Food supplement registrations in the European Union are subject to the requirements as set out by Regulation (EU) 2015/2283. These regulations require a complete dossier submission for new novel foods, to demonstrate that the product being registered is safe for human consumption and that any claims made about the product are supported by evidence. In addition to completing a product registration with the EFSA, you may also be required by the specific Member States to complete an additional registration in order to list your product on their market.
For this reason, it is best to partner with a firm that can offer regulatory support tailored specifically to meet the requirements for each member state in the European Union.
dicentra provides the following services to help support your member state product registration
- Preparation of safety dossiers
- Preparation of efficacy dossiers to support health claims
- Dossier submissions
- Liaison with Responsible Regulatory Authority
- Scientific literature review
- Scientific and Medical Writing
Contact us below to learn how our Food Supplement Regulatory Services can help get your products to market in the European Union