Genetic Modification
Genetically modified (GM) foods and other types of novel foods can only be marketed in the European Union if they have passed a rigorous safety assessment.
Novel Foods
A novel food is defined as a food or food ingredient which does not have a significant history of consumption within the EU before May 1997.
All novel foods are subject to a pre-market safety assessment under the novel foods regulation (EC) 258/97. In the UK the ACNFP carries out all novel food assessments.
Risk assessment and authorisation of GM foods
The current procedures for evaluation and authorisation of GM foods are laid down in Regulation (EC) 1829/2003 on GM food and feed, which came into force in April 2004. The safety assessments are carried out by the European Food Safety Authority (EFSA), which published updated guidelines for the assessment of GM plants in March 2005.
Each application is reviewed on a case-by-case basis, including a detailed consideration of the potential for toxic, nutritional and allergenic effects. GM foods may only be authorised for sale if they are judged not to present a risk to health, not to mislead consumers, and not to be of less nutritional value than the foods they are intended to replace.
EFSA is responsible for publishing information concerning applications submitted under this legislation. Further details can be found on the EFSA website.
In carrying out its evaluation, EFSA may consult the authority responsible for food safety assessment in one of the EU Member States. In the UK this is the Food Standards Agency, which seeks expert advice on GM foods from the independent Advisory Committee on Novel Foods and Processes (ACNFP) as appropriate.
When an authorisation is requested that includes cultivation of GM crops for feed or food use, EFSA will consult the national competent authorities designated under Directive 2001/18/EC, which deals with the deliberate release of GMOs to the environment. The Department for Environment Food and Rural Affairs (DEFRA) is the contact point for the UK.
EFSA’s final opinion on each application is published for public comment before any decision on authorisation is taken. Check the European Commission’s website to get the maximum notice of these consultation periods.
The final decision on authorisation rests with Member States, who vote on each GM food at the Standing Committee on the Food Chain and Animal Health. The European Commission maintains a Register of GM food and feed materials that are authorised in the EU.
Labelling
In the case of pre-packaged GM food/feed products, European (Regulation (EC) No 1829/2003 and No 1830/2003) requires that the list of ingredients must indicate “genetically modified” or “produced from genetically modified [name of the organism]”. In the case of products without packaging these words must still be clearly displayed in close proximity to the product (e.g a note on the supermarket shelf).
These labelling requirements do not apply to GM food/feed products in a proportion no higher than 0.9 percent of the food/feed ingredients considered individually and if this presence is adventitious or technically unavoidable.Products such as meat, milk and eggs from animals fed on GM animal feed will also not need to be labelled. Details on the labelling rules can be found on the table on the FSA website: www.food.gov.uk/gmfoods/gm_labelling
Guidance
BRC/FDF Technical Standard for the Supply of Identity Preserved Non-GM Food Ingredients and Product
GM food and feed, and traceability and labelling of GMOs: Guidance notes on the regulations
Biotechnology Chronology
The word “biotechnology” according to the story ‘Banking on Biotech’ (Syracuse Post-Standard, September 29, 2002), first appeared in print in 1919. But humans were combining biological processes with technology to create medicines and foods long before anybody invented a word for it. Humans began growing crops and domesticating livestock around 8000 B.C.They began using yeast to ferment beer and leaven bread between 4000 B.C. and 2000 B.C. Mouldy soybean curds became the world’s first antibiotic when the Chinese used them to treat boils in 500 B.C.
2001 Complete human genome sequence published.
2000 109 million acres of biotech crops grown in 13 countries.
1998 Rough draft of the human genome map is produced, showing the locations of more than 30,000 genes.
1997 Dolly the sheep becomes the first animal cloned from an adult cell.
1994 First breast cancer gene is discovered.
1994 FDA approves an enzyme encoded by a marker gene called the kanamycin or kan (r) gene.
1993 FLAVRSAVR tomato, the first genetically engineered whole food approved by the FDA, hits the market.
1990 First experimental gene therapy treatment is performed successfully on a 4-year-old girl with an immune disorder.
1988 US Congress funds the Human Genome Project, a massive effort to map and sequence the human genetic code as well as the genomes of other species.
1986 Interferon becomes first anti-cancer drug produced through biotechnology.
1985 Genetic fingerprinting entered as evidence in a courtroom for the first time.
1984 DNA fingerprinting technique is developed.
1983 The first genetic markers for specific inherited diseases are found.
1982 U.S. Food and Drug Administration approves first biotech drug human insulin produced in genetically modified bacteria.
1980 U.S. Supreme Court approves principle of patenting genetically engineered life forms, allowing Exxon to patent an oil-eating microorganism. Herbert Boyer and Stanley Cohen obtain a patent for gene cloning.
1979 Human growth hormone first synthesized.
1978 Recombinant human insulin first produced.
1971 First complete synthesis of a gene .
1970 Researchers discover restriction enzymes that cut and splice genetic material, opening the way for gene cloning.
1966 The genetic code is cracked.
1963 New wheat varieties developed by Norman Borlaug increase yields by 70 percent.
1958 DNA is made in a test tube for the first time.
1955 An enzyme involved in the synthesis of a nucleic acid is isolated for the first time.
1953 Using Rosalind Franklin’s photographs, James Watson and Francis Crick describe the double helical structure of DNA, marking the beginning of the modern era of genetics.
1951 Rosalind Franklin obtains sharp X-ray diffraction photographs of DNA.
1950 Artificial insemination of livestock using frozen semen is successfully accomplished.
1946 Scientists discover that genetic material from different viruses can be combined to form a new type of virus, an example of genetic recombination.
1944 DNA, a nucleic acid, is proven to carry genetic information.
1941 Term “genetic engineering” first used.
1938 The term “molecular biology” is coined.
1930 US Congress passes the Plant Patent Act, enabling the products of plant breeding to be patented.
1928 While looking for a substance that would kill bacteria but leave living tissue alone, Alexander Fleming accidentally discovers that a mould is killing the staphylococci on a set of culture dishes. The mould is identified by a colleague as penicillin and developed into the first mass-produced antibiotic.
1927 Hermann J. Muller uses X-rays to cause artificial gene mutations in fruit flies.
1919 First use of the word “biotechnology” in print.
1911 First cancer-causing virus is discovered by Peyton Rous.
1906 The term “genetics” is introduced.
1902 The term “immunology” first appears.
1879 German embryologist Walther Fleming, while examining salamander larvae under a microscope, notices tiny rod-like structures inside the cell’s nucleus that appear to be dividing. The tiny threads are later called chromosomes.
1869 Johann Friedrich Miescher discovers DNA in human white blood cells and in the sperm of trout.
1865 Science of genetics begins: Austrian monk Gregor Mendel studies garden peas and discovers that genetic traits are passed from parents to offspring in a predictable way.
1859 Charles Darwin publishes the theory of evolution by natural selection. Using his theory, plant breeders crossbreed cotton, developing hundreds of varieties with superior qualities.
1830-3 Proteins and the first enzyme are discovered.
1797 Edward Jenner inoculates a child with a viral vaccine to protect him from smallpox. He invents the word “vaccination” to describe his experimental treatment, which will eventually rid the world of what was then a major killer of children.
1675 Antony van Leeuwenhoek discovers bacteria. He also discovers sperm cells and blood cells.
1663 Robert Hooke discovers existence of the cell.
1595 Zacharias Janssen, a Dutch lens-maker, invents the microscope, possibly with help from his father, Hans.
1322 An Arab chieftain first uses artificial insemination to produce superior horses
500 BC First antibiotic: Mouldy soybean curds used to treat boils in China.
4000-2000 BC Biotechnology first used to leaven bread and ferment beer, using yeast, in Egypt. Production of cheese and fermentation of wine starts in Sumeria, China and Egypt.
8000 BC Humans domesticate crops and livestock. Potatoes first cultivated for food
Source: Biotechnology Industry Organization, Chemical Heritage Foundation and various Internet sites