Upcoming CLP Deadline: Potential Impact on REACH Dossier Updates

31 January 2025

The Delegated Regulation on CLP, (EU) 2024/197, amending Regulation (EC) 1272/2008 and enforced since April 2023, introduced new hazard classes:

  • Endocrine disruption for human health, Category 1 and 2
  • Endocrine disruption for the environment, Category 1 and 2
  • PBT (persistent, bioaccumulative and toxic) and vPvB (very persistent and very bioaccumulative)
  • PMT (persistent, mobile and toxic) and vPvM (very persistent and very mobile).

The new requirements apply to substances placed on the market for the first time on or after 1 May 2025, including new quantities of substances already on the market before that cut-off date. Substances that were placed on the market before 1 May 2025, and are already in the supply chain, do not need to be reclassified or relabelled until 1 November 2026.

From 1 May 2026 at the latest, mixtures that are placed on the market for the first time, including new quantities of mixtures already on the market before that date, must comply with the new rules. Mixtures that were placed on the market before 1 May 2026, and are already in the supply chain, are not required to be reclassified or relabelled until 1 May 2028.

In case of changes in the classification and labeling of the registered substance due to the new hazard classes, the REACH registration dossier must be updated within 6 months from the date when the decision to change the substance's classification and labelling was taken (Regulation (EC) No 1907/2006, Art. 22(1) and Commission Implementing Regulation (EU) 2020/1435). This includes the CSR update and the reevaluation of the CSA. Changes to the classification and labelling of the registered substance should be communicated in the SDS.

Contact our experts if you need help assessing the endocrine disruptive (ED), persistent, mobile or bioaccumulative properties of your substances and mixtures.

New Regulation (EU) 2025/40 on Packaging and Packaging Waste

27 January 2025

Regulation (EU) 2025/40 of the European Parliament and of the Council of 19 December 2024 on packaging and packaging waste was published in the Official Journal of the European Union on 22 January 2025. It will enter into force on 11 February 2025 and apply from 12 August 2026.

This regulation replaces the previous Directive 94/62/EC and introduces stricter obligations focused on a circular economy. It applies to all packaging, regardless of the material used, and to all packaging waste, regardless of whether it comes from industry, commerce, offices, services or households.

The aim of the regulation is to regulate the entire life cycle of packaging in order to minimise its impact on the environment and protect human health. This includes measures to prevent packaging waste, promote reuse and recycling and reduce the use of primary raw materials. It also defines the requirements for the design of packaging to improve its reusability and recyclability.
A central element of the regulation is the introduction of harmonised rules for the entire life cycle of packaging, including requirements for environmental compatibility and labelling, to enable it to be placed on the market. It also sets out requirements for extended producer responsibility, the prevention of packaging waste, the reuse or refilling of packaging and the collection and treatment, including recycling, of packaging waste.

The regulation also sets targets for the reuse and recycling of packaging. For example, certain quotas for the reuse of packaging are to be achieved by 2030. In addition, the regulation sets requirements for the minimum content of recycled plastic in certain packaging.

ECHA Publishes Guidance on New CLP Hazard Classes

27 November 2024

ECHA has recently published new guidance documents to support the application of the CLP criteria following the revision of the CLP Regulation on March 31, 2023. These updates focus on new hazard classes including endocrine disruption (ED), persistence, bioaccumulation, and toxicity (PBT/vPvB, PMT/vPvM).

The new classification system under CLP integrates existing scientific approaches with practical guidance for industry and regulators. It does not require new testing. Instead, it uses existing data to assess and classify substances, ensuring consistency across EU chemical safety frameworks.

For detailed information, you can consult ECHA’s guidance documents available on their official website or watch their latest webinar presenting the recently published guidance on new CLP hazard classes.

As ECHA plans further updates to its guidance documents, industry should be prepared for future refinements that may require re-evaluation of substances already classified, or modification of classification criteria and collection of new evidence in cases where data is lacking. Stakeholders should also expect tight implementation deadlines. It is therefore advisable for industry to start early with the assessment of available data for endocrine activity and adverse effects in order to prioritise substances likely to fall under the ED criteria.

Interpreting ED-related data still requires considerable expert judgement and experience. Incorporating toxicological and regulatory expertise can help you efficiently navigate the complexities of toxicity testing, including ED assessment, and ensure robust justifications for scientifically sound and defensible classifications.

With in-depth regulatory and scientific expertise in all relevant disciplines, SCC can provide you with professional advice and custom-tailored solutions to ensure your regulatory compliance now and in the future. Get in touch with our experts here.

Ukraine Adopts Regulation on Chemical Safety, Ukraine REACH

31 October 2024

In July 2024, the Ukrainian government formally approved Law No. 2804-IX, the technical regulation on ensuring chemical safety and management of chemical products. The Ukraine REACH regulation (or UA REACH) follows the example of EU REACH and will come into force on 23 January 2025, six months after its approval.

The new regulation affects importers, manufactures, suppliers and downstream users who must register chemical substances and their mixtures in volumes exceeding one tonne per year before they can place them on the Ukrainian market.

SCC Joins Forces with Ramboll

6 September 2024

We are pleased to announce that we have joined the global engineering, architecture and consultancy company Ramboll to complement and enhance its health sciences expertise. Joining forces, Ramboll and SCC aim to play a leading role in the European and global product safety and regulatory affairs market and enable our clients to protect biodiversity and natural resources through sustainable solutions.