Non-food legislation – November 2024

Hazardous substances – Rules and regulations
EU: ECHA has added one chemical to the Candidate List of substances of very high concern (SVHCs). The list now contains 242 entries for chemicals that can harm people or the environment. ECHA has also updated the guidance on applying the CLP regulation. Advice on the new hazard criteria for endocrine disruptors is now included, among other things.
At the Environment Council meeting on 14 October 2024, EU ministers discussed the implementation of the Chemicals strategy for sustainability, with a focus on actions not delivered to date, including the revision of REACH and addressing PFAS. ECHA and authorities from Denmark, Germany, the Netherlands, Norway and Sweden have released a progress update (256 kB) on the proposal to restrict PFAS under REACH. The more than 5,600 comments received during the consultation in 2023 have helped to identify uses that were not specifically named in the initial proposal, such as packaging for pharmaceuticals.
ECHA has published the sixth and final report (780 kB) of its Integrated Regulatory Strategy 2019-2023. The report shows that ECHA has grouped and screened 6,000 substances since 2019 and addressed almost all of the 4,100 high production volume chemicals. Around 1,900 of the substances screened may potentially require risk management measures.
In a study (807 kB) published in Frontiers in Toxicology, Stockholm University researchers investigate whether the information provided in applications for authorisation under REACH allows for the identification of non-essential uses of SVHCs. Of the 100 analysed uses, 55% were categorised as essential, while 10% were categorised as non-essential. For 35% of the uses it was not possible to assess their essentiality.
NL: The government (in Dutch) reports that all PFAS will be placed on the SVHC list (in Dutch). This means that all these substances will be subject to an immediate minimisation obligation.

Pharmaceutical products
EU: The EC has published a revision of the ‘Guidance on borderline between medical devices and medicinal products under Regulation (EU) 2017/745 on medical devices’.
NL: The Medicines Evaluation Board CBG (in Dutch) has updated its policy on the package leaflet (MEB5, in Dutch) and labelling (MEB6, in Dutch) for pharmaceutical products. The biggest change is the pictogram policy: in MEB 6, the layout of the standardised pictograms has been changed and the set of pictograms included in the ‘Positive list of Pictograms’ has been expanded. Use of the same set of pictograms in the package leaflet will also be permitted. Comments on the changes can be submitted until 13 December 2024.
CBG (in Dutch) also reports that the first trial has started to replace the paper package leaflet by the digital package leaflet, the e-PIL (electronic Patient Information Leaflet). The trial focuses on medicines given in hospitals. Here, patients receive their medicines under the guidance of the healthcare provider.

Research
On 28 October 2024, FPF and ETH co-hosted the Swiss Symposium on Endocrine Disrupting Chemicals. Recordings of all talks are available here.
A study (1.63 MB) published by EUON analyses the release of nanoparticles from consumer products, highlighting potential exposure that consumers and the environment may face. An FPF article reports on five recent studies assessing human samples for the presence of microplastics and their association with negative health outcomes. A UC Riverside study documents how Southern Californians are chronically being exposed to toxic airborne plasticisers.
 

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