When it comes to health and safety and communicating with downstream users, the most relevant legislative texts are as follows:
- REACH (Registration, Evaluation, Authorisation and Restrictions of Chemical substances), the role of which is to improve the protection of human health and the environment from the risks that can be posed by chemicals. Under REACH, every substance manufactured or imported in the EU above 1 tonne must be registered by the entity that imports or manufactures it, unless it is exempt from registration. Furthermore, there is an obligation to communicate upstream (towards suppliers) and downstream (to customers) on substances by means of Safety Data Sheets (SDS) and chemical safety reports as the case may be. SDS are the key tool for hazard and risk management communication in the supply chain, as defined by REACH.
- Classification, Labelling & Packaging (CLP) Regulation, which harmonises requirements concerning the classification, labelling and packaging of chemical substances and mixtures in line with the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) approved by the United Nations.
- In 2020, the European Commission published the EU’s chemicals strategy for sustainability towards a toxic-free environment under the Green Deal. Among 50 actions described within the Strategy, the revision of the regulation on CLP and the REACH with related initiatives were among those.
- On 19 December 2022, the Commission proposed a revised regulation on CLP and introduced new hazard classes. A public consultation on the proposal is open till 30 March 2023. The co-legislative process starts in 2023.
- The EC proposal on the revision of REACH regulation is foreseen with other related initiatives in 2023.
The cement industry fully complies with the obligations laid out in the REACH and the Classification, Labelling and Packaging (CLP) legislations whose aim is to protect human health and the environment.
Harmonised information relating to emergency health response – Annex VIII to CLP:
- According to Article 45 of the CLP Regulation, companies placing hazardous mixtures on the market are obliged to provide information about certain hazardous mixtures to the relevant national bodies. The national bodies make this information available to poison centres so that they can give advice to the citizens or medical personnel in the event of an emergency. Annex VIII to the CLP Regulation, adopted in March 2017, defines the harmonised requirements for poison centre notifications (PCN) applicable as of 1 January 2021. In addition, there is a grandfathering period until 1st January 2025 for importers and downstream users who have submitted information related to hazardous mixtures to a body appointed before the date of applicability.
- CEMBUREAU has advocated on workability issues for the cement sector and worked out on the ‘standard formulas’ approach for cement. The Commission delegated regulation C(2020) 5758 final included standard formulas for cement.
Clinker is a substance and is thus exempt from REACH registration. Nevertheless, it must be classified and labelled and a Safety Data Sheet (SDS) must be provided, if it is placed on the market, and this C&L has been notified to the European Chemicals Agency. Cement is a preparation and is therefore also not subject to REACH registration, although it must also be classified and labelled. Nevertheless, because it is a preparation, no C&L notification to ECHA is necessary. An SDS, possibly with an exposure scenario, must be provided. In terms of CLP, please refer to image for classification used by all CEMBUREAU members, for Portland cement clinker and common cements.
Furthermore, CEMBUREAU has prepared safety data sheet templates for its Members (covering both “Portland cement clinker” and “Common cements”) which take into account the REACH requirements. The (EU) 2020/878 Regulation amending Annex II of REACH was published in 2020 and entered into force.
Scientific studies have also shown that cement preparations containing chromium VI may cause allergic reactions in certain circumstances, if there is direct and prolonged contact with the human skin. All uses of cement bear the risk of direct and prolonged contact with the human skin, with the exception of controlled closed and totally automated processes, according to REACH Annex XVII, CLP Annex II and Directive 2003/53/EC and latterly common National helpdesk response in ECHA Q&A.
Chromium (VI) compounds generally are classified as skin sensitisation 1, and therefore the classification limit for mixtures containing these substances is 1 %. When the concentration of chromium (VI) is reduced to below 2 ppm (0,0002 %) of soluble chromium (VI) of the total dry weight of the cement, the concentration limit for classification as sensitising is unlikely to be reached, and thus the hazard statement H317 would not apply.
It should be noted that the cement mixture containing below 0,0002 % soluble chromium (VI) of the total dry weight of the cement would also not be subject to the labelling requirement set in point 2.3 of Part 2 of Annex II, regarding the statement EUH203.
Please note, however, that if reducing agents are used, then the packaging must include the information on the packaging date, the storage conditions and the storage period appropriate to maintaining the activity of the reducing agent and to keeping the content of soluble chromium VI below 0,0002 %.