Regulatory Affairs overview: March 2024

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

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Biocides

1. New Bee Guidance published by ECHA in February 2024.?

New Bee Guidance published by ECHA in February 2024 (in accordance with Article 19(1)(b)(iv) of the EU Biocidal Products Regulation).

To carry out a risk assessment on bees either if the active substance is authorized for the PT18?(insecticides, acaricides and products to control other arthropods), or the substance active has an insecticidal mode of action, and if the bees are exposed.?

Scope of the Guidance Document: risk assessment for chemical biocidal substances applied as or reaching the environment through outdoor spraying, manure/sludge application, and irrigation. The Guidance is focused?on PT18 uses. Possible sources of exposure covered: overspray, application of manure/sludge to agricultural soil or grassland, small scale spray around the house, irrigation of private gardens with treated water. Tiered approach scheme proposed for biocidal active substances for the exposure estimation in different scenarios, hazard characterization and a risk assessment methodology covering both dietary and contact exposure. Depending on the toxicity of the active substance and biocidal product, acute (contact and oral) toxicity studies to chronic toxicity study (oral toxicity) especially on honey bees could be requested. This document also provides recommendations for higher tier assessment, metabolite risk assessment and biocidal product risk assessment (mixtures).

ECHA hosted a webinar on this subject on March 5, 2024 – Replay is available on ECHA’s YouTube channel.

2. New IUCLID version and SPC format into IUCLID

From February 10, 2024, a new format for the SPC document is required for BPR submissions through R4BP3. The SPC documents in .xml format are no longer valid and the SPC editor has been disengaged. All the SPC documents submitted in support of new or existing applications will have to be in the IUCLID format .i6z.?

Conversion of .xml files into .i6z format is easy: just import your .xml file into IUCLID and it will be converted into the new .i6z format. Then, a simple export action will be necessary.

To ease this conversion, a new version of IUCLID 6 has been released (v7.12.4).

A webinar session presenting the updates in the SPC was held last February, 15 and is available on ECHA's website.

If you need support with the preparation of the SPC in the new IUCLID format, if need support with your Biocides submission, do not hesitate to contact us at [email protected].

3. Next products' submission deadlines

Be ready for the next important deadlines for the submission of new biocidal products!

• Formic acid (CAS No: 64-48-6) for PT2, PT3, PT4 and/or PT5 by October 31,
• Chrysanthemum cinerariaefolium, extract from open and mature flowers of Tanacetum cinerariifolium (CAS No: 89997-63-7) for PT18 by January 31, 2025
• Alkyl (C12-16) dimethylbenzyl ammonium chloride (ADBAC/BKC) (CAS No: 68424-85-1) for PT2 by June 30, 2025
• Pentapotassium bis(peroxymonosulphate) bis(sulphate) (KMPS) (CAS No: 70693-62-8) for PT2, PT3, PT4 and PT5 by June 30, 2025

Anticipate the deadline and start the preparation of your dossier if your biocidal products contain these substances or a combination of different substances and PTs. If you need technical assistance to successfully achieve your goals in the dossier preparation you can contact us at [email protected]

REACH

1. IUCLID Updates and Deadlines

The latest version of IUCLID (v7.12.4) is now available. ECHA Cloud Services users will see their IUCLID being upgraded automatically, starting on February 5, 2024. This new version contains improvements including:

• Updated Candidate List of SVHC
• Improved report generator
• Latest updates relevant to the preparation of Summaries of Product Characteristics (SPC)

The update is particularly relevant for preparing SCIP dossiers, CLP notifications and Poison Centre Notifications (PCNs). The obligation to submit PCNs applied from January 1, 2021, with varying transition periods depending on the end use of the mixture. The final transition periods will end on January 1, 2025, after which all notifications, regardless of the use type, will need to notified in the harmonized format.

2. Newly Proposed Restriction on BPA and other Bisphenols

The European Commission has published its draft regulation proposing a restriction on the use of bisphenol A (BPA) and other bisphenols in food contact materials (FCM). The restriction will impose a full ban on the use of BPA in food contact materials (FCMs), including plastic and coated packaging. It will also address the use of other bisphenols in FCMs which fall under the category of "mutagenic", "carcinogenic", "toxic to reproduction" or "endocrine disrupting", in order to avoid regrettable substitution whereby BPA is replaced by an equally harmful substance. The draft act also sets out derogations and transitional periods that may apply to businesses. The restriction is open for commenting by interested parties for a period of 4 weeks, with a deadline on March 8, 2024. The commenting period provides an opportunity for businesses to submit comments and any concerns they may have. If adopted, the restriction on bisphenols is anticipated to take effect between late 2025 and early 2026.

3. UK REACH Reports and Work Programmes

The UK’s HSE (Health and Safety Executive) has published the UK REACH Report, which outlines the relevant UK REACH activities up to the end of the 2022/2023 Work Programme. The report provides an assessment of the progress of the key deliverables and targets within the last year. The HSE has also published the UK REACH Work Programme, which describes the activity that the HSE and other relevant agencies will carry out to operate UK REACH in 2023/24. The Work Programme includes targets for the upcoming year, for example to evaluate one substance in the Rolling Action Plan. Both the UK REACH Report and Work Programme documents are provided annually, as UK REACH requires that the HSE, supported by the Environment Agency, provides a report and programme of work for UK REACH operational activities.

4. ECHA consultation on recommending five substances for the REACH Authorization List

ECHA regularly recommends substances from the Candidate List to be included in the Authorization List by the Commission. If a substance is included in the Authorization List, it cannot be placed on the market or used after a given date unless an authorization is granted for a specific use. ECHA is considering recommending the following substances for the REACH Authorization List:

• Melamine,
• Bis(2-ethylhexyl) tetrabromophthalate covering any of the individual isomers and/or combinations thereof (TBPH),
• S-(tricyclo[5.2.1.0 2,6]deca-3-en-8(or 9)-yl) O-(isopropyl or isobutyl or 2-ethylhexyl) O-(isopropyl or isobutyl or 2-ethylhexyl) phosphorodithioate,
• Diphenyl(2,4,6-trimethylbenzoyl)phosphine oxide,
• Barium diboron tetraoxide.

Consequently, ECHA has opened a consultation period until May 7, 2024. ECHA is looking for information on the uses of these substances, possible exemptions from authorization and on the structure of the supply chains.

In need for personalized 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]

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