26 replies to this topic

[MFSC]

Issue with risk assessment and if allergen  should be listed as CCP.

 

In a small facility and producing products with many allergens.  These are ready to eat products.

 

Have a sanitation program- but using the same process equipment for many products.  

Labels are verified, but there is there is a possibility of cross contamination.  On  products that have no known allergens- state may contain peanuts etc.

 

So would you list as CCP?   If CCP - what are the controls- always a possibility of cross contamination.

 

Thanks

[Charles.C]

Dear MFSC,

 

Labels are verified, but there is there is a possibility of cross contamination

 

 

More like a certainty maybe.

 

You must have a long list on most labels or do you use one version with "everything" on it ?.

 

As per yr info., the usual CCP relates to control of labelling.

 

Rgds / Charles.C

[RRF]

No, you do not need allergens to be a CCP. You can control through pre-req programs thus making it not likely to occur.

[MM1]

Dear MFSC,

 

It is hard to set allergen contamination as a CCP since it is not detectable/measurable instantaneously. You can control allergens through GMP and have controls to identify and prevent possible contamination steps. You can have labelling as a CCP as this can be checked and corrected.

 

Regards,

 

MM

[Charles.C]

Dear All,

 

With respect to Prerequisite options, this may depend on the relevant standard/legislation involved. If any.

 

I seem to remember that Canada has a convenient list of accepted prerequisite programs.?

 

Rgds / Charles.C

[cazyncymru]

Within my HACCP Risk Assessments, I address allergens, as well as chemical, microbial & physical contaminants.

 

I also have a series of (separate) allergen risk assessment that are evolved from the HACCP

 

So, yes , I think allergen can be a CCP (depending on your risk assessment)

 

Caz

[Africanfoodsafetyco]

 You should carry out a comprehensive hazard analysis and risk assessment of your operations in your HACCP plan. Then deduce actions on how cross contaminaion is going to be prevented in a non- dedicated setting as yours. In my former job as  QA manager we had the same.

 

I will share what we did;

 

... Possible solutions are

• - segregation by colour coded  labelling at all stages e.g designated storage areas for allergenic ingredients using  colour coded labels in warehouse,.
•   segregation by time  e.g  pack allergenic containing products last,
• dedicated staff changing procedures e.g when packing allerginic products there is deep wash down and staff change to may be red aprons or
• colour to indicate allerginic operation, tools/utensils are colour coded e.g red for peanut products only,  green for maybe gluten containing ingredients,
• staff changeover procedures and hygiene of non- dedicated equipment are all part of your plans.

 

You also produce procedures from the above e.g

 

Staff changeover procedure from Allergic to non allergic products- include the clause that ideally you will produce the non- allergic products first to prevent carry overs and also deep cleaning of equipment and staff protective clothing, tools and untensils are colour coded to prevent cross contamination.

 

Hope you find this useful.

[Charles.C]

Dear AfricanfoodsafetyCo,

 

Thks for post and welcome to the Forum !

(nice to see someone from the home of the Black Stars)

 

Rgds / Charles.C

[moskito]

Hi,

 

as Caz mentions allgergens should be part of HACCP like biological, chemical and physical risks. But in my opinion it is hard to create a CCP in most cases. One exception might be the "gluten-free" label which limits can be checked by a specific, sensitive test. A CCP is possible as long as

• the allergen is distributed homogeneously and not chunky - chunky contamination can not be controlled by HACCP measures
• the test is specific for an allergen (many ELISA are directed to plant proteins by using polyclonal antibodies ! and are not specific for an allergeniv protein)
• the test is sensitive enough

For most allergens no specific limits exists worldwide - how to define a limit ? Detectebility? Health risk?

 

Finally, today we don't have allergen levels as CCP. Declaration as "may contain...." will be done by single case decision - in most cases based on FDA Threshold Group Guideline (in the past) and Vital 2 (today).

This means we have biological, chemical and physical risks on one site in HACCP and allergens on the other hand.

Final rhetorical question: Why allergens don't belong to either biological or chemical risk? Exactly....

 

Regards

moskito

[Charles.C]

Dear moskito,

 

After discussions in previous threads here, i lost faith in the VITAL "numbers".

 

I think the "may contain..." will be with us for a long, long time.

 

Practically, I think it's all so much (haccp) easier to make the Allergen Program a PRP as far as possible? (As per RedRockFoods comment.).

 

Rgds / Charles.C

[Charles Chew]

Clearly, in my interpretation, Allergen (or GMO) is NOT a "process" but instead a hazardous effect arising from specific materials. The purpose of hazard analysis is to determine the severity and likelihood of occurrence of process steps which can be controlled through "kill-steps" via control measures as CP or CCP. 

 

A case of cause versus effects. Impact from Allergens differ from person to person. IMO, there are sufficient current good industrial practices designed to control Allergen issues.

[Charles.C]

Hi Charles,

 

Codex definitions -

 

Hazard: A biological, chemical or physical agent in, or condition of, food with the potential to cause an adverse health effect.

 

Hazard  analysis:  The  process  of  collecting  and  evaluating  information  on  hazards  and  conditions leading  to  their  presence  to  decide  which  are  significant  for  food  safety  and  therefore  should  be addressed in the HACCP plan.

 

( Consideration should be given to what control measures, if any exist, can be applied to each hazard. )

 

HACCP plan: A document prepared in accordance with the principles of HACCP to ensure control of hazards which are significant for food safety in the segment of the food chain under consideration.

 

Perhaps Prerequisites should also be allowed to  include Postrequisites

 

Rgds / Charles

[Charles Chew]

Hello Charles C.

 

Again, the Codex is very clear under the 5 preliminary steps which includes the "Process Flow". The purpose of the 7 principles is to establish the HACCP Plan and one of the requirements is to analyse potential hazards arising from "Ingredients / Materials" and the  "Resultants from the Processes" respectively.

 

Requirements to determine control measures under the two different categories differ. Control on ingredient / materials are not part of the HACCP Plan but rather through other means.  Hence, IMO Allergen (from Ingredients) cannot be classified as a CCP nor GMO.

 

IMO, current industrial practices through cleaning programmes and verifications are sufficient to manage potential cross contamination of Allergen during changeover of production, etc. 

[nguyenquanghuy]

Issue with risk assessment and if allergen  should be listed as CCP.

 

In a small facility and producing products with many allergens.  These are ready to eat products.

 

Have a sanitation program- but using the same process equipment for many products.  

Labels are verified, but there is there is a possibility of cross contamination.  On  products that have no known allergens- state may contain peanuts etc.

 

So would you list as CCP?   If CCP - what are the controls- always a possibility of cross contamination.

 

Thanks

Dear

 

According to me no need.

Usually allergen already present in raw materials, in case no program can control ( prevent: PrP or reduce or eleminate: OPrP) so if we set up CCP how we monitor the reduceing process until acceptable level

similar for allergen develop during process.

[Charles.C]

Hello Charles C.

 

Again, the Codex is very clear under the 5 preliminary steps which includes the "Process Flow". The purpose of the 7 principles is to establish the HACCP Plan and one of the requirements is to analyse potential hazards arising from "Ingredients / Materials" and the  "Resultants from the Processes" respectively.

 

Requirements to determine control measures under the two different categories differ. Control on ingredient / materials are not part of the HACCP Plan but rather through other means.  Hence, IMO Allergen (from Ingredients) cannot be classified as a CCP nor GMO.

 

IMO, current industrial practices through cleaning programmes and verifications are sufficient to manage potential cross contamination of Allergen during changeover of production, etc. 

 

Hi Charles,

 

I think we are talking about decisions as to  (width of) scope. (And presumably  the “risks” related thereof.).

 

Eg –

II. Scope of Hazard Analysis

Unlike HACCP principles 2 through 6, which are usually limited to operations within the facility's control, hazard analysis has a much broader scope and must include factors both within and outside of the facility.

 

The following is a listing of what should be included (at a minimum) in the hazard analysis:

 

Ingredients and raw materials: source, composition, handling, transportation, and storage.

Activities conducted in the process and handling system: steps identified on the flow diagram.

Equipment used in manufacture and processing: specific parameters important to controlling, reducing, or preventing hazards.

Equipment and facility sanitation.

Food product distribution: transportation, delivery, wholesale/retail practices, and intended use.

 

 EDIS - FS13900.pdf   1.45MB   508 downloads

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

Q2.      What range of hazards should be considered for the hazard identification and subsequent analysis?

 

A2.      The scope of the HACCP application and the prerequisite programmes will influence this choice.

 

Normally the hazards identified are those that are reasonably expected to occur in association with:

 

•   raw material;

•   inputs (as defined in A Guide to HACCP Systems in the Meat Industry);

•   process steps.

 

Hazards normally dealt with by a prerequisite programme, e.g. personal hygiene, may have to be considered in the development of a HACCP plan for a product and process involving special conditions, e.g. those involving a cook step. Alternatively, these hazards could already be effectively addressed by an appropriate prerequisite programme, e.g. clearly indicating the specific personnel hygiene requirements when working with raw or cooked product. The processor must be able to demonstrate appropriate control of the hazard, either through the HACCP plan or by the prerequisite programme.

 

Q3.      What inputs have to be considered in the HACCP plan?

 

A3.      Inputs,  as  defined  in  the  Guide,  are  incoming  materials  such  as  consumable  or  non-consumable  items  added  to  the  product  during  the  process  (e.g.  ingredients,  food additives, packaging). Recyclable or other items that come in contact with the product (e.g. hooks/gambrels) are not considered as inputs. Some premises may want to include food contact processing aides (e.g. legging paper) to ensure that all food contact materials are considered, and that hazards associated with them are adequately addressed. This decision is up to the processor.

 MAFF, haccp_v1.pdf   253.09KB   445 downloads

 

I would imagine you are not too enthusiastic about this type of approach  –

 

 ILSI HACCP Concept.pdf   189.09KB   381 downloads

 

I guess the PAS220, etc output team (or its ISO adopters) wouldn’t be either.

 

But it is also IMO incontestable that PAS220, et al reduce the workload / head scratching. 

 

So ultimately we probably agree with respect to CCPs although i have noted that allergen cleaning operations in some process analyses are becoming popular as a  proposal for a model OPRP. Worrying line of thought for me.

 

Rgds / Charles

 

PS (added) - Almost forgot, Codex -

 

The scope of the HACCP plan should be identified.  The scope should describe which segment
of the food chain is involved and the general classes of hazards to be addressed (e.g. does it cover all
classes of hazards or only selected classes).

[Charles Chew]

Hi Charles C.

 

I have no issues with any organizations who wish to categorize Allergens as CCP but the cost of validation and verification during activities involving pre-process to in-process and post process will be enormously cumbersome, impractical and financially mind-boggling. 

[Ayman Zaki]

In a previous job, I had label verification as oPRP for FSSC. The risk assessment highlighted the allergen because it was ready to eat product. So, it was something higher than PRPs and not a CCP. For some reasons, I find all auditors always happy with it.

[Bean Queen]

I prefer to address allergens in my "Allergen Control Program" and "Sanitation Program"

Since you have various types of allergens, the greatest challenge is to prevent cross contamination with other allergens.. The best way to control is to eliminate or prevent this prior to product change over. Preventive action is what I practice.

[sozcan]

We have the same issue. Over 250 different products, all 8 allergens and shared equipment. We have an allergen control program in place to manage allergens from receiving to shipping. It is a PRP. Besides that, I initiated Label checks for allergens as a CCP since we print the labels in house, change ingredient suppliers frequently, and have too many recipes to work with. Most of the recalls are from undeclared allergens, so CCP for allergen checks on labels is a must for us. 

[mruth84]

We have a label change control log. 

[Mr. Incognito]

If you have sufficient PRPs that cover the exensive requirements you need in place to handle that many allergens you should be able to be able to have it just as a PRP.

 

That would obviously require a good cleaning plan with the allergen component explaining what needs to be done between different product runs.

 

An allergen run matrix and order (products should be run in this order whenever possible to reduce possible cross contamination)

 

A good allergen swabbing program.

 

Excellent training on GMP's and allergens with quizzes and GMP audits.

 

You can have, depending on staff, a quality technician or supervisor sign off on format changes to lessen the risk of allergen contamination.

 

Traffic patterns for moving allergens around.  How to handle partial opened boxes of allergens.  Proper storage of allergens to prevent cross contamination. GWP (Good warehousing practices).  You can have colored stickers for allergens (one to designate an allergen is an allergen or a different color for each allergen ingredient).

 

The problem with making it a CCP is you have to have your critical limits which means you will have to be sending a lot of product out for testing to make sure there is no cross contamination and if there is any detected (because your limit will have to be 0 I would suspect) you will have to recall all of the affected product (yes that's not a bad thing to recall it but as a PRP you have more options than a drop dead recall).

 

My suggestion:  Put together a good, all encompassing, web of supporting programs.

[Cahaya]

Hi,

 

i'm new. my co is now heading for the iso22000. we have issue on allergen. since 8 out of 9 of our product is using allergen raw material as a main ingredients (isolated soy protein, soy sauce, gluten, cheese, celery). currently we are in stage of revising the Haccp Plan. Since the allergen contains ingredients make the ingredients become sensetive ingredients, and by referring to this group discussion, it is wise for us to develop a allergen program.

 

Can anyone share with me any related reference to the allergen?

 

thanks

Cahaya

[Charles.C]

Hi,

 

i'm new. my co is now heading for the iso22000. we have issue on allergen. since 8 out of 9 of our product is using allergen raw material as a main ingredients (isolated soy protein, soy sauce, gluten, cheese, celery). currently we are in stage of revising the Haccp Plan. Since the allergen contains ingredients make the ingredients become sensetive ingredients, and by referring to this group discussion, it is wise for us to develop a allergen program.

 

Can anyone share with me any related reference to the allergen?

 

thanks

Cahaya

 

Dear Cahaya,

 

What kind of allergen information are you seeking ?

 

There are probably over 100 threads here invoving allergens.

 

There are, from memory, at least 2 detailed Procedures (ie SOPs) here for Allergen Control Programs.

 

Rgds / Charles.C

[Cahaya]

Hi Charles,

 

I've developed the Allergen control program. In the program we are emphasis on the allergen declaration from the suppliers of all the ingredients supplied to us. We also indicate certain colour code for the ingredients during the storing. At the end products, we have to declare any allergen ingredients used on the label itself. Is it enough? Since we never received any complaint from any allergic consumer to our food from local consumers, we dont really know how to handle it. Is there any standard guideline to build up the program?

[Charles.C]

Hi Charles,

 

I've developed the Allergen control program. In the program we are emphasis on the allergen declaration from the suppliers of all the ingredients supplied to us. We also indicate certain colour code for the ingredients during the storing. At the end products, we have to declare any allergen ingredients used on the label itself. Is it enough? Since we never received any complaint from any allergic consumer to our food from local consumers, we dont really know how to handle it. Is there any standard guideline to build up the program?

Dear Cahaya,

 

The attachments below previously posted by various people may give some ideas. The first two are intended to be SOPs.

 

 acp1 - QC-COR-7000 Allergen Control Program.DOC   212.5KB   1309 downloads

 acp2 - Allergen Control Program.doc   34.5KB   1352 downloads

 acp3 - developing an allergen control program.pdf   355.25KB   1025 downloads

 acp4 - allergen control program, USA meat and poultry industry.pdf   152.11KB   617 downloads

 acp5 - Multi-Allergen Programs,matrix Canada, Agricultural Products.pdf   31.86KB   632 downloads

 acp6 - Management,Labelling,allergen,intolerance, EU,risk eval.,checklist,2005.pdf   358.79KB   764 downloads

 acp7 - Kraft supplier haccp allergen control program.ppt   7.69MB   1056 downloads

 

Rgds / Charles.C