by Dr Eleanor Grimes, PhD
18th February 2020 saw the release of the latest Adaptation to Technical Progress of the EU CLP (Classification, Labelling and Packaging Regulation). Updates include new mandatory EU supplemental hazard statements and potential classification changes for products containing Titanium dioxide, new notes added to Annex VI and a series of new and amended Annex VI harmonised, mandatory minimum classifications. These changes are due to enter into force on 1st October 2021.
Two new EUH statements have been added to address products containing Titanium dioxide. For liquid products containing 1% or more of Titanium dioxide particles with aerodynamic diameter equal to or below 10 μm the phrase EUH211: “Warning! Hazardous respirable droplets may be formed when sprayed. Do not breathe spray or mist.” will be required labelling, whilst for solid mixtures containing 1 % or more of titanium dioxide the phrase EUH212: “Warning! Hazardous respirable dust may be formed when used. Do not breathe dust.” is mandated. Additionally any products labelled with the above phrases that are not intended for the general public, and also not classified as hazardous will also require the EUH statement EUH210 “Safety data sheet available on request.”
The Annex VI table has been amended to include three new notes (to address the incoming changes for Titanium dioxide), these are as follows:
Note V: If the substance is to be placed on the market as fibres (with diameter < 3 μm, length > 5 μm and aspect ratio ≥ 3:1) or particles of the substance fulfilling the WHO fibre criteria or as particles with modified surface chemistry, their hazardous properties must be evaluated in accordance with Title II of this Regulation, to assess whether a higher category (Carc. 1B or 1A) and/or additional routes of exposure (oral or dermal) should be applied.
Note W: It has been observed that the carcinogenic hazard of this substance arises when respirable dust is inhaled in quantities leading to significant impairment of particle clearance mechanisms in the lung. This note aims to describe the particular toxicity of the substance; it does not constitute a criterion for classification according to this Regulation.
Note 10: The classification as a carcinogen by inhalation applies only to mixtures in powder form containing 1 % or more of titanium dioxide which is in the form of or incorporated in particles with aerodynamic diameter ≤ 10 μm.
Annex VI in CLP lists the harmonised mandatory minimum classification for a series of substances. Anyone selling or using the substances listed in the ATP update to Annex VI will be required to re-classify their products and update their SDS and labels accordingly before the implementation deadline in September 2021.
Substances affected by the 14th ATP include 2 deleted substances, 12 updated substances and 17 new substances. One of the major changes within these substances is the inclusion of ten new ATE’s (Acute toxicity estimates), which is a relatively new type of information being included in Annex VI, as prior to the release of the 14th ATP only four substances, including Nicotine, had been assigned one.
Of the updated substances, the most contentious classification update has been that for Titanium dioxide, which has now officially received its carcinogenicity classification. For more information on the effect this change may have please see the original article posted when this decision was ratified.
Recommended Action Items
- Review the new, updated and deleted entries to Annex VI to determine those that may impact your product line.
- Update the affected labels and SDSs prior to the 9 September 2021 deadline.
- Add the two new EUH phrases and all applicable translations to your authoring software library.
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