February Regulatory Updates


The Delegated Directive 2024/232, which amends Annex III of Directive 2011/65/EU (RoHS) regarding the exemption for cadmium and lead in rigid polyvinyl chloride (PVC) profiles containing recovered material used for windows and electronic and electric doors, has been published. Additionally, a Decree transposing two Delegated Directives has also been released.


In recent developments concerning regulations on materials in contact with foods, several key updates have been published in the Official Journal of the European Union and by Swiss authorities.

  1. Amendment to the Directive on Water Quality for Human Consumption: A correction to Directive (EU) 2020/2184, passed by the European Parliament and Council on December 16, 2020, has been made public. This amendment primarily involves the replacement of the term “component” with “constituent” and clarifies the definition of “composition.” This directive pertains to the quality standards of water intended for human consumption.
  2. New Regulations for Drinking Water Quality: The European Commission has enacted three delegated regulations and three implementing acts under Directive (EU) 2184/2020. These new legislative pieces establish minimum quality requirements for drinking water across the European Union. The European Parliament and the Council now have a two-month period to raise any objections to these delegated acts. Should there be no objections, all six acts will be officially published in the Official Journal by the end of March.
  3. Revision of Swiss Ordinance on Food Contact Materials: Switzerland has released a revision of its ordinance regarding materials and objects designed to come into contact with foodstuffs. This update signifies Switzerland’s ongoing commitment to ensuring the safety and regulatory compliance of materials in direct contact with


The European Chemicals Agency (ECHA) introduced new guidelines on February 14, 2024, to protect bees from harmful biocides. This initiative is aligned with the EU’s goals to reverse pollinator decline by 2030 and preserve biodiversity. It focuses on assessing the risks of insecticides and acaricides to bees, including potential harm to their nervous and immune systems.

The guidelines will aid companies in securing approvals for biocidal substances and products, ensuring compliance with the EU Biocidal Products Regulation. Authorities will also benefit from clear principles for evaluating product applications.

ECHA’s Director, Peter van der Zandt, highlighted the importance of bees to ecosystems and the human population, pointing out the threats they face from chemicals, climate change, and habitat loss. A webinar scheduled for March 5 will further discuss the guidelines, inviting participation and questions.

The European Commission and EU Member States will later determine the implementation timeline for these guidelines. Developed in response to the EU’s biodiversity strategy and Pollinators Initiative, the guidance was crafted with contributions from experts and stakeholders, complementing EFSA’s guidance on the impact of plant protection products on bees.

Hazardous Chemicals

Under EU Regulation No. 649/2012 concerning the export and import of hazardous chemicals, there’s a requirement for exporters and importers to declare the quantities of hazardous chemicals they’ve exported or imported in the previous year within the first quarter of each year.

The deadline for such declarations, according to the Prior Informed Consent (PIC) Regulation, is March 31, 2024. Exporters and importers established in EU member states must report to their National Designated Authority (DNA) the quantities of chemicals listed in Annex I of the PIC Regulation that were exported or imported during the previous calendar year (2023).

In Italy, the designated authority for this task is the Ministry of Health – Directorate-General for Health Prevention.

The obligation to report covers:

  • Chemicals listed in Annex I of the PIC Regulation.
  • Ingredients listed in Annex I that are part of mixtures in concentrations triggering labeling obligations under the CLP (Classification, Labelling, and Packaging) Regulation, regardless of the presence of other substances.
  • Ingredients from parts 2 or 3 of Annex I contained in non-reactive articles or in mixtures with concentrations triggering labeling obligations under the CLP Regulation, irrespective of other substances.

Companies can make these declarations through the ePIC platform