4 replies to this topic

[LGreen]

We are looking at running a new product that has nuts in the formula.  With that being said, we have current products without any nuts or tree nuts so do not have any labeling on the current film and products for this allergen.  If we get this new formula with nuts up and running, I understand that we will need to complete a Hazard Analysis and Risk Assessment for such - making sure our GMP's are followed for each fun.  Anything else we need to make sure to complete for that area?  

Also - I'm not sure what type of labeling would need to be required on the non-nut product and does this labeling need to be on the nutritional panel or can the label of "processed in the same facility that processes nuts" be included on the package in a different area than the label.

Any help is appreciated.

[Tony-C]

Hi lynzy05,

 

If you are running new product that has nuts in the formula on the same production line as non-allergen products then this is likely to be a whole new ball game.

 

You need to get a thorough understanding of BRCGS Global Standard for Food Safety Issue 9 Section 5.3 Management of allergens which includes:

5.3.3 Risk assessment for cross-contamination (cross-contact)

5.3.4 Cross-contamination (cross-contact) procedures

5.3.8 Allergen cleaning regimes

BRCGS Guidance: Some standard cleaning regimes will be insufficient to ensure the removal of all allergenic material. Therefore, specific cleaning procedures must be present on site where allergen- containing materials require control.

Cleaning procedures must be designed to remove or reduce to acceptable levels any allergenic material.

 

For existing product labels, see Clause 5.3.6:

Where a justified, risk-based assessment demonstrates that the nature of the production process is such that cross-contamination (cross-contact) from an allergen cannot be prevented, a warning should be included on the label. Legislation, national guidelines or codes of practice shall be used when making such a warning state.

Clause 5.3.6 Guidance: On-pack warning labels

Where well-implemented and managed allergen management controls cannot prevent cross-contamination (cross-contact) and there is a significant and genuine risk of the presence of an allergen that would not otherwise be present and is therefore not mentioned elsewhere on the product (e.g. in the ingredients list), the use of on-pack advisory warning labels should be considered – i.e. an on-pack, advisory, consumer-facing warning label stating that there is a risk of cross-contact from an allergen, which cannot be prevented. While different wording may be used in different countries (see below), such warnings are often referred to as ‘may contain’ labels, as they refer to unpreventable cross-contact rather than to the deliberate inclusion of the allergen in the product.

The use of a warning label should be justifiable on the basis of the risk assessment and procedure (clauses 5.3.3 and 5.3.4) and should not be a substitute for effective implementation of good manufacturing practices. Reference must be made to national legislation, guidelines or codes of practice when making such a statement to ensure that best practice is followed.

 

Allergen warnings/labelling must be as per legislation requirements, normally allergen statements are included in or near ingredient listings.

 

Kind regards,

 

Tony

[Dorothy87]

Hi  

 

just to add a few things 

 

issues you will have while conducting risk assessment  : 

 

- Nuts are specific, not sure what type of production lines you have but trust me sometimes is hard to get rid of them with a single clean. 

- You will probably need to think about different colour coding cleaning equipment (to avoid cross-contamination) and color-coding system for storage. 

- Cleaning between and rapid tests will delay production - speak to production and planner about this. Sometimes is better to re-schedule production and place products with nuts as the last one 

- Prepare yourself or allergens validation (laboratory tests)  and verification (internal rapid test) - not sure if this will be expensive in USA but in UK is quite costly 

- Think about production operatives, they shouldn`t use same coats (cross-contamination) 

 

[chrisrushworth]

We are looking at running a new product that has nuts in the formula.  With that being said, we have current products without any nuts or tree nuts so do not have any labeling on the current film and products for this allergen.  If we get this new formula with nuts up and running, I understand that we will need to complete a Hazard Analysis and Risk Assessment for such - making sure our GMP's are followed for each fun.  Anything else we need to make sure to complete for that area?  

Also - I'm not sure what type of labeling would need to be required on the non-nut product and does this labeling need to be on the nutritional panel or can the label of "processed in the same facility that processes nuts" be included on the package in a different area than the label.

Any help is appreciated.

 

 

RA needs to consider where the raw materials are stored, how they are stored (locked nut cupboard), what happens if not all used up (WIP), do you action "REWORK" as this will also have to be considered for cross contamination potential.

 

We use LFT swabs for validation of cleaning after/before non-nut containing production.

 

Time segregation is also applicable, Nuts at the EOD.

 

Colour coded PPE (gloves/aprons?)

Colour coded designated cleaning equipment?

 

I would also consider a verification of your cleaning, by sending the first product (non-nut) produced after cleaning of a nut product to a UKAS lab for tree/peanut testing to verify that your controls/cleaning procedures remove all protein traces.

Regards to PALS, its worth adding a statement saying manufacturered in a factory that also handles nuts ..

BUT remember PALS don't cover everything... controls and verification swabs/testing are your due diligence defence....

 

Good luck..

[kconf]

If you never ran allergens (nuts) before on this line, what has your statement been until now? If a customer wanted to inquire of any nuts in product, how would you handle it?

 

As long as you are fine with the non-nuts products containing nuts, you can state it on your packaging as a warning. 

 

Did you have nuts in your facility but on a different line at all or is this the first time introducing nuts?