Directive 98/8/EC set out a two-step process of approving biocidal products:
The Directive, therefore, foresaw that all biocidal products would be authorised at the national level. In order to obtain access to the wider EU market, companies had to apply for mutual recognition of the national authorisations.
It is estimated that there are tens of thousands of biocidal products on the market and, in contrast to plant protection or medicinal products, the sector is dominated, at least numerically, by SMEs. The size of the market for any particular product both in terms of geography and economic value is often quite small. Given the character of the sector, national authorisations, coupled with a mutual recognition procedure, was considered to be the best approach.
The new Regulation therefore maintains the same rules for the authorisation and mutual recognition for the majority of biocidal products.
However, at the same time, the new Regulation foresees that certain biocidal products will be eligible for a centralised authorisation, which would be of interest for products to be placed on the entire EU market.
The text further sets out that the centralised authorisation is optional, i.e. companies marketing such products could choose to go through national authorisation followed by mutual recognition or through centralised authorisation. This means that the two systems (national authorisation followed by mutual recognition and centralised authorisation) will coexist in parallel.
The European Chemicals Agency (ECHA) will play a key role in the centralised authorisation (e.g. the preparation of opinions on the authorisation of a biocidal product).This approach was inspired by the system which exists since 1994 for medicinal products, and which has proven to be very successful. In this system, the European Medicines Agency plays a role very similar to the one foreseen for ECHA.