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Finding potential substances of concern – how it happens
The SVHC Roadmap aims to have all the relevant currently known substances of very high concern (SVHCs) included in the Candidate List for authorisation by 2020. The work is done by the Member States, the European Commission and ECHA. Two Member State representatives share their views on the roadmap implementation with ECHA Newsletter.
Fleur van Broekhuizen works in RIVM, the Dutch National Institute for Public Health and the Environment that supports the Dutch competent authority. She describes the roadmap as a structure that helps to organise the work and optimises transparency, communication and accountability towards stakeholders and the general public. "The roadmap is designed to harmonise the screening for and assessment of potential SVHC substances. It aims to make the process more efficient and transparent," she says.
Eva Stocker works at Umweltbundesamt, the Environment Agency in Austria that provides expertise for the Austrian competent authority. She says that Member State competent authorities (MSCAs) have a key role in the implementation of the roadmap. They are involved at several stages of the process, from helping ECHA to develop an efficient screening approach, to deciding what the most appropriate risk management measures are.
Benefits of the roadmap for stakeholders
Communication is one of the central elements of the roadmap. "One objective of the SVHC Roadmap, strongly demanded by stakeholders during the last years' discussion, is to increase the transparency of the authorities' work on the selection of potential SVHC candidates and the outcome of the risk management options analysis (RMOA)," Ms Stocker notes.
| Eva Stocker. |
Image: Eva Stocker.
Progress in this area has already been made and a new tool is being developed for this purpose. "Industry and the general public will be informed about the substance-specific activities as soon as the work on the RMOA starts. This will be done using the Public Activity Coordination Tool (PACT) that will be available later in 2014 on ECHA's website. With the help of this tool, the same information will be available for all stakeholders," Ms Stocker explains.
The PACT will give an early indication of the substances that are on the ‘radar' of the authorities and allow stakeholders to plan and, if needed, to adapt their strategic business decisions. The general public also benefits from knowing which individual substances are under scrutiny in the context of the roadmap.
In addition to this transparency, the roadmap will also increase predictability for industry. "At this point, the SVHC criteria are clearly set in REACH. If you deal with a substance that meets those criteria, you may expect it to be assessed one day. Now, under the roadmap, the approaches for identifying SVHCs and implementing risk management measures are agreed by all Member States. This will bring more clarity for industry and shows that we are all using the same approach. That is a big benefit for companies," Ms van Broekhuizen emphasises.
Risk management options analysis
To enable a proper discussion on the most appropriate route for regulatory risk management of a substance of concern, preparation of an RMOA is a key step.
The purpose of the RMOA is to clarify whether risk management activities are required for a substance and to identify the most appropriate instrument to address the concern. Documenting the RMOA and sharing it with other Member States, ECHA and the European Commission promotes early discussion and should ultimately lead to a common understanding on the action pursued.
Ms Stocker and Ms van Broekhuizen agree that data from registration dossiers is the main source of information when carrying out an RMOA. However, the sometimes poor quality of the registrations makes it difficult to conclude on sound risk management measures only on the basis of the information provided in the dossiers. Therefore, further assessment and requests for more information from the registrants is often needed. Keeping the registration dossier up-to-date allows more efficient RMOA, thereby reducing the cases whereby Member States base their analysis on a worst case scenario.
| Fleur van Broekhuizen. |
Image: Fleur van Broekhuizen.
The Member States develop draft RMOAs that work as a starting point for further analysis and considerations. "After the first draft RMOA is developed, it will be discussed internally to identify remaining questions, information gaps and to enable us to prepare final policy choices," Ms van Broekhuizen describes the process carried out in the Netherlands. "We normally contact the lead registrant to obtain more information on intended uses because that information is a key factor in making choices on the most appropriate RMO. When the information received from industry has been taken into account, the draft RMOA is sent to other MSCAs for commenting," she explains.
Ms van Broekhuizen says that even though Member States can comment on the draft RMOA, the outcome is not an officially agreed EU document, but a Member State conclusion.
Cooperation among Member States
Participation in the roadmap work is voluntary and the Member States are involved to varying degrees. It is particularly efficient to coordinate activities among all the Member States. This is, however, only one of the benefits of cooperation. All Member States have their own areas of expertise when it comes to assessing chemicals for the roadmap and by sharing these competencies, they can learn from each other.
"We have in Austria a ‘tradition' of working together with other Member States on RMOA and SVHC dossiers. We appreciate the fruitful exchange of views and the efficient use of specific expertise that is available in different countries," Ms Stocker says.
Ms van Broekhuizen shares this opinion and emphasises the opportunity to learn from each other. "As each MSCA has its own unique experiences, national regulations, involvement with industry and non-governmental organisations, as well as its cultural identity, I think we can learn a lot by joining forces and sharing information and knowledge".
Under the roadmap, there are various groups that consist of experts from different Member States who regularly meet to discuss issues. Both Ms Stocker and Ms van Broekhuizen are, for example, members of the Sensitiser Coordination Group which focuses on substances with sensitising properties. "Our intention is to make this a monthly discussion platform where the MSCAs can share information and co-ordinate their activities, ask each other questions and raise difficulties encountered during the assessment of potential SVHCs," Ms van Broekhuizen says.
Encouraging new MSCAs to join the work
Both Ms Stocker and Ms van Broekhuizen think that the success of the roadmap depends, to a large extent, on Member States' resources and commitment to contribute. Supporting each other by sharing knowledge and experience will be vital to get the best out of all the resources available. The MSCAs are therefore working together, helping the less experienced MSCAs and motivating not yet active Member States under the roadmap to join the work. This is essential to be able to meet the expectations.
"The roadmap estimates that approximately 400 SVHC substances need to be screened in depth. If we all contribute to screening 50 substances each year, we will be a bit below schedule in 2017, but this may change with the increasing involvement of MSCAs and when more experience is gained on the roadmap process," Ms van Broekhuizen reflects.
However, the real aim of the roadmap, according to Ms van Broekhuizen, is not to deliver high numbers of SVHC candidates but to find the relevant ones, i.e. those in need of risk management measures.
Interviews by Päivi Jokiniemi
Top image: Fotolia
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Biocidal Products Committee:
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
30 November-4 December (tentative);
7-11 December (tentative)
Member State Committee:
7-11 December (tentative)
Management Board meeting: