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The EFSA Journal (2009) 1176, 1-11
© European Food Safety Authority, 2009
SCIENTIFIC OPINION
Labelling reference intake values for n-3 and n-6 polyunsaturated fatty
acids
Scientific Opinion of the Panel on Dietetic Products, Nutrition and Allergies
on a request from the Commission related to labelling reference intake
values for n-3 and n-6 polyunsaturated fatty acids 1
(Question No EFSA-Q-2009-00548)
Adopted on 30 June 2009
PANEL MEMBERS
Jean-Louis Bresson, Albert Flynn, Marina Heinonen, Karin Hulshof, Hannu Korhonen,
Pagona Lagiou, Martinus Løvik, Rosangela Marchelli, Ambroise Martin, Bevan Moseley,
Hildegard Przyrembel, Seppo Salminen, Sean (J.J.) Strain, Stephan Strobel, Inge Tetens,
Henk van den Berg, Hendrik van Loveren and Hans Verhagen.
SUMMARY
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 α-
linolenic 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
1 For citation purposes: Scientific Opinion of the Panel on Dietetic products, Nutrition and Allergies on a request from
European Commission related to labelling reference intake values for n-3 and n-6 polyunsaturated fatty acids. The EFSA
Journal (2009) 1176, 1-11.
Labelling reference intake values for n-3 and n-6 polyunsaturated fatty acids
The EFSA Journal (2009) 1176, 2-11
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 acids
The 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 ~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 acids
The 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-6 PUFA 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.
Key words: labelling reference intake values, n-3 polyunsaturated fatty acids, n-6
polyunsaturated fatty acids, essential fatty acids, alpha-linolenic acid, linoleic
acid, long-chain polyunsaturated fatty acids, eicosapentaenoic acid,
docosahexaenoic acid, dietary reference values, dietary recommendations.
Labelling reference intake values for n-3 and n-6 polyunsaturated fatty acids
The EFSA Journal (2009) 1176, 3-11
TABLE OF CONTENTS
Panel Members ............................................................................................................................................ 1
Summary ..................................................................................................................................................... 1
n-3 polyunsaturated fatty acids ............................................................................................................... 2
Long-chain n-3 polyunsaturated fatty acids ............................................................................................ 2
n-6 polyunsaturated fatty acids ............................................................................................................... 2
Table of Contents ........................................................................................................................................ 3
Background as provided by the EC ............................................................................................................. 4
Terms of reference as provided by the EC .................................................................................................. 4
Assessment .................................................................................................................................................. 5
1.Introduction ........................................................................................................................................ 5
2.Polyunsaturated fatty acids ................................................................................................................. 8
2.1.n-3 polyunsaturated fatty acids .................................................................................................. 8
2.2.Long-chain n-3 polyunsaturated fatty acids ............................................................................... 8
2.3.n-6 polyunsaturated fatty acids .................................................................................................. 8
Conclusions ................................................................................................................................................. 9
References ................................................................................................................................................... 9
Glossary / Abbreviations ........................................................................................................................... 11
Labelling reference intake values for n-3 and n-6 polyunsaturated fatty acids
The EFSA Journal (2009) 1176, 4-11
BACKGROUND AS PROVIDED BY THE EC
In the context of the procedure for the authorisation of health claims under Regulation (EC)
No 1924/2006, the Member States discussed and voted at a meeting of 20 February 2009 in
the Standing Committee of the Food Chain and Animal on the first batch of health claims
applications to be either authorised or rejected.
To this end, the Member States and the Commission discussed concerns expressed by some
Member States in relation to the conditions of use for the health claim on essential fatty acids
(α-linolenic acid and linoleic acid) and normal growth and development of children.
The Member States and the Commission agreed that EFSA should be asked to give general
advice on reference values for the purpose of labelling for fatty acids to enable the review of
the conditions of use for the health claim referred to, but equally important to be able to set
appropriate conditions of use for the foreseen health claims on fatty acids, both for health
claims pursuant to Article 14 of Regulation (EC) No 1924/2006 but also for health claims
covered by Article 13 of that Regulation.
EFSA has already provided advice on nutrition claims concerning omega-3 fatty acids,
monounsaturated fat, polyunsaturated fat and unsaturated fat (EFSA-Q-2004-1073),
commented on the Recommended Nutritional Intake (RNI) for essential fatty acids, and
advised to distinguish RNI for α-linolenic acid in the range of 2 g/day for adults, and RNI for
long chain n-3 polyunsaturated fatty acids (LC n-3 PUFA), mainly eicosapentaenoic acid
(EPA) and docosahexaenoic acid (DHA), for which recommended intakes for cardio-
protective effects are in the range of 200-500 mg/day.
SCF defined in 1993 Population Reference Intakes (PRI) of 2 E% for omega-6
polyunsaturated fatty acids (n-6 PUFA). The corresponding amounts far n-6 PUFA are 4.5
g/day for females and 6 g/day for males, respectively. Considering that the point of reference
for the omega-3 fatty acids in the EFSA opinion is the daily intake for an adult male, 6 g/day
is included into the terms of reference.
TERMS OF REFERENCE AS PROVIDED BY THE EC
EFSA is requested to provide an opinion in accordance with Article 29(1)(a) of Regulation
(EC) No 178/2002 on the following aspects:
¾ Whether reference values for the purpose of labelling for essential fatty acids can be
established.
To this end, EFSA is asked in particular to consider the appropriateness of:
¾ 2 g for short-chain omega-3 fatty acids
¾ 200 mg for long chain omega-3 fatty acids
¾ 6 g for omega-6 fatty acids
Labelling reference intake values for n-3 and n-6 polyunsaturated fatty acids
The EFSA Journal (2009) 1176, 5-11
ASSESSMENT
1. Introduction
The proposed labelling reference intake values for n-3 and n-6 polyunsaturated fatty acids
(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 to convey the relative
significance of the food as a source of PUFAs in the context of a total daily diet, and can also
be used to set appropriate conditions of use for health claims on PUFAs. For practical
application, a single reference intake value is proposed for each type of PUFA using rounded
values for ease of calculation.
The PUFAs for which advice on labelling reference values is requested are the n-3 PUFA α-
linolenic acid (ALA), the long chain n-3 PUFAs (mainly eicosapentaenoic acid (EPA) and
docosahexaenoic acid (DHA)) and n-6 PUFAs (mainly linoleic acid (LA)). Labelling
reference intake values for PUFA may be derived from science-based intake
recommendations for the general population established by national and international
authorities (DoH, 1991; GR, 2006; NNR, 2004; AFSSA, 2001; DACH, 2008; Eurodiet, 2000;
WHO, 2003; USDA, 2005) taking into account observed intakes in the population. For these
PUFA, intake recommendations for the general population are sometimes aimed at the
prevention of deficiency symptoms but are more usually based on evidence of relationships
between intake and neurodevelopment and/or risk of cardiovascular diseases. 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 (Table
1).
Table 2 compiles dietary intakes of n-3 and n-6 PUFAs among adults according to recent
dietary surveys in some European countries. National dietary surveys from most European
countries report intakes of total PUFAs, whereas only some provide data for n-6 PUFAs
and/or LA, and for n-3 PUFAs and/or ALA, EPA and DHA.
Labelling reference intake values for n-3 and n-6 polyunsaturated fatty acids
The EFSA Journal (2009) 1176, 6-11
Table 1. Proposed labelling reference intake values for n-3 and n-6 PUFAs and
recommended dietary intakes from national and international bodies (adults).
n-3 PUFA ALA EPA+DHA n-6 PUFA
(mainly LA)
% of
energy g/day % of
energy g/day % of
energy
mg/da
y
% of
energy g/day
Reference intake
value in ToR
- - - 2 - 200 - 6
SCF, 1993 0.5 - - - - - 2 -
WHO, 2003 1-2 - - - - - 5-8 -
United Kingdom
DoH, 1991
>0.2
>1
SACN, 2004 - - - - - 450 - -
Eurodiet, 2000 - - - 2 - 200 4-8 -
The Netherlands
(GR, 2001 and
2006)
- - 1 - - 450 2 -
Nordic Countries
(NNR, 2004)
1 - 1 - - 450
≥4 -
France, (AFSSA,
2001)
Adult men 0.8 2 - - 0.2 500 4 -
Adult women 0.8 1.6 - - 0.2 400 4 -
USA (FNB, 2002)
Adult men
Adult women
0.6-1.2
1.6
1.1
- - 5-10 -
14-17
11-12
Germany, Austria,
Switzerland
(D-A-CH, 2008)
0.5 - - - - - 2.5 -
The EFSA Journal (2009) 1176, 7-11
© European Food Safety Authority, 2009
Table 2. Mean dietary intake of n3- and n-6 polyunsaturated fatty acids (and clusters) among adults according to recent dietary
surveys in some European countries
ALA EPA + DHA LA References
Men Women Men Women Men Women
g/d E% g/d E% mg/d E% mg/d E% g/d E% g/d E%
Austria 1.2 0.5 1.1 0.6 280 NA 251 NA 17 7.1 14 7.1
Elmadfa et al., 2009
France 0.9 0.36 0.7 0.38 420 0.17 350 0.18
10.6 4.1 8.1 4.2
Astorg et al., 2004
Finland 2.5 1.0 1.8 1.0 NA NA NA NA 9.9 3.9 7.2 3.9 Paturi M et al., 2008.
Germany * 1.59 0.6 1.32 0.6 290 0.11 210 0.10 14.3 5.2 10.9 5.2 Linseisen et al., 2003
** 2.25 0.8 1.51 0.8 340 0.12 220 0.11 18.6 6.5 11.6 5.8 Linseisen et al., 2003
The
Netherlands
1.95 0.6 1.26 0.6 100 0.03 80 0.05 17.8 5.8 12.0 5.5 Kruizinga et al., 2007
Sweden # 1.5 NA 1.2 NA - - - - 9.7 NA 7.8 NA Becker and Pearson,
1998
* German EPIC Cohort from centre H and ** centre P
# median intake; median intake of EPA = 100 mg for males and females; median intake of DHA = 240 mg for males and 210 mg for
females.
NA = not available
The EFSA Journal (2009) 1176, 8-11
© European Food Safety Authority, 2009
2. Polyunsaturated fatty acids
2.1. n-3 polyunsaturated fatty acids
The n-3 fatty acid most abundant in food is ALA. ALA is considered to be nutritionally
essential because of its specific function as precursor for the long-chain n-3 PUFA EPA and
DHA.
The proposed labelling reference intake value for ALA (2 g) 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 ~0.4-
0.8 E%) (Table 2). Intake recommendations for ALA range from a minimum of 0.2 E%
(aimed at the prevention of deficiency symptoms) to about 1 E% (based on considerations of
cardiovascular health) (Table 1). One E% corresponds to between 2 and 3 g /day for energy
intakes of 1800 kcal/day for women and 2700 kcal/day for men (EFSA, 2005).
The Panel considers that the proposed labelling reference intake value for the n-3 PUFA ALA
(2 g) is consistent with recommended intakes for individuals in the general population in
European countries based on considerations of cardiovascular health.
2.2. Long-chain n-3 polyunsaturated fatty acids
In most European populations the quantitatively most important long-chain n-3 PUFA in the
diet are EPA and DHA. Dietary long-chain n-3 PUFAs also include DPA. Long-chain n-3
PUFAs can also be synthesised from ALA in animal tissues through the sequential action of
various desaturases and elongases. Together with the n-6 PUFAs, long-chain n-3 PUFAs are
important structural components of cell membranes and contribute to their functions. EPA is
also a precursor of eicosanoids.
National and international bodies have based their recommendations for dietary intake of
EPA and DHA on the inverse relationship observed between the consumption of these long-
chain n-3 PUFAs (primarily from fish and fish oils) and a lower risk of coronary artery
disease. Such recommendations range from 200 mg to 500 mg per day (Table 1; EFSA,
2005). Most recent evidence derived form meta-analysis of randomized trials and large
prospective studies shows that, when only healthy subjects are considered, the intake of EPA
plus DHA is negatively related to cardiovascular risk in a dose-dependent way up to about
250 mg/d (1–2 servings of oily fish per week), with little additional benefit observed at higher
intakes (Mozaffarian and Rimm, 2006; Mozaffarian, 2008; Harris et al., 2008, 2009a and
2009b). The proposed labelling reference intake value for long chain n-3 PUFAs (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 80 mg/d and 420 mg/d (Table 2).
The Panel proposes 250 mg/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.
2.3. n-6 polyunsaturated fatty acids
n-6 PUFAs mainly include LA, and to a lesser extent arachidonic acid (ARA). Strictly
speaking, only LA is essential. Since the synthesis of ARA from LA seems to be sufficient in
humans after 6 months of age under the current lifestyle and dietary habits, no requirement
Labelling reference intake values for n-3 and n-6 polyunsaturated fatty acids
The EFSA Journal (2009) 1176, 9-11
for preformed ARA can be defined. Linoleic acid, when incorporated into skin ceramides, is
essential for maintaining the water-permeability barrier of the skin thereby avoiding excessive
trans-epidermal water loss and the accompanying energy loss from water evaporation. AA is
the precursor for series 2 prostanoids and series 4 leukotrienes.
In Europe, average intakes of cis n-6 PUFAs range between 3.8 E% to nearly 6 E%.
Distribution of intakes were only available for the Netherlands, ranging from 2.6 to 9.8 E% at
the 5th and the 95th percentile, and for the UK, ranging from 1.9 to 10.5 E% at the 2.5th and
97.5th percentile, respectively. Since LA is the primary n-6 PUFA, the intake of LA might be
only slightly lower than the intake of total n-6 PUFA. In some European countries, average
LA intakes in adults range from nearly 7 g/day to approximately 19 g/day, corresponding to
3.9 to 6.5 E% (Table 2).
No intake recommendations have been specifically set for ARA in adults. Intake
recommendations for LA range from a minimum of 1 E% (aimed at the prevention of
deficiency symptoms) to about 4-10 E% (based on considerations of cardiovascular health
and mean observed intakes in healthy populations), which correspond to 2-3 and 8-30 g
LA/day, respectively, for energy intakes of 1800-2700 kcal/day. The lower bound of intake
recommendations based both on considerations of cardiovascular health and on average
observed intakes in healthy populations is 4 E%, which corresponds to about 8-12 g/d (Table
2).
The proposed labelling reference value of 6 g has been calculated from the SCF (1993)
Population Reference Intake (PRI) of 2 E% for n-6 PUFA (mainly LA), which was based on
rough estimates from feeding studies in infants, extrapolated to a reference energy intake of
2700 kcal/day (adult male). This amount is lower than mean intakes observed in Europe
(between 7 and 19 g/d). It is also lower than intakes recommended for individuals in the
general population based on considerations of cardiovascular health (4 E%; equivalent to 8-12
g/d for adults) by some national and international authorities (Table 1).
The Panel proposes 10 g as labelling reference intake value for the n-6 PUFA LA, which is
consistent with recommended intakes for individuals in the general population in European
countries based on considerations of cardiovascular health.
CONCLUSIONS
The Panel concludes that:
• The proposed labelling reference value for the n-3 PUFA ALA (2 g) is consistent with
recommended intakes for individuals in the general population in European countries
based on considerations of cardiovascular health.
• The Panel proposes 250 mg/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.
• The Panel proposes 10 g as labelling reference intake value for n-6 PUFA LA, which
is consistent with recommended intakes for individuals in the general population in
European countries based on considerations of cardiovascular health.
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GLOSSARY / ABBREVIATIONS
E% expressed as % of energy intake
EU European Union
kcal Kilocalories