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Regulation 3
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” |
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