The birth of a standard is never an easy process, particularly one such as REACH that is forging new paths through an issue as controversial as chemical safety. The Helsinki Chemicals Forum 2012 (HCF 2012) conference held May 24-25, 2012 and Seventh Stakeholder's Day, emphasized not just the progress made but also the confusion and compliance issues that are causing headaches for all concerned.
Geert Dancet, Executive Director of the European Chemicals Agency (ECHA), recapped the events since ECHA's inception. He stated that there have been some 25K registrations to the REACH standard for 4300 substances, while some 3M C&L notifications have been received for 107K substances. Thus, the registration process continues to move toward REACH's ultimate goal of chemical safety throughout the EU. However, he stated there are numerous challenges still to come, most significantly meeting the upcoming 2013 and 2018 registration deadlines as well as new EU Biocidal Products and PIC Regulations. Unfortunately, despite the progress, it appears that very few if any organizations have achieved authorization.
ECHA's Head of Dossier Submission and Dissemination Kevin Pollard subsequently discussed the phase-in substance registrations over the coming year. He explained that 3551 substances are covered by the 2013 deadline, most of which have registrations underway but many still need to be identified, and there are some 746 substances with no identified lead, meaning that there's considerable work ahead to meet the deadline.
Several issues are contributing to the difficulty of achieving authorization. Definitely the registration tools have been difficult to use and are poorly organized. Apparently 86% of the registration information provided is insufficient. ECHA is addressing this with the release of IUCLID 5.4 that should resolve most of the input problems and confusion. But this is only part of the problem; an inordinate number of organizations are registering as SMEs when they are not, resulting in rejected registrations.
In addition, only about 8% of the dossiers are closed without quality issues. Apparently one of the most frequent compliance failures is unclear substance identification, and in some cases the testing proposals are incorrect and were not submitted correctly or omitted.
In order to improve dossier quality, ECHA performs compliance checks and focuses on end points that affect safety. Part of the reason for the low pass rate is that ECHA is doing more intense compliance checks and finding things that were missed previously.
Focus on Downstream Users
Greater emphasis this year was placed on educating downstream users (DUs), which led to lively discussing of how to define a DU as well as how to inform them. This ties into the Chemical Safety Assessment (CSA) that determines a substance's hazards and to defines conditions of safe use, including exposure scenarios. When performing a CSA, the manufacturer must consider the DUs, but where does this stop? On the manufacturing floor? With the end-user who purchases the final product?
During the Q&A sessions, one person asked how it could be determined if the DU has the correct extended SDS. Another questioner pointed out that some extended SDSs are hundreds of pages long, and asked who was going to read that? Further, the DU doesn't always have access to the SDS, yet it's not always clear who should or how to provide this information. It becomes extremely difficult to ensure that DUs are using a substance safely when the information to do so is not readily available. Further, the issue of providing chemical safety information is very different from DUs reading and understanding it.
In addition to IUCLID 5.4, version 2.0 of the CHESAR IT tool will also be released by the end of June 2012. Further, SUBSport, a website that offers information and tools on safe alternatives to hazardous chemicals, was introduced during the conference. The SUBSport database provides a list of restricted substances, substitution examples, etc
The first sunset dates for hazardous materials occur in 2014, so the registration process needs to be speeded up. Beyond the dates discussed above is the bigger picture: according to Rob Visser, former Deputy-Director, OECD Environment Directorate, "chemical safety is expected to be a priority until at least 2080 driven by environmental factors that contribute to disease and rising health care costs." These issues will not go away. "Chemical safety is a moving target," Visser explained. "As new types of chemicals are developed, safety issues evolve and become moving targets, in particular endocrine disruptors and manufactured nanomaterials will come under greater scrutiny."
Interestingly many other nations are beginning to implement a REACH comparable standard, so while the road is not always smooth, the end-goal has been acknowledged and is now shared by other countries.
HCF 2013 and the 2013 Stakeholder's Day will become separate events, driven by the need to hold the stakeholder's day prior to the May 2013 deadline. HCF 2013 will be held from June 18-19, 2013.