FSA Consultation Letter, 2 July 2007

PARNUTS – Proposed Infant Formula and Follow-on Formula (England) Regulations 2007

For a copy of the consultation document, see: Infant Formula Consultation

The Infant Formula and Follow-on Formula (England) Regulations 2007 will implement European Commission Directive 2006/141/EC and Council Directive 92/52/EEC. The new Regulations will revoke and replace, in England, the existing Infant Formula and Follow on Formula Regulations 1995. Responses are requested by: 28 September 2007

Consultation details

European infant formula and follow-on formula legislation

Commission Directive 2006/141/EC on infant formula and follow-on formula and amending Directive 1999/21/EC, was published on 30 December 2006 (OJ No. L401, 30.12.2006, p.1). The Directive required European Union (EU) Member States to adopt and publish, by 31 December 2007 at the latest, laws and administrative provisions to implement the Directive at a national level. A copy of the Directive can be found at the EU website. [See Commission Directive 2006/141/EC ]

Directive 2006/141/EC seeks, in summary, to ensure that:

• the essential composition of infant formulae and follow-on formulae satisfy the nutritional requirements of infants in good health as established by generally-accepted scientific data
• the labelling of infant formulae and follow-on formulae allows the proper use of such products and promotes and protects breastfeeding
• the rules on composition, labelling and advertising are in line with the principles and aims of the International Code of Marketing of Breast-Milk Substitutes ('the Code')
• information provided to carers about infant feeding does not counter the promotion of breastfeeding

These aims are given effect by the main provisions of the Directive which provide for:

• a general requirement that no product other than infant formula may be marketed or otherwise represented as suitable for satisfying by itself the nutritional requirements of normal, healthy infants during the first months of life until the introduction of complementary feeding
• a general requirement that infant formulae and follow-on formulae shall not contain any substance in such quantity as to endanger the health of infants and young children
• detailed requirements for the essential composition of infant formulae and follow-on formulae
• a general limit on the level of any individual pesticide residue that may be present in infant formulae and follow-on formulae and specific lower limits for a few very toxic pesticides
• mandatory and non-mandatory particulars for the labelling of infant formulae and follow-on formulae
• the requirements for the labelling of infant formula and follow-on formula to also apply to presentation and advertising
• restrictions on the nutrition and health claims that can be made in relation to infant formulae
• the labelling, presentation and advertising of infant formula and follow-on formula to avoid any risk of confusion by the consumer between these two categories of products
• the provision of information on infant and young child feeding for use by families and those involved in the field of infant and young child nutrition

The Directive repeals and replaces Directive 91/321/EEC, as amended (the previous European legislation to control the composition, labelling and marketing of infant formulae and follow-on formulae placed on the market within the EU).

Statutory Instrument

The draft Statutory Instrument (the draft Infant Formula and Follow-on Formula ( England ) Regulations 2007) is intended to implement Directive 2006/141/EC in England . The draft Statutory Instrument (also referred to as 'the regulations' for the purposes of this consultation) puts in place offences linked to the provisions of the Directive and enforcement provisions and penalties associated with these offences so that the Directive can be enforced in England.

The regulations would revoke and replace, in England , the Infant Formula and Follow-on Formula Regulations 1995 (SI 1995, No. 77), as amended (referred to as the ‘previous Regulations' for the purposes of this consultation).

The previous regulations also implemented Council Directive 92/52/EEC on infant formula and follow-on formulae intended for export to third countries. The Regulations would implement Council Directive 92/52/EEC.

The Agency will consult on draft Guidance Notes to help stakeholders interpret the provisions of the Regulations before 1 January 2008.

Regulatory Impact Assessment

The partial Regulatory Impact Assessment (RIA), considers the impact of regulations (in terms of cost, benefits and risks) on consumers, businesses, the public sector, charities and the voluntary sector.

A previous version of the partial RIA, assessing the impact of an earlier draft of Directive 2006/141/EC, was published by the Agency in 2004. The partial RIA of this consultation aims to quantify the impact of:

• maintaining the status quo (i.e. not implementing the Directive in England by means of the regulations)
• implementing the Directive in England by means of the regulations

The Agency would welcome comments and evidence from stakeholders in those areas highlighted in grey text boxes throughout the partial RIA. In summary, the Agency would welcome comments from stakeholders regarding:

• what should be considered as ‘advertising' for the purposes of the Regulations
• the proposed notification procedure for infant formula and the format of the proposed notification form in Appendix V of the RIA
• the interpretation of the term ‘idealise' for the purposes of these Regulations
• the provisions which require infant formula and follow on formula to be packaged, presented and advertised in a way which avoids any risk of confusion between them
• the proposal to further restrict the advertising of infant formula
• any other aspect of the proposed provisions in the draft Regulations
• their preferred option with respect to the domestic Regulations (i.e. to maintain the status quo by retaining the previous Regulations or to implement the Directive by means of the new proposed Regulations)
• the costs associated with not implementing the Directive and thus maintaining the previous Regulations
• policy and administrative compliance costs which are over and above what a business would do commercially, with respect to the approval of new claims relating to infant formula
• policy and administrative compliance costs which are over and above what a business would do commercially, in relation to the provisions of the Regulations regarding:
  • Composition (reformulation to ensure compliance with the updated mandatory compositional requirements)
  • Labelling (re-labelling associated with the new mandatory labelling provisions)
  • Notification (costs associated with notifying the Agency on marketing of new infant formula)
  • Any other aspect of the legislation which would impose new administrative burdens, or have an impact on businesses
• the impact that implementing the Regulations may have on the charity and voluntary sectors
• the impact that implementing the Regulations may have on enforcement authorities and health professionals
• the economic, social and environmental costs and benefits associated with maintaining the status quo and implementing the Regulations so that a sustainability assessment can be completed
• any other aspect of the Regulations, the proposed options or the draft Regulatory Impact Assessment not addressed above