Using Safety Data Sheet Authoring - Collecting Data for Publication

Have a glance at regulation based content for safety data sheets and the SDS authoring process.

We will now have a closer look at safety data sheet authoring. Here we gather a lot of the information published in the safety data sheet. This information is related to the different sections of the safety data sheet:

• For some sections, there are dedicated regulations in place which define how to assess information, for example, Components with Occupational Exposure Limits, Hazardous Ingredients, GHS Classification, or Waste Code.

• For other sections, information to be published is more specific to the product, its applications or its uses; for example, First Aid Measures, Fire Fighting Measures, Accidental Release Measures, or Personal Protection Measures.

You gather the information by assessing related compliance requirements for the unpackaged product.

We are now looking at compliance requirements which must be assessed to prepare content of safety data sheets. For example:

• Substances with occupational exposure limits – OEL
• Hazardous ingredients
• Waste code

But also emergency information like:

• First Aid Measures
• Firefighting Measures
• Personal Protection Measures
• Accidental Release Measures

Some of these compliance requirements are related to legal regulations like those on substances with occupational exposure limits or waste codes applicable for disposure of the product.

Other compliance requirements relate to information which must be provided in safety data sheets, but there are no specific regulations, which define the content. For example, first aid, or firefighting measures, personal protection, or accidental release measures. Such information relates to the products or the product portfolio.

Looking at the content of a safety data sheet, we see that besides the safety data sheet related assessments at the unpackaged product level, the safety data sheet has additional content:

• Dangerous goods information, resulting from dangerous goods assessments;
• Information, related to substances like toxicological information, occupational exposure limits, regulation-based classifications, or other data resulting from substance assessments.

This means that in the safety data sheet authoring process, which is a core product compliance process, all our product compliance specialists are involved:

• Product stewardship specialist, who is liable for authoring of the safety data sheet;
• Master data specialist, who takes care for substance related assessments and basic data like physical-chemical data.
• Dangerous goods specialist, in charge of dangerous goods assessments and the resulting dangerous goods classification data.

Understand how content for safety data sheets evolves from compliance assessments and the product's properties.

We will now have a look at safety data sheet related assessments, which provide information to be published on the safety data sheet.

Basic compliance data, along with listed substances, provide the foundation for almost any further assessment.

For safety data sheet related assessments, we have two groups of compliance requirements provided with the system embedded content:

You activate these CRs from the system embedded content and use them to assess safety data sheet related information for your products:

• Information on Hazardous Ingredients
• Components with Occupational Exposure Limits
• SARA Hazard Classification
• Storage Class
• NFPA Rating
• Waste Code
• Registration of Confidential Business Information

You can create your own company CRs based on the examples provided with the content:

• First Aid Measures
• Firefighting Measures
• Accidental Release Measures
• Personal Protection Measures

Be aware, that in the compliance requirements coming with the system embedded regulatory content, you can also add company-own phrases.

Depict the prerequisites you must take care of for safety data sheet authoring.

Safety data sheets have a regulation defined structure. For some of the sections belonging to this structure, you also must apply regulations when gathering the related content, for example, when it comes to components with occupational exposure limits.

You find compliance requirements for these sections with the system embedded regulatory content.

To complete the content for your product's safety data sheet, you make use of

• Physical-chemical and safety-related data, toxicological and ecotoxicological data maintained for the product;
• Dangerous goods assessments;
• Assessments on substances along with basic compliance data of substances.

Regarding components with occupational exposure limits (OEL), there are specific apps to manage and activate compliance requirements.

Create company specific compliance requirements for SDS related assessments, for example for firefighting measures.

For initial creation of a company specific compliance requirement, you press the Create First Version of the CR. You define names for the compliance requirement and the first version. Then you select the applicable compliance pattern. Maintain the pattern specific details, for example assign phrases to the phrase enabled fields.

When finished, you release your new compliance requirement version.

Before you can make use of a compliance requirement, you must activate it. Only activated compliance requirements are available for assignment to compliance purposes.

You can also deactivate obsolete compliance requirement versions.

To have compliance requirements available for assessment in a compliance view, you must assign compliance requirements to compliance purposes. Only compliance purposes can be assigned to a compliance view

You start creation of a new, company-own compliance requirement (CR) by creating the first version in the Manage Compliance Requirements – Safety Data Sheets app.

The assignment of the compliance pattern is key – it defines the data structures and, where applicable, compliance calculations.

Be aware, that you can create your own CRs only for specific compliance patterns.

You cannot edit or replace regulation-based compliance requirements provided with system embedded regulatory content.

In the example, we create a CR for Firefighting Measures.

The available phrase-enabled fields of the compliance requirements are defined by the compliance pattern.

From here, you can directly navigate to the Manage Phrase-Enabled Fields app to edit the assignment of phrases for the individual fields.

Here, you have two options to assign phrases to a field:

• Create your own phrase
• Copy from Existing Phrase.

Copy from Existing Phrase – when you copy phrases from the system embedded content, you have numerous translations at hand.

When you Create your own phrases – be aware of the translations you need, you must add all these translations.

When you finished with managing phrase-enabled fields, you navigate back to your compliance requirement (CR).

Here you check the available phrases per field.

You finalize editing your compliance requirement by setting the maintenance status to released.

Then you must activate the CR version.

To activate your released compliance requirement version, you use the Activate Compliance Requirements – Safety Data Sheets app:

• Only upon activation, the first version of a new CR is available for assignment to a compliance purpose, which makes it available for assessment in compliance views.
• Activation of a subsequent version of a CR makes the new version available for assessment in compliance views.

To assess the compliance requirement assigned to a product via a compliance purpose, you use the Manage Basic Compliance Data – Unpackaged Products app and navigate to the compliance assessments – here the Safety Data Sheet related assessments.

You open the details of the compliance requirement and work on the assessment.

Here you edit the details of the compliance assessment by selecting the phrases applicable for your product.

When finished, you release the completed compliance assessment.

Let's look at how components with occupational exposure limits are identified and how you can extend compliance requirements with own OEL lists.

Regulations provide lists of substances with assigned occupational exposure limits (OELs).

System embedded content provides compliance requirements containing these substance lists.

For such compliance requirements assigned to a product, the system automatically calculates affected substances upon release of the analytical composition against the given substance list.

Resulting affected substances are included into the assessment of the compliance requirement for the product stewardship specialist to review and release.

For compliance requirements focusing on substances with occupational exposure limits (OELs), automated compliance calculations determine affected substances from released analytical composition.

As soon as you release the analytical composition of the product, automatic compliance calculations determine the affected substances with occupational exposure limits.

You find the results in the assessment of the related compliance requirement.

You can supplement a regulation-based compliance requirement on components with occupational exposure limits (OELs) with a company-own list of components with OELs.

This may be applicable for example in case you as the manufacturer of a product have evidence to apply an occupational exposure limit which is more restrictive than the limit given in regulations or to define a limit for a substance not having an OEL so far.

Define substances to be masked from on the analytical composition.

The objective of Confidential Business Information (CBI) definition is to not disclose individual substances being components of the product.

CBI definition is based on the analytical composition of the unpackaged product.

You maintain CBI definition in the compositions section of the compliance view of the unpackaged product.

In the Compositions section, you use the action Create Confidential Business Information (CBI) to define substances intended to not be disclosed, for example, on safety data sheets.

Upon creation of confidential business information, you assign the applicable legal area. Usually, the definition is valid globally.

Navigate into the details of the newly created confidential business information to edit data.

You define the print settings for concentration information from the available options:

• Calculate Ranges Based on Regulations: This is the preset option.
• Use Substance-Specific Value: For this option, you can maintain the value or a range per substance.

In the next step, you add substances for confidential business information.

Add substances for confidential business information from the released analytical composition.

With the print setting Use Substance-Specific Values for concentrations you can, for example, enter a range for the concentration of the substance for confidential information.

After saving and releasing the data, you find the confidential business information for the selected legal area in the compositions section of the unpackaged product.

Review and activate compliance requirements for confidential business information registration.

Compliance requirements for confidential business information registration are provided with the systems embedded regulatory content.

Since the registration of confidential business information is based on specific regulations, it is not necessary to create customer specific compliance requirements with compliance pattern registration of confidential business information.

Phrase-enabled fields allow to maintain textual information on the registration, for example to be outputted on safety data sheets.

Process integration for compliance requirements with compliance pattern confidential business information registration defines, if the assessment is made on:

• The unpackaged product and the components thereof
• Substances

Upon activation of the compliance requirement with compliance pattern confidential business information, you select the preferred legal area for the analytical composition to be used when assessing the registration of confidential business information.

Next, you assign the activated compliance requirement to a compliance purpose for assignment to your products.

You find the compliance assessment for confidential business information registration in the safety data sheet related assessments.

In the example compliance assessment, you can have confidential business information registration on two levels:

• Registration of the product
• Registration of components

You can maintain an additional statement using phrases and the concentration of a mixture, contained in the product.

Registration of components relate to the legal area specific analytical composition selected upon activation of the compliance requirement version. In case the legal area composition does not exist or is not released, fall-back is the globally valid analytical composition.