SDS latest Regulations

Having compliant Safety Data Sheets (SDS) on hand is critical for all suppliers of
substances and mixtures. Not only do they aid in effectively informing workers
of all associated hazards, but they also help employers meet their obligation
to assess health and safety risks from the presence of hazardous chemicals
and to protect public health and the environment. The EU has slightly different
rules than OSHA when it comes to SDS authoring, but all sheets must also
comply with the Globally Harmonized System (GHS).
SDS are integral to the Registration, Evaluation, Authorization and Restriction of

Chemicals (REACH) regulations. REACH requirements are everchanging and
have continuously been adapted to include the Globally Harmonized System
(GHS) rules. Further modifications have been made to these rules through
amendments to Annex II of REACH. According to Regulation (EC) No 1272/2008
(Classification, Labelling and Packaging Regulation (CLP) , SDS communicates
safety information when a substance or mixture has been deemed hazardous.
All SDS generated after 31 December 2022 must be formatted according to
Regulation (EU) 2020/878; remember to adopt this new format as soon as
possible when generating new SDS.
This article will list CLP SDS requirements and outline the changes made
according to Regulation (EU) 2020/878.
A quick summary of
Regulation 2020-878-EU
Commission Updates
General Requirement
 Use simple, clear, and precise language.

 All SDS pages should be numbered or use phrases to indicate
the presence of a following page (ex. Continued on next page
or End of safety data sheet)
Section 1 Requirement
 Indicate the Unique Formulation Identifier of all your mixtures

in section 1 of your SDS.
 The Product ID in Section 1 of SDS should indicate the word
“Nanoform”, if any nanoforms are present.
Section 2 Requirement
 Section 2.3 other hazards, should indicate the substance(s)

with the concentration =>0,1 % by weight when included on
the list established in accordance with Article 59(1) of REACH
for having endocrine disrupting properties, or is identified as
having endocrine disrupting properties in accordance with the
criteria set out in Commission Delegated Regulation (EU)
2017/2100 or Commission Regulation (EU) 2018/605.
Other Requirements
 Provide information on endocrine disruptors in sections 11 and

12.
CLP SDS Authoring

Requirements
The EU has clearly outlined general requirements for SDS creation to
address the included information's format and objectives which
were briefly mentioned in the general section in the quick summary
above. You must always take these into account before formulating
your SDS. The first requirement states that must use clear and
precise language, avoiding jargon or obscure acronyms. Avoid any
language that may indicate that the substance is not hazardous,
such as “may be dangerous”, “no health effects”, or “safe
under most conditions of use” if they are inconsistent with the
classification. As mentioned before, the second rule states that you
must number all pages, to elaborate further the rule says you must
specify the total on each page (for example, “page 1 of 10”), and
indicate the presence of a following page (ex. Continued next page)
and the end of the document (End of safety data sheet).
In addition to these necessary items, every safety data sheet must:
 Be concise and prepared by a competent person (someone with

sufficient knowledge for the completion of a section of SDS or the
entire SDS such as a qualified chemist). Suppliers must always provide
accurate product information.
 Enable users to take protective measures in the workplace. The writer
of the SDS must clearly inform the intended audience of the hazards of
a substance or mixture and provide safe storage, handling, and
disposal information.
 List the information in such a way that allows employers to decipher if
there are hazardous substances in the workplace and assess risk to the
health and safety of workers during operating practices.
 Avoid jargon that may be difficult for the reader to understand, as well
as vague acronyms, abbreviations, or statements that may indicate
that the product is not hazardous (if inconsistent with the product’s
classification).
CLP Guidance on Completing

the SDS
With the above considerations, you are ready to compile your SDS.
Each SDS section addresses different properties and requires
research, and even laboratory tests, to determine the appropriate
classifications. Shown below are the sections of CLP SDS according
to the EU.
SDS SECTION 1: Identification of the substance/mixture and of the

company/undertaking
SDS SECTION 2: Hazards identification
SDS SECTION 3: Composition/information on ingredients
SDS SECTION 4: First aid measures
SDS SECTION 5: Firefighting measures
SDS SECTION 6: Accidental release measures
SDS SECTION 7: Handling and storage
SDS SECTION 8: Exposure controls/personal protection
SDS SECTION 9: Physical and chemical properties
SDS SECTION 10: Stability and reactivity
SDS SECTION 11: Toxicological information
SDS SECTION 12: Ecological information
SDS SECTION 13: Disposal considerations
SDS SECTION 14: Transport Information
SDS SECTION 15: Regulatory information
SDS SECTION 16: Other information
You may wonder which section to tackle first and how to compile
them in a sequence that promotes efficient data collection.
Fortunately, the EU provides the following framework to help you
compile your SDS with ease. Sticking to the framework’s sequence
(shown below) is highly recommended; identifying hazards in
Section 2, for instance, may only be possible once you have
determined the inputs of all other sections.
Each section of the SDS requires thorough research and evaluation.
For example, determining hazard classification, such as Acute
Toxicity, requires many formulas and must be classified based on
exposure routes and hazard severity. In contrast, carcinogenicity
classification needs evaluation of existing data to put them in one of
three categories accurately. ERA has detailed eBooks on various
ways of determining these properties.
Revised Requirements for EU

Safety Data Sheets -
Regulation 2020-878-EU
Commission
CLP compliance requires up-to-date knowledge of requirements and
changes to ensure accurate SDS. The EU published REGULATION
(EU) 2020/878, which defines new content. From December 2022
forward, the EU SDS requests variations in the SDS sections
concerning product identification and hazard communications.
Section 1 has been amended pursuant to REGULATION (EU)

2020/878. According to CLP regulations, each chemical requires a
Unique Formula Identifier (UFI), and it should be clearly indicated on
the first page of the SDS. If you do not have a readily available UFI,
you can generate one at https://ufi.echa.europa.eu/#/create.
Endocrine-disrupting properties of the substance must be clearly

indicated throughout multiple sections of the SDS, including Section
2 (Category 2.3: Other hazards), 11 (Subcategory 11.2.1: Endocrine
Disrupting Properties) and 12 (Category 12.6: Endocrine Disrupting
Properties).
Below are the phrases that you should use if your substance
contains endocrine chemicals or no endocrine chemicals.
Section 2
Containing Endocrine chemicals
2.3 Other hazards
The substance(s) below is included on the list established in

accordance with Article 59(1) of REACH for having endocrine
disrupting properties, or is identified as having endocrine disrupting
properties in accordance with the criteria set out in Commission
Delegated Regulation (EU) 2017/2100 or Commission Regulation
(EU) 2018/605.
No Endocrine chemicals
 Other hazards
The substance(s) is not included in the list established in accordance

with Article 59(1) of REACH for having endocrine disrupting
properties, or is not identified as having endocrine disrupting
(EU) 2018/605.
Section 11
11.2.1 Endocrine disrupting properties
Adverse health effects caused by endocrine disrupting

properties : The substance(s) below is included on the list
established in accordance with Article 59(1) of REACH for having
endocrine disrupting properties, or is identified as having endocrine
disrupting properties in accordance with the criteria set out in
Commission Delegated Regulation (EU) 2017/2100 or Commission
Regulation (EU) 2018/605.
11.2.1 Endocrine disrupting properties
Adverse health effects caused by endocrine disrupting properties:

No data available
Section 12
12.6 Endocrine Disrupting Properties
The substance(s) below is included on the list established in

accordance with Article 59(1) of REACH for having endocrine
disrupting properties, or is identified as having endocrine disrupting
(EU) 2018/605.
12.6 Endocrine Disrupting Properties
The substance(s) is not included in the list established in accordance

with Article 59(1) of REACH for having endocrine disrupting
properties, or is not identified as having endocrine disrupting
(EU) 2018/605.
Click the image below to view a fully compliant CLP sample SDS to
guide you in creating your own SDS. The sample is generated using
the ERA SDS authoring solution.
SDS Authoring, the ERA way
All these details can be challenging to remember when authoring
your SDS. According to the American Chemical Society, an individual
would require 8 to 16 hours to produce the first draft of a fully
compliant SDS without software assistance. At ERA, we believe that
no one should have to work this hard on a single product; our tool is
expertly built and incorporates the expertise of many chemical
experts to provide you with accurate and compliant SDS in a matter
of minutes, including the above-mentioned CLP changes.
ERA’s software has been updated to include:
 A to add the UFI number on your SDS.

 The ability to indicate nanoform information
 The functionality to identify whether a chemical classifies as endocrine
disruptive or not, and to display the statement under Section 2
(Category 2.3: Other hazards), 11 (Subcategory 11.2: Endocrine
Disrupting Properties) and 12 (Category 12.6: Endocrine Disrupting
Properties)
Watch a personalized demo below to learn how you can have quick
access to fully compliant SDS and in-depth consultation from
seasoned experts.

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Having compliant Safety Data Sheets (SDS) on hand is critical for all suppliers of

SDS are integral to the Registration, Evaluation, Authorization and Restriction of

 Use simple, clear, and precise language.

 Indicate the Unique Formulation Identifier of all your mixtures

 Section 2.3 other hazards, should indicate the substance(s)

 Provide information on endocrine disruptors in sections 11 and

CLP SDS Authoring

In addition to these necessary items, every safety data sheet must:

 Be concise and prepared by a competent person (someone with

CLP Guidance on Completing

SDS SECTION 1: Identification of the substance/mixture and of the

Revised Requirements for EU

Section 1 has been amended pursuant to REGULATION (EU)

Endocrine-disrupting properties of the substance must be clearly

2.3 Other hazards

The substance(s) below is included on the list established in

The substance(s) is not included in the list established in accordance

Containing Endocrine chemicals

11.2.1 Endocrine disrupting properties

Adverse health effects caused by endocrine disrupting

11.2.1 Endocrine disrupting properties

Adverse health effects caused by endocrine disrupting properties:

Containing Endocrine chemicals

12.6 Endocrine Disrupting Properties

The substance(s) below is included on the list established in

12.6 Endocrine Disrupting Properties

The substance(s) is not included in the list established in accordance

ERA’s software has been updated to include:

 A to add the UFI number on your SDS.

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