Implementation of the CLP Regulation

Implementation of the CLP Regulation

Implementation of the CLP Regulation

Classification for Portland cement clinker and common cements

31 January 2011

Introduction

The new Regulation on classification, labelling and packaging of substances and mixtures (CLP, Regulation 1272/2008) requires substances and mixtures to be classified for a number of hazardous properties, the so-called hazard classes or endpoints. There are three categories of hazard classes: physical hazards, health hazards and environmental hazards.

In order to correctly classify a substance or mixture, the manufacturer or importer has to take into account all available information (amongst othersnew data generated from tests in accordance with the CLP; epidemiological data and human experience data, such as occupational data and data from accident databases; or information generated under REACH). There is no obligation to carry out new tests for the health hazards or environmental hazards for endpoints for which information is missing. However, for physical hazards, the tests have to be carried out if no information is available.

Classifying substances in accordance with the new classification under the CLP Regulation is mandatory as of 1 December 2010. Mixtures need to be classified according to the CLP as of 1 June 2015, but they can be classified according to the CLP prior to this date. The CEMBUREAU Board decided that the new classification for common cements under the CLP Regulation should be used as of 1 December 2012.

The first two sections of this document contain the classification and labelling for Portland cement clinker and common cements as agreed by the CEMBUREAU Board on 28 September 2010. The lastsection contains a table with for each endpoint/hazard class, the source of the information and an argumentation used to derive the classification.

A“-”in a cell”means that an assessment was made and the data is sufficient to conclude that no classification is necessary for the specific endpoint.

The full set of studies used for the classification (and also referred to in the templates for the SDS for Portland cement clinker and common cements (T16579 and T16580) are available on CEMBUREAU’s extranet. The pictograms used for the pictogram which shows the Personal Protective Equipment recommended to work with cement are also available from the extranet.

The text of the CLP Regulation can be downloaded here: (Regulation (EC) No 1272/2008

More information about the CLP Regulation can be found from ECHA’s website:

The graph below gives an overview of the timelines for the application of the CLP Regulation (

  1. Classification and labelling elements for Portland cement clinker

Classification Portland cement clinker

Hazard class / Hazard category / Classification procedure
Skin irritation / 2 / On the basis of test data
Serious eye damage/eye irritation / 1 / On the basis of test data
Skin sensitisation / 1 / On the basis of literature survey
Specific target organ toxicity single exposure respiratory tract irritation / 3 / On the basis of literature survey

Note: CEMBUREAU will carry out the notification of the classification of Portland cement clinker for the companies in the CEMBUREAU membership if these companies which so. For more information, contact your national association or the CEMBUREAU Secretariat ().

Label Portland cement clinker

The label is to be drafted in the language of the country where the clinker is placed on the market (unless the MS provides otherwise). More than one language may be used on a label, but the same details need to appear in all languages used and the statements have to be grouped per language. For packaging between 3 and 50 litres, the label is to be at least 74*105 mm in size and for packaging between 50 and 500 litres, the label is to be at least 105*148 mmin size. Each hazard pictogram shall cover at least one fifteenth of the label surface and be at least 1 cm² large (CLP Annex I 1.2)

If the Portland cement clinker is provided in bulk (unpackaged), the labelling information and other relevant hazard information is provided through other means than a label, usually the Safety Data Sheet. If the clinker is provided to the general public, a copy of the label elements is to be provided.

For clinker sold to the general public, the following two precautionary statements should be added:

Keep out of reach of children

Dispose of contents/container to appropriate waste collection point

The nominal quantity of the Portland cement clinker in the packages made available to the general public has to be provided on the label, unless this quantity is specified elsewhere on the package.

Special packaging requirements

Not applicable

  1. Classification and labelling elements for Common cements

Classification common cements

Hazard class / Hazard category / Classification procedure
Skin irritation / 2 / On the basis of test data
Serious eye damage/eye irritation / 1 / On the basis of test data
Skin sensitisation / 1 / On the basis of literature survey
Specific target organ toxicity single exposure respiratory tract irritation / 3 / On the basis of literature survey

Label common cements


The label is to be drafted in the language of the country where the cement is placed on the market (unless the MS provides otherwise). More than one language may be used on a label, but the same details need to appear in all languages used and the statements have to be grouped per language. For packaging between 3 and 50 litres, the label is to be at least 74*105 mm in size and for packaging between 50 and 500 litres, the label is to be at least 105*148 mm in size. Each hazard pictogram shall cover at least one fifteenth of the label surface and be at least 1 cm² wide (CLP Annex I 1.2)

If the cement is provided in bulk (unpackaged), the labelling information and other relevant hazard information is provided through other means than a label, usually through the Safety Data Sheet. However, if the bulk cement is provided to the general public, a copy of the label elements is to be added.

The following pictogram should be added on the bags of cement (but not included in the label itself).

Supplemental information (1)

Unless cements or cement mixtures are already classified and labelled as a sensitiser with the hazard statement H317, ‘May cause an allergic skin reaction’, the label on the packaging of cements and cement mixtures that contain, when they are hydrated, more than 0,0002 % soluble chromium (VI) of the total dry weight of the cement shall bear the statement:

EUH203 — ‘Contains chromium (VI). May produce an allergic reaction’

If reducing agents are used, then the packaging of cement or cement-containing mixtures shall include information on the packing 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 %.

T17105/IC1 of 1931 January 2011

  1. Basis for the classification of Portland cement clinker and common cements

The studies referred to below can be downloaded from CEMBUREAU’s extranet “Cindi”.

Hazard class / Category / Reference / Argumentation
Portland cement clinker
Physical hazards
Explosives / - / Clinker is not explosive or pyrotechnic as it is not in itself capable by chemical reaction of producing gas at such temperature and pressure and at such a speed as to cause damage to the surroundings. It is not capable of a self-sustaining exothermic chemical reaction.
Flammable gases / - / Clinker is not a gas
Flammable aerosols / - / Clinker is not used as an aerosol
Oxidising gases / - / Clinker is not a gas
Gases under pressure / - / Clinker is not a gas
Flammable Liquids / - / Clinker is not a liquid
Flammable solids / - / Clinker is inorganic and commonly known not to be flammable. It is not readily combustible or does not cause or contribute to fire through friction
Self-reactive substances and mixtures / - / Clinker is not self-reactive. It is not thermally unstable or is not liable to undergo a strong exothermic decomposition even when devoid participation of oxygen (air).
Pyrophoric liquids / - / Clinker is not a liquid
Pyrophoric solids / - / Clinker is not pyrophoric. It does not ignite within five minutes after coming into contact with air.
Self-heating substances and mixtures / - / Clinker is not self-heating. It is not liable to self-heat by reaction with air and without energy supply.
Substances and mixtures which in contact with water emit flammable gases / - / Clinker in contact with water does not emit flammable gases
Oxidising liquids / - / Clinker is not a liquid
Oxidising solids / - / Clinker is not oxidising as it does not cause or contribute to the combustion of other materials.
Organic peroxides / - / Clinker is not an organic substance and it does not contain the bivalent –O-O– structure
Corrosive to metals / - / TNO report MT-RAP-10-00166, Corrosive to aluminium test in extract water of “Portland cement clinker”, May 2010 / Portland cement clinker is not corrosive to steel. Steel is used as concrete reinforcement element and it is commonly known that cement protects the steel by passivation. Portland cement clinker is the main ingredient of cement.
Portland cement clinker is not corrosive to aluminium, but the extract water from a 1:1 ground clinker mixture did cause more than 13.5% of mass loss in aluminium specimens. Therefore, wet Portland cement mixtures should not be brought into contact with aluminium.
P. 185 of the guidance document on the CLP application states that the testing procedure for this endpoint, in particular for solids which become liquids, requires further work by the Committees in charge of developing test methods under the UN GHS program.
Hazard class / Category / Reference / Argumentation
Health hazards
Acute toxicity dermal route / - / Observations on the effects of skin irritation caused by cement, Kietzman et al, Dermatosen, 47, 5, 184-189 (1999) / Limit test, rabbit, 24 hours contact, 2,000mg/kg body weight – no lethality. Cement used in study is Portland cement with over 90% of Portland cement clinker
Acute toxicity inhalation route / - / TNO report V8801/02, An acute (4-hour) inhalation toxicity study with Portland Cement Clinker CLP/GHS 03-2010-fine in rats, August 2010 / No acute toxicity by inhalation observed
Acute toxicity oral route / - / See Annex / No indication of oral toxicity from studies with cement kiln dust. Cement kiln dust contains Portland cement clinker in varying amounts
Skin irritation / 2 / Observations on the effects of skin irritation caused by cement, Kietzman et al, Dermatosen, 47, 5, 184-189 (1999)
Human experience / Portland cement clinker in contact with wet skin may cause thickening, cracking or fissuring of the skin. Prolonged contact in combination with abrasion may cause severe burns. Cement used in the study is Portland cement with over 90% Portland cement clinker.
Serious eye damage/eye irritation / 1 / TNO report V8815/09, Evaluation of eye irritation potential of cement clinker G in vitro using the isolated chicken eye test, April 2010
TNO report V8815/10, Evaluation of eye irritation potential of cement clinker W in vitro using the isolated chicken eye test, April 2010 / Portland cement clinker caused a mixed picture of corneal effects and the calculated irritation index was 128. This means that Portland cement clinker is classified as category1
Skin sensitisation / 1 / Epidemiological assessment of the occurrence of allergic dermatitis in workers in the construction industry related to the content of Cr(VI) in cement, NIOH, Page 11, 2003.
European Commission’s Scientific Committee on Toxicology, Ecotoxicology and the Environment (SCTEE) opinion of the risks to health from Cr (VI) in cement (European Commission, 2002). / Some individuals may develop eczema upon exposure to wet clinker dust, caused either by the high pH which induces irritant contact dermatitis after prolonged contact, or by an immunological reaction to soluble Cr (VI) which elicits allergic contact dermatitis.
Respiratory sensitisation / - / Portland Cement Dust - Hazard assessment document EH75/7, UK Health and Safety Executive, 2006. Available from: / There is no indication of sensitisation of the respiratory system
Germ cell mutagenicity / - / Investigation of the cytotoxic and proinflammatory effects of cement dusts in rat alveolar macrophages, Van Berlo et al, Chem. Res. Toxicol., 2009 Sept; 22(9):1548-58
Cytotoxicity and genotoxicity of cement dusts in A549 human epithelial lung cells in vitro; Gminski et al, Abstract DGPT conference Mainz, 2008 / No indication
Carcinogenicity / - / Portland Cement Dust - Hazard assessment document EH75/7, UK Health and Safety Executive, 2006. Available from:
Comments on a recommendation from the American Conference of Governmental Industrial Hygienists to change the threshold limit value for Portland cement, Patrick A. Hessel and John F. Gamble, EpiLung Consulting, June 2008 / No causal association has been established between Portland cement exposure and cancer.
The epidemiological literature does not support the designation of Portland cement as a suspected human carcinogen
Portland cement is not classifiable as a human carcinogen (According to ACGIH A4: Agents that cause concern that they could be carcinogenic for humans but which cannot be assessed conclusively because of a lack of data. In vitro or animal studies do not provide indications of carcinogenicity that are sufficient to classify the agent with one of the other notations.).
Portland cement contains over 90% Portland cement clinker
Reproductive toxicity / - / No evidence from human experience
Specific target organ toxicity single exposure respiratory tract irritation / 3 / Portland Cement Dust - Hazard assessment document EH75/7, UK Health and Safety Executive, 2006. Available from: / Portland Cement clinker dust may irritate the throat and respiratory tract. Coughing, sneezing, and shortness of breath may occur following exposures in excess of occupational exposure limits.
Overall, the pattern of evidence clearly indicates that occupational exposure to cement dust has produced deficits in respiratory function. However, evidence available at the present time is insufficient to establish with any confidence the dose-response relationship for these effects.
Specific target organ toxicity (STOT) repeated exposure respiratory tract irritation / - / Prospective monitoring of exposure and lung function among cement workers, Interim report of the study after the data collection of Phase I-II 2006-2010, Hilde Notø, Helge Kjuus, Marit Skogstad and Karl-Christian Nordby, National Institute of Occupational Health, Oslo, Norway, March 2010, / There is an indication of COPD. The effects are acute and due to high exposures. No chronic effects or effects at low concentration have been observed.
Aspiration hazard / - / Not applicable as Portland cement clinker is not used as an aerosol.
Environmental hazards
Hazardous to the aquatic environment / - / (1)U.S. EPA, Short-term Methods for Estimating the Chronic Toxicity of Effluents and Receiving Waters to Freshwater Organisms, 3rd ed. EPA/600/7-91/002, Environmental Monitoring and Support Laboratory, U.S. EPA, Cincinnati, OH (1994a) and 4th ed. EPA-821-R-02-013, US EPA, office of water, Washington D.C. (2002).
(2)U.S. EPA, Methods for Measuring the Acute Toxicity of Effluents and Receiving Waters to Freshwater and Marine Organisms, 4th ed. EPA/600/4-90/027F, Environmental Monitoring and Support Laboratory, U.S. EPA, Cincinnati, OH (1993) and 5th ed. EPA-821-R-02-012, US EPA, office of water, Washington D.C. (2002).
(3)Environmental Impact of Construction and Repair Materials on Surface and Ground Waters. Summary of Methodology, Laboratory Results, and Model Development. NCHRP report 448, National Academy Press, Washington, D.C., 2001.
(4)Final report Sediment Phase Toxicity Test Results with Corophium volutator for Portland clinker prepared for Norcem A.S. by AnalyCen Ecotox AS, 2007. / Ecotoxicological tests with Portland cement on Daphnia magna (1) and Selenastrum coli (2) have shown little toxicological impact. Therefore LC50and EC50 values could not be determined (3). There is no indication of sediment phase toxicity (4). The cement used for the test contains over 90% Portland cement clinker.
Hazardous to the ozone layer / - / Not applicable

Common cements may contain varying quantities of Portland cement clinker, Fly ash, Blast furnace slag, Calcium sulfate, Natural pozzolans, Burnt shale, Silica fume or Limestone.

None of these substances influence the above given classification (do not give rise to a more severe classification).

Hazard class / Category / Reference / Argumentation
Common cements
Physical hazards
Explosives / - / Cement is not explosive or pyrotechnic as it is not in itself capable by chemical reaction of producing gas at such temperature and pressure and at such a speed as to cause damage to the surroundings. It is not capable of a self-sustaining exothermic chemical reaction.
Flammable gases / - / Cement is not a gas
Flammable aerosols / - / Cement is not used as an aerosol
Oxidising gases / - / Cement is not agas
Gases under pressure / - / Cement is not a gas
Flammable Liquids / - / Cement is not flammable liquid
Flammable solids / - / Cement is inorganic and commonly known not to be flammable. It is not readily combustible or does not cause or contribute to fire through friction
Self-reactive substances and mixtures / - / Cement is not self-reactive. It is not thermally unstable or is not liable to undergo a strong exothermic decomposition even when devoid participation of oxygen (air).
Pyrophoric liquids / - / Cement is not a liquid
Pyrophoric solids / - / Cement is not pyrophoric. It does not ignite within five minutes after coming into contact with air.
Self-heating substances and mixtures / - / Cement is not self-heating. It is not liable to self-heat by reaction with air and without energy supply.
Substances and mixtures which in contact with water emit flammable gases / - / Cement in contact with water does not emit flammable gases
Oxidising liquids / - / Cement is not a liquid
Oxidising solids / - / Cement is not oxidising (does not cause combustion)
Organic peroxides / - / Cement is not an organic substance and it does not contain the bivalent –O-O- structure
Corrosive to metals / - / TNO report MT-RAP-10-00166, Corrosive to aluminium test in extract water of “Portland cement clinker”, May 2010 / Common cements contain varying quantities of Portland cement clinker, fly ash, blast furnace slag, gypsum, natural pozzolans, burnt shale, silica fume and limestone.
Portland cement clinker is not corrosive to steel. Steel is used as concrete reinforcement element and it is commonly known that cement protects the steel by passivation.
Portland cement clinker is not corrosive to aluminium, but the extract water from a 1:1 ground clinker mixture did cause more than 13.5% of mass loss in aluminium specimens. Therefore, wet Portland cement mixtures should not be brought into contact with aluminium.
The other ingredients in common cements are not corrosive to metals.
P. 185 of the guidance document on the CLP application states that the testing procedure for this endpoint, in particular for solids which become liquids, requires further work by the Committees in charge of developing test methods under the UN GHS program.