REACH

REACH

Regarding the REACH Regulation (EC) No 1907/2006, the UK’s withdrawal from the EU will have implications for Irish companies who source their chemicals from UK suppliers. Any Irish company currently purchasing their chemicals in the UK should now review and consider the impact that the EU withdrawal will have on their future business and duties under REACH. In addition, any company purchasing from an IE distributor, should ask their supplier where they source their chemicals, as over 36% of companies we asked in 2017 indicated they got their chemicals from a UK supplier.

Registration

REACH requires (with some exemptions) that any substance manufactured in, or imported into, the EU at greater than 1 tonne per annum be registered. Registrations that are currently in place from UK companies will no longer be valid once the transitional period ends on 31st December 2020 (as only EU legal entities can register under REACH).

Changes in roles regarding registration

At present, if an Irish company sources their substances from a UK supplier, then their role under REACH is as a downstream user and as such they have no registration obligations. However, after the transitional period, the UK will be considered a third country and so any substances imported into Ireland from the UK will be deemed as being imported from outside the EU. Thus, any Irish company who continues to source their substances from a UK supplier after 31st December 2020 will lose their downstream status and will have a role as an EU importer and thus may have registration obligations under REACH. Any Irish company potentially finding themselves in such a situation should speak to their UK supplier and determine his plans post withdrawal - will he appoint an Only Representative in one of the EU-27 Member States (if he is a manufacturer) for example. Alternatively, as registration can be a resource intensive and costly process, if the Irish company wishes to avoid future registration obligations, they should now consider sourcing those chemicals from another supplier based in one of the EU-27/EEA countries.

Joint submissions with a UK based lead registrant

Irish registrants who are in a joint submission for which a UK based company is the lead registrant and owner of data for which the Irish company has obtained a letter of access allowing them to refer to the data need to be aware that the UK company’s registration will be non-existent following the transitional period. In such a situation, it should be ensured that the lead registrant moves to the EU-27/EEA or that a legal entity change is completed so that the current lead registrant becomes an EU-27/EEA based only representative. Alternatively, a new lead registrant can be appointed and the lead registrant role transferred before the end of the transitional period.

Only Representatives

If an Irish company is considered as a downstream user under REACH due to the appointment by his non-EU supplier of an only representative (OR), and that OR is based in the UK, then the Irish company needs to be aware that once the UK leaves the EU(end of transitional period), the UK based company can no longer act as OR. In such a case, the OR would need to move its business to an EU-27/EEA country, or a different OR in EU-27/EEA would need to be appointed by the non-EU manufacturer.

Impact on authorisations

If an Irish company relies on a REACH authorisation granted to a UK supplier (or a pending application for authorisation), then they should be aware that their use will no longer be covered after the transitional period. REACH authorisations will lose their legal effect as of 31st December 2020. This means that the Irish company will need to rely on a supplier with a valid authorisation from amongst the EU-27/EEA. If this is not possible, and the Irish company wishes to continue using the substance after that date, then they will need to apply for an authorisation themselves. In any event, it is recommended that such companies speak to their suppliers now about their supplier’s intentions post UK withdrawal, as the UK company may avail of the possibility to appoint an OR in EU-27/EEA and transfer the authorisation to that OR post UK withdrawal.


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 the REACH Regulation. 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.

From 1 Jan 2021, EU based companies sourcing chemical products directly from Great Britain (GB) will find that their role under REACH will change from being a downstream user or distributor to being an importer with added responsibilities for compliance of chemicals.

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 and regulated 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.

Responsibilities of importers under REACH with regard to safety data sheets:

initial responsibility for drawing up a SDS in the supply chain and should ensure that the SDS information takes account of uses of the chemical, as far as those uses are known

  • responsible for the content of the SDS and the accuracy of that content
  • ensure 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
  • ensure that, where required, the National Information Poison Centre number is included in section 1.4 of the SDS
  • ensure that the hazard information on the chemicals label is consistent with the information provided in section 2.2 of the SDS
  • ensure that Irish occupational limit values (OELs) are listed, as relevant, in section 8 of the SDS
  • ensure that extended SDSs are compiled and passed on in the supply chain as required.


Further information:

HSA webpages on REACH
HSA webpages on Restrictions
HSA webpages on SDSs


HSA Webinars on Chemicals & Brexit and Q&As are available at this link:
https://www.hsa.ie/eng/news_events_media/events/hsa_webinars/webinar_recordings/  

Commission Readiness Notice on Brexit & REACH

ECHAs Q&As on the UKs withdrawal from the EU & REACH

ECHAs Q&As on the Ireland/Northern Ireland Protocol


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