Non-food legislation – May 2021

01 June 2021

EU regulations – chemicals and sustainability
The EC has published two roadmaps, one on the revision of CLP and one on the revision of REACH. The new Chemicals Strategy for Sustainability requires a targeted revision of these Regulations. The roadmaps are open for feedback until 1 June 2021.
ECHA has published updated IUCLID tools for poison centre notifications. ECHA’s annual report (1.83 MB) on its Integrated Regulatory Strategy shows that ECHA assessed around 1900 registered chemicals in groups in 2020. 290 of these may be candidates for further regulatory risk management. A recent report (711 kB) published by ECETOC reviews the information used to determine chemical exposure levels that are safe for human health. In a recent study (1.42 MB) the EC maps initiatives and research activities related to sustainability that are relevant for the development of sustainable-by-design criteria for chemicals, materials and products.

Chemicals – regulations in Canada and France
Canada: The government has published an order that adds plastic manufactured items to Schedule 1 (List of Toxic Substances) of the Canadian Environmental Protection Act (CEPA). The government has also published a notice of intent to address PFAS as a class of chemicals to better address situations where exposure occurs to multiple PFAS at the same time. France: As part of the Second National Endocrine Disruptor Strategy, ANSES has drawn up a list of substances of interest and identified a selection of priority substances. ANSES is also recommending a method to establish whether the substances assessed are known, presumed or suspected EDCs.

Next step in revision of EU Machinery Directive
The EU Machinery Directive is under revision. Recently the EC adopted a proposal for a regulation which is open for feedback until 13 July 2021.

Nanoplastics and microplastics
The EC has launched a consultation on the definition of a nanomaterial. The consultation is open until 30 June 2021. Nature News has published an article in which scientists are interviewed about the health risks of microplastics and nanoplastics.

Research on the health effects of endocrine-disrupting chemicals (EDCs)
EDCs may influence hormonal shifts during pregnancy as well as contribute to postpartum depression, according to NYU Langone Medical Center research. The study (1.01 MB) is published in the Endocrine Society’s Journal of Clinical Endocrinology & Metabolism. NRDC has announced the release of the PFAS-Tox Database containing health and toxicology studies.

Medical devices and pharmaceutical products
As of 26 May 2021 the Medical Devices Regulation (MDR) applies in the EU, after being postponed for a year due to COVID-19. Implementing Decision (EU) 2021/610 of 14 April 2021 references EN ISO 11607 part 1 and part 2 for meeting the requirements for the packaging of the medical devices. In an article that you can download after filling in your details, Smithers gives a global overview of standards related to extractables and leachables testing for medical devices and pharmaceutical products. With the introduction of the coronavirus self-test, a wide variety of packaging came on the NL market that did not always meet the requirements. Also, the communication about when to use a self-test was not always clear. The IGJ (in Dutch) signals this in a recent publication (in Dutch, 377 kB). University of Antwerp researchers are developing a vaccination tray to handle vaccines more safely, quickly and efficiently.

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