In Europe, Food Supplements must comply with European Directive 2002/46 / EC as well as with any local legislation that may apply in each country. The aim of the Directive 2002/46/EC is to protect consumers against potential health risks from those products and to ensure that they are not provided with misleading information. With respect to the safety of food supplements, the Directive lays down a harmonised list of vitamins and minerals that may be added for nutritional purposes in food supplements (in Annex I to the Directive). Annex II of the Directive contains a list of permitted sources (vitamin and mineral substances) from which those vitamins and minerals may be manufactured.
Microbiological Testing
ELINEK carries out the necessary microbiological tests that must be performed on each batch of food supplements.
The tests which are performed are: TAMC (Total Aerobic Microbial Count) TYMC (Total combined Yeasts & Moulds Count), as well as the detection and identification (with biochemical tests) of the following pathogenic microorganisms: Bile-tolerant Gram negative Bacteria, Escherichia coli, Ps.aeruginosa, St.aureus. Salmonella spp. Candida albicans Ps.aeruginosa, St.aureus & Candida albicans based on methods of the European Pharmacopoeia
Chemical Testing
ELINEK can determine the following chemical analysis to Food Supplements
- Determination of vitamins
- HEAVY METALS (Arsenic (As), Lead (Pb), Chromium (Cr), Cadmium (Cd), Cobalt (Co), Nickel (Ni)
- FORMALDEHYDE
- DIOXINE
- ALLERGENS IN FINAL PRODUCT
- GLUTEN FREE
- GMO FREE
For more information on chemical analysis, you can contact our experts.
Food Supplements Registration
Food supplements registration is mandatory before they are placed on the market. The notification must be made in each European country that will be made available. This means that there is a specific registration requirement in each member country.
ELINEK can assist you in registering/notifying your products in the system.
Label Review
Labelling of food supplements is subject to the European Commission’s Regulation 1169/2011 which provides the mandatory information required on all labels.
ELINEK can guide you to be the labeling of your products, in accordance with the above Legislation.