The Fifth Review regulation (1451/2007/EC) came into effect on the 24/12/2007. It updates and replaces the Second Review regulation (2032/2003/EC and its amendments (1048/2005/EC and 1849/2006/EC (the Third and Fourth review regulations))).
The main changes this regulation makes are:
It allows for the removal from consideration of Animal and Human foodstuffs marketed as Attractants or Repellents (product type (PT) 19, i.e. honey, jam) until the end of the end of the review period, at present 14th May 2010. These 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 compromise extracts or individual substances isolated from food or feed’. (See Article 6).
When a non-inclusion decision has been published for a substance in a particular product type, then from the date of publication there is a 12 month phase out from sale period. (See Article 4 (2)).
Also when support has been withdrawn for a substance in the review programme, it states that it can be taken over by another participant. This must happen within the 3 month period as outlined by the Commission. This change of support can only happen on one occasion. (See Article 12). So if you have an interest in taking over support of a substance, you must do it within this 3 month period otherwise it will be withdrawn from the review process and would then have to be treated as a new active.
Where a substance is supported through the review, others apart from the original Applicant may submit dossiers to support the active. However, they will have to work to the same timescale as the original submission. (See Articles (7) and (8)).
Also the regulation provides updated and simplified Annexes for existing chemicals, the Member States responsible for evaluation and the product types that support has been registered under. The 5th review regulation should now be used to check substance notification under the review programme as it replaces previous review regulations.
The 5th review regulation of the Biocidal Products Directive can be accessed at http://eur-lex.europa.eu/LexUriServ/site/en/oj/2007/l_325/l_32520071211en00030065.pdf
UK CA
January 2008