Commission Implementing Regulation (EU) 2019/387 of 11 March 2019 authorising an extension of use of Schizochytrium sp. (ATCC PTA-9695) oil as a novel food and the change of the designation and of the specific labelling requirement of Schizochytrium sp. (ATCC PTA-9695) oil 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.)

• CELEX: Implementing Regulation (EU) 2019/387
• Articles: 4

Article 1

1.   The entry in the Union list of authorised novel foods, established under Implementing Regulation (EU) 2017/2470, referring to the substance Schizochytrium sp. (ATCC PTA-9695) oil shall be amended as specified in the Annex to this Regulation.

2.   The entry in the Union list referred to in paragraph 1 shall include the conditions of use and labelling requirements laid down in the Annex to this Regulation.

Article 2

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

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 .

Schedules & Appendices

ANNEX

ANNEX

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

(1)

The entry for ‘ Schizochytrium sp. (ATCC PTA-9695) 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

‘

Schizochytrium

sp. (ATCC PTA-9695) oil

Specified food category

Maximum levels of DHA

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Oil from the microalgae Schizochytrium sp.’’

Dairy products except milk-based drinks

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

Dairy analogues except drinks

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

Spreadable fats and dressings

600 mg/100 g

Breakfast cereals

500 mg/100 g

Food Supplements as defined in Directive 2002/46/EC

250 mg DHA/day for general population

450 mg DHA/day for pregnant and lactating women

Total diet replacement for weight control as defined in Regulation (EU) No 609/2013 and meal replacements for weight control

250 mg/meal

Milk-based drinks and similar products intended for young children

200 mg/100 g

Foods intended to meet the expenditure of intense muscular effort, especially for sportsmen

Foods bearing statements on the absence or reduced presence of gluten in accordance with the requirements of Commission Implementing Regulation (EU) No 828/2014

Foods for special medical purposes as defined in Regulation (EU) No 609/2013

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

Bakery products (breads, rolls, and sweet biscuits)

200 mg/100 g

Cereal bars

500 mg/100 g

Cooking fats

360 mg/100 g

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

80 mg/100 ml

Infant formula and follow-on formula as defined in Regulation (EU) No 609/2013

In accordance with Regulation (EU) No 609/2013

Processed cereal-based foods and baby foods for infants and young children as defined in Regulation (EU) No 609/2013

200 mg/100 g

Fruit/vegetable puree

100 mg/100 g

(2)

The entry for ‘ Schizochytrium sp. (ATCC PTA-9695) oil’ in Table 2 (Specifications) is replaced by the following:

Authorised novel food

Specification

‘

Schizochytrium

sp. (ATCC PTA-9695) oil

The novel food is obtained from the strain ATCC PTA-9695 of the microalgae Schizochytrium sp.

Peroxide value (PV): ≤ 5,0 meq/kg oil

Unsaponifiables: ≤ 3,5 %

Trans-fatty acids: ≤ 2,0 %

Free fatty acids: ≤ 0,4 %

Docosapentaenoic acid (DPA) n-6: ≤ 7,5 %

DHA content: ≥ 35 %’