Commission Implementing Decision (EU) 2016/1189

law://eu/dec/2016/1189@2026-11-12

Contents

THE EUROPEAN COMMISSION,Having regard to the Treaty on the Functioning of the European Union,Having regard to Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients^note, and in particular Article 7 thereof,Whereas:

(1)On 26 September 2012, the company Dairy Crest Ltd made a request to the competent authorities of Ireland to place UV-treated milk on the market as a novel food within the meaning of point (f) of Article 1(2) of Regulation (EC) No 258/97.

(2)On 10 January 2013, the competent food assessment body of Ireland issued its initial assessment report. In that report it came to the conclusion that UV-treated milk meets the criteria for novel food set out in Article 3(1) of Regulation (EC) No 258/97.

(3)On 16 January 2013, the Commission forwarded the initial assessment report to the other Member States.

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

(5)On 9 February 2015, the Commission consulted the European Food Safety Authority (EFSA) asking it to carry out an additional assessment for UV-treated milk as novel food in accordance with Regulation (EC) No 258/97.

(6)On 10 December 2015, EFSA concluded in its opinion on the safety of UV-treated milk as a novel food^note that UV-treated milk is safe under the intended conditions of use.

(7)That opinion gives sufficient grounds to establish that UV-treated milk as a novel food complies with the criteria laid down in Article 3(1) of Regulation (EC) No 258/97.

(8)The UV treatment of the pasteurised milk results in an increase in the vitamin D content of the milk. Regulation (EU) No 1169/2011 of the European Parliament and of the Council^note specifies what is regarded as a significant amount for vitamins and minerals. Therefore, it is important to inform the consumer adequately on the presence of vitamin D produced by UV-treatment in the product.

(9)Regulation (EC) No 1925/2006 of the European Parliament and of the Council^note lays down requirements on the addition of vitamins and minerals and certain other substances to foods. The use of UV-treated milk should be authorised without prejudice to the requirements of that legislation.

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

HAS ADOPTED THIS DECISION:

Article 1 #

UV-treated milk as specified in Annex I to this Decision may be placed on the market in the Union as a novel food for the uses defined and at the maximum levels established in Annex II to this Decision without prejudice to the specific provisions of Regulation (EC) No 1925/2006.

Article 2 #

The designation of UV-treated milk authorised by this Decision for the labelling of the foodstuffs shall be ‘UV-treated’.Where UV-treated milk contains an amount of vitamin D that is considered significant in accordance with Point 2 of Part A of Annex XIII to Regulation (EU) No 1169/2011 of the European Parliament and of the Council, the designation for the labelling shall be accompanied by ‘contains vitamin D produced by UV-treatment’ or ‘milk containing vitamin D resulting from UV-treatment’.

Article 3 #

This Decision is addressed to Dairy Crest Ltd, Claygate House, Littleworth Road, Esher, Surrey, KT10 9PN, United Kingdom.

Annex I

Specification of uv-treated milk

Definition:

UV-treated milk is cow's milk (whole and semi-skimmed) to which a treatment with ultraviolet (UV) radiation via turbulent flow is applied after pasteurisation. The treatment of the pasteurised milk with UV radiation results in an increase in the vitamin D₃ (cholecalciferol) concentrations by conversion of 7-dehydrocholesterol to vitamin D₃.

UV radiation: a process of radiation in ultraviolet light within the wavelength of 200-310 nm with energy input of 1045 J/l.

Vitamin D3:

Chemical name	(1S,3Z)-3-[(2E)-2-[(1R,3aS,7aR)-7a-methyl-1-[(2R)-6-methylheptan-2-yl]-2,3,3a,5,6,7-hexahydro-1H-inden-4-ylidene]ethylidene]-4-methylidenecyclohexan-1-ol
Synonym	Cholecalciferol
CAS No	67-97-0
Molecular weight	384,6377 g/mol

Annex II

Authorised uses of uv-treated milk

Food category	Range of vitamin D₃
Pasteurised whole milk^note	5–32 μg/kg for general population excluding infants
Pasteurised semi-skimmed milk^note	1–15 μg/kg for general population excluding infants

Commission Implementing Decision (EU) 2016/1189

Commission Implementing Decision (EU) 2016/1189

Article 1 #

Article 2 #

Article 3 #

Annex I

Specification of uv-treated milk

Definition:

Vitamin D3:

Contents:

Annex II

Authorised uses of uv-treated milk

Key facts

Connections

History · 2 versions

Article 1 #

Article 2 #

Article 3 #

Annex I

Specification of uv-treated milk

Definition:

Vitamin D3:

Contents:

Annex II

Authorised uses of uv-treated milk