This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 23 April 2021.

For the Commission

The President

Ursula VON DER LEYEN

( 1 ) OJ L 327, 11.12.2015, p. 1 .

( 2 ) Commission Implementing Regulation (EU) 2017/2470 of 20 December 2017 establishing the Union list of novel foods in accordance with Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods ( OJ L 351, 30.12.2017, p. 72 ).

( 3 ) Regulation (EU) No 609/2013 of the European Parliament and of the Council of 12 June 2013 on food intended for infants and young children, food for special medical purposes, and total diet replacement for weight control and repealing Council Directive 92/52/EEC, Commission Directives 96/8/EC, 1999/21/EC, 2006/125/EC and 2006/141/EC, Directive 2009/39/EC of the European Parliament and of the Council and Commission Regulations (EC) No 41/2009 and (EC) No 953/2009 ( OJ L 181, 29.6.2013, p. 35 ).

( 4 ) Annex I (NF application 2012), Progress Biotech bv, 2012 (unpublished).

( 5 ) Detailed description of the production process, Progress Biotech bv, 2019 (unpublished).

( 6 ) Annex II (chemical characteristics), Progress Biotech bv, 2019 (unpublished).

( 7 ) Annex III (fatty acid analysis), Progress Biotech bv, 2019 (unpublished).

( 8 ) Annex IV (sterol analysis), Progress Biotech bv, 2019 (unpublished).

( 9 ) Annex V (heavy metals analysis), Progress Biotech bv, 2019 (unpublished).

( 10 ) Annex VI (PAH analysis), Progress Biotech bv, 2019 (unpublished).

( 11 ) Annex VII (mycotoxin analysis), Progress Biotech bv, 2019 (unpublished).

( 12 ) Annex VIII (dioxin, dioxin like, PCB, pesticides analysis), Progress Biotech bv, 2019 (unpublished).

( 13 ) Annex IX (microbiological analysis), Progress Biotech bv, 2019 (unpublished).

( 14 ) Annex XI (retrospective stability study), Progress Biotech bv, 2019 (unpublished).

( 15 ) Annex XII (analytical lab certificates), (unpublished).

( 16 ) Appendix B.2 (compositional data), Progress Biotech bv, 2019 (unpublished).

( 17 ) Annex IV (protein analysis), Progress Biotech bv, 2020 (unpublished).

( 18 ) Annex VI (3 MCPD & glycidyl ester analyses), Progress Biotech bv, 2020 (unpublished).

( 19 ) Annex VII (physicochemical analysis), Progress Biotech bv, 2020 (unpublished).

( 20 ) Annex VIII (microbiological analysis), Progress Biotech bv, 2020 (unpublished).

( 21 ) Annex IX (heavy metals analysis), Progress Biotech bv, 2020 (unpublished).

( 22 ) Annex X (mycotoxin analysis), Progress Biotech bv, 2019 (unpublished).

( 23 ) Annex XI (PAH, dioxin and dioxin-like contaminants analysis), Progress Biotech bv, 2020 (unpublished).

( 24 ) Annex XII (fatty acid profile analysis), Progress Biotech bv, 2020 (unpublished)

( 25 ) Annex XIV (sterol composition analysis), Progress Biotech bv, 2020 (unpublished).

( 26 ) Annex XVII (hydrolytic rancidity analysis over time), Progress Biotech bv, 2020 (unpublished).

( 27 ) Annex 1 (marine biotoxin analysis), Wageningen Food Safety Research Lab, 2020 (unpublished).

( 28 ) Annex 3 (stability study), Progress Biotech bv, 2018 (unpublished).

( 29 ) Annex I (certificate of analysis), Progress Biotech bv, 2016 (unpublished).

( 30 ) EFSA Journal 2020;18(10):6242.

( 31 ) EFSA BIOHAZ Panel, 2020. Statement on the update of the list of QPS-recommended biological agents intentionally added to food or feed as notified to EFSA 11: suitability of taxonomic units notified to EFSA until September 2019. EFSA Journal 2020;18(2):5965, 57 pp.

COMMISSION IMPLEMENTING REGULATION (EU) 2021/670 of 23 April 2021 authorising the placing on the market of ANNEX