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Editor-in-chief:
Johanna Salomaa-Valkamo
Johanna Salomaa-Valkamo
Editor:
Päivi Jokiniemi
Biocides - state of play and challenges ahead
We spoke with Mr Michael Flüh, Head of Unit and Mr Pierre Choraine, Head of Sector from the European Commission's Health and Food Safety (SANTE) Directorate-General, to look at the next milestones for the biocides regulatory framework.
On track: biocides deadlines
By 1 September 2015, ECHA had received 158 applications from companies asking to be included on the list of active substances and suppliers, known as the Article 95 list.
"Companies are aware of their obligations under the Biocidal Products Regulation (BPR). Now it is the national authorities' responsibility to make sure they comply with the legislation," says Mr Flüh.
In the first phase of enforcement, Member States check the documentation sent by the companies and verify whether it is compliant with the legislation or not. However, there may still be products placed on the market without the authorities' knowledge.
"Therefore, there needs to be a second phase when authorities must go from paper checks to supermarkets or factories to verify whether a product is compliant or not. This will be a major challenge for enforcement authorities in the future", he adds.
Mr Choraine stresses that the European Commission now expects the national authorities to enforce the obligation. "We recognise though that this is a complex matter and that Member States will have to use their sensible judgement and take proportionate actions. There might, for instance, be cases where non-compliance could be the result of difficult data-sharing negotiations.
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| Mr Pierre Choraine. Image: ECHA. |
In addition, the Review Programme is now on track with an average of 50 assessments concluded each year. "ECHA is achieving the planned output," says Mr Flüh. The programme is expected to be finalised by 2024. "Only then, will the mission be achieved", he points out.
You can read more about what the Review Programme is in the article 'Want to know about...the Review Programme?'
High expectations for Union authorisation
Union authorisation (UA) enables companies to get authorisation for their biocidal products at Union level with just one application. This allows quick and easy access to the whole EU market and reduces the administrative burden on applicants. After more than a year in place, companies are now starting to explore this new possibility.
"In the beginning, the number of applications received for Union authorisation was quite low. Now, the trend has changed and the number is continuing to rise. We hope that this is not a one-off event and that it becomes a stable and predictable trend," Mr Flüh remarks.
"We see this EU-wide authorisation offering a lot of benefits for industry so our expectations are high," he says and continues: "The legislation is still quite new and it can take some time before the market is fully aware of the benefits they can get out of it".
New study on fees
New study on fees
Last year, the European Commission launched a study to evaluate the fees companies need to pay for biocides applications. It was triggered by the fact that initial expectations for fees from Union authorisation were not being met.
"Our concern is that our assumptions, such as fee-based income for ECHA, are not going to materialise to the same amounts as anticipated a few years ago," Mr Choraine explains.
Some companies have also complained that the fees are too high. "In this case, the fees are an obstacle for the market to submit applications".
The outcome of the study is expected shortly. "Based on the results, we will see whether some of the assumptions made at the start of the BPR have to be reconsidered and whether the amount of fees has to be adjusted".
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| Mr Michael Flüh. Image: EC. |
RAC and the BPC: a good interaction is very important
Mr Flüh and Mr Choraine both highlight the importance of a good interaction between the Committee for Risk Assessment (RAC) and the Biocidal Products Committee (BPC) for the decision-making of the European Commission.
The Commission approves or rejects an application for an active substance based on the opinion of the BPC. When the substance is carcinogenic, mutagenic and reprotoxic (CMR), both the BPC and the Commission need have the opinion of the RAC on the classification of the substance. This information comes from the RAC. Therefore, a good synchronisation of both RAC and BPC opinions make the work easier.
"It is very important that when the BPC delivers its opinion on an active substance, that we have the RAC opinion on the classification of the substance. This is crucial for the smooth functioning of the BPC's work," they say.
Enforcement Group
At present, biocides are not part of ECHA's Enforcement Forum, which deals with enforcement issues throughout Europe. But ECHA and the Commission have recently established a Biocides Enforcement Group.
"The idea is to meet back-to-back with ECHA's Forum to benefit from the experts present at that moment," Mr Choraine explains.
The group will discuss how to best use the resources and exchange views and priorities on enforcement.
"The idea is that the group will eventually be integrated into the Forum, although for the moment it is a separate entity," Mr Flüh concludes.
Further information:
 | Next milestones » Improving the IT tool: The Commission wants ECHA to improve the biocides IT tool R4BP. "The underlining idea is to give industry and applicants a powerful tool to enable them to fulfil their legal requirements. The users are still encountering problems when making use of R4BP," Mr Flüh says. » Treated articles: To place articles treated with a biocidal product on the EU market, the active substance needs to be approved or under evaluation. For those active substances that are not yet in the approval process, companies need to submit an application for the active substance by 1 September 2016 to continue to be legally on the market. "Treated articles (Article 94) are very relevant for the import of articles into the EU. The legislation says that articles can only be treated with substances under assessment in the EU. This is an issue for international trade and we have informed third countries. It will also be an issue for enforcement in the future, and we have to continue making efforts to inform our trading partners," Mr Flüh says. » Maximum residue limit (MRL): MRL is the highest level of a pesticide residue that is legally accepted by the EU in or on food or feed. The amounts of residue found in food must be safe for consumers and must be as low as possible. Biocides may also end up in the food chain and can present a health risk. "At the moment, we are still discussing the right approach with the Member States and are proposing to focus on identifying the substances of greatest concern. Afterwards, we need to make sure that the controls really focus on these substances," Mr Choraine explains. » Rodenticides: Substances used as rodenticides will be reviewed in 2016 under the Review Programme. In 2017, there will be major work on the comparative assessment of all products containing rodenticides. |
Text by Julia Sierra
Top image: Fotolia
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Events
October-December 2020
Enforcement Forum:
4-7 November
Biocidal Products Committee:
6-8 October;
30 November-4 December (tentative)
Committee for Risk Assessment:
6-8 October (RAC-52B);
30 November-4 December (tentative);
7-11 December (tentative)
Committee for Socio-Economic
Analysis:
30 November-4 December (tentative);
7-11 December (tentative)
Member State Committee:
7-11 December (tentative)
Management Board meeting:
16-17 December
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