"Borderline" - Products
Food supplements & foodstuffs intended for particular nutritional uses
& novel food & cosmetics
– borderline products?
Food supplements & foodstuffs intended for particular nutritional uses & novel food & cosmetics – borderline products?
There is an increasing popularity of food supplements and foodstuffs intended for particular nutritional uses as well as novel food for a modern and healthy life style. Opposite to this popularity is a highly complex framework of European legislation, often lacking precise definitions and leaving plenty of room for interpretation. Meanwhile also the supervision of borderline products and the examination whether they are safe and legal is increasing in the European Economic Area.The correct classification of products especially drawing the line between medicinal drugs and foodstuffs, medical devices or even cosmetics is a challenge even for the experts. For the classification detailed knowledge of the various legislations and scientific background is essential.
Relevant Regulations and Directives in the European Union:
- Food regulation (178/2002/EC)
- Novel food regulation (258/97/EC)
- Food supplement directive (2002/46/EU):
- Food additives for technological purposes directive (89/107/EEC)
- Foods for particular nutritional uses directive (89/398/EEC)
- Regulation on genetically modified food and feed (1829/2003/EC)
- Medical devices directive (42/83/EEC)
- Cosmetics directive (76/768/EEC)
- Directives relating to the labelling, presentation and advertising (2000/13/EC) and on nutrition labelling for foodstuffs (90/496/EEC)
- Health-claims regulation (1924/2006/EC)
We offer the following tasks:
- Classification in different product categories (medicinal products, food supplements, food additive, novel food, foodstuff intended for particular nutritional uses, traditional medicinal product, medical devices, cosmetics)
- Professional advise for a successful marketing strategy in the EU
- Applications according to § 68 (exemption) and § 54 (general disposition) LFBG (German Food Law) in Germany.
- Application for a health claim
- Labelling according to Health-Claims Regulation and other relevant directives
PharmaLex has on its disposal experts of all relevant branches who will develop the optimal strategy for your company and the specific product. We will compile the necessary documentation and give you comprehensive support.
Just call us!