Ref. Ares(2019)3792554 - 13/06/2019
29. November 2018
Inter-Service Consultation
on the 14th ATP list to the Annex VI of Regulation (EC) No 1272/2008
Dear Commissioner Vella,
The European Commission services have started an Inter-Service Consultation with the aim
to update Annex VI (Harmonised classification and labelling for certain hazardous
substances) of Regulation (EC) No 1272/2008 for a total of 20 substances. We write to you
concerning the substance
titanium dioxide (TiO2) which is included in this list. The
industries represented by the signatory associations are users of TiO2. We believe that the
hazard that has been observed with this substance should not follow the way of an Annex VI
entry and we have for that the following reasons:
TiO2 is safe for consumers and has a societal function
TiO2 is a chemically inert white powder that is widely used as pigment in products like paints,
inks, plastics but also in many other industries such as paper, construction, glass, steel,
pharmaceutical, cosmetics, leather, and textiles. It is used in any product that needs
whitening. TiO2 provides the highest opacity by far and has no equivalent technical
replacement. The substance is an ingredient that is incorporated during manufacturing into
these end-products. Consumers buy these end-products and have no access to the powder
form of TiO2.
The proposed classification broadens the scope of the regulation considerably
It is proposed to classify TiO2 as Carcinogenic Cat. 2 ‘suspected of causing cancer by
inhalation’. The observed toxicological effect result is not specific to the substance but to the
overload mechanism that can be observed with any inert dust. A classification of TiO2 will
put dust effects into the scope of the regulation and thereby sets a precedent for roughly 300
substances with similar dust effects.
There are existing safeguards for workers against dust
Relevant dust levels of TiO2 will only occur at the workplace where rules on occupational
safety have to be followed. With no hazard for the consumer we consider a classification
inappropriate. Warning the European citizen for inhalation of TiO2 dust is ineffective or even
misleading, because it is incorporated in the mixtures and lung overload is irrelevant.
Exempting mixtures from classification would prevent at least this nuisance.
Unintended consequences by a classification: no recyclability for millions of products
Following the proposed classification, products at end of life or left-over that contain 1% or
more of titanium dioxide would have to be considered as hazardous waste and could not be
used for recycling. Other legislation would ban products that contain TiO2. Under the toy
safety directive most colours would be banned from school-paint boxes. To mitigate these
impacts the European Commission services consider exemptions.
Alternatives for a way forward have not been fully explored
After expert meetings (CARACAL & REACH Committee)
a considerable number of
Member States remain with an objection to a classification according Annex VI. They
point to non-existing exposure for consumers and extensive negative consequences for
mixtures and articles that use TiO2.
The Member States that object to a harmonised classification are in favour of a discussion
on exposure levels for workers and consider occupational dust limits as the more
appropriate instrument. Such alternative proposal has been tabled by Germany. It has no
effect on downstream legislation and establishes safeguards where needed.
By using an Annex VI entry for TiO2, the scope of the regulation would be broadened to
roughly 300 substances which may be expected to show similar overload dust effects. If
such inert dusts were subject to the rules for Occupational Health it would be a lot more
effective and proportionate. Even with ‘mixture exemptions’ the downstream legislation has
to be adapted with every next such substance.
Our request
We call on you to take note of the reasons mentioned here in evaluating the Annex VI entry
of TiO2 during this Inter-Service Consultation.
We remain at your disposal for any further discussion with you and your services.
Yours sincerely,
Jan van der Meulen
Dr. Martin Kanert
Managing Director, European Council of
Executive Manager, European Printing Ink
the Paint, Printing Ink and Artists' Colours
Association (EuPIA)
Industry (CEPE)
Antonio Caballero González
Alexandre Dangis
General Secretary, European Mortar
Managing Director, European Plastics
Industry Organization (EMO)
Converters (EuPC)
Mauro Scalia
Dr. Roger Doome
Director Sustainable Businesses,
Secretary General, Industrial Minerals
European Apparel and Textile
Association – Europe (IMA-Europe)
Confederation (EURATEX)
Philip Bruce
Dr. Alberto Arnavas
Managing Director, Association of the
Director General, European Federation for
European Adhesive & Sealant Industry
Construction Chemicals (EFCC)
(FEICA)
Patrizia di Mauro
John Dixon
Secretary General, International
Director Regulatory Affairs,
Association of Painting Contractors
Flexible Packaging Europe (FPE)
(UNIEP)
Gustavo Gonzalez-Quijano
Bjoern-Markus Sude
Secretary General, The European Leather
Director, I&P Europe Imaging & Printing
Association (COTANCE)
Association (I&P Europe)
Beatrice Klose
Susan Hancock
Secretary General, European Federation
Secretary General, European Lubricant
for Print & Digital Communication
Association (ATIEL)
(INTERGRAF)
Dr. Wilhelm Rauch
Business Manager, Industrievereinigung
Chemiefaser e.V. (IVC)