Preparing efficient Poison Centre Notification (PCN) submissions
Poison Centre Notifications have been a legal requirement for many products since 1st January 2021. From a technical standpoint, completing a PCN submission doesn’t need the same scientific expertise required to complete a full product registration...however, collating and compiling the mandatory data for your PCN can be a time-consuming task and, as always, nuances within the online systems involved can make the process frustrating for the applicant.
Here we’ll look at the PCN submission process, the data requirements, and challenges to be aware of, ensuring that your PCN submissions are as stress-free as possible.
Why do I need to complete Poison Centre Notification submissions?
Poison Centre Notifications are a requirement introduced under Article 45 of the CLP Regulation.
Your obligations for making a PCN submissions will vary depending upon the product, its hazard classification, and the market location.
Placing products on the EU market
As of 1st January 2021, all new consumer or professional use products* not already notified under national legislation require a PCN to be submitted to each Member States appointed body (if the product is classified for human health or physical hazards) before the product is placed on the market in that country. Biocide and pesticide products also fall under this obligation.
Submission of the required information is made via a PCN to the European Chemicals Agency (ECHA). The dossier must detail the full product chemical composition, toxicological information, relevant product and mixture details, all intended uses, as well as label components. This new format aims to structure the information on hazardous mixtures in a clear and easily accessible way, in case of poisoning incidents in the EU.
* Although consumer and professional use products are already subject to the above requirements, the next approaching deadline is 1st January 2024, for industrial use products.
Completing a PCN submission (end to end process)
What about products on the Great Britain (GB) market - National Poisons Information Service (NPIS)
Those wishing to supply products to the GB market can voluntarily submit information to the National Poisons Information Service (NPIS) using a product Safety Data Sheet (SDS). Unlike EU PCN submissions, a Unique Formula Identifier (UFI) is not required for GB NPIS. However, if you already hold a UFI for an EU PCN, NPIS will associate the two if the UFI is clearly displayed on the front page of the supplied SDS. Please note that submission to NPIS is not a substitute for product registration.
Are there any additional requirements Products on the Northern Ireland (NI) market?
From a regulatory perspective, NI is treated as part of the European Union. Therefore, if you are bringing a product to market in NI you will need to generate an EU UFI and PCN dossier as with any other EU country. However, GB NPIS (who also operates on behalf of NI) does not have access to the ECHA Submission Portal, or any of the information held within it, so the full PCN dossier (as an i6z file) must be submitted directly to the GB NPIS via email. As above, this does not replace the requirement for a product registration.
What will it cost and how long does it take?
The total time required is very much dependant on:
- Number of co-formulants present
- Presence of a mixture in mixture (MiM is essentially another PCN dossier within the original)
- Number of countries where submission is required
For example, a PCN for three countries, containing two common co-formulants is a simpler dossier structure than a product to be submitted to one country but includes seven substances (of which one is a mixture in a mixture itself containing 14 components). Typically, a full PCN submission takes between 14 and 30 hours depending on complexity.
What information will you need?
A basic overview of the mandatory information required:
- Details of all relevant legal entities
- Full composition – a list of all co-formulants* and percentage content, with CAS numbers and function.
- SDS of products and all co-formulants
- Any existing UFI codes
- Basic physical-chemical properties
- Packaging specifications
* If a co-formulant is a mixture, you will also need full composition, and classification of this mixture.