Gluten-"free" Declaration
Good Morning All
We have a very stubborn customer who wants us to declare our products as gluten free.
We have carried out some analysis and confirm their product contains less than 20ppm gluten on the sample sent to be analysed.
However I am not happy to just declare that all product are confirmed as gluten free when the site uses wheat flour across the site, but in their products we use certified gluten free ingredients.
I can put in place testing of every batch, nut does this mean it becomes a positive release and would need to put in place procedures for this.
They want to declare on the spec as follows:
On product specification:
This product is suitable for coeliacs: YES
This product contains gluten: NO
Statement at bottom of product specification:
This product is does not, and is certified not to, contain gluten, and the recipe is tested twice per year as a minimum, and when there is a material change in the recipe or production process/es, to validate it is gluten free.
the producer is BRC certified, is able to provide full traceability of all ingredients and products, and adopts allergen management policies and procedures to remove the risk of cross contamination.
Although gluten cross contamination presents an extremely low risk, ingredients containing gluten are stored and handled on site.
What would everyone suggest?
Hi Wayne
As you have confirm through analysis the products sold to this particular customer are gluten free.
The suggested statement at the bottom of the specification clearly sated that site stored and use gluten containing products but you have policies and procedure to ensure that risk of cross contamination is minimum due to control measures you have implemented.
The suggested statement does not say that site is gluten free or does not manufacture gluten containing products.
In my opinion I will comply with the request and do testing of all their products twice a year as suggested to ensure compliance.
Kindregards
Dr Humaid Khan
Managing Director
Halal international Services
Australia
Hi wayne,
Offhand it sounds like a "may contain gluten" would be more appropriate unless you are highly confident (ie validated) that the risk of cross-contamination is negligible.
I am curious as to what the relevant Regulatory requirements say regarding the specification declarations.
For example. Oats do not contain gluten but their packaging labels don't say "gluten free" due to cross contamination from other gluten containing products in the same plant. (which you said you have) Unless you have a perfect program that controls allergen cross contamination? Not sure about claiming its gluten free.
I agree with the others above. Couple of years ago the company i was working for then went through our GFCP audit and even that only requires an annual audit. But we didn't have other gluten on site either.
I would say positive release and CIP for production line(e.g. ELISA kit) during change over and annual gluten tests is sufficient.
We test every batch when claiming gluten free but we are a continuous process going from gluten containing products on the same line, we positive realease the first 2 hours (in case of carry over)
If there are products which are not declared as gluten free but dont have gluten as an ingredient we dont declare 'may contain' they are run after the GF products before the gluten prods
I would assess the likelyhood of contaminating to 20ppm at your site, so its more of a 'low risk' allergen IMO
I am a bit shocked of the lack of understanding of coeliac disease
my company is dedicated gluten free site and even we have strict controls that involves:
- raw material testing (ingredients which have a significant risk of contamination in the supply chain, and/or those which have tested positive for allergens in the past),
- product testing (all batches in in-house lab) and annual accredited lab testing
At the end of the day you are responsible for placing unsafe product on the market therefore for (most of all) consumer safety and due diligence, controls have to be put in place
It sounds like this could be handled through segregated storage for gluten free ingredients and an allergen clean prior to production. You can validate the clean with allergen swabs.
As others have said, you must validate your process, changeovers, sanitation, and sampling/testing. You need to consult with other management to determine how valuable it is in making the customer happy and have a continued relationship. Sometimes, the customer just isn't worth what they may be asking for from you. In that case you can cut ties and go on about your business.
But...if the customer has great value then abide by what they require and do it to the tee. I wouldn't be comfortable with only 2 times a year testing to verify...I mean maybe, but it really depends on the validation and level of confidence you have in the SOP's being carried out to a T consistently.
As others have said, you must validate your process, changeovers, sanitation, and sampling/testing. You need to consult with other management to determine how valuable it is in making the customer happy and have a continued relationship. Sometimes, the customer just isn't worth what they may be asking for from you. In that case you can cut ties and go on about your business.
But...if the customer has great value then abide by what they require and do it to the tee. I wouldn't be comfortable with only 2 times a year testing to verify...I mean maybe, but it really depends on the validation and level of confidence you have in the SOP's being carried out to a T consistently.
I agree fully, I approached the forum because sometimes you start questioning your own judgement and forums like this just reinforce your thinking was correct from the start.
I am not happy with two tests per annum, we need to validate every batch but unless the business is willing to invest in extra testing the answer to the customer is no.
They have said other suppliers have done what they asked, I have asked them for the contacts to determine how they managed this, as yet the customer has not given me any evidence to back up that their other suppliers have undertaken what they wanted, which leads me to believe they are bullying us for their own gain.
I am a bit shocked of the lack of understanding of coeliac disease
my company is dedicated gluten free site and even we have strict controls that involves:
- raw material testing (ingredients which have a significant risk of contamination in the supply chain, and/or those which have tested positive for allergens in the past),
- product testing (all batches in in-house lab) and annual accredited lab testing
At the end of the day you are responsible for placing unsafe product on the market therefore for (most of all) consumer safety and due diligence, controls have to be put in place
It does appear that way, these sales people who sell an idea but don't think of the consequence and leave the compliance team to pick up the pieces, I am very reluctant to just bow down to their pressure. We can put the controls in place but for the two products they are wanting to put on their so called gluten free menu to satisfy the Kardashian style elite who sip their chia skinny latte with roasted coffee beans sprinkled with some crap from an island no one has ever heard of, and eating smashed avocado on their gluten free toast at £9.99, and talking about how their life is so divine! and not focus on the real reason that gluten is a serious issue for people with coeliac disease.
I agree fully, I approached the forum because sometimes you start questioning your own judgement and forums like this just reinforce your thinking was correct from the start.
I am not happy with two tests per annum, we need to validate every batch but unless the business is willing to invest in extra testing the answer to the customer is no.
They have said other suppliers have done what they asked, I have asked them for the contacts to determine how they managed this, as yet the customer has not given me any evidence to back up that their other suppliers have undertaken what they wanted, which leads me to believe they are bullying us for their own gain.
I've been in this position a number of times. All you can really do is explain what is required to meet the customer's needs, the cost of doing so, and the potential risk to whoever is making those decisions. I usually factor in PITA when calculating the costs because added SOP's and testing always increase PITA. A few times it has worked and the customer has either backed down, or upper management or sales have said no to the customer. But...most of the time I was told to do what we have to do to minimize and eliminate risk and do what the customer is asking. It can be frustrating especially when a customer has a direct line of communication to you, the QA Manager. In those times I always remind myself we are doing what is required for the business and I need to do my role regardless what I think about the customer. Maybe it can help if you follow this approach.
You can't really ask a customer to provide you contacts of other suppliers that have done things for them...that's just not good business, you will alienate the customer.
We were told by a 3rd party certifying group that if you have gluten containing ingredients in the same facility that you wish to produce gluten containing ones, you cannot get certified as gluten free. Only if it was produced in a separate facility that did store/use any gluten containing ingredients. So we are working with a company to develop products for us because they do not utilize any gluten containing ingredients in their facility.
We were told by a 3rd party certifying group that if you have gluten containing ingredients in the same facility that you wish to produce gluten containing ones, you cannot get certified as gluten free. Only if it was produced in a separate facility that did store/use any gluten containing ingredients. So we are working with a company to develop products for us because they do not utilize any gluten containing ingredients in their facility.
This seems fishy to me...In a previous facility we co-packed product. One product required gluten free certification. We had ingredients and products at the time containing gluten stored and processed on same equipment. We received a gluten free certification for the product, not the facility. Of course, we had to validate and verify the process to ensure a gluten free product.
You may be speaking of a gluten free certification for a facility and not product or equipment dependent. From what I understand you can have different types of gluten free certification.
Hi,
simple question from your insurance company: How do you garantee that... (e.g. by validated processes, analytics)
Rgds
moskito