Nutrition applications: frequently asked questions
EFSA is responsible for verifying the scientific substantiation of health claims submitted for authorisation in the EU. This evaluation serves as a basis for the European Commission and Member States to decide whether to authorise the claims.
Frequently Asked Questions
1. Does EFSA perform a safety assessment as part of its evaluation of health claims made on foods?
The Scientific Opinions of the EFSA NDA Panel relate solely to the scientific substantiation of health claims submitted for authorisation in the EU. They do not constitute an assessment of the safety of the food/constituent for which a health claim is made. The safety assessment of food/constituent might be required by legal frameworks other than the one for health claims.
2. Are the requirements the same for all health claim evaluations?
Yes, but there are different types of health claim.
‘Function’ claims – this category, dealt with under Article 13 of Regulation EC 1924/2006, includes claims referring to the role of a nutrient or other substance in the growth, development and functions of the body, to psychological and behavioural functions, and to slimming or weight control. See more on Article 13.1 and Article 13.5 health claims and related guidances for applicants.
Reduction of disease risk and child development or health – these claims are dealt with under Article 14 of Regulation 1924/2006. Reduction of disease risk claims are claims which refer to a significant reduction of a risk factor in the development of a human disease, such as: “Plant sterols have been shown to reduce cholesterol levels, a risk factor in the development of coronary heart disease.” See more on Article 14 health claims and related guidances for applicants.
3. What is a nutrition claim and what is EFSA’s role in assessing nutrition claims?
A nutrition claim states or suggests that a food has particular beneficial nutritional properties. Examples include “low fat”, “source of omega-3 fatty acids” or “high in fibre”.
On the basis of Article 8 of Regulation EC 1924/2006, nutrition claims are only permitted if they are listed in the Annex of that Regulation.
Unlike health claims, nutrition claims cannot be the subject of an application for authorisation.
4. What is the regulatory and procedural framework for novel foods?
In November 2015, the European Parliament and the Council have agreed on new procedures for novel foods and traditional foods by adopting Regulation EU 2015/2283. The revised rules increase the efficiency of the authorisation process by creating a centralised authorisation system.
Under the new regulation an applicant who intends to place on the EU market a novel food submits an application to the European Commission. The Commission makes this application available to the Member States and may request EFSA for a scientific assessment. EFSA has nine months to adopt an opinion (Article 10).
A different procedure is available in the same Regulation EU 2015/2283 for applicants who intend to place on the EU market a traditional food from a third country. In this case, the applicant submits a notification to the European Commission (Article 14). The Commission forwards the notification to the Member States and to EFSA. Should either a Member State or EFSA raise any objection to the introduction of the traditional food, the applicant has the possibility to submit an application to the Commission addressing the safety objections raised (Article 16). The Commission will forward the application to EFSA who will issue an opinion within 6 months from receipt of the valid application (Article 17).
Taking into account the EFSA assessment, the Commission eventually puts forward a proposal on the authorisation of a novel food or traditional food.
The new rules under Regulation EU 2015/2283 apply as of 1 January 2018.
For further information on the legal framework and applicable guidance documents, you can consult the dedicated Novel food area.
If you have any further questions related to the authorisation of novel and traditional foods, please contact: Unit E2 – Food processing, technologies and novel foods, European Commission’s Directorate-General for Health and Food Safety (DG SANTE).
5. What is the regulatory and procedural framework for nutrient sources?
The application procedure for sources of vitamins and minerals added to food including trace elements (amino acids, essential fatty acids, fibre, various plants and herbal extracts) commonly called ‘nutrient sources) is set down in Regulation EC 1925/2006.
The use of chemical substances as ‘sources’ of vitamins and minerals in food is regulated in the European Union by the establishment of positive lists of substances, annexed to the relevant sectorial legislation:
- Directive 2002/46/EC for food supplements;
- Regulation EC 1925/2006 for ‘fortiﬁed’ foods;
- Regulation EC 108/2008 on the addition of vitamins and minerals and of certain other substances to foods
- Regulation EU 609/2013, covering infant formula and follow-on formula (IF and FOF); processed cereal-based food and baby food (PCBF); food for special medical purposes (FSMP);and total diet replacement for weight control (TDR).
The currently applicable administrative and scientific guidance documents for nutrient sources are:
- European Commission Guidance on submissions for safety evaluation of substances added for specific nutritional purposes in the manufacture of food
- Guidance on submission for safety evaluation of sources of nutrients or of other ingredients proposed for use in the manufacture of food adopted by the Scientific Committee on Food in 2001
- Guidance on safety evaluation of sources of nutrients and bioavailability of nutrient from the sources from 2018.
The European Commission confirms the administrative acceptance of the application and may request EFSA to perform a scientific assessment. EFSA’s evaluation doesn’t have a legally binding time limit for nutrient sources added to food, which is instead agreed jointly by the European Commission and EFSA on a case-by-case basis. The agreed time limit can be extended during the evaluation process if EFSA requests additional information from the applicant.
If you have any further questions related to the authorisation of nutrient sources added to food, please contact: E1 – Food information and composition, European Commission’s Directorate-General for Health and Food Safety (DG SANTE).
6. Short cuts for applicants
- Applications for health claims:guidance for applicants
- Submission to competent authority of a Member State
- Contact regarding authorisation: Unit E1 – Nutrition, Food Composition and Information and Unit E2 Food processing, technologies and novel foods, European Commission’s Directorate-General for Health and Food Safety (DG SANTE)
- Ask a question web form