Ref. Ares(2020)5556052 - 15/10/2020
September and December 2018 REACH Committee meetings, the REACH Committee
discussed the draft Commission Regulation in February and March 2019.
Moreover, with regard to your concern that TiO2 classification will have negative effects on
the European chemical industry and the circular economy, please note that the classification
under CLP does not entail in itself any automatic restriction or banning of products
containing TiO2. Thus, when a substance is subject to harmonised classification only
labelling and packaging obligations are triggered. It is not excluded that the classification of
substances according to CLP may have consequences on other legislation (e.g. product
specific legislation). However, as the CLP classification is based only on a scientific
assessment of the hazardous properties of a substance, those potential consequences cannot
be addressed under the CLP but must be addressed under those other pieces of legislation. It
should also be emphasised that the most significant consequences occur for substances
classified as carcinogen category 1, rather than category 2.
In addition, regarding the impact assessment to which you refer in your letter, please note that
the Commission considers that such impact assessment is not necessary, either in the
framework of the harmonisation of classification in general or in the context of the 14th ATP
in particular. The CLP Regulation does not stipulate any obligation to perform an impact
assessment in the process of harmonised classification according to Article 37 of the
Regulation. More importantly, and regardless of any such obligation, it is considered that the
benchmark criterion of ‘significant impacts’, which is normally required for an impact
assessment to take place, is not relevant for the harmonised classification of substances under
the CLP Regulation. Indeed, the impacts in CLP Regulation of a new classification are
related mainly to labelling and packaging. Thus, as previously mentioned, when deciding on
the harmonised classification of a substance, any decision on harmonised classification
should solely rely on the hazardous properties of the substance, in line with the nature and the
spirit of the CLP Regulation, and not on the assessment of any potential impacts in other
legislation. Such potential downstream consequences of classification should be assessed in
the corresponding pieces of legislation or they are considered to have been assessed when
those pieces of legislation were adopted.
Finally, the Commission services are fully aware of the proposals made by different
stakeholders and Member States, including the Czech Republic, to only address the issue
under the workers protection legislation, through the establishment of EU occupational
exposure limits (OELs). However, the concerns with TiO2 - although mainly, but not
exclusively, a workers protection issue - pertain also to consumers, and, importantly, to the
self-employed, where occupational health and safety (OSH) legislation is not applicable and
where CLP would provide the necessary information to initiate the necessary actions to
ensure protection. It is important to know that CLP provides information on hazardous
properties of substances and mixtures and on basic safety measures to be taken (e.g. wear
gloves), while other pieces of legislations (e.g. REACH, OSH) provide more detailed risk
management measures to deal with specific hazard properties identified under CLP.
Harmonised classification and labelling according to CLP not only has a direct effect on
workers, self-employed professionals and consumers, it also has an indirect effect as it is the
basis for the development, in particular by industry, of more detailed or case-specific risk
management measures under REACH and OSH. Therefore, the Commission believes that the
CLP Regulation is the relevant legal instrument to address the overall human health concern
related to TiO2 that can be complemented by more specific legislation, including workers
protection legislation.
Yours sincerely,
(e-signed)
Kęstutis Sadauskas
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