GMOs Labelling: Detection Methods Likely to Have Casting Vote on Interpretation and Enforcement
Aug 30, 2000
The question as to whether – and why -
genetically modified (GM) foods and food ingredients should bear special labelling -
undoubtedly one of the hottest regulatory issues ever in the food sector in the European
Union – has now become history. GM labelling is a legal obligation in the EU.
However, that does not mean though that all questions have been solved. Out of the typical
questions raised by GM labelling only one has been solved in an almost unambiguous way,
that is the one regarding what information should be provided on the labelling (content).
For the rest, both the determination as to when specific labelling should be required, and
how to verify that the conditions triggering compulsory labelling are met, not to mention
the interpretation and likely enforcement by the 15 EU Member States, remain - at best -
unclear.
The first piece of EU legislation regulating
the labelling of GM foods was Regulation No 258/97 (the Novel Foods Regulation). It
applies to novel foods and novel food ingredients (including foods and food ingredients
containing or consisting of GMOs, and foods and food ingredients produced from but not
containing GMOs) and sets up (see its Article 8) the labelling requirements that are
applicable when those novel products are substantially different from their traditional
counterparts. Their specific labeling is then reviewed by the competent national
authorities as part of the authorization process.
Then, specific rules were laid down by
Regulation No 1139/98 (as amended) for the labelling of foodstuffs derived from the GM
Soya and maize that had been authorized respectively by the Decisions 96/281/EC and
97/98/EC issued on the basis of Directive 90/220/EEC (currently under revision as is
discussed in an other article in this issue of EU Advisory). This Regulation was deemed
necessary because GM foods produced from these GM seeds were not considered as novel under
the Novel Food Regulation on grounds that they had been placed on the market prior to the
entry into force of the latter Regulation and were consequently subjected to neither
pre-market approval, nor to specific GM labelling requirements. Pursuant to this
Regulation, specific GM labelling is compulsory for all foods and food ingredients which
are due to be delivered as such to the final consumer or mass caterers and which are
produced in whole or in part from these Soya and maize. By contrast, this text provides
that no GM labelling is required where no GM DNA and/or protein can be found in the
individual ingredients of the foodstuff. A negative non-exhaustive list still to be drawn
by the EC Commission will determine the products that meet the absence of DNA/protein
criteria and that are therefore exempted from labelling. Products, such as starch
hydrolysates, are candidates for this list. Also, importantly, it establishes a 1%
threshold for adventitious contamination below which GM labelling is not required provided
operators have taken appropriate steps to avoid using GM Soya and maize.
Regulation 50/2000 requires GM labelling for
foodstuffs containing GM additives and GM flavourings. This Regulation enshrines similar
labelling statements as well as the same criteria of absence of DNA/protein for GM
labelling exemption. The setting up of a de minimis threshold is also contemplated but not
yet determined. Obviously, considering the criteria retained for GM labelling, the
implementation of these Regulations is only possible using appropriate detection methods
for genetic modification which is the responsibility of the operators.
Aside from this legislation, work is
currently ongoing in the EU on the possible use of the « GM–free » claim.
The main question for the European legislator is to determine whether such a claim is
strictly reserved to products that have been produced without using genetic engineering or
whether it may also be used on the label of products produced from, but not containing,
GMOs. Other initiatives are expected in the GMOs area, notably concerning the GM additives
sold as such. Needless to say, these discussions will
continue to attract the attention of all interested parties and, because of the many
ambiguities in the texts, the many questions remaining regarding the interpretation and
enforcement of the labelling requirements are likely to be solved in a manner that will
have more to do with actual detection methods than strict legal interpretation.
© Article from Keller and Heckman’s ‘European
Advisory". June 2000 issue.
For further information, please contact Rachida Semail at semail@khlaw.be
or Jean Savigny at savigny@khlaw.be.