Non-food legislation – August 2023
Hazardous substances – EU rules and regulations
The EU has amended its lists of CMR substances under REACH. SGS reports that the EU has informed the WTO of its intention to regulate PFHxA, its salts and PFHxA-related substances as a new entry under Annex XVII of REACH.
The Council has adopted its negotiating position (690 kB) on the proposed revision (766 kB) of the regulation for the classification, labelling and packaging of chemicals (CLP regulation). The EP recently published a briefing (1.43 MB) on the proposal.
ECHA’s annual report (1.52 MB) on its Integrated Regulatory Strategy shows that ECHA assessed more than 2000 substances in 61 groups in 2022. For nearly 500 of these substances risk management measures may be needed.
The Ombudsman has opened an own-initiative inquiry on EC delays in introducing restrictions to mitigate the risks of specific chemicals and in placing chemicals on the list of substances where use is subject to prior authorisation.
Hazardous substances – Rules and regulations outside the EU
FPF reports that a resolution (157 kB) on the impacts of chemicals, waste, and pollution on human health was adopted at the 76th World Health Assembly.
China: SGS reports that the government has banned the production, use, import and export of five persistent chemicals (POPs) as of June 2023.
UK: HSE reports that the UK REACH submission deadlines have been extended by 3 years to 27 October 2026, 27 October 2028 and 27 October 2030 depending on tonnage and toxicity.
US: The EPA has announced its framework for addressing new PFAS and new uses of PFAS.
U.S. DOT is seeking input from industry stakeholders regarding updating (216 kB) the hazardous materials (hazmat) regulatory system.
California: OEHHA has announced that it is limiting its proposed Proposition 65 No Significant Risk Level (NSRL) for antimony trioxide of 0.13 micrograms per day to 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.
Maine: SGS reports that the government has published an amendment to the PFAS regulations. Amendment LD 217 (145 kB) postpones the notification deadline and gives manufacturers more options on how to report.
Pharmaceutical issues
On 27 June 27 2023, the US FDA issued a final guidance for industry entitled “Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer (DTC) Promotional Labeling and Advertisements.”
Radboudumc research shows that the appearance of medicines is important for proper use Standardisation and better information could reduce antibiotic resistance. The research (838 kB) is published in The Lancet Global Health.
Pharma.be (in Dutch) gives an update on the e-PIL project that is investigating whether the paper package insert can be replaced by the electronic package insert in hospitals.
Research
People in the Netherlands are ingesting too much PFAS through food and drinking water. New research (1.33 MB) by RIVM confirms this. However, the total quantity of PFAS is lower than previously calculated.
Researchers from the Local Health Authority (ASL) Salerno have found microplastics in human semen. An article (2.33 MB) about the research is published in Science of The Total Environment.
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