FSA Letter (CPD/0012), 17 March 2006
The FSA letter attached the latest version (Revision 4) of the Commission's Draft working document for a Commission Directive on infant formulae and follow-on formulae (recast version), [SANCO D4/KL/mm/D440180 Rev.4], which will be discussed at the Dietetic Foods Expert Working Group (Infant Formulae and Follow-on Formulae), in Brussels on 4 April 2006. Also attached is the covering letter from the Commission to the competent authorities of EU Member States relating to Revision 4 of the Directive.
[Note: The working document Revision 4 is available on this site: Revision 4 (pdf file, 1.3MB)]
The main proposed changes compared to Revision 3 are summarised below:
Article 5 – A new article on the notification procedures for the use of new ingredients in infant formulae
Article 5 is a new article which includes the notification procedures previously detailed in Article 4 of Revision 3. In addition, there is a proposal for a new provision allowing a Member State to temporarily suspend trade in an infant formula containing an ingredient which has not been used in such products previously. The Article proposes that the Member State could take this action only if it had detailed scientific grounds for establishing that the suitability of the infant formula had not been adequately demonstrated. Any such suspension would then be discussed at the Standing Committee on the Food Chain and Animal Health. Your comments are sought on this proposal.
Article 9(1) – The names by which infant formula and follow-on formula are sold within the EU
The Commission has asked Member States to check whether the change to the definitions of infant formulae and follow-on formulae would mean that the names under which the products are sold need to be revised. This request does not affect the English definitions of infant formula and follow-on formula, which are the same as those given in Revision 3.
Article 9(3)(b) – Changes to the labelling of the mineral and vitamin content of follow-on formula
Currently, follow-on formula labelling may bear information on vitamins and minerals expressed as a percentage of the reference values in Annex VIII of Directive 91/321/EEC only when the quantities present are at least equal to 15 percent of those reference values (Article 7(2) of Directive 91/321/EEC refers). Revision 4 proposes that this requirement is removed. In effect this would permit follow-on formula labelling to bear information on vitamins and minerals in percentage terms when the quantities present are below 15 percent of the relevant reference value given in Annex VI of Revision 4. Your comments are sought on this suggested amendment.
Annex I – The essential composition of infant formula
The compositional requirements for infant formulae have been revised to reflect the outcome of the discussions on this subject at previous meetings of the Working Group (my letters of 26th January 2006 and of 20th September 2005 refer).
Annex II – The essential composition of follow-on formula
The compositional requirements for follow on formulae have been revised to reflect the outcome of the discussions in previous meetings, where these are relevant. Revision 4 proposes deletion of the text which refers to the term ‘chemical index’ within the ‘Protein’ section of Annex II. This is because the chemical index is not referred to in relation to the protein requirements for follow-on formula; as a consequence Annex VI would also be deleted. Please note that we intend to agree to this suggestion unless there are any strong reasons to the contrary.
Annex III – The addition of ferrous bisglycinate to the list of suitable sources of iron for use in infant formula and follow on formula
Ferrous bisglycinate has been added as a source of iron based on the favourable opinion of the European Food Safety Authority.
The proposed changes will be discussed at a meeting of the Dietetic Foods Expert Working Group (Infant Formulae and Follow-on Formulae), in Brussels on 4 April 2006. If you wish to comment on Revision 4 of the recast Directive before this meeting, (with particular reference to Article 5, Article 9(3)(b) and Annex II) please submit all comments by 29 March 2006.