The second part of our briefing looks at the main safety issues associated with GM - as defined by the WHO - and the differences between regulation in the EU and the US.

More or less since the concept of genetic modification entered the public consciousness it has attracted controversy. Campaigners have aimed to draw attention to alleged risks to personal health and to the environment, though it is arguably the former that has resonated more with the public.

In the UK and elsewhere, 'frankenfoods' newspaper stories have appeared regularly across the media spectrum, while detailed and informed discussion of the environmental aspects to the debate is often limited to the broadsheets.

The debate in the UK over a planned public dialogue about GM to be undertaken by the Food Standards Agency (FSA) provided an illustration of how the two sides of the debate view consumer sensibilities over the GM issue. 

The planning of the dialogue, which has still not gone ahead, proved to be in itself a highly contentious process, leading to resignations from the FSA steering committee charged with setting its agenda. In essence, there was disagreement over how the issue should be presented to the public because some of those supportive of GM fear the public's response is intrinsically 'anti-science' and, fed by colourful reporting and campaigning rhetoric, widespread public suspicion of GM is irrational and ill-informed.

Food safety criteria

The World Health Organization (WHO) categorises the main food safety issues associated with GM as falling into three areas: allergenicity, gene transfer and outcrossing. 


WHO states that, as a matter of principle, the transfer of genes from commonly allergenic foods is discouraged unless "it can be demonstrated that the protein product of the transferred gene is not allergenic". However, it adds that no allergic effects have been found relative to GM foods currently on the market. 

Gene transfer

Gene transfer from GM foods to cells of the body or to bacteria in the gastrointestinal tract would cause concern if the transferred genetic material adversely affects human health, WHO states. In particular, this is a concern if antibiotic resistance genes, implanted during genetic modification, were transferred. While it concedes that the probability of such transfer taking place is low, a recent FAO/WHO expert panel encouraged the use of GM technology without antibiotic resistance genes.


The movement of genes from GM plants into conventional crops or related species in the wild is known as "outcrossing". While this may be viewed as primarily an environmental concern, with the threat of disrupting eco-systems, WHO states that the mixing of crops derived from conventional seeds with GM crops may have "an indirect effect on food safety and food security". It is for this reason that a clear separation of fields bearing GM crops and conventional crops has been mandated by a number of countries.

Regulatory process in the EU

As previously stated, the regulatory process for GMOs in the EU is tighter than in the US and other countries, such as Brazil and Argentina, where GM cultivation has also developed far more quickly. 

The question campaigners ask and for all stakeholders to consider is whether the more permissive regulatory processes in some countries are sufficient. Some campaigners believe the tighter framework in the EU is still not sufficiently rigorous and, for example, call for stricter controls on the importation of feeds made with GM crops.

The EU regulatory process begins with a risk assessment by the European Food Safety Authority (EFSA). If that is positive, EFSA's assessment forms the basis of a Draft Decision by the European Commission. Post-release monitoring, traceability and labelling plans need to be approved prior to marketing the product. Traceability is ensured by labelling and administrative records throughout the food chain. A table showing GM crops authorised in the EU is reproduced in Part Four of this briefing.

The EU regulatory system for GM is currently in a state of flux. Last July, the European Commission proposed giving EU member states the right to ban or allow the cultivation of GM crops, while preserving existing EU-wide controls on GM production. The proposal has been put before both EU ministers and the European Parliament for approval. 

However, in September, EU agriculture ministers failed to support the proposal, with Germany, France, Italy and Spain all expressing doubts over the viability of the plan. The move had already come under fire in the European Parliament. In February, a slight relaxation of the EU's zero tolerance ban on unauthorised GM crops received an initial go-ahead from member states, though this also remains subject to ratification by the European Parliament and Council of Ministers.

Currently, shipments of crops found to contain even trace levels of unauthorised GM material are rejected but the new rule would allow shipments of animal feed containing up to 0.1% of unauthorised GM crops into the EU.

Europabio alludes to two European Commission reports published in 2000 and 2010, covering 25 years of EU-funded research on potentially harmful effects of GM crops or food on human health or the environment, concluding that "there is, as of today, no scientific evidence associating GMOs with higher risks for the environment or for food and feed safety than conventional plants and organisms".

Regulation in the US

While the regulatory environment in the US is undoubtedly far more relaxed than in the EU, a recent furore over GM salmon has sparked renewed public concern over GM technology.

Earlier this month, the California Assembly Health Committee approved a measure which would see mandatory labelling of genetically modified fish in California. As it stands, no genetically modified fish is on sale in the US but the Food and Drug Administration (FDA) heard an application from Massachusetts-based AquaBounty Technologies for its AquAdvantage salmon last September, concluding that more research was necessary before a decision could be reached.

However, the debate over GM salmon and the recent California move has re-ignited the GM debate in the US. Not only does US law require no specific labelling of GM food but the Food and Drug Administration's position is that labelling should not "suggest or imply that GM foods are in any way different from other foods". 

US campaigners welcomed the California decision and are hoping that more state legislatures will tighten up their own regulations on GM. Currently as many as 14 state legislatures are debating whether to introduce labelling requirements for GM foods. 

As a result of the more permissive regulatory structure, GM is far more commonly found in processed foods in the US than in the EU. The Grocery Manufacturers Association (GMA), which represents US food producers, estimates that as much as 80% of processed food sold in the US contains some genetically modified ingredient. The GMA opposes mandatory labelling.

GM labelling in the EU

A critical difference between the regulatory approach in the EU and the US relates to labelling. According to EU law, any food or animal feed products containing or obtained from GM plants (when GM accounts for more than 0.9% of a particular ingredient) must be labelled as containing GMOs.

"This allows consumers to make an informed choice," Europabio states. The European GM trade body also points out that the 0.9% threshold was not a scientifically determined level but was agreed as part of the political settlement over GM regulation. "It is important to remember that in many cases the introduced trait in the GM plant simply helps improve the field performance of the crop," Europabio continues. "For farmers, choice is guaranteed through coexistence measures for organic, GM and conventional crops. Across the EU, co-existence measures have been very successful."

However, major retailers in the UK and in other EU countries still decline to carry products which are made from GMOs, reflecting public distrust of the technology. 

While products made from GMOs have to labelled, a key focus for campaigners has been the lack of a labelling requirement for meat and dairy products made from animals reared on GM feeds.

A GfK/NOP opinion poll commissioned last year by two campaign groups, GM Freeze and Friends of the Earth, found that 89% of consumers, from a sample of 1,000, said they would like to see food products made from animals fed on a diet including GM ingredients to be clearly labelled as such.

"We would like to see compulsory labelling at the EU level of meat and dairy products fed on GM feed which there is clearly strong public support for," GeneWatch UK director Helen Wallace tells just-food. "And an alternative, which would be a good first step, would be for the UK to follow what’s already been done in a number of other countries, which is to introduce a government-supported voluntary labelling scheme."

Voluntary labelling initiatives along these lines have already been introduced in a number of EU countries, while some retailers in the UK are now including information on-pack if meat or dairy products have been produced without using any GM feeds. Given the tenor of various debates over GM in the EU to date, there is a strong likelihood that pressure to extend labelling to products made from animals fed on GM feeds will increase.

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