Last reviewed 25 July 2016

A common question at training courses and on various forums on safety data sheet (SDS) writing is what substances need to be declared in s.3 of the SDS. In this article, Gill Pagliuca discusses the requirements which must be included in this section for substances.

The requirements for the format and content of SDS are set out in Annex II of the REACH Regulation which provides detailed instructions on what must be included and where it should be included in the document. Annex II of REACH has been revised a number of times since it was introduced, and the latest version of Annex II is EU Regulation 2015/830 which came into force on 1 June 2015. While all new and updated SDSs must meet the requirements of this update, there is a transitional provision allowing that SDSs provided to any recipient before 1 June 2015 may continue to be used and need not comply with this latest update until 31 May 2017, unless these are required to be updated to reflect new hazard or safety information before this date.

For substances, Annex II requires that s.3.1 of the SDS includes the chemical identity of the main constituent, together with 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. Suppliers of substances may also choose to voluntarily include any other constituents in this section including classified constituents below cut-off values and non-classified constituents.

For hazardous mixtures, Annex II requires that s.3.2 of the SDSs includes all substances classified for either a health or environmental hazard under CLP that are present in concentrations equal to or greater than the lowest of either the:

  • generic cut-off values set out in Table 1.1 of CLP, or the generic concentration limits given in parts 3 to 5

  • specific concentration limits (SCLs) given in either Annex VI to CLP or in the Classification and Labelling Inventory (CLI) (this includes SCLs that have been set in REACH registration dossiers)

  • for constituents classified as either Aquatic Acute 1 or Aquatic Chronic 1, the generic concentration limit divided by the M factor if available

  • concentration limits set out in Annex II to CLP (ie those that trigger the requirement to use EUH statements).

The generic concentration limits have been helpfully summarised in EU Regulation 2015/830 in the following table.

List of hazard classes, hazard categories and concentration limits for which a substance shall be listed as a substance in a mixture in subsection 3.2.1.1.

Hazard class and category

Concentration limit (%)

Acute toxicity, category 1, 2 and 3

≥ 0,1

Acute toxicity, category 4

≥ 1

Skin corrosion/irritation, category 1, subcategories 1A, 1B, 1C and category 2

≥ 1

Serious damage to eyes/eye irritation, category 1 and 2

≥ 1

Respiratory/skin sensitisation ≥ 0, 1 Germ cell mutagenicity category 1A and 1B

≥ 0,1

Germ cell mutagenicity category 2

≥ 1

Carcinogenicity category 1A, 1B and 2

≥ 0,1

Reproductive toxicity, category 1A, 1B, 2 and effects on or through lactation

≥ 0,1

Specific target organ toxicity (STOT) — single exposure, category 1 and 2

≥ 1

Specific target organ toxicity (STOT) — repeated exposure, category 1 and 2

≥ 1

Aspiration hazard

≥ 10

Hazardous to the aquatic environment — Acute, category 1

≥ 0,1

Hazardous to the aquatic environment — Chronic, category 1

≥ 0,1

Hazardous to the aquatic environment — Chronic, category 2, 3 and 4

≥ 1

Hazardous for the ozone layer

≥ 0,1

Also required to be listed in s.3.2 are the following.

  • Substances for which there are Union workplace exposure limits which are not already included above.

    Note:

    This requirement specifies substances for which there is a Union workplace exposure limit, ie one that has an EU-wide exposure limit, rather than one that is listed in national exposure limit lists such as the UK EH40. Substances with a Union workplace exposure limit are those included in the ILV/IOELV directives, Directive 91/322/EEC, Directive 2000/30/EC, Directive 2006/15/EC and Directive 2009/161/EU. Many suppliers do, however, also choose to include substances for which there is a national exposure limit available.

  • Substances that are persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB), or substances included in the Candidate List of Substances of Very High Concern (SVHC) for reasons other than the hazards referred to above if the concentration ≥ 0.1%. Substances included for other reasons are, for example, those with endocrine disrupting properties.

REACH also requires that SDSs be made available for certain non-hazardous mixtures. SDSs are required for non-hazardous products that contain substances hazardous to health or the environment, or for which a Union workplace exposure limit has been set, at a concentration equal to or greater than 1% by weight for non-gaseous mixtures and 0.2% by volume in gaseous mixtures; or that contain 0.1% by weight for substances which are PBT or vPvB or included the Candidate List of SVHC for reasons other than those that trigger CLP classification. Any substance in such a mixture must also be included in s.3.2 of the SDS.

Just as for substances, suppliers of mixtures may also choose to voluntarily include any other constituents in this section including classified constituents below cut-off values and non-classified constituents.

Substances listed in s.3.1 or 3.2 must be identified by an appropriate product identifier. As a general rule, the product identifier(s) used in SDSs should be the same as are used on the labels for the product. The product identifier will normally consist of two parts: a chemical name, and a suitable identification number.

For a registered substance, the chemical name of the main constituent must be consistent with that provided in the registration dossier. For non-registered substances, the chemical name should be determined in accordance with Article 18(2) of the CLP Regulation. This specified that the chemical name should be one of the following:

  • if the chemical is included in Annex VI of CLP, one of the names given therein

  • if the chemical is not included in Annex VI, but is included in the CLI, a name listed there

  • if not listed in either Annex VI or the CLI, either the IUPAC name or another internationally recognised name.

The second part of the chemical name is the identification number. This is usually either the Annex VI Identification number, the EC number, or the CAS number. Annex VI Identification numbers are often shown, however, in practice it may be less useful than the CAS or EC numbers, as they are not widely used, apart from in Annex VI of CLP and the CLI. CAS and EC numbers are much more frequently used throughout not just the ECHA databases, but also other databases worldwide that users might want to consult to find further information about a particular constituent substance.

When choosing a name to use in s.3 of the SDS, some consideration should also be given to the choice of name, as for many chemicals there will be several to choose from. The purpose of an SDS, like a label, is to communicate with the user. A more common name that is well recognised by users may be preferable, provided that the common name unambiguously identifies the substance, for example, in the case of fragrances, the International Nomenclature Cosmetic Ingredients (INCI) name may be more easily recognised by users than a more complex chemical name.

SDSs also need to be translated into the language of the countries where the product is being supplied. Translations are required for names of Annex VI substances. Although not included in the published versions of Annex VI, the translated names can be obtained from the CLI by clicking on the name in the harmonised classification. A pop-up box will appear with the names in all of the EU languages.

In addition to information on identity, this section requires that information be provided on the quantity of substance in the mixture, either as a percentage, or a percentage range. Percentage ranges, while protecting confidentiality, must not be so large as to cast doubts on the classification of the mixture. Thus, they should avoid being greater than the upper generic or specific concentration limit bands for the overall classification of the mixture if at all possible.

REACH also requires that for all substances required to be listed in this section, either their CLP classification be given, or if not classified as hazardous, the reason for inclusion such as “vPvB”, or “substance with a WEL” be given.

One additional point to consider is that while it is not required to explicitly state if a substance has been listed on the Candidate List of SVHCs, this is information that customers often ask for, and if software systems permit, it may be useful to indicate this information too. If not possible in this section, consider adding it in s.15 of the SDS.