Poison Centres ECHA Obligations

Article 45 of the CLP Regulation defines importers and downstream users who place dangerous mixtures on the market as responsible parties. In all cases, the obligation always lies with the EU as a legal entity, which means that a supplier of the mixture who is not domiciled in the EU cannot replace the responsible party who is domiciled in the European Union. It is also important to note that compliance with the notification obligation is a precondition for placing the mixture on the market; this may be of importance in cases where the placing on the market of the product is not done by the importer or downstream user.

More information about the different actors in the supply chain and the activities leading to the filing obligation can be found in the Guidance on Annex VIII.

For which mixes do I have to submit information?

The obligation applies to marketed mixtures classified in relation to human health or physical hazards.

Please note that biocides and plant protection products are within the scope of this obligation and that the reporting requirements apply in addition to other obligations under the Biocides Regulation and the Plant Protection Products Regulation.

Which mixtures are exempt?

The reporting requirement does not apply to mixtures considered hazardous only because of environmental hazards. Mixtures exempted from reporting requirements include the following:

radioactive mixtures
mixtures subject to customs supervision
mixtures used in scientific research and development
medicines and veterinary products, cosmetics, medical devices and food and food products
mixtures classified as pressurized gases and explosives only

When do I have to make information available to poison control centers under the new rules?

For all “new” products that have not yet been notified under national legislation, you must submit the required information before placing the mixture on the market. Submissions must be made in the harmonized format, in accordance with the corresponding application dates. The date of application depends on the type of use of the mixture, i.e. the end user:

January 1, 2021 Blends for private or professional use
January 1, 2024 Mixtures for industrial use

Prior to these dates, mixtures remain subject to current national requirements and responsible parties should contact the designated body in the country concerned for further information.

What happens to the notices I have already filed?

You may benefit from a transitional period for all products that you have previously notified and that are already on the market. These notifications will remain valid until January 1, 2025 or until changes are made to the product (e.g. changes in the composition of the mixture, toxicological properties or product identifiers).

January 1, 2024 Mixtures for industrial use
However, if your product remains unchanged until January 1, 2025, you will have to submit a new application in the harmonized format, as no data migration is foreseen.
If your product is no longer manufactured before the end of the transition period, you will not have to submit a new application.
14%

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Regulating the transport of dangerous goods by road in Spanish territory.

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