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
– 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 1 st 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)

• 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

– 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
(plus amendments in EU Reg. No 116/2010)
(Group 2)
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
APPROVED
INGREDIENT
Vitamin A
REJECTED Vitamin A
WORDING
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.
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.
EFSA ref.
Adopted 2 July 2009
Adopted 2 July 2009

HEALTH CLAIMS, ART 13 (1) : EU
APPROVED
INGREDIENT
Biotin
APPROVED
APPROVED
Calcium, Vitamin D
Fluoride
WORDING Conditions of use
Biotin contributes to normal energy-yielding metabolism'
Calcium and vitamin D are needed for the maintenance of normal bone' .
'Fluoride contributes to maintenance of tooth mineralisation'
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
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
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
APPROVED
APPROVED
REJECTED
REJECTED
INGREDIENT CLAIM Ref
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
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.
Immune Balance drink, activates body's defence
Milk product: rich in fibre and protein, the reduction of the sense of hunger in the female population or in the general adult population
EU Community List,
29.10.2009
EFSA-Q-2009-00229
Adopted: 15 May 2009
EFSA-Q-2009-00517
Adopted: 15 October 2009
EFSA-Q-2008-396
Adopted: 4 December 2008

HEALTH CLAIMS, ART 14 : EU
APPROVED
APPROVED
APPROVED
REJECTED
REJECTED
REJECTED
INGREDIENT CLAIM Ref
Plant stanol esters
(Unilever)
Calcium
(Yoplait)
Vitamin D
(Yoplait)
Eye q
Combination of
Bifidobacteria
Ocean Spray Cranberry products
Plant stanol esters have been shown to lower/reduce blood cholesterol. High cholesterol is a risk factor in the development of cardiovascular heart disease
Calcium is needed for the normal growth and development of bone in children
Vitamin D is needed for the normal growth and development of bone in children
Eye q provides the nourishment that helps children to maintain concentration levels
Probiotic bifidobacteria lead to a healthy intestinal flora comparable to the composition of the intestinal flora of breastfed infants’ intestine
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
21.10.2009
EU Community List
21.10.2009
EU Community List
21.10.2009
EU Community List
21.10.2009
Draft EU Commission Reg.
2010
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
– 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