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 legal representation:

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

As a result of our services, our Clients’ products can enter EU markets lawfully and swiftly.

 

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 label draft required for placing on the market and for the 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 submissions only from legal entities established in the EU/EEA. Consequently, a US, UK or Asian company cannot file independently under Annex VIII to the CLP 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 legal representation. With a duly executed mandate, we act on behalf of our Client, prepare and submit PCN dossiers, and handle all interactions with the authorities.

 

What does the service include?

  • Legal representation throughout the entire submission process (based on power of attorney).
  • 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) code generation and forwarding to partners for labelling.
  • Advice on SDS/label alignment with CLP/REACH requirements.

 

How does it work? (step by step)

  1. Quotation and contract execution
  2. Power of attorney and formal designation of legal 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: amendments, 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 legal representation fee
General administration, liaison with authorities and partners, and ongoing availability.

2) Service-based fees

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

Volume discounts are available for multiple submissions.

 

Why ToxInfo Kft.?

  • 24+ 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.

 

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 submissions can be made 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 a few working days.

What happens in case of changes (composition, packaging, label)?
The submission must be updated; we handle and file such updates with the authority as part of our service.

Is the submission valid in every EU country?
PCN may involve different national submission channels; we support compliance with the requirements of each target market.

Who generates the UFI code?
The UFI is generated by the submitter; we perform this and provide it for labelling.

 

Request a quote / further information

Please contact our customer service by phone or by email.

Customer service

 

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