REACH Restrictions for DEHP DBP BBP and DIBP Starting on July 7 2024 Argentina

  • REACH Restrictions for DEHP DBP BBP and DIBP Starting on July 7 2024 Argentina
  • REACH Restrictions for DEHP DBP BBP and DIBP Starting on July 7 2024 Argentina
  • REACH Restrictions for DEHP DBP BBP and DIBP Starting on July 7 2024 Argentina
  • What phthalates are restricted in REACH Annex XVII entry 51?
  • Currently REACH Annex XVII entry 51 restricts three phthalates, (bis (2-ethylhexyl) phthalate (DEHP), dibutyl phthalate (DBP), benzyl butyl phthalate (BBP) in plasticised materials of toys and childcare articles. The new amendment expands the restricted phthalates by newly adding diisobutyl phthalate (DIBP) and the scope of the products.
  • Are phthalates suitable DNELs under Article 57(F) of reach?
  • RAC (2017) stated in the opinion on the restriction proposal on phthalates that the Commission is considering to identify the four phthalates as substances of equivalent concern (SVHC) under Article 57(f) of REACH and that this raises additional uncertainties regarding the appropriateness of the derived DNELs.
  • When did DNELs for DEHP and DBP come out?
  • Reference DNELs for DEHP and DBP were derived in 2013 for reproductive toxicity and thus pre-date RAC’s opinion of 201711 on the restriction proposal from ECHA and Denmark on these phthalates as well as the opinion of EFSA on several phthalates (EFSA 2019)12.
  • Can a threshold be found in a case of phthalate ethylhexyl (DEHP) and di?
  • In accordance with the mandate from the Executive Director of ECHA, the rapporteur developed the opinion, summarising the justifications for the feasibility of finding a threshold in the context of applications for authorisation and review reports in the cases of bis(2-ethylhexyl) phthalate (DEHP) and dibutyl phthalate (DBP).
  • Are DEHP and DBP non-threshold substances?
  • Due to the uncertainty listed above and also noted in a report of 2016 by the European Commission3 related endocrine disrupting properties in general, RAC proposes that an applicant may choose to assume that DEHP and DBP are non-threshold substances for the purposes of an application for authorisation for pragmatic reasons.
  • Are DEHP and DBP anti-androgenic?
  • The mode of action of DEHP and DBP was identified to be anti-androgenic in the MSC Support Document for the identification as SVHC for endocrine disrupting properties for human health and the environment18, more specifically through reduced foetal testosterone.

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