Update on the current position of the Biocidal Products Directive (BPD).

The programme for the review of existing active substances used in biocidal products is controlled by a series of European Commission Regulations. These can be found on the European Chemicals Bureau website

The latest Review Regulation is the Third Review Regulation ( Commission Regulation (EC) No 1048/2005 ), which came into force on 13 June 2005. This:

• Amends the Second Review Regulation (EC) No 2032/2003 .
• Gives the third (Part C) and fourth (Part D) priority lists and the associated Rapporteur Member States.
• Gives the opportunity for an active, which has only been identified, or one that has been notified but not for use in the particular product type you are interested in, to be upgraded to the 'notified' status by submitting a full dossier for review on the active substance and a representative product containing it, to a Member State Competent Authority by 1 March 2006. (This method of entering the review process is set out in article 4b of the Third Review Regulation).

How do the Second and Third Review Regulations affect the placing of biocidal products on the EU market?

To place a biocidal product on the EU market you need to check if the active substance(s) in a biocidal product has been identified or notified for that particular use. You need to check the Second and Third Review Regulations and can check by CAS/EC numbers of the active substance to find which Annex it is listed on.

In the Second Review Regulation, Annex I includes the list of all accepted identified and notified active substances. (NB This is different to the Annex I of the BPD, which is empty at present but will be a list of active substances that have been assessed and considered to be acceptable for use in biocidal products). So you need to then further check Annex II and Annex III to find out if an active substance has been identified or notified. Annex II lists the notified biocidal active substances with the related product types in which they have been notified for review. Annex III lists those active substances that have only been identified.

The Second Review Regulation is updated by the Third Review Regulation so you need to first check the Second Review Regulation to find if your substance is listed in the Annexes and then check if any amendments have been made to the listing for your substance in the Third Review Regulation.

On checking the Second and Third Review Regulations, you find:

• That an active substance has been neither identified nor notified (it is not on the Annexes) then it cannot be used in biocidal products placed on the EU market. They would be treated as 'new' active substances, which have to be assessed under the BPD and gain Annex I inclusion before products can be placed on the EU market.
• That an active substance has been identified but not notified, or notified but not for the particular product type that is relevant to your products, such products can only be placed on the market (subject to any requirements under existing national legislation), until 1 September 2006. By this date the products would have to have been removed from the market. Companies wishing to market biocidal products containing these active substances after 1 September 2006 would have to apply as a ‘new’ active substance and prepare a dossier for both the active substance and the product itself as outlined in Sections IIA and IIB of the BPD. Or upgrade to the 'notified' status by 1 March 2006 by submitting a full dossier for review on the active substance and a representative product containing it.

That an active substance has been notified for use in the relevant product type then products containing it can be placed on the market (subject to any requirements under existing national legislation), until the review has been completed. If the substance is successful in gaining Annex I inclusion, then products containing it will need to be authorised under the BPD if they are to remain on the market. Once an active substance is included on Annex I then those companies who supply biocidal products containing that active substance will require authorisation if their products are to remain on the market.

UK CA
June 2006