Proposal for a Regulation of the European Parliament and of the Council on nutrition and health claims made on foods - Presidency proposal - Montesquieu Instituut

 

COUNCIL OFBrussels, 22 June 2005

THE EUROPEAN UNIONPUBLIC

10341/05

LIMITE

Interinstitutional File:

2003/0165 (COD)

DENLEG 29 SAN 115 CODEC 534

NOTE from :

General Secretariat

to : Delegations

No. prev. doc.: 10073/05 DENLEG 27 SAN 109 CODEC 503

No. Cion prop.: 11646/03 DENLEG 44 SAN 162 CODEC 1024

Subject:

Proposal for a Regulation of the European Parliament and of the Council on nutrition and health claims made on foods Presidency proposal

Delegations will find attached a Presidency proposal for the recitals revised following the

comments received in the written consultation. Changes are highlighted in bold with respect to

document 10073/05.

Further comments can be sent electronically to the Secretariat:

Proposal for a

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

on nutrition and health claims made on foods

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Article 95

thereof,

Having regard to the proposal from the Commission 1,

Having regard to the opinion of the European Economic and Social Committee 2,

Acting in accordance with the procedure laid down in Article 251 of the Treaty 3,

Whereas:

(1) There is an increasing number of foods labelled and advertised in the Community with

nutrition and health claims. In order to ensure a high level of protection for consumers

(2) Differences between national provisions relating to such claims may impede the free

movement of foods, and create unequal conditions of competition. They thus have a

direct impact on the functioning of the internal market. It is therefore necessary to adopt

Community rules on the use of nutrition and health claims on foods.

(3) General labelling provisions are contained in Directive 2000/13/EC of the European

Parliament and of the Council of 20 March 2000 on the approximation of the laws of the

Member States relating to the labelling, presentation and advertising of foodstuffs 4, as

amended by Commission Directive 2001/101/EC 5. Directive 2000/13/EC generally

prohibits the use of information that would mislead the purchaser or attribute medicinal

properties to food. This Regulation should complement the general principles [...] 6 in

Directive 2000/13/EC and lay down specific provisions concerning the use of nutrition

and health claims concerning foods to be delivered as such to the consumer.

(3a) This Regulation should apply to all nutrition and health claims made in commercial

communications, including inter alia generic advertising of food and promotional

campaigns, such as those supported in all or in part by public authorities. It should not

apply to claims which are made in non-commercial communications, such as dietary

guidelines or advice issued by public health authorities and bodies, or non-commercial

communication and information in the press and [...] in scientific publications 7. This

Regulation should also apply to trade-marks and other brand names which may be

construed as nutrition or health claims 8.

(4) At international level Codex Alimentarius has adopted General Guidelines on Claims in

1991 and Guidelines for the Use of Nutrition Claims in 1997. An amendment to the latter

has been adopted by the Codex Alimentarius Commission. That amendment concerns

the inclusion of Health Claims in the 1997 Guidelines. Due consideration is given to the

definitions and conditions set in the Codex Guidelines.

(4a) The possibility of using the claim "low fat" for spreadable fats provided in Regulation

(EC) 2991/94 should be adapted to the provisions of this Regulation at the earliest

opportunity. In the meantime, Regulation (EC) 2991/94 applies for the products it covers.

(5) There is a wide range of nutrients and other substances including, but not limited to,

vitamins, minerals including trace elements, amino-acids, essential fatty acids, fibre,

various plants and herbal extracts with a nutritional or physiological effect that might be

present in a food and be the subject of a claim. Therefore, general principles applicable to

all claims made on foods should be established in order to ensure a high level of

consumer protection, give the consumer the necessary information to make choices in full

knowledge of the facts, as well as creating equal conditions of competition for the food

industry 10.

(6) Foods promoted with claims may be perceived by consumers as having a nutritional,

physiological or other health advantage over similar or other products [...] to which such

nutrients are not added. This may encourage consumers to make choices, which directly

influence their total intake of individual nutrients or other substances in a way which

would run counter to scientific advice. To counter this potential undesirable effect, it is

appropriate to impose certain restrictions as regards the products bearing claims. In this

context, factors such as the presence of certain substances such as the alcohol content of

the product or the nutrient profile of the product are appropriate criteria for determining

whether the product can bear claims. The use of such criteria at national level, whilst

justified for the purpose of allowing consumers to make informed nutritional choices, is

likely to result in barriers to intra-Community trade and should therefore be harmonised

at Community level.

(6a) The application of nutrient profiles as a criterion would aim at avoiding a situation where

nutrition or health claims mask the overall nutritional status of a food product, which

could mislead consumers when trying to make healthy choices in the context of a

balanced diet. Nutrient profiles as foreseen in the Regulation would be intended for the

sole purpose of governing the circumstances in which claims may be made. They should

be based on generally acceptable scientific data relative to the relationship between diet

and health. Profiles should also, however, allow for product innovation and should take

into account the variability of dietary habits and traditions and the fact that individual

products have an importance in the context of an overall diet. 11

(7) The establishment of a nutrient profile should take into account the content of different

nutrients and substances with a nutritional or physiological effect, in particular those such

as fat, saturated fat, trans-fatty acids, salt/sodium and sugars whose excessive intakes in

the overall diet are not recommended [...] as well as poly- and monounsaturated fats,

available carbohydrates other than sugars, vitamins, minerals, protein and fibre. When

setting the nutrient profiles, the different categories of foods and the place and role of

these foods in the overall diet shall be taken into account. Exemptions to respect

established nutrient profiles may be necessary for certain foods or categories of foods

depending on their role and importance in the diet of the population. These would be

complex technical exercises and the adoption of the relevant measures should be

entrusted to the Commission, taking into account the advice of the European Food

Safety Authority. 12

(7a) Food supplements as defined in Directive 2002/46/EC of the European Parliament and of

the Council presented in a liquid form and containing more than 1.2% by volume of

alcohol are not considered as beverages under this Regulation.

(8) There is a wide variety of claims currently used in the labelling and advertising of foods

in some Member States relating to substances that have not been shown to be beneficial

or for which at present there is not sufficient scientific agreement. It is necessary to

ensure that the substances for which a claim is made have been shown to have a

(9) In order to ensure that the claims made are truthful, it is necessary that the substance that

is the subject of the claim is present in the final product in quantities that are sufficient, or

that the substance is absent or present in suitably reduced quantities, to produce the

nutritional or physiological effect claimed. The substance should also be available to be

used by the body. In addition, and where appropriate, 13 a significant amount of the

substance producing the claimed nutritional or physiological effect should be provided by

a quantity of the food that can reasonably be expected to be consumed.

(10) It is important that claims on foods can be understood by the consumer and it is

appropriate to protect all consumers from misleading claims; however the European

Court of Justice has found it necessary in adjudicating on advertising cases since the

enactment of Directive 1984/450/EEC to examine the effect on a notional, typical

consumer. In line with the principle of proportionality, and to enable the effective

application of the protections contained in it, this Regulation takes as a benchmark the

average consumer, who is reasonably well-informed and reasonably observant and

circumspect, and taking into account social, cultural and linguistic factors, as interpreted

by the European Court of Justice, but makes provision to prevent the exploitation of

consumers whose characteristics make them particularly vulnerable to misleading claims.

Where a claim is specifically aimed at a particular group of consumers, such as children,

it is desirable that the impact of the claim be assessed from the perspective of the average

member of that group. The average consumer test is not statistical test. National courts

and authorities will have to exercise their own faculty of judgement, having regard to the

(11) Scientific substantiation should be the main aspect to be taken into account for the use of

nutrition and health claims and the food business operators using claims should justify

them. 14

(11a) A nutrition or health claim should not be made if it is inconsistent with generally

accepted nutrition and health principles or if it encourages or condones excessive

consumption of any food or disparages good dietary practice.

(12) Given the positive image conferred to foods bearing nutrition and health claims and the

potential impact these foods may have on dietary habits and overall nutrient intakes, the

consumer should be able to evaluate their global nutritional quality. Therefore, nutrition

labelling should be compulsory and should be extensive on all foods bearing health

claims.

(12a) General nutritional labelling provisions are contained in Directive 90/496/EEC.

According to this Directive, where a nutrition claim appears on labelling, in presentation

or in advertising, with the exclusion of generic advertising, nutrition labelling should be

compulsory. Where a nutrition claim is made for sugars, saturates, fibre or sodium, the

information to be given should consist of Group 2 as defined in Article 4(1) of that

Directive. In order to achieve a high level of consumer protection, this obligation to

provide full information should apply mutatis mutandis where any health claim is made,

(13) A list of permitted nutrition claims and their specific conditions of use should also be

created based on the conditions for the use of such claims that have been agreed at

national or international level and laid down in Community legislation. Any claim

considered to have the same meaning for consumers as a nutrition claim included in the

above-mentioned list should be subject to the same conditions of use therein indicated.

As an example, claims related to the addition of vitamins and minerals such as "with...",

"restored...", "added...", or "enriched..." should be subject to the conditions set for the

claim "source of...". The list should be regularly updated in order to take into account

scientific and technological developments 15. Furthermore, for comparative claims it is

necessary that the products being compared should be clearly identified to the final

consumer.

(13a) Conditions for claims such as lactose free or gluten free, addressed to a group of

consumers with specific disorders, should be dealt with in Directive 89/398/EEC on

foodstuffs intended for particular nutritional uses. In addition, that Directive provides the

possibility that foodstuffs for normal consumption can indicate their suitability for use by

these groups of consumers if they fulfil the conditions for such statement. Until the

conditions for such statements are set at EU level, Member States may maintain or adopt

relevant national measures.

(14) Health claims should only be authorised for use on the Community market after a

scientific assessment of the highest possible standard. In order to ensure harmonised

(15) There are many factors, other than dietary ones, that can influence psychological and

behavioural functions. Communication on these functions is thus very complex and it is

difficult to convey a comprehensive, truthful and meaningful message in a short claim to

be used in the labelling and advertising of foods. Therefore, it is appropriate, when using

psychological and behavioural claims, to require scientific substantiation 16.

(16) In the light of Commission Directive 96/8/EC of 26 February 1996 on foods intended for

use in energy-restricted diets for weight reduction 17 which prohibits, in the labelling,

presentation and advertising of products covered by that Directive, any reference to the

rate or amount of weight loss which may result from their use [...], it is considered

appropriate to [...] to extend this restriction to all foods. 18

(17) Health claims other than those referring to the reduction of disease risk, based on

generally accepted scientific data, should undergo a different type of assessment and

authorisation. It is therefore necessary to adopt a Community list of such permitted

claims after consulting the Authority.

(18) In order to keep up with scientific and technological developments, that list should be

revised promptly whenever necessary. Such revisions are implementing measures of a

technical nature and their adoption should be entrusted to the Commission in order to

simplify and expedite the procedure.

(19) A varied and balanced diet is a prerequisite for good health and single products have a

relative importance in the context of the total diet, and that diet is one of the many factors

influencing the onset of certain human diseases. Other factors such as age, genetic

predisposition, the level of physical activity, the consumption of tobacco and other drugs,

environmental exposure and stress may all influence the onset of human diseases.

Specific labelling requirements should therefore apply in respect of claims relating to the

reduction of a disease risk.

(20) In order to ensure that health claims are truthful, clear, reliable and useful to the

consumer in choosing a healthy diet, the wording and the presentation of health claims

should be taken into account in the opinion of the Authority and in the subsequent

authorisation procedure.

(21) In some cases, scientific risk assessment alone cannot provide all the information on

which a risk management decision should be based. Other legitimate factors relevant to

the matter under consideration should therefore be taken into account.

(22) For the sake of transparency and in order to avoid multiple applications in respect of

claims, which have already been assessed, a public Register containing the lists of such

claims should be established and updated by the Commission.

(25) Given the particular nature of foods bearing claims, additional means to those usually

available to monitoring bodies should be available in order to facilitate efficient

monitoring of those products.

(26) [...] Adequate transitional [...] measures are 20 necessary to enable food business

operators to adapt to the requirements of this Regulation.

(27) Since the objectives of the proposed action cannot be sufficiently achieved by the

Member States and can therefore be better achieved at Community level, the Community

may adopt measures, in accordance with the principle of subsidiarity as set out in Article

5 of the Treaty. In accordance with the principle of proportionality, as set out in that

Article, this Regulation does not go beyond what is necessary in order to achieve those

objectives.

(28) The measures necessary for the implementation of this Regulation should be adopted in

accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the

procedures for the exercise of implementing powers conferred on the Commission 21.