WHAT IS UK REACH
The EU REACH (REACH stands for Registration, Evaluation, Authorisation and Restriction of Chemicals) regulation has been brought into UK law under the European Union (Withdrawal) Act 2018. UK REACH, the UK’s independent chemicals regulatory framework, starts on 1 January 2021. Anyone making, selling or distributing chemicals in the UK needs to follow UK REACH rules. The key principles of the EU REACH Regulation have been retained, with the necessary changes to make it operable in a domestic context.
For the duration of the Northern Ireland Protocol, Northern Ireland will remain part of EU regulatory systems for chemicals to ensure frictionless movement of goods within the island of Ireland, whilst remaining within the UK customs territory. Therefore, Northern Ireland businesses will retain their current EU REACH status and obligations allowing them to maintain current supply chains to the EU/EEA.
The aims of UK REACH include:
l To provide a high level of protection of human health and the environment from the use of chemicals.
l To make the people who place chemicals on the market (manufacturers and importers) responsible for understanding and managing the risks associated with their use.
l To promote the use of alternative methods for the assessment of the hazardous properties of substances, e.g. quantitative structure-activity relationships (QSAR) and read across.
The REACH etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/758)
The REACH etc. (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1577)
The REACH etc. (Amendment etc.) (EU Exit) (No.2) Regulations 2019 (S.I. 2019/858)
The REACH etc. (Amendment etc.) (EU Exit) (No.3) Regulations 2019 (S.I. 2020/1144)
Who is affected?
Businesses that manufacture or import 1 tonne or more of substance each year are responsible for “registering” that substance with “The Agency”, which is the Health and Safety Executive (HSE). 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.
Manufacturers: produce or extract a substance either through chemical synthesis, smelting or extraction. They are required to hold a valid registration for these substances under UK REACH.
Importers: bring chemical substances into GB from either the EU/EEA or NI or from the rest of the world. They have responsibilities to hold registrations for these substances unless their non-GB suppliers, where applicable, have appointed an Only Representative to take on the duties on behalf of the GB importers.
Importers under UK REACH who were downstream users under EU REACH: GB downstream users (who before the end of the transition period imported chemicals from EU/EEA and relied on an EU REACH registration held further up the supply chain) will become importers under UK REACH. They must ensure that the substances they import are covered by a valid UK REACH registration.
Downstream users: 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.
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. This may help maintain access to the GB market for their substances by reducing the responsibilities for importers.
Distributors: companies that store and place on the market a substance, on its own or in a preparation for third parties. They do not directly handle the substance. Providing they do not have importer responsibilities, they do not need to register with REACH. They do have an important responsibility to pass on information down the supply chain, including Safety Data Sheets.
Formulators: companies that produce mixtures and supply them further down the supply chain or directly to consumers. They mix together substances and/or mixtures, with no chemical reaction taking place during the process.
Framework of UK REACH
The chart below is a conceptual representation of the UK REACH framework.
(Click the picture above for a larger view)
How to comply
1. Downstream User Import Notification (DUIN)
GB-based companies that were downstream users or distributors prior to the end of the transition period, under EU REACH, who do not hold the registrations themselves, previously benefitting from the EU suppliers or EU ORs, will become importers at the point that when UK REACH enters into force. The transitional provision: Downstream User Import Notification (DUIN) aims to help minimise disruption to the existing trades.
Downstream users and distributors under EU REACH are able to notify The Agency regarding the substances that they wish to continue importing into GB from the EU. This notification must be made by 27 Oct. 2021. Once the notification is completed, your registration obligation is effectively deferred until 2, 4 or 6 years plus 300 days after the end of the transition period. If you opt not to submit a notification, then either a full registration would be due for any substances imported at or above 1 tonne per year, or that import must cease. A non-GB based manufacturer, formulator or article producer can appoint a GB-based OR to submit notifications.
To notify the Agency, information below shall be provided:
Imports of 1 to 10 tonnes a year:
· identity of manufacturers/importers
· substance identity to the extent it is available to them
· classification and labelling to the extent it is available to them
· details of any authorisations
· details of any restrictions
· any other available and relevant information necessary to enable appropriate risk management measures to be identified and applied
· registration number(s) assigned by ECHA to the extent it is available to them
Imports of over 10 tonnes a year, except for the information mentioned above:
· identification and application of appropriate measures to control risks identified in the Chemical Safety Report to the extent it is available to them
· safety data sheets
Within the deadline depending on tonnage band and/or hazard profile, if the importing into the UK will continue, a new registration submission is required, complying with the full information requirement for your tonnage band under UK REACH. The first step to any new registration is to submit an Article 26 inquiry. The information requirements for registration under UK REACH are identical to the requirements of EU REACH.
GB-based holders of EU REACH registrations will benefit from this transitional provision, including:
· GB-based manufacturers and importers;
· GB-based Only Representatives (ORs);
· GB-based legal entities that held an EU REACH registration and transferred it to an EU-based legal entity at any point after 29 March 2017 (the date the UK notified its intention to leave the EU) and before 31 Dec 2020.
By 30 Apr 2021, the GB-based holders of EU REACH registrations shall provide some initial information to the Agency, including:
· evidence of your existing EU registration your ECHA registration number, the registration date assigned by ECHA and other relevant evidence as requested by the Agency
· identity of the registrant (Article 10(a)(i)) you will use this information to create your UK REACH-IT account
· substance identity (Article 10 (a)(ii))
· information on the manufacture and use of the substance (Article 10(a)(iii))
· an indication as to which, if any, of the relevant information on manufacture and use has been reviewed by an assessor (Article 10(a)(viii))
· notification of any ECHA decision which relates to the existing registration. These should be attached to Section 13 of your IUCLID dossier
At this point, the UK REACH registration number will be issued. Then within the deadline depending on tonnage band and/or hazard profile, you will need to 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.
(Click the picture above for a larger view)
Where “grandfathering” and downstream user import notifications do not apply, a registration will be required prior to the manufacture or import activity.
Under UK REACH, the principle of "one substance, one registration" has been retained. This means that all registrants of the same substance should be part of a 'joint registration'. Data requirements under UK REACH are identical with EU REACH.
For substances that have not previously been registered with ECHA under EU REACH, the information requirements for the tonnage band must be fulfilled in their entirety before the registration is granted, taking into account appropriate data waivers.
For substances that were previously registered under EU REACH, which you are intending to manufacture or import into the UK for the first time, you will still be required to submit a registration. However, it may be that you are able to defer the submission of the full information requirement such that you are able to share data with other registrants and grandfathered registrants. If this applies to you, you will be informed at the point your Article 26 inquiry dossier becomes successful.
Other obligations under UK REACH
HSE and the Appropriate Authorities evaluate the information submitted by companies to examine the quality of the registration dossiers and the testing proposals and to clarify if a given substance constitutes a risk to human health or the environment.
Evaluation under UK REACH focuses on three different areas:
· Examination of testing proposals submitted by registrants
· Compliance check of the dossiers submitted by registrants
· Substance evaluation
Once the evaluation is done, registrants may be required to submit further information on the substance.
Ø Notifying substances in articles
Importers and producers of articles must notify the Agency if substances listed on the Candidate list (the list of substances of very high concern (SVHCs)) are present in their article(s), if the substance is present in the articles in quantities totalling over 1 tonne per producer or importer per year, and if the substance is present in those articles above a concentration of 0.1 % w/w.
GB-based companies will need to comply with the authorisation aspects of UK REACH to continue to use substances listed on Authorasation list (Annex XIV). The existing EU Authorisation list has been retained under UK REACH.
Restrictions are an instrument to protect human health and the environment from unacceptable risks posed by chemicals. Restrictions are normally used to limit or ban the manufacture, placing on the market (including imports) or use of a substance.