Template for GMO hazard analysis

Hi,

We manufacture yoghurt. Our new buyer require us to carry out a documented GMO hazard analysis to determine the absence of GMO's in the product.

Can someone attach a template I could take a look at please or any advise where to start?

Thank you

Ildiko

If the client is a brand owner / retailer then they'll often have lists of ingredients that they consider to be potential GM risks - I'd start by asking if they have one of these, as it may then simply be a case of checking whether your product actually contains any of the listed components.

We're also yogurt producers and are Non-GMO certified by SGS. The CB didn't ask us to do GMO analysis, they're satisfied with Non-GMO statements for all ingredients. As I was told by the lab, GMO analysis is pretty expensive. Why should you waste your money on unnecessary testing? 

Thank you for your reply, very helpful. 

I have GMO statement for all ingredient used on site.

Thank you for your reply.

Yes, the client is a brand owner/retailer. great advice! I will do. 

Hi,

in principle GMO are not a hazard as long as the GMO a registered.

Here you are looking for a unintended contamination. So, if you are asking for statements you have to be aware on the legislation (in the EU 1829/2004 and 1830/2004) and you have to talk on detection limits, the possible events and have to get informations on the supply chain. We have created 4 GMO risk classes for our raw materials.

For risk classes 3 and 4 we have special requirements incl. monitoring. For risk class 4 we get an CoA with delivery and do own monitoring test 4x/y.

Rgds

moskito

Hi,

 

in principle GMO are not a hazard as long as the GMO a registered.

Here you are looking for a unintended contamination. So, if you are asking for statements you have to be aware on the legislation (in the EU 1829/2004 and 1830/2004) and you have to talk on detection limits, the possible events and have to get informations on the supply chain. We have created 4 GMO risk classes for our raw materials.

For risk classes 3 and 4 we have special requirements incl. monitoring. For risk class 4 we get an CoA with delivery and do own monitoring test 4x/y.

 

Rgds

moskito

^^^^ (red)

Debatable. eg Whose Principle ?

Hi,

legal principles wth respect to food safety - which are dependent on the legal environment (US, EU, Japan, China etc.).

Rational:

If a GMO has been checked by e.g. EU authorities, passed the safety assessment and the use is permitted in the EU, such GMO as such is IMO per official definition not a hazard in the view of food safety. Otherwise each additive which needs also such permission would be a hazard. An additive like lecithin is a safe ingredient. But if lecithin derives from an allergenic source (e.g. soy) there is an additional intrinsic allergen risk by protein contamination (which is not for highly refined soy oil). Soy is - in most areas - an allergen independent if grown conventionally as well as organic as well as GMO. In the registration process it will be checked whether the GMO has developed an additional allergenic potential compared to the not modified version.
Other allergens like sesame are not listed as a food allergen globally. The legal definition of the registered GMO (soy, sesame etc.) is IMO independent from other intrinsic food safety risks.

So, it would like to draw this clear line. It is all a question of definition in the legal context which might differ from a scientific/medicinal.

Rgds

moskito

Hi,

 

legal principles wth respect to food safety - which are dependent on the legal environment (US, EU, Japan, China etc.).

 

Rational:

If a GMO has been checked by e.g. EU authorities, passed the safety assessment and the use is permitted in the EU, such GMO as such is IMO per official definition not a hazard in the view of food safety. Otherwise each additive which needs also such permission would be a hazard. An additive like lecithin is a safe ingredient. But if lecithin derives from an allergenic source (e.g. soy) there is an additional intrinsic allergen risk by protein contamination (which is not for highly refined soy oil). Soy is - in most areas - an allergen independent if grown conventionally as well as organic as well as GMO. In the registration process it will be checked whether the GMO has developed an additional allergenic potential compared to the not modified version.
Other allergens like sesame are not listed as a food allergen globally. The legal definition of the registered GMO (soy, sesame etc.) is IMO independent from other intrinsic food safety risks.

 

So, it would like to draw this clear line. It is all a question of definition in the legal context which might differ from a scientific/medicinal.

 

Rgds

moskito

Whilst I don't disagree with you on the scientific/regulatory front, and in terms of "real" hazards as relevant for food safety purposes, the context of the OP's question seems to be somewhat distinct from this. Some of the brands and retailers here in the UK have adopted (or perhaps misappropriated ) a HACCP-style approach for areas that could perhaps be categorised as hazards to their brand value as seen in the context of consumer sentiment / media portrayal. I've seen this for GMOs, vegan/vegetarian claims, Kosher/Halal status (even when certified), so I assume it's only going to become more widespread. 

Hi,

 

in principle GMO are not a hazard as long as the GMO a registered.

Here you are looking for a unintended contamination. So, if you are asking for statements you have to be aware on the legislation (in the EU 1829/2004 and 1830/2004) and you have to talk on detection limits, the possible events and have to get informations on the supply chain. We have created 4 GMO risk classes for our raw materials.

For risk classes 3 and 4 we have special requirements incl. monitoring. For risk class 4 we get an CoA with delivery and do own monitoring test 4x/y.

 

Rgds

moskito

 

 

 

Thank you for your response. 

I assume risk category 1 & 2 are both low risk. What's the difference between risk 1 and risk 2 category ingredients. Can you please tell a couple of example. Thank you

Whilst I don't disagree with you on the scientific/regulatory front, and in terms of "real" hazards as relevant for food safety purposes, the context of the OP's question seems to be somewhat distinct from this. Some of the brands and retailers here in the UK have adopted (or perhaps misappropriated ) a HACCP-style approach for areas that could perhaps be categorised as hazards to their brand value as seen in the context of consumer sentiment / media portrayal. I've seen this for GMOs, vegan/vegetarian claims, Kosher/Halal status (even when certified), so I assume it's only going to become more widespread. 

 Dear pHruit,

I agree to "HACCP-like" as a type of risk assessment. We apply where ever possible FMEA (VACCP, TACCP etc.)
I have had many discussions with UK private label clients and I told them the same for 'our' HACCP. We keep it separate. But we apply risk assessments (outside the genuine HACCP) in depth to prevent our brand and polices e.g. for GMO.

I think in general we have the same point of view.

Rgds

moskito

 

Hi,

 

in principle GMO are not a hazard as long as the GMO a registered.

Here you are looking for a unintended contamination. So, if you are asking for statements you have to be aware on the legislation (in the EU 1829/2004 and 1830/2004) and you have to talk on detection limits, the possible events and have to get informations on the supply chain. We have created 4 GMO risk classes for our raw materials.

For risk classes 3 and 4 we have special requirements incl. monitoring. For risk class 4 we get an CoA with delivery and do own monitoring test 4x/y.

 

Rgds

moskito

 

 

 

Thank you for your response. 

I assume risk category 1 & 2 are both low risk. What's the difference between risk 1 and risk 2 category ingredients. Can you please tell a couple of example. Thank you

 

Dear IIdiko,

I can provide some examples. But this is not simply transferable to others because it is based on our individual situation (company policies, data systems in place, type of raw material, some general rules (don't from ... (supplier x, country, traders etc.),history, experiences).
We always try to build 4 risk classes (microbial, chemical, physical, finished products, GMO...) which helps in the daily business (release of...; set up of monitoring programs)

With GMO the principle is to follow the supply chain, where ever possible with docs (e.g. soy IP).

Definition of classes with examples:

Class 1:
Highly processed raw materials in which no or hardly any plant DNA is found (solvents such as ethanol, carriers such as triacetin or glycerine, oils etc.)
- analysis not useful. -> Class I is not routinely analysed.

Class 2:
Critical GMO raw materials which are not authorised and not used in the country of origin of the raw material
(e.g. source rice from Italy instead of...)

Class 3:
Critical GMO raw materials which are almost unprocessed or only mechanically treated parts of a plant (e.g. flours).
In the case of chemical treatment stages, the distinction to Class I must be clarified.
Delivery with special GMO-CoA (ervery x batches)

Class 4:
Critical GMO raw materials which are known to be used in the country of origin in addition to the non-GMO variant (soy lecithin from Brazil).
This class also includes raw materials with a low content of critical GMO raw materials (e.g. chocolates with a soya lecithin content of 0.5%)

Each delivery with special GMO-CoA and supply chain docs.

No acceptance of levels of contanimation of registered events > 0,1%. Zero tolerance for non regstered.

This can only be the frame and is not carved in stone. Often you have take individual case decision. In some cases I have done "supported raw material batch releases for our supplier e.g for soy lecithin which should become of part a composed raw material delivered to us (only for the GMO-part, not in general).

For sampling and testing (supplier or monitoring) we have defined parameters (methods, events). Data sourcing on registered events per country, applied GMO per country and monitoring of recalls for non authorized events (per country -> don't buy in....)

Coming back to the beginning. Overall there is a complex system of informations around the examples and class building.

And now CRISPR/Cas.....

Rgds

moskito