GB MCL List Update
Overview:
The recent revelation by the Health and Safety Executive (HSE) that the 14th and 15th Adaptations to Technical Progress (ATPs) to CLP were not retained in GB law has significant implications. This summary aims to elucidate the background, the ensuing actions by the HSE, and the potential impacts on businesses.
Background:
Upon the publication of the GB MCL, the HSE included a note regarding the 14th and 15th ATPs, indicating their retention in GB CLP with specific application dates. However, a subsequent communication from the HSE on January 11, 2024, contradicted this, disclosing that the entries were not, in fact, retained.
HSE's Proposed Actions:
The HSE, as the GB CLP Agency, proposes to rectify this discrepancy by updating the status of GB MCL list entries for 90 substances impacted by the 14th and 15th ATPs. The EU harmonised classification and labelling (EU CLH) entries for these substances were not retained in GB law after the transition period ended on December 31, 2020.
To address this, the HSE plans to utilise the Article 37 and Article 37A procedures of the GB CLP Regulation. A consolidated Technical Report and Agency Opinion have been published, and a Recommendation to Ministers will follow, seeking consent from the Ministers in the Devolved Governments. The proposed GB MCLs are expected to gain mandatory legal effect in GB, with an anticipated entry into force and compliance dates of April 2024.
A subsequent CLP ebulletin will be issued upon the update of the GB MCL list. Importantly, duty holders are reassured that no immediate action is required, as they were previously advised to follow harmonised classification and labelling during the Implementation Period.
Impacts on Businesses:
The overall impact on businesses is anticipated to be minimal, considering that most should have already implemented the 14th and 15th ATPs by their respective application dates. The proposed changes aim to maintain the 'status quo,' aligning with the mandatory classification and labelling agreed upon while the UK was still an EU Member State.
However, special attention is warranted for two substances—titanium dioxide in powder form and granulated copper—where additional information necessitates further assessment under the Article 37A procedure of the GB CLP Regulation.
Conclusion:
With the majority of substances likely already integrated into business practices, only those dealing with titanium dioxide in powder form and granulated copper may need to take specific actions. Businesses are advised to await the formal adoption of classifications into GB MCL, expected in April 2024, before updating hazard communication protocols, including safety data sheets and labels.
EU Biocidal Product Regulation: Recent Active Substance Approval and Non-Approval Decisions
Approved Active Substances:
Sulfur Dioxide
- Generated From: Sulfur by combustion
- Product Type Affected: 04
- Action for Suppliers: Apply for EU BPR product authorisation by October 1, 2024, for continued supply in Northern Ireland (NI).
Formic Acid
- CAS: 64-18-6
- EC: 200-579-1
- Product Types Affected: 02, 03, 04, and 05
- Action for Suppliers: Apply for EU BPR product authorisation by November 1, 2024, to maintain supply in NI.
(Note: New product supply in NI is prohibited until product authorisation is granted.)
Action for Active Substance Suppliers:
If you supply the mentioned active substances for use in biocidal products of the relevant product types, consider applying for technical equivalence.
Technical equivalence demonstration is crucial for EU BPR product authorisation.
(Note: Lack of technical equivalence may impede product authorisation for biocidal products containing the active substances.)
Non-Approved Active Substance:
Silver Zinc Zeolite
- CAS: 130328-20-0
- EC: 603-404-0
- Product Type Affected: 04
- Biocidal products containing this active substance in product type 04 cannot be supplied or used in NI after December 18, 2024. Manage stocks for removal from the NI supply chain by the specified date.
- New treated articles with this active substance cannot enter the supply chain or be imported into NI after June 15, 2024.
- Existing treated articles in NI supply chains before June 15, 2024, can continue to be supplied and used.
Product approvals under the Control of Pesticides Regulations (COPR) for affected NI products will be revoked in line with the specified dates.
UK REACH: Second Recommendation for Inclusion in Annex 14
In a significant development, the Health and Safety Executive (HSE) issued the second recommendation for the inclusion of diisohexyl phthalate (EC: 276-090-2 and CAS: 71850-09-4) in Annex 14 of UK REACH. This recommendation aims to subject the specified substance to authorisation.
Draft Recommendation Overview:
In September 2023, HSE initially published a draft recommendation proposing the addition of diisohexyl phthalate to Annex 14 of UK REACH. The draft underwent a comprehensive 3-month commenting period, concluding in December.
Updated and Finalised Recommendation:
The recommendation has undergone necessary updates and is now finalised as the second recommendation put forth by HSE, acting as the Agency for UK REACH. This recommendation is submitted to the Appropriate Authorities, comprising the Secretary of State for (Defra), along with the Scottish and Welsh Ministers. The Appropriate Authorities will ultimately make the decision regarding the inclusion of diisohexyl phthalate in Annex 14.
Further Proceedings:
Stakeholders and concerned parties are encouraged to access the relevant documents associated with this recommendation. These documents are instrumental in understanding the specifics of the recommendation and its potential implications.
RIFM Concentration Survey 043: Request for Concentration Data on 156 Fragrance Ingredients
Overview:
The Research Institute for Fragrance Materials (RIFM) is currently conducting its 43rd concentration survey to gather essential data for safety assessments of fragrance ingredients. This comprehensive survey involves the participation of fragrance compounders, focusing on the concentrations of 156 fragrance materials. The deadline for submission is March 8, 2024.
Key Points:
Importance of Data
- RIFM emphasises the significance of exposure data for a thorough safety assessment across various endpoints.
The Creme RIFM Aggregate Exposure Model
- The Creme RIFM Aggregate Exposure Model, a probabilistic aggregate exposure model, is highlighted for calculating total systemic exposure. This model utilises distributions to model various parameters, providing insights into real-life consumer exposure to fragrance materials.
Confidentiality
- Concentration data provided by participants will remain confidential, with entries incorporated into the model without disclosing the data sources.
Participant Eligibility
- Only fragrance compounders, specifically companies blending fragrance ingredients for marketed fragrance mixtures, are eligible to provide information. Concentrations should reflect those currently in use.
Submission Guidelines
- Participants are urged to submit data on all materials, even if there have been no changes since the last survey, considering the five-year re-survey cycle.
- For natural complex substances (NCSs), the RIFM identifier takes precedence over the CAS Number.
- The submission deadline is March 8, 2024.
Additional Considerations
- The survey includes fragrance ingredients used in 'technologies' aiming to release fragrance under specific conditions, emphasising the reporting of the fragrance ingredient rather than the parent material(s).
- Participants must report concentrations for each product type, even if a material is used in a product with dual uses.
- The Creme Global portal facilitates the submission process, providing a user-friendly interface for data transfer and survey completion.
Action Required
Participants are encouraged to register and submit their survey responses by March 8, 2024, via the Creme Global portal.
For detailed instructions, participants can refer to the RIFM Data Portal guide.
Webinars and Contacts
RIFM has conducted webinars explaining the survey process and portal system. Interested participants can register for and view these webinars through the provided links.
For further inquiries, participants can contact Dr. Anne Marie Api at amapi@rifm.org or Gretchen Ritacco at gritacco@rifm.org.
Amendments to Cosmetic Ingredient Lists in Taiwan: Effective July 1, 2024
On January 4, 2024, the Taiwan Food and Drug Administration (TFDA) announced its intention to restructure the current cosmetic ingredient lists, with proposed amendments open for public comments until March 4, 2024. These changes are slated to come into effect on July 1, 2024.
Reasons for Amendments
1. Reclassification of Specific Purpose Cosmetics:
Currently, cosmetic products in Taiwan are categorised into general cosmetics and specific purpose cosmetics.
Starting from July 1, 2024, all specific purpose cosmetics, as per Article 5 of the Cosmetic Hygiene and Safety Act, will be regulated as general cosmetics.
To align with this reclassification, TFDA proposes abolishing the existing List of Specific Purpose Ingredients in Cosmetic Products and reallocating its ingredients.
Streamlining of Antibacterial Ingredients Regulation:
TFDA notes that countries such as the EU, the United States, Japan, ASEAN, and others do not have separate regulations for antibacterial ingredients in cosmetics.
Considering this, TFDA plans to discontinue Taiwan's current List of Antibacterial Ingredients Allowed in Cosmetic Products.The ingredients from this list will be reassigned to other relevant lists.
Details of Proposed Amendments
1. List of UV Filters in Cosmetic Products:
Newly Established: A new list will be created, encompassing 27 UV filters.
Inclusion Criteria: The list will include 26 ingredients currently used for sunscreening, along with Titanium Dioxide from the restricted ingredients list.
2. List of Ingredients Restricted in Cosmetic Products:
Additions: 122 ingredients will be added.
Revisions: 31 existing ingredients will undergo revisions.
Deletions: 2 ingredients will be removed.
Use Conditions: For overlapping ingredients from the abolished lists, TFDA will combine their use conditions into the restricted ingredients list.
Product Type Updates: Applicable product types for some existing ingredients will be updated to align with international regulations.
Action Required
Interested stakeholders are encouraged to review the proposed amendments and provide comments by the deadline of March 4, 2024. The TFDA aims to ensure the continued safe use of ingredients through these restructuring efforts.
Full amendments can be found here.
Important Announcements Regarding GB Active Substances
Open Invitation for GB Review Programme Participation
HSE has issued an open invitation for interested parties to notify their intention to participate in the GB Review Programme for the active substance/product type combination:
- Peanut butter in product type 19. Deadline for Notification: 14 March 2024.
Failure to submit a notification to take over the role of participant by the deadline may lead to a GB non-approval decision for this active substance/product type combination. Biocidal products and treated articles containing such substances will then be required to be removed from the GB market.
Upcoming GB Active Substance Expiry Dates:
Biocidal products containing the following active substance/product type combinations are set to expire under the GB BPR on the specified dates:
- (RS)-4-hydroxy-3-(3-oxo-1-phenylbutyl)coumarin (Warfarin) (CAS 81-81-2 EC 201-377-6) in product type 14
Expiry Date: 30 June 2024
- Polyhexamethylene biguanide hydrochloride with Mn of 1600 and PDI of 1.8 (PHMB (1600;1.8)) (CAS 27083-27-8 / 32289-58-0 EC n/a) in product types 02, 03, and 11
Expiry Date: 30 June 2024
- Chlorophacinone (CAS 3691-35-8 EC 223-003-0) in product type 14
Expiry Date: 30 June 2024
- 4-bromo-2-(4-chlorophenyl)-1-ethoxymethyl-5-trifluoromethylpyrrole-3-carbonitrile (Chlorfenapyr) (CAS 122453-73-0 EC 602-782-4) in product type 08
Expiry Date: 30 April 2025
- 1-[[2-(2,4-dichlorophenyl)-4-propyl-1,3-dioxolan-2-yl]methyl]-1H-1,2,4-triazole (Propiconazole) (CAS 60207-90-1 EC 262-104-4) in product type 09
Expiry Date: 31 May 2025
Upon expiry, these active substances cannot be used in biocidal products or treated articles of the relevant product types in GB. Holders of affected authorisations or approvals will be contacted for further steps, with an opportunity to provide comments or additional information.
California Prohibits 26 Chemicals in Cosmetics: A Breakdown
California Governor Gavin Newsom has signed Assembly Bill 496, a new law aimed at banning 26 chemicals commonly found in cosmetics. This legislation builds upon the state's existing Toxic-Free Cosmetics Act from 2020, which initially banned 24 chemicals in personal care products.
Key Points:
Expansion of Legislation:
Assembly Bill 496 expands the scope of prohibited chemicals in cosmetics beyond the initial 24, bringing the total to 50 banned substances.
The original law from 2020, which bans 24 chemicals, is set to take effect in 2025.
Effective Date:
The recent legislation, banning an additional 26 chemicals, will be enforced starting in 2027.
This grace period until 2027 allows companies time to reformulate their products and comply with the new regulations.
Banned Ingredients:
The banned ingredients include substances found in various cosmetic items such as hair products, body wash, and nail polish.
Specific chemicals, like vinyl acetate and certain colours, are among the newly prohibited substances.
Health Concerns:
The prohibition stems from increasing health concerns associated with the use of these chemicals in personal care products.
Assemblymember Laura Friedman, the bill's introducer, emphasises the importance of non-toxic personal care items and draws attention to the European Union, which has already restricted nearly 2,000 chemicals in such products.
Link to Health Problems:
The banned chemicals have been linked to various health problems, including cancer and genetic defects.
The move reflects a commitment to consumer safety and public health, especially given that the U.S. cosmetic industry is not legally obligated to seek FDA approval before releasing products.
California's SB 253: Paving the Way for Emission Transparency
California's lawmakers have approved a groundbreaking bill, SB 253, aimed at compelling major companies operating within the state to disclose extensive information regarding their emissions. This bill, currently awaiting Governor Gavin Newsom's decision, has the potential to usher in a new era of transparency in emissions reporting.
Key Points
Legislation Overview:
SB 253 is poised to become a transformative law that mandates comprehensive emissions disclosures from major companies.
The bill is currently awaiting approval from Governor Gavin Newsom, who has not yet indicated his stance.
Scope of Reporting:
If enacted, the legislation will require businesses with annual revenues exceeding $1 billion to report a wide range of emissions data.
Reporting will cover not only emissions from direct facilities but also include those originating from indirect sources such as suppliers, employee commutes, and corporate travel.
Resistance from Business Sector:
The bill encountered strong opposition from the business sector, with notable resistance efforts led by certain entities.
Lobbying against the bill intensified, especially as the legislative session approached its conclusion.
Importance of Emission Transparency:
The emphasis on comprehensive emissions reporting reflects a growing recognition of the need for transparency in corporate environmental practices.
Stakeholders, including consumers, investors, and regulatory bodies, are increasingly prioritising information on a company's carbon footprint and efforts to mitigate environmental impact.
