The EU health claims regulation: impact on the marine lipids

: European Regulation (EC) No 1924/2006 applies to all types of pre-packed foods for the final consumer, including food intended to supply hospitals, canteens and similar mass caterers, bearing nutrition and health claims. Commercial communications ( labelling, presentation or advertising of foods ), trade names and other brand names which may be construed as nutrition or health claims are covered by the Regulation. Since the date it was brought into force (1 st July 2007), all nutrition and health claims for food products must be authorised prior to the marketing of the products, either by means of a nominative evaluation procedure or a generic evaluation. In light of the provisions of the new Regulation and the transitional measures in effect, what is the future of lipid ’ health communication ’ and more particularly of marine lipid communication? For certain lipids of marine origin ( e.g., EPA, DHA, etc .) play an unquestionable nutritional – not to say health – role in the human diet, a fact which is widely accepted by the scientific community.

Since the 1 st July 2007, all nutrition and health claims for food products must be authorised prior to the marketing of the products, either by means of a nominative evaluation procedure or a generic evaluation.
In light of the provisions of the Regulation, the first and second EFSA opinions batches and rules concerning the transitional periods, what is the future of lipid "health communication" and more particularly of marine lipid communication?

Legislation
The Regulation (EC) No 1924No /2006 applies to all nutrition and health claims including: commercial communications (labelling, presentation and promotional campaigns); trade marks and other brand names which may be construed as nutrition or health claims.
It applies to claims relating to all types of foods intended for final consumers, including: foods intended for supply to hospitals, canteens, etc.; foods supplied without packaging or loose.

Nutrition claims
Nutrition claim means any claim which states, suggests or implies that a food has particular beneficial nutritional properties due to: the energy (calorific value) it provides; or provides at a reduced or increased rate; or does not provide; and/or the nutrients or other substances it contains; or contains in reduced or increased proportions; or does not contain.
In accordance with Article 8 (1) of Regulation (EC) No 1924No /2006, nutrition claims are permitted only if they are listed in the Annexe of that Regulation, lastly amended by Regulation (EC) No 116/2010 2 and are in conformity with the conditions set out in that Annexe.

Health claims
Health claim means any claim that states, suggests or implies that a relationship exists between a food category, a food or one of its components and health.As provided for in the Regulation on nutrition and health claims, different types of health claims will be authorised by the Commission.For the first type, the so-called "function" health claims, an EU positive list will be drawn up by the Commission [the so-called Article 13 (1) generic claims list].This list will consist of well-established health claims relating to the growth, development and the functions of the body [Article 13(1)(a)].In addition, claims that refer to psychological and behavioural functions [Article 13(1)(b)] and claims on slimming or weight control [Article 13(1)(c)] will be included in this list.For the latter type of claims, it should be noted that claims which make reference to the rate or amount of weight loss remain prohibited under the Regulation.In accordance with Article 13(5), any additions of health claims [referring to Article 13(1)] to the Community Register based on newly developed scientific data and/or which include a request for the protection of proprietary data are subject to the authorisation procedure.In addition, health claims referring to the reduction of a risk factor in the development of a disease [Article 14(1)(a)] and health claims referring to children's development and health [Article 14(1)(b)] will be authorised, such as "Plant stanol esters have been shown to reduce blood cholesterol.Blood cholesterol is a risk factor in the development of coronary heart disease" and "Vitamin D is needed for children's bone growth and development".

Nutrition claims
The subject of nutrition has not been discussed again between Member States since April 2010.The latest draft of the Commission dated January 2010.The project is still in interdepartmental consultation within the Commission and prompted many discussions among the various services (including interest on the claim "less than X% of ...", a public health perspective).Nutrition claims which could be included in the final draft of the second revision would be: -Reduced to … / Energy value reduced; Enriched (the threshold should be reduced to 25%).
-No added sugar (a clarification should be made in the conditions of use).
-Less than X% … not sure of the store.This revision would be submitted to a vote of SCFCAH at the earliest, the beginning of September 2010.

Article 13(1) generic claims list
After the first batch of EFSA opinions in October 2009 and a second in February 2010, the next review of EFSA on health claims continue to be made generic batch: the next in September 2010 and the third in 2011.The Access database 6 of Article 13(1) health claims contains the 4,637 main health claim entries submitted to EFSA for evaluation and has been updated in May 2010.In this context, the Commission wants to make decisions on generic claims authorised in batches.The draft decision on the first batch is being discussed between the Member States (about a hundred generic claims) to decide on some labels and conditions of use."Where the text would be voted at SCFCAH October 2010, it would be published at the earliest beginning in January 2011 which then enter into force in February 2011".The Commission and Member States have accepted that a limited number of records that can be completed and reassessed may be eligible for this supplemental application procedure: -Health claims about the micro-organisms had a negative opinion because of a lack of characterisation of microorganism; -Health claims for which EFSA has concluded that the evidence was not sufficient to establish a causal link.The list of allegations concerned will be posted on the website of the Commission on or before the date of entry into force of the first list of generic health claims authorised.There will be a period of three months to resubmit these claims from the entry into force of the first list of permitted claims.

Periods of transition
A transition period of six months shall apply to enter into force the authorised first commission regulation on generic claims planned normally for February 2011.It means that the transitional periods for using the health claims refused by EFSA should end by August 2011 (figure 1).Also, the allegations which have never been submitted in Articles 13(1) and 13(5) will be banned after the publication of this first commission regulation.All generic claims [Article 13(1)] and specific claims [Article 13(5)] still being evaluated in the publication of the first commission regulation can be used during their evaluation and the publication of the appropriate commission decision.
In this respect, it should mean that the EC should confirm that all the specific allegations [Article 13(5)] made before the publication of the first commission regulation will continue to be used during their evaluation and the publication of the appropriate commission decision.

Nutrient profiles
In addition, in order to bear claims, foods will have to have appropriate nutrient profiles which will be set.This will enhance the consumers' ability to make informed and meaningful choices.Article 4 of the Regulation foresees the setting of nutrient profiles, via the regulatory committee procedure with European Parliament and Council scrutiny by January 2009.In simple terms, nutrient profiles will determine whether foods are eligible or not to bear claims, on the basis of their nutrient composition.Nutrient profiles will be based primarily on the levels of nutrients for which excessive intakes in the overall diet are not recommended.
3 Opinion of the Panel on dietetic products, nutrition and allergies (NDA) on a request from the Commission related to scientific and technical guidance for the preparation and presentation of the application for authorisation of a health claim.

Nutrition Claims
Source of vitamin A or vitamin D A claim that a food is a source of vitamins and/ or minerals, and any claim likely to have the same meaning for the consumer, may only be made where the product contains at least 15% of the recommended daily allowances (RDAs) specified in the Annexe of the Commission Directive 2008/100/EC9 supplied by 100 g or 100 mL, or per package if the package contains only a single portion (table 1).

High of vitamin A or vitamin D
A claim that a food is high in vitamins and/or minerals, and any claim likely to have the same meaning for the consumer, may only be made where the product contains at least twice the value of "source of vitamin A or vitamin D".

Source of omega-3 fatty acids
A claim that a food is a source of omega-3 fatty acids, and any claim likely to have the same meaning for the consumer, may only be made where the product contains at least 0.3 g alpha-linolenic acid per 100 g and per 100 kcal, or at least 40 mg of the sum of eicosapentaenoic acid and docosahexaenoic acid per 100 g and per 100 kcal.

High omega-3 fatty acids
A claim that a food is high in omega-3 fatty acids, and any claim likely to have the same meaning for the consumer, may only be made where the product contains at least 0.6 g alpha-linolenic acid per 100 g and per 100 kcal, or at least 80 mg of the sum of eicosapentaenoic acid and docosahexaenoic acid per 100 g and per 100 kcal.

High monounsaturated fat
A claim that a food is high in monounsaturated fat, and any claim likely to have the same meaning for the consumer, may only be made where at least 45% of the fatty acids present in the product derive from monounsaturated fat under the condition that monounsaturated fat provides more than 20% of energy of the product.

High polyunsaturated fat
A claim that a food is high in polyunsaturated fat, and any claim likely to have the same meaning for the consumer, may only be made where at least 45% of the fatty acids present in the product derive from polyunsaturated fat under the condition that polyunsaturated fat provides more than 20% of energy of the product.

High unsaturated fat
A claim that a food is high in unsaturated fat, and any claim likely to have the same meaning for the consumer may only be made where at least 70% of the fatty acids present in the product derive from unsaturated fat under the condition that unsaturated fat provides more than 20% of energy of the product.

Generic Health Claims Article 13(1)
Several positive opinions on vitamin D and fatty acids (EPA, DHA and DPA) were given by EFSA and are displayed on the consolidated EFSA access database of Article 13(1) health10 .

Calming
Non-compliance with the Regulation as, on the basis of the evidence presented in the dossiera cause and effect relationship between the consumption of the food for which the claim is made and the claimed effect has not been established.Eye q baby ® , containing a combination of the n-3 polyunsaturated fatty acids (PUFAs), eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA) and the n-6 PUFA gamma-linolenic acid (GLA)

Q-
Eye q baby ® provides the nourishments that support healthy central nervous system development Non-compliance with the Regulation as, on the basis of the evidence presented in the dossiera cause and effect relationship between the consumption of the food for which the claim is made and the claimed effect has not been established.

Table 2 .
Timetable of the next EFSA and European Commission publication.Health claims [Article 14(1)(b)] authorised concerning marine lipids.

Table 1 .
Nutritional claims authorised concerning lipids -Annexe of the Regulation (EC) 1924/2006.Non-compliance with the Regulation as, on the basis of the evidence presented in the dossier a cause and effect relationship between the consumption of the food for which the claim is made and the claimed effect has not been established.