Control guideline for genetically modified food

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Publish date: January 8/2024

Guideline/version: 2323/04.02.00.01/2020/6

These guidelines are intended for the use of food control authorities and food business operators. Activities by the authorities must be based on the competence laid down in the law and strictly comply with the law. Since the Finnish Food Authority does not have the competence to issue norms in the matter concerned, these guidelines are not, by their legal nature, binding on other authorities or operators. These guidelines contain both direct quotations from legislation and the views of the authority in charge of food control, the Finnish Food Authority, on how the food legislation should be applied. In the last instance, matters concerning the application of legislation are settled by a court of law.

1 Introduction

Genetically modified organism (GMO) means a living organism that is capable of reproduction, such as a plant, microbe or seed, whose genome has been altered by means of genetic engineering. The purpose of alteration is, for example, to improve the yield or nutritional value of a particular crop.

Genetically modified foods mean foods that are or contain genetically modified organisms or are composed or prepared from such organisms (e.g. frozen maize prepared from genetically modified maize, taco shells prepared from genetically modified maize flour, or tofu that contains genetically modified soya protein).

Genetically modified food is safe. Genetically modified organisms or food may not be placed on the market unless they have been authorised in the EU. The authorisation procedure is based on a risk assessment carried out by the European Food Safety Authority (EFSA). Only products that have been confirmed as being safe for humans, animals and the environment can be authorised for the EU market.

Indication of genetic modification appears on the labelling. The consumer must be informed of any genetically modified material used in the manufacture of a food. The words ‘genetically modified’ or ‘produced from genetically modified soya beans’, for example, must appear in the list of ingredients on the food packaging immediately following the genetically modified ingredient or the ingredients produced from a genetically modified organism.

The control of genetically modified food is part of the regular food control that is based on the food business operator’s in-house control. The operator is responsible for the compliance of its products and also takes genetically modified organisms into account in its in-house control. Food control in practice is carried out by municipal food control authorities, the Finnish Food Authority’s inspection veterinarians and border and organic production control acting under the Finnish Food Authority’s instructions. Genetically modified food is also controlled by the Finnish Customs, the National Supervisory Authority for Welfare and Health Valvira and the Finnish Defence Forces. The regulatory control of genetically modified food is primarily based on documentary control, which may also be supplemented by the analysis of control samples.

The Finnish Food Authority is not aware of any foods currently (October 2023) placed on the market in Finland that would contain genetically modified products authorised in the EU. However, since the placing on the market of genetically modified food does not require notification, it is possible that imported food includes some genetically modified products. Genetically modified foods can be identified from the labelling.

Over the years, control inspections have come across some foods that have contained genetically modified ingredients authorised in the EU without this having been indicated in the labelling. Finnish Customs have also discovered some genetically modified varieties not authorised in the EU. However, there have been few occurrences of non-conformances and the errors encountered in respect of the labelling requirements have been isolated cases.

More information about genetically modified products (in Finnish) and genetically modified foods can be found on the Finnish Food Authority website.

2 Legislation and guidelines

All Finnish Food Authority guidelines on genetically modified products can be found at the website of Finnish Food Authority.

3 Requirements applying to genetically modified foods

3.1 Authorisation procedure

Under Regulation (EC) No 1829/2003, genetically modified organisms for food use or foods may not be cultivated or placed on the market in the EU unless granted authorisation. Since 1996, a number of genetically modified plants (maize, soya, rape, cotton, sugar beet) have been authorised for placing on the EU market. Several maize varieties produced through a single gene transfer event have been approved for cultivation in the EU (as of May 2023).

Under Government Decree 910/2004 (as amended), the Finnish Food Authority serves as the national contact point for applications concerning genetically modified products. The Finnish Food Authority is responsible for forwarding documents such as authorisation applications, requests for statement and statements related to applications filed in Finland between the authorisation applicant, EFSA and the competent authorities. The Finnish Food Authority is also responsible for ensuring that EFSA’s statements on the applications are available to the public. The public has the opportunity to file a comment on EFSA’s statement in their native language for 30 days.

Further information about the authorisation of genetically modified foods can be found at the website of Finnish Food Authority. (in Finnish and Swedish only)

3.2 Labelling

Under Regulation (EC) No 1829/2003, consumers shall be provided with information about the genetically modified organisms used in the production of a food or the ingredients produced from them. Genetically modified foods shall be labelled according to the following principles:

  • Where the food consists of more than one ingredient, the words ‘genetically modified’ or ‘produced from genetically modified [name of the ingredient]’ shall appear in the list of ingredients immediately following the ingredient concerned.
  • Where the ingredient is designated by the name of a category (e.g. ‘spice mixture’), the words ‘contains genetically modified [name of organism]’ or ‘contains [name of ingredient] produced from genetically modified [name of organism] ’ shall appear in the list of ingredients.
  • Where there is no list of ingredients, the words ‘genetically modified’ or ‘produced from genetically modified [name of organism] ’ shall appear clearly on the labelling.

The indications referred to above may also appear in a footnote to the list of ingredients. In this case they shall be printed in a font of at least the same size as the list of ingredients.

Where the food is offered for sale as non-pre-packaged food, or as pre-packaged food in small containers of which the largest surface has an area of less than 10 cm2, the information on genetic modification must be permanently and visibly displayed either on the food display or immediately next to it, or on the packaging material, in a font sufficiently large for it to be easily identified and read.

The labelling requirements do not apply to food containing material which contains, consists of or is produced from genetically modified organisms in a proportion no higher than 0.9 % of each food ingredient (a maximum of 0.9% of the food where it consists of just one ingredient). In this case, the presence of this must material is adventitious or technically unavoidable. On order to establish this, operators must be in a position to supply evidence to satisfy the competent authorities that they have taken appropriate steps to avoid the presence of such material.

The Regulation does not apply to food produced using genetically modified organisms where there is no material derived from the genetically modified source material present in the finished food. The labelling requirement thus does not apply to processing aids or fermentation products produced with genetically modified microbes, such as additives, flavours or vitamins, if no genetically modified microbe is present in the final product. Nor are products obtained from animals fed with genetically modified feed or treated with genetically modified medicinal products subject to the authorisation or labelling requirements referred to in Regulation ((EC) No 1829/2003, introductory sentence 16).

At the time of the publication of the guidelines, the regulation also applies to varieties produced using new genome editing technologies, regardless of whether they can be produced using conventional plant breeding technologies.  The Commission’s proposal for a regulation on crops produced using certain new genome editing technologies is still under progress when revising the guidelines.

3.3 ‘GMO free’ marketing claim

Genetically modified foods are subject to a mandatory labelling obligation (see section 3.2). The consumer can be confident that if there is no indication of genetic modification in the labelling, the foodstuff is not genetically modified. However, regulations do not prohibit the use of voluntary marketing claims stating that gene technology has not been utilised in the production of the food concerned, or that the product does not contain any genetically modified ingredients. However, the labelling shall always be clear and unambiguous, and it may not mislead the consumer in the manner referred to in paragraph 1 of Article 7 of Regulation (EU) No 1169/2011 on the provision of food information to consumers.

At present, the EU has not specified any common principles for marketing claims such as ‘GMO free’, ‘GMO-free production’, and the like. The Finnish Food Authority has drawn up a guideline for food business operators and the control authorities for the use of the voluntary ‘GMO free’ marketing claim on food and feed.

According to the guideline:

  • The ‘GMO free’ or a similar marketing claim may only be used with food products that contain genetically modified ingredients in the form authorised in the EU (soya, maize or rape) only if the food product contains no genetically modified ingredients. This means the content of the genetically modified ingredient must be 0% (below the detection limit). Even the presence of a minute level of any genetically modified ingredient in such a product will be considered as being misleading. Only properties in respect of which the product concerned differs from other similar products may be attributed to a food product.
  • The ‘GMO free’ or a similar marketing claim is not permitted at all on food products that contain only ingredients of which no genetically modified variety authorised in the EU exists because such a claim would be misleading.
  • The voluntary ‘produced without gene technology’, ‘GMO free’ or other similar marketing claim may only be used on foodstuffs of animal origin (e.g. meat, milk, egg or farmed fish) when the animal concerned has been fed with regular feed throughout its lifecycle. This means that the adventitious or accidental presence of gm material in feed may be at most 0.9%. Should an operator use the marketing claim ‘the animal has been fed with GMO-free feed’ or similar, the operator must ensure that the gm material content in the feed was 0% (below the detection limit.
  • The GMO free marketing claim may be used for food products that contain several of the product categories listed above (e.g. convenience food or seasoned meat product) only where the criteria referred to above are met in respect of each ingredient in the product. Should an individual ingredient meet the criteria, the claim may only be used in conjunction with that ingredient, for example in a list of ingredients, but not as a marketing claim for the whole product.

3.4 Traceability

Under Regulation (EC) No 1830/2003, any genetically modified products and material placed on the market shall be traceable. In this connection, ‘traceability’ means the ability to trace genetically modified organisms and products produced from genetically modified organisms at all stages of their placing on the market through the production and distribution chains from one operator to another. This makes it easier, among other things, to implement the appropriate risk management measures, such as the withdrawal of products where necessary.

At all stages of the placing on the market of a genetically modified product, operators shall ensure that the following information is transmitted in writing to the operator receiving the product:

  • that it contains or consists of a genetically modified organism;
  • the unique identifier assigned to that genetically modified organism at the first stage of the placing on the market, for example maize Bt11 (SYN- BT11-1). You can find the identifiers for authorised genetically modified foods in the EU in the EU Register of GMOs.

Documents relating to genetically modified products are subject to holding obligation of 5 years from each transaction. The operator shall have in place systems and standardised procedures to allow the holding and management of such documents. The systems must be able to trace the operator who supplied the product and the operator to whom the product was delivered.

4 Operator’s liability and in-house control

The food business operator – for example, the importer or the manufacturer – is responsible for the compliance of its products and is also required to take genetically modified organisms into account in its in-house control. In its in-house control, the operator must identify and assess the requirements related to foods that may potentially be genetically modified. The operator must also be able to prove with reference to relevant documents (e.g. appropriate procurement contracts and/or analysis certificates) that the critical points are under control.

The operator must, in particular, take genetically modified material into account in its in-house control if the operator:

  • Manufactures, contracts to manufacture, packages, imports (from the internal market and/or third countries) or forwards foods that are or contain genetically modified organisms or ingredients manufactured from them.
  • Manufactures, contracts to manufacture, packages, imports (from the internal market and/or third countries) or forwards foods that with high probability may be or contain genetically modified organisms or ingredients manufactured from them. These so called high-risk foods include plants cultivated across the world as genetically modified varieties (e.g. soya and maize cultivated in the USA, rape cultivated in Canada, rice cultivated in China, papaya grown in Thailand or the USA).
  • Uses in its products the voluntary ‘GMO free’ or a similar marketing claim.

In this case, the operator must ensure and be capable of demonstrating the following, among other things:

  • The operator shall ensure that the raw materials that may potentially include genetically modified material are consistent with what was ordered (i.e. are or are not genetically modified).
  • The operator must be able to prove with reference to relevant documents and/or analyses (as part its in-house control or on behalf of the supplier of the food/ingredient) that the foods only contain genetically modified organisms authorised for food use in the EU. The use of genetically modified organisms that have not been authorised in the EU is prohibited.
  • The labelling relating to genetic modification is in compliance with the applicable legislation. Should a food be genetically modified or a food ingredient contain genetically modified material in excess of 0.9 %, the required reference to genetic modification must be indicated in the list of ingredients or elsewhere on the labelling.
  • The statutory traceability requirements relating to genetically modified organisms and foods are met (e.g. an indication of the presence of genetically modified material and a unique identifier; 5-year archival requirement for documents).
  • The voluntary ‘GMO free’ or a similar marketing claims used in the products do not mislead the consumer.

In-house control must check how the consistency of the raw material or product with what was ordered is ensured. The manufacturer must be aware and certain whether or not the raw materials used (soya, maize, rapeseed, rice or papaya) or the products manufactured of them are genetically modified and whether the varieties concerned have been authorised in the EU. This must be primarily ensured by means of, for example, a batch-specific contract, warranty or analysis certificate obtained from the supplier.

Operators who import prepacked products containing so-called high-risk foods (e.g. bars containing soya intended for athletes), must pay special attention to the accuracy of documents and labelling. For example, US legislation does not require the labelling of genetically modified food. Labelling must comply with EU law before placing the products on the market.

The law requires genetically modified organisms or products to be accompanied by an indication that the product contains or consists of genetically modified organisms or ingredients at all stages of the placing on the market throughout the production and distribution chain. The operator must be able to submit such documents to the controller where necessary or when requested to do so. It is important that the documents can be seamlessly linked to the batch to be delivered. Should any genetically modified ingredient be used in the manufacture of a product, this must be indicated in the labelling of the product sold to consumers or institutional kitchens.

Operators who use the ‘GMO free’ or other similar marketing claim on their food of vegetable origin shall verify by means of analyses that the genetically modified ingredient level in the product is 0% (the detection limit). A representative sample shall be analysed in an accredited laboratory using a validated method. The operator must be able to provide batch-specific analysis results if requested to do so by the authority. Operators who use a similar marketing claim in foods obtained from animals must ensure that written agreements covering the entire chain are in place. Additionally, the operator must verify that the ingredients of the product can be traced over the entire chain.

Operators must also observe that special import requirements have been imposed on rice products imported from China.

If the operator intends to avoid genetically modified ingredients, it must assess which of its products potentially contains high-risk ingredients on a case-by-case basis and from which products and how often in-house control samples need to be taken. The need for examining samples arises if, for example, the operator has some reason to doubt the compliance of the product on the basis of, for example, RASFF notifications or information otherwise obtained. Should the operator have previously used genetically modified ingredients or products and switches to a batch that is not genetically modified, the operator must ensure by means of analyses that the lines and facilities have been properly cleaned between the batches of any genetically modified material.

If the operator notices or becomes aware that a product the operator manufactures, contracts to manufacture, imports, packages or sells does not comply with the regulatory requirements, the operator must take the necessary actions. Examples of such shortcomings include:

  • analysis has indicated that the food concerned contains genetically modified material that has not been authorised in the EU,
  • an indication of the presence or absence of genetically modified material in ‘high-risk foods’ is missing from procurement contracts and analysis certificates are missing,
  • the genetically modified foods or ingredients used that are authorised in the EU are not indicated on the packaging,
  • the operator is not able to provide traceability documents for the genetically modified organisms or foods,
  • the ‘GMO free’ or a similar marketing claim used by the operator misleads the consumer.

More detailed information about withdrawals and the operator’s obligations can be found on the Finnish Food Authority website. The Finnish Food Authority has also drawn up a separate instructions on the withdrawal of unauthorised genetically modified food and feed.

5 Regulatory control

The control of genetically modified food is part of the regular food control based on the food business operator’s in-house control and inspections. The purpose of regulatory control is to check that the operator has identified and assessed the requirements related to potential genetically modified foods and is able to prove with reference to relevant documents (e.g. procurement contracts, product specifications, analysis certificates and/or audits) that the critical points are under control. In the regulatory control of genetically modified foods, the emphasis is on documentary control. Documentary control may also be supplemented by the analysis of control samples.

The control authorities must keep up to date with the presence of genetically modified foods in Finland because the topic is of interest from the point of view of consumers, the media and politicians, among others. Regulatory control seeks to contribute to securing the consumer’s trust in the authenticity of products and the correctness of their labelling.

5.1 Municipal food control authorities and the Finnish Food Authority’s inspection veterinarians

Municipal food control authorities and the Finnish Food Authority’s inspection veterinarians’ control, as instructed by Food Authority, the effectiveness and due implementation of in-house control in their in respective fields in accordance with the Oiva system (Oiva assessment guidelines for notified and approved food establishments, 11.3 Genetically modified ingredients). Further information about the Oiva system and assessment guidelines for genetically modified ingredients can be found at Oivahymy.fi -webpage.

The regulatory control of genetically modified food is primarily based on documentary control because GMO analyses are expensive and require specific analytics. In support of documentary control, the food control authorities may inspect the correctness of product labelling by means of spot checks and, where necessary, determine by means of analyses whether or not the product contains any genetically modified ingredients. If the operator fails to commission the analyses deemed necessary in the in-house control, the authority must take the samples and commission the analyses. Regulatory samples must also be taken in the event that there is a reason to suspect the regulatory compliance of the raw material or product. It is also desirable that the authorities include surveys related to genetically modified foods in their food control plans. The Finnish Food Authority’s sampling instructions for foods analysed for potential genetically modified ingredients and a sampling form can be found on the Finnish Food Authority website.

This Control Guideline supplements the Oiva Guideline and also contains sampling instructions (Annex 1) and a sampling form (Annex 2). The VATI system is used to store and report control data of genetically modified foods in the same way as other control data.

5.2 Regional state administrative authorities

Regional state administrative authorities (regional state administrative agencies) control and advise municipal authorities and also take the control of genetically modified foods into account when performing their audits.

5.3 Finnish Food Authority

The Finnish Food Authority is responsible, by means of guidance, training and communications, for ensuring that the national food control operates on a risk- informed basis in both an effective and equitable manner. To this end, the Food Authority has drawn up the guidelines listed in section 2 for genetically modified foods. Where necessary, the Food Authority also plans and coordinates nationwide sampling and control projects for which more extensive special expertise is required. The Food Authority’s organic control is responsible for the control of genetically modified materials in accordance with the legislation concerning organic production.

5.4 Customs

Since no genetically modified plants are currently cultivated in Finland, genetically modified foodstuffs are always imported products. The compliance of foodstuffs of non-animal origin imported from outside the borders of Europe and from EU Member States is controlled by the Finnish Customs in accordance with its own control plan. Each year, Customs analyses 100-150 food samples for genetically modified ingredients. These samples are mainly from soya, maize, rice or papaya. More information about the control carried out by Customs can be found at the Customs Laboratory website.

6 Sampling and analyses

In certain situations, it is advisable that both the operator and the control authorities ensure regulatory compliance by means of analyses. In the sampling of genetically modified foods, the sampling instructions drawn up by The Finnish Food Authority must be complied with, and the data pertaining to the sampling must be marked on the sampling form.

Sampling is targeted on a risk-informed basis at raw materials or finished foods that potentially contain genetically modified material (e.g. soya, maize, rapeseed, rice, papaya). Organic products are also included within the scope of the control. Where possible, the samples should be taken from raw materials used in manufacture. This makes it possible to control the products entering the market at the beginning of their production cycle.

It is not worth taking samples from highly processed products (such as starch, flakes or snacks from maize, starch syrup, maltodextrin, soya lecithin, soy sauce or oils). Processing the product limits verification of the intact DNA and analyses will thus not be successful.

Should products bearing the ‘GMO free’ or a similar marketing claim (foods of plant origin) be found on the market, it is advisable to include them in the sampling plan.

Examples of possible sampling points include:

soya tofu products, soya beverages and the products processed from it (e.g. snack products), sports products (in particular snack bars and protein powders originating from the United States); soya beans, flour, protein, concentrate and isolate (as such or in textured form);
soya protein hydrolysate
maize maize cob, grains (e.g. popcorn raw material), flours, flakes, semolina, ready-made tortillas
rapeseed raw material for oil manufacture
flax flaxseed meal
rice particularly rice products originating from China
papaya particularly papaya products originating from Thailand or the United States.

Soya protein is used very frequently in various kinds of foods. Products containing soya include plant-based protein products, meat pies, rice pasties, other convenience foods (e.g. kebab meat, frankfurters, grill sausage, ham product or mixed condiments and seasonings), frozen foods, bakery and baker’s confectionery products (especially gluten free).

7 Measures in response to omissions and offences

If the control authority notices that the measures taken by the operator to secure compliance with the Food Act and product-specific requirements are not sufficient or the operator breaches the food regulations currently in force, the control authority is required to take the necessary control measures as defined in the Food Act (23/2006). Depending on the case, measures may need to be taken either immediately in connection with the inspection visit, or at a later stage based on the analysis result obtained from the sample. The Finnish Food Authority has drawn up a guideline on the use of administrative coercive measures in food control pursuant to the Food Act (Finnish Food Authority Guideline 3761/04.02.00.01/2020/3 “Opas elintarvikelain mukaisten hallinnollisten pakkokeinojen käytöstä elintarvikevalvonnassa, in Finnish and Swedish).

If an indication of the presence or absence of genetically modified material in so- called high-risk foods is missing from the operator’s procurement contracts or analysis certificates are missing, the operator shall be urged to take corrective action. The same line of action shall be taken if the operator is not able to provide traceability documents for the genetically modified organisms or foods. Additionally, the operator shall be urged to make the in-house control of its purchases more effective.

On the other hand, should the finished product contain authorised genetically modified material in excess of the 0.9 % threshold value, but the labelling includes no indication of the presence of genetically modified material, the operator will be called on to correct the labelling of any products held in stocks and to make its in- house control more effective. This would be a case of a labelling error that represents no danger to health, so there is no need to initiate withdrawal of the products from the market.

If the operator uses the ‘GMO free’ or a similar marketing claim in its products, but is unable to demonstrate it with an analysis certificate (foods of plant origin) or appropriate documents (foods of animal origin), the marketing claim may be regarded as being misleading and the operator will be called on to remove the labelling.

The presence of unauthorised genetically modified ingredients in a foodstuff will invariably result in the withdrawal of the products from the market. The threshold of 0% is complied with in respected of unauthorised materials. The Finnish Food Authority’s guideline on the withdrawal of unauthorised genetically modified food and feed can be found at the Finnish Food Authority website.

8 Further information

Further information about genetically modified products (e.g. seeds, feeds, foods), the related legislation and control and the varieties authorised in the EU, among other things can be found on the Finnish Food Authority’s websites at Genetically modified organisms (Muuntogeeniset tuotteet, in Finnish and Swedish) and Genetically modified food as well as the European Commission website.

Annex 1.

Finnish Food Authority Guideline 2324/04.02.00.01/2020/6: Sampling instructions for foods analysed for potential genetically modified ingredients (in Finnish)

Annex 2.

Sampling form (in Finnish)

Entry into force

This guideline is in force from 8 January 2024 and replaces the earlier version 5.

Updates to version 6

Links updated throughout the guidelines

3.1 specified the number of genetically modified varieties in cultivation in the EU

3.2 specified the scope of application of the guidelines regarding varieties produced using new genome editing technologies