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Food Suplements FSMA exemption?


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#1 Drumstick

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Posted 26 November 2019 - 04:42 PM

Hi all,

 

I've been asked by a European dietary supplements manufacturer who is going to export to Canada if they have to meet FSMA without the exemption to subparts C (hazard analysis and risk-based preventive controls) and G (suply chain program); in the USA, dietary supplements manufacturers have an exemption to those subparts (they have to comply with 21 CFR part 111 instead). I've checked this link:

 

https://laws-lois.ju...-7.html#docCont

 

...where it says:

 

46 (1) Unless otherwise specified, the requirements of this Part apply in respect of

  • (a) any foods that are to be exported or sent or conveyed from one province to another; Not the case

  • (b) any edible meat products (not the case) that are imported, during their storing and handling in their imported condition, for the purpose of the exercise of an inspector’s powers under the Act; and 

  • © any food animals from which meat products that are to be exported or sent or conveyed from one province to another may be derived (not the case)

I'm not an expert on Canadian regulations, so I'm not sure at all if I'm properly understanding this; I'm not even sure about how FSMA is applied in Canada  :crybaby:. The summary of my question would be:"Does a food supplement manufacturer who is going to export to Canada have to comply with HARPC and supply chain program of 21 CFR 117?".

Thank you in advance for your help!

Kind regards.

 



#2 pHruit

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Posted 26 November 2019 - 04:52 PM

Surely FSMA and the US Code of Federal Regs don't apply at all in Canada?



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#3 Drumstick

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Posted 26 November 2019 - 08:55 PM

Hi Phruit, thank you for your answer.

 

I think it applies somehow; I have read in several places that Canada adopted FSMA preventive controls...but as I'm not in contact with Canada,regulations, I'm not sure to which extent...


 



#4 FurFarmandFork

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Posted 26 November 2019 - 11:30 PM

Canada is revamping their FS regs to look like ours, but our regulations have nothing to do with theirs (other than some parity agreements).

 

Use https://www.inspecti...1/1526653035700 as your resource and ignore the US stuff if you're doing business in Canada.


QA Manager and food safety blogger in Oregon, USA.

 

Interested in more information on food safety and science? Check out Furfarmandfork.com for more insights!

Subscribe to have one post per week delivered straight to your inbox.

 


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#5 Drumstick

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Posted 27 November 2019 - 12:44 PM

Hi FurFarmandFork,

 

Thank you very much for your answer, that sounds reasonable :spoton: . The confusion comes because they use the term "preventive controls", the same as the FDA uses. I've been reading the Canadian preventive controls provisions, and well, yes, they pursue the same goal as the FDA ones...but I find the Canadian ones more open, more flexible. My perception (maybe wrong; please is there any Canadian in the room? :shades: ) is that as long as you have a HARPC, or HACCP, or whatever that follows the Codex guidelines, everything will be ok. 

 

Apart from that, I haven't find anything specific for dietary supplements...is there anything of that sort in the Canadian regulations? 

 

Regards.






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