- Biocidal Products Regulation
- Authorisation of biocidal products
- National authorisation and mutual recognition
National authorisation and mutual recognition
Companies planning to sell their products in one EU Member State must apply for product authorisation in that country. To do so, they submit an application for national authorisation through R4BP 3.
The Member State competent authority evaluates the application and makes a decision on the authorisation within 365 days.
Where an active substance is identified as a candidate for substitution, the Member State should carry out a comparative assessment to check whether other authorised biocidal products, non-chemical control or prevention methods that present a significantly lower overall risk for human health, animal health and the environment are available.
If there is already an authorised product, which is sufficiently effective, presents no other significant economic or practical disadvantages and does not affect the occurrence of resistance in the target organism, the new product will be restricted or prohibited.
If a company wishes to extend the national product authorisation to other markets, it can ask other Member States to recognise it. Companies can apply for mutual recognition either in sequence or in parallel.
To apply for mutual recognition in sequence, companies first need to get their product authorised in one Member State. After this, they can request other Member States to recognise this authorisation.
For mutual recognition in parallel, the company can submit an application for product authorisation in one Member State (called the reference Member State) and simultaneously ask other countries to recognise the authorisation as soon as it is granted.
In both cases, applications are submitted via R4BP 3. The mutual recognition process will take approximately five months from the validation of the application by the evaluating competent authority.
If the concerned Member Stetes do not agree to mutual recognition, the case will be referred to the coordination group, which has 60 days to seek agreement. The coordination group is a body formed by representatives of the Member States and the Commission.
If the coordination group cannot reach an agreement, the matter is referred to the Commission which may ask ECHA for an opinion on the scientific or technical aspects of the case.