Non-food legislation – September 2022

04 October 2022

Hazardous substances – rules and regulations
: The EC has opened a consultation on a draft act that would introduce new hazard classes to the CLP Regulation. The feedback period ends 18 October 2022. The EC has requested ECHA to collect information on the potential risk of PVC and PVC additives to human health and the environment. The results are expected by May 2023. Based on these, the EC may ask ECHA to prepare a REACH restriction proposal. US: EPA is taking a significant action under Administrator Regan’s PFAS Strategic Roadmap to protect people and communities from the health risks posed by certain PFAS with plans to designate PFOA and PFOS as hazardous substances under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA). The government has announced a Final Rule that amends the Federal Hazardous Materials Regulations (HMR) to harmonise US laws with numerous international standards. The Final Rule improves safety, streamlines the transport of hazardous materials and encourages shippers to package goods more efficiently.

Updated EU Blue Guide on the implementation of product rules
The EC has published an updated version of the Blue Guide on the implementation of product rules. The guide is meant for a better understanding of the product rules and facilitation of their uniform application across sectors throughout the single market.

EU: Pharmaceutical packaging
Volume 4 of "The rules governing medicinal products in the European Union" contains guidance for the interpretation of the principles and guidelines of good manufacturing practices (GMP) for medicinal products for human and veterinary use. In August 2022, a revision of Annex 1 Manufacture of Sterile Medicinal Products was published. The deadline for coming into operation is 25 August 2023, except for point 8.123 which is postponed until 25 August 2024.

Changes in guidance on UK Conformity Assessed (UKCA) marking
SGS reports that the UK government has made a range of changes to its guidance regarding Conformity Assessed (UKCA) marking. In addition, the government intends to introduce legislation which will allow manufacturers to apply the UKCA mark on the basis of their existing CE certification.

In a recent study (2.11 MB), DTU evaluated six chemical substances (including BPA) and found that they possess endocrine disrupting effects - and especially combination effects when they are assessed together. Northwestern University chemists have developed a process using low temperatures and inexpensive, common reagents, that causes two major classes of PFAS compounds to fall apart — leaving behind only benign end products. The research is published in Science (abstract).

Plastics and human health – more research needed
In an article (822 kB) published in Annals of Global Health, a number of research institutions announce the formation of the Minderoo – Monaco Commission on Plastics and Human health. The commission plans to enumerate, and where possible to quantify, the multiple hazards that plastic poses to human health from extraction of its fossil carbon feedstocks through its everyday use, to its leakage into the environment. A literature review (1.46 MB) carried out by RIVM concludes that reliable standard techniques should be developed to analyse microplastics in the soil. Until such techniques are available, researchers will be unable to carry out reliable analyses into what effects the presence of microplastics in our soil has on human health.

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