Background
Titanium dioxide is an inorganic chemical substance used - in the form of a white pigment - in various products, including paints, cosmetics, medicinal products, and toys. In recent years, it has been at the center of significant regulatory and legal scrutiny.
In 2016, the French competent authority (ANSES) proposed classifying titanium dioxide as a carcinogen by inhalation. The European Chemicals Agency's Committee for Risk Assessment (RAC) endorsed this classification in 2017, prompting the European Commission to adopt, in 2019, a regulation classifying titanium dioxide as suspected of being carcinogenic to humans, by inhalation, in powder form containing 1% or more of particles of a diameter equal to or below 10 μm. This classification was challenged by various manufacturers, importers, downstream users, and suppliers before the General Court of the European Union (General Court).
In 2022, the General Court annulled the classification1, finding that: first, the Commission had committed a manifest error in assessing the acceptability and reliability of a scientific study on which the classification had been based; and second, it had infringed the criterion that classification can relate only to substances with the intrinsic property to cause cancer. France and the Commission subsequently appealed to the Court of Justice (ECJ) against that judgment of the General Court.
On 6 February 2025, Advocate General (AG) Ćapeta delivered her Opinion2 in these cases, recommending that the ECJ overturn this annulment. This Opinion attracted significant attention from both the industry and the scientific community. In its judgment of 1 August 2025, the ECJ delivered its final ruling3, upholding the annulment of the classification of titanium dioxide, while notably diverging from the AG Opinion.
This article critically examines the AG's recommendations alongside the ECJ's final ruling, highlighting the legal reasoning and impact of their respective positions in the case of titanium dioxide.
The AG Opinion's recommendations
In her Opinion of 6 February 2025, AG Ćapeta brought forward bold recommendations that gave rise to significant legal and regulatory concerns. In summary, the AG Opinion emphasized that:
- the General Court exceeded the limit of its power to review the Commission's decision on the classification of titanium dioxide. In this regard, the AG noted that "(i)n cases of scientific uncertainty relevant for the identification and classification of hazardous substances, the CLP Regulation bestows the role of final interpreter (of scientific data) on the Commission" (par. 84). And, in her view, rightly so, as "(t)he courts are not scientists and cannot become scientists" (par. 86).
In this context, the AG concluded that, in the case of titanium dioxide, the General Court's role should have been limited to reviewing whether the RAC "had examined, with all objectivity, the factors necessary to determine what it considered to be the relevant density of titanium dioxide particles" (par. 93). However, according to the AG, while the General Court acknowledged that the RAC had considered the phenomenon of agglomeration and its impact on density, it nonetheless disagreed with the RAC's conclusion that the use of the standard density value was appropriate (par. 94-95). In doing so, the General Court wrongly "replaced its own assessment for that of the Commission" (par. 96) and thus,"exceeded the limit of its power of judicial review" (par. 97). Arguably, although the AG referred to the RAC's duty to objectively assess all the relevant factors, she did not explain - beyond citing uncertainty - why she believed that duty had been fulfilled.
Notably, in this respect, the AG added that an annulment of the contested regulation would still be possible if the option chosen by the Commission were "scientifically impossible" (par. 99). However, in this regard, it could be argued that proving scientific impossibility (a negative) is difficult, if not impossible, to demonstrate.
Finally, the AG stated that while she sympathized with the argument that "the RAC Opinion does not clearly explain why the RAC opted for the standard particle density value despite being aware of the agglomeration phenomenon", she nonetheless held that "an insufficient explanation" does not mean that the RAC did not take into consideration all the relevant facts (par. 100). This could be viewed as providing further ground to situations where Commission decisions with significant industry repercussions stand, even if they are not fully justified.
- the concept of 'intrinsic properties' must be interpreted broadly to extend beyond chemical composition. The AG thought that the General Court was wrong to apply a strict interpretation of the concept of "intrinsic properties" as the "properties which a substance has in and of itself"' (par.111 and 115). Accordingly, it was wrong to conclude that titanium dioxide's carcinogenicity by inhalation stems from extrinsic factors - namely, the quantity inhaled and resulting lung inflammation - rather than its intrinsic properties (par. 115 and 116).
Instead, the AG suggested that "in the light of the context and purpose of the CLP Regulation, the concept of 'intrinsic properties' must be interpreted broadly" (par.118) to include not only chemical composition, but also "hazards emanating from a specific form, physical state, characteristic or use" (par. 121). According to the AG, this broader interpretation would align with the Globally Harmonised System of Classification and Labelling of Chemicals (GHS) and the REACH Regulation4 (par. 131–138), as well as with earlier case law - specifically, the Nickel Institute and Etimine cases ( par.143)5.
As a result, the AG maintained that even if harmful effects arise only under certain exposure conditions - such as high inhalation levels or particle accumulation – these characteristics may still qualify as intrinsic properties. Excluding them would undermine the Regulation's objective of ensuring a high level of protection of human health (par. 122–125). This approach seemed to shift the focus away from the substance's inherent characteristics toward more generic and non-substance-specific effects.
iii. the General Court wrongly introduced the concept of "decisiveness" into its legal evaluation, as it is contrary to the "weight of evidence" approach under the CLP Regulation (par. 156-164).
More specifically, the AG thought that "the 'weight of evidence' determination constitutes an approach that requires that all available information bearing on the determination of hazard be considered together" (par. 158). However, according to the AG, the concept of decisiveness "implies the determinative nature of one piece of evidence over another" and "does not appear in the CLP Regulation" (par. 160). In fact, it "is antagonistic to the very idea of weighing different pieces of evidence against one another to determine– also in view of the objective of the CLP Regulation– a high level of protection of human health" (par. 161). However, by opposing the possibility of treating any single piece of evidence as decisive, the AG arguably seems to have interpreted the "weight of evidence" approach in a way that risks flattening distinctions among studies - potentially edging toward an 'equal weight of evidence' interpretation, a constraint not expressly found in the CLP Regulation.
In this context, the AG proposed that the ECJ set aside the General Court's judgment of 2022 and refer the case back to it for the resolution of the remaining pleas in law.
Implications for the industry if the AG Opinion had been upheld
Had the AG Opinion been (fully) upheld by the ECJ (which was unlikely), the implications for the industry would have been significant. Indeed, the AG's approach seemed to suggest a much broader discretion for the RAC and the Commission, and a narrower scope of judicial review by the EU Courts.
Therefore, an ECJ ruling upholding this approach would significantly raise the bar for challenging EU regulatory decisions, making it harder for industry stakeholders to contest future RAC opinions adopted by the Commission. Under the AG's reasoning, EU Courts would be limited to a formalistic and superficial check of the EU authorities' procedural compliance, rather than conducting a meaningful review of how the authorities reached their conclusions. Three points support this view.
First, beyond citing scientific uncertainty, the AG did not explain why she believed that the RAC had objectively considered all relevant factors, although she acknowledged that the RAC's explanation was "insufficient". Second, by dismissing the idea that some evidence can be decisive, she limited the Courts' ability to focus on how the authorities had assessed critical evidence. Third, the standard implicitly suggested by the AG was that the authorities' reasoning need only avoid being "scientifically impossible" — a threshold so high it arguably renders judicial review largely ineffective.
Finally, beyond a procedural impact, the AG Opinion could have reshaped the substantive hazard classification criteria by including harmful effects arising from physical form, particle size, or use, even where these effects are generic and not substance-specific. This would limit the companies' ability to argue such effects are not intrinsic, further limiting the avenues for legal challenge.
In this context, and as the AG Opinion is merely advisory, an ECJ ruling on titanium dioxide was awaited to clarify these matters.
The ECJ's final word
In a significant win for the industry, the ECJ's final judgment of 1 August 2025 dismissed the appeals and largely diverged from the AG's recommendations. On the contrary, it upheld the General Court's annulment of the Commission's classification of titanium dioxide as a suspected human carcinogen. In particular, in relevant parts the ECJ found that:
- the RAC failed to demonstrate that it had taken all relevant factors into account when assessing the scientific evidence. The ECJ thought as follows: albeit enjoying broad discretion, which implies limited judicial review, EU authorities "must be able to show before the Courts of the European Union that (...) they actually exercised their discretion"by considering "all the relevant factors and circumstances of the situation" (par. 107).
However, in this case, "the RAC Opinion contained nothing which would have enabled the General Court to conclude that that committee had effectively exercised its discretion and duly taken into consideration that agglomeration phenomenon in order to decide that it was necessary (...) to adopt (...) the standard value of primary particles oftitanium dioxide" (par.121).Moreover, scientific uncertainties(relating to the agglomeration phenomenon and the density oftitanium dioxideparticles) could not relieve the RAC of that obligation nor prevent the General Court from verifying whether the RAC had fulfilled it (par.123).
Therefore, the ECJ ruled that, although the General Court was wrong to "substitute its own findings (...) for those of the competent authorities" on the appropriate density value (par. 116), it was correct in "holding that the RAC had failed to take into account all the relevant factors in order to calculate the lung overload for (...) the Heinrich study" (par. 125). Accordingly, the General Court's decision was well founded and required only a 'substitution of grounds'(par. 117).
In this context, the ECJ partly agreed with the AG that the General Court wrongly replaced the RAC's judgment on the standard density value but disagreed that this error warranted annulment of the General Court's decision. The ECJ also emphasized the RAC's duty to provide reviewable reasoning in its decisions and did not comment on the AG's argument on the standard of scientific impossibility (par. 99 of the Opinion).
- the concept of decisiveness is compatible with the 'weight of evidence'approach under the CLP Regulation. Specifically, the ECJ confirmed that the "weight of evidence" approach under Annex I to the CLP Regulation permits the RAC to assign "more weight to some of the evidence over other evidence" when determining the classification of a substance (par. 83). It also clarified that, by classifying the Heinrich study as a 'decisive study', "the General Court did not (...) 'disregard' all the other evidence taken into account by the RAC" (par. 84).
Finally, the ECJ found that, based on the wording used in the RAC Opinion, "the Morrow calculation played a decisive role" in concluding that the Heinrich study was reliable and acceptable, with the result that the General Court was not wrong to classify that calculation as 'decisive' (par.95). In this context, the ECJ directly contradicted the AG's position on decisiveness.
iii. the appeals based on the "intrinsic properties" reasoning were ineffective. As the ECJ explained, the General Court had discussed the concept only "for the sake of completeness" after ruling on the main complaint – namely, manifest errors of assessment as regards the Heinrich study (par. 134-137). As a result, the ECJ did not have to take a position on whether the General Court correctly interpreted the concept of "intrinsic properties" or on its earlier rulings in the Nickel Institute and Etimine cases.
What the ECJ ruling on titanium dioxide means for the industry
With the EU industry under increasing pressure and a broad political consensus that action is urgently needed to revive its competitiveness, the ECJ judgment on titanium dioxide seems timelier than ever. Its positive impact goes well beyond titanium dioxide or the chemical sector, as it influences how EU authorities approach decision-making processes more generally.
Regarding titanium dioxide, the annulment of its classification means that there is no longer a legal requirement to classify and label certain powder forms of TiO₂ as suspected carcinogens. As a result, this prevents further regulatory consequences, such as potential bans or restrictions on the use of the substance.
Beyond titanium dioxide, this ruling sets an important precedent for how the EU authorities should assess other comparable active substances. More broadly, it offers the following key takeaways for the EU decision-making processes that extend beyond the chemical sector:
- First and foremost, it reaffirms the EU Courts' power to review the EU authorities' decisions, making it clear that scientific uncertainty alone cannot be used as a blanket justification for decisions that have significant repercussions for the industry. The authorities must provide sound, evidence-based reasoning that can be meaningfully reviewed by the EU Courts.
- Second, it promotes transparency and accountability by requiring the authorities to objectively evaluate all relevant facts and clearly explain how they exercised their discretion in doing so.
- Ultimately, by fostering more transparent, sound, and reviewable EU regulatory processes, the ECJ ruling on titanium dioxide safeguards an essential condition for increasing investors' confidence and enabling the industry to innovate, compete, enter, and remain in the European market.
For further information and assistance regarding this judgment and its potential implications, please contact our EU Regulatory team: Koen Van Maldegem, Maud Grunchard, Simon Englebert, Andromachi Kila.
Footnotes
1. See CURIA - Documents.
2. See CURIA - Documents.
3. See CURIA - Documents.
4. See Regulation - 1907/2006 - EN - REACH - EUR-Lex.
5. The General Court had concluded that "the classifications of nickel, lead and their respective powders are not comparable to that of titanium dioxide, of which only particles of a certain size, but not the solid substance, are subject to the contested classification and labelling, which, moreover, relate to a different health hazard class" (par. 173 of the General Court's judgment).
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