In an article published on March 28, 2019, by regulatory news provider Chemical Watch, reporter Emma Davies informed that the Risk Assessment Committee (RAC) of the European Chemicals Agency (ECHA) has now “for the first time” set up a “working group to deal exclusively with authorization applications.” These will focus particularly on nonylphenol and octylphenol ethoxylates, two groups of endocrine disrupting chemicals (EDCs) for which several dozen authorization applications are expected to be filed this spring. Both are classified as substances of very high concern (SVHC) based on their endocrine disrupting properties in the environment, which occur largely due to degradation into the EDCs nonylphenol (NP, CAS 25154-52-3) and octylphenol (OP, CAS 27193-28-8).
RAC informed that “some of the authorization applicants may choose a threshold-based approach, while others will follow a non-threshold route.” A recent report by the Danish Technical University “recommend[s] that risk assessments [of EDCs] use a non-threshold approach as default” (FPF reported). However, RAC is following a recommendation given in the 2016 report by the European Commission, stating “that authorization applicants are responsible for demonstrating whether . . . [EDCs] have thresholds below which no adverse effects are expected to occur.” RAC shall then “assess the validity of the assessment [made by the applicant] and ultimately decide on the possible existence or not of this threshold.” Nonetheless, Tim Bowmer, chair of the RAC, said that “the committee expects that most applicants will opt for a non-threshold route.” In this case, the assessment will focus on “whether emissions [in particular to water, soil and sediment] have really been minimized or not.”
Emma Davies (March 28, 2019). “ECHA sets up working group for deluge of EDC authorization applications.” Chemical Watch
European Commission (December 12, 2016). “Report from the Commission to the European Parliament, the Council and the European Economic and Social Committee in accordance with Article 138(7) of REACH to review if the scope of Article 60(3) should be extended to substances identified under Article 57(f) as having endocrine disrupting properties with an equivalent level of concern to other substances listed as substances of very high concern.” COM(2016) 814 final (pdf)
Danish Centre on Endocrine Disrupters (February 2019). “Report on interpretation of knowledge on endocrine disrupting substances (EDs) – what is the risk?” (pdf)