ECHA

The implementation plan for the ‘Roadmap on substances of very high concern for 2020' was endorsed by the Member State competent authorities in their meeting at the end of November.

"This is an important step towards reaching the policy goal of having all the relevant substances of very high concern on the Candidate List by 2020. We now have agreed lines on how we, Member States and the European Commission will work together to identify those substances that are relevant under the roadmap and should therefore be further processed in the coming years," says Elina Karhu, Head of ECHA's Risk Management Identification Unit.

The aim of the implementation plan is to enhance common understanding on how authorities screen substances, generate further information where necessary, and channel substance to the most efficient regulatory processes. "A common approach is necessary to make the implementation predictable," says Ms Karhu.

Elina Karhu, Head of Risk Management Identification.

A common screening approach will be used to identify substances for further scrutiny. The result of the screening might be that there is no further action required or that the data in the registration is enough for authorities to act upon. "However, we expect that in many cases, we need further information on the substance. For this, we can use the REACH evaluation processes: substance evaluation or compliance check. Then, we also need to do a proper assessment to find out whether this information confirms that the substance indeed meets the relevant criteria or not. For this we can use either the formal process of harmonised classification and labelling, when the criteria is in the CLP Regulation, or our informalsubstance expert groups. If we go through the expert groups, we then need to continue with the formal SVHC identification process," Ms Karhu explains.

When there is a sufficient understanding of the intrinsic properties of a chemical, either based on the registration data or after generation of additional information, the most appropriate risk management option should be selected to address the concern.

"We have the possibility to use authorisation or restriction under REACH or other legal instruments in the EU. We may also conclude that there is no need for further regulatory actions in addition to what is already in place. This is the approach we have been developing in co-operation with Member States and the Commission and will continue to develop and apply under the roadmap." Ms Karhu says and continues, "Coordination of authorities' activities during the screening and risk management option analysis will hopefully bring efficiency gains as we can ensure that we are not duplicating work or leaving gaps between our processes."

Focusing on five substance groups

The work on identifying substances of very high concern has been on-going since the beginning of REACH and the Candidate List of substances of very high concern already includes 144 substances.

The roadmap actions aim to continue and build up on what has already been done. It focuses on specific groups of substances that will be looked at in more detail by the authorities. These are CMRs, PBTs and vPvBs, endocrine disruptors, sensitisers, and petroleum and coal stream substances.

A lot of work which is crucial for the implementation of the roadmap is already ongoing. "For example, we have together with Member States gone through our databases to identify substances that have a harmonised classification as a CMR and are registered for non-intermediate uses and added those to the Candidate List. We have also done systematic screenings on respiratory sensitisers, which have been registered and have a harmonised classification and labelling. For these two groups, the roadmap implementation plan foresees as a new activity to identify new candidates that are likely to have similar properties and see whether harmonised classification and labelling should be proposed for these substances," Ms Karhu says.

On PBTs and vPvBs, ECHA and the Member States have continued the work started under the previous legislation and included those substances that fulfil the SVHC criteria in the Candidate List. In addition, the databases have been screened for potential PBTs. "In most cases, available information on potential PBTs, even though compliant with REACH, is not enough to determine whether the criteria are met. If so, we need to ask for more information. This takes time."

As with potential PBTs, it will also take time before many new endocrine disrupting chemicals are added to the Candidate List. "We have done screenings on endocrine disrupters and added first of them to the Candidate List, but in many cases we need more test data and therefore it is important to do the ground work first."

The petroleum and coal stream substances have not been screened under REACH so far. "Some of these may be CMRs or PBTs. There is a need for systematic work on these substances and we have decided that under the roadmap we will start looking into, in particular, those petroleum and coal stream substances that have non-fuel uses," Elina Karhu points out.

Registration data is key 

The screening and risk management option approaches rely heavily on the data available in registration dossiers and CLP notifications.

Therefore, the quality of data is very important. "It is the responsibility of the registrant to make sure that the registration data is up-to-date and accurate. For instance, if we do not have sufficient understanding of how a substance is used, we need to take a conservative approach when estimating the potential for exposure and how wide dispersive uses are. It is beneficial for registrants to proactively give information, for example, on uses, exposure and risk management measures. This helps us to make informed decisions," Ms Karhu stresses and reminds that registration data can act as evidence that there is no need for further regulatory action.

Another important aspect is that when the information is provided in the registration dossier, the authorities have an obligation to use it. "We of course welcome information through our various public consultations and use that in our decision-making as well. This applies in particular to information which cannot be included in the registration data, such as information on alternatives and socio-economic aspects related to the use of the substances. However, third parties providing information and comments during public consultations should pay attention to what information is asked for and can be used in that specific phase of the regulatory process," Ms Karhu points out.

In addition, industry and NGOs can contribute to the work of the expert groups. "There are also representatives from industry and NGOs in the PBT and endocrine disrupters' expert groups," Ms Karhu adds.

Increasing transparency and predictability 

One of the cornerstones of the roadmap is open and transparent communication. This is necessary to help stakeholders, such as industry, NGOs and the general public, to understand the objectives and scope of the roadmap.

ECHA will publish the implementation plan online in mid-December together with a new web section that focuses solely on the roadmap actions. "The web section will explain how we aim to find new SVHCs, what we do in screening, in the assessment phases and in risk management option analysis. There will also be basic information on the different substance groups," Elina Karhu says.

Later, substance-specific information will also be made available. This substance-specific communication will increase the predictability of how substances with certain hazard,fate or use profiles will be dealt with by the authorities.

"The communication around the roadmap will allow stakeholders to be better prepared and to make longer term, proactive planning. It provides them with earlier information about the substances the authorities are looking into, which risk management route they may be directed to and what the estimated timelines are. The roadmap informs about the plans before the formal regulatory processes, such as identification of SVHCs, kicks in."

CMR: Carcinogenic, mutagenic and reprotoxic chemicals 
PBT: Persistent bioaccumulative toxic chemical 
vPvB: Very persistent and very bioaccumulative chemical 
Sensitisers: Chemicals that cause allergic reaction in normal tissue after exposure 
Endocrine disrupters: Chemicals that at certain doses, can interfere with the endocrine (or hormone system) in mammals. These disruptions can cause cancerous tumours, birth defects, and other developmental disorders.
Petroleum and coal stream substances: Chemicals used to transform crude petroleum or coal into intermediate and end products, such as fuels (e.g. gasoline, diesel, and kerosene), finished non-fuel products (e.g. solvents, greases, and asphalt) and feedstock for the petrochemical industry. 

Further information:

• Roadmap on Substances of Very High Concern for 2020
• Authorisation under REACH 

Did you know?   In March 2010, Vice-President Tajani and Commissioner Potočnik announced their long-term policy objective to have "all relevant currently known SVHCs included in the Candidate List by 2020". The ‘Roadmap on Substances of Very High Concern for 2020', adopted by the Commission in 2012, sets the framework for achieving this policy objective.   The Roadmap focuses on presenting a credible process to ensure that the 2020 objective is achieved by defining methodologies, setting clear deliverables, planning and sharing responsibilities.   Collaboration of all actors (European Commission, ECHA and the Member States) is needed to make the implementation a success.   No numerical goal for substances to be included in the Candidate List has been set as how many or which substances will be identified as relevant SVHCs cannot be pre-judged.

High-level overview of the SVHC Roadmap implementation.

Interview by Hanna-Kaisa Torkkeli
Top image: Fotolia