However, nine years after its enforcement in 2009, an evaluation by the EU Commission brought to light that, in practice, this regulation does not work satisfactorily. The EU has now agreed on an action plan to facilitate the Mutual Recognition process.
The Mutual Recognition regulation EU 764/2008 was set up to support the free movement of goods within the European Union.
What is Mutual Recognition?
The regulation states that products that are lawfully marketed in one EU Member State must in principle be admitted to other Member States as well. If, for instance, a dietary supplement is legally marketed in one Member State, other Member States are supposed to accept the product, unless they have serious concerns about the safety for the local population. The Mutual Recognition process covers only products for which EU regulations are not harmonized, e.g. dietary supplements with vitamins/minerals for which the maximum levels are different in different EU Member States. It does not cover foods for special medical purposes (FSMPs), for which the EU regulations are fully harmonized.
How to start the process of Mutual Recognition?
Contact the product contact points (PCP)
of your target market.
The PCPs are the main communication channel between business operators and competent national authorities and are supposed to respond to inquiries within 15 working days.
What can you do in case of problems?
If a national authority does not accept your product, you can contact SOLVIT
, a EU-funded body to assist businesses and ascertain their EU rights.
If the problem cannot be resolved through SOLVIT, the EU commission may become involved. In this case, the national authority of the target market has the burden to prove that public health is endangered by the product in question.
What will be improved in the future?
As part of the new strategy, in December 2017 the Commission tabled a legislative proposal to make it easier for companies, especially small and medium-sized enterprises, to sell their products across Europe.
The action plan comprises:
- Trainings of the national authorities and exchange of officials between Member States to increase awareness of the Mutual Recognition process and to enhance trust in other Member States regulations.
- Strengthening of the SOLVIT process
- Implementation of a voluntary “Mutual Recognition Declaration” filled in by the business operator on the product in question to demonstrate to the competent authorities of the target Member State that the product is lawfully marketed in another Member State.
A guidance document on the application of the Mutual Recognition Regulation to food supplements can be found here.
If you have any questions on the mutual recognition process or the expected changes, please contact us.