These are applications based on scientific proof obtained recently and/or including an application for data protection subject to industrial copyright (article 13.5), and those claims relating to the reduction of a risk factor in a disease, or the health and development of children (article 14).

Ensure that the health claim proposed in the application includes all details required in article 13.5, or article 14 of the regulation.

According to article 15.4 of the regulation, all applications must be prepared and presented compliance with the scientific and technical guidance document for preparing and presenting health claims, , drawn up by the European Food Safety Authority (EFSA).

Guidance for applicants on health claims

If possible, the dossier presented according to the guidance document should be written in English. If it is not, there may be a delay in assessing the application while it is being translated by EFSA. It is essential to comply with the requirements below:

• Clear identification of a single foodstuff or substance responsible for the effect under claim, regardless of whether it forms part of the composition of several food products, and therefore, these may be candidates to carry the health claim.
• Definition of a single relationship to health.
• Inclusion of a single draft of the health claim.

All the claims must fulfil the general criteria contained in articles 3, 5 and 6 of the regulation, stipulating that the claim must not:

• Be false, ambiguous or deceptive;
• Give rise to doubts on safety and/or the suitability of nutrients of other foods;
• Encourage or approve excess consumption of a food;
• Confirm, suggest or give to understand that a balanced and varied diet cannot provided the correct amount of nutrients in general;
• Refer to bodily changes that may cause alarm to consumers or exploit their fears, either in wording or by pictures or symbols;
• The presence, absence or reduction of the content of a nutrient or other substance in a food category, which according to the claim has a beneficial nutritional or physiological effect, proven by widely accepted scientific testing.
• The nutrient or substance in the claim is contained in the end product in significant amounts, as defined by EU legislation or, if there are no rules for the case, in amounts (increased, reduced or absent) that provide a nutritional of physiological effect as claimed, proven by widely accepted scientific testing.
• Whenever appropriate, the nutrient or substance under claim must be in a form that can be assimilated by the body.
• The amount of the product that can reasonably be expected to be consumed provides a significant quantity of the nutrient or other substance referred to in the claim, as defined by EU legislation, or in cases where there are no rules, in a significant quantity to produce the claimed nutritional or physiological effect, proven by widely accepted scientific testing.
• The use of nutritional claims and health properties will only be authorised if it can be expected that the average consumer understands the beneficial effects as described in the claim.

The following claims for health properties are prohibited:

• Claims that suggest that health may be affected if the food in question is not consumed;
• Claims that refer to the speed or amount of weight loss;
• Claims that refer to recommendations by individual doctors or other health professionals.
• Claims that confirm, suggest or imply that a food has preventative, treatment or curative properties for a disease in humans.

Finally, according to article 10.3 of the regulation, claims referring to general, non–specific benefits of the nutrient or food for general good health or welfare relating to health – they can only be made if accompanied by a specific claim included in the lists given in article 13 or 14.

Once the application has been completed, send two copies by e-mail and two copies on paper of the complete dossier to the Sub-directorate General of Managing Food Risk, at the Spanish Agency for Food Safety and Nutrition (AESAN), which will forward all valid applications to EFSA, for its opinion according to article 16 of the regulation. AESAN will acknowledge receipt of applications with 14 days of receiving them.

Finally, after EFSA has given its opinion, applications for claims will be approved by committee procedure in the Standing Committee for the Food Chain and Animal Health (General food legislation section):

The lists of authorised or rejected health claims will appear on an EU register, together with conditions of use and the reasons for rejection, for disallowed claims.