Are all the “REACH candidate lists” identical?
Are all the “REACH candidate lists” identical?
mardi 14 février 2023
The European “Candidate List of substances of very high concern for Authorisation” which applies in the European Union, Norway, Iceland, Liechtenstein, and Northern Ireland has last been updated on 17 January 2023. It contains 233 entries. Each entry corresponds to a substance, or a group of substances, which are either already subject to authorisation or intended to be added to the list of substances subject to authorisation (REACH Annex XIV). There are significant differences between this EU/EEA/NI Candidate list and its equivalents in the UK or in Switzerland, although all three lists stem from the same origin.
The “UK Candidate List of substances of very high concern (SVHCs) for authorisation” was copied from the EU Candidate list as it was on 31 December 2020 and has not been modified since then. This means that it still contains only 209 entries, including the latest inclusions of 25 June 2020.
From the “Initial assessments of substances added to the EU Candidate List in 2021” performed by the Health and Safety Executive (HSE) and the Environment Agency and published on 28 January 2022, it appears that the British authorities decided to examine the substances which were not yet on the UK list in the light of the UK market’s specificities. The substances were provisionally allocated to one of three groups:
• Group 1: Call for evidence and regulatory options management analysis (RMOA). Dioctyltin dilaurate and phenol are examples.
• Group 2: Possible RMOA but of lower priority. Concerns Tetraglyme and Lysmeral.
• Group 3: No action under UK REACH at this time. Bisphenol B and Resorcinol are examples of substances belonging to this group.
These different procedures may well result in some of the substances never making it into the UK Candidate list.
In Switzerland, the Candidate list is known as Annex 3 of the Chemicals Ordinance (ChemO). It is available in three languages on the website of the Common notification authority for chemicals. It too originates from the EU. There is however a delay between the inclusion of new entries in the EU and the inclusion of those same entries in Annex 3 ChemO. The latter currently contains 223 entries. EU’s entries of June 2022 and January 2023 are not yet included.
In this case, it seems that there is no wish to assess the substances separately considering information or criteria specific to Switzerland. The delay is just the consequence of the procedures that need to be followed in order to duly amend Annex 3 ChemO.
The duty to communicate information on SVHCs in articles is present in all three legislations and, in practice, triggered by the publication of each list update on the appropriate website.
The provisions in Art. 33 of EU REACH, Art. 33 of UK REACH, and Art. 71 ChemO are quite similar. In ChemO, for example (translation courtesy of Fedlex):
“1 Anyone who commercially supplies an object containing a substance of very high concern in a concentration greater than 0.1 % by weight must provide the following information:
a. the name of the substance concerned;
b. all the information required to allow safe use of the object, insofar as this is available to the supplier.
2 This information must be provided free of charge:
a. to professional users or traders: without being so requested;
b. to private users: on request within 45 days.”
The distinct duty to notify SVHCs in articles under certain conditions exists under EU REACH and under UK REACH. Notifications must be submitted to the relevant “agency”: ECHA or HSE. The duty to notify substances in articles in UK REACH is identical to the provisions under EU REACH.
There is no equivalent provision in the Swiss legislation. However, Article 5 ChemO requires manufacturers of objects containing substances listed in Annex 3 to assess whether these substances may endanger human health (directly or indirectly) or the environment when these objects are used as intended, or in a foreseeable manner, or when they are appropriately disposed of.
Follow the links below to learn more about the different candidate lists:
EU REACH Candidate list
UK REACH Candidate list
Swiss Candidate list
Assessments of substances added to the EU REACH Candidate List in 2021
Or contact us if you need help with your regulatory compliancy processes.