The European Commission has presented a proposal to amend the EU’s examination comitology procedure with the aim of forcing Member States to vote and take responsibility in the adoption of controversial decisions mostly affecting health and the environment, such as pesticides, GMOs, and chemicals.  If adopted, the proposed amendments are likely to result in an even stronger precautionary approach and the adoption of fewer approvals of politically sensitive products in the EU.  The amendments would also mean that companies who seek to have such products approved will need to put more efforts into influencing Member States and their national constituencies.  They are also likely to result in increased litigation before the EU Courts.

The Examination Procedure

The EU adopts most of its legislation and regulatory measures as “implementing acts” that are adopted by the European Commission after consulting Member States and do not require the full involvement of the European Parliament and Council through a full legislative procedure. For example, the European Commission adopted around 1500 implementing acts in 2016.

These implementing acts are adopted through the so-called “comitology” procedures regulated in Regulation 182/2011 on the Commission’s Exercise of Implementing Powers (“Implementing Powers Regulation”).  The most common comitology procedure is the “examination” procedure through which many key regulatory decisions in the areas of health, environmental and energy policy are adopted.  Implementing acts adopted through the examination procedure include approvals in the area of pesticides, biocides, GMOs, REACH, as well as exemptions from prohibitions on chemicals used in electronics.

The examination procedure requires the Commission to present its proposal to a Standing Committee of Member State representatives, who are typically national officials with a regulatory expertise in the dossier. In the areas of health and the environment, the Commission will usually be empowered to make a proposal only on the basis of a scientific review by one of the EU’s scientific bodies, e.g., EFSA, ECHA or the Commission’s scientific committees.

The Standing Committee must take a decision in favor or against the proposal by qualified majority, which requires a vote of 55% of Member States (i.e., currently 16 Member States) representing at least 65% of the European Union’s population.  Under the current rules, abstentions or Member States that are not represented at the Committee meeting neither count for attaining the qualified majority, nor are deducted from the required figures to meet such a qualified majority. The vote at the Committee may have three different outcomes: a favorable opinion, a negative opinion, or no opinion at all.

If the Committee fails to adopt an opinion because it cannot reach a qualified majority vote, the Commission may adopt its proposal except in certain cases, such as those concerning the protection of health or safety of humans, animals or plants. In those cases, the Commission must present its proposal to an Appeal Committee composed of Member State Permanent Representatives.  If the Appeal Committee also fails  to reach a qualified majority in favor or against the Commission’s proposal, it is up to the Commission to decide whether to adopt it.

Political Deadlock in Sensitive Sectors

In practice, the examination procedure results in a no opinion situation that forces the Commission to decide on its own in around less than 2% of all the proposals that the Commission presents. Yet, these situations occur in politically very sensitive areas that many times entail the application of the EU’s precautionary principle.  For example, last year the Commission was forced to decide on the adoption of the extension of the approval period for the pesticide glyphosate after the Member States were unable to reach a qualified majority in favor or against the Commission’s proposal.  There have also been numerous similar situations concerning the approval of GMOs.

Given the domestic political sensitivity of approvals on pesticides, GMOs and similar decisions, Member States will often prefer not to participate in the adoption of what is ultimately a political decision even if the Commission’s proposal is supported by the EU’s scientific bodies. In these cases, the Commission is thus left with the politically uncomfortable situation of either having to take the blame for adopting its proposal in the absence of sufficient Member State political support, or for dropping a proposal that it considers to be scientifically supported.

The Commission’s Proposed Amendments

To solve this political deadlock, the Commission proposes four key amendments to the comitology examination procedure with the objective of forcing Member States to vote in favor or against proposals it presents for adoption through this procedure. The four amendments would change the functioning of the Appeal Committee, but not that of the lower Standing Committees.

First, the Commission’s proposal would change the voting rules in the Appeal Committee so that Member States that abstain or are not represented at the Committee’s meeting are considered as “non-participating Member States” when calculating whether a vote in the Committee reaches a qualified majority.  The qualified majority (55% of Member States representing 65% of the population of the EU) would be calculated taking into account only those Member States that actually vote.

Second, the votes of the Member States at the Appeal Committee would be publicly disclosed. Currently, the Commission publishes for each proposal the total number of votes in favor, against or abstentions, but not the vote of each particular Member State.

Third, if adopted, the proposed amendments would allow the Commission to present for a second time its proposal to the Appeal Committee if it fails to deliver an opinion by qualified majority. However, if the second referral takes place, the Appeal Committee would be composed by Ministers of the Member States.

Fourth, where the Appeal Committee composed of Ministers still fails to deliver an opinion by qualified majority, the proposal would allow the Commission to refer the matter to the Council of the European Union for a non-binding opinion with a view to obtaining its political guidance on the implications of its failure to reach a qualified majority in favor or against the Commission’s proposal.

Impact: Stretching the Limits of the Precautionary Principle

The European Commission justifies its proposed amendments as necessary to ensure a democratic decision making process. According to the Commission, in particularly sensitive areas, Member States should take a clear position and not leave it to the Commission to decide.

However, it is questionable whether the Commission’s proposed amendments will increase the democratic accountability of the European Union, rather than result in a much more complex and politicized decision making process. The EU’s democratic legitimacy is not only based on Member States having a bigger say, and it is difficult to find regulatory systems around the world where legislative bodies adopt highly complex and technical decisions, such as marketing authorizations for a particular GMO or pesticide.  Instead, the democratic legitimacy of any implementing act, such as a market approval, is based on the EU regulatory framework (e.g., the Regulation on Plant Protection Products, Regulation on Biocidal Products) that allows the Commission to adopt those implementing acts and that was adopted by both the European Parliament and Council through a full ordinary legislative procedure.  One could argue that the Commission is giving away its responsibilities and, as a result, undermining its own credibility.  Moreover, it unclear whether the Commission’s proposed amendments are worth it given that they are trying to solve an issue that affects less than 2% of all the EU’s implementing measures.

Most importantly, the proposed amendments are likely to result in the EU adopting even fewer approvals for particular sensitive products or regulatory areas. A system that forces Member States to vote and to make their votes public in highly sensitive areas should increase the likelihood of a negative vote by those Member States, as they will fear domestic criticism; or to force the Commission to adopt a more precautionary approach when considering whether to present a proposal for approval, even after a positive scientific review.  These effects will be further emphasized once Brexit takes place, as the United Kingdom has tended to be an active supporter of a science-based approach, and its positions have often been followed by smaller or less active Member States.

In effect, the proposed amendments would emphasize the application of the precautionary principle in the EU and, are likely to discredit it in the long run. If, as expected, the proposed amendments result in more cases where Member States reject the adoption of approvals of sensitive products, it will be particularly difficult for the Commission to repeatedly justify before the EU courts the failure to take measures that have the backing of the EU’s scientific bodies. While the precautionary principle grants the Commission and other EU institutions a margin of discretion, EU law also requires that they justify their decisions.  It is unclear how far the EU Courts will go in stretching the application of the precautionary approach to cover such political rejections of scientific recommendations.

From a practical point of view, the Commission’s proposed amendments will require companies to master even more the EU’s comitology procedures, focus much of their efforts in convincing Member States and their political constituencies, and seriously consider that any proposal affecting their products may ultimately result in significant litigation before the EU courts.

The Commission’s proposal must now be considered for adoption by the European Parliament and Council through the ordinary legislative procedure. Ironically, the proposed amendments give the Parliament a new opportunity to increase its powers in the EU comitology decision making.  Member States, in turn, are expected to receive the Commission’s proposed amendments very negatively.  It remains to be seen whether they will be ready to consider the proposal, which they may amend significantly, or whether they will simply sit on it.