FSA Consultation letter, 26 June 2003

PARNUTS - Proposed regulations regarding baby and infant food

Draft Infant Formula and Follow-on Formula (Amendment) (England) Regulations 2004 and draft Processed Cereal-based Foods and Baby Foods for Infants and Young Children (England) Regulations 2004

Commission Directives 2003/13/EC and 2003/14/EC, which extend the provisions on pesticide residues in processed cereal-based foods, baby foods, infant formulae and follow-on formulae, have been published . We are required to introduce national measures to implement these provisions and we request your comments on proposed regulations to address this requirement.

Draft Infant Formula and Follow-on Formula (Amendment) (England) Regulations 2004

These Regulations would implement, in England, Commission Directive 2003/14/EC amending Directive 91/321/EEC on infant formulae and follow-on formulae. Separate parallel legislation is being prepared in Scotland, Wales and Northern Ireland. The Infant Formula and Follow-on Formula (Amendment) (England) Regulations 2004 amend the Infant Formula and Follow-on Formula Regulations 1995, as amended, in relation to England. The 1995 Regulations extend to Great Britain. These Regulations

• In implementation of Directive 2003/14/EEC, prohibit the sale, or export to third countries, of infant formulae or follow-on formulae containing pesticide residues above certain levels. Different levels are set depending on the pesticide in question (regulations 4, 5, 7 and 10 and Schedule);
• Make some consequential amendments (regulations 3 and 6);
• In implementation of Directive 1999/50/EC, make provision as to analytical methods for determining levels of pesticide residues (regulation 7);
• Give port health authorities a role in enforcement (regulation 8)
• Make some technical changes to the provision applying various provisions of the Food Safety Act 1990 (regulation 9).

These provisions would come into force on 6 March 2005.

Draft Processed Cereal-based Foods and Baby Foods for Infants and Young Children (England) Regulations 2004

These Regulations would implement, in England, Commission Directive 2003/13/EC amending Directive 96/5/EC on processed cereal-based foods and baby foods for infants and young children. At the same time, they would consolidate the Processed Cereal-based Foods and Baby Foods for Infants and Young Children Regulations 1997 and its 1999 and 2000 amendments. Separate parallel legislation is being prepared in Scotland, Wales and Northern Ireland.

The Processed Cereal-based Foods and Baby Foods for Infants and Young Children (England) Regulations 2004 provide for the continued implementation in England of Commission Directive 96/5/EC as amended by Commission Directives 1998/36/EC and 1999/39/EC and now as further amended by Commission Directive 2003/13/EC.

These Regulations

• Prohibit the sale of processed cereal-based foods and baby foods for infants and young children unless they comply with the manufacturing and compositional requirements in regulations 5 to 7 and the labelling requirements in regulation 8 (regulation 4);
• Exempt from their application any baby food, excluding processed cereal-based baby foods, which is a milk intended for young children (regulation 3);
• Specify the enforcement authorities (regulation 9);
• Create an offence and prescribe a penalty (regulation 10);
• Provide a defence in relation to exports in accordance with Articles 2 and 3 of Council Directive 89/397/EEC (regulation 11);
• Apply certain provisions of the Food Safety Act 1990 (regulation 12);
• Contain a revocation provision (regulation 13);
• In implementation of Directive 2003/13/EC, prohibit the sale of processed cereal-based foods and baby foods if those foods contain pesticide residues above certain levels. Different levels are set depending on the pesticide in question (regulation 7 and Schedules 6 and 7);
• In implementation of Directive 1999/39/EC, make provision as to analytical methods (regulation 7(5))
• In implementation of Directive 98/36/EC, impose a maximum limit for added vitamin A in certain processed cereal-based foods (Schedule 5, Part II, entry 1)
• Also make some minor, drafting and technical changes to the existing regulations, particularly to the provision applying certain provisions of the Food Safety Act 1990 (regulation 12). Port Health Authorities now have a role in enforcement (regulation 9). The offence provision now relates only to a contravention of the restrictions on sale in regulation 4 (regulation 10).

These provisions would come into force on 6 March 2005.

The FSA invite comments on the draft regulations and partial Regulatory Impact Assessments, which outline the estimated costs and benefits of introducing these regulations (available on the FSA web site). It would also be extremely useful if you could indicate the financial costs or benefits associated with the introduction of these measures by completing and returning the enclosed Regulatory Impact Assessment Questionnaires.

Comments are requested by 18 September.