Department Of Health
Classifying, labelling and packaging substances and mixtures
On 1 January 2021, the European Union (EU) Classification, Labelling and Packaging of Chemical Substances and Mixtures (CLP) Regulation was replaced in Great Britain (GB) by the GB CLP Regulation.
In Northern Ireland (NI), chemicals (substances or mixtures) placed on the market must comply with the EU CLP Regulation.
The Birmingham Unit of the National Poisons Information Service (NPIS) acts 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 NPIS by businesses wishing to place their products on the GB or NI markets.
For guidance on other aspects of the EU CLP Regulation or the GB CLP Regulation please visit the Health and Safety Executives (HSE) website.
Submitting information relating to emergency health response and preventative measures to the appointed body
Placing products on the Great Britain (GB) market
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 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 email@example.com. 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, before 31 December 2020, you were a downstream user or distributor placing mixtures on the GB market and supplied by EU or EEA-based businesses, and those supply arrangements have continued, you are now an importer, as defined under the GB CLP Regulation.
In addition, you may complete the voluntary submission of SDS to NPIS, as stated above.
For further guidance on the duties and obligations on GB-based businesses under the GB CLP Regulation that are not related to the submission of information to the NPIS, visit HSE or email firstname.lastname@example.org.
Placing products on the Northern Ireland (NI) market
The EU CLP Regulation, including Annex VIII, applies 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 are importers, 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 does 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 and exported as an .i6z dossier
- if produced using a third-party tool, the submission must then 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 email@example.com.
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 youre a manufacturer of hazardous mixtures based in Great Britain (GB) or Northern Ireland (NI)
Manufacturers may also voluntarily submit information to the NPIS in the form of a SDS by email to firstname.lastname@example.org.