New GB-CLP regulation and GB safety data sheets

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[UK–EU Trade and Cooperation Agreement]

[GB classification, labelling and packaging (CLP) regulation]

[Hazard classification]

[Product labelling]

[Safety data sheets]

GB chemical companies now have to comply with a new GB-regulation for the classification, labelling, and packaging of chemicals, which became effective on 1 January 2021

This post updates you on the GB-CLP Regulation and GB safety data sheets (SDSs), now that the Brexit transition period is finished and new UK Regulations have come into force.

Please see our SDS services or contact us for more information.

UK–EU Trade and Cooperation Agreement

Regulations in both jurisdictions look the same for now, but dual compliance is required.

Since 31st January 2020, the UK has no longer been a Member State of the EU. A transition period ran until 31 December 2020, during which UK chemicals regulation remained aligned with the EU. During the transition period, the UK Government and the EU negotiated a new trade agreement to define their future relationship.

The Trade and Cooperation Agreement [1] was published on 24th December 2020, coming into force just a week later.

It was good news for the UK chemicals industry, as it secured some important benefits:

  • Tariff- and quota-free movement of goods;
  • A commitment to cooperation on chemicals, including the exchange of non-confidential information between the EU and UK authorities, and cooperation on electronic formats and tools used to store data, ie use of IUCLID;
  • Commitment to implementing a version of the UN GHS [2] for hazard classification, safety data sheet preparation, and labelling.

However, the Agreement falls short of what the UK Chemicals Industry wanted [3] for chemical regulation, particularly:

  • Partnership of UK authorities in the European Chemicals Agency (ECHA), preventing the need for re-registration of substances under a new UK REACH regulation;
  • Alignment between the UK and EU chemicals regulations, to ease compliance with both systems.

This article examines the new UK regulatory landscape for classification, labelling and packaging of chemicals under GB CLP.

A separate blog post on the UK REACH provisions is available here, or see our EU- and UK-REACH services here.

GB chemical companies now have to comply with a new GB-regulation for the classification, labelling, and packaging of chemicals, which became effective on 1 January 2021 [4].

GB refers to England, Scotland and Wales. Northern Ireland remains part of the UK, but operates under EU chemical law, according to the Northern Ireland Protocol [5].

The important principle for considering regulatory compliance is that GB is completely separated from the EU. Regulations in both jurisdictions look the same for now, but dual compliance is required.

GB classification, labelling and packaging (CLP) regulation

Regulatory divergence makes little sense for UK industry, who prefer a single set of rules for hazard classification, product labelling, and safety data sheets.

The Trade and Cooperation Agreement [1] indicates that both GB and EU will retain the recommendations of the Globally Harmonised System (GHS) [2] produced by the United Nations.

The EU adopted the GHS principles in 2008 with the publication of the Classification, Labelling and Packaging Regulation (CLP Regulation) [6]. The CLP Regulation is regularly updated to improve clarity, update harmonised classifications, and implement changes made to the GHS.

The EU version was ‘lifted and shifted’ into GB legislation as it was on 31 December 2020, so that the EU and GB Regulations are now similar, but completely separate, applying only in their respective jurisdications, allowing growing divergence between the EU and GB.

Regulatory divergence makes little sense for UK industry, who prefer a single set of rules for hazard classification, product labelling, and safety data sheets.

The Trade and Cooperation Agreement indicates a willingness to share non-confidential data and make transparent decisions regarding chemical policy (see Trade and Cooperation Agreement, Chemicals Annex TBT-3), but no requirement to prevent divergence:

Nothing in this Article shall oblige either Party to achieve any particular outcome regarding the implementation of the UN GHS in its territory or regarding the classification of a given substance.’

Hazard classification

Hazard classification involves comparing the hazard information of a substance or mixture with the criteria for hazard classes laid down in the CLP Regulation. It provides a simple, shorthand description of hazards, and is the basis for product labelling and the safety data sheet (SDS).

The European Chemicals Agency (ECHA) has world-beating resources, supported by chemical data from the EU REACH Registration programme, for evaluating hazard classification of substances:

  • A list of harmonised, mandatory classifications (Annex VI or EU CLP Regulation);
  • REACH registration dossiers with recommended classifications and summary test data;
  • A classification and labelling inventory (CLI) that contains most substances in commerce (as well as Annex VI and REACH Registration summaries).

The UK has either copied these resources, or intends to rebuild them, as indicated below.

GB mandatory classification and labelling list

The EU list of harmonised classifications in Annex VI of the EU CLP Regulation standardises the hazard classification of over 4300 substances. The classifications are only partial, and have to be completed by the classifier for those hazard classes not included in the harmonised classification.

These harmonised classifications give assurance that chemical product will display the same warnings throughout the EU countries.

A new GB mandatory classification and labelling list (GB MCL List) has been compiled as a dowloadable Excel spreadsheet. This reproduces the EU Annex VI list, as of 31 December 2020, giving:

  • Partial, mandatory classifications (note the name change from EU ‘harmonised classifications’);
  • Labelling elements, including pictograms, signal word, hazard statements and supplementary hazards;
  • Specific concentration limits (SCLs) to calculate the classification of mixtures containing the substances;
  • M-factors for calculating aquatic toxicity classification of mixtures containing the substances;
  • ATEs for calculating acute toxicity classification of mixtures containing the substances.

The UK will not have access to ECHA documentation for any new proposals for EU harmonised classifications, so the UK authority will choose between implementing EU decisions without full knowledge, or making their own decisions with the possibility of divergence from the EU.

Divergence would mean the same product having different hazard classification, labelling and safety data sheet for GB and the EU.

GB industry can apply to the UK Health and Safety Executive (HSE; the Agency for GB CLP) to amend the GB MCL listing, or the HSE can amend it, in the following cases:

  • Where a substance classification on the MCL is incorrect;
  • Where a substance not yet on the MCL may meet the criteria for classification as a respiratory sensitiser, or CMR (carcinogen, mutagen, reproductive toxicant).

The GB MCL will be updated annually.

REACH registration data

An indication of the futility of the UK REACH scheme is that it is unlikely add any hazard data to that currently available in the EU database.

The UK–EU Trade and Cooperation Agreement does not envisage any partnership of UK authorities in the European Chemicals Agency (ECHA). This means that the EU’s vast database of information on chemical hazards and use is largely lost to UK policymakers.

The UK chemical industry was a main contributor to the EU Registration programme. UK industry is now tasked with populating an inferior UK database with similar information at a cost of GBP 1 billion [7].

There are still calls from the UK chemical industry to either re-negotiate access to the ECHA database, or allow UK REACH Registration without a full data package. There are concerns that the burden of compliance with UK REACH will make UK industry less competitive in the EU market.

UK chemicals policy will be set back years compared to that of the EU, because the UK will not have data on currently used chemicals until October 2027, the final deadline of the UK-REACH transition period.

A separate blog post on the UK REACH provisions is available here, or read about our EU- and UK-REACH Services here.

GB REACH registration applies to all substances supplied in GB at greater than 1 tonne per year, whether supplied neat or as part of a mixture.

The UK has a transition period during which the UK-REACH registrations for substances currently on the GB market can be submitted. Previous UK holders of EU REACH Registrations can ‘grandfather‘ their registrations into UK REACH up until 30 April 2021.

GB importers from the EU who were downstream users under the EU REACH scheme can submit a notification (DUIN) before 27 October 2021, and benefit from a 2 to 6 year period before full registration is required.

An indication of the futility of the UK REACH scheme is that it is unlikely add any hazard data to that currently available in the EU database, or to change the hazard classification, product labelling, or safety data sheet of GB registered substances.

For most commercial substances, there is sufficient information publicly available on the ECHA website to find the classification and even check it against summary test data. Over 22 000 substance registrations have been made under EU REACH.

Classification and Labelling Inventory (CLI)

The EU classification and labelling inventory (CLI) of substances comprises the harmonised classifications from the CLP Regulation Annex VI and the classifications from the REACH registration dossiers, but its unique feature is that it also contains classifications for other hazardous substances that do not require registration, for example for supply at < 1 tonne per year:

  • Hazardous substances (no minimum quantity) that are placed on the market neat;
  • Hazardous substances (no minimum quantity) that are placed on the market mixtures at above the concentration that results in the classification of the mixture as hazardous.

These classifications were individually made by companies through a notification process. Notification is required within one month of placing on the market, for both EU and GB.

The CLI is still the wild-west of classification lists, as many substances have a huge variation of notified hazards.

Notifiers are supposed to liaise with one another to arrive at an agreed hazard classification. Also, classifiers are supposed to use the CLI classification, or provide reasons for deviations from it to ECHA (CLP Article 16). Neither of these provisions have been effective.

ECHA established and maintains the EU CLI.

The UK have adopted ECHA’s CLI as it stood on 31 December 2020, and those substances do not require re-notification to the UK HSE.

For substance newly placed on the GB market, or not on the EU CLI, the manufacturer or importer must submit a notification to HSE within one month of placing on the GB market. Also, if the hazard data changes, resulting in a new classification, then a GB CLI notification will be required.

Product labelling

The hazard classification of chemical substances and mixtures leads to the pictograms, signal words, hazard- and precautionary-statements that are required on the product labels.

The details of how to convert the classification into these label parts is given in the EU CLP Regulation.
These rules have been replicated in GB law, so there will be continuity of requirements for labels, provided that ingredient classifications do not diverge, as described above.

There are many other pieces of legislation that can impact the label for a chemical product, and the GB versions should be consulted:

  • REACH (eg ‘Restricted to professional users’ for CMR products);
  • Detergents (Regulation 648/200, eg listing of specified constituents such as surfactants);
  • Aerosol dispensers (Directive 75/324/EEC, eg flammability labelling);
  • Biocides (Regulation 528/2012, eg listing of active ingredients).

Each of these may also diverge from EU legislation over time and lead to differences between EU and GB product labelling.

GB labels must be in English, but other languages can be added. A GB supplier address should be given on the product label.

Safety data sheets (SDSs)

The specification for EU safety data sheets is given in Annex II of EU REACH, which is occasionally updated.

The most recent update (EU Regulation 2020/878) sets out formatting changes and additional information requirements for new safety data sheets, including:

  • Unique formula identification (UFI) code, if available;
  • Acute toxicity estimates, M-factors, and specific concentration limits;
  • Specific requirements for endocrine disruptors and products in nano-form;
  • More detail on physico-chemical properties and test methods

Existing SDSs can continue to be used in the EU until 31 December 2022.

The details of the changes required by this regulation for EU SDSs can be found in our Safety Data Sheet (SDS) Contents Guide.

This update regulation applied from 1 January 2021, and so was not transposed into UK legislation. GB SDSs legislation specifies the older formatting (as was specified in EU Regulation 2015/830).

Poison centre notification and UFIs are not mandatory in GB.

Suppliers can apply to the UK HSE for an alternative chemical name to be used in Section 3 for some hazardous ingredients, similar to the provision in EU CLP Article 24. If granted, the alternative chemical name can be used in SDS and on label in order to keep the ingredient confidential.

References to legislation in the SDS, should be to UK legislation, eg for:

  • Wastes
  • Occupational exposure limits and monitoring
  • Standards for personal protective equipment
  • Worker protection (eg COSHH)
  • Storage
  • Flammable atmospheres
  • Emergency planning
  • Specialist products, such as detergents, biocides, and aerosols
  • Vulnerable workers
  • Test methods

GB SDSs must be in English, but other languages can be added. A GB supplier address should be given on in Section 1 of the SDS.

References

[back to Trade and Cooperation Agreement] [back to GB CLP requirements] [back to REACH registration data]

[1] Trade and Cooperation Agreement Between the European Union and the European Atomic Energy Community, of the One Part, and the United Kingdom of Great Britain and Northern Ireland, of the Other Part; 24 December 2020.

[2] Globally Harmonized System of Classification and Labelling (GHS); Eighth Revised Edition; United Nations; 2019.

[3] Britain at work; Chemical Industries Association; November 2019.

[4] The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019; UK Statutory Instrument 2019 No. 720.

[5] Northern Ireland Protocol; CP346; Cabinet Office; December 2020.

[6] 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 (as amended).

[7] Peter Foster in the Financial Times: UK chemical industry warns of £1bn cost to duplicate EU regime; 3 August 2020.

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