl]trimethoxysilane should remain within the existing specific migration limits for this substance, namely 0,05 mg/kg. Therefore, the two additives should be included in the Union list.

| (24) | The Authority has adopted a scientific opinion (14) on the use of the additive N,N′-bis(2,2,6,6-tetramethyl-4-piperidinyl) isophthalamide (FCM No 1051). The Authority concluded that when its migration does not exceed 5 mg/kg food, the use of this additive does not endanger human health. Therefore, it should be included in the Union list subject to a migration limit of 5 mg/kg food. |
| --- | --- |

(24)

The Authority has adopted a scientific opinion (14) on the use of the additive N,N′-bis(2,2,6,6-tetramethyl-4-piperidinyl) isophthalamide (FCM No 1051). The Authority concluded that when its migration does not exceed 5 mg/kg food, the use of this additive does not endanger human health. Therefore, it should be included in the Union list subject to a migration limit of 5 mg/kg food.

| (25) | The Authority has adopted a scientific opinion (15) on the use of the starting substance 2,4,8,10-tetraoxaspiro[5,5]undecane-3,9-diethanol,β3,β3,β9,β9-tetramethyl- (‘SPG’, FCM No 1052). The Authority concluded that when this substance is used as a monomer in the production of polyesters, when its migration does not exceed 5 mg/kg food, and when the migration of the oligomers of less than 1 000 Da does not exceed 50 μg/kg food (expressed as SPG), the use of this additive does not endanger human health. Therefore, it should be included in the Union list and its use authorised subject to compliance with those specifications. |
| --- | --- |

(25)

The Authority has adopted a scientific opinion (15) on the use of the starting substance 2,4,8,10-tetraoxaspiro[5,5]undecane-3,9-diethanol,β3,β3,β9,β9-tetramethyl- (‘SPG’, FCM No 1052). The Authority concluded that when this substance is used as a monomer in the production of polyesters, when its migration does not exceed 5 mg/kg food, and when the migration of the oligomers of less than 1 000 Da does not exceed 50 μg/kg food (expressed as SPG), the use of this additive does not endanger human health. Therefore, it should be included in the Union list and its use authorised subject to compliance with those specifications.

| (26) | The authorisation of the substances with FCM Nos 871, 1031 and 1052 provided for in this Regulation, requires that the migration of the low molecular weight oligomeric fraction less than 1 000 Da shall not in total exceed a migration limit of 50 μg/kg food. Analytical methods to determine the migration of this oligomeric fraction are complex. A description of those methods is not necessarily available to competent authorities. Without a description it is not possible for the competent authority to verify that the migration of oligomers from the material or article complies with the migration limit for these oligomers. Therefore, business operators placing on the market the final article or material containing that substance should be required to provide a description of the method and a calibration sample if required by the method. |
| --- | --- |

(26)

The authorisation of the substances with FCM Nos 871, 1031 and 1052 provided for in this Regulation, requires that the migration of the low molecular weight oligomeric fraction less than 1 000 Da shall not in total exceed a migration limit of 50 μg/kg food. Analytical methods to determine the migration of this oligomeric fraction are complex. A description of those methods is not necessarily available to competent authorities. Without a description it is not possible for the competent authority to verify that the migration of oligomers from the material or article complies with the migration limit for these oligomers. Therefore, business operators placing on the market the final article or material containing that substance should be required to provide a description of the method and a calibration sample if required by the method.

| (27) | The Authority has adopted a scientific opinion (16) on the use of the additive fatty acids, C16–18 saturated, hexaesters with dipentaerythritol (FCM No 1053). Since any content of lower esters (e.g. penta-, tetra-,) does not give rise to a safety concern, the Authority concluded that the use of fatty acids, C16–18 saturated, esters with dipentaerythritol does not endanger human health, provided that the substance is produced using a fatty acid precursor obtained from edible fats or oils. Therefore, the additive fatty acids, C16–18 saturated, esters with dipentaerythritol should be included in the Union list without restricting it to hexaesters, subject to the requirement that its fatty acid precursor is obtained from edible fats or oils. |
| --- | --- |

(27)

The Authority has adopted a scientific opinion (16) on the use of the additive fatty acids, C16–18 saturated, hexaesters with dipentaerythritol (FCM No 1053). Since any content of lower esters (e.g. penta-, tetra-,) does not give rise to a safety concern, the Authority concluded that the use of fatty acids, C16–18 saturated, esters with dipentaerythritol does not endanger human health, provided that the substance is produced using a fatty acid precursor obtained from edible fats or oils. Therefore, the additive fatty acids, C16–18 saturated, esters with dipentaerythritol should be included in the Union list without restricting it to hexaesters, subject to the requirement that its fatty acid precursor is obtained from edible fats or oils.

| (28) | The Authority has adopted a scientific opinion (17) on the safety of aluminium from dietary intake, which establishes a tolerable weekly intake of 1 mg aluminium per kg body weight per week. Applying the conventional exposure assumptions for food contact materials, the migration limit would have to be set at 8,6 mg/kg food. The opinion however notes that the current dietary exposure of a significant part of the Union's population likely exceeds this level. Therefore, it is appropriate to limit the contribution from exposure by food contact materials to the overall exposure by applying an allocation factor of 10 % to the conventionally derived migration limit. Therefore, a migration limit for aluminium of 1 mg/kg food is considered appropriate for food contact materials. |
| --- | --- |

(28)

The Authority has adopted a scientific opinion (17) on the safety of aluminium from dietary intake, which establishes a tolerable weekly intake of 1 mg aluminium per kg body weight per week. Applying the conventional exposure assumptions for food contact materials, the migration limit would have to be set at 8,6 mg/kg food. The opinion however notes that the current dietary exposure of a significant part of the Union's population likely exceeds this level. Therefore, it is appropriate to limit the contribution from exposure by food contact materials to the overall exposure by applying an allocation factor of 10 % to the conventionally derived migration limit. Therefore, a migration limit for aluminium of 1 mg/kg food is considered appropriate for food contact materials.

| (29) | The Authority has adopted a scientific opinion on dietary reference values for zinc (18). This confirms the opinion expressed by the Scientific Committee on Foods (SCF) in 2002 (19) which sets the tolerable upper level of zinc for adults to 25 mg per day. In Annex II to Regulation (EU) No 10/2011, the migration limit for zinc is set at 25 mg/kg food. As dietary exposure from other sources significantly contributes to the total exposure, and according to the Authority, the upper level could be exceeded in combination with the current migration limit. Therefore to reduce the contribution from food contact materials to the total exposure to zinc, and taking into account that the total dietary exposure to zinc is in the range of the upper limit but generally below, it is appropriate to use an allocation factor of 20 % for the exposure from food contact material. It is therefore appropriate to amend the migration limit specified in Annex II to the Regulation to 5 mg/kg food. |
| --- | --- |

(29)

The Authority has adopted a scientific opinion on dietary reference values for zinc (18). This confirms the opinion expressed by the Scientific Committee on Foods (SCF) in 2002 (19) which sets the tolerable upper level of zinc for adults to 25 mg per day. In Annex II to Regulation (EU) No 10/2011, the migration limit for zinc is set at 25 mg/kg food. As dietary exposure from other sources significantly contributes to the total exposure, and according to the Authority, the upper level could be exceeded in combination with the current migration limit. Therefore to reduce the contribution from food contact materials to the total exposure to zinc, and taking into account that the total dietary exposure to zinc is in the range of the upper limit but generally below, it is appropriate to use an allocation factor of 20 % for the exposure from food contact material. It is therefore appropriate to amend the migration limit specified in Annex II to the Regulation to 5 mg/kg food.

| (30) | A single specification of the amount of saponifiable matter in vegetable oil to be used for food simulant D2 is sufficient to specify that food simulant. Therefore, any further specifications are not necessary and the note below Table 1 of Annex III to the Regulation should be deleted. |
| --- | --- |

(30)

A single specification of the amount of saponifiable matter in vegetable oil to be used for food simulant D2 is sufficient to specify that food simulant. Therefore, any further specifications are not necessary and the note below Table 1 of Annex III to the Regulation should be deleted.

| (31) | The Regulation does not lay down specific migration testing provisions for fresh unpeeled fruits and vegetables as no food simulant has been assigned to these products. Possible health risks to consumers from migrating substances, including substances that should not be present to any extent can therefore remain undetected. A food simulant should thus be assigned to those products in Table 2 of Annex III to Regulation (EU) No 10/2011. Those fruits and vegetables vary widely in properties, but are dry. Food simulant E is suitable for dry foods but may overestimate the contact surface depending on size and shape of the fruits and vegetables. Moreover, fruits and vegetables may be peeled before consumption removing part of the migrants. The overestimation should be addressed with a correction factor and the correction procedure should be set out in point 3 of Annex III to the Regulation. |
| --- | --- |

(31)

The Regulation does not lay down specific migration testing provisions for fresh unpeeled fruits and vegetables as no food simulant has been assigned to these products. Possible health risks to consumers from migrating substances, including substances that should not be present to any extent can therefore remain undetected. A food simulant should thus be assigned to those products in Table 2 of Annex III to Regulation (EU) No 10/2011. Those fruits and vegetables vary widely in properties, but are dry. Food simulant E is suitable for dry foods but may overestimate the contact surface depending on size and shape of the fruits and vegetables. Moreover, fruits and vegetables may be peeled before consumption removing part of the migrants. The overestimation should be addressed with a correction factor and the correction procedure should be set out in point 3 of Annex III to the Regulation.

| (32) | Only food simulant A is assigned for fresh vegetables that are peeled and/or cut. As such vegetables can be acidic, it is appropriate that food simulant B is also specified for peeled and/or cut vegetables. Therefore, that category should be added to Table 2 of Annex III to the Regulation. |
| --- | --- |

(32)

Only food simulant A is assigned for fresh vegetables that are peeled and/or cut. As such vegetables can be acidic, it is appropriate that food simulant B is also specified for peeled and/or cut vegetables. Therefore, that category should be added to Table 2 of Annex III to the Regulation.

| (33) | Testing in several different food simulants provides no added value if it is scientifically evident that one food simulant always yields the highest migration results for a specific substance or material, and this food simulant can therefore be considered as the most severe for such a substance or material. Therefore, a general derogation to the assignment of food simulants should be included in Annex III to the Regulation to allow the testing in only one food simulant if appropriate scientific evidence is documented showing that that food simulant is the most severe. |
| --- | --- |

(33)

Testing in several different food simulants provides no added value if it is scientifically evident that one food simulant always yields the highest migration results for a specific substance or material, and this food simulant can therefore be considered as the most severe for such a substance or material. Therefore, a general derogation to the assignment of food simulants should be included in Annex III to the Regulation to allow the testing in only one food simulant if appropriate scientific evidence is documented showing that that food simulant is the most severe.

| (34) | Point 5 of Annex IV to the Regulation requires a written confirmation that the requirements laid down in Regulation (EC) No 1935/2004 are met. However, most of the provisions set out in Regulation (EC) No 1935/2004 cannot directly apply to plastic materials or articles, or to the substances used to manufacture those materials or articles. Therefore the reference to Regulation (EC) No 1935/2004 should be made more specific by adding references to the provisions of that Regulation to which confirmation of compliance is required. |
| --- | --- |

(34)

Point 5 of Annex IV to the Regulation requires a written confirmation that the requirements laid down in Regulation (EC) No 1935/2004 are met. However, most of the provisions set out in Regulation (EC) No 1935/2004 cannot directly apply to plastic materials or articles, or to the substances used to manufacture those materials or articles. Therefore the reference to Regulation (EC) No 1935/2004 should be made more specific by adding references to the provisions of that Regulation to which confirmation of compliance is required.

| (35) | Substances found in food already in contact with a material or article that is being tested for its compliance, do not necessarily originate from that material or article, but may originate from other sources, including other food contact materials or articles with which the food has been in contact previously. Therefore, the amount of a substance present in the food which does not originate from the tested material or article should not be taken into account to determine the compliance with the Regulation. This correction should equally apply to all substances for which the Regulation sets a specific migration limit or for which no migration is permitted. While Section 1.4 of Chapter 1 of Annex V to the Regulation already includes a requirement to take account of contamination from other sources, it is appropriate, in the interests of legal certainty, to clarify that prior to comparing tests results to the applicable specific migration limit, the test result should be corrected to take into account contamination from other sources. |
| --- | --- |

(35)

Substances found in food already in contact with a material or article that is being tested for its compliance, do not necessarily originate from that material or article, but may originate from other sources, including other food contact materials or articles with which the food has been in contact previously. Therefore, the amount of a substance present in the food which does not originate from the tested material or article should not be taken into account to determine the compliance with the Regulation. This correction should equally apply to all substances for which the Regulation sets a specific migration limit or for which no migration is permitted. While Section 1.4 of Chapter 1 of Annex V to the Regulation already includes a requirement to take account of contamination from other sources, it is appropriate, in the interests of legal certainty, to clarify that prior to comparing tests results to the applicable specific migration limit, the test result should be corrected to take into account contamination from other sources.

| (36) | The migration testing conditions should always be at least as strict as the real conditions of use. Therefore, the second paragraph of Section 2.1.3 of Chapter 2 of Annex V to the Regulation should be amended to make it clear that the testing conditions cannot be adjusted to conditions that are less strict than the real conditions of use. |
| --- | --- |

(36)

The migration testing conditions should always be at least as strict as the real conditions of use. Therefore, the second paragraph of Section 2.1.3 of Chapter 2 of Annex V to the Regulation should be amended to make it clear that the testing conditions cannot be adjusted to conditions that are less strict than the real conditions of use.

| (37) | Business operators use food processing equipment that is capable of precisely controlling the time and temperature conditions at which the food and the equipment, or, if the food is already packaged, its packaging, are in contact, such as during pasteurisation and sterilisation of the food. Such equipment must always be operated in accordance with good manufacturing practice. Therefore when using the exact worst foreseeable processing conditions applied in such equipment as testing conditions for migration testing, this testing will be representative for the actual migration, and will rule out possible adverse effects to human health. The standardised testing conditions set out in Table 1 and 2 of Annex V may significantly overestimate migration, and consequently place an unreasonable burden on business operators. Therefore it is appropriate to amend the Regulation to allow the use of actual processing conditions used in such equipment as testing conditions for migration testing. |
| --- | --- |

(37)

Business operators use food processing equipment that is capable of precisely controlling the time and temperature conditions at which the food and the equipment, or, if the food is already packaged, its packaging, are in contact, such as during pasteurisation and sterilisation of the food. Such equipment must always be operated in accordance with good manufacturing practice. Therefore when using the exact worst foreseeable processing conditions applied in such equipment as testing conditions for migration testing, this testing will be representative for the actual migration, and will rule out possible adverse effects to human health. The standardised testing conditions set out in Table 1 and 2 of Annex V may significantly overestimate migration, and consequently place an unreasonable burden on business operators. Therefore it is appropriate to amend the Regulation to allow the use of actual processing conditions used in such equipment as testing conditions for migration testing.

| (38) | Certain worst foreseeable conditions of use may occur in practice under which it is not technically feasible to use food simulant D2 for testing. Appropriate alternative food simulants and rules for verification of compliance should be specified for such conditions. |
| --- | --- |

(38)

Certain worst foreseeable conditions of use may occur in practice under which it is not technically feasible to use food simulant D2 for testing. Appropriate alternative food simulants and rules for verification of compliance should be specified for such conditions.

| (39) | The title and titles of columns of Tables 1 and 2 of Section 2.1.3 of Chapter 2 of Annex V to the Regulation do not clearly set out that the temperature specified for testing represents the temperature of the food simulant used during the test. Those tables should therefore be amended to ensure correct application of the specified testing conditions. |
| --- | --- |

(39)

The title and titles of columns of Tables 1 and 2 of Section 2.1.3 of Chapter 2 of Annex V to the Regulation do not clearly set out that the temperature specified for testing represents the temperature of the food simulant used during the test. Those tables should therefore be amended to ensure correct application of the specified testing conditions.

| (40) | The temperature specified for testing above 175 °C is not representative for all foreseeable conditions to which food contact materials may be subjected. Therefore, appropriate rules for testing above 175 °C should be added to Table 2 of Section 2.1.3 of Chapter 2 of Annex V to the Regulation. |
| --- | --- |

(40)

The temperature specified for testing above 175 °C is not representative for all foreseeable conditions to which food contact materials may be subjected. Therefore, appropriate rules for testing above 175 °C should be added to Table 2 of Section 2.1.3 of Chapter 2 of Annex V to the Regulation.

| (41) | Section 2.1.4 of Annex V to the Regulation specifies testing conditions for contact times beyond 30 days. Those conditions include a formula and provide specific conditions which can both be used to determine a testing temperature for testing at accelerated conditions. It however does not clarify that the formula should only be applied when the standardised testing conditions do not apply. This section also does not clearly specify test conditions for storage at frozen conditions or when an article or material is initially filled under hot-fill conditions. This section should therefore be amended to ensure the formula is only applied for conditions not specified by the standard conditions, and to clarify the test condition for hot-fill and frozen conditions. |
| --- | --- |

(41)

Section 2.1.4 of Annex V to the Regulation specifies testing conditions for contact times beyond 30 days. Those conditions include a formula and provide specific conditions which can both be used to determine a testing temperature for testing at accelerated conditions. It however does not clarify that the formula should only be applied when the standardised testing conditions do not apply. This section also does not clearly specify test conditions for storage at frozen conditions or when an article or material is initially filled under hot-fill conditions. This section should therefore be amended to ensure the formula is only applied for conditions not specified by the standard conditions, and to clarify the test condition for hot-fill and frozen conditions.

| (42) | Section 2.1.6 of Annex V to Regulation (EU) No 10/2011 specifies that when testing repeated use materials the migration limit should already be respected in the first migration test when testing the migration of substances for which the Regulation specifies that the specific migration is set as non-detectable. This however should include all substances for which this is the case and therefore also include those specified in Annex II to the Regulation. It is therefore appropriate to delete the specific reference from the Regulation and to clarify that this rule applies to all substances for which the migration should be non-detectable. |
| --- | --- |

(42)

Section 2.1.6 of Annex V to Regulation (EU) No 10/2011 specifies that when testing repeated use materials the migration limit should already be respected in the first migration test when testing the migration of substances for which the Regulation specifies that the specific migration is set as non-detectable. This however should include all substances for which this is the case and therefore also include those specified in Annex II to the Regulation. It is therefore appropriate to delete the specific reference from the Regulation and to clarify that this rule applies to all substances for which the migration should be non-detectable.

| (43) | If the migration behaviour of a material or article is well established, a single test may suffice to screen its compliance with the Regulation. Provided that a justification for such substitution on the basis of the known behaviour of the material is documented, a series of tests representative for various time and temperature combinations that would foreseeably be used in the real use of a material or article, can be substituted by a single test. Such a substitution may significantly reduce the testing burden, without compromising the high level of human health protection that this Regulation seeks to achieve. Therefore, it is appropriate to provide for the possibility of applying a single screening test in appropriate circumstances. |
| --- | --- |

(43)

If the migration behaviour of a material or article is well established, a single test may suffice to screen its compliance with the Regulation. Provided that a justification for such substitution on the basis of the known behaviour of the material is documented, a series of tests representative for various time and temperature combinations that would foreseeably be used in the real use of a material or article, can be substituted by a single test. Such a substitution may significantly reduce the testing burden, without compromising the high level of human health protection that this Regulation seeks to achieve. Therefore, it is appropriate to provide for the possibility of applying a single screening test in appropriate circumstances.

| (44) | Table 3 in Chapter 3 of Annex V to the Regulation currently states that the standardised testing condition OM6 represents the worst case conditions for food simulants A, B and C. However, it also represents the worst case conditions for food simulant D1, and this food simulant can also be used in this test. Therefore, the Regulation should be corrected to include references to food simulant D1 in this context. |
| --- | --- |

(44)

Table 3 in Chapter 3 of Annex V to the Regulation currently states that the standardised testing condition OM6 represents the worst case conditions for food simulants A, B and C. However, it also represents the worst case conditions for food simulant D1, and this food simulant can also be used in this test. Therefore, the Regulation should be corrected to include references to food simulant D1 in this context.

| (45) | According to the text provided below Table 3 in Section 3.1 of Annex V to the Regulation, the standardised testing condition OM7 represents the worst case conditions for ‘fatty food simulants’. However, it only represents the worst case conditions for food simulant D2 and the Regulation should be clarified accordingly. |
| --- | --- |

(45)

According to the text provided below Table 3 in Section 3.1 of Annex V to the Regulation, the standardised testing condition OM7 represents the worst case conditions for ‘fatty food simulants’. However, it only represents the worst case conditions for food simulant D2 and the Regulation should be clarified accordingly.

| (46) | It is not always technically feasible to test overall migration with food simulant D2. In Section 3.2 of Annex V, the Regulation only specifies a substitute test for the standardised testing condition OM7. However substitute tests for conditions OM1 to OM6 should also be specified to allow for overall migration testing when food simulant D2 cannot be used under these standardised testing conditions. Therefore it is appropriate to include appropriate substitute tests in this section. |
| --- | --- |

(46)

It is not always technically feasible to test overall migration with food simulant D2. In Section 3.2 of Annex V, the Regulation only specifies a substitute test for the standardised testing condition OM7. However substitute tests for conditions OM1 to OM6 should also be specified to allow for overall migration testing when food simulant D2 cannot be used under these standardised testing conditions. Therefore it is appropriate to include appropriate substitute tests in this section.

| (47) | It is not always technically feasible to test overall migration of repeated use Articles in an oily medium using the same sample three times. Therefore an alternative testing approach should be specified. |
| --- | --- |

(47)

It is not always technically feasible to test overall migration of repeated use Articles in an oily medium using the same sample three times. Therefore an alternative testing approach should be specified.

| (48) | Regulation (EU) No 10/2011 does not specify a method for verifying compliance with the overall migration limit set out in Article 12 of the Regulation. However, the accuracy of the determination as to whether materials or articles comply with the prescribed limit is dependent on the existence of an appropriate verification method. It is therefore appropriate to include a reference to Regulation (EC) No 882/2004 (20) which specifies rules for the selection of appropriate methods for the verification of compliance. |
| --- | --- |

(48)

Regulation (EU) No 10/2011 does not specify a method for verifying compliance with the overall migration limit set out in Article 12 of the Regulation. However, the accuracy of the determination as to whether materials or articles comply with the prescribed limit is dependent on the existence of an appropriate verification method. It is therefore appropriate to include a reference to Regulation (EC) No 882/2004 (20) which specifies rules for the selection of appropriate methods for the verification of compliance.

| (49) | The Regulation does not clearly specify that the application of the Fat Consumption Reduction Factor (FRF) should not allow the specific migration of a single substance to exceed the overall migration limit. It is therefore appropriate to include such a prohibition in Section 4.1 of Chapter 4 of Annex V to the Regulation. |
| --- | --- |

(49)

The Regulation does not clearly specify that the application of the Fat Consumption Reduction Factor (FRF) should not allow the specific migration of a single substance to exceed the overall migration limit. It is therefore appropriate to include such a prohibition in Section 4.1 of Chapter 4 of Annex V to the Regulation.

| (50) | Regulation (EU) No 10/2011 should therefore be amended accordingly. |
| --- | --- |

(50)

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

| (51) | In order to limit the administrative burden and to provide business operators with sufficient time to adjust their practices to comply with the requirements of this Regulation, transitional measures should be provided. |
| --- | --- |

(51)

In order to limit the administrative burden and to provide business operators with sufficient time to adjust their practices to comply with the requirements of this Regulation, transitional measures should be provided.

| (52) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, |
| --- | --- |

(52)

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

Regulation (EU) No 10/2011 is amended as follows:

| (1) | Article 3 is amended as follows:






  (a) | point 16 is replaced by the following:






  ‘(16) | “non-fatty food” means a food for which in migration testing only food simulants other than food simulants D1 or D2 are laid down in Table 2 of Annex III to this Regulation;’; |
| --- | --- | --- | --- |

(1)

Article 3 is amended as follows:

(a)

point 16 is replaced by the following:

‘(16)

“non-fatty food” means a food for which in migration testing only food simulants other than food simulants D1 or D2 are laid down in Table 2 of Annex III to this Regulation;’;

| (b) | point 18 is replaced by the following:






  ‘(18) | “specification” means composition of a substance, purity criteria for a substance, physico-chemical characteristics of a substance, details concerning the manufacturing process of a substance or further information concerning the expression of migration limits;’; |
| --- | --- | --- |

(b)

point 18 is replaced by the following:

‘(18)

“specification” means composition of a substance, purity criteria for a substance, physico-chemical characteristics of a substance, details concerning the manufacturing process of a substance or further information concerning the expression of migration limits;’;

| (c) | a new point 19 is added:






  ‘(19) | “hot-fill” means the filling of any article with a food with a temperature not exceeding 100 °C at the moment of filling, after which the food cools down to 50 °C or below within 60 minutes, or to 30 °C or below within 150 minutes.’; |
| --- | --- | --- |

(c)

a new point 19 is added:

‘(19)

“hot-fill” means the filling of any article with a food with a temperature not exceeding 100 °C at the moment of filling, after which the food cools down to 50 °C or below within 60 minutes, or to 30 °C or below within 150 minutes.’;

| (2) | in Article 6(3), point (a) is replaced by the following:






  ‘(a) | all salts of aluminium, ammonium, barium, calcium, cobalt, copper, iron, lithium, magnesium, manganese, potassium, sodium, and zinc of authorised acids, phenols or alcohols;’; |
| --- | --- | --- |

(2)

in Article 6(3), point (a) is replaced by the following:

‘(a)

| (3) | Article 11 is amended as follows:






  (a) | paragraph 2 is deleted; |
| --- | --- | --- |

(3)

Article 11 is amended as follows:

(a)

paragraph 2 is deleted;

| (b) | paragraph 3 is replaced by the following:

  ‘3.   By derogation from paragraph 1, additives which are also authorised as food additives by Regulation (EC) No 1333/2008 or as flavourings by Regulation (EC) No 1334/2008 shall not migrate into foods in quantities having a technical effect in the final foods and shall not:






  (a) | exceed the restrictions provided for in Regulation (EC) No 1333/2008 or in Regulation (EC) No 1334/2008 or in Annex I to this Regulation for foods for which their use is authorised as food additive or flavouring substances; or |
| --- | --- | --- |

(b)

paragraph 3 is replaced by the following:

‘3.   By derogation from paragraph 1, additives which are also authorised as food additives by Regulation (EC) No 1333/2008 or as flavourings by Regulation (EC) No 1334/2008 shall not migrate into foods in quantities having a technical effect in the final foods and shall not:

(a)

exceed the restrictions provided for in Regulation (EC) No 1333/2008 or in Regulation (EC) No 1334/2008 or in Annex I to this Regulation for foods for which their use is authorised as food additive or flavouring substances; or

| (b) | exceed the restrictions set out in Annex I to this Regulation in foods for which their use is not authorised as food additive or flavouring substances.’; |
| --- | --- |

(b)

exceed the restrictions set out in Annex I to this Regulation in foods for which their use is not authorised as food additive or flavouring substances.’;

| (c) | the following paragraph 4 is added:

  ‘4.   Where it is specified that no migration of a particular substance is permitted, compliance shall be established using appropriate migration test methods selected in accordance with Article 11 of Regulation (EC) No 882/2004 that can confirm the absence of migration above a specified limit of detection.
  For the purposes of the first subparagraph, unless specific detection limits have been set for particular substances or groups of substances, a detection limit of 0,01 mg/kg shall apply.’; |
| --- | --- |

(c)

the following paragraph 4 is added:

‘4.   Where it is specified that no migration of a particular substance is permitted, compliance shall be established using appropriate migration test methods selected in accordance with Article 11 of Regulation (EC) No 882/2004 that can confirm the absence of migration above a specified limit of detection.

For the purposes of the first subparagraph, unless specific detection limits have been set for particular substances or groups of substances, a detection limit of 0,01 mg/kg shall apply.’;

| (4) | in Article 13, paragraph 3 is replaced by the following:

  ‘3.   Substances under paragraph 2(b) shall not migrate into food or food simulant, in accordance with Article 11(4). The detection limit set out in the second subparagraph of Article 11(4) shall apply to groups of substances if they are structurally and toxicologically related, including isomers or substances with the same relevant functional group, or to individual substances that are not related, and shall include possible set-off transfer.’; |
| --- | --- |

(4)

in Article 13, paragraph 3 is replaced by the following:

‘3.   Substances under paragraph 2(b) shall not migrate into food or food simulant, in accordance with Article 11(4). The detection limit set out in the second subparagraph of Article 11(4) shall apply to groups of substances if they are structurally and toxicologically related, including isomers or substances with the same relevant functional group, or to individual substances that are not related, and shall include possible set-off transfer.’;

| (5) | in Article 17(3), point (a) is replaced by the following:






  ‘(a) | mg/kg using the actual content of the container for which the closure is intended applying the total contact surface of sealing article and sealed container if the intended use of the article is known, while taking into account the provisions of paragraph 2;’; |
| --- | --- | --- |

(5)

in Article 17(3), point (a) is replaced by the following:

‘(a)

mg/kg using the actual content of the container for which the closure is intended applying the total contact surface of sealing article and sealed container if the intended use of the article is known, while taking into account the provisions of paragraph 2;’;

| (6) | Article 18 is amended as follows:






  (a) | paragraph 4 is replaced by the following:

  ‘4.   For materials and articles not yet in contact with food verification of compliance with the overall migration limit shall be carried out in food simulants as set out in Annex III in accordance with the rules set out in Chapter 3 of Annex V.’; |
| --- | --- | --- |

(6)

Article 18 is amended as follows:

(a)

paragraph 4 is replaced by the following:

‘4.   For materials and articles not yet in contact with food verification of compliance with the overall migration limit shall be carried out in food simulants as set out in Annex III in accordance with the rules set out in Chapter 3 of Annex V.’;

| (b) | paragraph 7 is replaced by the following:

  ‘7.   Before comparing specific and overall migration test results with the migration limits the correction factors set out in point 3 of Annex III and Chapter 4 of Annex V shall be applied in accordance with the rules set out therein.’; |
| --- | --- |

(b)

paragraph 7 is replaced by the following:

‘7.   Before comparing specific and overall migration test results with the migration limits the correction factors set out in point 3 of Annex III and Chapter 4 of Annex V shall be applied in accordance with the rules set out therein.’;

| (7) | Annexes I, II, III, IV and V are amended in accordance with the Annex to this Regulation. |
| --- | --- |

(7)

Annexes I, II, III, IV and V are amended in accordance with the Annex to this Regulation.

Article 2

Plastic materials and articles complying with Regulation (EU) No 10/2011 as applicable before the entry into force of this Regulation, may be placed on the market until 14 September 2017 and may remain on the market until exhaustion of stocks.

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.

The provisions on the specific migration limits for aluminium and for zinc set out in point 2(a) of the Annex and the assignments of food simulants in point 3(c) of the Annex shall apply from 14 September 2018.

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

Done at Brussels, 24 August 2016.

For the Commission

The President

Jean-Claude JUNCKER

---

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

1

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

2

(3)  
  EFSA Journal 2009; 7(10):1364.

3

EFSA Journal

(4)  
  EFSA Journal 2014; 12(6):3712.

4

EFSA Journal

(5)  
  EFSA Journal 2015;13(7):4171.

5

EFSA Journal

(6)  
  EFSA Journal 2007, 555-563, 1-31, doi: 10.2903/j.efsa.2007.555.

6

EFSA Journal

(7)  
  EFSA Journal 2014;12(11):3909.

7

EFSA Journal

(8)  
  EFSA Journal 2014;12(10):3866.

8

EFSA Journal

(9)  
  EFSA Journal 2015;13(1):3979.

9

EFSA Journal

(10)  
  EFSA Journal 2014;12(6):3718.

10

EFSA Journal

(11)  
  EFSA Journal 2015;13(2):4019.

11

EFSA Journal

(12)  
  EFSA Journal 2015;13(4):4063.

12

EFSA Journal

(13)  
  EFSA Journal 2016;14(3):4408.

13

EFSA Journal

(14)  
  EFSA Journal 2014;12(10):3867.

14

EFSA Journal

(15)  
  EFSA Journal 2014;12(10):3863.

15

EFSA Journal

(16)  
  EFSA Journal 2015;13(2):4021.

16

EFSA Journal

(17)  
  EFSA Journal (2008) 754, 1-34.

17

EFSA Journal

(18)  
  EFSA Journal 2014;12(10):3844.

18

EFSA Journal

(19)  SCF/CS/NUT/UPPLEV/62 Final, http://ec.europa.eu/food/fs/sc/scf/out177_en.pdf

19

(20)  Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules (OJ L 165, 30.4.2004, p. 1).

20

---

ANNEX

Annexes I, II, III, IV and V to Regulation (EU) No 10/2011 are amended as follows:

| (1) | Annex I is amended as follows:






  (a) | in point 1, the paragraph referring to Column 8 of Table 1 is replaced by the following:

  ‘Column 8 (SML [mg/kg]): the specific migration limit applicable for the substance. It is expressed in mg substance per kg food. It is marked as ND (“not-detectable”) if the substance is one in respect of which no migration is permitted, to be determined in accordance with Article 11(4).’; |
| --- | --- | --- |

(1)

Annex I is amended as follows:

(a)

in point 1, the paragraph referring to Column 8 of Table 1 is replaced by the following:

‘Column 8 (SML [mg/kg]): the specific migration limit applicable for the substance. It is expressed in mg substance per kg food. It is marked as ND (“not-detectable”) if the substance is one in respect of which no migration is permitted, to be determined in accordance with Article 11(4).’;

| (b) | in point 1, the last paragraph before Table 1 is deleted; |
| --- | --- |

(b)

in point 1, the last paragraph before Table 1 is deleted;

| (c) | in point 1, in column 10 of Table 1, in the entries for the substances with FCM substance Nos 72, 642, 672, 776, 782, 923 and 974, the word ‘should’ is replaced by the word ‘shall’; |
| --- | --- |

(c)

in point 1, in column 10 of Table 1, in the entries for the substances with FCM substance Nos 72, 642, 672, 776, 782, 923 and 974, the word ‘should’ is replaced by the word ‘shall’;

| (d) | in point 1, Table 1 is amended as follows:






  (i) | in column 10, in the entries for the substances with FCM substance Nos 93, 199, 262, 326, 637, 768, 803, 810, 815, 819 and 884, the words ‘simulant D’ are replaced by the words ‘simulant D1 and/or D2’; |
| --- | --- | --- |

(d)

in point 1, Table 1 is amended as follows:

(i)

in column 10, in the entries for the substances with FCM substance Nos 93, 199, 262, 326, 637, 768, 803, 810, 815, 819 and 884, the words ‘simulant D’ are replaced by the words ‘simulant D1 and/or D2’;

| (ii) | the entries concerning substances with FCM substance Nos 87, 391, 641, 752, 779 and 974 are replaced by the following:















  ‘87 | 86285 | | Silicon dioxide, silanated | yes | no | no | | | For synthetic amorphous silicon dioxide, silanated: primary particles of 1–100 nm which are aggregated to a size of 0,1–1 μm and may form agglomerates within the size distribution of 0,3 μm to the mm size.’ | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| ‘391 | 22932 | 0001187-93-5 | perfluoromethyl perfluorovinyl ether | no | yes | no | 0,05 | | Only to be used in:






  — | anti-stick coatings; |

(ii)

the entries concerning substances with FCM substance Nos 87, 391, 641, 752, 779 and 974 are replaced by the following:

‘87

86285

Silicon dioxide, silanated

yes

no

no

For synthetic amorphous silicon dioxide, silanated: primary particles of 1–100 nm which are aggregated to a size of 0,1–1 μm and may form agglomerates within the size distribution of 0,3 μm to the mm size.’

‘391

22932

0001187-93-5

perfluoromethyl perfluorovinyl ether

no

yes

no

0,05

Only to be used in:

—

anti-stick coatings;

| — | fluoro- and perfluoropolymers intended for repeated use applications where the contact ratio is 1 dm2 surface in contact with at least 150 kg food.’ |
| --- | --- |

—

fluoro- and perfluoropolymers intended for repeated use applications where the contact ratio is 1 dm2 surface in contact with at least 150 kg food.’

‘641

22331

0025513-64-8

mixture of (35-45 % w/w) 1,6-diamino-2,2,4-trimethylhexane and (55-65 % w/w)1,6-diamino-2,4,4-trimethylhexane

no

yes

no

0,05’

‘752

39890

0087826-41-3

0069158-41- 4

0054686-97-4

0081541-12-0

bis(methylbenzylidene)sorbitol

yes

no

no’

‘779

39815

0182121-12-6

9,9-bis(methoxymethyl)fluorene

yes

no

yes

0,05

(2)’

‘974

74050

939402-02-5

phosphorous acid, mixed 2,4-bis(1,1-dimethylpropyl)phenyl and 4-(1,1-dimethylpropyl)phenyl triesters

yes

no

yes

5

SML expressed as the sum of the phosphite and phosphate forms of the substance, 4-tert-amylphenol and 2,4-di-tert-amylphenol.

The migration of 2,4-di-tert-amylphenol shall not exceed 1 mg/kg food.’

| (iii) | the following entries are inserted in numerical order of the FCM substance numbers:















  ‘871 | | 0287916-86-3 | dodecanoic acid, 12-amino-, polymer with ethene, 2,5-furandione, α-hydro-ω-hydroxypoly (oxy-1,2-ethanediyl) and 1-propene | yes | no | no | | | Only to be used in polyolefins at levels of up to 20 weight %. These polyolefins shall only be used in contact with foods for which Table 2 of Annex III assigns food simulant E, at ambient temperature or below, and when migration of the total oligomeric fraction of less than 1 000 Da does not exceed 50 μg/kg food. | (23)’ |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| ‘1031 | | 3238-40-2 | furan-2,5-dicarboxylic acid | no | yes | no | 5 | | Only to be used as a monomer in the production of polyethylene furanoate. The migration of the oligomeric fraction of less than 1 000  Da shall not exceed 50 μg/kg food (expressed as furan-2,5-dicarboxylic acid). | (22)
  (23) |
| 1034 | | 3710-30-3 | 1,7-octadiene | no | yes | no | 0,05 | | Only to be used as a crosslinking co-monomer in the manufacture of polyolefins for contact with any type of foods for long term storage at room temperature, including when packaged under hot-fill conditions.’ | |
| ‘1045 | | 1190931-27-1 | perfluoro{acetic acid, 2-[(5-methoxy-1,3-dioxolan-4-yl)oxy]}, ammonium salt | yes | no | no | | | Only to be used as a polymer production aid during the manufacture of fluoropolymers under high temperature conditions of at least 370 °C. | |
| 1046 | | | zinc oxide, nanoparticles, coated with [3-(methacryloxy)propyl] trimethoxysilane (FCM No 788) | yes | no | no | | | Only to be used in unplasticised polymers.
  The restrictions and specifications specified for FCM substance No 788 shall be respected. | |
| 1048 | | 624-03-3 | ethylene glycol dipalmitate | yes | no | no | | (2) | Only to be used when produced from a fatty acid precursor that is obtained from edible fats or oils. | |
| 1050 | | | zinc oxide, nanoparticles, uncoated | yes | no | no | | | Only to be used in unplasticised polymers. | |
| 1051 | | 42774-15-2 | N,N′-bis(2,2,6,6-tetramethyl-4-piperidinyl) isophthalamide | yes | no | no | 5 | | | |
| 1052 | | 1455-42-1 | 2,4,8,10-tetraoxaspiro[5,5]undecane-3,9-diethanol,β3,β3,β9,β9-tetramethyl- (“SPG”) | no | yes | no | 5 | | Only to be used as a monomer in the production of polyesters. The migration of oligomers of less than 1 000  Da shall not exceed 50 μg/kg food (expressed as SPG). | (22)
  (23) |
| 1053 | | | fatty acids, C16–18 saturated, esters with dipentaerythritol | yes | no | no | | | Only to be used when produced from a fatty acid precursor that is obtained from edible fats or oils’ | |

(iii)

the following entries are inserted in numerical order of the FCM substance numbers:

‘871

0287916-86-3

dodecanoic acid, 12-amino-, polymer with ethene, 2,5-furandione, α-hydro-ω-hydroxypoly (oxy-1,2-ethanediyl) and 1-propene

yes

no

no

Only to be used in polyolefins at levels of up to 20 weight %. These polyolefins shall only be used in contact with foods for which Table 2 of Annex III assigns food simulant E, at ambient temperature or below, and when migration of the total oligomeric fraction of less than 1 000 Da does not exceed 50 μg/kg food.

(23)’

‘1031

3238-40-2

furan-2,5-dicarboxylic acid

no

yes

no

5

Only to be used as a monomer in the production of polyethylene furanoate. The migration of the oligomeric fraction of less than 1 000  Da shall not exceed 50 μg/kg food (expressed as furan-2,5-dicarboxylic acid).

(22)

(23)

1034

3710-30-3

1,7-octadiene

no

yes

no

0,05

Only to be used as a crosslinking co-monomer in the manufacture of polyolefins for contact with any type of foods for long term storage at room temperature, including when packaged under hot-fill conditions.’

‘1045

1190931-27-1

perfluoro{acetic acid, 2-[(5-methoxy-1,3-dioxolan-4-yl)oxy]}, ammonium salt

yes

no

no

Only to be used as a polymer production aid during the manufacture of fluoropolymers under high temperature conditions of at least 370 °C.

1046

zinc oxide, nanoparticles, coated with [3-(methacryloxy)propyl] trimethoxysilane (FCM No 788)

yes

no

no

Only to be used in unplasticised polymers.

The restrictions and specifications specified for FCM substance No 788 shall be respected.

1048

624-03-3

ethylene glycol dipalmitate

yes

no

no

(2)

Only to be used when produced from a fatty acid precursor that is obtained from edible fats or oils.

1050

zinc oxide, nanoparticles, uncoated

yes

no

no

Only to be used in unplasticised polymers.

1051

42774-15-2

N,N′-bis(2,2,6,6-tetramethyl-4-piperidinyl) isophthalamide

yes

no

no

5

1052

1455-42-1

2,4,8,10-tetraoxaspiro[5,5]undecane-3,9-diethanol,β3,β3,β9,β9-tetramethyl- (“SPG”)

no

yes

no

5

Only to be used as a monomer in the production of polyesters. The migration of oligomers of less than 1 000  Da shall not exceed 50 μg/kg food (expressed as SPG).

(22)

(23)

1053

fatty acids, C16–18 saturated, esters with dipentaerythritol

yes

no

no

Only to be used when produced from a fatty acid precursor that is obtained from edible fats or oils’

| (e) | in point 2, in Table 2, the entry concerning the group restriction with Group Restriction No 2 is replaced by the following:








  ‘2 | 89
  227
  263
  1048 | 30 | expressed as ethyleneglycol’ |
| --- | --- | --- | --- | --- |

(e)

in point 2, in Table 2, the entry concerning the group restriction with Group Restriction No 2 is replaced by the following:

‘2

89

227

263

1048

30

expressed as ethyleneglycol’

| (f) | in point 3, in column 2 of Table 3, in the entries for Notes 4 and 5, the word ‘should’ is replaced by the word ‘shall’; |
| --- | --- |

(f)

in point 3, in column 2 of Table 3, in the entries for Notes 4 and 5, the word ‘should’ is replaced by the word ‘shall’;

| (g) | in point 3, in Table 3, the following entries are added:






  ‘(22) | When used in contact with non-alcoholic foods for which Table 2 of Annex III assigns food simulant D1, food simulant C shall be used for verification of compliance instead of food simulant D1; |
| --- | --- | --- |
| (23) | When a final material or article containing this substance is placed on the market, a well described method to determine whether the oligomer migration complies with the restrictions specified in column 10 of Table 1 shall form part of the supporting documentation referred to in Article 16. This method shall be suitable for use by a competent authority to verify compliance. If an adequate method is publicly available, reference shall be made to that method. If the method requires a calibration sample, a sufficient sample shall be supplied to the competent authority on its request.’ |

(g)

in point 3, in Table 3, the following entries are added:

‘(22)

When used in contact with non-alcoholic foods for which Table 2 of Annex III assigns food simulant D1, food simulant C shall be used for verification of compliance instead of food simulant D1;

(23)

When a final material or article containing this substance is placed on the market, a well described method to determine whether the oligomer migration complies with the restrictions specified in column 10 of Table 1 shall form part of the supporting documentation referred to in Article 16. This method shall be suitable for use by a competent authority to verify compliance. If an adequate method is publicly available, reference shall be made to that method. If the method requires a calibration sample, a sufficient sample shall be supplied to the competent authority on its request.’

| (2) | Annex II is amended as follows:






  (a) | point 1 is replaced by the following:






  ‘1. | Plastic materials and articles shall not release the following substances in quantities exceeding the specific migration limits below: | Aluminium = 1 mg/kg food or food simulant |
| --- | --- | --- | --- | --- |

(2)

Annex II is amended as follows:

(a)

point 1 is replaced by the following:

‘1.

Aluminium = 1 mg/kg food or food simulant

| | Barium = 1 mg/kg food or food simulant |
| --- | --- |

Barium = 1 mg/kg food or food simulant

| | Cobalt = 0,05 mg/kg food or food simulant |
| --- | --- |

Cobalt = 0,05 mg/kg food or food simulant

| | Copper = 5 mg/kg food or food simulant |
| --- | --- |

Copper = 5 mg/kg food or food simulant

| | Iron = 48 mg/kg food or food simulant |
| --- | --- |

Iron = 48 mg/kg food or food simulant

| | Lithium = 0,6 mg/kg food or food simulant |
| --- | --- |

Lithium = 0,6 mg/kg food or food simulant

| | Manganese = 0,6 mg/kg food or food simulant |
| --- | --- |

Manganese = 0,6 mg/kg food or food simulant

| | Zinc = 5 mg/kg food or food simulant.’; |
| --- | --- |

Zinc = 5 mg/kg food or food simulant.’;

| (b) | point 2 is replaced by the following:






  ‘2. | Primary aromatic amines which are not listed in Table 1 of Annex I shall not migrate or shall not otherwise be released from plastic materials and articles into food or food simulant in accordance with Article 11(4). The detection limit referred to in the second subparagraph of Article 11(4) applies to the sum of primary aromatic amines released.’; |
| --- | --- | --- |

(b)

point 2 is replaced by the following:

‘2.

| (3) | Annex III is amended as follows:






  (a) | Table 1 ‘List of food simulants’ is replaced in its entirety by the following:

  ‘Table 1


  List of food simulants







  Food simulant | Abbreviation |
| --- | --- | --- | --- |
| Ethanol 10 % (v/v) | Food simulant A |
| Acetic acid 3 % (w/v) | Food simulant B |
| Ethanol 20 % (v/v) | Food simulant C |
| Ethanol 50 % (v/v) | Food simulant D1 |
| Any vegetable oil containing less than 1 % unsaponifiable matter | Food simulant D2 |
| poly(2,6-diphenyl-p-phenylene oxide), particle size 60-80 mesh, pore size 200 nm | Food simulant E’ |

(3)

Annex III is amended as follows:

(a)

Table 1 ‘List of food simulants’ is replaced in its entirety by the following:

‘Table 1

List of food simulants

Food simulant

Abbreviation

Ethanol 10 % (v/v)

Food simulant A

Acetic acid 3 % (w/v)

Food simulant B

Ethanol 20 % (v/v)

Food simulant C

Ethanol 50 % (v/v)

Food simulant D1

Any vegetable oil containing less than 1 % unsaponifiable matter

Food simulant D2

poly(2,6-diphenyl-p-phenylene oxide), particle size 60-80 mesh, pore size 200 nm

Food simulant E’

| (b) | point 3, excluding Table 2, is replaced by the following:
  ‘3.   Specific assignment of food simulants to foods for migration testing of materials and articles not yet in contact with food

  For testing migration from materials and articles not yet in contact with food the food simulants that corresponds to a certain food category shall be chosen according to Table 2 below.
  For testing migration from materials and articles intended to come into contact with foods not listed in Table 2 below, or a combination of foods, the general food simulant assignments in point 2 shall be used for specific migration testing, and for overall migration testing the food simulant assignments in point 4 shall be applicable.
  Table 2 contains the following information:






  — | Column 1 (Reference number): contains the reference number of the food category |
| --- | --- | --- |

(b)

point 3, excluding Table 2, is replaced by the following:

‘3.   Specific assignment of food simulants to foods for migration testing of materials and articles not yet in contact with food

For testing migration from materials and articles not yet in contact with food the food simulants that corresponds to a certain food category shall be chosen according to Table 2 below.

For testing migration from materials and articles intended to come into contact with foods not listed in Table 2 below, or a combination of foods, the general food simulant assignments in point 2 shall be used for specific migration testing, and for overall migration testing the food simulant assignments in point 4 shall be applicable.

Table 2 contains the following information:

—

Column 1 (Reference number): contains the reference number of the food category

| — | Column 2 (Description of food): contains a description of the foods covered by the food category |
| --- | --- |

—

Column 2 (Description of food): contains a description of the foods covered by the food category

| — | Column 3 (Food simulants): contains sub-columns for each of the food simulants |
| --- | --- |

—

Column 3 (Food simulants): contains sub-columns for each of the food simulants

The food simulant for which a cross is contained in the respective sub-column of column 3 shall be used when testing migration of materials and articles not yet in contact with food.

For food categories where in sub-column D2 or E the cross is followed by an oblique stroke and a figure, the migration test result shall be corrected by dividing the result by this figure. The corrected test result shall then be compared to the migration limit to establish compliance. The test results for substances that shall not migrate in detectable quantities shall not be corrected in this way.

For food category 01.04 food simulant D2 shall be replaced by 95 % ethanol.

For food categories where in sub-column B the cross is followed by (*) the testing in food simulant B can be omitted if the food has a pH of more than 4,5.

For food categories where in sub-column D2 the cross is followed by (**) the testing in food simulant D2 can be omitted if it can be demonstrated that there is no “fatty contact” with the plastic food contact material.’;

| (c) | Table 2 is amended as follows:






  (i) | the entries with reference numbers 04.01 and 04.04 are replaced by the following:












  ‘04.01 | Fruit, fresh or chilled: | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| A. | unpeeled and uncut |

(c)

Table 2 is amended as follows:

(i)

the entries with reference numbers 04.01 and 04.04 are replaced by the following:

‘04.01

Fruit, fresh or chilled:

A.

unpeeled and uncut

X/10’

| B. | peeled and/or cut |
| --- | --- |

B.

peeled and/or cut

X

X (*)

‘04.04

Vegetables, fresh or chilled:

| A. | unpeeled and uncut |
| --- | --- |

A.

unpeeled and uncut

X/10’

| B. | peeled and/or cut |
| --- | --- |

B.

peeled and/or cut

X

X (*)

| (ii) | in the entry with reference number 04.05 is replaced by the following:













  ‘04.05 | Processed vegetables:






  A. | Dried or dehydrated vegetables whole, sliced or in the form of flour or powder. |
| --- | --- | --- | --- |

(ii)

in the entry with reference number 04.05 is replaced by the following:

‘04.05

Processed vegetables:

A.

Dried or dehydrated vegetables whole, sliced or in the form of flour or powder.

X’

| B. | (obsolete) |
| --- | --- |

B.

(obsolete)

| C. | Vegetables in the form of purée, preserves, pastes or in its own juice (including pickled and in brine). |
| --- | --- |

C.

Vegetables in the form of purée, preserves, pastes or in its own juice (including pickled and in brine).

X (*)

X

| D. | Preserved vegetables: |
| --- | --- |

D.

Preserved vegetables:

| I. | In an oily medium |
| --- | --- |

I.

In an oily medium

X

X

| II. | In an alcoholic medium |
| --- | --- |

II.

In an alcoholic medium

X

| (d) | the following point 5 is added:
  ‘5.   General derogation to the assignment of food simulants

  By derogation from the assignments of food simulants in points 2 to 4 of this Annex, where testing with several food simulants is required, a single food simulant shall be sufficient if on the basis of evidence acquired using generally recognised scientific methods this food simulant is shown to be the most severe food simulant for the particular material or article being tested under the applicable time and temperature conditions selected in accordance with Chapters 2 and 3 of Annex V.
  The scientific basis on which this derogation is used shall in such cases form part of the documentation required under Article 16 of this Regulation.’; |
| --- | --- |

(d)

the following point 5 is added:

‘5.   General derogation to the assignment of food simulants

By derogation from the assignments of food simulants in points 2 to 4 of this Annex, where testing with several food simulants is required, a single food simulant shall be sufficient if on the basis of evidence acquired using generally recognised scientific methods this food simulant is shown to be the most severe food simulant for the particular material or article being tested under the applicable time and temperature conditions selected in accordance with Chapters 2 and 3 of Annex V.

The scientific basis on which this derogation is used shall in such cases form part of the documentation required under Article 16 of this Regulation.’;

| (4) | in Annex IV, point (5) is replaced by the following:






  ‘(5) | confirmation that the plastic materials or articles, products from intermediate stages of manufacture or the substances meet the relevant requirements laid down in this Regulation and in Article 3, 11(5), 15 and 17 of Regulation (EC) No 1935/2004;’; |
| --- | --- | --- |

(4)

in Annex IV, point (5) is replaced by the following:

‘(5)

| (5) | Annex V is amended as follows:






  (a) | Section 1.4 of Chapter 1 is replaced by the following:
  ‘1.4.   Account of substances originating from other sources

  In case there is evidence linked to the food sample that a substance partially or wholly originates from a source or sources other than the material or article for which the test is being carried out, the test results shall be corrected for the amount of that substance originating from the other source or sources before comparing the test results to the applicable specific migration limit’; |
| --- | --- | --- |

(5)

Annex V is amended as follows:

(a)

Section 1.4 of Chapter 1 is replaced by the following:

‘1.4.   Account of substances originating from other sources

In case there is evidence linked to the food sample that a substance partially or wholly originates from a source or sources other than the material or article for which the test is being carried out, the test results shall be corrected for the amount of that substance originating from the other source or sources before comparing the test results to the applicable specific migration limit’;

| (b) | in Section 2.1.3 of Chapter 2, the text before Table 1 is replaced in its entirety by the following:

  ‘The sample shall be placed in contact with the food simulant in a manner representing the worst of the foreseeable conditions of use as regard contact time in Table 1 and as regard contact temperature in Table 2.
  By way of derogation to the conditions set out in Tables 1 and 2, the following rules apply:






  (i) | If it is found that carrying out the tests under the combination of contact conditions specified in Tables 1 and 2 causes physical or other changes in the test specimen which do not occur under worst foreseeable conditions of use of the material or article under examination, the migration tests shall be carried out under the worst foreseeable conditions of use in which these physical or other changes do not take place; |
| --- | --- | --- |

(b)

in Section 2.1.3 of Chapter 2, the text before Table 1 is replaced in its entirety by the following:

‘The sample shall be placed in contact with the food simulant in a manner representing the worst of the foreseeable conditions of use as regard contact time in Table 1 and as regard contact temperature in Table 2.

By way of derogation to the conditions set out in Tables 1 and 2, the following rules apply:

(i)

If it is found that carrying out the tests under the combination of contact conditions specified in Tables 1 and 2 causes physical or other changes in the test specimen which do not occur under worst foreseeable conditions of use of the material or article under examination, the migration tests shall be carried out under the worst foreseeable conditions of use in which these physical or other changes do not take place;

| (ii) | if the material or article during it intended use is subjected only to precisely controlled time and temperature conditions in food processing equipment, either as part of food packaging or as part of the processing equipment itself, testing may be done using the worst foreseeable contact conditions that can occur during the processing of the food in that equipment; |
| --- | --- |

(ii)

if the material or article during it intended use is subjected only to precisely controlled time and temperature conditions in food processing equipment, either as part of food packaging or as part of the processing equipment itself, testing may be done using the worst foreseeable contact conditions that can occur during the processing of the food in that equipment;

| (iii) | if the material or article is intended to be employed only for hot-fill conditions, only a 2-hour test at 70 °C shall be carried out. However, if the material or article is intended to be used also for storage at room temperature or below, the test conditions set out in Tables 1 and 2 of this Section or in Section 2.1.4 of this Chapter apply depending on the duration of storage. |
| --- | --- |

(iii)

if the material or article is intended to be employed only for hot-fill conditions, only a 2-hour test at 70 °C shall be carried out. However, if the material or article is intended to be used also for storage at room temperature or below, the test conditions set out in Tables 1 and 2 of this Section or in Section 2.1.4 of this Chapter apply depending on the duration of storage.

If the testing conditions representative for the worst foreseeable conditions of intended use of the material or article, are not technically feasible in food simulant D2, migration tests shall be done using ethanol 95 % and isooctane. In addition a migration test shall be done using food simulant E if the temperature under the worst foreseeable conditions of intended use exceeds 100 °C. The test that results in the highest specific migration shall be used to establish compliance with this Regulation.’;

| (c) | in Table 1, the title of the table is replaced by the following:


  ‘Selection of test time’; |
| --- | --- |

(c)

in Table 1, the title of the table is replaced by the following:

‘Selection of test time’;

| (d) | in Table 1, the title of column 2 is replaced by the following:

  ‘Time to be selected for testing’; |
| --- | --- |

(d)

in Table 1, the title of column 2 is replaced by the following:

‘Time to be selected for testing’;

| (e) | Table 2 is replaced by the following:

  ‘Table 2


  Selection of test temperature







  Worst foreseeable contact temperature | Contact temperature to be selected for testing |
| --- | --- | --- |
| T ≤ 5 °C | 5 °C |
| 5 °C < T ≤ 20 °C | 20 °C |
| 20 °C < T ≤ 40 °C | 40 °C |
| 40 °C < T ≤ 70 °C | 70 °C |
| 70 °C < T ≤ 100 °C | 100 °C or reflux temperature |
| 100 °C < T ≤ 121 °C | 121 °C (*1) |
| 121 °C < T ≤ 130 °C | 130 °C (*1) |
| 130 °C < T ≤ 150 °C | 150 °C (*1) |
| 150 °C < T < 175 °C | 175 °C (*1) |
| 175 °C < T ≤ 200 °C | 200 °C (*1) |
| T > 200 °C | 225 °C (*1) |

(e)

Table 2 is replaced by the following:

‘Table 2

Selection of test temperature

Worst foreseeable contact temperature

Contact temperature to be selected for testing

T ≤ 5 °C

5 °C

5 °C < T ≤ 20 °C

20 °C

20 °C < T ≤ 40 °C

40 °C

40 °C < T ≤ 70 °C

70 °C

70 °C < T ≤ 100 °C

100 °C or reflux temperature

100 °C < T ≤ 121 °C

121 °C (*1)

121 °C < T ≤ 130 °C

130 °C (*1)

130 °C < T ≤ 150 °C

150 °C (*1)

150 °C < T < 175 °C

175 °C (*1)

175 °C < T ≤ 200 °C

200 °C (*1)

T > 200 °C

225 °C (*1)

| (f) | Section 2.1.4 of Chapter 2 is replaced by the following:
  ‘2.1.4.   Specific conditions for contact times above 30 days at room temperature and below

  For contact times above 30 days (long term) at room temperature and below, the specimen shall be tested in accelerated test conditions at elevated temperature for a maximum of 10 days at 60 °C (*2).






  (a) | Testing for 10 days at 20 °C shall cover all storage times at frozen condition. This test can include the freezing and defrosting processes if labelling or other instructions ensure that 20 °C is not exceeded and the total time above – 15 °C does not exceed 1 day in total during the foreseeable intended use of the material or article. |
| --- | --- | --- |

(f)

Section 2.1.4 of Chapter 2 is replaced by the following:

‘2.1.4.   Specific conditions for contact times above 30 days at room temperature and below

For contact times above 30 days (long term) at room temperature and below, the specimen shall be tested in accelerated test conditions at elevated temperature for a maximum of 10 days at 60 °C (*2).

(a)

Testing for 10 days at 20 °C shall cover all storage times at frozen condition. This test can include the freezing and defrosting processes if labelling or other instructions ensure that 20 °C is not exceeded and the total time above – 15 °C does not exceed 1 day in total during the foreseeable intended use of the material or article.

| (b) | Testing for 10 days at 40 °C shall cover all storage times at refrigerated and frozen conditions including hot-fill conditions and/or heating up to 70 °C ≤ T ≤ 100 °C for maximum t = 120/2^((T-70)/10) minutes. |
| --- | --- |

(b)

Testing for 10 days at 40 °C shall cover all storage times at refrigerated and frozen conditions including hot-fill conditions and/or heating up to 70 °C ≤ T ≤ 100 °C for maximum t = 120/2^((T-70)/10) minutes.

| (c) | Testing for 10 days at 50 °C shall cover all storage times of up to 6 months at room temperature, including hot-fill conditions and/or heating up to 70 °C ≤ T ≤ 100 °C for maximum t = 120/2^((T-70)/10) minutes. |
| --- | --- |

(c)

Testing for 10 days at 50 °C shall cover all storage times of up to 6 months at room temperature, including hot-fill conditions and/or heating up to 70 °C ≤ T ≤ 100 °C for maximum t = 120/2^((T-70)/10) minutes.

| (d) | Testing for 10 days at 60 °C shall cover storage above 6 months at room temperature and below, including hot-fill conditions and/or heating up to 70 °C ≤ T ≤ 100 °C for maximum t = 120/2^((T-70)/10) minutes. |
| --- | --- |

(d)

Testing for 10 days at 60 °C shall cover storage above 6 months at room temperature and below, including hot-fill conditions and/or heating up to 70 °C ≤ T ≤ 100 °C for maximum t = 120/2^((T-70)/10) minutes.

| (e) | For storage at room temperature the testing conditions can be reduced to 10 days at 40 °C if it is shown by scientific evidence that migration of the respective substance in the polymer has reached equilibration under this test condition. |
| --- | --- |

(e)

For storage at room temperature the testing conditions can be reduced to 10 days at 40 °C if it is shown by scientific evidence that migration of the respective substance in the polymer has reached equilibration under this test condition.

| (f) | For worst foreseeable conditions of intended use not covered by the test conditions set out in points (a) to (e), the testing time and temperature conditions shall be based on the following formula:
  t2 = t1 * Exp (9627 * (1/T2 – 1/T1)) | t1 is the contact time |
| --- | --- | --- |

(f)

For worst foreseeable conditions of intended use not covered by the test conditions set out in points (a) to (e), the testing time and temperature conditions shall be based on the following formula:

t2 = t1 * Exp (9627 * (1/T2 – 1/T1))

t1 is the contact time

| | t2 is the testing time |
| --- | --- |

t2 is the testing time

| | T1 is the contact temperature in Kelvin. For room temperature storage this is set at 298K (25 °C). For refrigerated conditions it is set at 278K (5 °C). For frozen storage it is set at 258 K (– 15 °C). |
| --- | --- |

T1 is the contact temperature in Kelvin. For room temperature storage this is set at 298K (25 °C). For refrigerated conditions it is set at 278K (5 °C). For frozen storage it is set at 258 K (– 15 °C).

| | T2 is the testing temperature in Kelvin. |
| --- | --- |

T2 is the testing temperature in Kelvin.

(*2)  When testing at these accelerated test conditions the test specimen shall not undergo any physical or other changes compared to the real conditions of use, including a phase transition of the material.’;"

| (g) | the first paragraph of Section 2.1.5 of Chapter 2 is replaced by the following:

  ‘If a material or article is intended for different applications covering different combinations of contact time and temperature the testing shall be restricted to the test conditions which are recognised to be the most severe on the basis of scientific evidence.’; |
| --- | --- |

(g)

the first paragraph of Section 2.1.5 of Chapter 2 is replaced by the following:

‘If a material or article is intended for different applications covering different combinations of contact time and temperature the testing shall be restricted to the test conditions which are recognised to be the most severe on the basis of scientific evidence.’;

| (h) | in Section 2.1.6 of Chapter 2, the third paragraph is replaced by the following:

  ‘The material or article shall respect the specific migration limit already in the first test for substances that are prohibited from migrating or from being released in detectable quantities under Article 11(4).’; |
| --- | --- |

(h)

in Section 2.1.6 of Chapter 2, the third paragraph is replaced by the following:

‘The material or article shall respect the specific migration limit already in the first test for substances that are prohibited from migrating or from being released in detectable quantities under Article 11(4).’;

| (i) | the first paragraph of Section 2.2 of Chapter 2 is replaced by the following:

  ‘To screen if a material or article complies with the migration limits any of the following approaches can be applied which are considered at least as severe as the verification method described in section 2.1.’; |
| --- | --- |

(i)

the first paragraph of Section 2.2 of Chapter 2 is replaced by the following:

‘To screen if a material or article complies with the migration limits any of the following approaches can be applied which are considered at least as severe as the verification method described in section 2.1.’;

| (j) | Section 2.2.3 of Chapter 2 is replaced by the following:
  ‘2.2.3.   Migration modelling

  To screen for specific migration, the migration potential can be calculated based on the residual content of the substance in the material or article applying generally recognised diffusion models based on scientific evidence that are constructed in a way that must never underestimate real levels of migration.’; |
| --- | --- |

(j)

Section 2.2.3 of Chapter 2 is replaced by the following:

‘2.2.3.   Migration modelling

To screen for specific migration, the migration potential can be calculated based on the residual content of the substance in the material or article applying generally recognised diffusion models based on scientific evidence that are constructed in a way that must never underestimate real levels of migration.’;

| (k) | Section 2.2.4 of Chapter 2 is replaced by the following:
  ‘2.2.4.   Food simulant substitutes

  To screen for specific migration, food simulants can be replaced by substitute food simulants if it is based on scientific evidence that the substitute food simulants result in migration that is at least as severe as migration that would be obtained using the food simulants specified in Section 2.1.2’; |
| --- | --- |

(k)

Section 2.2.4 of Chapter 2 is replaced by the following:

‘2.2.4.   Food simulant substitutes

To screen for specific migration, food simulants can be replaced by substitute food simulants if it is based on scientific evidence that the substitute food simulants result in migration that is at least as severe as migration that would be obtained using the food simulants specified in Section 2.1.2’;

| (l) | in Section 2.2 of Chapter 2, the following paragraph 2.2.5 is added:
  ‘2.2.5.   Single test for successive combinations of time and temperature

  If the material or article is intended for a food contact application where it is successively subject to two or more time and temperature combinations, a single migration contact test time can be defined based on the highest contact test temperature from Section 2.1.3 and/or 2.1.4 by using the equation as described in point (f) of Section 2.1.4. The reasoning justifying that the resulting single test is at least as severe as the combined time and temperature combinations shall be documented in the supporting documentation provided for in Article 16.’; |
| --- | --- |

(l)

in Section 2.2 of Chapter 2, the following paragraph 2.2.5 is added:

‘2.2.5.   Single test for successive combinations of time and temperature

If the material or article is intended for a food contact application where it is successively subject to two or more time and temperature combinations, a single migration contact test time can be defined based on the highest contact test temperature from Section 2.1.3 and/or 2.1.4 by using the equation as described in point (f) of Section 2.1.4. The reasoning justifying that the resulting single test is at least as severe as the combined time and temperature combinations shall be documented in the supporting documentation provided for in Article 16.’;

| (m) | Table 3 in Chapter 3 is replaced by the following:

  ‘Table 3


  Standardised conditions for testing the overall migration








  Column 1 | Column 2 | Column 3 |
| --- | --- | --- | --- |
| Test number | Contact time in days [d] or hours [h] at contact temperature in [°C] for testing | Intended food contact conditions |
| OM1 | 10 d at 20 °C | Any food contact at frozen and refrigerated conditions. |
| OM2 | 10 d at 40 °C | Any long term storage at room temperature or below, including when packaged under hot-fill conditions, and/or heating up to a temperature T where 70 °C ≤ T ≤ 100 °C for a maximum of t = 120/2^((T-70)/10) minutes. |
| OM3 | 2 h at 70 °C | Any food contact conditions that include hot-fill and/or heating up to a temperature T where 70 °C ≤ T ≤ 100 °C for maximum of t = 120/2^((T-70)/10) minutes, which are not followed by long term room temperature or refrigerated storage. |
| OM4 | 1 h at 100 °C | High temperature applications for all types of food at temperature up to 100 °C. |
| OM5 | 2 h at 100 °C or at reflux or alternatively 1 h at 121 °C | High temperature applications up to 121 °C. |
| OM6 | 4 h at 100 °C or at reflux | Any food contact conditions at a temperature exceeding 40 °C, and with foods for which point 4 of Annex III assigns simulants A, B, C or D1. |
| OM7 | 2 h at 175 °C | High temperature applications with fatty foods exceeding the conditions of OM5.’ |

(m)

Table 3 in Chapter 3 is replaced by the following:

‘Table 3

Standardised conditions for testing the overall migration

Column 1

Column 2

Column 3

Test number

Contact time in days [d] or hours [h] at contact temperature in [°C] for testing

Intended food contact conditions

OM1

10 d at 20 °C

Any food contact at frozen and refrigerated conditions.

OM2

10 d at 40 °C

Any long term storage at room temperature or below, including when packaged under hot-fill conditions, and/or heating up to a temperature T where 70 °C ≤ T ≤ 100 °C for a maximum of t = 120/2^((T-70)/10) minutes.

OM3

2 h at 70 °C

Any food contact conditions that include hot-fill and/or heating up to a temperature T where 70 °C ≤ T ≤ 100 °C for maximum of t = 120/2^((T-70)/10) minutes, which are not followed by long term room temperature or refrigerated storage.

OM4

1 h at 100 °C

High temperature applications for all types of food at temperature up to 100 °C.

OM5

2 h at 100 °C or at reflux or alternatively 1 h at 121 °C

High temperature applications up to 121 °C.

OM6

4 h at 100 °C or at reflux

Any food contact conditions at a temperature exceeding 40 °C, and with foods for which point 4 of Annex III assigns simulants A, B, C or D1.

OM7

2 h at 175 °C

High temperature applications with fatty foods exceeding the conditions of OM5.’

| (n) | in Section 3.1 of Chapter 3, the paragraphs below Table 3 are replaced by the following:

  ‘Test OM7 also covers food contact conditions described for OM1, OM2, OM3, OM4 and OM5. It represents the worst case conditions for food simulant D2 in contact with non-polyolefins. In case it is technically not feasible to perform OM 7 with food simulant D2 the test can be replaced as set out in Section 3.2.
  Test OM6 covers also food contact conditions described for OM1, OM2, OM3, OM4 and OM5. It represents worst case conditions for food simulants A, B, C and D1 in contact with non-polyolefins.
  Test OM5 covers also food contact conditions described for OM1, OM2, OM3, and OM4. It represents the worst case conditions for all food simulants in contact with polyolefins.
  Test OM2 covers also food contact conditions described for OM1 and OM3.’; |
| --- | --- |

(n)

in Section 3.1 of Chapter 3, the paragraphs below Table 3 are replaced by the following:

‘Test OM7 also covers food contact conditions described for OM1, OM2, OM3, OM4 and OM5. It represents the worst case conditions for food simulant D2 in contact with non-polyolefins. In case it is technically not feasible to perform OM 7 with food simulant D2 the test can be replaced as set out in Section 3.2.

Test OM6 covers also food contact conditions described for OM1, OM2, OM3, OM4 and OM5. It represents worst case conditions for food simulants A, B, C and D1 in contact with non-polyolefins.

Test OM5 covers also food contact conditions described for OM1, OM2, OM3, and OM4. It represents the worst case conditions for all food simulants in contact with polyolefins.

Test OM2 covers also food contact conditions described for OM1 and OM3.’;

| (o) | Section 3.2 of Chapter 3 is replaced by the following:
  ‘3.2.   Substitute overall migration tests for tests with food simulant D2

  If it is not technically feasible to perform one or more of the tests OM1 to OM6 in food simulant D2, migration tests shall be done using ethanol 95 % and isooctane. In addition a test shall be done using food simulant E in case the worst foreseeable conditions of use exceed 100 °C. The test that results in the highest specific migration shall be used to establish compliance with this Regulation.
  In case it is technically not feasible to perform OM7 with food simulant D2 the test can be replaced by either test OM8 or test OM9 as appropriate given the intended or foreseeable use. Both tests involve testing at two test conditions for which a new test sample shall be used for each test. The test condition that results in the highest overall migration shall be used to establish compliance with this Regulation.








  Test number | Test conditions | Intended food contact conditions | Covers the intended food contact conditions described in |
| --- | --- | --- | --- | --- |
| OM8 | Food simulant E for 2 hours at 175 °C and food simulant D2 for 2 hours at 100 °C | High temperature applications only | OM1, OM3, OM4, OM5 and OM6 |
| OM9 | Food simulant E for 2 hours at 175 °C and food simulant D2 for 10 days at 40 °C | High temperature applications including long term storage at room temperature | OM1, OM2, OM3, OM4, OM5 and OM6’ |

(o)

Section 3.2 of Chapter 3 is replaced by the following:

‘3.2.   Substitute overall migration tests for tests with food simulant D2

If it is not technically feasible to perform one or more of the tests OM1 to OM6 in food simulant D2, migration tests shall be done using ethanol 95 % and isooctane. In addition a test shall be done using food simulant E in case the worst foreseeable conditions of use exceed 100 °C. The test that results in the highest specific migration shall be used to establish compliance with this Regulation.

In case it is technically not feasible to perform OM7 with food simulant D2 the test can be replaced by either test OM8 or test OM9 as appropriate given the intended or foreseeable use. Both tests involve testing at two test conditions for which a new test sample shall be used for each test. The test condition that results in the highest overall migration shall be used to establish compliance with this Regulation.

Test number

Test conditions

Intended food contact conditions

Covers the intended food contact conditions described in

OM8

Food simulant E for 2 hours at 175 °C and food simulant D2 for 2 hours at 100 °C

High temperature applications only

OM1, OM3, OM4, OM5 and OM6

OM9

Food simulant E for 2 hours at 175 °C and food simulant D2 for 10 days at 40 °C

High temperature applications including long term storage at room temperature

OM1, OM2, OM3, OM4, OM5 and OM6’

| (p) | Section 3.3 of Chapter 3 is replaced by the following:
  ‘3.3.   Verification of compliance

  3.3.1.   Single use articles and materials

  At the end of the prescribed contact time, to verify compliance the overall migration is analysed in the food simulant using an analytical method in accordance with the requirements of Article 11 of Regulation (EC) No 882/2004.
  3.3.2.   Repeated use articles and materials

  The applicable overall migration test shall be carried out three times on a single sample using another portion of food simulant on each occasion. The migration shall be determined using an analytical method in accordance with the requirements of Article 11 of Regulation (EC) No 882/2004. The overall migration in the second test shall be lower than in the first test, and the overall migration in the third test shall be lower than in the second test. Compliance with the overall migration limit shall be verified on the basis of the level of the overall migration found in the third test.
  If it is not technically feasible to test the same sample three times, such as when testing in oil, the overall migration test can be carried out by testing different samples for three different periods of time lasting one, two and three times the applicable contact test time. The difference between the third and the second test results shall be considered to represent the overall migration. Compliance shall be verified on the basis of this difference, which shall not exceed the overall migration limit. In addition, it shall not be higher than the first result and the difference between the second and the first test results.
  By derogation from the first paragraph, if, on the basis of scientific evidence, it is established that for the material or article being tested the overall migration does not increase in the second and third tests and if the overall migration limit is not exceeded in the first test, the first test alone shall be sufficient.’; |
| --- | --- |

(p)

Section 3.3 of Chapter 3 is replaced by the following:

‘3.3.   Verification of compliance

3.3.1.   Single use articles and materials

At the end of the prescribed contact time, to verify compliance the overall migration is analysed in the food simulant using an analytical method in accordance with the requirements of Article 11 of Regulation (EC) No 882/2004.

3.3.2.   Repeated use articles and materials

The applicable overall migration test shall be carried out three times on a single sample using another portion of food simulant on each occasion. The migration shall be determined using an analytical method in accordance with the requirements of Article 11 of Regulation (EC) No 882/2004. The overall migration in the second test shall be lower than in the first test, and the overall migration in the third test shall be lower than in the second test. Compliance with the overall migration limit shall be verified on the basis of the level of the overall migration found in the third test.

If it is not technically feasible to test the same sample three times, such as when testing in oil, the overall migration test can be carried out by testing different samples for three different periods of time lasting one, two and three times the applicable contact test time. The difference between the third and the second test results shall be considered to represent the overall migration. Compliance shall be verified on the basis of this difference, which shall not exceed the overall migration limit. In addition, it shall not be higher than the first result and the difference between the second and the first test results.

By derogation from the first paragraph, if, on the basis of scientific evidence, it is established that for the material or article being tested the overall migration does not increase in the second and third tests and if the overall migration limit is not exceeded in the first test, the first test alone shall be sufficient.’;

| (q) | the first paragraph of Section 3.4 of Chapter 3 is replaced by the following: ‘To screen if a material or article complies with the migration limits, any of the following approaches can be applied which are considered at least as severe as the verification method described in Sections 3.1 and 3.2.’; |
| --- | --- |

(q)

the first paragraph of Section 3.4 of Chapter 3 is replaced by the following: ‘To screen if a material or article complies with the migration limits, any of the following approaches can be applied which are considered at least as severe as the verification method described in Sections 3.1 and 3.2.’;

| (r) | Section 3.4.2 of Chapter 3 is replaced by the following:
  ‘3.4.2.   Food simulant substitutes

  To screen for overall migration, food simulants can be replaced if based on scientific evidence the substitute food simulants result in migration that is at least as severe as migration that would be obtained using the food simulants specified in Annex III.’; |
| --- | --- |

(r)

Section 3.4.2 of Chapter 3 is replaced by the following:

‘3.4.2.   Food simulant substitutes

To screen for overall migration, food simulants can be replaced if based on scientific evidence the substitute food simulants result in migration that is at least as severe as migration that would be obtained using the food simulants specified in Annex III.’;

| (s) | in Section 4.1 of Chapter 4, the fifth paragraph is replaced by the following:

  ‘The specific migration in food or food simulant shall not exceed 60 mg/kg food before application of the FRF.’; |
| --- | --- |

(s)

in Section 4.1 of Chapter 4, the fifth paragraph is replaced by the following:

‘The specific migration in food or food simulant shall not exceed 60 mg/kg food before application of the FRF.’;

| (t) | in Section 4.1 of Chapter 4, the following paragraph is added:

  ‘When testing is performed in food simulant D2 or E and when the test results are corrected in application of the correction factor laid down in Table 2 of Annex III this correction may be applied in combination with the FRF by multiplying both factors. The combined correction factor shall not exceed 5, unless the correction factor laid down in Table 2 of Annex III exceeds 5.’; |
| --- | --- |

(t)

in Section 4.1 of Chapter 4, the following paragraph is added:

‘When testing is performed in food simulant D2 or E and when the test results are corrected in application of the correction factor laid down in Table 2 of Annex III this correction may be applied in combination with the FRF by multiplying both factors. The combined correction factor shall not exceed 5, unless the correction factor laid down in Table 2 of Annex III exceeds 5.’;

| (u) | Sections 4.2 and 4.3 of Chapter 4 are deleted. |
| --- | --- |

(u)

Sections 4.2 and 4.3 of Chapter 4 are deleted.

---

(*2)  When testing at these accelerated test conditions the test specimen shall not undergo any physical or other changes compared to the real conditions of use, including a phase transition of the material.’;”

---

(*1)  This temperature shall be used only for food simulants D2 and E. For applications heated under pressure, migration testing under pressure at the relevant temperature may be performed. For food simulants A, B, C or D1 the test may be replaced by a test at 100 °C or at reflux temperature for duration of four times the time selected according to the conditions in Table 1.’

---

| 25.8.2016 | EN | Official Journal of the European Union | L 230/43 |
| --- | --- | --- | --- |

25.8.2016

EN

Official Journal of the European Union

L 230/43

---

COMMISSION IMPLEMENTING REGULATION (EU) 2016/1417

of 24 August 2016

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, 24 August 2016.

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 | AR | 186,0 |
| MA | 149,6 |
| ZZ | 167,8 |
| 0707 00 05 | TR | 158,2 |
| ZZ | 158,2 |
| 0709 93 10 | TR | 144,5 |
| ZZ | 144,5 |
| 0805 50 10 | AR | 172,4 |
| CL | 147,5 |
| MA | 95,0 |
| TR | 154,0 |
| UY | 186,1 |
| ZA | 153,0 |
| ZZ | 151,3 |
| 0806 10 10 | EG | 222,1 |
| TR | 133,9 |
| ZZ | 178,0 |
| 0808 10 80 | AR | 161,5 |
| BR | 102,1 |
| CL | 154,7 |
| CN | 160,3 |
| NZ | 139,0 |
| US | 141,5 |
| UY | 93,1 |
| ZA | 86,7 |
| ZZ | 129,9 |
| 0808 30 90 | AR | 91,8 |
| CL | 120,4 |
| TR | 138,2 |
| ZA | 99,0 |
| ZZ | 112,4 |
| 0809 30 10 , 0809 30 90 | TR | 130,8 |
| ZZ | 130,8 |

(EUR/100 kg)

CN code

Third country code (1)

Standard import value

0702 00 00

AR

186,0

MA

149,6

ZZ

167,8

0707 00 05

TR

158,2

ZZ

158,2

0709 93 10

TR

144,5

ZZ

144,5

0805 50 10

AR

172,4

CL

147,5

MA

95,0

TR

154,0

UY

186,1

ZA

153,0

ZZ

151,3

0806 10 10

EG

222,1

TR

133,9

ZZ

178,0

0808 10 80

AR

161,5

BR

102,1

CL

154,7

CN

160,3

NZ

139,0

US

141,5

UY

93,1

ZA

86,7

ZZ

129,9

0808 30 90

AR

91,8

CL

120,4

TR

138,2

ZA

99,0

ZZ

112,4

0809 30 10 , 0809 30 90

TR

130,8

ZZ

130,8

---

(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’.

---

III Other acts

EUROPEAN ECONOMIC AREA

| 25.8.2016 | EN | Official Journal of the European Union | L 230/45 |
| --- | --- | --- | --- |

25.8.2016

EN

Official Journal of the European Union

L 230/45

---

EFTA SURVEILLANCE AUTHORITY DECISION

No 83/15/COL

of 18 March 2015

concerning the consistency of certain targets included in the national or functional airspace block plans submitted pursuant to Regulation (EC) No 549/2004 of the European Parliament and of the Council with the Union-wide performance targets for the second reference period [2016/1418]

THE EFTA SURVEILLANCE AUTHORITY,

Having regard to the Act mentioned at point 66t of Annex XIII to the EEA Agreement (Regulation (EC) No 549/2004 of the European Parliament and of the Council of 10 March 2004 laying down the framework for the creation of the single European sky (‘the Framework Regulation’) (1)) as adapted to the EEA Agreement by Protocol 1 thereto, and in particular Article 11(3)(c) thereof, and

Whereas:

| (1) | Pursuant to the Framework Regulation, the Kingdom of Norway (‘Norway’) is to adopt national or functional airspace block (‘FAB’) plans, including binding national targets or targets at the level of FABs, ensuring consistency with the Union-wide performance targets. That Regulation also provides that the EFTA Surveillance Authority (‘the Authority’) is to assess the consistency of those targets on the basis of the assessment criteria referred to in point (d) of its Article 11(6) and that the Authority may decide to issue recommendations in case it identifies that those criteria have not been met. Detailed rules in this regard have been set out in the act mentioned at point 66xf of Annex XIII to the EEA Agreement (Commission Implementing Regulation (EU) No 390/2013 (2)) (‘the Performance Regulation’) as adapted to the EEA Agreement by Protocol 1 thereto. |
| --- | --- |

(1)

Pursuant to the Framework Regulation, the Kingdom of Norway (‘Norway’) is to adopt national or functional airspace block (‘FAB’) plans, including binding national targets or targets at the level of FABs, ensuring consistency with the Union-wide performance targets. That Regulation also provides that the EFTA Surveillance Authority (‘the Authority’) is to assess the consistency of those targets on the basis of the assessment criteria referred to in point (d) of its Article 11(6) and that the Authority may decide to issue recommendations in case it identifies that those criteria have not been met. Detailed rules in this regard have been set out in the act mentioned at point 66xf of Annex XIII to the EEA Agreement (Commission Implementing Regulation (EU) No 390/2013 (2)) (‘the Performance Regulation’) as adapted to the EEA Agreement by Protocol 1 thereto.

| (2) | Union-wide performance targets in the key performance areas of safety, environment, capacity and cost-efficiency for the second reference period (2015-2019) were adopted by Commission Implementing Decision 2014/132/EU (3) and incorporated under point 66xe of Annex XIII to the EEA Agreement. |
| --- | --- |

(2)

Union-wide performance targets in the key performance areas of safety, environment, capacity and cost-efficiency for the second reference period (2015-2019) were adopted by Commission Implementing Decision 2014/132/EU (3) and incorporated under point 66xe of Annex XIII to the EEA Agreement.

| (3) | Norway submitted to the Authority the performance plans at FAB level, along with the other States which are part of the North European Functional Airspace Block (‘NEFAB’), by letter dated 17 July 2014 (Document No 716241). The plan was subsequently modified by corrigenda, the latest one dated 14 November 2014. For its assessment, the Authority has based itself on the most recent information submitted. |
| --- | --- |

(3)

Norway submitted to the Authority the performance plans at FAB level, along with the other States which are part of the North European Functional Airspace Block (‘NEFAB’), by letter dated 17 July 2014 (Document No 716241). The plan was subsequently modified by corrigenda, the latest one dated 14 November 2014. For its assessment, the Authority has based itself on the most recent information submitted.

| (4) | The Performance Review Body, which has assisted the Authority in assessing the implementation of the performance scheme pursuant to Article 3 of the Performance Regulation, submitted an initial assessment report to the Authority on 7 October 2014 and an updated version of that report on 15 December 2014. The Authority further received from the Performance Review Body reports based on information from national supervisory authorities on the monitoring of the performance plans and targets submitted in accordance with Article 18(4) of Performance Regulation. |
| --- | --- |

(4)

The Performance Review Body, which has assisted the Authority in assessing the implementation of the performance scheme pursuant to Article 3 of the Performance Regulation, submitted an initial assessment report to the Authority on 7 October 2014 and an updated version of that report on 15 December 2014. The Authority further received from the Performance Review Body reports based on information from national supervisory authorities on the monitoring of the performance plans and targets submitted in accordance with Article 18(4) of Performance Regulation.

| (5) | Concerning the key performance area of safety, the consistency of the targets submitted by Norway, as regards the NEFAB States, regarding the effectiveness of safety management and the application of severity classification on the basis of the Risk Analysis Tool (‘RAT’) methodology has been assessed, in accordance with the principles laid down in point 2 of Annex IV to the Performance Regulation. That assessment has demonstrated that the targets submitted by Norway, as regards the NEFAB, are consistent with the relevant Union-wide performance target. |
| --- | --- |

(5)

Concerning the key performance area of safety, the consistency of the targets submitted by Norway, as regards the NEFAB States, regarding the effectiveness of safety management and the application of severity classification on the basis of the Risk Analysis Tool (‘RAT’) methodology has been assessed, in accordance with the principles laid down in point 2 of Annex IV to the Performance Regulation. That assessment has demonstrated that the targets submitted by Norway, as regards the NEFAB, are consistent with the relevant Union-wide performance target.

| (6) | Concerning the key performance area of environment, the consistency of the targets submitted by Norway, as regards the NEFAB States, has been assessed, in accordance with the principles laid down in point 3 of Annex IV to the Performance Regulation. The assessment uses the respective FAB reference values for horizontal en route flight efficiency of the actual trajectory that, when applied, ensure at Union level that the Union-wide performance target is met, calculated by the Network Manager and set out in the Network Operations Plan (2014-2018/2019) in its most recent version of June 2014 (‘Network Operations Plan’). That assessment has demonstrated that the targets submitted by Norway, as regards NEFAB, are consistent with the relevant Union-wide performance target. |
| --- | --- |

(6)

Concerning the key performance area of environment, the consistency of the targets submitted by Norway, as regards the NEFAB States, has been assessed, in accordance with the principles laid down in point 3 of Annex IV to the Performance Regulation. The assessment uses the respective FAB reference values for horizontal en route flight efficiency of the actual trajectory that, when applied, ensure at Union level that the Union-wide performance target is met, calculated by the Network Manager and set out in the Network Operations Plan (2014-2018/2019) in its most recent version of June 2014 (‘Network Operations Plan’). That assessment has demonstrated that the targets submitted by Norway, as regards NEFAB, are consistent with the relevant Union-wide performance target.

| (7) | Concerning the key performance area of capacity, the consistency of the targets submitted by Norway, as regards the NEFAB States, for en route Air Traffic Flow Management (‘ATFM’) delay has been assessed, in accordance with the principles laid down in point 4 of Annex IV to the Performance Scheme Regulation, by using the respective FAB reference values for capacity that, when applied, ensure at Union level that the Union-wide performance target is met, calculated by the Network Manager and set out in the Network Operations Plan. That assessment has demonstrated that the targets submitted by Norway, as regards NEFAB, are consistent with the relevant Union-wide performance target. |
| --- | --- |

(7)

Concerning the key performance area of capacity, the consistency of the targets submitted by Norway, as regards the NEFAB States, for en route Air Traffic Flow Management (‘ATFM’) delay has been assessed, in accordance with the principles laid down in point 4 of Annex IV to the Performance Scheme Regulation, by using the respective FAB reference values for capacity that, when applied, ensure at Union level that the Union-wide performance target is met, calculated by the Network Manager and set out in the Network Operations Plan. That assessment has demonstrated that the targets submitted by Norway, as regards NEFAB, are consistent with the relevant Union-wide performance target.

| (8) | Concerning the key performance area of cost-efficiency, the targets expressed in en route determined unit costs submitted by Norway, as regards the NEFAB States, have been assessed, in accordance with the principles laid down in point 5, in conjunction with point 1, of Annex IV to the Performance Regulation, by taking account of the trend of en route determined unit costs over the second reference period and the combined period of the first and the second reference period (2012-2019), the number of service units (traffic forecast) and the level of en route determined unit costs in comparison to States having a similar operational and economic environment. That assessment has demonstrated that the targets submitted by Norway, as regards NEFAB, are consistent with the relevant Union-wide performance target. |
| --- | --- |

(8)

Concerning the key performance area of cost-efficiency, the targets expressed in en route determined unit costs submitted by Norway, as regards the NEFAB States, have been assessed, in accordance with the principles laid down in point 5, in conjunction with point 1, of Annex IV to the Performance Regulation, by taking account of the trend of en route determined unit costs over the second reference period and the combined period of the first and the second reference period (2012-2019), the number of service units (traffic forecast) and the level of en route determined unit costs in comparison to States having a similar operational and economic environment. That assessment has demonstrated that the targets submitted by Norway, as regards NEFAB, are consistent with the relevant Union-wide performance target.

| (9) | Therefore, the Authority considers that the targets included in the performance plans drawn up by Norway, as regards NEFAB, are consistent with the Union-wide performance targets in all four key performance areas, |
| --- | --- |

(9)

Therefore, the Authority considers that the targets included in the performance plans drawn up by Norway, as regards NEFAB, are consistent with the Union-wide performance targets in all four key performance areas,

HAS ADOPTED THIS DECISION:

Article 1

The targets included in the performance plans submitted by Norway, as regards NEFAB, pursuant to Regulation (EC) No 549/2004, listed in the Annex, are consistent with the Union-wide performance targets for the second reference period set out in Implementing Decision 2014/132/EU.

Article 2

This Decision is addressed to Norway.

Done at Brussels, 18 March 2015.

For the EFTA Surveillance Authority

Oda Helen SLETNES

President

Helga JÓNSDÓTTIR

College Member

---

(1)  
  OJ L 96, 31.3.2004, p. 1.

1

(2)  Commission Implementing Regulation (EU) No 390/2013 of 3 May 2013 laying down a performance scheme for air navigation services and network functions (OJ L 128, 9.5.2013, p. 1).

2

(3)  Commission Implementing Decision 2014/132/EU of 11 March 2014 setting the Union-wide performance targets for the air traffic management network and alert thresholds for the second reference period 2015-19 (OJ L 71, 12.3.2014, p. 20).

3

---

ANNEX

Performance targets in the key performance areas of safety, environment, capacity and cost-efficiency included in the national or functional airspace block plans submitted pursuant to Regulation (EC) No 549/2004 found to be consistent with the Union-wide performance targets for the second reference period

KEY PERFORMANCE AREA OF SAFETY

Effectiveness of Safety Management (EOSM) and the application of the severity classification based on the Risk Analysis Tool (RAT) methodology

| EFTA State | FAB | EOSM | RAT Ground STATE Level % | RAT Overall ANSP Level % |
| --- | --- | --- | --- | --- |
| | | State level | ANSP level | 2017 | 2019 | 2017 | 2019 |
| | | | SC | Other MO | SMI | RI | ATMS | SMI | RI's | ATMS | SMI | RI's | ATMS | SMI | RI's | ATMS |
| Norway | NEFAB | C | C | D | 90 | 90 | 80 | 100 | 100 | 100 | 95 | 95 | 85 | 100 | 100 | 100 |
| [Finland] |
| [Latvia] |
| [Estonia] |

EFTA State

FAB

EOSM

RAT Ground STATE Level %

RAT Overall ANSP Level %

State level

ANSP level

2017

2019

2017

2019

SC

Other MO

SMI

RI

ATMS

SMI

RI's

ATMS

SMI

RI's

ATMS

SMI

RI's

ATMS

Norway

NEFAB

C

C

D

90

90

80

100

100

100

95

95

85

100

100

100

[Finland]

[Latvia]

[Estonia]

KEY PERFORMANCE AREA OF ENVIRONMENT

Horizontal en route flight efficiency of the actual trajectory

| EFTA State | FAB | FAB Target Environment |
| --- | --- | --- |
| 2019 |
| Norway | NEFAB | 1,22 % |
| [Finland] |
| [Latvia] |
| [Estonia] |

EFTA State

FAB

FAB Target Environment

2019

Norway

NEFAB

1,22 %

[Finland]

[Latvia]

[Estonia]

KEY PERFORMANCE AREA OF CAPACITY

En route Air Traffic Flow Management (ATFM) delay in min/flight

| EFTA State | FAB | FAB Target En-Route Capacity |
| --- | --- | --- |
| | | 2015 | 2016 | 2017 | 2018 | 2019 |
| Norway | NEFAB | 0,12 | 0,12 | 0,13 | 0,13 | 0,13 |
| [Finland] |
| [Latvia] |
| [Estonia] |
| |

EFTA State

FAB

FAB Target En-Route Capacity

2015

2016

2017

2018

2019

Norway

NEFAB

0,12

0,12

0,13

0,13

0,13

[Finland]

[Latvia]

[Estonia]

KEY PERFORMANCE AREA OF COST-EFFICIENCY

Legend:

| Key | Item | Units |
| --- | --- | --- |
| (A) | Total En-route Determined Costs | (in nominal terms and in national currency) |
| (B) | Inflation rate | (%) |
| (C) | Inflation index | (100 = 2009) |
| (D) | Total En-route Determined Costs | (in real 2009 prices and in national currency) |
| (E) | Total En-route Services Units | (TSUs) |
| (F) | En-route Determined Unit Cost (DUC) | (in real 2009 prices and in national currency) |

Key

Item

Units

(A)

Total En-route Determined Costs

(in nominal terms and in national currency)

(B)

Inflation rate

(%)

(C)

Inflation index

(100 = 2009)

(D)

Total En-route Determined Costs

(in real 2009 prices and in national currency)

(E)

Total En-route Services Units

(TSUs)

(F)

En-route Determined Unit Cost (DUC)

(in real 2009 prices and in national currency)

NEFAB

Charging Zone: Norway — Currency: NOK

| | 2015 | 2016 | 2017 | 2018 | 2019 |
| --- | --- | --- | --- | --- | --- |
| (A) | 1 006 927 248 | 1 032 667 449 | 1 051 204 724 | 1 064 624 439 | 1 073 048 403 |
| (B) | 1,6 % | 1,7 % | 2,1 % | 2,5 % | 2,5 % |
| (C) | 109,5 | 111,4 | 113,7 | 116,6 | 119,5 |
| (D) | 919 164 836 | 926 904 186 | 924 136 061 | 913 105 964 | 897 883 922 |
| (E) | 2 287 878 | 2 367 954 | 2 438 992 | 2 499 967 | 2 549 966 |
| (F) | 401,75 | 391,44 | 378,90 | 365,25 | 352,12 |

2015

2016

2017

2018

2019

(A)

1 006 927 248

1 032 667 449

1 051 204 724

1 064 624 439

1 073 048 403

(B)

1,6 %

1,7 %

2,1 %

2,5 %

2,5 %

(C)

109,5

111,4

113,7

116,6

119,5

(D)

919 164 836

926 904 186

924 136 061

913 105 964

897 883 922

(E)

2 287 878

2 367 954

2 438 992

2 499 967

2 549 966

(F)

401,75

391,44

378,90

365,25

352,12

---

| 25.8.2016 | EN | Official Journal of the European Union | L 230/51 |
| --- | --- | --- | --- |

25.8.2016

EN

Official Journal of the European Union

L 230/51

---

EFTA SURVEILLANCE AUTHORITY DECISION

No 111/15/COL

of 31 March 2015

amending the list contained in point 39 of Part 1.2 of Chapter I of Annex I to the Agreement on the European Economic Area listing border inspection posts in Iceland and Norway agreed for veterinary checks on live animals and animal products from third countries and repealing EFTA Surveillance Authority Decision No 311/13/COL [2016/1419]

THE EFTA SURVEILLANCE AUTHORITY,

Having regard to point (5)(b) of the Introductory Part of Chapter I of Annex I to the EEA Agreement,

Having regard to the Act referred to at point 4 of Part 1.1 of Chapter I of Annex I to the EEA Agreement (Council Directive 97/78/EC of 18 December 1997 laying down the principles governing the organisation of veterinary checks on products entering the Community from third countries (1)), as amended and adapted to the EEA Agreement by the sectoral adaptations referred to in Annex I to that Agreement, and in particular Article 6(2) thereof,

Having regard to the Act referred to at point 111 of Part 1.2 of Chapter I of Annex I to the EEA Agreement (Commission Decision 2001/812/EC of 21 November 2001 laying down the requirements for the approval of border inspection posts responsible for veterinary checks on products introduced into the Community from third countries (2)), as amended, and in particular Article 3(5) thereof,

as adapted to the EEA Agreement by point 4(d) of Protocol 1 to the EEA Agreement and Articles 1(2) and 3 of Protocol 1 to the Surveillance and Court Agreement,

Whereas:

By letter of 19 January 2015 (Doc No 742451, IS ref. Mast14090047/0.2.7.0), the Icelandic Food and Veterinary Authority (MAST) informed the Authority that the border inspection post Húsavik (IS HUS 1) had been closed. MAST therefore requested that the border inspection post be removed from the lists of border inspection posts in Iceland and Norway agreed for veterinary checks on live animals and animal products from third countries.

According to Directive 97/78/EC, the Authority shall draw up and publish a list of approved border inspection posts which may subsequently be amended or supplemented to reflect changes in the national lists. The current list of approved border inspection posts was adopted by the Authority on 17 July 2013 by Decision No 311/13/COL.

It is therefore the Authority's obligation to amend the list of border inspection posts in Iceland and Norway and to publish a new list, reflecting the change concerning Húsavik border inspection post.

The Authority, by its Decision No 65/15/COL, referred the matter to the EFTA Veterinary and Phytosanitary Committee assisting the EFTA Surveillance Authority. The Committee approved unanimously the proposed modification to the list. Accordingly, the draft measures are in accordance with the opinion of the Committee.

According to point 6 of EFTA Surveillance Authority Decision No 494/13/COL of 11 December 2013, the College Member with special responsibility for veterinary and phytosanitary matters is empowered to adopt draft measures amending the list of border inspection posts in an EFTA State agreed for veterinary checks on live animals and animal products from third countries if the draft measures are in accordance with the opinion of the EFTA Veterinary and Phytosanitary Committee assisting the EFTA Surveillance Authority.

HAS ADOPTED THIS DECISION:

| 1. | The border inspection post Húsavik (IS HUS 1) is removed from the list contained in point 39 of Part 1.2 of Chapter I of Annex I to the Agreement on the European Economic Area of border inspection posts in Iceland and Norway agreed for veterinary checks on live animals and animal products from third countries. |
| --- | --- |

1.

| 2. | Veterinary checks on live animals and animal products brought into Iceland and Norway from third countries shall be carried out by the competent national authorities at the agreed border inspection posts listed in the Annex to this Decision. |
| --- | --- |

2.

| 3. | The EFTA Surveillance Authority Decision No 311/13/COL of 17 July 2013 is hereby repealed. |
| --- | --- |

3.

| 4. | This Decision shall enter into force on the day of its signature. |
| --- | --- |

4.

| 5. | This Decision is addressed to Iceland and Norway. |
| --- | --- |

5.

| 6. | This Decision shall be authentic in the English language. |
| --- | --- |

6.

Done at Brussels, 31 March 2015.

For the EFTA Surveillance Authority

Helga JÓNSDÓTTIR

College Member

Xavier LEWIS

Director

---

(1)  
  OJ L 24, 30.1.1998, p. 9.

1

(2)  
  OJ L 306, 23.11.2001, p. 28.

2

---

ANNEX

LIST OF AGREED BORDER INSPECTION POSTS

| 1 | = | Name |
| --- | --- | --- |
| 2 | = | TRACES Code |
| 3 | = | Type







  A | = | Airport |
| F | = | Rail |
| P | = | Port |
| R | = | Road |

1

=

Name

2

=

TRACES Code

3

=

Type

A

=

Airport

F

=

Rail

P

=

Port

R

=

Road

4

=

Inspection centre

5

=

Products

| HC | = | All products for Human Consumption |
| --- | --- | --- |
| NHC | = | Other Products |
| NT | = | No temperature requirements |
| T | = | Frozen/chilled products |
| T(FR) | = | Frozen products |
| T(CH) | = | Chilled products |

HC

=

All products for Human Consumption

NHC

=

Other Products

NT

=

No temperature requirements

T

=

Frozen/chilled products

T(FR)

=

Frozen products

T(CH)

=

Chilled products

6

=

Live Animals

| U | = | Ungulates: cattle, pigs, sheep, goats, wild and domestic solipeds |
| --- | --- | --- |
| E | = | Registered equidae as defined in Council Directive 90/426/EEC |
| O | = | Other animals |

U

=

Ungulates: cattle, pigs, sheep, goats, wild and domestic solipeds

E

=

Registered equidae as defined in Council Directive 90/426/EEC

O

=

Other animals

5-6

=

Special remarks

| (1) | = | Checking in line with the requirements of Commission Decision 93/352/EEC taken in execution of Article 19(3) of Council Directive 97/78/EC |
| --- | --- | --- |
| (2) | = | Packed products only |
| (3) | = | Fishery products only |
| (4) | = | Animal proteins only |
| (5) | = | Wool hides and skins only |
| (6) | = | Only liquid fats, oils, and fish oils |
| (7) | = | Icelandic ponies (from April to October only) |
| (8) | = | Equidae only |
| (9) | = | Tropical fish only |
| (10) | = | Only cats, dogs, rodents, lagomorphs, live fish, reptiles and other birds than ratites |
| (11) | = | Only feedstuffs in bulk |
| (12) | = | For (U) in the case of solipeds, only those consigned to a zoo; and for (O), only day old chicks, fish, dogs, cats, insects, or other animals consigned to a zoo |
| (13) | = | Nagylak HU: This is a border inspection post (for products) and crossing point (for Live animals) on the Hungarian Romanian border, subject to transitional measures as negotiated and laid down in the Treaty of Accession for both products and live animals. See Commission Decision 2003/630/EC |
| (14) | = | Designated for transit across the European Community for consignments of certain products of animal origin for human consumption, coming to or from Russia under the specific procedures foreseen in relevant Community legislation |
| (15) | = | Aquaculture animals only |
| (16) | = | Fish meal only |

(1)

=

Checking in line with the requirements of Commission Decision 93/352/EEC taken in execution of Article 19(3) of Council Directive 97/78/EC

(2)

=

Packed products only

(3)

=

Fishery products only

(4)

=

Animal proteins only

(5)

=

Wool hides and skins only

(6)

=

Only liquid fats, oils, and fish oils

(7)

=

Icelandic ponies (from April to October only)

(8)

=

Equidae only

(9)

=

Tropical fish only

(10)

=

Only cats, dogs, rodents, lagomorphs, live fish, reptiles and other birds than ratites

(11)

=

Only feedstuffs in bulk

(12)

=

For (U) in the case of solipeds, only those consigned to a zoo; and for (O), only day old chicks, fish, dogs, cats, insects, or other animals consigned to a zoo

(13)

=

Nagylak HU: This is a border inspection post (for products) and crossing point (for Live animals) on the Hungarian Romanian border, subject to transitional measures as negotiated and laid down in the Treaty of Accession for both products and live animals. See Commission Decision 2003/630/EC

(14)

=

Designated for transit across the European Community for consignments of certain products of animal origin for human consumption, coming to or from Russia under the specific procedures foreseen in relevant Community legislation

(15)

=

Aquaculture animals only

(16)

=

Fish meal only

Country: Iceland

| 1 | 2 | 3 | 4 | 5 | 6 |
| --- | --- | --- | --- | --- | --- |
| Akureyri | IS AKU1 | P | | HC-T(1)(2)(3), NHC(16) | |
| Hafnarfjörður | IS HAF 1 | P | | HC(1)(2)(3), NHC-NT(2)(6)(16) | |
| Ísafjörður | IS ISA1 | P | | HC-T(FR)(1)(2)(3) | |
| Keflavík Airport | IS KEF 4 | A | | HC(2), NHC(2) | O(15) |
| Reykjavík Eimskip | IS REY 1a | P | | HC(2), NHC(2) | |
| Reykjavík Samskip | IS REY 1b | P | | HC-T(FR)(1)(2)(3), HC-NT(1)(2)(3), NHC-NT(2)(6)(16) | |
| Þorlákshöfn | IS THH1 | P | | HC-T(FR)(1)(2)(3), HC-NT(6), NHC-NT(6) | |

1

2

3

4

5

6

Akureyri

IS AKU1

P

HC-T(1)(2)(3), NHC(16)

Hafnarfjörður

IS HAF 1

P

HC(1)(2)(3), NHC-NT(2)(6)(16)

Ísafjörður

IS ISA1

P

HC-T(FR)(1)(2)(3)

Keflavík Airport

IS KEF 4

A

HC(2), NHC(2)

O(15)

Reykjavík Eimskip

IS REY 1a

P

HC(2), NHC(2)

Reykjavík Samskip

IS REY 1b

P

HC-T(FR)(1)(2)(3), HC-NT(1)(2)(3), NHC-NT(2)(6)(16)

Þorlákshöfn

IS THH1

P

HC-T(FR)(1)(2)(3), HC-NT(6), NHC-NT(6)

Country: Norway

| 1 | 2 | 3 | 4 | 5 | 6 |
| --- | --- | --- | --- | --- | --- |
| Borg | NO BRG 1 | P | | HC (2), NHC(2) | E(7) |
| Båtsfjord | NO BJF 1 | P | | HC-T(FR)(1)(2)(3), HC-NT(1)(2)(3) | |
| Egersund | NO EGE 1 | P | | HC-NT(6), NHC-NT(6)(16) | |
| Hammerfest | NO HFT 1 | P | Rypefjord | HC-T(FR)(1)(2)(3), HC-NT(1)(2)(3) | |
| Honningsvåg | NO HVG 1 | P | Honningsvåg | HC-T(FR)(1)(2)(3) | |
| Kirkenes | NO KKN 1 | P | | HC-T(FR)(1)(2)(3), HC-NT(1)(2)(3) | |
| Kristiansund | NO KSU 1 | P | Kristiansund | HC-T(FR)(1)(2)(3), NHC-T(FR)(2)(3) HC-NT(6), NHC-NT(6) | |
| Larvik | NO LAR 1 | P | | HC(2) | |
| Måløy | NO MAY 1 | P | Gotteberg | HC-T(FR)(1)(2)(3), NHC-T(FR)(2)(3) | |
| Oslo | NO OSL 1 | P | | HC(2), NHC(2) | |
| Oslo | NO OSL 4 | A | | HC(2), NHC(2) | U,E,O |
| Sortland | NO SLX 1 | P | Sortland | HC-T(FR)(1)(2)(3) | |
| Storskog | NO STS 3 | R | | HC, NHC | U,E,O |
| Tromsø | NO TOS 1 | P | Bukta | HC-T(FR)(1)(2)(3) | |
| Solstrand | HC-T(FR)(1)(2)(3) | |
| Ålesund | NO AES 1 | P | Breivika | HC-T(FR)(1)(2)(3), NHC-T(FR)(2)(3) | |
| Skutvik | HC-T(1)(2)(3), HC-NT(6), NHC-T(FR) (2)(3), NHC-NT(6) | |

1

2

3

4

5

6

Borg

NO BRG 1

P

HC (2), NHC(2)

E(7)

Båtsfjord

NO BJF 1

P

HC-T(FR)(1)(2)(3), HC-NT(1)(2)(3)

Egersund

NO EGE 1

P

HC-NT(6), NHC-NT(6)(16)

Hammerfest

NO HFT 1

P

Rypefjord

HC-T(FR)(1)(2)(3), HC-NT(1)(2)(3)

Honningsvåg

NO HVG 1

P

Honningsvåg

HC-T(FR)(1)(2)(3)

Kirkenes

NO KKN 1

P

HC-T(FR)(1)(2)(3), HC-NT(1)(2)(3)

Kristiansund

NO KSU 1

P

Kristiansund

HC-T(FR)(1)(2)(3), NHC-T(FR)(2)(3) HC-NT(6), NHC-NT(6)

Larvik

NO LAR 1

P

HC(2)

Måløy

NO MAY 1

P

Gotteberg

HC-T(FR)(1)(2)(3), NHC-T(FR)(2)(3)

Oslo

NO OSL 1

P

HC(2), NHC(2)

Oslo

NO OSL 4

A

HC(2), NHC(2)

U,E,O

Sortland

NO SLX 1

P

Sortland

HC-T(FR)(1)(2)(3)

Storskog

NO STS 3

R

HC, NHC

U,E,O

Tromsø

NO TOS 1

P

Bukta

HC-T(FR)(1)(2)(3)

Solstrand

HC-T(FR)(1)(2)(3)

Ålesund

NO AES 1

P

Breivika

HC-T(FR)(1)(2)(3), NHC-T(FR)(2)(3)

Skutvik

HC-T(1)(2)(3), HC-NT(6), NHC-T(FR) (2)(3), NHC-NT(6)

---

| 25.8.2016 | EN | Official Journal of the European Union | L 230/56 |
| --- | --- | --- | --- |

25.8.2016

EN

Official Journal of the European Union

L 230/56

---

EFTA SURVEILLANCE AUTHORITY DECISION

No 221/15/COL

of 3 June 2015

amending EFTA Surveillance Authority Decision No 83/15/COL concerning the consistency of certain targets included in the national or functional airspace block plans submitted pursuant to Regulation (EC) No 549/2004 of the European Parliament and of the Council with the Union-wide performance targets for the second reference period [2016/1420]

THE EFTA SURVEILLANCE AUTHORITY,

Having regard to the Act mentioned at point 66t of Annex XIII to the EEA Agreement (Regulation (EC) No 549/2004 of the European Parliament and of the Council of 10 March 2004 laying down the framework for the creation of the single European sky (‘the Framework Regulation’) (1)), as adapted to the EEA Agreement by Protocol 1 thereto, and in particular Article 11(3)(c) thereof,

Whereas:

Incorrect entries regarding the Kingdom of Norway were discovered in the table containing the key performance area of safety in the Annex of the EFTA Surveillance Authority Decision No 83/15/COL of 18 March 2015, which need to be corrected,

HAS ADOPTED THIS DECISION:

Article 1

In the Annex to College Decision No 83/15/COL, the part concerning the key performance area of safety, is replaced by the following:

‘KEY PERFORMANCE AREA OF SAFETY

Effectiveness of Safety Management (EOSM) and the application of the severity classification based on the Risk Analysis Tool (RAT) methodology

| EFTA State | FAB | EOSM | RAT Ground Level % | RAT Overall Level % |
| --- | --- | --- | --- | --- |
| | | State level | ANSP level | 2017 | 2019 | 2017 | 2019 |
| | | | SC | Other MO | SMI | RI | ATMS | SMI | RI's | ATMS | SMI | RI's | ATMS | SMI | RI's | ATMS |
| Norway | NEFAB | C | C | D | 95 | 95 | 85 | 100 | 100 | 100 | 90 | 90 | 85 | 100 | 100 | 100’ |
| [Finland] |
| [Latvia] |
| [Estonia] |

EFTA State

FAB

EOSM

RAT Ground Level %

RAT Overall Level %

State level

ANSP level

2017

2019

2017

2019

SC

Other MO

SMI

RI

ATMS

SMI

RI's

ATMS

SMI

RI's

ATMS

SMI

RI's

ATMS

Norway

NEFAB

C

C

D

95

95

85

100

100

100

90

90

85

100

100

100’

[Finland]

[Latvia]

[Estonia]

Article 2

This Decision is addressed to the Kingdom of Norway.

Done at Brussels, 3 June 2015.

For the EFTA Surveillance Authority

Oda Helen SLETNES

President

Helga JÓNSDÓTTIR

College Member

---

(1)  
  OJ L 96, 31.3.2004, p. 1.

1

---

| 25.8.2016 | EN | Official Journal of the European Union | L 230/58 |
| --- | --- | --- | --- |

25.8.2016

EN

Official Journal of the European Union

L 230/58

---

EFTA SURVEILLANCE AUTHORITY DECISION

No 293/15/COL

of 14 July 2015

to approve the national programme established by Iceland for the control of salmonella in poultry and poultry products [2016/1421]

THE EFTA SURVEILLANCE AUTHORITY,

Having regard to the Act referred to at point 8b of Part 7.1 of Chapter I of Annex I to EEA Agreement (Regulation (EC) No 2160/2003 of the European Parliament and of the Council of 17 November 2003 on the control of salmonella and other specified food-borne zoonotic agents (1)),

Having regard to the Act referred to at point 17 of Part 6.1 of Chapter I of Annex I to the EEA Agreement (Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific hygiene rules for food of animal origin (2)),

Having regard to the Act referred to at point 53 of Part 7.2 of Chapter I of Annex I to EEA Agreement (Commission Regulation (EU) No 200/2010 of 10 March 2010 implementing Regulation (EC) No 2160/2003 of the European Parliament and of the Council as regards a Union target for the reduction of the prevalence of Salmonella serotypes in adult breeding flocks of Gallus gallus (3)),

Having regard to the Act referred to at point 55 of Part 7.2 of Chapter I of Annex I to EEA Agreement (Commission Regulation (EU) No 517/2011 of 25 May 2011 implementing Regulation (EC) No 2160/2003 of the European Parliament and of the Council as regards a Union target for the reduction of the prevalence of certain Salmonella serotypes in laying hens of Gallus gallus and amending Regulation (EC) No 2160/2003 and Commission Regulation (EU) No 200/2010 (4)),

Having regard to the Act referred to at point 57 of Part 7.2 of Chapter I of Annex I to EEA Agreement (Commission Regulation (EU) No 200/2012 of 8 March 2012 concerning a Union target for the reduction of Salmonella enteritidis and Salmonella typhimurium in flocks of broilers, as provided for in Regulation (EC) No 2160/2003 of the European Parliament and of the Council (5)),

Having regard to the Act referred to at point 51 of Part 7.2 of Chapter I of Annex I to EEA Agreement (Commission Regulation (EU) No 1190/2012 of 12 December 2012 concerning a Union target for the reduction of Salmonella Enteritidis and Salmonella Typhimurium in flocks of turkeys, as provided for in Regulation (EC) No 2160/2003 of the European Parliament and of the Council (6)), as adapted to the EEA Agreement by point 4(d) of Protocol 1 to the EEA Agreement and Articles 1(2) and 3 of Protocol 1 to the Surveillance and Court Agreement,

Having regard to Decision No 494/13/COL of the EFTA Surveillance Authority (‘the Authority’) of 11 December 2013 empowering the College Member with special responsibility for veterinary and phytosanitary matters to take certain decisions and measures (Document No 683826), in particular point 1 thereof,

Whereas:

The purpose of Regulation (EC) No 2160/2003 is to ensure that proper and effective measures are taken to detect and control salmonella and other zoonotic agents at all relevant stages of production, processing and distribution, particularly at the level of primary production, in order to reduce their prevalence and the risk they pose to public health.

An EEA target was established for the reduction of the prevalence of all Salmonella serotypes with public health significance in breeding flocks of Gallus gallus at the level of primary production by Regulation (EU) No 200/2010.

An EEA target was established for the reduction of the prevalence of certain Salmonella serotypes in laying hens of Gallus gallus by Regulation (EU) No 517/2011.

An EEA target was established for the reduction of Salmonella Enteritidis and Salmonella Typhimurium in flocks of broilers by Regulation (EU) No 200/2012.

An EEA target was established for the reduction of Salmonella Enteritidis and Salmonella Typhimurium in flocks of turkeys by Regulation (EU) No 1190/2012.

In order to achieve the EEA targets Member States are to establish national programmes for the control of salmonella in the relevant populations and submit them to the Authority in accordance with Regulation (EC) No 2160/2003.

Iceland has submitted its national programme for the control of salmonella in poultry and poultry products. The control programme aims at reducing the prevalence of all Salmonella serovars below 1 % for all flocks of poultry, i.e. in breeding flocks of Gallus gallus; laying hens of Gallus gallus; flocks of broilers; and flocks of turkeys.

The Authority considered that the programme presented by Iceland should be approved as it complied with the relevant EEA veterinary legislation, and in particular with Regulation (EC) No 2160/2003. For good measure, the Authority notes that Iceland has not provided the information necessary to assess whether the control programme is equivalent to that approved for Finland and Sweden as provided for in Article 8 of Regulation (EC) No 853/2004.

The Authority, therefore, by its Decision No 209/15/COL, referred the matter to the EFTA Veterinary and Phytosanitary Committee. The Committee approved unanimously the proposed Decision to approve the national control programme established by Iceland for the control of salmonella in poultry and poultry products. Accordingly, the draft measures are in accordance with the opinion of the Committee,

HAS ADOPTED THIS DECISION:

| 1. | The national programme established by Iceland for the control of salmonella in breeding flocks of Gallus gallus; laying hens of Gallus gallus; flocks of broilers; and flocks of turkeys is approved. |
| --- | --- |

1.

| 2. | This Decision is addressed to Iceland. |
| --- | --- |

2.

| 3. | The Decision shall enter into force immediately. |
| --- | --- |

3.

| 4. | This Decision shall be authentic in the English language. |
| --- | --- |

4.

Done at Brussels, 14 July 2015.

For the EFTA Surveillance Authority

Helga JÓNSDÓTTIR

College Member

Markus SCHNEIDER

Acting Director

---

(1)  
  OJ L 325, 12.12.2003, p. 1.

1

(2)  
  OJ L 139, 30.4.2004, p. 55.

2

(3)  
  OJ L 61, 11.3.2010, p. 1.

3

(4)  
  OJ L 138, 26.5.2011, p. 45.

4

(5)  
  OJ L 71, 9.3.2012, p. 31.

5

(6)  
  OJ L 340, 13.12.2012, p. 29.

6

---