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 manufactures, importers and downstream users required by the GB CLP Regulation will continue to apply. For further guidance on the changes for GB-based business 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).
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:
These submissions should be made via email to sds.npis@nhs.net. Please indicate clearly in the main body of the email: the name of the product, the name of the legal entity and the UFI. If no date of issue is provided on the SDS, the NPIS will assign a date of when it is uploaded onto our database.
Dossiers submitted to NPIS Birmingham must only list English tradenames in the ‘Product Identity’ or ‘Product Identifier’ sections.
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. ECHA have produced a series of videos on how to produce PCNs which can be accessed here:
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.
If you have any further queries, please contact environmental.hazards@dhsc.gov.uk or please visit DHSC guidance.