Working Document Prepared by the Commission Services for Discussion

27-01-2014

WORKING DOCUMENT prepared by the Commission services for discussion

of the SCFCAH-GFL meeting of 10FEB 2014

on new EFSA opinions (Article 14.1.B)

A. Health claim related to vitamin C and increasing non-haem iron absorption (Question No-EFSA-Q-2008-176)[1]

Application submitted by Specialised Nutrition Europe (formerly IDACE) submitted pursuant to Article 14 of Regulation (EC) No 1924/2006. Target population proposed by the applicant is infants and young children from birth to three years of age.

1. The EFSA advice

The Panel considered that the food constituent, Vitamin C, which is the subject of the health claim, is sufficiently characterised. Vitamin C occurs naturally in foods and is authorised for addition to foods.

Increasing non-haem iron absorption is a beneficial physiological effect for infants and young children.

A cause and effect relationshiphad been established between the dietary intake of vitamin C and increasing non-haem iron absorption.

The Panel has already assessed a claim on vitamin C and increasing non-haem iron absorption with a favourable outcome (EFSA NDA Panel, 2009). The target population was the general population. The Panel considers that the role of vitamin C in increasing non-haem iron absorption applies to all ages, including infants and young children (from birth to three years).

2. The wording proposed by EFSA

The following wording reflects the scientific evidence: "Vitamin C contributes to increasing non-haem iron absorption".

3. Conditions of use proposed by EFSA

The Panel considers that in order to bear the claim:

follow-on formulae should comply with the criteria of composition of follow-on formulae as laid down in Directive 2006/141/EC;
nutritionally complete foods for special medical purposes intended for use by infants and nutritionally complete foods for special medical purposes other than those intended for use by infants should comply with the criteria of composition of these foods as laid down in Directive 1999/21/EC;
processed cereal-based foods for infants and young children should comply with the criteria of composition of these foods as laid down in Directive 2006/125/EC;
other foodstuffs intended for infants and young children should provide at least 15 % of the reference values for nutrition labelling for foods intended for infants and young children as laid down in Directive 2006/141/EC.

Such amounts can be easily consumed as part of a balanced diet. The target population is infants and children up to three years. No Tolerable Upper Intake Level has been set for vitamin C in this age group (EFSA, 2004).

B. Health claim related to iron and contribution to normal formation of haemoglobin and red blood cells (Question No-EFSA-Q-2008-147)[2]

1. The EFSA advice

The Panel considers that the food constituent, iron, which is the subject of the health claim, is sufficiently characterised.

The Panel considers that contribution to normal formation of haemoglobin and red blood cells is a beneficial physiological effect for infants and young children.

The Panel concludes that a cause and effect relationship has been established between dietary intake of iron and contribution to normal formation of haemoglobin and red blood cells.

The Panel has already assessed a claim on iron and contribution to normal formation of haemoglobin and red blood cells with a favourable outcome (EFSA NDA Panel, 2009). The target population was the general population. The Panel considers that the role of iron in normal formation of haemoglobin and red blood cells applies to all ages, including infants and young children (from birth to three years).

2. The wording proposed by EFSA

The following wording reflects the scientific evidence: "Iron contributes to normal formation of haemoglobin and red blood cells".

3. Conditions of use proposed by EFSA

The Panel considers that in order to bear the claim

follow-on formulae should comply with the criteria of composition of follow-on formulae as laid down in Directive 2006/141/EC;
nutritionally complete foods for special medical purposes intended for use by infants and nutritionally complete foods for special medical purposes other than those intended for use by infants should comply with the criteria of composition of these foods as laid down in Directive 1999/21/EC;
processed cereal-based foods for infants and young children should comply with the criteria of composition of these foods as laid down in Directive 2006/125/EC;
other foodstuffs intended for infants and young children should provide at least 15 % of the reference values for nutrition labelling for foods intended for infants and young children as laid down in Directive 2006/141/EC.

Such amounts can be easily consumed as part of a balanced diet. The target population is infants and children up to three years. No Tolerable Upper Intake Level has been set for iron (EFSA, 2004).

C. Health claim related to iodine and contribution to normal thyroid function (Question No-EFSA-Q-2008-144)[3]

1. The EFSA advice

The Panel considers that the food constituent, iodine, which is the subject of the health claim, is sufficiently characterised. Iodine occurs naturally in foods and is authorised for addition to foods.

The Panel considers that contribution to normal thyroid function is a beneficial physiological effect for infants and young children.

The Panel concludes that a cause and effect relationship has been established between dietary intake of iodine and contribution to normal thyroid function.

The Panel has already assessed a claim on iodine and normal thyroid function (and normal production of thyroid hormones) with a favourable outcome (EFSA NDA Panel, 2009). The target population was the general population. The Panel considers that the role of iodine in normal thyroid function applies to all ages, including infants and young children (from birth to three years).

2. The wording proposed by EFSA

The following wording reflects the scientific evidence: "Iodine contributes to normal thyroid function".

3. Conditions of use proposed by EFSA

The Panel considers that in order to bear the claim

follow-on formulae should comply with the criteria of composition of follow-on formulae as laid down in Directive 2006/141/EC;
nutritionally complete foods for special medical purposes intended for use by infants and nutritionally complete foods for special medical purposes other than those intended for use by infants should comply with the criteria of composition of these foods as laid down in Directive 1999/21/EC;
processed cereal-based foods for infants and young children should comply with the criteria of composition of these foods as laid down in Directive 2006/125/EC;
other foodstuffs intended for infants and young children should provide at least 15 % of the reference values for nutrition labelling for foods intended for infants and young children as laid down in Directive 2006/141/EC.

Such amounts can be easily consumed as part of a balanced diet. The target population is infants and children up to three years. A Tolerable Upper Intake Level (UL) for iodine has been established for children, and has been set at 200 μg/day for children of 1-3 years of age (SCF, 2002).

D. Health claim related to iodine and contribution to normal cognitive development (Question No-EFSA-Q-2008-145)[4]

1. The EFSA advice

The Panel considers that contribution to normal cognitive development is a beneficial physiological effect for infants and young children.

The Panel concludes that a cause and effect relationship has been established between dietary intake of iodine and contribution to normal cognitive development.

The Panel has already assessed a claim on iodine and contribution to normal cognitive and neurological function with a favourable outcome (EFSA NDA Panel, 2010). The target population was the general population. The Panel notes the well-established role of iodine in preventing iodine deficiency disorders such as retarded mental and physical development in children and adolescents, and impaired mental function and reduced cognitive capacity for people of all ages (WHO, 2001).

2. The wording proposed by EFSA

The following wording reflects the scientific evidence: "Iodine contributes to normal cognitive development".

3. Conditions of use proposed by EFSA

The Panel considers that in order to bear the claim

follow-on formulae should comply with the criteria of composition of follow-on formulae as laid down in Directive 2006/141/EC;
nutritionally complete foods for special medical purposes intended for use by infants and nutritionally complete foods for special medical purposes other than those intended for use by infants should comply with the criteria of composition of these foods as laid down in Directive 1999/21/EC;
processed cereal-based foods for infants and young children should comply with the criteria of composition of these foods as laid down in Directive 2006/125/EC;
other foodstuffs intended for infants and young children should provide at least 15 % of the reference values for nutrition labelling for foods intended for infants and young children as laid down in Directive 2006/141/EC.

Prepared by the Commission services.

The above text cannot be regarded as an official position of the European Commission

[1]The EFSA Journal 2014;12(1):3514

[2] The EFSA Journal 2014;12(1):3515

[3]The EFSA Journal 2014;12(1):3516

[4]The EFSA Journal 2014;12(1):3517