Session Basic Substances Dr. Patrice Marchand (ITAB) 1
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Session Basic Substances
Dr. Patrice Marchand (ITAB)
1
Fertilisers
Phyto Regulation EC 1107/2009
Article 23 Basic
Substance (BS)
Article 22 Low Risk Substance
(LRS)
Article 47 Abiotic
Biostimulants (BSt)
Article 14 Exigences
(Fert)
Regulation Fert EC(2003/2003 ‐ 223/2012 ‐ 463/2013)
Regulation EC Biostimulants 2022
PPPa.s.
Plant Protection ProductsBiostimulants Abiotic / Biotic
elicitors
Article 25 Synergists, phytoprote
ctants
Article 58 adjuvants
Zonal approval
≠ with EPPO zones !3
Guidance documents
4
Basic substances
5
1. Basic substances: Definitions (1)
• Recital 18 (RCE 1107/2009):« 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 »
1. Basic substances: Definitions (2)
• Article 23 (RCE 1107/2009):(a) is not a substance of concern;(b)does not have an inherent capacity to cause endocrine disrupting, neurotoxic or immunotoxic effects;(c)is not predominantly used for plant protection purposes but nevertheless is useful in plant protection either directly or in a product consisting of the substance and a simple diluent; and(d)is not placed on the market as a plant protection product.
Basic substances (specifications)2.By way of derogation from Article 4, a basic substance shall be approved where any relevantevaluations, carried out in accordance with other Community legislation regulating the use of thatsubstance for purposes other than for a plant protection product, show that the substance hasneither an immediate or delayed harmful effect on human or animal health nor an unacceptableeffect on the environment.
3.By way of derogation from Article 7 an application for the approval of a basic substance shallbe submitted by a Member State or by any interested party to the Commission.4.The Commission shall ask the Authority for an opinion, or for scientific or technicalassistance. The Authority shall provide its opinion or the results of its work to the Commissionwithin 3 months of the date of the request.
5. Articles 6 and 13 shall apply. Basic substances shall be listed separately in the Regulationreferred to in Article 13(4).
6. The Commission may review the approval of a basic substance at any time. It may take intoaccount the request of a Member State to review the approval.
Where the Commission concludes that the criteria referred to in paragraph 1 are no longersatisfied, a Regulation to withdraw or amend the approval shall be adopted in accordancewith the regulatory procedure referred to in Article 79(3).
In reg. 540/2011
8
Bio-control by effects
9
Stimulation
• from Plant growth stimulation to• Natural defenses stimulationSince all stimulators are not naturals…• Plant defenses stimulation• Systemic acquired resistance (SAR)• Systemic transferred resistance
10
Control
• External: Predators, macro‐org• Destruction: chemically, physically, by waves…• Space competition: µ‐org• Repellence: smell, by waves• Disturbance: nets, by waves, pheromones• Attraction: food supply• Nothing: no understanding
11
« Fuge » effet
• Physically: barriers, damp or water‐proof,• Repellence: smell, by waves, pheromones• Lure effect
12
3432302826242220181614121086420
2011 2012 2013 2017 2018 201913
Biocontrol: statsNew approved substances
2014Chimique
2015 2016Biocontrôle Substances de base
14
• Examples– Apple trees,– Bioagressor: codling moth Cydia pomonella– Traps vs adults (monitoring)
Semiochemicals
‐ plant (ex : horsetail)
‐ animal (ex : whey/lactoserum)
‐ microbial (?)
‐ or mineral (ex: talc)
origin15
Natural substancesPresent in nature and from
Natural substances from
mineral origin
17
• Examples– Olive trees,– Bioagressor: Ceratitis capitata– Talc or clay vs adults (lure, color change, insectifuge)
Minerals
Natural substances from
animal origin
Type‐ solids (ex : chitosan, tallow)
‐ liquids (ex: milk, whey)
‐ gaz (phero‐/kairomones)‐ (somehow)
from Animals
20
• Examples– Vineyards,– Bioagressor: Powdery mildew Plasmopara viticola–Whey (physical barrier (bio‐film), fungifuge, acidic properties, antioxidant properties, space competition ofµ‐organisms?)
from Animals
Natural substances from
vegetal origin
Types‐ extracts (ex : decoction, infusions),
aqueous / solvents
‐ oils and
‐ essential oils
‐ powders and plants parts (ex: bark, leaves, bulbs)
‐ purified a.s. (sugar, lecithins)22
Natural substances from vegetal origin
• Plant extracts, willow, willow bark, knotweed,(garlic), horsetail, liquorice, nettle, (fenugrec),lecithins, fructose, sucrose, vinegar, charcoal,pepper, quassia,
• vegetable oils and derivatives, sunflower oil, essential oil of onion
• Ethylene ?• IBA, Indole Butyric Acid from willow
23
Natural substances from vegetal origin
Regulatory pathway
24
RCOP
Règlement Phyto
RèglementAB
Ferti Annexe
I
Interconnexion of GD
DGSanté
DG AGRI
Phyto Annexe
II
*: standing committee for fertilizing materials**: Regulatory committee of organic production (RCOP)£: standing committee of plant animal food feed (PAFF)
Règlement Biostimulants abiotiques
**
AB
DGGrow
Règlement Fertilisants
COREPER *
Ferti
£ CPVAADAAA
Phyto
RèglementPhyto
DG in Bruxelles
DGSantéCPVADAAA£
Phyto
VOTE£: standing committee of plant animal food feed (PAFF)(Comité permanent des végétaux, , des animaux, des denrées alimentaires et des aliments pour anim26aux CPVADAAA)
English
Nat. Lang
Way of bibliographic research
Scientific Tool
latin
Product
Bibliographic Strategy
Plant
name
Scholar
Science direct…
Webof science
Key words
monographies
§5
All properties
includingRawmaterialaccessibility
Targeted data
§2
§6
§8
§5.12
§3
Chemical properties
ToxicologicalpropertiesActive
properties Toxicologicalproperties
Food properties Chemical
componentsToxicologicalproperties GAPTable
§7
§2
§1&2
§2
§in
Dossier
Field EXP
names
EMEA…
FAO…
Toxicity
Biocide
Target
Non‐target
sewage
Food
Components
Environnement27
Horsetail Application Dossier !
165 pages + 465 p bibliography2006‐2012 ! 28
Approval pathway
Guidelines EC/EU (guide de lecture)‐ SANCO/10363/2012 rev. 9‐ Out of value
29Rev. 1.2
Translation in EN needed
Admissibility Questions
Approval Transferorganic
30
Basic substance pathway
Approval timning ≈ 21 monthsNb of months : déposit approval Basic Substance
26,7 Equisetum arvense30 Chitosan Chlorhydrate13,6 Saccharose30 Calcium Hydroxyde25 Vinegar16,3 Lecithines25,1 Salix spp.cortex16,1 Fructose18,3 Sodium bicarbonate10,6 Lactoserum / Whey17,6 Diammonium Phosphate13,1 Sunflower oil22,7 Clayed Charcoal17,3 Urtica spp.16,5 Hydrogen Peroxide13,4 Sodium Chloride10,8 Bier16,1 Mustard seed powder70 Talc19,2 Onion oil
Basic substances =
Actives substances
Agricultural meaning
Case (real) in progress
• With the Process
Natural Product
• In the core of the application• Usefulness, then
GAP TABLE !33
Horsetail (Equisetum arvense) antifungal
Crops
Targets
Usage : application
Conditions Stages de3l4ay
Sugar insectifuge
Crops
Targets application
delayConditions Stages
35
Effect of saccharose on egg lying
36
Effect of saccharose onAmino Acids/ acids leaf surface content
37
Lecithin fungicide
CropsTargets Applications
DelayStages
38
LecithinFungicide against Mildew (Vineyards)
Control Lecithin Eucalyptus oil Clove oil
Basic Substances
40
• They are– biocides: vinegar, Quassia amara,– plant strengtheners: horsetail (E. arvense), chitosan,– physical barriers: calcium hydroxide, talc,– biofilms: chitosan,– physiological transformers: sugars– pH modifiers: sodium bicarbonate, whey, vinegar,– attractants: Di Ammonium Phosphate (DAP)
• They are not:– PPP: A.S. already approved,– Up to now: no adjuvant (Art. 58), no synergist (Art. 25)
Basic substances: Definition(s !) by categories
• They may be– foodstuff: sodium bicarbonate, talc, beer yeast (vs cerevisane?), whey / milk (lactose intolerance?), vegetable oils, essential oils, alcoholic drinks (beer)
– neutral compounds: chitosan, sugars– feedstuff: plant powder,– fertilizers: Di Ammonium Phosphate (DAP)– light medicinal products: calcium hydroxide, N‐Acetyl cysteine? essential oils?
– plant aqueous extracts: macerations? Urtica spp.– non‐renewed natural active substances: garlic juice?
Basic substances: Definition(s !) by origin
43
(2011‐2018)• 20 (16) Dossiers approuvés (par l’ITAB)
– mars 2014 prêle ‐ Equisetum Arvense (1)– mars 2014 chitosan (2) Chipro GmbH– juillet 2014 saccharose (3)– mars 2015 hydroxyde de calcium (4) IFOAM‐EU– mai 2015 vinaigre, saule ‐ Salix cortex, lécithine (5,6,7)– juillet 2015 fructose (8)– octobre 2015 bicarbonate sodium (9) EPA, DK– mars 2016 petit‐lait et PDA (10, 11)– octobre 2016 huile de tournesol (12)– janvier 2017 purin d’ortie, charbon‐argile, H2O2 (13,14,15)– juillet 2017 chlorure de sodium (sel de mer) (16)– octobre 2017 bière, poudre de graines de moutarde (17,18)– mars 2018 talc E553b (19)– juillet 2018 huile d’oignon (20) Bionext (NL)
Approved basic substances
Approved basic substances
2014
2015
– Prêle Equisetum arvense
– Chitosan
– Sucre
– Hydroxyde de calcium
– Lécithine
– Vinaigre (TS)
– Extrait de saule Salix cortex
– Fructose
– Bicarbonate de sodium
44
Approved basic substances2016
2017
– Phosphate di ammonium
– petit‐lait
– huile de tournesol
– ortie (purin)
– charbon argileux
– H2O2
– chlorure de Sodium
– bière
– poudre de graines de moutarde
– talc– huile d’oignon 452018
8 years of applications
* Les retraits « volontaires » des pétitionnaires correspondent à de nombreuses situations :‐ Absence de N° CAS, impossibilité à répondre aux questions de l’EFSA…
614%
37%
1331%
2048%
Retrait*
Non‐admissibleNon‐aprouvée Approuvée
Evolution du nb substances de base
47
3
9
11
16
20 20
00 00 00 01
9
12
16
18
0
2
6
4
8
10
12
14
16
18
20
22
2011 2012 2013 2014 2016 2017 2018 2019
Evolution du nb substances de base in organic production
SB
2015
SB UAB
AllowedIn Organic production
Total BS
48
Active Substances in
Organic Farming
49
Plant protection products allowed in Organic Farming
50
• Regulation (EC) n° 889/2008– Annex II products for plant protection–Modified par :
• Implementing Regulation (EC) n° 354/2014• Implementing Regulation (EC) n° 2016/673• Implementing Regulation (EC) n° 2018/1584• Implementing Regulation (EC) n° 2019/2164
– « organic biopesticide »
• « Utile » (EC Reg 1107/2009),• No efficacy for some people,• Known or new,• Approved AND not for sale therefore…
Substances de base approuvées Bilan
NOT for SALE Quiz• Which VAT ? 5,5 %Foodstuff
(sugar) 20 %PPP
(H2O2)
10 %« Biocontrol or organic»
(Horsetail) 2,1 %
Medicinal products(CaOH2)
• Merci de votre attention
53
Publications"Basic Substances: An approval opportunity for Low Concern Natural Products under EU pesticide regulation", P A Marchand, Pest Management Science, 2015, 71 (9), pp. 1197‐1200 "Basic substances under EC 1107/2009 phytochemical regulation: experience with non‐biocide and food products as biorationals" P A Marchand, Journal of Plant Protection Research, 2016, 56(3), pp. 312‐318"Basic Substances under EU Pesticide Regulation: an opportunity for Organic Production?" P A Marchand, Organic Farming, 2017, 3(1), pp. 16–19"Basic and Low risk Substances under European Union pesticide regulations: A new choice for biorationals portfolio of small and medium‐sized enterprises" P A Marchand, Journal of Plant Protection Research, 2017, 57(4), pp. 433‐440" Basic substances as renewable and affordable crop protection products" P A Marchand,Chronicle of Bioresource Management, 2017, 1(2), pp. 065‐066"Biorational substitution of piperonyl butoxide in Organic Production: effectiveness of vegetableoils as synergists for pyrethrums", P A Marchand, C Dimier‐Valet, R Vidal, Environmental Scienceand Pollution Research, 2017, pp. 1‐7."Novel plant protection regulation: new perspectives for Organic Production?" P A Marchand,Organic Farming, 2018, 4(1), pp. 3‐6"Biocontrol active substances: evolution since the entry in vigour of Reg. 1107/2009" D Robin, PA Marchand, Pest Management Science, 2018, 74(1x), pp. , doi:org/10.1002/ps.5199"Vineyard evaluation of stilbenoid‐rich grape cane extracts against downy mildew: a large‐scale study", Billet K, Delanoue G, Arnault I, Besseau S, Oudin A, Courdavault V, P A Marchand, Giglioli‐Guivarc’h N, Guérin L, Lanoue A, Pest Management Science, 2018, 74(1x), doi:org/10.1002/p5s4.5237
Publications"Basic Substances: An approval opportunity for Low Concern Natural Products under EU pesticide regulation", P A Marchand, Pest Management Science, 2015, 71 (9), pp. 1197‐1200 "Basic substances under EC 1107/2009 phytochemical regulation: experience with non‐biocide and food products as biorationals" P A Marchand, Journal of Plant Protection Research, 2016, 56(3), pp. 312‐318"Basic Substances under EU Pesticide Regulation: an opportunity for Organic Production?" P A Marchand, Organic Farming, 2017, 3(1), pp. 16–19, doi: 10.12924/of2017.03010016"Valerian and Yarrow: Two medicinal plants as crop protectant against late frost" M Stefanini, L Merrien, P A Marchand, International Journal of Economic Plants, 2018, 5(4), pp. 192‐196. "Lecithins: a food additive valuable for antifungal crop protection" M Jolly, R Vidal, P A Marchand, International Journal of Economic Plants, 2018, 5(3), pp. 104‐107."Biocontrol active substances: evolution since the entry in vigour of Reg. 1107/2009" D C Robin,P A Marchand, Pest Management Science, 2019, 75(4), pp. 950‐959"The major interest for crop protection of agrochemical substances without maximum residue limit (MRL)" M Charon, D Robin, P A Marchand, Biotechnologie, Agronomie, Société et Environnement, 2019, 23(1), pp. 22‐29."Willow Extract (Salix cortex), a Basic Substance of Agronomical Interests" MG Deniau, R Bonafos, M Chovelon, C‐E Parvaud, A Furet, C Bertrand, PA Marchand, International Journal of Bio‐resource and Stress Management, 2019, 10(4), pp. ."Rodent repellents at a European Union Plant Protection Product level, an orphan use toconsider" M Stefanini, M Charon, P A Marchand, 2020, Journal of Plant Protection Research,60(1), pp. X‐XXX
55
6 MARCH 2020
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