Declarations for the Grand Duchy of Luxembourg

Note related to the hazardous mixture notifications to Belgian Poison Centre

 

Notification system

Hazardous products have to be notified to the Belgian Poison Centre once they are placed on the Belgian market. No matter which kind of firm is placing it on the market.

Belgium chose to use two different systems in parallel:

  • The already existing national system in Belgium using a XLS tool (EDF file on the Poison Centre website)
  • The e-Delivery system from the ECHA PCN Portal using a IUCLID tool

In the future, you will be able to choose between one of those two systems to notify your products to the Poison Centre. It is not necessary to notify via the two systems for the products placed on the market in Belgium.

WARNING:

For several technical issues, the Belgian Poison Centre is currently not able to read information coming from the ECHA PCN Portal and will not be able to read it at the 1st January 2021.

WE THEREFORE ASK YOU TO NOTIFY YOUR PRODUCTS DIRECTLY TO THE BELGIAN POISON CENTRE AND TO PREFER THE XLS FORM OF THE CENTRE.

The Poison Centre will release an announcement on its website once he will be able to proceed with the notifications coming through the ECHA PCN Portal. The exact date for this release is not known yet.

Obviously, notifications that will already be listed in our database will not have to be re-notified via the PCN Portal and will remain valid.

 

Identification number UFI

The UFI is a new number that has to be put on the label of the hazardous mixture from the 1st January 2021 for the new mixtures, and in  2025 for mixtures already on the market on the 1st January 2021. It is a unique number for a mixture/producer than can be generated via the ECHA website. It is useful for the hazardous mixture notification to the Poison Centre.

If you want to update your label for mixture already on the market before 2021 by placing the UFI number on it, it is possible. In this case we ask you to inform the Poison Centre by using the XLS file with the following information:

  • The responsible for the placing on the market
  • Name of the product

-          UFI number (only 1 UFI per row in the Excel sheet)

Updates related to the addition of a UFI only are free of charge.

Since June 2015, the public and the health professionals of the Grand Duchy of Luxembourg have access to the Belgian Poison Center via the free number (+352) 8002-5500.

In order to answer the calls adequately, the medical doctors of the Poison Centre need to have access to the ingredients of the products on the Luxembourg market.

In application of the article 45 of the European regulation UE 1272/2008, the Belgian Poison Centre can receive the ingredients of dangerous mixtures, including biocides, on the Luxembourg market.

The data needed are similar to those for the products on the Belgian market.

No remuneration is due to declare the products on the Luxembourg market.

The products on the market in Belgium and in the Grand Duchy of Luxembourg do not need to be declared twice as long as they are identical (same commercial denomination, same ingredients, same label).

An e-mail address depot.lux@poisoncentre.be has been created to receive the data and answer the questions of the manufacturers.

It is not mandatory to declare the mixtures that are not classified as dangerous. However, we invite the companies to declare all their products, either classified as dangerous or not dangerous as intoxications occur with all types of products. It is important for the medical doctors to have access to the ingredients of a product in case of an intoxication, especially in case of an accidental ingestion.

 I.  NOTIFICATIONS TO THE BELGIAN POISON CENTRE

a. Mandatory notifications:

  • Notification of mixtures  classified as hazardous, based on the regulation (EC) No 1272/2008, because of its effects on health or because of its physical effects.

Which information to include in the notification?

1- SDS: the SDS (safety data sheet), in accordance with article 31 and annexe II of the REACH regulation (EC) No 1907/2006 correctly completed.One language is enough (French, Dutch or English).

2- The complete chemical Composition of the mixture: complete list of ingredients (name, CAS number and/or EINECS) with their concentrations.

3- Label: a picture of the label and/or the mixing packaging to allow the MD or pharmacist, together with the caller, to identify the mixture in question perfectly.

Your declaration includes:

      • An EDF declaration worksheet: this is a simple Excel file (compatible with Open Office) that you complete before sending it back to us.
      • For each mixture declared many documents: SDS, composition, label. All documents should preferably be provided in PDF format.

 

  • Notifications of biocides

    For more details about biocides please contact::
    Administration de l'Environnement
    biocides@aev.etat.lu
    https://www.environnement.public.lu

    Your declaration includes:

    • An EDF declaration worksheet: this is a simple Excel file (compatible with Open Office) that you complete before sending it back to us.
    • For each mixture declared many documents: SDS, composition, label. All documents should preferably be provided in PDF format.

b. Voluntary notifications:

There is no obligation to notify non-classified mixtures or mixtures only classified for the environmental hazards (with H4xx statement) to the Poison Centre.
However, we invite the companies to notify all products, hazardous or not as accidents with all products can happen. It is important for the medical team to have access to the composition of a product involved in an incident and especially for incidental intake.

If you include the Poison Control Centre emergency number on your labels and/or safety data sheets, the composition of your mixtures must have been declared to the Poison Control Centre.

Your declaration includes:

 

 You can send us your declaration:

  • By e-mail: depot@poisoncentre.be
    (max. size for e-mail: 5Mb. You can send us your declaration in several mails if required).

  • By post (on CD/DVD/ USB):

Your CD/DVD/ USB must be sent at the following address:
Belgian Poison Centre
p/a Militair Hospitaal Koningin Astrid
Bruynstraat 1, 1120 Brussel
BELGIË


II.  NOTIFICATIONS TO OTHER AUTHORITIES

 

 

You are a Luxembourgish company and you have questions on REACH or CLP?
The REACH & CLP Helpdesk Luxembourg can help you: https://echa.europa.eu/-/luxembourg-helpdesk