OBJECTIVE: the regulation concerns the placing on the market in the Community of foods resulting
from biotechnology.
COMMUNITY MEASURE: Regulation (EC) No 258/97 of the European Parliament and of the
Council concerning novel foods and novel food ingredients.
SUBSTANCE: the regulation applies to the placing on the market of novel foods and novel food
ingredients:
- containing genetically modified organisms within the meaning of Directive 90/220/EEC on the
deliberate release into the environment of genetically modified organisms;
- products from, but not containing, genetically modified organisms;
- with a new or intentionally modified primary molecular structure;
- consisting of or isolated from micro-organisms, fungi or algae;
- isolated from plants and from animals, except for those having a history of safe food use;
- to which has been applied a production process which gives rise to significant changes in the
composition or structure which affect their nutritional value, metabolism or level of undesirable
substances.
The regulation sets the general principle according to which the novel foods or food ingredients must
not:
- present a danger for the consumer,
- mislead the consumer,
- differ from foods or food ingredients which they are intended to replace to such an extent that their
normal consumption would be nutritionally disadvantageous for the consumer. In order to protect
public health, novel foods and novel food ingredients are subject to a single safety assessment
through a Community procedure before being placed on the market within the Community. This
assessment is carried out by the national authorities in cooperation with the Commission. A
simplified procedure is provided for in the case of novel foods or novel food ingredients which are
substantially equivalent to existing foods or food ingredients.
With a view to providing adequate information to the consumer, the regulation sets specific
additional requirements as regards labelling. The final customer is informed of:
- any characteristic or food property (composition, nutritional value, use) which renders a novel food
no longer equivalent to an existing food;
- the presence in the product of substances which are not present in the existing equivalent product
and which (a) may have implications for the health of certain sectors of the population (e.g.
allergenic substances); (b)give rise to ethical concerns;
- the presence of a genetically modified organism.
The Scientific Committee for Food will be consulted on any matter falling within the scope of this
Regulation. No later than five years from the date of entry into force of this Regulation the
Commission will report to Parliament and the Council on the implementation of this Regulation.
ENTRY INTO FORCE: 15/05/1997
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