• Introduction

The Convention on Biological Diversity (CBD) defines biotechnology as:“any technological application that uses biological systems, living organisms, or derivatives thereof, to make or modify products or processes for specific use”.

The modern biotechnology includes gene technology and has the potential to increase production in agriculture, forestry and fisheries. It has already proven its value in microbial production of enzymes, antibiotics and therapeutic proteins. Recent new developments include new plants resistant to specific herbicides, plants giving higher crop yields and rice specifically genetically engineered to contain pro-vitamin A (beta carotene) and iron.

Genetically Modified Organisms are defined within EU legislation according to the two directives 90/219/EEC on contained use and 2001/18/EC (repealing directive 90/220/EEC) on deliberate release.

• Legislation

There is no harmonized legislation on a global basis, concerning GMOs. 

In the EU, a GMM to be used as a food or food ingredient would fall under the scope of the novel food regulation 258/97/EC, with references 2001/18/EC for the definition of a GMO. (A genetically modified microorganism (GMM) is also a GMO). Labelling regulations are also in place.

In the US products are assessed on their safety, regardless of production techniques or GMO status.  To date there is no labelling requirement based on the GMO status of the product.

In Australia and New Zealand products of gene technology are required to be approved prior to sale.  Labelling requirements are also in place.

Codex has established an Intergovernmental Task Force on Foods Derived from Biotechnology.  The aim is to complete the work by March 2003.

• Benefits

Microorganisms from across the broad spectrum of the species have been used for centuries in the manufacturing of food and feed. With gene techniques it is possible to create GMMs with very specific characteristics.

Future GMM applications will undoubtedly focus on high value-added end products with defined benefits in improved organoleptic quality, health, nutrition and safety.

• Safety/Technical 

Gene techniques provide the potential to direct the movement of specific and useful genetic segments with efficiency and accuracy. It is a precise tool, which offers great certainty about the traits introduced into the organism. Given sufficient time and selective pressure, as well as a means of identification, evolution would ultimately generate an analogue to the specific genetic trait of interest. EFFCA is convinced that by these techniques the consumers will benefit from microorganisms creating end products of high value.

Information about the process used to produce a GMM is important in understanding the new characteristics of the modified microorganism. Therefore, the strategy for construction of improved microorganisms has an impact on the safety assessment of the GMM, e.g. the choice of donor, host organism and marker genes.

Prior to the introduction of a GMM, a full safety assessment according to regulatory guidelines is carried out.

Key constituents to be dealt with include: taxonomic identification, characterisation of the donor and host organisms, assessment of the genetic construction and marker genes, analytical studies on the composition of the food and consumption pattern, and toxicological and allergenic considerations.

For living GMM in food, attention should focus particularly on their capability to survive and colonize the gastro intestinal tract and maintain the genomic stability. Since DNA occurs in all foods, the transferred genetic material itself is not subject to a safety evaluation.

The concept of substantial equivalence allows for comparison of the GMM food/food ingredient that is being assessed with a conventional counterpart.

The recent FAO/WHO Expert Consultation on foods derived from Biotechnology (2000) concluded that substantial equivalence contributes to a robust safety assessment framework. If substantial equivalence is found between a new food and an existing food, its safety can be treated in the same manner. It means that the GMM is as safe as its conventional counterpart.

• Challenges

The main challenges that face EFFCA and the microorganism industry when considering the introduction of GMMs are :  

            Assessment according to the Novel Food Regulation in EU

            Consumer perception and acceptance  

            Labelling and criteria for making nutrition and functional claims

            Elucidate the Europe-wide definition of self-cloning in relation to gene technology  

• Ethics

EFFCA trusts that the use of GMMs in food production is ethically acceptable if it confers a benefit to the quality of products, health of consumers and/or animals, or its use affords efficient and/or environment-friendly industrial processes. New genetically modified microorganisms are required to undergo full assessment according to regulatory guidelines, within the context of their intended use.

The ethical aspects of gene technology should be considered on a case-by-case basis by assessing the benefits against the potential risks.  The use of GMMs should respect human dignity, rights and values.  EFFCA supports the cooperation in the field of biotechnology between developed and developing countries.  Developing of any kind of biological weapons is strictly opposed. If a GMM is known to present a potential risk to certain groups because of ethnic, religious or ideological reasons, appropriate information must be given.