Non-food legislation – April 2024

30 April 2024

Hazardous substances – Rules and regulations
EU: The EC has adopted the proposed regulations on a lower limit for HBCDD.
ECHA (214 kB) has announced that 28 substances have been proposed for evaluation under the REACH Community rolling action plan (CoRAP) for the years 2024-2026.
UK: SGS reports that the government has published version 4 of its GB mandatory classification and labelling list (GB MCL list) for substances and mixtures. The revisions will apply from 2 September 2025.

Medicines for humans – EU legislation
The EP has adopted its position on the revision of the EU's pharmaceutical legislation. The revision includes proposals for a new directive and a new regulation, which would replace the existing pharmaceutical legislation, including the legislation on medicines for children and for rare diseases. The EP also published a briefing (419 kB) on the revision.

Medical devices – EU legislation
In January, the EC proposed giving companies more time to apply the regulations for medical devices and in vitro diagnostic medical devices (IVDR) to ensure that these devices are available to patients whenever they need them. Recently the EP published a briefing (100 kB) about this proposal.
The EC has updated the language requirements for each Member State for manufacturers of medical devices and in vitro diagnostic medical devices.

Veterinary medicines – EU legislation
EU: CBG (in Dutch) reports the publication of three EU implementing acts for veterinary medicines. IA 2024/875 concerns pictograms and abbreviations that are allowed to be used on packaging. IA 2024/878 deals with when a label for a small immediate packaging unit may be used. IA 2024/916 amends implementing regulation (EU) 2021/17 establishing a list of variations not requiring assessment.
France: Draft legislation on distance selling of veterinary medicinal products and labelling rules for certain veterinary medicinal products has been sent to the EC.

Research on PFAS
The EU waste management association FEAD has announced the publication of the scientific article titled ‘The Presence of PFAS in Wastes and Related Implications on the Current and Proposed European Regulatory Framework: A Systematic Critical Review’ in Detritus. The study was commissioned by FEAD in response to the PFAS restriction proposal submitted by a number of Member States to ECHA in 2023.
 

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