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EU PCN Notice

According to Article 45 of the EU CLP Regulation (EC) No. 1272/2008 on the Classification, Labeling, and Packaging of Substances and Mixtures, starting from January 1, 2021, importers and downstream users within the European Economic Area shall submit a notification (PCN) to the Poison Centres in accordance with the unified requirements of Annex VIII of the CLP Regulation when placing hazardous mixtures on the market. The Poison Centre website is established by the European Chemicals Agency (ECHA) and provides tools, guidance, and support to help businesses, national institutions, and poison centres meet new requirements.

 

A PCN includes: 

- Name and contact information of the submitter;

- Unique Formula Identification (UFI);

- Product name, category, ingredients, hazard identification, toxicological information, colour, packaging, and other information.

 

Note: UFI is the code printed on the label of a hazardous mixture product to establish a clear association between the product and its PCN notification information.

 

Core requirements of CLP regulations
Classification and tags:

Classify chemicals based on their physical, health, and environmental hazards.

Use unified label elements (such as image symbols, signal words, hazard statements, and precautionary statements).

Packaging requirements:

Ensure that the packaging is leak proof and meets safety requirements.

Toxic Center Notification (PCN):

Notify hazardous mixtures so that poison centers can provide accurate emergency response information in case of emergencies.

 

Scope of application of PCN notification
Applicable products:

All mixtures classified as hazardous (including electronic cigarette liquids, cleaning agents, paints, etc.).

Exempted products:

Products such as drugs, cosmetics, food, and feed that are not subject to CLP regulations.

 

Main content of PCN notification
PCN notifications must include the following information:

Product identification:

Product name, Unique Formula Identifier (UFI), and purpose.

Ingredient information:

The composition and concentration range of the mixture.

Classification and label information:

Hazard classification and labeling information for the mixture.

Supplier Information:

Supplier name, address, and contact information.

Emergency response information:

Detailed information required by the poison center in emergency situations.

 

Process of PCN Notification
Preparation stage:

Determine whether the product belongs to hazardous mixtures.

Collect information on the ingredients, classification, and labeling of the product.

Generate Unique Recipe Identifier (UFI):

Generate UFI using the tools provided by ECHA and label it on the product label.

Submit PCN notification:

Submit a notification through ECHA's PCN Portal.

The submission format must comply with the uniform requirements of Appendix VIII.

Update and maintenance:

If the composition or classification of the product changes, the PCN notification should be updated in a timely manner.

 

Tools and support for PCN notifications
ECHA provides the following tools and resources to assist businesses in completing PCN notifications:

IUCLID software:

Used for preparing and submitting PCN notifications.

PCN portal:

A platform for online submission and management of PCN notifications.

UFI Generator:

A tool for generating unique recipe identifiers (UFIs).

Guidelines and Training:

ECHA provides detailed guidelines and training materials to help businesses understand and meet PCN notification requirements.

 

Time requirements for PCN notification
New product: Complete PCN notification before launching on the market.

Existing products: PCN notification will be completed in stages based on the purpose of the mixture and the time of market launch

Consumer use: Starting from January 1, 2021.

Professional use: Starting from January 1, 2021.

Industrial use: Starting from January 1, 2024.

 

The significance of PCN notification
Emergency response:

Provide accurate information to the poison center to ensure quick response in emergency situations.

Compliance:

Meet the requirements of CLP regulations, avoid legal risks and market access barriers.

Consumer safety:

Improve product transparency and safety to protect consumer health.

 

Your company's PCN notification service
Your company can provide the following services to customers to help them meet CLP regulations and PCN notification requirements:

Regulatory Consultation:

Provide a detailed interpretation of CLP regulations and PCN notifications.

Data preparation:

Assist clients in collecting and organizing information on product ingredients, classification, and labeling.

UFI generation:

Use ECHA tool to generate a unique formula identifier (UFI).

PCN submission:

Submit notifications through ECHA's PCN portal.

Continuous support:

Provide notification updates and maintenance services.

 

summary
CLP regulations and PCN notifications are important regulatory requirements of the European Union for hazardous mixtures, aimed at safeguarding human health and environmental safety. Your company's professional services can assist clients in efficiently completing PCN notifications, ensuring that products comply with EU regulatory requirements, smoothly enter the European market, and achieve compliant operations.

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