- Getting ready for the Biocidal Products Regulation
- World of biocides brought up to date
- Steering the work to make the new biocides regulation a success
- From our stakeholders: "Support for small enterprises is crucial"
- Setting up national biocides helpdesks
- New online tools for biocides applications
- Raising awareness on the new Biocidal Products Regulation
- Working together for better communication on the safe use of chemicals
- What to do when receiving an extended safety data sheet?
- Working towards the REACH dossier evaluation goal
- Setting the scene for applications for authorisation
- Board of Appeal members' term in office prolonged
- Guest column: Reflections on the review of REACH
- Making use of derived no-effect levels generated under REACH
- Call for creative ideas to overcome REACH challenges
- Croatia joins the EU chemicals management framework
- Debating chemicals policy
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Article related to: biocides
From our stakeholders: "Support for small enterprises is crucial"
Katariina Sairinen, Regulatory Affairs Specialist at the Finnish healthcare company Algol Pharma, has been closely following the regulatory developments on biocides during the past years. "As the legislation changes, everyone has to learn - both authorities and companies. The challenge for SMEs is, of course, the question of resources," she says.
"In our case, we only have one person to follow the regulatory developments on several sectors, which requires specific knowledge. Therefore, the role of national biocides helpdesks is crucial, especially for small enterprises. They help companies to understand why certain measures are taken. Further support from both national authorities and ECHA, such as through stakeholder events, guidance documents and informative websites, is also very welcome. So far, the recognition process has gone smoothly for us."
Algol Pharma is an international healthcare company providing regulatory services to other companies as well as importing and distributing pharmaceuticals, food supplements, medical devices and cosmetics. Among its clients are companies producing biocidal products, and Algol Pharma is importing two insect repellents to Finland. The company has already applied for mutual recognition for two biocidal products in Finland.
Interview by Tiiu Bräutigam
Experienced with biocides regulations
Ilona den Hartog, Registration Officer at AkzoNobel Surface Chemistry AB, says her company has been following the development of the BPR very closely since they are an active member in the European Biocidal Product Formulators (EBPF) working group under CEFIC.
"The challenge has been to predict the consequences for us as a producer of active substances and consequently for our customers. Our active substances were already on the market many years before the Biocidal Products Directive (predecessor of BPR) was implemented and we had to follow the procedure for existing substances," Ms den Hartog says.
Her company also had to ‘register' biocides before the directive. "This was for countries where national registration schemes existed, such as the Netherlands, Sweden, Finland and Belgium," she clarifies.
Ms den Hartog is glad that the new regulation introduces obligations for alternative suppliers. "Under the BPD, producers that did not make investments in biocides dossiers could still remain on the market until the decision on Annex I inclusion was taken. We are happy that the BPR finally brings an end to this – in our opinion – very unfair situation."
As for ECHA, Ms den Hartog hopes that the Agency can improve the efficiency of the evaluation process and produce clear and workable guidance documents. "We also hope that the Member States will become more open for communication with industry in trying to solve open issues together. There should be a combined interest and effort both from industry and the authorities to make sure that biocides are used safely."
In the past months, debate on providing more support for SMEs and potentially reducing their financial burden has been intense. AkzoNobel agrees that SMEs need special attention. "Large industries have different investment possibilities compared to small companies and their marketed volumes of biocidal products are normally higher," Ms den Hartog points out.
However, compliance with the regulation may also pose a financial challenge for the bigger players. "Large companies usually market a bigger variety of different biocidal products, which in turn leads to an increase in the costs. As a consequence, the number of different biocidal products could well decrease in the future."
In addition, the costs for getting authorisation for a biocidal product will come on top of the investments already made by the active substance producers. "Those companies are carrying a heavy financial burden, which is often increased by REACH registration costs," she concludes.
AkzoNobel Surface Chemistry AB is the world's leading supplier of specialty surfactants. The company produces four active substances, which are all under evaluation in the review programme of the Biocidal Products Directive.
Interview by Hanna-Kaisa Torkkeli
Simplification would benefit SMEs
Consultant Piet Blancquaert, is helping companies to comply with the new regulation. He is concerned for SMEs who are struggling with the complexity of biocides legislation.
"There are companies that don't know what a biocidal product authorisation is, as some of the EU Member States currently do not have a national authorisation scheme. Many of the companies cannot justify an authorisation cost of a couple of hundred thousand euros for one or a few Member States where they have their products on the market. If they can, they need to make a joint effort and go to several Member States," he says.
The BPR aims to increase transparency on the different processes and offers industry clear, fixed timelines for active substance approvals and product authorisations. In addition, the online submission system will ease the submission of applications.
However, the biocides world is complex and explaining to people who are not used to working in a regulatory framework but who now need to comply with the law is not easy. "It is like going from zero to 10 000 for them. Biocides guidance document are hundreds of pages long, IUCLID takes time and effort to master and you also need to learn about REACH to understand the interlinks between the regulations. I feel there is a mismatch of market and costs."
Dr Blancquaert says that simplification of procedures would benefit SMEs. "Access to data is also very important. On the one hand, companies should be treated equally, and on the other, SMEs need cost relief. This is very challenging."
Interview by Hanna-Kaisa Torkkeli
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1-4 and 8-11 June (tentative);
7-11 and 14-18 September (tentative)
Committee for Risk Assessment:
1-5 and 8-12 June;
7-11 and 14-18 September (tentative)
Member State Committee:
Biocidal Products Committee:
Management Board meeting: