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)
Article 1
Article 2
Article 3
ANNEX
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 |
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Dairy analogues except drinks |
200 mg/100 g or for analogues to cheese products 600 mg/100 g |
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Spreadable fats and dressings |
600 mg/100 g |
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Breakfast cereals |
500 mg/100 g |
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Food Supplements as defined in Directive 2002/46/EC |
250 mg DHA/day for general population |
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450 mg DHA/day for pregnant and lactating women |
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Total diet replacement for weight control as defined in Regulation (EU) No 609/2013 and meal replacements for weight control |
250 mg/meal |
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Milk-based drinks and similar products intended for young children |
200 mg/100 g |
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Foods intended to meet the expenditure of intense muscular effort, especially for sportsmen |
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Foods bearing statements on the absence or reduced presence of gluten in accordance with the requirements of Commission Implementing Regulation (EU) No 828/2014 |
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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 |
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Bakery products (breads, rolls, and sweet biscuits) |
200 mg/100 g |
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Cereal bars |
500 mg/100 g |
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Cooking fats |
360 mg/100 g |
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Non-alcoholic beverages (including dairy analogue and milk-based drinks) |
80 mg/100 ml |
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Infant formula and follow-on formula as defined in Regulation (EU) No 609/2013 |
In accordance with Regulation (EU) No 609/2013 |
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Processed cereal-based foods and baby foods for infants and young children as defined in Regulation (EU) No 609/2013 |
200 mg/100 g |
|
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Fruit/vegetable puree |
100 mg/100 g |
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 %’ |