Do you formulate mixtures using chemicals sourced from within the EU?

Do you bring in chemicals from within the EU for formulation?

Companies who source substances or mixtures from within the EU (including Iceland, Norway, Liechtenstein and Northern Ireland) for the purposes of formulation are not considered as importers under chemical legislation, but are considered ‘downstream users’.

Have you checked whether classification applies to the final formulated mixture?

Downstream users who formulate mixtures must determine whether classification applies to the final mixture based on the criteria set out in the CLP Regulation. Where classification applies, the formulator is responsible for classifying, labelling and packaging in accordance with CLP. If the mixture is classified under certain hazard classes and sold to the general public, the formulator must ensure the packaging includes a tactile warning of danger and/or a child-resistant fastening.

For hazardous mixtures placed on the market, do you need to provide a safety data sheet?

If the mixture is classified in any hazard class (physical, health or environment) in accordance with CLP and/or is included on the candidate list the formulator is responsible for compiling and providing the safety data sheet to recipients. If the mixture contains ≥ 1% (0.2% for gaseous) of a substance posing a health or environmental hazard, or ≥ 0.1% of a CMR, PBT or vPvB substance or contains a substance that has an occupational exposure limit value, the safety data sheet should be available on request. Formulators do not need to provide safety data sheets to non-professional consumers, but must provide them to other recipients in their supply chain.

If a safety data sheet is not required, the recipient should still receive information on registration, authorisation, restriction and risk management measures.

Have you determined whether notification to the National Poison Centre is required?

Formulators of hazardous (health and/or physical endpoint classifications) mixtures placed on the Irish market must notify the National Poison Information Centre (NPIC) and include their emergency telephone number in Section 1.4 of the safety data sheet.

Please note that all EU poison centres will be harmonised and information for professional and consumer uses can be submitted to the Poison Centre Notification (PCN) portal from 1st January 2021, which will include the generation of a Unique Formula Identifier (UFI) for inclusion on the label and safety data sheet. Industrial uses must be notified to the PCN portal from 1st January 2024 and until that time should be submitted as normal to NPIC.  If you have notified to the National Poison Centre before 1st January 2021 you may benefit from a transitional period before notifying to the PCN until 1st January 2025.

Have you checked whether any substance in your mixture requires Authorisation?

Substances listed on Annex XIV (Authorisation List) may only be placed on the market after the substance’s ‘sunset date’ if an Authorisation has been granted by ECHA.

Have you checked whether any substance in your mixture is Restricted?

Formulators must be cognisant of the substances listed on Annex XVII (Restriction List) and ensure that the intended use of the product they are placing on the market complies with the specific conditions of the restriction text.

Is the product you are formulating considered a detergent?

Detergents must comply with the additional, specific labelling and packaging requirements outlined in the Detergents Regulation (EC) No. 648/2004 and on our website.