Survey of foodstuffs for the presence of genetically modified (GM) soy January 2002
The purpose of this study was twofold; to determine the extent and type of genetically modified (GM) soy ingredients on the Irish market; and to ensure that appropriate labelling reflecting GM status accompanied those foods.
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1. Summary
The Food Safety Authority of Ireland (FSAI) regularly monitors the food supply for compliance with regulations and has recently completed a survey of soy-based food. The purpose of this study was twofold; to determine the extent and type of genetically modified (GM) soy ingredients on the Irish market; and to ensure that appropriate labelling reflecting GM status accompanied those foods. This is the second such survey of GM food ingredients to be completed by the FSAI and forms part of its duty as the competent authority for novel foods in Ireland.
This study focused in particular on dried soy products, soy substitutes for dairy products and soy infant formulae. The results show that in an initial general screen, 18 of the 37 samples tested were positive for GM ingredients. The 18 positive samples were further screened to identify the particular GM constituent and the Roundup Ready gene (Monsanto) was detected in all but 3 samples. Roundup Ready is the terminology used to describe the trait conferring resistance to the herbicide glyphosate in plants.
The GM content of 11 of these Roundup Ready positive samples was found to be at trace levels only, which meant that quantification was not feasible. Of the 7 samples quantified, all 7 had significantly less than the threshold level of 1 % GM and as such specific GM labelling rules were not triggered for any of the foods tested.
A number of the products that were found to contain some level of GM ingredient were labelled to indicate that they contained no GM ingredients. This is in contravention of EU legislation prohibiting false or misleading claims on food labelling and with regulations governing the labelling of organic produce.
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2. The Food Safety Authority of Ireland - the competent authority for novel food in Ireland
The FSAI’s mission is to protect consumers’ health by ensuring that food consumed, distributed, marketed or produced in Ireland meets the highest standards of food safety and hygiene. In order for consumers to be able to make an informed choice about the food they buy, they must be provided with the appropriate information and currently this is achieved mainly through product labelling. As the competent authority for novel foods in Ireland, the FSAI is charged with enforcing novel food regulations by ensuring that only authorised GM ingredients are present in the food supply. The FSAI is also charged with ensuring that specific labelling requirements pertaining to genetic modification are adhered to and that the consumer is not misled by any labelling information.
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3. Genetically modified organisms (GMOs)
The deliberate release of genetically modified organisms (GMOs) into the environment and the application of modern biotechnology to food production is still the focus of public and political debate in some countries. Though this debate has receded somewhat in Ireland, the issue of food safety remains in the spotlight as a result of recent food scares throughout Europe and this has led to a more discerning consumer. More than 50 types of GMOs are authorised for general release around the world and the number is expected to rise in the future. In Europe, only ingredients derived from a small number of GM plants are authorised for food and these include, 1 GM soybean, 5 GM maize, 11 GM oilseed rapes and 1 GM tomato.
Estimates indicate that more than 100 million acres of GM crops were planted globally in 2001, an increase on previous years. GM foods have been on the market in North America, and several other continents, for a number of years and are consumed daily by hundreds of millions of people.
GMOs and GM food are subjected to a comprehensive risk assessment prior to receiving authorisation for marketing within the European Community and are governed by strict regulations aimed at protecting human health and the environment.
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4. Legislation regulating GM food in Ireland
At present, GM food is regulated in Ireland under the European Novel Food Regulation, 1997 EC 258/97 which covers labelling and authorisation to market the food within the EU. Labelling of GM foods is also governed by Regulation EC 1139/98, which relates to the labelling of specific GM soybean and maize varieties that were on the market prior to the Novel Foods Regulation 258/97. Regulation EC 49/2000 amended Regulation 1139/98 by extending the requirements to foods sold to mass caterers and by setting a de minimis threshold of 1% for the adventitious contamination of non-GM material. In other words, provided that genetically modified DNA or protein is present at levels of 1% or less, has already been authorised by the EU and the supplier can provide evidence that the ingredients were obtained from a non-GM source, then there is no requirement to have GM labelling.
The “1 % threshold” applies to the ingredients and not to the final food. Therefore, unless the whole food comprises a single ingredient it is the percentage of the ingredient, and not the percentage of the whole food, that is measured as percentage GM. Regulation EC 50/2000 provides for similar labelling rules for additives and flavourings that have been genetically modified or have been derived from genetically modified organisms.
The requirements of the current labelling rules are triggered by the presence of GM DNA or protein in the final food. Ingredients that no longer contain detectable amounts of DNA or protein, such as refined oils, do not require GM labelling as those ingredients are deemed indistinguishable from their conventional counterpart.
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5. Soybean
The soybean is a very versatile source of food and though it can be eaten whole after being boiled or roasted, most soybeans are processed into a variety of foods. About two-thirds of all manufactured food products contain derivatives or ingredients made from soy. Soy foods include tofu, tempeh, miso (made by fermenting soy protein), TVP (textured vegetable protein), soy sauces, soy oil and margarine, soy flour and soy dairy alternatives. Soy lecithin acts as an emulsifier and bulking agent and is found in a wide variety of processed foods.
Soy is now a global staple food with approximately 110 million tonnes of beans being produced each year. The US produces about 60% of the world’s soybeans, while soybeans and their products account for 25% of US agricultural exports to the EU. Other countries supplying the world soybean market are Brazil (14%), China (10%) with smaller amounts from Argentina, Taiwan, Canada and India.
Weed control is a critical aspect of modern farming that can affect yields and until recently soybean farmers had to use a cocktail of herbicides to alleviate the pressures exerted by rapidly growing weeds. Through biotechnology, farmers can now grow genetically modified soybeans that have been engineered to survive applications of specific herbicides. One variety of GM soybean, a Monsanto product called Roundup Ready soybean, is resistant to the herbicide glyphosate which is also known as Roundup. US approval for the use of Roundup Ready soybeans was granted in Spring 1995 by the US Environmental Protection Agency and in 2001 over 65% of the soybeans planted in the US were Roundup Ready varieties.
Currently, only one transgenic soybean, Roundup Ready line 40-3-2 developed by Monsanto, has been authorised for the EU market under Directive 90/220/EEC. However, Ireland does not grow soybeans and therefore any soy products on the Irish market are derived from imported soybeans or soybean products.
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6. Current Study
By carrying out regular surveys of the food supply for GM ingredients, the FSAI assesses the level of compliance within the industry and takes remedial action if necessary. An initial study, published in May 2001, to determine the presence of GM maize ingredients in foods such as tortilla chips and taco shells indicated that while a large percentage of samples contained GM maize, none of the samples had GM levels at or above the threshold limit of 1%. As the maize varieties that were identified had been authorised for food use within the EU, specific GM labelling was not necessary.
Following on this initial study, the FSAI has recently completed a similar survey of soy-based foods on the market in Ireland. Ingredients derived from soybeans comprise the other main GM food ingredient authorised within the EU. The foods involved in this survey included dried soy products, soy dairy alternatives and soy infant formulae. These products were all bought ‘off the shelf’ by the FSAI in a number of health food shops and supermarkets. All samples were purchased in packaged form, as would be available to the consumer, but where possible, were sent for scientific analysis with only FSAI identification markings. Analysis of the soy samples involved a general polymerase chain reaction (PCR) screen for GM DNA using promoter (35S) and terminator (T-nos) specific DNA primers. Samples that were found to be GM positive were then subjected to further PCR screening using available primers to ascertain the particular GM event present. Some positive samples were shown to have very minor amounts of the GM ingredient, too small to allow quantification, but where possible the GM event was quantified relative to the whole ingredient.
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7. Results
The results provided relate solely to the sample tested and may not necessarily be representative of the general labelling or GM status of that product. The samples were collected by FSAI staff and GM analysis carried out by a commercial GM-testing facility.
7.1 Infant Formulae BRAND PRODUCT GM CLAIM GM CONTENT GM EVENT GM% Cow and Gate Infant Formula None Yes RR 0.11% Farleys Infant Formula None Yes RR 0.11% SMA Infant Formula None Yes RR 0.13% Notes:
GM Claim: Refers to GM-specific label on packaging
GM Content: Yes: Positive signal – GMO detected
No: No specific signal – No GMO detected
Trace: Weak positive signal – Trace amounts of GMO detected
GM Variety: Two sets of primers were tested:
- PAT- JV which picks up GM event W62,W98
- Roundup Ready specific primers (RR)
NA: Not applicable as GM not detected
GM %: Percentage of GM to Non-GM DNA present in the sample
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7.2 Dried Soya Substitutes
BRAND PRODUCT GM CLAIM GM CONTENT GM EVENT GM% Bonsoy Soya Milk Organic / Produced from non-GM soybeans No NA - Granose Soya Cream Produced from non-GM soybeans Yes RR <0.1% Granovita Soya Yoghurt Peach and Apricot None Weak Trace RR - Granovita Soya Yoghurt Strawberry None No NA - Provamel Soya Milk Organic / GMO free No NA - Provamel Soya Milk With Added Calcium None No NA - Provamel Soya Milk -Vanilla Flavour Organic / GMO free No NA - Provamel Soya Drink -Banana Flavour None Trace RR - Provamel Soya Drink -Chocolate Flavour None Yes RR <0.1% Provamel Soya Cream GMO free and tested Trace RR - Provamel Soya Dessert -Vanilla Flavour Organic No NA - Provamel Soya Dessert -Chocolate Flavour GMO free and tested Trace RR - Sunrise Soya Milk Organic / Produced from non-GM soybeans No NA - GM Claim: Refers to GM-specific label on packaging
GM Content: Yes: Positive signal – GMO detected
No: No specific signal – No GMO detected
Trace: Weak positive signal – Trace amounts of GMO detected
GM Variety: Two sets of primers were tested:
- PAT- JV which picks up GM event W62,W98
- Roundup Ready specific primers (RR)
NA: Not applicable as GM not detected
GM %: Percentage of GM to Non-GM DNA present in the sample
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7.3 Dried Soy Products
BRAND GM CLAIM GM CONTENT GM VARIETY GM % Cooked Soya-Bran None Trace Trace - Lecigran Lecithin Granules Tests negative for GMO material No NA - Lecithin Granules Tests negative for GMO material Trace RR - Organic Soya Beans Organic No NA - Organic Soya Flour Organic Yes RR <0.1 Organic T.V.P. Soya Mince Organic No NA - Soya Bran None Trace RR negative - Soya Flour GM free / organically grown No NA - Soya Flour None Trace RR negative - Soya Flour GM free Trace RR - Soya Flour (full fat) None Trace RR negative - Soya Lecithin Granules GMO free No NA - T.V.P. Brown Mince GM free No NA - T.V.P. Natural Chunks GM free No NA - T.V.P. Natural Chunks GMO free / organically grown No NA - T.V.P. Natural Mince GMO free / organically grown No NA - T.V.P. Savoury Chunks GM free No NA - T.V.P. Soya Chunks None No NA - T.V.P. Soya Chunks None No NA - T.V.P. Soya Mince None Trace RR - T.V.P. Soya Mince None Yes RR <0.1 Notes:
GM Claim: Refers to GM-specific label on packaging
GM Content: Yes: Positive signal – GMO detected
No: No specific signal – No GMO detected
Trace: Weak positive signal – Trace amounts of GMO detected
GM Variety: Two sets of primers were tested:
- PAT- JV which picks up GM event W62,W98
- Roundup Ready specific primers (RR)
NA: Not applicable as GM not detected
GM %: Percentage of GM to Non-GM DNA present in the sample
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8. Conclusion
Only one GM soybean ingredient, derived from GTS line 40/3/2 was detected in any of the samples tested. Since this is an authorised GM food ingredient within the EU, it has already undergone a risk assessment and is thus not considered to be a food safety concern. GM soy ingredients were detected in 18 of the 37 samples tested. Of those 18 positive samples, 11 contained only trace amounts of GM DNA, which were too low to be quantified. Variety screening was performed on all 18 samples and Roundup Ready soy was detected in all but three of these. Due to technical limitations, those three samples remain unidentified.
Quantification of the 7 positive samples indicated that they were all substantially below the threshold limit of 1% and thus labelling to indicate GM content was not required under current legislation. However, the Regulations stipulate that some form of identity preservation system is in place to demonstrate that the presence of such GM ingredients is the result of adventitious or unavoidable contamination. The FSAI has addressed this concern with the parties involved.
At present, there is no specific European legislation relating to the use of labelling claims such as “GM free” and therefore, such labelling falls under the general requirements of the Food Labelling Directive EC 2000/13. Under this Directive claims that are false or misleading to the consumer are prohibited. Therefore, a food that contains a GM ingredient(s), but labelled to indicate or suggest that it is GM-free is in breach of this legislation. As is evident from the results of this survey, a number of food labels had claims regarding GM status that were not substantiated and thus these foodstuffs are in breach of EC 2000/13. Additionally, one sample that tested positive for GM soy carried an organic label in contravention of 1991 Council Regulation 2092/91 and amended in 1999 by Council Regulation 1804/99. This amendment says that labelling of produce as organic is permitted only when the product has been produced without the use of genetically modified organisms and/or any products derived from such organisms. The FSAI has addressed these concerns with the parties involved.
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Regulations Cited
1. Council Regulation (EC) No 1139/98 of 26 May 1998 concerning the compulsory indication of the labelling of certain foodstuffs produced from genetically modified organisms of particulars other than those provided for in Directive 79/112/EEC.
2. Commission Regulation (EC) 49/2000, amending Council Regulation (EC) No 1139/98, concerning the compulsory indication on the labelling of certain foodstuffs produced from genetically modified organisms of particulars other than those provided for in Directive 79/112/EEC (Official Journal of the European Communities, L6 of 11.1.2000, p. 13).
3. Commission Regulation (EC) No 50/2000, on the labelling of foodstuffs and food ingredients containing additives and flavourings that have been genetically modified or have been produced from genetically modified organisms (Official Journal of the European Communities, L6 of 11.1.2000, p15).
4. Directive 2000/13/EC of the European Parliament and of the Council of 20 March 2000 on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs.
5. European Communities (Labelling, Presentation and Advertising of Foodstuffs) Regulations, 2000, Statutory Instrument No. 92 of 2000 (Ireland).
6. Council Regulation (EEC) No 2092/91 of June 1991, organic production of agricultural products and indications referring thereto on agricultural products and foodstuffs. Amended by Council Regulation (EC) No 1804/1999 of July 1999.
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Further Information
Further information on this survey can be obtained from:
Food Safety Information Centre,
Food Safety Authority of Ireland,
Abbey Court, Lower Abbey Street, Dublin 1
Tel: (01) 817 1300. Fax: (01) 817 1301
E-mail: info@fsai.ie