Systematic evaluation and assessment of existing active substances

The EU review programme sets itself the task to assess existing active substances which are currently permitted for use in biocidal products. By 31 October 2008, the final deadline for submitting active substance dossiers in the 4th priority list, all required dossiers should have been submitted to the EU biocidal products authorities. By way of interim result of the EU review programme, 678 dossiers were submitted out of 1682 notified active substance/product type combinations. Decisions regarding inclusion in Annex I/IA have been published for more than 40 active substances.

Before the respective provisions of the review programme started taking effect (prohibition of active substances which have not been reported – neither identified nor notified), about 15000 biocidal products were on the market in the EEA, containing more than 1000 active substances.

By September 2006 the number of active substances had decreased to less than 420. Pursuant to Article 16 (2) of the BPD 98/8/EC, active substances have to be assessed under a specific work programme (the so-called EU review programme) which is supported by all Member States of the European Union and which was originally projected to run for 10 years. The first phase of this work programme started with the publication of the 1st Review Regulation (EC) No. 1896/2000 requiring an identification/notification process for biocidal active substances in different tiers. The result of this procedure, published in the 2nd Review Regulation (EC) No. 2032/2003, was that 579 active substances were identified and 416 were notified (only these substances were intended for review for the purpose of being included in the active substance list of the BPD and thus marketable in the long term for designated product types). The 2nd Review Regulation was finally consolidated and amended by Regulation (EC) No. 1451/2007 (5th Review Regulation).

The active substance assessment is spread over time by means of 4 priority lists. According to EU Directive 2009/107/EC, amending the Biocidal Products Directive, the EU review programme is currently scheduled to be finalized until 2014. Up to then, the transitional provisions applicable in individual EU Member States shall apply for notified active substances whose detailed assessment has not been completed, as well as for biocidal products containing these substances.