Basic Substances under EU Pesticide Regulation: An Opportunity for Organic Production?
|Patrice Marchand 1|
|1 Institut Technique de l'Agriculture Biologique (ITAB), Paris, France|
* Corresponding author.
Recently created  by Article 23 of EC Regulation No 1107/2009 , the “Basic Substances” category is now operative with 15 approvals at the EU level . Basic Substances are plant protection products with specific criteria for approval. Consequently, this status specified no maximal residue limit and high potential for inclusion in the Organic Farming regulation (EC) No 889/2009  Annex II. Clearly, bio-sourced and traditional botanical extracts (as decoction, herbal tea…), light supports/aids, and plant defence enhancers used as crop protection are obvious candidates. Diverse applicants were engaged for different initial reasons and have succeeded in their applications. These biorational candidates clearly targeted the organic agriculture crop protection market or were even carried out by the organic sector itself.
2.- First Implication of the Organic Sector: Implementing Regulation EU No 354/2014
Annex II of organic farming regulation for exclusively managing plant protection substances was previously focused on products of low concern, although some of them were not approved under general pesticide regulations . Horizontal harmonization of pesticide regulation in organic farming was clearly needed and was achieved after a substantial change in 2014 following few years of unchanged situation. Thus, when the Implementing Regulation (EU) No 354/2014  came into full force, Annex II of organic farming regulation was widely modified. Indeed, Implementing Regulation (EU) No 354/2014 suppressed quite a number of substances from Annex II and some others will or may follow in the future for a number of reasons, including: candidate substances for substitution, non–renewal of the approval following decision of the applicants, toxicological concerns, or limited economic interest.
This last category clearly corresponds to the basic substances definition in Recital 18 of Regulation (EC) No 1107/2009 . Some parties believe that this decrease in the number of substances was very important, but these adjustments regarding general pesticide regulation were necessary and were taken on legal grounds. Although the existence of traditional plant protection products (PPP) is evident in Organic Farming, their EU approval under general regulations is compulsory. This action was called horizontal legislation alignment by DGAgri in Recital 6 of Implementing Regulation (EU) No 354/2014:
“As regards the horizontal legislation for plant protection products, Commission Implementing Regulation (EU) No 540/2011…it is appropriate to adapt the relevant parts of Annex II to Regulation (EC) No 889/2008 to that list. In particular, gelatine, rotenone extracted from Derris spp. and Lonchocarpus spp. and Terphrosia spp., diammonium phosphate, copper octanoate, potassium aluminium (aluminium sulphate, kalinite), mineral oils and potassium permanganate should be deleted from that Annex” .
Some other substances were maintained in Annex II as described in the Recital 7 of Implementing Regulation (EU) No 354/2014:
“As regards the active substances lecithin, quassia extracted from Quassia amara and calcium hydroxide for which applications for approval have been already submitted to the Commission under Regulation (EC) No 1107/2009, it is appropriate at this stage to keep them exceptionally on the list in Annex II to Regulation (EC) No 889/2008 until their assessment is finalised. In view of the conclusions of the assessment the Commission will take appropriate action regarding the presence of the three substances concerned on the list in Annex II to Regulation (EC) No 889/2008”.
This was the case for lecithin, calcium hydroxide and Quassia maintained in Annex II as the application Dossiers were constituted and submitted. Accordingly, these applications permitted the approval of the first 2 of these 3 substances. Quassia dossier is currently waiting for the outcome by the European Food Safety Authority (EFSA).
While certain applications were individually launched  without any contact or collusion between applicants, nor coordination, some approvals were organized by the organic farming sector . We believe that these applications need to be organized now, and even driven through an organizational strategy by the organic farming sector itself, especially for its needs at EU level.
2.1.- Current Implications for Organic Farming
Initial interest was manifested by the organic sector. Furthermore, as soon as the candidate substance is identified as not being a biocide, foodstuff or from edible vegetable or animal origin, it is entitled and even preferred. Initially, the organic sector proposed a list of potential candidate substances , but, at the same time, some small- and medium-sized enterprises started to investigate this opportunity . Moreover, some Member States also applied for basic substances . Following, horsetail extract (Equisetum arvense)  approval, the French Institut Technique de l'Agriculture Biologique (ITAB) obtained approvals for 8 more basic substances .
2.1.2.- Organic Farming: Source of Candidates Dossiers
A primary list of possible basic substances is maintained by DGSanté . Although this list was informative in the beginning and is still helpful while being constantly updated, the number of items recorded is quite restrictive compared to the vast field of possible applications. Even only considering the traditional organic uses or biodynamic preparations of botanicals, the list is impressive. Envisaged botanicals at the fourth stage of the previous plant protection products regulation  and previous substances not approved  may also be good candidates.
2.1.3.- Affordability of the Approval Process
Regarding cost, no fee is charged . Dossiers applications are accessible to any growers' association or technical organization. These light financial charges explain the high level of applications, although these applications fit perfectly Recital 18 (page 3 of plant protection products Regulation) :
“Certain substances which are not predominantly used as plant protection products may be of value for plant protection, but the economic interest of applying for approval may be limited. Therefore, specific provisions should ensure that such substances, as far as their risks are acceptable, may also be approved for plant protection use”.
However, for the constitution of chapter number 3 of the application (agricultural uses or Good Agricultural Practices, utility or efficacy) field trials are at same level of cost for chemicals, bio-control agents or organic farming biopesticides; idem for ecotoxicological tests requirements (i.e. bees or earthworms trials).
3.- Consideration by Organic Farming Sector: Recent Impact
Although, these applications have been spontaneous, it is clear that regulation of the approved basic substances by the organic farming sector is needed. Until now, all approved substances reached the Annex II categorization and were, according to our point of view, eligible to organic farming and most of them are candidates. Considering this emphasis of candidacy, the organic farming sector should not be alarmed by the multiplication of substance applications since most of them have no biocidal properties at all. For instance, a recent plant seed extract may be a good candidate  as sunflower oil is undergoing the application process. Of course, mild biochemicals or herbicides may apply and succeed, but are likely to be excluded by organic farming rules, although they may still be considered by some countries outside the EU . Considering this surge in applications, after a few approvals, including the two maintained substances in Annex II by Implementing Regulation (EU) No 354/2014, another modification of this Annex was published early in 2016 corresponding to a reorganization .
The entry into force of the last modification of the Annex II of organic farming regulation (Implementing Regulation (EU) No 2016/673 ) links to an extensive change of this annex. The sub-class of “Basic substances” box was generated and corresponding criteria designated for substances only for the control of pests and diseases.
“Only those basic substances within the meaning of Article 23(1) of Regulation (EC) No 1107/2009 of the European Parliament and of the Council  that are covered by the definition of “foodstuff” in Article 2 of Regulation (EC) No 178/2002 of the European Parliament and of the Council  and have plant or animal origin”.
Thus, insecticides and fungicides were clearly included, together with plant strengtheners, repellents and lure compounds, whereas substances used as herbicides are excluded. It could therefore be concluded that direct inclusion in Annex II of approved basic substances may occur when these criteria are respected and corresponding substance may be used directly after approval in organic production.
Because application does not mean approval and since the pathway is quite an obstacle course, not all applications end up with a positive vote. Admissibility is one of the deciding steps together with the outcome from EFSA  and the final decision from the Commission. In this journey, small Non-Governmental Organization applicants may find the application process more difficult than official European Member States' governmental agencies. Few dossiers have already been rejected (non-approbation), or are expected to be rejected, although they are of interest for organic farming. The main question raised is the final issue of the claimed usages (good agricultural practices), especially of the so called “orphans”. If these orphan or minor uses are not fulfilled by the way of these basic substances, it is unlikely that small- and medium-sized enterprises would invest millions of Euros for such substances if they were freely available on the non-plant protection products market.
Suspected toxicity is the main argument for the non-approval of an evaluated applied Basic Substance. Maximum residue limits arising from these considerations may be the key point. Are these substances recyclable as regular active substances (plant protection products)? Are the same substances as active substances giving rise to plant protection products with maximum residue limits good candidates and of interest from the organic farming point of view? Is this line of questioning in organic farming similar to the current H2020 “EU Framework Programme for Research and Innovation”  SFS-08 research program “Organic inputs—Contentious inputs in organic farming” ?
Basic Substances are effective as a new category of mild crop protection products. Some are of interest for organic farming or even driven by the organic production sector itself. Aside from this, approved Basic Substances suitable for organic farming Annex II will increase content of this annex with numerous approved basic candidates. Questions are already being raised by Member States unaware of the work of diverse applicants (organic farming Non-Governmental Organizations, Member States, small- and medium-sized enterprises) regarding officially permitted substances. Not overcoming the regulatory prerogatives of the Expert Group for Technical advice on Organic Production (EGTOP) and the Regulatory Committee on Organic Production (RCOP), the question is asked about the collection, the organization and the rule of these candidacies and applications by organic farming parties in the near future and ultimately, the acceptance or not by the organic production sector itself.
Funding: The author wishes to thank the French Ministry of Ecology (MEDDE; CP ITAB PNPP V14 26-11-10, 2010-12), the French Ministry of Agriculture (MAAF) and ONEMA (Biocontrol Project, Action 17B, 2012-13; PARMA, 2014–2016) for financial support. The author would like to thanks Trevor M. Fenning of Forest Research (UK) for providing helpful advice on the editing and writing of the manuscript.
|||Villaverde JJ, Sevilla-Mor´ an B, Sand´ ın-Espa˜ na P, L´ opez-Goti C, Alonso-Prados JL. Biopesticides in the framework of the European Pesticide Regulation (EC) No. 1107/2009. Pest Management Science. 2014;70(1). doi:10.1002/ps.3663.|
|||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 Direc- tives 79/117/EEC and 91/414/EEC. 2009;L 309. Available from: http://data.europa.eu/eli/reg/2009/1107/oj.|
|||Marchand PA. Basic substances: an opportunity for approval of low-concern substances under EU pesticide regulation. Pest Man- agement Science. 2015;71(9). doi:10.1002/ps.3997.|
|||Commission Regulation (EC) No 889/2008 of 5 September 2008 lay- ing down detailed rules for the implementation of Council Regulation (EC) No 834/2007 on organic production and labelling of organic prod- ucts with regard to organic production, labelling and control. 2008;L 250. Available from: http://data.europa.eu/eli/reg/2008/889/oj.|
|||Commission Implementing Regulation (EU) No 354/2014 of 8 April 2014 amending and correcting Regulation (EC) No 889/2008 laying down detailed rules for the implementation of Council Regulation (EC) No 834/2007 on organic production and labelling of organic products with regard to organic production, labelling and control. 2014;L 106. Available from: http://data.europa.eu/eli/reg impl/2014/354/oj.|
|||Marchand PA. Basic substances under EC 1107/2009 phytochem- ical regulation: experience with non-biocide and food products as biorationals. Journal of Plant Protection Research. 2016;56(3). doi:10.1515/jppr-2016-0041.|
|||European Commission Health and Consumers Directorate- General SANCO /10069/2013 rev.3. 2014; Available from: http: //ec.europa.eu/food/plant/pesticides/approval active substances/ docs/list candidates basic en.pdf.|
|||Commission Implementing Regulation (EU) No 563/2014 of 23 May 2014 approving the basic substance chitosan hydrochloride in accor- dance with Regulation (EC) No 1107/2009 of the European Parlia- ment and of the Council concerning the placing of plant protection products on the market, and amending Commission Implement- ing Regulation (EU) No 540/2011. 2014;L 156. Available from: http://data.europa.eu/eli/reg impl/2014/563/oj.|
|||Commission Implementing Regulation (EU) 2015/2069 of 17 Novem- ber 2015 approving the basic substance sodium hydrogen carbonate in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protec- tion products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011. 2015;L 301. Available from: http://data.europa.eu/eli/reg impl/2015/2069/oj.|
|||Commission Implementing Regulation (EU) No 462/2014 of 5 May 2014 approving the basic substance Equisetum arvense L., in ac- cordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending Implementing Regulation (EU) No 540/2011. 2014;L 134. Available from: http: //data.europa.eu/eli/reg impl/2014/462/oj.|
|||Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market. 1991;L 230. Available from: http://data.europa.eu/eli/dir/1991/414/oj.|
|||2007/442/EC: Commission Decision of 21 June 2007 concerning the non-inclusion of certain active substances in Annex I to Coun- cil Directive 91/414/EEC and the withdrawal of authorisations for plant protection products containing these substances (notified un- der document number C(2007) 2576). 2007;L 166. Available from: http://data.europa.eu/eli/dec/2007/442/oj.|
|||van der Waal JWH. Grapefruit seed extracts as organic post-harvest agents: precious lessons on efficacy and compliance. Organic Agri- culture. 2015;5(1). doi:10.1007/s13165-014-0093-z.|
|||O’Sullivan J, Van Acker R, Grohs R, Riddle R. Improved herbicide effi- cacy for organically grown vegetables. Organic Agriculture. 2015;5(4). doi:10.1007/s13165-015-0107-5.|
|||Commission Implementing Regulation (EU) 2016/673 of 29 April 2016 amending Regulation (EC) No 889/2008 laying down detailed rules for the implementation of Council Regulation (EC) No 834/2007 on organic production and labelling of organic products with regard to organic production, labelling and control). 2016;L 116. Available from: http://data.europa.eu/eli/reg impl/2016/673/oj.|
|||Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Au- thority and laying down procedures in matters of food safety. 2002;L 31. Available from: http://data.europa.eu/eli/reg/2002/178/oj.|
|||H2020 The EU Framework Programme for Research and Innovation; Available from: https://ec.europa.eu/programmes/horizon2020/.|
|||H2020 (SFS-08-2017) Organic inputs—Contentious inputs in organic farming; Available from: http://ec.europa.eu/research/participants/ portal/desktop/en/opportunities/h2020/topics/sfs-08-2017.html. 19|