Reporting substance classification changes
If the classification of a substance changes, manufacturers of a product based on such a substance are obliged to determine whether this has consequences for their product. Producers are responsible for this and must take any required action themselves. They may have to modify the label or this could have consequences for the authorisation. Labels of plant protection products and biocidal products can be modified by requesting an administrative change from the Ctgb or via R4BP (the biocidal products register of ECHA).
The competent authorities continuously test whether the classification of substances complies with technical and scientific progress. These substances can be active substances, solvents or other co-formulants. Amendments to the list are regularly published in an ATP (adaptation to technical and scientific progress). This year, two amendments to the CLP Regulation (the Classification, Labelling and Packaging Regulation) were published. On 20 April 2021, Regulation 2021/643 (16th ATP) was published; this is an amendment to Annex VI, Part 1. On 28 May 2021, Regulation 2021/849 (17th ATP) was published to amend the harmonised classification in Part 3, Table 3 of Annex VI. These regulations amend the CLP Regulation.
In the 16th ATP, the formulation of a number of notes in Part 1, Annex VI was improved. In addition, Notes J to R of Section 220.127.116.11 and Notes 8 and 9 of Section 18.104.22.168 have been reformulated. The 17th ATP included substances on which the Risk Assessment Committee (RAC) of the European Chemical Agency (ECHA) published an opinion in 2019. In total, 22 new classifications of substances have been included, 39 classifications have been amended and 1 classification has been removed. This could mean that producers have to change the product label or this could have consequences for the authorisation. Producers are expected to keep track of these changes themselves.
In the 17th ATP, the list with harmonised classification and labelling (C&L) of substances has been updated and supplemented (Part 3, Table 3 of Annex VI). This includes the harmonised classification of 17 active substances in plant protection products and/or biocidal products; the classifications of 31 active substances have also been changed and, if applicable, supplemented with acute toxicity estimates (ATE) and m-factors. Regarding the labelling of products for which applications are pending, the Ctgb takes account of the new or amended classification of substances according to the 17th ATP.
For existing authorisations, compliance with these new harmonised classifications is not immediately mandatory. This enables suppliers to change the labelling and packaging of the products to comply with the new classifications and to sell existing stocks. The transition period for existing labels will end on 17 December 2022.