Scope

This Regulation sets up the conditions for the use of:

  • Nutrition claims (such as “low fat”) and
  • Health claims (such as “helps lower cholesterol”),
  • Based on nutrient profiles

This regulation was born in order to ensure the effective functioning of the internal market whilst providing a high level of consumer protection. If well clarified and ruled, claims should be a basis of unequal competition between suppliers and impede the free circulation of food.

 

Claim definition

The Regulation (Article 2§2.1)) defines claims as “any message or representation (…) including pictorial, graphic or symbolic representation, in any form, which states, suggests or implies that a food has particular characteristics.” This could protect fresh fruit and vegetables from the use (rather abuse) of the positive image of these products by other processed foods.

Nutrition and health claims may be used in the labelling, presentation and advertising of foods placed on the market.

 

General requirements 

The use of nutrition and health claims shall only be permitted if the average consumer can be expected to understand the beneficial effects as expressed in the claim.

  • Nutrition and health claims shall be based on and substantiated by generally accepted scientific evidence.
  • They shall not refer to change in bodily functions which could give rise to or exploit fear in the consumer.
  • Claims rules shall only be accepted if they are made in a commercial framework. Non-commercial communication such as dietary guidelines, advices issued by public health authorities or press is not ruled by this regulation.

Trademarks or brand names that can be interpreted as a nutrition or health claim but which do not meet the requirements of the regulation must be phased out by January 19, 2022.

 

Nutrition declaration

Foods exhibiting the mandatory nutrition declaration should include the following:

(a)  Energy value;

(b)  The amounts of fat, saturates, carbohydrate, sugars, protein and salt.

This information can also be supplemented with the amounts of the following:

(a) mono-unsaturates;
(b) polyunsaturates;
(c) polyols;
(d) starch;
(e) fibre;
(d) vitamins & minerals listed in Annex XIII of the Regulation.

 

Use nutrition and health claims

The use of those claims shall only be permitted if:

  • the substance has been shown to have a beneficial physiological or nutritional effect
  • there are scientific evidence of the benefits of the substance as it is in the product
  • the substance is in a form that is available to be used by the body
  • the substance is in such a quantity that it has been proved has positive effects on the body
  • the average consumer can be able to understand the beneficial effects as expressed in the claim

Nutrient profiling

N.B.: According to article 4§1 of the Regulation, nutrient profiles should have been developed by 19 January 2009, based on an opinion of the European Food Safety Authority (EFSA). The European Commission has not been able to respect this deadline.

Claims may only be used if a food product meets a certain profile, i.e. appropriate ratios of salt, fat and sugar. Nutrition claims can fail one criterion, i.e. if only one nutrient (salt, sugar or fat) exceeds the limit of the profile a claim can still be made provided the high level of that particular nutrient is clearly marked on the label. For example, a yogurt can make a low-fat claim even if it has a high sugar content but only if the label clearly states "high content of sugar". Health claims cannot fail any criteria.

National recommendations on food intake (i.e. “5 a day”) will be taken into account.

Exemptions

Exemptions from the requirement to respect established nutrient profiles is envisaged for certain food or categories of foods depending on their role and importance in the diet of the population. Exemptions include: “Fruit, vegetables, and their products presented fresh, frozen, dried, or under any other form in so far as they contain no added sugars, salt or fat”. This has been met in Regulation (EU) No1169/2011- “A nutrition declaration shall not be mandatory for unprocessed products that comprise a single ingredient or category of ingredients”.         

 

Food categories, specific conditions & thresholds

The European Commission is proposing a categoryFruits, vegetables, nuts, and their products”, with the specific condition that the finishing products contain a minimum of 50g per 100g of fruit, vegetable or nut. The following thresholds would also apply: 400mg sodium, 5g saturates and 15g sugars per 100g.

 

Expression of nutrients & energy

Any amount of nutrient or energy referred to in the nutrition declaration shall be expressed as ‘sold’ per 100g. However, where appropriate (perhaps particularly regarding fresh fruit & vegetables), the information may also relate to the food after preparation and the information relates to food as prepared for consumption; for example, ‘after boiling’ or ‘after roasting’, etc.

Additionally, the energy value and nutrient volume may also be expressed per portion if it is easily recognizable by the consumer, if the portion used is quantified on the label and if it is accompanied by the expression per 100g.

 

Application for authorisation

Every application shall be sent to the national competent authority of a member state. This authority shall acknowledge receipt of an application and provide every document link with it to the Authority. Consequently, the Authority shall inform the other member states and the commission.

An application shall include the following:

  • the category of food in respect of which the health claim is to be made 
  • a copy of the all studies, including scientific ones, which have been carried out to demonstrate the health claim 
  • a proposal for the wording of the health claim for which authorisation is sought including, as the case may be, specific conditions of use 
  • a summary of the application 

Nutrition Claims

‘Nutrition claim’ means any claim which states, suggests or implies that a food has particular beneficial nutritional properties due to energy, nutrients or other substances. A list of authorised nutrition claims and the conditions for use is published in the Annex of the Regulation.

Claims included: Low energy, Energy-reduced, Energy-free, Low fat, Fat-free, Low saturated fat, Saturated fat-free, Low sugars, Sugars-free, With no added sugars, Low sodium/salt, Very low sodium/salt, Sodium/salt-free, Source of fibre, High fibre, Source of protein, High protein, Source of (vitamin/s) and/or (mineral/s), Contains (nutrient/substance), Increased (nutrient), Reduced (nutrient), Light/lite, Naturally/natural, source of omega-3 fatty acids, high omega-3 fatty acids, high monounsaturated fat, high polyunsaturated fat, high unsaturated fat

Comparative claims: a comparison may only be made between foods of the same category, taking into consideration a range of foods of that category. This may need to be inquired further as there is no suggestion of an official definition of ‘category’.

Claims made for Recommended Daily Allowance (RDA): any claims made must be for at least 15% of the RDA and this must be per 100g of the product rather than the average portion size of the product.

 

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 constituents and health.

Health claims shall only be permitted if the following information is included in the labelling, or if no such labelling exists, in the presentation and advertising:

  • a statement indicating the importance of a varied and balanced diet and a healthy lifestyle;
  • the quantity of the food and pattern of consumption required to obtain the claimed beneficial effect;
  • where appropriate, a statement addressed to persons who should avoid using the food; and
  • an appropriate warning for products that are likely to present a health risk if consumed to excess.

The following health claims shall not be allowed:

  • claims which suggest that health could be affected by not consuming the food;
  • claims which make reference to the rate or amount of weight loss;
  • claims which make reference to recommendations of individual doctors or health professionals and other associations.

 

Functional claims (Article 13 of the Regulation) (such as "calcium is good for your bones") refer to:

  • The role of a nutrient/substance in growth, development and the functions of the body;
  • Psychological and behavioural functions;
  • Slimming and weight control or reduction of hunger, increase of satiety or the reduction of available energy from the diet.

 

The European Commission is required to draw up a "positive list" of permitted 'function' health claims in the EU, based on Member States' lists of health claims already approved at national level. The European Food Safety Authority (EFSA) will provide scientific advice to support the European Commission and Member States in this process.

The list has eventually been published in Spring 2012 through Commission Regulation (Eu) No 432/2012. As of 14 December 2012, only the approved 'function' health claims may be authorised on foodstuffs.

The full database of health claims received for assessment, as well as the EFSA’s Register of Questions providing an overview of EFSA’s work on the list of Article 13 health claims are available at EFSA’s website.

 

These claims do not include those related to children's development or health or disease risk reduction claims (Article 14 of the Regulation). Disease reduction claims (defined as any health claim that states, suggests or implies that the consumption of a food category, a food or one of its constituents significantly reduces a risk factor in the development of a human disease), and claims referring to the health of children will require full authorisation on a case-by-case basis, following the submission of a scientific dossier to EFSA.

On 26 July 2007, EFSA published its final guidance document on how companies can apply for health claim authorisations. The guidance document addresses what applicants need to include in their application, in particular concerning the scientific data and evidence required to support a claim. It also includes examples and clarifications regarding the type of information that must be submitted. EFSA's Nutrition, Dietetic Products and Allergies Panel will evaluate the wording of a health claim to ensure that it reflects the scientific evidence and is understandable in terms of its relevance for human health. Claims that are considered vague, confusing or misleading will not receive a favourable opinion.