LegalizeCommission Implementing Regulation (EU) 2023/65 of 6 January 2023 correcting Implementing Regulation (EU) 2017/2470 establishing the Union list of novel foods, Implementing Regulation (EU) 2018/1648 authorising the placing on the market of xylo-oligosaccharides as a novel food, Implementing Regulation (EU) 2019/1686 authorising the extension of use of bovine milk basic whey protein isolate as a novel food, and Implementing Regulation (EU) 2021/96 authorising the placing on the market of 3'-sialyllactose sodium salt as a novel food (Text with EEA relevance)
This is the act as published. Later amendments are not folded into the text below: each one is a separate act in this repository and an entry in this law's history.
| Authorised novel food | Conditions under which the novel food may be used | Conditions under which the novel food may be used | Additional specific labelling requirements | Other requirements | Data Protection |
|---|---|---|---|---|---|
| ‘Bovine milk basic whey protein isolate | Specified food category | Maximum levels | The designation of the novel food on the labelling of the foodstuffs containing it shall be “Milk whey protein isolate”. Food supplements containing bovine milk basic whey protein isolate shall bear the following statement: “This food supplement should not be consumed by infants/children/adolescents under the age of one/three/eighteen () years” () Depending on the age group the food supplement is intended for. | Authorised on 20 November 2018. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283. Applicant: Armor Protéines S.A.S., 19 bis, rue de la Libération 35460 Saint-Brice-en-Coglès, France. During the period of data protection the novel food bovine milk basic whey protein isolate is authorised for placing on the market within the Union only by Armor Protéines S.A.S. 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 Armor Protéines S.A.S. End date of the data protection: 20 November 2023.’ | |
| ‘Bovine milk basic whey protein isolate | Infant formulae as defined in Regulation (EU) No 609/2013 | 30 mg/100 g (powder) | The designation of the novel food on the labelling of the foodstuffs containing it shall be “Milk whey protein isolate”. Food supplements containing bovine milk basic whey protein isolate shall bear the following statement: “This food supplement should not be consumed by infants/children/adolescents under the age of one/three/eighteen () years” () Depending on the age group the food supplement is intended for. | Authorised on 20 November 2018. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283. Applicant: Armor Protéines S.A.S., 19 bis, rue de la Libération 35460 Saint-Brice-en-Coglès, France. During the period of data protection the novel food bovine milk basic whey protein isolate is authorised for placing on the market within the Union only by Armor Protéines S.A.S. 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 Armor Protéines S.A.S. End date of the data protection: 20 November 2023.’ | |
| ‘Bovine milk basic whey protein isolate | Infant formulae as defined in Regulation (EU) No 609/2013 | 3,9 mg/100 mL (reconstituted) | The designation of the novel food on the labelling of the foodstuffs containing it shall be “Milk whey protein isolate”. Food supplements containing bovine milk basic whey protein isolate shall bear the following statement: “This food supplement should not be consumed by infants/children/adolescents under the age of one/three/eighteen () years” () Depending on the age group the food supplement is intended for. | Authorised on 20 November 2018. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283. Applicant: Armor Protéines S.A.S., 19 bis, rue de la Libération 35460 Saint-Brice-en-Coglès, France. During the period of data protection the novel food bovine milk basic whey protein isolate is authorised for placing on the market within the Union only by Armor Protéines S.A.S. 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 Armor Protéines S.A.S. End date of the data protection: 20 November 2023.’ | |
| ‘Bovine milk basic whey protein isolate | Follow-on formulae as defined in Regulation (EU) No 609/2013 | 30 mg/100 g (powder) | The designation of the novel food on the labelling of the foodstuffs containing it shall be “Milk whey protein isolate”. Food supplements containing bovine milk basic whey protein isolate shall bear the following statement: “This food supplement should not be consumed by infants/children/adolescents under the age of one/three/eighteen () years” () Depending on the age group the food supplement is intended for. | Authorised on 20 November 2018. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283. Applicant: Armor Protéines S.A.S., 19 bis, rue de la Libération 35460 Saint-Brice-en-Coglès, France. During the period of data protection the novel food bovine milk basic whey protein isolate is authorised for placing on the market within the Union only by Armor Protéines S.A.S. 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 Armor Protéines S.A.S. End date of the data protection: 20 November 2023.’ | |
| ‘Bovine milk basic whey protein isolate | Follow-on formulae as defined in Regulation (EU) No 609/2013 | 4,2 mg/100 mL (reconstituted) | The designation of the novel food on the labelling of the foodstuffs containing it shall be “Milk whey protein isolate”. Food supplements containing bovine milk basic whey protein isolate shall bear the following statement: “This food supplement should not be consumed by infants/children/adolescents under the age of one/three/eighteen () years” () Depending on the age group the food supplement is intended for. | Authorised on 20 November 2018. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283. Applicant: Armor Protéines S.A.S., 19 bis, rue de la Libération 35460 Saint-Brice-en-Coglès, France. During the period of data protection the novel food bovine milk basic whey protein isolate is authorised for placing on the market within the Union only by Armor Protéines S.A.S. 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 Armor Protéines S.A.S. End date of the data protection: 20 November 2023.’ | |
| ‘Bovine milk basic whey protein isolate | Total diet replacement foods for weight control as defined in Regulation (EU) No 609/2013 | 300 mg/day | The designation of the novel food on the labelling of the foodstuffs containing it shall be “Milk whey protein isolate”. Food supplements containing bovine milk basic whey protein isolate shall bear the following statement: “This food supplement should not be consumed by infants/children/adolescents under the age of one/three/eighteen () years” () Depending on the age group the food supplement is intended for. | Authorised on 20 November 2018. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283. Applicant: Armor Protéines S.A.S., 19 bis, rue de la Libération 35460 Saint-Brice-en-Coglès, France. During the period of data protection the novel food bovine milk basic whey protein isolate is authorised for placing on the market within the Union only by Armor Protéines S.A.S. 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 Armor Protéines S.A.S. End date of the data protection: 20 November 2023.’ | |
| ‘Bovine milk basic whey protein isolate | Foods for special medical purposes as defined in Regulation (EU) No 609/2013 | 30 mg/100 g (powder formula for infants during the first months of life until the introduction of appropriate complementary feeding) | The designation of the novel food on the labelling of the foodstuffs containing it shall be “Milk whey protein isolate”. Food supplements containing bovine milk basic whey protein isolate shall bear the following statement: “This food supplement should not be consumed by infants/children/adolescents under the age of one/three/eighteen () years” () Depending on the age group the food supplement is intended for. | Authorised on 20 November 2018. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283. Applicant: Armor Protéines S.A.S., 19 bis, rue de la Libération 35460 Saint-Brice-en-Coglès, France. During the period of data protection the novel food bovine milk basic whey protein isolate is authorised for placing on the market within the Union only by Armor Protéines S.A.S. 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 Armor Protéines S.A.S. End date of the data protection: 20 November 2023.’ | |
| ‘Bovine milk basic whey protein isolate | Foods for special medical purposes as defined in Regulation (EU) No 609/2013 | 3,9 mg/100 mL (reconstituted formula for infants during the first months of life until the introduction of appropriate complementary feeding) | The designation of the novel food on the labelling of the foodstuffs containing it shall be “Milk whey protein isolate”. Food supplements containing bovine milk basic whey protein isolate shall bear the following statement: “This food supplement should not be consumed by infants/children/adolescents under the age of one/three/eighteen () years” () Depending on the age group the food supplement is intended for. | Authorised on 20 November 2018. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283. Applicant: Armor Protéines S.A.S., 19 bis, rue de la Libération 35460 Saint-Brice-en-Coglès, France. During the period of data protection the novel food bovine milk basic whey protein isolate is authorised for placing on the market within the Union only by Armor Protéines S.A.S. 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 Armor Protéines S.A.S. End date of the data protection: 20 November 2023.’ | |
| ‘Bovine milk basic whey protein isolate | Foods for special medical purposes as defined in Regulation (EU) No 609/2013 | 30 mg/100 g (powder formula for infants when appropriate complementary feeding is introduced) | The designation of the novel food on the labelling of the foodstuffs containing it shall be “Milk whey protein isolate”. Food supplements containing bovine milk basic whey protein isolate shall bear the following statement: “This food supplement should not be consumed by infants/children/adolescents under the age of one/three/eighteen () years” () Depending on the age group the food supplement is intended for. | Authorised on 20 November 2018. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283. Applicant: Armor Protéines S.A.S., 19 bis, rue de la Libération 35460 Saint-Brice-en-Coglès, France. During the period of data protection the novel food bovine milk basic whey protein isolate is authorised for placing on the market within the Union only by Armor Protéines S.A.S. 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 Armor Protéines S.A.S. End date of the data protection: 20 November 2023.’ | |
| ‘Bovine milk basic whey protein isolate | Foods for special medical purposes as defined in Regulation (EU) No 609/2013 | 4,2 mg/100 mL (reconstituted formula for infants when appropriate complementary feeding is introduced) | The designation of the novel food on the labelling of the foodstuffs containing it shall be “Milk whey protein isolate”. Food supplements containing bovine milk basic whey protein isolate shall bear the following statement: “This food supplement should not be consumed by infants/children/adolescents under the age of one/three/eighteen () years” () Depending on the age group the food supplement is intended for. | Authorised on 20 November 2018. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283. Applicant: Armor Protéines S.A.S., 19 bis, rue de la Libération 35460 Saint-Brice-en-Coglès, France. During the period of data protection the novel food bovine milk basic whey protein isolate is authorised for placing on the market within the Union only by Armor Protéines S.A.S. 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 Armor Protéines S.A.S. End date of the data protection: 20 November 2023.’ | |
| ‘Bovine milk basic whey protein isolate | Foods for special medical purposes as defined in Regulation (EU) No 609/2013 | 58 mg/day for young children | The designation of the novel food on the labelling of the foodstuffs containing it shall be “Milk whey protein isolate”. Food supplements containing bovine milk basic whey protein isolate shall bear the following statement: “This food supplement should not be consumed by infants/children/adolescents under the age of one/three/eighteen () years” () Depending on the age group the food supplement is intended for. | Authorised on 20 November 2018. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283. Applicant: Armor Protéines S.A.S., 19 bis, rue de la Libération 35460 Saint-Brice-en-Coglès, France. During the period of data protection the novel food bovine milk basic whey protein isolate is authorised for placing on the market within the Union only by Armor Protéines S.A.S. 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 Armor Protéines S.A.S. End date of the data protection: 20 November 2023.’ | |
| ‘Bovine milk basic whey protein isolate | Foods for special medical purposes as defined in Regulation (EU) No 609/2013 | 380 mg/day for children and adolescents from 3 to 18 years of age | The designation of the novel food on the labelling of the foodstuffs containing it shall be “Milk whey protein isolate”. Food supplements containing bovine milk basic whey protein isolate shall bear the following statement: “This food supplement should not be consumed by infants/children/adolescents under the age of one/three/eighteen () years” () Depending on the age group the food supplement is intended for. | Authorised on 20 November 2018. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283. Applicant: Armor Protéines S.A.S., 19 bis, rue de la Libération 35460 Saint-Brice-en-Coglès, France. During the period of data protection the novel food bovine milk basic whey protein isolate is authorised for placing on the market within the Union only by Armor Protéines S.A.S. 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 Armor Protéines S.A.S. End date of the data protection: 20 November 2023.’ | |
| ‘Bovine milk basic whey protein isolate | Foods for special medical purposes as defined in Regulation (EU) No 609/2013 | 610 mg/day for adults | The designation of the novel food on the labelling of the foodstuffs containing it shall be “Milk whey protein isolate”. Food supplements containing bovine milk basic whey protein isolate shall bear the following statement: “This food supplement should not be consumed by infants/children/adolescents under the age of one/three/eighteen () years” () Depending on the age group the food supplement is intended for. | Authorised on 20 November 2018. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283. Applicant: Armor Protéines S.A.S., 19 bis, rue de la Libération 35460 Saint-Brice-en-Coglès, France. During the period of data protection the novel food bovine milk basic whey protein isolate is authorised for placing on the market within the Union only by Armor Protéines S.A.S. 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 Armor Protéines S.A.S. End date of the data protection: 20 November 2023.’ | |
| ‘Bovine milk basic whey protein isolate | Food supplements as defined in Directive 2002/46/EC | 25 mg/day for infants | The designation of the novel food on the labelling of the foodstuffs containing it shall be “Milk whey protein isolate”. Food supplements containing bovine milk basic whey protein isolate shall bear the following statement: “This food supplement should not be consumed by infants/children/adolescents under the age of one/three/eighteen () years” () Depending on the age group the food supplement is intended for. | Authorised on 20 November 2018. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283. Applicant: Armor Protéines S.A.S., 19 bis, rue de la Libération 35460 Saint-Brice-en-Coglès, France. During the period of data protection the novel food bovine milk basic whey protein isolate is authorised for placing on the market within the Union only by Armor Protéines S.A.S. 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 Armor Protéines S.A.S. End date of the data protection: 20 November 2023.’ | |
| ‘Bovine milk basic whey protein isolate | Food supplements as defined in Directive 2002/46/EC | 58 mg/day for young children | The designation of the novel food on the labelling of the foodstuffs containing it shall be “Milk whey protein isolate”. Food supplements containing bovine milk basic whey protein isolate shall bear the following statement: “This food supplement should not be consumed by infants/children/adolescents under the age of one/three/eighteen () years” () Depending on the age group the food supplement is intended for. | Authorised on 20 November 2018. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283. Applicant: Armor Protéines S.A.S., 19 bis, rue de la Libération 35460 Saint-Brice-en-Coglès, France. During the period of data protection the novel food bovine milk basic whey protein isolate is authorised for placing on the market within the Union only by Armor Protéines S.A.S. 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 Armor Protéines S.A.S. End date of the data protection: 20 November 2023.’ | |
| ‘Bovine milk basic whey protein isolate | Food supplements as defined in Directive 2002/46/EC | 250 mg/day for children and adolescents from 3 to 18 years of age | The designation of the novel food on the labelling of the foodstuffs containing it shall be “Milk whey protein isolate”. Food supplements containing bovine milk basic whey protein isolate shall bear the following statement: “This food supplement should not be consumed by infants/children/adolescents under the age of one/three/eighteen () years” () Depending on the age group the food supplement is intended for. | Authorised on 20 November 2018. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283. Applicant: Armor Protéines S.A.S., 19 bis, rue de la Libération 35460 Saint-Brice-en-Coglès, France. During the period of data protection the novel food bovine milk basic whey protein isolate is authorised for placing on the market within the Union only by Armor Protéines S.A.S. 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 Armor Protéines S.A.S. End date of the data protection: 20 November 2023.’ | |
| ‘Bovine milk basic whey protein isolate | Food supplements as defined in Directive 2002/46/EC | 610 mg/day for adults | The designation of the novel food on the labelling of the foodstuffs containing it shall be “Milk whey protein isolate”. Food supplements containing bovine milk basic whey protein isolate shall bear the following statement: “This food supplement should not be consumed by infants/children/adolescents under the age of one/three/eighteen () years” () Depending on the age group the food supplement is intended for. | Authorised on 20 November 2018. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283. Applicant: Armor Protéines S.A.S., 19 bis, rue de la Libération 35460 Saint-Brice-en-Coglès, France. During the period of data protection the novel food bovine milk basic whey protein isolate is authorised for placing on the market within the Union only by Armor Protéines S.A.S. 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 Armor Protéines S.A.S. End date of the data protection: 20 November 2023.’ |
ANNEX IV
Correction of Implementing Regulation (EU) 2021/96
In point 1 of the Annex to Implementing Regulation (EU) 2021/96, in Table 1 (Authorised novel foods), the entry for ‘3'-Sialyllactose (3'-SL) sodium salt (microbial source)’ is replaced by the following:
| Authorised novel food | Conditions under which the novel food may be used | Conditions under which the novel food may be used | Additional specific labelling requirements | Other requirements | Data Protection |
|---|---|---|---|---|---|
| ‘3'-Sialyllactose (3'-SL) sodium salt (microbial source) | Specified food category | Maximum levels (expressed as 3'-Sialyllactose) | The designation of the novel food on the labelling of the foodstuffs containing it shall be “3'-Sialyllactose sodium salt”. The labelling of food supplements containing 3'-Sialyllactose sodium salt shall bear a statement that they should not be consumed: a) if foods containing added 3'-Sialyllactose sodium salt are consumed the same day. b) by infants and young children | Authorised on 18 February 2021. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283. Applicant: Glycom A/S, Kogle Allé 4, DK-2970 Hørsholm, Denmark. During the period of data protection, the novel food 3'-sialyllactose sodium salt is authorised for placing on the market within the Union only by Glycom A/S, 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 Glycom A/S. End date of the data protection: 18 February 2026.’ | |
| ‘3'-Sialyllactose (3'-SL) sodium salt (microbial source) | Unflavoured pasteurised and unflavoured sterilised (including UHT) milk products | 0,25 g/L | The designation of the novel food on the labelling of the foodstuffs containing it shall be “3'-Sialyllactose sodium salt”. The labelling of food supplements containing 3'-Sialyllactose sodium salt shall bear a statement that they should not be consumed: a) if foods containing added 3'-Sialyllactose sodium salt are consumed the same day. b) by infants and young children | Authorised on 18 February 2021. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283. Applicant: Glycom A/S, Kogle Allé 4, DK-2970 Hørsholm, Denmark. During the period of data protection, the novel food 3'-sialyllactose sodium salt is authorised for placing on the market within the Union only by Glycom A/S, 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 Glycom A/S. End date of the data protection: 18 February 2026.’ | |
| ‘3'-Sialyllactose (3'-SL) sodium salt (microbial source) | Unflavoured fermented milk-based products | 0,25 g/L (beverages) | The designation of the novel food on the labelling of the foodstuffs containing it shall be “3'-Sialyllactose sodium salt”. The labelling of food supplements containing 3'-Sialyllactose sodium salt shall bear a statement that they should not be consumed: a) if foods containing added 3'-Sialyllactose sodium salt are consumed the same day. b) by infants and young children | Authorised on 18 February 2021. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283. Applicant: Glycom A/S, Kogle Allé 4, DK-2970 Hørsholm, Denmark. During the period of data protection, the novel food 3'-sialyllactose sodium salt is authorised for placing on the market within the Union only by Glycom A/S, 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 Glycom A/S. End date of the data protection: 18 February 2026.’ | |
| ‘3'-Sialyllactose (3'-SL) sodium salt (microbial source) | Unflavoured fermented milk-based products | 0,5 g/kg (products other than beverages) | The designation of the novel food on the labelling of the foodstuffs containing it shall be “3'-Sialyllactose sodium salt”. The labelling of food supplements containing 3'-Sialyllactose sodium salt shall bear a statement that they should not be consumed: a) if foods containing added 3'-Sialyllactose sodium salt are consumed the same day. b) by infants and young children | Authorised on 18 February 2021. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283. Applicant: Glycom A/S, Kogle Allé 4, DK-2970 Hørsholm, Denmark. During the period of data protection, the novel food 3'-sialyllactose sodium salt is authorised for placing on the market within the Union only by Glycom A/S, 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 Glycom A/S. End date of the data protection: 18 February 2026.’ | |
| ‘3'-Sialyllactose (3'-SL) sodium salt (microbial source) | Flavoured fermented milk-based products including heat-treated products | 0,25 g/L (beverages) | The designation of the novel food on the labelling of the foodstuffs containing it shall be “3'-Sialyllactose sodium salt”. The labelling of food supplements containing 3'-Sialyllactose sodium salt shall bear a statement that they should not be consumed: a) if foods containing added 3'-Sialyllactose sodium salt are consumed the same day. b) by infants and young children | Authorised on 18 February 2021. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283. Applicant: Glycom A/S, Kogle Allé 4, DK-2970 Hørsholm, Denmark. During the period of data protection, the novel food 3'-sialyllactose sodium salt is authorised for placing on the market within the Union only by Glycom A/S, 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 Glycom A/S. End date of the data protection: 18 February 2026.’ | |
| ‘3'-Sialyllactose (3'-SL) sodium salt (microbial source) | Flavoured fermented milk-based products including heat-treated products | 2,5 g/kg (products other than beverages) | The designation of the novel food on the labelling of the foodstuffs containing it shall be “3'-Sialyllactose sodium salt”. The labelling of food supplements containing 3'-Sialyllactose sodium salt shall bear a statement that they should not be consumed: a) if foods containing added 3'-Sialyllactose sodium salt are consumed the same day. b) by infants and young children | Authorised on 18 February 2021. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283. Applicant: Glycom A/S, Kogle Allé 4, DK-2970 Hørsholm, Denmark. During the period of data protection, the novel food 3'-sialyllactose sodium salt is authorised for placing on the market within the Union only by Glycom A/S, 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 Glycom A/S. End date of the data protection: 18 February 2026.’ | |
| ‘3'-Sialyllactose (3'-SL) sodium salt (microbial source) | Beverages (flavoured drinks, excluding drinks with a pH less than 5) | 0,25 g/L | The designation of the novel food on the labelling of the foodstuffs containing it shall be “3'-Sialyllactose sodium salt”. The labelling of food supplements containing 3'-Sialyllactose sodium salt shall bear a statement that they should not be consumed: a) if foods containing added 3'-Sialyllactose sodium salt are consumed the same day. b) by infants and young children | Authorised on 18 February 2021. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283. Applicant: Glycom A/S, Kogle Allé 4, DK-2970 Hørsholm, Denmark. During the period of data protection, the novel food 3'-sialyllactose sodium salt is authorised for placing on the market within the Union only by Glycom A/S, 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 Glycom A/S. End date of the data protection: 18 February 2026.’ | |
| ‘3'-Sialyllactose (3'-SL) sodium salt (microbial source) | Cereal bars | 2,5 g/kg | The designation of the novel food on the labelling of the foodstuffs containing it shall be “3'-Sialyllactose sodium salt”. The labelling of food supplements containing 3'-Sialyllactose sodium salt shall bear a statement that they should not be consumed: a) if foods containing added 3'-Sialyllactose sodium salt are consumed the same day. b) by infants and young children | Authorised on 18 February 2021. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283. Applicant: Glycom A/S, Kogle Allé 4, DK-2970 Hørsholm, Denmark. During the period of data protection, the novel food 3'-sialyllactose sodium salt is authorised for placing on the market within the Union only by Glycom A/S, 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 Glycom A/S. End date of the data protection: 18 February 2026.’ | |
| ‘3'-Sialyllactose (3'-SL) sodium salt (microbial source) | Infant formula as defined in Regulation (EU) No 609/2013 | 0,2 g/L in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer | The designation of the novel food on the labelling of the foodstuffs containing it shall be “3'-Sialyllactose sodium salt”. The labelling of food supplements containing 3'-Sialyllactose sodium salt shall bear a statement that they should not be consumed: a) if foods containing added 3'-Sialyllactose sodium salt are consumed the same day. b) by infants and young children | Authorised on 18 February 2021. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283. Applicant: Glycom A/S, Kogle Allé 4, DK-2970 Hørsholm, Denmark. During the period of data protection, the novel food 3'-sialyllactose sodium salt is authorised for placing on the market within the Union only by Glycom A/S, 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 Glycom A/S. End date of the data protection: 18 February 2026.’ | |
| ‘3'-Sialyllactose (3'-SL) sodium salt (microbial source) | Follow-on formula as defined in Regulation (EU) No 609/2013 | 0,15 g/L in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer | The designation of the novel food on the labelling of the foodstuffs containing it shall be “3'-Sialyllactose sodium salt”. The labelling of food supplements containing 3'-Sialyllactose sodium salt shall bear a statement that they should not be consumed: a) if foods containing added 3'-Sialyllactose sodium salt are consumed the same day. b) by infants and young children | Authorised on 18 February 2021. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283. Applicant: Glycom A/S, Kogle Allé 4, DK-2970 Hørsholm, Denmark. During the period of data protection, the novel food 3'-sialyllactose sodium salt is authorised for placing on the market within the Union only by Glycom A/S, 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 Glycom A/S. End date of the data protection: 18 February 2026.’ | |
| ‘3'-Sialyllactose (3'-SL) sodium salt (microbial source) | Processed cereal-based food and baby food for infants and young children as defined in Regulation (EU) No 609/2013 | 0,15 g/L (beverages) in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer | The designation of the novel food on the labelling of the foodstuffs containing it shall be “3'-Sialyllactose sodium salt”. The labelling of food supplements containing 3'-Sialyllactose sodium salt shall bear a statement that they should not be consumed: a) if foods containing added 3'-Sialyllactose sodium salt are consumed the same day. b) by infants and young children | Authorised on 18 February 2021. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283. Applicant: Glycom A/S, Kogle Allé 4, DK-2970 Hørsholm, Denmark. During the period of data protection, the novel food 3'-sialyllactose sodium salt is authorised for placing on the market within the Union only by Glycom A/S, 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 Glycom A/S. End date of the data protection: 18 February 2026.’ | |
| ‘3'-Sialyllactose (3'-SL) sodium salt (microbial source) | Processed cereal-based food and baby food for infants and young children as defined in Regulation (EU) No 609/2013 | 1,25 g/kg for products other than beverages | The designation of the novel food on the labelling of the foodstuffs containing it shall be “3'-Sialyllactose sodium salt”. The labelling of food supplements containing 3'-Sialyllactose sodium salt shall bear a statement that they should not be consumed: a) if foods containing added 3'-Sialyllactose sodium salt are consumed the same day. b) by infants and young children | Authorised on 18 February 2021. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283. Applicant: Glycom A/S, Kogle Allé 4, DK-2970 Hørsholm, Denmark. During the period of data protection, the novel food 3'-sialyllactose sodium salt is authorised for placing on the market within the Union only by Glycom A/S, 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 Glycom A/S. End date of the data protection: 18 February 2026.’ | |
| ‘3'-Sialyllactose (3'-SL) sodium salt (microbial source) | Milk-based drinks and similar products intended for young children | 0,15 g/L in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer | The designation of the novel food on the labelling of the foodstuffs containing it shall be “3'-Sialyllactose sodium salt”. The labelling of food supplements containing 3'-Sialyllactose sodium salt shall bear a statement that they should not be consumed: a) if foods containing added 3'-Sialyllactose sodium salt are consumed the same day. b) by infants and young children | Authorised on 18 February 2021. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283. Applicant: Glycom A/S, Kogle Allé 4, DK-2970 Hørsholm, Denmark. During the period of data protection, the novel food 3'-sialyllactose sodium salt is authorised for placing on the market within the Union only by Glycom A/S, 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 Glycom A/S. End date of the data protection: 18 February 2026.’ | |
| ‘3'-Sialyllactose (3'-SL) sodium salt (microbial source) | Total diet replacement foods for weight control as defined in Regulation (EU) No 609/2013 | 0,5 g/L (beverages) | The designation of the novel food on the labelling of the foodstuffs containing it shall be “3'-Sialyllactose sodium salt”. The labelling of food supplements containing 3'-Sialyllactose sodium salt shall bear a statement that they should not be consumed: a) if foods containing added 3'-Sialyllactose sodium salt are consumed the same day. b) by infants and young children | Authorised on 18 February 2021. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283. Applicant: Glycom A/S, Kogle Allé 4, DK-2970 Hørsholm, Denmark. During the period of data protection, the novel food 3'-sialyllactose sodium salt is authorised for placing on the market within the Union only by Glycom A/S, 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 Glycom A/S. End date of the data protection: 18 February 2026.’ | |
| ‘3'-Sialyllactose (3'-SL) sodium salt (microbial source) | Total diet replacement foods for weight control as defined in Regulation (EU) No 609/2013 | 5 g/kg (products other than beverages) | The designation of the novel food on the labelling of the foodstuffs containing it shall be “3'-Sialyllactose sodium salt”. The labelling of food supplements containing 3'-Sialyllactose sodium salt shall bear a statement that they should not be consumed: a) if foods containing added 3'-Sialyllactose sodium salt are consumed the same day. b) by infants and young children | Authorised on 18 February 2021. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283. Applicant: Glycom A/S, Kogle Allé 4, DK-2970 Hørsholm, Denmark. During the period of data protection, the novel food 3'-sialyllactose sodium salt is authorised for placing on the market within the Union only by Glycom A/S, 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 Glycom A/S. End date of the data protection: 18 February 2026.’ | |
| ‘3'-Sialyllactose (3'-SL) sodium salt (microbial source) | Food for special medical purposes as defined in Regulation (EU) No 609/2013 | In accordance with the particular nutritional requirements of the persons for whom the products are intended | The designation of the novel food on the labelling of the foodstuffs containing it shall be “3'-Sialyllactose sodium salt”. The labelling of food supplements containing 3'-Sialyllactose sodium salt shall bear a statement that they should not be consumed: a) if foods containing added 3'-Sialyllactose sodium salt are consumed the same day. b) by infants and young children | Authorised on 18 February 2021. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283. Applicant: Glycom A/S, Kogle Allé 4, DK-2970 Hørsholm, Denmark. During the period of data protection, the novel food 3'-sialyllactose sodium salt is authorised for placing on the market within the Union only by Glycom A/S, 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 Glycom A/S. End date of the data protection: 18 February 2026.’ | |
| ‘3'-Sialyllactose (3'-SL) sodium salt (microbial source) | Food Supplements as defined in Directive 2002/46/EC, excluding food supplements for infants and young children | 0,5 g/day | The designation of the novel food on the labelling of the foodstuffs containing it shall be “3'-Sialyllactose sodium salt”. The labelling of food supplements containing 3'-Sialyllactose sodium salt shall bear a statement that they should not be consumed: a) if foods containing added 3'-Sialyllactose sodium salt are consumed the same day. b) by infants and young children | Authorised on 18 February 2021. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283. Applicant: Glycom A/S, Kogle Allé 4, DK-2970 Hørsholm, Denmark. During the period of data protection, the novel food 3'-sialyllactose sodium salt is authorised for placing on the market within the Union only by Glycom A/S, 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 Glycom A/S. End date of the data protection: 18 February 2026.’ |
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