Related Resources
Quality of food supplements – Europe
When it comes to the quality of food supplements, the first text to consider is Regulation (EC) No. 178/2002, which lays down the general principles and requirements of food law. […]
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 […]
Service details
Evaluation of the regulatory status of food additives within the European Union (regulations 1333/2008).
Scientific evaluation of the data, in accordance with regulatory requirements of admissibility
- Analysis of additive characterization data and analytical methods
- Exposure calculation
- Analysis of the pharmacokinetic and stability data of the additive
- Analysis of safety/toxicity and allergenicity studies on the additive
Recommendations from our experts
- Strengths and weaknesses of the rationale
- Additional information to be provided, including any toxicological and/or quality studies to be carried out.
Constitution & submission of the dossier
- Constitution of the request for authorization
- Submission to the European Commission
Follow-up and communication exchanges with the authorities (EFSA, European Commission).
