Soy

Regulatory Requirements of Soy

Soy is recognized as one of the major allergens worldwide. In the European Union, soybeans are included in the list of the 14 allergens that must be declared on food labels according to regulation (EU) No 1169/2011. Internationally, soy is also classified among the so-called big 8 allergens, as identified by the WHO/FAO.

Importance of Soy and Rising Allergy Cases

The soybean (Glycine maxima) belongs to the legume family and contains over 35 % protein, making it a crucial plant-based protein source for human consumption. Products such as soy sauce, soy milk, tofu, miso, and tempeh are increasingly popular. Soy is also widely used for oil production and the manufacture of the emulsifier soy lecithin. With the growing presence of soy products in the market, there has been a parallel increase in soy allergies globally. The increased use of soy in food production can lead to accidental cross-contamination of foods.

Allergenic Proteins in Soy

Even small concentrations of approximately 10 mg of soy protein (WHO/FAO) can trigger allergic reactions. Therefore, soy allergens are subject to labeling in many countries. The allergenic proteins of soybeans are identified as Gly m1 to Gly m6, with ß-conglycinin (Gly m5) and the heat-stable glycinin (Gly m6) being the main storage proteins. Analysis of soy proteins in soy-free foods is essential in order to safe soy allergic consumers.

Which Soy Detection Method to Choose – Lateral Flow Test, ELISA or PCR?

We offer a broad range of soy test kits – but which method to choose? Which soy detection method is the right choice for your needs? We have summarized the different options for you.

Soy Lateral Flow Devices (LFD’s)

LFDs offer a fast, simple, and cost-effective solution to manage the risk of soy cross-contamination. These tests allow for immediate on-site testing, significantly reducing the time to market for food product batches. R-Biopharm‘s product portfolio comprises two dipstick test systems for the qualitative detection of soy protein residues on surface swabs, CIP water and food matrices. The RIDA®QUICK Soya (Art. No. R7103) system is specifically designed for surface swabs and enables high specificity through the detection of denatured soy proteins. Furthermore, the heating step increases robustness of test sensitivity with regard to varying sample processing grades. In contrast, the simplified test procedure of the bioavid Soy incl. Hook line (Art. No. BLH712-15) enables rapid sample analysis with a superior sensitivity in food matrices and CIP water. Moreover, the inclusion of a hook line prevents false-negative evaluation of samples containing very high amounts of analyte.

Soy Enzyme-Linked Immunosorbent Assay (ELISA):

ELISA is a standard method for soy detection, known for its high sensitivity and specificity. It enables precise quantification of soy proteins in complex food matrices, ensuring adherence to regulatory requirements. The RIDASCREEN®FAST Soya (Art. No. R7102) is a sandwich enzyme immunoassay for the quantitative analysis of native and processed soy proteins in food.

Real-time PCR for Soy Detection:

Real-time PCR is a sensitive and specific molecular method for detecting soy in food products. It works by amplifying soy‑specific DNA sequences allowing precise identification even when soy is present in (highly) processed or mixed foods. SureFood®ALLERGEN Soya (Art. No. S3601) is a real-time PCR kit designed for the qualitative and / or quantitative detection of soy DNA in accordance with regulation (EU) 1169/2011. It enables laboratories to verify whether soy is present in raw materials or finished products. For the quantitative determination the use of the laboratory reference material SureFood®QUANTARD Allergen 40 (Art. No. S3301) containing 40 mg soya / kg food sample and a detection system including a standard series is required.

Key benefits of monitoring soy allergens

• Consumer safety: Protects individuals with soy allergies from potentially severe allergic reactions by ensuring accurate detection and labeling of soy allergens in food products.
• Regulatory compliance: Helps manufacturers comply with food allergen labeling regulations in the EU and other countries, ensuring that all soy-containing products are properly labeled.
• Quality assurance: Maintains the integrity and safety of food products by accurately identifying and quantifying soy allergens, preventing accidental exposure.
• Cross-contamination prevention: Ensures that food production environments are free from soy allergens, preventing cross-contamination and ensuring the safety of allergen-free products.
• Advanced detection methods: Utilizes highly specific and sensitive detection techniques, such as ELISA and real-time PCR, to accurately detect and quantify soy traces, even in processed foods.

Conclusion

Monitoring for soy allergens is essential for protecting consumer health, ensuring regulatory compliance, and maintaining product quality. By employing advanced detection methods such as ELISA and real-time PCR, manufacturers can accurately identify and quantify soy contamination, preventing allergic reactions and ensuring the safety of their products. This proactive approach supports robust allergen management, upholds food safety standards, and fosters consumer trust in soy-free products.