The
Novel Food Regulation (European Parliament and Council Regulation 258/97)
lays down detailed rules for the authorization of novel foods and novel food
ingredients. It defines novel foods as foods and food ingredients that were not
used to a significant degree in the EU before May 15, 1997, which fall into the
following specific categories:
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foods and food
ingredients with a new
or intentionally modified primary molecular structure |
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foods and food
ingredients consisting of or isolated from micro-organisms, fungi or
algae |
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foods and food ingredients consisting of or
isolated from plants and food ingredients isolated from animals, except for
foods and food ingredients obtained by traditional propagating or
breeding practices with a history of safe use |
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foods and food ingredients to which a production process not currently
used has been applied, where that process gives rise to significant
changes in the composition or structure of the foods or food ingredients
which affect their nutritional value, metabolism or level of undesirable
substances |
Novel foods must undergo a
safety assessment before they can be placed on the EU market. Applications must
be submitted in accordance with
Commission Recommendation 97/618/EC
concerning the scientific aspects and the presentation of information required
to support an application. Products considered "substantially equivalent" by a
national competent food authority as regards their composition , nutritional
value, metabolism, intended use and the level of undesirable substances, may
follow a simplified procedure.
The EU's
new rules for GM food & feed
provide for the establishment of a separate regime to deal with the
authorization and traceability of novel foods and novel food ingredients that
consist of or contain or are derived from GMO’s. Article 46(1) of the new
regulation on GM food & feed (Regulation
1829/2003) provides that applications for the authorization of a GM food
made under Novel Foods Regulation, which have received a final scientific
assessment before the coming into force of the new regulation, are still to be
processed under the Novel Foods Regulation. Pre-market approval of non-GM novel
foods will continue under Regulation 258/97.
- "Proposal
for a New Novel Foods Framework Regulation" (GAIN report E48014 - Feb. 2008)
The following novel foods were approved to be commercialized in the EU:
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Maize germ oil high in unsaponifiable
matter (Commission
Decision 2006/723/EC)
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Rapeseed oil high in unsaponifiable matter
(Commission
Decision 2006/722/EC)
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Lycopene from Blakeslea trispora (Commission
Decision 200/721/EC)
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Diagylglycerol oil of plant origin (Commission
Decision 2006/720/EC)
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Food and food ingredients derived
from GM Roundup Ready maize line GA21 (Commission
Decision 2006/69/EC)
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Food and food ingredients derived
from GM maize line MON 863 (Commission
Decision 2006/68/EC)
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Rye bread with added phytosterols /
phytostanols (Commission
Decision 2006/59/EC)
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Rye bread with added phytosterols /
phytostanols (Commission
Decision 2006/58/EC)
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Isomaltulose (Commission
Decision 2005/581/EC)
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Food and food ingredients derived
from GM maize line NK 603 (Commission
Decision 2005/448/EC)
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Milk based beverages with added
phytosterols / phytostanols (Commission
Decision 2004/845/EC)
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Sweetcorn from GM maize line Bt11 (Commission
Decision 2004/657/EC)
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Yellow
fat spreads, milk based fruit drinks, cheese type products, yoghurt type
products, with added phytosterols
/ phytostanols (Commission
Decision 2004/336/EC)
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Milk type products and yoghurt type
products with added phytosterol esters (Commission
Decision 2004/335/EC)
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Yellow fat spreads, milk and yoghurt
type products, spicy sauces with added phytosterols / phytostanols (Commission
Decision 2004/334/EC)
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Yellow fat spreads, milk and
fermented milk type products, salad dressings, soy drinks, cheese type products
with added phytosterols / phytostanols (Commission
Decision 2004/333/EC)
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Salatrims (reduced calorie triacylglycerides
(Commission
Decision 2003/867/EC)
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Oil rich in DHA from the micro-algae Schizochytrium sp (Commission
Decision 2003/427/EC)
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Noni juice (Commission
Decision 2003/426/EC)
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Coagulated potato proteins and
hydrolysates therof (Commission
Decision 2002/150/EC)
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Dextran produced by Leuconostoc mesenteroides
(Commission
Decision 2001/122/EC)
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Pasteurized fruit preparations pasteurized by high-pressure treatment (Commission
Decision 2001/424/EC)
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Trehalose (Commission
Decision 2001/721/EC)
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Yellow fat spreads with added
phytosterol esters (Commission
Decision 2000/500/EC)
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Phospholipides from egg yolk (Commission
Decision 2000/195/EC)
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Three products were refused:
Betaine, the herbal product Stevia Rebaudiana and
Nangai nuts.
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