EUROPEAN COMMUNITY – Commission Directive – Implementation – Infant formulae and Follow-on formulae – Directive providing date for prohibition of trade in non-compliant products – Whether prohibition date referring only to compositional elements of formulae or also including packaging and labelling – Commission Directive 2006/141/EC, art 18 – Infant Formula and Follow-on Formula (England) Regulations 2007 (SI 2007/3521), regs 1, 17–19 – Infant Formula and Follow-on Formula (Wales) Regulations 2007 (SI 2007/3573), regs 1, 17-19

Regina (The Infant and Dietetic Foods Association Ltd) v Secretary of State for Health; WLR (D) 68

QBD: Mitting J: 29 February 2008

The reference to “products” in art 18 of the Commission Directive 2006/141/EC on Infant Formulae and Follow-on Formulae was not limited to the compositional elements of the formulae but also covered packaging and labelling, with the result that the prohibition on trade in products which did not comply with the Directive was to have effect from 31 December 2009.

Mitting J so held when upholding a claim by the Infant and Dietetic Foods Association Ltd for judicial review of the Infant Formula and Follow-on Formula (England) Regulations 2007 and the Infant Formula and Follow-on Formula (Wales) Regulations 2007, the effect of regs 1 and 17–19 of which would have been that the packaging and labelling requirements would have come into force on 11 January 2008, had the Regulations been valid and had their coming into force not been suspended by reason of the proceedings.


MITTING J said that the Secretary of State relied primarily on the contention that the word “products” was used throughout both the recitals and the articles of Directive 2006/141/EC to mean formulae, and not to include labelling. That contention had powerful support and, had it been right, it would have been compelling. But in art 13(8)(a) “products” definitely had a different meaning, as the word “shape” was inapplicable to a powder to be made usable by the addition of water. It would also have been difficult to construe “products” in art 14(3) in the sense contended for by the Secretary of State. Further it could not be accepted that “adopt and publish” was to be construed in a way which would support the Secretary of State’s position. Previous provisions and the travaux préparatoires all pointed to the conclusion that art 18 was not limited to the compositional elements of formulae but extended to packaging and labelling, and it followed that regs 1 and 17-19 of the Infant Formula and Follow-on Formula (England) Regulations 2007 and the Infant Formula and Follow-on Formula (Wales) Regulations 2007 had not accurately transposed the second indent of art 18, which provided that the prohibition on trade in products which did not comply with Directive 2006/141/EC was to have effect from 31 December 2009.

Appearances: Michael Beloff QC and Gerard Clarke (Osborne Clarke) for the claimant;
Paul Lasok QC (Treasury Solicitor) for the defendant.

Reported by: Philip Ridd, solicitor