5 replies to this topic

[SHAHIDA]

Hi all

In a flour mill gluten is an inherent allergen and the company is declaring it on the label. There is no claim for gluten free. How can we conduct validation and verification? There is no other ingredient used at the facility that contains any other allergen. How can it be documented to meet the audit requirements.

 

[QA@Foodsafety]

Hi Sahida,

Just need a little bit clearification to understand- if you are declaring Gluten on your label, what you need to verifiy and validate?

[Scampi]

We process and handle only 1 product type that is a major allergen

 

We DO NOT validate, as there is no point

 

We do have controls in place re: handwashing for inadvertent allergens but that's it

 

I would argue that since you are a mill, and you do not produce any gluten free products, a statement as such should be more than sufficient for any auditor---then ensure you're allergen control procedure covers employee lunch storage, handwashing etc.

[G M]

Some auditors like to see you acknowledge what the other allergens are, and make a statement that you have reviewed all materials/products to confirm that only X is present in your facility.

[patti.garcia]

I believe you might audit or risk assess your suppliers for other allergens that may contact your ingredients.

[Tony-C]

Hi SHAHIDA,

 

Welcome to the IFSQN forums.

 

I don’t see this as a massive issue to you but as Patti has posted, one of my main concerns would be other allergens being present in the materials you receive from your supplier.

 

For the FSSC 22000 Certification Scheme Version 6 the requirements for allergen management, validation and verification are covered in 3 documents as outlined below.

 

Validation and verification are prescribed in International ISO Standard 22000 2018 Food safety management systems — Requirements for any organization in the food chain.

Section 8.5.3 Validation of control measure(s) and combinations of control measures

Section 8.8 Verification related to PRPs and the hazard control plan - 8.8.1 Verification

ISO 22000 isn’t particularly specific in what validation and verification is required.

 

Technical ISO/TS Specification 22002-1 Prerequisite programmes on food safety —

Part 1: Food manufacturing has requirements in Section 10.3 Allergen management but does not refer to validation and verification.

Section 9 Management of purchased materials 9.1 General requirements refers to verification:

Purchasing of materials which impact food safety shall be controlled to ensure that the suppliers used have the capability to meet the specified requirements. The conformance of incoming materials to specified purchase requirements shall be verified.

 

FSSC 22000 Certification Scheme Part 2 | Requirements for Organization to be Audited

 

Section 2.5.2 Product Labeling and Printed Materials (All Food Chain Categories) has requirements regarding allergens:

a) Finished products are labelled according to all applicable statutory and regulatory requirements in the country of intended sale, including allergen and customer specific requirements.

b) Where a product is unlabelled, all relevant product information shall be made available to ensure the safe use of the food by the customer or consumer.

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

 

Section 2.5.6 Management of Allergens (All Food Chain Categories) covers allergens validation and verification:

The organization shall have a documented allergen management plan that includes:

c) Identification and implementation of control measures to reduce or eliminate the risk of

cross-contamination, based on the outcome of the risk assessment; and

d) Validation and verification of these control measures shall be implemented and maintained as documented information. Where more than one product is produced in the same production area that have different allergen profiles, verification testing shall be conducted at a frequency based on risk, e.g., surface testing, air sampling and/or product

testing;

f) All personnel shall receive training in allergen awareness and specific training on allergen control measures associated with their area of work

 

2.5.13 Product Design and Development (Food Chain Categories BIII, C, D, E, F, I & K)

A product design and development procedure shall be established, implemented, and maintained for new products and changes to product or manufacturing processes to ensure safe and legal products are produced. This shall include the following:

a) Evaluation of the impact of the change on the FSMS taking into account any new food safety hazards (incl. allergens) introduced and updating the hazard analysis accordingly,

 

So although there are requirements for validation and verification, there is only limited guidance.

 

As per previous posts, the important aspects to consider are:

1. Verification of your suppliers to ensure there is no risk of other allergens being present in the wheat you are purchasing. Consider if your suppliers handle other allergenic material and the potential for cross-contamination.

2. Rules for food on site such as in the canteen/rest areas and food brought to site by staff. Controls of protective clothing (such as removal of protective clothing when going for breaks) to ensure any other allergenic food consumed on site is not carried into product areas on protective clothing.

3. A simple training programme for staff to ensure they are aware of types of allergens and controls you have in place including the site rules and an emphasis on the prohibition of personal food items from product areas.

 

Kind regards,

 

Tony