Commission Implementing Regulation (EU) 2019/110Show full title

Commission Implementing Regulation (EU) 2019/110

of 24 January 2019

authorising an extension of use of Allanblackia seed oil as a novel food under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) 2017/2470

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

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

Having regard to Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No 258/97 of the European Parliament and of the Council and Commission Regulation (EC) No 1852/2001(1), and in particular Article 12 thereof,

Whereas:

(1) Regulation (EU) 2015/2283 provides that only novel foods authorised and included in the Union list may be placed on the market within the Union.

(2) Pursuant to Article 8 of Regulation (EU) 2015/2283 Commission Implementing Regulation (EU) 2017/2470(2) establishing a Union list of authorised novel foods was adopted.

(3) Pursuant to Article 12 of Regulation (EU) 2015/2283, the Commission is to submit a draft implementing act authorising the placing on the Union market of a novel food and updating the Union list.

(4) Commission Decision 2008/559/EC(3) authorised, in accordance with Regulation (EC) No 258/97 of the European Parliament and of the Council(4) and following the European Food Safety Authority's Opinion (‘the Authority’)(5), the placing on the market of Allanblackia seed oil as a novel food to be used in yellow fat spreads and cream based spreads.

(5) On 22 September 2014, the company Unilever NV/Unilever PLC made a request to the competent authority of the Netherlands in accordance with Article 4 of Regulation (EC) No 258/97 for an extension of use and use levels of Allanblackia seed oil. The application requested to extend the use of Allanblackia seed oil to an additional food category, namely, mixtures of vegetable oils and milk, and to increase the maximum use levels of Allanblackia seed oil for food categories already authorised by Decision 2008/559/EC. The application also requested change of the specification of Allanblackia seed oil, in particular concerning: the simplification of the indication of small amounts of the saturated fatty acids: lauric, myristic and palmitic acid to one combined parameter (C12:0 — C14:0 — C16:0); the omission of the indication of small amounts (each below 1 %) of palmitoleic and arachidic acid and inclusion of Poly Unsaturated Fatty Acids (PUFA); the omission of the indication of the iodine value; increasing the maximum limits for trans-fatty acids (TFA) (from ≤ 0,5 % to ≤ 1 %); increasing the maximum limits for the peroxide value (from ≤ 0,8 to ≤ 1,0 meq/kg); increasing the maximum limits for the unsaponifiable matter (from ≤ 0,1 % to ≤ 1 %). The Authority has no safety concerns regarding the proposed changes of specification parameters.

(6) On 13 December 2017, the competent authority of the Netherlands issued its initial assessment report. In that report, it concluded that the extension of uses and proposed maximum use levels of Allanblackia seed oil and modification of the specification of Allanblackia seed oil meet the criteria for novel food set out in Article 3(1) of Regulation (EC) No 258/97.

(7) Pursuant to Article 35(1) of Regulation (EU) 2015/2283, any request for placing a novel food on the market within the Union submitted to a Member State in accordance with Article 4 of Regulation (EC) No 258/97 and for which the final decision has not been taken before 1 January 2018 shall be treated as an application submitted under Regulation (EU) 2015/2283.

(8) While the request for an extension of use of Allanblackia seed oil was submitted to a Member State in accordance with Article 4 of Regulation (EC) No 258/97, the application also meets the requirements laid down in Regulation (EU) 2015/2283.

(9) In accordance with Article 10(3) of Regulation (EU) 2015/2283, the Commission consulted the Authority on 25 April 2018, asking it to provide a scientific opinion by carrying out the assessment for Allanblackia seed oil as a novel food.

(10) On 27 June 2018, the Authority adopted Scientific Opinion on the safety of Allanblackia seed oil for extended uses in mixtures of vegetable oils and milk and in yellow fat and cream based spreads up to 30 % (w/w)(6) as requested by the applicant. That opinion is in line with the requirements of Article 11 of Regulation (EU) 2015/2283. Mixtures of vegetable oils and milk fall under the food category: Dairy analogues, including beverage whiteners.

(11) The opinion of the Authority gives sufficient grounds to establish that Allanblackia seed oil, with the modified specification, in the proposed uses and use levels complies with Article 12(1) of Regulation (EU) 2015/2283.

(12) 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 U.K.

1. The entry in the Union list of authorised novel foods, established in Implementing Regulation (EU) 2017/2470, referring to the substance Allanblackia seed oil shall be amended as specified in the Annex to this Regulation.

2. The entry in the Union list referred to in the first paragraph shall include the conditions of use and labelling requirements laid down in the Annex to this Regulation.

Article 2 U.K.

The Annex to Implementing Regulation (EU) 2017/2470 is amended in accordance with the Annex to this Regulation.

Article 3 U.K.

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 January 2019.

For the Commission

The President

Jean-Claude Juncker

ANNEX U.K.

The Annex to Implementing Regulation (EU) 2017/2470 is amended as follows:

(1)

The entry for ‘Allanblackia seed oil’ in Table 1 (Authorised novel foods) is replaced by the following:

Authorised novel food	Conditions under which the novel food may be used		Additional specific labelling requirements	Other requirements
‘ Allanblackia seed oil	Specified food category	Maximum levels	The designation of the novel food on the labelling of the foodstuffs containing it shall be “Allanblackia seed oil”’
	Yellow fat spreads and cream based spreads	30 g/100 g
	Mixtures of vegetable oils (*) and milk (falling under the food category: Dairy analogues, including beverage whiteners)	30 g/100 g
	(*) Except olive oils and olive pomace oils as defined in Part VIII of Annex VII of Regulation (EU) No 1308/2013.

(2)

The entry for ‘Allanblackia seed oil’ in Table 2 (Specifications) is replaced by the following:

Authorised Novel Food

Specification

‘ Allanblackia seed oil

Description/Definition: Allanblackia seed oil is obtained from the seeds of the allanblackia species: A. floribunda (synonymous with A. parviflora) and A. stuhlmannii. Composition of fatty acids (as a % of the total fatty acids): Lauric acid — Myristic acid — Palmitic acid (C12:0 – C14:0 – C16:0): sum of these acids < 4,0 % Stearic acid (C18:0): 45-58 % Oleic acid (C18:1): 40-51 % Poly unsaturated fatty acids (PUFA): < 2 % Characteristics: Free fatty acids: max 0,1 % of total fatty acids Trans fatty acids: max 1,0 % of total fatty acids Peroxide value: max 1,0 meq/kg Unsaponifiable matter: max 1,0 % (w/w) of the oil Saponification value: 185-198 mg KOH/g’

(1)

OJ L 327, 11.12.2015, p. 1.

(2)

Commission Implementing Regulation (EU) 2017/2470 of 20 December 2017 establishing the Union list of novel foods in accordance with Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods (OJ L 351, 30.12.2017, p. 72).

(3)

Commission Decision 2008/559/EC of 27 June 2008 authorising the placing on the market of allanblackia seed oil as novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council (OJ L 180, 9.7.2008, p. 20).

(4)

Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel foods ingredients (OJ L 43, 14.2.1997, p. 1).

(5)

EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2007. Safety of Allanblackia seed oil for use in yellow fat and cream based spreads, EFSA Journal (2007) 580, 1-10.

(6)

EFSA Journal 2018; 16(8):5362.