A group of NGOs has called on EU member states to propose a restriction on the use of titanium dioxide in consumer articles, based on REACH article 68(2).
The article provides a “simplified procedure” that can be applied when substances classified as carcinogenic, mutagenic or toxic for reproduction (CMR) could be used by consumers.
The standard restriction procedure of articles 69 to 73 requires preparation of an Annex XV dossier to initiate the restriction process, a public consultation, opinions by Echa committees and a consultation with the agency’s Enforcement Forum.
In a letter to REACH committee members, the NGOs urge the proposal in addition to a scheduled discussion at their meeting on 13 June on measures for the harmonised classification and labelling of the substance as a category 2 carcinogen.
The French authorities submitted an intention to propose a harmonised classification for titanium dioxide as a category 1B carcinogen in November 2015.
The European Environmental Bureau (EEB), the Health and Environment Alliance (HEAL); and the European Environmental Citizens Organisation for Standardisation (Ecos) say they are “deeply concerned” about recent industry lobbying to push the CLP regulation’s “purely scientific endeavour” to include socio-economic considerations, such as:
- market consequences of the decision;
- impact on the circular economy;
- claimed lack of alternatives; and
- even the indispensable ‘bright colours’ it provides.
They are also concerned that risk and exposure aspects are being considered when classification should be based solely on the hazards of the substance.
“The CLP process is a scientific hazard-based process where there is no room for these misleading risk or political considerations,” they say.
Additionally, a proposed derogation for the classification of titanium dioxide when suspended in a liquid – even for products that are sprayed and therefore may be inhaled and potentially cause cancer – is “worrying”, the NGOs say.
Such a derogation “is not supported by robust scientific data that demonstrates that a sprayed liquid or solid matrices containing titanium dioxide will undoubtedly not cause cancer”, they add. “On the contrary it seems logical that spray particles can in fact be very easily inhaled. For example, if paint is being sprayed, the possibility of intoxication by inhalation remains.”
In 2017 Echa’s Risk Assessment Committee (Rac) issued an Opinion on the hazard classification of all forms of titanium dioxide and proposed classification as a carcinogen category 2 through inhalation. The NGOs say there is “no reference at all to either powder or liquid form of [titanium dioxide], indeed the proposed classification applies to the overall chemical substance”.
As acknowledged by Rac, the NGOs add, titanium dioxide lung carcinogenicity is associated with inhalation of respirable particles. For this reason, Rac considers the toxicity profile observed as a basic property of inhaled and respirable particles of titanium dioxide. Therefore, the NGOs say, from a toxicological point of view (following the CLP regulation criteria) all inhalable forms of the substance “deserve a classification as carcinogen category 2 at the least”.
They urged member states to follow Rac’s opinion on the classification of the chemical and reject any derogation or limitation to the classification.
The NGOs refute arguments that workers are already protected through occupational health legislation and derived occupational exposure limits (OELs) and that consumers are not exposed. “There is extensive evidence that OELs are not protective for the nano forms and freelancers and artists are not covered by occupational legislation in the EU,” they say and give the example of consumers being put at risk by using spray paints and spray sunscreens containing the chemical.
The NGOs end their letter by warning that if the competent authorities do not follow Echa’s opinion, “a very bad precedent will be set as competent authorities will open the door for disregarding science in future”.