November Regulatory Updates

CLP:

ECHA Updates CLP Regulation Guidance: Key Changes Explained

This November, ECHA published an updated version of the guidance on applying the Classification, Labelling, and Packaging (CLP) Regulation. The new guidance offers a more user-friendly structure and incorporates significant content updates compared to the previous version (6.0, January 2024).

1. Structural Changes:

• The updated guidance (version 1.0) is now divided into multiple parts for easier reference, replacing the single-document format of version 6.0.
• A summary table in the overview document (Table 2.1) tracks changes introduced in all versions since 2009.
• The guide is split into the following parts:
  • Part 1: General principles for classification and labelling (including Annex I, previously Annex V).
  • Part 2: Physical hazards (including Annex I, previously Annex VII).
  • Part 3: Health hazards (including Annex I, previously Annex VI).
  • Parts 4/5: Environmental and additional hazards (covering Annexes I-IV).

2. Content Updates: The new version not only reorganizes the structure but also introduces substantial updates in key areas:

• Part 2: Physical Hazards
  • Comprehensive updates for hazard classes (Sections 2.1 to 2.16).
  • Incorporation of revised test guidelines (CLP ATP 12).
  • Alignment with scientific developments and comparability between EU and UN methods.
  • Removal of references to the now-obsolete Dangerous Substances Directive (DSD).
  • A new section (2.17) on desensitized explosives.
• Part 3: Health Hazards
  • Addition of Section 3.11, addressing endocrine disruptors affecting human health.
• Parts 4/5: Environmental and Additional Hazards
  • New sections:
    • Section 4.2: Endocrine disruptors (environmental impact).
    • Section 4.3: PBT/vPvB (persistent, bioaccumulative, and toxic substances) and PMT/vPvM (persistent, mobile, and toxic substances).

Key Takeaways: The updated guidance ensures improved accessibility and reflects the latest scientific and regulatory developments. Key updates address physical hazards, endocrine disruption, and PBT/vPvB and PMT/vPvM substances. These changes aim to enhance the accuracy and usability of information for stakeholders involved in chemical classification, labelling, and packaging.

 

Biocides:

IUCLID Version 8.13.2 Service Release: Key Updates

The latest release of IUCLID, version 8.13.2, is now available, introducing crucial enhancements to improve functionality, performance, and user experience. This update ensures more efficient chemical data management, aligning with regulatory compliance needs.

Key Features of the Update:

1. Improved System Performance:
   • Faster loading times and optimized data processing provide a smoother and more efficient user experience.
2. Enhanced User Interface:
   • Updates to the web interface make data entry more intuitive and navigation simpler, boosting accessibility for users at all levels.
3. Reporting Enhancements:
   • Streamlined reporting capabilities enable users to extract and present data more effectively, offering better insights for regulatory submissions.
4. Strengthened Security Features:
   • Advanced security measures protect sensitive data and ensure compliance with data protection standards.

Why It Matters: The new features in IUCLID v8.13.2 empower businesses to meet regulatory requirements with greater ease, accuracy, and efficiency, reinforcing ECHA’s commitment to facilitating robust and secure chemical data management.

For businesses relying on IUCLID, this update represents a critical step toward streamlining operations and enhancing compliance readiness.

 

CIT Biocidal Active Substance Not Approved for PT 6 Use

The European Commission has released a draft implementing regulation announcing its intention to not approve the biocidal active substance 5-chloro-2-methyl-2H-isothiazol-3-one (CIT) for use in product-type 6 (PT 6), which covers preservatives for products during storage. This decision is made under Regulation (EU) No. 528/2012.

Key Details:

• The draft regulation indicates that CIT will not be approved for PT 6 applications.
• The Commission plans to formally adopt this decision in February 2025.

 

REACH:

ECHA Adds Triphenyl Phosphate to REACH Candidate List

On 7 November 2024, the European Chemicals Agency (ECHA) updated the REACH Candidate List by designating Triphenyl Phosphate (EC 204-112-2, CAS 115-86-6) as a Substance of Very High Concern (SVHC) due to its environmental risks and toxicity to aquatic life.

About Triphenyl Phosphate: This substance is classified as highly toxic to aquatic life with long-term environmental hazards. It is widely used across multiple sectors and applications, including:

• Consumer products: adhesives, sealants, coatings, and cosmetics.
• Industrial applications: building materials, electronics, machinery, and textiles.
• Household items: flooring, furniture, toys, and paper products.

Its presence in durable materials can lead to low but continuous environmental release, raising concerns about its long-term impact on ecosystems.

Implications for Businesses: If your company operates in sectors such as manufacturing, construction, or consumer goods, and Triphenyl Phosphate is present in your products, you are required to:

1. Provide information about this substance to downstream users and consumers.
2. Explore safer alternatives to mitigate risks.
3. Update safety data sheets (SDS) to reflect the latest changes in the REACH Candidate List.

This update highlights the importance of monitoring regulatory changes and proactively addressing environmental and health concerns in supply chains and product portfolios.