REACH

The UK’s withdrawal from the EU has implications for Irish companies who source their chemicals from UK (GB) suppliers. UK (GB) refers to England, Scotland and Wales, but not Northern Ireland. Any Irish company purchasing/intending to purchase chemicals in the UK (GB) should consider the impact of Brexit on their business and obligations under REACH. These Irish companies will be EU importers and thus will have obligations under REACH that they would not have had previously. For Irish companies sourcing chemicals in Northern Ireland, there is no impact, as in accordance with the Ireland and Northern Ireland Protocol, REACH applies in Northern Ireland. This means that companies in Northern Ireland need to be compliant with EU REACH and Irish companies sourcing chemical products in Northern Ireland are not considered as EU importers.

Registration

REACH requires (with some exemptions) that any substance manufactured in, or imported into, the EU at greater than 1 tonne per annum must be registered. Registrations that were previously held by a  UK (GB) companies are no longer valid (as of 1st January 2021). Irish companies sourcing chemicals in the UK (GB) need to be aware of  this and possible consequences for them with respect to registration obligations under REACH. Companies who have queries on this should contact our Helpdesk chemicals@hsa.ie.

Changes in roles regarding registration

Prior to Brexit, if an Irish company sourced their substance from a UK (GB) supplier, then their role under REACH was that of a downstream user, and as such, they had no registration obligations. However, since 1st January 2021, as UK (GB) is considered a third country, any substance imported into Ireland from UK (GB) is deemed to be imported from outside the EU. Thus, the role of an Irish company who source their substances from a UK (GB) supplier changed from that of a downstream user to one of an EU importer. With that change in role, comes extra obligations under REACH. If an Irish company is in such a situation, they should speak to their UK (GB) supplier and determine if the supplier has put in place measures to ensure continued supply to the EU. The UK (GB) supplier may have appointed an Only Representative (OR) in one of the EU-27 Member States (if they are a manufacturer or formulator) or if the UK (GB) supplier was a REACH registrant, they may have transferred the REACH registrations to an EU based legal entity before the end of the transition period. If neither of these options are in place, then the Irish company may be required to register the substances before they can be imported into Ireland. In general, Irish companies who wish to avoid registration obligations should consider changing supplier and sourcing their chemicals from a supplier based in one of the EU-27/EEA countries.

Joint submissions with a UK (GB) based lead registrant

Irish registrants who were in a REACH joint submission for which a UK (GB) based company was the lead registrant and owner of data for which the Irish company had obtained a letter of access allowing them to refer to the data, need to be aware that the UK (GB) company’s registration is now non-existent. It should be ensured that the lead registrant moved to the EU-27/EEA or that a legal entity change was completed so that the lead registrant became an EU-27/EEA based only representative. Alternatively, a new lead registrant may have been appointed and the lead registrant role transferred (this should have been completed before the end of the transition period).

Only Representatives

If an Irish company was previously considered as a downstream user under REACH due to the appointment by their non-EU supplier of a UK (GB) based OR, then the Irish company needs to be aware that the UK (GB) based company can no longer act as OR since 1st January 2021. In such a case, the OR should have moved its business to an EU-27/EEA country, or a different OR in EU-27/EEA should have appointed by the non-EU manufacturer. Any Irish company in this situation should have spoken to their OR or to their non-EU supplier to see what, if any, arrangements were put in place before the end of the transition period.

Exemption from registration for re-imported substances (article 2(7)(c) of REACH)

Under REACH, as exemption from registration applies to substances registered in the EU, exported out of the EU and then re-imported back into EU chemically unchanged within the same supply chain. IE companies sourcing GB-formulated mixtures may be able to avail of this exemption if the GB formulator sources REACH registered substances in the EU for their formulations. In such a scenario, the IE company may be seen as re-importer of substances in the mixture and so could rely on the re-import exemption, if the conditions as outlined in the Regulation are met. These conditions are as follows:

  › Substance must be registered before export
  › Substance exported and re-imported must be the same
  › Substance must proceed from the same supply chain in which it was registered
  › Re-importer must be provided with certain information on the substance(e.g. safety data sheet)

If any IE company thinks this exemption may apply to them and want further information, they should contact our Chemicals Helpdesk at chemicals@hsa.ie.

Impact on authorisations

If an Irish company previously relied on a REACH authorisation granted to a UK (GB) supplier, then they should be aware that this authorisation is now no longer valid and their use is no longer authorised. REACH authorisations previously granted to UK (GB) companies lost their legal effect as of 31st December 2020. This means that the Irish company needs to source a supplier with a valid authorisation that covers their use from amongst the EU-27/EEA. If this is not possible, and the Irish company wishes to continue using the substance, they need to apply for an authorisation for their own use themselves. It is recommended that Irish companies speak to their UK (GB) suppliers; they may have availed of the possibility to appoint an OR in the EU-27/EEA and may have transferred the authorisation to that OR.

Restrictions

Substances of unacceptable risk to human health and the environment are restricted for placing on the market and for use within the EU. Restricted substances are listed in Annex XVII of REACH. Restricted substances cannot be manufactured, used or placed on the market unless they comply with the conditions set out in the restriction entry on Annex XVII. Irish companies sourcing substances in the UK (GB) may now need to comply with REACH restrictions, as the EU importer.

Responsibilities of importers under REACH with regard to restricted substances:

Importers have responsibilities to check for substances restricted under REACH and are responsible for ensuring that:

• substances imported into the EU comply with restriction requirements as set out in Annex XVII
• imported mixtures and articles do not contain banned substances
• imported mixtures and articles containing substances listed as restricted, comply with the conditions of the specific restrictions.

Safety Data Sheets

Safety data sheets (SDS) are required under REACH. Each EU supplier of a hazardous chemical, whether a manufacturer, importer, downstream user, distributor or an only representative, must provide customers with a SDS complying with REACH. Annex II of the Regulation sets out detailed information which must be provided in a SDS under 16 required headings. Please see more on SDSs on our REACH webpages.

EU importers are responsible:

• preparing the SDS
• ensuring that the SDS information takes account of uses of the chemical, as far as those uses are known
• the content and accuracy of the SDS
• ensuring that SDSs are provided as per the requirements of Article 31 of REACH
• as the EU supplier, their (importers) details must be included in section 1.3 of the SDS
• ensuring that, where required, the National Information Poison Centre number is included in section 1.4 of the SDS
• ensuring that the hazard information on the chemical label is consistent with the information provided in section 2.2 of the SDS
• ensuring that Irish occupational limit values (OELs) are listed, as relevant, in section 8 of the SDS
• ensuring that extended SDSs are compiled and passed on in the supply chain as required.

Further information:

HSA Brexit Webinar recording

ECHA’s Brexit Q&As  

Updated guide for new importers of chemicals subject to REACH

Flowcharts of obligations for under REACH/CLP/Detergents Regulations:

Flowchart of obligations under REACH and CLP Regulations for an Irish formulator of mixtures sourcing chemical substances from UK (Great Britain) after 1st Jan 2021

Flowchart of obligations under REACH, CLP & Detergents Regulations for an Irish distributor sourcing chemical products from UK (Great Britain) after 1st Jan 2021

Flowchart of obligations under REACH and CLP Regulations for an Irish end user of a chemical product sourced in the UK (Great Britain) after 1st Jan 2021

Flowchart of obligations for an Irish end user of a chemical product sourced in Northern Ireland after 1st Jan 2021