HSE Chemicals Legislative Reform Proposals

4.1.1 Chemicals supplied to the Great Britain (GB) market can sometimes have properties with the potential to cause harm (hazardous properties). Such chemicals are regulated under the assimilated Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures (GB CLP) so that people using them, in industry or as consumers, can understand their hazardous effects. The purpose of GB CLP is to ensure a high level of protection of human health and the environment.

4.1.2 GB CLP adopts the United Nations Globally Harmonized System of classification and labelling of chemicals (‘the UN GHS’); a voluntary internationally agreed system, upon which the classification and labelling provisions of GB CLP are based. The UN GHS facilitates trade by providing the basis for harmonising regulations on chemicals at national, regional, and worldwide levels.

4.1.3 GB CLP applies to manufacturers, importers, downstream users (e.g. formulators) and distributors (e.g. retailers) that supply chemicals to the GB market. Within scope are chemical substances, mixtures, explosive articles and pyrotechnic articles regardless of their volume or weight. Some specialised chemicals, such as cosmetics, food, and waste are regulated under alternative product- and sector-specific laws and are not in scope.

4.1.4 Before placing chemicals on the GB market, suppliers are required to:

• Classify their chemicals through mandatory classification or self-classification to identify and evaluate hazardous properties. Mandatory classification specifies the legally binding classifications and accompanying hazard labelling that must be used, which may cover some or all hazard classes. Where no mandatory classification exists, the supplier must gather and evaluate all the available information, then compare it to the classification criteria and decide on the classification (self-classification)
• Communicate the hazards identified via labelling
• Ensure the safe and secure packaging of their chemicals prior to them being placed on the GB market

4.1.5 GB CLP places additional requirements on certain suppliers of chemicals. For example, manufacturers and importers are required to notify HSE when supplying a new substance to the GB market and are responsible for updating their notifications following a change in classification.

4.2 Transition from EU CLP to GB CLP

4.2.1 Prior to the UK’s exit from the European Union, the classification, labelling and packaging framework applicable to the UK was Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures (‘EU CLP’). EU CLP was adopted by Member States on 16 December 2008 and was published in the Official Journal on 31 December 2008. It entered into force on 20 January 2009.

4.2.2 EU CLP was incorporated into GB law under Section 3 of the European Union (Withdrawal) Act 2018. Amendments were made to the retained EU CLP Regulation to address deficiencies that would arise from the UK's withdrawal from the EU. For example, the responsibilities previously held by the European Chemicals Agency (ECHA) were transferred to HSE, such as evaluation of legally binding classifications and labelling. The modifications made were limited as the powers provided did not permit changes to policy.

4.2.3 The resulting CLP regime includes supplier requirements that are unnecessary and burdensome. It has also created disproportionate and inefficient processes to deliver scientific and technical updates, and a lack of legislative powers to introduce wider updates of a non-scientific or non-technical nature. In line with the Regulatory Action Plan (RAP), reform of GB CLP is required to address these problems to remove nonessential requirements on business and the ability to keep pace with the EU where appropriate. The changes would need to be delivered through a mix of primary and secondary legislation.

4.2.4 In order to facilitate its dual access to both the UK Internal Market and EU Single Market, Northern Ireland (NI) continues to apply EU CLP under the terms of the Windsor Framework. The Government recognises the potential for differences between GB CLP and EU CLP to become a source of trade friction between GB and NI and will seek to mitigate any regulatory barriers between NI and the rest of the UK, in line with the manifesto commitment to protect the UK Internal Market.

4.2.5 On 20 January 2025, the Secretary of State for NI set out the Government’s commitment to take any future steps necessary to avoid new barriers that would affect supplies of such products into NI. They made this commitment in recognition of the deeply held and genuine concerns raised by Members of the Northern Ireland Assembly about the EU’s recent reform to its own CLP regime. The UK Government recently consulted on the operation of the UK Internal Market Act 2020 and is analysing the responses received to understand whether further actions are needed to safeguard the UK Internal Market.

4.3 Making GB CLP Evaluation More Agile and Predictable

4.3.1 HSE, as the GB CLP Agency, produces legally binding ‘mandatory’ classification and labelling requirements that chemical suppliers must use where applicable. These classifications and labelling elements are set out in the GB Mandatory Classification and Labelling (GB MCL) List which HSE has a statutory duty to maintain using the legal procedures set out in Articles 37 and 37A of GB CLP.

4.3.2 These procedures are administrative as they do not require the creation of new laws. Instead, changes to the GB MCL List are made with the Secretary of State’s approval and the consent of Scottish and Welsh Government ministers. To inform decision making, both procedures include the consideration of scientific, impact and policy considerations, which are set out in the publicly available technical reports and Agency opinions produced by HSE.

4.3.3 Article 37 links GB MCL evaluation activity to that of the EU’s analogous harmonised classification and labelling (EU CLH) system by creating a statutory obligation to consider all EU Committee for Risk Assessment (RAC) opinions on harmonised classification proposals made under Article 37(4) of EU CLP, even for those which consider substances or hazard classes not authorised for use in GB. In such cases, HSE is still legally required to prepare a technical report and an Agency opinion, the production of which can take up to 18 months.

4.3.4 The requirement to consider RAC opinions that are not relevant to GB adds additional burdens for the regulator. This issue is exacerbated by the recent revisions of EU CLP, under which the six new hazard classes introduced into EU CLP by Regulation (EC) 2023/707 have been prioritised for consideration under the EU CLH system. This will result in a greater proportion of RAC opinions featuring non-GB CLP hazard classes.

4.3.5 In addition, statutory timelines set out in Article 37 of the GB CLP Regulation, are currently triggered by the publication of a RAC opinion, requiring evaluations to be sequenced by the RAC opinion publication date determined for the EU. The current timelines restrict HSE’s ability to prioritise its GB MCL evaluation work appropriately and to provide suppliers with regulatory clarity to a timescale dictated by relevance to the GB market.

4.3.6 Taking this into account, HSE believes that amendments to the Article 37 and 37A procedures are necessary to provide greater certainty for duty holders and to ensure that future GB MCL evaluation activity can be delivered predictably and sustainably.

4.3.7 HSE would seek to consolidate Articles 37 and 37A into one procedure under which proposals for mandatory classification and labelling would be evaluated, thereby simplifying the process for substance and mixture classification in GB. The consolidated procedure would include a fast-track evaluation pathway (depicted in Figure 1) for assessing classification proposals from territories that adopt the UN GHS and have a transparent classification process. Fast-track evaluation amends the time limit for publication of a technical report from 6 to 12 months whilst removing the requirement to publish an Agency opinion and its associated 12 month time limit. If compared to the existing Article 37 procedure, fast track evaluation would result in a 12 month reduction for delivery of changes to the GB MCL List following publication of the technical report. Figure 1 provides a possible way in which a fast-track procedure would work. Classification proposals from jurisdictions that do not adopt the UN GHS and do not have a transparent classification process would be evaluated under a full process, similar to that currently described in Article 37A.

Figure 1: Possible route to fast-track evaluation for assessing classification proposals from UN GHS adopting territories that have a transparent classification process.

4.3.8 The mechanism by which consent is obtained for updates to the GB MCL List also presents burdens as its current design is duplicative. The current mechanism includes a copy of HSE’s ministerial recommendation being sent to devolved government (DG) ministers twice. Under the Article 37 and 37A procedures, HSE is required to send a copy of its recommendation to DG ministers. A copy of the recommendation is also sent to DG ministers when the UK Government minister seeks DG consent to satisfy the requirements of Article 53B of GB CLP.

4.3.9 HSE is seeking to omit from the consolidated procedure the legal requirement for HSE to send a copy of its ministerial recommendation to DG ministers. This would reduce the administrative burdens arising from this aspect of delivery of the GB MCL system and ensure that resource is used proportionately.

4.3.10 The consolidated procedure retains the ability to consider EU RAC opinions whilst providing the option for faster consideration of classification proposals from other jurisdictions also adopting the UN GHS. The consolidated procedure would be complemented by a GB MCL workplan setting out the classification proposals to be considered in future. As well as providing transparency for stakeholders, the workplan would enable early stakeholder input.

4.3.11 The proposed changes would not impact the obligation under Article 36(1) of GB CLP to subject substances with the most significant hazards to mandatory classification and labelling requirements. HSE remains committed to the evaluation of classification proposals that focus on carcinogenic, mutagenic, reproductive toxic and respiratory sensitising hazards. These proposals would be prioritised for fast-track evaluation where they originate from EU. The amendment of Article 37 would not affect HSE’s ability under Article 36(3) of GB CLP to evaluate RAC opinions featuring the new EU CLP hazard classes on a case-by-case basis where sufficient justification is provided. Nor would it prevent the adoption and prioritisation of these hazard classes in future, should the UK Government’s position on the inclusion of these hazard classes in GB CLP change.

To what extent do you agree or disagree that HSE’s proposal for fast-track process will improve the existing GB MCL evaluation procedures described in Articles 37 and 37A?

If you answered ‘don’t know’, please go to the next question. Otherwise, please briefly explain the reason(s) for your response.

To what extent do you agree or disagree with HSE’s proposal that the criteria for  fast-track evaluation should be based on a jurisdiction’s adoption of GHS, rather than publication of an ECHA RAC opinion?

If you answered ‘don’t know’, please go to the next question. Otherwise, please briefly explain the reason(s) for your response.

Are there any unintended consequences which you think may result from changing the Article 37 and 37A procedures in GB CLP?

If ‘yes’, please briefly explain what these unintended consequences might be.

4.4.1 Article 40 of GB CLP requires the following suppliers to provide HSE with classification and labelling information on new chemical substances they place on the GB market: GB-based manufacturers and importers; and NI-based manufacturers, downstream users and distributors directly supplying the GB market. Further notifications must be made by suppliers when the classification of these substances change.

4.4.2 The notifications received by HSE populate a GB CLP notification spreadsheet. HSE, as the GB CLP Agency, has an inherited duty under Article 42 of GB CLP to set up and maintain a publicly facing database for such notifications. However, this type of database is not in existence due to resource constraints on establishing it around the time of EU Exit. HSE has subsequently come to the view that such a database is not essential for how it regulates chemicals.

4.4.3 The GB CLP notification requirements replicate the supplier obligations of EU CLP, which was necessary to align with the policy constraints imposed during the UK’s EU Exit. However, the GB CLP notification requirements are viewed as disproportionately burdensome due to their onerous resource implications for notifiers and the non-value added nature of the requirements themselves.

4.4.4 The European Commission’s 2017 review of EU CLP and other EU chemicals legislation estimated that the time taken to submit a notification to the analogous Classification and Labelling Inventory is 11 minutes. Informal stakeholder engagement with GB CLP-regulated businesses conducted by HSE in 2024 indicated that submission of a notification to the GB CLP notification database takes on average approximately three times longer (36 minutes) which suggests that GB CLP notifiers currently face increased burdens to comply.

4.4.5 The notification requirements aim to provide oversight of chemicals placed on the GB market which are excluded from the provisions of the assimilated Regulation (EC) No 1907/2006 on the registration, evaluation, authorisation and restriction of chemicals (UK REACH) or the Biocidal Products Regulation (BPR); and to encourage industry cooperation to agree self-classifications. However, experience shows that the outcomes of such self-classifications are variable and the only way HSE could assure the robustness of any self-classifications would be to validate the entries itself, thereby undermining the rationale for self-classification.

4.4.6 HSE achieves oversight through alternative means set out in legislation. Under Article 49 of GB CLP, suppliers are required to maintain information used to classify and label chemicals they place on the GB market, and to make it available on request to HSE and enforcement authorities. Part 1.1.0 of Annex I to GB CLP encourages suppliers to cooperate to meet classification and labelling requirements. Where data and expertise is shared for these purposes, suppliers are expected to document the basis for classification decisions and to make it available on request to HSE and enforcement authorities. As such, the information received via notification is not used by HSE for GB CLP enforcement or delivery purposes.

4.4.7 A publicly available notification database risks containing inaccurate information and diverging classifications for the same substances, as HSE does not verify submissions and there is no duty to notify HSE if the supply of a previously notified substance to the GB market ceases. Additionally, the identity of notifiers is not made publicly available which prevents communication between notifiers of the same substance and acts as a barrier to industry cooperation.

4.4.8 To ease burdens on businesses, HSE is seeking to remove the GB CLP requirements relating to notification, namely the Article 40 supplier obligations to notify the GB CLP Agency and the Article 42 duties to establish and maintain the notification database. Such actions would reduce the time and cost of regulatory compliance for business and support the government commitment in the RAP to cut administrative costs for business by 25% by the end of the Parliament. It would also remove an unnecessary regulatory statutory requirement and prevent the significant financial expense to establish and maintain a Government Digital Service-compliant database.

4.4.9 Revoking the notification database obligations would not change the general requirements for suppliers to classify, label and package their chemicals under Article 4 of GB CLP. These are separate obligations applying to a wider range of suppliers and chemicals than those in scope of notification and allow for the regulation of hazard communication. Existing provisions in other chemicals regulations provide oversight of chemicals supplied to the GB market, such as UK REACH. Under UK REACH, manufacturers and importers of chemical substances supplied in quantities of 1 tonne or more per year must submit a registration to HSE for those substances. Therefore, HSE is confident that the revocation of the notification database will not inhibit its ability to regulate hazard communication in the supply and use of chemicals in GB.

To what extent do you agree or disagree that removal of the Article 40 requirement to notify the GB CLP Agency would save businesses time?

If you answered ‘don’t know’, please go to the next question. Otherwise, please briefly explain the reason(s) for your response.

Are there any unintended consequences which you think may result from removing Article 40?

If ‘yes’, please briefly explain what these unintended consequences might be.

4.5.1 Suppliers of hazardous chemicals to the GB market must apply the relevant mandatory classifications and accompanying labelling elements set out in the GB Mandatory Classification and Labelling (MCL) List. Some entries on the GB MCL List have explanatory notes assigned to them which suppliers must take into account when applying mandatory classification and labelling.

4.5.2 The GB MCL List is an administrative list, hosted on the HSE website, whereas the notes accompanying GB MCL entries are described in Part 1 of Annex VI to the GB CLP legislation. The difference in location of GB MCL information arises from the relocation of the mandatory classification and labelling list from Annex VI to HSE’s website to enable post-EU Exit updates of the GB MCL List to be made through simpler, non-legislative procedures. HSE understands that the resulting difference in location of GB MCL information makes it difficult for suppliers to find the necessary information and extends the time taken to classify.

4.5.3 HSE is seeking to move the notes assigned to GB MCL entries from Part 1, Annex VI to HSE’s website. The notes assigned to GB MCL entries would be located on the same spreadsheet as the GB MCL List or in an accompanying document hosted in the same location.

4.5.4 This change would simplify the process duty holders have to follow to identify a mandatory classification and the accompanying notes, which in practice would reduce the time taken to carry out classification. Additionally, this would align the process of adding, amending or removing notes pertaining to GB MCL entries with that of the GB MCL procedure, ensuring more efficient updates through an administrative, rather than legislative, process.

To what extent do you agree or disagree that changing the location of the GB MCL notes would make it easier to access GB MCL information?

If you answered ‘don’t know’, please go to the next question. Otherwise, please briefly explain the reason(s) for your response.

Are there any unintended consequences which you think may result from the relocation of technical provisions?

If ‘yes’, please briefly explain what these unintended consequences might be.

4.6.1 Article 53 of GB CLP provides an ongoing power to update the Regulation but its use is limited to the implementation of scientific and technical developments arising from the UN GHS. It is necessary to consider issues that are beyond the scope of the UN GHS or at a faster pace than is possible at the UN GHS to provide regulatory clarity or respond to international changes in areas such as UK free trade agreements with other countries in a timely manner. However, a continuing power does not exist through which such issues can be addressed in the GB CLP regime.

4.6.2 HSE is seeking the creation of an ongoing power, exercisable by statutory instrument under which GB CLP and its supporting legislation can be amended to:

• Implement UN GHS provisions in a fundamentally different way to reduce regulatory burden while maintaining existing levels of protection
• Make non-scientific and non-technical changes to improve compliance with or address ambiguities in the legislation for duty holders, Devolved Governments and other regulators
• Incorporate suitable classification, labelling and packaging requirements that are in force in NI to harmonise requirements across the UK, ease trade friction for GB businesses supplying NI or international markets and to ensure that the UK maintains parity with other countries on health and environmental protections
• Implement scientific and technical aspects of international agreements beyond UN GHS, such as international treaties or UK Free Trade Agreements, which may enable the UK to meet its international commitments without imposing new regulatory regimes on businesses

4.6.3 The proposed power is necessary to create agility in the CLP regime, allowing it to adapt quickly and support growth in light of wider political, technological and scientific developments; and to ensure that HSE has a vehicle to implement international obligations on an ongoing basis.

Are there any unintended consequences which you think may result from the creation of an ongoing power under which GB CLP and its supporting legislation can be amended?

If you answered ‘don’t know’, please go to the next question. Otherwise, please briefly explain the reason(s) for your response.

4.7.1 The majority of the changes to CLP relate to the streamlined running of the regime and HSE’s ability to focus on the substances of greatest concern. The proposal with direct impacts on business would be the revocation of the GB CLP notification database, which will save dutyholders time and the associated cost of notification. The total savings from this are expected to be around 36 minutes per notification across around 2,400 notification per annum which equates to an estimated saving of £34,000 per annum for business. We will develop this analysis further through consultation on detailed proposals.

4.8.1 The revision of the EU CLP Regulation (Regulation (EC) No. 1272/2008) by two pieces of amending legislation, Commission Delegated Regulation (EU) 2023/707 and Regulation (EU) 2024/2865, introduced differences between the EU CLP and GB CLP regimes.

4.8.2 The Government recognises that the operation of distinct CLP regimes in Northern Ireland and Great Britain has the potential to impact on the operation of the UK internal market. As set out in the letter from the Secretary of State for Northern Ireland to the Speaker of the Northern Ireland Assembly on 20 January 2025, the Government’s assessment is that the majority of those trading relevant products between Great Britain and Northern Ireland are likely to trade with the EU as well as within the UK, and therefore will have incentives to comply with EU arrangements. As such, the Government’s assessment is that the impact of distinct arrangements is unlikely to have a significant adverse impact on the UK internal market.

4.8.3 Nonetheless, the Government has also been clear that it will take any necessary steps to protect the UK’s internal market and avoid the development of disincentives for traders to move goods from Great Britain to Northern Ireland.

4.8.4 For that reason the Government is considering the incorporation of these measures into the domestic CLP regime on a UK-wide basis, where this is relevant for Great Britain, and with the intention of supporting the smooth operation of the UK internal market and reducing barriers to trade with the EU.

4.8.5 Commission Delegated Regulation (EU) 2023/707 introduced six new hazard classes into EU CLP:

• endocrine disruption (ED) for human health and the environment (separate hazard classes)
• persistent, bioaccumulative, toxic (PBT)
• very persistent, very bioaccumulative (vPvB)
• persistent, mobile, toxic (PMT)very persistent, very mobile (vPvM)
• very persistent, very mobile

4.8.6 The new hazard classes are now the focus of United Nations Globally Harmonized System for the Classification and Labelling of Chemicals (UN GHS) discussions and the UK Government is engaging in these international discussions on whether and how to include the potential hazard issues in the UN GHS.

4.8.7 Regulation (EU) 2024/2865 further amended the EU CLP Regulation to improve how chemical hazards are classified, provide clearer safety warnings and improve compliance and user safety. These new measures are aimed at optimising labelling provisions concerning hazard communication, introducing labelling rules such as minimum font size, line spacing and colouring, whilst also permitting for broader use of fold-out labels.

4.8.8 The EU CLP Regulation, as amended, already applies in Northern Ireland under the Windsor Framework and includes the following measures:

Changes to hazard identification

• Application of the six new hazard classes to classification and labelling
  Suppliers are required to self-classify and label their chemical substances and mixtures in accordance with the hazard classes specified in paragraph 5. Chemical substances with these hazard classes will be prioritised for EU Harmonised Classification and Labelling. Suppliers are required to apply harmonised classification and labelling elements where available for the chemicals they intend to supply
• Clarified rules for the evaluation and classification of complex substances containing more than one constituent
  Where data on individual constituents are available, such substances should be classified using the same classification rules as mixtures unless otherwise specified in Annex I to EU CLP. Relevant data on the multi-constituent substance should be  taken into account but where an absence of certain properties or less severe properties is indicated, data on the substance should not override the information available on the individual constituents

Changes to hazard communication

• Additional label formatting rules
  Suppliers must label their chemicals in accordance with new rules which specify the minimum font size, background colour and line spacing to be used
• Broader use of fold out labels
  The general use of fold out labels is permitted. Previously under EU CLP, use of fold out labels was limited to chemicals in small or unsuitably shaped packaging. Rules governing the location of information in fold out labels are also introduced
• Rules on voluntary use of digital labelling Non-obligatory information can be provided in a digital only format. When using digital labelling suppliers have to fulfil new requirements which include being searchable and accessible to all users in the EU free of charge, being available in less than two clicks and not tracking any user data
• New deadline for updating labels
  Suppliers must update their labels within six months following a change in the classification and labelling of their chemical(s) which results in an additional hazard class, a more severe hazard class or category or new supplemental labelling elements
• Refill station labelling
  Where chemicals are supplied via refill for example detergents, a visible label must be firmly affixed to the refill station
• Additional hazard communication requirements for advertisements
  More hazard information is required in advertisements for hazardous substances and mixtures. In addition to the hazard class, advertisements should contain the hazard pictogram, the signal word and the hazard statements. The types of advertisements regulated under EU CLP are widened to include distance sales offers also
• Labelling Exemptions
  Derogations to the labelling requirements of EU CLP are introduced for chemicals supplied without packaging (such as fuel at filling stations), chemicals contained in very small packaging with contents below 10ml, and ammunition

Adaptation to new methods of supply

• Risk management at refill stations
  New rules focusing on risk management are introduced for suppliers of chemicals by refill. Suppliers must ensure that clean and suitable packaging is used, the refill station’s operating buttons are kept out of reach of children. Appropriate training of the supplier’s staff must be undertaken and the supplier must be available to provide immediate assistance at the moment of refill. The sale via refill of chemicals with certain hazardous properties is prohibited. These properties are acute toxicity, specific target organ toxicity, carcinogenicity, germ cell mutagenicity, reproductive toxicity, respiratory sensitisation, skin corrosion/irritation, aspiration hazard, flammability, ED, PBT, vPvB, PMT and vPvM

4.8.9 In line with the Government’s commitment to protecting the UK internal market in all circumstances, it committed to explicitly consult on applying a consistent regime across the UK, should this be required to safeguard the UK internal market.  This call for views is distinct from but complements that commitment.

4.8.10 HSE is interested in your views on these recent revisions to EU CLP, their potential impact on the UK’s internal market and the merits of applying a consistent regime across the UK, taking into account the current requirements of GB CLP. The information you provide below will be used by the UK Government  to understand how best to address the impact, if any, of the associated changes in classification and labelling on trade between Great Britain and Northern Ireland, as well as to help inform any future impact assessments.

Do you agree or disagree that a consistent CLP regime between Great Britain and Northern Ireland is beneficial to safeguard the UK Internal Market?

If you answered ‘Agree’ or ‘Strongly Agree’, what would you see as the main benefits of a consistent CLP regime between Great Britain and Northern Ireland?

Do you agree or disagree that the current CLP regime between Great Britain and Northern Ireland is working?

If you answered ‘Do not agree or disagree’ or ‘Don’t know’, please move to the next question.

Otherwise, please briefly describe in what ways the current CLP regime between GB and NI is either working or not working.

Do you think the Government should apply any of the EU CLP Regulation measures detailed in paragraph 4.8.8 in Great Britain?

If you answered ‘Yes’, please briefly describe which measure(s) should be applied to GB, and the reasons why.  

Please indicate what the practicalities of applying the measure(s) would be, and whether the measure(s) would promote and/or boost trade between Great Britain and Northern Ireland. 

​​​Also, can you please provide further details of the approximate time and/or costs or savings incurred in the event of applying these measures.​​​​​​

Do you have any further thoughts or views about the application of EU CLP Regulation measures in GB (e.g. the potential impact on UK-EU trade; impact on UK industry)?

If you answered ‘Yes’, please briefly detail these further thoughts about the application of EU CLP Regulation measures in GB.