February 11, 2021
For observers, the EU’s increasing reliance on technical barriers to trade – most often health and phytosanitary measures – amounts to protectionism. But this is not the case, because the Union remains committed to free trade. The explanation lies in its willingness to impose upon third countries the precautionary principle and its own subjective view of science.
The problem is a significant one, as 20% of Specific Trade Concerns raised by WTO Contracting Parties relate to the European Union. These complaints involve issues that are technical but of huge importance: GMOs, beef hormones, use of antibiotics in animal production, zero tolerance for MRLs, and so on. More generally, the European Union has influence over dietary habits, as demonstrated by the ‘plant-based diet’ included in the Green Deal, or ‘Europe’s Beating Cancer Plan’ which recommends taxes on sugar and soft drinks.
This highly intrusive phenomenon carries considerable consequences for producers (as it drastically reduces their technical options), consumers (whose free choice is – in my opinion – excessively limited) and third countries which not only have to deal with significant over-costs that do not take account of regional characteristics, but also find themselves forced to develop specific production chains for the EU. In reality, the European Union is showing signs of unpleasant authoritarianism on this issue by refusing to admit that the need for food security can be upheld differently from one continent to another, and by failing to accept that there are alternative methods of equivalent effect available.
The precautionary principle in all its glory
During TTIP negotiations, the United States and the European Union shared the same willingness to ensure a high level of food safety for consumers, but were unable to reach agreement on how this principle should be realised in practice, due to Washington and Brussels’s differing perceptions of risk assessment, risk management and food standards. In Brussels, the precautionary principle is king!
Article 2 of the Lisbon Treaty states that the EU “shall promote scientific and technological advance”, giving the impression that the precautionary principle and the innovation principle go hand in hand. Nothing could be further from the truth. Unlike the precautionary principle (Article 191), the innovation principle is not recognised by the Treaties, so its use remains at the discretion of the Commission services which occasionally (or indeed, rarely) resort to it. Meanwhile, the precautionary principle is applied universally by DG SANTE, DG ENV and DG CLIMA. It is also guest of honour at the European Parliament and within several Member States, where its use tends to harden with the temptation to place the burden of proving harmlessness upon the producer (thus moving from a risk-based assessment to a hazard-based assessment). These developments will isolate the European Union even further from the United States and other great world powers.
Risk assessment vs risk management
The US and the EU have created their own systems, one diametrically opposed to the other. In the States, the situation is clear: the Food & Drug Administration (FDA) is in charge of BOTH the evaluation and management of risk. In the EU, it is the reverse: the risk evaluation is delegated to agencies (EFSA for food, EMA for medicines), but the risk management is entrusted to the Commission.
The perverse effects of this dual structure are reinforced by the status of the agencies: in the US, one could say that – even if the expression is inappropriate – the FDA lays down the law. Its analysis is paramount, and the legislator respects it. In the EU, it is the reverse: the agencies deliver opinions that the Commission is not bound by. Let us recall the glyphosate affair, when the Commission barely paid lip service to EFSA’s positive opinion. There was also the Orphacol case, when the Commission opposed the authorisation of an orphan medicine in defiance of the unanimous view of EMA, and was eventually sanctioned by the Court of Justice.
The result of all this is that the EU’s agencies are becoming factories of doubt. And in matters of food safety, there is nothing worse than doubt. Supposed to be objective, scientific opinion in this area is taking on a subjective character, varying according to different people and situations.
Many delegated acts, implementing acts and RPS measures,
and Better Regulation imperfectly applied
These quickly-sketched cases, which will receive more in-depth analysis in a soon-to-be-published second article, are naturally linked to delegated acts, Regulatory Procedure with Scrutiny (RPS) measures and implementing acts. Here too, as in many other files, we see a major governance defect within the EU and a chronic failure to uphold the principles of Better Regulation, i.e. lack of impact assessment, public consultations carried out too rapidly, expert groups insufficiently involved in the Commission’s draft, opaque discussions and an inability to identify expert group members.
Considering the above, any harmonisation of procedures between the European Union, the United States and the other great world powers is impossible, although it is necessary to demand more sustained attention from the WTO and Codex Alimentarius regarding an extension of recognised international standards.
The only practicable solution – provided the European Union accepts the need to come down from its Olympus – lies in the main global players really listening to each other with a view to expanding equivalence agreements and accepting alternative methods, as long as they offer all scientific guarantees of equivalent effect.
Also read my follow-up contribution: