On December 7, 2021, the European Chemicals Agency (ECHA) published its first reports on the assessment of regulatory needs for groups of chemicals including a report on ortho-phthalates. The phthalates in the report were divided into six subgroups. Group one was composed of phthalic acids and salts while groups two through six were divided based on the length of the carbon chain of the phthalate molecule. ECHA found that phthalates in subgroup 4 with backbones composed of 4 to 6 carbon atoms need “further EU regulatory risk management” through a combination of restriction and authorization. Additionally, according to ECHA, some of the phthalates in subgroup 5 and 6 with generally longer carbon chains are “suspected to contain constituents with shorter carbon chains (i.e. those belonging to subgroup 4)” and thus those substances “need to be regulated based on these constituents, if present at relevant concentrations.” The regulation is thought to be necessary due to evidence that all substances in subgroup 4, and anything structurally similar, are “[likely] reproductive toxicants at least for development, potentially also for fertility” and are expected endocrine disrupting chemicals (EDCs).
Substances in subgroup 4 include bis(2-ethylhexyl) phthalate (DEHP, CAS 117-81-7), benzyl butyl phthalate (BBP, CAS 85-68-7), and dibutyl phthalate (DBP, CAS 84-74-2), all of which are used in food contact applications (FPF reported). Some of the substances in subgroup 4 are already included on various European regulations including some being registered as substances of very high concern (SVHC). However, ECHA proposes to address the endocrine disrupting properties of this group of phthalates by identifying them all as SVHCs. It further proposes “to explore, how to regulate ortho-phthalates as a group… [to] ensure not only that any ortho-phthalate [that is] currently identified, but also any “new” ortho-phthalate with similar structure would be covered and regulated.”
All of subgroup 1 and most chemicals in subgroups 2 and 3 were found to not need further regulatory risk management according to ECHA. The few exceptions were dimethyl phthalate (DMP, CAS 131-11-3) and diethyl phthalate (DEP, CAS 84-66-2) in subgroup 2 due to recent research indicating a potential endocrine disrupting hazard for the environment. Diallyl phthalate (DAP, CAS 131-17-9) from subgroup 3 has potential reproductive toxicity and endocrine disrupting properties that should be reviewed through further study. All three substances are found in the Food Packaging Forum’s food contact chemicals database (FCCdb).
ECHA’s group assessments of regulatory needs are suggestions for EU regulatory bodies but are not themselves a regulation, nor do they initiate regulatory proceedings. The purpose of the initiative “is to help authorities conclude on the most appropriate way to address the identified concerns for a group of substances or a single substance.” A list of all substances included in ECHA’s regulatory assessments, as well as the assessments themselves, are publicly available.
ECHA is currently seeking comments on whether to restrict ten ortho-phthalates through a REACH restriction dossier. Comments and contributions of evidence are being accepted until January 26, 2022.
Reference
ECHA (December 2021). “Assessment of regulatory needs: Ortho-phthalates.” (pdf)
Read More
ECHA (December 7, 2021). “First assessments of regulatory needs for groups of chemicals published.”
ECHA (December 2021). “Assessment of regulatory needs list.”
ECHA (December 14, 2021). “Assessing groups of chemicals: what you need to know.”
