Nutrition & Health Claims Regulations (EC No. 1924/2006)

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NUTRITION & HEALTH CLAIMS (SCOTLAND)
REGULATIONS 2007
Ruth Birt
Regulatory Solutions
28 April 2010
•
Nutrition & Health Claims (Scotland) Regulations 2007 SI
No 383
•
Nutrition & Health Claims (Scotland) (Amendment)
Regulations 2010
•
Nutrition & Health Claims Regulation EC No. 1924/2006
–
–
–
–
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Scope
Definitions
General Conditions
Nutrition Claims and Annex
Health Claims
• Types
• Authorisation procedures
•
Examples
•
Enforcement
•
Web addresses
Nutrition & Health Claims
•
Nutrition & Health Claims (Scotland) Regulations 2007 SI No 383
– Implements the Nutrition & Health Claims Regulation (EC) No 1924/2006*
– Came into force 1st October 2007
– Introduces offences and penalties
– Each food authority within its area shall execute and enforce the provisions of
these (2007) Regulations and of the (EU) Regulation
•
Nutrition & Health Claims (Scotland) (Amendment) Regulations 2010
– Still awaited (consultation deadline 29 March 2010)
– To introduce an ambulatory reference to accommodate future changes
e.g. the recent five fatty acid claims in Regulation EU No 116/2010
*Official Journal L 12 3-18, 18.1.2007
Nutrition & Health Claims
•
Nutrition & Health Claims Regulation EC No 1924/2006 (“NHCR”)
– Aims to bring harmonisation across EU countries
– Aims to safeguard consumers’ trust
– Introduced definitions for claim, nutrition claim, health claim
– Provided an Annex of permitted Nutrition Claims
– Requires manufacturers to submit scientific data to support health claims
– Will result in a Community Register of approved (and rejected) health claims
– Will establish specific nutrient profiles which food/food categories must comply
with to carry nutrition or health claims
Nutrition & Health Claims
•
NHCR
– introduced many time lines/transitional periods
• 1 July 2007: NHCR came into force
• 19 January 2008: deadline for health claims to be filed in a Member State to allow
continued use, while under EFSA consideration
• 19 January 2009: nutrient profiles to be established*
• 31 July 2009: final date to permit marketing of non-compliant products
• 19 January 2010: deadline for end of use of nutrition clams which are not included in
the Annex (and were on products before 1 January 2006) *
• 31 January 2010: EU Commission expected to publish list of Art 13 Claims*
• 19 January 2022: deadline for removal of trade/brand names from non-compliant
products (and were on the market pre-Jan 2005)
Nutrition & Health Claims
• The Regulation applies:
– to nutrition & health claims made in commercial communications,
whether in the labelling, presentation or advertising to the final
consumer
– without prejudice to
• Foodstuffs for particular nutritional uses (Directive 89/398/EEC, now 2009/39/EC)
• Rules relating to mineral waters (Directive 80/777/EEC)
• Rules on quality of water intended for human consumption (Directive 98/83/EC)
• Food supplements (Directive 2002/46/EC)
Article 1
Nutrition & Health Claims
• Definitions:
– ‘Claim’ means any message or representation, which is not mandatory
under Community or national legislation, including pictorial, graphic or
symbolic representation in any form, which states, suggests or implies
that a food has particular characteristics. (Art. 2.2.1)
– ‘Nutrition claim’ means any claim which states, suggests or implies
that a food has particular beneficial nutritional properties due to:
• the energy it provides / has reduced or increased / does not provide
OR
• the nutrients or other substances it contains / has in reduced or
increased quantities / does not contain (Art. 2.2.4)
Article 2
Nutrition & Health Claims
• Definitions:
– ‘Health claim’ means any claim that states, suggests or implies that a
relationship exists between a food category, a food or one of its
constituents, and health (Art. 2.2.5)
– ‘Disease risk reduction claim’ means any health claim that states,
suggests or implies that of consumption of a food category, a food or
one of its constituents significantly reduces a risk factor for the
development of a human disease (Art. 2.2.6)
Article 2
Nutrition & Health Claims
•
Claims must :
– be true and substantiated
– be understandable for the consumer i.e. the average consumer of the
target group
•
Claims must not:
– be false, ambiguous or misleading
– give rise to doubt about the safety and/or the nutritional adequacy of other
foods
– encourage or condone excess consumption of a food;
– state, suggest or imply that a balanced and varied diet cannot provide
appropriate quantities of nutrients in general;
– refer to changes in bodily functions which could give rise to or exploit fear
in the consumer, either textually or through pictorial, graphic or symbolic
representations.
Article 3
Nutrition & Health Claims
• Claims only permitted if
– shown to have a beneficial nutritional /physiological effect based
on science
– in a quantity that produces the claimed effect
– the nutrient/substance is in a bio-available form
– the quantity of product that can be expected to be consumed
provides a significant amount of nutrient
– the average consumer can be expected to understand the
beneficial effects as expressed in the claim
– refers to the food ready for consumption
Article 5
Nutrition & Health Claims
• Shall be based on and substantiated by generally accepted scientific
evidence.
• A food business operator shall be able to justify the use of the claim.
• A food business operator or a person placing a product on the
market must be able to produce all data establishing compliance
with the Regulation, if requested e.g. by the competent authorities
Article 6
Nutrition claims
• Must be listed in the Annex
(plus amendments in EU Reg. No 116/2010)
• Must be in conformity with the applicable conditions
• Full (Group 2) nutrition labelling is required (also when
health claims made)
• For comparative nutrition claims a range of foods of the
same category should be used
Articles 7-9
Health claims
• To carry a health claim :
– Specific conditions apply including statements
• re: importance of a varied & balanced diet, healthy lifestyle
• quantity and food pattern required to achieve benefit
• re: warning who should not consume
– General, non-specific benefits, ‘well-being’ claims must be
accompanied by a specific health claim
– Rules concerning recommendations by national associations inc.
medical/dietetic professionals and health-related charities
– Restrictions on the use of health claims include
• claims referring to rate/amount of weight loss;
• claims suggesting health affected if do not consume the food
Articles 10-12
Health claims
• Article 13
– Art 13.1
• Role of a nutrient or other substance in growth, developemnt and functions fo the body
• Psychological and behavioural functions
• Slimming or weight control in the sense of hunger /ior increase in the sense of satiety or to
the reduction of available energy from the diet
– claims based on generally accepted science
– authorisation via the ‘Generic List’
– Art.13.5
• based on newly developed scientific data/desire intellectual property
protection
• full authorisation procedure
• Article 14
– for ‘reduction of disease risk’ claims
– Claims referring to children’s development & health
– full authorisation procedure
Health claims
• Authorisation procedure
– Files reviewed by EFSA (European Food Safety Authority)
– Complex and costly
– Requires very detailed scientific substantiation e.g.sources of
scientific data:
• National/international expert consensus reports, including
authoritative statements e.g. SACN, FDA
• Human intervention studies, including use of biomarkers
• Human observational/epidemiological studies
• Animal and in vitro studies
• Traditional knowledge and experience of use
– EU Commission then chooses to accept/reject EFSA Opinion
and adopt into law; companies have 6 months to act after
adopted.
HEALTH CLAIMS, ART 13 (1) : EFSA OPINIONS
INGREDIENT
WORDING
EFSA ref.
APPROVED
Vitamin A
The Panel concludes that a cause and effect
relationship has been established between
the dietary intake of vitamin A and normal
cell differentiation, normal function of the
immune system, maintenance of normal skin
and mucous membranes, maintenance of
normal vision, and normal metabolism of
iron.
Adopted 2 July 2009
REJECTED
Vitamin A
The Panel concludes that a cause and effect
relationship has not been established
between the dietary intake of vitamin A and
maintenance of normal bone, maintenance
of normal teeth, maintenance of normal hair,
maintenance of normal nails, and protection
of DNA, proteins and lipids from oxidative
damage.
Adopted 2 July 2009
HEALTH CLAIMS, ART 13 (1) : EU
INGREDIENT
APPROVED
Biotin
APPROVED
Calcium, Vitamin D
APPROVED
Fluoride
WORDING
Conditions of use
Biotin contributes to normal
energy-yielding metabolism'
Claim may be used only for
food which is at least a source
of biotin as referred to in the
claim SOURCE OF.. in Annex
to Reg 1924/2006
Calcium and vitamin D are
needed for the maintenance of
normal bone' .
Claim may be used only for
food which is at least a source
of calcium and vitamin D as
referred to in the claim
SOURCE OF.. in Annex to
Reg 1924/2006
'Fluoride contributes to
maintenance of tooth
mineralisation'
Claim may be used only for
food which is at least a source
of fluoride as referred to in the
claim SOURCE OF.. in Annex
to Reg 1924/2006
HEALTH CLAIMS, ART 13 (5) : EU
INGREDIENT
CLAIM
Ref
APPROVED
Xylitol
Chewing gum sweetened with 100% xylitol
has been shown to reduce dental plaque.
High contents/levels of dental plaque is a
risk factor in the development of caries in
children
EU Community List,
29.10.2009
APPROVED
Water-soluble tomato
concentrate (WSTC)
“helps maintain normal platelet
aggregation”.
In order to achieve the claimed effect, 3
g WSTC I or 150 mg WSTC II in up to
250 mL of either fruit juices, flavoured
drinks or yogurt drinks (unless heavily
pasteurised) should be consumed daily.
The target population is adults between
35 and 70 years of age.
EFSA-Q-2009-00229
Adopted: 15 May 2009
REJECTED
Immune Balance drink,
activates body's defence
EFSA-Q-2009-00517
Adopted: 15 October 2009
REJECTED
Milk product: rich in
fibre and protein,
the reduction of the sense of hunger in
the female population or in the general
adult population
EFSA-Q-2008-396
Adopted: 4 December 2008
HEALTH CLAIMS, ART 14 : EU
INGREDIENT
CLAIM
Ref
APPROVED
Plant stanol esters
(Unilever)
Plant stanol esters have been shown to
lower/reduce blood cholesterol. High
cholesterol is a risk factor in the
development of cardiovascular heart
disease
EU Community List
21.10.2009
APPROVED
Calcium
(Yoplait)
Calcium is needed for the normal
growth and development of bone in
children
EU Community List
21.10.2009
APPROVED
Vitamin D
(Yoplait)
Vitamin D is needed for the normal
growth and development of bone in
children
EU Community List
21.10.2009
REJECTED
Eye q
Eye q provides the nourishment that
helps children to maintain concentration
levels
EU Community List
21.10.2009
REJECTED
Combination of
Bifidobacteria
Probiotic bifidobacteria lead to a healthy
intestinal flora comparable to the
composition of the intestinal flora of
breast-fed infants’ intestine
Draft EU Commission Reg.
2010
REJECTED
Ocean Spray Cranberry
products
Regular consumption of 2 servings per
day of an Ocean Spray product each
typically containing 80mg cranberry
proanthocyanidins helps reduce the risk
of urinary tract infection in women by
inhibiting the adhesion of certain
bacteria in the urinary tract
EU Community List
30.112009
Health Claims
• Rejection:
– Outside scope e.g. medicinal; filed as Art 13(1) but product
specific (not generic)
– Insufficient evidence
– Discounted study population group e.g. sick for healthy; data on
infant < 6 months to demonstrate effect in > 6 months child
– Ingredient not been characterised e.g. probiotics
– No cause and effect established
Enforcement
• Art 13 (‘Generic’ list)
– was to be adopted Jan 2010
– first batch under debate at EU level; expect adoption in Sept
2010
– some claims rejected out right, some are proposed for rejection
– LACORS guidance:
• Products can be sold until end of shelf-life, if were legitimately
labelled at outset
• If products have multiple claims, take a pragmatic approach on relabelling requests until all claims on pack have been assessed
Enforcement
• Health claims will be permitted with specific wording. Is there room
for flexibility of wording?
– Will depend on future outcomes (only have feedback so far on Art 13.5 and Art.
14) but seen some flexibility via the EU process e.g. helps maintain normal
platelet aggregation which contributes to healthy blood flow
• Implications of FSA Guidance Notes
• Where will challenges come from
–
–
–
–
Enforcers?
FSA?
ASA?
Competitors?
Web links
– EFSA Register of Questions
http://registerofquestions.efsa.europa.eu/roqFrontend/questionsL
istLoader?panel=NDA&foodsectorarea=26
– EU Community Register
http://ec.europa.eu/food/food/labellingnutrition/claims/community
_register/index_en.htm
– FSA e.g. IP letters; Guidance Notes: legislation
http://www.food.gov.uk
– Official Journal
http://eur-lex.europa.eu/en/index.htm
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