ChemRegs Newsletter – August 2025
Titanium dioxide classification annulment
Titanium dioxide (TiO₂) is one of the world’s most widely used white pigments, prized for its brightness and opacity in everything from paints and plastics to cosmetics and food products. However, the regulatory landscape for this ubiquitous material has just undergone significant upheaval following the overturning of the EU CLP classification for titanium dioxide by the European Court of Justice (ECJ) on 1 August 2025.
The ECJ’s ruling centres around the classification of titanium dioxide as a suspected carcinogen by inhalation.
In 2020, the European Commission classified certain forms of titanium dioxide as a Category 2 carcinogen (Carc. 2, H351) under the CLP (Classification, Labelling and Packaging) Regulation, particularly focusing on powder forms with particles of specific sizes. This classification also triggered specific labelling requirements for certain mixtures containing titanium dioxide and was introduced into EU CLP via the 14th Adaptation to Technical Progress (ATP) to CLP, with effect from October 2021.
The European Chemicals Agency (ECHA) also produced a ‘Guide on the classification and labelling of titanium dioxide‘ in September 2021, giving advice and examples of classification for titanium dioxide and a strategy for assessing the need to classify mixtures containing titanium dioxide.
Various manufacturers, importers, downstream users and suppliers of titanium dioxide challenged the classification and filed lawsuits before the General Court of the European Union to overturn the classification .
By judgment of 23 November 2022, the General Court annulled the contested classification and labelling, citing procedural shortcomings and insufficient scientific justification. It found, in particular, that the Commission had committed a manifest error in its assessment of the acceptability and reliability of a scientific study on which the classification had been based.
France and the European Commission subsequently appealed to the European Court of Justice (ECJ) against the judgment of the General Court, and the annulment was put on hold.
In a landmark ruling on 1 August 2025, the ECJ dismissed the appeals from Commission and France in Joined Cases C-71/23 P and C-82/23 P, France v CWS Powder Coatings and Others. It thus upheld the judgment of the General Court and the annulment of the contested classification of titanium dioxide as a carcinogen.
This means that for titanium dioxide, or products containing it in the EU, the ECJ ruling removes:
- The Carc. 2, H351 (inhalation) classification
- Supplemental hazard statements EUH211 and EUH212
- Associated Notes V, W, and 10 in Annex VI of CLP
The judgment has direct legal effect and so companies do not need to wait for a new ATP for this to be incorporated into EU CLP.
However, despite this regulatory reprieve, uncertainty remains. The ECJ ruling does not end regulatory scrutiny of titanium dioxide. ECHA and the European Commission are expected to revisit the scientific evidence and may propose new restrictions, especially as research into nanoforms and inhalable particulates evolves. Future regulatory action is possible if the agencies address the identified shortcomings.
In parallel, the EU’s Chemicals Strategy for Sustainability, part of the broader European Green Deal, aims to strengthen the regulation of chemicals deemed hazardous or persistent. As such, titanium dioxide remains in the regulatory crosshairs, with the possibility of future reclassification or restrictions if new data emerges.
DEFRA reforms to the waste carrier, broker and dealer system in England
The Department for Environment, Food & Rural Affairs (DEFRA) has published a policy paper on reforming the current waste carrier, broker and dealer (CBD) registration system in England.
The current CBD system makes it hard for regulators to target high-risk waste operators properly. It does not differentiate between small and large players, or the risks posed by the types and quantities of waste handled or managed by them.
DEFRA’s proposal aims to simplify the current terminology around waste carriers, brokers and dealers to become ‘waste controllers’ and ‘waste transporters’ and assign legal responsibility to these new terms. This will more effectively link responsibility for the waste to those taking decisions on the fate of that waste.
Waste controllers are those who: organise waste collection, its transportation or end destination; make arrangements for its assessment and ensure it has been classified; arrange the recovery or disposal of waste on behalf of others; and buy or sell waste. Examples could include brokers, dealers, consultants, waste sites etc.
This includes those who do not take physical possession of the waste when performing those activities.
Waste transporters are those who are instructed by a controller to move waste between locations without input on the end destination and classification. Examples include hauliers, contractors, and delivery drivers.
Waste controller-transporters are those who act as a controller but also transport the waste. Examples include waste sites that control and transport waste, skip companies, and waste collection companies.
Existing registrations are to be replaced by a ‘standard rules’ environmental permit or a registered exemption.
There will be 3 permit types:
- Waste controller only
- Waste transporter only
- A combined waste controller-transporter permit
Each permit type will be differentiated according to the activity carried out under the permit and renewals will be undertaken at a frequency of every 3 years. Permits will be differentiated further by the scale of the operations undertaken and type of waste carried by the permit holder with additional tiers that take into consideration the type and volume of waste carried.
This tiered approach will ensure that those carrying large amounts of the most at-risk waste types will be distinctly identified and charged accordingly. These tiers will be differentiated to cover 4 levels of risk, ensuring that additional charges and permit conditions will reflect the risk of waste transported and controlled.
There will be some exemptions from needing a permit. There will be registered and non-registered exemptions. Registered exemptions will need to be re-registered every 3 years.
The Environmental Permitting Regulations (EPR) contain a requirement for waste operators to demonstrate operator competence, of which technical competence is a part.
As waste transporters and controllers will be moved into the EPR they will be subject to these requirements. This means mandatory technical competence will be introduced for the permit holder and any nominated persons within the business. As is the case for site permits, there will be 2 routes to demonstrate competence: individual and workplace based.
The individual assessment route would be a similar assessment method to the current Chartered Institute for Wastes Management (Waste Management Industry Training and Advisory Board) (CIWM(WAMITAB)) system for site permits but the content may differ in complexity.
Alternatively, a workplace-based qualification could be obtained, which would allow the workplace to demonstrate competence rather than requiring individual qualifications. DEFRA is working with industry to develop the details of this framework, but would be similar to the current system run by Energy & Utility Skills (EU Skills) for site permits.
Once the new system is ‘live’, those with an existing upper-tier registration will be required to apply for the relevant permit when their registration is due for renewal, thereby naturally creating a staggered approach over 3 years.
The Environment Agency will notify all current upper-tier registrants to make them aware of the changes and of the need to apply for a permit (or register an exemption if applicable) when their registration expires.
Those with existing lower tier-registrations, where there is no requirement to renew, and who will be required to either register an exemption or apply for a permit, must do so within 12 months of the system going ‘live’. After this time, their lower-tier registration will cease to exist.
New applicants (who do not already hold an upper- or lower-tier registration) will be required to apply for a permit or register an exemption (whichever is applicable) from the date the new system goes live.
The duty of care legislation and code of practice will be amended in due course to reflect these reforms and the introduction of a digital waste tracking service.
The full policy paper can be accessed here: https://www.gov.uk/government/publications/reforming-the-waste-carrier-broker-and-dealer-system/reforming-the-waste-carrier-broker-and-dealer-system
Publication of GB mandatory classification and labelling (GB MCL) Agency Opinions
The next batch of new GB MCL Agency Opinions is now available for download in the GB MCL publication table.
A GB MCL Agency Opinion formally proposes the GB mandatory classification and labelling for chemical substances, based on the scientific and technical assessment of the scientific data in line with the GB CLP Regulation, together with an assessment of the policy and socio-economic impacts on the UK.
It sets out whether there is adequate scientific evidence to support a new or revised GB MCL of a substance and what the potential impact of the proposed GB MCL may be.
These GB MCL Agency Opinions relate to substances for which HSE (as the GB CLP Agency) published an Agency Technical Report under Article 37 of the GB CLP Regulation in 2024.
At the time of publication, the classification and labelling proposed in these Agency Opinions have not been agreed and/or adopted in Great Britain.
The GB MCL publication table is available here, and the new Opinions are identified in column I of the table with the prefix “New !”.
HSE expect to publish the next batch of Agency Opinions in September 2025.
For more information on anything in this Newsletter, please contact us at info@chemregs.co.uk