The Novel Foods (Authorisations) and Smoke Flavourings (Modification of Authorisations) (Scotland) Regulations 2022

Regulation 3

SCHEDULE 3 Authorisation of Schizochytrium sp. (WZU477) oil

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.
	Infant formula and follow-on formula as defined in Regulation (EU) 609/2013	In accordance with Regulation (EU) 609/2013
					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 of Canaalstaete, Kanaalweg 33, 2903LR Capelle aan den Ijssel, the Netherlands.
					During the period of data protection, the novel food Schizochytrium sp. (WZU477) oil is authorised for placing on the market within Scotland 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 will expire at the end of 29 June 2027.”

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”