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3 Replies Latest reply: Nov 19, 2012 12:06 PM by KellyMayfield RSS

LIO Disclosures

Sinfo_Cesare Newbie
Currently Being Moderated
Hi,
our customer uses to manage 2 different descriptions for each material specification.
He would like to use the first description (extended description) in all the different forms (material specification seach, formulation, etc.), while the second description (short description) has to appear only in LIO statements.

Is there any possibility to set up material specification and LIO profile to do it?

Regards,
Cesare
  • 1. Re: LIO Disclosures
    KellyMayfield Expert
    Currently Being Moderated
    Are you currently creating regulatory breakdowns on the material specifications?

    If the material specification contains a single component breakdown you can use the component catalog term or free text component as the "second description". This will appear in the LIO tree.
  • 2. Re: LIO Disclosures
    Sinfo_Cesare Newbie
    Currently Being Moderated
    Hi,
    by now we didn't think to manage regulatory breakdowns on the material specifications.
    The main reason is that for many ingredients (material specifications) our customer doesn't know and doesn't need to collect the exactly components composition.

    Anyway, to follow the solution you proposed, for each ingredient our customer has to:
    - create and handle both a material specification and a component
    - set up the material specification in way to contain a single component breakdown

    If I well understand, it's a little bit uncomfortable!

    Is there any other possibility?

    Thank you,
    Regards,
    Cesare
  • 3. Re: LIO Disclosures
    KellyMayfield Expert
    Currently Being Moderated
    This is correct, a material is made up of components. Some breakdowns will only contain one component, but some will contain multiple components. If you could make it predictable to know which materials always only have one component in the breakdown then you could automate the creation of that breakdown using a workflow or save event or even just a nightly process that runs when a specification is created. If ALL materials only contain one component then it will be a very easy task. If this is the case please let us know, we haven't run across this use case yet.

    Components/breakdowns bring a lot of benefits.

    1. They allow you to know the full breakdown of a material (including those created using formulations) which is critical for compliance and regulatory
    2. Component Catalog allows you to place labeling rules around a component per region or any other restrictions needed for regulatory labeling. See naming/disclosure example below.
    3. Allow you to capture the moisture amounts at the component level. With this captured proper moisture loss can be captured and adjusted. This is critical when dealing with any sort of moisture loss or reconstitution. This will also greatly affect labeling and compliance use cases.
    4. We plan on continuing this concept in future product releases, so functionality & features will only increase around the breakdown as well as labeling and compliance. Any effort will not be wasted.

    Here's a few examples of why breakdowns are worth the effort.

    You may have a material spec for a protein flavoring pack. Its true breakdown may be Whey, Dried Apple, Brown Sugar, Salt
    In the US it may be required to call Whey "Whey" on the label. But when labeling for Europe you may need to always call Whey "Milk Protein" so it appears as an obvious allergen. This is possible when using component catalog terms and LIO. Component Catalog allows you to guide labelers when they are investigating the ingredient tree. You can divide rules by region or any restriction you see fit.

    Long term management is also a great benefit. For example, 5 years from now Whey may be considered dangerous if it makes up more than 5% of your product. If you have breakdowns in place you will be able to easily figure out what products have more than 5% whey. In the example above if you didn't use the breakdown you would only know which products used the protein flavoring pack, then you would have to manually investigate each formulation, intermediate formulation etc. This sort of task is happening now around genetically modified raw products, where some states are requiring all GMO products to be labeled.

    It may seem like extra work to maintain a breakdown when you are just loading raw materials into the system but the benefits of creating regulatory breakdowns will reveal themselves when you get further into formulation management, labeling, compliance and regulatory tasks. At the very least use free text components so that as you use the raw materials in formulations a valid breakdown is created. I highly recommend using breakdowns and if all raw materials just contain a single component I recommend using an automated system event to create the breakdowns. Remember to also add the total solids/moisture attribute at the component level as well.

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