ECHA - Guidance of the application of CLP criteria [November 2012]

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Guidance on the Application of the CLP Criteria Version 3.0 - November 2012Serious eyedamage/eye irritationRespiratorysensitisationall yes yes available in section 3.31 yes noSkin sensitisation 1 yes yesto be provided insection 3.4 40to be provided insection 3.4 (see above)Germ cellmutagenicityall no no currently not possibleCarcinogenicity all yes yes available in section 3.6Reproductiveavailable in section 3.7all yes yestoxicityand in Annex VISTOT-SE 1 yes no available in section 3.82 no no see section 3.83 yes yes available in section 3.8STOT-RE 1 yes no available in section 3.92 no no see section 3.9Aspiration hazard 1 not appropriate not appropriate not necessary1.5.2 Multiplying factors (M-factors)Article 10(2) M-factors for substances classified as hazardous for the aquatic environment, acutecategory 1 or chronic category 1, shall be established by manufacturers, importers and downstreamusers.Article 10(4) Notwithstanding paragraph 2, M-factors shall not be set for harmonised hazard classesor differentiations for substances included in Part 3 of Annex VI for which an M-factor is given inthat Part.However, where an M-factor is not given in Part 3 of Annex VI for substances classified ashazardous to the aquatic environment, acute category 1 or chronic category 1, an M-factor based onavailable data for the substance shall be set by the manufacturer, importer or downstream user.When a mixture including the substance is classified by the manufacturer, importer or downstreamuser using the summation method, this M-factor shall be used.For the hazard class “Hazardous to the Aquatic Environment”, SCLs are not applicable.Instead the M-factors concept is used.The M-factors are used in application of summation method for classification of mixturescontaining substances that are classified as very toxic. The concept of M-factors has beenestablished to give an increased weight to very toxic substances when classifying mixtures.M-factors are only applicable to the concentration of a substance classified as hazardous tothe aquatic environment (categories Acute 1 and Chronic 1) and are used to derive by thesummation method the classification of a mixture in which the substance is present. They are,however, substance-specific and it is important that they are being established already whenclassifying substances.For further guidance in how to establish the M-factor see Section 4.1.3.3.3 of this document.40 Guidance on the setting of SCLs relating to the revised criteria for respiratory and skin sensitization that arebased on the 2 nd ATP to the CLP Regulation is planned for a future update of this guidance document.50
Guidance on the Application of the CLP Criteria Version 3.0 - November 2012M-factors should have been established in accordance with Article 10 of CLP and beavailable in the C&L Inventory.For the harmonised classifications in Annex VI to CLP, M-factors shall be set by themanufacturer, importer or downstream user in case there is no M-factor provided, inaccordance with CLP Article 10(4).1.6 MIXTURES1.6.1 How to classify a mixtureThe classification of mixtures under CLP is for the same hazards as for substances. As ageneral rule and as is the case with substances, available data on the mixture as a wholeshould primarily be used to determine classification where applicable. If this cannot be done,further approaches to mixture classification may be applied.It is important to choose the most appropriate method to determine the classification for amixture for each hazard class, differentiation or category. The method will depend on whetherthe mixture is being assessed for physical, health or environmental hazards and on the typeand quality of information that is available (see also section 1.2.3 of this document on form orphysical state).It is important to get a clear picture on which substances and mixtures are contained in amixture. Basic information on substances would include the substance identity, itsclassification and any applied SCLs or M-factors, and concentration in the mixture and, whererelevant, details of any impurities and additives including their identity, classification andconcentration. Where an ingredient in a mixture is itself a mixture, it is necessary to getinformation on the ingredient substances of that mixture together with their concentrations,classifications and any applied SCLs or M-factors.Useful sources for such information are the SDS from the supplier of the substance or themixture, and the C&L Inventory provided by ECHA, which also includes the harmonisedclassifications of substances listed in Annex VI to CLP.REACH: Article 31(3)The supplier shall provide the recipient at his request with a safety data sheet compiled in accordancewith Annex II, where a mixture does not meet the criteria for classification as dangerous inaccordance 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 % byvolume 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 non-gaseous mixtures at least onesubstance that is persistent, bio-accumulative and toxic or very persistent and very bio-accumulativein accordance with the criteria set out in Annex XIII or has been included for reasons other than thosereferred 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.NOTE: Article 31(3) is amended from 1 June 2015 by CLP Article 59 (2)(b) to read as follows:The supplier shall provide the recipient at his request with a safety data sheet compiled in accordancewith Annex II, where a mixture does not meet the criteria for classification as hazardous inaccordance with Titles I and II of Regulation (EC) No 1272/2008, but contains:(a) in an individual concentration of ≥ 1 % by weight for non-gaseous mixtures and ≥ 0,2 % byvolume for gaseous mixtures at least one substance posing human health or environmental51
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ECHA - Guidance of the application of CLP criteria [November 2012]

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