Recalls caused by the presence of allergens have seen a steady rise in Europe. The number of RASFF alerts related to allergens has increased each year for the past four years and 2019 looks set to be no different. In the year to end-November, 153 alerts were issued already topping 2018’s total of 138.
So, what is behind this trend?
In a new report, RQA Group stresses that the complex nature of the food supply chain means it is particularly vulnerable to contamination issues.
“Allergen management is multifaceted and requires numerous controls to be implemented effectively throughout the supply chain – from raw material suppliers to final labelling and packing and distribution. Any system is only as robust as its’ weakest link and failure of any one of these controls at any point in the supply chain can result in undeclared allergens and a recall or withdrawal,” the report’s authors stressed.
RQA outlines the ten ‘weakest links’ that commonly contribute to an allergen-related recall and how to safeguard against them.
#1: Training
Insufficient training and a lack of awareness can be a driving force behind rising allergen recalls. RQA stressed that allergen training should be included in the induction process for all new employees – and ‘repeated regularly’ to drive the message home. “Visitors and contractors should receive training appropriate to their site activities before entering production areas."
Training should focus on the ‘implications’ of the presence of undeclared allergens, including the need to manage risk and the role individuals play in reducing cross-contact risk.
“Senior management, marketing, product developers, engineers, operators, production schedulers should all receive general allergen training in addition to specific training related to their allergen management responsibilities,” RQA advised.
#2: Supplier management
Food makers need to have confidence that the information about the allergen status of raw materials and ingredients is correct and complete.
“Always clarify information from suppliers – query anything unusual, don’t accept generic terms and don’t make assumptions. Keep asking questions until you are satisfied with the response – data gaps should not be accepted,” the advisory group suggests.
And as part of a food manufacturer’s due diligence, they should ensure the information provided in specifications, packaging and labels tally.
“Look out for hidden allergens – they are not always obvious.”
#3: Production site and equipment
Allergens should be physically segregated in storage areas, ‘preferably under locked control’.
The physical space of a production facility is important. “Adequate space between production lines and around equipment ensures that cleaning and inspection of cleaning is effective to minimise the risk of allergen cross contact,” RQA noted.
Where ‘practically possible’ production areas or lines and equipment should be dedicated to specific allergen profiles. This includes weighing equipment, and colour coded scoops and other hand-held utensils. And where allergen free claims are made everything – from equipment to personnel and maintenance tools – should be segregated.
Manufacturers also need to consider the risk of airborne contamination and offset this through dedicated air handling units.
And allergens might be hiding where you would least expect.
“Other potential sources of allergenic materials should be risk-assessed. Some examples include peanut oil in lubricants, wheat flour in cardboard packaging release agents, and peanuts in non-toxic internal rodent indicator baits.”
#4: Process controls
Using the wrong ingredient in a recipe should be a ‘never event’. There are a number of control systems that can be employed to avoid mistakes. Manual verification with supervisory cross checks at the point of both weighing up and addition is a low-tech solution. While ‘more sophisticated’ software systems utilising barcode generation and scanning is another option.
RQA continued: “Where physical separation is not possible, cross-contact can be avoided using temporal segregation through production scheduling. Production runs should be scheduled so that products without allergenic materials are produced first after the last full clean, and product produced subsequently have must have increasingly complex but compatible allergen profiles.”
Risks – such as the temptation to adjust the production schedule – must be ‘closely managed’.
#5: Changeovers
Changeovers between products are frequently seen as production downtime or as a non-value adding activity – but this attitude presents a risk factor, according to RQA.
“Management pressure to minimise the amount of time between production runs can result in failures of changeover processes leading to wrong packaging being used with incorrect allergen declarations (another never event), or cross-contamination through inadequate cleaning.”
Thorough and effective changeovers are therefore fundamental to allergen management.
Effective changeovers require:
- Line clearance: Removal of product previously manufactured on the line, ingredients and packaging and the line cleaning.
- Set up: Bringing new ingredients or product and packaging to the line and re-setting equipment such as date-code printers, vision systems, online check weighers and metal detectors.
- Start up: All activities from line clearance and set up should be checked, confirmed and signed off before the next production run begins.
Packing of products into incorrect packaging is one of the main reasons for UK FSA Allergen Alerts.
#6: Cleaning
Effective cleaning must be a fundamental part of any allergen management strategy.
“Cleaning procedures for food contact surfaces should be validated by analysis to ensure that they are effective at removing allergens.
“Environmental cleaning should consider accumulations of settled allergenic material on flat surfaces, e.g. machine guards, windowsills, shelves and cleaning methods should prohibit the use of high-pressure hoses or air blowing that may create allergen containing aerosols or distribute powder or small particulates."
#7: Labelling
Ingredient lists and allergen declarations on products must comply with allergen labelling regulations. For the EU, this is EU 1169/2011. This requires the labelling of the 14 main allergens:
- celery.
- cereals containing gluten – including wheat (such as spelt and Khorasan), rye, barley and oats.
- crustaceans – such as prawns, crabs and lobsters.
- eggs.
- fish.
- lupin.
- milk.
- molluscs – such as mussels and oysters.
“Ensure that there are systems in place to ensure that following a recipe change to a product all old packaging is not only withdrawn from use but destroyed so it cannot be used in error.
“It is good practice to design packaging to clearly differentiate between different varieties of similar products to minimise the chance of incorrect use,” RQA advised.
#8: Labelling for exports
Allergen labelling regulations vary from country to country, and as well as the 14 main EU allergens there are another 10 allergens which may potentially need to be declare. Theses are:
- Buckwheat Beef
- Bee Pollen/Propolis Chicken
- Royal Jelly Pork
- Mango Tomato
- Peach Latex
Check local regulation.
#9: Food preparation for direct sale
From October 2021, the way food businesses in the EU must provide allergen labelling information for food that is Prepacked for Direct Sale (PPDS) will change.
“Foods will need to have a label with a full ingredients list with allergenic ingredients emphasised within it. These changes will provide essential information to help people with a food allergy or intolerance to make safe choices when buying food Prepacked for Direct Sale food,” RQA noted.
#10: Allergen testing
Allergen testing and analysis is complex. RQA suggested that to ensure that analysis undertaken provides the information you need there are some ‘simple rules’ to follow:
- Analysis for cross contact allergens should consider the type of potential cross contact, and involve different time points within a batch, multiple batches, or possibly different production runs.
- A stringent, risk-based ongoing sampling plan should be implemented where any pack claim is made.
- Composite samples dilute the true allergen concentration and report a value that does not represent the level in each individual sample.
- The choice of test kits for use on the manufacturing site or laboratory analysis depends on the required outcome – an unquantified check to verify cleaning or a quantified result to inform a risk assessment.
RQA concluded: “Through a better understanding of the risks, putting an allergen management plan in place to mitigate these weakest links, and carrying out regular allergen risk reviews, you should be able to avoid a costly and brand damaging product recall.”