ChemRegs Newsletter – October 2020
Revisions to Safety Data Sheets from January 2021
Annex II of the Registration, Evaluation and Authorisation of Chemicals (REACH) Regulation (EC) No 1907/2006 has been amended by EU Regulation 2020/878, which was published in July 2020. Annex II gives the requirements for the compilation of EU safety data sheets.
The regulations will come into force from 1 January 2021, which will mean that all new EU safety data sheets will need to be authored taking into account the new requirements. All existing EU safety data sheets will need to be updated by 31 December 2022.
It is understood that the UK does not intend to adopt this update to Annex II after the UK leaves the EU at the end of this year. This means that safety data sheets may no longer be compliant for both UK REACH and EU REACH after this date, and safety data sheets must be created to ensure compliance according to the regulations in both the EU and the UK in order to continue trading products in these areas from 1 January 2021.
The main provisions of the new revised Annex II 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)).
- The main changes for each section of the safety data sheet are as follows:
Section 1
Section 1.1 – Where a 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 i.e. “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”.”
Section 2
Section 2.3 other hazards — Information shall be provided on whether the substance or mixture meets the criteria for PBT or vPvB 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) 2017/2100 or Commission Regulation (EU) 2018/6054.
Section 3
Sub 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. The additional information for nanoforms could follow the model shown in Table 1 of the ECHA guidance.
Sub section 3.2 – the 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.
Also – for all the substances given in 3.2 — the specific concentration limit, the M-factor and the acute toxicity estimate for the substance in Part 3 of Annex VI to Regulation (EC) No 1272/2008 or as determined in accordance with Annex I to that Regulation shall be indicated, if available — if the substance as used in the mixture is in nanoform and is as such registered or addressed by the downstream user chemical safety report, the particle characteristics that specify the nanoform, as described in Annex VI, shall be indicated. If the substance as used in the mixture is in nanoform but is not registered or addressed by the downstream user chemical safety report, the particle characteristics which have impact on the safety of the mixture, shall be provided. For nanoform components, the same characterisation requirements detailed 2 for section 3.1 of 3 the SDS apply (see Table 1 of the ECHA guidance).
Section 9
Sub section 9.1. “Information on basic physical and chemical properties” has been updated — they now should be:
(a) Physical state
(b) Colour
(c) Odour
(d) Melting point/freezing point
(e) Boiling point or initial boiling point and boiling range
(f) Flammability
(g) Lower and upper explosion limit
(h) Flash point
(i) Auto-ignition temperature
(j) Decomposition temperature
(k) pH
(l) Kinematic viscosity
(m) Solubility
(n) Partition coefficient n-octanol/water (log value)
(o) Vapour pressure
(p) Density and/or relative density
(q) Relative vapour density
(q) Decomposition temperature
(r) Particle characteristics
There are requirements within sub section 9.2 to add certain properties if they are relevant for safe use. They include new sub sub section 9.2.1 “Information with regard to physical hazard classes”.
This sub sub section lists properties, safety characteristics and test results, which may be useful to include in the safety data sheet when a substance or mixture is classified in the respective physical hazard class. Data deemed relevant with regard to a specific physical hazard but not resulting in classification (e.g. negative test results close to the criterion), may also be appropriate to indicate.
New sub sub section 9.2.2 “Other safety characteristics”
Properties, safety characteristics and test results listed below may be useful to indicate as regards a substance or a mixture:
Other physical and chemical parameters shall be indicated if their indication is relevant for the safe use of the substance or mixture.
Section 11
Addition of new sub section 11.2 “Information on other hazards”
Addition of new sub sections:
Information on adverse health effects caused by endocrine disrupting properties shall be provided, where available, for the substances identified as having endocrine disrupting properties in sub section 2.3. This information shall consist of brief summaries of the information derived from application of the assessment criteria laid down in the corresponding Regulations ((EC) No 1907/2006, (EU) 2017/2100, (EU) 2018/605), that is relevant to assess endocrine disrupting properties for human health.
11.2.2. Other information
Other relevant information on adverse health effects shall be included even when not required by the classification criteria.
Section 12
Addition of new sub section 12.6. “Endocrine disrupting properties”
Information on adverse effects on the environment caused by endocrine disrupting properties shall be provided where available, for the substances identified as having endocrine disrupting properties in subsection 2.3. This information shall consist of brief summaries of the information derived from application of the assessment criteria laid down in the corresponding Regulations ((EC) No 1907/2006, (EU) 2017/2100, (EU) 2018/605), that is relevant to assess endocrine disrupting properties for the environment.
The old sub section 12.6 Other adverse effects, now becomes 12.7 Other adverse effects
Section 14
Sub section 14.7 title changed to “Maritime transport in bulk according to IMO instruments.”
The full text is available online at https://eur-lex.europa.eu/eli/reg/2020/878/oj
Other News
The Carriage of Dangerous Goods and Use of Transportable Pressure Equipment (Amendment) (EU Exit) Regulations 2020
The EU Exit legislation to amend the Carriage of Dangerous and Use of Transportable Pressure Equipment Regulations 2009 (CDG 2009) was approved last month by both the House of Commons and the House of Lords. The purpose of further amending CDG 2009 is to ensure that Great Britain has a functioning statute book at the end of the transition period (“IP completion day”).
The new statutory instrument has now been signed into law as the Carriage of Dangerous Goods and Use of Transportable Pressure Equipment (Amendment) (EU Exit) Regulations 2020 . The regulations also have an explanatory memorandum, which explains what the statutory instrument does and why.
The new CDG Regs amend references predicated on the UK being a member State of the European Union (“EU”), maintain the dangerous goods regulatory framework and the international process behind it, including the power for the Secretary of State to grant authorisations and implement new exceptions to and apply existing derogations from the standards imposed by Directive 2008/68/EC of the European Parliament and of the Council of 24 September 2008 on the inland transport of dangerous goods (“the Dangerous Goods Directive”).
It will also maintain recognition of the EU pi marking for Transportable Pressure Equipment (“TPE”) and allow for the optional use of a UK ‘rho’ marking for TPE either manufactured in GB or imported and conformity assessed in GB by appointed inspection bodies. The instrument will also implement an aspect of the Protocol on Ireland/Northern Ireland (“NIP”), part of the “Agreement on the withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union and the European Atomic Energy Community” dated 19th October 2019 (“the Withdrawal Agreement”), in relation to TPE on the GB market which has either been manufactured in Northern Ireland or conformity assessed in Northern Ireland.
The requirements for those involved in the carriage of dangerous goods by road and rail within GB are not being changed by this instrument.
The requirements for those operating in the transportable pressure equipment industry will be amended so that what were, prior to this instrument, notified bodies in GB, can continue their role as appointed bodies for TPE that is either for non-EU or non-Northern Ireland use, or for transporting dangerous goods between the GB and the EU or Northern Ireland to the extent permitted by Article 4 of the Dangerous Goods Directive.
The CDG 2009 Regulations, as amended by this instrument, will continue to function as before by ensuring that the regulatory framework for the carriage of dangerous goods by road and rail will remain in place on IP completion day. The amendments made by this instrument will revise references predicated on the UK being a member State of the EU and retain the power for the Secretary of State to grant authorisations, apply existing derogations approved prior to IP completion day and issue new exceptions.
RIDDOR reporting of COVID-19
HSE has published guidance on when and how coronavirus incidents should be reported under RIDDOR (the Reporting of Injuries, Diseases and Dangerous Occurrences Regulations 2013).
RIDDOR applies to all sectors and workplaces in Great Britain. The reporting requirements relating to cases of, or deaths from, COVID-19 under RIDDOR apply only to occupational exposure, that is, as a result of a person’s work.
A report should only be made under RIDDOR, relating to coronavirus, when:
- an accident or incident at work has, or could have, led to the release or escape of coronavirus. This must be reported as a dangerous occurrence
- a worker has been diagnosed as having COVID-19 attributed to an occupational exposure to coronavirus. This must be reported as a case of disease
- a worker dies as a result of occupational exposure to coronavirus
Visit HSE website for further details on the above, along with examples.
ECHA SCIP database ready for use
- Industry can now submit information on substances of very high concern (SVHCs) in their articles to ECHA’s SCIP database. The aim is to make recycling of products safer and improve information about dangerous chemicals in products. SCIP is the database for information on Substances of Concern in articles or in complex objects, established under the Waste Framework Directive (WFD).
The database ensures that the information on articles containing SVHCs on ECHA’s Candidate List is available throughout the whole lifecycle of products and materials, including the waste stage. The information in the database is being made available to waste operators and consumers, who will be able to access and use the data from February 2021 onwards.
For more information on anything in this Newsletter, please contact us at info@chemregs.co.uk