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FSSC Certification for CO2 Manufacturing from Natural Fermentation

FSSC Certification ISO22000 Carbon Dioxide CO2 Accreditation Stage1 Regulatory

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#1 alvindman

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Posted 04 December 2015 - 12:14 PM

Hi all!

 

Any of you who have worked on having a CO2 plant certified for FSSC?

 

I am having a hard time compiling the regulatory requirements for CO2.

 

Offhand, we have checked on ISBT and it said that the hazards at final product are Oxides of Nitrogen and Polyaromatic hydrocarbons.

 

However, we know that methanol and acetaldehyde are present at raw gas. Are these regulated too? From what standards? Are they considered regulated too if they are just potential "impurities" of the final product.

 

thanks in advance. a beginner here on ISO 22000. :)


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#2 dr. Humaid Khan

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Posted 23 December 2015 - 04:33 AM

 HI Alvindman  

 

Attached is a product specification for CO2. It may be helpful in resolving the regulatory issues.. It appears that you need to control the amount of aldehydes and methanol in the final products.

 

Kind regards

Dr. Humaid Khan


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#3 dr. Humaid Khan

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Posted 23 December 2015 - 04:57 AM

Sorry I forgot to attached the document.

Attached Files


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#4 alvindman

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Posted 08 January 2016 - 11:19 PM

thanks for the reply. Acetaldehyde however might just be a quality issue and not a food safety issue.

 

Should you have reference/basis of food safety regulations for aldehydes/methanol in CO2, would appreciate receiving the info.

 

 

Regards!


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#5 syju28380

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Posted 19 January 2016 - 08:04 AM

Hi Alvindman,

 

The EIGA website has lot of material. I am attaching some of them. Please check if they have updated the documents. I had downloaded more than 3 months back.

 

https://www.eiga.eu/index.php?id=181

 

Attached File  EIGA-CO2 Backfeed Contamination-Doc_68_08_E.pdf   208.4KB   13 downloads

Attached File  EIGA-Doc_95_12_Avoidance_of_Failure_of_CO_and_of_CO_CO2_Mixtures_Cylinders.pdf   263.81KB   8 downloads

Attached File  EIGA-Doc_125_11_Guide_to_the_Supply_of_Gases_for_Use_in_Foods.pdf   144.18KB   15 downloads

Attached File  EIGA-Doc_126_11_Minimum_Specifications_for_Food_Gas_Applications.pdf   57.55KB   14 downloads

Attached File  EIGA-Doc_182_13_Pre-fill_Inspection_of_Customer_Owned_Cylinders.pdf   75.38KB   6 downloads

Attached File  EIGA-Gas compatability with Al alloy container-Doc_161_10_E.pdf   73.79KB   6 downloads

Attached File  EIGA-Info_TS_04_14_Transport_of_Gases_Contactor_Management.pdf   98.02KB   9 downloads

Attached File  EIGA-Refrigerated CO2 storage-Doc_66_08_E.pdf   199.82KB   10 downloads

Attached File  EIGA-TB_02_12_Microbiological_Quality_of_Medical_Pharmaceutical_and_Food_Grade_Gases.pdf   29.68KB   14 downloads

Attached File  EIGA-TB_05_12_Recommended_Method_for_the_Determination_of_Hydrocarbons_in_Gas_Cylinders.pdf   67.37KB   6 downloads


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#6 alvindman

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Posted 23 January 2016 - 04:03 PM

my difficulty is to assess whether all the specifications are related to food safety or not?

 

for example:

 

it clearly said that acetaldehyde should be within specific level. but is acetaldehyde a food safety concern in CO2 or specified just for quality?

if it is not a food safety concern, then it should not be included in hazards analysis anymore. is that right?


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#7 syju28380

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Posted 01 February 2016 - 12:44 PM

Dear All,

 

Please check this HACCP made for CO2 purification from a distillation plant.  I have used the old Yoghurt HACCP format and is in very crude form. 

 

May I request other members to have a look and please let me know their comments and suggestions?

 

To Alvindman, about your question..

 

In my understanding, since these parameters in food grade CO2 has stringent concentration level requirements than the industrial use CO2, can only mean that there is some food safety hazard associated with it. For those parameters for which the value of food grade and industrial use are the same, I think you may exclude it from Hazard analysis. 

 

 

Regards,

Syju

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#8 alvindman

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Posted 02 February 2016 - 12:42 PM

Hi syju! Nice to have someone here from the same industry. I have a very different approach to CCP/OPRP. As of now, our CCP is water scrubbing and critical limits are the flowrate and temperature because these controls the ability of the step to reduce the amount of hydrocarbons, etc.

 

Our critical limits are more of operational limits rather than that of the product.


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#9 alvindman

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Posted 02 February 2016 - 12:42 PM

Dear All,

 

Please check this HACCP made for CO2 purification from a distillation plant.  I have used the old Yoghurt HACCP format and is in very crude form. 

 

May I request other members to have a look and please let me know their comments and suggestions?

 

To Alvindman, about your question..

 

In my understanding, since these parameters in food grade CO2 has stringent concentration level requirements than the industrial use CO2, can only mean that there is some food safety hazard associated with it. For those parameters for which the value of food grade and industrial use are the same, I think you may exclude it from Hazard analysis. 

 

 

Regards,

Syju

Hi syju! Nice to have someone here from the same industry. I have a very different approach to CCP/OPRP. As of now, our CCP is water scrubbing and critical limits are the flowrate and temperature because these controls the ability of the step to reduce the amount of hydrocarbons, etc.

 

Our critical limits are more of operational limits rather than that of the product.


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#10 syju28380

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Posted 02 February 2016 - 04:45 PM

Hi Alvindman,

 

Thanks; will you be able to share the structure and logic of the HACCP?

 

Regards,

Syju


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#11 alvindman

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Posted 03 February 2016 - 10:55 AM

Hi Alvindman,

 

Thanks; will you be able to share the structure and logic of the HACCP?

 

Regards,

Syju

 

 

This is what I used.

 

http://fskntraining...._04_English.pdf

 

See related thread about this here:

 

http://www.ifsqn.com...d-g/#entry85787

 

 

 

Good luck!


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#12 syju28380

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Posted 03 February 2016 - 11:19 AM

Thanks a lot


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#13 Charles.C

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Posted 03 February 2016 - 01:05 PM

Hi alvindman/syju,

 

I can offer a few comments although zero experience this area. Apologies in advance if following text duplicates info. already posted.

 

I assume the product is definitively intended to be "Food Grade". ?

 

i agree with OP that logically fssc should only be concerned with safety. SQF levels 2/3 would be a different situation.

 

With respect to specifications an analogous thread for nitrogen (2011) is here -

 

http://www.ifsqn.com...-in-production/

 

IMO it will be necessary, additionally to fssc,  to demonstrate that the finished product is "Food Grade" where this is interpreted as having a composition in compliance with the Purity requirements as referenced to an "appropriate" standard. (I assume that, as in Excel, the objective for final product is "Food Grade")

 

It will probably be necessary to evaluate / validate that all the declared max. "contaminant"  levels are complied with, regardless of whether specifically safety-relatable or not. Such is a "Food Grade" ingredient. (I recall there are some similar "safety" issues with Compressed Air micro. standards)

 

Some declared Food Grade standards do exist, eg -

 

http://www.boc.com.a...xide-food-grade

 

http://www.linde-gas...ases/index.html

(previously Linde published their specs in the open (eg see top linked thread/post3/N2), but seems no longer).

 

PS - regarding excel -

 

Offhand, i am unsure how you can make a risk assessment on a mixture of contaminants. Particularly as their individual  hazard statuses appear as yet unspecified.

 

For the purposes of fssc, i would expect  the "input" in "1C" to be handled as a PRP in view of text in typical iso22002 standards. Non-compliance with the input specification would result in rejection. (in a normal way, excessive rejection rates would impact a "supplier's approval",. seems you may require an analogous internal criterion).

 

If it is known that a later process step will eliminate a specific hazard, this "auto-cancels" the input risk. So if you can validate that a given (max.) level of a specific  hazardous contaminant is satifactorily reduced to <= Food Grade level in the final output, this should be an effective PRP specification).

 

Failure of a non-safety parameter does not prevent the input being rejected purely on QA grounds of course (~=SQF Lvl 3)

 

IMO whether there are any CCPs / OPRPs requires specific knowledge of the process / how individual contaminants are handled / new hazards generated.

 

I suspect a little more research required from a fssc / hazard POV.


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Kind Regards,

 

Charles.C


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#14 syju28380

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Posted 04 February 2016 - 05:28 AM

Dear Charles,

 

Thanks a lot for your guidance; much appreciated.

 

I had used the Linde food grade sheet, ISBT guide and the EIGA specification for the CO2 when I made the sheet. 

 

In this particular case, the unit checks the CO2 thrice- on gas receipt, after purification when moving to storage and when filling in customer's tanker and since the last two checks make sure that non food grade can't end up with customer, this has to be the only CCP.

 

But, my worry is that, will it be a concern if there is just one CCP in the HACCP study (the final lab check that conforms the food grade limits) from a certifying body auditor perspective? It is always better to avoid the need to explain and justify things. I hope treating a PRP/OPRP scenario as a CCP won't make them raise questions. 

 

From Alvindman's logic, I am checking the flow rates and time period for scrubbing, absorption etc in the processes to see whether any of them can affect the concentration levels in the final product. Earlier, my logic to avoid them was purely on the assumption that the PRPs (supplier approval, incoming material inspection, machine validation and calibrations) rule out the inability to control the flow rate and component concentrations which I now think may not be correct. If these processes are controlled, may be the unit can improve their efficiency and output.

 

Regarding the decision tree, as you can see, I had used the same Modarres method as in your old Yoghurt sheet which I think is the easiest way to demonstrate logical decision making.

 

Additionally, from an approach perspective, the logic used widely in ISO 14001 (ref attached file) to evaluate significant aspects is also a good way. The step 2 has to be replaced with the food safety hazards in place of environmental. But this step 2 of food hazards has to be outcome of HACCP study. 

 

Regards,

Syju

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#15 alvindman

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Posted 04 February 2016 - 05:38 AM

Hi Syju,

 

From my perspective, lab analysis are just verifications and are not controls. Compliance to specifications is just a result of a controlled process - CCP/oPRP.

 

Maybe the experts can enlighten us on this.

 

 

Alvin


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#16 Charles.C

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Posted 04 February 2016 - 06:08 AM

Hi Syju,

 

From my perspective, lab analysis are just verifications and are not controls. Compliance to specifications is just a result of a controlled process - CCP/oPRP.

 

Maybe the experts can enlighten us on this.

 

 

Alvin

 

Hi Syju/alvindman,

 

The essential point afaik is that HACCP is concerned with proactive evaluation/prevention of significant hazards (SH) . CCPs are initiated to control such occurrences (more precisely associated with a location where the control action is implemented).

 

FSSC is a FSMS system whose FS portion is based on ISO's version of HACCP.

 

The starting point of a HACCP plan/hazard analysis must logically be to define (a) the potential hazards experienced when progressing through the flowchart. (b) Their Risks. (c)  The significant hazards (SH). (d) The controls for the SH. (e) The CCP/OPRPs associated with (d). (Validation is supposed to come between d/e)

 

IMO, No significant hazards > No CCPs and No OPRPs (the last statement may be debatable depending on how one characterises an "OPRP").

 

 

A lab analysis may fulfil various requirements, eg monitor a CCP,  implement validation/verification, etc


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Kind Regards,

 

Charles.C


#17 syju28380

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Posted 04 February 2016 - 06:25 AM

Hi Alvin,

 

I get your point. But I am little confused with the logic from normal food industries. I am a starter in food safety and my understanding may be totally illogical. please see the example below 

 

It is common practice that metal detection used as a CCP at the end of packing and dispatch to check/verify that there is no metal pieces in.

As per your logic, the CCP has to be in the process control by making sure no metal pieces break and fall in it from the equipment, pipes, machinery etc and not the final verification by a metal detector

 

In the CO2 case, suppose we control the process (scrubbing and purifying) to a degree that it can give out food grade CO2 alone. And we verify that by a check before giving it off to client. From my understanding, here the process controls become OPRPs and PRPs and the end check is the CCP

 

Regards,

Syju


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#18 syju28380

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Posted 04 February 2016 - 06:28 AM

Sorry.... I posted without seeing the reply by Charles...


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#19 Charles.C

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Posted 04 February 2016 - 06:38 AM

Sorry.... I posted without seeing the reply by Charles...

 

"Food Grade" is a term which IMEX covers both Safety and Non-safety elements.

(But note that their are various interpretations, eg -

http://rainsaucers.c...-and-food-grade

http://www.plasticsi...tic-food-grade/

https://foodgrademat...-and-suppliers/

Food Grade Chemical Ingredients. Food grade chemical ingredients comply with the Food Chemicals Codex (FCC) is a compendium of internationally recognized monograph standards and tests for the purity and quality of food ingredients, e.g., antimicrobial preservatives, flavors, coloring agents, and minerals

https://www.spectrum...20&respid=22372

 

Theoretically HACCP assumes food grade ingredients as received contain no intrinsic significant hazards other than maybe allergens, [radiological (!!), genetic

(!!)]

(this "quality" is assured by the ingredient complying to FG specification(s), for example as given in Food Chemicals Codex)(hence the importance of the "Product Specification" )

 

So, IMO,  HACCP will not guarantee a "Food Grade" output since it is not focused on Non-safety characteristics. For example it is not interested in moisture, per se, but would be if the level is related to some other hazardous factor, eg microbiological.


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Kind Regards,

 

Charles.C


#20 syju28380

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Posted 04 February 2016 - 06:47 AM

Dear Charles,

 

Thanks. 

 

Since our aim of this HACCP is with reference to FSSC 22000 which I understand is practically ISO 22000+ISO 22002-1. In my understanding, ISO 22000 has to cover ISO 9001 requirements and hence all quality related parameters are to be complied with.

 

Hence all the concentrations levels specified for "food grade" becomes mandatory whether it relates to food safety or not. 

 

Regards,

Syju


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#21 Charles.C

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Posted 04 February 2016 - 07:18 AM

Dear Charles,

 

Thanks. 

 

Since our aim of this HACCP is with reference to FSSC 22000 which I understand is practically ISO 22000+ISO 22002-1. In my understanding, ISO 22000 has to cover ISO 9001 requirements and hence all quality related parameters are to be complied with.

 

Hence all the concentrations levels specified for "food grade" becomes mandatory whether it relates to food safety or not. 

 

Regards,

Syju

 

From memory, ISO9001's interpretation of  "Quality" is "fit for use". (among others)

 

In this case 'fit for use" is, i believe, interpretable as complying to a Product Specification.

 

However, IIRC, ISO9001, offers no guarantee that the selected Specification is safe. Or "Food Grade". This is the responsibility of the contractual parties.

 

I have never directly worked with ISO9001 so no problem to be corrected. :smile:

 

I think you misunderstand the scope of iso/fssc22000.  It is solely focused on safety. hence the title FSMS.


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Kind Regards,

 

Charles.C


#22 syju28380

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Posted 04 February 2016 - 07:22 AM

Agree totally...


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#23 alvindman

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Posted 04 February 2016 - 09:53 AM

Therefore moisture shouldn't be considered a part of your HACCP study because it is only there for quality and not for food safety.

 

Difficulty is to understand/know if the values/parameters set by international organizations (Such as EIGA, ISBT) re Carbon dioxide is food safety related or quality related only.


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#24 alvindman

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Posted 04 February 2016 - 10:07 AM

Hi Alvin,

 

I get your point. But I am little confused with the logic from normal food industries. I am a starter in food safety and my understanding may be totally illogical. please see the example below 

 

It is common practice that metal detection used as a CCP at the end of packing and dispatch to check/verify that there is no metal pieces in.

As per your logic, the CCP has to be in the process control by making sure no metal pieces break and fall in it from the equipment, pipes, machinery etc and not the final verification by a metal detector

 

In the CO2 case, suppose we control the process (scrubbing and purifying) to a degree that it can give out food grade CO2 alone. And we verify that by a check before giving it off to client. From my understanding, here the process controls become OPRPs and PRPs and the end check is the CCP

 

Regards,

Syju

 

 

I am a beginner too in ISO 22000. :)

 

From my understanding:

 

CCP/oPRP's will control the hazard - approach is preventive because we don't want to produce unsafe product

As CCP we need to control our scrubber temp and flowrate based on validated critical limits.

 

If the flowrate/temp will be beyond the set critical limits, we need to initiate action since we might just have produced a potentially unsafe product.

 

 

 

On metal detector it can be viewed in two ways:

 

1)

CCP/oPRP - anything in downstream process that will prevent metal inclusion in the product (probably sieving, magnet, etc)

Verification - is the final metal detection

 

2)

If there is no other measures can prevent possible metal inclusion in the product, if you follow the decision tree, then the metal detection step can be a CCP/oPRP.

 

 

 

Ultimately, I think your decision to put the analysis as CCP can be accepted as long as the method you used is logical.

 

Can you make a complete HACCP plan if your CCP is the analysis?


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#25 syju28380

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Posted 04 February 2016 - 10:13 AM

Right; I guess the point is to perform a logical sequence of HACCP study and control the food safety hazards. 


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