Food Law News - UK - 2007

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:

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

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The Agency will consult on draft Guidance Notes to help stakeholders interpret the provisions of the Regulations before 1 January 2008.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

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:

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