Lycopene extracted from tomatoes is authorised within the EU as food colouring agent (E160d). The lycopene oleoresin from tomatoes to be used as a novel food ingredient contains 5-15 % lycopene and is prepared by a production process identical to that for the production of the additive E160d, although E160d is prepared using an additional concentration step to obtain an oleoresin that contains 60-70 % lycopene.

SUMMARY Following an application from Mead Johnson & Company 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 docosahexaenoic acid and arachidonic acid and brain development. The scope of the application was proposed to fall under a health claim referring to children’s development and health. The food constituents that are the subject of the health claim are docosahexaenoic acid (DHA) and arachidonic acid (ARA), which are well characterised fatty acids that can be quantified in foods by established methods. 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 brain 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 contribution to the normal development of the brain is beneficial for infants’ and children’s development and health. The applicant identified a total 33 publications as being pertinent to the health claim for humans. A total of 13 full publications which report original data from RCTs on the effects of 1 For citation purposes: Scientific Opinion of the Panel on Dietetic Products, Nutrition and Allergies on a request from Mead

Following a request from the European Commission, the Panel on Dietetic Products, Nutrition and Allergies was asked to provide a scientific opinion on a list of health claims pursuant to Article 13 of Regulation 1924/2006. This opinion addresses the scientific substantiation of health claims in relation to gamma-linolenic acid and reduction of inflammation. The scientific substantiation is based on the information provided by the Member States in the consolidated list of Article 13 health claims and references that EFSA has received from Member States or directly from stakeholders.The food constituent that is the subject of the health claims is gamma-linolenic acid. The Panel considers that gamma-linolenic acid is sufficiently characterised.The claimed effect "Immune health" is not sufficiently defined but in the context of the proposed wording, the Panel assumes that the claimed effect refers to "reducing inflammatory reactions".The Panel considers that under certain circumstances the reduction of inflammation might be beneficial to human health. The Panel notes that the provided review of gamma-linolenic acid and the mechanistic in vitro study provide little evidence for the claimed effect of gamma-linolenic acid on reduction of inflammation.On the basis of the data available, the Panel concludes that a cause and effect relationship has not been established between the consumption of gamma-linolenic acid and reduction of inflammation.

Following a request from the European Commission, the Panel on Dietetic Products, Nutrition and Allergies was asked to review and provide advice on labelling reference intake values for n-3 and n-6 polyunsaturated fatty acids (PUFA).The proposed labelling reference intake values for n-3 and n-6 PUFA provided by the Commission in the terms of reference are intended to represent typical recommended daily intakes (adults). These values can be used in food labelling to facilitate comparison of the PUFA content of food products and to help convey the relative significance of the food as a source of PUFA in the context of a total daily diet, and can also be used to set appropriate conditions of use for health claims on PUFA. For practical application, a single reference intake value is proposed for each nutrient using rounded values for ease of calculation.The PUFA for which advice on labelling reference intakes is requested are the n-3 PUFA alinolenic acid (ALA), the long chain n-3 PUFA (mainly eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA)), and the n-6 PUFA (mainly linoleic acid (LA)).Labeling reference intake values for PUFA may be derived from science-based intake recommendations for the general population established by national and international authorities taking into account observed intakes in the population. For these PUFA, intake recommendations for the general population are sometimes aimed at the avoidance of deficiency symptoms but more usually are based on evidence of relationships between intake and neurodevelopment and/or cardiovascular health. PUFA intake recommendations for the general population established by national authorities in different EU countries are not uniform and reflect the different criteria on which they are based.n-3 polyunsaturated fatty acidsThe n-3 fatty acid most abundant in food is ALA. The proposed labelling reference intake value for ALA (2g) is towards the upper end of the range of average intakes observed in adults in some European countries (0.7 -2.3 g/d or similar to 0.4-0.8 E%). Intake recommendations for ALA based on considerations of cardiovascular health and neurodevelopment are about 1 E%, corresponding to 2 - 3 g ALA/day for energy intakes 1800-2700 kcal/day. The Panel considers that the proposed labelling reference intake value for the n-3 PUFA ALA (2g) is consistent with recommended intakes for individuals in the general population in some European countries based on considerations of cardiovascular health.Long-chain n-3 polyunsaturated fatty acidsThe quantitatively most important long-chain n-3 PUFA in the diet are EPA and DHA.Most recent evidence shows that the intake of EPA plus DHA is negatively related to cardiovascular risk in a dose-dependent way up to about 250mg/d (1-2 servings of oily fish per week) in healthy populations. The proposed labelling reference intake value for long chain n-3 PUFA (200 mg) is lower than this value, as are observed average intakes of EPA plus DHA in adults in some European countries, which vary between 80mg/d and 420 mg/d.The Panel proposes 250mg/d as the labelling reference intake value for the long-chain n-3 PUFAs EPA plus DHA, which is in agreement with most recent evidence on the relationship between the intake of these fatty acids and cardiovascular health in healthy populations.n-6 polyunsaturated fatty acids n-6PUFA mainly include LA, and to a lesser extent arachidonic acid (ARA).The proposed labelling reference intake value of 6g of n-6 PUFA is lower than mean intakes observed in Europe (between 7 and 19 g/d). It is also lower than the lower bound of intake recommended for individuals in the general population by some national and international authorities based on considerations of cardiovascular health (4 E%, equivalent to 8-12 g/d for adults).The Panel proposes 10g as labelling reference intake value for the n-6 PUFA LA, which is consistent with recommended intakes for adult individuals in the general population in European countries based on considerations of cardiovascular health.

Following a request from the European Commission, the Panel on Dietetic Products, Nutrition and Allergies was asked to provide a scientific opinion on a list of health claims pursuant to Article 13 of Regulation 1924/2006. This opinion addresses the scientific substantiation of health claims in relation to fermented dairy products and "healthy digestion". The scientific substantiation is based on the information provided by the Member States in the consolidated list of Article 13 health claims and references that EFSA has received from Member States or directly from stakeholders.The food constituent that is the subject of the health claim is Bifidobacterium Bb-12 and soluble fibre in fermented dairy products. The Panel considers that the strain Bifidobacterium animalis ssp. lactis Bb-12 is sufficiently characterised. The Panel considers that the soluble fibre is not sufficiently characterised.The claimed effect "healthy digestion" is not sufficiently defined but in the context of the proposed wording, the Panel assumes that the claimed effect relates to aspects of promoting the growth of "beneficial" bacteria and decreasing potentially pathogenic intestinal microorganisms. The Panel considers that decreasing potentially pathogenic intestinal microorganisms might be beneficial to human health.As the information provided in the list is insufficient to characterise the soluble fibre in the fermented dairy products and the references cited did not provide any scientific data that could be used to substantiate the claimed effect, the Panel concludes that a cause and effect relationship has not been established between the consumption of "Bifidobacterium animalis ssp. lactis Bb-12 and soluble fibre in fermented dairy products" and decreasing potentially pathogenic intestinal microorganisms.

Following an application from Danone S.A. submitted pursuant to Article 14 of Regulation 9EC) No 1924/2006 via the Competent Authority of Spain, the Panel on Dietetic Products, Nutrition and Allergies was asked to deliver an opinion on the scientific substantiation of a health claim related to: dairy fresh cheese and bone growth.The scope of the application was proposed to fall under claims referring to children's development and health.The health claim, according to the applicant, relates to all food products based on fresh cheese made from cows' milk which contain at least 120 mg of calcium, 120 mg of phosphorus and 0.75 mu g of vitamin D per daily portion of 100 g as well as protein at a level of at least 20% of the energy value. The compositional criteria proposed by the applicant with regard to protein, calcium, phosphorus and vitamin D do not characterise one type of product but cover a range of products differing significantly in composition. The Panel considers that the food constituents calcium, vitamin D, phosphorus and protein are sufficiently characterisedThe claimed effect is "contributes to healthy bone growth". The target population is children. The Panel considers that normal growth and development of bone is beneficial to children's development and health.No intervention studies have been provided addressing specifically the effects of consumption of a food corresponding to the compositional specifications proposed by the applicant and growth and development of bone in children. The Panel refers to its opinions on calcium, vitamin D and on calcium and vitamin D and bone growth in children. There is good consensus on the role of protein and phosphorus in growth and development of bone. No Tolerable Upper Intake Levels (UL) have been established for phosphorus.On the basis of the data presented, the Panel concludes that cause and effect relationships have been established separately between the intakes of calcium, vitamin D, phosphorus, and protein and normal growth and development of bone in children and adolescents. Recommended intakes of calcium, vitamin D, protein and phosphorus to meet requirements for normal growth and development of bone in children and adolescents have been established. Intakes for calcium and vitamin D may be inadequate for normal growth and development of bone in subgroups of children and adolescents in a number of EU countries. No evidence of inadequate intakes of protein or phosphorus in European children or adolescents has been provided by the applicant.Many nutrients contribute to normal growth and development of bone. A dose-response relationship has not been established between either protein or phosphorous intakes within (or above) the range observed in European populations and normal growth and development of bone in children or adolescents. Reference to the need for phosphorus or protein for normal growth, development and maintenance of bone may suggest a specific importance of these nutrients for bone health that is not justified by the scientific evidence on the adequacy of intakes of these nutrients in EU populations.The following wordings reflect the scientific evidence: 'calcium is needed for the normal growth and development of bone in children'; 'vitamin D is needed for the normal growth and development of bone in children'. The conditions for the use of the claims on calcium and vitamin D are the same as assessed in earlier Opinions.

Following a request from the European Commission, the Panel on Dietetic Products, Nutrition and Allergies was asked to provide a scientific opinion on a list of health claims pursuant to Article 13 of Regulation 1924/2006. This opinion addresses the scientific substantiation of health claims in relation to kaki fruit and maintenance of vision. The scientific substantiation is based on the information provided by the Member States in the consolidated list of Article 13 health claims and references that EFSA has received from Member States or directly from stakeholders.The food that is the subject of the health claims is kaki fruit. The Panel considers that kaki fruit is sufficiently characterised.The claimed effect is "eye health". The Panel considers that normal vision is beneficial to human health.None of the references provided reported on studies with kaki fruit. The Panel notes that the references cited provided no scientific data that could be used to substantiate the claimed effect.On the basis of the data available, the Panel concludes that a cause and effect relationship has not been established between the consumption of kaki fruit and maintenance of normal vision.

Following a request from the European Commission, the Panel on Dietetic Products, Nutrition and Allergies was asked to deliver a scientific opinion on the safety of 'Chia seed (Salvia hispanica) and ground whole Chia' as a food ingredient.The Panel has been requested to specify whether the authorisation of Chia as a food ingredient for bread is likely to have an effect on public health and to focus on the concerns of a scientific nature raised by various Members States. On 5 October 2005 the "Opinion of the Scientific Panel on Dietetic Products, Nutrition and Allergies on a request from the Commission related to the safety of Chia (Salvia hispanica L.) seeds and ground whole Chia seeds as a novel food ingredient intended for use in bread" was adopted. On the basis of the available data the safety of Chia could not be established and additional studies were required.In 2006 the 'Columbus Paradigm Institute S.A.' became responsible for this application and submitted an amended file in order to provide the information necessary to establish the safety of Chia.From the compositional data on Chia seeds, its nutritional characteristics and the proposed use, the Panel considers that there is no reason to consider this novel food ingredient nutritionally disadvantageous to the consumer under the proposed conditions of use.There is no evidence of adverse effects of whole Chia seeds and whole ground Chia seeds, while there are still uncertainties with regard to the potential allergenicity of Chia. However, the Panel recognises the difficulty of predicting, using methodologies available to date, the potential allergenicity of this NF, noted the provided complementary information showing no indication of allergenicity and considers that concerns on this issue could be reasonably addressed by appropriate management measures.The toxicological information on Chia seeds from animal and controlled human studies is limited. However, experience gained from previous and current use of Chia seeds for food purposes in non-EU countries can be regarded as supportive evidence to allow a positive conclusion on the safety of Chia seeds and ground whole Chia seeds under the proposed conditions of use.Based on the available data, the Panel concludes that it is unlikely that the use of Chia seeds in bread at a maximum of 5 % would have an adverse effect on public health.

Following an application from Brudy Technology S.L. submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Spain, the Panel on Dietetic Products, Nutrition and Allergies was asked to deliver an opinion on the scientific substantiation of a health claim related to Algatrium and antioxidant response.The scope of the application was proposed to fall under a health claim based on newly developed scientific evidence and includes a request for the protection of proprietary data.The food constituent that is the subject of the health claim is Algatrium, which is derived from fish oil and contains docosahexaenoic acid (DHA) as active ingredient (67%). Other long chain polyunsaturated fatty acids (LC-PUFA), such as eicosapentaenoic acid (EPA, about 10%) are also present. Manufacturing process, specifications and stability information of the DHArich fish oil were provided by the applicant. The Panel considers that Algatrium is sufficiently characterised.The claimed effect is "promotes your antioxidant response" by "stimulation of the own cells' antioxidant defences". The target population is the general population. The Panel considers that the claimed effect "promotes your antioxidant response" by "stimulation of the own cells' antioxidant defences" might be beneficial to human health.The applicant has identified a total of 18 studies considered pertinent to the claim. These studies include five human studies and 13 in vitro cell studies. Three of the human intervention studies are not performed with Algatrium. The Panel considers these studies not pertinent to the claim. Two unpublished studies investigated effects on oxidative damage in male cyclists receiving 500 mg to 3500 mg of Algatrium daily during one to three months. The primary outcome was the change in 8-hydroxy-2'-deoxyguanosine (8-OHdG) excretion in 24 h urine. The Panel does not consider measurement of 8-OHdG excretion in urine a reliable biomarker of DNA damage. Therefore, these studies are not useful as a source of evidence to support the claimed effect. The Panel also considers that the evidence provided does not establish that a reduction of 8-OHdG excretion indicates a beneficial change in function.Of the thirteen in vitro studies identified by the applicant, only one was carried out using Algatrium to investigate its effect on the cellular redox status in vitro. The data provided does not establish the validity of this in vitro study to support the claimed effect in vivo.The Panel concludes that a cause and effect relationship between the consumption of Algatrium and the claimed effect has not been established.

The novel food ingredient, alfalfa protein concentrate (APC), consists of a complex of protein (45-60 %), minerals (Ca, Fe, Mg), and vitamins (A, D, E, K). APC is extracted from lucerne (Medicago sativa spp. sativa) also known as alfalfa. Alfalfa is processed to first provide a press juice from which the proteins associated with carotenoid and chlorophyll pigments are separated by heat treatment and centrifugation and thereafter dried at sufficiently low temperature. The final product is granulated after adding ascorbic acid (600 mg/kg) and stored in inert gas or in cold storage. Alfalfa protein concentrate is currently marketed as animal feed. The applicant proposes the use of APC as a food supplement with a recommended consumption of 10 g per day.

Following a request from the European Commission, the Panel on Dietetic Products, Nutrition and Allergies was asked to provide a scientific opinion on a list of health claims pursuant to Article 13 of Regulation 1924/2006. This opinion addresses the scientific substantiation of health claims in relation to alpha-linolenic acid and the following claimed effects: maintenance of normal blood cholesterol concentrations and maintenance of normal blood pressure.The food constituent that is the subject of the health claims is alpha-linolenic acid (ALA). The Panel considers that ALA is sufficiently characterised.Maintenance of normal blood cholesterol concentrationsThe claimed effect is "blood cholesterol". The Panel assumes that the target population is the general population. The Panel considers that the maintenance of normal blood cholesterol concentrations is beneficial to human health.On the basis of the data available, the Panel concludes that a cause and effect relationship has been established between the dietary intake of ALA and the reduction of blood cholesterol concentrations. In order to bear the claim a food should contain at least 15% of the proposed labelling reference intake value of 2 g ALA per day. Such amounts can be easily consumed as part of a balanced diet. The target population is the general population.Maintenance of normal blood pressureThe claimed effect is "blood pressure". The Panel assumes the target population is the general population. The Panel considers that the maintenance of normal blood pressure is beneficial to human health.In weighing the evidence the Panel took into account that the observed effects of ALA intake on blood pressure in the human intervention studies were inconsistent, the lack of evidence in these studies that study design, including the study size, was appropriate to demonstrate an effect of ALA on blood pressure, that cross-sectional studies have considerable limitations as a source of evidence for the claim, the lack of evidence for a plausible mechanism for the claimed effect.On the basis of the data available, the Panel concludes that the evidence provided is insufficient to establish a cause and effect relationship between the dietary intake of ALA and the maintenance of normal blood pressure.

Following a request from the European Commission, the Panel on Dietetic Products, Nutrition and Allergies was asked to provide a scientific opinion on a list of health claims pursuant to Article 13 of Regulation (EC) No1924/2006. This opinion addresses the scientific substantiation of health claims in relation to iodine and the following claimed effects: thyroid function and production of thyroid hormones, energy-yielding metabolism, maintenance of vision, maintenance of hair, maintenance of nails, and maintenance of skin. The scientific substantiation is based on the information provided by the Member States in the consolidated list of Article 13 health claims and references that EFSA has received from Member States or directly from stakeholders.The food constituent that is the subject of the health claims is iodine which is a well recognised nutrient and is measurable in foods by established methods. The Panel considers that iodine is sufficiently characterised.The Panel concludes that a cause and effect relationship has been established between the dietary intake of iodine and normal thyroid function and normal production of thyroid hormones, normal energy-yielding metabolism, and maintenance of normal skin.The Panel considers that, in order to bear the claim, a food should be at least a source of iodine as per Annex to Regulation (EC) No 1924/2006. Such amounts can be easily consumed as part of a balanced diet. The target population is the general population.The Panel concludes that a cause and effect relationship has not been established between the dietary intake of iodine and maintenance of normal vision, maintenance of normal hair, and maintenance of normal nails.

Following a request from the European Commission, the Panel on Dietetic Products, Nutrition and Allergies was asked to provide a scientific opinion on a list of health claims pursuant to Article 13 of Regulation 1924/2006. This opinion addresses the scientific substantiation of health claims in relation to Hibiscus sabdariffa L. and improvement of diuretic function and bowel motor function. The scientific substantiation is based on the information provided by the Member States in the consolidated list of Article 13 health claims and references that EFSA has received from Member States or directly from stakeholders.The food constituent that is the subject of the health claims is Hibiscus sabdariffa L.. The Panel considers that Hibiscus sabdariffa L. has been sufficiently characterised with the following conditions of use: Infusion (from the flower): single amount of 1.5 g, and equivalent quantity in extract.Improvement of diuretic functionThe claimed effect "renal elimination/organism draining" is not sufficiently defined but from the proposed wordings the Panel assumes that the claimed effect relates to improvement of diuretic function. The Panel considers that no evidence has been provided to establish that improvement of diuretic function is beneficial to human health of the general population.The Panel notes that the references cited did not provide any scientific data that could be used to substantiate the claimed effect. The Panel concludes that a cause and effect relationship has not been established between the consumption of Hibiscus sabdariffa L. and improvement of diuretic function.Bowel motor functionThe claimed effect is "constipation/intestinal health". From the proposed wordings the Panel assumes that the claimed effect refers to changes in bowel function. The Panel considers that improvement of bowel motor function within the normal range might be beneficial to human health.The Panel notes that the references cited did not provide any scientific data that could be used to substantiate the claimed effect. The Panel concludes that a cause and effect relationship has not been established between the consumption of Hibiscus sabdariffa L. and improvement of bowel motor function within the normal range.

Following a request from the European Commission, the Panel on Dietetic Products, Nutrition and Allergies was asked to provide a scientific opinion on a list of health claims pursuant to Article 13 of Regulation 1924/2006. This opinion addresses the scientific substantiation of health claims in relation to Ocimum basilicum L. and improvement of diuretic function. The scientific substantiation is based on the information provided by the Member States in the consolidated list of Article 13 health claims and references that EFSA has received from Member States or directly from stakeholders.The food constituent that is the subject of the health claim is Ocimum basilicum L.. The Panel considers that Ocimum basilicum L. has been sufficiently characterised with the following conditions of use: dried leaf: 2-4 g, 2-3 times/day, and equivalent quantity in extract.The claimed effect "renal elimination/organism draining" is not sufficiently defined but from the proposed wordings the Panel assumes that the claimed effect relates to improvement of diuretic function. The Panel considers that no evidence has been provided to establish that improvement of diuretic function is beneficial to human health of the general population.The Panel notes that the reference cited did not provide any scientific data that could be used to substantiate the claimed effect. The Panel concludes that a cause and effect relationship has not been established between the consumption of Ocimum basilicum L. and improvement of diuretic function.

Following a request from the European Commission, the Panel on Dietetic Products, Nutrition and Allergies was asked to provide a scientific opinion on a list of health claims pursuant to Article 13 of Regulation 1924/2006. This opinion addresses the scientific substantiation of health claims in relation to "olive biophenols" and decreasing potentially pathogenic intestinal microorganisms. The scientific substantiation is based on the information provided by the Member States in the consolidated list of Article 13 health claims and references that EFSA has received from Member States or directly from stakeholders.The food constituent that is the subject of the health claim is "olive biophenols". The Panel considers that "olive biophenols" are not sufficiently characterised.The claimed effect is "strong anti-bacterial properties". The Panel considers that decreasing potentially pathogenic intestinal microorganisms might be beneficial to human health.As the information provided in the list is insufficient to characterise "olive biophenols" that are the subject of the health claim and as the only reference which was accessible to the Panel did not provide any scientific data that could be used to substantiate the claimed effect, the Panel concludes that a cause and effect relationship has not been established between the consumption of "olive biophenols" and decreasing potentially pathogenic intestinal microorganisms.

Following an application from Mead Johnson & Company 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 docosahexaenoic acid and arachidonic acid and brain development.The scope of the application was proposed to fall under a health claim referring to children's development and health.The food constituents that are the subject of the health claim are docosahexaenoic acid (DHA) and arachidonic acid (ARA), which are well characterised fatty acids that can be quantified in foods by established methods. 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 brain 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 contribution to the normal development of the brain is beneficial for infants' and children's development and health.The applicant identified a total 33 publications as being pertinent to the health claim for humans. A total of 13 full publications which report original data from RCTs on the effects of DHA supplementation (with or without ARA) on brain development in physiologic conditions and in subjects born at term and have been presented, reporting the results from eight study designs. All these studies were conducted in term infant populations fed different formulas from birth through the first months of life up to 12 months at the maximum.In two RCTs, formulas with less than 0.2% DHA (in various combinations with ARA) from birth through six or 12 months of age had no effect on neurodevelopmental indices measured with different methods as compared to standard, unsupplemented formulas. Two double-blind RCTs investigated the effects of formulas supplemented with DHA around 0.3% either alone or in combination with ARA at around the same level (ARA: DHA ratio = 1) form birth to 6-12 months of life on Bayley's Mental and Psychomotor Developmental Indices (MDI and PDI) at 12 and 24 months or at 18 months of age as compared to unsupplemented formulas. No differences in MDI or PDI scores were observed among the formula-fed groups. In another double-blind RCT, term infants allocated at birth to consume a formula supplemented with 0.15-0.25% DHA and 0.30-0.40% ARA (ARA: DHA ratio = 1.7: 1 to 2: 1) for four months had significantly more intentional solutions and higher intention scores at 10 months of age than infants who received the unsupplemented formula.In the remaining three study designs, formulas supplemented with either 0.3 % DHA alone or in combination with ARA in higher dosages (ARA: DHA ratio from 1.4: 1 to 2: 1) were used in the intervention groups. These doses of DHA and the DHA: ARA ratio are in the range of those recommended by the applicant to obtain the claimed effect.In the first study, term infants consuming a formula supplemented with 0.30% DHA and 0.44% ARA for four months scored significantly higher in the Brunet-Lezine test than infants in the control (unsupplemented) formula group at four months of age, but these differences were not sustained at 24 months of life. In the second study, healthy term infants consuming a formula supplemented with 0.3% DHA and 0.45% ARA (ARA: DHA ratio = 1.5) for two months had mildly abnormal GMs significantly less often than did infants receiving the unsupplemented formula. No differences between groups were found in clinical neurological condition, neurological optimality score, fluency score, or the Bayley's MDI or PDI at 18 months of life. The third study included infants randomised at the age of five days to consume either a formula with DHA 0.35% alone, a formula with DHA 0.36% plus ARA 0.72%, or a control formula devoid of DHA and ARA for 17 weeks. Infants supplemented with DHA and ARA yielded significantly higher MDI scores at 18 months than infants in the control group. No significant differences between groups were observed among the three groups regarding the PDI or the Behaviour Rating Scale. Infants were tested at four years of age for Intelligence Quotient (IQ). Verbal IQ in the control and DHA-supplemented formula groups was significantly lower than in the DHA plus ARA group. No differences were observed among groups regarding the full scale IQ or the performance IQ.The Panel notes that none of the studies using formulas supplemented with doses of DHA and ARA lower than proposed in the conditions of use or 0.3% DHA and an ARA: DHA ratio of one show an effect of DHA and ARA supplementation on neurodevelopment indices infants as compared to unsupplemented formulas. The Panel also notes that the four studies using either slightly lower DHA doses or about 0.3% DHA and the ARA: DHA ratio proposed in the conditions of use (between 1.4: 1 and 2: 1) show a short-tem beneficial effect of DHA and ARA supplementation on different measures of neurodevelopment. However, the different testing ages and the use of different tests for assessment limit the comparability of the studies. Also, the predictive value of the neurodevelopment tests used is uncertain. Indeed, only two of the studies above show an effect beyond the supplementation period, and only one reports a sustained effect beyond the first year of life in a limited sample of subjects. In no case the breastfed reference group showed lower developmental indices when compared to any formulafed group.On the basis of the data presented, the Panel concludes that the data presented are insufficient to establish a cause an effect relationship between the intake of infant and follow-on formula supplemented with DHA at levels around 0.3% of the fatty acids and a ratio ARA: DHA between 1.4: 1 and 2: 1 and the contribution to normal brain development in infants and young children from birth to three years of age.

SUMMARY Following an application from Merck Selbstmedikation GmbH submitted pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of Germany, the Panel on Dietetic Products, Nutrition and Allergies was asked to deliver an opinion on the scientific substantiation of a health claim related to DHA and support of the cognitive development of the unborn child and breastfed infant. The scope of the application was proposed to fall under a health claim referring to children's development and health. The food constituent that is the subject of the proposed claim is docosahexaenoic acid derived from tuna oil and presented in soft gel capsules which contain >200 mg DHA, >50 mg eicosapentaenoic acid (EPA) and between 11.4 and 14.4 mg d-α-tocopherol. The food supplement is intended for pregnant and lactating women. DHA is a well characterised fatty acid the absorption of which is well documented. DHA can be quantified in foods by established methods. The Panel considers that the food constituent, DHA, for which the claim is made is sufficiently characterised.

SUMMARY Following an application from Merck Selbstmedikation GmbH submitted pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of Germany, the Panel on Dietetic Products, Nutrition and Allergies was asked to deliver an opinion on the scientific substantiation of a health claim related to DHA and support of the visual development of the unborn child and breastfed infant. The scope of the application was proposed to fall under a health claim referring to children's development and health. The food constituent that is the subject of the proposed claim is docosahexaenoic acid derived from tuna oil which is presented in soft gel capsules which contain >200 mg DHA, >50 mg eicosapentaenoic acid (EPA) and between 11.4 and 14.4 mg d-α-tocopherol. The food supplement is intended for pregnant and lactating women. DHA is a well characterised fatty acid the absorption of which is well documented. DHA can be quantified in foods by established methods. The Panel considers that the food constituent, DHA, for which the claim is made is sufficiently characterised.

Following a request from the European Commission, the Panel on Dietetic Products, Nutrition and Allergies was asked to provide a scientific opinion on a list of health claims pursuant to Article 13 of Regulation 1924/2006. This opinion addresses the scientific substantiation of health claims in relation to inositol and cognitive function. The scientific substantiation is based on the information provided by the Member States in the consolidated list of Article 13 health claims and references that EFSA has received from Member States or directly from stakeholders.The food constituent that is the subject of the health claim is inositol. The Panel considers that inositol is sufficiently characterised.The claimed effect is "cognitive and mental performance". In the context of the proposed wordings cognitive and mental performance are both interpreted as cognitive function. The Panel considers that normal cognitive function is beneficial to human health.The Panel considers that the evidence provided does not establish that patients with Alzheimer's disease, depression, panic disorder, obsessive compulsive disorder, bipolar disorder, bulimia nervosa and diabetic polyneuropathy are representative of the general population with regard to cognitive function, or that results obtained in studies on patients with these diseases and relating to the treatment of their symptoms can be extrapolated to cognitive function in the general population.On the basis of the data available, the Panel concludes that a cause and effect relationship has not been established between the dietary intake of inositol and normal cognitive function.