Industry Advisory: ECHA Assessments Demand Vigilance
In response to the European Chemical Agency's (ECHA) Assessment of Regulatory Needs reports (ARN), major industry associations – Eurometaux, International Fragrance Association (IFRA), FuelsEurope, and Downstream Users of Chemicals Co-ordination Group (DUCC) – have collaborated to issue crucial recommendations for chemical suppliers. The ARN, a preliminary step by ECHA, assesses the need for potential regulatory risk management for substances. From 2019 to 2022, ECHA evaluated approximately 5,000 substances, revealing that 60% may not require further regulatory risk management. The remaining 40% may necessitate additional data collection before considering regulatory risk management.
Key Recommendations for Chemical Suppliers:
- Read Carefully: Scrutinize assumptions in ARN reports, considering missing information and the screening level nature of the assessment.
- Update Dossier: Keep registration dossiers current by correcting outdated information and filling identified data gaps.
- Feedback to ECHA: Identify errors and inform ECHA via the feedback button, as stakeholder input may prompt updates.
- Prepare for Action: Proactively collect data for upcoming public consultations and evidence gathering, anticipating potential regulatory actions.
- Inform Customers: Maintain transparency by keeping customers informed about potential regulatory actions.
- Stay Informed: Be aware of varying timelines for regulatory actions through channels like the PACT list, ECHA Newsletter, Restriction Roadmap, and the Registry of Intention.
Global Shifts: Animal Testing Banned in Chile and Canada
Chile and Canada have taken significant steps in the global movement towards cruelty-free cosmetics. In Chile, the Senate unanimously passed a bill banning cosmetic animal testing and trade. The legislation, following a multi-year campaign led by Humane Society International (HSI) and Te Protejo, prohibits the manufacturing, import, and marketing of cosmetics tested on animals. In Canada, the Budget Implementation Act (Bill C-47) officially enforces a ban on cosmetics animal testing and trade. Corporate and non-profit leaders, including industry giants like Lush, Unilever, Avon, L’Oreal, and Procter & Gamble, supported these initiatives.
Future Prospects: Humane Cosmetics Act in the U.S.
In the United States, a bipartisan delegation has reintroduced the Humane Cosmetics Act, aiming to prohibit the sale of cosmetic products developed using animal testing. The act is under review in Congress and, if passed, will lead to a nationwide prohibition of animal-tested cosmetics.
FDA Introduces Digital Tools for Cosmetic Facility Submissions
On January 8, 2024, the U.S. Food and Drug Administration (FDA) introduced Structured Product Labelling (SPL) Xforms, a digital tool for cosmetic product facility registrations and product listings. This initiative aligns with the Modernisation of Cosmetics Regulation Act (MoCRA), providing electronic options such as Cosmetics Direct and SPL-formatted submissions through the Electronic Submissions Gateway (ESG). While paper submissions remain an option, the FDA strongly encourages electronic submissions for efficiency and timeliness.
Peru's Hazardous Substances Regulation Takes Effect
Peru has implemented the 'Regulation and Supervision of Hazardous Substances for Domestic, Industrial, and/or Public Health Use' (No. 031-2023-sa). This Supreme Decree complements Legislative Decree No. 1570, focusing on comprehensive chemical substances management. It applies to natural and legal persons engaged in activities related to hazardous substances, categorising them into industrial chemical products, disinfectant products, pesticide products, and hazardous products under the Rotterdam Convention.
EU Commission's Workshop: Paving the Way for Animal-Free Safety Assessments
The EU Commission held a workshop on December 11-12, 2023, to develop a roadmap for phasing out animal testing in chemical safety assessments. This commitment aims to outline milestones and specific actions, addressing relevant chemical legislation such as REACH, Biocidal Product Regulation, Plant Protection Products Regulation, and human and veterinary medicines.
GB MCL List Update: HSE's Proactive Approach
The Health and Safety Executive (HSE), acting as the GB CLP Agency, is set to modify the status of entries in the Great Britain mandatory classification and labelling (GB MCL) list. This adjustment pertains to 90 substances included in the GB MCL list from the 14th and 15th Adaptations to Technical Progress (ATPs) after the UK's departure from the European Union.
Proposal and Procedures:
- Background: The EU harmonised classification and labelling (EU CLH) entries for these 90 substances were not retained in GB law after the transition period ended on December 31, 2020.
- Resolution Plan: HSE proposes using the Article 37 and Article 37A procedures of the GB CLP Regulation to update the GB MCL list.
- Technical Report and Agency Opinion: A consolidated Technical Report and Agency Opinion have been published, available on the HSE GB CLP publication table.
Future Steps:
- Ministerial Decision: HSE will recommend to Ministers, with consent from the Devolved Governments, to give the proposed GB MCLs mandatory legal effect in GB.
- Entry into Force: Expected entry into force and compliance dates for these 90 substances are slated for April 2024, following publication in the HSE GB CLP table.
- Communication: Duty holders are not required to take action, as HSE had previously advised adherence to harmonised classification and labelling during the Implementation Period.
- Classification Unchanged: Following the update, the classification and labelling of these substances will generally remain unchanged, except for substances like titanium dioxide in powder form and granulated copper, subject to additional assessments under Article 37A of the GB CLP Regulation.
- Ebulletin: A further CLP ebulletin will be issued to communicate updates on the GB MCL list.
Philippines: Reassessing Chemical Management Policies
The Philippines Department of Environment and Natural Resources, Environmental Management Bureau, has initiated a comprehensive review of existing policies on the management of chemicals. This review, covering Administrative Orders, Memorandum Circulars, and policies under Chemical Management, aims to identify gaps, overlaps, conflicts, and potentially obsolete policies.
Milestones in CLP Legislative Provisions
A significant milestone was reached during the trilogue meeting on December 5, where a political agreement on the final CLP legislative provisions was secured. Fragrance industry leaders, including IFRA, Cosmetics Europe, and CEFIC, played a vital role in advocating for specific provisions related to Natural Complex Substances (NCS) and the grouping of chemical substances for harmonised classification and labelling.
Key Outcomes:
- Derogation for Natural Complex Substances: Specific provisions include a derogation for substances extracted from plants or plant parts not chemically modified, offering flexibility in classification rules.
- Transversal Provisions: Transversal provisions ensure clear scientific reasoning in grouping chemical substances, considering available information and predicting properties within the group.
- Review Clause: A review clause is incorporated, requiring a scientific report five years after the entry into force of the CLP regulation.
- Legislative Approval: The Council formally adopted the new Regulation in December, with the European Parliament vote scheduled for January 11, 2024. Upon formal adoption, the Regulation will be published in the Official Journal of the EU (OJEU), expected in late January 2024, and will enter into force 20 days after publication.
