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EN 1 EN
CEPE GUIDELINE ON SAFETY DATA SHEETS
for the Paint, Varnish, Printing Ink and Artists’ Colours Industry
9th
Edition
Part 1
General guidance for compiling safety data sheets in accordance with Annex II to REACH, as amended
by Commission Regulation (EU) No. 453/2010
Date of Issue: 2010-09-17
Replaces 8th
edition as from 2010-12-01
(both editions exist in parallel until 2010-11-30)
The 9th Edition was prepared by the members of the CEPE Technical Committee “Labelling and Safety Data Sheet”
This Guide was drawn up by a CEPE Committee based on current knowledge and information available. Neither the Committee nor CEPE can accept any responsibility for consequences arising in certain cases should these recommendations be employed.
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PREAMBLE
This 9th edition of the CEPE Guideline on Safety Data Sheets for the Paint, Varnish, Printing Ink and Artists’ Colours Industry follows a different layout from the eight previous editions. It deals with the content of safety data sheets (SDSs) as provided to professional users under the provisions of Annex II of the REACH Regulation (EC) No 1907/2006, as amended by Commission Regulation (EU) No. 453/2010. This guide contains a number of amendments and additions to the previous versions and includes all new SDS content and format changes required from 1 December 2010. It also uses the terminology of Regulation (EC) No. 1272/2008 on the classification, labelling and packaging of substances and mixtures (“CLP”) in line with the amendments made by this regulation to REACH. To assist members, Chapters 2 and 3 of this guide contain both the relevant legal text and corresponding CEPE guidance for each section. This guide consists of five parts: Part 1: General guidance for compiling SDSs Part 2: Model Safety Data Sheets Part 3: CEPE Phrase Catalogue Part 4: (withdrawn) Part 5: Printing Ink Sector (EuPIA) specific guidance Part 3 (CEPE Phrase Catalogue) is a separate Excel file containing standard phrases which make up the model SDS, plus additional plug-in phrases for SDS and relevant label phrases in a number of European languages. The model SDS contained in Part 2 are generated from the Phrase Catalogue, but are provided in English only as basic examples for added convenience. These guidelines are intended for use by CEPE members and/or to assist national associations to prepare their own guidance on the preparation of SDSs.
The European Chemicals Agency (ECHA) is preparing its own guidance document on the compilation of safety data sheets. This is expected to be published after 1 December 2010. Since it is not yet possible to refer to the ECHA guidance, some of the advice included in its draft version has been incorporated into this CEPE SDS Guide.
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TABLE OF CHANGES
Changes introduced since the previous version – 8th edition – 2009-06-10 (revised 2009-08-26)
ADDITIONS
In par. 4.2.21, Coatings and printing inks based on nitrocellulose
New pi-phrase 042 warning of incompatibility with amines
Par. 4.2.26 – Mixtures containing PVC or PVDC-based binders or chlorine-containing pigments
New pi-phrase 040 for hazardous decomposition product
Par. 4.2.27 – Radiation-curable mixtures, acrylate based
New pi-phrase 041 to warn of sensitising properties
AMENDMENTS
Preamble, chapters 1, 2 and 3 Substantially re-written to reflect new Annex II (Regulation 453/2010), with inclusion of legal text plus added CEPE guidance
Entire document References to “preparation” replaced by “mixture” References to “P phrase(s)” replaced by “L phrase(s)”
Par. 4.2.24 – Coatings and printing inks containing ≥ 5% N-methyl pyrrolidone
Pi-phrase 037 withdrawn
Chapter 4 – Plug-in Phrases Sub-section numbers identified References to Section 15 replaced by 2.2
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INDEX
1. INTRODUCTION AND METHODOLOGY 5 2. GENERAL REQUIREMENTS FOR SAFETY DATASHEETS 7 2.1 Legal text of REACH Article 31 plus CEPE guidance 7 2.2 Legal text of Commission Regulation (EU) No. 453/2010 amending REACH Annex II 11 (plus CEPE guidance)
3. DETAILED REQUIREMENTS FOR COMPILATION OF SAFETY DATA SHEETS
AND GUIDANCE FOR FILLING IN THE MODEL SHEETS 13 3.1 Detailed requirements (legal text plus CEPE guidance) 13 3.2 Guidance particular to the various model sheets 49
4. PLUG-IN PHRASES 50 4.1 Criteria for plug-in phrases 50 4.2 Specific plug-in phrases 51 4.3 Pi-phrase finder 57
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1. INTRODUCTION AND METHODOLOGY
This guide has been prepared by the CEPE Technical Committee Labelling and Safety Data Sheet and provides a harmonised industry approach to the provision of information in safety data sheets. It covers - the requirements for Safety Data Sheets set out in Article 31 (Title IV – Information in the Supply
Chain) of Regulation (EC) No 1907/2006 (“REACH”) - the detailed requirements for compilation of safety data sheets set out in Annex I of Commission
Regulation (EU) No. 453/2010 (replacing Annex II of REACH) - additional voluntary standards and agreements, which reflect the principles of the coatings
industry’s Coatings Care/Responsible Care programme.
This Guide is intended to be used by member companies, or by national associations as the basis of local guidance which also incorporates any relevant national legislative or other references needed in safety data sheets supplied into that member state. This 9
th Edition is primarily aimed at companies still applying the classification and labelling provisions
set out in the Dangerous Preparations Directive 1999/45/EC (“DPD”), as permitted until 31st May
2015. Companies already classifying and labelling their products according to Regulation (EC) No. 1272/2008 (“CLP”) may choose to compile SDS in accordance with Annex II of Regulation 453/2010, in which case they are recommended to refer to the 10
th. Edition of the CEPE SDS Guide (to be
developed after publication of this 9th edition).
Additional guidance on extending safety data sheets (incorporation of exposure scenario information) is in preparation by a CEPE task force and is due to be published by the end of 2010.
This guide consists of:
≠ the requirements of the regulations, with legal text reproduced verbatim to avoid the need for duplication or cross-reference. Note that a lot of SDS content is now obligatory where previously it was just suggested or recommended.
≠ additional CEPE guidance inserted alongside the legal text where necessary or appropriate. Such guidance is indicated using the following format:
CEPE guidance text
≠ a Phrase Catalogue with content for a series of model sheets for defined categories of products: SDS-01: for a basic solvent borne coating product
SDS-02: for a water borne coating product containing organic solvents. SDS-03: for coating powders. SDS-04: for a radiation curable coating product, acrylate based, classified Xi. SDS-05: for coating products containing isocyanates. SDS-06: for peroxide hardeners SDS-07: for a coating product not classified as dangerous and containing no flammable
substances and no other dangerous substances. SDS-08: for a coating product not classified as dangerous, containing no flammable
substances but some other dangerous substances. SDS-09: for a coating product not classified as dangerous but containing some flammable
substances with or without other dangerous substances. SDS-51: for a basic printing ink – classified as dangerous SDS-57: for a basic printing ink – not classified as dangerous SDS-59: for a basic printing ink – not dangerous but containing dangerous substances
In order to facilitate the translations in the various European languages, a code has been given to each sheet: SDS + number + language (e.g. SDS-01/EN). The compiled English model sheets SDS-XX/EN are also provided in Part 2 of the Guide as examples for added convenience.
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≠ criteria for use, and a series of “plug-in” phrases (also contained in the Phrase Catalogue), by which the model sheets can be extended to particular cases. In order to facilitate the translation in the various languages, a code has been given to these phrases: Pi + number + language (using ISO 2-letter language codes, e,g, EN = English).
Notes on terminology used in this Guide:
≠ For consistency with Regulation 453/2010, the term “mixture” (as used in the CLP Regulation) is used throughout. This has the same meaning as “preparation” in the previous EU legislation. (Note: standard model SDS text and plug-in phrases have been updated in this document, however in the CEPE Phrase Catalogue the term “preparation” may still appear until the next revision of the Phrase Catalogue.)
≠ The term “L phrase” is now used for additional label phrases developed by industry or required by the special provisions in Annex V to DPD (i.e. those which are not R- or S-phrases). This has the same meaning as “P phrase” in previous versions of the CEPE Guides but has been changed to prevent confusion in future with CLP precautionary (P-) statements.
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2. GENERAL REQUIREMENTS FOR SAFETY DATA SHEETS
2.1 Legal text of REACH Article 31 plus CEPE guidance
(consolidated text including all amendments applicable as from 1 December 2010):
Article 31
Requirements for safety data sheets
1. The supplier of a substance or a mixture shall provide the recipient of the substance or mixture with a safety
data sheet compiled in accordance with Annex II:
(a) where a substance meets the criteria for classification as hazardous in accordance with Regulation (EC)
No 1272/2008 or a mixture meets the criteria for classification as dangerous in accordance with Directive
1999/45/EC; or
(b) where a substance is persistent, bioaccumulative and toxic or very persistent and very bioaccumulative
in accordance with the criteria set out in Annex XIII; or
(c) where a substance is included in the list established in accordance with Article 59(1) for reasons other
than those referred to in points (a) and (b).
(c) refers to the Candidate List of Substances of Very High Concern – see the guidance note under 3.2.1(c) on page 22.
2. Any actor in the supply chain who is required, under Articles 14 or 37, to carry out a chemical safety
assessment for a substance shall ensure that the information in the safety data sheet is consistent with the
information in this assessment. If the safety data sheet is developed for a mixture and the actor in the supply
chain has prepared a chemical safety assessment for that mixture, it is sufficient if the information in the
safety data sheet is consistent with the chemical safety report for the mixture instead of with the chemical
safety report for each substance in the mixture.
Information in the SDS must be consistent with the chemical safety report (CSR) either for the whole mixture, if one exists, or for each individual substance in the mixture. Note that a mixture formulator is only obliged to produce a downstream user CSR if the conditions of use are not covered by the upstream supplier’s CSR. Additional CEPE guidance on the use of CSR/exposure scenario information in mixture SDS is currently in preparation, as mentioned in Chapter 1, Introduction and Methodology.
3. The supplier shall provide the recipient at his request with a safety data sheet compiled in accordance with
Annex II, where a mixture does not meet the criteria for classification as dangerous in accordance with
Articles 5, 6 and 7 of Directive 1999/45/EC, but contains:
(a) in an individual concentration of ≥ 1 % by weight for non-gaseous mixtures and ≥ 0,2 % by volume for
gaseous mixtures at least one substance posing human health or environmental hazards; or
(b) in an individual concentration of ≥ 0,1 % by weight for nongaseous mixtures at least one substance that
is persistent, bioaccumulative and toxic or very persistent and very bioaccumulative in accordance with the
criteria set out in Annex XIII or has been included for reasons other than those referred to in point (a) in the
list established in accordance with Article 59(1); or
(c) a substance for which there are Community workplace exposure limits.
CEPE recommends that SDS should be provided (to professional or industrial users) for all
products, whether or not required by the Regulation.
4. The safety data sheet need not be supplied where substances that are hazardous in accordance with
Regulation (EC) No 1272/2008 or mixtures that are dangerous in accordance with Directive 1999/45/EC,
offered or sold to the general public, are provided with sufficient information to enable users to take the
EN 8 EN
necessary measures as regards the protection of human health, safety and the environment, unless requested
by a downstream user or distributor.
For products offered to the general public, a SDS need not be provided (unless requested by a downstream user or distributor) if the product is supplied with sufficient information as described above. Such information may be on the label or on other packaging or literature supplied with the product (except for mandatory labelling elements, which must be on the product label – refer to CEPE Labelling Guide).
5. The safety data sheet shall be supplied in an official language of the Member State(s) where the substance
or mixture is placed on the market, unless the Member State(s) concerned provide otherwise.
6. The safety data sheet shall be dated and shall contain the following headings:
1. identification of the substance/mixture and of the company/undertaking;
2. hazards identification;
3. composition/information on ingredients;
4. first-aid measures;
5. fire-fighting measures;
6. accidental release measures;
7. handling and storage;
8. exposure controls/personal protection;
9. physical and chemical properties;
10. stability and reactivity;
11. toxicological information;
12. ecological information;
13. disposal considerations;
14. transport information;
15. regulatory information;
16. other information.
These 16 section headings are all mandatory. Sub-section headings are now also mandatory (see Part A point 0.4 and Part B in chapter 3.1 of this guide).
7. Any actor in the supply chain who is required to prepare a chemical safety report according to Articles 14
or 37 shall place the relevant exposure scenarios (including use and exposure categories where appropriate)
in an annex to the safety data sheet covering identified uses and including specific conditions resulting from
the application of Section 3 of Annex XI.
Any downstream user shall include relevant exposure scenarios, and use other relevant information, from
the safety data sheet supplied to him when compiling his own safety data sheet for identified uses.
Any distributor shall pass on relevant exposure scenarios, and use other relevant information, from the
safety data sheet supplied to him when compiling his own safety data sheet for uses for which he has passed
on information according to Article 37(2).
Additional CEPE guidance on the use of CSR/exposure scenario information in mixture SDS is currently in preparation, to be published by the end of 2010.
8. A safety data sheet shall be provided free of charge on paper or electronically no later than the date on
which the substance or mixture is first supplied.
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SDS can be provided to recipients via electronic means, e.g. by e-mail or to download from a website (provided you actively alert the customer). It is, however, advisable to be able to prove that the customer has received the SDS, so it may be preferable to send the document itself.
Recipient of the SDS
It is recommended that SDS are addressed to either:
- a named individual who has been nominated as responsible to receive SDS
- a responsible job title/function (e.g. managing director, company secretary) with the request to pass on to the appropriate department if necessary.
A record should be kept of SDS recipients, both for proof and to assist in the provision of future revisions.
9. Suppliers shall update the safety data sheet without delay on the following occasions:
(a) as soon as new information which may affect the risk management measures, or new information on
hazards becomes available;
(b) once an authorisation has been granted or refused;
(c) once a restriction has been imposed.
The new, dated version of the information, identified as ‘Revision: (date)’, shall be provided free of charge
on paper or electronically to all former recipients to whom they have supplied the substance or mixture
within the preceding 12 months. Any updates following registration shall include the registration number.
Examples of changes requiring an update to be issued ‘without delay’ are as follows1:
- Section 1: change in emergency telephone number
- Section 2: change in classification and labelling of the substance/mixture (including addition of CLP classification), if this becomes more severe
- Section 3: change/addition of a component which is/becomes CMR (CLP Cat. 1A/1B, DSD 1 or 2), PBT/vPvB, N;R50/53, or SVHC
- Section 8: change in personal protective equipment, exposure engineering controls or emission controls (if these become more stringent)
- Section 14: change in transport classification (excluding technical names after the proper shipping name)
- Section 15: granting/refusal of an authorisation or application of a restriction to a substance
- Annex: complete set of exposure scenarios available for all risk-determining substances in mixture. (On case-by-case basis, information from ES available for risk-determining substance(s), focussing on risk management measures)
Minor changes and edits might warrant the issuing of a new version of the SDS which is not required to be issued to all customers. Examples of minor changes are as follows:
- Change in layout
- Section 2 and 3: deletion of DPD and DSD classifications after 1 June 2015
- Section 3: registration number available for one or more components
- Section 8: change in OEL value and/or PNEC for a substance in the mixture
- Annex: availability of exposure scenario(s) for one or more substances in the mixture (not risk-determining)
- Other changes with no effect on the PPE, engineering controls or emission controls.
1 Source: DUCC document ‘Revision Management of Safety Data Sheets for mixtures complying with REACH and CLP Regulations’
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An incremental numbering system could be used to identify new versions and distinguish between major and minor updates (by increments in the integer and decimal respectively), i.e.:
Version 1.0: initial issue
Version 1.1: first minor change
Version 1.2: second minor change
Version 2.0: first major change, etc.
This is just an example; many other options are possible. Irrespective of the above, it is recommended to review SDS in full at regular intervals to ensure their contents remain current. Defining appropriate intervals is the responsibility of the compiler.
Electronic dissemination: see the guidance under point 8 above.
Record-keeping
REACH Article 36 imposes an obligation to assemble and keep available all the information you need to fulfil your duties under the regulation, for a minimum of 10 years after you last supplied the product. You should therefore ensure that you keep archived SDS, and records of the information used to compile them, and can provide these to a competent authority or to ECHA without delay upon request.
10. Where substances are classified in accordance with Regulation (EC) No 1272/2008 during the period from
its entry into force until 1 December 2010, that classification may be added in the safety data sheet together
with the classification in accordance with Directive 67/548/EEC.
From 1 December 2010 until 1 June 2015, the safety data sheets for substances shall contain the
classification according to both Directive 67/548/EEC and Regulation (EC) No 1272/2008.
Where mixtures are classified in accordance with Regulation (EC) No 1272/2008 during the period from its
entry into force until 1 June 2015, that classification may be added in the safety data sheet, together with the
classification in accordance with Directive 1999/45/EC. However, until 1 June 2015, where substances or
mixtures are both classified and labelled in accordance with Regulation (EC) No 1272/ 2008 that
classification shall be provided in the safety data sheet, together with the classification in accordance with
Directives 67/548/EEC and 1999/45/EC respectively, for the substance, the mixture and its constituents.
For a summary of the requirements in point 10, see the CEPE guidance box at the end of chapter 2.2 below.
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2.2 Legal text of Commission Regulation (EU) No. 453/2010 amending REACH Annex II (plus CEPE guidance)
Article 1
Regulation (EC) No 1907/2006 is amended as follows:
1. with effect from 1 December 2010:
(a) Annex II is replaced by Annex I to this Regulation;
(b) in Section 3.7 of Annex VI, in the title, the words “(see Safety Data Sheet heading 16)” are
replaced by “(see Section 1 of the safety data sheet)”;
2. with effect from 1 June 2015, Annex II to Regulation (EC) No 1907/2006 is replaced by Annex II to
this Regulation.
Article 2
1. Until 1 December 2010, suppliers of substances applying Article 61(2) of Regulation
(EC) No 1272/2008 may apply Annex II to Regulation (EC) No 1907/2006, as amended by point 1 of
Article 1 of this Regulation.
2. Until 1 December 2010, suppliers of mixtures may apply Annex II to Regulation (EC) No 1907/2006,
as amended by point 1 of Article 1 of this Regulation.
3. Until 1 June 2015, suppliers of mixtures applying Article 61(2) of Regulation (EC) No 1272/2008
may apply Annex II to Regulation (EC) No 1907/2006, as amended by point 2 of Article 1 of this
Regulation.
4. Until 1 June 2015, suppliers of mixtures applying paragraph 3 shall provide in subsection 3.2 of the
relevant safety data sheets the classification of the substances indicated in that subsection in
accordance with Directive 67/548/EEC, including indication of danger, symbol letter(s) and R
phrases, in addition to the classification including hazard statements in accordance with
Regulation (EC) No 1272/2008.
5. Until 1 June 2015, suppliers of mixtures applying paragraph 3 shall provide in subsection 2.1 of the
relevant safety data sheets the classification of the mixture in accordance with Directive 1999/45/EC
in addition to the classification including hazard statements in accordance with
Regulation (EC) No 1272/2008.
Until 1 June 2015, suppliers of mixtures meeting the criteria for classification in accordance with
Regulation (EC) No 1272/2008 shall, when applying paragraph 3, indicate the substances presenting
a health or environmental hazard within the meaning of Directive 67/548/EEC in Subsection 3.2 of
the relevant safety data sheets if those substances are present in concentrations equal to or greater
than the lowest of the values listed in point 3.2.1.(a) of Annex II to this Regulation in addition to the
substances mentioned in point 3.2.1. of that Annex.
Until 1 June 2015, suppliers of mixtures not meeting the criteria for classification in accordance with
Regulation (EC) No 1272/2008 shall, when applying paragraph 3, indicate the substances presenting
a health or environmental hazard within the meaning of Directive 67/548/EEC in Subsection 3.2 of
the relevant safety data sheets if those substances are present in an individual concentration equal to
or greater than 1% by weight in non-gaseous mixtures and 0,2% by volume in gaseous mixtures in
addition to the substances mentioned in point 3.2.2 of Annex II to this Regulation.
6. Without prejudice to Article 31(9) of Regulation (EC) No 1907/2006, for substances which are placed
on the market before 1 December 2010 and which are not required to be relabelled and repackaged in
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accordance with Article 61(4) of Regulation (EC) No 1272/2008, the safety data sheet need not be
replaced with a safety data sheet complying with Annex I to this Regulation before 1 December 2012.
Without prejudice to Article 31(9) of Regulation (EC) No 1907/2006, for mixtures which are placed
on the market before 1 June 2015 and which are not required to be relabelled and repackaged in
accordance with Article 61(4) of Regulation (EC) No 1272/2008, the safety data sheet need not be
replaced with a safety data sheet complying with Annex II to this Regulation before 1 June 2017.
7. Without prejudice to Article 31(9) of Regulation (EC) No 1907/2006, safety data sheets for mixtures
provided to any recipient at least once before 1 December 2010 may continue to be used and need not
comply with Annex I to this Regulation until 30 November 2012.
Article 3
This Regulation shall enter into force on the 20th day following its publication in the Official Journal
of the European Union.
Guidance on complete chapter 2.2
Regulation 453/2010 was published on 31 May 2010 and so entered into force on 20 June 2010. This document, the 9
th edition of the CEPE SDS Guide, is based on Annex I of 453/2010, i.e. the
‘2010 format’ for the SDS.
Compilers of SDS for mixtures should note the following implementation and transition periods:
≠ SDS are required to be in the 2007 REACH format (as per CEPE SDS Guide 8th edition) by
1st December 2010 at the latest – see the CEPE information note “New SDS Format from
June 1st 2007”, issued on 15
th March 2007. SDS not already in the 2007 format need to be
updated by 1st December 2010, either to the 2007 format or directly to the 2010 format.
The 8th and 9
th editions of the CEPE SDS Guide will exist in parallel until 1
st December 2010,
on which date the 8th edition will become obsolete.
≠ SDS in 2007 format which have already been issued to at least one recipient before 1st
December 2010 can still be used until 30 November 2012, if there is no change in their content, but should be converted to the 2010 format on or before that date. Any new or revised SDS with an issue date of 1
st December 2010 or later must be in the 2010 format.
≠ If you have applied CLP classification and labelling to your mixtures before 1 June 2015, you may begin using the 2015 SDS format instead (refer to CEPE SDS Guide 10
th edition, to be
prepared after publication of the 9th edition). Note however that DSD/DPD classifications for
substances and mixtures must still be given in all SDS until 31 May 2015 (inclusive), even where CLP classification and labelling is already being applied.
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3. DETAILED REQUIREMENTS FOR COMPILATION OF SAFETY DATA SHEETS AND GUIDANCE FOR FILLING IN THE MODEL SHEETS
3.1 Detailed requirements (legal text plus CEPE guidance) Annex I to Commission Regulation (EU) No.453/2010, amending REACH Annex II as of 1 December 2010 (but can optionally be applied earlier):
‘ANNEX II
REQUIREMENTS FOR THE COMPILATION OF SAFETY DATA SHEETS
PART A
0.1. Introduction
0.1.1. This Annex sets out the requirements that the supplier shall fulfil for the compilation of a safety data
sheet that is provided for a substance or a mixture in accordance with Article 31.
0.1.2. The information provided in the safety data sheet shall be consistent with the information in the
chemical safety report, where one is required. Where a chemical safety report has been completed, the
relevant exposure scenario(s) shall be placed in an annex to the safety data sheet.
0.2. General requirements for compiling a safety data sheet
0.2.1. The safety data sheet shall enable users to take the necessary measures relating to protection of
human health and safety at the workplace, and protection of the environment. The writer of the safety
data sheet shall take into account that a safety data sheet must inform its audience of the hazards of a
substance or a mixture and provide information on the safe storage, handling and disposal of the
substance or the mixture.
0.2.2. The information provided by safety data sheets shall also meet the requirements set out in Council
Directive 98/24/EC2. In particular, the safety data sheet shall enable employers to determine whether
any hazardous chemical agents are present in the workplace, and to assess any risk to the health and
safety of workers arising from their use.
0.2.3. The information in the safety data sheet shall be written in a clear and concise manner. The safety
data sheet shall be prepared by a competent person who shall take into account the specific needs and
knowledge of the user audience, as far as they are known. Suppliers of substances and mixtures shall
ensure that such competent persons have received appropriate training, including refresher training.
The competent person does not need to attend a special course or pass an official examination but shall have received appropriate and adequate training (internal or external), including refreshers as required, to carry out his/her responsibilities. Nevertheless the competent person should be able to prove his expertise if required, e.g. through professional qualifications, experience and relevant activity. A single person very rarely has extensive knowledge in all the fields covered by an SDS, therefore the competent person may need to rely on additional competence, internally or externally. The competent person should ensure the consistency of the SDS, especially if he acts as the coordinator of a group of people. Competent persons should have understanding and access to adequate knowledge in fields such as the following (non-exhaustive list):
- chemical nomenclature
2 Chemical Agents Directive, OJ L 131, 5.5.1998, p.11. – link to consolidated version
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- European regulations and directives relevant to chemicals and their implementation in national legislation
- relevant national or international guidelines from the respective sector association
- physical and chemical properties and hazard identification
- (eco)toxicology
- first aid measures
- safe handling and accident prevention
- transport provisions
- special national provisions (in workplace health and safety, environment etc.)
- additional product-specific knowledge if necessary.
0.2.4. The language used in the safety data sheet shall be simple, clear and precise, avoiding jargon,
acronyms and abbreviations. Statements such as “may be dangerous”, “no health effects”, “safe under
most conditions of use” or “harmless” or any other statements indicating that the substance or mixture
is not hazardous or any other statements that are inconsistent with the classification of that substance
or mixture shall not be used.
0.2.5. The date of compilation of the safety data sheet shall be given on the first page. When a safety data
sheet has been revised and the new, revised version is provided to recipients, the changes shall be
brought to the attention of the recipient in Section 16 of the safety data sheet, unless they have been
indicated elsewhere. In that case, the date of compilation identified as “Revision: (date)” as well as a
version number, revision number, supersedes date or other indication of what version is replaced shall
appear on the first page.
At the top of the first page, it is recommended to mention: “This Safety Data Sheet is prepared in accordance with Annex II to Regulation (EC) No 1907/2006”.
Changes to the SDS can be identified directly in the relevant sections (by lines, asterisks or other marks) or else listed in section 16.
See also the suggestion on version numbering on page 10.
0.3. Safety data sheet format
0.3.1. A safety data sheet is not a fixed length document. The length of the safety data sheet shall be
commensurate with the hazard of the substance or mixture and the information available.
0.3.2. All pages of a safety data sheet, including any annexes, shall be numbered and shall bear either an
indication of the length of the safety data sheet (such as “page 1 of 3”) or an indication whether there
is a page following (such as “Continued on next page” or “End of safety data sheet”).
0.4. Safety data sheet content
The information required by this Annex shall be included in the safety data sheet, where applicable
and available, in the relevant subsections set out in Part B. The safety data sheet shall not contain
blank subsections.
The full list of mandatory section and subsection headings is given in Part B, after section 16 in this chapter. Note that only these are required as discrete sections in the SDS; further itemisation (e.g. 3.2.1, 8.2.2.1 etc.) is not mandatory (these are explanatory points in Annex II, and the relevant content may be combined within a sub-section if preferred/appropriate).
Although not explicitly stated in the Regulation, it is recommended that sub-section numbers are printed in the SDS, as well as the corresponding sub-headings.
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0.5. Other information requirements
The inclusion of additional relevant and available information in the relevant subsections may be
necessary in some cases in view of the wide range of properties of substances and mixtures.
0.6. Units
The units of measurement as set out in Council Directive 80/181/EEC3 shall be used.
0.7. Special cases
Safety data sheets shall also be required for the special cases listed in paragraph 1.3 of Annex I to
Regulation (EC) No 1272/2008 for which there are labelling derogations.
The special cases, which require reduced, different or no labelling but must have an SDS, are as follows: - transportable gas cylinders - gas containers intended for propane, butane or liquefied petroleum gas (LPG) - aerosols and containers fitted with a sealed spray attachment and containing
substances or mixtures classified as presenting an aspiration hazard - metals in massive form, alloys, mixtures containing polymers, mixtures containing
elastomers - explosives placed on the market with a view to obtaining an explosive or pyrotechnic
effect.
General remarks about the CEPE Model Sheets/Phrase Catalogue:
Sections 4, 5, 6, 10, and parts of sections 7 and 8 of the various model sheets contain standard text suitable for most coating and printing ink products in the categories covered in the sheet and in most cases will need no additional information.
If however this standard information is not sufficient, it should be completed accordingly, e.g. with the use of the plug-in phrases of Chapter 4.
Sections 1, 2, 3, 9, 11 to 16 inclusive and parts of Sections 7 and 8 must be filled in on the basis of the individual parameters and properties of each product.
1. SECTION 1: Identification of the substance/mixture and of the company/undertaking
This section prescribes how the substance or mixture shall be identified and how the identified
relevant uses, the name of the supplier of the substance or mixture and the contact detail information
of the supplier of the substance or mixture including an emergency contact shall be provided in the
safety data sheet.
1.1. Product identifier
In the case of a substance, the product identifier shall be provided in accordance with Article 18(2) of
Regulation (EC) No 1272/2008 and as provided on the label in the official language(s) of the Member
State(s) where the substance is placed on the market, unless the Member State(s) concerned
provide(s) otherwise.
The description used for identification must be identical to that provided on the supply label.
3 OJ L 39, 15.2.1980, p. 40. Units of measurement – link to consolidated text
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For substances subject to registration, the product identifier shall be consistent with that provided in
the registration and the registration number assigned under Article 20(3) of this Regulation shall also
be indicated.
Note that a REACH registration number is to be given in 1.1 for a pure substance only. Registration numbers for substances in a mixture are to be given in sub-section 3.2.
Without affecting the obligations of downstream users laid down in Article 39 of this Regulation, the
part of the registration number referring to the individual registrant of a joint submission may be
omitted by a supplier who is a distributor or a downstream user 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.
In the case of a mixture, the trade name or designation shall be provided in accordance with Article
10(2.1) of Directive 1999/45/EC.
A single safety data sheet may be provided to cover more than one substance or mixture where the
information in that safety data sheet fulfils the requirements of this annex for each of those substances
or mixtures.
A single SDS may be used to cover multiple products, provided that either:
≠ all individual product identifiers are shown on the SDS, or
≠ some other suitable common identifier is shown on both the label and SDS (e.g. “ready-mixed colours”).
Products may be grouped into a single SDS as long as they all have the same classification and contain the same substances to be listed in section 3. The actual substance concentrations may vary as long as they are within the range stated on the SDS, and do not give rise to a difference in classification. See also subsection 9.2.
Other means of identification
Other names or synonyms by which the substance or mixture is labelled or commonly known, such as
alternative names, numbers, company product codes, or other unique identifiers may be provided.
1.2. Relevant identified uses of the substance or mixture and uses advised against
At least the identified uses relevant for the recipient(s) of the substance or mixture shall be indicated.
This shall be a brief description of what the substance or mixture is intended to do, such as “flame
retardant”, “anti-oxidant”.
Briefly describe the use(s) and application method(s) for the product. (Note that REACH descriptors of use, as detailed in ECHA guidance
4, are not required here.)
4 Guidance on information requirements and chemical safety assessment, Chapter R.12 Use descriptor system
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The uses which the supplier advises against and why shall, where applicable, be stated. This need not
be an exhaustive list.
Based on the exposure scenario(s), state any specific uses for which the product has been shown not to be suitable.
For products supplied only for use in vehicle refinish bodyshops (etc.) and not for consumer use, state here that it is “for professional use only”.
Where a chemical safety report is required, the information in this subsection of the safety data sheet
shall be consistent with the identified uses in the chemical safety report and the exposure scenarios
from the chemical safety report set out in the annex to the safety data sheet.
You are not required to attach exposure scenarios as an annex to the safety data sheet unless you have prepared your own chemical safety report (see also the guidance under Article 31(2), page 7). You may, however, choose to include exposure scenario information in an annex, in which case you must ensure it is consistent with the main body of the SDS. Refer to the additional CEPE guidance on extended safety data sheets (in preparation at the time of initial publication of this guide).
1.3. Details of the supplier of the safety data sheet
The supplier, whether it is the manufacturer, importer, only representative, downstream user or
distributor, shall be identified. The full address and telephone number of the supplier shall be given as
well as an e-mail address for a competent person responsible for the safety data sheet.
An e-mail address must be given for a competent person who can answer questions on the SDS. The use of non-personal e-mail addresses is recommended for privacy and practicality reasons. The email account must be active and monitored regularly to deal with enquiries promptly.
In addition, if the supplier is not located in the Member State where the substance or mixture is
placed on the market and he has nominated a responsible person for that Member State, a full address
and telephone number for that responsible person shall be given.
If you as the supplier are not located in the Member State where the product is supplied, and you have nominated an additional local person to answer questions on the SDS, you must also give their address and telephone number. If no such person has been nominated, no additional contact details are required.
For registrants, the information shall be consistent with the information on the identity of the
manufacturer or importer provided in the registration.
Where an only representative has been appointed, details of the non-Community manufacturer or
formulator may also be provided.
1.4. Emergency telephone number
References to emergency information services shall be provided. If an official advisory body exists in
the Member State where the substance or mixture is placed on the market (this may be the body
responsible for receiving information relating to health referred to in Article 45 of Regulation (EC)
No 1272/2008 and Article 17 of Directive 1999/45/EC), its telephone number shall be given and can
suffice. If availability of such services is limited for any reasons, such as hours of operation, or if
there are limits on specific types of information provided, this shall be clearly stated.
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If an official advisory body, e.g. Poison Centre, exists in the Member State where the product is supplied, its telephone number must be given on the SDS. In this case it is optional to provide another emergency telephone number, e.g. at your company or a third-party responder.
If there is no official body in the country where the product is supplied, you must provide an alternative emergency number (note: not the Poison Centre of a different Member State).
A non-exhaustive list of poison centres can be found at http://www.who.int/ipcs/poisons/en
Ensure that any necessary information is made available to the Poison Centre. If national rules apply these must be followed.
State the hours of operation on the SDS if not 24/7. Note there is no obligation in the Regulation to provide a 24-hour emergency number.
2. SECTION 2: Hazards identification
This section of the safety data sheet shall describe the hazards of the substance or mixture and the
appropriate warning information associated with those hazards.
2.1. Classification of the substance or mixture
In the case of a substance, the classification which arises from the application of the classification
rules in Regulation (EC) No 1272/2008 shall be given. Where the supplier has notified information
regarding the substance to the classification and labelling inventory in accordance with Article 40 of
Regulation (EC) No 1272/2008, the classification given in the safety data sheet shall be the same as
the classification provided in that notification.
The classification of the substance according to Council Directive 67/548/EEC shall also be given.
In the case of a mixture, the classification which arises from the application of the classification rules
in Directive 1999/45/EC shall be given. If the mixture does not meet the criteria for classification in
accordance with Directive 1999/45/EC, this shall be clearly stated. Information on the substances in
the mixture is provided under Subsection 3.2.
If the mixture is not classified, state: “This mixture is not classified as dangerous according to EC Directive 1999/45/EC”.
If the classification, including the hazard statements and R phrases, is not written out in full, reference
shall be made to Section 16 where the full text of each classification, including each hazard statement
and R phrase, shall be given.
The most important adverse physicochemical, human health and environmental effects shall be listed
consistent with Sections 9 to 12 of the safety data sheet, in a way as to allow non-experts to identify
the hazards of the substance or mixture.
If the mixture is classified, give its classification in subsection 2.1 and the label elements according to DPD in 2.2 (including any symbols, which need not be printed in colour). R- and S- phrases are to be given as full text in 2.2, but in 2.1 a reference to section 16 may be given instead.
2.2. Label elements
In the case of a substance, based on the classification, at least the following elements appearing on the
label in accordance with Regulation (EC) No 1272/2008 shall be provided: hazard pictogram(s),
signal word(s), hazard statement(s) and precautionary statement(s). A graphical reproduction of the
full hazard pictogram in black and white or a graphical reproduction of the symbol only may be
substituted for the colour pictogram provided in Regulation (EC) No 1272/2008.
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In the case of a mixture, based on the classification, at least the appropriate symbol(s), indication(s)
of danger, risk phrase(s) and safety advice appearing on the label in accordance with Directive
1999/45/EC shall be provided. The symbol may be provided as a graphical reproduction of the
symbol in black and white.
The applicable label elements in accordance with Article 25 and Article 32(6) of Regulation (EC) No
1272/2008, in the case of a substance, or Sections A and B of Annex V to Directive 1999/45/EC, in
the case of a mixture, shall be provided.
Whether the mixture is classified or not, include in 2.2 the full text of any L-phrases for physico-chemical, health and/or environment effects, as required in accordance with Annex V of the DPD or agreed by industry (refer to CEPE Labelling Guide Part 3 or Phrase Catalogue). We recommend that the L-codes themselves (which originate from CEPE and not from legal text) are not given on the SDS in case they cause confusion for customers.
2.3. Other hazards
Information on whether the substance or mixture meets the criteria for PBT or vPvB in accordance
with Annex XIII shall be provided.
Information shall be provided on other hazards which do not result in classification but which may
contribute to the overall hazards of the substance or mixture, such as formation of air contaminants
during hardening or processing, dustiness, dust explosion hazards, cross-sensitisation, suffocation,
freezing, high potency for odour or taste, or environmental effects like hazards to soil-dwelling
organisms, or photochemical ozone creation potential.
PBT/vPvB classification is not currently relevant for mixtures as a whole. PBT/vPvB information for substances in the mixture is to be given in section 3.2.
Information on any other relevant hazards which do not result in classification (e.g. dust explosion hazards for powder coatings) must be mentioned in subsection 2.3.
3. SECTION 3: Composition/information on ingredients
This section of the safety data sheet shall describe the chemical identity of the ingredient(s) of the
substance or mixture, including impurities and stabilising additives as set out below. Appropriate and
available safety information on surface chemistry shall be indicated.
3.1. Substances
The chemical identity of the main constituent of the substance shall be provided by providing at least
the product identifier or one of the other means of identification given in Subsection 1.1.
The chemical identity of any impurity, stabilising additive, or individual constituent other than the
main constituent, which is itself classified and which contributes to the classification of the substance
shall be provided as follows:
(a) the product identifier in accordance with Article 18(2) of Regulation (EC) No 1272/2008;
(b) if the product identifier is not available, one of the other names (usual name, trade name,
abbreviation) or identification numbers.
Suppliers of substances may choose to list in addition all constituents including non-classified ones.
This subsection may also be used to provide information on multi-constituent substances.
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For multi-constituent substances which you place on the market as your own products (e.g. petroleum-based solvents), it is recommended simply to follow the same approach regarding composition as communicated to you by your supplier.
3.2. Mixtures
The product identifier when available, concentration or concentration ranges and classifications shall
be provided for at least all substances referred to in points 3.2.1 or 3.2.2. Suppliers of mixtures may
choose to list in addition all substances in the mixture, including substances not meeting the criteria
for classification. This information shall enable the recipient to identify readily the hazards of the
substances in the mixture. The hazards of the mixture itself shall be given in Section 2.
The concentrations of the substances in a mixture shall be described as either of the following:
(a) exact percentages in descending order by mass or volume, if technically possible;
(b) ranges of percentages in descending order by mass or volume, if technically possible.
When using a range of percentages, the health and environmental hazards shall describe the effects of
the highest concentration of each ingredient.
If concentration ranges are used, these should be chosen to reflect both the actual substance concentration and the resultant mixture classification (the upper limit of a range must not appear to exceed the classification in section 2). Ranges are not specified in this Guide as these will vary widely, depending on the classification endpoints involved and, in some cases, substance-specific limits. Summation with other substances in the mixture may also need to be taken into account in setting the range for each substance.
Example:
Xylene concentration in the mixture is 15%.
Since the classification limits for xylene are 12.5% for Xn;R20/21 and 20% for Xi;R38, an appropriate range could be 12.5 to <20%, if there is no other substance in the mixture classified Xi;R38.
If, however, the mixture does contain another substance which, when combined with 16% or more of xylene, would make the whole mixture Xi;R38, the quoted concentration range for xylene should be adjusted, e.g. 12.5 to <16%, to avoid labelling the mixture as Xi;R38.
If the effects of the mixture as a whole are available, this information shall be included under Section
2.
Where the use of an alternative chemical name has been allowed under Article 15 of Directive
1999/45/EC or under Article 24 of Regulation (EC) No 1272/2008, that name can be used.
3.2.1. For a mixture meeting the criteria for classification in accordance with Directive 1999/45/EC, the
following substances shall be indicated, together with their concentration or concentration range in
the mixture:
(a) substances presenting a health or environmental hazard within the meaning of Council
Directive 67/548/EEC and substances presenting a health or environmental hazard within the
meaning of Regulation (EC) No 1272/2008, provided that information complying with the
classification criteria of that Regulation has been made available to the supplier of the mixture, if
those substances are present in concentrations equal to or greater than the lowest of any of the
following:
(i) the applicable concentrations defined in the table of Article 3 (3) of Directive 1999/45/EC;
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The substances above should be mentioned when their concentration in a mixture classified as dangerous is:
> 0.1% for T+ or T or Category 1 or 2 CMRs or Dangerous for the Environment
substances with the N symbol 5
> 1% for C, Xn or Xi or cat 3 CMRs or Dangerous for the Environment substances without the N symbol
5
> 0.1% for substances classified as sensitisers 5
unless different concentrations are given by (ii) below:
(ii) the specific concentration limits given in Part 3 of Annex VI to Regulation (EC) No
1272/2008;
Refer to Table 3.2 in Annex VI as long as the mixture is still being classified according to
DPD.
(iii) if an M-factor has been given in Part 3 of Annex VI to Regulation (EC) No 1272/2008, the
generic cut-off value in Table 1.1 of Annex I to that Regulation, adjusted using the calculation
set out in Section 4.1 of Annex I to that Regulation;
An M-factor is a multiplying factor applied to the concentration of a substance classified as hazardous to the aquatic environment Acute Cat.1 or Chronic Cat.1, (= N; R50(/53)) based on the degree of its toxicity (lower LC/EC50 value means higher M factor). The generic cut-off values must be reduced by successive factors of 10 in line with the M-factor. M-factors may be included in harmonised classifications listed in Part 3 of Annex VI to CLP.
(iv) the concentration limits given in Part B of Annex II to Directive 1999/45/EC;
(v) the concentration limits given in Part B of Annex III to Directive 1999/45/EC;
(vi) the concentration limits given in Annex V to Directive 1999/45/EC;
(vii) the specific concentration limits provided to the classification and labelling inventory
established under Regulation (EC) No 1272/2008;
As of 1 December 2010 all manufacturers and importers must notify the classification and labelling of their substances to an inventory controlled by the European Chemicals Agency (ECHA): see Articles 39-42 of CLP. This inventory (classification information only) will become publicly available on the ECHA website from January 2011.
If a manufacturer or importer sets specific concentration limits for a self-classified substance (not in Part 3 of Annex VI to CLP), these must be included in his notification to the inventory.
(viii) if an M-factor has been provided to the classification and labelling inventory established under
Regulation (EC) No 1272/2008, the generic cut-off value in Table 1.1 of Annex I to that
Regulation, adjusted using the calculation set out in Section 4.1 of Annex I to that Regulation.
M-factors may also be set for self-classified substances notified to the inventory by manufacturers or importers; see guidance under (iii) and (vii) above.
5 Unless a lower limit is required or considered more appropriate: see art. 3.3 of the Dangerous Preparations
Directive 1999/45/EC.
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(b) substances for which there are Community workplace exposure limits, which are not already
included under point (a);
This requirement applies only to substances with a Community exposure limit6.
No cut-off limit is defined for inclusion of substances which are not classified but have an occupational exposure limit (this is not believed to apply to any substances with a Community limit). However if this should arise a threshold of ≥1% w/w is recommended.
Classified substances with OELs, which would normally fall under (a) but are present below
the relevant threshold limits, should be disregarded.
(c) substances that are persistent, bioaccumulative and toxic or very persistent and very
bioaccumulative in accordance with the criteria set out in Annex XIII, or substances included in the
list established in accordance with Article 59(1) for reasons other than the hazards referred to in point
(a), if the concentration of an individual substance is equal to or greater than 0,1 %.
Substances identified by the supplier as PBT/vPvB, or those on the Candidate List of Substances of Very High Concern
7 if not already mentioned as a result of their classification
as per 3.2.1 (a) above, should be listed if present at ≥ 0.1%.
3.2.2. For a mixture not meeting the criteria for classification in accordance with Directive 1999/45/EC,
substances present in an individual concentration equal to or greater than the following concentrations
shall be indicated, together with their concentration or concentration range:
(a) 1% by weight in non-gaseous mixtures and 0,2% by volume in gaseous mixtures for
(i) substances which present a health or environmental hazard within the meaning of Council
Directive 67/548/EEC and substances which present a health or environmental hazard within
the meaning of Regulation (EC) No 1272/2008, provided that information complying with the
classification criteria of that Regulation has been made available to the supplier of the mixture;
or
(ii) substances which are assigned Community workplace exposure limits;
If the mixture itself is not classified, list in section 3.2 any classified or OEL substances which it contains at ≥ 1%.
(b) 0,1% by weight for substances which are persistent, bioaccumulative and toxic in accordance
with the criteria set out in Annex XIII, very persistent and very bioaccumulative in accordance with
the criteria set out in Annex XIII, or included in the list established in accordance with Article 59(1)
for reasons other than the hazards referred to in point (a).
If the mixture itself is not classified, list in section 3.2 any PBT/vPvB or Candidate List substances which it contains at ≥ 0.1%.
If a substance listed in section 3.2 has no classification, it is recommended to state why it has been mentioned, e.g. “OEL (see 8.1)”; “On Candidate List of SVHC”.
6As specified in Directives 2000/39/EC, 2006/15/EC and 2009/161/EU (first, second and third lists of indicative occupational exposure limit values) and Directive 2004/37/EC (carcinogens directive) 7 See http://echa.europa.eu/chem_data/authorisation_process/candidate_list_table_en.asp
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3.2.3. For the substances indicated in Subsection 3.2, the classification of the substance according to
Council Directive 67/548/EEC, including indication of danger, symbol letter(s) and R phrases,
shall be provided. The classification of the substance according to Regulation (EC) No
1272/2008, including the hazard class(es) and category code(s) as provided in Table 1.1 of Annex
VI to that Regulation as well as the hazard statements which are assigned in accordance with their
physical, human health and environmental hazards, shall also be provided, provided that information
complying with the classification criteria of that Regulation has been made available to the supplier
of the mixture. The hazard statements and R phrases do not need to be written out in full in this
section; their codes shall be sufficient. In cases where they are not written out in full, reference shall
be made to Section 16, where the full text of each relevant hazard statement and R phrase shall be
listed. If the substance does not meet the classification criteria, the reason for indicating the substance
in Subsection 3.2 shall be described, such as “non-classified vPvB substance" or "substance with a
Community workplace exposure limit".
For each listed substance (see above), give the CLP and DSD classifications:
≠ as listed in the classification column in Annex VI, Part 3, Table 3.1 and 3.2 of Regulation (EC) No. 1272/2008 for substances with harmonised classifications
≠ as provided by the supplier for self-classified substances, or for additional self-classified endpoints on substances with harmonised classifications.
Note: CLP classification information only needs to be given if you have received it.
Only risk phrase numbers and hazard statement codes need to be given here. The full text of these phrases and statements should be given in Section 16.
For substances assigned with specific Notas according to Annex VI Part 1 paragraph 1.1.3 of Regulation (EC) No 1272/2008, these can be mentioned here.
(Note that the full classification of each substance is required to be listed in 3.2. R-phrases or hazard statements should not be omitted based on the concentration of the substance in the mixture and its resulting contribution to the overall classification of the mixture.)
In cases where suppliers advise different classifications for the same substance, refer to the CEPE information note “Global sourcing of raw materials: supplier and purchaser responsibilities”.
3.2.4. For the substances indicated in Subsection 3.2 the name and, if available, the registration number, as
assigned under Article 20(3) of this Regulation shall be given.
Without affecting the obligations of downstream users laid down in Article 39 of this Regulation, the
part of the registration number referring to the individual registrant of a joint submission 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.
The EC number, if available, shall be given in accordance with Regulation (EC) No 1272/2008. The
CAS number, if available, and IUPAC name, if available, may also be given.
For substances indicated in this subsection by means of an alternative chemical name in accordance
with Article 15 of Directive 1999/45/EC or Article 24 of Regulation (EC) No 1272/2008, the
registration number, EC number and other precise chemical identifiers are not necessary.
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Names (of the substances required to be listed according to 3.2.1 or 3.2.2 above):
- substances with EU harmonised classifications should be indicated by the chemical name as given in Annex VI of Regulation (EC) N° 1272/2008 (CLP)
- self-classified substances can be indicated by the chemical name quoted by the supplier or the IUPAC name.
Note that Annex VI and IUPAC names are officially published in English only. It should therefore be acceptable to give these in English.
- substances subject to an occupational exposure limit should be indicated by the chemical name as given in the relevant EU Directive or national regulations.
- Substances that are PBT or vPvB or substances on the candidate list of REACH can be indicated by the names given in the relevant EU lists or other recognised name.
Give EC numbers where available; CAS numbers may also be included if available. Note: Certain classified substances can be referred to by generic names. See paragraph 2.6 of the Annex II of Regulation (EC) No 1907/2006 for further information. If available the registration number(s) should be given. Mixture suppliers may omit the part identifying the individual registrant (i.e. last 4 digits), subject to the conditions in the legal text above. Note that this concession only applies to joint submissions; in the case where there is only one registrant, or a registrant has reasons to submit a registration separately from the joint submission, the registration number must be given in full.
4. SECTION 4: First aid measures
This section of the safety data sheet shall describe the initial care in such a way that it can be
understood and given by an untrained responder without the use of sophisticated equipment and
without the availability of a wide selection of medications. If medical attention is required, the
instructions shall state this, including its urgency.
See standard text for section 4 in each model SDS in the Phrase Catalogue.
4.1. Description of first aid measures
4.1.1. First aid instructions shall be provided by relevant routes of exposure. Subdivisions shall be used to
indicate the procedure for each route, such as inhalation, skin, eye and ingestion.
4.1.2. Advice shall be provided as to whether:
(a) immediate medical attention is required and if delayed effects can be expected after exposure;
(b) movement of the exposed individual from the area to fresh air is recommended;
(c) removal and handling of clothing and shoes from the individual is recommended; and
(d) personal protective equipment for first aid responders is recommended.
4.2. Most important symptoms and effects, both acute and delayed
Briefly summarised information shall be provided on the most important symptoms and effects, both
acute and delayed, from exposure.
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4.3. Indication of any immediate medical attention and special treatment needed
Where appropriate, information shall be provided on clinical testing and medical monitoring for
delayed effects, specific details on antidotes (where they are known) and contraindications.
For some substances or mixtures, it may be important to emphasise that special means to provide
specific and immediate treatment shall be available at the workplace.
5. SECTION 5: Fire-fighting measures
This section of the safety data sheet shall describe the requirements for fighting a fire caused by the
substance or mixture, or arising in its vicinity.
See standard text for section 5 in each model SDS in the Phrase Catalogue.
5.1. Extinguishing media
Suitable extinguishing media:
Information shall be provided on the appropriate extinguishing media.
Unsuitable extinguishing media:
Indications shall be given whether any extinguishing media are inappropriate for a particular situation
involving the substance or mixture.
5.2. Special hazards arising from the substance or mixture
Information shall be provided on hazards that may arise from the substance or mixture, like hazardous
combustion products that form when the substance or mixture burns, such as “may produce toxic
fumes of carbon monoxide if burning” or “produces oxides of sulphur and nitrogen on combustion”.
5.3. Advice for fire-fighters
Advice shall be provided on any protective actions to be taken during fire-fighting, such as “keep
containers cool with water spray”, and on special protective equipment for fire-fighters, such as
boots, overalls, gloves, eye and face protection and breathing apparatus.
6. SECTION 6: Accidental release measures
This section of the safety data sheet shall recommend the appropriate response to spills, leaks, or
releases, to prevent or minimise the adverse effects on persons, property and the environment. It shall
distinguish between responses to large and small spills, in cases where the spill volume has a
significant impact on the hazard. If the procedures for containment and recovery indicate that
different practices are required, these shall be indicated in the safety data sheet.
See standard text for section 6 in each model SDS in the Phrase Catalogue.
6.1. Personal precautions, protective equipment and emergency procedures
6.1.1. For non-emergency personnel
Advice shall be provided related to accidental spills and release of the substance or mixture such as:
(a) the wearing of suitable protective equipment (including personal protective equipment referred
to under Section 8 of the safety data sheet) to prevent any contamination of skin, eyes and personal
clothing;
(b) removal of ignition sources, provision of sufficient ventilation, control of dust; and
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(c) emergency procedures such as the need to evacuate the danger area or to consult an expert.
6.1.2. For emergency responders
Advice shall be provided related to suitable fabric for personal protective clothing (such as
“appropriate: Butylene”; “not appropriate: PVC”).
Any advice provided by the suppliers of the relevant raw materials (e.g. solvents) should be copied into the mixture SDS.
6.2. Environmental precautions
Advice shall be provided on any environmental precautions to be taken related to accidental spills and
release of the substance or mixture, such as keeping away from drains, surface and ground water.
6.3. Methods and material for containment and cleaning up
6.3.1. Appropriate advice shall be provided on how to contain a spill. Appropriate containment techniques
may include any of the following:
(a) bunding, covering of drains;
(b) capping procedures.
6.3.2. Appropriate advice shall be provided on how to clean up a spill. Appropriate clean up procedures
may include any of the following:
(a) neutralisation techniques;
(b) decontamination techniques;
(c) adsorbent materials;
(d) cleaning techniques;
(e) vacuuming techniques;
(f) equipment required for containment/clean up (include the use of non-sparking tools and
equipment where applicable).
6.3.3. Any other information shall be provided relating to spills and releases, including advice on
inappropriate containment or clean up techniques, such as by indications like ‘never use …’.
6.4. Reference to other sections
If appropriate Sections 8 and 13 shall be referred to.
7. SECTION 7: Handling and storage
This section of the safety data sheet shall provide advice on safe handling practices. It shall
emphasise precautions that are appropriate to the identified uses referred to under Subsection 1.2 and
to the unique properties of the substance or mixture.
Information in this section of the safety data sheet shall relate to the protection of human health,
safety and the environment. It shall assist the employer in devising suitable working procedures and
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organisational measures according to Article 5 of Directive 98/24/EC8 and Article 5 of Directive
2004/37/EC9.
Where a chemical safety report is required, the information in this section of the safety data sheet
shall be consistent with the information given for the identified uses in the chemical safety report and
the exposure scenarios showing control of risk from the chemical safety report set out in the annex to
the safety data sheet.
See guidance box under sub-section 1.2 (page 17).
In addition to information given in this section, relevant information may also be found in Section 8.
7.1. Precautions for safe handling
Provide recommendations for handling in accordance with the hazardous properties of the product. The recommendations in this section will largely be based on the most relevant exposure scenario for the mixture (refer to the additional CEPE guidance mentioned in the introduction).
If appropriate in light of pack size, advice on safe physical handling can also be given, e.g. with reference to Directive 90/269/EEC on manual handling of loads or the corresponding national legislation.
7.1.1. Recommendations shall be specified to:
(a) allow safe handling of the substance or mixture, such as containment and measures to prevent
fire as well as aerosol and dust generation;
(b) prevent handling of incompatible substances or mixtures; and
(c) reduce the release of the substance or mixture to the environment, such as avoiding spills or
keeping away from drains.
Prescribe appropriate measures to prevent release to environment to comply with national regulations.
State: “Do not allow to enter drains or water courses.”
7.1.2. Advice on general occupational hygiene shall be provided, such as:
(a) not to eat, drink and smoke in work areas;
(b) to wash hands after use; and
(c) to remove contaminated clothing and protective equipment before entering eating areas.
7.2. Conditions for safe storage, including any incompatibilities
The advice provided shall be consistent with the physical and chemical properties described in
Section 9 of the safety data sheet. If relevant, advice shall be provided on specific storage
requirements including:
(a) How to manage risks associated with:
(i) explosive atmospheres;
8 Chemical Agents Directive – see p.13
9 Carcinogens Directive – see p.21
EN 28 EN
(ii) corrosive conditions;
(iii) flammability hazards;
(iv) incompatible substances or mixtures;
(v) evaporative conditions; and
(vi) potential ignition sources (including electrical equipment).
Provide details of any segregation requirements or special storage conditions applying to the product, e.g.
“Store away from…”: identify any chemicals with which the product may react and should therefore not be stored in close proximity.
Example: if the material is flammable, advise to “Store away from oxidising materials”
(b) How to control the effects of:
(i) weather conditions;
(ii) ambient pressure;
(iii) temperature;
(iv) sunlight;
(v) humidity; and
(vi) vibration.
(c) How to maintain the integrity of the substance or mixture by the use of:
(i) stabilisers; and
(ii) anti-oxidants.
(d) Other advice including:
(i) ventilation requirements;
(ii) specific designs for storage rooms or vessels (including retention walls and ventilation);
(iii) quantity limits under storage conditions (if relevant); and
(iv) packaging compatibilities.
Specify appropriate storage conditions based on the relevant exposure scenario(s).
“Store in accordance with…”: quote the current national regulations applicable to storage of the product.
“Store between... and... °C”: indicate minimum and maximum storage temperature.
7.3. Specific end use(s)
For substances and mixtures designed for specific end use(s), recommendations shall relate to the
identified use(s) referred to in Subsection 1.2 and be detailed and operational. If an exposure scenario
is attached, reference to it may be made or the information as required in Subsections 7.1 and 7.2
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shall be provided. If an actor in the supply chain has carried out a chemical safety assessment for the
mixture, it is sufficient that the safety data sheet and the exposure scenarios are consistent with the
chemical safety report for the mixture instead of with the chemical safety reports for each substance
in the mixture. If industry or sector specific guidance is available, detailed reference to it (including
source and issuing date) may be made.
The recommendations for this section will largely be based on the most relevant exposure scenario for the mixture or its hazardous substance(s), which should be referenced. In this section it is permissible to refer directly to an attached exposure scenario, if there is one, instead of providing the information here.
In the absence of an exposure scenario, provide information here including control measures for specific end uses.
8. SECTION 8: Exposure controls/personal protection
This section of the safety data sheet shall describe the applicable occupational exposure limits and
necessary risk management measures.
Where a chemical safety report is required, the information in this section of the safety data sheet
shall be consistent with the information given for the identified uses in the chemical safety report and
the exposure scenarios showing control of risk from the chemical safety report set out in the annex to
the safety data sheet.
8.1. Control parameters
8.1.1. Where available, the following national limit values, including the legal basis of each of them, which
are currently applicable in the Member State in which the safety data sheet is being provided shall be
listed for the substance or for each of the substances in the mixture. When listing occupational
exposure limit values, the chemical identity as specified in Section 3 shall be used.
8.1.1.1. the national occupational exposure limit values that correspond to Community occupational exposure
limit values in accordance with Directive 98/24/EC, including any notations as referred to in Article
2(1) of Commission Decision 95/320/EC10
;
8.1.1.2. the national occupational exposure limit values that correspond to Community limit values in
accordance with Directive 2004/37/EC, including any notations as referred to in Article 2(1) of
Commission Decision 95/320/EC;
8.1.1.3. any other national occupational exposure limit values;
8.1.1.4. the national biological limit values that correspond to Community biological limit values in
accordance with Directive 98/24/EC, including any notations as referred to in Article 2(1) of
Commission Decision 95/320/EC;
8.1.1.5. any other national biological limit values.
Include the occupational exposure limit values (e.g. ceiling, short-term, long-term limits) for- all substances listed in Section 3.2 which are either:
- included in the relevant member state occupational exposure limit list, or
- assigned an exposure limit agreed by suppliers or by an association. Information on national OELs can be found on http://osha.europa.eu/good_practice/risks/ds/oel/members.stm
10
Commission Decision of 12 July 1995 setting up a Scientific Committee for Occupational Exposure
Limits to Chemical Agents OJ L 188, 9.8.1995, p. 14.
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“According to…”: quote the reference of the Occupational Exposure Limits list used. (This will usually be the officially recognised list for the country into which the mixture is supplied).
8.1.2. Information on currently recommended monitoring procedures shall be provided at least for the most
relevant substances.
Repeat the monitoring procedures detailed in the exposure scenario provided by the substance supplier.
If national recommendations or guidance are available, then this may be referenced.
8.1.3. If air contaminants are formed when using the substance or mixture as intended, applicable
occupational exposure limit values and/or biological limit values for these shall also be listed.
If hazardous substances are known to be released during the identified use of your product, e.g. as a result of chemical reaction, any applicable exposure limit values for these released substances must be listed.
If there is an exposure limit for particulates in the relevant member state occupational exposure limit list and the product is intended to be applied using spraying techniques, it is recommended to include this limit in section 8.1.
Note: There is no need to list materials which have been assigned only nuisance dust limits where these are not relevant, e.g. the powder is incorporated into a non-sprayed liquid product so dust inhalation is not possible in practice.
For powder coatings, include the member state occupational exposure limits for total
inhalable dust and respirable dust where available.
8.1.4. Where a chemical safety report is required or a DNEL as referred to in Section 1.4 of Annex I or a
PNEC as referred to in Section 3.3 of Annex I is available, the relevant DNELs and PNECs for the
substance shall be given for the exposure scenarios from the chemical safety report set out in the
annex to the safety data sheet.
List all the DNELs/PNECs for the hazardous substances in the mixture, as provided in the extended SDS for the raw materials used.
8.1.5. Where a control banding approach is used to decide on risk management measures in relation to
specific uses, sufficient detail shall be given to enable effective management of the risk. The context
and limitations of the specific control banding recommendation shall be made clear.
(Guidance on this point will be added as exposure scenarios evolve and become clearer.)
8.2. Exposure controls
The information required in the present subsection shall be provided, unless an exposure scenario
containing that information is attached to the safety data sheet.
It is permissible to refer directly to the annexed exposure scenario(s) if available, otherwise provide specific guidance in this section as listed below.
Where the supplier has waived a test under Section 3 of Annex XI, he shall indicate the specific
conditions of use relied on to justify the waiving.
Where a substance has been registered as an isolated intermediate (on-site or transported), the
supplier shall indicate that this safety data sheet is consistent with the specific conditions relied on to
justify the registration in accordance with Articles 17 or 18.
The two paragraphs above are not relevant to mixtures.
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8.2.1. Appropriate engineering controls
The description of appropriate exposure control measures shall relate to the identified use(s) of the
substance or mixture as referred to in Subsection 1.2. This information shall be sufficient to enable
the employer to carry out an assessment of risk to the safety and health of workers arising from the
presence of the substance or mixture in accordance with Articles 4 to 6 of Directive 98/24/EC as well
as in accordance with Articles 3 to 5 of Directive 2004/37/EC, where appropriate.
This information shall complement that already given under Section 7.
8.2.2. Individual protection measures, such as personal protective equipment
8.2.2.1. The information on use of personal protective equipment shall be consistent with good occupational
hygiene practices and in conjunction with other control measures, including engineering controls,
ventilation and isolation. Where appropriate, Section 5 shall be referred to for specific fire/chemical
personal protective equipment advice.
Where exposure control/personal protection is needed, section 8.2 should specify in detail which equipment will provide adequate and suitable protection. Where appropriate, reference should be made to the relevant EN standards.
8.2.2.2. Taking into account Council Directive 89/686/EEC11
and referring to the appropriate CEN standards,
detailed specifications shall be given on which equipment will provide adequate and suitable
protection, including:
(a) Eye/face protection
The type of eye/face protection equipment required shall be specified based on the hazard of the
substance or mixture and potential for contact, such as safety glasses, safety goggles, face shield.
(b) Skin protection
(i) Hand protection
The type of gloves to be worn when handling the substance or mixture shall be clearly specified
based on the hazard of the substance or mixture and potential for contact and with regard to the
amount and duration of dermal exposure, including:
– the type of material and its thickness,
– the typical or minimum breakthrough times of the glove material.
If necessary any additional hand protection measures shall be indicated.
The CEPE TC LSDS recognises that specific information is unlikely to be available and that testing of gloves with all products is neither practical nor economically possible. The TC recommends that compilers:
1) Refer to the recommendations of the glove supplier on glove suitability/usage times etc for the particular solvent blend/product use. Assess such information for its value and include in your SDS, or
2) If glove suppliers are unable to provide appropriate information, the most suitable glove type(s) for the most significant solvent present should be selected from either
11
Personal Protective Equipment Directive, OJ L 399, 30.12.1989, p. 18 – consolidated version
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- lists compiled by member states, such as in the UK Health and Safety Executive’s publication on selection of gloves HSG206, or by other authoritative organisations
- the table in Best Practice Guideline 5 “Safe Use of Gloves” (June 2010) published by the European Solvents Industry Group (ESIG), available at http://www.esig.org/en/library/publications/best-practice-guides
Specific trials are recommended for corrosive and/or sensitizing mixtures.
Recommend hand checks for operators using sensitizing materials.
Give appropriate generic statements on safe use of gloves (see Phrase Catalogue):
- “There is no one glove material or combination of materials that will give unlimited resistance to any individual or combination of chemicals.”
- “For prolonged or repeated handling, use ____”
- “The instructions and information provided by the glove manufacturer on use, storage, maintenance and replacement must be followed.”
- “Gloves should be replaced regularly and if there is any sign of damage to the glove material.”
- “Always ensure that gloves are free from defects and that they are stored and used correctly.”
- “The performance or effectiveness of the glove may be reduced by physical/ chemical damage and poor maintenance.”
- “Barrier creams may help to protect the exposed areas of the skin, they should however not be applied once exposure has occurred.”
It is recommended to quote the source of any recommendation in this section of the SDS and to advise that the user checks the appropriateness of the gloves selected for the particular conditions of use.
(ii) Other
If it is necessary to protect a part of the body other than the hands, the type and quality of protection
equipment required shall be specified, such as gauntlets, boots, bodysuit based on the hazards
associated with the substance or mixture and the potential for contact.
If necessary, any additional skin protection measures and specific hygiene measures shall be
indicated.
(c) Respiratory protection
For gases, vapours, mist or dust, the type of protective equipment to be used shall be specified based
on the hazard and potential for exposure, including air-purifying respirators, specifying the proper
purifying element (cartridge or canister), the adequate particulate filters and the adequate masks, or
self contained breathing apparatus.
Specify the type of respiratory protective equipment to be used. Select from: air-fed, cartridge, disposable masks, full-face or half-mask model. Specify the type of filter to be used in line with the product type.
The following should be included when any applied industrial or decorative coating is likely to be subjected to sanding, flatting, welding or flame cutting operations:
“Dry sanding, flame cutting and/or welding of the dry paint film will give rise to dust and/or hazardous fumes. Wet [sanding]/[flatting] should be used wherever possible. If exposure cannot be avoided by the provision of local exhaust ventilation, suitable respiratory protective equipment should be used.”
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In addition, the following should be included where the coating is a two pack isocyanate:
“Under cool dry conditions, it is possible for the isocyanate to remain unreacted in the paint film for up to 30 hours after application. If dry flatting is unavoidable air fed respiratory protective equipment should be used.”
(d) Thermal hazards
When specifying protective equipment to be worn for materials that represent a thermal hazard,
special consideration shall be given to the construction of the personal protective equipment.
8.2.3. Environmental exposure controls
The information required by the employer to fulfil his commitments under Community environmental
protection legislation shall be specified.
Where a chemical safety report is required, a summary of the risk management measures that
adequately control exposure of the environment to the substance shall be given for the exposure
scenarios set out in the annex to the safety data sheet.
Refer to national legislation as mentioned in section 15, and state: "Do not allow to enter drains or water courses." (see Phrase Catalogue)
9. SECTION 9: Physical and chemical properties
This section of the safety data sheet shall describe the empirical data relating to the substance or
mixture, if relevant. The information in this section shall be consistent with the information provided
in the registration and/or in the chemical safety report where required, and with the classification of
the substance or mixture.
9.1. Information on basic physical and chemical properties
The following properties shall be clearly identified including, where appropriate, a reference to the
test methods used and specification of appropriate units of measurement and/or reference conditions.
If relevant for the interpretation of the numerical value, the method of determination shall also be
provided (for example the method for flash point, the open-cup/closed cup method):
(a) Appearance:
The physical state (solid (including appropriate and available safety information on granulometry and
specific surface area if not already specified elsewhere in this safety data sheet), liquid, gas) and the
colour of the substance or mixture as supplied shall be indicated;
(b) Odour:
If odour is perceptible, a brief description of it shall be given;
(c) Odour threshold;
(d) pH:
The pH shall be indicated of the substance or mixture as supplied or of an aqueous solution; in the
latter case, the concentration shall be indicated;
(e) Melting point / freezing point;
(f) Initial boiling point and boiling range;
EN 34 EN
(g) Flash point;
(h) Evaporation rate;
(i) Flammability (solid, gas);
(j) Upper/lower flammability or explosive limits;
(k) Vapour pressure;
(l) Vapour density;
(m) Relative density;
(n) Solubility(ies);
(o) Partition coefficient: n-octanol/water;
(p) Auto-ignition temperature;
(q) Decomposition temperature;
(r) Viscosity;
(s) Explosive properties;
(t) Oxidising properties.
If it is stated that a particular property does not apply or if information on a particular property is not
available, the reasons shall be given.
To enable proper control measures to be taken, all relevant information on the substance or mixture
shall be provided. The information in this section shall be consistent with the information provided in
a registration where one is required.
In the case of a mixture, the entries shall clearly indicate to which substance in the mixture the data
apply, unless it is valid for the whole mixture.
The properties mentioned in 9.1 must be listed in the SDS and should be considered as minimum requirements. If other properties are relevant/available, indicate these also.
In the case of a mixture, mention the values for the mixture itself if available, otherwise give values for the substance(s) which mainly contribute(s) to the specific property.
Standard phrases will be implemented in the Phrase Catalogue to indicate the reasons why data are not applicable or not available, e.g. (non-binding examples)
- Testing not possible due to nature of the product
- Not relevant/applicable due to nature of the product
- The product itself is not explosive, but the formation of explosive vapour (or dust) / air mixture is possible
etc.
In an SDS covering multiple products it may be necessary to provide ranges of values or generic information (e.g. “Colour: various”). These should only be used where such variation does not affect the safe use of the product (see also subsection 1.1).
EN 35 EN
9.2. Other information
Other physical and chemical parameters shall be indicated as necessary, such as miscibility, fat
solubility (solvent – oil to be specified), conductivity, or gas group. Appropriate and available safety
information on redox potential, radical formation potential and photocatalytic properties shall be
indicated.
10. SECTION 10: Stability and reactivity
This section of the safety data sheet shall describe the stability of the substance or mixture and the
possibility of hazardous reactions occurring under certain conditions of use and also if released into
the environment, including, where appropriate, a reference to the test methods used. If it is stated that
a particular property does not apply or if information on a particular property is not available, the
reasons shall be given.
Select appropriate text for these sub-sections from the Phrase Catalogue, or add relevant information as required.
10.1. Reactivity
10.1.1. The reactivity hazards of the substance or mixture shall be described. Specific test data shall be
provided for the substance or mixture as a whole, where available. However, the information may
also be based on general data for the class or family of substance or mixture if such data adequately
represent the anticipated hazard of the substance or mixture.
10.1.2. If data for mixtures are not available, data on substances in the mixture shall be provided. In
determining incompatibility, the substances, containers and contaminants that the substance or
mixture might be exposed to during transportation, storage and use shall be considered.
10.2. Chemical stability
It shall be indicated if the substance or mixture is stable or unstable under normal ambient and
anticipated storage and handling conditions of temperature and pressure. Any stabilisers which are, or
may need to be, used to maintain the chemical stability of the substance or mixture shall be described.
The safety significance of any change in the physical appearance of the substance or mixture shall be
indicated.
10.3. Possibility of hazardous reactions
If relevant, it shall be stated if the substance or mixture will react or polymerise, releasing excess
pressure or heat, or creating other hazardous conditions. The conditions under which the hazardous
reactions may occur shall be described.
For products containing auto-oxidising oils use plug-in phrase Pi-029 (see 4.2.18).
10.4. Conditions to avoid
Conditions such as temperature, pressure, light, shock, static discharge, vibrations or other physical
stresses that might result in a hazardous situation shall be listed and if appropriate a brief description
of measures to be taken to manage risks associated with such hazards shall be given.
10.5. Incompatible materials
Families of substances or mixtures or specific substances, such as water, air, acids, bases, oxidising
agents, with which the substance or mixture could react to produce a hazardous situation (like an
explosion, a release of toxic or flammable materials, or a liberation of excessive heat) shall be listed
EN 36 EN
and if appropriate a brief description of measures to be taken to manage risks associated with such
hazards shall be given.
10.6. Hazardous decomposition products
Known and reasonably anticipated hazardous decomposition products produced as a result of use,
storage, spill and heating shall be listed. Hazardous combustion products shall be included in Section
5 of the safety data sheet.
If specific information is known e.g. about decomposition products under specific conditions, it should be given here. (See default phrases in model SDS and plug-in phrases)
11. SECTION 11: Toxicological information
This section of the safety data sheet is meant for use primarily by medical professionals, occupational
health and safety professionals and toxicologists. A concise but complete and comprehensible
description of the various toxicological (health) effects and the available data used to identify those
effects shall be provided, including where appropriate information on toxicokinetics, metabolism and
distribution. The information in this section shall be consistent with the information provided in the
registration and/or in the chemical safety report where required, and with the classification of the
substance or mixture.
11.1. Information on toxicological effects
11.1.1. Substances
11.1.1.1. The relevant hazard classes for which information shall be provided, are:
(a) acute toxicity;
(b) skin corrosion/irritation;
(c) serious eye damage/irritation;
(d) respiratory or skin sensitization;
(e) germ cell mutagenicity;
(f) carcinogenicity;
(g) reproductive toxicity;
(h) STOT-single exposure;
(i) STOT-repeated exposure;
(j) aspiration hazard.
11.1.1.2. For substances subject to registration, brief summaries of the information derived from the
application of Annexes VII to XI shall be given, including, where appropriate, a reference to the test
methods used. For substances subject to registration, the information shall also include the result of
the comparison of the available data with the criteria given in Regulation (EC) No 1272/2008 for
CMR, categories 1A and 1B, following point 1.3.1 of Annex I to this Regulation.
11.1.2. Mixtures
11.1.2.1. The relevant effects, for which information shall be provided, are:
EN 37 EN
(a) acute toxicity;
(b) irritation;
(c) corrosivity;
(d) sensitisation;
(e) repeated dose toxicity;
(f) carcinogenicity;
(g) mutagenicity;
(h) toxicity for reproduction.
11.1.2.2. For the health effects of carcinogenicity, mutagenicity and toxicity for reproduction, classification for
a given health effect based on the conventional method outlined in Article 6(1)(a) of Directive
1999/45/EC, and relevant information for the substances listed under Section 3 shall be provided.
11.1.2.3. For other health effects, if a mixture has not been tested as a whole for a given health effect,
information relevant to that health effect relating to substances listed under Section 3 shall be
provided, if relevant.
11.1.3. Information shall be provided for each hazard class, differentiation or effect. If it is stated that the
substance or mixture is not classified for a particular hazard class, differentiation or effect, the safety
data sheet shall clearly state whether this is due to lack of data, technical impossibility to obtain the
data, inconclusive data or data which are conclusive although insufficient for classification; in the
latter case the safety data sheet shall specify “based on available data, the classification criteria are
not met.”
11.1.4. The data included in this subsection shall apply to the substance or mixture as placed on the market.
If available, the relevant toxicological properties of the hazardous substances in a mixture shall also
be provided, such as the LD50, Acute Toxicity Estimates or LC50.
11.1.5. Where there is a substantial amount of test data on the substance or mixture, it may be necessary to
summarise results of the critical studies used, for example by route of exposure.
11.1.6. Where the classification criteria for a particular hazard class are not met, information supporting this
conclusion shall be provided.
11.1.7. Information on likely routes of exposure
Information shall be provided on likely routes of exposure and the effects of the substance or mixture
via each possible route of exposure, that is, through ingestion (swallowing), inhalation or skin/eye
exposure. If health effects are not known, this shall be stated.
11.1.8. Symptoms related to the physical, chemical and toxicological characteristics
Potential adverse health effects and symptoms associated with exposure to the substance or mixture
and its ingredients or known by-products shall be described. Available information shall be provided
on the symptoms related to the physical, chemical, and toxicological characteristics of the substance
or mixture following exposure. The first symptoms at low exposures through to the consequences of
severe exposure shall be described, such as “headaches and dizziness may occur, proceeding to
fainting or unconsciousness; large doses may result in coma and death”.
11.1.9. Delayed and immediate effects as well as chronic effects from short and long term exposure
EN 38 EN
Information shall be provided on whether delayed or immediate effects can be expected after short or
long term exposure. Information on acute and chronic health effects relating to human exposure to the
substance or mixture shall also be provided. Where human data are not available, animal data shall be
summarised and the species clearly identified. It shall be indicated whether toxicological data is based
on human or animal data.
11.1.10. Interactive effects
Information on interactions shall be included if relevant and available.
11.1.11. Absence of specific data
It may not always be possible to obtain information on the hazards of a substance or mixture. In cases
where data on the specific substance or mixture are not available, data on similar substances or
mixtures if appropriate, may be used, provided the relevant similar substance or mixture is identified.
Where specific data are not used, or where data are not available, this shall be clearly stated.
11.1.12. Mixture versus substance information
11.1.12.1. The substances in a mixture may interact with each other in the body resulting in different rates of
absorption, metabolism and excretion. As a result, the toxic actions may be altered and the overall
toxicity of the mixture may be different from that of the substances in it. This shall be taken into
account when providing toxicological information in this section of the safety data sheet.
11.1.12.2. Classification of mixtures as having effects of carcinogenicity, mutagenicity or toxicity for
reproduction must be calculated from available information regarding substances in the mixture. For
other health effects, it is necessary to consider whether the concentration of each substance is
sufficient to contribute to the overall health effects of the mixture. The information on toxic effects
shall be presented for each substance, except for the following cases:
(a) if the information is duplicated, it shall be listed only once for the mixture overall, such as
when two substances both cause vomiting and diarrhoea;
(b) if it is unlikely that these effects will occur at the concentrations present, such as when a mild
irritant is diluted to below a certain concentration in a non-irritant solution;
(c) where information on interactions between substances in a mixture is not available,
assumptions shall not be made and instead the health effects of each substance shall be listed
separately.
11.1.13. Other information
Other relevant information on adverse health effects shall be included even when not required by the
classification criteria.
Guidance on 11.1
In addition to the standard model SDS text, test data for the whole mixture should be given in sub-section 11.1 if available; otherwise data for the individual hazardous substances in the mixture (identified in section 3.2) must be listed for the effects (a)-(h) in 11.1.2.1, if relevant for the classification of the mixture and if available (see 11.1.4).
Biocidal products will have been tested, so the relevant information for the whole mixture can be used here.
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12. SECTION 12: Ecological information
This section of the safety data sheet shall describe the information provided to evaluate the
environmental impact of the substance or mixture where it is released to the environment. Under
Subsections 12.1 to 12.6 of the safety data sheet a short summary of the data shall be provided
including, where available, relevant test data and clearly indicating species, media, units, test duration
and test conditions. This information may assist in handling spills, and evaluating waste treatment
practices, control of release, accidental release measures and transport. If it is stated that a particular
property does not apply or if information on a particular property is not available, the reasons shall be
indicated.
Information on bioaccumulation, persistence and degradability shall be given, where available and
appropriate, for each relevant substance in the mixture. Information shall also be provided for
hazardous transformation products arising from the degradation of substances and mixtures.
The information in this section shall be consistent with the information provided in the registration
and/or in the chemical safety report where required, and with the classification of the substance or
mixture.
12.1. Toxicity
Information on toxicity using data from tests performed on aquatic and/or terrestrial organisms shall
be provided when available. This shall include relevant available data on aquatic toxicity, both acute
and chronic for fish, crustaceans, algae and other aquatic plants. In addition, toxicity data on soil
micro and macro-organisms and other environmentally relevant organisms, such as birds, bees and
plants, shall be included when available. Where the substance or mixture has inhibitory effects on the
activity of micro-organisms, the possible impact on sewage treatment plants shall be mentioned.
For substances subject to registration, summaries of the information derived from the application of
Annexes VII to XI shall be included.
12.2. Persistence and degradability
Persistence and degradability is the potential for the substance or the appropriate substances in a
mixture to degrade in the environment, either through biodegradation or other processes such as
oxidation or hydrolysis. Test results relevant to assess persistence and degradability shall be given
where available. If degradation half-lives are quoted it must be indicated whether these half lives refer
to mineralisation or to primary degradation. The potential of the substance or certain substances in a
mixture to degrade in sewage treatment plants shall also be mentioned.
This information shall be given where available and appropriate, for each individual substance in the
mixture which is required to be listed in Section 3 of the safety data sheet.
12.3. Bioaccumulative potential
Bioaccumulative potential is the potential of the substance or certain substances in a mixture to
accumulate in biota and, eventually, to pass through the food chain. Test results relevant to assess the
bioaccumulative potential shall be given. This shall include reference to the octanol-water partition
coefficient (Kow) and bioconcentration factor (BCF), if available.
This information shall be given where available and appropriate, for each individual substance in the
mixture which is required to be listed in Section 3 of the safety data sheet.
12.4. Mobility in soil
Mobility in soil is the potential of the substance or the constituents of a mixture, if released to the
environment, to move under natural forces to the groundwater or to a distance from the site of release.
The potential for mobility in soil shall be given where available. Information on mobility can be
determined from relevant mobility data such as adsorption studies or leaching studies, known or
predicted distribution to environmental compartments, or surface tension. For example, Koc values
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can be predicted from octanol/water partition coefficients (Kow). Leaching and mobility can be
predicted from models.
This information shall be given where available and appropriate, for each individual substance in the
mixture which is required to be listed in Section 3 of the safety data sheet.
Where experimental data is available, that data shall, in general, take precedence over models and
predictions.
12.5. Results of PBT and vPvB assessment
Where a chemical safety report is required, the results of the PBT and vPvB assessment as set out in
the chemical safety report shall be given.
12.6. Other adverse effects
Information on any other adverse effects on the environment shall be included where available, such
as environmental fate (exposure), photochemical ozone creation potential, ozone depletion potential,
endocrine disrupting potential and/or global warming potential.
Guidance for Section 12
Relevant to all products, whether or not classified as dangerous for the environment. Guidance is provided on three possible situations.
General
In all cases, regardless of whether or not the product is classified as dangerous for the environment, include in this section of the safety data sheet the standard phrases:
- “There are no data on the mixture itself.” (if the product itself has not been tested)
- “The product should not be allowed to enter drains or water courses.”
Situation 1: the product is not classified as dangerous for the environment and does not contain any substances classified as dangerous for the environment
- Add the following (plug-in phrase Pi-026):
“The mixture has been assessed following the conventional method of the Dangerous Preparations Directive 1999/45/EC and is not classified as dangerous for the environment.”
Situation 2: the product is not classified as dangerous for the environment, but contains substances classified as dangerous for the environment. (Substance listed in section 3)
- Add the following (plug-in phrase Pi-027):
“The mixture has been assessed following the conventional method of the Dangerous Preparations Directive 1999/45/EC and is not classified as dangerous for the environment, but contains substance(s) hazardous to the aquatic environment according to Regulation (EC) No 1272/2008. See section 3 for details.”
For each substance classified as hazardous to the aquatic environment and listed in subsection 3.2 of the safety data sheet, include any appropriate information provided in the supplier’s safety data sheet for the substance under the relevant subheadings 12.1 to 12.6.
Situation 3: the mixture is classified as dangerous for the environment
- Add the following (plug-in phrase Pi-028):
“The mixture has been assessed following the conventional method of the Dangerous Preparations Directive 1999/45/EC and is classified for eco-toxicological properties accordingly. See Sections 2 and 3 for details.”
For those substances classified as hazardous to the aquatic environment and listed in section 3.2 of the safety data sheet, include any appropriate information provided in the supplier’s safety data sheet for the substance under the relevant subheadings 12.1 to 12.6.
EN 41 EN
13. SECTION 13: Disposal considerations
This section of the safety data sheet shall describe information for proper waste management of the
substance or mixture and/or its container to assist in the determination of safe and environmentally
preferred waste management options, consistent with the requirements in accordance with Directive
2008/98/EC of the European Parliament and of the Council12
of the Member State in which the safety
data sheet is being supplied. Information relevant for the safety of persons conducting waste
management activities shall complement the information given in Section 8.
Where a chemical safety report is required and where a waste stage analysis has been performed, the
information on the waste management measures shall be consistent with the identified uses in the
chemical safety report and the exposure scenarios from the chemical safety report set out in the annex
to the safety data sheet.
This section has to be adapted for national legislation.
13.1. Waste treatment methods
(a) Waste treatment containers and methods shall be specified including the appropriate methods
of waste treatment of both the substance or mixture and any contaminated packaging (for example
incineration, recycling, landfilling);
“Waste and emptied containers should ...”: The most appropriate advice based on national or local waste regulations should be given.
(b) Physical/chemical properties that may affect waste treatment options shall be specified;
“The European Waste Catalogue classification of this product, when disposed of as waste, is [add the relevant 6- digit code and relevant name from the European Waste Catalogue]”. Note: In the case of powder coatings, regardless of the classification as hazardous or non-hazardous, these should be consigned under the code 08 02 01 `Waste Coating Powders’,
“If this product is mixed with other wastes, the original waste product code may no longer apply and the appropriate code should be assigned. For further information contact your local waste authority.”
“Using information provided in this safety data sheet, advice should be obtained from the relevant waste authority on the classification of empty containers.”
(c) Sewage disposal shall be discouraged;
For all products, the following information should be given :
“Do not allow into drains or water courses or dispose of where ground or surface waters may be affected.
(d) Where appropriate, any special precautions for any recommended waste treatment option shall
be identified.
Any relevant Community provisions relating to waste shall be referred to. In their absence any
relevant national or regional provisions in force shall be referred to.
12
Waste Directive, OJ L 312, 22.11.2008, p. 3.
EN 42 EN
14. SECTION 14: Transport information
This section of the safety data sheet shall provide basic classification information for
transporting/shipment of substances or mixtures mentioned under Section 1 by road, rail, sea, inland
waterways or air. Where information is not available or relevant this shall be stated.
Where relevant, it shall provide information on the transport classification for each of the UN Model
Regulations: European Agreement concerning the International Carriage of Dangerous Goods by
Road (ADR)13
, Regulations concerning the International Carriage of Dangerous Goods by Rail
(RID)14
, European Agreement concerning the International Carriage of Dangerous Goods by Inland
Waterways (ADN)15
, all three of which have been implemented by Directive 2008/68/EC of the
European Parliament and of the Council on the inland transport of dangerous goods16
, International
Maritime Dangerous Goods (IMDG) Code17
(sea), and Technical Instructions for the Safe Transport
of Dangerous Goods by Air (ICAO)18
(air).
The following should be included for all products:
“Transport within user’s premises: always transport in closed containers that are upright and secure. Ensure that persons transporting the product know what to do in the event of an accident or spillage.”
For products not classified as dangerous for carriage use the following phrase:
“This mixture is not classified as dangerous according to international transport regulations (ADR/RID, ADN, IMDG, ICAO/IATA)".
14.1. UN number
The UN number (i.e. the four-figure identification number of the substance, mixture or article
preceded by the letters ‘UN’) from the UN Model Regulations shall be provided.
14.2. UN proper shipping name
The UN proper shipping name from the UN Model Regulations shall be provided, unless it has
appeared as the product identifier in Subsection 1.1.
14.3. Transport hazard class(es)
The transport hazard class (and subsidiary risks) assigned to the substances or mixtures according to
the predominant hazard that they present in accordance with the UN Model Regulations shall be
provided.
14.4. Packing group
The packing group number from the UN Model Regulations shall be provided, if applicable. The
packing group number is assigned to certain substances in accordance with their degree of hazard.
13 United Nations, Economic Commission for Europe, version applicable as from 1 January 2009, ISBN-
978-92-1-139131-2.
14 Annex 1 to Appendix B (Uniform Rules concerning the Contract for International Carriage of Goods
by Rail) of the Convention concerning International Carriage by Rail, version with effect from 1
January 2009.
15 Version as revised as of 1 January 2007.
16 OJ L 260, 30.9.2008, p. 1.
17 International Maritime Organisation, 2006 edition, ISBN 978-92-8001-4214-3.
18 IATA, 2007-2008 edition.
EN 43 EN
14.5. Environmental hazards
It shall be indicated whether the substance or mixture is environmentally hazardous according to the
criteria of the UN Model Regulations (as reflected in the IMDG Code, ADR, RID and ADN) and /or
a marine pollutant according to the IMDG Code. If authorized or intended for carriage by inland
waterways in tank-vessels, it shall be indicated whether the substance or mixture is environmentally
hazardous in tank-vessels only according to ADN.
14.6. Special precautions for user
Information shall be provided on any special precautions with which a user should or must comply or
be aware of in connection with transport or conveyance either within or outside his premises.
14.7. Transport in bulk according to Annex II of MARPOL 73/78 and the IBC Code
This subsection only applies when cargoes are intended to be carried in bulk according to the
following International Maritime Organisation (IMO) instruments: Annex II of the International
Convention for the Prevention of Pollution from Ships, 1973, as modified by the Protocol of 1978
relating thereto (MARPOL 73/78)19
and the International Code for the Construction and Equipment
of Ships carrying Dangerous Chemicals in Bulk (International Bulk Chemical Code) (IBC Code)20
.
The product name shall be provided (if different from that given in Subsection 1.1) as required by the
shipment document and in accordance with the name used in the lists of product names given in
chapters 17 or 18 of the IBC Code or the latest edition of the IMO’s Marine Environment Protection
Committee (MEPC).2/Circular21
. Ship type required and pollution category shall be indicated.
Guidance for Section 14
The following information should be provided (in the relevant sub-sections) with all products classified as dangerous for carriage, where there is a possibility of onward transport subsequent to purchase. For Transport in accordance with ADR/RID, ADN, IMDG and ICAO/ IATA:
14.1 UN number: {e.g. UN 1992}
14.2 UN proper shipping Name: {e.g. FLAMMABLE LIQUID, TOXIC, N.O.S (methanol, dichloromethane)}
14.3 Transport hazard class(es) {e.g. 3}
Subsidiary Risk {e.g. (6.1)}
Label numbers: {e.g. 3 + 6.1}
14.4 Packing Group: {e.g. III}
14.5 Environmental Hazards {e.g. Marine Pollutant}
14.6 Special Precautions for user Additional information that may be given in 14.6 includes: special provisions, tunnel code, Hazard Identification Number, particular packing provisions, IMDG segregation code, labelling information considered necessary for transport. IMDG Code (additional information):
Marine Pollutant substance: {e.g. white spirit}
19
MARPOL 73/78 – Consolidated edition 2006, London, IMO 2007, ISBN 978-92-801-4216-7. 20
IBC Code, 2007 edition, London, IMO 2007, ISBN 978-92-801-4226-6. 21
MEPC.2/Circular, Provisional categorization of liquid substances, version 14, effective 1 January 2009.
EN 44 EN
Note: indicate those substances contributing most (in % weight) to the identification of the mixture as a Marine Pollutant, with a maximum of 2. This indication is additional to the Technical Names required under the provision for N.O.S. entries and can apply to UN1210, UN1263, UN1866, etc.
If necessary refer to the CEPE list of simplified technical names, prepared by TC Transport.
Emergency Schedule Number: {e.g. F-E, S-D]
Viscous substances up to 30 litre packs: {e.g. “Transport in accordance with 2.3.2.5 of the IMDG Code”}
Note: the viscosity “exemption” does not apply to flammable liquids that are also toxic, corrosive or environmentally hazardous. ADR (additional information):
Viscous substances up to 450 litre packs: {e.g. “exempted according to ADR 2.2.3.1.5”}
Note: the viscosity exemption does not apply to flammable liquids that are also toxic, corrosive or environmentally hazardous. ICAO/IATA (additional information):
Viscous substances: The “viscosity exemption” provision does not apply to air transport.
14.7 Transport in bulk according to Annex II of MARPOL 73/78 and the IBC Code
This sub-section is not relevant for our industry – simply state that it is not applicable.
15. SECTION 15: Regulatory information
This section of the safety data sheet shall describe the other regulatory information on the substance
or mixture that is not already provided in the safety data sheet (such as whether the substance or
mixture is subject to Regulation (EC) No 2037/2000 of the European Parliament and of the Council
of 29 June 2000 on substances that deplete the ozone layer22
, Regulation (EC) No 850/2004 of the
European Parliament and of the Council of 29 April 2004 on persistent organic pollutants and
amending Directive 79/117/EEC23
or Regulation (EC) No 689/2008 of the European Parliament and
of the Council of 17 June 2008 concerning the export and import of dangerous chemicals24
).
15.1. Safety, health and environmental regulations/legislation specific for the substance or mixture
Information regarding relevant Community safety, health and environmental provisions (for example
Seveso category/named substances in Annex I of Directive 96/82/EC25
) or national information on
the regulatory status of the substance or mixture (including the substances in the mixture), including
advice regarding action that should be taken by the recipient as a result of these provisions shall be
provided. Where relevant the national laws of the relevant Member States which implement these
provisions and any other national measures that may be relevant shall be mentioned.
If the substance or mixture covered by this safety data sheet is the subject of specific provisions in
relation to protection of human health or the environment at Community level (such as authorisations
given under Title VII or restrictions under Title VIII) these provisions shall be mentioned.
22
OJ L 244, 29.9.2000, p. 1. – consolidated version 23
OJ L 229, 30.4.2004, p. 5. – consolidated version 24
OJ L 204, 31.7.2008, p. 1. – consolidated version 25
Seveso/COMAH Directive OJ L 10, 14.1.1997, p.13 – consolidated version
EN 45 EN
Give any other regulatory information on the substance or mixture that is not already provided in the safety data sheet. (Note that classification and labelling information does not appear in this section.)
Additional phrases to be included:
“The information contained in this safety data sheet does not constitute the user’s own assessment of workplace risks, as required by other health and safety legislation.
The provisions of the national health and safety at work regulations apply to the use of this product at work.”
In addition, where the use of the product (or components thereof) is restricted by other specific health, safety or environmental protection legislation, appropriate references should be included.
For products classified as highly or extremely flammable, dangerous for the environment etc. (as per Part 2 of Annex I to the Seveso directive) include:
“This product may add to the calculation for determining whether a site is within scope of the Seveso Directive on major accident hazards.”
Indicate any specific legislative provision applied to the product, or any substance therein, such as a Restriction or Authorisation under REACH,
15.2. Chemical Safety Assessment
It shall be indicated if a chemical safety assessment has been carried out for the substance or the
mixture by the supplier.
If you have conducted your own chemical safety assessment, indicate this fact here.
16. SECTION 16: Other information
This section of the safety data sheet shall describe the information relevant to the compilation of the
safety data sheet. It shall incorporate other information that is not included in Sections 1 to 15,
including information on revision of the safety data sheet such as:
(a) in case of a revised safety data sheet, a clear indication of where changes have been made to
the previous version of the safety data sheet, unless such indication is given elsewhere in the safety
data sheet, with an explanation of the changes, if appropriate. A supplier of a substance or mixture
shall maintain an explanation of the changes and provide it upon request;
(b) a key or legend to abbreviations and acronyms used in the safety data sheet;
(c) key literature references and sources for data;
(d) in the case of mixtures, an indication of which of the methods of evaluating information
referred to in Article 9 of Regulation (EC) No 1272/2008 was used for the purpose of classification;
You should indicate in Section 16 whether you have used mixture test data, weight of evidence determination using expert judgment, bridging principles or mixture ingredient data (calculation methods) in order to classify the mixture. If classifying according to the DPD conventional method, state this here if not already mentioned elsewhere in the SDS.
(e) list of relevant R phrases, hazard statements, safety phrases and/or precautionary statements.
Write out the full text of any statements which are not written out in full under Sections 2 to 15;
Include the full text of obligatory phrases/statements, but also additional phrases required by the CLP Regulation (e.g. EUH statements), referred to by number in other sections.
EN 46 EN
(f) advice on any training appropriate for workers to ensure protection of human health and the
environment.
If in accordance with Article 31(10) a supplier of a mixture chooses to identify and inform about the
classification necessary from 1 June 2015 in advance of using it for classification and labelling on the
package, he may include this classification in this section.
If you have already derived a CLP classification for your mixture, but are not yet applying it for product labelling, you may optionally provide it in section 16.
In section 16 providers of safety data sheets may also add disclaimers and/or additional information relevant to the compilation of the safety data sheet or the application of the product.
The following should be included for all products (dangerous and non-dangerous) for which a safety data sheet is provided:
“The product should not be used for purposes other than those shown in Section 1 without first referring to the supplier and obtaining written handling instructions. As the specific conditions of use of the product are outside the supplier’s control, the user is responsible for ensuring that the requirements of relevant legislation are complied with.”
A disclaimer should additionally be included. A suggested text is as follows:
“The information contained in this safety data sheet is based on the present state of knowledge and current national legislation. It provides guidance on health, safety and environmental aspects of the product and should not be construed as any guarantee of technical performance or suitability for particular applications.”
Reference should be made to any relevant legislation, supporting documents and publications produced by the industry trade association which are specifically mentioned or which provide further information.
If references to documents are included, use the following phrase:
“Further information and advice can be found in [quote titles, any reference, and source].”
This section can be used to include any other information considered relevant.
EN 47 EN
PART B
The safety data sheet shall include the following 16 headings in accordance with Article 31(6) and in addition
the subheadings also listed except Section 3, where only Subsection 3.1 or 3.2 need to be included as
appropriate:
SECTION 1: Identification of the substance/mixture and of the company/undertaking
1.1. Product identifier
1.2. Relevant identified uses of the substance or mixture and uses advised against
1.3. Details of the supplier of the safety data sheet
1.4. Emergency telephone number
SECTION 2: Hazards identification
2.1. Classification of the substance or mixture
2.2. Label elements
2.3. Other hazards
SECTION 3: Composition/information on ingredients
3.1. Substances
3.2. Mixtures
SECTION 4: First aid measures
4.1. Description of first aid measures
4.2. Most important symptoms and effects, both acute and delayed
4.3. Indication of any immediate medical attention and special treatment needed
SECTION 5: Fire-fighting measures
5.1. Extinguishing media
5.2. Special hazards arising from the substance or mixture
5.3. Advice for fire-fighters
SECTION 6: Accidental release measures
6.1. Personal precautions, protective equipment and emergency procedures
6.2. Environmental precautions
6.3. Methods and material for containment and cleaning up
SECTION 7: Handling and storage
7.1. Precautions for safe handling
7.2. Conditions for safe storage, including any incompatibilities
7.3. Specific end use(s)
SECTION 8: Exposure controls/personal protection
8.1. Control parameters
8.2. Exposure controls
SECTION 9: Physical and chemical properties
9.1. Information on basic physical and chemical properties
9.2. Other information
EN 48 EN
SECTION 10: Stability and reactivity
10.1. Reactivity
10.2. Chemical stability
10.3. Possibility of hazardous reactions
10.4. Conditions to avoid
10.5. Incompatible materials
10.6. Hazardous decomposition products
SECTION 11: Toxicological information
11.1. Information on toxicological effects
SECTION 12: Ecological information
12.1. Toxicity
12.2. Persistence and degradability
12.3. Bioaccumulative potential
12.4. Mobility in soil
12.5. Results of PBT and vPvB assessment
12.6. Other adverse effects
SECTION 13: Disposal considerations
13.1. Waste treatment methods
SECTION 14: Transport information
14.1. UN number
14.2. UN proper shipping name
14.3. Transport hazard class(es)
14.4. Packing group
14.5. Environmental hazards
14.6. Special precautions for user
14.7. Transport in bulk according to Annex II of MARPOL73/78 and the IBC Code
SECTION 15: Regulatory information
15.1. Safety, health and environmental regulations/legislation specific for the substance or mixture
15.2. Chemical Safety Assessment
SECTION 16: Other information'
EN 49 EN
3.2 Guidance particular to the various model sheets
3.2.1 Model Sheet for basic solvent borne mixtures (SDS-01/EN) This model has been prepared for a flammable or highly flammable solvent borne product. This model can however be extended to mixtures which present health or environmental hazards, which are not covered by other Model Safety Data Sheets. In such circumstances appropriate text (plug-in phrases) should be included in the relevant sections.
e.g. this model can also be extended to mixtures containing nitrocellulose. In this case refer to Chapter 4 of this guide, section 4.2.21.
If such mixtures contain PVC or PVDC binders or chlorine-containing pigments, refer to 4.2.26.
3.2.2 Model sheet for water borne mixtures, containing organic solvents (SDS-02/EN) If such mixtures contain PVC or PVDC binders or chlorine containing pigments, refer to 4.2.26. 3.2.3 Model sheet for coating powders (SDS-03/EN) If the product contains triglycidyl isocyanurate (TGIC), refer to the plug-in phrases relating to this substance (see Chapter 4.2.9).
3.2.4 Model sheet for radiation curable mixtures, acrylate based, classified Xi (irritant) (SDS-04/EN) If the product is classified Xi and R 43, refer to 4.2.27. 3.2.5 Model sheet for mixtures containing isocyanates (SDS-05/EN) This model does not require any specific guidance.
3.2.6 Model Sheet for peroxide hardeners (SDS-06/EN)
This model does not require any specific guidance. 3.2.7 Model sheet for mixtures not classified as dangerous, and containing no dangerous
substances (SDS-07/EN) and 3.2.8 Model sheet for mixtures not classified as dangerous, but containing dangerous
substances (SDS-08/EN and SDS-09/EN) Although not classified as dangerous, some mixtures can however contain solvents and/or quantities of other hazardous substances below the concentration limit for classification. For liability reasons as well as in response to customers' requests, it is useful and recommended to deliver SDS for non-dangerous mixtures, with or without hazardous substances (for those containing hazardous substances it is a legal requirement to provide the SDS on request). It is recommended to do this using a lay-out similar to the one used for dangerous mixtures. SDS-07, 08, 09 cover these possibilities. For specific guidance on model SDS for printing inks, refer to Part 5 of this Guide.
EN 50 EN
4. PLUG-IN PHRASES
4.1 CRITERIA FOR PLUG-IN PHRASES
The CEPE TC Labelling and Safety Data Sheet is responsible for the preparation of plug-in phrases for inclusion in the CEPE guide to safety data sheets. Plug-in phrases will be prepared by CEPE, as the particular circumstances require, and incorporated into this guide and the CEPE Phrase Catalogue.
Plug-in phrases are used to provide specific and/or supplementary information to users of the coatings industry’s products. Plug-in phrases are developed for inclusion in the relevant (sub)sections(s) of the safety data sheet (SDS), prepared in accordance with the provisions on Annex II to Regulation (EC) No 1907/2006 and subsequent amendments.
Plug-in phrases are prepared primarily for Section 7 (Handling and Storage), Section 11 (Toxicological Information) and Section 12 (Ecological Information). They are also prepared for other sections, as appropriate.
Plug-in phrases may be prepared for the following situations: a) for a substance that is not officially classified in Annex VI, Part 3 of Regulation (EC) No
1272/2008, but which - either has been self-classified by the supplier and/or
- for which there is information or data available on significant health or ecological effects, which are not covered by standard R-phrases/H-statements. (Examples are: evidence of genotoxicity in an in vivo study; a positive carcinogenicity result in a well conducted bioassay; information that a substance is very toxic to the environment.)
These plug-in phrases will not duplicate information about effects that are already covered by the “standard” text in model SDSs.
b) for a classified substance, where information or data on significant health effects is
available, which is not yet contained in the Annex VI entry. (Examples are: human carcinogenicity, mutagenicity or reprotoxicity; human sensitisation effects; substances giving narcotic effects.)
c) for a classified substance which is assigned a generic risk phrase/hazard statement, that
does not provide sufficient or unambiguous information on the health effect concerned. (Examples are: R68, R48; H372/H373, if target organs are not specified)
d) for Annex VI or self-classified substances, with specific hazards or risks that are not
adequately identified or explained in the information elsewhere in the SDS, in relation to the particular circumstances of use.
(examples are: the human carcinogenicity of zinc chromate; the sensitisation effects of di-isocyanate prepolymers.)
e) where information is necessary to provide specific guidance or advice on matters such as
safe storage, handling, application, treatment and disposal of products. (examples are: personal protection required when applying; restrictions on flatting of dry films; neutralising of residues before disposal.)
EN 51 EN
4.2 SPECIFIC PLUG-IN PHRASES 4.2.1 Mixtures intended to be sprayed In Section 7.1, add: Pi-001/EN
When operators, whether spraying or not, have to work inside the spray booth, ventilation is unlikely to be sufficient to control particulates and solvent vapour in all cases. In such circumstances they should wear a compressed air-fed respirator during the spraying process and until such time as the particulates and solvent vapour concentration has fallen below the exposure limits.
4.2.2 Mixtures containing epoxy constituents with an average molecular weight ∞∞∞∞700 (See also 4.2.3) In Section 2.1, add: Pi-002/EN:
The mixture may be a skin sensitiser. It may also be a skin irritant and repeated contact may increase this effect.
In Section 11.1, add: Pi-003/EN:
Based on the properties of the epoxy constituent(s) and considering toxicological data on similar mixtures, this mixture may be a skin sensitiser and an irritant. It contains low molecular weight epoxy constituents which are irritating to eyes, mucous membrane and skin. Repeated skin contact may lead to irritation and to sensitisation, possibly with cross-sensitisation to other epoxies.
Skin contact with the mixture and exposure to spray mist and vapour should be avoided. In Section 2.2:
After the phrase (L092) “contains epoxy constituents - see information supplied by the manufacturer” (resulting from the label), add:
Pi-004/EN: This information is supplied in the present Safety Data Sheet. 4.2.3 Mixtures containing reactive diluents with an epoxy functionality (see also 4.2.2) In Section 2.1, add: Pi-005/EN: The mixture may be a skin sensitiser. It may also be a severe skin irritant. In Section 11.1, add: Pi-006/EN:
Based on the properties of epoxy constituent(s) and considering toxicological data on similar mixtures, this mixture may be a skin sensitiser and a severe irritant. It contains epoxy based reactive diluents which are moderate to severely irritating to eyes, mucous membrane and skin and are strong sensitisers. Repeated skin contact may lead to irritation and to hyper-sensitivity, possibly with cross-sensitisation to other epoxies. Single oral exposure to doses of the epoxy based reactive diluents at or close to the lethal dose has been shown to cause transient neurotoxic effects in animals in some cases. However, uptake through skin and by inhalation has not caused such effects in animals. Prolonged exposure to high concentration may cause adverse effects in target organs such as liver and kidney.
In Section 2.2:
EN 52 EN
After the phrase (L092) “Contains epoxy constituents - see information supplied by the manufacturer” (resulting from the label) add:
Pi-004/EN: This information is supplied in the present Safety Data Sheet. 4.2.4 Mixtures containing methyl or ethyl glycol ethers and/or their acetates In Section 11.1, add: Pi-007/EN:
]name of the substance(s) as in Section 3.2_ show(s) evidence from animal experiments that exposure in excess of the occupational exposure limit can also have harmful effects on the blood, kidneys and central nervous system.
4.2.5 Mixtures containing butyl glycol ether and/or its acetate The former plug-in phrase Pi-019 is withdrawn, as this sector is now fully regulated. 4.2.6 Mixtures containing chromates
The former plug-in phrases Pi-008 and Pi-009 are withdrawn. They are no longer necessary as the health effects are addressed by the R-phrases/H-statements in Section 3.2 and appropriate sentences in Section 7.
4.2.7 Antifouling mixtures containing tri-organotin compounds The former plug-in phrase Pi-011 is withdrawn, as this sector is now fully regulated 4.2.8 Acid-curing mixtures with formaldehyde at a concentration of > 0.2% In Section 11.1, add:
Pi-012/EN: 1-component mixtures: formaldehyde is released during the curing. Formaldehyde may cause irreversible effects, is irritating to the mucous membranes and may cause skin sensitisation.
Pi-013/EN:
2-component mixtures: The spray mist contains formaldehyde. Some formaldehyde may be released during the curing. Formaldehyde may cause irreversible effects, is irritating to the mucous membranes and may cause skin sensitisation.
4.2.9 Coating powders containing TGIC (triglycidyl isocyanurate)
The former plug-in phrase Pi-014 is withdrawn. It is no longer necessary as the health effects are addressed by the R-phrases/H-statements in Section 3.2 and appropriate sentences in Sections 8 and 11.
In Section 8.1, add: Pi-015/EN:
The recommended OEL for coating powders containing TGIC is 3 mg/m3. This OEL must be
considered as a maximum exposure limit averaged over the measured time period (the normal time period in a working day is 8 hours), not normally to be exceeded. All reasonable practical attempts should be made to keep the actual levels as low as possible.
In Section 11.1, add: Pi-016/EN: Toxicological results of tests made on mixtures containing TGIC showed Acute toxicity: LD50 (oral), 16g/kg body weight LC50 (inhalation) > 11g/m
3
EN 53 EN
Sensitisation: Can provoke contact allergic reactions in humans Mutagenicity: Ames test: negative Chromosomal aberration test in mouse spermatogonial assay: positive Dominant lethal assay: negative
4.2.10 Mixtures containing ≥ 1% 2-butanone oxime, free or bonded
In Section 11.1, add: Pi-017/EN
May release 2-butanone oxime (ethyl methyl ketoxime) at elevated temperature. 4.2.11 Mixtures containing substances classified as dangerous for the environment, at a
concentration ≥ 0.1% (N symbol) or ≥1% (all others)
Pi-018 is withdrawn. See 4.2.15 and 4.2.16 below for “dangerous for the environment” plug-in phrases.
4.2.12 Mixtures containing caprolactam-blocked isocyanates In Section 7.1, add: Pi-020/EN:
During stoving/curing caprolactam will be released. Efficient oven extraction must be provided to safely discharge caprolactam from the workplace.
Reminder: mention the OEL of caprolactam in Section 8.1. In Section 11.1, add: Pi-021/EN:
Caprolactam is classified as harmful and the toxicity is described by the following risk phrases: Harmful by inhalation and if swallowed (R20/22) and irritating to eyes, respiratory system and skin (R36/37/38).
4.2.13 Water-borne printing inks containing aluminium pigments, where there is a
possibility of hydrogen formation In Section 7.1, add: Pi-022/EN: Exercise caution when opening to allow pressure release. In Section 10.3 add: Pi-023/EN: Product may release hydrogen gas – increased storage temperatures will accelerate this process. In Section 13.1 add: Pi-024/EN: Do not mix with other ink wastes.
4.2.14 Mixtures containing substances classified as sensitisers (R42/H334 or R43/H317) at
a concentration > 0.1% In Section 11.1 add: Pi-025/EN (identical with L99) Contains [name(s) of sensitising substance(s)]. May produce an allergic reaction.
EN 54 EN
4.2.15 Mixtures not classified as dangerous for the environment and not containing any substances dangerous for the environment
In Section 12.1, add: Pi-026/EN
The mixture has been assessed following the conventional method of the Dangerous Preparations Directive 1999/45/EC and is not classified as dangerous for the environment.
4.2.16 Mixtures not classified as dangerous for the environment but containing substance(s) dangerous for the environment
In Section 12.1, add:
Pi-027/EN The mixture has been assessed following the conventional method of the Dangerous Preparations Directive 1999/45/EC and is not classified as dangerous for the environment, but contains substance(s) dangerous for the environment. See section 3 for details.
4.2.17 Mixtures classified as dangerous for the environment In Section 12.1, add: Pi-028/EN
The mixture has been assessed following the conventional method of the Dangerous Preparations Directive 1999/45/EC and is classified for eco-toxicological properties accordingly. See Sections 2 and 3 for details.
4.2.18 Mixtures containing more than 10% air drying (auto oxidising) oils or high oil content binders
In Section 7.1, add: Pi-029/EN Materials such as cleaning rags, paper wipes and protective clothing, which are contaminated with the product may spontaneously self-ignite some hours later. To avoid the risks of fires, all contaminated materials should be [stored in purpose-built containers or in metal containers with tight-fitting self-closing lids.] or [laid out flat in a single layer to dry] or [placed in a closed metal container soaked with water] or [washed out well with warm soapy water before disposal] Contaminated materials should be removed from the workplace at the end of each working day and be stored outside. In addition, for cold set inks, add Pi-030/EN Materials such as cleaning rags, paper wipes etc, which are contaminated with coldset ink, need not be assigned to ADR class 4.2, provided they are transported in containers of less than 450 litres capacity (ADR 2.2.42.1.5(c), Note 2). This exemption may not apply if contaminated materials are mixed with other wastes 4.2.19 Coatings based on nitrocellulose (cellulose nitrate) containing 5% or more by
weight in the total mixture In Section 7.1, add
EN 55 EN
Pi-031/EN Due to the nitrocellulose content of this product, spray dusts and deposits have a low flammability threshold. The product should not be sprayed in the same booth as coatings that generate heat during drying (for instance air drying or forced dry auto-oxidising alkyds, styrenated alkyds or polyesters, etc), unless the spray booth and exhaust ducting are completely cleaned between each product change. 4.2.20 Printing inks based on nitrocellulose (cellulose nitrate) In Section 7.1, add Pi-032/EN Dry deposits of nitrocellulose inks are highly flammable. The product should not be applied on the same press as inks that generate heat during drying (for instance, two pack inks, drying vegetable oil and alkyd based inks), unless the press and exhaust ducting are completely cleaned between each product change. To avoid the risk of fire, do not allow this product to dry out. Pi-033/EN Please consult CEPE guideline for the safe use of cellulose nitrate printing inks and related products. 4.2.21 Coatings and printing inks based on nitrocellulose (cellulose nitrate) In Section 7.1, add Pi-034/EN Do not mix with other wastes. In Section 7.1 and in Section 10.5, After “Keep away from” and before “oxidising agents” add Pi-042/EN amines, 4.2.22 Coatings and printing inks that could release dangerous substances at high
temperature In Section 7.1, add Pi-035/EN May release (dangerous substance name) at temperatures above ... °C. 4.2.23 Coatings containing blocked isocyanates In Section 7.1, add Pi-036/EN Welding, grinding and other hot work on the already-coated substrate may cause free isocyanates to be formed and released. 4.2.24 Coatings and printing inks containing ≥ 5% N-methyl pyrrolidone Pi-037 is withdrawn as N-methyl pyrrolidone is now classified for reproductive toxicity in Annex VI to CLP (updated in 1
st ATP, Regulation (EC) No. 790/2009).
4.2.25 Mixtures containing fluoropolymers
EN 56 EN
In Section 10.6, add Pi-038/EN Carbonyl Fluoride and Hydrogen Fluoride may be formed above 200°C In Section 11.1, add Pi-039/EN Inhalation of thermal decomposition products may lead to adverse effects including pulmonary oedema 4.2.26 Mixtures containing PVC- or PVDC-based binders or chlorine-containing pigments In Section 10.6, After “such as carbon monoxide and dioxide, smoke, oxides of nitrogen” add Pi-040/EN , hydrochloric acid 4.2.27 Radiation-curable mixtures, acrylate-based, classified Xi and R43 (Skin Sens. 1,
H317) In Section 11.1 add: Pi-041/EN Component (name) has sensitising properties. Cases of hypersensitivity may occur, possibly with cross-sensitisation to other acrylate materials.
EN 57 EN
4.3 Pi-PHRASE FINDER
Pi-phrase
Relates to Status Location
001 Mixtures intended to be sprayed Current Section 4.2.1
002 Low molecular weight epoxy constituents Current Section 4.2.2
003 Low molecular weight epoxy constituents Current Section 4.2.2
004 Low molecular weight epoxy constituents Current Sections 4.2.2 / 4.2.3
005 Epoxy functional reactive diluents Current Section 4.2.3
006 Epoxy functional reactive diluents Current Section 4.2.3
007 Methyl/ethyl glycol ethers/acetates Current Section 4.2.4
008 Chromates Withdrawn from 4th edition (Section 4.2.6)
009 Chromates Withdrawn from 4th edition (Section 4.2.6)
010 Tri-organotins Withdrawn from 2nd
edition (Formerly 4.6)
011 Tri-organotin antifoulings Withdrawn from 5th edition (Section 4.2.7)
012 Formaldehyde in acid-cured mixtures Current Section 4.2.8
013 Formaldehyde in acid-cured mixtures Current Section 4.2.8
014 TGIC Withdrawn from 4th edition (Section 4.2.9)
015 TGIC Current Section 4.2.9
016 TGIC Current Section 4.2.9
017 2-butanone oxime Current Section 4.2.10
018 Substances dangerous for the environment Withdrawn from 4th edition (Section 4.2.11)
019 Butyl glycol ether/acetate Withdrawn from 6th edition Section 4.2.5
020 Caprolactam-blocked isocyanates Current Section 4.2.12
021 Caprolactam-blocked isocyanates Current Section 4.2.12
022 Water borne/aluminium inks Current Section 4.2.13
023 Water borne/aluminium inks Current Section 4.2.13
024 Water borne/aluminium inks Current Section 4.2.13
025 R42/43 sensitisers Current Section 4.2.14
026 Mixtures not classified as dangerous for the environment and not containing any substances dangerous for the environment
Current Section 4.2.15
027 Mixtures not classified as dangerous for the environment but containing substance(s) dangerous for the environment
Current Section 4.2.16
028 Mixtures classified dangerous for the environment
Current Section 4.2.17
029 Mixtures containing drying oils Current Section 4.2.18
030 cold set inks, Current Section 4.2.18
031 Coatings based on nitrocellulose (cellulose nitrate)
Current Section 4.2.19
032 Printing inks based on nitrocellulose (cellulose nitrate)
Current Section 4.2.20
033 Printing inks based on nitrocellulose (cellulose nitrate)
Current Section 4.2.20
034 Coatings and printing inks based on nitrocellulose (cellulose nitrate)
Current Section 4.2.21
035 Coatings and printing inks that could release dangerous substances at high temperature
Current Section 4.2.22
036 Coatings containing blocked isocyanates Current Section 4.2.23
037 Coatings and printing inks containing ≥ 5% N-methyl pyrrolidone
Withdrawn from 9th edition (Section 4.2.24)
038 Mixtures containing fluoropolymers Current Section 4.2.25
039 Mixtures containing fluoropolymers Current Section 4.2.25
040 Mixtures containing PVC or PVDC binders or chlorine-containing pigments
Current Section 4.2.26
EN 58 EN
041 Radiation-curable mixtures, classified Xi and R43
Current Section 4.2.27
042 Coatings and printing inks based on nitrocellulose (cellulose nitrate)
Current Section 4.2.21
