DH Letter (CQI/001 NVH/002/022), 13 June 2011
Commission Regulation (EU) 440/2011 was adopted on 6 May 2011 and published in the Official Journal of the European Union on 7 May 2011. This Regulation lists in Annex I and II permitted health claims and rejected health claims referring to children’s development and health with regard to docosahexaenoic acid (DHA) and arachidonic acid (ARA) and the trade names Lipil® and Enfamil® Premium.
This Regulation came into force on 27 May 2011 and following six months from this date the claims in Annex II must no longer be used.
The Regulation applies to health claims made for foods including foods intended for use in infants and young children including follow-on formula, weaning foods and medical foods. Health claims other than those listed in Annex IV of Commission Directive 2006/141/EC cannot be made on infant formula.
Notification of medical foods
Where the labelling of medical foods needs to be changed to comply with the requirements of the Regulation, we would be grateful for sight of any new product labelling. This can be submitted by the normal notification procedure to the Department of Health.
The claims in Annex I may be used, in compliance with the associated conditions of use and other relevant legislation, from 27 May. Other health claims referring to childrens’ development and health may only be used if: they are already authorised; or they are benefitting from a transition period; or were in use before 19 January 2007 and an application for authorisation has been submitted.