France officially adopted the Directive 2002/46/EC in March 2006 with Decree No 2006-352. Product declaration is mandatory in France, and declarations can be one of two types, which determine when products can be sold.
Article 15 Declarations are notifications of products containing only ingredients that comply with French regulations. These declarations can be submitted at the same time as the product is introduced to the market and require the submission of the notification paperwork and a copy of the label.
Article 16 Declarations are for products containing ingredients which are not listed in the French regulations, but are legally manufactured or commercialized in another EU Member State. These declarations must be submitted two months prior to introducing the product to market and require the submission of the notification paperwork, proof that the ingredient is legally manufactured or commercialized in another EU Member State and a copy of the label. There are no government notification fees at this time.
NHP Consulting will prepare the required regulatory documentation to achieve market compliance for food supplements in France.