Regulations for the EU Review-Programm

With the 5th EU Review Regulation (Regulation (EC) No 1451/2007), which entered into force on 31 December 2007, the complete list of active biocidal substances which are subject to a detailed evaluation under the Review Programme was published again, presumably for the last time before the end of the work programme. According to the current legal status (extension of deadline according to Directive 2009/107/EC) the review is expected to be finalised by 14 May 2014.

The 5th Review Regulation has replaced and consolidated the 2nd EU Review Regulation (No. 2032/2003) by incorporating all amendments thereof (3rd and 4th Review Regulation). New is that certain substances or products normally consumed by humans or fed to animals, which are on the market as repellents or attractants (product type 19), have been withdrawn from the review programme. It is intended to expressly take them out of the scope of Directive 98/8/EC at a later date.

In Article 6 these active substances are defined as follows: "For the purposes of this derogation, ‘food or feed’ means any edible substance or product of plant or animal origin, whether processed, partially processed or unprocessed, which is intended

or reasonably expected to be ingested by humans or animals; this category does not comprise extracts or individual substances isolated from food or feed."

If persons other than the original participants submit a dossier on an active substance for detailed assessment under the review programme, the time scale and deadlines applicable to them shall be the same as for the original participants (Article 7 (3) and 8). This applies in particular when support for a specific active substance/product type combination in the review programme has been withdrawn (withdrawal by the original participant) and another participant has taken over by sending a letter of intent to the EU Commission within the 3-month period as specified by the EU Commission in the relevant electronic “withdrawal notice”. Taking over the role of a participant can only happen once (Article 12 (4)). In order to prevent misuse, the person taking over support of a substance has to prove, within a specified period of time, that he/she has started preparing the full dossier. If the EU Commission does not receive such a letter of intent within the specified 3 months, the active substance/product type combination will be withdrawn from the review programme, and would then have the legal status of a new active substance.

Active substance/product type combinations for which a decision of non-inclusion has been published shall not be allowed on the market after 12 months from the date of publication (Article 4 (2)).

The list of existing active biocidal substances in the review programme (Annex II to the 5th Review Regulation) specifies the relevant Member State responsible for detailed assessment.

The 5th Review Regulation puts particular emphasis on the fact that efforts and measures should be undertaken to avoid duplication of work and above all testing on vertebrate animals, e.g. through joint action by participants submitting collective dossiers and actively pursuing a policy of information exchange.