France has bucked the European Union Food Supplements Directive (FSD) by removing maximum permitted levels (MPLs) in food supplements for vitamins K, B1, B2, B5, B8 and B12.
French supplement firms had protested the limits as being unnecessary on safety grounds and French authorities agreed in abolishing them recently, although the French supplements group Synadiet suggested companies should still consider the MPLs in formulations.
The levels include:
- Vitamin K: 25µg
- Vitamin B1: 4.2mg
- Vitamin B2: 4.8mg
- Vitamin B5: 18mg
- Vitamin B8: 450mg
- Vitamin B12: 3µg.
Products were now free to use, “doses they want of these vitamins in the French market” Synadiet noted but warned: “We can only encourage you to use a maximum of caution.”
“We suggest you stay in the range originally planned by the administration, sensitive to the precautionary principle,” the group said in a missive to its members.
“This is particularly the case of vitamin K, for which we recommend the utmost vigilance,” it added. “Indeed, this vitamin can interact with anti-coagulants. It would be appropriate and wise to remind consumers of the possible interaction of vitamin K with the treatments in question.”
The European Federation of Associations of Health Product Manufacturers (EHPM) said the move offered greater formulation flexibility.
“Since the levels are removed because there is not a safety issue, manufacturers will have to assess if and how they would use the opportunity for develop higher level products that has now been made possible for these nutrients,” a spokesperson told this publication.
“EHPM clearly welcomes the principle that where no safety concerns have been identified, there is no justifiable grounds for legal restrictions.”