Non-food legislation – January 2024
Hazardous substances – Rules and regulations in the EU
SGS reports that the EU recently issued an amendment (2024/197) to the CLP Regulation. The EP and the Council have reached a provisional agreement on the revision of the CLP regulation.
SGS reports that the EC has initiated consultations on a lower limit for HBCDD and on revised specifications for PFOS under the POP Regulation.
ECHA has investigated the potential risks of PVC and PVC additives. The report (1.22 MB) has been sent to the EC, which will decide whether there is a need for ECHA to prepare a REACH restriction proposal. ECHA has also opened a consultation on occupational exposure limits for Bisphenol A (BPA). Brunel University London reports that a group of experts has sent an open letter (201 kB) to the German authorities urging them to re-submit the REACH restriction proposal for bisphenols to ECHA. The EC has adopted three legislative proposals for improved chemicals data management, including establishing an EU chemicals data platform. ECHA’s annual report (1.64 MB) on the trade of chemicals under the Prior Informed Consent (PIC) Regulation shows a 24% increase in exports from the EU in 2022 compared to 2021.
Hazardous substances – Rules and regulations outside the EU
Australia: SGS reports that the government is prohibiting several persistent organic pollutants (POPs). The prohibitions will be implemented in phases, starting July 2024. Canada: Keller and Heckman reports that a federal judge has overturned the inclusion of all plastic manufactured items as “toxic substances” under the Canadian Environmental Protection Act (CEPA). Japan: SGS reports that the government has initiated a consultation on the ban of three POPs and has published regulations prohibiting the use, manufacture and import of PFHxS and its salts. UK: SGS reports that the government has revised the legislation on POPs. US: EPA has finalised a rule that prevents companies from starting or resuming the manufacture or processing of 329 inactive PFAS under the Toxic Substances Control Act (TSCA). EPA has also initiated a process to prioritize vinyl chloride and four other chemicals for risk evaluation under the TSCA. EPA is proposing updates to the Safer Choice Standard, including changes to the packaging requirements. California: OEHHA has added bisphenol S (BPS) to the Proposition 65 list. Keller and Heckman reports that the Court of Appeals for the Ninth Circuit has ruled that California cannot require cancer warning labels for glyphosate under Proposition 65. Prop 65 is a right-to-know law that requires individuals to receive a clear and reasonable warning before being exposed to certain chemicals. Illinois: Bill SB2705 banning or regulating products containing intentionally-added PFAS, has been introduced in the General Assembly.
Medicine, medical devices and tobacco
EU: The EC has updated the Q&A on Articles 13 & 14 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746 for medical devices. Luxembourg: Draft legislation introducing an obligation for new tobacco products to carry health warnings on the packaging has been sent to the EC. US: The FDA has approved safety labelling changes for opioid pain medicines.
A study (in Dutch, 460 kB) by the Dutch National Institute for Public Health and the Environment (RIVM) has found PFAS in sea foam along the Dutch coast. Örebro University research suggests that PFAS may increase the risk of disease in unborn children. The study (5.79 MB) is published in The Lancet Planetary Health. A study (8.04 MB) by Earth Action introduces a novel approach for quantifying the leakage of additives resulting from plastic waste.