Current status of the EU approval and authorisation proces
The biocides legislation consists of an approval program and an authorisation programme.
In the first programme, all active substances are evaluated by the EU. The second programme applies to biocidal products, each of which requires either an individual Member State authorisation or an EU authorisation. The product authorisation process starts when the active substance has been approved in each country in which the product is to be made available on the market.
- Step 1: The EU approves of the active substance
- Step 2: The Danish Environmental Protection Agency (Danish EPA) or another EU Member State authorises the product containing the active substances. When authorisation has been made by a Member State the product is authorised by mutual recognition in other EU Member States. An EU authorisation is valid in the whole Union.
Only approved active substances or those substances covered by the EU's review programme may be used in biocidal products.
See the unofficial list of substances in the review programme here
EU evaluation of active substances
The EU, represented by the relevant authorities from the 28 Member States, is evaluating a number of active substances and making decisions with respect to approval of the respective substances for future use for a given product type. After approval by the EU, active substances are included in the list of approved active substances under the BPR. Active substances not approved are no longer permitted and are added to a "negative list" (non-inclusion list). Remember that active substances not covered by the review programme may not be used either, unless they are subject to the transitional provisions of the BPR.
The active substances are approved or prohibited for use in a specific product type (often abbreviated to PT). For instance, an active substance approved for antifouling paint may not be used for other purposes.
Facts concerning the work on evaluation of active substances:
- 430: The number of dossiers for existing active substance or product type combinations awaiting EU evaluation as of mid-2013. An active substance may be included in several dossiers each concerning a use (product type) for which it is to be approved.
- 2025: The year when the EU expects to finish evaluating the active substance and product type combinations.
- 50: The number of active substances and product type combinations which the EU intends to evaluate per year.