ChemRegs Newsletter – February 2020

14th ATP to CLP Published

The European Commission has now published the 14th ATP to the CLP Regulation.

The harmonised classification and labelling of hazardous substances (contained in Annex VI of the CLP Regulation) is updated through an “Adaptation to Technical Progress (ATP)” adopted yearly by the Commission, following the opinion of the Committee for Risk Assessment (RAC). Other changes to CLP may also be implemented through an ATP.

The 14th ATP is officially known as “Commission Delegated Regulation (EU) 2020/217 of 4 October 2019 amending, for the purposes of its adaptation to technical and scientific progress, Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures and correcting that Regulation (Text with EEA relevance)”.

Although this was adopted on 4 October 2019, it has just only just been been published (18 February 2020) in the Official Journal of the European Union. Once published, it enters into force on the twentieth day following that of its publication (9 March 2020) but, apart the correction to pitch, coal tar, high temp., it only applies from 9 September 2021. 

The purpose of the 14th ATP is to amend Table 3 to Annex VI of the CLP Regulation by introducing new or revised entries for the harmonised classification and labelling of 28 substances and by removing 2 substances. The revised classifications include a carcinogen classification for cobalt metal and the controversial decision to classify titanium dioxide as a carcinogen category 2 by inhalation.

RAC proposed the controversial classification of titanium dioxide in its scientific opinion of 14 September 2017. As titanium dioxide-induced lung carcinogenicity is associated with inhalation of respirable titanium dioxide particles, retention and poor solubility of the particles in the lung, it was considered appropriate to define respirable titanium dioxide particles in the titanium dioxide entry. The deposited particles, but not solutes of titanium dioxide, are assumed to be responsible for the observed toxicity in the lung and subsequent tumour development.

The classification for titanium dioxide (CAS No 13463-67-7) will therefore apply to respirable TiO2 particles and the minimum classification of Carc. 2, H351 (inhalation) will need to be applied to the substance when it is in powder form containing 1% or more of particles with aerodynamic diameter ≤ 10 μm.

In order to avoid unjustified classification of non-hazardous forms of the substance, specific notes have been laid down for the classification and labelling of the substance and mixtures containing it. These are Notes V, W and 10.

• Note V: If the substance is to be placed on the market as fibres (with diameter < 3 μm, length > 5 μm and aspect ratio ≥ 3:1) or particles of the substance fulfilling the WHO fibre criteria or as particles with modified surface chemistry, their hazardous properties must be evaluated in accordance with Title II of this Regulation, to assess whether a higher category (Carc. 1B or 1A) and/or additional routes of exposure (oral or dermal) should be applied.
• Note W: It has been observed that the carcinogenic hazard of this substance arises when respirable dust is inhaled in quantities leading to significant impairment of particle clearance mechanisms in the lung. This note aims to describe the particular toxicity of the substance; it does not constitute a criterion for classification according to this Regulation.
• Note 10: The classification as a carcinogen by inhalation applies only to mixtures in powder form containing 1 % or more of titanium dioxide which is in the form of or incorporated in particles with aerodynamic diameter ≤ 10 μm.

In addition, as some hazardous dust or droplets could be formed during the use of mixtures containing titanium dioxide, it was considered necessary to inform the users of the precautionary measures that need to be taken to minimise the hazard for human health. This is to be done via the product label using new supplemental label statements:

• The label on the packaging of liquid mixtures containing 1 % or more of titanium dioxide particles with aerodynamic diameter equal to or below 10 μm shall bear the following statement: EUH211: ‘Warning! Hazardous respirable droplets may be formed when sprayed. Do not breathe spray or mist.’
• The label on the packaging of solid mixtures containing 1 % or more of titanium dioxide shall bear the following statement: EUH212: ‘Warning! Hazardous respirable dust may be formed when used. Do not breathe dust.’
• In addition, the label on the packaging of liquid and solid mixtures not intended for the general public and not classified as hazardous which are labelled with EUH211 or EUH212, shall bear statement EUH210. 

Titanium dioxide is used widely in a range of product types, including cosmetics and sun screens, paints, coatings, printing inks and plastics, and concerns have been raised over the potential negative impact that the harmonised classification and required label warnings will have.

The 14th ATP also includes the addition of harmonised ATE (Acute Toxicity Estimate) values for a number of substances and the classification of the substance pitch, coal tar, high temp. is corrected to address an administrative oversight in the 11th ATP.

It is recommended that you should review the 14th ATP to identify if any of your products are affected by the new harmonised classifications. Although these classifications are not mandatory until September 2021, suppliers can use them straight away. All CLP labels and REACH SDS will need to be updated by the deadline and the updated SDS will need to be provided to all recipients to whom the substance or mixture has been supplied within the preceding 12 months

The 14th ATP can be downloaded from:

https://eur-lex.europa.eu/legal-content/en/ALL/?uri=CELEX:32020R0217

Note – the 15th ATP to CLP is currently in draft form. This will also amend Table 3 of Annex VI to the CLP Regulation, by introducing new and revised entries for the harmonised classification and labelling of 60 substances and by deleting 2 entries.  It also amends Notes J to N, Note P and Note R in Part 1 of Annex VI. The final date for comments was 3 January 2020 and at present the publication in the Official Journal of the European Union is unknown.

Other News

WHO Guidance on Coronavirus

The World Health Organization (WHO) has published information and guidance regarding the current outbreak of coronavirus disease (COVID-19). This includes guidance for the public and for workers on how to protect themselves, contained in videos, FAQ, articles and downloadable posters.

The link is https://www.who.int/emergencies/diseases/novel-coronavirus-2019 

WHO has also made available a free E-Learning course that provides a general introduction to COVID-19 and emerging respiratory viruses. It is intended for public health professionals, incident managers and personnel working for the United Nations, international organizations and NGOs. This is available from  https://openwho.org/courses/introduction-to-ncov

HSE and Brexit

A third corrigendum to ADR 2019 has been published and is available for download from the UNECE website at https://www.unece.org/trans/danger/publi/adr/adr2019/19contentse.html

It is mostly editorial concerning minor changes to wording and corrections to mistakes.