to be provided in accordance with Article 10(2.1) of the DPD, i.e

Hazard statements (CLP)

H225, H301, H311, H314, H331, H370, H400

Code

Statements

H225

Highly Flammable liquid and vapour

CLP CLASSIFICATION

Flam. Liq. 2, H225 Acute Tox. 3, H301 Acute Tox. 3, H311 Acute Tox. 3, H331 STOT SE 1, H370 Aquatic Acute 1, H400 (M-Factor (self-classification) = 10) ] see SECTION 16

EU Classification

Directive 67/548/EEC (see SECTION 16 for full text of risk phrases) Highly flammable; F; R11 Toxic; T; R23/24/25 Toxic; T; R39/23/24/25 38 Full text or risk phrases numbers with reference to SECTION 16 for full text. 39 See Article 10(2) of CLP ; also note that M-factors are already available in Annex VI to CLP for some substances. 40 Although, strictly speaking, the M-factor is not part of the ”classification” itself, its determination for these substances and mixtures is an essential integral part of the classification procedure to ensure that mixtures containing such substances are correctly classified. ECHA therefore gives the strongest possible recommendation that information on M-factors be given in the SDS. 41 Note that additional numbering and sub-structuring below the sub-section level is not a legal requirement 37 Dangerous for the environment; N; R50 Directive 1999/45/EC Highly Flammable; F; R11 Toxic; T; R23/24/25 Toxic; T; R39/23/24/25 42 Note that, by contrast to the information required to define a “classification” according to the DSD for a substance in sub-section 2.1 above, in the case of classification of a mixture according to the DPD in this sub- section 2.2 the “indication of danger” is not part of the required information. 43 Note that additional numbering and sub-structuring below the sub-section level is not a legal requirement 38 Toxic for reproduction; Repr. Cat. 2; R60-61

Additional information

For full text of R-phrases and Hazard- and EU Hazard-statements: see SECTION 16.  For a mixture If the mixture is labelled according to the DPD [allowed until May 31st, 2015], the classification must be indicated according to that Directive: i.e. symbol letter(s) and R phrases and, for CMR effects, danger categories42. See note below. If the mixture is labelled according to the CLP Regulation, the classification is given according to that Regulation: indication of hazard classes and categories and hazard statements. In the latter case, the classification according to the DPD must also be indicated until May 31st, 2015. Both classifications should be clearly identified. Note: If a supplier of a mixture chooses to identify and inform about the classification according to the CLP Regulation in advance of using it for classification and labelling on the package, this classification may be included in SECTION 16. When the SDS is being provided on request for a non-classified mixture (according to the requirements of Article 31(3) of REACH), this should be indicated. It may also be desirable to indicate the specific reason for inclusion of the mixture within the scope of Article 31(3). An example of a statement to do this, in a case according to Article 31(3) (c), could be: ‘This product does not meet the criteria for classification in any hazard class according to Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures. However a safety data sheet is being supplied for it on request as it contains a component for which there is a Community workplace exposure limit’. Please note that additional information on the components of mixtures is likely to become available (e.g. as a result of new tests or other information exchanges) after the first registration deadline (30th November 2010) as result of SIEF, consortium and/or individual registrant activities. This process of increasing availability of information may continue until 2018 and beyond. An example of how the structure of this section could look during the transitional period (i.e. for a mixture for which CLP labelling has not yet been implemented between 01 December 2010 and 1 June 2015) is given below43: 2.1 For full text of R- phrases: see SECTION 16.

2.2 Label elements

Text Annex II [To 1 June 2015: “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. 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.”] [From 1st of June 2015: “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 statements

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. The applicable label elements in accordance with Article 25 and Article 32(6) of Regulation (EC) No 1272/2008 shall be provided.”] For substances, from 1 December 2010 the label elements are to be indicated according to the CLP Regulation44. These elements must include all label elements appearing on the label (i.e. including, where appropriate, the inner pack label elements45). For mixtures, the label elements indicated in this section may be according to either the DPD or according to the CLP Regulation (where the supplier has chosen to implement CLP labelling earlier than required46) until May, 31st 2015. In either case the label elements indicated must be consistent with the corresponding label affixed to the product. If the 44 Unless both the actual labelling of the packs and the SDS referring to it qualify for the relevant transitional provisions for substances already placed on the market before 1 December 2010 according to Article 61(4) of CLP and Article 2(6) of Regulation (EU) No. 453/2010 respectively, up to 1 December 2012 at the latest. 45 i.e. including, for example, hazard pictograms which do not have to appear on the outer packs according to Article 33(1) of CLP because they relate to the same hazard as in the rules for transport of dangerous goods 46 i.e. by implementing early the version of Annex II that comes into force on 1 June 2015 for his mixture according to the provisions of Article 2(3) of Regulation 453/2010. 39 supplier wishes to give information about future (or former) labelling, which is not currently applied, he should give this information in SECTION 16. From 1 June 2015 the label elements listed (and the actual labelling) must be according to the CLP Regulation, including all label elements as is the case for substances. Label elements according to the CLP Regulation include:  Hazard pictogram(s)47,  (R), in full or as a code with reference to and full text in SECTION 16;  H27153 May cause fire or explosion; strong oxidiser. 51 Sodium peroxide has been used as an actual example to further illustrate reduction of the number of precautionary statements. This is therefore not an example of a substance subject to authorisation. 52 Note that the product identifier, although a label element, is not given in sub-section 2.2 as it is not specified as one of the elements which should appear here. It is to be given in section 1.1. 53 Note the reference number of pictograms, R and S phrases, and H and P statements (e.g. “H271”) do not need to appear on the label and in sub-section 2.2 of the SDS; only their full text is required. However, in order to be able to check and/or compare labelling information, it is recommended to quote these numbers in sub-section 2.2 of the SDS. 42 H314 Causes severe skin burns and eye damage

Signal word

Hazard statement(s), H and EUH, in full (or give in full in Section 16 if not here);  Precautionary statement(s), P, in full  Any additional applicable label elements in accordance with Article 25 of CLP on “Supplemental information on the label” As indicated in the legal text quoted above, the hazard pictogram may be replaced by a graphical reproduction of the full hazard pictogram in black and white or a graphical reproduction of the symbol only. The precautionary statements may be selected in accordance with the criteria laid down in Part 1 of Annex IV of CLP taking into account the hazard statements and the intended or identified use or uses of the substance or the mixture. Once selected, the precautionary statements must be worded in accordance with Part 2 of Annex IV of CLP. In selecting the precautionary statements in accordance with Articles 22 and 28 of CLP, suppliers may combine the Precautionary Statements, having regard to clarity and comprehensibility of the precautionary advice (in this case the specific wording of the component phrases combined should be retained). It should be noted that according to Article 28(3) of CLP not more than six precautionary statements should appear on the label unless necessary. For further information on selection of precautionary statements see the ECHA Guidance on labelling and packaging in accordance with Regulation (EC) 1272/200848 It may be useful for industrial and professional users (not for consumers since they do not receive SDSs) to include special precautionary statements into appropriate Sections of the SDS main body in order to reduce the number of precautionary statements on the label49 50. Examples of such precautionary statements that could, for example, be given in sub-section 7.1 “precautions for safe handling” instead of on the label are as follows: Do not handle until all safety precautions have been read and understood. (P202) Wash hands thoroughly after handling (P264) Do not eat, drink or smoke when using this product (P270) 47 According to Article 2(3) of CLP " ‘hazard pictogram’ means a graphical composition that includes a symbol plus other graphic elements, such as a border, background pattern or colour that is intended to convey specific information on the hazard concerned; " 48 Available at: http://guidance.echa.europa.eu/guidance_en.htm 49 Note that the p-number (e.g. "P202") is not itself a part of the precautionary statement, but it may be useful to indicate it in brackets after the statement for ease of reference 50 Precautionary statements should be provided in the SDS (and not on the label) only when they would not be necessary on the label itself to reflect the nature and severity of hazards (see the conditions in Article 28(3) of CLP) 40 Label elements according to the DPD which are to be included in this sub-section include at least:  Symbol(s), (either a full colour reproduction of the symbol as it appears on the label or a reproduction of it in black and white)  Indication(s) of danger;  Danger

Precautionary statements

S), in full;  The applicable label elements in accordance with sections A and B of annex V to the DPD. According to REACH Article 65, holders of an authorisation, as well as downstream users referred to in Article 56(2) who include a substance subject to authorisation in a mixture, must include the authorisation number on the label of the respective substance or mixture before it is placed on the market. In such cases the authorisation number becomes a mandatory label element according to CLP (via Article 32(6) of CLP concerning “label element requirements resulting from other Community acts”) and must therefore be included in this section of the SDS. Required Label elements according to REACH Annex XVII (such as "Restricted to professional users" are also examples of label elements which should be included in the SDS, in sub-section 2.2. for substances and mixtures labelled according to CLP, and in Section 15 for mixtures labelled according to Directive 1999/45/EC. Label elements potentially arising out of national legislation may also be given here. An example of how the structure of this sub-section could look for a substance is given below51: 2.2: Label elements52 Labelling according to Regulation (EC) No 1272/2008 [CLP] P210 Keep away from heat/sparks/open flames/hot surfaces. – No smoking. P221 Take any precaution to avoid mixing with combustibles. P280 Wear protective gloves/protective clothing/eye protection/ face protection. P301+P330+P331 IF SWALLOWED: rinse mouth. Do NOT induce vomiting. P303+P361+P353+310 IF ON SKIN (or hair): Remove/Take off immediately all contaminated clothing. Rinse skin with water/shower. Immediately call a POISON CENTER55 or doctor/physician. P305+P351+P338 IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P371+P380+P375 In case of major fire and large quantities: Evacuate area. Fight fire remotely due to the risk of explosion.

Supplemental label elements

Not applicable Reduction of the number of precautionary statements According to Article 28(3) of CLP “Not more than six precautionary statements shall appear on the label, unless necessary to reflect the nature and the severity of the hazards”. The determination of which precautionary statements appear on the label should be carried out in compliance with the CLP regulation. The requirement of Annex II of REACH with respect to their inclusion in an SDS is simply that the statements which appear on the label be given in this sub-section (2.2) of the SDS. Further information on how the number of precautionary statements can be reduced to as close as reasonable to the target number of a maximum of six is given in the ECHA Guidance on labelling and packaging in accordance with Regulation (EC) No 1272/200857.

2.3 Other hazards

Text Annex II 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. 54 See next page for further information on how the number of precautionary statements has been reduced. 55 (Note spelling of “center” is US, carried-over from GHS) 56 If applicable 57 Available at: http://guidance.echa.europa.eu/guidance_en.htm 43 The information on other hazards which do not result in classification, but which must be given here, includes, for example information on the presence of sensitizers according to Article 25(6) of CLP (and corresponding DPD provisions). An example of how the structure of this sub-section could look, including some phrases that can be used if appropriate is given below: 2.3

Other hazards

Risk of blindness after swallowing the product Substance meets the criteria for vPvB according to Regulation (EC) No 1907/2006, Annex XIII Substance is phototoxic 44 4.3. SDS SECTION 3: Composition/information on ingredients Text Annex II 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. Either section 3.1 or 3.2 must be included below as appropriate for only one of either a substance or mixture as applicable58. It should be noted that the term “surface chemistry” as used in the text above is intended to refer to properties that may arise as a result of the particular surface properties of a (solid) substance or mixture (e.g. due to having certain dimensions in the nano range)59. 3.1. Substances Text Annex II 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. The chemical identifiers of the main constituent need to be added in this section (information from section 1.1). Note that it is not a requirement to separately give the classification (or indication of danger which applies in any case only to components of mixtures) etc for impurities in a substance (by contrast to the case for mixtures covered by point 3.2.3 in the legal text below) since these should already have been taken into account in the classification of the substance as registered under REACH / notified under CLP. An expanded illustrative example of how the structure of this section could look for a styrene monomer is given below60: 58 Whichever of these two sub-sections is not applicable becomes the only sub-section in the SDS which may be left completely blank. 59 It is specifically not intended to require information to be given here on surfactant properties of (liquid or dissolved) substances or mixtures. 45