Companies need to know which products they will keep in their portfolios, whether they can group products (for approval), and that the same approach will be taken at national and (European) Union level
Detailed guidance notes for the European Union’s (EU) new biocidal products regulation (BPR), (EU) No 528/2012 that is applicable from 1 September emerged as a pressing industry concern at an open day in Finland, organised by the Helsinki-based European Chemicals Agency (ECHA).
The aim of the meeting, held in June, was to bring biocide users, such as cleanroom managers, up-to-date with the incoming legislation.
Participants complained that guidance so far lacked case-by-case studies on how to deal with this complex regulation. Typical among comments were those from the Brussels-based Association for Soaps, Detergents and Maintenance Products (AISE).
‘We have started to prepare real cases and industry would be ready to support some form of guidance,’ said Sylvie Lemoine, Director of Technical and Regulatory Affairs at AISE.
‘We really need to take this one step further,’ she said. ‘It is strategic for companies. They need to know which products they will keep in their portfolios, whether they can group products (for approval), and that the same approach will be taken at national and (European) Union level.’
Pierre Choraine, biocides team co-ordinator at the European Commission\'s environment directorate general, said he hoped that case-by-case guidance would be discussed in a meeting this month (July) with member state authorities or, at the latest, in September.
We really need to take this one step further. It is strategic for companies
ECHA staff updated regulators and companies on guidance, IT tools and support for complying with the BPR regulation, which builds on and will immediately replace the EU’s biocidal products directive (Directive 98/8/EC) in September, except for a few transitional arrangements.
Guidance on information requirements for part A of the regulation has become available. Guidance on technical equivalence and on alternative suppliers is due before 1 September; and on procedural aspects in relation to active substances and in relation to biocidal products is due from October (and maybe early next year).
More information will follow. Guidance due in 2014 and beyond includes information on: mixture toxicity; risk assessments regarding human health; risk assessments on the environment; the impact of biocides on micro-organisms; efficacy assessment; and physical chemistry analytics assessments.
Adriana Lipkova, a junior scientific officer at ECHA, advised that until BPR regulation guidance is available, applicants should consult information associated with the old directive, which would be valid notwithstanding the references in this to the directive rather than the regulation and would be without prejudice to the scientific content.
In the meantime, ECHA has established a biocides helpdesk, with national biocides helpdesks due to be in place by 1 September, and the ECHA HelpNet system will provide online assistance.
IT tools under development and testing that will help companies comply with the regulation include: the IUCLID 5.5 International Uniform Chemical Information Database of technical and scientific information, with which companies create dossiers.
There is also the R4BP registry for biocidal products and administrative/regulatory information, through which the dossiers are submitted to ECHA and national authorities.
An invitation to test R4BP went out earlier this month and IUCLID said it may be downloaded from its own website.