Regulation 2
1. In Table 1 (authorised novel foods), after the entry for “Schizochytrium sp. (T18) oil”, insert the following entry—
| "Schizochytrium sp. (WZU477) 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.”. | Included in the list on 30 June 2022. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283. Applicant: Progress Biotech BV, Canaalstaete, Kanaalweg 33, 2903LR Capelle aan den Ijssel, the Netherlands. During the period of data protection, Schizochytrium sp. (WZU477) oil is authorised for placing on the market within Wales only by Progress Biotech BV unless a subsequent applicant obtains authorisation for the novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283 or with the agreement of Progress Biotech BV. The data protection ends at the end of 29 June 2027." | |
| Infant formula and follow-on formula as defined in Regulation (EU) No 609/2013 | In accordance with Regulation (EU) No 609/2013 |
2. In Table 2 (specifications), after the entry for “Schizochytrium sp. (T18) oil”, insert the following entry—
| "Schizochytrium sp. (WZU477) oil | Description/Definition: The novel food is an oil produced from the strain WZU477 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". |