Non-food legislation – June 2022

01 July 2022

Hazardous substances – EU rules and regulations
ECHA has added another chemical to the Candidate List of substances of very high concern (SVHCs). The list now contains 224 entries for chemicals that can harm people or the environment.
Annex VI of the CLP regulation lists notes that can be assigned to substances with harmonised classifications. These notes provide further instructions on how to classify and label certain substances or mixtures containing them. A draft act adding new notes to the list is open for feedback until 20 July 2022.
The Council and the Parliament have reached a provisional agreement to reduce limit values for the presence of persistent organic pollutants (POPs) in waste.
The EC has published its new Recommendation (236 kB) on the definition of nanomaterials, a deliverable of the Chemicals Strategy for Sustainability. The recommendation supports a coherent EU regulatory framework for nanomaterials, helping to align legislation across all sectors.
On 11 May 2022, the European Partnership for the Assessment of Risks from Chemicals (PARC), was launched. Coordinated by ANSES, PARC aims to bring together a broad community of research establishments and health agencies.

Hazardous substances – rules and regulations outside the EU
Canada: SGS reports that the government has opened a consultation period for its draft legislation on certain toxic substances under the Canadian Environmental Protection Act, 1999 (CEPA). If approved, the new law will enter into force six months after publication.
China: The government has issued an action plan on controlling new pollutants.
US: SGS reports that the governor of Colorado has signed HB 22-1345 (540 kB) into law to regulate PFAS in consumer goods. The new law will be implemented in phases, starting January 2024.

Pharmaceutical packaging – rules and regulations
The EC has published Q&As on the Unique Device Identification (UDI) System for medical devices.
The US FDA has released a final guidance for industry entitled “Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors.”

PFAS linked to hypertension in middle-aged women
Middle-aged women with higher concentrations of PFAS in their blood are at greater risk of developing high blood pressure, compared to their peers who have lower levels of these substances, according to new research (abstract) published in Hypertension, an American Heart Association journal.

Toxic cocktail of chemical pollutants linked to male infertility
Sperm counts have more than halved in the last 40 years. Brunel University researchers have found that one culprit is daily exposure to a mix of hormone-disrupting chemicals - with the cocktail effect way more dangerous than any single substance. Until now, studies into male infertility and chemical exposures have focused on phthalates. This new research (2.32 MB) published in Environment International reveals that bisphenols, polychlorinated dioxins and paracetamol affect infertility more.

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