Chesar Platform: First Operative Version Scheduled for Late April 2024
10 July 2023
Since 2021, ECHA has been working on a common chemical risk assessment platform, combining Chesar1 , an application for chemical safety assessments, and EUSES2 , a standalone tool widely (but not only) used for environmental exposure and risk assessment of biocides and chemicals.
Fit for Purpose Risk Assessment for Low-Concern Active Substances and Uses - Call for Proposal Published by EFSA
5 July 2023
On 19 June 2023, EFSA published a call for proposals and guide for applicants (GP/EFSA/PLANTS/2023/04) to develop an approach for fit for purpose risk assessment for potential low-risk pesticides. The call is open to listed competent organisations.
UK MDR: Great Britain extends the acceptance of CE marked medical devices and IVDs
29 June 2023
With the initial transitional period for CE marked medical devices expiring on 30 June 2023, the UK Medicines and Healthcare products Regulatory Agency (MHRA) has brought forward a legislation allowing to continue to place CE marked medical devices on the market in Great Britain. With this measure, the government intends to lessen the pressure on the industry and ease the transition to the new regulatory framework. The new timelines apply to:
REACH Revision 2024/2025: Nanomaterials
28 June 2023
The updated cross-sector definition for nanomaterials from 10th June 2022 (2022/C 229/01) will be included in the REACH revision text. Furthermore, it is planned to clarify the characterization requirements for nanoforms and for naming of nanosets. In addition, there are considerations to oblige downstream users to characterize nanoforms that they produce by transforming substances into them, if the nanoforms are not covered by the actual registration dossier. These considerations also include the downstream user obligation to provide information on the safe use of such nanoforms.The overview presentation about the entire scope of envisaged changes in the context of the REACH revision can be found here: CARACAL presentation.
REACH Revision 2024/2025: Mixture Allocation Factor (MAF)
27 June 2023
The proposed REACH revision introduces a new provision, the Mixture Allocation Factor (MAF). The concept of the MAF has been introduced in the risk management of chemical substances to consider adverse (eco)toxicological effects from different sources of exposure to the same substance (multi-exposures) and for several different substances (cocktail effect). The proposal intends to address the issue that most individual registrants do not know much about other uses of the same substances registered by competitors, and that they do not know how users of their substances, the general population and the environment are exposed to other substances.
REACH Revision 2024/2025: Registration of Polymers under REACH
26 June 2023
Polymers are currently exempted from registration under REACH, while their building blocks (monomers or other substances) need to be registered. As part of the REACH revision, the European Commission plans to extend the duty of registration to certain polymers of concern.
For this purpose, the European Commission will prepare a proposal that intends to amend REACH to establish registration requirements for polymers. Criteria will be established to determine those polymers that should be subject to registration requirements. These criteria shall identify the polymers that can be deemed to be hazardous, and which are termed “Polymers Requiring Registration” (PRR).
REACH Revision 2024/2025: Increased Information Requirements for Low Tonnages / Most Harmful Substances, incl. Endocrine Disruption
23 June 2023
The European Commission is currently revising the REACH Regulation and has already disclosed the envisaged changes. They were made public at the 48th CARACAL* Meeting on 28-29 March 2023.
The tentative REACH Revision timeline foresees the publication of the concrete legislative proposal latest in Q4, 2023 and of the final legislative proposal including the Annexes in 2024-2025.
One of the most relevant changes includes additional registration requirements for low tonnage substances and for most harmful substances including information on endocrine disruption.
Notified Body Confirmation Letter – EU 2023/607
6 June 2023
The European Commissioners have issued a new confirmation letter on the recent amendments to the Medical Device Regulation (MDR + IVDR).
The eagerly awaited publication of the Template for NB – Confirmation letter in the framework of Regulation (EU) 2023/607 has now been officially communicated by the European Commission.
Public-private partnership for consolidation of GHS classification launched by Japanese Government
26 April 2023Japan has launched a new initiative for the collection and joint review of data for the consolidated GHS classification of 157 target substances in the fiscal year 2023. The importance of government GHS classification results is increasing, due to the fact that the selected substances are subject to labeling and notification requirements under the Industrial Safety and Health Act (workers’ safety and protection).
European Commission extends MDR transition period
27 March 2023
On 7 March 2023, the Council of the European Union adopted the Commission's proposal granting notified bodies and manufacturers more time to certify medical devices in order to mitigate the risk of shortages. This followed the positive vote by the European Parliament in February.
To ensure continued access to medical devices for patients in need, the legislative proposal provides a longer transition period to adapt to the new rules laid down in the Medical Devices Regulation. Read also Council vote on the Medical Device Regulation extension.
EU commission adopted proposal for a longer transition period to adapt to MDR
13 January 2023
On the 6th January 2023, the European Commission adopted a proposal to give more time for medical device certification to mitigate the risk of bottlenecks. In addition to a press release, the European Commission published a Questions and Answers document and a Factsheet European Health Union: Supporting the transition to the new medical device framework.