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At the EU level the Directive 2002/46/EC is applicable alongside other Regulations of different character (such as the Food safety law Regulation 178/2002 and the Food Information to Consumers Regulation 1169/2011).
This EU legislation states the maximum and minimum level of substances, as well as several documentation and labelling requirements. Nevertheless, adding to these harmonized rules applies national legislation, which may state additional restrictions and labelling requirements. Furthermore, in certain EU countries it is also necessary to register the food supplement in a national database prior to place them in the market.
Therefore, Obelis can assist you through the food supplements EU revision service to meet the restrictions stated in the harmonized EU legislation and national legislation, such as maximum and minimum levels of vitamins and minerals and labelling requirements.
Moreover, when necessary, Obelis will also carry out the registration in national databases prior to the placing of the food supplement in the market.
Compliance Success Stories
“We can always count on the quick response of the Obelis team. Managing the huge amount of data necessary for a EU Notification is very complex yet they make is seem so easy.”
“We were under huge time and cost pressure for a new product line launch and we relied on Obelis. It was the right decision. Their expert team helped us to avoid possible regulatory complications.”
“I encourage companies to seek compliance before putting their devices on the market. Working with Obelis to gain swift regulatory approval across several markets has had a profound impact on our company.”
