Infant Formula and Follow-on Formula (Scotland) Regulations 2007

European infant formula and follow-on formula legislation
Commission Directive 2006/141/EC on infant formula and follow-on formula, 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.

In summary, Directive 2006/141/EC seeks 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
• restrictions on the advertising of infant formulae
• 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 that controlled the composition, labelling and marketing of infant formulae and follow-on formulae placed on the market within the EU.

Statutory Instrument
The draft Scottish Statutory Instrument (the draft Infant Formula and Follow-on Formula (Scotland) Regulations 2007) is intended to implement Directive 2006/141/EC in Scotland. The draft Scottish Statutory Instrument (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 Scotland.

The Regulations would revoke and replace, in Scotland, 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 formulae and follow-on formulae intended for export to third countries. The Regulations would implement Council Directive 92/52/EEC.

The Agency will consult, before 1 January 2008, on draft Guidance Notes to help stakeholders interpret the provisions of the Regulations.

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 provided in this consultation aims to quantify the impact of:

• maintaining the status quo (i.e. not implementing the Directive in Scotland by means of the Regulations)
• implementing the Directive in Scotland 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 III 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 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)
  • other aspect of the legislation which would impose new administrative burdens, or have an impact on businesses
  • impact that implementing the new Regulations may have on the charity and voluntary sectors
  • impact that implementing the Regulations may have on enforcement authorities and health professionals
  • 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 Partial RIA not addressed above

This consultation has been prepared in accordance with the HM Government Code of Practice on Consultation, which states that a consultation must follow better regulation best practice, including carrying out an Impact Assessment (Regulatory Impact Assessment in Scotland). The assessment is included in the consultation documents.

We are interested in what you thought of this consultation and would therefore welcome your general feedback on both the consultation package and overall consultation process. If you would like to assist us to improve the quality of future consultations, please feel free to share your thoughts with us by using the consultation feedback questionnaire.

Consultation feedback questionnaire (Word)

Consultation feedback questionnaire (pdf)

In accordance with the FSA principle of openness our Information Centre at Aviation House will hold a copy of the completed consultation. Responses will be open to public access upon request. The FSA will also publish a summary of responses, which may include personal data, such as your full name and contact address details. If you do not want this information to be released, please complete and return the Publication of Personal Data Form. Return of this form does not mean that we will treat your response to the consultation as confidential, just your personal data.

Data protection form (Word)

Data protection form (pdf)

Within three months of a consultation ending we aim to publish a summary of responses received and provide a link to it from this page.

If, after three months, the summary is still not showing, please contact the person who was responsible for the original consultation. Alternatively, you can contact Judith Taylor, the FSA Consultation Co-ordinator, on 020 7276 8633.
Email: judith.taylor@foodstandards.gsi.gov.uk