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Article related to: Biocides
Sylvie Lemoine, A.I.S.E, on the new Biocides Regulation: Great potential for improvement – but it needs to materialise
The chemicals used in biocides range from simple compounds to complex formulations, and are as diverse as the industry sectors involved, such as agriculture (pesticides) through to art and construction suppliers (paints).
ECHA is overseeing the new Biocidal Products Regulation (BPR), which concerns the placing on the market and use of biocidal products within the European Union. The new rules that apply from September will impact multinational organisations through to small companies; all of which bring different levels of experience and expertise to the table. The Association for Soaps, Detergents and Maintenance Products (A.I.S.E) represents another affected industry - producers of disinfectants and insecticides - required to seek product authorisation under the Regulation. ECHA Newsletter talks to Sylvie Lemoine, the A.I.S.E Director of Technical and Regulatory Affairs, to get the association's view of the changes.
Biocidal Products Regulation challenging for small companies
Biocidal products have been subject to EU law under the Biocidal Products Directive (BPD) since 1998. The new Regulation is designed to improve the functioning of the single market for biocide manufacturers and distributers within Europe, by simplifying authorisation and approval processes and introducing timelines for Member State evaluations. The changes, which apply from 1 September, provide new opportunities for industry, including the option of an EU-wide market authorisation of products. A more comprehensive application evaluation process will also require companies to submit more, and better quality data to ECHA, to ensure their dossiers can be properly assessed and processed.
Ms Lemoine says larger companies are generally aware of their responsibilities under the new requirements, and are putting resources in place to meet them. However, it's a different story for smaller companies.
"There are small companies that may not be members of national associations, and as we have seen under REACH, they are the unreachables when it comes to the new requirements." Small and medium sized companies need practical, simple advice from ECHA regarding their main duties under the Regulation, she says, suggesting case-by-case consultancy could be beneficial.
"We would like to see more scientific and regulatory advice for smaller companies. While it remains a challenging task for the big companies they do have resources; legal services and toxicologists and are undertaking portfolio refinement exercises to meet the costs, but the smaller ones cannot."
A.I.S.E is also concerned about the level of fees involved to submit authorisations applications to ECHA; the exact cost of which is still being determined by the European Commission.
One key change to the system, which may prove to be more cost effective for industry, is the option to apply for Union-wide authorisation. Companies will be able to apply for the authorisation to sell their products across the EU, instead of submitting applications to individual Member States. This option will be available for most biocide product types, but does exclude, for example, antifouling products used on ship hulls. A.I.S.E says while some multinationals are considering the option, industry remains sceptical.
"We would like to see union- authorisation work. It's an opportunity to have a harmonised approach to the EU market for biocides. Access to the market in 27 Member States, in principle, could attract companies, but it has to be reliable, predictable and not perceived as unaffordable."
"Because the evaluation still has to be done at Member State level it is not a ‘full European' assessment, so it remains unclear how this will work in practice," she added.
Fixed timelines bring certainty
ECHA's new Biocidal Product Committee is tasked with considering new active substance approvals, and will have to make a decision within 270 days, compared to the open-ended timeframes existing under the current system. In addition, the Committee will consider applications for Union-wide authorisation within a six-month period. Ms Lemoine says in principle the strict deadlines will provide more certainty for industry with regards to placing products on the market.
"This is something that has not been working at all under the current directive," she says, adding that the fixed timelines may still drift because Member States can effectively ‘stop the clock' and ask for more data.
New requirements for treated articles and labelling
The Biocidal Products Regulation introduces new legal requirements for objects treated with biocidal products, known as ‘treated articles'. This means items, such as furniture treated with wood preservatives, will now be covered, and companies based outside Europe will have to ensure that any biocidal substances used have been approved for use in the EU.
They are also obliged to put a label on the product notifying consumers that the treated article contains a biocidal product. Ms Lemoine says that questions regarding the definition remain.
"When does a treated article remain a treated article, and when does it qualify as a biocidal product, which means it will need to be authorised? The boundary is not clear, and we are concerned this will become a huge debate in the future."
"Water-based liquid detergents, like paints, contain preservatives which are biocidal products, and are therefore ‘treated articles'," she explains. "But there are no biocidal labels on laundry liquid products, and there will be other cases where it is even more borderline."
The Agency has the potential to ensure a ‘harmonised implementation' of the BPR, but A.I.S.E stresses that it will take more than providing information helpdesks and IT support systems. "When the regulation was approved we saw it as a great improvement over the directive. We are happy to see more robust procedures, deadlines introduced and the possibility of simplification with the new concept of biocide product families."
"But we need drive and ways to make it work. Whatever ECHA can do in that direction, together with the Commission, will help industry."
The chemicals used in biocides range from simple compounds to complex formulations, and are as diverse as the industry sectors involved, such as agriculture (pesticides) through to art and construction suppliers (paints). Images: Fotolia.
Interview by Susanna Dunkerley.
Top image: Ms Sylvie Lemoine from A.I.S.E. would like to see more scientific and regulatory advice for smaller companies on the new Biocides Regulation. Image: ECHA.
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Committee for Risk Assessment:
Committee for Socio-Economic
Biocidal Products Committee:
Member State Committee:
4-8 February (tentative)
Management Board meeting: