Regulatory Affairs overview: February 2024

Dive into our team's expertise in this new Linkedin newsletter on the Biocides and REACH markets.

Our experts offer a new opportunity to discover the latest developments in this sector once a month.

Stay up to date by subscribing!

Biocides

1. REACH/BPR?: Possible exemption of the biocidal active substances from the restriction for skin sensitising substances?in textiles, leather, hide, fur and synthetic leader

Under the REACH restriction framework, a particular attention has been rised on the presence of skin sensitising chemicals in clothing and related accessories, footwear, as well as textiles, leathers, furs, hides and synthetic leathers that are in direct contact with the skin and in certain disposable products. Indeed, these substances can migrate into the human body resulting in adverse effects if a safe threshold of the substance is exceeded.

During the 102nd Biocides CA meeting of the 8th December 2023, the possibility to exempt the biocidal active substances from this restriction for skin sensitising substances has been discussed, based on the conclusions from the Risk Assessment Committee (RAC) and Committee for Socio-Economic Analysis (SEAC).

2. Efficacy?– GB-BPR?: Supplementary GB product type 19 efficacy guidance published

ECHA (European Chemicals Agency) has recently adopted new efficacy technical guidance on how to perform the hazard and exposure assessment and risk characterisation for biocidal active substances and products used in product type (PT) 19 (repellent products). HSE also adopted this guidance for Great Britain but with 2 specific exceptions?: on mortality testing requirements for invertebrates, and on claims and tests for topical mosquito repellents.

All the additional information on these deviations are available in the specific GB guidance. Applicants submitting applications for repellent products after December 2023 should use the ECHA guidance along with the exceptions and supplementary information.

Click on this link to consult the GB BPR guide.

REACH

1. CLP (Classification, Labelling and Packaging) Regulation Updates

The harmonised classification and labelling of hazardous substances is updated through an Adaptation to Technical Progress (ATP), issued by the European Commission. ATPs are published in the Official Journal of the European Union as updates to Table 3 of Part 3 of Annex VI to CLP. The transition period following the publication of an ATP is generally 18 months. The 18th ATP is currently in force, having been published on the 3rd of May 2022, and the transition period ended on the 1st of December 2023. The 19th and 20th ATPs were both published on the 11th of July 2023, with the transition period for the 20th ATP ending on the 1st of February 2025. However, they can be applied voluntarily from the enter into force date of the 31st of July 2023. The 21st ATP was also published on the 5th of January 2024. It will come into force on the 25th of January 2024 and apply from 1st of September 2025.

2. ECHA’s new chemical database ECHA CHEM

ECHA has launched a new chemicals database known as ECHA CHEM. This new database allows the Agency to better handle the growing diversity and quantity of data, while taking advantage of technological advancements. The first release consists of information from over 100,000 REACH registrations submitted to ECHA. Subsequent releases are expected with information on additional registrations. The database will also be expanded later in 2024 with the release of the redesigned Classification and Labelling Inventory, followed by the first set of regulatory lists. A timeline of the expected developments can be found below:

New approval deadlines:

In need for personalised regulatory advice to meet your specific needs? Whether you need assistance about compliance, product registration or any other regulatory issue, our experts are here to provide support. Contact us or visit our website for more information:

[email protected]

staphyt.com