Planning ahead: meeting the demands of the post-REACH regulatory landscapeBy Richard Harrison, Marketing Manager, CPC, Envigo - 26th April 2018
The chemicals industry must prepare now for the post REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) regulatory environment – complying with the requirements and expectations of the European Chemicals Agency (ECHA) moving forwards, explains Richard Harrison, Marketing Manager, CPC, at Envigo.
Registrants of chemical substances should regard the REACH registration process they have been through as just the first step along a regulatory road that began in 2007. REACH is driven by an aspiration to create the “most comprehensive chemicals database in the world”. Consequently, ECHA’s current database will need to be kept up-to-date, aligned to the newest regulatory legislation, populated with the latest data and refreshed to include new or extended substance uses. Moreover, it must accurately reflect the tonnage levels for each chemical’s use.
31st May 2018 was the third and final deadline for REACH registration of substances used or imported in low volumes (1–100 tonnes per year) across Europe. A number of key steps must be followed once a substance dossier has been submitted to ECHA (Figure 1). Some of these activities will take place within 6–18 months of registration and it is imperative that registrants put plans and processes in place to address and respond to the requirements.
ECHA intends to publish all submitted dossiers on its website for public viewing by the end of the year – both to build public confidence in REACH and to raise dossier quality standards. Parts of a dossier flagged as confidential will remain as such until the validity of the confidentiality claim concerned is assessed. Registrants can use the dissemination preview tool to check what will be published. However, ECHA will substantiate each claim for confidentiality and may require additional information from the registrant. Therefore, there is the potential for claims not being upheld. Such confidentiality checks will probably run for several years.
Registrants are expected to regularly check the REACH-IT website for alerts and updates. REACH-IT is the channel through which all communications related to registration will be issued. Some of the activities that the ECHA requires are time limited – requiring registrants to act quickly. Consequently, advanced planning to devise simple and efficient checking systems is strongly recommended.
It is also imperative to keep the contact details of key staff and consultants supplied to REACH-IT fully up-to-date.
ECHA is also staging retrospective completeness checks (RCC) to bring the quality of dossiers up to a consistent level. At the moment, the primary focus is on dossiers submitted with data gaps due to on-going studies. An RCC can adversely impact the status of a registration. In the case of 3 of the 39 dossiers affected by this review process, the result has been a subsequent decision to revoke the initial registration of the chemical substances concerned.
An enforcement project will be launched in 2019 in which all national authorities will verify dossiers, especially those of strictly controlled substances. The audits will check that dossiers comply with latest legislation; it is a legal obligation to maintain dossiers and compliance will be validated. ECHA will expect to see clear evidence that processes are in place to facilitate dossier maintenance.
ECHA’s policy of on-going compliance checks will be maintained long term. The regulatory body is giving initial consideration to risk management and will focus on substances of very high concern (SVHC). However, all chemical substances will be open to review, in line with renewed assessment standards and changes in substance classification.
At present, there is a distinct lack of consistency in dossier updates by registrants, and to date only 33% of all submitted dossiers have been updated.
Though registrants should actively maintain dossiers, ECHA published a list of substances that could potentially be compliance checked on their website. In the case of SVHCs, the Public Activities Coordination Tool (PACT) lists substances that have, or are, undergoing a risk or hazard management assessment.
There is now no legal obligation to maintain Substance Information Exchange Forums (SIEFs) set up as part of the registration process. That said, there is an on-going need to maintain dossiers. Therefore, keeping SIEF-like structures or agreements in place will help ensure the on-going sharing of data and the subsequent costs that dossier maintenance entails.
ECHA published a review of REACH last month – highlighting the current registrations situation with a summary of what has been achieved and what remains to be completed. The review encourages dossier updates and improvement of evaluation procedures – a signal of ECHA’s future intentions.
Longer-term plans are still evolving as ECHA monitors and assesses what happens in practice. The supportive and responsive approach that ECHA has adopted is a necessary prerequisite for ensuring that REACH is an up-to-date and responsive chemical substances database.
Richard Harrison, Marketing Manager, CPC, at Envigo, Woolley Road, Alconbury, Huntingdon, Cambridgeshire, PE28 4HS, UK
T: +44 (0) 1480 892000