Submitting chemicals information to the appointed body from 1 January 2021
Guidance for companies placing hazardous mixtures on the UK market (such as manufacturers, importers, downstream users and distributors) from 1 January 2021.
New rules for January 2021
The UK has left the EU, and the transition period after Brexit comes to an end this year.
This page tells you what you’ll need to do from 1 January 2021. It will be updated if anything changes.
Check what else you need to do during the transition period.
Classifying, labelling and packaging substances and mixtures
From 1 January 2021, the European Union (EU) Classification, Labelling and Packaging of Chemical Substances and Mixtures (CLP) Regulation will be replaced in Great Britain (GB) by the GB CLP Regulation.
From 1 January 2021 in Northern Ireland (NI), chemicals (substances or mixtures) placed on the market in NI must comply with the EU CLP Regulation.
The Birmingham Unit of the National Poisons Information Service (NPIS) will act as the appointed body responsible for accepting information submitted by importers and downstream users of hazardous mixtures placed on either the GB or NI markets.
This guidance relates to the submission of information relating to emergency health response and preventative measures to the appointed body (poison centre) by businesses wishing to place their products on the GB or NI markets from January 2021.
For guidance on other aspects of the EU CLP Regulation or the GB CLP Regulation please visit the Health and Safety Executive’s (HSE) website.
Submitting information relating to emergency health response and preventative measures to the appointed body
Placing products on the Great Britain (GB) market
From 1 January 2021, GB-based importers and downstream users, and NI-based downstream users directly supplying the GB market with qualifying Northern Ireland goods (QNIGs), are encouraged to continue to voluntarily submit information relating to emergency health response, and preventative measures on hazardous mixtures placed on the GB market, to NPIS using a safety data sheet (SDS).
You should send this information by email to sds.npis@nhs.net. The submission of a SDS to the NPIS does not in itself mean that a given product is approved for sale.
There is no obligation to generate or submit a unique formula identifier (UFI) code in Great Britain but the NPIS will register your product with its associated UFI if one has already been generated. To support the NPIS, please ensure the UFI is clearly identifiable on the front page of the SDS.
If you’re a downstream user or distributor based in Great Britain who currently places mixtures on the market in England, Scotland and Wales, and is supplied by EU or EEA-based businesses, your duties may change after 31 December 2020. If these supply arrangements continue after the end of the transition period, you will become an importer, as defined under the GB CLP Regulation, and must comply with the duties of an importer. In addition, you may complete the voluntary submission of SDS to NPIS, as stated above.
Please note that other duties and obligations on manufacturers, importers and downstream users, required by the GB CLP Regulation, will continue to apply. For further guidance on the changes for GB-based businesses under the GB CLP Regulation that are not related to the submission of information to the NPIS, and what you need to do to prepare, please visit the HSE website or email ukreachca@hse.gov.uk.
Placing products on the Northern Ireland (NI) market
From 1 January 2021, the EU CLP Regulation, including the new Annex VIII, will apply in EU member states and in NI. Therefore, importers and downstream users placing hazardous mixtures on the NI market are required to provide specific information on their products to the NPIS in accordance with Annex VIII.
NI-based downstream users and distributors that are supplied with mixtures from GB-based businesses after 31 December 2020 become an importer, as defined under the EU CLP Regulation, and must comply with the duties of an importer, including providing specific information on their products to the NPIS in accordance with Annex VIII.
NPIS will not have access to the European Chemicals Agency (ECHA) poison centre notification (PCN).
Therefore submissions for NI must be provided in the form of a PCN and sent directly to NPIS Birmingham as the appointed body.
In order for submissions to be valid, they must be either:
- produced directly in the ECHA-approved IUCLID desktop/cloud platform
- if produced using a third-party tool, the submission must first be imported into the ECHA PCN, and exported as an .i6z dossier. This exported dossier will be accepted by NPIS as a submission
These submissions should be made via email to sds.npis@nhs.net.
The submission of a PCN to the NPIS does not in itself mean that a given product is approved for sale.
You must also include a UFI in the submission of information and on the label or, in some cases, the packaging of the products that contain a hazardous mixture.
ECHA have produced further guidance on preparing PCNs and the impact of the Ireland/Northern Ireland Protocol on the EU CLP Regulation.
If you’re a manufacturer of hazardous mixtures based in Great Britain (GB) or Northern Ireland (NI)
Manufacturers may also continue to voluntarily submit information to the NPIS in the form of a SDS by email to sds.npis@nhs.net.
If you’re a distributor based in Great Britain (GB) or Northern Ireland (NI)
GB-based distributors, who are currently supplied by EU-based businesses, if those supply arrangements continue, will become GB importers for the purposes of GB CLP on 1 January 2021.
NI-based distributors, who are currently supplied by EU-based businesses, will remain distributors under the EU CLP Regulation. The obligations for the NI-based distributors depend on the functions they will be carrying out. ECHA have produced guidance to support distributors.
There is no obligation under Article 45 or Annex VIII of the EU CLP Regulation for distributors (who only store and place substances on the market) to provide PCNs to NPIS. However, NPIS will still accept PCNs they submit.
Further information
If you have any further queries, please contact environmental.hazards@dhsc.gov.uk.