FDA MoCRA Portal Beta Test Started This Week
The MoCRA portal beta test is currently underway. While this means that selected beta testers are actively engaging with the system, please note that the portal is not yet accessible to the broader industry.
Enforcement Timeline Reminder:
While the statutory deadline for facility registration and product listing is December 29, 2023, it's essential to highlight that the FDA has announced a delay in enforcement until July 1, 2024. This extension specifically pertains to Facility Registration and Product Listing. All other statutory requirements, including adverse event tracking and reporting, safety substantiation, professional use labelling, records access, etc., remain unaffected.
PFAS Alert: No PFAS in Cosmetics Act Reintroduced in the House
In a crucial move, Representatives Debbie Dingell (D-MI), Brian Fitzpatrick (R-PA), and Annie Kuster (D-NH) have reintroduced the bipartisan No PFAS in Cosmetics Act (H.R.6519). This legislation aims to prohibit the use of per- and polyfluoroalkyl substances (PFAS) in cosmetic products. Notably, the bill mandates the Food and Drug Administration (FDA) to enforce the ban within 270 days of the legislation being enacted.
TiO2 Safety Alert: SCCS Triggers Debate on Titanium Dioxide in Oral Care Products
The European Union Scientific Committee on Consumer Safety (SCCS) has raised concerns about the safety of titanium dioxide (TiO2) in oral care products. While certain nano grades show no genotoxicity concerns, the SCCS emphasises the lack of adequate evidence for most TiO2 grades, sparking a debate on its safety in products like toothpaste and mouthwash. The preliminary opinion is open for comments until February 6, 2024, underscoring the need for nuanced risk assessments and further investigations into potential risks associated with long-term oral exposure to TiO2 nanoparticles.
ECHA Public Consultation Alert: Have Your Say on Hazard Classifications
The European Chemicals Agency (ECHA) has initiated public consultations on proposed harmonised classifications and labelings (CLH) for various substances, including ethylene bis[3,3-bis(3-tert-butyl-4-hydroxyphenyl)butyrate], metam-sodium, methyl isothiocyanate, and tebuconazole. If your business is impacted by the GB CLP Regulation, consider sharing relevant information with ECHA through their commenting webform by January 19, 2024.
Updated Guidance for Product Type 19 (PT 19) Efficacy Evaluations in Great Britain
The Health and Safety Executive (HSE) has released supplementary guidance for efficacy evaluations of product type 19 (PT 19), aligning with the ECHA efficacy guidance from December 2021. However, two exceptions have been introduced for Great Britain concerning mortality testing requirements for invertebrates and claims/test species for topical mosquito repellent. GB applicants should refer to this updated guidance for applications submitted from December 2023. Stay informed and ensure compliance with the latest efficacy evaluation criteria.
Latest Developments in Biocidal Regulations
Active Substance Renewal Decision: Propiconazole (Product Type 08)
The EU Biocidal Products Regulation (BPR) has renewed the active substance Propiconazole (CAS 60207-90-1, EC 262-104-4) in product type 08. The new expiry date is set for 30 November 2030. Suppliers on the EU Article 95 List for this combination must submit relevant data or a letter of access by 12 December 2024 to remain on the list. Evaluate the impact on your products and comply with renewal conditions.
Active Substance Non-Approval Decision: Silver Zeolite (Product Type 04)
Silver Zeolite (CAS 130328-18-6, EC 620-078-5) in product type 04 has not been approved under the EU BPR. Biocidal products containing this substance can no longer be supplied in Northern Ireland after 19 December 2024, or used after 19 June 2025. Manage your product stocks accordingly. Treated articles with this substance cannot enter the supply chain or be imported into NI after 16 June 2024.
Upcoming Expiry Dates for Active Substances
(RS)-4-hydroxy-3-(3-oxo-1-phenylbutyl)coumarin (Warfarin) in product type 14: Expiry on 30 June 2024.
Polyhexamethylene biguanide hydrochloride (PHMB) with Mn 1600 and PDI 1.8 in product types 02, 03, and 11: Expiry on 30 June 2024.
For further details, refer to the HSE website.
