ISO 22000:2018 Allergen Prevention Requirements
ISO 22000:2018 standard has only mentioned allergens on one
occasion, where it tries to explain food safety hazards, since ISO 22000
considers allergen as a chemical hazard which includes allergens and
radiological substances (3.22, note 2 for entry: Food safety hazards include
allergens and radiological substances). Thus, the ISO 22000 standard has
completely relied on its prerequisite programs to consider non-process
preventive measures while considering process allergens to be considered in the
category of significant food safety hazards. Hence, ISO 22000:2018 broadly
consider allergen as a chemical hazard, without offering specific concerns or
program requirements considered in private label standards such as SQF or BRC.
However, one of ISO 22000 sister standards or the technical specification, ISO
22002-1:2009, specifies requirements for establishing, implementing, and
maintaining an allergen management program. This program is prepared based on
the scientific approach of risk analysis, the HACCP principles, by assessing
allergen hazards. Thus, food manufacturers that have implemented their food
safety systems in alignment with ISO 22000:2005 have already taken actions
towards managing allergens as it is a prerequisite program required by the
international standard, but the new classification of process preventive
controls and non-process preventive controls has been introduced in the current
version of ISO 22000:2018, which has created two types of actions base on the
allergen cross-contact or intentional addition to the existing processes.
Hence, an effective allergen management program depends on the
physical segregation of allergenic foods and ingredients from all other
products and ingredients at every step of the food production process, which
starts from receiving raw materials to delivery of the final product. In
addition to the elimination of unintentional presence of allergens in food
products, education, and training of the staff on food allergen risks,
management and communication must be a top priority for food manufacturers. The
most applicable method is the declaration of allergens present in the product,
either by design or by potential manufacturing cross-contact, which must be
accurately indicated on labels for consumer products, or the accompanying
documentation for products intended for further processing. Consequently,
public health relevant to food allergies continues to grow, where the food
industry has boosted its efforts to maintain the management of food allergens.
Nonetheless, national legislations that regulate the labeling of food allergens
in many countries, other international standards, and voluntary guidelines have
been developed to help organizations effectively prevent food allergen
incidents.
Food Allergies
Food allergies are the inappropriate immune responses generated
due to constituents in the foods that are mostly protein substances causing
allergic reactions when the same food is eaten again. There are many different
types of allergic responses, but the primary concern in food allergen
management is primarily focused on the greatest impact over humans or animals,
where the immune system produces IgE antibodies to proteins in the food.
Nonetheless, food allergy must be differentiated from food intolerance, such as
lactose intolerance, which does not involve the immune system responses.
Food allergic reactions can be varied from very slight to severe
impacts and occasionally fatal, depending on the dose and the individual as
well as other factors, which affect a greater proportion of children than
adults. The reactivity to some allergenic foods, such as milk and egg, tends to
be largely outgrown, while allergy to others, such as peanuts, generally
persists. When an IgE-mediated reaction occurs due to a constituent of food
inside the body, a rapid release of chemicals such as histamine may occur
resulting in symptoms within minutes, but occasionally it may take up to 2 or
more hours after ingestion of the offending food. However, a severe systemic
reaction may occur in rare cases, leading to a sudden drop in blood pressure,
severe constriction of the airways, a generalized shock reaction, and multiple
organ failure, which is known as an anaphylactic shock that can lead to death
within minutes if not treated with adrenaline. There is a small number of
people in each community with such risk of food allergies with serious reactions,
and many documented cases of death resulting from accidental ingestion of an
offending food.
Presently, all the internationally recognized food standards
require (all or some of) peanuts, tree nuts, milk, eggs, lupin, sesame seeds,
fish, shellfish, crustaceans, soy, celery, mustard, Sulphites, and cereals
(wheat, rye, barley) to be declared on labels whenever they are present as
ingredients or as components of food additives or processing aids. Australia
and New Zealand, the United States, the European Union, Canada, Japan, and
other countries have similar requirements for these and other known food
allergens, but the US considers big 8 allergens and the EU has 14 declared
allergens while Canada has 13 priority allergens.
Food allergies affect around 10% of children up to the age of 1,
between 4 – 8% of children aged up to 5 and approximately 2% of adults, and
hospitalization for severe allergic reactions/anaphylaxis have doubled over the
last decade, where there is a five-fold increase for children aged between 0 to
4 years over hospital admissions. On the other hand, food allergies affect
around 2 to 4% of the population in Europe, and an estimated 5-8% of children,
where there is an estimated 10-20 million people suffer from food allergies in
the 500 million population of the 27 EU Member States, who believe they have a
food allergy is considerably higher at around 20% of the same population. Many
children outgrow their allergies, such as those to milk and eggs by the age of
5-7 years. Other allergies, such as to fish and peanuts, tend to persist.
Nonetheless, there is no practical cure exists for food allergy and allergic
consumers must avoid foods that contain the ingredient(s) to which they are
allergic. Hence, individuals with allergic conditions must rely on the
information provided on the label to determine whether the ingredients include
food that may be allergenic.
As for food recalls information, approximately 37% of food
recalls occurred in Australia from 2008 to 2017 were due to undeclared
allergens in the final product and 2% were due to mislabeling, where many foods
recall still occur due to the incorrect labeling of allergens contained in the
food. Hence, the common causes of these recalls can include changes in product
formulation or changes in a supplier’s ingredient formulation.
Furthermore, oral allergy syndrome (OAS) is a form of food
allergy in which people become allergic through inhaling pollen proteins (fruit
and vegetables) and then react to similar proteins in foods, where the symptoms
can only be felt by the allergic person, but severe reactions are extremely
rare. The development of a food allergy or any other allergy depends on complex
interactions between a person’s individual susceptibility and factors related
to exposure and the circumstances in which it occurs. Besides, children born to
allergic parents are more likely to become allergic themselves, as well as most
food allergies, begin in childhood, but onset can also take place later in life.
Coeliac disease is considered as an adverse reaction to foods
involving the immune system, which is an immunologically mediated, non-IgE
reaction to gliadin, a prolamin (gluten protein) found in wheat, and similar
proteins found in the crops of the genus Tritiaceae (barley, rye). Coeliac
disease is considered an autoimmune disorder of the small intestine that occurs
in genetically predisposed people of all ages from middle infancy onward. The
symptoms include chronic diarrhea, failure to thrive at a young age, and
fatigue, where longer-term impacts include osteoporosis and other severe health
effects have been reported.
Food intolerance refers to adverse reactions to foods, which do
not involve the immune system and are not usually the result of inherent toxicity.
However, food intolerance has some characteristic of the food involving
pharmacological activity to the affected individual such as enzyme deficiency
or the cause is sometimes unknown, which is not usually immediately
life-threatening, but such reactions can make the sufferer feel extremely
unwell and can have a major impact on working and social life. They may occur
very rapidly and mimic an allergic reaction, or can develop over many hours
until the offending substance has been removed, e.g. lactose intolerance.
The allergic reactions start with the recognition of the
allergen constituent (protein), where any process that modifies the structure
of a protein will have the potential to affect allergenicity. Thus, food
processing is usually a rigorous process that induces several physicals,
chemical, and biochemical changes, and nonetheless, certain methods may
enhance, reduce, or eliminate the allergenic potential of food while
potentially impact the allergenic potential of proteins. 0n the other hand,
processing can be used to remove the protein fraction of the food that reduces
the exposure to allergens to prevent allergic reactions, e.g. highly refined
seed oils. Such foods have granted exemptions in the labeling legislation, but
there are no general rules regarding how different allergenic foods respond to
physical (thermal, mechanical), chemical, or biochemical processing methods.
Consequently, if there is no sound evidence that a specific processing method
reduces allergenicity, it should be assumed that the allergenic potential of
processed food is identical to that of the food in its unprocessed form.
References:
ISO
22000:2018
https://www.fooddrinkeurope.eu/uploads/press-releases_documents/temp_file_FINAL_Allergen_A4_web1.pdf
https://multimedia.3m.com/mws/media/1648172O/food-safety-anz-edm-allergen-control-plan.pdf
https://erudus.com/14-major-food-allergens-for-eu-food-information-for-consumers/
https://www.iso.org/obp/ui/#iso:std:iso:ts:22002:-2:ed-1:v1:en
