Chemical substances

 By Natalia Fuentes, CPT SC | Regulatory

 March 1, 2021

Chemical substances

The United Kingdom (UK) completed its withdrawal from the European Union (EU) on 31^st December 2020, and as of 1^st January, 2021, became a third country and not member of the EU. EU legislation ceased to apply in the UK and therefore companies must be aware of the significant implications for compliance under the following independent chemical regulatory regimes summarised below.

• A comparison between EU and UK legislations
• REACH Regulation
  • Scenario
  • REACH Annex XVII Restrictions
  • REACH Substances of Very High Concern
  • Fees
  • Safety Data Sheets
• CLP Regulation
• PIC Regulation
• POP Regulation
• GB BPR
• GB PPP
• RoHS

A comparison between EU and UK legislations

The following table shows the legislation that may affect chemical substances, either on their own, in a mixture, or in an article. It shows the legislation before Brexit and after Brexit.

Due to the ever-changing regulatory scenario, the Information displayed on this website may be subject to changes, should any of the referred Authorities publish an update after the date of issue. Please check with our product experts or with the respective Authorities for any updates, prior to using these contents.

Please see below further information about UK chemicals legislation.

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REACH Regulation

Scenario

REACH has been replicated in the UK with the necessary changes to make it operable in a domestic context. This is known as UK REACH.

HSE, known as The Agency, is the UK Competent Authority for this regulation and assumes ECHA functions.

As of 1^st January 2021, the UK REACH and the EU REACH regulations operate independently from each other. Companies that supply and purchase substances, mixtures or articles to and from the EU/EEA/Northern Ireland and Great Britain (England, Scotland and Wales) will need to ensure that the relevant duties are met under both pieces of legislation.

Under the Northern Ireland Protocol, the EU REACH Regulation continues to apply to Northern Ireland, while UK REACH regulates the access of substances to the GB market (England, Scotland and Wales).

Your role in the supply chain (i.e. where and with whom you do business) will determine how the withdrawal affects you, as the role previously taken within EU REACH may have changed significantly under UK REACH. Thus, it is important to review your UK role/s, identify any areas where you may have new obligations, and understand the compliance deadlines to complete the required actions, mitigating risks to your business.

• Manufacturers/Importers ^[1]: Businesses that manufacture or import one or more tonnes of any given substance each year are responsible for 'registering' that substance with 'The Agency', i.e. the Health and Safety Executive (HSE).

  Importers are responsible for holding the registrations for these substances, unless their non-GB suppliers have appointed an Only Representative to take the duties on behalf of the GB importers.

  Registration applies to substances on their own, substances in mixtures and, in certain limited cases, to substances in articles (intended release). Under UK REACH registration, companies have to collect information on the properties and uses of the substances they manufacture or import in quantities of one or more tonnes per year. They should also assess the hazards of the substance and any potential risks presented by its uses.

  There are two possible scenarios:

  • 'Grandfathering': Relevant EU REACH registrations have been recognised under UK REACH: this is known as 'grandfathering'. Grandfathering allows you to have continued access to the GB market. However, GB-based holders of existing EU REACH registrations need to complete the ‘grandfathering’ process by providing basic information (mostly related to the Annex VI of EU REACH) to the Health and Safety Executive (HSE) by 30th April 2021 (within 120 days of the end of the transition period). You need to submit this information using the UK REACH IT system, ‘Comply with UK REACH’ ^[2].

    At this point, your UK REACH registration number will be issued to you. No registration fee will be levied by the Agency for grandfathering your registration.

    Within two, four or six years plus 300 days from the end of the Transition Period (depending on tonnage band and hazard profile of the substance (see table below)), you must comply with the full information requirements for your tonnage band under UK REACH, in accordance with Article 10. The information requirements for registration under UK REACH are identical to the requirements of EU REACH.

    Deadline	Tonnage	Hazardous properties
    28/10/2023 (2 years from 28 October 2021)	1000 tonnes or more per year	-    Carcinogenic, mutagenic or toxic for reproduction (CMRs) ≥ 1 tonne per year -    Very toxic to aquatic organisms (acute or chronic) ≥ 100 tonnes per year -    Candidate list substances (as at 31 December 2020)
    28/10/2025 (4 years from 28 October 2021)	100 tonnes or more per year	Candidate list substances (as at 27 October 2023)
    28/10/2027 (6 years from 28 October 2021)	1 or more tonnes per year

    
    

    All members of the joint registration will need to submit a separate member dossier containing certain information.

  • If you were not previously a registrant and you wish to manufacture or import chemicals into GB for the first time, no transitional provisions apply and you will be required to follow the processes for submitting a new registration under UK REACH. For any new registration the first step is to submit an Article 26 inquiry. Inquiry dossiers can be submitted to The Agency via ‘Comply with UK REACH’.
• Downstream users: These are companies or individual workers who directly handle chemical substances in the course of their business activities and are not themselves the GB-based manufacturer or importer of the substances.

  However, some businesses who were considered downstream users under EU REACH may find that they are classed as importers under UK REACH, if they are sourcing substances directly from the EU/EEA. This will mean they may have new registration responsibilities.
  
  Downstream User Import Notification (DUIN)

  By submitting a notification to The Agency within the first 300 days from the end of the transition period, regarding the substances you wish to continue importing into the GB from the EU, you effectively defer your registration obligation for up to six years plus 300 days after the end of the transition period.

  A downstream user import notification (DUIN) is not a pre-registration.

  It should be noted that, having notified under Article 127E, you are not obliged to register unless you wish to continue importing the notified substance after 300 days plus either two, four or six years of the end of the transition period.

  The information requirements can be found in Article 127E of the Statutory Instrument.

  This only needs to be done once per legal entity and covers all substances that you wish to continue importing from the EU. At this point, your UK REACH DUIN number will be issued to you. 

• Distributors: Companies that store and place on the market a substance, on its own or in a mixture, for third parties. They do not directly handle the substance. Providing they do not have importer responsibilities, they do not need to register under REACH. They do have an important obligation to pass information down the supply chain, including Safety Data Sheets.

  Some businesses who were considered distributors prior to the end of the transition period, under EU REACH, will become importers under UK REACH and therefore may have new registration responsibilities. Distributors under EU REACH are able to notify The Agency regarding the substances that they wish to continue importing into GB from the EU. Please refer to Downstream User Import Notification (DUIN) section above.

• Only representative: Under Article 8 of UK REACH, a non-GB manufacturer/formulator/producer of articles can appoint a GB-based Only Representative to fulfil the obligations of the GB-based importers.

  To remain legally on the EU market, GB-based Only Representative representing a non-EU company based in the UK will no longer be able to act as an Only Representative after the end of the transition period, unless it is relocated in an EU or EEA country and the registrations are transferred to that new Only Representative. 

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REACH Annex XVII Restrictions

UK REACH uses a restriction process to regulate the manufacture, placing on the market or use of dangerous substances, either on their own or in mixtures or articles, within GB.

Such activities may be limited or banned if they pose an unacceptable risk to human health or the environment.

The existing EU REACH Annex XVII restrictions are carried out across to UK REACH, therefore the immediate impact is low. However, the UK will be free to add its own restrictions based on the scientific opinion of the HSE and these will be published on GOV.UK. There are no mechanisms by which future EU Annex XVII restrictions will be automatically implemented in the UK.

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REACH Substances of Very High Concern

• Candidate List of SVHC – The UK adopted the existing substances included in the EU Candidate List but will be free to add additional substances. These substances could be different from those in Europe and vice versa.
  The immediate impact is low, however, as the candidate list is updated every six months, there is possibility for divergence between the UK and EU versions of this list. Thus, future deviations between UK and EU SVHC lists are possible.
  
  Notification of SVHC in articles
  UK REACH will still require notification of SVHC in articles by importers and producers of articles if the substance listed on the Candidate list (.xlsx) is present in those articles in quantities totaling over one tonne per producer or importer per year and if the substance is present in those articles above a concentration of 0.1% w/w.
  
  Importers and producers of articles must notify HSE no later than six months after the inclusion of the SVHC in the Candidate list. The information to submit consists of:

• • The identity and contact details of the company
  • The identity of the substance and its registration number, if available
  • The tonnage range of the substance in the notified article(s)ç
  • A brief description of the use(s) of the substance in the article(s) and of the uses of the article(s)

The information must be submitted through Comply with UK REACH using the relevant template.

• Authorisation list Annex XIV
  
  Authorisation is the process under UK REACH by which the use of particularly hazardous substances is phased out. It allows the use of the substance to continue in specific circumstances, where it’s deemed necessary.
  
  The Secretary of State makes decisions to add substances to the authorisation list and grant authorisations. These decisions are based on the scientific opinion of the HSE and it will be published on GOV.UK.
  
  The list of substances in Annex XIV of UK REACH “Authorisation List” is below:  Authorisations list (.xlsx)
  
  The existing EU Authorisation list (Annex XIV) has been retained in UK REACH. The same latest application dates and sunset dates apply to all entries except for 44 to 54, whose latest application dates are amended to 18 months after the end of the transition period, i.e. to 30^th June 2022 (Article 127GA (7) & (8)).
  In addition, some notes are inserted for the entries 4-7, 10-12, 14-23, 25, 27-46 and 40.
  GB-based companies will need to comply with the authorisation aspects of UK REACH to continue to use substances listed in Annex XIV. This will require particular action based on your role at the end of the transition period:
• • If an authorisation application had been submitted by the user or their supplier whilst the UK was a member of the EU but ECHA and/or Commission final opinion was not issued, then one of the transitional measures according to Article 127GA and/or Article 127G may apply.
  • For GB-based downstream users of GB/EU27/EEA-based authorisations, for which applicants had been submitted whilst the UK was a member of the EU but ECHA and/or Commission final opinion was not issued, then one of the transitional measures according to Article 127GA and/or Article 56(2) may apply. For existing authorisations recognised under UK law where ECHA and Commission final opinion was issued, Article 127H may apply.
  • GB-based holder of an existing EU REACH authorization:
    If you are a GB -based holder of an existing authorisation, your existing EU authorisation will be carried over (‘grandfathered’) into UK REACH, according to Article 127F and will not incur a fee from HSE.
    
    You are required, within 60 days of the end of the Transition Period, to supply the Agency (HSE) with technical information relating to the authorisation to enable the effective management and enforcement of the authorised substance.
    
    This information should be submitted by e-mail in IUCLID 6 format to ukreach.authorisation@hse.gov.uk using the subject “GB-based holder of an existing EU Authorisation”.
  • If an application is being submitted for a use that was not previously covered by an existing application, then the full authorisation process must be followed.
    To do this, firstly , you should contact the Agency to notify them of your intention to apply for UK REACH authorisation at ukreach.authorisation@hse.gov.uk, using the subject “notification of intention to submit an application for authorisation”.

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Fees

UK REACH will apply fees to the following processes:

• Fees for full registrations
• Fees for intermediate-only registrations
• Fees for tonnage updates
• Fees for other updates
• Fees for confidentiality requests in registrations
• Fees for PPORDs
• Fees for authorisation applications
• Fees for review of authorisation applications

The criteria and definitions applying to the categorisation of micro, small and medium enterprises (SMEs) can be viewed below:
Fees and charges table

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Safety Data Sheets

The format, content and conditions under which Safety Data Sheets are required, as specified in the EU REACH Regulation and the subsequent amendments, will remain the same. This means that Safety Data Sheets created under EU REACH will be valid under UK REACH.

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CLP Regulation

Chemicals placed on the market in Great Britain (England, Scotland and Wales) are regulated by the GB Classification, Labelling and Packaging Regulation, known as GB CLP.

The GB CLP Regulation applies to substances and mixtures, and to the following specific types of articles:

• Explosive articles 
• Pyrotechnic articles 

Where an article meets these definitions, it must be classified, labelled and packaged according to the GB CLP Regulation as if it were a substance or mixture.

GB CLP Regulation applies to GB-based manufacturers, importers, downstream users and distributors supplying the GB market, while substances, mixtures and some type of articles mentioned above placed on the market in Northern Ireland are subject to the EU CLP Regulation.

HSE is the GB CLP Agency that carries out certain CLP functions (such as notification of C&L) formerly undertaken by the European chemicals agency (ECHA).

The main duties and obligations to classify, label and package the hazardous substances and mixtures will remain. However, GB has a new mandatory classification and labelling system and a GB mandatory classification and labelling list (MCL list). All existing EU harmonised classification and labelling in force on 31^st December 2020 are retained in the GB MCL list.

Your role in the supply chain (i.e. where and with whom you do business) will determine how the withdrawal affects you, as the role previously taken within EU CLP may have changed significantly under GB CLP. Thus, it is important to review your UK role/s, identify any areas where you may have new obligations, and understand the compliance deadlines to complete the required actions, mitigating risks to your business:  

• Obligations of GB-based manufacturers and importers: Notify the classification and labelling of the substances you place on the GB market to HSE for inclusion in the GB CLP notification database established by HSE.
  
  GB CLP substance notification
  GB-based manufacturers and importers must submit their notification to HSE within one month of placing new substances on the GB market. In Great Britain, the National Poisons Information Service (NPIS) is the appointed body known as the National poison Centre.
  

  Substances requiring notification are:

• • Substances subject to REACH registration and placed on the market
  • Hazardous substances placed on the market on their own
  • Hazardous substances placed on the market in a mixture, resulting in that mixture being classified as hazardous

Notifications already made to ECHA and which were included in the ECHA Classification and Labelling Inventory on 31^st December 2020 do not need to be re-notified. Substances registered under EU REACH prior to 31^st December 2020 or under GB REACH after 31^st December 2020, GB CLP notification is deemed to have been fulfilled.

You can notify by entering the required information on the GB notification web form. In the event that the webform is unavailable, submissions to the GB CLP notification database can be made using the GB notification database template (see below) and emailing to GBCLP.notification@hse.gov.uk.
Classification Labelling and Packaging (CLP) UK Notification - UK Notification Database Contingency Template (.docx)

Note that if a GB-based company wants to export substances to the EU after the transition period ends, their products will have to comply with CLP Regulation and therefore classify and label them accordingly but GB-based company will no longer need to submit notifications to the C&L inventory, since this will have to be done by the importing company in the EU.

• Duties of GB-based downstream users and distributors: Some businesses who were considered downstream users or distributors under EU CLP may find that they are classed as importers under GB CLP and therefore must comply with the duties of an GB importer.
  

  On the other hand, to remain legally on the EU market, only EU/EEA-based importers and downstream users can submit a notification under Article 45 (poison centre notifications). If a company based in the UK notifies a mixture to the relevant appointed body in the Member States where the EU-based distributors place it on the market, this asset cannot be transferred. This submitted information will remain in the database, however the EU company will need to submit a notification themselves if they intend to import the same mixture into the EU.

  Note that the UFI code generated with a UK VAT can still be used by EU companies, as this code only links the product on the market to the submitted information.

Requesting the use of an alternative chemical name for the GB market

The GB alternative name CANNOT be used for mixtures placed on the EU market. HSE is responsible for administering requests for alternative chemical names in GB. To request the use of an alternative chemical name for the GB market, you can use this template to submit the relevant information (.docx) and send the completed template as an electronic document (Word, RTF or PDF) to GBCLP.alternativenames@hse.gov.uk.

Labels and packaging

Under the GB CLP Regulation, there are no significant changes to labelling and packaging requirements.  Hazard labelling for substances and mixtures placed on the GB market must be in English, although other languages may also appear in addition to English.

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PIC Regulation

The Great Britain Export and Import of Hazardous Chemicals Regulation (GB PIC) applies in England, Scotland and Wales.

Businesses exporting or importing PIC Listed chemicals (.xlsx) from or to Great Britain are required to comply with the GB PIC regime.

The EU PIC Regulation will continue to apply to Northern Ireland.

The GB PIC regime is similar to the existing EU PIC and is operated by the Health and Safety Executive (HSE) as the PIC Designated National Authority (DNA).

Under GB PIC, you must notify your intention to export PIC-listed chemicals to countries outside GB by completing a GB PIC export notification form (.docx) and send as an attachment by email to the GB PIC DNA at ukdna@hse.gov.uk. In addition, a safety data sheet for the chemical/mixture should be attached.

In addition, exporters and importers of PIC-listed chemicals must report their annual quantities to the DNA. The reports can be sent by email to the GB PIC DNA at ukdna@hse.gov.uk using the HSE templates:

• Template for annual reporting of exports of GB PIC chemicals (.docx)
• Template for annual reporting of imports of GB PIC chemicals (.docx)

The deadline is 31^st March each year for reporting quantities from the previous year.

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POP Regulation

Under the Northern Ireland Protocol, the EU POP Regulation continues to apply to Northern Ireland, while GB POP regulates the access of substances to the GB market (England, Scotland and Wales).

Companies that supply and purchase substances, mixtures or articles to and from the EU/EEA/Northern Ireland and Great Britain (England, Scotland and Wales) will need to ensure that the relevant duties are met under both pieces of legislation.

Restrictions on GB POPs are based on the European regulation on persistent organic pollutants Regulation (EU) 850/2004 repealed by Regulation (EU) 2019/1021. However, please note that any changes made to the above EU law after 31^st December 2020 will not be applicable in GB.

Currently, the UK has no plan to diverge from the EU requirements for restricted substances.

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GB BPR

An independent biocides regulatory regime is in operation in Great Britain (England, Scotland and Wales).

The most aspects of EU BPR will continue in the same way under the new GB Biocidal Products Regulation (GB BPR). However, please note that any changes made to the above EU law after 31^st December 2020 will not be applicable in GB.

HSE is the UK Competent Authority for this regulation.

However, if you are exporting biocidal products or treated articles to Northern Ireland, the EU, the EEA or Switzerland, you must comply with all legislation applicable in that country, including the EU Biocidal Products Regulation (EU BPR).

The GB List of Active Substances (.xlsx) will allow you to check the status of the active substance for the relevant product type(s) under the GB Biocidal Products Regulation (GB BPR).

If you manufacture or import biocidal products, you will need to check the status of the active substance in your product.

A GB version of the Article 95 List has been established and operates in the same way as the EU Article 95 List. Companies that were already on the EU list on 31^st December 2020 are included in the GB list. 

The GB Article 95 List gives details of the suppliers for active substance / product type combinations that can be used in biocidal products in GB. If the active substance supplier is not on the GB Article 95 List, then the biocidal product containing that active substance cannot be made available on the GB market. The GB Article 95 List is available online and regularly updated.

Visit this website for more information on the GB BPR legislation, such as the main differences between EU BPR and GB BPR, some relevant guidance, and the list of GB authorized biocidal products that can be supplied in GB, among others.

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GB PPP

An independent pesticides regulatory regime is in operation in Great Britain (England, Scotland and Wales). All relevant EU law in relation to the regulation of PPPs has been retained in GB law, however, new decisions taken under the EU regime after 31^st December 2020 will not apply in Great Britain. This includes active substance and maximum residue level (MRL) decisions, as the GB PPP regime will make its independent decisions.

Northern Ireland will continue to be subject to the existing EU law.

The Health and Safety Executive (HSE) will remain the national regulator for the whole of the UK, on behalf of the UK government and the devolved administrations.

Visit this website for more information on the GB PPP legislation.

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RoHS

In Great Britain and Northern Ireland, the Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment Regulations 2012 (as amended) are the underpinning legislation. The requirements are the same as EU RoHS. Manufacturers, importers and distributors, which include retailers are responsible for the compliance of EEE that they place or make available on the GB and/or NI market.

Manufacturers placing EEE on the market in Great Britain must evaluate their production controls to ensure that their products do not exceed the maximum prescribed levels of the following hazardous substances:

• Cadmium (Cd)
• Lead (Pb)
• Mercury (Hg)
• Hexavalent chromium (Cr (VI))
• Polybrominated biphenyls (PBB)
• Polybrominated diphenyl ethers (PBDE)
• Bis(2-ethylhexyl) phthalate (DEHP)
• Benzyl butyl phthalate (BBP)
• Dibutyl phthalate (DBP)
• Diisobutyl phthalate (DIBP)

Additional chemicals may be subsequently added to the restrictions list by the UK.

Substances exemptions: From 1^st January 2021, Great Britain operates its own RoHS exemptions regime, independent of the EU exemptions system and will make direct legislative exemptions where needed to introduce them.

The main change affecting Electrical and Electronic (E&E) products following the UK’s exit from the European Union is the introduction of the UKCA mark and how this will replace the CE mark as the product conformity mark for the GB market. To find out if you need to use the UKCA marking and how to use it, see Electrical and Electronics section

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^[1] Importers bring chemical substances into GB from either the EU/EEA or NI or from the rest of the world.

^[2] The Comply with UK REACH IT Service will only accept dossiers compiled using IUCLID 6 and above. If the dossiers are in an older IUCLID format, you will need to convert them as per the guidance on the IUCLID website.