New Developments in Regulations in Europe

ANGELA TÉLLEZ DEL RÍO

BY ANGELA TÉLLEZ DEL RÍO, CLARA VIGO ANGLADA, and JAYNE HARRIS
CONTRIBUTORS

The approval of active substances (a.s.) and subsequent authorization of derived plant protection products (PPPs) has experienced many changes in Europe. Indeed, the European regulatory landscape is one of the most complex regulatory frameworks globally.

The registration process of PPPs in European Union (EU) is one of the most scientifically robust in the world, but also ensures the highest level of protection for both human and animal health and for the environment.

The aim of this article is to summarize the main regulatory procedures and framework for placing PPPs on the EU market, such that stakeholders from outside EU may have a better understanding of EU regulatory framework.

Along with EFSA and the EU commission, the 27 Member States (MSs) are responsible for the evaluation of both a.s. and PPPs against agreed Uniform Principles (UP). They are referred to as the Rapporteur Member State (RMS) or Co-Rapporteur Member States (Co-RMS) for the a.s. evaluation, and as Zonal RMS (zMRS) or Concerned Member State (cMS) for product evaluations.

The EU Commission^[1] (COM) is the executive branch of the EU and COM decisions are legally binding. Their main duties are to set up the provisions of the legislation (e.g: Regulation 1107/2009), the provision of a.s. information, determination and amendment of maximum residue levels (MRLs), approval or non-approval decisions for a.s., and the preparation of a.s. “Review Report.”

The EFSA^[2] is an independent agency responsible for scientific advice and support, working closely with the EU Commission and ECHA. They undertake many tasks within the EU regulatory framework including: The evaluation of Draft Assessment Reports (a.s.), preparation of the “EFSA conclusion,” “Reasoned Opinions,“ and Guidance (administrative) documents as well as setting and controlling MRLs.

The ECHA^[3] is the authority responsible of the evaluation of Harmonized Classification and Labelling (CLH) dossiers and works with the industry to ensure sufficient information is available for chemicals placed on the EU market.

Regulation (EC) 1107/2009[4] provides legislative framework for setting out the rules and procedures for placing PPPs on the EU market and replaced the previous framework Directive 91/414/EEC. The Regulation entered into force on 14 June 2011 and introduced changes in both dossier format, data requirements, and procedures. The Regulation (EC) 1107/2009 also introduced a new hazard-based cut-off criteria, and aim for harmonization of the registration process across the EU. The regulation covers PPPs containing conventional chemical a.s. (e.g: glyphosate, tebuconazole, acetamiprid, etc.) and “biopesticides”[5] (containing micro-organisms, e.g: Bacillus thuringiensis, Beuveria basiana, etc. and plant extracts) at EU level.

In addition to the Regulation, there are several other legislative acts dealing with other regulatory aspects of PPPs (e.g: Residues, classification, labelling, and sustainable use of pesticides). There are also diverse delegated and implementing acts linked to the Regulation (e.g.: establishing Data Requirements, UP, rules on labeling, listing of approved substances, etc.) and Guidance Documents, describing in detail the commonly agreed interpretation and correct implementation of the different provisions of the Regulation.

The Regulation sets up two separate procedures of the placing of PPPs on the market:

1. Substance approval at EU level. The a.s. must be approved at EU level first, before an application for a product based on this a.s. may be considered. Dossiers submitted for the approval of a.s. must comply with the data requirements set out in Regulation (EU) 283/2013[6].

At least one use of one representative formulation must be proven safe for human and animal health (including their residues in food) and must not have any unacceptable effects on the environment before an a.s. can be achieved approved status. A non-approval decision may be taken if, for example the a.s. meets cut-off criteria (e.g. CMR Cat 1, PBT, vPvB, etc.)[7] and negligible exposure cannot be demonstrated.

2. Product authorization at MS level. The PPPs must be authorized in each separate MS before they can place on the market. To facilitate the product authorization, the regulation introduced a zonal system evaluation, establishing three regulatory zones (with comparable climatic and agricultural conditions): North, Central, and South. Dossiers submitted for the authorization of PPPs must comply with the data requirements set out in Regulation (EU) 284/2013[8].

The philosophy behind this two-step approach is the EU principle of subsidiary. The 1st step defines the commonly agreed intrinsic properties (endpoints) of a substance, which is best dealt with centrally at EU level. Whereas, the 2^nd step (national authorization at MS level), the risk assessment of individual PPPs and their uses largely depends on national agricultural practices, environmental and climatological conditions, and risk mitigation measures, which are best dealt with at national level.

Currently, a new strategy is in place to promote sustainable farming and achieve ambitious climate goals for the EU, known as the “European Green Deal.” It is intended that this strategy will make the EU the first climate-neutral continent by 2050. One of the central measures of this strategy is the reduction of pesticide use and risk by 50% by 2030.

The “EU Green Deal” and associated “Farm to Fork” strategy aim to reduce dependency on chemical pesticides and promote use of biopesticides (such as PPPs containing microorganisms), and so called “low-risk” substances.

This strategy introduces new data requirements and procedural approaches for biological products contain microorganisms and is applicable from 21 November, 2022. The new data requirements for microorganisms and PPPs containing microorganisms[9] are made considering the latest scientific knowledge and are based on the specific biological characteristics of the microorganisms (e.g.: Commission Regulation (EU) 2022/1439[10] and Commission Regulation (EU) 2022/1440[11]). The new procedural approach intend to simplify the process of approval and authorization of biological products containing microorganisms.

With these initiatives, it is intended that farmers across the EU will have better access to biological alternatives to synthetic chemical pesticides, giving farmers the tools they need to protect their crops in a more sustainable manner.

Active substances are initially approved for a fixed period (usually 10 years up to maximum period of 15 years, depending on the type of a.s.). Then, the a.s. must be re-evaluated (renewal of approval) to ensure that they continue to be without unacceptable risk to people or the environment according to the latest standards of assessment in EU, for up to 15 years upon application. The renewal programs (known as AIR-1 – AIR-5) define RMSs and timelines for submissions for all a.s. based on given expiry dates of a.s. The applicants must submit the renewal dossier 3 years before the expiration date of each a.s. to RMS and co-RMS.

The timelines for the first authorization of a PPP following zonal procedure should take around one year for zRMS and 120 days for cMS, according to the provisions of Article 33 of Regulation (EC) 1107/2009.

The estimated timelines for the evaluation of renewal of approval of an a.s. should take around 2 to 2.5 years in theory, if there are no delays in the evaluation process (e.g: Preparation of the Renewal Assessment Report (RAR), call for EFSA evaluations in specific areas, endocrine disrupting (ED) properties, stop(s) of the clock, COM vote, etc.)

After renewal of approval of each a.s., all products containing that a.s. must be reauthorized at MS level according to the provisions of Article 43 of Regulation (EC) 1107/2009. The applicants need to start early enough the planning of the Article 43 submission according to new data a.s. package and to comply with data requirements / guidance documents in place at time of submission.

Data protection rules prevent third companies to use other companies’ data for their own commercial purposes for a certain period of time to allow the companies to gain profits. The implementation of data protection rules allows for a period of exclusivity in the interest of data owners who have invested in the generation of data to support authorizations of PPP in the EU market, according to the legal provisions of Articles 59–62 and 80 of Regulation (EC) 1107/ 2009.

During the course of the protection period, a third party cannot use protected data in support of an application for authorization of their product, without the permission of the data owner (via a letter of access).

Data protection can apply to tests and study reports only if certified as compliant with the principles of Good Laboratory Practice (GLP) or Good Experimental Practice (GEP). Companies are required to claim data protection at the time of application.

Period of protection are granted for a limited period, usually 10 years for study used for a new a.s./new PPP dossier, 13 years for low-risk substances and 30 months for PPP renewal. Once the data are out of data protection, third parties can use the data of a.s. /PPP to register generic products in the EU market.

Photos from top to bottom: koya979 – stock.adobe.com, photo of Angela Téllez del Río courtesy of Knoell Iberia S.L, Grecaud Paul – stock.adobe.com,
Artur – stock.adobe.com,Chinnapong – stock.adobe.com, amnaj – stock.adobe.com, sebra – stock.adobe.com
[1] EU Commission: https://food.ec.europa.eu/plants/pesticides_en
[2] EFSA: https://www.efsa.europa.eu/en/topics/topic/pesticides[1] ECHA: https://echa.europa.eu/regulations/reach/evaluation/evaluation-procedure[1] Knoell: https://www.knoell.com/en/markets/crop-protection
[3] 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. OJ L 309.
[4] 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. OJ L 309.
[5] Biopesticides are pest management agents and chemicals derived from natural sources such as bacteria, viruses, fungi, plants, animal, and minerals.
[6] Commission Regulation (EU) No 283/2013 of 1 March 2013 setting out the data requirements for active substances, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market. OJ L 93.
[7] CMR (carcinogenic, mutagenic or toxic for reproduction), PBT (persistent, bioaccumulative and toxic); vPvB (very persistent and very bioaccumulative)
[8] Commission Regulation (EU) No 284/2013 of 1 March 2013 setting out the data requirements for plant protection products, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market. OJ L 93.
[9] https://food.ec.europa.eu/plants/pesticides/micro-organisms_en
[10] Commission Regulation (EU) 2022/1439 of 31 August 2022 amending Regulation (EU) No 283/2013 as regards the information to be submitted for active substances and the specific data requirements for micro-organisms. OJ L 227.
[11] Commission Regulation (EU) 2022/1440 of 31 August 2022 amending Regulation (EU) No 284/2013 as regards the information to be submitted for plant protection products and the specific data requirements for plant protection products containing micro-organisms. OJ L 227.
[12] https://food.ec.europa.eu/plants/pesticides/approval-active-substances_en
[13] GAP (Good Agricultural Practices)