Policy paper

Rationale for prioritising substances in the UK REACH work programme: 2023 to 2024

Published 15 February 2024

This was published under the 2022 to 2024 Sunak Conservative government

Applies to England, Scotland and Wales

Executive summary

The UK regulation on the registration, evaluation, authorisation and restriction of chemicals (UK REACH) is part of the independent chemicals’ regulatory framework for Great Britain (England, Scotland and Wales). It enables decision-making that best reflects the needs of Great Britain, while ensuring a high level of protection of human health and the environment.

The UK REACH work programme sets out how the Health and Safety Executive (HSE), with the support of the Environment Agency, will deliver its regulatory activities to meet the objectives and timescales set out in UK REACH. This is the third year of operating UK REACH, and the work programme outlines the operational activities that will be undertaken in the financial year 2023 to 2024.

While the work programme covers a wide range of activities, one important risk management tool under UK REACH is the use of restriction. This document explains how priorities for this strand of potential risk management activity have been identified, based on a review of restriction proposals put forward by stakeholders, and substances proposed for restriction by other regulators, such as the European Chemicals Agency (ECHA). It does not, for example, cover the Stockholm Convention listing proposal on medium chain chlorinated paraffins (MCCPs) led by the UK, nor the full range of substances being examined by HSE under the work programme.

The Department for Environment, Food and Rural Affairs (Defra) and the Scottish and Welsh Governments are the appropriate authorities for UK REACH. We (the appropriate authorities) worked with HSE, the Environment Agency and stakeholders, such as non-governmental organisations (NGOs) and trade associations, to identify priorities for the UK REACH work programme in 2023 to 2024.

We used this exercise primarily to identify priorities for 2 types of activity in UK REACH:

1. Restriction – a mechanism for limiting, banning or imposing conditions on the manufacture, use, or placing on the market of a substance or group of substances.
2. Regulatory management options analysis (RMOA) – analysis produced by HSE or the Environment Agency to assess the potential human health and environmental risks associated with the use of a substance or group of substances, alongside the existing regulatory framework and any specific controls relating to them. RMOAs may make recommendations which can include filling evidence gaps and risk management actions under UK REACH.

We have identified the following 5 priorities for the 2023 to 2024 UK REACH work programme:

1. Per- and polyfluoroalkyl substances (PFAS) – (a) start preparing a restriction dossier on PFAS in fire-fighting foams (FFFs); and (b) assess potential additional restrictions on further wide dispersive uses of PFAS and PFAS likely to be released from consumer articles.
2. Formaldehyde and formaldehyde releasers in articles – continue the RMOA initiated under the 2022 to 2023 work programme and consider its recommendations.
3. Bisphenols in thermal paper – continue the RMOA initiated under the 2022 to 2023 work programme and consider its recommendations.
4. Hazardous flame retardants – further develop the risk assessment on flame retardants and consider the recommendations on completion.
5. Intentionally added microplastics – monitor progress of the evidence project initiated and commissioned under the 2022 to 2023 work programme.

This document sets out how and why we have established these priorities. It also explains why some proposals were not adopted. We intend to reconsider these proposals when identifying priorities for future annual work programmes.

In addition, we may identify other activities to support the aims of UK REACH, such as commissioning projects to gather more evidence.

For any enquiries regarding this publication, email reachworkprogramme@defra.gov.uk.

Introduction

UK REACH forms part of the regulatory regime for chemicals in Great Britain (England, Scotland and Wales). It entered into force on 1 January 2021 after the UK left the EU and the EU REACH regulation was brought into UK law.

The statutory purpose of UK REACH is to ensure a high level of protection for human health and the environment in Great Britain. REACH stands for registration, evaluation, authorisation and restriction of chemicals.

Defra, the Scottish and Welsh Governments, HSE and the Environment Agency have together identified the priorities outlined below for the next annual UK REACH work programme. To do this, we considered proposals from various sources, including EU REACH (which remains a key information source), and sought views from across Defra and other government departments.

Since UK REACH came into force, our work programme has prioritised the issues that are most effectively addressed through UK REACH, and where action would have the greatest impact for human health and the environment in Great Britain.

In summer 2022 we engaged with stakeholders to review our restriction prioritisation approach. We then developed a revised prioritisation process, which was presented to stakeholders for feedback. Invitations to participate in the prioritisation process were issued to the UK Chemicals Stakeholder Forum and its wider interest group, representing over 150 members. However, there were limited responses to the invitation to rank proposals in order of priority. We also conducted workshops to inform our priorities and articulate our prioritisation principles. Around 25 stakeholder organisations attended the workshops, including representatives from NGOs, industry, trade associations and academia.

We used the following broad principles to identify the proposals that were most closely aligned with England’s Environmental Improvement Plan and the UK’s 25 Year Environment Plan, ensuring chemicals are safely used and managed and continuing to phase out the most harmful and persistent pollutants in favour of safer and more sustainable alternatives.

Proposals are given higher priority where there is an evidence-based risk of either: 

• human exposure to hazardous substances within Great Britain, and risk management action through UK REACH would provide the greatest positive impact compared with other proposals 
• long-lasting or damaging impact on the environment, and risk management action through UK REACH would provide the greatest positive impact compared with other proposals 

In addition, for proposals to be given higher priority, both of the following must apply: 

• appropriate risk management action is not already being taken in Great Britain or at an international level to address the risk (for example, through the Stockholm Convention, which the UK is a party to) 
• there are no other risk management measures (regulation or other control measures) which already adequately address the risk identified

For the proposals we are not taking forward, this document provides the rationale behind why they were not considered a priority this year. We will continue to review the proposals not prioritised for action this year and reconsider them for regulatory action under UK REACH in future work programmes.

Multi-annual approach

The priorities identified in collaboration with a wide range of stakeholders since UK REACH came into force have generated significant ongoing multi-year workstreams, such as the development of restriction dossiers on PFAS. We anticipate that much of HSE’s capacity to develop restrictions over the next five years will be devoted to PFAS.

We will continue to review the risk management options for our other prioritised workstreams in the coming years. Recommendations will emerge from ongoing RMOAs and research projects on challenging and wide-ranging issues, such as flame retardants, bisphenols, formaldehyde and formaldehyde releasers, and microplastics, which may lead to further action. Substance evaluations initiated under UK REACH and the potential identification of substances of very high concern (SVHCs) may also trigger further regulatory actions.

We will remain flexible and will consider any emerging chemical issues to be addressed in Great Britain and any changes to legislation as we review work programme priorities annually.

Priorities for the 2023 to 2024 UK REACH work programme

1. Per- and polyfluoroalkyl substances

Description of proposal

A proposal to begin the development of a restriction on Per- and polyfluoroalkyl substances (PFAS) in fire-fighting foams (FFFs), and to explore restrictions on further wide dispersive uses of PFAS and PFAS likely to be released from consumer articles.

Agreed action

Begin the development of a restriction on PFAS in FFFs, and explore potential further PFAS restrictions.

Primary hazards

Various hazards depending on the sub-group of PFAS – for example, persistent, bioaccumulative and toxic (PBT).

Rationale

PFAS are a large group of synthetic chemicals, consisting of several thousand individual substances. These substances are used in a wide range of product types, such as stain repellents, lubricants, packaging, electronics, and in fire-fighting foams, because they have several desirable technical properties (such as oil resistance, water resistance and low chemical reactivity).

The appropriate authorities agreed that understanding the risks posed by PFAS was a priority under the first UK REACH work programme in 2021 to 2022. Defra asked HSE, supported by the Environment Agency, to examine the risks posed by PFAS and to develop an RMOA to assess uses, exposure routes, and risk management actions specific to Great Britain.

The RMOA was published on the HSE website in April 2023. It recommends that UK REACH restriction is an appropriate measure to control certain identified risks. The appropriate authorities have considered the recommendations and have agreed to begin the development of a restriction dossier on PFAS in FFFs and explore further restrictions covering a wide range of industrial and consumer uses.

2. Formaldehyde and formaldehyde releasers in consumer articles

Description of proposal

A proposal to address the risks of formaldehyde emissions from consumer articles, particularly from manufactured wood, such as medium density fibreboard (MDF).

Agreed action

An RMOA to review the evidence base and evaluate options for a potential restriction began under the 2022 to 2023 work programme. It will continue under the 2023 to 2024 programme.

Primary hazards

Sensory irritation.

Rationale

One of the most significant sources of formaldehyde emissions in homes is wood-based panels. European (including British) manufacturers of wood-based panels adopted a voluntary standard on formaldehyde emissions in 2007. However, panels manufactured outside the UK and EU are not always compliant, and any new restrictions are therefore likely to mainly affect imports.

In 2020, the European Chemicals Agency (ECHA) adopted a proposal to restrict formaldehyde and formaldehyde releasers in articles, primarily to address sensory irritation. Both the Committee for Risk Assessment (RAC) and Committee for Socio-economic Analysis (SEAC) under EU REACH supported introducing a restriction. However, the analysis conducted for the EU proposal used simulated rather than measured data. As a result, HSE will need to assess whether the EU’s data is sufficiently representative of the situation in Great Britain, or whether it will require more data specific to Great Britain.

During the prioritisation process, government departments and other stakeholders supported addressing the sources of formaldehyde. To determine the most appropriate measures to achieve this, HSE is reviewing the evidence by conducting an RMOA with support from the UK Health Security Agency. This could supplement other actions across government, such as the publication of guidance on indoor air quality and introduction of other regulations, including the Construction Products Regulations 2022. The RMOA will conclude in 2024, and the appropriate authorities will then consider its recommendations.

3. Bisphenols in thermal paper

Description of proposal

A proposal to expand the existing UK REACH restriction on the use of Bisphenol-A (BPA) in thermal paper to include other bisphenols.

Agreed action

An RMOA to review the evidence base and evaluate options for a potential restriction was initiated under the 2022 to 2023 work programme. This work will continue under the 2023 to 2024 programme.

Primary Hazards

Endocrine disruption, toxic to reproduction, carcinogenic.

Rationale

Bisphenols are commonly used to produce inks used in thermal papers. Manufacturers use BPA as a colour developer.

BPA is already restricted in thermal paper under both EU REACH and UK REACH due to concerns over endocrine disruption and being toxic to reproduction. This is covered by entry 66 of Annex XVII (restrictions list) in both versions of the legislation. However, a study conducted by ECHA showed that manufacturers are substituting BPA with other bisphenols with a similar hazard profile – such as bisphenol-S (BPS).

Expanding the existing restriction to other bisphenols could be considered to help prevent further regrettable substitution. This could also encourage manufacturers to move towards non-bisphenol thermal papers.

Information on the properties of various bisphenols is limited, and there are unresolved environmental risks to explore before initiating any measures to address the risks. There is also no direct EU precedent for this restriction. However, in 2022 a bisphenol used in thermal paper was identified for substance evaluation in the UK REACH Rolling Action Plan. This evaluation will inform our work on bisphenols.

HSE (with the Environment Agency advising on environmental concerns) is therefore conducting an RMOA to review the available evidence relevant to Great Britain and expand the scope of a restriction (if it is deemed appropriate). The RMOA will conclude in 2024, and the appropriate authorities will then consider its recommendations.

4. Hazardous flame retardants

Description of proposal

A proposal to address the risks of using hazardous flame retardants.

Agreed action

Under the 2022 to 2023 work programme, the Environment Agency commissioned a review and update to its risk assessment on flame retardants, published in 2003, to feed into wider chemicals policy. The Environment Agency, supported by HSE, will continue to develop this work under the 2023 to 2024 work programme.

Primary Hazards

Endocrine disruption, neurotoxic, carcinogenic, toxic to liver, immune system, and kidney effects.

Rationale

Chemical flame retardants are used in products to prevent or slow the development of fires. They are widely used in articles such as furniture, building materials and electronics. However, some groups of flame retardant are hazardous to both human health and the environment.

Several substances used as flame retardants are already subject to restrictions (under UK REACH and other regulations). In some cases, this has led to regrettable substitution with other substances that have similar hazard profiles. This is likely because previous action on flame retardants has concentrated on managing risks from individual chemicals (or small groups of chemicals) due to their impact on the environment.

The risks from some flame retardants are wide ranging, complex and cut across several human health and environmental issues. Therefore, any action to address the risks requires a coordinated approach between UK REACH and other policy areas, such as waste management and fire safety.

The Environment Agency commissioned a review and update to the 2003 report with current evidence on the use of flame retardants in the UK and their possible impacts on the environment and human health. They will work with others, including HSE, to use this information to identify suitable groups of chemicals for further investigation and risk management and to support the development of other chemicals policies. The appropriate authorities will consider the recommendations of this work in 2023 to 2024.

5. Intentionally added microplastics

Description of proposal

A proposal to investigate the risks of intentionally added microplastics.

Agreed action

The proposal to investigate the risks of intentionally added microplastics was adopted under the 2022 to 2023 work programme. This work will be continued in 2023 to 2024 with an evidence project to review emissions of intentionally added microplastics and the risks they pose (both to human health and the environment), including a socio-economic assessment.

Primary hazards

While there is some uncertainty regarding the hazards involved, intentionally added microplastics are likely to be persistent in the environment and cause physical obstruction. They may also contain chemical hazards from additives in the plastics and absorb pollutants in the environment.

Rationale

Intentionally added microplastics are often added to products, such as paints, infill material on sports pitches, and detergents, to serve a specific purpose. However, the risks that microplastics pose are not well characterised. Existing concerns relate mainly to environmental risks, but more recent studies suggest there are also risks to human health.

Some uses of intentionally added microplastics are already regulated within the UK. During 2018 and 2019 the four UK administrations separately introduced bans on microbeads in certain wash-off personal care products and cosmetics (which sometimes contain microbeads as exfoliants).

In 2019, a proposal was submitted under EU REACH to ban the placing on the market of microplastics as a substance, on its own or in a mixture in a concentration equal to or greater than 0.01% weight for weight (w/w). Both the RAC and SEAC agreed that introducing a restriction was the most appropriate measure to address the risks. The EU REACH Committee voted in favour of the restriction in April 2023, and it came into force on 25 September 2023.

The Environment Agency submitted comments on behalf of several government bodies in response to the consultation on the 2019 EU proposal for restricting microplastics supporting the application of the precautionary principle (considering risk reduction measures when the risk is uncertain). They also stated that any measures adopted on this basis must be proportionate, based on cost-benefit analysis, and subject to review when new information becomes available.

Defra has commissioned an evidence project to assess the scale of the risks and identify the most effective measures to address them in the short to medium term. It will also help identify wider evidence gaps that need to be addressed in the longer term to support a more strategic approach to managing intentionally added microplastics. This project will continue in 2023 to 2024, and the appropriate authorities will consider its recommendations once complete.

Proposals not considered a priority in 2023 to 2024

1. Restriction on workplace exposure for five cobalt salts

Description of proposal

A proposal to address occupational exposure to cobalt carbonate, cobalt di(acetate), cobalt dichloride, cobalt dinitrate and cobalt sulphate.

Primary hazards

Carcinogenic and mutagenic.

Rationale

Manufacturers use cobalt salts in a wide range of applications, including to manufacture batteries, surface treatments and in fermentation applications.

In 2018, a proposal was submitted under EU REACH to restrict the manufacture and placing on the market of the cobalt salts listed in concentrations equal to or above 0.01% by weight. RAC agreed a restriction was appropriate (with some modifications), but also proposed the EU Commission set a binding occupational exposure limit (BOEL – an upper limit on the concentration of hazardous substances allowed in the air).

HSE responded to the consultation on the EU proposal with the view that introducing an EU-wide BOEL would be more effective than a restriction. This view has not changed now the UK has left the EU. The European Commission has since stopped the procedure for introducing the ECHA restriction in favour of introducing occupational exposure limits (OELs) instead.

Within Great Britain, under the Control of Substances Hazardous to Health (COSHH) regulations, there is already a workplace exposure limit (WEL) for all cobalt and cobalt compounds of 0.1mg per cubic metre (mg/m3) over an 8-hour time-weighted average (TWA). This legal limit on occupational exposure via inhalation applies to all cobalt compounds, including those listed in the ECHA restriction proposal.

Additionally, because the cobalt salts are identified as carcinogenic and mutagenic substances, COSHH requires that the exposure level is reduced to a level as low as reasonably practicable (ALARP). This reduces the exposure to below the WEL, to a level at which regulators expect to see workplace risks controlled within Great Britain.

If it is determined that specific additional risk management measures are required within Great Britain, the COSHH regulations would be a more appropriate route, as exposure primarily occurs in the workplace.

2. Restriction introducing workplace exposure limits on dimethylformamide

Description of proposal

A proposal to address occupational exposure to dimethylformamide (DMF).

Primary hazards

Toxic to reproduction.

Rationale

Industry commonly uses DMF as a solvent during the production of polymers, pharmaceuticals and some textiles, leather and fur. The primary route of exposure is therefore occupational.

In 2022 a restriction came into force under EU REACH (entry 76) on DMF as a constituent of other substances or in mixtures, unless manufacturers and downstream users take appropriate risk management measures. An example of such measures would be limiting inhalation to 6mg per cubic metre (mg/m3) and exposure via the skin to 1.1mg per kg per day (mg/kg/day). The restriction took effect across the EU on 12 December 2023. 

DMF is already subject to a WEL within the UK, which limits long-term exposure to 15mg per cubic metre (mg/m3) and short-term exposure to 30mg per cubic metre (mg/m3). COSHH also requires employers to assess the risks of exposure (via all routes including the skin) to hazardous substances. They must then identify and implement measures to further reduce exposure, in proportion to the health risk, regardless of the existence of exposure limits set by the regulation.

If it is determined that specific additional risk management measures are required within Great Britain, this should be implemented in accordance with the COSHH regulations as exposure primarily occurs in the workplace. However, Defra, the Scottish and Welsh Governments and HSE will together continue to consider the evidence gathered under EU REACH for these substances when prioritising substances for action under UK REACH in a future work programme.

3. Restriction of polycyclic aromatic hydrocarbons (PAHs) in rubber crumb used for synthetic sports pitches

Description of proposal

A proposal to restrict the placing on the market of rubber granules and mulches as infill material on synthetic turf sports pitches or in loose form on playgrounds.

Primary hazards

Carcinogenic.

Rationale

Rubber crumb, used in sports pitches, is often produced from end-of-life tyres. There was a concern in the EU that this could lead to rubber crumb containing high levels of PAHs, leading to a risk for users of synthetic turf pitches and some playgrounds. In the UK, rubber crumb from waste materials can be permitted for reuse as a product under a quality protocol, to ensure recycled materials are handled correctly and can be used with minimised environmental impacts.

Entry 50 of Annex XVII under UK REACH already restricts the use of extender oils in the production of rubber tyres if they contain more than 1 milligram per kilogram (mg/kg) of some PAHs (and 10mg per kg (mg/kg) in total). Substances classed as category 1A or 1B carcinogens (known or presumed carcinogenic in humans) and listed under appendix 1 or 2 (including PAHs) are also restricted under entry 28 of Annex XVII.

In 2022, an amendment to entry 50 of the Annex XVII under EU REACH came into force limiting PAHs to 20mg per kg (mg/kg) in granules or mulches used as infill material in synthetic turf pitches or in loose form on playgrounds or in sport applications. The amendment applied from 10 August 2022.

Data submitted to the public consultation on the ECHA restriction indicated that at least 95% of the material in use within the UK falls within the limit set in the 2022 amended entry 50 of Annex XVII under EU REACH. A study conducted for the ECHA restriction dossier similarly found that most pitches across the EU (and including the UK) are already compliant with the restriction.

In 2020, the Sports Pitch Construction Association (SAPCA) introduced a code of practice setting a concentration limit of 20mg per kg (mg/kg) in rubber infill material manufactured by its members. The aim is to reduce the use of infill material that is non-compliant with the concentration limits set by the EU restriction. SAPCA continues to work closely with the UK government on this issue.

The effectiveness of existing restrictions on PAHs and the precautionary measures taken by the sports sector means this is not a priority for action this year. The Environment Agency is currently undertaking a routine review of the tyre-derived rubber materials quality protocol to ensure it reflects current uses in products, remains fit for purpose, and takes account of the latest available evidence on both environmental and human health impacts. Our evidence project on microplastics will also examine the risks in the UK.

We will continue to consider whether restriction under UK REACH may be beneficial when setting priorities in future work programmes.

4. Restriction of lead compounds in polyvinyl chloride (PVC)

Description of proposal

A proposal to address the risks to the public from lead exposure through direct contact and, predominantly, indirect environmental contact from emissions during PVC articles’ service life, treatment, and disposal as waste.

Primary hazards

Toxic to reproduction, neurotoxic.

Rationale

Lead-containing compounds can be used to stabilise PVC. However, the European PVC industry has voluntarily phased out the use of lead in PVC (read more detail on this measure in the VinylPlus Progress Report 2021).

This means that since 2015, virgin PVC produced in the EU (and the UK) should not contain lead. This restriction would only affect imports of lead-containing PVC from outside the EU.

In 2016, a proposal was submitted under EU REACH to restrict the use of lead compounds in finished articles produced from polymers or co-polymers of PVC. However, the European Parliament vetoed the proposal in 2020, which required the EU Commission to submit a revised proposal.

The RAC opinion on the proposal concluded that PVC is a minor source of indirect exposure to lead via the environment, when compared with other sources such as lead shot (HSE have recently published a restriction dossier on lead in ammunition). The EU also identified a potential restriction on PVC and its additives in the Restrictions Roadmap under the Chemicals Strategy for Sustainability. In May 2023 the European Commission decided to include the proposed restriction in Annex XVII of the EU REACH Regulation.

In September 2022 the Environment Agency commissioned a report on additives in PVC to further understand the potential risks to the environment and human health in Great Britain. The evidence gathered will be used to inform the appropriate authorities on the potential issues which may arise from the use of PVC additives, including lead compounds.

5. Restriction of skin sensitisers in clothing and related articles

Description of proposal

A proposal to prevent sensitisation to substances in textile and other articles that come into direct and prolonged contact with the skin and to prevent allergic contact dermatitis in those who are already sensitised.

Primary hazards

Skin sensitisation.

Rationale

Hazardous substances are often found in textiles as impurities from the manufacturing process, but some are intentionally added to change their properties.

Category 1A and 1B carcinogenic, mutagenic and reprotoxic (CMR) substances are already restricted under entry 72 of Annex XVII in clothing (and related accessories), textiles that under reasonably foreseeable conditions come into contact with the skin, and footwear. Entry 43 of Annex XVII restricts certain dyes detectable at concentrations above 30mg per kg (mg/kg) (or 1,000mg/kg if listed in Appendix 9 of Annex XVII) in textiles and leather that come into direct contact with the skin.

In 2019 a proposal was submitted under EU REACH to limit the concentration of substances classified under the Classification, Labelling and Packaging (CLP) regulations as skin sensitisers. Both RAC and SEAC under EU REACH agreed that a restriction was the most appropriate measure to address the risks. The European Commission has not yet decided whether to include the proposed restriction in Annex XVII of the EU REACH Regulation. 

HSE submitted comments to the consultation on the proposal questioning how many skin sensitisers remain in finished textiles (and so present a risk). They also expressed concern over the lack of available analytic methods for detecting some of the substances in scope of the restriction and some of the assumptions made on the exposure scenarios. These concerns remain now that the UK has left the EU.

While this is not a priority for action this year, future work in this area may include reviewing the evidence base within Great Britain. The appropriate authorities may then consider taking action on a subset of skin sensitisers in a future prioritisation exercise.

6. Restriction of hazardous substances in disposable nappies

Description of proposal

A proposal to introduce concentration limits on hazardous substances in disposable nappies.

Primary hazards

Skin sensitisation, endocrine disrupting, carcinogenic, toxic to reproduction.

Rationale

There is a possibility that trace amounts of hazardous substances could be present in disposable nappies as a result of the manufacturing process or impurities in the raw materials.

Some substances in scope of the EU proposal, such as certain phthalates, are already restricted in UK REACH under entries 51 and 52 of Annex XVII in ‘childcare articles’ (defined in the entry as including articles intended to facilitate hygiene). The proposal under EU REACH also identifies other substances of concern, such as PAHs and formaldehyde.

In 2020, France submitted a proposal under EU REACH to introduce concentration limits on substances found in disposable nappies. However, RAC concluded that the proposal was not justified because the risks were not demonstrated or characterised for several substances, including formaldehyde and PAHs. SEAC also concluded that the benefits were not demonstrated due to a lack of evidence.

HSE considers it highly unlikely that it would reach a different conclusion in UK REACH. The appropriate authorities will continue to keep this issue under review should any further evidence emerge, but this is not a priority for action this year.

7. Hazardous substances in period products

Description of proposal

A proposal by stakeholders to address the risks of hazardous substances in period products (including tampons, sanitary pads and menstrual cups), and to increase transparency of ingredients and test results from manufacturers.

Primary hazards

Skin sensitisation, endocrine disruption, carcinogenic, mutagenic, toxic to reproduction.

Rationale

There is a possibility that hazardous substances may be present in period products as a result of the manufacturing process or impurities in the raw materials. However, in addition some period products contain substances intentionally added to serve a specific purpose, such as to improve absorbency, and these have caused consumer concern due to potential hazards.

In a study into feminine hygiene products, the French Chemicals Agency (ANSES) did not find any risk associated with the presence of the substances tested. In addition, research by the Swedish Chemicals Agency (KEMI) found no reason for concern from chemicals in period products. Chemicals identified in the products were present only in low concentrations, with no evidence of risk of health impacts. Defra is continuing to monitor research in this area.

There remain possible unresolved environmental concerns over disposable period products (such as resource use and waste). However, it is likely that UK REACH would not be the most appropriate regulation to address these concerns.

8. Restriction of the use of D4, D5 and D6 in wash-off and leave-on cosmetics

Description of proposal

A proposal to extend the existing restriction on the cyclic siloxanes octamethylcyclotetrasiloxane (D4) and decamethylcyclopentasiloxane (D5) in wash-off cosmetics (entry 70 of Annex XVII) to include dodecamethylcyclohexasiloxane (D6) and apply to leave-on cosmetics.

Primary hazards

Very persistent, very bioaccumulative (vPvB) (D4, D5, D6); PBT (D4).

Rationale

Industry uses D4, D5 and D6 to produce a variety of products, such as cosmetics (skin creams, deodorants), dry cleaning fluids, and various silicone polymers and gels used in construction, vehicle manufacture and polishes.

D4, D5 and D6 were identified as substances of very high concern (SVHCs) under EU REACH, while the UK was still a member of the EU. The Environment Agency prepared the original restriction dossier for D4 and D5 in wash-off cosmetics (entry 70 of Annex XVII) but did not consider there to be sufficient evidence to justify extending it to leave-on cosmetics. This view has not changed now that the UK has left the EU, although surveillance is ongoing through monitoring schemes performed by industry.

In 2019, ECHA submitted a proposal to extend the restriction on D4 and D5 to include D6 and to add leave-on cosmetics and other consumer and professional products. The European Commission accepted this proposal in December 2023. The Environment Agency submitted comments during the EU public consultation, highlighting the need to address the relevance of air emissions in more detail, but recognising the benefit of including D6 in the original restriction (its hazardous properties were not confirmed at the time of the UK proposal).

The EU is preparing a proposal to list D4, D5 and D6 as persistent organic pollutants (POPs) under the UN Stockholm Convention. If the EU submits their proposal, and it is agreed at the POPs Review Committee and further agreed at the Conference of the Parties, the substances would be banned or restricted globally, including the UK.

Norway has recently completed an evaluation of three linear siloxanes (close analogues of the cyclic siloxanes D4, D5, D6) because they are suspected of being PBT and vPvB. The evaluation concluded that they all meet criteria for addition to the candidate list of SVHCs and recommended that they be restricted under Annex XVII to prevent substitution for D4, D5 and D6.

It may therefore be most efficient to deal with D6, L3, L4 and L5 together, taking into account evidence of changes in the products supplied to the UK in response to the EU restrictions, as well as the level of environmental exposure within the UK. The appropriate authorities will continue to monitor the D4, D5 and D6 POP proposal and any follow-up actions to the evaluations on L3, L4 and L5.

As part of the UK REACH work programme in 2022 to 2023, HSE initiated an RMOA to decide if it should recommend that D4, D5 and D6 are added to Annex XIV. To inform the RMOA, HSE launched a call for evidence on 2 March 2023 to gather information on uses and emissions of D4, D5 and D6 in Great Britain. The RMOA will continue in 2023 to 2024, and the appropriate authorities will then consider its recommendations.

9. Restriction of the manufacture, use and placing on the market of Dechlorane Plus™

Description of proposal

A proposal to restrict the manufacture and placing on the market of Dechlorane Plus™.

Primary hazards

Very persistent, very bioaccumulative.

Rationale

Dechlorane Plus™ is a polychlorinated flame retardant found primarily in plastic coatings (such as wire coatings), plastic roofing materials and in materials such as nylon and polypropylene.

The Environment Agency nominated Dechlorane Plus™ as an SVHC under EU REACH. They considered that authorisation was the most appropriate risk management route, given significant uncertainties in the use pattern and level of supply and apparently limited environmental exposure potential. Under the EU transition arrangements, Dechlorane Plus™ is on the UK SVHC candidate list.

In 2020, Norway proposed Dechlorane Plus™ for listing as a POP under the UN Stockholm Convention. The proposal was agreed by the POPs Review Committee (POPRC) in September 2022. In May 2023 the recommendation from POPRC was agreed at the Conference of the Parties (COP). The listing as POP to the Stockholm Convention was agreed with several time limited specific exemptions, meaning the production and use of Dechlorane Plus™ will be globally restricted with the aim for its eventual elimination.

In 2021, ECHA submitted a proposal under EU REACH to restrict the manufacture and placing on the market of Dechlorane Plus™ as a constituent, in a mixture or in an article at a concentration equal to or above 0.1% by weight. In 2022 RAC and SEAC concluded that restriction is the most appropriate measure to address the identified risks. The European Commission has not yet decided whether to include the proposed restriction in Annex XVII of the EU REACH Regulation.

Restrictions on substances under the Stockholm Convention take precedence over UK REACH restrictions and may render any work undertaken under UK REACH redundant.

10. Restriction of placing on the market, or use as a substance in articles, of 2,4-dinitrotoluene

Description of proposal

A proposal to restrict 2,4-dinitrotoluene (2,4-DNT) being used or placed on the market as a substance in articles for supply to the public or professional workers.

Primary hazards

Carcinogenic and mutagenic.

Rationale

2,4-DNT is a substance used in manufacturing plastics. Manufacturers use 2,4-DNT as a plasticiser, in deterrent coatings and to produce pyrotechnics used in automotive safety applications.

In 2021, a proposal was submitted under EU REACH to restrict 2,4-DNT from being placed on the market as a substance in articles for supply to the general public or to professional workers above a 0.1% concentration, due to carcinogenic and suspected mutagenic properties. The proposal included derogations for explosives and military uses. RAC and SEAC have concluded that restriction is the most appropriate measure to address the identified risks for 2,4-DNT. The European Commission has not yet decided whether to include the proposed restriction in Annex XVII of the EU REACH Regulation. 

Due to being a category 1B carcinogen, 2,4-DNT is already subject to a restriction under entry 28 of Annex XVII under UK REACH. It is also on Annex XIV under UK REACH.

There are no current authorisations in place for this substance under UK REACH or EU REACH, nor has HSE received any notifications of the import of this substance in articles. This suggests the substance is not currently used or imported in high volumes within the UK.

The appropriate authorities have agreed that activity under UK REACH is not a priority for 2023 to 2024. However, the potential benefits of a restriction under UK REACH to address any uses that fall outside the scope of the existing bans in Great Britain will be reconsidered when setting priorities in future years.

11. Restriction of the use of lead in fishing weights

Description of proposal

A proposal to investigate the risks of using lead in fishing weights and consider if a UK REACH restriction is required through an RMOA.

Primary hazards

Toxic to wildlife by ingestion.

Rationale

Fishing weights were historically made from lead because it is readily available, inexpensive, dense and easily mouldable. However, lead is also highly toxic to both human health and wildlife.

In 2019, a proposal was submitted under EU REACH to restrict the use of lead in fishing sinkers and lures as part of a restriction on the use of lead in projectiles. In 2022 RAC and SEAC concluded that restriction is the most appropriate measure to address the identified risks. The European Commission has not yet decided whether to include the proposed restriction in Annex XVII of the EU REACH Regulation.

The prioritisation exercise therefore considered proposals to introduce additional measures on lead fishing weights. Lead fishing weights are not within scope of the proposed restriction on lead in ammunition under UK REACH.

However, lead fishing weights between 0.06g and 28.35g were banned in England in 1986 (similar regulations apply in Wales and Scotland) and the evidence suggests that this ban has addressed the concern. Therefore, this is not a priority for action under UK REACH this year. However, the potential benefits of a restriction under UK REACH to address any uses relevant to fishing that fall outside the scope of the existing bans in Great Britain will be reconsidered when setting priorities in future years.

12. Restriction of the use of calcium cyanamide in fertilisers

Description of proposal

A proposal to restrict the use of calcium cyanamide in fertilisers.

Primary hazards

Readily breaks down into a substance that is harmful to aquatic life.

Rationale

Calcium cyanimide is used as a fertiliser, pesticide and in the manufacture of other chemicals.

In 2019 a proposal was submitted under EU REACH to ban the placing on the market of calcium cyanamide for use as a fertiliser. RAC concluded that a restriction is the most appropriate measure to address the risk across the EU. However, the SEAC concluded that it is uncertain whether the proposed restriction is the most appropriate measure. The European Commission has not yet decided whether to include the proposed restriction in Annex XVII of the EU REACH Regulation. 

There is uncertainty about the severity and extent of risk since no documented monitoring data was provided on which to assess the veracity of the risk assessment. There are also unresolved concerns about the alternatives that would be used in its place were it to be restricted.

The appropriate authorities will continue to monitor trends on the use of the substance within the UK. However, calcium cyanamide was not highlighted as a concern by anyone involved in this process, and it is not considered a priority for action this year.

13. Reuse of creosote-treated wood

Description of proposal

A proposal to restrict the use and placing on the market of certain creosote-treated wood products which are not already covered by the UK REACH Regulation.

Primary hazards

Carcinogenic, PBT, vPvB, and potentially toxic to reproduction.

Rationale

Creosote is derived from the distillation of tar from wood or coal. Its primary use is as a wood preservative.

Creosote contains a complex mixture of persistent, bioaccumulative and toxic PAHs. Creosote-treated wood articles present risks to human health and the environment and are already restricted by entry 31 of Annex XVII of the UK REACH Regulation, but some second-hand uses are derogated. However, all uses that could lead to direct exposure of the general public are banned under this restriction. This includes uses inside buildings, in playgrounds and parks, garden furniture, and food and plant containers. The main derogated second-hand uses of creosote-treated wood are in railway sleepers, transmission poles and fencing.

In January 2022 France submitted a restriction proposal under the safeguard clause of EU REACH. Creosote is covered under the Biocidal Products Regulation (BPR) and EU REACH Annex XVII entry 31, but second-hand products treated with creosote can still be bought and sold on the market. Therefore, the EU REACH proposal aims to restrict the use and the placing on the market of certain wood treated with creosote and other creosote-related substances.

Currently, 15 creosote-based products are authorised in the UK under the UK BPR, and wood may be treated with creosote for various end uses, including railway sleepers, fence panels, electricity poles, telecommunication poles and fencing. The authorisations for these creosote-containing products expire on 1 May 2026.

The EU REACH dossier does not quantify the benefits of the proposed restriction options: potential emissions avoided were not assessed. Restriction of second-hand use may lead to an increase in primary uses permitted under entry 31. It may also conflict with commitments to promote reuse and recycling under the waste hierarchy. Therefore, we are not prioritising this proposal this year. We will monitor the development of the EU proposal and review the opinions of ECHA’s RAC and SEAC.

14. PAHs in clay targets

Description of proposal

Proposal to restrict the placing on the market and use of substances containing PAHs in clay targets for shooting.

Primary hazards

Carcinogenic, PBT and vPvB.

Rationale

Clay targets (also known as clay pigeons) are produced using binders such as coal tar pitch high temperature (CTPHT), petroleum pitch and other types of resins. They are commonly used by sports shooters and small game hunters to practise. During use, these substances can be emitted into the environment, while the collecting of the targets can lead to human exposure.

CTPHT is on Annex XIV of both EU and UK REACH, but authorisation does not apply to the placing on the market of substances in articles, so imports of clays containing CTPHT continue to be permitted.

In July 2021, the European Commission requested that ECHA prepare an Annex XV restriction dossier on substances containing PAHs in clay targets. ECHA proposed to restrict the placing on the market of clay targets containing more than 0.005% by weight of the sum of the concentrations of 18 indicator PAHs, to prevent the import of clays containing CTPHT. A joint opinion by the RAC and SEAC was sent to the European Commission in December 2022 in support of the proposed restriction, which included a 1-year transition period with a 1% concentration limit. The European Commission has not yet decided whether to include the proposed restriction in Annex XVII of the EU REACH Regulation.

The International Sports Shooting Federation already limits PAHs in clay targets for international events such as the Olympics, so the targets used in these events would already be compliant with this proposed restriction. Alternatives with very low or no PAH-content are available, and the UK is a major producer of eco-clay targets, free from CTPHT.

HSE has not received any authorisation applications for CTPHT, which means that it is not legally used in Great Britain for the manufacturing of clays. It has not received any notifications of substances in articles that would indicate imports in large volumes. Any potential imports of clays containing CTPHT are therefore currently limited to volumes under 1 tonne per importer per year, or in concentrations below 0.1% weight for weight.

We will continue to monitor notifications of substances in articles to identify any change in import trends and consider the potential benefits of introducing a restriction in future work programmes.

15. N,N-Dimethylacetamide and 1-ethyl-2-pyrrolidone

Description of proposal

A proposal to restrict occupational exposure to N,N-Dimethylacetamide (DMAC) and 1-ethyl-2-pyrrolidone (NEP) in industrial and professional settings.

Primary hazards

Toxic to reproduction, harmful in contact with skin and harmful if inhaled.

Rationale

DMAC and NEP are used as solvents or processing agents across various industrial sectors such as textile fibre manufacture, electrical wire insulation, pharmaceuticals, agrochemicals, and membrane manufacture. Primary routes of exposure are inhalation or dermal contact.

In 2018 ECHA prepared an RMOA for the three dipolar aprotic solvents DMAC, DMF and N-methyl pyrrolidone (NMP). In 2022 the Netherlands submitted a restriction proposal (Annex XV report) under EU REACH to address risks associated with the use of DMAC and NEP in industrial and professional settings. The proposed restriction states that DMAC and NEP should not be manufactured, placed on the market or used in a concentration greater than or equal to 0.3%. The European Commission and ECHA concluded that a restriction for DMAC is justified to prevent unacceptable risks for workers and users due to exposure. NEP was not part of the RMOA commissioned under EU REACH, however due to its classification and similar physicochemical properties to DMAC, the same arguments were considered to justify a restriction.

The joint RAC and SEAC opinion was submitted to the European Commission in June 2023. The European Commission has not yet decided whether to include the proposed restriction in Annex XVII of the EU REACH Regulation.

Within Great Britain, COSHH regulations require employers to assess the risks of exposure (by all routes, including the skin) to hazardous substances. They must then identify and implement measures to further reduce exposure, in proportion to the health risk. If it is determined that specific additional risk management measures are required within Great Britain for DMAC and NEP, the COSHH regulations would be a more appropriate route as exposure primarily occurs in the workplace. Defra, the Scottish and Welsh Governments and HSE will together continue to consider the evidence gathered under EU REACH for these substances when prioritising substances for action under UK REACH in a future work programme.