EN
L 128/60
Official Journal of the European Union
15.5.2023
COMMISSION IMPLEMENTING REGULATION (EU) 2023/949 of 12 May 2023 authorising the placing on the market of iron milk caseinate as a novel food and amending Implementing Regulation (EU) 2017/2470 (Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No 258/97 of the European Parliament and of the Council and Commission Regulation (EC) No 1852/2001 (1), and in particular Article 12(1) thereof,
Whereas:
(1)
Regulation (EU) 2015/2283 provides that only novel foods authorised and included in the Union list of novel foods may be placed on the market within the Union.
(2)
Pursuant to Article 8 of Regulation (EU) 2015/2283, Commission Implementing Regulation (EU) 2017/2470 (2) has established a Union list of novel foods.
(3)
On 16 June 2020, the company Société des Produits Nestlé S.A. (‘the applicant’) submitted an application to the Commission in accordance with Article 10(1) of Regulation (EU) 2015/2283 to place iron milk proteinate, a complex of iron with casein obtained from bovine milk stabilised by phosphate, on the Union market as a novel food.
The applicant requested for iron milk proteinate to be used as a source of iron in milk and dairy powder products, soft-drinks marketed in relation to physical exercise, powder cocoa beverage preparations, powder or liquid malt-based coffee substitutes, cereal bars, noodles other than glass noodles, stock cubes or granulates (bouillon bases), single meal replacements for weight control, total diet replacement for weight control as defined in Article 2 of Regulation (EU) No 609/2013 of the European Parliament and of the Council (3), foods for special medical purposes as defined in Article 2 of Regulation (EU) No 609/2013 excluding foods for infants and young children, and in food supplements as defined in Article 2 of Directive 2002/46/EC of the European Parliament and of the Council (4) intended for the general population excluding infants and young children.
The proposed use levels in food supplements indicated in the application were up to 700 mg/day corresponding to up to 14 mg iron per day.
The applicant also proposed that food supplements containing iron milk proteinate should not be used if other foods with added iron milk proteinate are consumed the same day.
(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) Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements (OJ L 183, 12.7.2002, p. 51).