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УкраїнськаPCN & UFI
PCN notification of hazardous mixtures under CLP
The uniform PCN format, based on Annex VIII of the CLP Regulation, is used for the notification of hazardous mixtures in all EU Member States. The notification is submitted for each country where the mixture is placed on the market. The notification is made via the ECHA Submission Portal for each market separately. The aim is to ensure rapid access of healthcare professionals to important information in the event of an incident with an impact on health.
From 1 January 2025, according to Annex VIII of the CLP Regulation, the use of the PCN format is mandatory for all mixtures placed on the market that are classified as hazardous to human health (H3XX) or in terms of physical hazards (H2XX).
Who has the reporting obligation?
A PCN is a mandatory notification of a hazardous mixture, primarily submitted by importers, downstream users and contract formulators.
Importer
It imports the hazardous mixture into the European Economic Area, which includes EU Member States as well as Iceland, Liechtenstein and Norway.
Downstream user
A company that formulates its own mixture, or performs filling or repackaging in other containers.
Toll formulator
A third party who creates a product on behalf of another company.
Distributor
It is obliged to check whether there has been a notification for the country in which it is marketing the product and to supplement it if necessary.
What needs to be reported to the PCN portal
The notification applies to all mixtures that are classified as hazardous to human health (H3XX) or in terms of physical hazards (H2XX).
Products for CONSTRUCTION
paints and varnishes, sealants, adhesives, plasters, and asphalt mixtures
Products for ENGINEERING
lubricants, oils, car cosmetics and chemicals, rust and bolt releasers
Products for AGRICULTURE
industrial fertilisers, herbicides, insecticides and fungicides
Products for HOUSEHOLDS
detergents, washing powders, air fresheners, and fragrances
Products for WATER TREATMENT
pool chemistry, aquarium water treatment, drinking water treatment
Products for E-CIGARETTES
disposable cigarettes, liquid refills for electronic cigarettes
Which mixtures are exempt from PCN?
The notification does not apply to safe mixtures and mixtures considered hazardous only to the environment. Mixtures in several other categories are also exempted.
Safe mixtures
Veterinary preparations
Cosmetics
Food and feed
Pharmaceuticals
Waste
Mixtures classified only as hazardous to the environment
Gases under pressure and explosives
Tools for creating announcements
Dedicated tools such as SBLCore, which has a fully integrated S2S (system-to-system) interface, can be used to create and submit PCN notifications. Companies can also process and submit notifications via IUCLID or, using S2S integration, create and submit notifications to the ECHA portal directly from their internal system. Regardless of the method chosen, the notification must always be in the PCN format, which is harmonised and defined in Annex VIII to the CLP Regulation.
SOFTWARE SBLCore
SBLCore software offers PCN creation functionality similar to IUCLID applications. With one button, the file is simply created from the information contained in the safety data sheet. Thanks to the S2S link, PCN notification can then be sent directly to the ECHA portal.
More about the software
IUCLID ONLINE APPLICATION
The most common way to create a PCN is in the IUCLID online application. The app checks the content of notifications during their creation. The final notification must then be uploaded to the ECHA portal.
What a PCN notification must contain
Trade name of the product
Type and size of packaging
UFI code (UFI generator)
Target group (consumer, professional, industry)
Destination countries and notification languages
Intended use (using the EuPCS catalogue)
Ingredients and their concentrations (min. 70% composition of the mixture)
Physical values (state, colour and pH value)
Product classification and labeling
Toxicological information
How to comply with annex VIII obligations
Numbering system
Establish a sustainable numbering system for your products so that each mixture has a unique number to use for creating the UFI code. You can use e.g. catalogue numbers or the internal numbering of your products.
UFI code
After you have established a numbering system, assign a UFI code to each product. SBLCore software or a web generator can be used to generate it.
Registration in the portal
After registration, you must create a notification file and send it to the PCN portal. You can also use SBLCore software to generate the necessary documents and then link it to the portal for submission.
Sending notifications
Go to ECHA and re-register your business if you do not already have login details. To send notifications, you need to request to be assigned a Legal Entity UUID.
How to register in the PCN portal
The first step in submitting a notification is to create a registration in ECHA Cloud Services and obtain a so-called “Legal entity” that links created notifications to a profile you have set up.
Open a web browser and go to ECHA Cloud Services. Here you will find the main signpost for registration and login to ECHA Cloud Services.
On the home page, locate and click the button or link called “Register”. This will begin the process of registering a new account.
Fill in all the required information on the registration page. Required fields are marked with an asterisk (*). Make sure you enter correct and up-to-date information to avoid registration problems.
Click the “Create User” button when you have completed all the required fields. This will send your registration details for processing.
You will receive a message containing a link to confirm your registration at the email address you provided during registration. Open this email and click the confirmation link to activate your account.
After confirming your registration, you will be redirected to the ECHA Cloud Services page, where you will log in with your chosen credentials.
After logging in, you will be taken to the Dashboard section. Click the “Create new Industry Legal Entity” button here. Fill in all the required fields related to your business and click on “Create”.
This successfully completes the registration process for your company in ECHA Cloud Services.
If a third party is managing the notification, add them as a user in your account and assign them the necessary roles.
You will also need a VAT number or company key to generate the UFI code. This data can also be replaced with a one-time key.
Have another question? Get in touch
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