Commission Implementing Regulation (EU) 2021/670 of 23 April 2021 authorising the placing on the market of Schizochytrium sp. (WZU477) oil as a novel food under Regulation (EU) 2015/2283 of the European Parliament and of the Council, and amending Commission Implementing Regulation (EU) 2017/2470 (Text with EEA relevance)
1. Schizochytrium sp. (WZU477) oil as specified in the Annex to this Regulation shall be included in the Union list of authorised novel foods established in Implementing Regulation (EU) 2017/2470.
2. For a period of five years from the date of entry into force of this Regulation only the initial applicant:
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Company: Progress Biotech bv,
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Address: Canaalstaete, Kanaalweg 33, 2903LR Capelle aan den Ijssel, the Netherlands,
is authorised to place on the market within the Union the novel food referred to in paragraph 1, unless a subsequent applicant obtains authorisation for that novel food without reference to the data protected pursuant to Article 2 of this Regulation or with the agreement of Progress Biotech bv.
3. The entry in the Union list referred to in paragraph 1 shall include the conditions of use and labelling requirements laid down in the Annex to this Regulation.
The data contained in the application file on the basis of which the novel food referred to in Article 1 has been assessed by the Authority, claimed by the applicant as proprietary and without which the novel food could not have been authorised, shall not be used for the benefit of any subsequent applicant for a period of five years from the date of entry into force of this Regulation, without the agreement of Progress Biotech bv.
The Annex to Implementing Regulation (EU) 2017/2470 is amended in accordance with the Annex to this Regulation.
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .
Supplementary provisions
ANNEXSupplementary provisions
ANNEX
The Annex to Implementing Regulation (EU) 2017/2470 is amended as follows:
(1)
in Table 1 (Authorised novel foods), the following entry is inserted:
Authorised novel food
Conditions under which the novel food may be used
Additional specific labelling requirements
Other requirements
Data protection
‘ 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 shall be “Oil from the microalgae Schizochytrium sp.”
Authorised on 16 May 2021. 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, the novel food is authorised for placing on the market within the Union only by Progress Biotech bv unless a subsequent applicant obtains authorisation for that 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.
End date of the data protection: 16 May 2026 (5 years).’
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), the following entry is inserted:
Authorised Novel Food
Specification
‘ 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/g
Peroxide value (PV): ≤ 5,0 meq/kg oil
Moisture and volatiles: ≤ 0,05 %
Unsaponifiables: ≤ 4,5 %
Trans-fatty acids: ≤ 1,0 %
Docosahexaenoic acid (DHA): ≥ 32,0 %
p-anisidine value: ≤ 10’
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.
