Biocides
Agrochemicals
Biocides
Notified existing active substances are currently being reviewed at EU level.
The review dossiers contain detailed information on efficacy, physical chemical
properties, analytical methods, mammalian toxicology, ecotoxicology,
environmental fate, exposure assessments, risk assessments and risk
management measures. Those active substances deemed to be sufficiently
efficacious and having an acceptable risk profile are authorised in accordance
with this Regulation.
Products containing active substances included in the ongoing review programme
of existing active substances can continue to be marketed according to existing
national schemes while the active substance is being reviewed at EU level. Following
a decision on approval of those active substances, an application to ask for the
authorisation of the associated products in the appropriate Member States (or the Agency
in the case of an application for Union authorisation) will need to be submitted.
Active substances not included in the review programme are deemed to be new active substances
and must be approved at EU level before the associated product can be placed on the market.
SECTOR
Sector
Biocidal Products Regulation – Commission Regulation (EU) No. 528/2012
From the 1st September 2013, the Biocidal Products Regulation (BPR, Commission Regulation No. 528/2012)
replaces Directive 98/8/EC. The scope of the Regulation has been extended with new provisions regarding articles
and materials treated with biocidal products (including furniture and textiles), active substances generated in situ
and active substances deliberately incorporated or impregnated into the final food contact material to achieve
a biocidal function.
The Regulation introduces several new aspects such as the concept of the ‘Union Authorisation’ which allows
companies to obtain an authorisation for certain biocidal products that is applicable across the whole of the EU.
The Regulation also introduces new rules for hazard-based exclusion and substitution criteria, comparative
assessment, mutual recognition, nanomaterials, obligatory sharing of vertebrate animal data and rules for a
‘simplified procedure’. A key change of the Regulation also requires that all manufacturers or importers of active
substances should demonstrate suitable access to an active substance dossier; otherwise a phased withdrawal
of authorised products will apply.
APC’s regulatory team monitors all developments in these areas and is able to advise on the implications for your
active substance and/or product.
APC . Cromwell Office Park . York Road . Wetherby . LS22 7SU . United Kingdom
Tel: +44 (0)1937 587962
Email: [email protected]
www.apc.eu.com