What are GMOs?
A genetically modified organism (GMO) is, among other places, defined in chapter 13 of the Swedish Environmental Code (SFS 1998:808) as

"...an organism in which the genetic material has been altered in a way that does not occur naturally by mating or natural recombination..."

In this context, "organism" means any biological entity capable of replication or of transferring genetic material, and the term thus includes seeds, fruits and pollen. A definition of genetically modified micro-organisms (GMMs) is provided in the Genetically Modified Organisms (Contained Use) Ordinance (SFS 2000:271). A micro-organism is defined as

"...any microbiological entity, cellular or non-cellular, capable of replication or of transferring genetic material, including viruses, viroids, and animal and plant cells in culture"

Certain organisms, resulting from the use of specific tried and tested genetic modification methods and known not to involve any risks in terms of health or the environment, may be exempted from some of the provisions of the Environmental Code. The criteria for exemption are set out in the Genetically Modified Organisms (Deliberate Release) Ordinance (SFS 2002:1086) and the Genetically Modified Organisms (Contained Use) Ordinance (SFS 2000:271).

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These products must be labeled.
GMO labeling was introduced to give consumers the freedom to choose between GMOs and conventional products. If foods were produced using genetic engineering, it must say so on the label. Labeling regulations, however, are not this simple. They must take things like legal issues and feasibility into account. Exactly what must be labeled, how, and why is explained in the following. Foods and ingredients that come from a GMO or contain a GM ingredient must be labeled. Here are some examples:

GOODS AND INGREDIENTS REQUIRE LABELING
1. If the product is a genetically modified organism (GMO):
...• GM tomato with a prolonged storage life
...• Fresh GM chicory greens
...• Sweet corn from GM maize
...• GM potato

2. If the product contains genetically modified microorganisms:
...• Yogurt with genetically modified lactobacilli
...• Cheese with GM moulds
...• Wheat beer with GM yeast
...• Salami with GM lactobacilli
...• Yeast extract from GM yeast

3. If the product was directly made from genetically modified organisms, whether or not ....they can be found in the final product.
...• Breakfast cereal made from GM maize*
...• Starch derived from GM maize*, GM potatoes, or GM wheat
...• Bread with GM soy protein* or GM soy flour*
...• Glucose, glucose syrup, etc. made from GM maize starch*
...• Ketchup made from GM tomatoes
...• Oil made from GM soybeans* or GM rapeseed (canola)*
...• Margarine made from GM soybean oil*
...• Crisps made from GM potatoes
...• Sugar made from GM sugar beets
...• Smoked salmon made from GM salmon

4. If the product contains additives or flavors that were directly made from genetically ....modified organisms. As with foods, all additives and flavors require labeling if the ....direct production line stems from genetically modified plants and plant products:
...• Lecithin from GM soy*
...• Vitamin E (tocopherol) from GM soy*
...• Cellulose from GM cotton*
...• Flavors derived directly from proteins from GM soy*

Exception: Unintentional admixtures of GMOs up to 0.9 percent (with respect to the raw material). Deliberate admixtures of GMOs always require labeling, regardless of the percentage GM content in the final product.

5. Labeling is also required for foods or ingredients made from agricultural raw materials ....that only partly consist of genetically modified organisms. GMO content below the 0.9 ....percent threshold for the respective ingredient does not need to be labeled when:
...1. the GM content was introduced by chance due to unintentional mixing
...2. the producer can prove that all necessary measures were taken to avoid unintentional .......mixing and that care was taken to use only GM-free ingredients
...3. the detected GMOs are approved within the EU

Many of the food examples given above are not available in stores, because the respective GMOs have not yet been authorized in the EU. Only examples marked with * can currently be found in foods on the market.

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These products do not require labeling.
Certain applications of genetic engineering do not require labeling This is determined by two basic rules. Products that are produced with the help of genetically modified organisms (GMO), rather than actually made out of them, do not require labeling In other words, labeling is only required for foods that are made from parts of the genetically modified organisms themselves. Labeling is restricted to products that are legally considered foods. Substances that assist in food production (e.g. processing aids or enzymes), carrier substances (e.g. for vitamins or flavors), or culture media for microorganisms (e.g. medium for growing yeast) are not considered foods. Therefore, they do not need to appear on the list of ingredients. When GMOs are used for non-foods, labeling is not required.

With no immediate relation to GMOs, no labeling is required for meat, eggs, milk, and dairy products from animals raised with GM feed. The GM feed itself, however, requires labeling

Additives, vitamins, or flavors that are produced with the help of GM microorganisms do not require labeling The GM microorganisms themselves or their residues must not be present in the final product.

Examples:
• Vitamin B2 (Riboflavin)
• Glutamate
• Aspartame (artificial sweetener)

Some microorganisms used in the food industry are grown on substrates that were produced from genetically modified organisms. These microorganisms, or products thereof, do not require labeling

Examples:
• Baker’s yeast cultured on medium containing GM maize
• Vitamin C produced by microorganisms raised using glucose derived from GM ...cornstarch
• Citric acid produced by microorganisms raised using molasses derived from GM sugar ...beets

Various additives, vitamins, and flavors are applied to carriers in order to facilitate transportation, prolong shelf-life, and allow for more precise dosage. These carrier substances can be made from GMOs. Since they are not considered foods, they do not require labeling Carrier substances may be made from starch, dextrin, or glucose that may be produced from GM products.

Enzymes are not legally considered foods. Therefore they do not require labeling when produced from genetically modified microorganisms.

Examples:
• Bread (enzyme: amylase)
• Cheese (enzyme: chymosin)
• Juice (enzyme: pectinase)

Foods, ingredients, and additives do not require labeling if they were produced from "GM-free" raw materials, even when some traces of GMOs are detectable. Exemption from labeling only applies if
• the GM proportion in the respective ingredient is below the 0.9 percent threshold.
• the admixture was unintentional and technically unavoidable.
• the detected GMOs are authorized within the EU.

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What activities regarding GMOs are regulated?
Under chapter 13 of the Environmental Code, a consent (permit) or notification is required for all activities involving genetically modified organisms (GMOs). Prior to any contained use or deliberate release of GMOs, an investigation must be carried out as a basis for a risk assessment of the activity in question. This risk assessment then determines what protective measures need to be taken. A consent for an activity involving GMOs may only be granted if the activity is ethically justifiable. In the Environmental Code, the term 'contained use' refers to any activity in which 'organisms are genetically modified or in which such genetically modified organisms are cultured, stored, transported, destroyed, disposed of or used in any other way, and for which specific containment measures are used to limit their contact with, and to provide a high level of safety for, the general population and the environment'. Specific containment measures may be physical barriers or a combination of physical and other barriers.

Examples of contained use include the culture of micro-organisms in sealed vessels, the use of laboratory animals in the production of pharmaceuticals, and the growing of plants in glasshouses. The level of containment required varies according to the risk and the type of organism involved. A glasshouse, for example, can serve as a containment for plants, but not necessarily for micro-organisms.

A 'deliberate release' is defined in the Environmental Code as any intentional introduction of genetically modified organisms into the environment without containment, e.g. a field trial. Before a deliberate release takes place, consent must be obtained from the competent supervisory authority.

The expression 'placing on the market' means, according to the Environmental Code, supplying or making a product available to third parties, e.g. by selling it. Before a product can be placed on the market, consent must be obtained. Decisions on consents for placing on the market are taken collectively by the EU member states. They then apply throughout the European Union, and a consent under the Swedish Ordinance SFS 2002:1086 is not required.

In case a genetically modified organism is to be exported or in other ways moved out of the community the exporter is responsible for notifying the country in question in accordance with the rules laid down in Reg. No 1946/2003.

The Ordinance SFS 2000:271 applies to all contained uses of genetically modified organisms. Deliberate releases and placing on the market are regulated by the Ordinance SFS 2002:1086. In addition to these ordinances, various regulations have been issued by the authorities responsible for granting consents.

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User responsible for risk assessment.
Genetic engineering allows genetic material from different organisms to be combined, which may give rise to situations involving many unknown factors. Prior to any use of genetically modified organisms, an investigation of the consequences for human health and the environment has to be carried out, both in cases where a consent is required and where notification is sufficient. Chapter 13 of the Environmental Code stipulates that this investigation is to be undertaken 'in accordance with scientific knowledge and proven experience'. Additional rules governing such investigations may also be issued by the Government and the relevant sectoral authorities. Responsibility for undertaking a risk assessment rests with the user, while the competent authority makes an appraisal of whether the assessment carried out is appropriate.

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Other GMO-related issues.
All medicinal products, whether or not they contain GMOs, have to undergo a range of tests before they can be approved. Medicines containing GMOs are covered by various legislation, including the Swedish Medicinal Products Act (SFS 1992:859) and Regulation (EC) No 726/2004. Further details can be found on the Swedish Medical Products Agency's website. It should be noted that pre-approval trials of such medicines may also involve contained use of GMOs.

Regulation (EC) No 1829/2003 applies when a human food or animal feed contains, consists of or has been produced from GMOs. Regulation (EC) No 1830/2003 is concerned with the traceability and labeling of GMOs. Rules on transboundary movements of GMOs are set out in Regulation (EC) No 1946/2003. The use of gene technology in relation to humans is regulated by the Act concerning the Use of Certain Genetic Technology in Medical Screening (SFS 1991:114) and the Act concerning Measures for Purposes of Research or Treatment involving Human Ova (SFS 1991:115). These issues fall within the remit of the National Board of Health and Welfare.

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Public access to information.
It is important to ensure a high degree of transparency in the handling of applications and notifications relating to GMOs, a need that is met by the Swedish principle of public access to information. Some information though, such as certain technical data, is covered by the provisions of the Secrecy Act (SFS 1980:100) and the Secrecy Ordinance (SFS 1980:657).

In the specific case of GMOs, the Secrecy Ordinance imposes certain restrictions on the confidentiality that would otherwise apply. With regard to investigations, the granting of consents and supervision relating to GMOs, confidentiality does not apply if the interest in a circumstance affecting human or animal health, the environment or a similar public interest becoming public knowledge carries such weight that the information concerned should be disclosed. Decisions reached on applications etc. considered by an authority are always to be made public. In the case of a notification or an application for consent, confidentiality does not apply to the following information:

• A general description of the genetically modified organisms
• The name and address of the person or organization undertaking the activity concerned
• The purpose of the activity
• The location of the activity
• The risk category to which the activity is assigned
• Protective measures
• Plans for monitoring and for emergency response
• Risk assessments referred to in chapter 1, section 6 of SFS 2002:1086 or section 7 of SFS ...2000:271.

What are GMOs?
Required labeling
Not required labeling
Regulated activities
Responsibilities
Other GMO issues
Public information