Biocidal Products

The authorisation procedure in Europe for biocides requests a 2-step approach:

First, the biocidal active substance has to be approved at European level for a given Product Type (PT);

 

Second, the product containing these active substances has to be authorised. This authorisation is only possible with an approved active substance. 

 

Since September 2015 biocidal products must contain substances from suppliers that are listed on a list maintained by ECHA.

 

Approval applications for new active substances are no longer handled by an evaluating Member State but are processed by the European Chemicals Agency ECHA.  Active substances that are PBT or CMR (both exclusion criteria) will no longer be approved as active substances, unless they are needed for an urgency use.

 

There are various authorisation procedures. Besides national authorisations union authorisations are now possible. This means that these products can be placed on the market in every EU Member State.

 

The BPR introduced the concept of “product families”. These are groups of products that vary, for instance, only in fragrance or color. If you got a product family authorisation, all products belonging to that group may then be placed on the market through a simple notification.

Last but not least there is a simplified authorisation procedure for those products that contain active substances listed in annex I of the BPR and that contain no substances of concern.

Treated articles, that were not within the scope of the old BPD are now regulated by the biocides regulation. For instance, wood from outside the EU treated with insecticides may only be imported if the applied insecticide is approved in the EU.

 

As for the REACH regulation 1907/2006 there is also a provision within the BPR that data must be shared to avoid testing on vertebrates. That means that before conducting such study a request in that sense must be submitted to ECHA. In case the data are available from a different organisation the applicant and the concerned organisation must find an agreement on data sharing.

(Source)

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