Twelfth update of the CLP Regulation

We continuously check whether the classification of substances is still in accord with recent technical and scientific advances. Adaptations to current classifications are periodically published in an “ATP” (adaptation to technical and scientific progress) of the CLP Regulation (classification, labelling and packaging). The most recent ATP (27 March 2019) contains several changes to the classification and associated data requirements for substances and mixtures. As a result, producers may have to change their product label, or this may have consequences for their authorisation. Producers are expected to keep track of these adaptations themselves.

The 12th ATP (Regulation (EU) 2019/521) implements the 6th and 7th amendments to the United Nations Global Harmonized System (GHS) in the CLP Regulation. The main changes are:

  • The phrase about substances that are explosive in their dry state (EUH001) has been replaced by its own hazard category: desensitised explosives. For desensitised explosives, 3 hazard statements have been added indicating increased risk of explosion if the desensitising agents are reduced: risk of fire (H208), with the risk of shattering (H207) as well as air pressure effects (H206).
  • There is a new category for pyrophoric gases within the flammable gases: gases that can ignite spontaneously upon exposure to air (H232).
  • The general lower limits (Table 1.1) have been extended with a limit value for substances that may irritate the airways or cause drowsiness and dizziness (STOT SE 3: H335, H336) and for hazard if the substance enters the lungs while being swallowed (Asp. Tox.1: H304).

The introduction to the list of precautionary measures (Annex IV) has been amended. Furthermore, the appendices have been amended due to the new hazard categories, and the definitions of a number of endpoints for human toxicology have been modified for clarity.

Application to amend current authorisation

These amendments may have consequences for the classification and data requirements for plant protection products and biocidal products. If the classification of a substance changes, producers of a product based on such a substance are obliged to determine whether that has consequences for their product. Producers are responsible for keeping track of these changes themselves and for taking any required action, such as changing the product label. The changes may also have consequences for the authorisation. Producers of plant protection products and biocidal products can submit an administrative request for amendment of the label to the Ctgb or via R4BP, the biocidal products catalogue of ECHA (the European Chemicals Agency). If this has consequences for the classification of an authorised product, the authorisation must be amended prior to the date that the 12th ATP takes effect (17 October 2020).