Scientific Documents

Enfamil® Premium and visual development - Scientific substantiation of a health claim related to Enfamil® Premium and visual development pursuant to Article14 of Regulation (EC) No 1924/2006[1]

Summary (28 KB)

Opinion (58 KB)

Summary

Following an application from Mead Johnson Nutritionals submitted pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of France, the Panel on Dietetic Products, Nutrition and Allergies was asked to deliver an opinion on the scientific substantiation of a health claim related to Enfamil® Premium and visual development.

The scope of the application was proposed to fall under a health claim referring to children’s development and health.

The food constituent which is the subjects of the health claim is Enfamil® Premium. DHA and ARA in Enfamil® Premium are derived from single cell oils. The absorption of DHA and ARA is well documented. The Panel considers that the food constituents DHA and ARA are sufficiently characterised.

The claimed effect is the contribution to the optimal visual development of infants and young children. The target population proposed by the applicant is infants and young children (from birth to three years of age). The Panel considers that a normal visual function is beneficial for infants’ and children’s development and health.

The applicant identified a total of 43 publications as being pertinent to the health claim. A total of 12 publications which report original data from randomised controlled trials (RCTs) on the effects of DHA supplementation (with or without ARA) on visual development in physiological conditions and in infants born at term and one pooled analysis including four of the RCTs indicated above were considered as pertinent to substantiate the claimed effect. An additional RCT not included in the application also met these requirements.

All the studies presented by the applicant as pertinent to the health claim have been already evaluated by the Panel in a previous Opinion in relation to the effects of DHA and ARA supplementation on visual development in infants and young children (from birth to three years of age). No data has been presented showing an effect of any of the components of Enfamil® Premium on visual development in addition to that observed for DHA. The Opinion of the Panel on the effects of DHA and ARA supplementation on visual development in infants and young children applies to the present application.

On the basis of the data presented, the Panel concludes that a cause and effect relationship has been established between the intake of infant and follow-on formula supplemented with DHA at levels around 0.3% of total fatty acids and visual function at 12 months in formula-fed infants born at term from birth up to 12 months and in breastfed infants after weaning up to 12 months. The Panel could have not reached this conclusion without considering the studies claimed by the applicant as proprietary.

The following wording reflects the scientific evidence: “DHA contributes to the visual development of infants”.

In order to bear the claim a formula should contain at least 0.3% of the total fatty acids as docosahexaenoic acid. Such amounts can be easily consumed as part of a balanced diet.

The target population is infants (formula-fed infants born at term from birth up to 12 months and breastfed infants after weaning up to 12 months).