Regulation 2
SCHEDULE 2Authorisation of Schizochytrium sp. (FCC-3204) oil as a novel food
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 2003(1), 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 609/2013(2) | 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". |
S.I. 2003/1719 (W. 186), to which there are amendments not relevant to these Regulations.
EUR 2013/609, amended by S.I. 2019/651 and 2020/1476.