Commission Regulation (EU) No 440/2011 of 6 May 2011 on the authorisation and refusal of authorisation of certain health claims made on foods and referring to children’s development and health Text with EEA relevance

• CELEX: Regulation (EU) No 440/2011
• Articles: 5

Article 1

1.   The health claims listed in Annex I to this Regulation may be made on foods on the European Union market in compliance with the conditions laid down in that Annex.

2.   The health claims referred to in paragraph 1 shall be included in the Union list of permitted claims referred to in Article 14(1) of Regulation (EC) No 1924/2006.

Article 2

1.   The health claims listed in Annex II to this Regulation shall not be included in the Union list of permitted claims as provided for in Article 14(1) of Regulation (EC) No 1924/2006.

2.   However, they may continue to be used for 6 months after the entry into force of this Regulation.

Article 3

This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union .

Schedules & Appendices

ANNEX I

ANNEX I

Permitted health claims

Application – Relevant provisions of Regulation (EC) No 1924/2006

Applicant – Address

Nutrient, substance, food or food category

Claim

Conditions of use of the claim

Conditions and/or restrictions of use of the food and/or additional statement or warning

EFSA opinion reference

Article 14(1)(b) health claim referring to children’s development and health

Mead Johnson & Company, 3 rue Joseph Monier-BP 325, 92506 Rueil-Malmaison Cedex, France

Docosahexaenoic acid (DHA)

Docosahexaenoic acid (DHA) intake contributes to the normal visual development of infants up to 12 months of age.

Information shall be given to the consumer that the beneficial effect is obtained with a daily intake of 100 mg of DHA.

When the claim is used on follow-on formula, the food shall contain at least 0,3 % of the total fatty acids as DHA.

Q-2008-211, Q-2008-688, Q-2008-689

Article 14(1)(b) health claim referring to children’s development and health

Merck Selbstmedikation GmbH, Roesslerstrasse 96, 64293 Darmstadt, Germany

Docosahexaenoic acid (DHA)

Docosahexaenoic acid (DHA) maternal intake contributes to the normal development of the eye of the foetus and breastfed infants.

Information shall be given to pregnant and lactating women that the beneficial effect is obtained with a daily intake of 200 mg of DHA in addition to the recommended daily intake for omega-3 fatty acids for adults, i.e. 250 mg DHA and eicosapentaenoic acid (EPA).

The claim can be used only for food which provides a daily intake of at least 200 mg DHA.

Q-2008-675

Article 14(1)(b) health claim referring to children’s development and health

Merck Selbstmedikation GmbH, Roesslerstrasse 96, 64293 Darmstadt, Germany

Docosahexaenoic acid (DHA)

Docosahexaenoic acid (DHA) maternal intake contributes to the normal brain development of the foetus and breastfed infants.

Information shall be given to pregnant and lactating women that the beneficial effect is obtained with a daily intake of 200 mg of DHA in addition to the recommended daily intake for omega-3 fatty acids for adults, i.e. 250 mg DHA and EPA.

The claim can be used only for food which provides a daily intake of at least 200 mg DHA.

Q-2008-773

ANNEX II

ANNEX II

Rejected health claims

Application – Relevant provisions of Regulation (EC) No 1924/2006

Nutrient, substance, food or food category

Claim

EFSA opinion reference

Article 14(1)(b) health claim referring to children’s development and health

Docosahexaenoic acid (DHA) and arachidonic acid (ARA)

Docosahexaenoic acid (DHA) and arachidonic acid (ARA) contribute to the optimal brain development of infants and young children.

Q-2008-212

Article 14(1)(b) health claim referring to children’s development and health

Lipil®

Lipil® contributes to optimal brain development of infants and young children.

Q-2008-690

Article 14(1)(b) health claim referring to children’s development and health

Enfamil® Premium

Enfamil® Premium contributes to optimal brain development of infants and young children.

Q-2008-691