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BEACHTEC

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Posted 17 April 2015 - 03:46 PM

Hello -  I need some help with a question. Recently I was asked by a client (I'm a consultant) for the regulatory definition of what is Contact Packaging vs. Non-Contact Packaging. It's an interesting question because everyone seems to know (myself included) which is which but he wanted me to point him to a clear definition, based on any applicable regulations.

 

On top of that, to what level does one go get things like MSDS's on the Non-contact materials. That is to say, where do you stop? The Box? The banding on a pallet? The pallet itself? I guess one could say get EVERYTHING... but that kind of shotgun thinking, which would work, does not advance anyones understanding of the practice or the regulatory demands that are driving them. 

 

Searching through the FDA website actually offered no "clear" guidance on the issue and of course the Codex is mostly organized by commodity. Any one have any guidance? Thank you!!!

 

m



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Posted 17 April 2015 - 08:11 PM

Hi, Beachtec;

 

The regulation is governed by Title 21. FDA defines food contact in a tier depending on the type of packaging (direct, secondary, indirect). These links may help;

 

Attached File  CFR-2011-title21-vol3-part175 Adhesives and Components of Coatings.pdf   306.25KB   111 downloads

(indirect food additives)

Attached File  CFR-2011-title21-vol3-part176 Paper and Paperboard Components.pdf   311.19KB   120 downloads

(indirect food additives)

Attached File  CFR-2000-title21-vol3-part177 Indirect Food Additives - Polymers.pdf   552.85KB   86 downloads

 

 

Not entirely sure why you would need an SDS for secondaries (tape, straps, etc.) in a food safety program. NFPA ratings for health are always 0. The hazard is usually for fire...  :uhm:

 

 

Hope this helps.


Edited by Charles.C, 19 April 2015 - 01:12 PM.
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Marshenko

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Posted 17 April 2015 - 08:50 PM

My best copy pasta job....

 

Food Contact Substance (FCS) - Section 409 of the FD&C Act defines an FCS as any substance that is intended for use as a component of materials used in manufacturing, packing, packaging, transporting, or holding food if such use of the substance is not intended to have any technical effect in such food. Additional information can be found on the Food Contact Substances Notification Program page.

There is a hierarchy from Food Contact Substance (FCS) through Food Contact Material (FCM) to Food Contact Article (FCA).

  • The Food Contact Substance (the subject of an FCN) is a single substance, such as a polymer or an antioxidant in a polymer. As a substance, it is reasonably pure (the Chemist's definition of substance). Even though a polymer may be composed of several monomers, it still has a well-defined composition.
  • Food Contact Material (FCM) is made with the FCS and (usually) other substances. It is often (but not necessarily) a mixture, such as an antioxidant in a polymer. The composition may be variable.
  • The Food Contact Article is the finished film, bottle, dough hook, tray, or whatever that is formed out of the FCM.


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Charles.C

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Posted 19 April 2015 - 01:32 PM

I'm almost certain this OP has come up before in different ways.

 

I deduce from the posts #2 and #3  that within the context of the the OP -

 

(1) "Non-contact packaging" is seemingly not included within the context of Food Contact Packaging (FCP) requirements in post #2. Presumably considered as low (negligible) likelihood to contact food?.

2) From a regulatory POV, the components of Food Contact Packaging are regarded as indirect [food] additives, their acceptability is determined by presence/compliance with the 3  lists of post #2 (and post #3? [see 5 below])

(3) i could not find any specific requirement in lists of post #2  as to validation docs. of any particular "quality" of the components (eg MSDS as per OP) but i anticipate it is required ?

(4) i saw no mention of inks  (per se) within the  lists of post #2 ??

(5) Do the defs in post #3 result in another   set of acceptable chemical components of quality mentioned in post #3, ie "reasonably pure" (whatever that means). If so,  is there a specific reason why one uses the list of post #2 vs that of  #3  or vice-versa ?


Kind Regards,

 

Charles.C


BEACHTEC

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Posted 20 April 2015 - 03:11 PM

Hi, Beachtec;

 

The regulation is governed by Title 21. FDA defines food contact in a tier depending on the type of packaging (direct, secondary, indirect). These links may help;

 

attachicon.gifCFR-2011-title21-vol3-part175 Adhesives and Components of Coatings.pdf

(indirect food additives)

attachicon.gifCFR-2011-title21-vol3-part176 Paper and Paperboard Components.pdf

(indirect food additives)

attachicon.gifCFR-2000-title21-vol3-part177 Indirect Food Additives - Polymers.pdf

 

 

Not entirely sure why you would need an SDS for secondaries (tape, straps, etc.) in a food safety program. NFPA ratings for health are always 0. The hazard is usually for fire...  :uhm:

 

 

Hope this helps.

 

I'm almost certain this OP has come up before in different ways.

 

I deduce from the posts #2 and #3  that within the context of the the OP -

 

(1) "Non-contact packaging" is seemingly not included within the context of Food Contact Packaging (FCP) requirements in post #2. Presumably considered as low (negligible) likelihood to contact food?.

2) From a regulatory POV, the components of Food Contact Packaging are regarded as indirect [food] additives, their acceptability is determined by presence/compliance with the 3  lists of post #2 (and post #3? [see 5 below])

(3) i could not find any specific requirement in lists of post #2  as to validation docs. of any particular "quality" of the components (eg MSDS as per OP) but i anticipate it is required ?

(4) i saw no mention of inks  (per se) within the  lists of post #2 ??

(5) Do the defs in post #3 result in another   set of acceptable chemical components of quality mentioned in post #3, ie "reasonably pure" (whatever that means). If so,  is there a specific reason why one uses the list of post #2 vs that of  #3  or vice-versa ?

 

Thank you so much for your reply!!!

 

Of particular interest here are the non-contact packaging materials. I can easily understand that materials in contact packaging materials could be consider food additives under certain conditions; its logical. It's the indirect definitions and regulations I can not find.

 

More directly, I am aware of a situation where a non-direct contact packaging material came in direct contact with a food item during production. The FDA became involved and asked for MSDS sheets for EVERYTHING. I was not aware of any requirement to do so and as you might imagine some of them took a great deal of time and trouble to get (sure you bought that strapping from XYZ, Co. but who REALLY made it? In one case there were 6 vendors in the sales chain!). 

 

This pompted a conversation about what is direct contact and non contact (there is also an incidental contact type, again I could find no guidance here); where are the definitions and requirements for an item intended as NON CONTACT.

 

I have been through 175 which does seem to be meant as the guidance document here... but no dice. I was wondering if there was another reg or doc that I am missing that offers guidance.

 

Thank you!!!



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