Echa has selected 162 substances from REACH registration dossiers for further scrutiny by the member state competent authorities.
The substances will be manually screened by national authorities to decide whether regulatory action is needed.
Echa does not make the list of shortlisted substances public because they are chosen purely by automated selection by IT. Manual verification is needed to confirm a potential concern.
The 2016 exercise saw 305 substances selected for screening. Of those, 184 were examined by member states and 132 required follow-up activities. They included a substance evaluation in the Community Rolling Action Plan (Corap); a compliance check; proposal for harmonised classification and labelling (CLH); and proposal for risk management option analysis (RMOA).
The selection is based on an automated IT screening of the whole REACH registration database, together with information from other REACH and CLP processes and external sources, such as published scientific data, Qsar models and databases on uses and exposure.
In the latest screening, Echa focused on substances that are potentially carcinogenic, mutagenic or toxic to reproduction (CMRs), persistent, bioaccumulative and toxic (PBTs), endocrine-disrupting, sensitising or have potential specific target organ toxicity following repeated exposure (STOT Re) properties.
Substances are reintroduced to the shortlist if member states did not prioritise them for manual screening in previous rounds. But if dossiers are updated in the meantime for hazard, use or exposure information, it is possible that these substances are no longer a priority. They may also be subject to a new testing proposal examination related to the potential concern, Echa says.
The screening approach includes exclusion criteria. This means substances listed for evaluation in the Corap, on the candidate list or subject to RMOA for the same potential concern, and manually screened in the last three years, are excluded from the latest shortlist. Also excluded are substances subject to an ongoing compliance check.
Echa says companies affected will receive a letter inviting them to update their dossiers. This will ask them to address any shortcomings as soon as possible, as up to date information will help national authorities confirm the concern indicated by the screening, and if regulatory action is still needed.
Over the past year senior member state and Echa officials have been making the argument that updating dossiers is in registrants’ best interests .
If a member state, or Echa, take actions on a substance, the information is published on the agency’s website. This will appear, for example, in the list of substances potentially subject to compliance checks, the registry of intentions, the draft Corap and the public activities coordination tool (PACT), which lists substances under hazard assessment or RMOA. Companies can check the status of their substance through the Search for chemicals facility on Echa’s homepage.
The previous three rounds of IT screening have identified 893 substances for further scrutiny. Of those, member states have examined 581 substances. Twenty two per cent required no further action, while 78% required follow-up activities, with some substances having more than one outcome:
- 32% required substance evaluation in Corap;
- 28% required a compliance check;
- 9% were proposed for CLH;
- 7% were proposed for RMOA; and
- 6% were proposed for other activities.