ECHA publishes two new Guidance documents concerning biocides
The European Chemicals Agency (ECHA) has today published Guidance on information requirements for biocides and on active substance suppliers.
Helsinki, 16 July 2013 – Two new guidance documents are applicable from 1 September 2013, the date of entry into operation of the Biocidal Products Regulation (BPR).
The aim of the Guidance on information requirements is to provide detailed and practical direction on the study data and other information that should be submitted, when applying for active substance approval or authorisation of biocidal products according to the BPR.
The Guidance is derived from the Technical Notes for Guidance on Data Requirements under the former legislation – the Biocidal Products Directive (BPD). However, users should be aware that the information required under the BPR is different from that which was required under the BPD.
Some of the major differences from the previous BPD guidance include harmonisation with guidance from other legal frameworks when applicable (for example, CLP, REACH and the Plant Protection Products Regulation) and a more formalised and systematic approach for accepting adaptations to information requirements, with Member States having to inform and assist applicants with adaptation requests.
The present guidance document only covers the information requirements for chemical active substances and chemical biocidal products (i.e. covering Title 1 of Annex II and III of the BPR). Guidance on information requirements for substances of concern in the biocidal product, Guidance on micro-organisms and Guidance on nanomaterials will be separately available later.
The Guidance on active substance suppliers explains the obligations for companies under Article 95 of the BPR. It provides guidance on who has to submit the required information under Article 95 to ECHA, which information has to be submitted and guidance on the regulatory consequences.