SHE Matters: EU Court annuls Regulation on Titanium Dioxide

The EU General Court has recently annulled a Commission Delegated Regulation (Regulation (EU) 2020/217 which sought to amend the EU Classification Labelling and Packaging Regulation in relating to Titanium Dioxide by classifying it as a carcinogenic substance in its powdered form.

The applicants in the case were manufacturers, importers and users of Titanium Dioxide, and various trade associations of which they were members.

The background to the case was that in 2016, the European Chemicals Agency (ECHA) received a dossier from the French competent authority. The RAC (the Committee for Risk Assessment within ECHA) then adopted an opinion on classification. The Commission adopted the Regulation in question on the basis of the RAC opinion.

The applicants argued that the classification and labelling proposed under the legislation was vitiated by manifest errors of assessment, in particular regarding the acceptability and reliability of a study (known as the Heinrich study) on which the RAC opinion was based. The French authority had already considered this study was unreliable, as regards the rat population used for testing, and used a single excessive dose testing.

The applicants also claimed that the contested classification and labelling in the regulation were based on carcinogenicity due to the effects of a lung overload of titanium dioxide particles and that the RAC committed manifest errors in the assessment of the degree of lung overload which occurred during the Heinrich study by wrongly concluding that it was not excessive.

The Court held that:

The requirement to base the classification of a carcinogenic substance on reliable and acceptable studies (as required in CLP Regulation) was not satisfied.

In assuming that the results of the scientific study on which it based its opinion on the classification and labelling of Titanium Dioxide were sufficiently reliable, relevant and adequate for assessing the carcinogenic potential of that substance, the RAC committed a manifest error of assessment.

The Commission based the regulation on the RAC Opinion and followed its conclusions, and therefore made the same manifest error as the RAC.

There was a further “manifest error of assessment” because the labelling and classification of the substance did not relate to an “intrinsic property to cause cancer” as required by the relevant rules.

The ability of the Court to annul the Regulation in this case depended on there being one or more “manifest errors of assessment”.

Generally speaking, in the evaluation of scientific studies, as in carrying out any assessment or making a decision, EU institutions enjoy a broad discretion.

However, the (EU ) Courts may, under general principles of EU administrative law, intervene where there has been a “manifest error of assessment”. Under the case law this may take the form of:

1. Failure to assess the material facts of the case
2. Failure to take into account a relevant factor
3. Taking into account an irrelevant factor that distorted the analysis
4. Failure to satisfy the burden of proof (where this is relevant)

The Court annulled the offending Regulation, because in making it the Commission had adopted an opinion of the RAC, which in the view of the Court was based on two such “manifest errors of assessment”.

These proceedings represent a significant victory for the applicants,. The substance is used in a wide variety of products such as paints, coating materials, varnishes, plastics, laminated paper, cosmetics, medicinal products and toys. It would clearly have had significant adverse implications for manufacturers of those products if the substance had to be treated as intrinsically carcinogenic, if in fact it is only in very specific circumstances, which are highly unlikely to be relevant to the users of the products in question, that carcinogenic effects can be observed.

There may well be pressure for an appeal to be brought on the Titanium Dioxide case, as there would appear to be very strong feelings as regards the TD issue on the part of campaigners – commentators on this case have already sought to argue that the outcome was a result of industry lobbying. However, on the face of it the Court appears to have had very strong grounds for annulling the act in the case and accordingly the Commission may well seek to follow some other approach on that particular issue.