As of 1 January 2021, importers and downstream users of hazardous mixtures in terms of Article 45 of the CLP Regulation are subject to certain requirements to provide information. These requirements are also evident from Annex VIII to the CLP Regulation, which was revised by Delegated Regulation (EU) 2020/1677 (PDF). The revisions serve to harmonize information relating to emergency health response and preventive measures.
Which information must be provided?
The scope of the information which must be provided is evident from Part B of Annex VIII. Extensive information is to be provided about the product so as to enable clear identification of the mixture. This includes the “unique formula identifier” (UFI) as well as the trade/brand name. Additional information must also be provided, such as e.g. the classification of the mixture, label elements and toxicological information (Part B, No. 2) and extensive information about the manufacturer must be provided as well, including information about notification requirements and the responsible contact person.
To whom do the requirements apply?
The information must be provided to the responsible body pursuant to Article 45 of the CLP Regulation (pursuant to § 16e(1) of the Chemicals Act (only in German), the responsible body in Germany is the Federal Institute for Risk Assessment, BfR). Only “importers” in terms of Article 2 No. 17 and “downstream users” in terms of Article 2 No. 19 of the CLP Regulation are required to submit information. Distributors or consumers are generally not considered to be downstream users and therefore are not required to provide information.
But with the United Kingdom’s withdrawal from the EEA, the roles of the market operators have changed virtually overnight. Distributors purchasing mixtures from the EEA will now be importing products from a third country and may qualify as importers under certain circumstances. It should be kept in mind, however, e.g. that the CLP Regulation will continue to apply in Northern Ireland based on the Protocol on Northern Ireland (Article 5(4) of the Protocol in conjunction with Annex 2 No. 23). Accordingly, no information has to be submitted in these cases, since the information provided by the supplier in Northern Ireland remains valid as long as the company based in the EEA continues to operate as a distributor only.
Transitional period in effect through 1 January 2025 …
The duty to provide information generally applies as of 1 January 2021. Importers and downstream users which submitted information about hazardous mixtures to an appointed body prior to that date which did not (yet) conform to the provisions of Annex VIII have until 1 January 2025 to correct these problems (Annex VIII, Part A, No. 1.4).
… but not for everyone!
However, the wording of this provision raises another problem, since the validity of the period depends on which operator submitted the information. Only a distributor based in the EEA which has itself submitted information prior to 1 January 2021 has until 1 January 2025 to comply with the Annex. But if a company based in the UK submitted the information to BfR, the German “distributor” or importer may not invoke the transitional period.back