4 replies to this topic

[Konstantinos]

- The manufacturer produces a pepper paste with soya as the only declared allergen.

- The product is made on the same production line where wheat is also used.

- Manufacturer specification indicates a HIGH risk of cross-contamination with wheat.

- The product label does not mention wheat, either as an ingredient or via precautionary allergen labelling (PAL), such as “may contain wheat''.

- The paste is produced in the same processing area and on the same equipment as products containing wheat ingredients.

- Product testing has confirmed the presence of gluten in the range of 33 to 141ppm. Source of gluten has not fully identified although the manufacturer pointed out wheat/wheatflour, other sources of cereal gluten might exist.  

- No comprehensive allergen risk assessment has been conducted.

- The cleaning process is validated solely through visual inspection.

- The manufacturer has a dedicated gluten-free (GF) production line but does not use it for the red pepper paste, despite the known wheat contamination risk.

 

- On the implementation of corrective action to this critical non conformance, customer who bought the above product says that the corrective action should be to add the wheat/wheat flour as an ingredient in the ingredients list, and not as a 'may contain' label, due to inappropriate allergen risk assessment, product testing results and presence of GF line which is not used for this product. Do you agree or not?

 

Please, support your answer, if possible, with law requirements, guidelines recommended by national inspection authorities, Codex Alimentarius, BRC or FSSC22000 or SQF standard references.     

Edited by Konstantinos, 28 November 2024 - 04:49 PM.

[pabloqa]

As I understand, in the US (I can't say about the UK) precautionary labelling does not exempt you from good practices, so it is strictly optional to state "manufactured on equipment that processes...", or "made in a facility that also handles..." when an allergen is not an ingredient. However, given your situation, I would consider adding a statement immediately next to ingredient list, for example: “Contains wheat, milk, and soy.”.

This is what I understand about the US FDA requirements, if someone would like to correct me, please feel free.

[Dorothy87]

hi

 

Clearly, something is not right there, 

 

From the BRC perspective : 

 

5.3.4 

 

Procedures shall be established to ensure the effective management of allergenic materials to prevent cross-contamination (cross-contact) of products not containing the allergen. These shall include, as appropriate:

 

• physical or time segregation while allergen-containing materials are being stored, processed or packed

• the use of separate or additional protective overclothing when handling allergenic materials

• use of identified, dedicated equipment and utensils for processing

• scheduling of production to reduce changes between products containing an allergen and products not containing the allergen

• systems to restrict the movement of airborne dust containing allergenic material

• waste handling and spillage controls

• restrictions on food brought onto site by staff, visitors and contractors and for catering purposes.

 

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 statement.

 

Then.. 

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.

 

Then.. 5.3.8

 

Equipment or area-cleaning procedures shall be designed to remove or reduce to acceptable levels any potential cross-contamination (cross-contact) by allergens. The cleaning methods shall be validated to ensure that they are effective and the effectiveness of the procedure

routinely verified. Cleaning equipment used to clean allergenic materials shall either be:

• identifiable and specific for allergen use

• single use

• effectively cleaned after use.

 

The risk assessment must be in place which is leading to cleaning validation and verification - I would ask them about validation exercise and I would expect at least 3 sets of cleaning validation, then cleaning verification (rapid swabs) after product containing gluten.  having all of these in place I would add may contain statement, rapid swabs are not quantifiable and is super easy to end up in cross-contamination.

 

Alternatively they should produce this in the GF site... 

Edited by Dorothy87, 29 November 2024 - 11:34 AM.

[Scampi]

From CFIA     https://inspection.c...s-and-gluten#c4

A cross-contamination statement is a declaration on the label of a prepackaged product that alerts consumers of the possible presence of an allergen in the food.

Cross-contamination statements may be declared by food manufacturers and importers when, despite all reasonable measures, there is the unintended presence of food allergens in the food. Cross-contamination statements are not a substitute for good manufacturing practices.

 

Like all labelling statements, cross-contamination statements are subject to subsection 5(1) of the Food and Drugs Act (FDA) and must be truthful and not misleading.

If the label of a prepackaged product declares that due to the risk of cross-contamination, the product may contain a food allergen or gluten, the cross-contamination statement:

1. must be declared immediately after the contains statement if there is one, after the phenylalanine statement if there is no contains statement, or after the list of ingredients if there are no such statements. The cross-contamination statement must appear within the same background colour and/or within the same solid borders as the statement or list of ingredients [B.01.010.4(1)(a)(i) to (iii) and B.01.010.4(1)©, FDR]
2. must appear in both English and French if the preceding statement(s) or list appear in both languages [B.01.010.4(1)(b), FDR]
3. must appear without any intervening written, printed or graphic material between it and the contains statement, the phenylalanine statement or, if there are none, the list of ingredients [B.01.010.4(1)(d), FDR]
4. must appear in bold, if the cross-contamination statement is not introduced by a title and if it begins on the same line on which the statement or list that immediately precedes it ends [B.01.010.4(1)(e), FDR]
5. if the cross-contamination statement is introduced by a title, that title must appear in bold if the statement begins on the same line on which the statement or list that immediately precedes it ends [B.01.010.4(1)(f), FDR], and
6. if the cross-contamination statement is preceded by a phenylalanine statement and begins on the same line on which the statement ends, the title, or the declaration itself if there is no title, must be shown in a type that is at least 0.2 mm greater than the height of the type used in the statement(s) [B.01.010.4(1)(g), FDR]

[Tony-C]

Hi Konstantinos,

 

   

 

Your post feels somewhat like an exam question where you are asked how many non-conformances you can find!

 

The sort answer is the supplier is paying complete disregard to allergen management and should be delisted and a new supplier found. At a push consider keeping the supplier if they switch to the dedicated gluten-free (GF) production line but this would be out of desperation given their attitude to allergen management.

 

Regarding advice and references, as you are in the UK here are some links provided to information provided by the Food Standards Agency. There are also some links for Codex Alimentarius, BRCGS, FSSC22000 and SQF.    

 

FSA Precautionary allergen labelling includes:

When precautionary allergen labelling should be used

When precautionary allergen labelling should not be used

Allergen cross-contamination

Minimising risk of allergen cross-contamination

Risk analysis for allergen cross-contamination

Conducting a risk assessment for allergen cross-contamination

Managing unintended allergens in food manufacturing

Managing unintended allergens i the supply chain

Allergen management resources for food businesses

 

FSA Food allergen labelling and information requirements technical guidance includes:

Food allergen labelling and information requirements technical guidance: Summary

Food allergen labelling and information requirements technical guidance: Introduction

Food allergen labelling and information requirements technical guidance: General background on allergens

Food allergen labelling and information requirements technical guidance: Part 1: Guidance for businesses providing prepacked food

Food allergen labelling and information requirements technical guidance: Part 2: Guidance for businesses providing non-prepacked food

Food allergen labelling and information requirements technical guidance: Part 3: Guidance for businesses providing food prepacked for direct sale

Food allergen labelling and information requirements technical guidance: Enforcement of the measures

Food allergen labelling and information requirements technical guidance: Glossary of terms used

Food allergen labelling and information requirements technical guidance: References and Resources

Food allergen labelling and information requirements technical guidance: Relevant Legislation

Food allergen labelling and information requirements technical guidance: Review and contacts

 

A Precautionary Allergen Labelling statement or information [such as ‘may contain’] should only be provided with prepacked or non-prepacked foods if an unavoidable risk of allergen cross-contamination has been identified following a risk assessment that cannot be sufficiently controlled through controls, such as segregation and cleaning.

Its use is not a substitute for good food hygiene and safety practices, and it could be considered misleading food information if it does not convey a real risk to the consumer. A checklist to understand when and how to apply precautionary allergen labelling to food product is provided in this FSA guidance.

 

Codex Alimentarius Code of Practice on Food Allergen Management for Food Business Operators CXC 80-2020

4.1.2 Equipment - 4.1.2.1 Manufacturing

Food manufacturing facilities commonly handle multiple allergens, frequently on the same equipment. Ideally these facilities would be designed to use processing lines dedicated to food with specific allergen profiles and where feasible, manufacturers should consider the use of dedicated lines, however, this is not feasible in all cases.

Production sequencing (i.e. separation by time) should be considered as an option, especially for small businesses. An analysis of the process, including the equipment design, should be conducted to determine the likelihood of allergen cross-contact and whether dedicated processing lines, equipment redesign, or other control measures are needed to prevent or minimise allergen cross-contact.

 

BRCGS - 5.3 Management of allergens

Fundamental

The site shall have a system for the management of allergenic materials which minimises the risk of allergen contamination (cross-contact) of products and meets legal requirements for labelling in the country of sale.

Clause 5.3.4:

Procedures shall be established to ensure the effective management of allergenic materials to prevent cross-contamination (cross-contact) of products not containing the allergen.

 

FSSC 22000 Additional Requirements Version 6 - 2.5.6 Management of Allergens (All Food Chain Categories)

Requirements for a documented allergen management plan that includes:

a) A list of all the allergens handled on site

b) Risk assessment covering all potential sources of allergen cross-contamination

c) Identification and implementation of control measures

d) Validation and verification of these control measures

e) Precautionary or warning labels only used where the outcome of the risk assessment identifies allergen cross-contamination as a risk to the consumer, even though all the necessary control measures have been implemented.

 

SQF Food Safety Code - 2.8.1 Allergen Management (Mandatory)    

2.8.1.1 The responsibility and methods used to control allergens and to prevent sources of allergens from contaminating product shall be documented and implemented.

2.8.1.4 Where allergenic material may be intentionally or unintentionally present cleaning and sanitation of product contact surfaces between line changeovers shall be effective, appropriate to the risk and legal requirements, and sufficient to remove all potential target allergens from product contact surfaces, including aerosols as appropriate, to prevent cross-contact.

Separate handling and production equipment shall be provided, where satisfactory line hygiene and clean-up or segregation are not possible.

 

Kind regards,

 

Tony