Poison Centre Notification (PCN) submissions for non-EU companies – legal representation

MSDS-Europe – Poison Centre Notification (PCN) submissions for non-EU companies – legal representation

 

EU PCN legal representation

Manufacturers and importers established outside the EU/EEA cannot submit PCN notifications independently. As an EU-established legal entity, ToxInfo Kft. provides comprehensive support for PCN submissions:

  • we prepare and submit the IUCLID dossier,
  • manage updates and UFI codes,
  • and act as your expert partner in communication with the competent authorities.

As a result of our services, our clients’ products can be placed on EU markets lawfully and efficiently.

 

Who is this service for?

For manufacturers, distributors, or brand owners established outside the EU/EEA who intend to place hazardous mixtures on the EU market. As a related service, we prepare or update the Safety Data Sheet (SDS) and the label draft required for placing the product on the market and for PCN submission. Where needed, we translate the SDS into the official language(s) of the target Member State(s) and adapt it to specific regulatory requirements.

 

Obligations (in brief)

The ECHA system accepts PCN notifications only from legal entities established in the EU/EEA. Consequently, a US, UK, or Asian company cannot submit independently under Annex VIII to the CLP Regulation (Regulation (EC) No 1272/2008)—even if all other documentation is compliant.

 

The solution: ToxInfo representation in the EU

ToxInfo Kft., a Hungary-based chemical safety consultancy, provides authorised representation. With a duly executed mandate, we act on behalf of our client, prepare and submit PCN dossiers, and handle interactions with the authorities.

 

What does the service include?

  • Authorised representation throughout the submission process (based on a power of attorney, where applicable).
  • IUCLID dossier compilation and PCN submission using client-provided data.
  • Change management / updates (composition, packaging, classification, labelling).
  • Liaison with competent authorities (responding to queries, submitting clarifications).
  • UFI (Unique Formula Identifier) generation and forwarding to partners for labelling.
  • Advice on SDS/label consistency and alignment with CLP/REACH requirements.

 

How does it work? (step by step)

  1. Quotation and contract execution
  2. Power of attorney (where required) and formal designation of representation
  3. Data collection (SDS, mixture composition, product variants, use, packaging)
  4. IUCLID dossier preparation and quality checks
  5. PCN submission and handling of acknowledgements
  6. UFI allocation and labelling guidance
  7. Post-submission follow-up: updates, authority queries, status reporting

 

Data security and liability

All information provided is treated as confidential; disclosure to third parties occurs only where required by law or expressly authorised by the client. Liability and confidentiality provisions are set out in the contract.

 

Pricing – transparent structure

1) Annual representation fee
General administration, liaison with authorities and partners, and ongoing availability.

2) Service-based fees

PCN submissions and updates, plus optional add-ons (e.g. SDS preparation/revision, label design, UFI management).

Volume discounts are available for multiple submissions.

 

Why ToxInfo Kft.?

  • 25+ years of experience in CLP/REACH and chemical safety.
  • International client base, working with manufacturers from dozens of countries.
  • Fast and precise administration—typically within a few working days (depending on dossier complexity and data quality).

 

Do I need an EU representative for PCN if my products are marketed in the EU but my company is outside the EU/EEA?
Yes. PCN notifications can be submitted only by a legal entity established in the EU/EEA; ToxInfo acts as your authorised representative.

How long does the submission take?
It depends on dossier complexity and data quality; complete data speeds up the process. Typically, it takes a few working days.

What happens in case of changes (composition, packaging, label)?
The notification must be updated; we handle and submit such updates to the appointed bodies as part of our service.

Is the notification valid in every EU country?
The PCN format is harmonised, but submissions must be made for each Member State where the mixture is placed on the market; language and certain national requirements can differ. We support compliance for each target market.

Who generates the UFI code?
The UFI is generated by the notifier; we generate it and provide it for labelling.

 

Request a quote / further information

Please contact our customer service by phone or email.

Customer service

 

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