Türkiye’s Authorities Shed Light on New KKDIK Registration Deadlines

16 November 2023

On 14 November, Türkiye’s Ministry of Urbanisation and Climate Change (MoEUCC) submitted a draft regulation on the planned extension of the registration deadlines offering further prolongations as initially expected:


  • 1000 t/a and above
  • between 100-1000 t/a and classified as aquatic acute 1/ aquatic chronic 1
  • 1-10 t/a, 10-100 t/a, 100-1000 t/a and classified as CMR category 1A/1B
  31 December 2026
  •  between 100 - 1000 t/a
  31 December 2028
  • 1 - 10 t/a, 10 - 100 t/a
  31 December 2030

The new registration schedule still needs to be confirmed by the official revision in the next weeks.

Japan CSCL: 2024 notification schedule for new small and low volume chemicals available

7 November 2023

In October, Japan’s authorities published the 2024 notification schedule for new chemical substances intended for annual manufacture or import in small (≤ 1 t p.a.) and low (≤10 t p.a.) volumes. Substances cannot be manufactured or imported unless officially approved. Applications need to be submitted online via the e-Gov website or by post as paper documents or optical discs to the Ministry of Economy, Trade and Industry (METI). Approvals can be expected approximately one month after the submission deadlines.

Türkiye Announces Plans to Extend KKDIK Registration Deadlines

6 November 2023

On 19 October 2023, Türkiye’s Ministry of Urbanisation and Climate Change (MoEUCC) confirmed its preliminary plan to replace the single end-December 2023 registration deadline by staggered deadlines according to tonnage and/or classification, giving registrants at a minimum 2 more years for substance registration. This came in response to a series of recent discussions with the industry stakeholders who have been facing serious difficulties in meeting the new requirements within the initially set deadline of end December 2023. The new registration schedule – if confirmed by the official revision in the next weeks – could be as follows:


  • 1000 t/a and above
  • between 100-1000 t/a and classified as aquatic acute 1/ aquatic chronic 1
  • 1-10 t/a, 10-100 t/a, 100-1000 t/a and classified as CMR category 1A/1B
  31 December 2025
  •  between 100 - 1000 t/a
  31 December 2026
  • 1 - 10 t/a, 10 - 100 t/a
  31 December 2027

SCCS Guidance on the Safety Assessment of Nanomaterials in Cosmetics (2nd Revision) Published

7  August 2023

On 6th June 2023, the Scientific Committee on Consumer Safety (SCCS) adopted its second revision of the “Guidance on the safety assessment of nanomaterials in cosmetics”. This document helps risk assessors in preparing safety assessments and dossiers for nanomaterials (NMs) used in cosmetics.

The updated Guidance is structured in separate sections covering Requirements for Safety Assessment (2.1), Physicochemical Characterisation (3), Exposure Assessment (4), Hazard Identification and Dose-Response Characterisation (5), and Risk Assessment (6) of NMs. A summary and conclusions of the main aspects discussed are provided in Section (7).

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 2023

Japan 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.