What Is Allergens?
Allergen analysis is the detection of allergenic ingredients that are not intentionally added to the product but may have passed through cross-contamination. The most common method is ELISA targeting the allergenic protein; When species discrimination is required, PCR targeting the DNA of the component is used.
Purpose of Allergens
The aim is to provide the basis for claims such as 'gluten-free', to verify the effectiveness of cleaning and line separation measures, and to assess whether the 'may contain' warning on the label is actually necessary.
Which Products Is Allergens Applied To?
- Products declared gluten-free
- Chocolate, biscuits and bakery products
- Ready meals and sauces
- baby foods
- Production line cleaning swabs and rinse waters
In Which Sectors Is Allergens Used?
Standards Related to Allergens
- AB 1169/2011 Ek II (alerjen listesi)
- AOAC 2012.01 (gluten — ELISA, R5 antikoru)
- ISO 21571 (nucleic acid extraction in food)
- Turkish Food Codex Labeling and Consumer Information Regulation
Allergens Conditions
- Method
- Protein-targeted ELISA; real-time PCR for species discrimination
- Scope
- Gluten, milk (casein/β-lactoglobulin), eggs, soy, hazelnuts and nuts, sesame, mustard, fish and shellfish
- Sample preparation
- Homogenization and allergen-specific protein/DNA extraction
- Quality control
- Positive and negative controls; matrix effect control
Equipment for Allergens
- Analytical balance and homogenizer
- Sample preparation apparatus (extraction, filtration, concentration)
- Kromatografi veya spektrometri sistemi
- Temperature controlled storage and conditioning cabinets
Sample Requirements for Allergens
- The sample should be taken to be homogeneous and representative of the lot.
- For analytes that are sensitive to light or oxygen, a dark colored and tightly closed container should be used.
- The sample amount varies with the number of analytes; If more than one analysis is requested, the total amount increases.
- The product name, list of ingredients and declared value, if any, must be provided with the sample.
Duration of Allergens
ELISA results can be obtained within one business day. PCR-based studies take slightly longer due to extraction and validation.
Allergens Procedure
- 1The sample is homogenized to prevent contamination.
- 2Protein or DNA appropriate to the allergen is extracted.
- 3Transferred to ELISA plate or PCR reaction.
- 4Calibration standards and controls are worked together.
- 5The measurement is taken and the result is calculated.
- 6The result is reported in mg/kg or as detected/not detected.
Allergens Acceptance Criteria
The legislation, not the method, determines whether the result will be considered appropriate or not. The relevant communiqué of the Turkish Food Codex, EU 2073/2005 and 1881/2006 and the specification of the buyer company define different limits depending on the product group; The report gives the measured value and takes the limit from the applicable legislation.
Evaluation of Results
The 'gluten-free' declaration for gluten is regulated by EU 828/2014 and is based on a numerical threshold; There is no generally accepted threshold for other allergens. Therefore, the result is interpreted together with the business's allergen management plan and risk assessment.
Allergens Report
- Sample description, batch/lot information and arrival conditions
- Sampling method (if taken by the laboratory)
- Applied analysis method and reference standard
- Analysis date and incubation conditions, if any
- Result and its unit
- Measurement uncertainty (if requested)
- A statement that the result applies only to the specimen submitted for testing
Accreditation
EUROLAB holds internationally recognised accreditation obtained from accreditation bodies party to the IAF and ILAC multilateral recognition arrangements, under ISO/IEC 17025 for laboratory testing, ISO/IEC 17020 for inspection and surveillance, and ISO/IEC 17021-1 and ISO/IEC 17065 for system and product certification. This chain ensures the reports and certificates issued are accepted worldwide.
Whether this test can be offered within accredited scope depends on your product and the standard applied; since accreditation is method-based, the scope is confirmed in writing at the quotation stage.
Scope and authorisationsRelated Regulations
- Turkish Food Codex Regulation and related product communiqués
- EU 1881/2006 — maximum limits of contaminants in food
- Turkish Food Codex Labeling and Consumer Information Regulation
Food Testing — What Does This Testing Field Cover?
The section below describes the field that the Allergens test belongs to; the conditions and acceptance criteria of this particular test are given in the sections above. The scope specific to your product is confirmed in writing at the quotation stage.
Food testing shows that a product is safe for consumption and contains what its label states. The family works along three axes: microbiological safety, chemical safety and nutritional composition. All three require different laboratory infrastructure, a different body of methods and a different turnaround time.
The most distinctive feature of the field is TIME PRESSURE. A steel specimen can wait on a shelf; a raw milk or fresh meat sample cannot. The time the sample was taken, the transport temperature and how long it takes to reach the laboratory directly determine the validity of the result. In food microbiology the cold chain record is therefore an inseparable part of the test report.
On the microbiological side there are two different questions and they must not be confused. DETECTION of a pathogen is a qualitative question: is Salmonella present in the sample or not? ENUMERATION of indicator organisms is a quantitative question and an indicator of production hygiene. The absence of a pathogen in a product does not show that hygiene is good; if the total mesophilic aerobic count is high, there is a problem in the process.
On the chemical side, pesticide residues, mycotoxins, heavy metals, additives, veterinary drug residues and process contaminants (acrylamide, furan, PAH) are measured. Multi-residue methods in this area (QuEChERS-based LC-MS/MS and GC-MS/MS) can screen hundreds of active substances in a single analysis; limits are defined separately for each product–substance pair.
On the composition side, protein, fat, moisture, ash, fibre, sugar profile, fatty acid composition, vitamin and mineral content are determined. These values are the basis of the nutrition declaration on the label and the tolerance ranges are defined in legislation — the difference between the declared value and the measured value must stay within that tolerance.
There is NO CE marking on food, and this shapes how the field works. Conformity is demonstrated through operating a HACCP-based food safety system, complying with labelling rules and not exceeding contaminant, residue and microbiological limits. A test result produces evidence not for a certificate but for a functioning system.
Allergen management carries particular weight. The presence of an undeclared allergen in a product is one of the most frequent causes of food recalls. Analysis here runs together with cleaning validation: it is shown that the line has been cleaned adequately after a production run containing an allergen and that the risk of cross-contamination is under control.
Voluntary schemes have become effectively mandatory in this field. Retail chains require their suppliers to hold a certificate under a GFSI-recognised scheme (BRCGS, IFS, FSSC 22000); without it, getting onto the shelf is practically impossible.
Method groups in this field
Pathogen detection
Detection of Salmonella, Listeria monocytogenes, Campylobacter, Cronobacter and Shiga toxin-producing E. coli; culture-based and molecular methods.
Indicator counts
Total mesophilic aerobic count, Enterobacteriaceae, coliforms and E. coli, coagulase-positive staphylococci, yeasts and moulds, lactic acid bacteria, sulphite-reducing Clostridia.
Pesticide and veterinary residues
Multi-residue screening by LC-MS/MS and GC-MS/MS with QuEChERS extraction.
Mycotoxins and contaminants
Aflatoxins, ochratoxin A, deoxynivalenol, patulin; heavy metals (ICP-MS), acrylamide and PAH compounds.
Nutritional composition
Kjeldahl protein, fat and fatty acid profile, moisture, ash, dietary fibre, sugar profile, vitamin and mineral analyses.
Allergens and authenticity
Gluten, milk, egg, nut and soy allergen analyses; molecular methods for species identification and adulteration detection.
Commonly confused in this field
- Sampling is half the result. A sample transported at the wrong temperature or delayed gives an invalid result even if it is analysed correctly in the laboratory.
- The absence of a pathogen does not show that hygiene is good; indicator counts give separate information and the two are read together.
- A result from a sample taken from a lot can be generalised to the whole lot only if the sampling plan was set up statistically.
- Limits are defined in separate regulations by product group and are updated regularly; a conformity decision based on an outdated limit table may be wrong.
- For exports, the limits of the destination country may differ from EU limits; the same product may be compliant in one market and non-compliant in another.
Which decisions these results support
- Verification of the HACCP plan and process monitoring
- The basis for the nutrition declaration and allergen information on the label
- Health certificates before export and compliance with destination market limits
- Supplier and lot-based acceptance control
- Shelf-life studies and determining storage conditions
- Producing evidence for audits under GFSI-recognised schemes
Related Tests
Frequently Asked Questions About Allergens
Can the 'May contain' warning be removed by analysis?
Not with a single analysis result. Necessity of warning; It is based on a risk assessment consisting of line separation, cleaning verification, supplier control and iterative analysis.
How to choose between ELISA and PCR?
It is the protein that causes the allergic response; therefore the primary choice is ELISA. However, when heat treatment degrades the protein or species separation is required, PCR provides complementary information.