Allergen monitoring in FSSC 22000 version 6
Please, could someone help me with the interpretation about the topic 2.5.2 at part 2 of the FSSC 22000 scheme version 6?
The text says:
Where a claim (e.g. allergen, nutritional, method of production, chain of custody, raw material status, etc.) is made on the product label or packaging, the organization shall maintain evidence of validation to support the claim and shall have verification systems in place.
Reading this text, I understand that if I declare that my product contains an allergen I must prove that it really does. For example, if I declare that my product contains milk, must I have some evidence of that? Does it make sense? For me, the logical process would be have an laboratorial evidence that none other allergen that I don´t declare is in my product, not prove that those that I already declare really are there. How should I interpret this topic?
I can’t speak to FSSC 22000 v6 specifically, but:
Usually when people are talking about allergen claims, they are referring to allergen-free claims — in the example you gave, I would not worry too much. The exception might be precautionary labeling.
To build from your example — if you are making ice cream and the first ingredient is milk, I would not worry about proving that milk is in your product. However, here are two additional possibilities:
1. Let’s imagine that one of your ice cream flavors has a peanut butter swirl and you choose to place a “May contain peanuts” label on every single flavor you make. In this case, it might be prudent to document your decision to include the warning label — why is it that you don’t feel able to successfully manage that allergen in your facility?
2. Let’s imagine that none of your ice cream flavors use peanut, so all of your labels claim, “Peanut-free”. Where is your confidence coming from? What guarantees have you received from your suppliers and what in-house precautions (testing, cleaning, storage etc) do you follow to protect your products from cross-contact?
Hi GustavoAmerico,
FSSC 22000 Additional Requirements
2.5.2 PRODUCT LABELING AND PRINTED MATERIALS (ALL FOOD CHAIN CATEGORIES
c) Where a claim (e.g. allergen, nutritional, method of production, chain of custody, raw material status, etc.) is made on the product label or packaging, the organization shall maintain evidence of validation to support the claim and shall have verification systems in place.
This section is not about allergen declaration but it does apply when you are claiming a product is ‘allergen free’ which I’ll come on to.
This requirement is for products where claims are made on finished packs and can include:
• specific provenance or origin (e.g. Madagascan vanilla)
• breed/varietal claims (e.g. Specific fish such as haddock)
• assured status (e.g. GLOBALG.A.P.)
• genetically modified organism (GMO) status (GMO free)
• identity preserved (e.g organic)
• allergen free (e.g. gluten free)
When the claim relates to raw materials purchasing records, traceability of raw material usage, final product packing records and mass balance tests need to be maintained to substantiate the claims. Systems need to minimise the risk of purchasing fraudulent or adulterated food raw materials and to ensure that all product descriptions and claims are legal and accurate.
Strict controls on material identification, traceability and segregation are required to preserve the integrity of any claims made.
Where sites manufacture a product with an allergen-free claim stringent controls are required with regards to the raw materials, supplier and controls to prevent cross-contamination on site including considering the prohibition of the allergen from site even in staff facilities. Due to the very serious repercussions of an 'allergen free' product being contaminated with an allergen, it is essential that any 'allergen free" claim is based on rigorous controls and the claim is validated and continually verified.
Kind regards,
Tony
Hi GustavoAmerico,
FSSC 22000 Additional Requirements
2.5.2 PRODUCT LABELING AND PRINTED MATERIALS (ALL FOOD CHAIN CATEGORIES
c) Where a claim (e.g. allergen, nutritional, method of production, chain of custody, raw material status, etc.) is made on the product label or packaging, the organization shall maintain evidence of validation to support the claim and shall have verification systems in place.
This section is not about allergen declaration but it does apply when you are claiming a product is ‘allergen free’ which I’ll come on to.
This requirement is for products where claims are made on finished packs and can include:
• specific provenance or origin (e.g. Madagascan vanilla)
• breed/varietal claims (e.g. Specific fish such as haddock)
• assured status (e.g. GLOBALG.A.P.)
• genetically modified organism (GMO) status (GMO free)
• identity preserved (e.g organic)
• allergen free (e.g. gluten free)
When the claim relates to raw materials purchasing records, traceability of raw material usage, final product packing records and mass balance tests need to be maintained to substantiate the claims. Systems need to minimise the risk of purchasing fraudulent or adulterated food raw materials and to ensure that all product descriptions and claims are legal and accurate.
Strict controls on material identification, traceability and segregation are required to preserve the integrity of any claims made.
Where sites manufacture a product with an allergen-free claim stringent controls are required with regards to the raw materials, supplier and controls to prevent cross-contamination on site including considering the prohibition of the allergen from site even in staff facilities. Due to the very serious repercussions of an 'allergen free' product being contaminated with an allergen, it is essential that any 'allergen free" claim is based on rigorous controls and the claim is validated and continually verified.
Kind regards,
Tony
Thank you for your answer, Tony.
So, if in my product label or packing there´s no a claim of "allergen free", I still must have some evidence about that? I produce different flavors of a product and have a list of all allergen involved in each of these products. There´s no one specific that I declare as "free", I declare just as "contains" or "can contain"
Thank you for your answer, Tony.
So, if in my product label or packing there´s no a claim of "allergen free", I still must have some evidence about that? I produce different flavors of a product and have a list of all allergen involved in each of these products. There´s no one specific that I declare as "free", I declare just as "contains" or "can contain"
Hi GustavoAmerico,
If you don’t have a claim of ‘allergen free’ you wouldn’t need any evidence of that.
Declaring ‘contains’ based on the information available to you is fine.
Best practice for ‘can contain’ is that is okay providing that this isn’t because you or your suppliers are not applying generally accepted precautions to prevent cross-contamination. You will also need to consider relevant national/international & customer requirements for product labelling.
Kind regards,
Tony