New EU CLP Regulations Challenge Businesses

In a recent update to the EU Classification, Labelling and Packaging (CLP) Regulation, the European Commission has introduced several new hazard classes that could significantly impact companies' product assessments. The new classes include Persistent, Bioaccumulative, and Toxic (PBT), very Persistent and very Bioaccumulative (vPvB), Persistent, Mobile, and Toxic (PMT), very Persistent and very Mobile (vPvM), and Endocrine Disruptors (ED) for both human health and the environment.

Challenges in Compliance

1. Tight Implementation Timeline

Companies are facing a tight deadline to comply with the new regulations. They must review their entire product lines by deadlines ranging from May 1, 2025, to May 1, 2028, depending on whether the product is a substance or mixture and its market status. This process can be time-consuming, often requiring additional tests or new data to determine if products meet the criteria for these new hazard classes.

2. Data Gaps and Complexity of Assessments

A significant challenge is the lack of existing data for many substances needed for thorough assessments. Properties such as mobility and endocrine disruption are new considerations, and persistence evaluations may require costly high-tier simulation tests (e.g., OECD 307, 308, 309) to assess degradation under realistic environmental conditions. Existing data for these simulations are limited, adding to the complexity.

3. Lack of Expertise

The complexity and novelty of the required assessments for the new hazard classes pose a challenge due to the lack of updated guidance. While existing guidelines, such as the REACH Guidance on PBT/vPvB assessment and the EFSA-ECHA guidance on endocrine disruptors, can be referred to, they are lengthy and complex. Many companies may lack the expertise to navigate these documents and perform the required assessments effectively.

Challenges in Substance Evaluation

1. Complex Testing and Interpretation

Evaluating substances for the new hazard classes involves navigating numerous pitfalls and interpreting complex test results. For example, assessing substance persistence is complicated by the variability in degradation testing and the unique properties of substances. Testing volatile substances for biodegradation can lead to inaccurate results if the substance escapes from non-airtight systems, potentially indicating falsely low biodegradation potential.

2. UVCBs and Tailored Assessment Approaches

Substances of Unknown or Variable Compositions, Complex Reaction Products, and Biological Materials (UVCBs) present additional difficulties. Each constituent of a UVCB has distinct environmental fate and toxicity properties, requiring a tailored assessment approach. Comprehensive data collection for each constituent is necessary, demanding more extensive data than for mono-constituent substances.

The recent amendments to the EU CLP Regulation introduce significant challenges for companies, requiring them to adapt quickly and navigate complex new hazard classes. The tight implementation timeline, data gaps, and lack of specific guidance pose substantial hurdles. Companies must prepare for a detailed and potentially costly compliance process to meet the new regulatory requirements effectively.