Bridges Trade BioResVolume 3Number 13 • 11th July 2003

European Parliament Adopts Biotech Regulations on Traceability and Labelling


European Parliament Adopts Biotech Regulations on Traceability and Labelling

The European Parliament on 2 July adopted in its second reading two Commission proposals on the labelling and traceability of genetically modified (GM) food and feed. The Parliament’s vote will now have to be approved by the European Council of Ministers, expected for later this month. US farm groups and governmental sources strongly criticised the draft regulations for being unworkable, while civil society groups welcomed amendments introduced by the Parliament to regulate co-existence between GM and non-modified crops.

Specifically, the European Parliament approved the thresholds adopted by the Environment and Agriculture Ministers in late-2002, i.e. a threshold of 0.9 percent, below which GM products would be exempt from labelling, and 0.5 percent for the adventitious presence of GM organisms (GMOs) that are unauthorised but have nevertheless been assessed as risk-free (see BRIDGES Trade BioRes, 11 December 2002). They also amended the draft regulations to allow EU member states to impose “appropriate measures” to avoid the unintended presence of GMOs in other products (”co-existence”).

New regulations evoke various reactions

While the amendment to allow the implementation of co-existence measures was hailed as an important step forward by civil society groups, which have long been campaigning for strong measures to prevent contamination (see BRIDGES Trade BioRes, 10 March 2003), they called for such measures to be made mandatory rather than optional. Friends of the Earth also criticised the 0.9 percent threshold as too high and called for strict liability regulations.

US farm groups strongly criticised the Parliament’s decision, which they fear will create an even greater barrier to trade than the current de facto moratorium on the approvals of GMOs, currently being challenged by the US and others at the WTO (see BRIDGES Trade BioRes, 15 May 2003). “With this new labelling and traceability requirement, the EU has only made a bad situation worse,” said the American Farm Bureau, which urged the US administration to continue to “aggressively prosecute” the WTO case. Similarly strong criticism could be heard from US government sources. “We think [the draft regulations] are unworkable, and unenforceable,” said US Department of Agriculture trade official David Hegwood.

The Parliament’s vote will now have to be approved by the European Council of Ministers, expected for later this month. The regulation would then enter into force in September with a six-months compliance period. While the European Commission has repeatedly said that the de facto moratorium would be lifted once the regulations entered into force, it remains unclear whether the US and others would drop their WTO challenge even if approvals resumed.

What will be different under the new regulations?

- While the European food safety regulations introduced broad traceability requirements for food, feed, food-producing animals and any other substances intended for food use (see BRIDGES Trade BioRes, 7 March 2002), there are currently no specific requirements for products that contain or are derived from GMOs. Under the new regulations, operators using or handling GM products would be required to retain the information at each stage of the placing on the market.

- The new regulations would require labelling for GM feed and for products derived from but no longer containing GMOs, these are exempt from labelling under current rules.

- The current rules do not set a threshold for the accidental presence of unapproved GMOs in food or feed that have been assessed as risk-free. Under the new rules, the threshold would be 0.5 percent.

- Under the draft regulations, the current authorisation process would be simplified with a “one door - one key” procedure, i.e. a single risk assessment and a single application would be required to obtain approval for the deliberate release of GMOs into the environment and for use in food or feed. Scientific risk assessments would be conducted by the European Food Authority. The Commission would then draft a proposal for granting or refusing authorisation, which would be submitted for approval by member states within a Regulatory Committee.

“Wallström and Byrne welcome EP acceptance of a trustworthy and safe approach to GMOs and Gm food and feed,” EU PRESS RELEASE, 2 July 2003; “US unimpressed and unconvinced by new GMO legislation in the EU,” EurActiv, 3 July 2003; “MEPs back tougher GM labels,” FOEE, 2 July 2003; “US government, farmers aghast at proposed European biotech rules,” AFP, 3 July 2003.