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Q Must a manufacturer or importer do physical hazard testing for classification purposes for substances not included in Annex VI to CLP or for substances included in Annex VI, but not classified for a specific physical hazard, and for which no adequate and reliable information is already available for the physical hazards?
A

According to CLP Article 40 (3), substances placed on the market on or after 1 December 2010 must be notified within one month after their placing on the market. In addition, CLP Article 4 (1) stipulates that the manufacturer or importer must classify their substances in accordance with Title II of CLP before placing them on the market.

Furthermore, CLP Article 8 (2) requires that for the purposes of determining whether a substance entails any of the physical hazards referred to in Part 2 of Annex I to CLP, the manufacturer or importer must perform the tests required in that Part, to allow classification of the substance, unless adequate and reliable information is already available.

Therefore, manufacturers and importers are required to perform physical hazard testing so as to classify their substances not included in Annex VI to CLP, or included but not classified for a specific physical hazard, and to notify this classification to ECHA within one month after their placing on the market.

However, substances may be placed on the market in very small quantities only (e.g. the quantity of a substance used in R&D (Research and Development)). These quantities may not be sufficient for the testing of physical hazards. When there is no adequate and reliable information already available on the physical hazards of these substances, it may not be feasible and/or proportionate for the manufacturer or importer to perform the tests required in Part 2 of Annex I to CLP. In those cases physical hazard testing should not be required. Nevertheless, every effort should be made to assess the physical hazards using any available theoretical methods e.g. UN test methods screening tests, along with expert judgment, and the most severe of the resulting classifications should be applied. Finally, as it is explained in FAQ ID=186 for R&D substances in particular, if neither test data are available nor any other adequate information indicates that a substance should be classified, a notification to the C&L Inventory is not required.

Modified Date: 08/08/2019
Topic: CLP
Scope: Notification-Classification and Labelling Inventory
ID: 0230
Version: 1.1
This answer has been agreed with national helpdesks.

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