FSA Information, 7 April 2006
Commission’s Dietetic Foods Expert Working Group meeting on the working document (Revision 4) for a draft proposal for a recast of Directive 91/321/EEC held on 4th April 2006
[Note: The working document Revision 4 is available on this site: Revision 4 (pdf file, 1.3MB). See also EU News Item 17 March 2006]
General comments
The Working Group (WG) agreed the text of Revision 4 of the recast Directive, subject to minor amendments which will be drafted by the Commission. The draft recast Directive will be submitted to the Standing Committee on the Food Chain and Animal Health (SCoFCAH) for discussion, and a possible vote, at their 26th June meeting. The Food Standards Agency will represent the UK at the June SCoFCAH meeting.
References for the purposes of this Bulletin
The draft Codex infant formula standard, published as Annex IV(A) to the Report of the 27th Session of the Codex Committee on Nutrition and Foods for Special Dietary Uses (CCNFSDU) is referred to in this Bulletin as the ‘Codex draft standard’.
Infant formula and follow-on formula composition
The majority of the compositional requirements for infant formula (IF) and follow on formula (FOF) had been agreed at previous WG meetings.
Discussions at the meeting focussed on a small number of amendments to the compositional requirements of the Directive which had been agreed in principle at the 20th January WG meeting. These amendments were highlighted in Revision 4 and, after minor discussions, were agreed by the WG. The amendments are detailed below:
Notification of the use of new ingredients
Due to the requirements of the Novel Foods Regulation (EC) 258/97, manufacturers must gain prior approval for the use of novel foods [see Note 2 below] in infant formula. The recast of Directive 91/321/EEC will also require prior approval for the use of new ingredients about which claims would be made (Articles 9 and 12 of Revision 4 refer).
Articles 4 and 5 of Revision 4 would require infant formulae which contained any other new ingredients [see Note 3 below], to be notified to EU competent authorities (notification would be required when an infant formula containing a new ingredient is placed on the market in the EU for the first time). Article 5 also allows Member States to temporarily suspend the marketing of infant formula which contained new ingredients if they had sufficient scientific justification to do so.
Many Member States did not support notification of the use of new ingredients on marketing, stating instead that prior approval should be required for all new ingredients in infant formula. The Commission agreed to reflect further on this matter.
Labelling and advertising of follow on formula
At previous meetings, a number of Member States had submitted written comments to the WG outlining the need to restrict/ban FOF advertising within the EU. These proposals had received limited support. As a result, at the 20th January WG, the Commission invited MSs to consider how the existing text in the Directive regarding FOF labelling and advertising could be strengthened. In response to this call, the UK proposed that Article 9(9) should be amended to read: “Infant formulae and follow-on formulae shall be labelled in such a way that it enables consumers to make a clear distinction between these products so as at avoid any risk of confusion between infant formulae and follow-on formulae.” The proposal received positive initial feedback from a number of MSs. The Commission invited all Members of the WG to submit comments on the wording before the June SCoFCAH meeting.
The Food Standards Agency would welcome comments on the proposed amendment to the wording of Article 9(9) by 26th May 2006.
Infant formula claims
The UK requested clarification from the Commission about the types of infant formula claims that would be prohibited by Article 9(7) in Revision 4. The Commission explained that the claims provisions of both the recast Directive and the current Directive prohibit the use of any claims relating to the composition of infant formula which are not included in Annex IV. The Commission noted that claims are defined in the draft Nutrition and Health Claims (NHC) Regulation and that a cross-reference will be included in the recast Directive if the NHC Regulation is agreed before the June SCoFCAH meeting.
The Commission noted that the text of Article 12, (on the procedures for assessing new claims), would be amended to reflect the text of the Nutrition and Health Claims Regulation once the latter had been agreed.
Authorisation of an infant formula based on whey protein partial hydrolysates with a protein content of at least 1.9 g protein/100 kcal
The Commission stated that in view of the positive EFSA Opinion on an infant formula based on partial hydrolysates, a Commission Decision will be issued which will temporarily authorise the marketing of the product. The Commission also asked MSs for their views on how permanent authorisation could be facilitated via the recast Directive. The Commission circulated a draft specification (Annex A [see below]) for the permanent authorisation of the product and asked MSs for their views on how the specification could be incorporated into the Annexes of the recast Directive. The Commission asked MSs to submit any views before the June SCoFCAH.
Next Steps
The Commission will produce an updated draft of the recast Directive which will be submitted to the 26th June SCoFCAH for discussion and a possible vote. The updated draft will be distributed to MSs in advance of the SCoFCAH meeting.
The Food Standards Agency would be grateful for responses to the question in the paragraph on FOF labelling and advertising (before 26th May) and will consult with UK stakeholders when the new draft of the recast Directive is published by the Commission in advance of the 26th June SCoFCAH meeting. The Food Standards Agency will represent the UK at the June SCoFCAH meeting.
Notes:
1) Infant formulae manufactured from cow’s milk with a protein content between the minimum level (1.8 g/100 kcal) and 2 g/100 kcal; Infant formulae manufactured from protein hydrolysates with a protein content between the minimum level (1.8 g/100 kcal) and 2.25 g/100 kcal.
2) Under the terms of the Novel Foods Regulation (EC) 258/97, novel foods are identified as foods that do not have a significant history of consumption within the EU prior to 15 May 1997 and are subject to a pre-market safety assessment.
3) For the purposes of Articles 4 and 5 of Revision 4, ‘new ingredients' are considered as those ingredients which have not been used in infant formula previously and which would not be the subject of nutrition and health claims.
Annex A
This is a preliminary working document and does not necessarily reflect the views of the European Commission
Specifications for the protein source, protein processing and protein quality used in the manufacture of infant formulae based on hydrolysates of whey protein derived from cows' milk protein with a protein content of at least 0.47 g1100 kJ (1.9 g1100 kcal)
Protein content
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Protein source
Demineralised sweet whey protein derived from cows' milk after enzymatic precipitation of caseins using chymosin, consisting of:
- 63% caseino-glycomacropeptide free whey protein isolate with a minimum protein content of 95% of dry matter and protein denaturation of less than 70% and a maximum ash content of 3%; and
- 37% sweet whey protein concentrate with a minimum protein content of 87% of dry matter and protein denaturation of less than 70% and a maximum ash content of 3.5%.
Protein processing
Two stage hydrolysis process using a trypsin preparation with a heat treatment (from 3 to 10 . minutes at 80 to 100°C) step between the two hydrolysis steps
Protein quality
Amino acid pattern as defined in Annex V of Directive 91/32 1/EEC of 14 May 199 1 on infant formulae and follow-on formulae.