Non-food legislation – November 2023

Hazardous substances – Rules and regulations in the EU
The EC has left the REACH revision proposal out of its 2024 work programme. The European Court of Justice has dismissed the appeal brought by Chemours Netherlands, thus confirming the identification of GenX as a substance of very high concern (SVHC). ECHA’s third report (633 kB) on the operation of the Prior Informed Consent (PIC) Regulation shows that the overall workload of the implementation has continued to increase due to the constant addition of new chemicals subject to PIC and the increase in substances subject to explicit consent from non-EU importing countries prior to export. ECHA has also published Key areas of regulatory challenge 2023 (551 kB). This report identifies areas where research is needed to protect people and the environment from hazardous chemicals. France: SGS reports that the government has published a decree (in French) listing the endocrine disruptor substances (EDCs) for reporting in products. Two other decrees on presenting the information were also published.

Hazardous substances – Rules and regulations outside the EU
China: SGS reports that the government has revised its list of prohibited hazardous chemicals. The amended list became effective on 18 October 2023. UK: SGS reports that HSE has published the second edition of its GB mandatory classification and labelling list (GB MCL list). The government is considering an alternative transitional registration model (ATRm) for UK REACH. A recent review shows that the regulators do not need to hold a complete replica of all the registration data on all chemical substances held under EU REACH. They can adopt a more targeted approach by using information already available. US: California: OEHHA has adopted a Proposition 65 No Significant Risk Level (NSRL) of 0.13 micrograms per day for exposures to antimony trioxide by the inhalation route. Prop 65 is a right-to-know law that requires individuals to receive a clear and reasonable warning before being exposed to certain chemicals. Keller and Heckman reports that OEHHA has also issued a Proposed Rulemaking to amend the warning requirements under Prop 65. The most significant change is that short-form warnings would be required to name at least one Prop 65-listed chemical per endpoint.

Medicinal products for human use
The Heads of Medicines Agencies (HMA), the EC and EMA have published for the first time electronic product information (ePI) for selected human medicines harmonised across the EU. The creation and testing of ePIs in real regulatory procedures is being explored through a one-year pilot initiative.
Redispensing cancer drugs using packaging with a temperature sensor reduces both environmental impact and medical costs, according to a study by Radboudumc. The study will now be expanded to 14 NL hospitals. Reissue is only allowed in the context of a scientific study because of EU rules, however, the researchers hope that the approach can eventually be used nationwide, and for other drugs.

Research
“Short-chain” and “ultrashort-chain” PFAAs have been thought to be suitable replacements for PFAS. ACS reports on a recent study finding that the levels of PFAAs in many indoor and human samples are similar to or higher than those of PFAS.
The Minderoo Foundation has created a database that maps more than 3,500 studies on plastic chemical exposure and human health impacts.
University of Gothenburg researchers have found hundreds of toxic chemicals in recycled plastic, including pesticides and pharmaceuticals.
 

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