Professional Documents
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e-mail: vesna.gojkovic@yahoo.com
*
Abstract
The share of the population that has symptoms of functioning. However, some products can contain
intolerance or allergic reactions to food is increasing. substances which cause so called “unwanted reactions”
Having in mind diversity of food ingredients, consumers in an organism. These reactions are numerous and can
are increasingly demanding avoidance or clear label- be manifested in various ways. The most frequent un-
ling of these substances, thus a challenge faced by the wanted reactions to food are allergic reactions. They
producers and distributors of food products is great. are a reaction of an immune system to the presence of
certain food ingredients (proteins most often), which,
This paper presents a developed allergen management
if taken into an organism, are capable to cause an un-
system in the production and packaging of powdered
wanted reaction [1]. Food can cause different types
food products with different allergens contained. The
of reactions, but the most important ones are those
key elements of established system are related to ef-
which influence the immune system causing it to start
fective planning of production, cleaning of production
producing IgE antibodies.
lines, separation, and proper food product labelling.
It is estimated that 2 - 4% of population in Europe is
Verification procedures for implemented allergen
allergic to food. Data about young population are even
management system and possible cross-contamina-
more unfavorable: 5 - 8% of children show some kind
tion was performed by ELISA method. The following
of allergic reactions to food. 10 - 20 million people in
ELISA methods were carried out: ridascreen 7100, ver-
the European Union are highly sensitive to certain
atox 8410, veratox 8470, respectively gluten, soya, and
types of food. There are estimates which say that 20%
milk allergens. Established methods for the validation
of total European population is allergic to food [2]. In
of allergen management system showed that the sys-
European White Book on Allergy [3], it is stated that in
tem is set up effectively.
the period between 1960 and 1970 number of persons
Established verification procedures in the allergen with atopic allergy symptoms rose by 100%, and in the
management system confirm that system implemen- period from 1980 to 1997 number of people suffering
tation is performed according to the defined plans and from it rose 2 - 3 times in all European countries. Cur-
that with the application of other prerequisite pro- rently, 25 - 30% of people in Europe suffer from some
grams, this system guarantees that the allergen con- form of allergy (5 - 8% adults and 10 - 15% children).
tamination of food products is reduced to a minimum.
Most allergic reactions to food disappear in most chil-
dren aged 5 - 7. In rare cases (reactions to peanut or
Key words: Food allergens, Allergen management, fish) reactions are long-lasting. In practice there are no
Prerequisite programs. medicines for food allergies, because of which most
individuals have to avoid food which contains ingre-
dients causing allergic reactions [4, and 5]. Expenses of
1. Introduction
treatments of patients sensitive to food allergens are
Food products should ensure adequate intake of nu- very high (for example, 29 billion euros are spent in
tritional ingredients necessary for human organism Western Europe) [2].
76
Journal of Hygienic Engineering and Design
Symptoms of allergic reactions include one or more of Food allergies can be mild but unpleasant, but also can
the following problems: have serious consequences with fatal ending for those
• skin problems (nettle rash, itching, dermatitis, ecze- who ate food which contained potential allergens.
ma, conjunctivitis, swelling of lips, problems inside Every process influencing the change of protein struc-
the mouth), ture can potentially cause an allergy [16]. Processes
• respiratory problems (asthma, breathing difficulties, during food production and processing induce more
rhinitis, throat swelling) and physical, chemical and biochemical proteine changes
• gastrointestinal problems (nausea, stomach ache, influencing the protein potential to become allergenic.
vomiting, diarrhoea). Certain procedures in food industry can increase, de-
crease and totally eliminate this property of proteins
In some cases reactions can lead to sudden fall in blood [17]. In order to prevent an allergic reaction in some
pressure, narrowing of reaspiratory airways, shock re- cases it is enough to eliminate certain fractions of pro-
action and failure of some organs [4]. In the most se-
teins from a product. Effectiveness of conducted ac-
vere cases this can lead to death within one minute.
tivities can be very effectively tested by using fast test
An example of illness caused by allergy to food ingredi- methods [18].
ents is celiac disease. Celiac disease is an autoimmune
The most common advice to the allergic persons is
disorder caused by the presence of gliadine, i.e. prol-
to avoid consuming food which contains allergens.
amin (protein gluten) which can be found in wheat
At first sight it seems simple, but the fact that allergic
and similar grains, which is not IgE mediated. Problems
people react to small amounts of allergens and that
are manifested as a disorder in functioning of intestine
most common causes of allergies (milk, eggs, wheat,
in genetically predisposed people. It is estimated that
nuts) are present in a large number of food products,
1% of people worldwide show symptoms of celiac dis-
makes avoiding allergens complicated and lasting.
ease [6]. Special attention is paid to allergy testing of
genetically modified food [7, 8]. In the goal of efficiacy in protecting products and con-
sumers from the presence of allergens, it is necessary
Allergy to milk proteins is frequent with infants young-
er than 3 years. It happens in 3% of children. When to apply higher procedures, known as Good Manufac-
they are older 70 - 90% of children become tollerant turing Practice (GMP), during the whole supply and
and age out of allergies [9]. production chain (origin of raw materials, factory and
equipment design, hygiene in production processes,
Food which can cause allergic reactions in sensitive in- handling food, storaging, transport of productas, clean-
dividuals can be different. The most common causes of ing, personal hygiene). When the same equpment is
allergies are: grains that contain gluten, milk, chocolate, used during production of multiple products, and only
eggs, peanuts, nuts, fish, molluscs, soybean, crustacea, one can contain allergens, special measures have to be
sesame seeds, celery, SO2 [10, 11, and 12]. These eight taken to prevent the presence of allergenes and con-
food products cause more than 90% of all allergic reac- tamination of other products with key allergenes.
tions to food. Allergic reactions to soybean, milk, eggs
and flower are most common in children and they usual-
ly become less sensitive to this food eventually [13, and 2. Materials and Methods
14]. Allergies to crustacea (shrimp, crab, lobster, etc.) and
fish usually develop in adulthood, whereas allergies to This paper presents part of activities undertaken in
peanuts and nuts equally affect children and adults, and one company, which deals with production and pack-
last throughout life. Proteins from leguminosas, among aging various powdery materials, with the goal to pre-
which are soybean proteins, have special status when it vent the presence of allergens in final products. During
comes to the attention that has to be paid while eating. the analysis of risks caused by allergens, assessment
Out of 34 proteins with antigene behaviour in soybean of the risk regarding the presence of allergens in the
flower, 17 are IgE reactive and are allergens [15]. Milk ingredients themselves was done as well as the possi-
of differend kinds of mammals, except for camel milk, bility of cross-contamination using the same process
has identical proteins which have similar immunologi- equipment for the production of food with and with-
cal properties. In literature, information can be found out allergens. Analysis was performed regarding 14 al-
saying that goat, horse, donkey milk have certain prop- lergens which are known as the most common sources
erties due to which they can be used as a material for of intolerance, either as ingredients or as supplements
production of anti-allergy products. in the food production process. Analysis was done re-
garding the following allergens:
Special attention is paid to a large number of addi-
tives which can be found in food, especially additives 1. Grains that contain gluten, which are: wheat, rye,
acquired through different biotechnical procedures. barley, oats, spelt and durum wheat or their hybrids
These substances are responsible for causing allergic and products, except:
reactions in sensitive people.
77
Journal of Hygienic Engineering and Design
(a) glucose syrups based on wheat, including dextrose; 3. Results and Discussion
(b) wheat derived maltodextrin;
3.1 Managing allergens in production process
(c) glucose syrup based on barley;
(d) grains used in production of alcohol destilates in- Food manufacturers are responsible for the safety of
cluding ethyl alcohol of agricultural origin. their products. This also refers to the presence of aller-
2. Crustacens and crustacean products. gens in products [1, 22 - 30]. Three phases of allergy
management strategy are being shown in this paper:
3. Eggs and egg products.
identification, separation and labelling. In order to pre-
4. Fish and fish products, except: vent residues in finished products, a comprehensive
(a) fish gelatin used as carrier for vitamin or carotenoid control plan has been made (Table 1). The plan includes
preparations; allergen identification, ingredients control, packing, la-
(b) fish gelatin or fish bladder gelatin (isinglass) for clar- belling, planning the order of manufacturing different
ification of beer and wine. products on the same lines, effective cleaning and staff
5. Peanuts and peanut products. training.
6. Soybeans and soybean products, except: The first step was to identify key allergens. They are the
(a) completely refined soybean oil and fat; most common cause of food allergies (gluten, eggs,
(b) natural mixed tocopherols (E306), natural D - alpha milk, soy, peanuts, walnut and other kinds of stone fruit
tocopherol, natural D - alpha tocopherol acetate, like hazelnut, almond, cashew, then shrimp, shellfish,
and natural D - alpha tocopheryl succinat from soy- celery, sesame, lupine, mustard, sulphur dioxide (Table
bean; 2). Raw materials and procedures during processing
(c) extracted phytosterol and phytosterol ester from and storage were analysed in the second phase in or-
soybean oil; der to determine products which are produced on the
(d) vegetable stanol ester produced from sterol in soy- same plant lines and contain key allergens.
bean oil.
At all levels of food production, food processing, food
7. Milk and milk products (including lactose), except:
storage and use, additional control was introduced in
(a) whey used for alcohol destilates including ethyl al-
order to prevent cross-contamination with raw materi-
cohol of agricultural origin;
als or residual allergens during production as well as to
(b) lactitol.
inform consumers on presence of allergens in traces if
8. Nuts: almond (Amygdaluscommunis L), hazel (Co-
there is a slightest possibility for it. In order to confirm
rylusavellana), nut (Juglansregia), cashew nut (An-
that their products do not contain allergens, compa-
arcadiumoccidenatle), pecan nut (Caryaillinoinensis
nies have to make sure that none of the products con-
(Wangenh), brazil nut (Bertholletiaexecelsa), pista-
tain ingredients which act like allergens and that none
chio (Pistacia vera), macadamia or Queensland nuts
of the products cause slightest risk of cross-contamina-
(Macadamiaternifolia) and their products, except
tion during production or packing in plants where oth-
nuts used for production of alcohol destolates in-
er products that contain allergens are being processed.
cluding ethyl alcohol of agricultural origin.
9. Celery and celery products. GMP starts with detailed analysis of raw materials and
suppliers (Table 3). The attention is being paid to the
10. Mustard and mustard products.
estimate of presence of peanuts and walnuts which
11. Sesame and sesame products. have been used as a raw material in other products
12. Sulphur dioxide and sulphite with a concentration processing. Supplier has to provide information on
greater than 10 mg/kg or 10 mg/L expressed as usage of raw materials which carry allergens in sup-
total SO2 regarded as products intended for con- plier’s plant (Table 3). Suppliers are obliged to inform
sumation as such or as a reconstituted product in the company about the allergens present even in very
accordance with manufacturer’s instructions. small amounts, for example the amounts that are suffi-
13. Lupin and lupin products. cient for an ingredient to be a precursor of taste.
14. Molluscs and mollusc products [19, and 20]. The company’s authorities must particularly asses
the risk of cross-contamination of products which are
Within the GMP used in the company, various activi- packed on the same lines in the same facility In all cases
ties regarding identification, separation and marking where there is a risk of cross-contamination, producers
of allergens have been done, which are in accordance give information about it in a product label (Figure 1).
with current regulations [21]. As an example of GMP in
production process of finished products labelled as “al- Appropriate measures have been undertaken in the
lergen free products”, an overview of activities for the production facilities and storage rooms in order to en-
production of the following products was given: vege- sure their traces do not contaminate other products
table food supplement, pudding powder with vanillin and raw materials during transport of raw materials
flavour and powdered sugar. in the production facility. Raw materials containing
78
Journal of Hygienic Engineering and Design
Table 1. Plan for production of powdered products with the instruction for prevention of cross-contamination
When receiving raw materials from suppliers, the Allergen Statement which clearly shows which
allergens are present in the raw materials or which allergens may be present in traces, must be submitted
by suppliers.
Allergen Statement must be in accordance with the Rulebook on the provision of food information to
Supply of raw consumers (‘The Official Gazette of B&H’, no. 68/13) or EU regulation 1169/2011 on the provision of food
materials information to consumers
Information on allergens must be stated on product labels for products for which supplier mentioned in
the Allergen Statement that they contain allergens or that allergen presence is possible in traces.
Products from recall are specifically labelled as raw materials for internal use only and are being kept
separate from other raw materials.
Storage Raw materials that contain allergens should be stored separately in the lower part of the warehouse.
During production planning, always plan activities on the development of products from the "sweet
program” separately from activities on the development of products from the "salty program."
During production planning, be sure to take into account the procedures for preventing crossing of the
products that contain allergens with products that do not contain them and with products which do
not have information on presence of allergens labelled.
In the plant for production of powdered and granular products, products containing following allergens
are being produced:
o Celery (vegetable food supplements, soups),
o Gluten (wheat semolina, wheat crumbs, white -kernelled wheat, soups)
o Sesame (sesame),
o Milk (whipped cream, ice-cream desert, hot white chocolate),
o Soy (chocolate pudding, whipped cream chocolate, chocolate ice-cream dessert, stracciatella
ice-cream dessert, Boni quick, classic Hot Chocolate, Hot Chocolate-flavoured hazelnut)
o Nuts (hazelnut, almond).
The nutrition facts table must include information on the content of allergens according to the
legislation.
To avoid cross-contamination, plan the production in such way to enable continued production of
products containing the same allergen.
After completion the production of products with allergens, perform washing of machines and
Production of equipment that have been in contact with the product according to the plan of plant hygiene.
powdered and
Moving to production of other product, which does not contain allergens or which will not be labelled
granulated
with information on the possible presence of allergens, is done with the obligatory records of sequence
products
of production.
Exceptionally, when making ‘Vegetable Food Supplement, at the same time, in the same plant, yet on
a different equipment, products from a ‘salty program’ can be produced (rice, wheat, popcorn, pepper,
paprika, bay leaves, oregano ,soda, citric acid preservative, potassium met-bisulphate, soup or baking
powder.
If, for some reason, dust is formed on machines where the product containing allergen is produced,
making all other products should be discontinued, and machine shut down.
Mixer is being washed upon completion of the product containing allergen, after the end of production
of non-ferrous products, after completion of the production of products with distinctive flavour, and
after production of baking powder.
Mixer does not need to be washed if vanilla sugar or vanilla pudding were mixed in it and followed by
any other product from the sweet program. Mixer should be air dusted.
Mixer does not need to be washed if chocolate pudding was mixed in it and followed by any other
chocolate product.
Weekly plan for pudding production should predict that light puddings are produced at the beginning
of the week, and dark puddings at the end of the week.
Weekly plan for cream production should predict that light creams are produced at the beginning of the
week, followed by dark creams and chocolate creams come at the end of the week. Plan should include
that production of ‘coffee cream’ must be last.
Product label of product containing allergens must clearly indicate the allergens. In case there is a risk
Product labelling
from cross-contamination, product label must indicate there is a possibility of presence of allergens.
Storage and Products that contain allergens should be packed in sealed containers, stored in separate rooms and
transport transported separately from products without allergens.
79
Journal of Hygienic Engineering and Design
expressed as SO2
Product
Question
name
Is the presence
of the following
allergens possible NO NO NO NO NO NO NO NO DA NO NO NO NO NO
in ingredients or in
product?
Is the presence
Vegetable
of the following
food
allergens possible
supplement NO NO NO NO NO YES YES NO NO NO NO NO NO NO
in other products
made on the same
line?
Is it necessary to
state the presence NO NO NO NO NO NO NO NO YES NO NO NO NO NO
of allergen?
Is the presence
of the following
allergens possible NO NO NO NO NO NO NO NO NO NO NO NO NO NO
in ingredients or in
product?
Pudding Is the presence
powder of the following
with vanillin allergens possible
NO NO NO NO NO YES YES NO YES NO NO NO NO NO
flavour in other products
made on the same
line?
Is it necessary to
state the presence NO NO NO NO NO NO NO NO NO NO NO NO NO NO
of allergen?
Is the presence
of the following
allergens possible NO NO NO NO NO NO NO NO NO NO NO NO NO NO
in ingredients or in
product?
Is the presence
Powdered
of the following
sugar
allergens possible
YES NO NO NO NO YES YES NO YES NO NO NO YES NO
in other products
made on the same
line?
Is it necessary to
state the presence NO NO NO NO NO NO NO NO NO NO NO NO NO NO
of allergen?
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Journal of Hygienic Engineering and Design
Table 3. Example of description of raw materials and the allergens must be transported in sealed containers
assessment of presence of allergens with information that they should not be mixed with
From internal other ingredients. A convenient method for identify-
Presence or From
cross- ing compounds that contain allergens and their sepa-
absence of allergens Recipe*
contamination ration from other materials, which are used in compa-
Eggs/products of these - - nies, is to label packaging with different colours. High
risk allergens (e.g. walnuts and raw materials which
Peanuts/products contain walnuts) are kept in locked storage room and
- -
of these are available only to authorised people.
Fish/products of these - - Different products are being produced on the same
Gluten/products lines. Work plan in a company strives to decrease the
- -
of these risk of transferring allergens from one product to an-
Crustaceans/products other. After one product has been processed, detailed
- - cleaning is performed (Table 4). Only after the efficien-
of these
Lupine/products cy of undertaken measures has been checked, other
- - product can be processed. Products that contain aller-
of these
gens are processed at the end of the day, i.e. just be-
Milk (incl. lactose)/
+ n. a. fore the detailed cleaning of machines and facility thus
products of these
lowering the risk of transferring allergens.
Nuts/products of these - -
The company uses fast methods to determine how
Celery/products successful cleaning was and sometimes samples are
- -
of these sent to the certified laboratory for quantitatively deter-
Mustard/products mination of the amount of allergens in products and
- -
of these for verification of the results (Table 5).
Sesame/products
- - Special precautions are taken during the reception of
of these
the product form recall and their reprocessing. Such
Soy protein/products products are clearly labelled as raw materials for inter-
- -
of these
nal use only and precautions are taken when they are
Sulfite (concentration used as a raw material.
- -
> = 10 mg/kg)
Additional problems in plants are powdered raw ma-
Molluscs/products
of these
- - terials and powdered final products (powdered raw
materials and products, dust and similar). Such sub-
Legend:
+ = present, stances can be airborne into other parts of the plant
- = absent, ? may contain traces Based on EU legislation and in such way they can contaminate products with
* = allergen from recipe (04 Glucose syrup from wheat? No labelling allergens [25]. Additional measures are taken in the
acc. to 2011/1169/EC)
plant to prevent transfer of allergens through clothes
General remark:
- Production locations are allowed to use alternative methods as into other rooms.
long as they are validated against the given international approved
methods.
Besides risks relating to products which contain aller-
- Additional information regarding legal status, application and han- gens, there are risks relating to the staff being aller-
dling of the product will be supplied on request. gic to certain ingredients. In this case, it is necessary
to prevent every contact of an individual person with
allergens and substances which contain allergens. Vis-
itors to a plant must be informed on risk and advised
not to enter certain part of a facility where allergens
can be present even in traces.
81
Journal of Hygienic Engineering and Design
82
Journal of Hygienic Engineering and Design
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