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Päivi Jokiniemi and Paul Trouth
Article related to: REACH
How are substances of concern identified?
Some chemical substances may be of concern for human health and the environment. ECHA, Member States and the European Commission are working together to identify these substances of concern and make sure that they are properly controlled. Read how the work is done.
Selecting substances that matter most
Taking regulatory measures on substances of concern aims to increase the protection of human health and the environment. Screening potential substances of concern is vital if all relevant substances of very high concern (SVHCs) are to be on the Candidate List for SVHCs by 2020.
ECHA, the Member States and the Europan Commission have developed a common screening approach to identify substances with certain hazards, exposures and risk profiles. They will then manage them through the most appropriate REACH or CLP process. The screening is based on information available on ECHA's registration database and in the C&L Inventory as well as external sources, such as assessments made by other regulatory authorities.
The common screening helps authorities address the SVHCs in a more consistent manner and it should avoid duplicating work.
How is the screening done?
Screening scenarios have been developed which can be used in IT based mass screening exercises. This is the first phase of screening and is conducted once a year.
The substances identified through the IT screening are then manually scrutinised by the Member States. The manual screening better defines the hazard profile or the risk based concerns for each substance. However, it is not a thorough assessment of the information available on the substance. It aims to confirm if further steps need to be taken.
After the manual screening, substances of potential concern will be processed depending on the need for further additional information or for further regulatory action.
One of the outcomes is the need for further regulatory risk management and the need to develop a risk management option analysis (RMOA). The information box below explains the other potential outcomes.
How to address the concern?
Where a concern is identified, the Member State, or ECHA at the request of the Commission, can choose to perform a risk management option analysis to conclude on the best way forward. The outcome can be:
- a proposal for harmonised classification and labelling;
- SVHC identification and inclusion on the Candidate List of SVHCs. This may eventually lead to inclusion on the Authorisation List;
- a proposal for restriction;
- a decision that the substance needs to be discussed under other legislation; or
- no further action.
What role can you play?
Take the opportunity to consider replacing substances of concern with safer alternatives. Be innovative, do research in order to find substitutes or safer alternatives and develop new production technologies.
The main source of information for screening is the registration database. Therefore, it is important that your registration dossiers are up-to-date and that the information on uses, tonnages and conditions of use are accurate. This information is used to prioritise substances for further work but also to find out if a substance is of lower priority. This could be, for example, a substance that is only used in industrial settings under strictly controlled conditions.
You can see which substances are being examined on ECHA's website. The tool for advance notice helps you to follow-up the status of your substance. Check it regularly and update your dossier if needed.
Potential outcomes of the screening
Compliance checks: ECHA examines the registration dossiers to check that they comply with the registration information requirements. If a dossier does not comply, ECHA requests the registrant to submit further information or carry out additional testing.
Member States carry out substance evaluation, which aims to clarify whether the use of a substance poses a risk to human health or the environment. As a result, registrants may be asked to send additional information or perform tests that are not part of the standard requirements for REACH registration. Based on the additional information, the Member State may conclude that further risk management measures are needed, such as harmonised classification and labelling, SVHC identification or restriction.
If the substance needs further assessment in terms of its persistence, bioaccumulative nature or toxicity (PBT), or endocrine disruption properties (ED), then Member States can consult the PBT or ED expert group before further action. Both groups provide informal, non-binding scientific advice on questions related to the identification of PBT, very persistent and very bioaccumulative (vPvB) and endocrine disrupting properties of chemicals.
Harmonised classification and labelling harmonises the hazard classification of a substance at the EU level. This classification is legally binding for all suppliers who place the substance on the EU market on its own or in mixtures. For the SVHC identification of sensitisers and substances that are carcinogenic, mutagenic and toxic to reproduction (CMRs), harmonised classification and labelling is the first step.
In the authorisation process, identification of a substance as a substance of very high concern (SVHC) and inclusion in the Candidate List of SVHCs is the first step. Based on ECHA's recommendation, the European Commission decides if a substance should also be included in the Authorisation List. If a company wants to continue using substances on the Authorisation List after the defined sunset date, they need to submit an application to ECHA requesting authorisation for specified uses.
If a chemical poses an unacceptable risk that needs to be addressed on an EU level, a Member State or ECHA, at the request of the Commission, may propose a restriction on the manufacturing, placing on the market or use of the substance of concern.
Other actions may also follow, for example, enforcement at national level. It is also possible that no further action at this point in time will be needed.
| Overview of the process of identifying and controlling substances of concern. |
Click the image to view a bigger version.
- SVHC Roadmap to 2020 implementation
- Tool for advance notice
- Screening of substances of potential concern
- Addressing Chemicals of Concern
- PBT expert group
- ED expert group
- Harmonised classification and labelling
- Are there safer alternatives?
- Terminology – in 23 languages
Did you know?
ECHA is working towards having all relevant substances of very high concern on the Candidate List for SVHCs by 2020. In March, ECHA published a report on the first years' work to that end.
The main achievements so far are the setting up of the common screening approach; the streamlining of the different REACH and CLP processes to identify the substances that matter most; and enhancing coordination of activities on these substances among authorities.
ECHA's weekly e-News will keep you informed about current developments on the screening, risk management option analysis (RMOA) and all REACH and CLP processes.
Text by Nedyu Yasenov
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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)