SCHEDULE 2Authorisation of Schizochytrium sp. (FCC-3204) oil as a novel food

Regulation 2

1.

In Table 1 (authorised novel foods), after the entry for “Schizochytrium sp. (ATCC PTA-9695) oil”, insert the following entry—

"Schizochytrium sp. (FCC-3204) oil

Specified food category

Maximum levels of DHA

The designation of the novel food on the labelling of the foodstuffs containing it is “Oil from the microalgae Schizochytrium sp.”.

The labelling of food supplements containing  Schizochytrium sp. (FCC-3204) oil must bear a statement that they should not be consumed by infants and children under 3 years of age."

Food Supplements as defined in the Food Supplements (Wales) Regulations 20036, excluding food supplements for infants and children under 3 years of age

1g/day

Infant formula and follow-on formula as defined in Regulation (EU) No 609/20137

In accordance with Regulation (EU) No 609/2013

2.

In Table 2 (specifications), after the entry for “Schizochytrium sp. (ATCC PTA-9695) oil”, insert the following entry—

"Schizochytrium sp. (FCC-3204) oil

Description/Definition:

The novel food is an oil produced from the strain FCC-3204 of the microalgae Schizochytrium sp.

Composition:

Acid value: ≤ 0.5 mg KOH (potassium hydroxide)/g  

Peroxide value (PV): ≤ 5.0 meq (milliequivalent)/kg oil  

Moisture and volatiles: ≤ 0.05 %  

Unsaponifiables: ≤ 4.5 %  

Trans-fatty acids: ≤ 1.0 %  

Docosahexaenoic acid (DHA): ≥ 32.0 %  

P-anisidine value: ≤ 10".