41 replies to this topic

[Charles.C]

Hi alvindman,

 

I note that there are numerous examples of Companies producing "food gases" being certified to FSSC 22000, eg -

 

 FSSC 22000,Food Grade CO2.pdf   116.45KB   108 downloads

 

But i was unable to find any examples on the IT of  CO2 process interpretation from a haccp POV.

 

You might consider approaching a consultant if you have a budget.

 

Alternatively, you could contact a potential FSSC22000 auditor and probe a little. I have found the lure of potential business can be a quite effective catalyst  in eliciting free advice in such situations. IMEX auditing companies tend to maintain a detailed internal encyclopedia of field accumulated knowledge.

 

If interested in acquiring more background knowledge of ISO 22000, the attachments linked in this current thread may be helpful  -

 

http://www.ifsqn.com...ering-business/

(eg post 11, post 13[2nd link])

 

PS -

 

Referring to the attachment in post 3, my prediction is that the list of items given in AppendixA will likely be regarded as typical  "hazardous  contaminants" (with maybe the exception of items 1,3 and the last one, and taking note of the * points) and therefore requiring to be controlled  if present in yr own input mixture. (the list, not surprisingly, has similarities but some unequal limits (usually greater) as compared to those in the typical Food Grade specification).

 

 I also noted the fermentation comment in sec. 5.1.3 which may require consideration.

 

I'm curious as to whether all the "impurities" listed are routinely reduced (same step?) in a standard CO2 treatment process. Probably yes if the design objective is to produce Food Grade CO2.

[syju28380]

Hi,

 

I had contacted the Certifying body auditor, and also certified CO2 manufacturers. To add to my worries, I am getting contradictory answers regarding the approach. I guess, it depends on the CB, individual auditor etc. 

 

Alvin, can you please let us know what were the major findings/observations raised by the CB auditor when you took stage I?

 

Regarding the EIGA specification parameters listed in appendix A, the moisture limit is 50ppm v/v (20ppm w/w); but the specification provided ISBT requires 20ppm v/v. This value vary depending on the customer.

For eg: one of the largest soft drink/cola manufacturer ask for 20ppm v/v moisture in CO2 where as a major beer manufacturer ask for 40ppm v/v

 

The possible additional contaminants are specified in Appendix B for each process including that for Fermentation. But the comment 5.1.3 makes it very complex for a CO2 purifier that take the input gas from a distillery that is not FSSC/ISO 22000 certified. 

 

Regards,

Syju

.

[syju28380]

Dear Alvin,

 

I am really stuck with how to do an effective inspection of the inside of the pipes. I read that Carbon Dioxide in aqueous solutions are highly corrosive to steel pipes depending on PH and Temperature. 

 

What was your approach to the sanitation, cleaning and maintenance PRPs to avoid the contamination from the pipes, steel columns and storage tank etc?

• The methods
• The frequency of cleaning/sanitation
• verification methods

 

Regards,

Syju

[Charles.C]

Hi,

 

I had contacted the Certifying body auditor, and also certified CO2 manufacturers. To add to my worries, I am getting contradictory answers regarding the approach. I guess, it depends on the CB, individual auditor etc. 

 

Alvin, can you please let us know what were the major findings/observations raised by the CB auditor when you took stage I?

 

Regarding the EIGA specification parameters listed in appendix A, the moisture limit is 50ppm v/v (20ppm w/w); but the specification provided ISBT requires 20ppm v/v. This value vary depending on the customer.

For eg: one of the largest soft drink/cola manufacturer ask for 20ppm v/v moisture in CO2 where as a major beer manufacturer ask for 40ppm v/v

 

The possible additional contaminants are specified in Appendix B for each process including that for Fermentation. But the comment 5.1.3 makes it very complex for a CO2 purifier that take the input gas from a distillery that is not FSSC/ISO 22000 certified. 

 

Regards,

Syju

.

 

Hi Syju,

 

if you look at yr min.specs (4th item) download in post 5, there are at least 3 organisations issuing "specs" and USFDA is also mentioned. Note the assay minimum (99/99.5%) is less than, i think, the min. value usually quoted for Food Grade (99.9%). The EC spec. in fact only uses 2 impurity criteria. The variations suggest that the basis of the limits quoted is "subjective". Not at all unusual.

 

Normally, FS standards prioritize regulatory official specifications/limits above private ones although if the latter is more strict, its compliance will obviously satisfy both.

 

It is equally unclear where the Food Grade specifications mentioned by suppliers are validated.

[syju28380]

Hi Charles,

 

Thanks a lot. 

 

I have received a reply from the ISBT technical committee about the impurity concentrations in CO2. given verbatim and now another term "beverage grade" has come in. 

 

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Yes there are differences in contaminant specifications between food grade and ISBT beverage grade in both EIGA and CGA QVL specifications. The common practice here in the U.S. is to meet ISBT beverage grade specifications in finished liquid.  Beverage grade, not food grade, carbon dioxide is the specification of product being sold to beverage companies.Yes there are differences in contaminant specifications between food grade and ISBT beverage grade in both EIGA and CGA QVL specifications.

-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

 

They have not said anything about the food hazards related, but just on the final concentration levels. 

 

Regards,

Syju

[Charles.C]

Hi syju,

 

 Indeed beverage grade is another popular terminology. There is a menu of other, more ambiguous, names listed on Linde website.

 

The US situation with respect to Food Grade / Beverage Grade terminologies appears to have become something of an industrial “hot potato,” notably due to FSMA.

The most recent  link/attachments I saw are as of March 2015 / August 2014 –

 

http://www.weldingan...ons-compliance/

 Food Gases, USFDA, FSMA.pdf   736.12KB   69 downloads

 

And one retrospective comment - the sample certificate i attached in post 26 demonstrates that "Food Grade" may appear in the Scope (and likely Beverage Grade also). However it remains unclear what compositional elements were required to be classified as FS "hazards" and therefore included in the haccp plan "proper". Whether FSMA's involvement  will influence the choices/options for Scope is unclear (to me).

 

With respect to CO2/haccp/fssc here are a few more related observations -

 

(A)

This document is old (2001) but looks to be an informed explanation of the historical basis of the typical CO2  "contaminant" menus -

 

http://www.foodsafet...ide-guidelines/

 

I noted this comment -

 

For each listed parameter, a rationale for its inclusion has been provided. Three rationale definitions were identified:
• Sensory: Any attribute that negatively impacts the taste, appearance, or odor of beverage.

• Process: Any attribute that defines a key parameter in a controlled process and an important consideration in the beverage industry.

• Regulatory: Any attribute whose limit is Set by governing regulatory agencies. Once purified to food grade and to the beverage quality levels described, the carbon dioxide must be handled to avoid contamination. All applicable principles of safety and Good Manufacturing Practices (GMPs) for food additives should be applied throughout the process, from production through delivery, storage and use.

 

(It is curious  IMO that there is no specific mention of Safety (=Regulatory?), some of the currently listed items, eg HCN, benzene surely qualify)(benzene would fall in the 2001 "aromatic hydrocarbons" category though)

(Note that ~50% of [2001] items are sensory, if still unchanged these would not conventionally be of haccp interest)("Process" is ambiguous)

 

(B)

From a FS POV, there seems to have been a similarity of interpretive approach between the  "food gases" and compressed air (CA) with respect to "specifications".

 

For interest/comparison, can see the CA consequences in this relatively recent Standard for CA -

 

 cdx1 - BCAS Food Grade Compressed Air - COP,Rev.001,2006.pdf   320.28KB   31 downloads

 

 

During the production, processing, handling, packaging and transporting of food at all stages from source to consumer, the safety of the food may become compromised and then subject to a recall. One source of possible contamination is when compressed air is used in conjunction with the food chain.

Contaminants commonly associated with compressed air are categorised in the form of dirt (solid particles), water (as humidity) and oil. Other influences are the presence of microbiological organisms such as bacteria which may be transported through a compressed air system or propagated due to the conditions existing in a compressed air system.
Contaminants that may be a potential hazard in food for human consumption need to be subject to control as a lack of control could result in a potential prosecution. Compressed air may come into direct or indirect contact with food. Where compressed air comes into direct contact with food, in particular during production or processing, this requires a much higher level of contaminant control and particular attention needs to be placed on contaminants added during the compression and the distribution process. e.g. bread packing,  fluidised bed in the transfer of flour from a tanker etc.

 

 

Scope

..........

Guidance on the Hazard Analysis and Critical Control Points identifying the elements needed to meet the users' health and hygiene requirements for compressed air systems are included as identified in The Food Hygiene (England) Regulations 2005, Schedule 2.It identifies contributory elements associated with food safety standards as identified in BRC requirements.

..........

 

 

The HACCP process should be applied to determine the level of contamination by the use of the tests identified in clause 7 and then to verify if these levels are within the values identified in clause 6. If the values are outside of those in clause 6 then remedial action shall be taken.

 

 

+ sections 6,7

Note that the precise correlation between "contaminants" and "safety" is somewhat "implicit". Also note the word "prosecution" in above quote, ie a Regulatory factor.

(such ambiguities have created considerable, only partially resolved, confusion in the haccp handling of CA, notably within the SQF sub-forum)

 

Do any of the other FS Standards accept CO2 for FS Certification purposes, or discuss its spec. requirements as an ingredient ? A possible reference source if yes.

 

(C)

i also noted the FSSC viewpoint on food gases -

 cdx2 - fssc scope of food gases.png   131.25KB   5 downloads

 

I am not aware if Codex defines a purity specification for CO2 as a food additive. If so this could be the controlling “contaminant menu” from FSSC's POV . If not, I daresay the choice is open. Regardless, any  local food regulations will  presumably supercede Codex if they exist, such as EC, JEFCA, FDA. Possibly even  Beverage Grade.

 

(D)

Not my area but i noticed the CO2 process extract attached below. I deduce that, at least in principle, achievement of the various contaminant spec. menus may simply be a case of appropriate filtration. if so, the lengthiest list of requirement(s) would seem not a major hurdle unless due economic limitations. I doubt FSSC will care if you exceed their minimum expectations.

 

 cdx3 - carbon dioxide purification.png   996.36KB   3 downloads

(It, again, implies that several of the listed impurities are related to flavour rather than toxicity. Emphasizes the necessity of well-understanding yr product's intended application)

 

(E)

Seems to me that, based on own specific interest, the OP has 1 initial query to address to the proposed FSSC auditor –

What “Grades” are acceptable to be referenced within the Certificate’s Scope ?

If the answer is that it is totally determined by presented, validatable, data  then I guess all options are available.

 

Afaik, “sensory” factors are not required to be considered within the fssc hazard analysis scheme but could be included within the overall FS system via a PRP (ie iso22002-1).

 

@ alvindman - hope the above of some interest/assistance. It's an interesting topic

 

PS - I'm surprised ISBT made no mention of US Regulatory bodies, eg FDA. Perhaps because a US-centric scenario only. So far anyway.

 

PPS - JFI - some of content in this thread overlaps a parallel thread  -

http://www.ifsqn.com...he-bi-products/

[syju28380]

Great work, Charles... thanks a lot...

[alvindman]

Hi,

 

I had contacted the Certifying body auditor, and also certified CO2 manufacturers. To add to my worries, I am getting contradictory answers regarding the approach. I guess, it depends on the CB, individual auditor etc. 

 

Alvin, can you please let us know what were the major findings/observations raised by the CB auditor when you took stage I?

 

Regarding the EIGA specification parameters listed in appendix A, the moisture limit is 50ppm v/v (20ppm w/w); but the specification provided ISBT requires 20ppm v/v. This value vary depending on the customer.

For eg: one of the largest soft drink/cola manufacturer ask for 20ppm v/v moisture in CO2 where as a major beer manufacturer ask for 40ppm v/v

 

The possible additional contaminants are specified in Appendix B for each process including that for Fermentation. But the comment 5.1.3 makes it very complex for a CO2 purifier that take the input gas from a distillery that is not FSSC/ISO 22000 certified. 

 

Regards,

Syju

.

 

Hi Syju!

 

 

1. Major Findings in Stage 1

 

    Stage 1 is more of desk audit. Presence/absence of documentation.

    a. We had some findings on hazards analysis - on how we rate the significance of hazards

    b. Inadequate process flow diagram

    c. Absence of updated policy on Personnel Hygiene and Policy on Food Defense and Bioterrorism

 

    Tip: Our CB audited us against the standard verbatim. If it said shall record - you should have a record. If the standard says to have a policy on a,b,c,d,e.. then it must be all written.

   

 

2. On different limits

 

    As far as I understand you should follow the strictest limit which is ISBT. Our auditor said acetaldehyde is a hazard in CO2 which I still am not convinced because its concentration is very low - 

    I think  it is more of sensory concern. (hence the topic)

 

 

3. On cleaning of CO2 lines

 

    Our plant uses stainless steel pipes and equipment and for the past 20 years, we never had a corrosion problem, Our sanitation plan is only manual cleaning of lines and equipment at   

    defined frequency. Verification is just a visual check of supervisor if the equipment is clean. CB haven't commented on this.. yet.

 

 

 

I hope this helps!

 

 

I agree that ISBT lacks explanation on which of the impurities are actually health hazard. You may want to consider the impurities mentioned in FCC but use ISBT standard for the limits. 

[alvindman]

Hi syju,

 

 Indeed beverage grade is another popular terminology. There is a menu of other, more ambiguous, names listed on Linde website.

 

The US situation with respect to Food Grade / Beverage Grade terminologies appears to have become something of an industrial “hot potato,” notably due to FSMA.

The most recent  link/attachments I saw are as of March 2015 / August 2014 –

 

http://www.weldingan...ons-compliance/

Food Gases, USFDA, FSMA.pdf

 

And one retrospective comment - the sample certificate i attached in post 26 demonstrates that "Food Grade" may appear in the Scope (and likely Beverage Grade also). However it remains unclear what compositional elements were required to be classified as FS "hazards" and therefore included in the haccp plan "proper". Whether FSMA's involvement  will influence the choices/options for Scope is unclear (to me).

 

With respect to CO2/haccp/fssc here are a few more related observations -

 

(A)

This document is old (2001) but looks to be an informed explanation of the historical basis of the typical CO2  "contaminant" menus -

 

http://www.foodsafet...ide-guidelines/

 

I noted this comment -

 

(It is curious  IMO that there is no specific mention of Safety (=Regulatory?), some of the currently listed items, eg HCN, benzene surely qualify)(benzene would fall in the 2001 "aromatic hydrocarbons" category though)

(Note that ~50% of [2001] items are sensory, if still unchanged these would not conventionally be of haccp interest)("Process" is ambiguous)

 

(B)

From a FS POV, there seems to have been a similarity of interpretive approach between the  "food gases" and compressed air (CA) with respect to "specifications".

 

For interest/comparison, can see the CA consequences in this relatively recent Standard for CA -

 

cdx1 - BCAS Food Grade Compressed Air - COP,Rev.001,2006.pdf

 

 

 

+ sections 6,7

Note that the precise correlation between "contaminants" and "safety" is somewhat "implicit". Also note the word "prosecution" in above quote, ie a Regulatory factor.

(such ambiguities have created considerable, only partially resolved, confusion in the haccp handling of CA, notably within the SQF sub-forum)

 

Do any of the other FS Standards accept CO2 for FS Certification purposes, or discuss its spec. requirements as an ingredient ? A possible reference source if yes.

 

(C)

i also noted the FSSC viewpoint on food gases -

cdx2 - fssc scope of food gases.png

 

I am not aware if Codex defines a purity specification for CO2 as a food additive. If so this could be the controlling “contaminant menu” from FSSC's POV . If not, I daresay the choice is open. Regardless, any  local food regulations will  presumably supercede Codex if they exist, such as EC, JEFCA, FDA. Possibly even  Beverage Grade.

 

(D)

Not my area but i noticed the CO2 process extract attached below. I deduce that, at least in principle, achievement of the various contaminant spec. menus may simply be a case of appropriate filtration. if so, the lengthiest list of requirement(s) would seem not a major hurdle unless due economic limitations. I doubt FSSC will care if you exceed their minimum expectations.

 

cdx3 - carbon dioxide purification.png

(It, again, implies that several of the listed impurities are related to flavour rather than toxicity. Emphasizes the necessity of well-understanding yr product's intended application)

 

(E)

Seems to me that, based on own specific interest, the OP has 1 initial query to address to the proposed FSSC auditor –

What “Grades” are acceptable to be referenced within the Certificate’s Scope ?

If the answer is that it is totally determined by presented, validatable, data  then I guess all options are available.

 

Afaik, “sensory” factors are not required to be considered within the fssc hazard analysis scheme but could be included within the overall FS system via a PRP (ie iso22002-1).

 

@ alvindman - hope the above of some interest/assistance. It's an interesting topic

 

PS - I'm surprised ISBT made no mention of US Regulatory bodies, eg FDA. Perhaps because a US-centric scenario only. So far anyway.

 

 

Thank you Charles for helping us out. Glad you liked this little brain/skill exercise. Expect more from us.. beginners in ISO 22000 :)

[Charles.C]

Hi Syju!

1. Major Findings in Stage 1

 

    Stage 1 is more of desk audit. Presence/absence of documentation.

    a. We had some findings on hazards analysis - on how we rate the significance of hazards

    b. Inadequate process flow diagram

    c. Absence of updated policy on Personnel Hygiene and Policy on Food Defense and Bioterrorism

 

    Tip: Our CB audited us against the standard verbatim. If it said shall record - you should have a record. If the standard says to have a policy on a,b,c,d,e.. then it must be all written.

  

2. On different limits

    As far as I understand you should follow the strictest limit which is ISBT. Our auditor said acetaldehyde is a hazard in CO2 which I still am not convinced because its concentration is very low - 

    I think  it is more of sensory concern. (hence the topic)

 

3. On cleaning of CO2 lines

 

    Our plant uses stainless steel pipes and equipment and for the past 20 years, we never had a corrosion problem, Our sanitation plan is only manual cleaning of lines and equipment at   

    defined frequency. Verification is just a visual check of supervisor if the equipment is clean. CB haven't commented on this.. yet.

 

I hope this helps!

I agree that ISBT lacks explanation on which of the impurities are actually health hazard. You may want to consider the impurities mentioned in FCC but use ISBT standard for the limits. 

 

 

Hi alvindman,

 

Thks yr input which is valuable.

 

2 comments on respective red texts above –

 

(1) Documents I have seen/posted also suggest yr auditor was incorrect. Also see (2) below. You might ask for his /her jusification. (There may be confusion between the terms "contaminant" and "hazard".)

(2) I believe ISBT  elaborate on the "rationales" in their original document. An interesting question from a haccp POV is - which of the limits listed are validatable with respect to health safety considerations ?.

 

I deduce from yr post that the auditor did agree that the haccp analysis should be carried out on a chemical-by-chemical,  health risk basis ?. The decision  is important since it could be argued that non-compliance with any of the "Food Grade/Other Grade" specified limits automatically renders the ingredient “unsafe”.

 

(Essentially, but rather paradoxically, the scientific argument is that compliance to all the FG, etc specifications assures that the ingredient  is (food) “safe” but non-compliance does not necessarily mean that the product is “unsafe”. ) ( = "sufficient but not necessary" in anti-Maths Lingo)

 

IMO, the current topic is equally confusing regardless of haccp experience. Another example of Commerce meets Science.  

[syju28380]

Hi,

 

I have received some comments on the HACCP study. New points including microbiological hazards have come up

---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Do you have analytical monitoring on the incoming raw gas.  It looks like you just do periodic grab samples.  Have you ever done a fingerprint analysis of the feed stock gas to analyse for all potential contaminants and then verify your process is capable of either monitoring or removing all potential issues?

 

You talk about unclean pipes but rate the hazard as a 1.  Did you consider cleaning of the equipment and the potential for residual cleaning agents to remain in the system?

 

I don’t see in your analysis where you have considered any sulphur based compounds, although the ISBT guidelines spell that out as possible.  You do show it in your CCP chart but it does not appear you analyse for it based on your target list.

 

You talk about CO2 not supporting life, but you forgot about anaerobic bacteria, mold spores and etc.  Your process gas comes from fermentation, yet you rate the potential for micro-organisms in the feed gas as not applicable.  Illogical. 

 

You missed the point with allergens about cross contamination.

 

Do you allow loading tankers to return vapour to the tank?  It sounds like you do, as you talk about checking contaminants of back feed CO2.  That is a huge risk, but you have rated the likelihood and severity as low.

 

You did not cover the re-activation of the GAC, or potential break -through of contaminants. 

 

Is the storage tank fully isolated from the process until the interim storage tank is analysed or is their continuous flow into the storage tank.

 

You did not assess the risk of contaminant concentration in storage tanks, which is a known CO2 hazard and addressed in ISBT

--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

 

With Regards,

Syju

[Charles.C]

Hi,

 

I have received some comments on the HACCP study. New points including microbiological hazards have come up

---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Do you have analytical monitoring on the incoming raw gas.  It looks like you just do periodic grab samples.  Have you ever done a fingerprint analysis of the feed stock gas to analyse for all potential contaminants and then verify your process is capable of either monitoring or removing all potential issues?

 

You talk about unclean pipes but rate the hazard as a 1.  Did you consider cleaning of the equipment and the potential for residual cleaning agents to remain in the system?

 

I don’t see in your analysis where you have considered any sulphur based compounds, although the ISBT guidelines spell that out as possible.  You do show it in your CCP chart but it does not appear you analyse for it based on your target list.

 

You talk about CO2 not supporting life, but you forgot about anaerobic bacteria, mold spores and etc.  Your process gas comes from fermentation, yet you rate the potential for micro-organisms in the feed gas as not applicable.  Illogical. 

 

You missed the point with allergens about cross contamination.

 

Do you allow loading tankers to return vapour to the tank?  It sounds like you do, as you talk about checking contaminants of back feed CO2.  That is a huge risk, but you have rated the likelihood and severity as low.

 

You did not cover the re-activation of the GAC, or potential break -through of contaminants. 

 

Is the storage tank fully isolated from the process until the interim storage tank is analysed or is their continuous flow into the storage tank.

 

You did not assess the risk of contaminant concentration in storage tanks, which is a known CO2 hazard and addressed in ISBT

--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

 

With Regards,

Syju

 

Hi Syju,

 

Thanks.

 

The above  illustrates the importance of the initial Codex Steps -

 

(1) Defining the Scope of the HACCP study (including the "Standard" for the Final product )

(2) Creating a comprehensive Process flowchart,

(3)  doing a preliminary BCPA study of the entire process to evaluate the potential hazards.

 

Things tend to get complicated when you have various sub-sections and feedbacks.

[syju28380]

Hi,

 

The microbiological hazard in CO₂ came as a complete shocker to me. I could not find anything useful in the web too. 

 

If anyone has some material on this, kindly share..

 

Regards,

Syju

[alvindman]

We rated microbiological hazard as None since survival of microorganisms in CO2 is not expected.

 

We only included possible pathogens from operators during manual cleaning but rated low likelihood given the existing programs on personnel hygiene and procedures in manual cleaning.

 

---

 

what's your update syju?

[syju28380]

Hi Alvin,

 

I am still blank with the microbes in CO2. 

 

Syju

[alvindman]

Dear all,

 

I would just like to thank everybody who helped one way or another.

 

We just got certified to FSSC.

 

Makes me proud as FSTL.

 

Cheers, IFSQN!  

[syju28380]

Dear Alvin,

 

Congrats for the FSSC certification; I am still working on the HACCP study. 

 

Can you please share what was the auditor's queries about the anaerobic microbes in the raw CO2 gas intake (from fermentation)? I understand that initially, you had taken the route "CO2 is not life supportive". 

 

Syju