Food Law News - EU - 2006

FSA E-mail, 26 January 2006

PARNUTS - Recast Commission Directive 91/321/EEC on Infant Formulae and Follow-On Formulae Bulletin

The following is taken from a ‘Bulletin' circulated by the Food Standards Agency

Commission's Dietetic Foods expert Working Group meeting on the working document (Revision 3) for a draft proposal for a recast of Directive 91/321/EEC held 20 January 2006

General comments

Significant progress was made on agreeing the detailed compositional requirements of the recast Directive and on the principle of the Article which described the procedures for approving nutrition and health claims on infant formula.

References for the purposes of this Bulletin

The draft Codex infant formula standard, published as Annex IV(A) to the Report of the 27 th 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'.

The ‘Compositional Requirements for Infant Formula' sent by the Commission to Member States (MS) Working Group (WG) representatives on 10 January 2006 are referred to as the ‘new EU composition proposals'.

Infant Formula Composition

The Commission introduced the new EU composition proposals, stating that there was reasonable agreement between them and the SCF and Codex recommendations.

Protein conversion factor

The WG agreed that the wording in the Codex draft standard should be adopted in the recast Directive, namely “For the purposes of this standard, the calculation of the protein content should be based on N x 6.25, unless a scientific justification is provided for the use of a different conversion factor for a particular nitrogen source”.

Protein hydrolysates

The new EU composition proposal requires clinical evaluation of the use of hydrolysed formulae with a protein content <1.8 g per 100 kcal; this was consistent with the Codex draft standard. This requirement, and the text of the footnotes on protein hydrolysates in the new EU composition proposals, were agreed.

Choline and phospholipids.

Limits for these substances were considered together. The Commission noted that the new EU composition proposals reflected the text of the Codex draft standard, where the maximum recommended phospholipid content of =2 g/L of formula would permit the continued use of egg as a lipid source for infant formula (the SCF proposal of =1 g/L would prevent the use of egg as a lipid source as it is rich in phospholipids). After no objections were received, the choline and phospholipid values (7-50 mg per 100 kcal and =2 g/L) were agreed. The Commission also agreed to check the new EU composition proposals to ensure the appropriate use of the terms ‘total fats' or ‘total fatty acids' in the finalised draft of the recast Directive which will be submitted to the Standing Committee on the Food Chain and Animal Health (SCoFCAH) for approval by MSs.


There was an extensive discussion about the need to impose minimum lactose levels in formula. Some MSs wished to retain the current requirements of 91/321/EEC, whereas others stated that there was no scientifically proven need for the use of lactose as opposed to other similar carbohydrate sources.

The Commission noted the mixed views on the issue and stated that further discussions with Commission colleagues would be arranged before proposing a finalised position on lactose in the next draft of the Directive.

The WG agreed that sucrose and fructose can be used in hydrolysed formula, but not in formula based on cow's milk (sucrose/fructose are needed to improve the palatability of hydrolysed formula).

Minerals and trace elements

The new EU composition proposals contained values for maximum limits which took account of the 2003 SCF recommendations, CCNFSDU 2005 maxima/Guidance Upper Limits or values taken from the current medical foods Directive (1999/21/EC).

Iron, zinc, copper, selenium - The WG agreed ranges of 0.45-2.0 mg, 0.5-1.5 mg, 35-100 m g and 1-9 m g per 100 kcal for iron, zinc, copper and selenium respectively.


MSs expressed the view that the WG should not agree any maxima which are higher than either the SCF or Codex recommended levels. As a result, the Commission noted that the WG agreed the maxima outlined in the new EU composition proposals (listed below, expressed on a ‘ m g or mg per 100 kcal' basis):

Riboflavin : 80-400 m g

Niacin : 300-1500 m g

Vitamin : B6: 35-175 m g

Biotin : 1.5-7.5 m g

Folic acid : 10-50 m g

Vitamin C : 10-30 mg

Vitamin K : 4-25 m g

Table 2 (Nucleotide maxima) and Tables 3 & 4 (Amino acids)

The values listed in the new EU composition proposals, which match the 2003 SCF figures, were agreed. The Commission also agreed to check the footnotes to these tables to ensure that they reflect more fully the wordings expressed in the 2003 SCF report.

Notification of new ingredients

The Commission noted that there was no agreement on the notification procedures proposed in Revision 3 of the recast Directive and that further discussions on this issue would be held at a future WG.

Follow on formula advertising

The Commission noted that a number of MS had submitted written comments to the WG outlining the need to restrict/ban FOF advertising throughout the EU. Some MSs did not support a ban on FOF advertising. The Commission concluded by stating that the issue would be considered at the next meeting. MSs were invited to consider how the new proposed text at Article 8 could be strengthened to address concerns about FOF advertising.

Claims (Article 11 of Revision 3)

The Commission opened up discussions by reminding MSs that the proposals in Article 11 of Revision 3 were based on the procedures in the draft Nutrition and Health Claims (NHC) Regulation.

The Commission stated that the text could be amended to include a cross-reference to the definitions of nutrition and health claims in the Nutrition and Health Claims Regulation if the latter received a favourable second reading before May 2006. The Working Group agreed the text of Article 11 in principle, subject to any minor amendments to the text resulting from cross-checking with the draft NHC Regulation.

Six months' wording regarding the suitability of follow-on formula

The Commission noted that the ‘six months' wording in Revision 3 was in agreement with the Codex draft standard and that it must be retained in the Directive because the EU supported this wording at the CCNFSDU meeting in 2005.

EFSA opinion on a formula with a protein content of at least 1.9 g protein/100 kcal

The Chairman invited views from MSs on the positive Opinion of the NDA Panel related to the safety and suitability for particular nutritional use by infants of a formula based on whey protein partial hydrolysates with a protein content of at least 1.9 g protein/100 kcal. MSs agreed to the temporary authorisation of the product. The Commission will draft a clause for inclusion in the recast Directive which would allow for the permanent authorisation of such products, provided they receive a positive Opinion from EFSA.

Next Steps

Another meeting of the Working Group (WG) will be scheduled for late March/early April where discussions will be held on a new draft of the Directive (ie Revision 4). The Food Standards Agency will consult with UK stakeholders when the new draft of the Directive is published by the Commission.

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