Undeclared Allergen Incident & Investigation Protocol Guidelines & checklists for allergen investigations at retail/foodservice, manufacturing and food import businesses


REQUIREMENTs OF the food standards code



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5.2REQUIREMENTs OF the food standards code

Individuals with food allergies rely on allergen declaration information to make decisions about the foods they buy and consume. Food businesses are required to comply with Standard 1.2.4 of the Code which specifies the requirements for the labelling of ingredients in foods. In addition to this requirement, Standard 1.2.3 Clause 4 of the Code, specifies requirements for mandatory declarations of the main allergens (as listed in the table to clause 4)


4 Mandatory declaration of certain substances in food

  1. The presence in a food of any of the substances listed in the Table to this clause, must be declared in accordance with sub clause(2), when present as –

(a) an ingredient; or

(b) an ingredient of a compound ingredient; or

(c) a food additive or component of a food additive; or

(d) a processing aid or component of a processing aid.

 

(2) The presence of the substances listed in the Table to this clause must be –



(a)  declared on the label on a package of the food; or

(b) where the food is not required to bear a label pursuant to clause 2 of Standard 1.2.1 – 

(i) declared on or in connection with the display of the food; or

(ii) declared to the purchaser upon request; or 

(c) displayed on or in connection with food dispensed from a vending machine.

Table to clause 4


Added Sulphites in concentrations of 10 mg/kg or more

Cereals containing gluten and their products, namely, wheat, rye, barley, oats and spelt and their hybridised strains other than where these substances are present in beer and spirits standardised in Standards 2.7.2 and 2.7.5 respectively

Crustacea and their products

Egg and egg products

Fish and fish products, except for isinglass derived from swim bladders and used as a clarifying agent in beer and wine

Milk and milk products

Peanuts and peanut products

Sesame seeds and sesame seed products

Soybeans and soybean products

Tree nuts and tree nut products other than coconut from the fruit of the palm Cocos nucifera

Standard 1.2.3 also sets mandatory advisory and declarations for the presence of bee pollens in food (Clause 2); and warning statements for the presence of royal jelly in food (Clause 3).


It is the responsibility of the food supplier (e.g. importers, manufacturers, retailers and service providers) to:

  • declare allergens on the label (usually in the ingredient list),

  • display information about allergens next to food on sale (if food is not packaged), or

  • provide information about allergens in food if requested by a customer



6PROCEDURES

6.1Assess Food Allergen Complaint


Allegations of an undeclared allergen in food should be initially assessed as a serious (high risk) complaint due to the potential threat to human health and safety. When deciding whether to initiate a full investigation, the timeliness, motivation and plausibility of the complaint should be considered.
Record all relevant details including (refer to standard investigation protocol):

  • Name, address and phone number of the complainant

  • details of the complaint including the circumstances of the event

  • details of the food product in question including date marks/batch number, contact details of manufacturer listed on the label, customer order

  • details of the location, date and time of purchase

  • details of other people involved in the incident

  • any other relevant information

For circumstances where there is left over food arrange for the collection of the food and associated packaging if applicable as soon as possible.


Although most complaints will require investigation, the following options should be considered:

  • initiate full investigation (continue to 6.2)

  • advise manufacturer/vendor and request a response to the complaint

  • take no further action

6.2Investigation


The following considerations should be taken during an allergen investigation:

  • timeframe

  • premises and authority

  • key questions

  • sampling for evidence and evaluation



6.2.1Timeframe


Since the alleged presence of an undeclared allergen poses a significant risk to public health and safety, it is recommended that the investigation commence upon receipt of the complaint where possible.

6.2.2Premises and authority


Identify the location of the premises. Inform the vendor, manufacturer or importer and advise them of the complaint. The inspection should be conducted as soon as possible, to reduce the risk of further incidents occurring and to protect public health and safety. If the manufacturer or importer is located within a different jurisdiction, the complaint should be immediately referred to the food regulatory authority responsible for that area.

6.2.3Key questions


Checklists are provided in the attachments of this document. The checklists are intended to be used as guidance material for allergen investigations in the following sectors:

  • Retail/food service

  • Manufacturing

  • Imported food

Each checklist covers the following areas for investigation:




  1. Statutory Requirements for Allergen Investigations



  1. Allergen Investigation Assessment

    1. Supplier management and product receipt

    2. Food storage

    3. Food processing

    4. Cleaning and sanitising (where applicable)

    5. Food display (where applicable)

    6. Food packaging (where applicable)

    7. Product distribution




  1. Sampling/evidence.

Each checklist also has a Food Product Allergen Investigation Table. The table is to be used as a tool by the authorised officer to audit individual food products suspected of containing undeclared allergens.
The checklists are designed to assist officers in determining the source of the undeclared allergen to prevent a further incident occurring and to gather evidence of breaches in the relevant standards of the Code and the Food Act.
Possible ways an allergen incident may have occurred:

  • Labelling and disclosure – allergen containing food not labelled or information not given to customer when requested

  • Miscommunication between staff (e.g. waiting staff did not communicate the customer requirement to the kitchen)

  • Poor process control measures (e.g. cross-contamination of allergens during preparation, storage)

  • Inadequate or incorrect labelling from supplier

  • Changes in recipe and/or ingredients

Documented policies and procedures in relation to allergen control are not mandatory requirements under the Code. However, it is recommended that businesses have or are encouraged to have in place, documented allergen control policies and procedures in which they are complying with. Having allergen control policies and procedures in place allows a business to demonstrate that they are taking all necessary steps to prevent the likelihood of food being contaminated with an allergen. Documented policies and procedures and the compliance with these also provides an opportunity for businesses to demonstrates adequate skills and knowledge in allergen control and reduce the risk of an allergen incident occurring.


Enforcement agencies should also recognise that during investigations, the source of the allergen contamination (undeclared allergen) may have occurred from food supplied or manufactured by other food businesses. Enforcement agencies should always conduct further investigations at suspected food businesses in a timely manner to prevent a further incident occurring. If further inspections are required of premises outside the enforcement agencies jurisdiction or authorised functions, the complaint investigation should be referred to the relevant state or territory enforcement agency for action.

6.2.4Evidence


Obtaining evidence is a crucial part of the investigation. It is recommended that a range of evidence is collected including samples of the implicated food, photographic and documentary evidence. Food samples are critical in determining the allergen status of a food and for evidential purposes. For circumstances where there is left over food, submit it to the laboratory for analysis.
In addition to any leftover food, consideration should be given to taking samples of:

  1. The implicated food – where possible obtain samples of food from the same batch as well as food from an alternative batch. Samples may be obtained direct from retail outlets or obtained from the manufacturer, importer or retail/foodservice business at the time of inspection. Obtaining a sample of food at the foodservice business/manufacturer immediately after processing can assist in validating their relevant process(es) for allergen control.

  2. Individual ingredients from the manufacture/preparation of the implicated food

Photographic evidence should be taken where ever possible. Key areas for photographic evidence include;



  1. The alleged allergen-containing food, as well as packaging (if any)

  2. Menus, recipes/product specifications, allergen control policy/procedures, signage

  3. Storage, processing, packaging/labelling and display areas

  4. Product samples and environmental swab sites

Examination of records/documents at the time of inspection is critical. All relevant documents should be copied or photographed. Examples of records/documents which should be examined and obtained include;

  1. Any allergen control policy/procedures and relevant training records

  2. Complaint records

  3. Supplier agreements/correspondence in relation to allergen status of ingredients/food products

  4. Product specifications/menus/display signage/advertisements

  5. Process verification and validation records e.g. food safety program records, food sample analysis results

  6. Food receipt/processing/cleaning/packaging records

  7. Food labelling templates/drafts and approvals

  8. Invoices of sale

  9. Shipment/import records, custom declarations




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