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Formulators

Formulators are downstream users who produce mixtures and usually supply them further down the supply chain or directly to consumers. They mix together substances and/or mixtures, with no chemical reaction taking place during the process. Examples of such mixtures include paints, adhesives, cosmetics, lubricants, detergents and diagnostic kits.

These pages aim to provide relevant and useful information to help formulators to fulfil their obligations under REACH and CLP. The main legal obligations of downstream users are outlined on the Downstream user roles and obligations page. The obligations on supplying information on chemicals also apply to distributors.

Formulators

 

As a formulator, you are responsible for the classification, labelling and packaging of the mixture you place on the market. You need to be aware of the hazards of the mixture and communicate them in the supply chain.

Mixtures must be classified, labelled and packaged in accordance with the Classification, Labelling and Packaging (CLP) Regulation (Regulation (EC) 1272/2008). Mixtures placed on the market before 1 June 2015 which were classified, labelled and packaged in accordance with the Dangerous Preparations Directive (DPD) may remain on the market until 1 June 2017.

Step-by-step advice on how to meet the requirements of CLP for the classification of mixtures is provided in the Mixture classification web pages. As this is often based on the classification of the substances used in the mixture, this is an important consideration for formulators.

 

The classification of substances used in mixtures

The classification of the substances used in the mixtures is important for formulators for the following reasons:

  1. Substance classification must be included in the safety data sheet for the mixture.
  2. Substance classification can be the basis for classification of the mixture.

If any substance in the mixture has an EU harmonised classification included in Annex VI to the CLP Regulation, this classification is legally binding and must be used for the relevant hazard classes. Otherwise, or for additional hazard classes, you can use the substance classification of your suppliers. When the classification differs between different suppliers, you should try to find an agreement. If agreement is not reached, select the appropriate classification.

If, for any reason, you wish to classify a substance differently to that of all of your suppliers and cannot reach agreement with them, you must report your new classification to ECHA when your use of the substance exceeds one tonne per year. The procedure for reporting a new classification to ECHA is described on the page Submitting a downstream user report (classification differences).

If your new classification is based on new information, you are obliged to forward that new information to your suppliers.

You can check the status of the substance you use on the Classification and Labelling Inventory page. However, you should use your supplier(s) as the primary source of information to classify your mixture.

In contrast to other suppliers, distributors (including retailers) do not have to classify substances and mixtures themselves, but may use the classification that is provided in the safety data sheet. This also applies to any downstream users, as long as they do not change the composition of the substance or mixture supplied to them.

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