During the past week, I was intrigued by a post on the social media platform X from Pascal Canfin, Chair of the Committee on Environment, Public Health and Food Safety in the European Parliament which in translation read: “We have just rejected in Parliament a proposal from the Commission which would have allowed the importation of foodstuffs produced with a pesticide banned in Europe, tricyclazole. This would have been unfair competition that was unacceptable for our farmers. I welcome it.”
What intrigued me about this post was the implication that, because the Parliament had rejected the Commission proposal, the imports of foodstuffs (specifically, rice) produced with tricyclazole into the EU would no longer be possible. I contrast this with the position with respect to glyphosate where the Parliament had also strongly opposed the re-approval of this active substance and yet the Commission was able to proceed with its re-approval for a ten year period in November (see legislative act here).
What is the reason why the Parliament can obstruct the Commission proposal to raise the Maximum Residue Limit (MRL) for tricyclazole in rice but not prevent the re-approval of glyphosate?
The search for an answer brought me along the twists and turns of secondary legislation in the Union, and the important distinction between delegated and implementing acts. But before we examine their significance. let me first explain the issue of tricyclazole residues in rice.
Use of tricyclazole as a fungicide against rice blast
Rice blast is a serious fungal disease affecting rice crops worldwide caused by the fungus Magnaporthe oryzae. This disease can significantly reduce rice yields, affecting both quality and quantity of the harvested grain.
Tricyclazole is a systemic fungicide widely used to control rice blast. It works by inhibiting the synthesis of melanin in the fungus, disrupting its growth and preventing the spread of the disease. When applied preventively or at the early stages of infection, tricyclazole can effectively manage rice blast and protect the rice crop from significant damage.
Tricyclazole was included in the programme of work to examine the safety of previously-authorised pesticides under the 1999 Pesticides Regulation. Following an evaluation and a Commission review, the Standing Committee on the Food Chain and Animal Health concluded there were clear indications that tricyclazole may have harmful effects on human health and that data were missing to allow to set reliable values necessary to conduct the risk assessment. Other concerns were also identified by the rapporteur Member State in its assessment report. It therefore decided not to continue the authorisation of this active substance. Thus, since 30 March 2009, tricyclazole has not been allowed for use in the Union.
In 2012 Dow AgroSciences submitted an application to approve the use of tricyclazole in the EU, which was assessed by EFSA on the basis of its representative use as a fungicide on rice. The evaluation concluded in 2015 identified significant data gaps and critical areas of concern, and its use was not authorized.
As a consequence of its non-authorization, the then existing Maximum Residue Limit (MRL) of 1 mg/kg rice was scheduled to be reduced to the limit of quantification (LOQ) of 0.01 mg/kg. Dow AgroSciences also submitted an application in 2012 to maintain the existing MRL as an import tolerance to allow the import of rice treated with tricyclazole from third countries, using Brazil as the example. While the Evaluating Member State (in this case, Italy) initially recommended that the MRL should be set provisionally at the level 1 mg/kg to accommodate Brazilian exports, EFSA in its assessment concluded that the import tolerance request for tricyclazole in rice was not sufficiently supported by data needed to justify maintaining the existing EU MRL of 1 mg/kg in rice. The MRL for tricyclazole was reduced to the LOQ of 0.01 mg/kg after 1 Jan 2018.
In 2018 Corteva Agriscience (a new incarnation of Dow AgroSciences) applied for an import tolerance to set an MRL for tricyclazole on imports of rice from Brazil at 0.09 mg/kg. Following acquisition of additional data sought by EFSA for its evaluation, the data submitted in support of this MRL application were found to be sufficient to support an MRL proposal of 0.09 mg/kg for rice. EFSA concluded that the proposed use of tricyclazole on rice will not result in a consumer exposure exceeding the toxicological reference values and therefore is unlikely to pose a risk to consumers’ health. However, it did recommend additional risk assessment was needed to evaluate the metabolites of the group of triazole fungicides.
A digression on delegated and implementing acts
This section aims to explain the different bases on which the Commission can take decisions under powers conferred by the legislature in the basic acts. It gets into the nitty-gritty of differences between delegated and implementing acts (see this EPRS 2021 briefing for further background). For readers not interested in the detailed legal discussion, I summarise the key message of this section in the final two paragraphs, so skip down to that conclusion if you want to avoid the heavy going.
When deciding on legislation, to avoid overwhelming the legislature with technical and very detailed issues, it is usual to confer powers on the executive to adopt implementing rules, while reserving some powers for the legislature to supervise the actions of the executive. In the European Community, the ability to confer powers on the Commission to adopt implementing rules was granted in Article 202, Treaty of the European Community (Campo, 2021). The requirements in respect of the exercise of these implementing powers were laid down in Council Decision 1999/468 (‘the Comitology Decision’). Three different procedures – management, regulatory and advisory – were provided to scrutinize the role of the Commission via committees composed of representatives of the Member States.
In 2006, as a temporary measure, it was agreed to strengthen Parliament’s role in the supervision of the Commission’s powers by introducing a further procedure known as the regulatory procedure with scrutiny (RPS). Campo (2021) describes how this procedure consisted of two phases. In the first (executive) phase, the Commission is responsible for drawing up and submitting draft measures for examination by a committee of Member State representatives. In the second (supervisory) phase, this draft is submitted to the Council and Parliament to enable them to exercise their right of political supervision (meaning the right to oppose the adoption of the measure).
The Lisbon Treaty in 2009 made further changes by making a distinction between delegated acts in Article 290 TFEU and implementing acts in Article 291 TFEU . Delegated acts are broadly seen as the successor of the RPS (although with an important difference highlighted later). Article 290 TFEU provides that the objectives, content, scope and duration of the delegation of power shall be explicitly defined in the legislative acts. The Treaty provisions are supplemented by principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making including a Common Understanding on Delegated Acts. The Commission is required to consult experts designated by each Member State when drawing up a delegated act (but unlike under the RPS, this committee has no formal power to issue an opinion, it is simply consulted). The Treaty article allows the basic act to provide that a delegated act can enter into force only if no objection is expressed by either institution. Where this provision is included in the basic legislation, both the Council and Parliament have a veto power on delegated acts. For Parliament to exercise its right of veto requires an absolute majority and not just a majority of votes cast, i.e., a relative majority (Article 290, TFEU) while for the Council it requires a reinforced qualified majority (EPRS, 2021).
Where delegated acts confer on the Commission the power to supplement or amend certain non-essential elements of the legislative act, implementing acts are used where uniform conditions for implementing legally binding Union acts are needed. Article 291 TFEU provides that the Council and Parliament shall lay down in advance the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers. Note that it is the Council and Member States that are the key players when it comes to supervising the Commission’s implementing powers.
The procedures for adopting implementing acts are laid down in Regulation (EU) No 182/2011 (‘the Comitology Regulation’). Two types of procedures are envisaged: an advisory procedure and an examination procedure. Most basic acts specify the examination procedure. A committee composed of Member State representatives identified in the basic act expresses its opinion on the draft Commission implementing act by qualified majority. If there is a positive opinion, the act is adopted. If there is a negative opinion, the act is not adopted. If there is no opinion, the Commission may adopt the draft implementing act, with some exceptions. The exceptions relate to acts concerning taxation, financial services, definitive multilateral safeguard measures, and of specific relevance for our topic in this post, the protection of the health or safety of humans, animals or plants. There is also an exception if a simple majority of Member States vote against the measure (Article 5, Regulation 182/2011).
In that situation, the Commission may decide to submit an amended version of the draft act or submit the same act to the appeal committee for further deliberation. The appeal committee is similarly made up of representatives of Member States. In the appeal committee, a positive opinion means the draft act is adopted, a negative opinion means that the draft act cannot be adopted, and no opinion means that the Commission may adopt the draft implementing act (Article 6, Regulation 182/2011).
In the committee procedure, the Parliament has no direct role. However, along with the Council it has a right of scrutiny. Either institution can object that a draft implementing act exceeds the implementing powers provided for in the basic act. In such a case, the Commission shall review the draft implementing act, taking account of the positions expressed, and shall inform the Parliament and the Council whether it intends to maintain, amend or withdraw the draft implementing act (Article 11, Regulation 182/2011). However, unlike in the case of delegated acts, the Parliament has no right to veto the substance of an implementing act.
The remaining final step was to bring all the references to the way the Commission’s powers to adopt implementing legislation were supervised in the legislation adopted prior to the Lisbon Treaty into line with the streamlined approach set out in Articles 290 and 291 TFEU. This proved particularly contentious in the case of delegated acts. The Commission proposed a framework law that would have automatically converted all references to the use of the regulatory procedure with scrutiny (RPS) to the delegated act procedure. The Council was not happy with this. Under the RPS consultation with the committee of Member State experts was mandatory and required this committee to deliver an opinion (by QMV) on a draft implementing measure. Replacing this by a (non-binding) consultation of Member States on draft delegated acts was a very sensitive issue for many Member States (Campo, 2021).
Instead, references to the RPS in pre-Lisbon basic acts are amended on an individual case-by-case basis as the occasion arises. The RPS thus still exists whenever the pre-Lisbon basic (legislative) act envisages it and has not been amended. The alignment of the RPS with the post-Lisbon distinction between delegated and implementing acts is still ongoing. Of importance for this post is that the procedure for setting, modifying or deleting MRLs in the MRL legislation (Regulation (EC) 396/2005) remains the RPS.
Aligning the procedures for the supervision of implementing acts under Article 291 TFEU was much simpler. Article 13 of the Comitology Regulation automatically adapted the old advisory procedure (Art. 3 of the Comitology Decision) to the advisory procedure referred to in Art. 4 of the Comitology Regulation, and the management and regulatory procedures (Art. 4 and 5 of the Comitology Decision) to the examination procedure referred to in Art. 5 of the Comitology Regulation.
Key message for this section. This section has been hard going, with a lot of legal references. However, we can summarise the conclusions as follows. The Commission can be granted power to make rules under two separate procedures, using either delegated acts or implementing acts. Delegated acts are used when the Commission supplements or amends the provisions of a basic act, while implementing acts are used when the Commission is simply implementing the basic act. In the case of delegated acts, Parliament and Council each have a veto and can object to the Commission’s draft act thus preventing it from coming into force.
In the case of implementing acts, the power is with the Member States that can strike down a Commission proposal provided there is a qualified majority against the proposal. Parliament only has a right to state its view to the Commission that a particular implementing act exceeds the implementing powers provided for in the basic act. However, this does not amount to a right of revocation of delegation or objection to the act in question, as provided for delegated acts (EPRS, 2021). We will now see that the reason why Parliament is able to block an MRL decision but not the renewal of glyphosate is because the Commission’s power to make a decision follows different procedural routes in these two cases.
Procedure for glyposate renewal as an active substance
The approval or renewal of an active substance for use as a pesticide follows procedures laid down in the Pesticides Regulation (EC) 1107/2009. Article 20 of that Regulation provides for the renewal of active substances and states that a Regulation shall be adopted in accordance with the regulatory procedure referred to in Article 79(3) of that Regulation. This reference states that Articles 5 and 7 of Decision 1999/468/EC (‘Comitology Decision’) shall apply. Regulation (EU) 182/2011 (‘Comitology Regulation’) introduced after the Lisbon Treaty replaced the Comitology Decision and introduced two separate procedures for deciding implementing acts, the advisory and the examination procedure. Article 13(c) of that Regulation provides that, for basic acts adopted before the entry into force of that Regulation, where the basic act makes reference to Article 5 of Decision 1999/468/EC, the examination procedure referred to in Article 5 of the Comitology Regulation shall apply. Thus, the approval of glyphosate was considered an implementing decision taken under the examination procedure which only provides a very limited possibility for the Parliament to object.
The Commission forwarded its draft implementing decision approving the renewal of glyphosate to the Standing Committee on Plants, Animals, Food and Feed (SCoPAFF) made up of Member State representatives. The required majority to adopt (or reject) the proposal was not reached. The Commission then submitted its draft proposal to the Appeal Committee. On 16 November 2023, during a vote at the Appeal Committee, Member States again did not reach a qualified majority on the Commission’s proposal to renew the approval of glyphosate for 10 years. In the absence of a qualified majority in the Appeal Committee, the Commission argued it was legally obliged to adopt this decision before the expiry of the current approval. The Commission Implementing Regulation (EU) 2023/2660 renewing the approval was published in the Official Journal on 29 November 2023. The Parliament had no role in this process.
Procedure to raise the MRL for tricyclazole in rice
MRLs are established, modified or deleted under the MRL Regulation (EC) 396/2005 dating from 2005. It was updated by Regulation (EC) No 299/2008 to incorporate the changes made by the revision of the Comitology Decision in 2006, notably introducing the regulatory procedure by scrutiny (RPS).
This led to an amendment of Article 14 in the MRL Regulation dealing with decisions on applications concerning MRLs. Article 14 requires the Commission, following receipt of an opinion from EFSA and taking into account that opinion, to prepare a regulation to implement the setting, modification or deletion of an MRL. The 2008 amendment to the MRL legislation requires that that regulation shall be adopted in accordance with the regulatory procedure with scrutiny referred to in the amended Article 45(4) of the MRL Regulation.
Although the RPS procedure is now replaced by delegated acts, as noted above to make this change requires a specific amendment to the individual acts of basic legislation. This change has not been made as yet to the MRL legislation, which still refers to the RPS. According to Article 45(4) of the MRL Regulation the regulatory procedure with scrutiny applies according to Article 5a of Council Decision 1999/468. Under this procedure, both the Parliament and the Council have a right of veto.
On 18 January 2023, EFSA adopted a favourable Reasoned Opinion on the evaluation of the safety of the proposed modified MRL for tricyclazole in rice. The evaluation was triggered by an application for import tolerances pursuant to Article 6(2) and (4) of the MRL Regulation (EC) No 396/2005 for tricyclazole used in Brazil on rice. The Commission submitted therefore a proposal to modify the existing MRL for tricyclazole in rice, raising it from the limit of quantification (LOQ) established at 0.01 mg/kg to a level of 0.09 mg/kg, to the Standing Committee on Plants, Animals, Food and Feed (SCoPAFF) on 11 May 2023, for an opinion.
According to the recitals in the Commission draft Regulation, “The Authority concluded that, for the product concerned, all requirements with respect to completeness of data submission were met and that the modification to the MRL requested by the applicant was acceptable with regard to consumer safety on the basis of a consumer exposure assessment for 27 specific European consumer groups. The Authority took into account the most recent information on the toxicological properties of the substance, which was not previously available and was only provided with the application concerned. Neither the lifetime exposure to this substance via consumption of all food products that may contain it, nor the short-term exposure due to high consumption of the relevant products showed that there is a risk that the acceptable daily intake or the acute reference dose is exceeded.”
The Committee was unable to deliver an opinion on the draft Commission Regulation, as a qualified majority for or against the proposed measure was not reached. Under the RPS procedure, the Commission therefore proposed its draft Regulation in August to the Council. Following an initial exchange of views in early September, delegations confirmed their positions in writing by 8 September 2023. The outcome of that consultation confirmed the lack of the required qualified majority either in favour or against the Commission proposal. 16 Member States were in favour but 8 were against, while 3 abstained. The absence of a negative opinion meant that, from the Council’s side, the Commission could proceed with the draft implementing act.
However, the Parliament on 14 December 2023 passed a resolution by an absolute majority objecting to the draft act. While the resolution repeats the wording in the MRL legislation that import tolerances can only be established if they are safe for EU consumers and makes reference to the precautionary principle, it does not directly contradict the EFSA reasoned opinion that the higher MRL does not pose an unacceptable risk to consumers.
Instead, the reason for opposing the Commission proposal put forward by the Parliament is that it would allow imports into the Union which do not comply with Union standards. It argues that this situation may in the long-term lead to unfair competition to rice producers meeting Union standards. It also claims that the Commission regulation would undermine food security and, in the absence of appropriate traceability and information means, could generate deceptive practices for consumers.
As a final addendum, there is scope for confusion arising from the Parliament’s resolution which is entitled ‘Objection to an implementing act: Maximum residue levels for tricyclazole’. However, reference to an implementing act in this title should not be taken to refer to the concept of implementing acts introduced in the Lisbon Treaty in 2009 but should be understood in its pre-Lisbon context when all secondary legislation was referred to as implementing legislation without the later distinction between delegated and implementing acts. The Commission’s draft Regulation is effectively a delegated act using the Lisbon Treaty terminology where the Parliament has a right of veto.
The staring point for this post was to understand why Parliament was able to prevent the Commission from raising the MRL for tricyclazole in rice but unable to prevent the Commission from re-approving glyphosate for a further ten years. The reason is that the measures were put forward under different procedures which differ in the powers given to Parliament. Glyphosate approval took the form of an implementing regulation where the power to block a Commission proposal lies only with the Member States, whereas changing the MRL took the form of a delegated act (more accurately, was processed under the regulatory procedure with scrutiny) in which both the Council and Parliament are given a veto power to block the Commission proposal.
Several questions arise.
Can the Parliament’s opposition be justified under the RPS procedure? The explanatory text attached to the Commission’s draft Regulation states bluntly: “If the Parliament does not oppose the measure, the latter shall be adopted by the Commission. If the Parliament opposes the measure it shall not be adopted by the Commission” (p. 2). But under the RPS procedure, and different to the case with delegated acts, Parliament’s ability to veto a Commission proposal appears to have limits. Under the 2006 amendment to the Comitology Decision that introduced the RPS procedure, Article 5a(d) requires Parliament to justify its decision to oppose adoption of a Commission measure on one of three grounds: “justifying their opposition by indicating that the draft measures proposed by the Commission exceed the implementing powers provided for in the basic instrument or that the draft is not compatible with the aim or the content of the basic instrument or does not respect the principles of subsidiarity or proportionality”.
Indeed, the Parliament resolution notes as grounds for its opposition that it “Considers that the proposal for a Council regulation exceeds the implementing powers provided for in Regulation (EC) No 396/2005” and that it “Considers that the proposal for a Council regulation is not compatible with the aim and content of Regulation (EC) No 396/2005” but it does not provide explicit grounds for these objections. Indeed, it is hard to argue that the Commission has exceeded its implementing powers provided in the MRL Regulation as that Regulation expressly provides for the Commission to table a regulation following receipt of a positive opinion from EFSA. Parliament’s concern with unfair competition from third country producers may be understandable, but it is not specifically reflected in the criteria (set out in Article 14 of the MRL Regulation) that the Commission should take into account when preparing its regulation to change an MRL. The main purpose of setting an MRL is to protect the health of consumers and, where appropriate, animals and arguably, given the EFSA opinion which is not directly criticised by the Parliament, the Commission’s draft Regulation is consistent with this aim and content.
An application for judicial review of Parliament’s position might be foreseen, either from the applicant for the higher import tolerance or from the Commission, although such a move by the Commission just prior to a European Parliament election would be highly controversial.
Are the right procedures laid down for measures to approve active substances and to change MRLs? Adding or removing active substances is done by an implementing act, while changes to MRLs are made by the regulatory procedure with scrutiny which is similar to a delegated act. In the hierarchy of sources of EU law, the treaties stand at the top, followed by basic acts, delegated acts and finally implementing acts (EPRS, 2021). It can be argued that the decision to add or remove an active substance is a potentially more far-reaching decision than setting the MRL for that active substance, yet the Parliament has only a very limited role in the former. Legal scholars themselves find it difficult to decide when a non-legislative change should be made as a delegated or implementing act, and this confusion appears well illustrated in this case.
Can Parliament effectively implement mirror clauses for pesticide use in future? A mirror clause for pesticide use would seek to prevent the import into the Union of products produced with the aid of a pesticide that is not approved for use in the EU. In general, MRLs for pesticides not approved in the EU are reduced to the limit of quantification. However, exporters can apply for import tolerances that would allow a higher MRL based on good agricultural practices in the country of origin, provided that this would not pose any risk to consumer health or, in appropriate cases, animals. Assuming the Parliament’s veto on raising the import tolerance for tricyclazole in rice will stand, then Parliament at any time in the future can prevent the Commission from introducing an import tolerance greater than the limit of quantification to facilitate imports from third countries. This means that the Parliament can insist on the application of the ‘mirror clause’ principle implying that third country producers should not gain an advantage where an active substance is no longer permitted for use in the European Union.
The main limitation on this power is that it is not retrospective. Parliament must make its objections known within the time period specified in the MRL Regulation following the publication of a draft Regulation to raise an MRL. There is no mechanism for Parliament to withdraw its consent to higher MRLs that have been approved in the past. In this case, it would be up to the Commission to decide to present a Regulation lowering MRLs for active substances no longer permitted for use in the EU to the limit of quantification.
Might the use of tricyclazole in rice be permitted in the EU again? If the main objection to a higher import tolerance for tricyclazole in rice is that it is unfair competition for domestic rice producers, a level playing field could be restored by permitting its use also in the EU. This would require the producers of the active substance to submit an application for its approval. Several previous applications have been turned down because of the lack of sufficient data to allow EFSA to determine the level of risk for consumers. EFSA provided a positive opinion for a higher import tolerance because the applicant provided additional information on the toxicological properties of the substance, which was not previously available and was only provided with the application concerned. However, the approval of an active substance is more demanding than for an import tolerance because evidence must also be provided that there will be no adverse impacts on the environment and biodiversity in addition to no risks for consumer and animal health. There is thus no guarantee that the favourable EFSA opinion concerning a higher MRL would be reflected in a favourable opinion to re-authorise tricyclazole for use in the EU.
This blog post was written by Alan Matthews.
Photo courtesy of iAGRI Tanzania, licensed as Attribution-NonCommercial-NoDerivs.