On the 26th June 2020, the European Commission published Regulation (EU) 2020/878, which amends Annex II of the REACH regulation. Updated regulation sets out the content and format for Safety Data Sheets (SDSs) within the EU.
Regulation and Annex shall apply from 1 January 2021, while SDSs not complying with this Annex may continue to be provided until 31. December 2022.
In other words - you need to update all your safety data sheets by the end of the year 2022.
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The changes to Annex II of REACH include:
allowing the possibility of the unique formula identifier (UF) to be indicated only in the SDS for hazardous mixtures supplied for use only at industrial sites and requirement that the UFI is indicated in the SDS for certain non-packaged mixtures;
SDS requirements for substances and mixtures with endocrine disrupting potential;
specific concentration limits, multiplying factors and acute toxicity estimates relevant for the safe use should be include in SDS;
data regarding nanoforms must be included in SDS.
Let's check new SDS section by section...
SECTION 1: Identification of the substance/mixture and of the company/undertaking
1.1 Product identifier
- 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”.
Other means of identification
Where a mixture has a unique formula identifier (UFI) and that UFI is indicated in the safety data sheet, then the UFI shall be provided in this subsection.
SECTION 2: Hazards identification
2.3. Other hazards
Information shall be provided on whether the substance 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. For a mixture, information shall be provided for each such substance that is present in the mixture at a concentration equal to or greater than 0,1 % by weight.
3. SECTION 3: Composition/information on ingredients
3.1. Substances
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.
3.2. Mixtures
3.2.1 For a mixture meeting the criteria for classification in accordance with Regulation (EC) No 1272/2008, the following substances (see also Table 1.1) shall be indicated, together with their concentration or concentration range in the mixture:
(c) provided that the concentration of an individual substance is equal to or greater than 0,1 %, substances that meet any of the following criteria:
— substances that are persistent, bioaccumulative and toxic or very persistent and very bioaccumulative in accordance with the criteria set out in Annex XIII,
— substances included in the list established in accordance with Article 59(1) for reasons other than the hazards referred to in point (a) of this subsection such as endocrine disrupting properties,
— substances identified as having endocrine disrupting properties in accordance with the criteria set out in Delegated Regulation (EU) 2017/2100 or Regulation (EU) 2018/605.
3.2.2. For a mixture not meeting the criteria for classification in accordance with Regulation (EC) No 1272/2008, substances present in an individual concentration equal to or greater than the following concentrations shall be indicated, together with their concentration or concentration range:
(b) 0,1 % by weight for substances that meet any of the following criteria:
— substances included in the list established in accordance with Article 59(1) for reasons other than the hazards referred to in point (a) of this subsection such as endocrine disrupting properties;
— identified as having endocrine disrupting properties in accordance with the criteria set out in Delegated Regulation (EU) 2017/2100 or Regulation (EU) 2018/605;
3.2.3. For the substances indicated in subsection 3.2:
- 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.
SECTION 9: Physical and chemical properties
9.1. Information on basic physical and chemical properties
- Each property which need to be mentioned under this subsection is explained in more details
9.2. Other information
In addition to the properties mentioned in subsection 9.1, other physical and chemical parameters shall be indicated, such as the properties listed in subsections 9.2.1 and 9.2.2, if their indication is relevant for the safe use of the substance or mixture.
9.2.1. Information with regard to physical hazard classes
9.2.2. Other safety characteristics
SECTION 11: Toxicological information
11.2.1. Endocrine disrupting properties
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 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 human health.
SECTION 12: Ecological information
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.
12.7. Other adverse effects
Information on any other adverse effects on the environment shall be included where available, such as environmental fate (exposure), photochemical ozone creation potential, ozone depletion potential or global warming potential.
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Start to prepare for the new changes now and be ready for the implementation date of 1st January 2023.
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