Suitability Overview

Suitability Constraints are rules or compliance checks which can be targeted at parties including regions, customers, suppliers, even your own business, for example to reflect policies about ingredient use.

The rules can be applied in many different circumstances, to combinations of item types, single items, items in applications and relating to the application and dosage. When ‘Suitability Check’ is triggered the item is checked against all the rules that apply and a Suitability Report is generated for the User. Suitability checks can be undertaken during product development and selection and can also be linked to document production. This means ongoing compliance is possible to manage.

The key reasons to use Suitability checking are to:

Ensure all formulations developed comply to internal or customer policies on ingredient use / non-use.
Add rules to limit the hazards which would apply to a product used in an application at a specified dosage.
Find matching items which meet customer restrictions, so non-compliant products are not submitted to customers
Generate reports which show the reasons for non-compliance to aid formulation modification.
Link the supply of documents to Suitability Checking, so product compliance is determined before issuing a document. This is a useful way of monitoring on going compliance.

Using Suitability Checks

Select the Item using instant search. Select the appropriate Party or Parties and the relevant Application(s) and Dosage(s). Alter the TO and the format for reporting if required. Then Select ‘Check Suitability’.

This will check the scenario, then give a message which indicates the item either passed or failed the suitability check, with an option to ‘Show Details’. Select ‘Show Details’ to access a PDF report with expanded information about the conditions of the check and the nature of the failed and / or passed checks.

Places where Suitability Checking can be used

During Product Development: When adding a formulation access ‘Check Suitability’ in ‘Other Menu’. This checks the formulation currently in development.
During Product Selection: Find Matching Items contains the facility to Check Suitability during a search (at the bottom of the screen), or on an individual basis (select a single item from the list and ‘Check Suitability’ becomes available (no longer greyed out).
During Document Production: Individual documents or parties can have Suitability Checking added as part of the process of producing documents. If an item fails a suitability check, the document is held and can only be produced by specified Users. Because documents are usually produced in response to customer requests or changing circumstances, introducing suitability checking into document production is a convenient way of ensuring compliance is monitored on ongoing basis.
On Demand: Suitability Checking can be triggered from many different menu options, and specifically from ‘Check Item Suitability’.

Suitability Checking can relate to parties or party groups, and can be applied to Documents.
Parties can also have Attachments added to them. This can be a useful place to add customer specific regulatory information. You could even add region specific regulations to party groups.

Examples of Suitability Constraints

Constraints can be targeted at the physical composition (the composition exploded to physical raw materials), or targeted at regulatory composition (the composition exploded to full depth which includes all the raw material components). The choice as to where to target the constraint needs to take the situation into account.

Sometimes there is more than one way to implement a constraint. All constraints should be tested before use to ensure you get the results you expect.

A list of example suitability constraints follow, plus details, which may be helpful for orientation and learning how to add suitability constraints.
Example A – Ban Ingredients
Example B – Limit ingredients to a specific percentage in concentrated form, or in application
Example C – Ban hazards

Example A – Ban ingredients

To ban ingredients, there are 2 common ways to do this:

Example 1: If you have a group of ingredients which share something common (e.g. polycyclic musks), you can group them with a property and ban the property. To do this :

Group the materials with the property.

Add a property e.g. PM (Polycyclic Musk) as a Yes/No property, calculated based on ‘ANY’ PM property present
Add PM = Yes to the raw materials affected

Add the suitability constraint as

A Regulatory item property limit on property PM with 0% Limit (0% limit is in effect a ban)
Add a comment if would like to, these can be useful to summarise the intention of the constraint (e.g. No polycyclic musks allowed at all) .

The benefit of the above approach is PM can be calculated for mixtures, so you have a positive identity of mixtures containing PMs. This approach is useful for high priority / common restrictions. For more about properties, look at the Properties Overview

Example 2: If you want to limit raw materials on a case by case basis:

Add a suitability check with ‘Regulatory Item Limit’ (or physical item limit), then
- List raw materials affected,
- Enter a limit of zero.

Example B – Limit ingredients to specific percentage in concentrated form, or in application

This is similar to the above example except we are limiting rather than banning the ingredients. In the first example below, we will limit an ingredient in the concentrated product supplied, and in the second example we will limit an ingredient in relation to the application and dosage used by the intended customer.

Example 1: Limit Physical Ethanol to a small percentage which limits the physical (directly added) ethanol to 0.09% in the concentrated product supplied.

Add a constraint with a Physical item Limit
List items to be limited
Add a limit of 0.09

Example 2: Limit the ingredient, expressed at final dosage used by customer in their application

Add a constraint with a Physical item Limit
List items to be limited
Add a limit of 0.0009
Tick ‘In Application’ box

Example C – Ban hazards

Sometimes you need to ban a hazard from appearing on a product you supply, or to avoid the carry over of hazards from your product to your customers product. A key example is to limit GHS pictograms on a consumer pack, or avoid particular hazards on the product you supply for health and safety reasons. Most GHS hazards have trigger point’s, the concentration at which the hazard applies, e.g. 10% for skin irritation category 2. This style of hazard has a TFV[1], where TFV=1 always represents the trigger point for the hazard to apply. In this situation, you should set a Property Maximum just below the trigger point (which is TFV <1, e.g. 0.9999) to avoid the hazard. In the first example below, we will limit hazards in the concentrated product supplied, and in the second example we will limit hazards in relation to the application and dosage used by the intended customer.
Example 1: Ban CMR hazards from appearing on a concentrated product supplied.

Add a constraint with a Property Maximum
List properties to be limited (select the properties which have ‘=’ at the end)
Add a limit of 0.9999 (just below the TFV trigger of 1)

Example 2: Ban the environmental hazard pictogram from appearing on the product application which will be supplied by your customer (e.g. the candle produced by your customer)

In this example the purpose is to prevent an environment pictogram from appearing on the customer’s product e.g. a candle sold in Europe. The key hazards are therefore Environmental Chronic Categories 1 and 2, and Environmental Acute Category 1. Environmental Chronic categories are cumulative, therefore by limiting Category 2, this in turn limits Category 1.

Add a constraint with a Property Maximum
List properties to be limited (select the properties which have ‘=’ at the end)
Add a limit of 0.9999 (just below the TFV trigger of 1)
Tick ‘In Application’ box

Example 3: To ban a hazard from being present on any ingredients of the product supplied e.g. no materials with Carcinogen 1A classification (regardless of level), use ‘Property Forbidden’