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Between Domestic Fears and International Disciplines: EU Regulation of Biotechnology
Unformatted Document Text:  19 the regulation, “novel foods” were defined as all foods and food ingredients that had “not hitherto been used for human consumption to a significant degree within the Community” and included both foods that had been genetically modified as well as foods produced from, but not containing GMOs (for example, oils processed from genetically modified crops but no longer containing any traces of GM material). 16 The regulation went on to impose an authorization procedure for such novel foods, similar to the authorization procedure of Directive 90/220. As in the earlier directive, any individual seeking to market such novel foods would be required to submit an application in the member state in which it would first be placed on the market. That state would conduct a thorough assessment and take a decision, which once again could be contested by any member state, triggering the centralized EU regulatory procedure in which the Commission would again take the leading role, supervised by the Standing Committee on Foodstuffs consisting of member state representatives. Assuming that a given novel food was authorized for marketing, moreover, the Novel Foods Regulation also imposed additional requirements, including the labeling of foods containing GMOs or derived from GMOs (provided that the latter were “no longer equivalent” to their conventional counterparts). Significantly, however, the regulation also went on to provide a simplified regulatory procedure for foods derived from, but no longer containing, GMOs, provided that those foods remained “substantially equivalent” to existing foods in terms of “their composition, nutritional value, metabolism, intended use and the level of undesirable substances contained therein” (Article 3). Such a determination would be made by the competent authority in the member state receiving the application, and would be notified to the Commission, which would in turn notify the other member states. In practice, this provision would prove to be significant in the coming years, as member states would the regulation, see also Hunter (1999: 217-225) and Commission of the European Communities, “Novel Foods and Novel Food Ingredients,” http://europa/eu.int/scadplus/leg/en/lvb/I21119.htm , accessed on 11 April 2004. 16 The regulation would not apply to food additives, flavorings, or extraction solvents, governed by other EU legislation (Article 2).

Authors: Shaffer, Gregory.
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19
the regulation, “novel foods” were defined as all foods and food ingredients that had “not
hitherto been used for human consumption to a significant degree within the Community”
and included both foods that had been genetically modified as well as foods produced
from, but not containing GMOs (for example, oils processed from genetically modified
crops but no longer containing any traces of GM material).
16
The regulation went on to impose an authorization procedure for such novel
foods, similar to the authorization procedure of Directive 90/220. As in the earlier
directive, any individual seeking to market such novel foods would be required to submit
an application in the member state in which it would first be placed on the market. That
state would conduct a thorough assessment and take a decision, which once again could
be contested by any member state, triggering the centralized EU regulatory procedure in
which the Commission would again take the leading role, supervised by the Standing
Committee on Foodstuffs consisting of member state representatives. Assuming that a
given novel food was authorized for marketing, moreover, the Novel Foods Regulation
also imposed additional requirements, including the labeling of foods containing GMOs
or derived from GMOs (provided that the latter were “no longer equivalent” to their
conventional counterparts).
Significantly, however, the regulation also went on to provide a simplified
regulatory procedure for foods derived from, but no longer containing, GMOs, provided
that those foods remained “substantially equivalent” to existing foods in terms of “their
composition, nutritional value, metabolism, intended use and the level of undesirable
substances contained therein” (Article 3). Such a determination would be made by the
competent authority in the member state receiving the application, and would be notified
to the Commission, which would in turn notify the other member states. In practice, this
provision would prove to be significant in the coming years, as member states would
the regulation, see also Hunter (1999: 217-225) and Commission of the European Communities, “Novel
Foods and Novel Food Ingredients,”
http://europa/eu.int/scadplus/leg/en/lvb/I21119.htm
, accessed on 11
April 2004.
16
The regulation would not apply to food additives, flavorings, or extraction solvents, governed by other
EU legislation (Article 2).


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