What is Poison Centre Notification?
Under Article 45 of Regulation on Classification, Labeling and Packaging of Substances and Mixtures (CLP Regulation) and Annex VIII, importers and downstream users are required to notify hazardous mixtures to the appointed bodies (i.e, poison centres) using the harmonized format and content by specified deadline before placing their products on EU market.
What is UFI?
Unique Formula Identifier (UFI) is a unique 16-digit alphanumeric code (VDU1-414F-1003-XXXX) that unambiguously links the submitted information on a mixture (and hence information relevant for the treatment of patients) to a specific product. The UFI of a specific mixture is based on the value added tax (VAT) number of a company and a formulation number (For instance: 0-268 435 255) assigned by the company to this specific mixture. UFI can be generated by using a UFI Generator on ECHA website.
UFI shall be printed on or affixed to the label of products.
Who Shall Notify
Importers and Downstream Users that intend to place hazardous mixtures on the EU market (manufactures of substances and distributors do not need to submit notification).
EU Poison Center Notification Portal, Member State Competent Authority on CLP or (poison centres)
Scope of Notification
Chemical Products that fulfilled all the following 3 conditions must complete notification:
- Classified for physical or health hazards;
- Place on EU market
Note: Biocidal products and plant protection products are subject to PCN Notification. But if the product is an article, then circumstances alter cases:
1.Combination of an article (functioning as a container or a carrier material) and a substance/mixture, e.g: inkjet printer cartridge, candles, wet cleaning wipes, desiccant bags, the mixtures are subject to submission obligations under Article 45 and Annex VIII;
2.Articles (as such), e.g: one-piece plastic spoon, are not subject to submission obligations under Article 45 and Annex VIII;
3.Article with an integral substance/mixture (i.e, the substance/mixture forms an integral part of the article), e.g: thermometer with liquid, are not subject to submission obligations under Article 45 and Annex VIII
Products Exempted from PCN:
- Mixtures only classified for environmental hazards
- Radioactive mixtures
- Mixtures subject to Customs supervision
- Mixtures used in R&D and development
- Medicinal products and veterinary medicinal products
- Medical devices
- Food and feeding stuffs
- Mixtures only classified with gases under pressure
Mixtures with no hazards or only with environmental hazards may submit notification on a voluntary basis. In some cases, PCN Notification may help ensure the protection of CBI: mixtures for which submission of information is not required can be also used in the formulation of other classified mixtures (mixture in a mixture or MiM) generating potential gaps in the knowledge of mixture composition. Following a submission made voluntarily, the supplier could communicate the compositional information to the customer via the UFI.
- Mixtures for consumer use: 1 Jan. 2021;
- Mixtures for professional use: 1 Jan. 2021;
- Mixtures for industrial use: 1 Jan. 2024;
Before the above dates, mixtures continue to be subject to existing national requirements. If a company has already submitted information relating to hazardous mixtures in accordance with Article 45(1) before the relevant compliance date, there is no obligation to comply with Annex VIII until 1 January 2025 (transitional period), except in cases where there is a need to provide updated information.
- Choose the market placement;
- Confirm the use type of the notified products and required information. The information requirements and compliance date can be identified according to the use types;
- Collect products information with harmonized format, including submitter information, components of the mixtures, classification, labeling, toxicological information, packages of the products, category, colors, etc. according to Annex VIII of CLP;
- Generate UFI and affix it on the label and packages;
- Prepare Notification dossier;
- Submit notification dossier through PCN Portal or EU member states submission system;
- Timely update the notification if the products information is altered;