Iron milk caseinate authorised as a novel food in certain foods and supplements
Published by AGRINFO on
Commission to include iron milk caseinate as a source of iron for use in certain foods and food supplements. TBT consultation
Draft Commission Regulation amending Annex II to Regulation (EC) No 1925/2006 of the European Parliament and of the Council and Annex II to Directive 2002/46/EC of the European Parliament and of the council as regards iron milk caseinate added to foods and used in the manufacture of food supplements
Draft Annex
Draft Commission Delegated Regulation amending the Annex to Regulation (EU) No 609/2013 of the European Parliament and of the Council to allow the use of iron milk caseinate as a source of iron in total diet replacement for weight control and food for special medical purposes, excluding infants and young children
Draft Annex
Update
The European Commission has informed the World Trade Organization Technical Barriers to Trade (WTO TBT) Committee that it plans to include iron milk caseinate in the list of sources of iron that can be used in certain foods, food supplements, total diet replacements for weight control, and foods for special medical purposes, excluding for infants and young children (G/TBT/N/EU/1020, G/TBT/N/EU/1021).
What is changing?
Regulation (EU) 2023/949 authorised the use of iron milk caseinate as a novel food in May 2023. In line with this decision, the European Commission is now updating the list of sources of iron that may be used in foods (Annex II to Regulation 1925/2006) and in food supplements (Annex II to Directive 2002/46/EC).
It also proposes to amend the Annex to Regulation 609/2013 allowing the inclusion of iron milk caseinate as a source of iron in foods for special medical purposes, and in total diet replacements for weight control (excluding for infants and young children).
Why?
In its evaluation of the safety of iron milk caseinate as a novel food, EFSA (2022) concluded that this substance is safe under the proposed conditions of use (excluding uses for infants and young children), and that it is a source from which iron is bioavailable. If a company intends to add a mineral to foods or food supplements, the specific mineral source must be listed under the relevant laws. In addition to being authorised as a novel food, the EU needs to update these other laws to include the new mineral source.
Timeline
Comments on the proposal can be submitted via the National TBT notification authority of the country concerned to the EU TBT Enquiry Point before 19 December 2023.
Proposed date of adoption: second quarter of 2024.
What are the major implications for exporting countries?
Under Regulation 2023/949, only the company Société des Produits Nestlé S.A. may sell iron milk caseinate on the EU market until June 2028, unless Nestlé permits it, or if another company obtains a novel food authorisation for these uses on the basis of its own scientific data (without using Nestlé's protected data).
Background
Regulation 2023/949 authorised iron milk caseinate as a novel food in certain foods and food supplements, subject to specific conditions.
Based on EFSA’s favourable opinion, iron milk caseinate was included in the Union list of authorised novel foods in the Annex to Regulation 2017/2470.
Under the laws on adding vitamins/ minerals to foods (Regulation 1925/2006), food supplements (Directive 2002/46/EC), and foods for particular nutritional uses (Regulation 609/2013), only those vitamins and minerals that are listed, and the sources listed, may be used in these products. Each law has its own list, set out in an Annex.
Resources
EFSA (2022) Safety of iron milk proteinate as a novel food pursuant to Regulation (EU) 2015/2283 and bioavailability of iron from this source in the context of Directive 2002/46/EC. EFSA Journal, 20(9): 7549.
Directive 2002/46/EC relating to food supplements
Regulation (EU) 2023/949 authorising the placing on the market of iron milk caseinate as a novel food
Regulation 1925/2006 on the addition of vitamins and minerals and of certain other substances to foods
Regulation 609/2013 on food intended for infants and young children, food for special medical purposes and total diet replacement for weight control
Regulation 2015/2283 on novel foods
Regulation 2017/2470 establishing the Union list of novel foods
Sources
Draft Regulation as regards iron milk caseinate added to foods and used in the manufacture of food supplements
Draft Annex
Draft Delegated Regulation to allow the use of iron milk caseinate as a source of iron in total diet replacement for weight control and food for special medical purposes, excluding infants and young children
Draft Annex
Disclaimer: Under no circumstances shall COLEAD be liable for any loss, damage, liability or expense incurred or suffered that is claimed to have resulted from the use of information available on this website or any link to external sites. The use of the website is at the user’s sole risk and responsibility. This information platform was created and maintained with the financial support of the European Union. Its contents do not, however, reflect the views of the European Union.