National Organic Program | Post Strengthening Organic Enforcement deadline: Q&A Session with our experts

Register & submit your questions →

Health Claims

We help you understand what you can say about your product and the relationship between ingredients and health benefits.

Contact us

Related Resources

FoodChain ID and NOW Foods Partner to Showcase Regulatory Leadership

COMPANY NOW® Foods As a natural products leader, NOW’s dedication to superior quality at value prices has fueled its growth from a local health food store to a market leader…

How to create a compliant supplement label for Europe?

The labeling of a food supplement is highly regulated. The mandatory labeling information is listed in Directive 2002/46/EC. As it is also a foodstuff, the mandatory information laid down in…

What are the requirements for selling supplements online in Europe?

According to Article 14 of Regulation (EU) No. 1169/2011 of 25 October 2011 on the provision of food information to consumers (known as the FIC Regulation), the mandatory information required…

Novel foods and food supplements: understanding the European legal framework

A novel food is defined in Regulation (EU) 2015/2283 as a food for which human consumption was negligible in the European Union before 15 May 1997, when the first novel food regulation…

What are health claims?

A claim is any message or representation, not required by International or national legislation, including representation in the form of pictorial, graphic or symbolic matter in any form, which states, suggests or…

What are the Novel Foods ?

Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods, applicable since 1 January 2018, allows novel foods to be subject to simpler, clearer…

How to sell Dietary Supplements on Amazon

The following article is available for the sellers who want to sell products in the US market with Amazon.com. If you plan to sell supplements products on Amazon US, you…

Service Details

claim is any message or representation, not required by international or national legislation, including representation in the form of pictorial, graphic or symbolic matter in any form, which states, suggests or implies that a food has particular characteristics. A health claim is any claim which states, suggests or implies a relationship between a category of food, a food or one of its constituents and health. A nutrition claim states, suggests or implies that a food has particular beneficial nutritional properties (e.g. high fibre, low fat, source of protein).

We can help you understand what you can legally say about your product and the relationship between ingredients and health benefits. We can also evaluate whether or not you can use an existing authorized claim, or if you need to do a health claim dossier to obtain approval to a new claim.

Our health claim service includes:

Scientific Gap Analysis of Data in Accordance with Regulatory Admissibility Criteria

  • EFSA/FDA opinions and guidance on the same applications/ingredients
  • Clinical studies on the applications/ingredients
  • Characterization data on the applications/ingredients

Expert Recommendations

  • Strengths and weaknesses of the substantiation
  • Suggestion of alternative claims to apply in line with your expectations, general EFSA requirements and available scientific data.
  • Complementary elements to provide including additional clinical studies.

File Constitution & Submission

  • Preparation of the health claim file.
  • National EFSA authority submission.

Authorities Communication Exchanges (Member states, EFSA & European Commission, FDA)