Safety data sheet update: Regulation 2020/878

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‘These requirements make the SDS more onerous for the compiler, but gives greater transparency for the reader’

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This post informs you of the changes to safety data sheets required by a new regulation that amends REACH Annex II requirements for the compilation of safety data sheets‘ from July 2020.

A full guide to the contents of safety data sheets is given here.

Summary and timeline

The EU Commission has issued new legislation (Regulation 2020/878), requiring extensive updates to current safety data sheets (SDSs). The updates relate to:

  • addition of technical content on the acute toxicity estimates (ATEs), multiplying factors (M-factors), and specific concentration limits for substances and ingredients of mixtures
  • specific mention of new hazards, particularly nanomaterials and endocrine disruptors
  • more detailed requirements for physico-chemical properties
  • data from modelling required for environmental effects where no direct test data available
  • formatting changes

Detailed changes are given in the table below.

Regulation 2020/878 [1] amends Annex II of the REACH Regulation [2] and gives the legal requirements for the content safety data sheets. The legislation applies from 1 January 2021, but current SDSs are allowed until 31 December 2022, giving suppliers time to adapt.

As well as bringing in changes specific to the EU, Regulation 2020/878 implements changes made internationally in the UN’s Globally Harmonised System of Classification and Labelling (GHS), Revisions 6 and 7.

Acute Toxicity Estimates (ATEs)

Before stringent animal welfare legislation was implemented in the EU, acute toxicity testing in animals used doses of the test chemical intended to be lethal, giving key parameters of lethal dose (LD50, for oral or dermal exposures), or lethal concentration (LC50) for inhalation exposure.

For many years, such testing has not been allowed in the EU. Instead the acute toxicity has been measured using sub-lethal doses. This has hampered comparing results from older experiments, yielding LD50 or LC50 results, with newer experiments giving acute toxicity ranges or categories.

The CLP Regulation [3], Annex I, Table 3.1.2 gives the conversion of range or category data into acute toxicity point estimates, ie a single value.

The ATE for a substance or mixture is either the respective LD50 or LC50 value, if available, or the acute toxicity point estimate.

The ATEs for components of a mixture have to be included in Section 3.2 (mixtures) of the SDS. This is an onerous task for SDS compilers, because real experimental data is required for each component that needs to be listed.

Downstream users benefit from the extra information. The extra ATE data in suppliers’ SDSs should allow them to classify the final product more accurately, particularly if their product is formulated as a blend of mixtures, ie ‘mixtures in a mixture’.

The ATE for a substance is included in Section 3.1 (substances) of the SDS.

Multiplication factors (M-factors)

‘M-factors might be seen by non-technical users as pointless, baffling, and symptomatic of the unnecessary technicization of SDSs’

The EU hazard classification system for aquatic environment comprises the following Categories, based on aquatic toxicity data and biodegradability:

  • Aquatic Hazard (Acute), Category 1
  • Aquatic Hazard (Long-Term), Category 1, 2 or 3

M-factors are assigned to substances that are highly toxic, and may cause environmental effects at low concentrations. Substances with aquatic toxicity below 1 mg/L may attract an M-factor (10, 100, 1000 etc.). The M-factors are used in the calculation of the hazard classification of mixtures, based on the hazards and concentration of its component substances (called the summation method).

The M-factors are not formally part of the classification, but they have been included in the list of harmonized classifications in Annex VI of the CLP Regulation and the EU Classification and Labelling Inventory.

Until the new Regulation 2020/878, it has not been mandatory to list the M-factors in the SDS. The new regulation requires M-factors to be included in the Section 3.1 (substances), and 3.2 (mixtures).

These requirements make the SDS more onerous for the compiler, but gives greater transparency for the reader in understanding the derivation of the hazard classification. However, M-factors might be seen by non-technical users as pointless, baffling, and symptomatic of the unnecessary technicization of SDSs.

Specific Concentration Limits (SCLs)

Mixtures are usually classified for health or environmental effects based on the component substances, particularly their hazard classification and concentration. To classify the mixture, the CLP Regulation [2], Annex I, contains generic concentration limits for each health and environmental hazard class and category. If the ingredient with the hazard class and category is present in the mixture above the concentration limit, then the mixture is also classified for that hazard.

However, sometimes the generic concentration limits are not fit for specific substances. In some cases, Annex VI of the CLP Regulation or the Classification and Labelling Inventory contain SCLs for use with specific substances. Usually the SCL is lower than the generic concentration limit, eg for isothiazoline preservatives that may cause skin sensitization at very low levels.

The SCLs are not formally part of the classification. The new Regulation 2020/878 requires SCLs to be included in the Section 3.1 (substances), and 3.2 (mixtures).

As with M-factors, the requirement to write the SCLs in the SDS, allows the downstream user to better understand the product hazard classification, and use the data for classification of their own products.

Endocrine disruptors

Endocrine glands secrete hormones into the bloodstream. Hormones control many functions in an organism, such as growth, behaviour and sexual maturation. Endocrine disruptors (EDs) affect the normal function of the endocrine system, causing adverse health effects in an organism or its offspring. EDs can cause effects through a number of mechanisms, including mimicking hormones or blocking hormone receptors.

EDs are relevant for human health effects, but also wildlife species, particularly aquatic species such as fish and amphibians. Higher predators that feed on such creatures may also be affected, for example polar bears.

Because of the complexity of endocrine systems, and the variety of ways in which chemicals can cause adverse effects, the testing system for EDs is lengthy and expensive.

Click here for the definition of an endocrine disruptor, and here for more information.

Endocrine disrupting effects are to be added to Section 2.3 (other hazards) of the SDS, along with PBT and vPvB effects and other effects mentioned for Candidate List substances.

Regulation 2020/878 requires that any endocrine disruptors present at >0.1wt% in a mixture have to be listed in Section 3.2 (mixtures) of the SDS (for both classified and non-classified mixtures).

Section 11 (toxicological information) of the SDS has been split into two sub-sections. The title of Section 11.1 describes only hazards in the EU classification system (ie in the CLP Regulation 1272/2008 [3] ). Any endocrine disrupting effects should be detailed in a new Section 11.2, entitled ‘Information on other hazards’.

Environmental endocrine disruption gets a dedicated new Sub-section 12.6, Endocrine disrupting properties.

Nanoforms

Nanoforms contain very small particles, with >50% of the particles with dimensions of 1 to 100 nm. They have very high surface area compared to normal chemical forms. This can affect physico-chemical properties. This alteration of physical properties is why nanomaterials have found widespread use in coatings, anti-bacterial clothing, and cosmetics.

The toxicology of nanoforms is not well-established. The physico-chemical properties and the specific shapes (eg balls and tubes) of nanomaterials makes differences likely compared with the same substance with larger particle sizes. Toxicological testing and analysis can be difficult with nanomaterials.

The definition of nanoforms and nanomaterials can be found here.

In Section 1.1 (product identifier) of the SDS, the product identifier for a substance comprises the chemical name and an identification number (such as the EC number). The new regulation 2020/878 requires the product identifier to include the word ‘nanoform’ if the substance is nanoform or include nanoforms.

In Section 3.1 (substances) of the SDS, covering the identity of the substance, the physical parameters of the nanoform particle should be given. The data requirements are given in Annex VI of REACH, but include:

  • Particle size distribution, with percentage of particles in the range 1 to 100 nm.
  • Description of any surface treatments
  • Shape, aspect ratio and other morphological characterisation
  • Surface area per unit mass or volume
  • Analytical methods for determining particle characteristics.

If a mixture contains a nanomaterial substance, then the above physical parameters should be given for the component in Section 3.2 (mixtures).

Section 9.1 (information on basic physical and chemical properties) contains a new sub-heading for particle characteristics, that requires the description of nanoforms if present in the product. Other physico-chemical properties may be affected by the presence of nanoforms (eg water solubility and partition coefficient), and any such effects should be noted.

Table of changes by Section of the SDS

SDS SectionNew requirements
Section 1.1 Product identifierNanoform substances: include ‘nanoform’ in product identifier if SDS pertains to nanoform substances or include nanoforms.
Mixtures: add the unique formula identifier (UFI) for poison centre notification, if available (see CLP Regulation, Annex VIII).
Section 2.3 Other hazardsEndocrine disruption should be mentioned if the product may produce adverse effects through this mechanism.
3.1 SubstancesInformation on any ATE, M-factor and SCL should be provided, if available.
For nanoforms, give particle characteristics as detailed in REACH Annex VI.
3.2 MixturesThreshold concentrations for inclusion in Section 3.2 reduced for some hazards:
Aspiration hazard: from 10% to 1%
Respiratory and skin sensitisers, Cat 1A reduced from 0.1 to 0.01%
• specific mention of endocrine disruptors at >0.1%.
Add supplemental hazard statements (eg EUH phrases), ATEs, M-factors and SCLs for declarable components.
Section 9 Physical and chemical propertiesMuch more detail is required by the Regulation when describing the results of physico-chemical testing.
The method of determination shall be provided, including measurement and reference conditions.
The recommended list order of the properties has changed.
Sub-heading ‘Appearance’ has been split into ‘physical state’ and ‘colour’.
Colour: For variations on colour range of products, use ‘various’ to describe colour.
Odour‘ and ‘odour threshold‘ have been combined.
Melting point and boiling point: indicate if decomposition or sublimation occur before or during melting or boiling. It is technically impossible to determine the Mp/Bp for mixtures.
Sub-heading ‘Initial boiling point and boiling range’ changed to ‘Boiling point or initial boiling point and boiling range’.
Flammability: now applies to solid, liquids and gases (previously only solids and gases). Indicate if substance or mixture is ignitable (ie can be set on fire, even if not classified for flammability).
Sub-heading ‘Upper/lower flammability or explosive limits’ changed to ‘Lower and upper explosion limit’. The term ‘explosion limit’ is synonymous with ‘flammability limit’, used outside the EU.
Flash point: either the Fp of the mixture, otherwise that of the substance with the lowest Fp shall be indicated.
Auto-ignition: either the auto-ignition temperature of the mixture, otherwise that of the substance with the lowest auto-ignition temperature shall be indicated.
Decomposition: give the temperature, or ‘no decomposition observed up to x °C’.
Sub-heading ‘Density’ changed to ‘Density and/or relative density’.
Sub-heading ‘Vapour density’ changed to ‘relative vapour density’.
New sub-heading: ‘Particle characteristics’ for solids, including particle size, or size distribution, and description of any nanoforms.
9.2 Other information: much more detailed recommendations (but not mandatory): safety characteristics and test results for the hazard classes in which the product is classified, eg for aerosols: total percentage by mass of flammable components; for flammable liquids: information on sustained combustibility may be provided.
Section 11 Toxicological informationSection 11 is split into two sub-sections.
Section 11.1: new title: ‘Information on hazard classes as defined in Regulation (EC) No 1272/2008’, instead of ‘Information on toxicological effects’.
New Section 11.2 ‘Information on other hazards’. Any information on endocrine disrupting properties should be given, along with other adverse health effects not covered in the main section.
Section 12 Ecological informationSub-sections 12.1 (Toxicity), 12.2 (Persistence and degradability) and 12.3 (Bioaccumulative potential): information from reliable models shall be provided if experimental data not available.
New Section 12.6: ‘endocrine disrupting properties’.
Other adverse effects’ moved to Sub-section 12.7.
Section 14 Transport informationSub-section 14.2 (UN proper shipping name): give the proper shipping name according to UN Model regulation, supplemented with the technical name in brackets, plus any variations for inland transport (ADR, RID, and ADN), unless it is the same in each one. IMDG name to be added separately.
Sub-section 14.3 give the hazard class according to UN Model regulation, plus any variations for inland transport (based on ADR, RID, and ADN).
Sub-section 14.7: Title changed to ‘Maritime transport in bulk according to IMO instruments’ from ‘Transport in bulk according to Annex II of Marpol and the IBC Code’. The Regulation requires more information on bulk transportation.

References

[Back to Summary] [Back to ATEs] [Back to SCLs] [Back to endocrine disruptors]

[1] Commission Regulation (EU) 2020/878 of 18 June 2020 amending Annex II to Regulation (EC) No 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH).

[2] Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) (as amended).

[3] Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures (as amended).

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