Caroline Raine discusses the forthcoming changes to safety data sheets following the publication of the REACH Annex II regulations (2020/878). The regulations were published in July and will require all safety data sheets to be updated by the end of December 2022. It will apply from 1 January 2021.
The requirement to supply a safety data sheet is from the EC Regulation 1907/2006 on the Registration, Evaluation and Authorisation of Chemicals (REACH). Annex II of REACH lays out the requirements for the compilation of the safety data sheets.
REACH requires that safety data sheets are supplied when:
the substance or mixture is dangerous as per the EC Regulation 1272/2008 on classification, labelling and packaging of substances and mixtures (CLP)
the substance (not mixture) is classifiable as Persistent, Bioaccumulative and Toxic (PBT) or very Persistent and very Bioaccumulative (vPvB)
the substance is included in the list in Annex XIV (being a list of substances subject to authorisation)
the mixture is not dangerous but contains:
≥1% by weight (≥0.2% by volume for gases) of any substance posing a health or environmental hazard
any substance for which there is a Community workplace exposure limit
non-gaseous mixtures containing ≥0.1% by weight of any substance classified as PBT or vPvB.
Earlier this year the European Commission launched a consultation on changes to REACH Annex II. This Annex has since been amended by EU Regulation 2020/878 published in July 2020.
The main provisions are:
to align it with the GHS 6th/7th Revised Editions (particularly section 9);
to align it with requirements for nanomaterials;
clarify requirements related to poison centres (Unique formula identifiers (UFIs)).
Let’s have a look at the changes working through each section of the safety data sheet.
The Unique Formula Identifier (UFI) is to be included in Section 1 of the safety data sheet. The UFI is an alpha-numeric 16-character code that is generated from the company’s VAT number and an internal code that has been allocated to the product. There are provisions in place if a supplier is not registered for VAT and there is no VAT number. This code must then be placed on the product label and becomes part of the notification to the poison centre.
The UFI is to be added to Section 1.1:
Where the mixture has a unique formula identifier (UFI) in accordance with section 5 of Part A of Annex VIII to Regulation (EC) No 1272/2008 and that UFI is indicated in the safety data sheet, then the UFI shall be provided in this subsection.
Also, within Section 1.1 there is a requirement if the safety data sheet applies to different forms to declare this “if the safety data sheet pertains to one or more nanoforms, or substances that include nanoforms, this shall be indicated by using the word “nanoform”.”
Within Section 2.3 other hazards — Information shall be provided on whether the substance or mixture meets the criteria for persistent, bioaccumulative and toxic or very persistent and very bioaccumulative in accordance with Annex XIII, whether the substance was included in the list established in accordance with Article 59(1) for having endocrine disrupting properties, and whether the substance is a substance identified as having endocrine disrupting properties in accordance with the criteria set out in Commission Delegated Regulation (EU) 2017/21003 or Commission Regulation (EU) 2018/6054.
Section 3.1 — for substances — The specific concentration limit, the M-factor and the acute toxicity estimate for substances included in Part 3 of Annex VI to Regulation (EC) No 1272/2008 or determined in accordance with Annex I to that Regulation shall be indicated, if available.
If the substance is registered and it covers a nanoform, the particle characteristics that specify the nanoform, as described in Annex VI, shall be indicated. If the substance is not registered, but the safety data sheet covers nanoforms, the particle characteristics of which have impact on the safety of the substance, those characteristics shall be indicated.
Table 1.1 — 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 has been updated.
Hazard class and category
Acute toxicity, category 1, 2 and 3
Acute toxicity, category 4
Skin corrosion/irritation, category 1, categories 1A, 1B, 1C and category 2
Serious damage to eyes/eye irritation, category 1 and 2
Respiratory sensitiser category 1 or category 1B
Respiratory sensitiser category 1A
Skin sensitiser category 1 or category 1B
Skin sensitiser category 1A
Germ cell mutagenicity category 1A and 1B
Germ cell mutagenicity category 2
Carcinogenicity category 1A, 1B and 2
Reproductive toxicity, category 1A, 1B, 2 and effects on or via lactation
Specific target organ toxicity (STOT) — single exposure, category 1, 2 and 3
Specific target organ toxicity (STOT) — repeated exposure, category 1 and 2
Hazardous to the aquatic environment — Acute, category 1
Hazardous to the aquatic environment — Chronic, category 1
Hazardous to the aquatic environment — Chronic, category 2, 3 and 4
Hazardous for the ozone layer
Section 9 properties have been updated — the left column shows the new requirements.
(a) Physical state
(c) Odour threshold
(d) Melting point/freezing point
(e) Boiling point or initial boiling point and boiling range
(e) Melting point/freezing point
(f) Initial boiling point and boiling range
(g) Lower and upper explosion limit
(g) Flash point
(h) Flash point
(h) Evaporation rate
(i) Auto-ignition temperature
(i) Flammability (solid, gas)
(j) Decomposition temperature
(j) Upper/lower flammability or explosive limits
(k) Vapour pressure
(l) Kinematic viscosity
(l) Vapour density
(m) Relative density
(n) Partition coefficient n-octanol/water (log value)
(o) Vapour pressure
(o) Partition coefficient: n-octanol/water
(p) Density and/or relative density
(p) Auto-ignition temperature
(q) Relative vapour density
(q) Decomposition temperature
(r) Particle characteristics
(s) Explosive properties
(t) Oxidising properties
There are requirements within section 9.2 to add certain properties if they are relevant for safe use. They include:
gases under pressure
self-reactive substances and mixtures
self-heating substances and mixtures
substances and mixtures, which emit flammable gases in contact with water
corrosive to metals
And in section 9.2.2 other safety considerations.
Properties, safety characteristics and test results listed below may be useful to indicate as regards a substance or a mixture:
self-accelerating polymerisation temperature
formation of explosible dust/air mixtures
radical formation potential
Those are the major changes. There are, of course, lots of others: for example, Section 11.2.1 Endocrine disrupting properties and Section 12.6 endocrine disrupting properties; and section 14.7 Changes from Transport in bulk according to Annex II of MARPOL and the IBC code to “Maritime transport in bulk according to IMO instruments.”
The regulations will come into force from 1 January 2021, which will mean that all new safety data sheets will need to be authored taking into account the new requirements. All existing safety data sheets will need to be updated by 31 December 2022.
The timescales are quite demanding and in the consultation period many comments were in relation to the implementation dates. Hopefully the European Commission will include more realistic timeframes in the final version.
Start to prepare for the new changes and be ready for the implementation date of 1 January 2021 for new Safety Data Sheets.
Start to gather your information so that you can update your safety data sheets.
Talk to your software suppliers to make sure that the changes are being incorporated into your software templates.
Ensure that you update your safety data sheets in good time for the 31 December 2022 deadline.
And of course, make sure that any new safety data sheets that you write after 1 Jan 2021 meet the new requirements!