ALA and LA and growth and development of children. Adopted on 11 July 2008

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1 The EFSA Journal (2008) 783, 1-9 ALA and LA and growth and development of children Scientific substantiation of a health claim related to α-linolenic acid and linoleic acid and growth and development of children pursuant to Article 14 of Regulation (EC) No 1924/ Scientific Opinion of the Panel on Dietetic Products, Nutrition and Allergies (Question No EFSA-Q ) Adopted on 11 July 2008 PANEL MEMBERS Jean-Louis Bresson, Albert Flynn, Marina Heinonen, Karin Hulshof, Hannu Korhonen, Pagona Lagiou, Martinus Løvik, Rosangela Marchelli, Ambroise Martin, Bevan Moseley, Andreu Palou, Hildegard Przyrembel, Seppo Salminen, Sean (J.J.) Strain, Stephan Strobel, Inge Tetens, Henk van den Berg, Hendrik van Loveren and Hans Verhagen. SUMMARY Following an application from Unilever PLC/NV submitted pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of The Netherlands, the Panel on Dietetic Products, Nutrition and Allergies was asked to deliver an opinion on the scientific substantiation of a health claim related to: α-linolenic acid and linoleic acid and growth and development of children. The scope of the application was proposed to fall under health claims referring to children s development and health. The food/constituent subject of the health claim is described as essential fatty acids (the omega 3 (n-3) fatty acid α-linolenic acid or C18:3n-3 (ALA) and the omega 6 (n-6) fatty acid linoleic acid or C18:2n-6 (LA)) provided in the form of triglycerides, which are well recognized nutrients and are measurable in foods by established methods. ALA and LA are well absorbed when consumed in the form of triglycerides. This evaluation applies to all appropriate sources of ALA and LA in the specified amounts. The Panel considers that the food/constituents which are the subject of the health claim are sufficiently characterised. The claimed effect is normal growth and development in children, which is beneficial to children s health. Normal growth and development requires adequate intakes of energy and all essential nutrients, including the essential fatty acids ALA and LA. The target population for the health claim is children from 1 to 12 years of age. 1 For citation purposes: Scientific Opinion of the Panel on Dietetic Products, Nutrition and Allergies on a request from Unilever PLC/NV on α-linolenic acid and linoleic acid and growth and development of children. The EFSA Journal (2008) 783, 1-10 European Food Safety Authority, 2008

2 The evidence presented to support that LA and ALA are essential to growth and development of children are mainly case reports documenting clinical signs and symptoms of essential fatty acid (EFA) deficiency (largely as LA deficiency) in infants and children, one randomised intervention trial on the effects of LA deficiency in infants and two case reports documenting specific ALA deficiency in children 6-7 years of age. The Panel considers that a cause and effect relationship is established between the intake of ALA and LA and normal growth and development of children. The applicant cites reports on LA and ALA intake in children in some EU countries being low or below the recommended (adequate) intakes which were based on observed median intakes in the US. Reported intakes of LA and ALA for children in the EU exceed the amounts of LA and ALA below which adverse effects on growth and development due to EFA deficiency have been observed. The Panel considers that the evidence provided does not establish that intakes of ALA and LA are inadequate for normal growth and development of children in the EU population. The wording essential fatty acids are needed for normal growth and development of children reflects the scientific evidence. The Panel considers that the evidence provided does not establish a benefit for normal growth and development of children of LA intakes greater than about 1% of total energy and of ALA greater than about 0.2% of total energy. These quantities are reported to be consumed by children as part of the recommended balanced diet. Key words: Essential fatty acids, linoleic acid, alpha linolenic acid, growth, development, children. The EFSA Journal (2008) 783, 2-9

3 TABLE OF CONTENTS Panel Members...1 Summary...1 Table of Contents...3 Background...4 Steps taken by EFSA...4 Terms of reference...4 EFSA Disclaimer...4 Acknowledgements Information provided by the Applicant Food/constituent as stated by the applicant Health relationship as claimed by the applicant Wording of the health claim as proposed by the applicant Specific conditions for use as proposed by the applicant Assessment Characterisation of food/constituent Relevance of the claimed effect to human health Scientific substantiation of the health claim Panel s comments on the proposed wording Conditions and restrictions of use...7 Conclusions...7 Documentation provided to EFSA...8 References...8 The EFSA Journal (2008) 783, 3-9

4 BACKGROUND Regulation (EC) No 1924/ harmonises the provisions that relate to nutrition and health claims and establishes rules governing the Community authorisation of health claims made on foods. As a rule, health claims are prohibited unless they comply with the general and specific requirements of that Regulation and are authorised in accordance with this Regulation and included in the lists of authorised claims provided for in Articles 13 and 14 thereof. In particular, Article 14 to 17 of that Regulation lay down provisions for the authorization and subsequent inclusion of reduction of disease risk claims and claims referring to children s development and health in a Community list of permitted claims. According to Article 15 of that Regulation, an application for authorisation shall be submitted by the applicant to the national competent authority of a Member State, who will make the application and any supplementary information supplied by the applicant available to European Food Safety Authority (EFSA). STEPS TAKEN BY EFSA The application was received on 10/01/2008. The scope of the application was proposed to fall under claim referring to children s development and health. During the completeness check 3 of the application, the applicant was requested to provide missing information on 31/01/2008. The applicant provided the missing information on 14/02/2008. The application was considered valid by EFSA and the scientific evaluation procedure started on 14/03/2008. During the meeting on 11/07/2008, the NDA Panel, in the light of the overall data submitted adopted an opinion on α-linolenic acid and linoleic acid and growth and development of children. TERMS OF REFERENCE EFSA is requested to evaluate the scientific data submitted by the applicant in accordance with Article 16 of Regulation (EC) No 1924/2006. On the basis of that evaluation, EFSA will issue a scientific opinion on the information provided by the applicant concerning: α-linolenic acid and linoleic acid and growth and development of children. EFSA DISCLAIMER The present opinion does not constitute, and cannot be construed as, an authorisation to the marketing of α-linolenic acid and linoleic acid, a positive assessment of its safety, nor a decision on whether α-linolenic acid and linoleic acid are, or are not, classified as a foodstuff. It should be noted that such an assessment is not foreseen in the framework of Regulation (EC) No 1924/ European Parliament and Council (2006). Regulation (EC) No 1924/2006 of the European Parliament and of the Council of 20 December 2006 on nutrition and health claims made on foods. Official Journal of the European Union OJ L 404, Corrigendum OJ L 12, , p In accordance with EFSA Scientific and Technical guidance for the Preparation and Presentation of the Application for Authorisation of a Health Claim. The EFSA Journal (2008) 783, 4-9

5 It should also be highlighted that the scope, the proposed wording of the claim and the conditions of use as proposed by the applicant may be subject to changes pending pending the outcome of the authorization procedure foreseen in Article 17 Regulation (EC) No 1924/2006. ACKNOWLEDGEMENTS The European Food Safety Authority wishes to thank the members of the Working Group for the preparation of this opinion: Jean-Louis Bresson, Albert Flynn, Marina Heinonen, Hannu Korhonen, Ambroise Martin, Andreu Palou, Hildegard Przyrembel, Seppo Salminen, Sean (J.J.) Strain, Inge Tetens, Henk van den Berg, Hendrik van Loveren and Hans Verhagen. 1. Information provided by the Applicant Applicant s name and address: UNILEVER PLC/NV ; Unilever PLC: Port Sunlight, Wirral, Merseyside, CH62 4ZD, UK and Unilever NV: Weena 455, Rotterdam, 3013 AL, Nederland 1.1. Food/constituent as stated by the applicant Essential fatty acids (EFA: omega 3 fatty acid α-linolenic acid or C18:3n-3 (ALA) and the omega 6 fatty acid linoleic acid or C18:2n-6 (LA)) these are provided in the form of triglycerides in a variety of fully refined vegetable oils mixed to give fat liquid preparations of vegetable oils and fats and fat spreads. There are no partially hydrogenated fats in the products which contain fat soluble vitamins, preservative (potassium sorbate), flavourings and colour (beta carotene) additives Health relationship as claimed by the applicant α -linolenic acid and linoleic acid are essential for the proper growth and development of children Wording of the health claim as proposed by the applicant Regular consumption of essential fatty acids is important for proper growth and development of children Specific conditions for use as proposed by the applicant A minimum daily intake of 0.3 g α-linolenic acid (ALA) and 2.1 g of linoleic acid (LA), representing 15% of the dietary recommendation of 2 g and 14 g, respectively, as specified by the International Margarine Association of the Countries of Europe. These amounts may be obtained in 20 g of fat spreads or 20 ml liquid products. 2. Assessment 2.1. Characterisation of food/constituent ALA and LA are well recognised nutrients and are measurable in foods by established methods. They are well absorbed when consumed in the form of triglycerides. The applicant manufactures ALA and LA-rich fat spreads and liquid preparations of vegetable fat for which complete specifications, full description of the manufacturing process and stability information are provided. However, the scientific evidence provided by the applicant to substantiate the health claim has been obtained using ALA and LA from a variety of sources The EFSA Journal (2008) 783, 5-9

6 and not exclusively from the specific food products manufactured by the applicant. This evaluation will apply to all appropriate sources of ALA and LA in the specified amounts. The Panel considers that the food/constituents which are the subject of the health claim are well characterised Relevance of the claimed effect to human health The claimed effect is normal growth and development in children, which is beneficial to children s health. Normal growth and development requires adequate intakes of energy and all essential nutrients, including the essential fatty acids ALA and LA Scientific substantiation of the health claim The applicant performed a literature search in PubMed and Web of Science between March and September 2007 using the terms essential fatty acids, linoleic acid, alpha-linolenic acid, omega- 3, omega-6, growth, deficiency, mental development, visual development, children and infants. The applicant states that all human intervention trials and all relevant observational studies identified were reviewed, whereas animal studies were generally not considered. Publications from non-peer reviewed journals and publications not in English were not considered, with the exception of publications related to dietary intakes where also non-peer reviewed reports and reports in one of other formal EU languages were taken into account. The Panel notes that recommended intakes of LA and ALA in the UK for infants, adults and children based on requirements to prevent deficiency have not been considered by the applicant (DoH, 1991). The applicant also presents a number of observational and intervention studies assessing the effects of infant formula supplemented with long-chain polyunsaturated fatty acids as compared to either infant formula with LA and ALA or human milk on growth, visual and neural development in infants. The applicant acknowledges that such studies are not directly related to the health claim, e.g., not conducted in the target population, not designed to address the relationship between LA, ALA and growth and development in children. The Panel considers that the studies presented are not pertinent to the health claim. The target population for the health claim is children from 1 to 12 years of age. The evidence presented to support that LA and ALA are essential to growth and development of children is based on case reports documenting clinical signs and symptoms of EFA deficiency (largely as LA deficiency) in infants and children, one randomised intervention trial on the effects of LA deficiency in infants and two case reports documenting specific ALA deficiency in children 6-7 years of age. The studies of Hansen et al. (1958a and b, 1963) demonstrated that LA is essential for normal growth and development in infants and this is supported by case reports on LA deficiency in infants and children maintained on total parenteral nutrition (TPN) without fat or with minimal fat content (Caldwell et al., 1972; Cooke et al., 1985; Farrell et al., 1988; Friedman et al., 1976). In a randomised intervention trial, Hansen et al. (1963) found that infants who were fed a diet practically devoid of fat or extremely low in LA (< 0.1% of total energy) from birth or from 12 weeks of age until the age of 6 months or 1 year had clinical evidence of LA deficiency (growth deficits, dermatological lesions) which disappeared promptly when infants were provided with 1% of energy or more as LA. It has also been established that ALA is essential for normal development but there are fewer data on deficiency in children. ALA deficiency has been observed in two cases of children 6-7 years of age who received either enteral or TPN formulations almost devoid of ALA (Holman, 1982 and 1998, Bjerve et al., 1998). Clinical signs of ALA deficiency are more subtle than signs of LA deficiency and are largely confined to neurological and behavioural problems. The EFSA Journal (2008) 783, 6-9

7 The Panel considers that a cause and effect relationship is established between the intake of ALA and LA and normal growth and development of children. About 1-2 % of total dietary energy intake from EFA and quite small amounts of LA (about 1 % of total energy) and ALA (about 0.2 % of total energy) are needed to prevent adverse effects on growth and development in infants (Gurr, 1992). Dietary intake recommendations for LA and ALA vary among different authorities. WHO recommendations for infants are at least 3 4.5% of total energy from LA and at least 0.5% energy from ALA to meet essential fatty acid requirements (WHO/FAO, 1994). In the UK it is recommended that in infants, children and adults LA should provide at least 1% of total energy and ALA at least 0.2% of total energy to prevent deficiency on the basis that there is no evidence that higher amounts are beneficial (DoH, 1991). Higher recommendations (adequate intakes) for LA and ALA have been established in the US on the basis of observed median intakes (IoM, 2005). Recommendations by other national and international bodies presented by the applicant are expressed as total n-3 and n-6 fatty acids as percentage of total energy intake. The applicant cites reports of intake of LA and ALA in children in some EU countries being low or below the IoM (2005) recommendations (Elmadfa, 2003; Koletzko et al., 2000; DGE 2004; Lagström, 1999; Gregory et al., 1995; Gregory et al., 2000). Intakes of LA and ALA for children in these studies exceed the amounts of LA and ALA below which adverse effects on growth and development due to EFA deficiency have been reported. The Panel considers that the evidence provided does not establish that intakes of ALA and LA are inadequate for normal growth and development of children in the EU population Panel s comments on the proposed wording The Panel considers that the wording essential fatty acids are needed for proper growth and development of children reflects the scientific evidence Conditions and restrictions of use The applicant specifies that the proposed claim would be warranted for foods which provide a minimum daily intake of 0.3 g α-linolenic acid (ALA) and 2.1 g of linoleic acid (LA). This is 15% of the dietary intake recommendation for adults of 2 g ALA and 14g LA, respectively, as given by the International Margarine Association of the Countries of Europe. The source of these intake recommendations for LA (14g/d) and ALA (2g/d) is not referenced and the basis of these recommendations is not provided in the application. The Panel considers that the evidence provided does not establish a benefit for normal growth and development of children of LA intakes greater than about 1% of total energy and of ALA greater than about 0.2% of total energy. This quantity can be consumed as part of a balanced diet. CONCLUSIONS On the basis of the data presented, the Panel concludes that: ALA and LA are well recognised nutrients and are measurable in foods by established methods. They are well absorbed when consumed in the form of triglycerides. The Panel considers that the food/constituents which are the subject of the health claim are well characterised. The EFSA Journal (2008) 783, 7-9

8 The claimed effect is for normal growth and development in children. Normal growth and development requires adequate intakes of energy and all essential nutrients, including the essential fatty acids (ALA and LA). A cause-effect relationship is established between the intake of ALA and LA and normal growth and development of children. Although there are reports of LA and ALA intakes in young children in EU countries that are low or less than recommendations based on adequate intakes in the US, reported intakes of LA and ALA for children in the EU exceed the amounts of LA and ALA below which adverse effects on growth and development due to EFA deficiency have been observed. The wording essential fatty acids are need for normal growth and development of children reflects the scientific evidence. The evidence provided does not establish a benefit for normal growth and development of children of LA intakes greater than about 1% of total energy and of ALA greater than about 0.2% of total energy. This quantity can be consumed as part of a balanced diet. DOCUMENTATION PROVIDED TO EFSA Health claim application on α-linolenic acid and linoleic acid and growth and development of children pursuant to Article 14 of the Regulation (EC) No 1924/2006 (Claim serial No: NL). February Submitted by Unilever PLC/NV. REFERENCES Bjerve KS, Thorensen L and Borsting S (1988) Linseed and cod liver oil induce rapid growth in a 7-year old girl with n-3 fatty acid deficiency. J. Parent. Ent. Nutr. 12, Caldwell MD, Jonsson HT, Othersen HB Jr, Essential fatty acid deficiency in an infant receiving prolonged parenteral alimentation. J Pediatr. 81, Cooke RJ, Zee P, Yeh YY, Safflower oil emulsion administration during parenteral nutrition in the preterm infant. 1. Effect on essential fatty acid status. J Pediatr Gastroenterol Nutr. 4, DGE (Deutsche Gesellschaft für Ernährung), Ernährungbericht Bonn, DGE. DoH (Department of Health), Dietary reference values for food energy and nutrients for the United Kingdom. Report of the Panel on Dietary Reference Values of the Committee on Medical Aspects of Food Policy, HM Stationary Office, London. Farrell PM, Gutcher GR, Palta M, DeMets D, Essential fatty acid deficiency in premature infants. Am J Clin Nutr. 48, Friedman Z, Danon A, Stahlman MT, Oates JA, Rapid onset of essential fatty acid deficiency in the newborn. Pediatrics. 58, Gregory, J. R., Collins D, Davies P, Hughes J, Clarke P. (1995) National Diet and Nutrition Survey: children aged 1.5 to 4.5 years. Volume 1. Report of the Diet and Nutrition survey, London: HMSO. The EFSA Journal (2008) 783, 8-9

9 Gregory J., Lowe S, (2000). National Diet and Nutrition Survey: Young People Aged 4 to 18 Years. London: The Stationery Office. Gurr MI (1992). Fats that are essential in the diet. In: Role of fats in food and nutrition. 2 nd Edition. Elsevier Applied Sciences. Hansen AE, Haggard ME, Boelsche AN, Adam DJ, Wiese HF, 1958a. Essential fatty acids in infant nutrition. III. Clinical manifestations of linoleic acid deficiency. J Nutr. 66, Hansen AE, 1958b. The problem of the essential fatty acids in relation to human nutrition. Am J Clin Nutr. 6, Hansen AE, Wiese HF, Boelsche AN, Haggard ME, Adam DJD and Davis H. (1963). Role of linoleic acid in infant nutrition. Pediatrics, 31: Holman RT, Johnson SB and Hatch TF (1982). A case of human linoleic acid deficiency involving neurological abnormalities. Am J Clin Nutr 35: Holman RT (1998). The slow discovery of the importance of Ώ3 essential fatty acids in human health. J Nutr 128: 427S-433S. IoM (Institute of Medicine), Dietary reference intakes for energy, carbohydrates, fiber, fat, protein and amino acids (Macronutrients). The National Academy of Sciences, USA. Koletzo B, Agostoni C, Carlson SE, Clandinin T, Hornstra G, Neuringer M, Uauy R, Yamashiro Y, Willatts P, Long chain polyunsaturated fatty acids (LC-PUFA) and perinatal development. Acta Paediatr. 90, Lagström H Seppänen R, Jokinen E, Niinikoski H, Rönnemaa T, Viikari J, Simell O, Influence of dietary fat on the nutrient intake and growth of children from 1 to 5 y of age: the Special Turku Coronary Risk Factor Intervention Project. Am. J. Clin. Nutr. 69, WHO/FAO (Wordwide Health Organization / Food and Agriculture Organization), Fats and oils in human nutrition. Report of a joint expert consultation. Food and Agriculture Organization of the United Nations and the World Health Organization. FAO Food Nutr Pap. 57:i-xix, The EFSA Journal (2008) 783, 9-9