GUIDELINES FOR THE SAFETY DATA SHEET TEMPLATE
FOR COMMON CEMENTS
31 March 2011
Introduction
In December 2008, a comprehensive new system for the classification, labelling and packaging of hazardous substances and mixtures entered into force in the EU (CLP Regulation). This new system has also induced changes in the safety datasheets for hazardous substances and mixtures.
This document contains guidelines and a new template for the SDS of common cements. It was drafted by CEMBUREAU H&S experts from national associations, companies and outside experts covering the following fields of expertise: toxicology, eco-toxicology, medicine, process technical knowledge, quality assurance, law, and industrial hygiene. Some experts followed specific training in developing SDS. As such, this group fulfils the definition of “competent person” as given in the ECHA guidance on the SDS.
The first part of this document contains explanations for some of the specific sections of the template for the SDS. The template itself is the second part of this document.
Mixtures must be classified, labelled and packaged according to the new CLP (Regulation (EC) No 1272/2008) as of 1 June 2015. Before that day, mixtures should be classified, labelled and packaged according to the Dangerous preparations Directive (Council Directive 67/548/EEC). However, manufacturers or importers may decide to follow the CLP Regulation prior to 1 June 2015. If this is the case, the SDS must also contain the classification under the old system of the Dangerous preparations Directive until 31 May 2015.
The CEMBUREAU Board decided to recommend to CEMBUREAU member companies that they should classify, label and package common cements according to the CLP Regulation as of 1 December 2012. Before that date, manufacturers or importers should classify, label and package common cements according to the Dangerous Preparations Directive and follow the previous version oftemplate for the SDS of common cements attached below:
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 (
Together with the new system for classification and labelling, a new SDS format was introduced by the legislator. It is given in the amended Annex II of REACH(Commission Regulation (EU) 453/2010).
The REACH Regulation itself can be downloaded from this web page.
ECHA is currently preparing a guidance document for the SDS. As soon as it is finalised, a link will be added here.
Explanations for some of the sections of the template SDS
The text between square brackets and in italic blue [text], contains instructions for the parts which need to be adapted by the manufacturer/importer.
1.1Product identifier
The identity of all substances in the mixture that contribute to the classification of the mixture as regards acute toxicity, skin corrosion or serious eye damage, germ cell mutagenicity, carcinogenicity, reproductive toxicity, respiratory or skin sensitisation, specific target organ toxicity (STOT) or aspiration hazard should be given. The following substances might need to be mentioned when present in the specific common cements:
Substance / EINECS / CAS / Endpoint from above listPortland cement clinker / 266-043-4* / 65997-15-1 / Serious eye damage, Skin sensitisation andSTOT SE
Oil Shale Thermal Processing Residue (Burnt oil shale) / Not assigned yet / 93685-99-5 / Serious eye damage, STOT RE and STOT SE
Flue dust from production of cement clinker / 270-659-9 / 68475-76-3 / Serious eye damage,Skin sensitisation and STOT SE
*Entry is called Cement, portlandchemicalsbut describes Portland cement clinker
1.2Relevant identified uses of the mixture and uses advised against
This section needs to be completed with the information from the ES of the substances in cement, subject to registration and for which a chemical safety assessment was made. See also the explanation under 16.5. If the information from the ES is not fully included in the SDS, the ES need to be added to the SDS as an annex to the SDS.
2.1.Classification of the substance or mixture
2.1.1According to Regulation (EC) No 1272/2008
CEMBUREAU recommends giving the full hazard and precautionary statements in this section, instead of referring to the full statements in section 16.
2.1.2According to Directive 1999/45/EC
This section must be included only until 31 May 2015. As of 1 June 2015, only the classification according to Regulation (EC) No 1272/2008 shall be given.
2.2.Label elements
The label elements given in this section must be consistent with the label affixed to the product.
Hence, the label elements according to the CLP Regulation must be given as of the date on which the cement is classified according to that Regulation (1 December 2012 date agreed by the CEMBUREAU Board).
Until that date, this section must contain the label elements according to the Dangerous Preparations Directive (Directive 1999/45/EC).
2.2.1According to Regulation (EC) No 1272/2008
P501 Dispose of contents/container to ... in accordance withlocal/regional/national/international regulation(to be specified).
This sentence needs to be completed by manufacturer/importer with the requirements in accordance with local/regional/national/ international regulation, eg, through the national implementation of Directive 2004/12/EC on packaging and packaging waste, amending Directive 94/62/EC or other measures.
If the nominal quantity of common cements in the package is not mentioned on the package made available to the general public, then the manufacturer/importer must mention this quantity on the label. In the latter case, the quantity must also be added to the section 2.2.1 of the SDS as one of the labelling elements.
“H317 May cause an allergic skin reaction” is not used in Germany as the German authorities did not accept this to be used for chromate reduced cements.
Supplemental information to be added by the manufacturer/importer as applicable
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 % of the total dry weight of the cement ready for use.
3.2.Mixtures
This subsection should list all the substances in the specific cement (including reducing agents and other chemical additives):
a)Which present a health or environmental hazard and present in cement in concentrations above the concentrations given in the table below:
Hazard class and categories of the substance / Threshold (% w/w)Acute toxicity Cat. 1. 2 and 3 / ≥ 0.1%
Acute toxicity Cat. 4 / ≥ 1.0%
Skin corrosion/irritation Cat. 1A, 1B, 1C and 2 / ≥ 1.0%
Serious damage to eyes/eye irritation Cat. 1 and 2 / ≥ 1.0%
Sensitisation (skin and respiratory tract) / ≥ 0.1%
Germ cell mutagenicity 1A and 1B / ≥ 0.1%
Germ cell mutagenicity Cat. 2 / ≥ 1%
Carcinogenicity Cat. 1A, 1B and 2 / ≥ 0.1%
Reproductive toxicity Cat. 1A, 1B, 2 and effects via or on lactation / ≥ 0.1%
STOT SE Cat. 1 and 2 / ≥ 1.0%
STOT RE Cat. 1 and 2 / ≥ 1.0%
Aspiration hazard / ≥ 10.0%
Acute aquatic toxicity Cat.1 / ≥0.1%
Chronic aquatic toxicity Cat. 1 / ≥0.1%
Chronic aquatic toxicity Cat. 2, 3 and 4 / ≥ 1.0%
Hazardous for the ozone layer / ≥ 0.1%
b)For which there are Community workplace exposure limits, not already included under a),
c) Which are PBT or vPvB in accordance with the criteria set out in Annex XIII to REACH Regulation
The product identifier, concentration or concentration ranges and classification shall be provided in descending order.
The table below contains an indicative list of substance to be listed in this section, but the manufacturer/importer needs to adapt it to his specific cement:
Substance / Conc. range (W/W in cement) / Regis-tration number° / EINECS / CAS / Classification 67/548/EEC / Classification Regulation 1272/2008Symb. [C&L] / R / Hazard class, category / Hazard statement
Portland cement clinker / 5-100% / Not applicable / 266-043-4 / 65997-15-1 / Xi / R37 / STOT SE 3 / H335: May cause respiratory irritation
R38 / Skin irritation 2 / H315: Causes skin irritation
R41 / Serious eye damage/eye irritation 1 / H318: Causes serious eye damage
R43 / Skin sensi-tisation 1 / H317: May cause an allergic skin reaction
Oil Shale Thermal Processing Residue (Burnt oil shale)* / 6-35%‡ / 01-2119703178-42-XXXX / Not attributed yet / 93685-99-5 / Xn / R48/20 / STOT RE 2 / H373: May cause damage to lung through prolonged or repeated exposure by inhalation
R37 / STOT SE 3 / H335: May cause respiratory irritation
R41 / Serious eye damage/eye irritation 1 / H318: Causes serious eye damage
Flue dust from production of cement clinker / 0-5% / 01-2119486767-17-XXXX / 270-659-9 / 68475-76-3 / Xi / R37 / STOT SE 3 / H335: May cause respiratory irritation
R38 / Skin irritation 2 / H315: Causes skin irritation
R41 / Serious eye damage/eye irritation 1 / H318: Causes serious eye damage
R43 / Skin sensi-tisation 1 / H317: May cause an allergic skin reaction
...
Other / Substances with a Community workplace exposure limit
°individual part of registration number may be omitted by the supplier of the mixture provided that:
(a)this supplier assumes the responsibility to provide the full registration number upon request for enforcement purposes, or, if the full registration number is not available to him, to forward the request to his supplier, in line with point (b).; and
(b)this supplier provides the full registration number to the Member State authority responsible for enforcement (hereinafter referred to as the “enforcement authority”) within 7 days upon request, received either directly from the enforcement authority or forwarded by his recipient, or, if the full registration number is not available to him, this supplier shall forward the request to his supplier within 7 days upon request and at the same time inform the enforcement authority thereof.
This does not apply to imported mixtures
‡The maxamount of Burnt oil shale added to cement is such that the content of RCS in the cement does not exceed 1%
*A variety of different grades of “burnt shale” were registered. These different grades have different classifications depending on mineralogy, granulometry and respirable crystalline silica content. The burnt shale which is used in cement (2-25% free lime, 1-25% calcite and 1-25% quartz) has the classification given in this table. If cement manufacturers use another type of burnt shale in cement, they need to adapt the above classification.
The table from the EN 197-1 standard on Common cement types can be adapted to the individual needs of the company.
Any further standards applicable to the product (national or for specific cement properties) should be given here as well.
For other non-common cement types, the template may need further adaptation.
8.1.Control parameters
This section should list, where available, the national limit values (occupational or other), including the legal base for each of them, currently applicable in the MS where the SDS is provided. When listing occupational exposure limit values, the chemical identity as specified in Section 3 shall be used. If no limit values are available for cement, then the values for general dust can be given.
Some examples of control parameters are given below.
Name – limit value / Limit value type / Value (as 8 h TWA) / Unit / Legal referenceFrance
General dust / OELV total inhalable dust* / 10 / mg/m³ / Article R.4222-10 of Occupational Code
General dust / OELV alveolar fraction* / 5 / mg/m³ / Article R.4222-10 of Occupational Code
Germany
General dust / OELV total inhalable dust / 10 / mg/m³ / Working place limit values
General dust / OELV alveolar dust / 3 / mg/m³ / Working place limit values
Portland cement dust / OELV total inhalable dust / 5 / mg/m³ / Working place limit values
Portugal
Cement dust / VLE-MP total inhalable dust / 10 / mg/m³
Cement dust / VLE-MP alveolar dust / 3 / mg/m³
* Dust reputedly without any specific effects
Information on the currently recommended monitoring procedures shall be given.
The template for the SDS contains the engineering controls and individual protection measures for an inhalation DNEL of 3 mg/m³ are given. In the annex to this document, tables with engineering controls and individual protection measures for an inhalation DNEL of 1mg/m³ and 5 mg/m³ are given so that the tables in the template of the SDS can be adapted to the specific national situation if necesary.
15.1.Safety, health and environmental regulations/legislation specific for the substance or mixture
To be completed by the manufacturer/importer: any relevant national measures applicable to common cements: eg for Germany, content from TRGS, GefStoffV.
16.2Abbreviations and acronyms
If used in section 3.2 and not written in full, the R phrases listed below should be added to the list of abbreviations in section 16.2
R37/38Irritating to respiratory system and skin
R41Risk of serious damage to eyes
R43May cause sensitisation by skin contact
R48/20Harmful: danger of serious damage to health by prolonged exposure through inhalation
16.5Further information
The content of the SDS needs to be in line with the information from the exposure scenarios (received from the suppliers)of substances subject to registration and classified as dangerous and which are present in the common cement. In particular, according to the new format of the SDS (Regulation 453/2010 amending Annex II of REACH, and guidance document on extended SDS the content of the ES, the uses, the so-called operational conditions and the risk management measures have to be included in sections 1.2, 7 and 8 (and possibly in section 13 – waste) of the SDS. It is not necessary to add the ES of the individual substances to the SDS, unless the mixture is used under different operational conditions or the uses require different risk management measures. In the latter case, the ES have either to be consolidated in ES relevant for the downstream user and annexed to the SDS or the relevant ES should be annexed as such to the SDS.
The information from the ES of flue dust from cement clinker production has been incorporated in this template for the SDS of common cements. If applicable, further information from the ES of the following substances (non-exhaustive list) needs to be added to the SDS or the ES need to be added as an annex to the SDS:
- Burnt oil shale
Admixtures
T16580/IC1 of 3331 March 2011
Safety Data Sheetaccording to Regulation (EC) No 1907/2006 (REACH)as amended by Reg 453/2010
[Template SDS Common cements]
Product:[Trade name]
[Revised] Version 2 / EN of [date]Replaces all previous versionsPrint date:[date]
______
SECTION 1: Identification of the substance/mixture and of the company/undertaking
1.1Product identifier
[Trade name or designation in accordance with Article 10(2) of Dir. 1999/45/EC to be completed by the manufacturer/importer]
[Identity of all substances in the mixture that contribute to the classification of the mixture as regards acute toxicity, skin corrosion or serious eye damage, germ cell mutagenicity, carcinogenicity, reproductive toxicity, respiratory or skin sensitisation, specific target organ toxicity (STOT) or aspiration hazard]
[Own company identifiers may be added such as names by which mixture is commonly known, numbers, company product codes, other unique identifiers]
1.2.Relevant identified uses of the substance or mixture and uses advised against
Cements are used in industrial installations to manufacture/formulate hydraulic binders for building and construction work, such as ready-mixed concrete, mortars, renders, grouts, plasters as well as precast concrete.
Common cements and cement containing mixtures (hydraulic binders) are used industrially, by professionals as well as by consumers in building and construction work, indoor and outdoor. The identified uses of cements and cement containing mixtures cover the dry products and the products in a wet suspension (paste).
PROC / Identified Uses - Use Description / Manufacture/ Formulation of / Professional/ Industrial use ofbuilding and construction materials
2 / Use in closed, continuous process with occasional controlled exposure / X / X
3 / Use in closed batch process / X / X
5 / Mixing or blending in batch process for formulation of preparations and articles / X / X
7 / Industrial spraying / X
8a / Transfer of substance or preparation from/to vessels/large containers atnon-dedicatedfacilities / X
8b / Transfer of substance or preparation from/to vessels/large containers a dedicatedfacilities / X / X
9 / Transfer of substance or preparation into small containers / X / X
10 / Roller application or brushing / X
11 / Non-Industrial spraying / X
13 / Treatment of articles by dipping and pouring / X
14 / Production of preparations or articles by tabletting, compression extrusion, pelletisation / X / X
19 / Hand-mixing with intimate contact and only PPE available / X
22 / Potentially closed processing operations with minerals/metals at elevated temperature Industrial setting / X
26 / Handling of solid inorganic substances at ambient temperature / X / X
[This section needs to be completed with the information from the ES of the substances in cement, subject to registration and for which a chemical safety assessment was made. The information from the ES of flue dust has already been included above. If the information is not included in the SDS, then reference to be made to ES which need to be attached in Annex]
1.3.Details of the supplier of the safety data sheet
[To be completed by the manufacturer or importer]
[If the supplier is not located in the MS where the cement is placed on the market and he has nominated a responsible person for that MS, the full address and telephone number of that responsible person shall be given]
[If an Only Representative has been nominated (for the substances in the mixture cement and subject to registration), details of non-community manufacturer or formulator may also be provided]
Company name:
Full address:
Telephone number:
E-mail address of person responsible for the SDS:
[It is recommended to use a generic email address that can be checked by different persons. There is no requirement to mention the name of a physical person in the SDS]
1.4.Emergency telephone number
[From official advisory body if it exists, eg according to Art. 45 of CLP or from company, to be completed by manufacturer/importer]
Emergency telephone number:
Hours of operation:[To be completed if applicable]
Information provided will be limited to: [To be completed if applicable]
Service is provided in the following language:
[It is recommended to have an emergency telephone number available 24h/7 days]
SECTION 2: Hazards identification
2.1.Classification of the substance or mixture
2.1.1According to Regulation (EC) No 1272/2008