Applications antivenom centers.

According to the European CLP Regulation (EC No. 1272/2008), as a manufacturer or importer of chemical consumer products, you are obliged to provide consumers with sufficient information on the hazards and safe use. This is obviously important to ensure consumer safety. However, incidents can never be completely prevented.

What if consumers do need medical attention after coming into contact with a chemical product? Then it is important that (medical) professionals have sufficient information to act appropriately. Therefore, in many cases you are obliged to report your chemical products to the appropriate authorities of the EU member states where the product is sold. These are also called antitoxin centers.

Mode of operation by 2021.

As of Jan. 1, 2021, notification of a product to national poison centers will be arranged through a European contact point. For this purpose, a special portal has been developed by the European Chemicals Agency (ECHA): the Poison Centre Notification Portal (PCNP).

This way of submitting information requires effort from companies. Not only has the way the information is submitted changed, the changes also affect the amount of information to be submitted as well as the way you label your products.

Précon has been unburdening customers for years by registering their products for them with the appropriate anti-poison centers and can help you do just that!

or call NL +31 (0)30 656 60 10
or call BE +32 (0)3 616 08 69

What can we help our clients with?

Register products antivenom centers
Review products
Categorizing products
Drafting SDS
Preparation of legally compliant labels
UFI administration

What do you need to do to register with the antivenom centers?

Harmonized notification
From Jan. 1, 2021, notification to European antivenom centers will be organized centrally.

European Product Categorization System (EuPCS)
To meet your obligations under the European CLP Regulation, you must provide information on the main intended use of your mixtures. The EuPCS was developed for this purpose. Through this system you assign a product category to your mixture. This is used in your application. Précon can support you in correctly categorizing your products.

Safety Data Sheet (MSDS)
A substantively correct SDS is essential for notifying your products. The SDS contains the information you need to notify a product to ECHA.

Poison Centres Notification Portal (PCNP).
Notifications are made through the online portal of the European Chemicals Agency (ECHA). In this, companies can enter information about their hazardous mixtures in a structured way. The information then becomes available to antitoxin centers. Précon has extensive experience in notifying products through the PCNP and can take care of your notifications.

UFI code
As of Jan. 1, 2021, the UFI code you use when registering your products will be a mandatory labeling element. Of course, it is important to keep track of which UFI codes are used for different formulations. Précon can help you prepare legally compliant labels and maintain UFI records.

Related trainings.

Frequently asked questions.

When am I required to report a product to the poison control center?

If the product (mixture) is classified as hazardous according to the CLP regulation and the hazard falls into the categories of health hazards or physicochemical hazards.

When will Annex VIII of the CLP Regulation enter into force?

The amendments in Annex VIII do not take effect simultaneously for all types of products. The following effective dates apply by product group:
- Jan. 1, 2021: products for consumer and professional use;
- Jan. 1, 2024: products for industrial use;
- Jan. 1, 2025: products previously notified (end of transition period).

If you sell consumer products that require notification, that means your new products must be notified through the new "Poison Centre Notification Format" starting Jan. 1, 2021.

How should I report my hazardous mixture to the European poison centers?

Companies must use the "Posion Centre Notification format" for notification. This is an online portal that allows companies to submit information about their hazardous mixtures to ECHA and the poison centers. The following information must be submitted:

- Product identifiers as trade name and UFI code;
- Contact details of the submitter;
- Classification and labeling of the mixture;
- Toxicological information and physical and chemical properties;
- Concentration or concentration range of the mixture ingredients;
- Classification and identification of the mixture ingredients.

What is a UFI code?

To simplify the work of poison centers and allow for faster identification of a dangerous mixture, the UFI code was created. The UFI code, or Unique Formula Identifier, is a unique 16-digit alphanumeric code that links a mixture to the information available at the poison centers.

The UFI code is mandatory on the label and in the safety data sheet, and is also part of the information to be reported to the poison control centers. The UFI code must be generated by companies themselves in an ECHA-managed web application.

When should a notification be renewed or updated?

A notification must be updated in the following cases:
- The name or product identification of the mixture is changed;
- The hazard classification of the mixture is changed;
- New toxicological information about the mixture or components becomes available;
- The composition of the mixture has changed.