Non-food legislation – September 2023

03 October 2023

Hazardous substances – EU rules and regulations
SGS reports that ECHA has launched a consultation over the listing of six chemicals as substances of very high concern (SVHC).
Eleven EU industry associations have expressed concerns (456 kB) about the revision of the CLP regulation. One of their concerns is the proposed requirement of a minimum font size of 1.4mm x-height for products under 3L instead of 1.2mm. In a study (1.23 MB) commissioned by CEPE no difference was found in the legibility of the two font sizes at 30cm distance.
The German authorities have withdrawn their proposal to restrict bisphenols that have endocrine disrupting properties. They intend to re-submit an updated proposal to ECHA once they have considered the information submitted during the consultation and reworked the scope of the restriction.
Exposure to Bisphenol A (BPA) in Europe is well above acceptable health safety levels, according to a briefing published by the European Environment Agency (EEA). This poses a potential health risk to millions of people.

Hazardous substances – Rules and regulations outside the EU
UK: SGS reports that the government has notified (75 kB) the WTO of a proposal to amend the GB mandatory classification and labelling list under the GB CLP Regulation.
US: The White House has published a report (1.52 MB) on sustainable chemistry. The report outlines current Federal government activities and identifies critical data gaps and research needs, as well as other opportunities for strategic action, with the goal of coordinating Federal programs and activities.

Pharmaceutical issues
Saudi Arabia: The FDA has published a document (476 kB) with requirements for reclosable packaging for medicinal products that may cause a significant risk of toxicity to children if accidentally ingested and defining the list of medicines that require a child-resistant packaging.
US: The FDA has announced a 1-year stabilisation period to accommodate additional time that trading partners in the pharmaceutical supply chain may need to adhere Drug Supply Chain Security Act (DSCSA) requirements for electronic drug tracing at the package level. The FDA also added a number of guidelines.

Recognition of CE marking in the UK
The government has announced the intention to extend recognition of the CE marking for placing most goods on the market in Great Britain indefinitely, beyond December 2024. Products need a CE marking for sale in the EU, the UKCA marking is not recognised.

University of Rhode Island research shows that exposure to microplastics through drinking water induces behavioural changes in mice. The study mice began to move and behave peculiarly, exhibiting behaviours akin to dementia in humans. The study (3.62 MB) is published in the International Journal of Molecular Sciences.
Recent research by the University of Illinois at Urbana-Champaign shows that exposure to di-isononyl phthalate (DiNP) disrupts the pregnancy of mice. DiNP is an endocrine-disrupting chemical commonly found in plastic products such as packaging.

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