Integrated Regulatory Strategy - infographic
What is a substance of potential concern?
Substances (or groups of substances) of potential concern are those substances which need further regulatory risk management and for which authorities need to take action without undue delay.
These include substances for which further information is needed to clarify their hazard properties or substances with confirmed hazards (e.g. those already on the Candidate List or with a harmonised classification) and for which further regulatory action needs to be considered due to their uses and potential exposure to workers, consumers or the environment.
The focus for authorities is on substances being potential substances of very high concern (SVHCs).
The chemical universe is a mapping tool of all registered substances under REACH, in which each substance is assigned to a pool that indicates the regulatory actions already started or under consideration for that substance. Those substances where the need for suitable regulatory actions still needs to be determined are also identified.
The chemical universe helps national authorities, ECHA and the Commission to plan their work, and to focus on substances of (potential) concern and identify appropriate regulatory actions. This is key for authorities to achieve the objectives of REACH and contribute to the 2030 goals of the World Summit on Sustainable Development.
Working with groups
Authorities have refocused to address groups of structurally similar substances rather than single substances. This:
Ensures that a bigger share of all registered substances are addressed in a shorter period of time. This supports the reduction of the number of substances that have not yet been addressed, identifies those substances in need of further regulatory action as well as those for which no further action is needed at that stage.
Brings consistency and regulatory coherence to authorities’ work as they address similar substances.
Supports better-informed substitution by industry. Grouping ensures that substances that are not currently registered, or that are only registered for intermediate uses but which could be potential substitutes for known substances of concern, are considered by authorities.
Generation of further information and assessment
The work with groups helps to identify which data needs to be generated or further assessed for a particular substance. This data generation clarifies whether or not the substance has hazardous properties.
The main tools for generating missing hazard information are compliance checks and substance evaluation. The data is then assessed to determine whether it confirms the hazard.
Dedicated expert groups have been established to support Member States to define testing strategies, carry out assessments, and make conclusions for persistent, bioaccumulative and toxic (PBT), very persistent and very bioaccumulative (vPvB), or endocrine-disrupting properties of substances.
Member States consult the expert groups before a substance enters the formal substance evaluation or SVHC identification decision-making process.
Regulatory management option analysis (RMOA)
Carrying out a regulatory management option analysis (RMOA) helps authorities decide the most appropriate way to address the identified concern. RMOA is an informal tool not defined in legislation.
The outcome of this analysis could be to:
suggest to confirm the hazard properties through harmonised classification and labelling (CLH) or identification of a substance of very high concern (SVHC); or
move the (groups of) substance(s) to further regulatory risk management processes under REACH (e.g. restriction) or under other legislation (e.g. setting OELs).
RMOA is preferably done at an early stage, for instance, when the group is identified. It can be revisited at a later stage, if necessary. For example, after further information is generated and the hazard has been clarified or when new insights on uses are available. An RMOA can be done by ECHA or by a Member State.
The outcome of the RMOA is shared in order to increase transparency and predictability of authorities’ work.
REACH/CLP regulatory risk management
Hazards can be confirmed either through harmonised classification (CLH) or through identification as a substance of very high concern (SVHC).
Harmonised classification and labelling: A substance is normally subject to harmonised classification and labelling if it meets the criteria for carcinogenicity, mutagenicity, reproductive toxicity (CMR) or respiratory sensitisation.
Identification as an SVHC: A substance may be identified as an SVHC if it meets the criteria for a CMR substance, a PBT/vPvB substance, or a substance that gives rise to an equivalent level of concern as such substances. The substance is then placed on the Candidate List.
Harmonised classification and inclusion in the Candidate List have important consequences for the company level risk management and they trigger or enable authorities to take further regulatory risk management. Under REACH, two main further regulatory risk management tools are available:
Authorisation, which involves two steps after substance has been included in the Candidate List:
Recommendations for the Authorisation List: ECHA prioritises and regularly recommends substances from the Candidate List for inclusion in the Authorisation List. The Commission takes the final decision on inclusion.
Applications for authorisation: If a substance is on the Authorisation List, it cannot be placed on the market or used after the sunset date unless an authorisation has been granted for a particular use. Companies need to submit their applications for authorisation to ECHA.
Restriction: A restriction limits or bans the manufacture, placing on the market or use of a substance that poses an unacceptable risk to human health or to the environment.
Stakeholders are informed about a substance entering regulatory risk management in the registry of intentions until outcome and the public activities coordination tool (PACT). Substances entering the CLH process can be submitted by Member State competent authorities, or by manufacturers, importers or downstream users. In the case of SVHC and Restriction the proposal may be prepared by Member States or ECHA.