Managing Substance Concept and Company Substances

Understand how you utilize company substances and how these relate to listed substances.

Substances are an important element of product compliance.

• Substances represent the chemical view of products or raw materials. Analytical compositions provide insight on this most detailed breakdown.
• Numerous regulations target on substances. Substances can be restricted or explicitly allowed. There can be limits or thresholds defined for substances.

SAP S/4HANA for product compliance comes with system embedded regulatory content, which comprises of more than 320.000 listed substances.

Listed substances means substances being addressed in regulations or other legal sources.

Since a company will never need to access all available listed substances, and the exact substance definition needs to be laid down by the expert, you create company substances. These company substances are the subset of substances from the listed substances library required for your products or raw materials.

In general, a company substance is linked to an existing listed substance, but it is also possible to create company substances without, means with link to a new listed substance. Frequently this is called a private substance, since it is a company-specific (listed) substance.

We take a closer look at listed substances:

The root listed substance is the focal point for substances. Each company substance is related to a root listed substance - an existing one or a new, "private" listed substance.

The root listed substance can have substance variants - for example, a substance being gaseous, but also can be liquified or compressed, or common dilutions of the substance. When you create a company substance, you can assign substance variants, represented by substance conditions.

The root listed substance can be assigned to substance groups - for example, substances having similar chemical properties like bromides or arsenic compounds.

Polymers are very special substances, you can identify such substances by setting the indication Polymer Substance on the company substance. A polymer substance can have different relations of the belonging monomer substances, which can be maintained in related polymer compositions of the polymer substance.

Now we look at substances being subject to regulations. Typically, in such cases, there are lists of substances published as annexes to regulations.

Compliance requirements being the digital version of such regulations comprise substance lists. These substance lists can have assigned

• Root listed substances, which is most common
• Substance variants, if the regulation focuses on such a variant specifically
• Listed substance groups, this is to address substances with similar chemical properties like bromides or arsenic compounds. You can modify substance groups assigned to a substance list of a compliance requirement version by assigning or unassigning company substances to a substance group. Such changes are specific to one substance list, but are propagated to succeeding compliance requirement versions.

Manage your company substances and relate them to listed substances.

Beside the compliance requirements, substances are the second pillar of product compliance. Numerous compliance requirements relate to restrictions regarding substances, which are incorporated in the compliance requirement as substance lists.

The system comes pre-filled with substances, called listed substances, because these substances are listed in regulations. Since you will only use a subset of the huge substance library, and substance definitions must be made by an expert; a company substance has to be created first. The created company substance is linked to a listed substance.

In case, there exist variants of the substance, for example, for gas, which can be liquified or compressed, or to identify specific quality grades, you have to choose the appropriate substance variant by assigning the appropriate substance condition.

By creating company substances and so building your company's substance library the master data specialist - product compliance provides prerequisites for

• Analytical composition, which represents the most detailed, chemical level of raw materials and products
• Assessments of substances for substance-related compliance requirements. This is most prominent in the solution area product marketability.

Company substances are fundamental master data for products and raw materials.

You need company substances to create analytical compositions of your raw materials and further to calculate analytical compositions for your unpackaged products. The analytical composition represents the chemical level of products and raw materials.

Many substances are subject to regulations, usually affected substances are published as substance lists attached to these regulations. This is, why in product compliance we use the term listed substance.

To bridge the chemical level of products and raw materials to regulations, the relation of your company substances to listed substances is essential. In turn, assessments made for a company substance once are propagated to any product or raw material using the substance.

Taking care of the inventory of company substances and processing compliance assessments on company substances are tasks of the master data specialist - product compliance.

In the Manage Substances Compliance app, you get an overview on your company substances.

Utilize the search to retrieve a specific substance by name or number.

If the substance you are searching for is not yet available as a company substance, you use the action Create.

In most cases, you will link the new company substance to an existing listed substance from the system-embedded regulatory content.

Utilize the search to find the appropriate listed substance in the substance library.

Check your newly created company substance.

You can give the company substance an internal name to supplement names originating from the listed substance.

There are no translations for the internal name.

The internal name is intended to be used as a common name in internal communication.

In the Names section, you find the names coming from the linked listed substance. These names are names being found in regulations.

You can give the company substance company-specific names to supplement names originating from the listed substance.

This is helpful, for example in case you need to distinguish variants of the substance, represented by assigned conditions.

By assigning conditions, you can identify a specific variant of the listed substance, assigned to the company substance.

In the Groups section, you can see the assignment of the substance to substance groups on lists of compliance requirements.

These assignments are related to the root listed substance, your company substance is linked to.

Here you can modify group assignments:

• Remove the substance from the group of a compliance requirement.
• Add the substance to the group of a compliance requirement.

Define polymer substances and variants thereof with their specific polymer compositions.

Polymer substances are a special kind of substances, since they are the result of the combination (polymerization) of monomer substances - this can be:

• one monomer substance, for example, polyethylene consisting of ethylene monomers;
• more than one monomer substances, for example, polyester mainly consisting of two monomers, one with multiple hydroxyl groups, the other having multiple carboxyl-acid groups.

There are regulations applicable for both, the polymer substance and the monomer substance(s).To serve these regulations, you can

• Identify a substance as being a polymer substance;
• Maintain polymer composition(s) - multiple polymer compositions are required for example in case there are variations in the ratio of the ingoing monomer substances.

You identify a substance as being a polymer substance according to the OECD definition by setting the identifier on the substance header.

A 'POLYMER' means a substance consisting of molecules characterized by the sequence of one or more types of monomer units and comprising a simple weight majority of molecules containing at least three monomer units which are covalently bound to at least one other monomer unit or other reactant and consists of less than a simple weight majority of molecules of the same molecular weight. Such molecules must be distributed over a range of molecular weights wherein differences in the molecular weight are primarily attributable to differences in the number of monomer units. In the context of this definition a 'MONOMER UNIT' means the reacted form of a monomer in a polymer."

Source: https://www.oecd.org/env/ehs/oecddefinitionofpolymer.htm

You must identify the polymer composition by a specific name.

It is possible to have polymer substances assigned to the current polymer composition.

There can be multiple polymer compositions for a polymer substance since, for example, ratio of monomers may vary, so each polymer composition must be identified by a specific name.

Remarks:

• Creation of a polymer composition does not depend on setting the polymer indication for the (company) substance.
• When you assign a polymer substance to, for example, the analytical composition of a raw material, this raw material is automatically indicated as a polymer.