In a paper circulated ahead of the meeting of the Competent Authorities for REACH and CLP (CARACAL) on March 20th, the Commission reiterated its stance that re-branders and re-labellers should be considered as distributors, and not downstream users, under CLP and REACH.

This means that, re-branders (companies which only stick their own brand on an existing product, when placing it in a new market), as opposed to downstream users, are not to be considered as duty-holders pursuant to Art. 45 of CLP.

Article 45 specifies legal obligations regarding notifications imposed on importers and downstream users of chemical mixtures. And, under Annex VIII of the Regulation, they are also required to notify poison centres, if they are placing hazardous substances on the market by set deadlines (the first being 1st January 2020). Distributors are exempted from any such legal obligations.

However, regardless of their article 45 exemption, all distributors must comply with CLP Article 4(10), which prohibits the placement of a mixture on the market unless it is CLP-compliant.

The clarification comes after the industry posed that the Commission’s interpretation could become a “major problem”.


In separate papers following the CARACAL meeting, industry stakeholders mostly gave their support to the clarifications, but raised questions about enforcement and the need for a more permanent solution.

The Irish Health and Safety Authority and Poisons Information Centre of Ireland said the amendment should reflect that the company mentioned on the mixture label is responsible for declaring the composition of the mixture to the appointed body, or for ensuring that their supplier has done so.

They added, that the proposed solution, will potentially leave information gaps until 2025, at which time all mixtures must be notified in the new format. For example, where a distributor notifies a product from another supplier, the optimal solution would be that the UFI of the original mixture is included in the notification. This would ensure that the toxicological and compositional information, related to the UFI, for that mixture, remains consistent.

Until 2025, mixtures already notified before the various Annex VIII deadlines probably will not have a UFI assigned. This means that it would not be possible to link the new ‘product’ with the formulation for the original mixture, unless the distributor asked their supplier to make a new notification, including the UFI, for that original mixture.

Download the paper here.

Make sure to find out about your obligations and how these could affect your business.

Hibiscus Plc is ready to support you with the authoring of Safety Data Sheets and production of labels to allow a smooth transition into compliance for 2020 onwards.


Call us regarding your labelling & SDS requirements on 0113 242 4272‪ ‬