The EFSA Journal (2008) 783, 1-9

ALA and LA and growth and development of children

Scientific substantiation of a health claim related to -linolenic acid and
linoleic acid and growth and development of children pursuant to Article 14
of Regulation (EC) No 1924/20061
Scientific Opinion of the Panel on Dietetic Products, Nutrition and Allergies
(Question No EFSA-Q-2008-079)

Adopted on 11 July 2008

PANEL MEMBERS
Jean-Louis Bresson, Albert Flynn, Marina Heinonen, Karin Hulshof, Hannu Korhonen, Pagona
Lagiou, Martinus Lvik, 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: -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 childrens
development and health.
The food/constituent subject of the health claim is described as essential fatty acids (the omega
3 (n-3) fatty acid -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
childrens 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 -linolenic acid and linoleic acid and growth and development of children. The EFSA Journal (2008)
783, 1-10

European Food Safety Authority, 2008

ALA and LA and growth and development of children

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.

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ALA and LA and growth and development of children

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 .....................................................................................................................................5
1. Information provided by the Applicant ..............................................................................................5
1.1.
Food/constituent as stated by the applicant ...............................................................................5
1.2.
Health relationship as claimed by the applicant.........................................................................5
1.3.
Wording of the health claim as proposed by the applicant ........................................................5
1.4.
Specific conditions for use as proposed by the applicant ..........................................................5
2. Assessment .........................................................................................................................................5
2.1.
Characterisation of food/constituent ..........................................................................................5
2.2.
Relevance of the claimed effect to human health ......................................................................6
2.3.
Scientific substantiation of the health claim ..............................................................................6
2.4.
Panels comments on the proposed wording..............................................................................7
2.5.
Conditions and restrictions of use..............................................................................................7
Conclusions .................................................................................................................................................7
Documentation provided to EFSA ..............................................................................................................8
References ...................................................................................................................................................8

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ALA and LA and growth and development of children

BACKGROUND
Regulation (EC) No 1924/20062 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 childrens
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 childrens
development and health.

During the completeness check3 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 -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: -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 -linolenic acid and linoleic acid, a positive assessment of its safety, nor a
decision on whether -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 1924/2006.
2

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,
30.12.2006. Corrigendum OJ L 12, 18.1.2007, p. 318.
In accordance with EFSA Scientific and Technical guidance for the Preparation and Presentation of the Application for
Authorisation of a Health Claim.

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ALA and LA and growth and development of children

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

Applicants 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 -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.
1.2.

Health relationship as claimed by the applicant

-linolenic acid and linoleic acid are essential for the proper growth and development of
children.
1.3.

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.
1.4.

Specific conditions for use as proposed by the applicant

A minimum daily intake of 0.3 g -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
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ALA and LA and growth and development of children

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.
2.2.

Relevance of the claimed effect to human health

The claimed effect is normal growth and development in children, which is beneficial to
childrens health. Normal growth and development requires adequate intakes of energy and all
essential nutrients, including the essential fatty acids ALA and LA.
2.3.

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, omega3, 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.
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ALA and LA and growth and development of children

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 34.5% 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; Lagstrm, 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.
2.4.

Panels 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.
2.5.

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 -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.

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ALA and LA and growth and development of children

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 -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: 0007NL). February 2008. 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, 521-525.
Caldwell MD, Jonsson HT, Othersen HB Jr, 1972. Essential fatty acid deficiency in an infant
receiving prolonged parenteral alimentation. J Pediatr. 81, 894-8.
Cooke RJ, Zee P, Yeh YY, 1985. Safflower oil emulsion administration during parenteral
nutrition in the preterm infant. 1. Effect on essential fatty acid status. J Pediatr
Gastroenterol Nutr. 4, 799-803.
DGE (Deutsche Gesellschaft fr Ernhrung), 2004. Ernhrungbericht 2004. Bonn, DGE.
DoH (Department of Health), 1991. 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, 1988. Essential fatty acid deficiency in
premature infants. Am J Clin Nutr. 48, 220-9.
Friedman Z, Danon A, Stahlman MT, Oates JA, 1976. Rapid onset of essential fatty acid
deficiency in the newborn. Pediatrics. 58, 640-9.
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.

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ALA and LA and growth and development of children

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. 2nd
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, 565-76.
Hansen AE, 1958b. The problem of the essential fatty acids in relation to human nutrition. Am
J Clin Nutr. 6, 625-7.
Hansen AE, Wiese HF, Boelsche AN, Haggard ME, Adam DJD and Davis H. (1963). Role of
linoleic acid in infant nutrition. Pediatrics, 31:171-192.
Holman RT, Johnson SB and Hatch TF (1982). A case of human linoleic acid deficiency
involving neurological abnormalities. Am J Clin Nutr 35: 617-623.
Holman RT (1998). The slow discovery of the importance of 3 essential fatty acids in human
health. J Nutr 128: 427S-433S.
IoM (Institute of Medicine), 2005. 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, 2001. Long chain polyunsaturated fatty acids (LC-PUFA) and
perinatal development. Acta Paediatr. 90, 460-464.
Lagstrm H Seppnen R, Jokinen E, Niinikoski H, Rnnemaa T, Viikari J, Simell O, 1999.
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, 516-23.
WHO/FAO (Wordwide Health Organization / Food and Agriculture Organization), 1994. 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, 1-147.

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