SDS Section 15 (Tab "15.2 Regulatory")
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On Tab 15.2, you indicate whether a Chemical safety assessment has been conducted on the product. You can also provide the NFPA and HMIS rating codes for the product, if you know or can obtain them.
Chemical safety assessment (Optional; required for EU/EEA)
Indicate whether or not a Chemical safety assessment has been conducted on the product. Your entry can be relatively simple, e.g.,
No Chemical Safety Assessment has been carried out for this substance/mixture by the supplier.
Chemical safety assessments are a part of the REACH[1] registration process when production or importation is anticipated to reach 10 metric tons per year. Completion of the Chemical safety assessment entry area is a requirement for the EU/EEA.
NFPA (Optional)
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Within the NFPA diamond, the blue quadrant represents health, the red quadrant represents fire, the yellow quadrant represents reactivity, and the white quadrant represents special hazards.
HMIS (Optional)
Enter the health, flammability, physical hazard, and personal protection codes into the color bars of the Hazardous Materials Identification System (HMIS) square. The interpretation for the codes is available here.
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Next, click on the “16 Other” tab.
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SDS Section 15 (Tab "15.2 Regulatory") — details
NOTE: The regulatory information appearing below applies to both Tabs "15.1 Regulatory" and "15.2 Regulatory".
Contents
A4.3.15 SECTION 15: Regulatory information
A4.3.15.1 Safety, health and environmental regulations specific for the product in question
SECTION 15: Regulatory information
15.1 Safety, health and environmental regulations/legislation specific for the substance or mixture
15.2 Chemical safety assessment
Item 15: Regulatory Information (header required; content optional):
I. OSHA guidance
From: “OSHA Brief: Hazard Communication Standard: Safety Data Sheets”, https://www.osha.gov/Publications/OSHA3514.html. NOTE: This section is optional under OSHA regulations.
This section identifies the safety, health, and environmental regulations specific for the product that is not indicated anywhere else on the SDS. The information may include:
· Any national and/or regional regulatory information of the chemical or mixtures (including any OSHA, Department of Transportation, Environmental Protection Agency, or Consumer Product Safety Commission regulations)
II. UN guidance
From "Globally Harmonized System of Classification and Labelling of Chemicals (GHS)", 7th Ed., by Secretariat, United Nations Economic Commission for Europe (UNECE). ©2017, United Nations. Reprinted with the permission of the United Nations.
A4.3.15 SECTION 15: Regulatory information
Describe any other regulatory information on the substance or mixture that is not provided elsewhere in the SDS (e.g. whether the substance or mixture is subject to the Montreal Protocol[16], the Stockholm Convention[17] or the Rotterdam Convention[18]).
A4.3.15.1 Safety, health and environmental regulations specific for the product in question
Provide relevant national and/or regional information on the regulatory status of the substance or mixture (including its ingredients) under relevant safety, health and environmental regulations. This should include whether the substance is subject to any prohibitions or restrictions in the country or region into which it is being supplied.
Footnotes:
[16] - Montreal Protocol means the Montreal Protocol on Substances that Deplete the Ozone Layer, as either adjusted and/or amended.
[17] - Stockholm Convention means the Stockholm Convention on Persistent Organic Pollutants.
[18] - Rotterdam Convention means the Rotterdam Convention on the Prior Informed Consent Procedure for Certain Hazardous Chemicals and Pesticides in International Trade.
III. European Union guidance
From: “COMMISSION REGULATION (EU) 2020/878 of 18 June 2020, amending Annex II to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)”. Official Journal of the European Union, 26.6.2020.
SECTION 15: Regulatory information
This section of the safety data sheet shall describe the other regulatory information on the substance or mixture that is not already provided in the safety data sheet (such as whether the substance or mixture is subject to Regulation (EC) No 1005/2009 of the European Parliament and of the Council of 16 September 2009 on substances that deplete the ozone layer [22] Regulation (EC) No 850/2004 of the European Parliament and of the Council of 29 April 2004 on persistent organic pollutants and amending Directive 79/117/EEC [23] or Regulation (EC) No 649/2012 of the European Parliament and of the Council of 4 July 2012 concerning the export and import of dangerous chemicals [24]).
15.1 Safety, health and environmental regulations/legislation specific for the substance or mixture
Information shall be provided regarding relevant Union safety, health and environmental provisions (for example, Seveso category/named substances in Annex I to Council Directive 96/82/EC [25]) or regarding the national regulatory status of the substance or mixture (including the substances in the mixture), including advice on action that should be taken by the recipient as a result of these provisions. Where relevant the national laws of the relevant Member States which implement these provisions and any other national measures that may be relevant shall be mentioned.
If the substance or mixture covered by this safety data sheet is the subject of specific provisions in relation to the protection of human health or the environment at Union level (such as authorisations given under Title VII or restrictions under Title VIII) these provisions shall be mentioned. Where an authorisation granted under Title VII imposes conditions or monitoring arrangements to a downstream user of the substance or mixture, they shall be provided.
15.2 Chemical safety assessment
This subsection of the safety data sheet shall indicate whether the supplier has carried out a chemical safety assessment for the substance or the mixture.
Footnotes:
[22] Regulation (EC) No 1005/2009 of the European Parliament and of the Council of 16 September 2009 on substances that deplete the ozone layer (OJ L 286, 31.10.2009, p. 1).
[23] Regulation (EC) No 850/2004 of the European Parliament and of the Council of 29 April 2004 on persistent organic pollutants and amending Directive 79/117/EEC (OJ L 158, 30.4.2004, p. 7).
[24] Regulation (EU) No 649/2012 of the European Parliament and of the Council of 4 July 2012 concerning the export and import of hazardous chemicals (OJ L 201, 27.7.2012, p. 60).
[25] OJL10,14.1.1997, p.13.
IV. Health Canada guidance
From: "Technical Guidance on the Requirements of the Hazardous Products Act and the Hazardous Products Regulations, WHMIS 2015 Supplier Requirements", Cat.: H129-64/1-2016E-PDF. December 2016. ©2016, Her Majesty the Queen in Right of Canada, as represented by the Minister of Health. The acronym "HPR" refers to the Canadian Hazardous Products Regulations.
Item 15: Regulatory Information (header required; content optional):
As per subsection 4(2) of the HPR, the content of the specific information elements may be omitted as long as the item number and heading appear on the SDS. If provided, this section offers information on the safety, health and environmental regulations, made within or outside Canada, specific to the product in question.
[rev. 4.9.2021]
[1] Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH). The European Chemicals Agency (ECHA) administers REACH.
[2] This shortcut is equivalent to clicking on the Help button on the entry form, and selecting “Background for this section”.