Dr Reach: Thinking ahead to 2013 and “data poor” substances

By the end of 2010, one can expect a massive sigh of relief to resonate from REACH managers across EU industry. This may be coupled with a groan from those that proved unsuccessful in meeting the deadline. But getting through 2010 is only the first step of REACH implementation, with a second important deadline just two and a half years behind.

It is hoped that registration in 2013 will be less onerous thanks to the experience gained in 2010. However, substances for registration in 2013 may be relatively “data poor” compared to high volume 2010 substances, data for many of which have already been subject to reporting under High Production Volume programmes.

This means that particular planning is necessary for testing of substances for the 2013 deadline. Starting in 2011 companies will have to begin filling physchem data gaps. Attempts to anticipate the outcomes of chemical safety assessments will become critical in order to limit unexpected obstacles for completion of the registration dossier.

In terms of substances registered, I expect numbers to be broadly similar between 2010 and 2013. However, substances to be registered in 2013 are more likely to be speciality chemicals with fewer registrants and consequently, more cases of companies submitting their own chemical safety reports, even if part of a joint registration.

A busy period

Between 2011 and mid-2013, I predict companies and consultants will be handling a number of REACH processes at once, such as:

• Responses to dossier and substance Evaluation: a number of registration dossiers will be reviewed by the European Chemicals Agency and actual substances will be evaluated to ensure chemical safety.
• Downstream user chemical safety assessments: after registration, downstream users may need to perform their own assessments if a specific use of a chemical is not sufficiently covered in the registration dossier from their supply chain.
• Managing restriction: the restriction process will become more prominent.
• Communication and notification requirements for substances of very high concern (SVHCs): the Candidate List of SVHCs will continue to be periodically updated, with notification requirements for articles beginning in mid 2011 under Article 7 (2) of REACH.
• Authorisation: applications for authorisations will be underway and sunset dates may begin to apply.
• Extensions to Registration: registration may be required for certain substances in articles under Article 7 (5) of REACH and the introduction of registration requirements for certain polymers remains a possibility.

At the same time, other legislation still places demands on chemical content. The interface between REACH and these frameworks should be better understood by 2013.

Tools and templates should be well-established by 2013, hopefully without further updates to IUCLID. The ECHA completeness check should be fully automated and the chemical safety assessment tool integrated with other procedures. Only then can the technical aspects of the registration process become transparent and therefore predictable.

As more chemical safety assessments are undertaken, the need for alternatives to the environmental release category (ERC) defaults will become more evident. I predict that the default values for ERCs, which are based on worst case scenarios and conservative estimates, will soon be obsolete. More realistic estimates are already becoming available through work being done by sector groups on specific environmental release categories (SPERCs).

Lessons learned

By 2013, REACH guidance will be further refined, building on best practice learned from evaluation of the first dossiers. Issues will be determined such as:

• Analytical data requirements: exactly which analytical data each registrant must submit to ECHA; 
• Confidentiality and waiving justifications: the level of information needed to justify data waiving and present confidentiality claims should become evident;
• Description of use: there will be better knowledge of the various methods and ‘levels’ of describing use, eg ‘use’ in a IUCLID dossier, an exposure scenario and a safety data sheet;
• Scope of DNELs: it will become clearer which DNELs are needed for hazardous substances and how to present qualitative assessments for non-hazardous substances;
• Use of read-across: industry will become more practiced at applying for read-across and precedents will be established as a result of dossier evaluations;
• Chemical safety assessment and report (CHESAR) tool: companies will have gained experience in using this tool which comes too late to be of much use for 2010 registration dossiers;
• Demonstration of strictly controlled conditions: from the large number of intermediates registered, the level of documentation needed to prove claims that they are used under strictly controlled conditions will become clearer.

A lot will be learned in these areas, but the temptation to inappropriately extend lessons to other situations must also be avoided. Assessments will often need to be performed and decisions taken on a case-by-case basis.

For this reason, when considering the potential data gaps and confidential business information involved, I think that registering 2013 substances will require even more detailed, hands-on, expert attention. Given the extent of foreseeable activities, resources may become very stretched over the next few years.

Dr Steffen Erler invites Chemical Watch readers to send comments to: steffen@chemicalwatch.com .