UK Regulatory News

On 15 February 2024, the UK Department for Environment, Food and Rural Affairs (DEFRA) published the UK REACH Work Programme which describes the operational work planned for the 2023/2024 financial ye...

On 15 February 2024, the UK Department for Environment, Food and Rural Affairs (DEFRA) published the UK REACH Work Programme which describes the operational work planned for the 2023/2024 financial year. The work programme was expected to be published in June 2023, which is a significant delay. The financial year ends on 5 April 2024. Several of the objectives described in the Work Programme have, however, already been achieved.

Key activities in the work programme

The UK REACH Work Programme for 2023/24 prioritises a number of key activities to ensure effective regulation of chemicals. The table below lists more detail on the priorities outlined in the program:

The Work Programme can be accessed here.

Restriction Priorities in the Work Programme

In addition to the Work Programme, DEFRA has published the rationale for financial year he prioritisation of substances in the UK REACH work programme. The rationale identifies the following 5 substances/substance groups as priorities for 2023/2024:

• Per- and polyfluoroalkyl substances (PFAS):

  • Start preparation of a restriction dossier on PFAS in fire-fighting foams (FFFs)

  • Assess potential additional restrictions on further wide dispersive uses of PFAS and PFAS likely to be released from consumer articles.

• Formaldehyde and formaldehyde releasers in articles: Continue the Regulatory Management Options Analysis (RMOA) initiated under the 2022/2023 work programme and consider its recommendations.

• Bisphenols in thermal paper: Continue the RMOA initiated under the 2022/2023 work programme and consider its recommendations.

• Hazardous flame retardants: Further develop the risk assessment on flame retardants and consider the recommendations on completion.

• Intentionally added microplastics; Monitor progress of the evidence project initiated and commissioned under the 2022 to 2023 work programme.

The rationale also includes a list of 15 proposals that are not considered a priority for 2023/2024.

The full text of the rationale is available here.

UK-REACH Report 2022/2023

Also on 15 February 2024, the UK-REACH Report 2022/2023 was published, outlining the relevant activities in 2022/2023. The Report can be accessed here.

The UK Health and Safety Executive (HSE) is urging all 'Comply with UK-REACH' users to log in to their Government Gateway accounts immediately. The 'Comply with UK-REACH IT' service, w...

The UK Health and Safety Executive (HSE) is urging all 'Comply with UK-REACH' users to log in to their Government Gateway accounts immediately. The 'Comply with UK-REACH IT' service, which has been operational for three years on 1 January 2024, requires users to log in at least once every 3 years to keep their accounts active.

Some users may not have accessed their Government Gateway accounts since meeting their initial regulatory obligations. Assistance is available from the UK Chemicals Helpline at 0330 159 1985 for those experiencing problems accessing 'Comply with UK REACH.'

HSE emphasises the importance of assigning multiple administrators to each 'Comply with UK REACH' account to prevent loss of access if an administrator leaves. It is important to note that data previously submitted via 'Comply with UK REACH' will no be deleted, but loss of access to the Government Gateway account means that previous submissions cannot be updated or progressed.

On 15 February 2024, the UK Department for Environment, Food and Rural Affairs (DEFRA) notified the World Trade Organization (WTO) of its decision to withdraw the approval for the active substance Fam...

On 15 February 2024, the UK Department for Environment, Food and Rural Affairs (DEFRA) notified the World Trade Organization (WTO) of its decision to withdraw the approval for the active substance Famoxadone in Great Britain (England, Scotland and Wales. Famoxadone is commonly used in plant protection products, regulated under the retained Regulation 1107/2009 (concerning the placing of plant protection products on the market).

This decision follows the non-renewal of the approval of Famoxadone in the European Union in 2021, due to the identification of a critical concern related to the high long-term risk to mammals, the high risk to aquatic organisms and the estimated exposure levels of workers during manual harvesting of crops exceeding the acceptable operator exposure level.

Assessment and Regulatory Context

Famoxadone, assessed for its effect on human health and ecotoxicological aspects, did not meet the requirements for approval under Article 4 of the retained Regulation No 1107/2009. The Health and Safety Executive (HSE) carried out an independent review, taking into account the risks to birds and other environmental factors.

Clear Risks and Expiring Authorisations

The decision shows that Famoxadone does not have a safe use that presents an acceptable risk to birds, leading to its withdrawal in Great Britain. The HSE stressed that the risks to birds were sufficiently clear that independent scientific advice was not required.

Existing authorisations for plant protection products containing Famoxadone will be withdrawn six months after the withdrawal of the active substance approval. A grace period for storage, disposal and use of the products will expire twelve months after the withdrawal. The decision reflects a comprehensive assessment of management of the risks associated with the use of Famoxadone in these products.

Staying Informed 

Stakeholders and the public are encouraged to stay informed of the changes as the GB Approvals register will be updated to reflect this latest decision by the HSE. The proposed commencement date is the second quarter of 2024 with implementation expected in the fourth quarter of 2025.

Further details of the assessment and decision can be found in the full report.

On 19 February 2024, the UK Health and Safety Executive (HSE) announced the postponement of active substance expiry dates for all biocidal active substance/product type combinations due to expire betw...

On 19 February 2024, the UK Health and Safety Executive (HSE) announced the postponement of active substance expiry dates for all biocidal active substance/product type combinations due to expire between 1 January 2024 and 31 December 2026. The new deadline for these expirations will be 31 January 2027.

The decision follows challenges beyond the control of the applicants, where approvals were at risk of expiring before a renewal decision could be taken under the GB Biocidal Products Regulation (GB BPR). In addition, this extension will allow time to consider possible reforms to the GB BPR. The HSE plans to publish detailed information on this development in the near future.

Impact on Active Substances/Product Type Combinations

Up to 110 active substance/product type combinations will be affected by this decision, subject to timely submission and acceptance of renewal applications. Currently, 46 combinations listed on the HSE website have met the renewal requirements, resulting in their expiry dates being postponed to 31 January 2027.

For those wishing to introduce new biocidal products containing these active substances, applications for GB BPR product authorisation are still open. However, it is emphasised that new products, including those with new trade names, should not be supplied in Great Britain (England, Scotland and Wales) until proper product authorisation has been granted.

Future Updates

The HSE assures stakeholders that there will be future updates on future postponements of expiry dates under this umbrella decision as they become relevant.

On 23 January 2023, the UK Health and Safety Executive (HSE) issued a reminder to all companies involved in the export and import of Prior Informed Consent (PIC) chemicals. Companies are required to s...

On 23 January 2023, the UK Health and Safety Executive (HSE) issued a reminder to all companies involved in the export and import of Prior Informed Consent (PIC) chemicals. Companies are required to submit detailed reports of their activities in 2023 by 31 March 2024. This annual reporting is a legal requirement under Article 10 of the GB PIC Regulation.

Detailed reporting required

Companies must provide the HSE with the exact quantities, measured in kilograms, of PIC chemicals they have either exported from or imported into Great Britain (England, Scotland, and Wales) during the previous year. The HSE has made templates available on its website to facilitate this process and  ensure that companies can efficiently comply with the reporting requirements.

This annual report must also include the movement of PIC chemicals to or from Northern Ireland (NI). When reporting exports and imports within the European Union, companies are not required to specify the EU country involved. However, reporting the movement of these chemicals to or from Northern Ireland will be useful for record-keeping purposes.

Exemptions from reporting

It is important to note that not all PIC chemical transactions are subject to this reporting requirement. Exemptions include:

• Special reference identification number (RIN) requests for exports for research and analysis purposes in quantities not exceeding 10 kg per year to each importing country.

• Imports for research and analysis purposes in quantities not exceeding 10 kg per year from any country.

For mixtures and articles, companies are only required to report the quantity of the PIC chemical contained in the mixtures and articles.

NIL returns

In cases where a company has not exported a particular PIC-listed chemical in 2023, despite having submitted an export notification for it, it must submit a NIL return to confirm this.

Submission guidelines

Completed templates should be sent to ukdna@hse.gov.uk no later than the 31 March 2024. The subject line of the email should include the text "GB PIC - Annual Reporting - Article 10 - 2023 - [company name]" to ensure the correct categorisation of the submission.

Publication of data

Later in the year, the HSE plans to publish the aggregated and anonymised data on its website, providing an insight into the trends and volumes of PIC chemical trade in 2023.

On 11 January 2024, the UK Health and Safety Executive (HSE) announced that it is proposing to update the status of the list entries for 90 substances on the Great Britain Mandatory Classification and...

On 11 January 2024, the UK Health and Safety Executive (HSE) announced that it is proposing to update the status of the list entries for 90 substances on the Great Britain Mandatory Classification and Labelling (GB MCL) list. These substances were included in the GB MCL list when the UK left the European Union.

Background on the 90 substances

The EU Harmonised Classification and Labelling (EU CLH) entries from the 14^th and 15^th Adaptation to Technical Progress (ATP) for the 90 substances were adopted in 2017 and 2018. They were subsequently included in the GB MCL list but were not retained in GB law following the UK's exit from the EU and the end of the transition period on 31 December 2020. At the time the HSE believed that the entries would be retained in full in Great Britain (England, Scotland and Wales), but this was not the case. The HSE has now decided to use the Article 37 and Article 37A procedures as a corrective measure to address this issue.

Proposed changes

The HSE has now published a consolidated Agency Opinion and is formally proposing mandatory classification and labelling for the 90 substances based on the scientific and technical assessment of the scientific data, in accordance with Article 37 and Article 37A of the GB Classification, Labelling and Packaging (GB CLP) Regulations. This initiative is supported by a consolidated Technical Report and Agency Opinion, both of which are now publicly available in the HSE GB CLP publication table.

The 90 substances are divided into 3 groups:

• For the 62 substances listed in Table 1 of the consolidated Agency Opinion, the Agency Opinion does not differ from the opinion of the EU Committee for Risk Assessment (RAC). Therefore no further consideration under Article 37A is required.

• For the 26 substances listed in Table 2, the Agency Opinion differs from the consolidated Agency Technical Report. However, the HSE has not received any new scientific or technical information that would change the proposed GB MCLs in Table 2 and therefore no further assessment under Article 37A is required for these substances.

• For the last two substances (titanium dioxide and granulated copper) listed in Table 3, the HSE is aware of information that may change the classification for these two substances. Therefore, these substances will be further assessed under the Article 37A procedure, and no GB MCL is proposed for these substances at this time.

Next steps

The HSE will make a recommendation to Ministers for a Ministerial Decision, with consent of the devolved Governments (Scotland and Wales), to legally enforce the proposed GB MCLs for these 90 substances. The expected compliance dates will be in line with their publication in the HSE’s GB CLP publication table, which is set for April 2024.

In the meantime, duty holders are reminded that no immediate action is required. The HSE had previously advised compliance with the harmonised classification and labelling of these substances as set out in the guidelines in the 14^th and 15^th ATPs.

The classification and labelling of most substances will not change following this update. However, specific substances such as titanium dioxide in powder form and granulated copper will require further assessment under the Article 37A procedure.

Indoxacarb, famoxadone, and mancozeb are three frequently used fungicides that the Health and Safety Executive (HSE) says facing potential withdrawal from the UK market. After reviewing these activ...

Indoxacarb, famoxadone, and mancozeb are three frequently used fungicides that the Health and Safety Executive (HSE) says facing potential withdrawal from the UK market.

After reviewing these active ingredients, the HSE discovered issues with their safety and potential effects on the environment.

There are several possible causes for withdrawal -

• Mancozeb: Exposure levels for farmers and bystanders beyond acceptable limits and new research indicates that it may interfere with hormones in both humans and wildlife.
• Famoxadone: Evaluations show that using famoxadone poses an intolerable risk to birds.
• Indoxacarb: Non-dietary exposure, such as through inhalation, for workers and residents living near treated areas is found to be too high.

The HSE proposes that the UK withdraw the applications for all three drugs. Farmers and producers who depend on these fungicides to protect their crops from disease would be greatly impacted by this decision. The World Trade Organization will now receive the proposal's details for review in conjunction with other nations.

The possibility of withdrawal raises concern about probable agricultural disruptions and the necessity for alternative fungal control measures. Industry groups are expected to express their concerns and potentially propose mitigation measures in the upcoming consultation period.

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