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.
For which mixtures do I need to submit information?
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.
What mixtures are exempted?
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;
- mixtures subject to customs supervision;
- mixtures used in scientific research and development;
- medicinal and veterinary products, cosmetic products, medical devices and food and feeding stuffs; and
- mixtures only classified as gases under pressure and explosives.
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:
- 1 January 2021 for consumer or professional use;
- 1 January 2024 for industrial use.
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.
What about my existing notifications?
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.
