Professional Documents
Culture Documents
Know Your Obligations - Poison Centres
Know Your Obligations - Poison Centres
Know Your Obligations - Poison Centres
To get prepared, some basic considerations regarding your role in the market need to be addressed.
Am I affected?
Duty holders under Article 45 are defined as importers and downstream users placing hazardous mixtures on the market. In all cases, the obligation lies with
the EU legal entity, which means that a non-EU supplier of the mixture cannot replace the EU-based duty holder. It is also important to consider that
fulfilment of the notification obligation is a pre-condition for placing the mixture on the market – this may be important in cases where placing on the market
is not performed by the importer or downstream user.
More information on the different actors in the supply chain and activities leading to submission obligations can be found in the Guidance on Annex VIII.
The obligation applies to mixtures placed on the market that are classified for human health or physical hazards.
Note that biocidal products and plant protection products are within the scope of this obligation, and the information submission requirements apply in
addition to other obligations under the Biocidal Products Regulation and Plant Protection Products Regulation.
The obligation to submit information does not apply to mixtures considered hazardous only due to environmental hazards. Mixtures exempted from the
submission requirements include also:
radioactive mixtures;
medicinal and veterinary products, cosmetic products, medical devices and food and feeding stuffs; and
When do I have to make information available to poison centres under the new rules?
For all ‘new’ products not already notified under national legislation, you must submit the required information before you place the mixture on the market.
Submissions should be made in the harmonised format, according to the relevant date of applicability. The date of applicability depends on the use type, i.e.
the end user, of the mixture:
Before these dates, mixtures may be subject to existing national requirements and duty holders should contact the appointed body in the country of interest
for further information.
For further information on how to determine the use type of your mixture and the relevant date of applicability, and information requirements, see step 3.
You may benefit from a transitional period for all products you have previously notified and which are already on the market. Such notifications will remain
valid until 1 January 2025 or until changes are made to the product (e.g. changes to the mixture composition, toxicological properties or product identifiers).
If your product requires a submission update as a result of changes, it must be made in the new harmonised format – note the different dates of
applicability according to the use type still apply.
If your product remains unchanged until 1 January 2025, you must nevertheless make a new submission in the harmonised format, as no migration of data
is planned.
If your product is discontinued before the end of the transition period, you do not need to make a new submission.
https://poisoncentres.echa.europa.eu/know-your-obligations 1/2
6/5/2020 Know your obligations - Poison Centres
European Chemicals Agency Telakkakatu 6, P.O. Box 400, FI-00121 Helsinki, Finland
https://poisoncentres.echa.europa.eu/know-your-obligations 2/2