The European Parliament (EP) has adopted a resolution calling on the European Commission to rescind legislation it recently adopted that extends the approved use of a group of 46 active substances in plant protection products (PPPs) until the fourth quarter of 2023. European lawmakers have criticized the extensions, undertaken due to authorities’ delays in renewing approvals of the substances under Regulation (EC) No 1107/2009, contending that the legislation is “not consistent” with the EU’s precautionary principle and, in deciding to extend the approvals, failed to consider the harmful properties some of the active substances possess or are suspected of possessing.
The Plant Protection Products Regulation
- Regulation (EC) No 1107/2009 concerning the placing of plant protection products on the market (PPPR) establishes the European Union rules for authorizing the sale, use, and control of plant protection products (PPPs). It is the 27-member bloc’s main cross-sectoral framework regulating PPPs, which are used to protect plants and plant products against pests and plant diseases, and to control weeds.
- In the EU, PPPs make up a subset of pesticides. Applications like insecticides, rodenticides, preservatives, anti-fouling agents, and disinfectants, which are also considered pesticides, fall under the separate category of biocides and, as such, are regulated under the Biocidal Products Regulation (528/2012/EU).
First-time, renewed, and extended approvals of active substances under PPPR
- Active substances must first be approved before being used in PPPs. They are defined under Article 2(2) of the PPPR as any chemicals, plant extracts, pheromones, or micro-organisms (including viruses) “having general or specific action against harmful organisms or on plants, parts of plants or plant products.” They are present in PPPs, along with safeners, synergists, and co-formulants, which are also formally defined under Article 2 of the PPPR.
- Applicants must submit an application, together with a supplementary dossier, that meets the conditions and requirements set out in Articles 4-13 and Annex II of the PPPR to obtain first-time approval for use as an active substance in a PPP on the EU market. First-time approvals are issued for up to 10 years.
- Active substances which applicants wish to renew approval for are subject to the criteria laid out in Articles 14-21 of PPPR and, until March 27, 2024, the requirements established in Regulation (EU) No 844/2012 setting out the provisions necessary for the implementation of the renewal procedure for active substances, as provided for in Regulation (EC) No 1107/2009. Entities renewing approval for active substances whose approval period is set to expire after March 27, 2024 and has not been extended pursuant to Article 17 of the PPPR will need to comply with Regulation (EU) 2020/1740, which repealed Regulation (EU) No 844/2012 and began to apply March 27, 2021. (See this flowchart created by the European Food Safety Authority (EFSA) for a step-by-step overview of the renewal process.)
- Under the PPPR, the main obligation to qualify for first-time approval and renewal of approval is meeting the Article 4 safety criteria for active substances. Among others, these comprise the restrictions under point 3 of Annex II excluding substances from approval that are, or have been, classified under the Classification, Labeling and Packaging Regulation (CLP, 1272/2008/EC) as category 1A or 1B carcinogens, mutagens, or reproductive toxins. Approval is also forbidden for substances with endocrine disrupting (ED); persistent, bioaccumulative, toxic (PBT); and very persistent, very bioaccumulative (vPvB) properties; as well as for persistent organic pollutants (POPs).
- The PPPR’s Article 17 allows the Commission to extend active substance approvals that are “likely to expire before a decision has been taken on renewal.” In such instances, which must be deemed “beyond the control of the applicant,” the Commission adopts a decision “postponing the expiry of the approval period for that applicant for a period sufficient to examine the application.”
- Active substance approvals can be renewed for a period of up to 15 years or, for active substances identified under Article 24 and point 4 of Annex II as candidates for substitution, no longer than seven years.
EP urges Commission to stop practice of extending approvals for active substances that don’t meet PPPR’s safety criteria
- European Parliament members (MEPs) adopted a non-binding resolution on October 18, 2022, demanding that the European Commission repeal Regulation (EU) 2022/1480 of September 7, 2022, as well as to address perceived flaws in the Commission’s current practice of extending active substance approvals under Article 17 of the PPPR.
- The resolution criticizes Regulation (EU) 2022/1480 for extending the approval periods for a large group of 46 active substances “in bulk.” The resolution indicates that by doing so, member states’ ability to scrutinize such decisions is diminished, more so than if the approvals were addressed in smaller numbers.
- Significantly, the resolution underscores a subset of the active substances whose approval periods the Commission has extended despite their possessing harmful properties. The following three are set apart and elaborated on in the text:
|Active substance||(Suspected) properties of concern||Way(s) substance is regulated in EU|
|8-hydroxyquinoline||EFSA identified endocrine-disrupting properties; toxic if swallowed; may damage the unborn child (Repr. 1B); very toxic to aquatic life; very toxic to aquatic life with long lasting effects; causes serious eye damage; and may cause an allergic skin reaction||Harmonized classification entry in Table 3 of Annex VI to CLP Regulation; listed as a candidate for substitution pursuant to point 4 of Annex II to Regulation (EC) No 1107/2009|
|chlorotoluron||associated with endocrine-disrupting properties according to cited studies; very toxic to aquatic life; very toxic to aquatic life with long lasting effects; suspected of causing cancer (Carc. 2); and suspected of damaging the unborn child (Repr. 2)||Harmonized classification entry in Table 3 of Annex VI to CLP Regulation; listed as a candidate for substitution pursuant to point 4 of Annex II to Regulation (EC) No 1107/2009|
|difenoconazole||suspected of inducing triazole-resistance in the fungal strain Aspergillus fumigatus; very toxic to aquatic life; very toxic to aquatic life with long lasting effects; harmful if swallowed; causes serious eye irritation; harmful if inhaled||listed as a candidate for substitution pursuant to point 4 of Annex II to Regulation (EC) No 1107/2009|
- In this context, the resolution points to the Article 4 and Annex II provisions of the PPPRwhich forbid approvals of active substances for use in PPPs that possess the specified hazards of concern, including 1B reproductive toxicity and endocrine disruption.
- The text also singles out the three mentioned substances, among six others, as “more hazardous pesticides” since they have been identified as candidates of substitution in accordance with point 4 of Annex II.
- Given these facts, the resolution argues, it is “unacceptable” for substances which are likely to be excluded from approval based on these hazards “to continue to be allowed for use in the Union, thereby putting public and environmental health at risk.”
- Along the same lines, it considers that Regulation (EU) 2022/1480 exceeds the implementing powers provided for in Regulation (EC) No 1107/2009 and does not conform with EU law “in that it does not respect the precautionary principle.”
- The precautionary principle is anchored in Article 191 of the Treaty on the Functioning of the European Union (TFEU) and clarified in a February 2000 EU Commission Communication. In short, it is a fundamental approach to managing risk that prescribes taking proactive measures to avert harm to the environment or human health that scientific evidence points to, but on which no scientific consensus has yet been achieved.
- The text thus calls for the repeal of Regulation (EU) 2022/1480 and the Commission’s resubmission of a new draft, “which takes into account the scientific evidence on the harmful properties of all the substances concerned, especially of 8-hydroxyquinoline, chlorotoluron and difenoconazole.”
- Accordingly, the resolution demands that the Commission only propose legislation that extends approvals of substances whose properties, based on “the current state of science,” would not “lead to a Commission proposal for non-renewal of the approval of the active substance concerned.” In other words, the EU executive is ordered to refrain from putting forward approval extensions for any active substance that fails to meet the safety criteria outlined in Article 4 and Annex II of the PPPR.
- Going forward, the resolution calls on the Commission to withdraw the approvals for substances, using its authority to do so under Article 21 of the PPPR, “if proof or reasonable doubt exists that they will not meet the safety criteria laid down in [the PPPR],” and “to duly justify its decisions to extend the approval periods of active substances.” It also looks to member states “to ensure the proper and timely reassessment of the approvals for the active substances for which they are the reporting Member States, and to ensure that current delays are solved effectively and as soon as possible.”
- It is not at all certain whether this resolution will have the desired effect on the Commission and the member states that the European Parliament is seeking.
- For one, resolutions don’t hold legally binding force in the EU. Instead, they serve as an informal “soft law” tool for the European Parliament to shine a light on legislation, questions of policy, and other affairs that the body deems of utmost importance. Though this tool is often used to seek commitments from other EU institutions (e.g., the Commission), experience has shown that the outcomes are not always in keeping with what MEPs request.
- In fact, this resolution itself acknowledges that earlier attempts in the form of multiple resolutions have not had the intended effect of changing the Commission’s behavior with respect to extending the approvals of these active substances (see Resolutions 2019/2826(RSP), 2020/2853(RSP), and 2021/2869(RSP)).
- Nonetheless, in email correspondence with AgencyIQ, an aide to Maria Arena, one of the MEPs responsible for tabling the resolution, stressed that the EP’s action still has value. “One more objection on our part is unlikely to change how the Commission interpret[s] its own law,” the aide wrote, but “how the precautionary principle is implemented especially when it comes to substances with known hazards” is “a fundamental issue for us in the Parliament.”
- MEP Arena’s aide contended that industry has exploited “this flaw” and been able to “have the approval of their substances extended year after year, sometimes for almost a decade for some substances.”
- The aide concluded, “This is why we keep raising objections to these cases to repeat again and again the position of the Parliament on what is in our view a major flaw of the implementation of the PPP regulation and that goes counter to the protection of human health and of the environment, which is the primary objective of the PPP regulation.”
- The resolution concludes by instructing EP President Roberta Metsola to forward the document to the Council, the Commission, and the member states. AgencyIQ will continue to follow developments related to the MEPs’ demands and will be sure to report on the Commission’s response.
Key Documents and Dates
- European Parliament resolution of 18 October 2022 on Commission Implementing Regulation (EU) 2022/1480 of 7 September 2022 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances… (October 18, 2022)
- Commission Implementing Regulation (EU) 2022/1480 of 7 September 2022 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances… (September 8, 2022)
- Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (November 24, 2009)