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Päivi Jokiniemi and Paul Trouth
Article related to: REACH
The voice of the Member States in ECHA
Under REACH, ECHA has to provide EU Member States and institutions with the best possible scientific and technical advice on chemicals. The role of the Member State Committee (MSC) is to resolve the different views of Member States on evaluation draft decisions or on proposals to identify substances of very high concern (SVHCs). We spoke to the MSC’s Chairman, Dr Watze de Wolf, to ask about the work of the committee and its future role.
The work of the MSC
ECHA’s Member State Committee (MSC) meets several times a year to discuss and seek agreements on complex and sensitive matters related to the safety of substances and their effects on human health and the environment.
The committee's involvement is triggered by diverging views of Member States on:
- dossier evaluation;
- substance evaluation; and
- when comments are received on human health and environmental effects during public consultations for identifying substances of very high concern (SVHCs).
But the committee is also regularly involved in:
- updates of the Community rolling action plan (CoRAP), which specifies the substances that will be evaluated by Member States over a three-year period; and
- recommendations for including priority substances on the Authorisation List.
Watze de Wolf.
In February 2018, the committee reached a landmark of 1 000 agreements and opinions on these processes.
“The key to this success has been close and constructive collaboration between all the actors involved in decision making. The achievement represents 10 years of hard work, multiplied by 10 for the efforts of ECHA, multiplied by 10 for the resources invested by the Member States,” Dr de Wolf tells.
“The decisions significantly contribute to the generation of knowledge on the safe use of chemicals and show the general public and registrants they can be confident that the scientific content of the decisions taken by ECHA are carefully scrutinised by its peers,” he adds.
Preparing and submitting dossiers
Under REACH, companies have to submit registration dossiers to ECHA. The dossiers have to provide information on the properties and uses of substances they produce or import in quantities of one tonne or more a year. The higher the tonnage, the more information a company needs to submit.
REACH lists standard information requirements and possibilities to adapt them. If a company wants to use an adaptation, they have to provide a detailed scientific justification with documentation.
If they identify a data gap and cannot fulfil the information requirements, they have to submit testing proposals to ECHA.
Once companies have submitted their dossiers to ECHA, the Agency carries out compliance checks on at least 5 % of dossiers in each tonnage band to make sure they comply with legal requirements under REACH.
If ECHA concludes that further testing or information is required, it sends draft decisions to concerned companies for their comments. The draft decisions can be modified based on the comments.
The draft decisions are then sent to the Member States, which can propose amendments to them. If a Member State proposes an amendment to ECHA’s draft decisions on testing proposals and compliance checks, the case is referred to the MSC to try to reach a unanimous agreement.
“One of the main challenges is to always keep lines of communication open with all actors from ECHA and the Member States. To reach an agreement, we need to understand who is saying what and to also spot unspoken things or implicit assumptions to find a mutually agreeable solution,” Dr de Wolf explains.
If the MSC unanimously agrees on a draft decision, either during the meeting or in written procedure, ECHA finalises the decision and sends it to the registrants concerned. If no agreement is reached, the draft decision and all relevant documents are referred to the European Commission.
Member States evaluate certain substances to clarify whether their use poses a risk to human health or the environment. The objective is to request further information from companies if a concern is suspected.
Together with the Member States, ECHA defines risk-based criteria and then selects substances that are to be evaluated. In this regard, the MSC provides opinions on the draft Community rolling action plan (CoRAP) prepared by ECHA.
“The CoRAP informs companies and stakeholders which substances will be evaluated by which Member States and what the initial grounds for concern are. The MSC provide an opinion on any Member State proposals to add substances to the CoRAP outside of the annual updates and also looks to find agreements if two or more Member States express an interest in evaluating the same substance,” Dr de Wolf explains.
Based on the MSC’s opinions, ECHA adopts the final CoRAP for substance evaluation.
The Member State then evaluates all registration dossiers for the substance as a whole and, where needed, proposes additional tests to generate missing data that should address the identified concern.
If ECHA or a Member State proposes an amendment to a draft decision on substance evaluation, the MSC tries to reach a unanimous agreement.
Identifying SVHCs and recommending substances for inclusion in the Authorisation List
Authorisation aims to ensure that SVHCs are progressively replaced by less hazardous substances or technologies where technically and economically feasible alternatives are available.
The Member States or ECHA (following a Commission request) can propose a substance to be identified as an SVHC based on its hazard properties. These can be:
- carcinogenic, mutagenic, toxic for reproduction (CMRs);
- persistent, bioaccumulative and toxic (PBT);
- very persistent and very bioaccumulative (vPvB); or
- substances, on a case-by-case basis, that cause an equivalent level of concern as CMR or PBT/vPvB substances.
Proposals to identify SVHCs undergo a 45-day public consultation. If no comments challenging the hazard identification proposal are received, the substance is added directly to the Candidate List.
But if new information is provided or challenging comments are received, the proposal, the comments received and the dossier submitter’s responses to them are referred to the MSC. The MSC then seeks an agreement on identification as an SVHC.
“If a unanimous agreement is reached, the substance is added to the Candidate List. But if not, we specify our scientific agreements and disagreements, after which an MSC opinion is prepared and we refer the matter to the Commission,” Dr de Wolf explains.
In a consequent step, ECHA looks at the substances on the Candidate List to decide which ones should be added to the Authorisation List as a priority. ECHA prepares a draft recommendation of which substances to include in the Authorisation List and consults this with the MSC.
“For the recommendation process, the MSC forms an opinion, taking the comments received during public consultation into account. ECHA then uses the opinion to finalise its recommendation on which substances to include on the Authorisation List as a priority,” Dr de Wolf says.
The MSC also issues opinions related to human health, the environment or other safety aspects of substances if ECHA’s Executive Director requests them to do so.
“We are lucky to have people with extensive scientific expertise in many different areas. The committee’s work also offers scientific support to improve cooperation between Member States, international organisations and third countries on substance safety,” Dr de Wolf adds.
Achievements in the past 10 years
“In the past decade, the committee has continually looked for ways to improve, taking into account lessons learnt from appeals, and feedback received from our members, from accredited stakeholders and from previous scientific discussions during cases,” Dr de Wolf explains.
These efforts have:
- increased opportunities for companies to be heard during evaluation decision-making processes;
- identified areas and endpoints that could benefit from further harmonisation; and
- helped develop harmonised scientific approaches for certain endpoints.
The committee plays a key role in preventing unnecessary animal testing. For example, when the MSC concludes that a current dataset appears to be enough for regulatory risk management measures under harmonised classification and labelling or SVHC identification.
“We were also the first regulatory body in Europe to take substance-specific decisions on regulating endocrine disruptors and several respiratory sensitisers by identifying them as SVHCs and imposing legal obligations on the manufacturers of products containing such substances,” he tells.
What the future holds
“I expect that the committee’s involvement in dossier evaluation may reduce in the coming years, but issues for substance evaluation and identifying SVHCs are likely to increase in complexity,” Dr de Wolf says.
“What is clear is that the role of the MSC will largely remain the same, that is, to continue to resolve diverging views between ECHA and the Member States,” he concludes.
|MSC agreements and opinions on...||Number|
|ECHA's draft decisions on referred dossier evaluation cases (testing proposals and compliance checks)||734|
ECHA's Community rolling action plan (CoRAP) and its annual updates
|ECHA's draft decisions on referred substance evaluation cases||129|
SVHC identification proposals:
|ECHA's draft recommendation for inclusion of priority substances in the Authorisation List (Annex XIV) (RECOM)||8|
|A request by ECHA's Executive Director under Article 77(3)c|| |
|In February 2018, the Member State Committee (MSC) reached a landmark of 1 000 agreements and opinions. This number has now been surpassed.|
How the Member State Committee is composed
The Member State Committee (MSC) has 29 regular members appointed for a three-year renewable mandate by each of the 28 EU Member States, as well as Norway. In addition, 25 Member States decided to appoint alternate members to replace their regular members when needed.
All members possess specific regulatory or scientific expertise in the areas of ECHA’s work that require the MSC’s involvement. In their routine committee tasks, they are often supported by advisors and invited experts for targeted discussions on specific scientific, technical or regulatory matters.
Representatives of the Commission and accredited stakeholder organisations are also invited to participate as observers to the committee’s work.
The MSC is chaired by Dr Watze de Wolf.
Interview by Nedyu Yasenov
Published on: 17 May 2018
Top image: European Union, 2014
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Biocidal Products Committee:
26 February-1 March
Committee for Risk Assessment:
Committee for Socio-Economic
18-22 March (tentative)
Management Board meeting:
Member State Committee:
13-17 May (tentative)