Skip to main content
Leaving UL Solutions website
Within UL Solutions we provide a broad portfolio of offerings to all the medical device industries. This includes certification, Approved/Notified Body and consultancy services. In order to protect and prevent any conflict of interest, perception of conflict of interest and protection of both our brand and our customers brand, we have processes in place to identify and manage any potential conflicts of interest and maintain impartiality. UL Solutions is unable to provide consultancy services to EU MDD, MDR or IVDD Notified Body, UKCA MD Approved Body or MDSAP Customers.
  • Regulatory Update

EU Updates Table of Harmonized Entries in Annex VI to CLP

Commission Delegated Regulation (EU) 2024/197 was published, introducing substances and updating existing entries to the table of harmonized classification and labeling of substances.

Scientist inspecting sample in a test tube

February 6, 2024

Regulation (EC) No 1272/2008, CLP, concerns the classification, labeling and packaging of chemical substances and mixtures that are released on the EU market.

As of June 1, 2015, chemical products must be labeled in accordance with the requirements of the CLP Regulation.

On Jan. 5, 2024, Commission Delegated Regulation (EU) 2024/197 was published. This introduced substances and updated existing entries to the table of harmonized classification and labeling of substances to the CLP Regulation (Regulation (EC) No 1272/2008).

These changes shall apply from Sept. 1, 2025. However, suppliers may classify, label, and package substances and mixtures in accordance with the CLP Regulation before that date.

The EU adopted a series of harmonized substance classification changes proposed between March 2021 and November 2021 in the twenty-first Adaptation to Technical Progress (ATP). The newest ATP contains 28 new additions and 24 amendments, but no deletions. Some substance classifications also include specific M-factors, specific concentration limits and substance ATE values as part of the overall classification.

UL Solutions’ global team of experts and worldwide network of testing laboratories offer you a variety of services to help increase consumer confidence in your products and stay on top of regulatory updates impacting your business.

Whether you need to access the North American, European or Asian markets, or any other market in the world, we can help.

We know how important it is for your business to avoid duplication of efforts and save costs and time by working with a service provider that can help you achieve your compliance goals.

Source

Commission Delegated Regulation (EU) 2024/197 of 19 October 2023 amending Regulation (EC) No 1272/2008 as regards the harmonised classification and labelling of certain substances

X

Get connected with our sales team

Thanks for your interest in our products and services. Let's collect some information so we can connect you with the right person.

Please wait…