Your obligations to submit to the poison centres for all your mixtures – scope, exceptions and deadlines. We are ready to support you.
According to Article 45 of the CLP Regulation importers and downstream users of mixtures classified for human health or physical effects are required to submit certain information to bodies appointed by EU Member States. Substances placed on the market on their own, either classified or not, are excluded from the obligation to submit information according to Article 45 of CLP.
The information will be used by poison centres for the purposes of making an emergency health response. The information needs to be provided to all countries in which the mixture is placed on the market. In order to harmonise the whole approach an Annex was added to the CLP Regulation in 2017 containing provisions on the extent and format of the information to be submitted (see).
The information must be submitted in a specific harmonised format and must contain submitter details, mixture information, uses and a Unique Formula Identifier (UFI). The UFI makes a link between the product and the submitted mixture information. Please be aware of the fact that generating an UFI alone does not fulfill the requirements but is only valid when combined with a submission of information in the Poison Centre Notification (PCN) format!
In order to support the submission of the information ECHA has developed several IT tools.
Detailed and specific information on the legal requirements and on the IT tools ECHA has developed can be found at here.
The following deadlines for submission apply:
- 1 January 2021: consumer uses
- 1 January 2021: professional uses
- 1 January 2024: industrial use only
It can be expected that the compilation of the requested information as well as the submission to the individual Member States poses an enormous challenge to chemical companies. Comprehensive compositional information, sometimes subject to confidentiality needs to be submitted, toxicological information needs to be compiled and information on the use of the mixture needs to be given. Last but not least the first deadline (applicable to mixtures for consumer uses) is approaching fast.
What kind of mixtures are subject to UFI / PCN? In principle, the obligation to submit information applies to all mixtures that are placed on the EU market and classified as hazardous based on their health or physical effects. Biocides are also included. Besides, there are exemptions from the rule. CFCS-Consult GmbH can help you identify the specific obligations referring to your product.
CFCS-Consult GmbH can support you in fulfilling the legal requirements referred to above.
With their expertise in classification & labelling, toxicological evaluation of substances and mixtures as well as their experience in the compilation and submission of dossiers in other regulatory fields they will be happy to compile the necessary information and support you in submitting the information.