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How will Poison Center Notification be Affected after Brexit

from CIRS by

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Since 1 Jan. 2021, EU enterprises that directly buy mixtures from Britain (Northern Ireland excepted) must complete poison center notifications under the CLP as Britain has left EU. The roles of related enterprises may also change for this reason. To help related enterprises better adapt to their roles, CIRS have collected some frequently asked questions:

Is an UK-based enterprise still available to get access to the PCN portal?

An UK-based enterprise may still login their ECHA Accounts from 1 Jan. 2021, but they cannot get access to the ECHA submission portal. As a result, they can no longer modify their notifications submitted before.

In Northern Ireland, the CLP Regulation continues to apply. Northern Ireland (NI)-based enterprises can still get access to the ECHA Submission Portal and submit a notification for mixtures that will place on EU market. However, mixtures placing on Northern Ireland market must complete a notification with NPIS. That is to say, NI-based enterprises may have to submit two notifications with both EU and the Britain.

From 1 January 2021, EU/EEA companies importing hazardous mixtures from the United Kingdom, except from Northern Ireland, have become duty holders under Article 45. Therefore, if you place hazardous mixtures covered by the scope of Article 45 on the EU/EEA market that are supplied by a United Kingdom company you have the obligation to notify to the relevant appointed bodies and include the UFI on the label before placing the mixture on the EU/EEA market.

Can I transfer my poison center notifications to an EU/EEA-based legal entity?

No, such functionality does not exist for poison centre notifications. In case of a change of legal entity, the new legal entity needs to submit a new poison centre notification. Please note that as long as the mixture composition does not change, the same UFI may be used by different legal entities.

The poison center notifications submitted by UK-based enterprises before 1 Jan. 2021 will not be deleted and the UFI information will continue to be valid.

What are the Suggestions after Brexit?

For GB-based enterprises that have completed poison center notifications

1. Their downstream users are based in EU/EEA: The notifying documents can still be found, yet they can no longer be modified. The GB-based enterprises should inform the EU/EEA based importers and the importers should submit new notifications. As long as the products composition does not change, the same UFI may be used by different legal entities.    

2. Their downstream users are based in GB or Northern Ireland: Enterprises should submit information to NPIS. 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.

For EU-based enterprises that have completed poison center notifications

1. Their downstream users are based in Northern Ireland: New notifications are not required;

2.  Their downstream users are based in GB: GB-based downstream users and distributors will become importers, as defined under the GB CLP Regulation and must comply with the duties of importers. In addition, these enterprises may complete the voluntary submission of SDS to NPIS, as stated above.

For those placing products on the Northern Ireland (NI) market

1. NI-based downstream users and distributors are supplied with mixtures by GB-based businesses: The NI-based downstream users or distributors will become 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 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 in accordance with the developers guide as published by ECHA
  • 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. 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.

2. NI-based distributors are supplied by EU/EEA-based enterprises: The NI-based enterprises will become EU downstream users or distributors. The NI-based enterprise should take into consideration of the products name, UFI, etc. If an UFI is not included in the notifications, then the NI-based enterprises should submit a notification as well.

Further Information  

NPIS News 

ECHA News