UK Regulatory News

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.

For more information, please reach out to info@auxilife.com or info@eu.auxilife.com

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On 16 November 2023, an amendment to the Persistent Organic Pollutant (POPs) Regulation came into force in Great Britain (England, Scotland, and Wales). The amendment adds perfluorohexane sulfonic aci...

On 16 November 2023, an amendment to the Persistent Organic Pollutant (POPs) Regulation came into force in Great Britain (England, Scotland, and Wales). The amendment adds perfluorohexane sulfonic acid (PFHxS), its salts, and PFHxS-related compounds to the list (Part A of Annex 1) of substances whose production, placing on the market and use are prohibited under the POPs Regulation.

PFHxS substances

PFHxS substances belong to the group of compounds collectively known as per- and polyfluoroalkyl substances (PFAS). They are used as surfactants in a wide range of industrial and commercial products such as food packaging, stain and water-resistant materials, fire-fighting foams, and paint additives. PFHxS, its salts, and PFHxS-related compounds were added to Annex A of the Stockholm Convention at COP-10 in June 2022 without any specific exemption. Each Party to the Convention is required to prohibit the chemicals listed in Annex A and/or to take the necessary legal and administrative measures to eliminate their production, use, import and export. The substances were banned in the EU in August 2023.

PFHxS, its salts, and PFHxS-related compounds are defined is as follows:

1. Perfluorohexane sulfonic acid (CAS No. 355-46-4, PFHxS), including branched isomers.

2. Its salts.

3. Any substance that contains the chemical moiety C₆F₁₃SO₂- as one of its structural elements and that potentially degrades to PFHxS.

PFHxS substances are highly resistant to chemical, thermal and biological degradation due to their strong carbon-fluorine bonds. This resistance to degradation makes them persistent in the environment. Numerous studies have documented elevated levels of PFHxS in soil, water and a variety of ecosystems. Human exposure to PFHxS occurs mainly through ingestion of food and drinking water but also in indoor environments through dust or from consumer products containing PFHxS or its precursors.

Amendment to POPs Regulation

The Persistent Organic Pollutants (Amendment) (No. 2) Regulations 2023 (Statutory Instrument 2023 No. 1217) amend Part A of Annex 1 to Regulation (EU) 2019/1021 of the European Parliament and of the Council on persistent organic pollutants by adding PFHxS, its salts, and PFHxS-related compounds.

The amendment specifies the following concentration limits up to which the newly listed substance may be present as an unintentional trace contaminant:

1. Where the sum of the concentrations of PFHxS and any of its salts present in a substance, mixture or article is equal to or below 0.025 mg/kg (0.0000025% by weight).

2. Where the sum of the concentrations of any PFHxS-related compounds present in a substance, mixture or article is equal to or below 1 mg/kg (0.0001% by weight).

3. Where the sum of the concentrations of PFHxS, any of its salts, and any PFHxS-related compounds present in concentrated fire-fighting foam mixtures that are to be used or are used in the production of other fire-fighting foam mixtures is equal to or below 0.1 mg/kg (0.00001% by weight).

A full impact assessment has not been carried out for this instrument, as it is expected to have minimal or insignificant effects on the private, voluntary, or public sectors. Instead, a de minimis assessment has been carried out, recognising that this instrument may impose some costs on businesses. However, the overall estimated net impact is expected to be less than £5 million per year.

On 28 November 2023, the UK’s Health and Safety Executive (HSE) published a new batch of 6 Agency Opinions formally proposing mandatory classification and labelling (MCL) for the substances they con...

On 28 November 2023, the UK’s Health and Safety Executive (HSE) published a new batch of 6 Agency Opinions formally proposing mandatory classification and labelling (MCL) for the substances they contain. The Agency Opinions relate to substances for which the HSE (as the GB CLP Agency) published Agency Technical Reports in November 2022 under Article 37 of the GB CLP Regulation. The next batch of Agency Opinions is expected to be published in December 2023.

Mandatory Classification and Labelling

Substances and mixtures placed on the GB market must be classified and labelled in accordance with the GB Classification, Labelling and Packaging (GB CLP) Regulation. There are two types of classification:

• Mandatory classification is a classification that has been made legally binding within Great Britain (England, Scotland and Wales). It is in line with the 'harmonised classifications' established under EU CLP. Mandatory classifications and the associated hazard labelling (MCL) are listed in the GB Mandatory Classification and Labelling List (GB MCL List). In cases where a substance has an MCL for some or all hazard classes, suppliers to the GB market are required to implement this classification.

• Self-classification involves the supplier collecting and assessing all available data and subsequently comparing it with the classification criteria. Self-classification applies to all mixtures and to substances which do not have a mandatory classification. Substances with a mandatory classification are still subject to self-classification for all hazard classes not covered by the mandatory classification.

In October 2023, 98 chemical substances were added to the GB MCL list. This was the first batch of substances added to be added to the list after Brexit. Agency Opinions have been published for another 61 substances (including the latest 6). A second batch of 26 substances is expected to be added to the GB MCL list in the first quarter of 2024.

Included Substances

The table below summarises information on the substances included in the current batch of Agency Opinions.

The UK’s Health and Safety Executive (HSE) has launched two public consultations on two substances, Pigment Red 83 and Solvent Violet 13, used in tattoo and permanent make-up (PMU) inks. The two sub...

The UK’s Health and Safety Executive (HSE) has launched two public consultations on two substances, Pigment Red 83 and Solvent Violet 13, used in tattoo and permanent make-up (PMU) inks. The two substances have been proposed for mandatory classification and labelling (MCL) under Great Britain’s Classification, Labelling and Packaging (CLP) Regulation and scientific or technical information and/or wider policy and impact considerations can be submitted via the HSE’s comment webform by 2 January 2024.

Restriction Proposal for Tattoo Inks

In its capacity as the Agency for UK-REACH, the HSE has prepared a proposal under Article 69(1) of UK­-REACH to restrict certain hazardous substances found in inks used for tattooing and permanent make-up (PMU). The proposed restriction applies to substances with a mandatory classification for various hazards, such as skin sensitisation (H317). It also includes substances that are banned for use in cosmetic products in the EU under Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products (as amended), commonly known as the Cosmetics Regulation.

The proposed restriction includes a derogation for 19 substances including Pigment Blue 15:3 and Pigment Green 7. Initially Pigment Red 83 and Solvent Violet 13 were also included in the derogation, but these two substances were removed because a review by the HSE identified data indicating potential concerns for skin sensitisation for these substances.

Pigment Red and Solvent Violet

The HSE has reviewed the available hazard information and found that there is a potential concern for skin sensitisation for two substances: Pigment Red 83 and Solvent Violet 13. Mandatory classification for skin sensitisation category 1B (H317) would bring the substances within the scope of the proposed restriction.

Therefore, the HSE as the Agency for GB CLP has prepared targeted reports to propose the mandatory classification and labelling of Pigment Red 83 and Solvent Violet 13 for skin sensitisation. The MCL reports are available here and here.

Information on the two substances is given in the table below:

Anyone with relevant information is encouraged to share it with the HSE. Relevant information includes scientific or technical information associated with the proposed classification, as well as information on the potential effects of the classification both positive and negative.

On 10 November 2023, the UK Department for Environment, Food & Rural Affairs (DEFRA) issued a call for information on a number of proposed persistent organic pollutants (POPs) in advance of a meeting ...

On 10 November 2023, the UK Department for Environment, Food & Rural Affairs (DEFRA) issued a call for information on a number of proposed persistent organic pollutants (POPs) in advance of a meeting of the POPs Review Committee (POPRC). DEFRA is seeking information on chlorpyrifos, medium-chain chlorinated paraffins (MCCPs) and long-chain perfluorocarboxylic acids (LC-PFCAs).

Stockholm Convention

The UK is a party to the UN Stockholm Convention on Persistent Organic Pollutants (POPs), which are substances that persist in the environment, accumulate in living organisms and pose a risk to human health and the environment. POPs can be transported by air, water or by migratory species across international borders, reaching regions where they have never been produced or used. The substances listed in the Convention are generally banned from production, marketing or use, unless specific exemptions or acceptable purposes for continued use are agreed. 

There is a process for Parties to propose a substance for listing if they have gathered evidence suggesting that it may be a POP. The technical scientific committee of the Stockholm Convention (POPRC) will then consider reviews and further develop the evidence that the substance has POP characteristics. 

If there is evidence that a substance has POP characteristics, the POPRC then considers the social and economic impacts of banning or restricting that substance and makes recommendations to the Conference of the Parties of the Stockholm Convention, which is held every 2 years. 

Chlorpyrifos

Chlorpyrifos is an organophosphate pesticide widely used as an insecticide in agriculture and as a biocide to control non-agricultural pests. Chlorpyrifos was banned in the UK in 2016 and in the EU in 2020.  

The POPRC has requested additional information on the socio-economic considerations for chlorpyrifos to support the preparation of a risk management evaluation as specified in Annex F of the Stockholm Convention. The deadline for comments is 24 November 2023 and the request form should be sent to POPs@defra.gov.uk.

Medium chain chlorinated paraffins

Chlorinated paraffins are used as plasticisers for polyvinyl chloride, as extreme pressure additives in metal-machining fluids, as additives to paints, coatings, and sealants to improve their resistance to chemicals and to water, and as flame retardants for plastics, fabrics, paints, and coatings.

Medium-chain chlorinated paraffins (MCCPs) were recommended for listing as POPs under the Stockholm Convention at the 19^th meeting of the POPRC (POPRC-19) in October 2023. The Committee decided to recommend to the Conference of the Parties to consider listing chlorinated paraffins with carbon chain lengths in the range C14–17 and chlorination levels of 45 % chlorine by weight or more in Annex A to the Convention with specific exemptions for some applications.

The Committee has invited Parties and observers to provide information that would assist it in the possible strengthening of the recommendations. The deadline is 24 January 2024 and the information submission forms for MCCPs can be found here.

Long-chain perfluorocarboxylic acids

Long-chain perfluorocarboxylic acids (LC-PFCAs), their salts and precursors have water, oil, dirt and grease repellent properties and can be found in a wide range of products, including personal care products, cleaning products, and surface treatments for textiles, upholstery, leather, automotive parts, carpet and paper products, and packaging. They belong to the group of per- and polyfluorinated substances (PFAS). 

The POPRC has adopted the Risk Management Evaluation of LC-PFCAs, their salts, and related compounds, and recommended that the substances be listed for elimination in Annex A to the Stockholm Convention. The Committee invited Parties and observers to provide information that would assist in the possible definition of specific exemptions for the production and use of LC-PFCAs, their salts and related compounds. The deadline for comments is 24 January 2024 and the information submission forms for LC-PFCAs can be found here.

On 9 November 2023, the UK Department for Environment Food & Rural Affairs (DEFRA) published a policy paper introducing an alternative transitional registration model (ATRm) for chemicals which aims t...

On 9 November 2023, the UK Department for Environment Food & Rural Affairs (DEFRA) published a policy paper introducing an alternative transitional registration model (ATRm) for chemicals which aims to reduce costs for businesses while maintaining DEFRA’s commitment to protecting human health and the environment.

UK-REACH

Following UK’s withdrawal from the EU, a regulatory framework for chemicals in Great Britain (England, Scotland and Wales), known as the UK Registration, Evaluation, Authorisation and Restriction of Chemicals (UK-REACH), was put in place. UK-REACH retains the key principles of EU-REACH and aims to maintain high standards of protection of human health and environmental in Great Britain. EU-REACH continues to apply in Northern Ireland under the terms of the Northern Ireland Protocol.

The Alternative Transitional Registration Model

DEFRA, in collaboration with the Health and Safety Executive (HSE) and the Environment Agency, has introduced an Alternative Transitional Registration Model (ATRm) in response to concerns from UK industry about the financial burden of accessing EU data packages for UK-REACH transitional registrations. The ATRm aims to reduce business costs while prioritising the commitment to protect human health and the environment.

The ATRm is the result of an intensive review process involving industry experts and stakeholders. DEFRA’s aim is to take a more targeted approach using existing information already available in the EU and globally to develop the detailed information held on chemical substances in a more focused way. The review has shown that UK regulators do not need to maintain a full replica of all chemical registration data under EU-REACH in order to carry out their regulatory work effectively.

The Government's ambition is to have a comprehensive view of the use of chemicals in Great Britain to ensure that industry complies with the safe use of chemicals. This approach will enable regulators to assess the risks associated with chemicals and take targeted action where risks are deemed unacceptable. The success of the strategy was demonstrated by the release of the risk management analysis for per- and polyfluoroalkyl substances (PFAS) earlier this year.

DEFRA’s progress to date

DEFRA has made progress in the areas listed below. Proposals are being developed and will be subject of consultation.   

• Refining the details of the 'use and exposure' information required from Great Britain registrants.

• Reducing the hazard information required for transitional registrations and intermediates to the essential minimum so that UK-REACH registrants will not generally need to access and pay for data packages from the EU.

• Significantly reduce the cost to industry associated with buying or accessing EU hazard information.

• Improve the powers of regulators to quickly request and receive data from registrants for regulatory or risk prioritisation purposes, ensuring the ability to respond quickly to new or emerging risks.

• Undertake a review of the current fee structure for UK-REACH to establish a more sustainable funding model, including a possible reduction in the current level of UK-REACH registration fees.

• Revise the UK-REACH restriction processes to provide greater flexibility to respond quickly to identified risks.

Conclusion

The introduction of the ATRm and associated changes will provide a stronger basis for identifying and managing high risk chemicals in Great Britain while addressing the financial burden on businesses during the transition to UK-REACH. Consultations on the detailed policy are expected to take place in early 2024.