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Annex 2 to FEDIOL request for adjustments into the Nutriscore for
bottled vegetable oils and fats
Scientific evidence regarding unsaturated fatty acids, polyunsaturated
fatty acids and omega 3 fatty acids
1. EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific
Opinion on health claims already evaluated (ID 215, 568, 674, 712, 1398,
1633, 1974, 4191, 4192, 4193, 4236, 4335, 4698, 4704) pursuant to Article
13(1) of Regulation (EC) No 1924/2006. EFSA Journal 2011; 9(6):2203.
[22
pp.].
doi:10.2903/j.efsa.2011.2203.
Available
online:
www.efsa.europa.eu/efsajournal and EFSA Panel on Dietetic Products,
Nutrition and Allergies (NDA); Scientific Opinion on the substantiation of
health claims related to alpha-linolenic acid and maintenance of normal
blood cholesterol concentrations (ID 493) and maintenance of normal
blood pressure (ID 625) pursuant to Article 13(1) of Regulation (EC) No
1924/2006 on request from the European Commission. EFSA Journal 2009;
7(9):1252. [17 pp.]. doi:10.2903/j.efsa.2009.1252. Available online:
www.efsa.europa.eu
Following EFSA assessment, health benefits of alpha-linolenic acid (ALA) have been
recognised as contributing to the maintenance of normal blood cholesterol levels, with a
daily intake of 2 g of ALA, for food being at least a source of ALA as referred to in the claim
Alpha-linolenic acid (ALA) (ID 568) The food constituent that is the subject of the health
-
d conditions of use and the references
provided, the Panel assumes that the food constituent, which is the subject of the health
claim, is alpha-linolenic acid (ALA). The Panel considers that the food constituent, alpha-
linolenic acid (ALA), which is the subject of the health claim, is sufficiently characterised
(EFSA Panel on Dietetic Products Nutrition and Allergies (NDA), 2009c).
claimed
general population. In the context of the proposed wordings, the Panel assumes
that the claimed effect refers to the maintenance of normal blood cholesterol
concentrations. A claim on ALA and maintenance of normal blood cholesterol
concentrations has already been assessed with a favourable outcome (EFSA Panel
on Dietetic Products Nutrition and Allergies (NDA), 2009c).
Replacement of mixtures of saturated fatty acids (SFAs) as present in foods or diets with
mixtures of polyunsaturated fatty acids (PUFAs) (ID 674, 4335) The food constituent that
context of the
proposed wordings, the Panel assumes that the food constituent, which is the subject of
the health claim, is saturated fatty acids (SFAs), which should be replaced by cis-
polyunsaturated fatty acids (cis-PUFAs) in foods or diets in order to obtain the claimed
effect. The Panel considers that the food constituent, saturated fatty acids as present in
F E D I O L A IS B L - T H E E U V E G E T A B L E O I L A N D P R O T E I N M EA L IN D U S T R Y
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foods or diets, and the food constituent, mixtures of cis-PUFAs, which should replace
SFAs in foods, and which are the subject of the health claim, are sufficiently characterised
(EFSA Panel on Dietetic Products Nutrition and Allergies (NDA), 2011a).
The claimed
the general population. In the context of the proposed wordings, the Panel assumes
that the claimed effects refer to the maintenance of normal blood LDL-cholesterol
concentrations. A claim on the replacement of mixtures of SFAs with cis-MUFAs and/or cis-
PUFAs in foods or diets and maintenance of normal blood LDL-cholesterol concentrations
has already been assessed with a favourable outcome (EFSA Panel on Dietetic Products
Nutrition and Allergies (NDA), 2011a).
2. EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA);
Scientific Opinion on the substantiation of health claims related to the
replacement of mixtures of saturated fatty acids (SFAs) as present in foods
or diets with mixtures of monounsaturated fatty acids (MUFAs) and/or
mixtures of polyunsaturated fatty acids (PUFAs), and maintenance of
normal blood LDL-cholesterol concentrations (ID 621, 1190, 1203, 2906,
2910, 3065) pursuant to Article 13(1) of Regulation (EC) No 1924/2006.
EFSA Journal 2011;9(4):2069. [18 pp.]. doi:10.2903/j.efsa.2011.2069.
Available online: www.efsa.europa.eu/efsajournal
The Panel concludes that a cause and effect relationship has been established
between the consumption of mixtures of dietary SFAs and an increase in blood cholesterol
concentrations, and that replacement of a mixture of SFAs with cis-MUFAs and/or
cis-PUFAs in foods or diets on a gram-per-gram basis may help maintain normal blood
LDL-cholesterol concentrations.
3. EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA);
fat and low trans spreadable fat rich in unsaturated and omega-3 fatty
-cholesterol concentrations pursuant to Article
14 of Regulation (EC) No 1924/2006. EFSA Journal 2011;9(5):2168. [13
pp.].
doi:10.2903/j.efsa.2011.2168.
Available
online:
www.efsa.europa.eu/efsajournal
The Panel concludes that a cause and effect relationship has been established
between the consumption of mixtures of dietary SFAs and an increase in LDL-cholesterol
concentrations, and that replacement of a mixture of SFAs with cis-MUFAs and/or
cis-PUFAs in foods or diets on a gram-per-gram basis reduces LDL-cholesterol
concentrations.
4. EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA);
Scientific Opinion on the substantiation of health claims related to oleic
acid intended to replace saturated fatty acids (SFAs) in foods or diets and
maintenance of normal blood LDL-cholesterol concentrations (ID 673, 728,
729, 1302, 4334) and maintenance of normal (fasting) blood
concentrations of triglycerides (ID 673, 4334) pursuant to Article 13(1) of
Regulation (EC) No 1924/2006. EFSA Journal 2011;9(4):2043. [17 pp.].
doi:10.2903/j.efsa.2011.2043.
Available
online:
www.efsa.europa.eu/efsajournal
The evidence provided by consensus opinions/reports from authoritative bodies and
reviews shows that there is good consensus that a mixture of SFAs increases total
and blood LDL-cholesterol concentrations relative to mixtures of cis-MUFAs (EFSA, 2004;
EFSA Panel on Dietetic Products Nutrition and Allergies (NDA), 2010; IoM, 2005;
Lichtenstein et al., 2006; Mensink et al., 2003; WHO/FAO, 2003), and that there is a
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linear dose-response relationship between blood LDL-cholesterol concentrations and
the amounts of long-chain SFAs consumed. It is also well established that
consumption of a mixture of SFAs results in increased blood HDL-cholesterol
concentrations compared with consumption of mixtures of cis-MUFAs (e.g. oleic acid), and
that in comparison with other fatty acids, except trans fatty acids (TFAs), SFAs increase
the total to-HDL cholesterol ratio (Mensink et al., 2003). A claim on the replacement of
mixtures of SFAs with cis-MUFAs and/or cis-PUFAs in foods or diets and maintenance of
normal blood LDL-cholesterol concentrations has already been assessed with a favourable
outcome (EFSA Panel on Dietetic Products Nutrition and Allergies (NDA), 2011). The
scientific conclusions in that opinion apply to the replacement of mixtures of SFAs as
present in foods or diets with oleic acid.
5. EFSA Panel on Dietetic Products, Nutrition, and Allergies (NDA);
Scientific Opinion on Dietary Reference Values for fats, including
saturated fatty acids, polyunsaturated fatty acids, monounsaturated fatty
acids, trans fatty acids, and cholesterol. EFSA Journal 2010; 8(3):1461.
[107 pp.]. doi:10.2903/j.efsa.2010.1461. Available online:
https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2010.1461
There is a negative (beneficial), dose-dependent relationship between the intake of linoleic
acid and blood LDL cholesterol concentrations, while this relationship is positive for
HDL cholesterol concentrations. In addition, linoleic acid (LA) lowers fasting blood
triacylglycerol concentrations when compared to carbohydrates. There is also evidence
that replacement of saturated fatty acids by n-6 polyunsaturated fatty acids (without
changing total fat intake) decreases the number of cardiovascular events in the
population.
(DHA) from alpha-linolenic acid. Intervention studies have demonstrated beneficial effects
of preformed n-3 long-chain polyunsaturated fatty acids on recognised cardiovascular risk
factors, such as a reduction of plasma triacylglycerol concentrations, platelet aggregation,
and blood pressure. These effects were observed at intakes 1g per day, well above levels
that were associated with lower cardiovascular disease (CVD) risk in epidemiological
studies. With respect to cardiovascular diseases, prospective epidemiological and dietary
intervention studies indicate that oily fish consumption or dietary n-3 long-chain
polyunsaturated fatty acids supplements (equivalent to a range of 250 to 500 mg
of eicosapentaenoic acid plus docosahexaenoic acid daily) decrease the risk of mortality
from coronary heart disease (CHD) and sudden cardiac death. An intake of 250 mg per
day of eicosapentaenoic acid plus docosahexaenoic acid appears to be sufficient for
primary prevention in healthy subjects. Therefore, and taking into account that
available data are insufficient to derive an Average Requirement, the Panel proposes
to set an Adequate Intake of 250 mg for eicosapentaenoic acid plus docosahexaenoic acid
for adults based on cardiovascular considerations.
6. WHO draft guideline on SAFA and TFA draft for public consultation May
2018
https://extranet.who.int/dataform/upload/surveys/666752/files/Draft
%20WHO%20SFA-
TFA%20guidelines_04052018%20Public%20Consultation(1).pdf
Reduced intake of saturated fatty acids has been associated with a significant reduction in
risk of coronary heart disease (CHD) when replaced with polyunsaturated fatty acids (PUFA)
or carbohydrates from whole grains (3-6).
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7. WHO draft guideline on total fats draft for public consultation April 2021
Dietary fat, including essential fatty acids, which cannot be synthesized by the human
body, is necessary for proper physiological function. To ensure an adequate intake of
energy and essential fatty acids, and to facilitate the absorption of lipid soluble vitamins,
total fat intake in most adults should be at least 15 20% of total energy intake (67),
although energy requirements are increased during pregnancy and lactation (6, 7, 62).
fat consumed are important for maintaining health. Public health interventions should
therefore aim to reduce total fat intake where necessary, while reducing saturated fatty
acid and trans fatty acid intake,through replacement with unsaturated fatty acids and/or
carbohydrates as needed (63, 64), and without increasing free sugars intake (58).
8. Fats and fatty acids in human nutrition: Report of an expert consultation.
Rome: Food and Agriculture Organization of the United Nations 2010
(https://www.who.int/nutrition/publications/nutrientrequirements/fats
andfattyacids_humannutrition/en/)
Regarding polyunsaturated fatty acids (PUFA), controlled feeding and cohort studies of
eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) intakes have demonstrated
physiological benefits on blood pressure, heart rate, triglycerides, and likely inflammation,
endothelial function, and cardiac diastolic function, and consistent evidence for a reduced
risk of fatal CHD and sudden cardiac death at consumption of ~250 mg/day of EPA plus
DHA (Burr et al., 1989; Gissi-Hf, 2008; Mozaffarian and Rimm, 2006; Yokoyama et al.,
2007). DHA also plays a major role in development of the brain and retina during foetal
development and the first two years of life (Cetin and Koletzko, 2008; Decsi and Koletzko,
2005; Helland et al., 2008), which
avoidable growth failure and undernutrition and reducing death and disease including the
development of obesity and noncommunicable diseases later in life. As far as n-6 to n-3
ratio is concerned, the 2002 Joint WHO/FAO Expert Consultation on Diet, Nutrition and the
Prevention of Chronic Diseases and its background scientific review had indicated a
balanced intake of n-6 and n-3 PUFAs is essential for health (WHO, 2003; Reddy and Katan,
2004). But there is a debate that increasing LA intake does not result in increased
arachidonic acid (AA) in plasma or platelet lipids, and does not increase formation of
proinflammatory mediators (Adam et al., 2003). Furthermore, both n-6 and n-3 fatty acids
have been shown to have anti-inflammatory properties that are protective of atherogenic
changes in vascular endothelial cells (De Caterina et al., 2000).
CONCLUSIONS AND RECOMMENDATIONS FOR POLYUNSATURATED FATTY
ACIDS (PUFA)
eic acid (LA) and alpha-linolenic acid (ALA) are
indispensable since they cannot be synthesized by humans.
CHD.
l studies to set an
acceptable intake to meet essential FA needs for linoleic acid (LA) and alphalinolenic acid
(ALA) consumption.
The minimum intake values for essential fatty acids to prevent deficiency symptoms are
estimated at a convincing level to be 2.5%E LA plus 0.5%E ALA. Based on epidemiologic
studies and randomized controlled trials of CHD events, the minimum recommended value
of total PUFA consumption for lowering LDL and total cholesterol concentrations, increasing
HDL cholesterol concentrations and decreasing the risk of CHD events is 6%E. Based on
experimental studies, risk of lipid peroxidation may increase with high (>11%E) PUFA
consumption, particularly when tocopherol intake is low. Therefore, the resulting
acceptable range for total PUFA (n-6 and n-3 fatty 16 Fats and fatty acids in human
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nutrition: Report of an expert consultation acids) can range between 6 and 11%E. The
adequate intake to prevent deficiency is 2.5 3.5%E. Thus, the recommended range (ADMR)
for PUFA is 6 11%E.
9. Hooper L, Martin N, Abdelhamid A, Davey Smith G. Reduction in saturated
fat intake for cardiovascular disease. Cochrane Database Syst Rev.
2015;6:CD011737. pmid:26068959.
A recent Cochrane review suggests that replacing foods that are rich in saturated fat (SFA),
such as meat, butter, and cheese, with foods that are rich in polyunsaturated fat (PUFA),
such as walnuts, fish, and vegetable oils such as sunflower and safflower oils, would lead
to 27% less cardiovascular events
There is a large body of evidence, including almost 60,000 people who have been in studies
assessing effects of reducing saturated fat for at least two years each. Together the studies
provide moderate quality evidence that reducing saturated fat and replacing it with
polyunsaturated fats reduces our risk of cardiovascular disease.
10. Sioen I, van Lieshout L, Eilander A, Fleith M, Lohner S, Szommer A, Petisca
C, Eussen S, Forsyth S, Calder PC, Campoy C, Mensink RP. Systematic
Review on N-3 and N-6 Polyunsaturated Fatty Acid Intake in European
Countries in Light of the Current Recommendations - Focus on Specific
Population
Groups.
Ann
Nutr
Metab.
2017;70(1):39-50.
doi:
10.1159/000456723. Epub 2017 Feb 11.
Fifty-three studies from 17 different European countries reported an intake of total n-3 and
n-6 PUFAs and/or individual n-3 or n-6 PUFAs in at least one of the specific population
groups: 10 in pregnant women, 4 in lactating women, 3 in infants 6-12 months, 6 in
children 1-3 years, 11 in children 4-9 years, 8 in adolescents 10-18 years and 11 in
elderly >65 years. Mean linoleic acid intake was within the recommendation (4 energy
percentage [E%]) in 52% of the countries, with inadequate intakes more likely in lactating
-linolenic acid intake was within the
recommendation (0.5 E%) in 77% of the countries. In 26% of the countries, mean
eicosapentaenoic acid and/or docosahexaenoic acid intake was as recommended. These
results indicate that intake of n-3 and n-6 PUFAs may be suboptimal in specific population
groups in Europe.
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