Some observations on the “development
risk” in regulations concerning genetically
modified foods, new foods and dietary
supplements

Regulations concerning products such as genetically modified foods, new food
products or dietary supplements all have in common the one thing, namely: significant
difficulties (if not impossibility) in describing the safety of their use once
marketed. The EU legislator in each of these products has “created” a singular
“legislative safety standard” – considering the absence of any reliable factual
standard of safety. The domain of law and science touches both on substantive
as well as procedural law; the latter can significantly serve to precise the level of
risk connected with introducing a product on to the market and its monitoring.
This absence of a reliable factual safety standard results from a serious gap
in scientific knowledge or vague areas of the product qualification, which is
a consequence of the defective law. In many instances it is impossible for the
producer to cite the “development risk”. The legislative standard of safety,
within which there is no identification of factual risk, nor even any attempt
towards doing so – brings forth the question on the boundaries of legislative
experimenting. Discretion in such situations may prove to be a legislator’s virtue,
according to the old principle of primum non nocere.

Załączniki:
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