On 18-19 April 2017, RPA Technical Director Linda-Jean Cockcroft attended ECHA’s Helsinki based Seminar on Applications for Authorisation. As well as addressing application strategy and evaluation, the seminar included a Q&A session on the main issues brought by the participants. Linda-Jean notes that “Given the imminent update to REACH Annex XIV, it is perhaps unsurprising that a core focus of the discussions related to the quantification and valuation of health and environmental impacts, and in particular the approach for PBT/vPvB substances, as well as those with endocrine disrupting properties for the environment”.
Meg Postle, an economist and a founding Director of RPA highlights that “The upcoming update to REACH Annex XIV heralds a new phase in the REACH Authorisation process. Up to now applicants have typically had to assess the costs and benefits from the continued use of carcinogens and mutagens for which effects thresholds or dose-response relationships were generated by the Risk Assessment Committee (RAC) and were available to use by the applicants. Now, however, substances like octylphenol and nonylphenol ethoxylates are being added to Annex XIV due to their endocrine disruption effects on the environment, which presents new challenges for prospective applicants wishing to secure continuity of supply and use of key products and substances”.
Exploring this issue in further detail, Linda-Jean also notes that the European Commission has stated that the responsibility for determining whether for endocrine disruptors there is a threshold or not is the responsibility of industry. This means that for the first time in the Authorisation application process, the RAC will not be establishing and publishing reference data on DNEL or a dose-response relationship. She adds, “We believe this will make it particularly difficult for the RAC to assess each application for Authorisation within the 10 month time line stipulated in the REACH Regulation, especially if different applicants take different approaches and base their applications on different scientific data”.
Further considering the subject of environmental endocrine disruptors in the context of Authorisation, Erwin Annys, REACH Director at Cefic, reminded those at the ECHA seminar that this threshold/non-threshold decision responsibility will make life rather difficult for industry applicants, not the least because a number of Member States have expressed major doubts about thresholds for such substances, given the high combination of uncertainties.
Reporting back on one of the break-out sessions at the seminar which dealt specifically with this subject, Tim Bowmer, Chairman of the RAC, said that there are problems with both the threshold and non-threshold approaches for environmental endocrine disruptors. However, the RAC is interested in a collaborative industry approach to assessing the data and is willing to discuss in advance with industry. To this end, it has been proposed that a Workshop be held towards the end of August this year, to consider the complexities and practicalities of applying for authorisation for these substances.
“For industry and for applicants for authorisation, establishing a threshold or developing a dose-response relationship for such effects will be very challenging” says Meg.
And one of the most frequently asked questions submitted by participants at the ECHA seminar was: how should the economic impacts of PBTs or EDs be evaluated in an Application for Authorisation?
“It is vitally important”, Meg continues, “that applicants can draw on the expertise required for translating the results of the Chemical Safety Report into a coherent assessment of the “costs” to the environment from the continued use of such substances. Although it is widely assumed that there is no standard methodology for the monetisation of impacts from environmental releases of an endocrine disruptor, experts in the field will be familiar with a range of approaches that have been put forward successfully in the past, including as part of work carried out by RPA for DG Environment of the European Commission, and which can help in this quantification”. RPA has considerable experience in economic assessment of environmental impacts, across a range of impact assessments and over many years and the RPA team includes a number of environmental and economics experts”.
In 2011 RPA (in collaboration with partners) completed an authoritative two-volume report on Assessing the Health and Environmental Impacts in the Context of Socio-economic Analysis under REACH on behalf of the European Commission. Links to both volumes are available on the European Commission website, here.