Europe prepares for drugs from genetically modified plants

Commercial development of pharmaceutical products and herbal has moved forward today with publication of the first European guidelines for the production of these genetically modified (GM) plants.

Prepared by the European Food Safety Authority Food (EFSA), based in Parma, Italy, guide describes how developers of genetically modified crops grown for uses other than human or animal consumption, such as the manufacture of pharmaceutical or industrial enzymes will must assess potential risks to humans, animals and the environment.

An EFSA risk assessment will be required where the company seeks approval for commercial cultivation of the plant. The evaluation will be forwarded to the European Commission and Member States to decide whether to grant permission. Unlike scientists who wish to grow GM crops for research purposes should only apply for a license in a separate member state in which they wish to grow crops.
On your marks

Reinhilde Schoonjans, scientific officer of the Scientific Panel of EFSA on GMO, the agency still has not received requests to modify plants to produce drugs. Internationally, only a few clinical trials of these drugs are ongoing, and will plant pharmed drugs on the market. Schoonjans but says the technology is developing rapidly and EFSA is currently unable to receive applications - will probably come mainly from university spin-offs. "We want to be ready," she says.

The EFSA will take into account the risks of growing genetically modified plants. Product safety at the plant will be considered by the European Medicines Agency (EMEA), which has guidelines for safety and quality requirements for plant-based medicines, which came into force in February.

Under the leadership of EFSA, developers should detail the biological differences between GM crops and conventional crops has been received and how they affect the function of the plant and growth. They also must do a risk assessment of engineered genes can be transferred to other plants and any hazards to humans and animals who accidentally eat transgenic crops.

Applicants must also specify the measures to take to monitor the plants and protection from exposure - such as warning signs, fences and sterilization of plants to prevent breeding.

How are GM foods labeled?

Labelling of GM foods and food products is also an issue. Overall, agribusiness industries believe that labeling should be voluntary and influenced by the demand for free market. If consumers prefer foods are labeled in non-labeled foods, then industry will have an incentive to regulate itself or risk alienating the customer. Consumer interest groups, on the other hand, want mandatory labeling. People have a right to know what they eat, argue that interest groups, industry and history has proved reliable in self-compliance with existing safety regulations. Current position of the FDA food labeling is regulated by food, medicines and cosmetics. Act which applies only to food additives, not whole foods or food products. The FDA contends that GM foods are substantially equivalent to not only genetically modified food, and therefore not subject to more stringent labeling requirements. If all GM foods and food products must be labeled, Congress must adopt radical changes in existing policy on food labeling.

There are many questions to be answered if labeling of GM foods becomes mandatory. First, consumers are willing to bear the cost of such an initiative? If the industry of food required for labeling of GM food factories will have to build two separate flow processing and control of production lines for this. Farmers should be able to GM crops and non-GM crops from mixing during planting, harvesting and shipping. It is almost certain that industry will pass along these additional costs to consumers in the form of higher prices.

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