ChemRegs Newsletter – November 2022
EU Court overturns classification of titanium dioxide
The Court of Justice of the EU (CJEU) has overturned the decision by the European Commission concerning the classification of titanium dioxide (TiO2) as a carcinogenic substance by inhalation in certain powder forms.
The EU General Court also annulled the European Commission Delegated Regulation 2020/217, in so far as it concerns the harmonised classification and labelling of titanium dioxide, in a judgment that was handed down on Wednesday 23 November in Joined Cases T-279/20, T-288/20 and T-283/20, CWS Powder Coatings and Others v Commission.
The Commission is assessing the judgement and will decide whether to appeal.
Titanium dioxide is an inorganic chemical substance used in the form of a white pigment for its colourant and covering properties in various products, ranging from paints to medicinal products and toys.
In 2016, the competent French authority submitted to the European Chemicals Agency (ECHA) a proposal to classify titanium dioxide as a carcinogenic substance. The following year, ECHA’s Committee for Risk Assessment (the RAC) adopted an opinion classifying titanium dioxide as a category 2 carcinogen, including the hazard statement H351 (inhalation).
Based on the RAC Opinion, the European Commission adopted Regulation 2020/217 (the 14th ATP to CLP), and introduced the harmonised classification and labelling of titanium dioxide as suspected of being carcinogenic to humans, by inhalation, in powder form containing 1% or more of particles with an aerodynamic diameter ≤10 μm.
In addition, certain mixtures containing titanium dioxide had to be labelled with the supplemental label element ‘Hazardous respirable dust may be formed when used. Do not breathe dust’ (EUH212) or ‘Hazardous respirable droplets may be formed when sprayed. Do not breathe spray or mist’ (EUH211).
Several applicants, who are manufacturers, importers, downstream users or suppliers of titanium dioxide, brought actions before the EU General Court for the partial annulment of Regulation 2020/217.
The Court has now ruled in their favour and said that the “Commission made a manifest error in its assessment of the reliability and acceptability of the study on which the classification was based and, second, it infringed the criterion according to which that classification can relate only to a substance that has the intrinsic property to cause cancer.”
The General Court determined that the requirement to base the classification of a carcinogenic substance on reliable and acceptable studies was not satisfied.
The full text of the General Court ruling can be found here and the press release can be read here.
Any appeal must be brought before the EU Court of Justice (CJEU) within two months and 10 days of the ruling. If no appeal is made, then the European Commission must “fill any legal vacuum created by the annulment of the act”. In other words, a new harmonised classification and associated labelling must be put in place.
Whether this means that the classification as a carcinogen is now revoked, or there will have to be an alteration to the 14th ATP, or a new ATP made, is not known.
With regards to GB, the 14th ATP to CLP was adopted in full when GB left the EU and this EU ruling does not affect the existing GB mandatory classification (GB MCL) of titanium dioxide. A new or revised GB mandatory classification and labelling proposal would have to be submitted before any changes were made.
Also affected are other downstream regulations which currently prohibit the use of titanium dioxide powders due to the carcinogenic classification, such as the pharmaceutical, cosmetics and food/feedingstuff regulations. These might need to be revised to remove the prohibition and how long this will take is unclear.
Exemption from appointing a DGSA
The GB DfT submitted a proposal (INF.7) to the Working Party on the Transport of Dangerous Goods at the recent RID/ADR/ADN Joint Meeting held in September 2022. The paper sought to clarify whether the exemption from appointing a DGSA within ADR and RID should apply to consignor only companies.
Provision 1.8.3.1 within ADR and RID requires the following participants – consignors, carriers, packers, fillers, loaders and unloaders – to appoint a safety adviser.
With regards to consignors, the transitional measure 1.6.1.44 within ADR and RID, requires “undertakings which participate in the carriage of dangerous goods only as consignors and who did not have to appoint a safety adviser on the basis of the provisions applicable until 31 December 2018 [to]… appoint a safety adviser”. This transitional period ends on 31 December 2022.
However, the exemption from appointing a safety adviser within 1.8.3.2 (b) only covers the following participants: carriers, packers, fillers, loaders and unloaders. This exemption does not currently include consignors.
The current text of the exemption in ADR 1.8.3.2 (b) is:
“The main or secondary activities of which are not the carriage or the related packing, filling, loading or unloading of dangerous goods but which occasionally engage in the national carriage or the related packing, filling, loading or unloading of dangerous goods posing little danger or risk of pollution”.
The proposed amendment is:
“1.8.3.2 The competent authorities of the Contracting Parties may provide that these requirements shall not apply to undertakings:
(a) ….
(b) The main or secondary activities of which are not the consignment, carriage or the related packing, filling, loading or unloading of dangerous goods but which occasionally engage in the national consignment, carriage or the related packing, filling, loading or unloading of dangerous goods posing little danger or risk of pollution.”
Several delegations agreed to the proposed amendments and the paper was adopted.
These changes will not appear in ADR and RID until the 2025 versions, as the publishing window for the 2023 versions had already passed when this proposal was submitted and adopted.
During this transitionary period, the DfT – as the GB Competent Authority – maintains the position that the exemption within ADR 1.8.3.2 (b) and RID 1.8.3.2 (c) does apply to consignor only companies. Note – in international carriage, Competent Authorities of other Contracting Parties may have a different interpretation of the relevant international dangerous goods regulations, including additional or different regulations through their own national legislation.
The DfT are exploring the potential of initiating a multi-lateral agreement to formalise this agreement with other signatories of ADR and RID (provided they wish to sign up to the agreement).
For more information on anything in this Newsletter, please contact us at info@chemregs.co.uk