MEDICINE, LAW & SOCIETY 
Vol. 14, No. 1, pp. 43–76, April 2021   
 
https://doi.org/10.18690/mls.14.1.43-76.2021 
© 2021 University of Maribor, University Press 
 
 
 THE IMPORTANCE OF LABELLING PRODUCTS 
WITH A GMO OR NON-GMO LABEL 
  
Accepted  
11. 02. 2021 
 
Revised 
22. 03. 2021 
 
Published 
23. 04. 2021 
KATJA MEŠKO KURALT 
University of Maribor, Faculty of Law, Maribor, Slovenia.  
E-mail: mesko.cat@gmail.com. 
 
CORRESPONDING AUTHOR 
mesko.cat@gmail.com. 
 
Keywords 
GMO  
label,  
transparency,  
product  
control, 
product  
approval  
process, 
Regulation 
1830/2003/EC 
Abstract The article is based on publicly available data, 
namely on European legislation and on publicly available 
instructions or recommendations/guidelines dealing with the 
field of GMO labelling in Slovenia. The importance of 
labelling GMO-free products and GMO-labelled products 
was analysed using a comparative research method. The 
analysis is based on a comparison of the basic terms with each 
other (i.e., GMO-labelled products, non-GMO-labelled 
products). It also is based on a review of the legal definition 
of the terms and on control over the use of the terms. The 
purpose of this paper is to define an important difference 
between the two concepts, which are hidden and (or) not 
defined for most consumers. 
 
 
44 MEDICINE, LAW & SOCIETY.   
 
1 General 
 
Presently, both the natural and social sciences are experiencing rapid innovations. 
Advancements that are still the subject of scientific research today, may become 
leading products on the market tomorrow. Some products take longer to enter the 
market than others, depending on several factors. These variables include the extent 
of the analyses and controls carried out, which are important for the free entry into 
the market of goods and services within a given area (e.g., within EU Member States; 
in the United States; worldwide, etc.). 
 
One of the innovations that has emerged in recent decades within the territory of 
the EU Member States is undoubtedly the offer of products labelled without 
genetically modified organisms (hereinafter: GMO-free). 
 
In general, products labelled without GMOs are those that did not contain or require 
GMOs in their production (i.e., from the production of raw materials for the product 
to the processing and production of raw materials into a product). On the other 
hand, there are products that do not have this label, which can result in two options. 
The first option is a product that does not have a GMO-free label but contains 
GMOs. The second option is a product that does not have a GMO-free label and 
does not contain GMOs, as it has not been tested by those authorized to label a 
product GMO-free. Regardless of labelling, products on the market can have both 
positive and negative effects on the individual purchaser. 
 
2 Introduction 
 
The main purpose of this paper is to define the difference between the labelling of 
products containing or produced from GMOs and the labelling of products with a 
GMO-free label. 
  
K. Meško Kuralt:  
The Importance of Labelling Products with a GMO or Non-GMO Label 45. 
 
 
The contribution is based on publicly available data, i.e., on EU law and on publicly 
available instructions or recommendations issued in Slovenia by independent 
institutions, which are the Institute for Control and Certification, the University of 
Maribor (hereinafter: IKC UM), the international company Bureau Veritas,1 
operating in Slovenia, and the Institute for Agriculture and Forestry Maribor.2 
 
The importance of labelling GMO-free products and GMO-labelled products was 
analysed using a comparative research method. The analysis is based on a 
comparison of these two basic concepts, on a review of the legal definition of the 
terms, and on the control of the use of the terms. 
 
2.1 General terms 
 
A GMO is an organism whose genetic material is modified through crossbreeding 
or natural recombination in ways that do not occur naturally. All GMOs authorized 
for import into the European market are pre-screened by the European Food Safety 
Authority – EFSA,3 which follows professional guidelines. Moreover, the legislation 
of EU Member States stipulates that products produced with or from GMOs must 
be clearly labelled (Neuwirth & Svetlicinii, 2015). 
 
In the field of GMO tracking and labelling, manufacturers must comply with 
Regulation (EC) No 1830/2003 of the European Parliament and of the Council of 
22 September 2003 concerning the traceability and labelling of genetically modified 
organisms and the traceability of food and feed products produced from genetically 
modified organisms and amending Directive 2001/18/EC (hereinafter: Regulation 
1830/2003/ES). Regulation 1830/2003/ES is explicitly implemented in all EU 
Member States. 
 
 
 
1 The company provides the services necessary to achieve, maintain and demonstrate compliance with the 
requirements of quality, environment, safety and health at work and social responsibility, including certification, e.g.: 
selected quality, organic production and processing, Donau soy (i.e., GMO-free soybean foods), integrated 
production, protected agricultural products and foodstuffs. 
2 It is an institute that deals with control and certification, for example: integrated and organic production and 
processing of agricultural products or food, also deals with the award of the label DEMETER, which represents 
bio-dynamic farming according to DEMETER guidelines, with control and certification of agricultural products 
and foods labeled Selected Quality and Vegan. The institute also performs controls of private standards e.g.: Global 
G.A.P. 
3 See section 3.2 for more information. 
46 MEDICINE, LAW & SOCIETY.   
 
In the field of GMO management, Regulation (EC) No 1829/2003 of the European 
Parliament and of the Council of 22 September 2003 on genetically modified food 
and feed (hereinafter: Regulation 1829/2003/EC) applies in addition to Regulation 
1830/2003/ES. Regulation 1829/2003/EC’s main purpose is to help ensure a high 
level of protection of human life and health, animal health and safety, the 
environment and consumer interests in relation to genetically modified food and 
feed, while simultaneously ensuring the effective functioning of the internal market. 
This Regulation also delineates both the procedure for the approval and control of 
GMOs and the rules for the labelling of GMOs. 
 
The GMO label is mandatory for plant products containing more than 0.9 percent 
of genetically modified ingredients. However, it is not necessary to label meat, milk, 
eggs, fish, and other foods of animal origin which have been fed GMOs.4 
 
Despite legal restrictions, GMO management is a topical issue in EU Member States. 
The advantages of the use of GMOs include the reduction of pesticide consumption 
and a richer yield, especially in previously unusable areas. Opponents of the use of 
GMOs insist that their dietary use not only reduces biodiversity and endangers the 
health of users but also may contain allergenic substances due to the introduction of 
new genes in plants (Bakshi, 2011; Krimsky, 2019). 
 
Slovenian and EU law both stipulate that a GMO is an organism or microorganism 
whose genetic material is materially altered, through the processes of crossing or 
recombination, in manners that do not occur under natural conditions (humans are 
exempt). More specifically, GMOs are those organisms or micro-organisms that are 
obtained only by certain prescribed techniques or methods, which do not include 
techniques or methods of mutagenesis, i.e., a set of techniques that allow the genome 
of living species to be altered without the introduction of foreign DNA (EU Court 
of Justice 2019). 
 
Despite the current definition, the Court of Justice ruled in Case C-528/16 that 
organisms created by mutagenesis techniques are also GMOs. It follows from the 
decision of the Court of Justice of the EU that new ways of changing organisms, ie., 
mutagenesis techniques or methods, does not mean that these techniques or 
 
4 Article 12 of Regulation 1829/2003/EC. 
K. Meško Kuralt:  
The Importance of Labelling Products with a GMO or Non-GMO Label 47. 
 
 
methods should be exempted from existing EU standards on GMOs (Meško Kuralt, 
2018; Wasmer 2019; EU Court of Justice 2019). 
 
Wasmer (2019) points out that companies and research institutions dealing with 
GMOs face considerable legal uncertainty. Although, in principle, the uncertainties 
associated with the procedure for applying for a GMO release can be resolved 
through procedural changes, in reality these uncertainties cannot be resolved without 
a change in EU law relating to GMOs. However, any such solution requires the 
constructive cooperation of not only the European institutions but also the EU 
Member States. Absent changes in GMO legislation, Wasmer argues that a crisis 
may arise, namely that regulatory agencies will fight to enforce the GMO regime, 
international trade relations will be adversely affected, European agriculture will be 
deprived of opportunities for sustainable innovation and employment, and research 
and development will cease (Wasmer, 2019). 
 
Substantial research has been performed concerning the effects of GMO (Buiatti et 
al. 2013; Launis 2008; Koch, 2010). Séralini, Mesnage, Clair and others are 
convinced, both theoretically and practically, that the use of GMOs in everyday life 
represents the right solution to prevent light currents in the world (Séralini et al., 
2011). 
 
Only GMO products that have been approved in the European Union can be 
obtained on the European market. The procedure for the authorization of (new) 
GMOs is performed in accordance with Regulation 1829/2003/EC5 in Directive 
2001/18/EC to the European Parliament and the Council of 12 March 2001 on the 
deliberate release into the environment of genetically modified organisms and 
repealing Council Directive 90/220/EEC (Directive 2001/18/EC).6 
 
 
5 In addition to the general principles set out in Regulation 178/2002/EC (i.e., risk analysis, free movement of food 
and feed between EU Member States, precautionary principle, consumer protection), the main objective of 
Regulation 1829/2003/EC is to define the basis for ensuring a high level of protection, human life and health, 
animal health and protection, the environment and consumer interests in relation to GM food and feed, while 
ensuring the effective functioning of the internal market, lay down procedures for the approval and control and 
determine the method of labeling GM food and feed. The procedure applies to: foodstuffs containing or consisting 
of GMOs; for foods produced from GMOs or containing ingredients produced from GMOs and GMOs for use 
in foodstuffs (Article 3 of Regulation 1829/2003/EC). 
6 The procedure for the administration of GMOs as or in products is defined in Part C of Directive 2001/18. The 
authorization procedure refers to a GMO or a combination of GMOs as a product or in products placed on the 
market (standard procedure). 
48 MEDICINE, LAW & SOCIETY.   
 
The GMO-free label provides information that the product both does not contain 
genetically modified organisms and that it is not produced from genetically modified 
organisms or with genetically modified organisms. The GMO-free label may be 
applied only when the products are actually inspected based on certain or 
standardized (commercial) criteria. Only then may such products be labelled 
»Pridelano/proizvedeno brez GSO – brez gensko spremenjenih organizmov©«, which 
represents a private certification scheme in Slovenia. The certification scheme is 
voluntary and available to all those manufacturers / providers that want to 
participate in the certification process. 
  
In Slovenia, the »Pridelano/proizvedeno brez GSO – brez gensko spremenjenih organizmov©« 
xx certificate, while not prescribed by law, has been awarded by the IKC UM since 
2011.  
 
In order to obtain the certificate, the acquirer must demonstrate compliance not only 
with the requirements of general legislation in the field of GMOs, but also with any 
additional private (commercial) standards and requirements. There are currently 600 
products on the market in Slovenia (accessed 10 August 2020), which are labelled 
»Pridelano/proizvedeno brez GSO – brez gensko spremenjenih organizmov©«. Thus, even 
ordinary products are not organic. 
 
Moreover, Slovenian legislation stipulates that only certain industrial property rights 
can be registered, i.e., patents, additional protection certificates, models, trademarks7 
and geographical indications, which have judicial protection of rights and 
representation of parties in proceedings (Article 1 of the Industrial Property Act). 
 
7 Trademarks, as one of the intellectual property rights, can be acquired not only at national and regional levels, but 
also at EU and international levels. Registration at the national level is done at the EU's national intellectual property 
offices, at the regional levels in Belgium, the Netherlands, or Luxembourg at the Benelux Office for Intellectual 
Property (BOIP), registration at the EU level can be done in all EU Member States by registering with the European 
Union Intellectual Property Office (EUIPO), and international registration takes place with the World Intellectual 
Property Organization (WIPO). National and regional trademarks are essential for those users who do not want or 
need trademark protection at the EU level. EU trademarks allow users who so wish to obtain protection in all EU 
Member States. In any case, the EU brand can be extended to the international level, so that the trademark obtained 
is valid in all signatory countries to the Madrid Protocol (European Union Intellectual Property Office, 2020). If the 
mark is not used or is used incorrectly, the mark may also be revoked from the proprietor. In more detail, as follows 
from the judgment of the High Court in Ljubljana, in Cpg 479/2017 substantive objections against the registered 
trademark owner are admissible without the need to initiate a special procedure, i.e., by an action or by a declaration 
of invalidity in proceedings before a registration authority. The only difference is in the scope of protection, as 
success with an action for annulment under Article 114 of the Intellectual Property Act - ZIL-1 causes the 
termination of the registered right (first and second paragraphs of Article 72 of ZIL-1), while the enforcement of 
nullity objections has effect only in a concrete dispute. 
K. Meško Kuralt:  
The Importance of Labelling Products with a GMO or Non-GMO Label 49. 
 
 
However, the legislation does not provide for certification of commercial 
designations such as e.g., »Pridelano/proizvedeno brez GSO – brez gensko 
spremenjenih organizmov©«. 
 
In Austria, the certification process for GMO-free food production is performed 
based on guidelines adopted by the State of Austria, i.e., Österreichische Codex-
Richtlinie zur Definition der Gentechnikfreien Produktion von Lebensmitteln und 
deren Kennzeichnung idgF, which have been in use since 1998. Given that all EU 
Member States follow a "farm-to-fork" strategy8, the widespread use of GMOs in 
Austria is not allowed. However, since 2010, an exception has been carved out in 
Austria for additives and technological agents used in the production of feed (e.g. 
amino acids, vitamins) that can be produced with the help of GMOs. In Austria 
(currently 10 August 2020), more than 3,500 products, including organic food, are 
labelled "Ohne Gentechnik hergestellt" (Arbeitsgemeinschaft für Gentechnik-frei 
erzeugte Lebensmittel, 2020). 
 
In Germany, the designation "Ohne Gentechnik" is based on the guidelines laid 
down in national regulations, i.e., Regelung zur Kennzeichnung "Ohne Gentechnik", 
which have been in force since 2008. Manufacturers of GMO-free labelled products 
also must comply with Regulation 1830/2003, which sets forth rules on the 
traceability and labelling of GMOs and the traceability of food and feed produced 
from GMOs, such as labelling of milk, meat and eggs where animals have been fed 
GMO-free feed for a long time. The restriction on GMO-free labelling does not 
apply to additives used in feed preparation (e.g., amino acids, vitamins) and animal 
treatment. In the production of food, additives, vitamins and enzymes, the 
legislation in the field of organic farming applies, i.e., Commission Regulation (EC) 
No 834/2007 of 28 June 2007 on organic production and labelling of organic 
products and repealing Regulation (EEC) No 2454/93 2454/93 2092/91 
(Regulation 834/2007/EC). Currently (accessed 10.8.2020) there are more than 
8000 products in Germany labelled "Ohne Gentechnik hergestellt" (Verband 
Lebensmittel ohne Gentechnik, 2020; Institute for Inspection and Certification, 
2020). 
 
8 The “farm to fork” strategy is at the heart of the Green Deal, which sets out how to make Europe the first climate-
neutral continent by 2050. The “farm to fork” strategy thus comprehensively addresses the challenges of sustainable 
food systems, recognizing the inextricable links between healthy people, healthy societies, and a healthy planet. It is 
also a central part of the Commission's agenda for dosing the United Nations Sustainable Development Goals 
(European Commission, 2020). 
50 MEDICINE, LAW & SOCIETY.   
 
 
3 Labelling of the product with the GMO label and with the GMO-free 
 label 
 
3.1 Meaning of labels on the product with "GMO" 
 
Only GMOs approved at the European Union level can be legally traded or made 
available to consumer in the market. The approval process begins by filing an 
application for the approval of an individual GMO and continues with review by the 
European Food Safety Authority (EFSA). Once the EFSA has issued a favourable 
opinion on the risk assessment for the approval of individual GMOs, the procedure9 
continues within the Standing Committee on the Food Chain and Animal Health 
(hereinafter: The Committee). 
 
If no decision is taken by The Committee, or if a qualified majority is not reached, 
the procedure shall continue with the Board of Appeal of the Council of the EU. 
Three solutions are possible if the Appellate Body of the Council of the EU does 
not decide on the approval of GMOs. The first solution is that the European 
Commission approves an individual GMO based on a positive opinion of the EFSA. 
The second solution is that GMOs are rejected. The third solution is where the 
European Commission does not take a decision on GMOs. 
 
Thus, the labelling of products that contain GMOs or produced from GMOs are of 
great importance in the application for approval of an individual GMO for 
marketing (hereinafter: application for approval of GMOs). Directive 2001/18/EC 
and Regulation (EC) No 1830/2003/EC10 help ensure both the traceability and 
labelling of GMOs at all stages of introduction of the product into the market. 
 
In addition to both the environmental risk assessment and satisfying the conditions 
for placing the products on the market and producing the other required information 
referred to in Article 13(2) of Directive 2001/18/EC and Article 5 of Regulation 
1828/2003/EC, the application for GMO approval additionally must be 
accompanied by a labelling proposal. The proposal must satisfy the requirements 
 
9 The procedure for the authorization of new GMOs for the market is based on Regulation 1829/2003/ES and 
Directive 2001/18/ES. 
10 Introductory remarks (29) of Regulation 1829/2003/ES. 
K. Meško Kuralt:  
The Importance of Labelling Products with a GMO or Non-GMO Label 51. 
 
 
laid down in Annex IV to Directive 2001/18/EC. The proposal for labelling thus 
already contains the proposed labelling of food and feed containing or produced 
from GMOs on the label or in the accompanying document. The proposed labelling 
must thus include the commercial name of the product, a statement: "this product 
contains genetically modified organisms", the name of the GMO, and the name and 
address of the person established in the EU responsible for placing the product on 
the market. All proposed labels must include information on genetic modification 
for the purpose of entry into one or more registries of changes in organisms that can 
be used to detect and identify GMO products for easier control and inspection. 
Information that cannot be placed, for confidentiality reasons, in the publicly 
accessible part of the register should be identified. 
 
An application for the approval of an individual GMO is thus submitted for the first 
time to the competent authority of an EU Member State. 
 
In Slovenia the competent authority is the Ministry of Agriculture, Forestry and 
Food. The competent authority shall acknowledge the date of receipt of the 
application and forward a summary of the application dossier both to the competent 
authorities of the other EU Member States and to the European Commission, which 
shall decide on the application. The approval procedure is continued in accordance 
with the rules set out in Part C of Directive 2001/18/EC. 
 
If an individual food or feed either containing GMOs or produced from GMOs is 
approved, all the above in relation to labelling shall also apply. This means that a 
food or feed containing or produced from GMOs contains the commercial name of 
the product, a statement: "this product contains genetically modified organisms", the 
name of the GMO, the name and address of the person established in the EU 
responsible for placing the product on the market and directions on how to obtain 
information in the publicly accessible part of the register. 
  
52 MEDICINE, LAW & SOCIETY.   
 
3.2 Meaning of the label on the product "GMO-free" 
 
To obtain the certificate and the mark "»Pridelano/proizvedeno brez GSO – brez 
gensko spremenjenih organizmov©« which is awarded by IKC UM, an application 
containing certain conditions defined by the rules of IKC UM is also required. In 
particular, a customer applying for the certification procedure for the label11 must 
not only be entered in the register of economic operators but must also have his 
activity registered and approved by the competent authority. 
 
At the suggestion of the customer applying for the certification process, IKC UM 
may also inspect the farm, production plant, feed mixer, warehouse, or shop. If a 
customer wishes to obtain a certificate granted by IKC UM, he must first register 
with IKC UM. The customer must include with the application a signed contract 
between the customer applying for the certification process and IKC UM. IKC UM 
then performs a customer check designed to assesses the level of risk, which is 
divided into four stages (level 0 - no risk, level 1 - low level of risk; the plant contains 
GMOs but there is no possibility of contamination, level 2 - medium level of risk; 
there is a possibility of contamination however, the various measures implemented 
by the customer prevent level 3 - high level of risk; there is a high level of risk of 
contamination with GMOs and certification according to the standard 
»Pridelano/proizvedeno brez GSO – brez gensko spremenjenih organizmov©« " is not possible). 
 
If the customer meets all the requirements of the documents specified in the rules 
of IKC UM and the products pass the inspection, the customer is issued a certificate 
and allowed to use the above mark. For the labelling of foodstuffs, the customer has 
the right to use this label by obtaining such a certificate. Certified feed can also be 
described as "Primerno za proizvodnjo živil po zasebnem standardu Pridelano/proizvedeno brez 
GSO – brez gensko spremenjenih organizmov ". To the extent that they comply with the 
rules set by the IKC UM, the owners of agricultural holdings or processing plants 
also have the right to use this mark. The same is true with respect to farms that have 
certified organic crops and food. The certificate according to the standard 
»Pridelano/proizvedeno brez GSO – brez gensko spremenjenih organizmov©«, issued by IKC 
UM, can also be permanently or temporarily revoked under certain conditions, and 
the scope of the certificate can also be expanded and reduced. The issuer of the 
 
11 It is a produced without GMOs - without genetically modified organisms. 
K. Meško Kuralt:  
The Importance of Labelling Products with a GMO or Non-GMO Label 53. 
 
 
certificate may also decide to issue only a partial certificate or to refuse to issue a 
certificate. Both possibilities are specified in the Rules of the certification procedure 
(Institute for Control and Certification UM, 2020). 
 
Another certificate provider, Bureau Veritas, is involved in the certification of the 
Donau Soja brand. This brand represents a quality scheme for food produced from 
soybeans and feed. The soybeans are grown only in the Danube basin. The scheme 
encourages and promotes the production and sale of GMO-free food and feed. The 
primary goal of this scheme is to increase soybean production in Europe and thus 
reduce the dependence of EU Member States on protein crop imports, while 
simultaneously offering a certified raw material that appears on the European market 
under a single brand. The Donau Soybean brand, which contains pre-prescribed 
standards, is intended for soybean growers, food producers (e.g., foodstuffs of 
animal and plant origin where soy is used as a basic raw material or as one of the 
ingredients), feed manufacturers and soybean traders. Bureau Veritas is a control 
body authorized by the international initiative Donau Soy to verify compliance with 
the requirements of the Donau Soy standard for the production and manufacture of 
soybean foods (Bureau Veritas, 2021). 
 
4 General information on the control over the scope of GMO use in 
 Slovenia 
 
Because Slovenia is one of the EU Member States, the producer of the GMO 
product must comply with several regulations, including Regulation 1829/2003/EC, 
Regulation 1830/2003/EC and Regulation implementing Regulation (EC) on 
genetically modified food and feed and Regulation (EC) on the traceability and 
labelling of genetically modified organisms, and Directive 2001/18/EC. 
 
The Inspectorate of the Republic of Slovenia for Agriculture, Forestry, Hunting and 
Fisheries - IRSKGLR, which is a body within the Ministry of Agriculture, Forestry 
and Food, has official supervision over the implementation of the above-mentioned 
regulations. This inspectorate performs official controls in the segment relating to 
food of animal origin. IKGLR also controls the production of genetically modified 
plants, which is defined in more detail in the Act on Co-existence of Genetically 
Modified Plants with Other Agricultural Plants (hereinafter: ZSGSROKR). 
 
54 MEDICINE, LAW & SOCIETY.   
 
Supervision of food and feed containing or produced from GMOs is carried out by 
the Administration for Food Safety, Veterinary Sector and Plant Protection 
(hereinafter: UVHVVR), which is also a body within the Ministry of Agriculture, 
Forestry and Food. In accordance with the Management of Genetically Modified 
Organisms Act (hereinafter: ZRGSO), control over GMOs is performed by the 
Inspectorate of the Republic of Slovenia for the Environment and Spatial Planning 
(hereinafter: IRSOP), which is a body within the Ministry of the Environment and 
Spatial Planning. 
 
The Health Inspectorate of the Republic of Slovenia (hereinafter: ZIRS) is also a 
body within the Ministry of Health. 
 
In connection with the provisions of the ZSGSROKR, acts that are contrary to the 
regulations are also punishable by a pre-determined sanction (for example: 
undeclared production of a genetically modified plant (hereinafter: GMP), GMP 
production contrary to a production declaration or annual production plan located 
in GMP production areas, non-implementation of coexistence measures and non-
compliance with GMP producers). 
 
According to the ZRGSO, the production of illegal GMPs is also punishable. 
 
The Nature Conservation Act (hereinafter: ZON) prohibits the cultivation of 
GMOs if the introduction / release of GMOs is prohibited. 
 
4.1 Review of the work of supervisory bodies that control the scope of 
 GMO use in Slovenia 
 
In Slovenia, the agricultural inspectorate, IRSKGLR, is responsible for the scope of 
GMOs. The 2017 IRSKGLR report states that the presence of GMOs was detected 
in tested products based on the analysis of green parts of maize, oilseed rape and 
soybean plants in fields or seeds on farms. Samples taken at harvest, included nine 
samples of maize, two samples of oilseed rape and five samples of soybean. Based 
on the opinion of the analysis assessor from the National Institute of Biology, all 
samples were consistent. Thus, this competent inspection did not expose any 
irregularities with respect to this area of work and accordingly, there was no need to 
impose any penalties. Linked to the 2016 report, it also appears that the Agricultural 
K. Meško Kuralt:  
The Importance of Labelling Products with a GMO or Non-GMO Label 55. 
 
 
Inspectorate inspected for the presence of GMOs in the green parts of maize, 
oilseed rape and soybean plants in fields or seeds on farms. Samples were taken 
partly before sowing and partly from seed residues after sowing. Eleven samples of 
maize, one sample of oilseed rape and two samples of soybean were taken. Based on 
the opinion of the National Institute of Biology analysis analyst, all samples were 
consistent. In 2015, the green parts of maize, oilseed rape and soybean plants in 
fields or seeds on agricultural holdings were analysed for the presence of GMOs. 
The Agricultural Inspectorate thus sampled conventional seeds for possible random 
or unintentional presence of genetic changes. Seven samples of maize, two samples 
of oilseed rape and one sample of soybean were taken on larger farms. All samples 
were negative for the presence of GMOs. Based on the report, in November 2015 
the Inspectorate for Agriculture, Forestry, Hunting and Fisheries also supervised the 
sale of rapeseed seeds of the RAGT seed company. The seeds of the hybrid oilseed 
rape HRC 918 were reported to contain GMOs, OXY 235 seeds. Consequently, it 
was established that the said GMO seeds may not be sold in Slovenia. Rather, in 
Slovenia, the only seeds on the authorized variety list are the BONANZA F1 oilseed 
rape seeds, RAGT seed plant, supplier R.A.G.T. SAATEN OSTERREICH.  
 
The IRSOP Work Report shows that in 2017, inspectors performed 119 regular, 48 
extraordinary and 22 other inspections in the field of GMO control. They issued 53 
warnings and issued six inspection decisions to remedy the non-compliance. No 
misdemeanour proceedings were instituted. IRSOP receives very few reports in this 
area of work. Most of the work is carried out based on a program of supervision of 
persons liable for work in closed systems. The most common shortcomings 
identified in the control of GMO handling in closed systems are related to record 
keeping (e.g., keeping records of supervision over the implementation of 
containment measures, keeping records of training, preparation of written 
instructions for external cleaning staff, regular review of emergency plans or 
emergency) and the failure to implement prescribed containment measures (ensuring 
control of vectors, i.e., barred windows in the laboratory). IRSOP receives 
notifications through the "EU alert" system, through which Member States and the 
European Commission are informed about unauthorized GMOs found on the EU 
market. One such example was the genetically modified petunias in 2017. Based on 
information obtained from the European Commission on suspected sales of 
genetically modified orange petunias on the EU market, and in some Slovenian 
horticulture, IRSOP introduced control procedures carried out on fourteen 
56 MEDICINE, LAW & SOCIETY.   
 
taxpayers (i.e., horticulture). In the proceedings, it was determined that orange 
petunias with commercial names, as stated in the European Commission's 
notification, were also sold in horticulture. Horticulture in Slovenia purchased these 
petunias from at least three wholesalers from EU Member States. Individual 
horticulturists reported during the inspection that they had been notified in advance 
of the suspected presence of GMOs in orange petunias and accordingly had 
withdrawn them from sale and destroyed them. Thus, during the inspection, they 
were no longer in stock, could no longer be purchased and were not available for 
inspection. Individual horticulturalists stated, however, that they had already sold 
petunia seedlings by the time of the inspection. One horticulture stated he had 
withdrawn and destroyed the rest of the seedlings while one horticulture reported 
that he had used the rest for its own use. In view of the above findings, there was 
no reason for further inspection procedures or for the imposition of inspection 
measures and so the proceedings against the taxpayers were terminated. 
 
In 2016, the IRSOP conducted eight regular inspections of GMO handling in closed 
systems involving either the first or second safety class.12 In relation to the identified 
shortcomings, a regulatory decision was issued (i.e., to ensure the implementation of 
the containment measure - work surfaces that can be cleaned), or warnings were 
issued on the minutes. The taxpayers involved in these inspections complied with 
the regulatory decisions within the agreed deadlines. The most common 
shortcomings identified as a result of these inspections were related to record 
keeping (records pertaining to supervision of detention measures, of training, of 
preparation of written instructions for external staff performing cleaning, regular 
checking of accident or emergency plans) and deficient implementation of 
prescribed detention measures. The taxpayers rectified the deficiencies in the 
minutes after the warnings were issued. 
  
 
12 Josef Stefan Institute, UL, Faculty of Veterinary Medicine - Mestni log, Faculty of Veterinary Medicine - Gerbičeva 
ulica, University of Ljubljana, Faculty of Chemistry and Chemical Technology, University of Ljubljana, Bio 
Technical Faculty, Department of Biology, UL, Bio Technical Faculty, Department of Agronomy, UL, Faculty of 
Electrical Engineering, University of Ljubljana, Faculty of Medicine - Institute of Biochemistry. 
K. Meško Kuralt:  
The Importance of Labelling Products with a GMO or Non-GMO Label 57. 
 
 
In 2015, the IRSOP conducted seven regular inspections of GMO handling in closed 
systems involving either the first or second safety class.13 The inspections revealed 
minor deficiencies, which were rectified by the taxpayers within a certain deadline. 
The most common deficiencies were related to the implementation of prescribed 
containment measures (i.e., minor damage to soil and laboratory equipment, missing 
biohazard label) and deficiencies in record keeping. 
 
4.2 Control over the labelling of GMO-free products in Slovenia 
 
IKC UM, as the owner of the certificate with the »Pridelano/proizvedeno brez GSO – 
brez gensko spremenjenih organizmov«© supervises the use of the certificate and label at 
points of sale, on websites and in the advertising and promotion of agricultural 
products or food/products or activities. Supervision is carried out as part of regular 
and additional controls. When supervising, IKC UM refers to its internal 
instructions.14 
 
In general, when IKC UM finds a discrepancy in the use of a valid certificate with 
the client, the client is notified of the irregularities or non-conformities and is given 
a deadline for taking appropriate action to bring these irregularities or shortcomings 
into conformance. However, where the supervisory authority finds non-
conformities in the context of an invalid certificate, it shall invite the client to provide 
a valid certificate. If this certificate is not available, the non-compliance shall be 
determined in accordance with the IKC UM operating instructions. 
 
If an infringement has been confirmed in the extraction process, IKC UM has 
several options. IKC UM may thus issue a certificate, may issue a certificate in part 
or provisionally approve it, or may not issue a certificate at all. However, when IKC 
UM finds non-compliance with a contractor who does not have a valid certificate 
(e.g.,: certification process is not completed or in progress, certificate revocation, 
certificate revocation, suspension) but a valid contract, IKC UM terminates the 
contract and requests references to immediate revocation IKC UM certificate for 
use in promotional or marketing purposes. When IKC UM finds non-compliance 
 
13 Lek d. d., Acies bio d.o.o., Institute of Chemistry Ljubljana, Faculty of Medicine Maribor, Faculty of Medicine 
Ljubljana, Institute of Pathology and Institute of Pharmacology, National Laboratory for Health, Environment and 
Food Maribor. 
14 More details in the Rules of the certification procedure, the Rules for the use of the IKC UM certificate and mark 
and the Rules for the use of certificates and marks of private certification schemes, IKC UM. 
58 MEDICINE, LAW & SOCIETY.   
 
with the Contractor, it terminates the contractual relationship and invites the 
Contractor in writing to immediately terminate the reference to the certificate and 
the IKC UM mark used for promotional or marketing purposes. 
 
Regarding the correct use of the certificate and the mark, third parties also can report 
violations to IKC UM. Alleged violations often consist of such matters as the 
unjustified reference to the certificate or unauthorized use of the mark for 
promotional and marketing purposes of the infringer. In case of identified violations, 
IKC UM notifies the violator in writing to immediately stop referring to the 
certificate and using the mark. 
 
4.3 Monitoring the use of GMO labelling in EU Member States 
 
 The labelling of food and feed containing or produced from GMOs is mandatory 
in EU Member States. The law stipulates that products produced from GMOs must 
be labelled with the words "genetically modified" or "produced from genetically 
modified (name of the organism)". The law also stipulates that operators must take 
steps to ensure the traceability of individual GMO labels through all phases of 
placing their products on the market (Ministry of Agriculture, Forestry and Food, 
2020).15 
 
It is generally accepted that GMO control authorities are responsible for taking 
action to prevent the spread of infections caused or likely to be caused by GMOs, 
to control GMO intake values where permitted, and to advise companies as well as 
individuals on the appropriate use of products that contain GMOs. GMO control 
authorities are autonomous bodies that conduct their work independently. This is 
critically important, as their work and decisions are not or should not be influenced 
either by politicians or private sector companies dealing with GMOs. In the territory 
of the EU Member States the following control authorities have the broad task of 
regulating the field of GMOs. 
 
15 It is a collection of internationally recognized standards and practices, instructions and other recommendations 
related to food, their production and safety standards. The Codex Alimentarius Commission, with a view to 
protecting human health, protecting the interests of consumers and promoting good business practice in 
international trade has adopted international standards for foodstuffs. The Codex Alimentarius Commission, 
established in 1963, is a joint body of the FAO and the WHO. The signatories of the Codex Alimentarius are 
countries that are otherwise members of the FAO and/or WHO. Slovenia has been a member since 1993 (World 
Health Organization, 2020). 
K. Meško Kuralt:  
The Importance of Labelling Products with a GMO or Non-GMO Label 59. 
 
 
The European Food Safety Authority (EFSA), established in 2002 in Parma, Italy, 
is an independent, scientific entity that is equipped to provide advice and 
information on the risks associated with the food chain. EFSA was established as 
part of a program designed not only to improve food safety in the EU but also to 
ensure a high level of consumer protection and restore and maintain confidence in 
the EU's food supply. Good cooperation is essential for the effective management 
of such an expansive area of food and feed safety, which is why the EFSA 
Management Board has adopted a cooperation strategy between the EU Member 
States and EFSA. The strategy requires each EU Member State to designate an 
information point that will be responsible both for organizing and coordinating 
work in the field of risk assessment at the national level and for the preparation and 
implementation of the EFSA work program (National Institute of Public Health, 
2020). 
 
In Slovenia, an agreement on the establishment of an information point for EFSA 
was signed by the Ministry of Agriculture, Forestry and Food. In Slovenia, within 
the adopted strategy, many different scientific networks (members) are included. 
These members are from different fields of work (e.g., members of the National 
Institute of Public Health are members of the scientific network for microbiological 
risk assessment, scientific network for risk assessment related to nanotechnology, 
scientific networks for food contact materials, scientific networks for data on food 
intake, scientific communication networks and scientific networks for novel foods) 
(National Institute of Public Health, 2020). 
 
EFSA's main task is to provide independent scientific advice on not only existing 
but also emerging food risks. In this way, EFSA contributes to the development of 
European legislation in the field of food safety, contributes to changes in rules and 
policies, and helps protect consumers from risks associated with the food chain. 
These same considerations also apply to products labelled with GMOs. Accordingly, 
EFSA is also responsible for food and feed safety, nutrition, animal health and 
protection, and plant health and protection. 
  
  
60 MEDICINE, LAW & SOCIETY.   
 
EFSA also collects scientific data and gathers expertise; provides independent, up-
to-date scientific advice on food safety; informs the public about its scientific work; 
and works with EU Member States, international organizations, and other 
stakeholders, to help develop and build confidence in EU food safety (European 
Food Safety Authority, 2020).  
 
Hilbeck, Meyer, Wynne et al. (2020) are convinced that EFSA is not performing its 
legally-required tasks. They believe that EFSA's predominant approach to assessing 
GM crops and food is based on what is called 'comparative safety assessment'. These 
comparisons require an overview of the sets of molecular, chemical, and phenotypic 
data from the GMP rather than the GMOs (many of which can only be remotely 
related to the GM variety). According to the authors, these data are not appropriate 
for predicting adverse biological, toxicological, and ecological effects. Moreover, the 
authors add that EFSA cites overly optimistic conclusions based on insufficient data 
from insufficient studies in its comparative environmental risk assessments. 
According to the authors, the responsibility for choosing how EFSA implements its 
scientific approach should lie with the risk manager. The authors add that such 
responsibility could be transferred to the European Commission if it implemented 
the explicit commitments it had made under the Codex Alimentarius for years. 
 
Deluyker (2017), however, is of the opinion that EFSA fully justifies its existence 
and that it operates in full compliance with legal norms. He adds that there are 
scientific experts at EFSA who rely upon existing evidence and agreed assessment 
methods, the results of which are made public. He also argues that the work carried 
out under EFSA is of this quality, exhibits consistency, is independent, and reflects 
impartiality, as well as transparency and openness. For successful operation, it is 
important to constantly monitor science, follow evolving trends (e.g., nature is 
increasingly burdened by external influences, so it is necessary to adapt in order to 
find good alternative solutions, especially in the field of human and animal nutrition, 
which encourages sustainable development). 
 
As stated by Chvátalová (2019), EFSA is an independent institution that performs 
its work in a completely professional, precise, and independent manner. Chvátalová 
examined part of the environmental risk assessment resulting from the EFSA 
scientific opinion, in particular the effects of MON810 maize on bees and 
earthworms. The EFSA scientific document is the basis for the decision to extend 
K. Meško Kuralt:  
The Importance of Labelling Products with a GMO or Non-GMO Label 61. 
 
 
the authorization for the legal cultivation of MON810 maize. His research indicates 
(Chvátalová, 2019) that “the scientific studies cited in the EFSA Opinion in the sections 
concerning the possible impacts of GM maize on honeybees and earthworms stem predominantly 
from reliable sources in terms of authorship, financial support, and status of the study. However, 
the reliability of the studies varies significantly concerning the ecological relevance of the experiments. 
Moreover, the body of referenced evidence is insufficient to draw conclusions on risk. Relevantly, 
several types of shortcomings in the use of scientific information in the risk assessment were identified 
as prevalent, namely: EFSA omits relevant available studies, selectively cites information, misquotes 
studies, fails to acknowledge uncertainties, fails to call for further research where needed, and fails 
to critically interpret studies and their findings.” 
 
The European Medicines Agency (EMA) is a decentralized EU agency responsible 
for the scientific evaluation, control and monitoring of the safety of medicines in the 
EU. Founded in 1995, it is headquartered in Amsterdam. The EMA is a network 
organization comprised of thousands of experts from all over Europe. These experts 
carry out the work of the seven EMA Scientific Committees (i.e., the Committee for 
Medicinal Products for Human Use, the Committee for Veterinary Use, the 
Committee for Orphan Medicinal Products, the Committee for Advanced 
Therapies, etc.). The main tasks of the EMA are: 
 
− encourages the development of medicines and their availability, 
− evaluates applications for marketing authorizations, 
− monitors the safety of medicines throughout their life cycle, and 
− provides information to healthcare professionals and patients 
(European Medicines Agency, 2016). 
 
One of the EMA’s roles is to link regulatory authorities and the pharmaceutical 
industry in order to discuss the scientific and technical aspects of the registration 
and maintenance of medicines. Coordination between authorities is achieved 
through the development of guidelines generated by The International Council for 
the Harmonization of Technical Requirements for Pharmaceuticals for Human Use 
(ICH). The key to satisfactory performance is the commitment on the part of the 
regulators to implement (enforce) these guidelines. Moreover, the ICH guidelines 
(i.e., around 60 guidelines) are increasingly recognized as international standards 
(European Commission, 2020b). 
62 MEDICINE, LAW & SOCIETY.   
 
EMA works closely with EU Member States and seeks to establish strong links with 
partner organizations around the world in order to, among other things, promote 
the timely exchange of regulatory information and expertise and to develop best 
practices in the field of drug regulation worldwide. The EMA is thus involved in a 
wide array of endeavours, such as investigating and examining the efficacy of 
products intended for markets outside the EU (e.g., products examined in 
accordance with the procedure laid down in Article 58 of Regulation (EC) No 
726/2004 of the European Parliament and of the Council of 31 March 2004 
Authorization and supervision of medicinal products for human and veterinary use 
and establishing a European Medicines Agency (Regulation 726/2004/EC), the 
quality of medicinal products and the development of international non-proprietary 
names. 
 
For EU Member States, one of the most important forums is the multilateral 
international cooperation of the ICH, which links regulatory authorities for the 
medicines and pharmaceutical industries from Europe, Japan, and the United States. 
The ICH Council focuses on coordination in the areas of safety, quality, and efficacy, 
which are the main criteria for approving new medicines. The International 
Veterinary Conference for Coordination is also a forum for medicines designed for 
veterinary use, and performs the same role as the ICH performs for human health 
(European Medicines Agency, 2020). 
 
In the EU Member States, Regulation 726/2004/EC, which deals primarily with 
marketing authorization procedures and the supervision of medicinal products for 
human and veterinary use, applies in the field of medicinal products. Generally, 
medicinal products containing or consisting of GMOs may be subject to 
environmental risks. Accordingly, a specific environmental risk assessment 
procedure must be carried out for those medicinal products. However, the COVID-
19 outbreak changed circumstances. Therefore, a (provisional) regulation has been 
adopted, namely, Regulation (EU) 2020/1043 of the European Parliament and of 
the Council of 15 July 2020 on the conduct of clinical trials with and supply of 
medicinal products for human use containing or consisting of genetically modified 
organisms intended to treat or prevent coronavirus disease (COVID-19) 
(hereinafter: Regulation 2020/1043/EC). This Regulation, in order to search for a 
vaccine against coronavirus disease, allows for all activities related to the conduct of 
clinical trials to develop a human medicine for the treatment or prevention of 
K. Meško Kuralt:  
The Importance of Labelling Products with a GMO or Non-GMO Label 63. 
 
 
COVID-19. It also provides that such products (materials) containing or consisting 
of GMOs do not require a prior environmental risk assessment or approval (Article 
2 of Regulation 2020/1043/EC). Obviously, the world currently is confronted with 
an emergency in which the use of GMOs plays an important role, not only for 
science but primarily for global public health. The importance of the use of GMOs 
in the world is underscored through such extraordinary events. Therefore, even the 
many detractors of GMOs must consider the potentially significant role they might 
play in the field of virology in the face of a pandemic taking the lives of millions.  
 
The European Chemicals Agency (ECHA) is dedicated to the safe use of chemicals. 
Established in 2007, and based in Helsinki, Finland, the ECHA is focused on 
European chemicals legislation that not only protects human health and the 
environment but also promotes innovation and competitiveness. The ECHA 
performs the following primary tasks: 
 
− assisting companies to help ensure compliance with the requirements 
of EU chemicals and biocides legislation; 
− working with international organizations and stakeholders to 
promote the safe use of chemicals; 
− developing and promoting a unique, free-of-charge database 
containing information on chemicals and their safe use; 
− working with the Commission and EU Member States on the 
identification of chemicals of concern and deciding at the EU level 
on risk management measures, and; 
− promoting innovation in the chemical industry by removing 
substances of concern and replacing them with safer substitutes 
(European Commission, 2020b). 
 
The ECHA thus regulates chemicals on the EU market. It both processes 
documentation regarding chemicals prepared by manufacturers and verifies their 
compliance with legal requirements. ECHA, together with EU Member States, 
focuses on the most hazardous substances in cases where additional risk 
management is needed to protect both the public and the environment. With the 
help of applicable legislation in the field of chemicals, the ECHA provides numerous 
benefits, in the realm of the adoption of measures designed to: 
64 MEDICINE, LAW & SOCIETY.   
 
− reduce exposure to hazardous chemicals; 
− better inform the public both on the hazards associated with 
chemicals and their safe use; 
− assist the public with complying with regulatory requirements (e.g., 
innovative companies can take advantage of the phasing-out 
requirement), and; 
− informing the public on the safe handling of hazardous chemicals. 
 
According to the British researcher Petruzzello (2020), the great advantage of 
chemicals16 over mechanical weed control is their ease of use. This is especially true 
for cereal fields, pastures, forests, and other cases where airplanes can be used to 
broadcast the chemicals used to control weeds. Millions of hectares are cultivated 
aerially each year, and modern herbicide-type tillage equipment makes weed control 
increasingly convenient (e.g., sprayers, tillage equipment and herbicide spreaders 
allow farmers to cultivate the soil faster; machines that simultaneously build flower 
beds, plant seeds, spray with insecticides and include fertilizers and herbicides in one 
process). 
 
However, some agricultural plants, known as herbicide-resistant crops, have been 
genetically engineered to resist certain chemical herbicides, in particular glyphosate. 
These GMOs have been available since the mid-1980s and allow for effective 
chemical weed control, as only plants, i.e., herbicide-resistant crops survive in fields 
 
16 Chemical weed control has been used for an exceptionally long time. Sea salt, industrial by-products and oils were 
used first. Selective control of broadleaf weeds in cereal fields was discovered in France in the late 1990s and this 
practice soon spread throughout Europe. Sulphates and nitrates of copper and iron were used, and sulfuric acid 
proved to be even more effective. The application was by spraying. Soon, sodium acetate became popular as a spray 
as a soil sterilizer. Thousands of kilometers of railways and sugar cane and rubber plantations in the tropics have 
used hazardous substances in exceptional quantities, often poisoning animals and occasionally humans. Diesel oil 
as a general herbicide and sodium dinitrokrezilat (Sinox) as a selective plant-killing agent were introduced in the first 
three decades of the 20th century. Sinox, the first major organic chemical herbicide, was developed in France in 
1896. In the late 1940s, new herbicides were developed from research during World War II, and the era of 
miraculous weed killers began. In 20 years, more than 100 new chemicals have been synthesized, developed and 
used. Chemical weed control has replaced plant disease and insect control in economic terms. The year 1945 marked 
a new period of chemical weed control. Then 2,4-D (2,4-dichlorophenoxyacetic acid), 2,4,5-T (2,4,5-
trichlorophenoxyacetic acid) and IPC (isopropyl-N-phenylcarbamate) were introduced, the first two selective as 
foliar sprays against broadleaf weeds, the third selective against grass species when applied through the soil. The 
new herbicides were revolutionary, as their high toxicity allowed for effective weed control at doses of one to two 
pounds per hectare. This was in contrast to carbon bisulfide, borax, and arsenic trioxide, which were needed at rates 
of up to one tonne per hectare, and sodium chlorate, required at rates of about 100 pounds per hectare. However, 
some of these early herbicides, including 2,4,5-T, were later assessed as hazardous to humans and the environment 
and discontinued in many countries. Effective herbicides continue to be developed, and some, such as glyphosate, 
are widely used worldwide (Petruzzello, 2020). 
K. Meško Kuralt:  
The Importance of Labelling Products with a GMO or Non-GMO Label 65. 
 
 
treated with the appropriate herbicide. However, as Petruzzello (2020) points out, 
these crops only serve to encourage increased application of chemicals to the soil, a 
practice which remains particularly controversial, especially in terms of both its 
environmental impact and general safety. 
 
The field of GMOs and chemicals is a particularly important area, especially in terms 
of its potentially detrimental consequences for humans and the environment. On 
the other hand, there are obvious benefits as well. For example, it both perpetuates 
and enhances the existence of certain crops, as their adaptability to weather 
conditions allows growth and development. To minimize the negative long-term 
effects of the use of chemicals, while at the same time maximizing their advantages, 
in my opinion it is necessary to constantly monitor and control this area, both 
professionally and secularly (i.e., objectively reporting the results and outcomes of 
the effects of chemicals containing GMOs or GMO products). 
 
The European Centre for Disease Prevention and Control (ECDC), founded in 
2005, and based in Stockholm, Sweden, seeks to improve the protection of the 
population of EU Member States against communicable diseases (e.g., helping EU 
Member States and monitoring the spread of COVID-19 disease across the EU). 
 
The ECDC is primarily tasked with analysing and interpreting data from the EU 
Member States concerning 52 communicable diseases and conditions. Its analysis is 
performed utilizing The European Surveillance System (TESSy).17 The ECDC 
provides scientific advice to EU Member States and EU institutions. It also works 
on the early detection of new communicable diseases and analysis of new threats to 
EU countries. The ECDC also coordinates the European Training Program in 
Interventional Epidemiology and the European Training Program in Microbiology 
in Public Health. In case of disease outbreak,18the ECDC aids EU Member States 
(European Commission, 2020c). The work of the ECDC is based on the knowledge 
of professional staff, trans-European disease networks and national public health 
authorities (European Center for Disease Prevention and Control, 2015). 
 
 
17 It is a computerized system that systematically provides the collection analyzed in the dissemination of data on 
communicable disease control in Europe. 
18 For example, in the event of an outbreak of Covid-19, the ECDC has issued long-term care guidelines for EU 
Member States, targeting both staff and residents in long-term care facilities (European Commission, 2020c). 
66 MEDICINE, LAW & SOCIETY.   
 
The ECDC operates three important systems covering different areas of disease 
management, namely: hazard detection and warning, epidemic notification, and 
disease monitoring. The ECDC works closely with other EU agencies and non-EU 
organizations, i.e., the European Medicines Agency, the European Food Safety 
Authority, and WHO. The ECDC’s work benefits the various EU public health 
stakeholders, including in particular (European Centre for Disease Prevention and 
Control, 2015): 
 
− national and sub-national public health authorities in the EU/EEA; 
− EU institutions; 
− other European policy makers, and; 
− public health experts, researchers, international organizations, and 
national authorities outside Europe. 
 
Having the technical ability and knowledge to be able to measure the number of 
GMOs in food has proven to be especially useful in the field of disease prevention 
and treatment. The measurements used are similar to those used by scientists to 
count and treat therapeutic viruses with a single dose of Zolgensma.19 Zolgensma is 
a gene therapy treatment used for babies suffering from spinal muscular atrophy and 
who are less than two years old. The drug was approved by the FDA in America in 
May 2019. Spinal muscular atrophy (SMA) is a severe neuromuscular disease 
characterized by loss of motor neurons, leading to progressive muscle weakness and 
paralysis (Naso et al., 2017). 
 
Modern drugs such as Zolgensma used in gene therapy make it possible to correct 
defects in human genes and thus treat dreadful genetic diseases. Unlike traditional 
medicines, these drugs do not contain chemical compounds, but instead viruses that 
serve as "delivery vehicles" for healthy replacement genes. Adeno-associated virus 
(AAV) is a non-enveloped virus that can be engineered to deliver DNA to target 
cells, and has attracted a significant amount of attention in the field, especially in 
clinical-stage experimental therapeutic strategies. The genetically modified adeno-
associated virus is important for use in gene therapy. Their different strains deliver 
 
19 This medicine has not yet been authorized in the EU, but the Committee for Medicinal Products for Human Use, 
which operates within the EMA in May 2020, recommended that Zolgensma be granted a conditional marketing 
authorization.  
K. Meško Kuralt:  
The Importance of Labelling Products with a GMO or Non-GMO Label 67. 
 
 
packets to different body tissues, on the target cells. By selecting an individual strain, 
the drug can be delivered to a specific selected tissue. The AAV virus efficiently 
transfers healthy genes to human cells, where it replaces inactive genes that cause 
disease (Naso et al., 2017). 
 
SMA causes a mutation in the survival motor neuron 1 gene (hereinafter: SMN1), 
which requires motor neurons - the nerve cells that control muscle contraction - to 
survive the SMN protein. The mutation prevents this gene from producing 
functional proteins. Zolgensma is designed to replicate working copies of the SMN1 
gene in motor neurons. Zolgensma thus comprises a shell (capsid) of a genetically 
modified AAV virus that contains a normal copy of the SMN1 gene for targeting 
motor neurons. When the SMN1 gene (called a transgene because it comes from an 
external source) reaches a patient’s cells, it allows those cells to produce SMN 
proteins. The SMN1 transgene in Zolgensmi consists of double-stranded DNA, 
which means that it has the same shape as natural genes and can be activated more 
quickly, making therapy faster and more effective. Zolgensma also includes genetic 
instructions for activating the transgene so that SMN protein production is 
continuous and sustained (Bio News Serices, 2021). 
 
Scientific methods are still urgently needed to develop revolutionary medicines. The 
method of counting GMOs is thus important for the development of Zolgensma. 
The National Institute of Biology (hereinafter: NIB) has developed experience in 
this counting method. NBI is thus collaborating with the biotechnology company 
AveXis from the Novartis Group in further research. 
 
The European Environment Agency (EEA) was established by Regulation 
1210/90/EEC and is based in Copenhagen, Denmark. Its main task is to provide 
targeted and reliable environmental information. Additionally, the EEA assists EU 
Member States not only in taking decisions on improving the environment and 
integrating environmental aspects into economic policies but also achieving 
sustainable development. 
 
68 MEDICINE, LAW & SOCIETY.   
 
Regulation 1210/90/EEC also established the European Environment Information 
and Observation Network20 (EIONET). Currently, 33 countries21 and six observer 
countries participate in this network.22 
 
The EEA has also established European thematic centres to manage, analyse and 
collect data on key environmental issues. The centres are organized into networks 
involving approximately 90 specialized organizations across Europe (e.g., the 
Commission, the European Parliament, the Council of the EU and other EU 
institutions, participating EU Member States, a number of NGOs23, the scientific 
and academic community, business organizations and companies). The public is also 
among the most important target groups. The EEA thus seeks to provide the public 
with a better understanding of the importance of environmental and climate change 
issues, including the recent impact of GMOs on humans, animals, plants, and the 
environment (European Environment Agency, 2019). 
 
The EEA publishes reports every five years on the state, trends, and prospects for 
the environment. These reports, which have been prepared since 1995, not only 
assess the state and forecasts of the European environment but also provide 
information on the implementation and development of EU policies. The 2020 
report was published at a time when the companies and consumers are facing false 
information and news. This reality is also reflected in the report, which ensures 
transparency by making comprehensive references to not only scientific findings but 
also an improved approach to assessing and communicating aspects of quality, 
uncertainty and knowledge gaps. The report was also the subject of extensive peer 
 
20 The EEA is the institution responsible for the development of Eionet and the coordination of its activities 
together with the national contact points in the EU Member States. 
21 28 EU Member States as well as Iceland, Liechtenstein, Norway, Switzerland, and Turkey. 
22 Albania, Bosnia and Herzegovina, Montenegro, Northern Macedonia, Serbia and Kosovo (in accordance with 
UN Security Council Resolution 1244/99 and the International Court of Justice Opinion on the Declaration of 
Independence of Kosovo) (access, 15.8.2020). 
23 In Case T-33/16, the EU General Court ruled that the effects of GMOs on human or animal health fall within 
the field of the environment, so that non-governmental organizations under Regulation 1367/2006 require the EU 
institutions and bodies to, the right to participate in decisions on the placing on the market of foods containing 
GMOs. Moreover, the EU General Court annulled a decision by the Commission rejecting an NGO's request to 
review decisions authorizing the placing on the market of foods, food ingredients and feed containing GM soy 
(Court of Justice, 2019). The main purpose of the Aarhus Convention is thus to give rights to the public and to 
impose obligations on parties and public authorities regarding access to information and public participation and 
access to justice in environmental matters. As follows from the Council Decision of 17 February 2005 on the 
conclusion of the Aarhus Convention (2005/370), better public access to information and wider participation in 
proceedings are important means of raising public awareness of environmental issues and promoting better 
implementation and enforcement of environmental legislation.  
K. Meško Kuralt:  
The Importance of Labelling Products with a GMO or Non-GMO Label 69. 
 
 
reviews by the EIONET Commission, the EEA Scientific Committee, and 
international experts. The 2020 report also contains topics that are important in 
terms of the impact of GMOs on the environment, and especially food production. 
Genetic diversity, adaptation of species and ecosystems to environmental change 
is/will be crucial for sufficient food production (European Environment Agency, 
2019). 
 
To preserve the most diverse biodiversity possible, especially the conservation of 
individual plant species, genetic diversity is imperative. The level of biodiversity is 
the variability within a species that allows organisms to better use, change, and adapt 
to environmental changes such as drought, moisture, and so on. Additionally, good 
plant and animal genetics are critically important for agriculture in general and, for 
the food supply specifically (Martinez & Amri, 2008). 
 
In addition to improving the quality of agricultural products, genetic diversity also 
supports regulation for ecosystems of processes such as pest and disease control. 
The vast geography of the EU Member States supports many varieties of crops and 
animal breeds. Unfortunately, many of the varieties of both crops and animals are 
classified as endangered. At least 130 previously known breeds of cattle are already 
classified as “extinct” (Hiemstra et. al., 2010; Food and Agriculture Organization, 
2018). 
 
Researcher Fu (2015) is convinced that gens diversity24 will be needed to increase 
crop yields. Lynch (2016) and Bohanec (2013) are also of the opinion that the greater 
the genetic diversity, the greater the possibility of resilience to future climate change. 
 
The EEA report for 2020 contains topics that are so important for observing the 
impact of GMOs on the environment. One of the areas is the area of food 
production. Genetic diversity, adaptation of species and ecosystems to 
environmental change is / will be key to sufficient food production (European 
Environment Agency, 2019). 
 
 
24 The Genetic diversity is the total number of genetic characteristics in the genetic makeup of a species, it ranges 
widely from the number of species to differences within species and can be attributed to the span of survival for a 
species (Biological online dictionary, 2020). 
70 MEDICINE, LAW & SOCIETY.   
 
For example, plants and animals that are genetically tolerant to high temperatures or 
drought or resistant to pests and diseases are important in adapting to climate 
change, which requires a diverse genetic basis (Food Agriculture Organization, 
2018). 
 
5 Conclusion 
 
Affixing GMO labels on products that are accessible to Slovenian consumers is 
certainly important. In practice, however, it is difficult to draw the line and determine 
which method of labelling is better or more effective for the consumer. The labelling 
of GMOs is a method that is legally determined, while the method of labelling 
without GMOs or with the label »Pridelano/proizvedeno brez GSO – brez gensko 
spremenjenih organizmov«© is not legally determined. 
 
As there is no product in Slovenia that would be available to consumers for free sale 
and would contain the GMO label, this method cannot be compared with the 
method of labelling products with the GMO-free label. The key topic in Slovenia is 
that the GMO-free label is increasingly used on products on the market. The GMO-
free label is not required by law. Products containing the GMO-free label or 
»Pridelano/proizvedeno brez GSO – brez gensko spremenjenih organizmov«© are hindered on 
the market by all other products showing that they have no “unfair competition.”25 
Products intended for consumers in Slovenia that do not have the label without 
GMOs or »Pridelano/proizvedeno brez GSO – brez gensko spremenjenih organizmov«© 
therefore do not represent products that could contain GMOs, but products on the 
market that comply with applicable regulations are safe for consumers. 
 
My opinion is that the labeling of GMO products in EU Member States does not 
pose any serious risks, as GMO-labeled products underwent a comprehensive 
approval process before entering the market. However, non-GMO products are 
more dangerous for the consumer from the point of view of legal certainty, as the 
authorization procedure for such products has not been tested. 
  
 
25 Article 63a of ZPOmK-1 stipulates that unfair competition is the actions of companies in entering the market, 
which is contrary to good business practice and which determines or even causes damage to other companies. 
K. Meško Kuralt:  
The Importance of Labelling Products with a GMO or Non-GMO Label 71. 
 
 
According to Zilberman et al. (2018), mandatory labeling of GMOs on products is 
not only inefficient but also unfair. The authors thus resist a situation that leads to a 
misperception of genetically modified foods, as labeling is a misleading opinion, 
which exacerbates the existence of the concept of GMOs. Moreover, according to 
these authors, the mandatory labeling of products is ill-advised since this approach 
will only serve to perpetuate a persistent negative belief held by some about GMOs 
and will limit such products’ potential benefits to both human well-being and a 
healthier, more sustainable environment. 
 
In recent years, EU legislation regarding genetically modified crops has come under 
severe criticism, primarily on the bases that legislation in this area is inconsistent, 
disproportionate, scientifically outdated, and unclear in scope. In 2017, for example, 
Zetterberg and Edvardsson Björnberg analyzed EU legislation on GMOs utilizing 
five criteria: legal safety, non-discrimination, proportionality, scientific flexibility, 
and the inclusion of non-verbal aspects. They concluded that the European 
regulatory framework for GMOs does not currently meet the criteria of legal 
certainty, non-discrimination, and scientific flexibility. These researchers also 
suggested two ways to reform existing legislation that will not only better meet the 
principles and criteria of legal certainty, non-discrimination, and scientific flexibility, 
but also address security concerns. The two suggested reforms are: a new risk 
assessment protocol and new crop legislation based on sustainability criteria. The 
new risk assessment protocol would employ more flexible rules than those currently 
in existence. These malleable rules would be adaptable in the future for the 
development of risk assessments for different groups of GMOs. This kind of 
flexibility is preferable to the current one-size-fits-all risk assessment approach. This 
is a legal solution that, to some extent, promotes the principle of non-discrimination, 
as it serves to relieve investigative burdens on low-risk genetically modified varieties. 
The second reform, new crop legislation based on sustainability criteria, would 
abandon the current "double path" and replace it with new crop legislation based on 
sustainability criteria applicable to all varieties, regardless of the cultivation methods 
used. Instead of focusing on whether the crop was developed by genetic 
modification or conventional cultivation methods, the proposed legislation would 
deviate from the values that are key to achieving sustainable development in plant 
breeding. This is a solution in line with the principle of non-discrimination; however, 
it presents a completely different regulatory logic, as the primary goal of such 
72 MEDICINE, LAW & SOCIETY.   
 
legislation would no longer be merely to avoid risk and harm, but also to achieve 
foreign sustainability goals (Zetterberg and Edvardsson Björnberg, 2017). 
 
 
Acts, Regulations and Court Decisions 
 
Act on Co-existence of Genetically Modified Plants with Other Agricultural Plants/Zakon o soobstoju 
gensko spremenjenih rastlin z ostalimi kmetijskimi rastlinami - ZSGSROKR, Official Gazette 
of RS, No. 41/09 w/amendments.  
Council Regulation (EEC) No 1210/90 of 7 May 1990 on the establishment of the European 
Environment Agency and the European Environment Information and Observation Network, 
Official Journal L 120, 11/05/1990. 
Court of Justice of the EU, Case C-528/16, French Agricultural Association and French associations 
against the French Minister for Agriculture and the French Prime Minister, ECLI: ECLI: EU: 
C: 2018: 583. 
Court of Justice of the EU/Sodišče Evropske unije (2019) Letno poročilo 2018, Letni pregled (online), 
retrieved from: https://curia.europa.eu/jcms/upload/docs/application/pdf/2019-
06/20190650_ra_pan_sl_2019-06-06_09-48-23_42.pdf (20 September 2020). 
Decree on the implementation of the Regulation (EC) on genetically modified food and feed, and of 
the Regulation (EC) concerning the traceability and labelling of genetically modified organisms 
and the traceability of food and feed products produced from genetically modified 
organisms/Uredba o izvajanju Uredbe (ES) o gensko spremenjenih živilih in krmi in Uredbe 
(ES) o sledljivosti in označevanju gensko spremenjenih organizmov ter sledljivosti živil in 
krme, izdelanih iz gensko spremenjenih organizmov, Official Gazette of RS, No. 84/05 
w/amendments. 
Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the 
deliberate release into the environment of genetically modified organisms and repealing 
Council Directive 90/220/EEC - Commission Declaration, Official Journal L 106, 17/04/2001 
w/amendments. 
Management of Genetically Modified Organisms Act/Zakon o ravnanju z gensko spremenjenimi 
organizmi – ZRGSO, Official Gazette of RS, No. 23/05 w/amendments. 
Nature Conservation Act/Zakon o ohranjanju narave – ZON, Official Gazette of RS, No. 96/04 
w/amendments. 
Prevention of Restriction of Competition Act/Zakon o preprečevanju omejevanja konkurence - 
ZPOmK-1, Official Gazette of RS, No. 66/08 w/amendments. 
Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 
laying down the general principles and requirements of food law, establishing the European 
Food Safety Authority and laying down procedures in matters of food safety, Official Journal L 
31, 1/02/2002. 
Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 
on genetically modified food and feed, Official Journal L 268, 18/10/2003. 
Regulation (EC) No 1830/2003 of the European Parliament and of the Council of 22 September 2003 
concerning the traceability and labelling of genetically modified organisms and the traceability 
of food and feed products produced from genetically modified organisms and amending 
Directive 2001/18/EC, Official Journal L 268, 18/10/2003. 
Regulation (EC) No 401/2009 of the European Parliament and of the Council of 23 April 2009 on the 
European Environment Agency and the European Environment Information and 
Observation Network, Official Journal L 126, 21/05/2009. 
Regulation (EU) 2020/1043 of the European Parliament and of the Council of 15 July 2020 on the 
conduct of clinical trials with and supply of medicinal products for human use containing or 
K. Meško Kuralt:  
The Importance of Labelling Products with a GMO or Non-GMO Label 73. 
 
 
consisting of genetically modified organisms intended to treat or prevent coronavirus disease 
(COVID-19), Official Journal L 231, 17/07/2020. 
 
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