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DATA REQUIREMENTS FOR REGISTRATION OF BIOPESTICIDES IN OECD MEMBERCOUNTRIES: SURVEY RESULTS
OECD ENVIRONMENT MONOGRAPH No. 106
ORGANISATION FOR ECONOMIC CO-OPERATION AND DEVELOPMENT
Paris 1996
28712
Document complet disponible sur OLIS dans son format d'origine
Complete document available on OLIS in its original format
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OECDENVIRONMENTMONOGRAPH
No. 106
DATA REQUIREMENTS FOR REGISTRATION OFBIOPESTICIDES IN OECD MEMBER COUNTRIES:
SURVEY RESULTS
Environment Directorate
ORGANISATION FOR ECONOMIC CO-OPERATION AND DEVELOPMENT
Paris 1996
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Also published in the Environment Monograph series:
Environment Monograph No. 77, DataRequirements for Pesticide Registration inOECD Member Countries: Survey Results(1992)
Environment Monograph No. 105, Report ofthe OECD Workshop on EnvironmentalHazard/Risk Assessment (1995)
Environment Monograph No. 108, FinalReporton the OECD Pilot Project to ComparePesticide Data Reviews (1995)
For a complete list of OECD EnvironmentalHealth and Safety publications, please seepage 115.
© OECD 1996
Applications for permission to reproduce or translate all or part of this material should be made to:Head of Publications Service, OECD, 2 rue André-Pascal, 75775 Paris Cedex 16, France
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OECD ENVIRONMENT MONOGRAPHS
The Environment Monograph series makestechnical documents prepared by the OECDEnvironment Directorate available to the public.For a complimentary copy of this document,contact the Environmental Health and SafetyDivision, OECD Environment Directorate, 2 rueAndré-Pascal, 75775 Paris Cedex 16, France.
Fax: (33-1) 45 24 16 75
E-mail: [email protected]
http://www.oecd.org/
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Foreword
This Environment Monograph presents the results of a survey of data requirementsfor the registration of biological pesticides (or "biopesticides") in OECD Member countries.The survey was conducted as part of the OECD Pesticide Programme in 1993-1994. Itfocused primarily on specific testing requirements for micro-organisms used for plantprotection, including organisms that have been genetically modified (GMOs). The survey alsocollected information on countries’ overall regulatory approach to other types and uses ofbiopesticides.
The purpose of the survey was to develop an inventory of current national datarequirements for biopesticides, in order to prepare for future efforts to increase theinternational harmonization of these requirements. The long-term goal is to enhance Membercountries’ ability to use each other’s evaluations of pesticide data, so that they can share thework of registration and re-registration. Greater international harmonization of datarequirements will also reduce trade barriers between countries, as well as reducing duplicativechemicals testing by industry.
The Joint Meeting of the Chemicals Group and the Management Committee of theSpecial Programme on the Control of Chemicals recommended that this document bederestricted. It is being published on the responsibility of the Secretary-General of the OECD.
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Contents
Résumé . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Survey Method . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Responding Countries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Survey Results: Part 1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Products Identified as Biopesticides (Table A) . . . . . . . . . . . . . . . . . . . . . . . . 19Requirements for Plant Protection Products (Table B) . . . . . . . . . . . . . . . . . . 19Requirements for Non-plant Protection Products (Table C) . . . . . . . . . . . . . . . 20Tier Testing of Micro-organisms (Table D) . . . . . . . . . . . . . . . . . . . . . . . . . . . 22Supplemental Requirements for Non-indigenous and
Genetically-engineered Organisms (Tables E and F) . . . . . . . . . . . . . . . . . . 22Status of Data Requirements (Table A) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23Policies and Programmes to Promote Biopesticides . . . . . . . . . . . . . . . . . . . 23Registered Products . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Survey Results: Part 2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Responses from the European Commission and EU Member States . . . . . . . 26Limitations of the Matrices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26Summary of Part 2 Findings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Conclusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Annexes
Annex 1 Tables Showing Individual Countries’ Responses to Part 1of the Questionnaire: The Registration Process . . . . . . . . . . . . . . . . 31
Annex 2 Biopesticides Registered in OECD Countries for PlantProtection and Other Uses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
Annex 3 Individual Countries’ Responses to Part 2 of the Questionnaire . . . . . . 75
Annex 4 Summary of Responses to Part 2 of the Questionnaire . . . . . . . . . . . . 99
Environmental Health and Safety Publications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 115
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Résumé
Introduction
Le présent rapport contient les résultats d’une enquête de l’OCDE dans ses paysMembres sur les données requises pour l’homologation des pesticides biologiques ou«biopesticides». L’enquête portait principalement sur les essais spécifiques requis pour lesmicro-organismes à usage phytosanitaire, y compris les organismes génétiquement modifiés(OGM). L’enquête a également recueilli des informations sur l’approche réglementairegénérale des pays concernant les autres types de biopesticides et leurs utilisations.
Cette enquête a été menée en 1993-1994 dans le cadre du Programme de l’OCDEsur les Pesticides. Il s’agissait de répertorier les données requises pour l’homologation desbiopesticides dans chaque pays, afin de préparer les futurs efforts d’harmonisation desdonnées requises au niveau international. L’objectif à long terme consiste à augmenter lacapacité des pays de l’OCDE à utiliser de manière réciproque les évaluations des données ;cela leur permettra de se répartir la charge de l’homologation des pesticides et de sonrenouvellement. Une plus grande harmonisation internationale des données requises réduiraégalement les obstacles aux échanges entre les pays et la duplication des essais (doubleemplois dans les essais) sur les produits chimiques réalisés par l’industrie pour être enconformité avec les diverses exigences des pays.
Méthode de l’enquête
L’enquête s’est appuyée sur un questionnaire conçu par le Secrétariat de l’OCDEavec l’aide d’un comité consultatif composé de représentants de l’Allemagne, de la Suède,de la Commission Européenne (CE) et de l’industrie des pesticides. Des experts des Etats-Unis, du Canada et du Programme de l’OCDE sur la Biotechnologie ont également révisé lequestionnaire.
Le questionnaire comportait deux parties. La partie 1 concernait tous les types etusages des biopesticides, usages phytosanitaires (agriculture, horticulture, forêts, ...) et autresusages (usages domestiques, santé publique, contrôle professionnel des insectes et animauxnuisibles, ...). La partie 1 s’intéressait à l’approche réglementaire générale des paysconcernant sept catégories de pesticides pouvant être considérés comme «biologiques» parceque remplissant l’un des deux critères suivants : (1) ils sont vivants, ou (2) ils existentnaturellement. Les pesticide concernés étaient les :
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micro-organismes tels que les bactéries, les algues, les fungi, les virus et lesprotozoaires ;phéromones ;régulateurs de croissance des insectes ;régulateurs de croissance des plantes ;extraits de plantes ; macro-organismes tels que les nématodes, lesacariens et les insectes prédateurs ; etplantes transgéniques, modifiées pour avoir des propriétés pesticides.
Dans la partie 1, il était également demandé aux pays de fournir des informationsgénérales sur :
les données requises pour les OGM, les ingrédients neutres et les organismesnon-indigènes ;l’utilisation des essais séquentiels ; etles politiques d’encouragement au développement et/ou à l’utilisation desbiopesticides.
En dernier lieu, la partie 1 demandait aux pays de fournir une liste de tous lesbiopesticides homologués et de soumettre des copies des données requises et des lignesdirectrices publiées.
La partie 2 du questionnaire s’intéressait exclusivement aux usages phytosanitairesdes micro-organismes . Il était demandé de fournir une liste spécifique des données requisespour l’homologation des micro-organismes, y compris les OGM, pour les usagesphytosanitaires. Les pays devaient compléter des séries de tableaux concernant les donnéesrequises pour les domaines d’essai suivants :
identité et propriétés biologiques ;fonction, mode d’action et manutention ;propriétés physico-chimiques ;fabrication, contrôle qualité et méthodes analytiques ;résidus ;efficacité ;toxicologie, pathogénicité et infectivité ;écotoxicologie ; etdevenir dans l’environnement.
Après avoir rempli les tableaux de la partie 2, les pays étaient invités à indiquer pourchaque élément de données : (1) si la conformité aux principes de Bonnes Pratiques deLaboratoire (BPL) était requise, (2) si des conseils pour mener les études étaient disponibles,et (3) la fréquence avec laquelle l’élément de données considéré était demandé. Lequestionnaire comportait une liste détaillée des éléments de données pouvant figurer danschaque domaine d’essai, et laissait aux pays la possibilité d’ajouter d’autres éléments.
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Pays ayant répondu à l’enquête
Le questionnaire a été envoyé à tous les pays Membres de l’OCDE et à la CE enseptembre 1993. Quatorze pays Membres, la Hongrie (pays en voie de transition économiqueà l’OCDE) et la CE ont complété le questionnaire. Les pays Membres ayant répondu sont lessuivants : Allemagne, Australie, Autriche, Canada, Danemark, Etats-Unis, Finlande, Italie,Japon, Norvège, Nouvelle-Zélande, Pays-Bas, Suède et Royaume-Uni. Deux autres paysMembres, la France et la Suisse, n’ont pas complété le questionnaire mais ont fourni desdocuments réglementaires et des listes de biopesticides homologués. Le Portugal a égalementenvoyé une liste de micro-organismes homologués pour un usage phytosanitaire.
Réponses à l’enquête : Partie 1
Les réponses des pays à la partie 1 du questionnaire sont présentées dans lestableaux A-F en Annexe 1.
Produits identifiés comme biopesticides (Tableau A)
Les 15 pays qui ont répondu à l’enquête et la CE ont tous indiqué qu’ils identifiaientles micro-organismes comme des biopesticides. Onze d’entre eux ont également désigné lesmacro-organismes et trois pays les plantes transgéniques. Quatre pays ont identifié lesphéromones, les régulateurs de croissance et les extraits de plantes comme desbiopesticides. Enfin, plusieurs pays ont fait remarquer qu’un pesticide devait être unorganisme vivant pour être «biologique». Certains pays et la CE ont déclaré que leurlégislation et/ou réglementation n’utilise pas le terme de «pesticide biologique».
Données requises pour les produits phytosanitaires (Tableau B)
En dépit de ces différences de terminologie, les pays tendent à aborder les donnéesrequises pour l’homologation des biopesticides de façon similaire, c’est-à-dire sous laréglementation des pesticides, en particulier pour les micro-organismes, les régulateurs decroissance, les extraits de plantes et, dans une certaine mesure, pour les phéromones. Lasituation est plus contrastée pour les macro-organismes et les plantes transgéniques.
L’enquête montre également que la plupart des pays différencient les organismesvivants des organismes non-vivants pour les données d’essai, ces dernières étant similairesou différentes des données requises pour homologuer les pesticides chimiques. Tous ontrépondu que des données étaient requises sur les ingrédients neutres des biopesticides.
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Données requises pour les produits à usages autres que phytosanitaires (Tableau C)
L’approche réglementaire des pays concernant les biopesticides pour les usagesautres que phytosanitaires est plus divergente ; cette conclusion n’est pas surprenante dansla mesure où la même divergence existe dans le cas des pesticides chimiquesconventionnels.
Là encore, comme pour les produits phytosanitaires, les pays tendent à différencierles produits vivants des produits non-vivants pour les données requises pour leshomologations. Tous requièrent également des données sur les ingrédients neutres.
Essais séquentiels sur les micro-organismes (Tableau D)
La plupart des réponses montrent que les pays appliquent des essais séquentielssoit de façon formelle, soit au cas par cas, dans les domaines de la toxicologie, pathogénicité,infectivité, écotoxicologie et du devenir environnemental. Seuls six pays utilisent les essaisséquentiels pour la mesure des résidus.
Données supplémentaires requises pour les organismes non-indigènes et lesorganismes génétiquement modifiés (OGM) (Tableaux E et F)
Dix pays requièrent, de façon générale ou au cas par cas, des informationssupplémentaires sur les organismes non-indigènes (par exemple le devenir et lecomportement dans l’environnement, les effets écotoxicologiques), informations qui ne sontnormalement pas demandées pour les organismes indigènes. Dix pays et la CE requièrentégalement des données supplémentaires pour l’homologation des OGM (par rapport auxorganismes qui existent naturellement).
Politiques et programmes pour promouvoir les biopesticides
La quasi-totalité des pays qui ont répondu à l’enquête ont déclaré avoir desprogrammes ou politiques, en sus du développement de nouvelles données requises pourl’homologation, destinés à encourager le développement et l’utilisation des biopesticides. Desprogrammes de promotion de la gestion de protection intégrée dans l’agriculture et/ou lesforêts semblent être l’approche la plus largement utilisée.
Réponses à l’enquête : Partie 2
Les réponses des pays à la partie 2 du questionnaire sont présentées dans deuxséries de tableaux en Annexes 3 et 4. Le cas échéant, les tableaux font la distinction entreles données requises pour la substance active ou la formulation, pour les usages extérieursou intérieurs et pour les usages alimentaires ou non-alimentaires.
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Les tableaux en Annexe 3 présentent les réponses individuelles des pays. Lestableaux en Annexe 4 proposent un résumé de ces réponses.
Résumé des conclusions de la Partie 2
Les réponses à l’enquête suggèrent que de nombreux de pays ont adopté uneapproche similaire pour organiser les données requises pour les micro-organismes, et qu’ilstendent s’intéresser aux mêmes domaines d’essai ou catégories d’étude. L’enquête révèledes différences pour les données requises dans certains domaines d’essai, en particulier lespropriétés physico-chimiques, l’écotoxicologie et le devenir dans l’environnement. L’enquêtesouligne également le fait que les pays n’ont pas tous la même approche pour l’homologationdes OGM.
L’enquête a également mis en évidence des différences fondamentales entre lesdonnées requises pour les micro-organismes et celles requises pour les pesticides chimiquestraditionnels.
Conclusion
L’enquête a montré que l’homologation de différents types de biopesticides est encours dans les pays Membres de l’OCDE. Un nombre substantiel de biopesticides ont étéhomologués pour les produits phytosanitaires et un nombre plus restreint pour les produitsautres que ceux qui servent à la protection des plantes. La plupart des pays qui ont réponduont établi des données requises pour les micro-organismes, et certains l’ont également faitpour d’autres types de biopesticides. Beaucoup ont déclaré que l’établissement de donnéesrequises différentes était l’un des éléments de leur programme national pour promouvoirl’homologation et l’utilisation des biopesticides.
Les résultats de l’enquête suggèrent qu’un noyau commun de données minimumpourrait être proposé pour les micro-organismes, en s’appuyant sur le recoupement déjàexistant dans les données requises de chaque pays. Les réponses ont également suggéréle besoin de travailler pour harmoniser les données requises pour les phéromones, pourlesquelles les pays semblent adopter des approches différentes.
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Introduction
This report presents the results of an OECD survey of Member countries’ datarequirements for the registration of biological pesticides, or "biopesticides". The surveyfocused principally on specific testing requirements for micro-organisms used for plantprotection, including organisms that have been genetically modified (GMOs). The survey alsocollected information about countries’ overall regulatory approach to other types and uses ofbiopesticides.
This survey was conducted as part of the OECD Pesticide Programme during 1993-1994. Its purpose was to develop an inventory of current national data requirements forbiopesticides, in order to prepare for future efforts to increase international harmonization ofthese requirements. The long-term goal of OECD work on pesticides is to increase Membercountries’ ability to use each other’s evaluations of pesticide data, so that they can share thework of registration and re-registration. Greater international harmonization of datarequirements will also reduce trade barriers between countries, as well as duplicative testingof chemicals by industry to comply with diverse national regulatory requirements.
Survey Method
The survey was based on a questionnaire designed by the OECD Secretariat withthe assistance of an advisory committee composed of representatives from Germany,Sweden, the European Commission (EC), and the pesticide industry. Experts from Canada,the United States, and the OECD Secretariat also reviewed drafts of the questionnaire.
The questionnaire was divided into two parts. Part 1 covered all biopesticide typesand uses, i.e. both plant protection (e.g. agriculture, horticulture and forestry) and non-plantprotection (e.g. household, public health, and professional pest control). Part 1 asked aboutcountries’ regulatory approach to seven categories of pesticides that could be consideredbiological because they are alive and/or naturally occurring. These included:
micro-organisms such as bacteria, algae, fungi, viruses and protozoa;pheromones ;insect growth regulators ;plant growth regulators ;plant extracts ;macro-organisms such as nematodes, mites and predatory insects; andtransgenic plants that have been modified to have pesticidal properties.
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Part 1 also requested general information on:
requirements for GMOs, inert ingredients, and non-indigenous organisms;use of tier testing; andpolicies to encourage the development and/or use of biopesticides.
Finally, Part 1 asked countries to list all biopesticides they have registered, and tosubmit copies of published data requirements and guidelines.
Part 2 of the questionnaire focused exclusively on plant protection uses of micro-organisms . Part 2 requested a specific listing of data requirements for registration of micro-organisms, including GMOs, for plant protection uses. Countries were asked to complete aseries of matrices showing their requirements in the following test areas:
identity and biological properties;function, mode of action, and handling;physical-chemical properties;manufacturing, quality control, and analytical methods;residues;efficacy;toxicology, pathogenicity, and infectivity;ecotoxicology; andenvironmental fate.
When completing the Part 2 matrices, countries were asked to indicate for each dataelement: (1) whether compliance with principles of Good Laboratory Practice was required,(2) whether guidance for conducting the study was available, and (3) whether the dataelement was always, frequently (in more than 80 per cent of registration submissions), lessfrequently (in fewer than 80 per cent of registration submissions), or never required. Thequestionnaire contained an extensive listing of possible data elements in each test area, andprovided space for countries to include additional elements.
Responding Countries
The questionnaire was sent to all OECD Member countries and the EC in September1993. Fifteen Member countries and the EC, as well as Hungary (an OECD Partner-In-Transition), completed it. The Member countries were: Australia, Austria, Canada, Denmark,Finland, France, Germany, Italy, Japan, the Netherlands, New Zealand, Norway, Sweden, theUnited Kingdom, and the United States. Switzerland submitted regulatory documents and listsof biopesticides registered, but did not complete the questionnaire. Portugal also submitteda list of micro-organisms registered for plant protection uses.
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Survey Results: Part 1
Countries’ responses to Part 1 of the questionnaire are presented in Tables A-F inAnnex 1. The summaries below (both the text and Tables 1-8) were developed from thesetables.
Products Identified as Biopesticides (Table A)
The survey began by asking countries to list categories of products they identified asbiopesticides. All 16 countries and the EC indicated that they identified micro-organisms asbiopesticides. Eleven countries also listed macro-organisms (of these, one country noted thatonly products for public health use were regulated, and another said that nematodes were theonly macro-organism regulated); three countries listed transgenic plants. Four countries alsoidentified pheromones, growth regulators, and plant extracts as biopesticides. Severalcountries noted that, to be "biological", a pesticide must be a living organism. A number ofcountries, as well as the EC, stated that their laws and/or regulations did not apply the term"biological pesticide".
Requirements for Plant Protection Products (Table B)
Despite these differences in terminology, survey respondents tended to approachbiopesticide registration and data requirements similarly, especially for plant protection uses.As shown in Table 1 below, all 17 survey respondents said they required micro-organisms,growth regulators, and plant extracts used for plant protection to be registered under pesticidelaw. Fourteen required or would in future require the registration of pheromones for pestcontrol (uses other than monitoring). Six countries also required or would require registrationof pheromones for monitoring and forecasting, while eight countries and the EC did not (inpractice, however, one respondent noted that pheromones used for monitoring were also usedfor mating disruption and other pest control measures and therefore would be registered). Bycontrast, only six of the respondents said they required or would require macro-organisms andtransgenic plants to be registered under pesticide law.
The survey responses showed a clear trend for countries to differentiate, in theirtesting requirements for plant protection products, between living and non-living organisms.Most respondents said they applied the same data requirements used for chemical pesticidesto growth regulators and plant extracts. Data requirements for viable micro-organisms, macro-organisms and transgenic plants were generally different, although many respondents saidthey were often based on requirements for chemicals. Approximately half the respondentssaid they used chemical data requirements for pheromones and non-viable micro-organisms;the other half said their requirements were different. All responding countries said theyrequired data on inert ingredients in biopesticides, and approximately half had established datarequirements for pre-registration field testing.
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Table 1Registration of Biopesticides for Plant Protection
(Number of Countries with Requirement)
pesticide type registrationrequired bypesticidelaw
reviewrequiredunder otherlaw orprogramme
registrationnotrequired
registration notnow requiredbut will be infuture
data requirements forregistration are the same as ordifferent from those forchemical pesticides
datarequirementsestablishedfor pre-registrationfield testing
same different
micro-organisms
naturallyoccurring
viable 17 17 8
non-viable 17 7 10 8
geneticallymodified
viable 17 10 15 10
non-viable 17 6 5 11 10
other
pheromones monitoring 6 8 1 6 3 4
other uses 14 3 1 8 5 5
insect growth regulators 17 16 1 7
plant growth regulators 17 16 1 7
plant extracts 17 17 7
macro-organisms 5 2 8 1 7 4
transgenic plants 3 10 3 3 8 7
Requirements for Non-plant Protection Products (Table C)
Countries’ regulatory approaches to biopesticides for non-plant protection uses weremore divergent than their approaches to plant protection products, a finding that was notsurprising since the same pattern occurred in the case of chemical pesticides. The mostimportant difference was in the requirement to register products. As shown in Table 2 below,just ten of the survey respondents currently required registration, under national pesticide law,of growth regulators, plant extracts, and non-viable naturally occurring micro-organisms. Stillfewer countries required such registration of pheromones, viable naturally occurring micro-organisms, and GMOs. The remaining countries either regulated the products under anotherlaw, did not require them to be registered, or might require registration in the future. Bycomparison, all 17 survey respondents required registration of products in these fivecategories for plant protection use.
As was seen with plant protection products, countries treated living and non-livingproducts differently in setting data requirements for registration. Table 2 shows that themajority of the countries responding to this question said their requirements for non-plantprotection uses of growth regulators and plant extracts were the same as their requirementsfor chemical pesticides, while their requirements for viable micro-organisms were different.Countries diverged most sharply in their approach to pheromones and non-viable micro-
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organisms: some treated them like chemicals, applying the same data requirements forregistration, and others established separate requirements. Fewer than half the respondingcountries had established pre-registration field testing requirements for the various types ofbiopesticides, but all respondents said they required data on inert ingredients.
Table 2Registration of Biopesticides for Non-plant Protection Uses
(Number of Countries with Requirement)
pesticide type registrationrequired bypesticidelaw
reviewrequiredunder otherlaw orprogramme
registrationnot required
registration notcurrentlyrequired but willbe in future
data requirements forregistration are the sameas or different fromthose for chemicalpesticides
datarequirementsare establishedfor pre-registrationfield testing
same different
micro-organisms
naturallyoccurring
viable 9 4 1 3 1 11 4
non-viable 10 4 1 2 6 8 5
geneticallymodified
viable 8 10 1 2 0 13 8
non-viable 9 8 1 2 4 9 8
other
pheromones monitoring 3 1 7 1 5 3 4
other uses 7 2 5 2 7 4 5
insect growth regulators 10 2 2 2 10 3 5
plant extracts 10 3 1 3 10 3 4
An issue which arose during the course of the survey was only partially dealt within countries’ responses, but it raises some interesting questions. This concerns therelationship between countries’ data requirements for biopesticides registered for plantprotection, and their requirements for the same pesticides when they are registered for non-plant protection uses. The survey found three overall approaches. First, there were countrieswhich did not require registration of biopesticides for non-plant protection uses, and whichtherefore had "different" data requirements for the different uses. Second, there wereexamples like the EC, which had developed separate data requirements for plant protectionproducts (whether chemical or biological), for biocides (chemical or biological), and for micro-organisms. However, it should be noted that these "different" sets of data requirements werelikely to overlap in at least some study areas. Finally, there were countries which used thesame basic set of data requirements for all product uses, but which tailored the requirementsto the particular use undergoing registration. A key question not answered by thesurvey – which would be important for future work on harmonized data sets – is the extentto which general data requirements tailored to specific uses were substantially different from
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requirements developed separately for separate uses. A second unanswered questionconcerns the way the data requirements were implemented, the circumstances under whichsome were waived, and how this contributed to the creation of distinct sets of requirementsfor different use patterns.
Tier Testing of Micro-organisms (Table D)
The questionnaire asked countries to indicate whether they used tier testing in theirdata requirements for micro-organisms on a formal or case-by-case basis. (Tier testing refersto the use of a stepped testing sequence, in which tests in higher tiers are required only ifspecified hazard levels were exceeded at earlier stages.) As seen in Table 3 , most surveyrespondents said they applied tier testing on either a formal or case-by-case basis todetermine toxicity, pathogenicity, infectivity, ecotoxicity and environmental fate. However, justseven countries used tier testing for residues. A total of six countries had developed or werein the process of developing formal testing tiers.
Table 3Tier Testing of Micro-organisms (Number of Countries Using Tiers)
test area formal tiers case-by-case
residues 1 6
toxicity 4 9
pathogenicity 2 10
infectivity 2 10
ecotoxicity 5 9
environmental fate 4 9
Supplemental Requirements for Non-indigenous and Genetically-engineered Organisms(Tables E and F)
The survey found that ten countries required, either generally or on a case-by-casebasis, information on non-indigenous organisms that was not normally required for indigenousorganisms. The supplemental information generally concerned fate and behaviour in theenvironment or ecotoxicological effects. Eleven respondents including the EC had additionalpolicies or registration requirements, not normally required for naturally occurring organisms,for GMOs.
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Status of Data Requirements (Table A)
The questionnaire asked countries to submit copies of data requirements developedseparately for biopesticides, along with guidelines and other supporting documents. As seenin Table 4 , the responses showed that several countries had developed data requirementsand/or guidelines for registration of one or more categories of biopesticide.
Table 4Availability of Data Requirements and/or Guidelines
final data requirements or guidelines are available for:
micro-organisms macro-organisms pheromones otherbiopesticides
ECAustriaFranceHungaryItalyThe NetherlandsNew ZealandUnited KingdomUnited States
HungaryNew Zealand(nematodes)
HungaryUnited States
HungaryUnited States
draft data requirements or guidelines are available for:
micro-organisms macro-organisms pheromones otherbiopesticides
AustraliaCanadaSweden
CanadaSweden
AustraliaCanada
Australia
Policies and Programmes to Promote Biopesticides
Nearly all the countries responding to the survey said they had some kind ofprogramme or policy, apart from development of separate data requirements, intended toencourage the development and use of biopesticides. These included research anddevelopment of biological controls, activities to promote their use in agriculture and forestry,and measures to facilitate registration of biopesticides, such as lower fees or faster registrationprocesses. Countries’ programmes to promote integrated pest management can also resultin increased use of biological controls. Table 5 gives an overview of the different types ofprogrammes and policies that were being carried out by the survey respondents.
23
Table 5Policies and Programmes to Promote Biopesticides
programmes and policies to promote biologicalpesticides
countries
shorter registration process France, United States
priority for registration United States
reduced registration fees United Kingdom
government initiatives to promote use of biologicalcontrols and integrated pest management in agricultureand/or forestry, including:
research/development of new products and methodsdevelopment of guidelines for integrated pestmanagementextension, training, and subsidies to assist thetransition from conventional to biodynamic andecological farminglaws requiring farmers to limit the use of chemicalpesticides, increase use of integrated pestmanagement methodssystems to provide farmers with information onintegrated pest management methods
Australia, Austria, Canada,Finland, France, Germany,Italy, Japan, theNetherlands, Sweden,United Kingdom
Registered Products
Nearly all the countries responding to the survey provided a list of biopesticidesregistered, or in the registration process, for plant protection or other uses. These sometimeslengthy lists confirmed that registration of biopesticides – particularly micro-organisms andpheromones – was actively underway in OECD Member countries. A compilation of theindividual country lists, organised by biopesticide type and use, is provided in Annex 2.Table 6 gives an overview of the number of countries with registrations of different types ofproducts.
24
Table 6Types of Biopesticides Registered
type of biopesticide use pattern number of countries withregistered products
micro-organism plant protection 17
non-plant protection 11
pheromone plant protection 9
non-plant protection 3
growth regulator plant protection 6
non-plant protection 3
plant extract plant protection 8
macro-organism non-plant protection 5
Survey Results: Part 2
Responses to Part 2 of the questionnaire, focusing on data requirements forregistration of micro-organisms for plant protection, are displayed in two sets of matrices inAnnexes 3 and 4. The matrices follow the questionnaire’s format, with a separate matrix foreach of the nine test areas and a comprehensive list of data elements in each area. Whereappropriate, the matrices distinguish between data requirements for the active ingredient vs.the formulation, for indoor uses vs. outdoor uses, and for food/feed uses vs. non-food/non-feed uses.
The matrices also indicate:
how often each data element is required during registration;
whether compliance with principles of Good Laboratory Practice is required;
whether test guidelines for specific data elements were available; and
whether additional comments were provided by the country.
(Owing to the number and length of individual countries’ comments, they have notbeen included in this document; they are, however, available on request from the OECDSecretariat at the address shown on page 5.)
25
The matrices in Annex 3 show individual countries’ responses. The matrices inAnnex 4 summarise those responses by indicating the number of countries that required eachdata element.
Responses from the European Commission and EU Member States
The changing situation in the European Union (EU) with respect to pesticide datarequirements complicated the analysis of the survey results. As the EC explained, variabledata requirements will operate in the EU until the year 2003, with:
new active substances, re-evaluated old active substances, and productscontaining them covered by the requirements of Directive 91/414/EEC; and
national data requirements or Directive 91/414/EEC covering old activesubstances not yet re-evaluated and plant protection products containing them.
Responses from both the EU Member States and the EC are shown in the matricesin Annex 3. The summary matrices in Annex 4, however, include only the responses from theEC and do not show individual EU countries’ replies except in those cases where a countryspecifically added a data element to the original list. (In the latter situation, responses areshown in parentheses.) EC responses are counted as 12, to reflect the anticipatedcompliance of EU countries with the EEC Directive. The responses of Austria, Finland andSweden are listed with those of the non-European Union countries, because they had not yetjoined the EU at the time of the survey.
Limitations of the Matrices
The limitations inherent in this type of survey should be kept in mind when reviewingthe data requirement matrices. The box-ticking approach can provide a useful overview ofdata requirements and a starting point for future work, but it cannot capture the complexity ofpesticide testing and the use of judgment that accompanies countries’ implementation of theirdata requirements. For both scientific and practical reasons, most countries exercise someflexibility in their acceptance of pesticide data and in their waiving of certain requirements incertain cases. Moreover, registration of micro-organisms is a relatively new exercise, andsome countries found it difficult to complete the matrices because they had registered only ahandful of products and therefore could not say with certainty how often a data element wasrequired.
In an effort to reflect the complexity and uncertainty of the situation, most countriesadded comments to the matrices. These comments, noted in the matrices with a "c", weretoo numerous to include in this report but are available on request from the OECD Secretariat.Other countries and the EC simply marked data elements with an "X" rather than indicatingwhether they were always, frequently, or less frequently required. It should thus be kept inmind that the matrices are intended only to provide an overview and starting point forharmonization, and not to serve as a definitive description of the registration of micro-organisms.
26
Summary of Part 2 Findings
The survey responses suggest that many countries had adopted a similar approachto structuring their data requirements for micro-organisms, and that they tended to emphasizethe same test areas or study categories. The survey reveals some differences in requirementsin certain test areas, most notably physical-chemical properties, ecotoxicology andenvironmental fate. It also underscores the fact that not all countries were taking the sameapproach to registration of GMOs. An overview of the survey findings for each study area ispresented in Table 7 .
The survey also highlights the key differences between data requirements for micro-organisms and requirements for traditional chemical pesticides, as shown in Table 8 .
Conclusion
The survey found that registration of various types of biopesticides was well underwayin OECD Member countries. Respondents had registered a considerable number ofbiopesticides for plant protection and a smaller number for non-plant protection uses. Mosthad established separate data requirements for micro-organisms, and some had done so forother biopesticide types. Many respondents said the establishment of separate datarequirements was one element of their country’s programme to promote registration and useof biopesticides.
The survey found that many countries had adopted a similar approach to structuringtheir data requirements for micro-organisms, and that they tended to emphasize the same testareas or study categories. Nevertheless, the survey revealed some differences in requirementsin certain test areas, most notably physical-chemical properties, ecotoxicology andenvironmental fate. It also showed that some countries required additional tests or additionalreview (e.g. under a second law or by a second regulatory body) for GMOs.
The survey results suggest that a minimum "common core data set" could beproposed for micro-organisms, based on the overlap that already exists in countries’requirements. The results also suggest a need for work towards harmonization ofrequirements for pheromones, where countries appear to be adopting differing approaches.
27
Table 7Summary and Comparison of Countries’ Data Requirements
test area summary and comparison of data requirements
identity and biologicalproperties
Survey respondents generally required the same information on identity and biologicalproperties of naturally occurring micro-organisms, e.g.:
scientific name, common name, subspecies, strain, serotype;history of the organism, relationship to known pathogens, natural occurrence and
geographic distribution, genetic stability, survivability.For genetically modified organisms, the EC and several non-European countries requiredadditional information not required by others on the donor organism, genetic material,vector, gene control region, modification technique, and site of new material in recipient.
physical-chemicalproperties
Survey respondents required only a few data elements on physical-chemical properties,and the elements they required were often different. The only elements required by all ormost respondents were storage stability, physical state, and appearance.
function, mode of actionand handling
Survey respondents’ requirements were very similar in this area, which includes informationranging from application rate to pre-harvest intervals to product packaging and storage.
manufacturing, qualitycontrol and analyticalmethods
All or most survey respondents required information on manufacturing, quality control, andmethods to show microbiological purity. Greater difference was seen in requirements formethods to detect and quantify residues in various media.
residues Survey responses were very similar in this test area. All respondents but one requiredinformation on the persistence, nature and magnitude of residues in/on crops or food; allrequired a summary and evaluation of residue behaviour and proposed maximum residuelevels; and nearly all (but not the EC) required information on the effects of processing orcooking on residues.
efficacy Survey responses were very similar in this test area except in the case of requirements fordata on dose-efficacy relationships and on use of the product in integrated pestmanagement systems. These data elements were listed by most or all non-EuropeanUnion respondents, but not by the EC.
toxicology, pathogenicityand infectivity
Respondents took a similar approach to data requirements throughout this test area. Mostor all required basic acute toxicity tests (oral, dermal, inhalation) as well as skin and eyeirritation/sensitivity for all registration submissions. Most or all required subchronic tests ona less frequent basis (for fewer than 20% of registration submissions). Several countriesand the EC required medical data (e.g. on applicator exposure, hypersensitivity/allergenicity incidents). Five to eight countries required data on genetic toxicity, dermalpenetration, and estimates of occupational exposure. The EC and a small number ofcountries sometimes required information on: neurotoxicity, metabolism, oncogenicity,long-term toxicity, developmental and reproductive effects, immunotoxicity and allergenicity/hypersensitivity.
ecotoxicology Ecotoxicology data were somewhat less rigorously required than toxicology data. The ECand most non-European Union respondents required basic acute toxicity, pathogenicity andinfectivity tests (bird, honey bee, freshwater fish, freshwater invertebrate), but half thecountries said the tests were required frequently (i.e. for 80-99% of registrationsubmissions) rather than always. Acute tests on other organisms such as earthworm,algae, wild mammal, estuarine and marine animal were seldom required. Long-termstudies and field tests were seldom or never required.
environmental fate Requirements for information on environmental fate showed a pattern similar to that seenin ecotoxicology. Six non-European Union respondents and the EC requiredlaboratory/microcosm testing on environmental fate (spread, mobility, multiplication andpersistence) in soil, water and air; but only half the countries said they always requiredsuch data. The same number of countries but not the EC required data on gene-transferrates/competitiveness in the environment for GMOs. Only a few non-European countriesand the EC said they required, even on an occasional basis, greenhouse or field studies.
28
Table 8Comparison of Data Requirements for Micro-organisms, Chemical Pesticides
test area requirements for micro-organisms
requirements for chemicals
identity/biological propertiesphysical-chemicalproperties
focus on identity andbiological properties
focus on physical-chemicalproperties
toxicology focus on hypersensitivity,allergenicity and genetictoxicity
greater focus on chronic,developmental andreproductive effects
environmental fate focus on multiplication inthe environment,competitiveness with otherorganisms
focus on photodegradationin various media
ecotoxicology fewer tests required overallthan for chemicals, butsome countries emphasizetesting of effects on non-target organisms
efficacy all countries required datain this area; somecountries required extratests not required forchemicals
not all countries requiredefficacy testing
29
30
Annex 1
Tables Showing Individual Countries’Responses to Part 1 of the Questionnaire:
The Registration Process
31
32
TA
BLE
AS
TA
TU
SO
FD
AT
AR
EQ
UIR
EM
EN
TS
AN
DP
RO
DU
CT
SC
OV
ER
ED
Cou
ntry
Pro
duct
sid
entif
ied
asbi
olog
ical
pest
icid
esS
tatu
sof
data
requ
irem
ents
EC
prod
ucts
cont
aini
ngm
icro
-org
anis
ms
orvi
ruse
sD
irect
ive
91/4
14/E
EC
whi
chde
fines
the
requ
irem
ents
for
auth
oriz
atio
nof
plan
tpr
otec
tion
prod
ucts
beca
me
oper
atio
nalo
n25
July
1993
.A
prop
osed
Cou
ncil
Dire
ctiv
eco
ncer
ning
auth
oriz
atio
n,pl
acin
gon
the
mar
ket,
use
and
cont
rolw
ithin
the
Com
mun
ityof
bioc
ides
,i.e
.pe
stic
ides
othe
rth
anpl
ant
prot
ectio
npr
oduc
ts,
has
been
adop
ted
byth
eC
omm
issi
onan
dw
illso
onbe
cons
ider
edby
the
Eur
opea
nP
arlia
men
t,th
eE
urop
ean
Eco
nom
ican
dS
ocia
lCom
mitt
eean
dth
eC
ounc
ilof
the
Eur
opea
nC
omm
uniti
es.
Bot
hD
irect
ives
dist
ingu
ish
betw
een
chem
ical
pest
icid
esan
dpe
stic
ides
cont
aini
ngm
icro
-org
anis
ms
orvi
ruse
s.
Aus
tral
ia1)
biol
ogic
ally
deriv
edch
emic
als
-di
rect
toxi
city
-in
dire
ctto
xici
tyse
mio
chem
ical
s(p
hero
mon
es)
horm
ones
grow
thre
gula
tors
enzy
mes
/pro
tein
spl
ant
and
anim
alex
trac
ts2)
mic
robi
als
3)ot
her
livin
gor
gani
sms
"Gui
delin
esfo
rR
egis
trat
ion
ofB
iolo
gica
lPro
duct
s"(O
ctob
er19
94)
have
been
prep
ared
and
circ
ulat
edfo
rus
eas
aw
orki
ngdo
cum
ent.
Aca
se-
by-c
ase
appr
oach
will
beta
ken
inde
term
inin
gth
eap
prop
riate
ness
ofce
rtai
nda
taan
dex
empt
ions
will
begr
ante
dw
hen
nece
ssar
y.
Aus
tria
mic
ro-
and
mac
ro-o
rgan
ism
s
Com
men
ts:
The
Aus
tria
nle
gisl
atio
ndo
esn’
tus
eth
ete
rm"b
iolo
gica
lpe
stic
ides
"
Det
ails
ofth
eda
tare
quire
men
tsar
eno
tye
tle
gally
fixed
,bu
tpr
actic
ally
they
are
inus
e.
33
Cou
ntry
Pro
duct
sid
entif
ied
asbi
olog
ical
pest
icid
esS
tatu
sof
data
requ
irem
ents
Can
ada
1)m
icro
bial
pest
cont
rola
gent
s2)
mac
ro-o
rgan
ism
s
Com
men
ts:
Mac
ro-o
rgan
ism
sdo
not
yet
requ
irere
gist
ratio
n,bu
tgu
idel
ines
for
regi
stra
tion
ofbi
olog
ical
cont
rola
gent
s(in
sect
s,m
ites
and
nem
atod
es)
are
bein
gde
velo
ped.
Phe
rom
ones
,pl
ant
extr
acts
,an
din
sect
and
plan
tgr
owth
regu
lato
rsar
eno
tid
entif
ied
asbi
olog
ical
pest
icid
esan
dre
quire
regi
stra
tion
asch
emic
alpe
stic
ides
.T
rans
geni
cpl
ants
with
pest
icid
alpr
oper
ties
are
regu
late
das
varie
ties
unde
rth
eS
eeds
Act
and
byH
ealth
Can
ada
asno
velf
oods
.
Mic
ro-o
rgan
ism
sC
urre
ntda
tare
quire
men
tsar
epu
blis
hed
inR
esea
rch
Per
mit
Gui
delin
esfo
rM
icro
bial
Pes
tC
ontr
olA
gent
s(P
RO
-93-
05),
and
Reg
istr
atio
nG
uide
lines
for
Mic
robi
alP
est
Con
trol
Age
nts
(PR
O-9
3-04
).T
hese
are
unde
rre
view
and
may
befu
rthe
rre
vise
d.
Phe
rom
ones
Dra
ftG
uide
lines
for
the
Reg
ulat
ion
ofP
hero
mon
esan
dO
ther
Sem
ioch
emic
als
have
been
prep
ared
but
not
yet
circ
ulat
edfo
rre
view
.It
ispr
opos
edth
atth
eda
tare
quire
men
tsfo
rre
gist
ratio
nof
man
yph
erom
one
prod
ucts
bele
ssth
anth
ose
for
trad
ition
alch
emic
als,
and
that
som
eph
erom
one
prod
ucts
beex
empt
edfr
omre
gist
ratio
nal
toge
ther
.
Mac
ro-o
rgan
ism
sD
raft
Gui
delin
esfo
rth
eIn
trod
uctio
nan
dR
elea
seof
Inve
rteb
rate
Bio
logi
calC
ontr
olA
gent
s(I
nsec
ts,
Mite
san
dN
emat
odes
)ar
eun
der
inte
rdep
artm
enta
lrev
iew
and
may
bere
vise
d.
Inse
ctan
dpl
ant
grow
thre
gula
tors
and
plan
tex
trac
tsar
ere
gula
ted
inth
esa
me
way
asot
her
chem
ical
pest
icid
es.
Den
mar
k1)
mic
ro-o
rgan
ism
s2)
mac
ro-o
rgan
ism
s3)
tran
sgen
icpl
ants
Com
men
ts:
Bio
logi
calp
estic
ides
incl
ude
only
pest
icid
esw
hich
cons
ist
ofliv
ing
orga
nism
s.P
hero
mon
es,
inse
ctan
dpl
ant
grow
thre
gula
tors
,an
dpl
ant
extr
acts
are
rega
rded
asch
emic
alpe
stic
ides
.
Dat
are
quire
men
tsfo
rm
icro
biol
ogic
alpl
ant
prot
ectio
npr
oduc
tsar
eth
ose
liste
din
EE
Cdi
rect
ive
91/4
14/E
EC
.D
etai
led
regu
latio
nsar
ees
tabl
ishe
din
Sta
tuto
ryO
rder
from
the
Min
istr
yof
the
Env
ironm
ent
No.
584
of9
July
1993
onP
estic
ides
.D
raft
guid
elin
esfo
rim
plem
entin
gth
ere
quire
men
tsar
epu
blis
hed
in19
93.
34
Cou
ntry
Pro
duct
sid
entif
ied
asbi
olog
ical
pest
icid
esS
tatu
sof
data
requ
irem
ents
Fin
land
Com
men
ts:
Bio
logi
calp
estic
ides
are
not
men
tione
dse
para
tely
inth
eF
inni
shle
gisl
atio
nno
rar
eth
eygr
oupe
din
diffe
rent
cate
gorie
s.U
seha
sbe
enth
ede
cisi
vefa
ctor
,i.e
.if
the
prod
uct
isin
tend
edfo
rus
eag
ains
tin
sect
s,pl
ant
dise
ases
,w
eeds
,et
c.it
has
been
regu
late
das
ape
stic
ide
whe
ther
orno
tth
epr
oduc
tis
ach
emic
alor
biol
ogic
alon
e.M
acro
-org
anis
ms
and
tran
sgen
icpl
ants
are
not
cons
ider
edto
bepe
stic
ides
atal
l.S
ince
beco
min
ga
mem
ber
ofth
eE
Uin
1995
,F
inla
ndha
sim
plem
ente
ddi
rect
ive
91/4
14/E
EC
,m
eani
ngth
atpr
oduc
tsco
ntai
ning
mic
ro-o
rgan
ism
sor
viru
ses
are
cont
rolle
das
biop
estic
ides
.
No
spec
ific
legi
slat
ion
and
nosp
ecifi
cda
tare
quire
men
ts.
Req
uire
men
tsar
ese
ton
aca
se-b
y-ca
seba
sis,
e.g.
:1)
Phl
ebia
giga
ntia
–no
toxi
n–
nost
udie
sre
quire
d.2)
Str
epto
myc
esgr
iseo
virid
is–
docu
men
tatio
nre
quire
d.
a)F
orpl
ant
extr
acts
,th
ere
quire
men
tsar
eth
esa
me
asfo
rsy
nthe
size
dpe
stic
ides
.T
hese
prod
ucts
are
not
cons
ider
edbi
olog
ical
pest
icid
es,
but
pest
icid
esin
gene
ral.
b)F
orm
icro
-org
anis
ms,
the
cont
entio
nals
tudy
requ
irem
ents
are
not
sost
rict
asfo
rch
emic
alsu
bsta
nces
.T
here
quire
men
tsar
eno
tof
ficia
llyst
ated
,ho
wev
er,
sinc
eth
ere
have
been
only
afe
wap
plic
atio
nsan
dth
ede
cisi
ons
are
mad
eon
aca
se-b
y-ca
seba
sis
intie
rs.
c)R
equi
rem
ents
for
mac
ro-o
rgan
ism
sor
tran
sgen
icpl
ants
have
not
been
cons
ider
ed,
sinc
eth
ese
are
not
clas
sifie
das
pest
icid
es.
The
sam
eis
true
for
som
eus
esof
pher
omon
es,
e.g.
for
mon
itorin
gpu
rpos
es.
The
Fin
nish
Pes
ticid
eA
ctw
asam
ende
din
Jan
1995
toco
mpl
yw
ithth
ege
nera
lreg
ulat
ions
of91
/414
/EE
C,
but
the
mor
esp
ecifi
cte
stre
quire
men
tsfo
rbi
opes
ticid
esw
illbe
esta
blis
hed
inth
efu
ture
byth
eM
inis
try
ofA
gric
ultu
rean
dF
ores
try.
(Gen
eral
data
requ
irem
ents
for
mic
ro-o
rgan
ism
san
dvi
ruse
sar
ese
tin
the
anne
xes
of91
/414
/EE
Can
ddr
aft
Bio
cide
Dire
ctiv
e)
Fra
nce
Com
men
ts:
Fra
nce
follo
ws
the
prin
cipl
esof
the
EC
see
EC
resp
onse
Ger
man
yfo
rpl
ant
prot
ectio
n:m
icro
-org
anis
ms
and
viru
ses
for
publ
iche
alth
:m
icro
-an
dm
acro
-or
gani
sms
are
cons
ider
edbi
olog
ical
pest
icid
es;
pher
omon
es,
plan
tex
trac
tsan
din
sect
grow
thre
gula
tors
are
bioc
hem
ical
s
No
sepa
rate
data
requ
irem
ents
are
publ
ishe
dfo
rbi
olog
ical
pest
icid
es,
beca
use
the
Ger
man
Pla
ntP
rote
ctio
nA
ctm
akes
nodi
stin
ctio
nbe
twee
nbi
olog
ical
and
chem
ical
subs
tanc
es.
Nev
erth
eles
s,th
eco
mpe
tent
Ger
man
auth
ority
reco
gniz
esth
atdi
ffere
ntap
proa
ches
are
requ
ired
toev
alua
tebi
olog
ical
vs.
chem
ical
activ
ein
gred
ient
s,an
ddi
ffere
ntap
proa
ches
are
ther
efor
eus
ed.
For
publ
iche
alth
pest
icid
es,
itis
com
mon
prac
tice
tosu
mm
ariz
em
icro
-an
dm
acro
-org
anis
ms
asbi
olog
ical
pest
icid
es,
and
pher
omon
es,
plan
tex
trac
tsan
din
sect
grow
thre
gula
tors
asbi
oche
mic
als.
How
ever
,th
isis
not
ade
finiti
onby
any
law
ordi
rect
ive.
Dat
are
quire
men
tsar
eba
sed
onth
ose
for
chem
ical
pest
icid
es.
35
Cou
ntry
Pro
duct
sid
entif
ied
asbi
olog
ical
pest
icid
esS
tatu
sof
data
requ
irem
ents
Hun
gary
1)liv
ing
orga
nism
ssu
itabl
efo
rbi
olog
ical
cont
rol
-m
icro
-org
anis
ms
(viru
ses,
viru
s-lik
eor
gani
sms,
bact
eria
,pr
otoz
oa,
fung
i,al
gae)
-m
acro
-org
anis
ms
(nem
atod
es,
para
sitic
and
pred
ator
yin
sect
s,tr
ansg
enet
icpl
ants
)2)
livin
gor
gani
sms
othe
rth
anth
ose
used
for
cont
rol(
polli
natin
gin
sect
)3)
chem
ical
sof
biol
ogic
alor
igin
(bio
chem
ical
s)-
inse
ctgr
owth
regu
lato
rs-
pher
omon
es-
plan
tgr
owth
regu
lato
rs-
plan
tex
trac
ts-
met
abol
ites
prod
uced
bym
icro
-org
anis
ms
(ant
ibio
tics)
-to
xins
prod
uced
byan
imal
s
Dat
are
quire
men
tsfo
rre
gist
ratio
nof
biol
ogic
alpe
stic
ides
,in
clud
ing
requ
irem
ents
for
field
tria
ls,
are
cont
aine
din
the
Pla
ntP
rote
ctio
nLa
wof
1988
.
Italy
1)m
icro
-org
anis
ms
2)ph
erom
ones
3)in
sect
grow
thre
gula
tors
4)pl
ant
grow
thre
gula
tors
5)pl
ant
extr
acts
6)m
acro
-org
anis
ms
7)tr
ansg
enic
plan
ts
Dat
are
quire
men
tsav
aila
ble
(bas
edon
EC
Dire
ctiv
es)
for
mic
ro-
orga
nism
sfo
rpl
ant
prot
ectio
nus
es,
gene
tical
lym
odifi
edpe
stic
ides
,an
dm
icro
-org
anis
ms
for
hous
ehol
dus
es.
Japa
n1)
mic
ro-o
rgan
ism
s2)
mac
ro-o
rgan
ism
s
Com
men
ts:
Phe
rom
ones
,in
sect
and
plan
tgr
owth
regu
lato
rs,
and
plan
tex
trac
tsar
ede
fined
asch
emic
alpe
stic
ides
.T
rans
geni
cpl
ants
are
defin
edas
seed
sor
seed
lings
,no
tas
pest
icid
es.
The
data
requ
irem
ents
for
mic
ro-o
rgan
ism
s,ph
erom
ones
and
mac
ro-o
rgan
ism
sar
eto
bepr
ovid
edon
aca
se-b
y-ca
seba
sis.
The
data
requ
irem
ents
for
regi
stra
tion
ofin
sect
and
plan
tgr
owth
regu
lato
rsan
dpl
ant
extr
acts
are
not
diffe
rent
from
thos
efo
rco
nven
tiona
lpes
ticid
es.
MA
FF
and
EA
are
curr
ently
inve
stig
atin
gde
velo
pmen
tof
data
requ
irem
ents
for
mic
robi
alpe
stco
ntro
lage
nts.
36
Cou
ntry
Pro
duct
sid
entif
ied
asbi
olog
ical
pest
icid
esS
tatu
sof
data
requ
irem
ents
The
Net
herla
nds
1)m
icro
-org
anis
ms
2)vi
ruse
s
Com
men
ts:
Phe
rom
ones
,in
sect
grow
thre
gula
tors
,pl
ant
grow
thre
gula
tors
and
plan
tex
trac
tsar
eid
entif
ied
asch
emic
alpe
stic
ides
.M
acro
-org
anis
ms
and
tran
sgen
icpl
ants
are
not
incl
uded
inth
eP
estic
ides
Act
1962
.
Dat
are
quire
men
tsfo
rbi
olog
ical
pest
icid
es(a
pplic
atio
nfo
rman
dda
tare
quire
men
ts,
June
1991
?)an
dgu
idel
ines
(Jun
e19
92)
are
avai
labl
e.T
heex
plan
ator
yno
tes
are
unde
rre
visi
on.
New
Zea
land
1)m
icro
-org
anis
ms
(bac
teria
,pr
otoz
oa,
ricke
ttsia
,fu
ngi,
viru
ses)
2)ne
mat
odes
Com
men
ts:
pher
omon
esar
eno
tco
nsid
ered
tobe
pest
icid
es,
and
ther
efor
edo
not
requ
irere
gist
ratio
ntr
ansg
enic
plan
tsha
veno
tye
tbe
enco
nsid
ered
,an
dth
equ
estio
nof
whe
ther
they
requ
irere
gist
ratio
nw
illbe
addr
esse
das
the
need
aris
es.
mac
ro-o
rgan
ism
sot
her
than
nem
atod
esdo
not
requ
irere
gist
ratio
n
Dat
are
quire
men
tsan
dgu
idel
ines
are
publ
ishe
din
Gui
delin
esfo
rth
eR
egis
trat
ion
ofB
iolo
gica
lPes
ticid
esan
d(f
oral
lpes
ticid
es)
Pro
cedu
res
for
Reg
istr
atio
nan
dE
xper
imen
talU
seP
erm
its.
Nor
way
mic
ro-o
rgan
ism
ssu
chas
bact
eria
,fu
ngia
ndvi
ruse
s
Com
men
ts:
The
Nor
weg
ian
legi
slat
ion
does
not
use
the
term
biol
ogic
alpe
stic
ides
,bu
tra
ther
the
gene
ral
term
s"in
gred
ient
"an
d"p
repa
ratio
n."
Dat
are
quire
men
tsar
ein
prin
cipa
lthe
sam
eas
thos
efo
rch
emic
alpe
stic
ides
,al
thou
ghin
prac
tice
they
are
diffe
rent
.R
equi
rem
ents
are
set
ona
case
-by-
case
basi
s.
Sw
eden
1)m
icro
-org
anis
ms
2)vi
ruse
s3)
nem
atod
es4)
inse
cts
5)A
rach
nida
Com
men
ts:
Onl
yliv
ing
orga
nism
sar
ere
gard
edas
biol
ogic
alpe
stic
ides
.
Unt
ilth
een
dof
1994
,a
biol
ogic
alpe
stic
ide
coul
dbe
offe
red
for
sale
and
used
ifth
eC
hem
ical
sIn
spec
tora
tede
cide
dto
gran
tan
exem
ptio
nfr
omth
ere
quire
men
tof
appr
oval
for
the
prep
arat
ion.
As
of1
Janu
ary
1995
,a
biol
ogic
alpe
stic
ide
can
beof
fere
dfo
rsa
lean
dus
edon
lyif
itis
appr
oved
unde
rth
eA
cton
Pre
limin
ary
Exa
min
atio
nof
Bio
logi
calP
estic
ides
.A
draf
tap
plic
atio
nfo
rmfo
rap
prov
alof
biol
ogic
alpe
stic
ides
isav
aila
ble
(incl
udin
gda
tare
quire
men
ts),
asw
ella
sgu
idan
cefo
rfil
ling
inth
efo
rm(o
negu
idan
cefo
rm
icro
-org
anis
ms
and
viru
ses;
one
for
nem
atod
es,
inse
cts
and
arac
hnid
a).
37
Cou
ntry
Pro
duct
sid
entif
ied
asbi
olog
ical
pest
icid
esS
tatu
sof
data
requ
irem
ents
Uni
ted
Kin
gdom
mic
ro-o
rgan
ism
son
lyM
icro
-org
anis
ms
are
regu
late
dun
der
the
Con
trol
ofP
estic
ides
Reg
ulat
ions
tobe
amen
ded
inS
prin
g19
94to
com
ply
with
91/4
14/E
EC
(App
endi
x9
ofC
OP
Rco
ntai
nsre
gist
ratio
ncr
iteria
for
biol
ogic
alag
ents
used
aspe
stic
ides
).G
enet
ical
lym
odifi
edm
icro
-or
gani
sms
are
also
regu
late
dun
der
The
Gen
etic
ally
Mod
ified
Org
anis
ms
(Del
iber
ate
Rel
ease
)R
egul
atio
ns19
92.
Mac
ro-
orga
nism
sar
eco
nsid
ered
inte
rms
of"r
elea
se"
unde
rth
eW
ildlif
ean
dC
ount
rysi
deA
ct(1
981)
alth
ough
inso
me
case
s,e.
g.us
ein
glas
shou
ses,
mac
ro-o
rgan
ism
sca
nbe
used
with
out
appr
oval
.O
ther
"bio
logi
calp
estic
ides
"fa
llou
tsid
esc
ope
ofU
Kre
gula
tions
.U
Kgo
vern
men
tde
part
men
tsar
ecu
rren
tlyco
nsid
erin
gbi
olog
ical
pest
icid
esot
her
than
mic
robi
als,
tose
eif
am
ore
com
preh
ensi
veas
sess
men
tsy
stem
isre
quire
d.
Uni
ted
Sta
tes
1)m
icro
bial
pest
icid
es(m
icro
-org
anis
ms)
2)bi
oche
mic
als
incl
udin
g:-
pher
omon
es,
inse
ctgr
owth
regu
lato
rsan
dpl
ant
grow
thre
gula
tors
,pr
ovid
edth
ey:
(1)
are
natu
rally
occu
rrin
gor
,if
synt
hesi
zed,
are
subs
tant
ially
sim
ilar
inch
emic
alst
ruct
ure
and
func
tiona
llyid
entic
alto
the
natu
rals
ubst
ance
,(2
)ha
vea
nont
oxic
mod
eof
actio
nto
the
targ
etpe
st-
plan
tex
trac
ts,
ifth
eym
eet
the
abov
etw
ocr
iteria
.3)
mac
ro-o
rgan
ism
s4)
tran
sgen
icpl
ants
Com
men
ts:
Nat
ural
lyoc
curr
ing
subs
tanc
esth
atdo
n’t
mee
tcr
iteria
for
desi
gnat
ion
asbi
olog
ical
pest
icid
ear
ere
gula
ted
like
conv
entio
nalp
estic
ides
but
rece
ive
spec
ial
cons
ider
atio
nfo
rda
taw
aive
rs.
Mac
ro-
orga
nism
sdo
not
requ
ireE
PA
regi
stra
tion.
Tra
nsge
nic
plan
ts(p
lant
pest
icid
es)
are
curr
ently
subj
ect
tore
gula
tion
unde
rfe
dera
lfo
odsa
fety
law
;re
gist
ratio
nun
der
fede
ral
pest
icid
ela
ww
illbe
requ
ired
inth
efu
ture
.
Dat
are
quire
men
tsfo
rbi
olog
ical
pest
icid
esar
eco
ntai
ned
inS
ubdi
visi
onM
and
40C
ode
ofF
eder
alR
egul
atio
nsP
art
158.
38
TA
BLE
B:
RE
GIS
TR
AT
ION
OF
BIO
PE
ST
ICID
ES
FO
RP
LAN
TP
RO
TE
CT
ION
pest
icid
ety
pe
regi
stra
tion
requ
ired
unde
rpe
stic
ide
law
(bio
logi
calo
rch
emic
al)
revi
ewre
quire
dun
der
othe
rla
wor
prog
ram
me
regi
stra
tion
not
requ
ired
regi
stra
tion
not
curr
ently
requ
ired
but
will
bein
futu
re
data
requ
irem
ents
for
regi
stra
tion
are
the
sam
eas
ordi
ffere
ntfr
omth
ose
for
chem
ical
pest
icid
es:
data
requ
irem
ents
esta
blis
hed
for
pre-
regi
stra
tion
field
test
ing
sam
edi
ffere
nt
mic
ro-o
rgan
ism
s
natu
rally
occu
rrin
gvi
able
Aus
,A
ut,
Can
,D
en,
Fin
,F
ra,
Ger
,H
un,
Ita,
Jap,
Nth
,N
or,
NZ
,S
we,
UK
,U
S,
EC
Aus
,A
ut,
Can
,D
en,
Fin
,F
ra,
Ger
,H
un,
Ita,
Jap,
Nth
,N
or,
NZ
,S
we,
UK
,U
S,
EC
Can
,D
en,
Fra
,H
un,
Ita,
Nth
,N
Z,
US
non-
viab
leA
us,
Aut
,C
an,
Den
,F
in,
Fra
,G
er,
Hun
,Ita
,Ja
p,N
th,
Nor
,N
Z,
Sw
e,U
K,
US
,E
C
Den
,G
er,
Jap,
Nor
,S
we,
UK
,U
S
Aus
,A
ut,
Can
,F
in,
Fra
,H
un,
Ita,
Nth
,N
Z,
EC
Can
,D
en,
Fra
,H
un,
Ita,
Nth
,N
Z,
US
gene
tical
lym
odifi
edvi
able
Aus
,A
ut,
Can
,D
en,
Fin
,F
ra,
Ger
,H
un,
Ita,
Jap,
Nth
,N
or,
NZ
,S
we,
UK
,U
S,
EC
Den
,F
ra,
Ger
,Ita
,Ja
p,N
th,
Nor
,N
z,U
K,
EC
Aus
,A
ut,
Can
,D
en,
Fin
,F
ra,
Ger
,H
un,
Ita,
Nth
,N
Z,
Sw
e,U
K,
US
,E
C
Can
,D
en,
Fra
,H
un,
Ita,
Nth
,N
or,
NZ
,U
S,
EC
non-
viab
leA
us,
Aut
,C
an,
Den
,F
in,
Fra
,G
er,
Hun
,Ita
,Ja
p,N
th,
Nor
,N
Z,
Sw
e,U
K,
US
,E
C
Ger
,Ita
,Ja
p,N
th,
Nor
,N
ZD
en,
Ger
,S
we,
UK
,U
S
Aus
,A
ut,
Can
,F
in,
Fra
,G
er,
Hun
,Ita
,N
th,
NZ
,E
C
Can
,D
en,
Fra
,H
un,
Ita,
Nth
,N
or,
NZ
,U
S,
EC
39
pest
icid
ety
pe
regi
stra
tion
requ
ired
unde
rpe
stic
ide
law
(bio
logi
calo
rch
emic
al)
revi
ewre
quire
dun
der
othe
rla
wor
prog
ram
me
regi
stra
tion
not
requ
ired
regi
stra
tion
not
curr
ently
requ
ired
but
will
bein
futu
re
data
requ
irem
ents
for
regi
stra
tion
are
the
sam
eas
ordi
ffere
ntfr
omth
ose
for
chem
ical
pest
icid
es:
data
requ
irem
ents
esta
blis
hed
for
pre-
regi
stra
tion
field
test
ing
sam
edi
ffere
nt
othe
r
pher
omon
esm
onito
ring
Den
,F
ra,
Hun
,Ja
p,S
we,
US
Aus
,A
ut,
Fin
,G
er,
Nth
,N
or,
NZ
,U
K,
EC
ItaD
en,
Fra
,Ja
p,N
th,
Sw
e,U
K
Aut
,H
un,
US
Den
,H
un,
Nth
,U
S
othe
rus
esA
us,
Aut
,C
an,
Den
,F
ra,
Ger
,H
un,
Jap,
Nth
,S
we,
UK
,U
S,
EC
Fin
,N
or,
NZ
ItaD
en,
Fra
,G
er,
Jap,
Nth
,S
we,
UK
,E
C
Aus
,A
ut,
Can
,H
un,
US
Can
,D
en,
Hun
,N
th,
US
inse
ctgr
owth
regu
lato
rsA
us,
Aut
,C
an,
Den
,F
in,
Fra
,G
er,
Hun
,Ita
,Ja
p,N
th,
Nor
,N
Z,
Sw
e,U
K,
US
,E
C
Aus
,A
ut,
Can
,D
en,
Fin
,F
ra,
Ger
,H
un,
Ita,
Jap,
Nth
,N
or,
NZ
,S
we,
UK
,E
C
US
Can
,D
en,
Hun
,Ita
,N
th,
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,U
S
plan
tgr
owth
regu
lato
rsA
us,
Aut
,C
an,
Den
,F
in,
Fra
,G
er,
Hun
,Ita
,Ja
p,N
th,
Nor
,N
Z,
Sw
e,U
K,
US
,E
C
Aus
,A
ut,
Can
,D
en,
Fin
,F
ra,
Ger
,H
un,
Ita,
Jap,
Nth
,N
or,
NZ
,S
we,
UK
,E
C
US
Can
,D
en,
Hun
,Ita
,N
th,
NZ
,U
S
plan
tex
trac
tsA
us,
Aut
,C
an,
Den
,F
in,
Fra
,G
er,
Hun
,Ita
,Ja
p,N
th,
Nor
,N
Z,
Sw
e,U
K,
US
,E
C
Aus
,A
ut,
Can
,D
en,
Fin
,F
ra,
Ger
,H
un,
Ita,
Jap,
Nth
,N
or,
NZ
,S
we,
UK
,U
S,
EC
Can
,D
en,
Hun
,Ita
,N
th,
NZ
,U
S
40
pest
icid
ety
pe
regi
stra
tion
requ
ired
unde
rpe
stic
ide
law
(bio
logi
calo
rch
emic
al)
revi
ewre
quire
dun
der
othe
rla
wor
prog
ram
me
regi
stra
tion
not
requ
ired
regi
stra
tion
not
curr
ently
requ
ired
but
will
bein
futu
re
data
requ
irem
ents
for
regi
stra
tion
are
the
sam
eas
ordi
ffere
ntfr
omth
ose
for
chem
ical
pest
icid
es:
data
requ
ire-
men
tses
tabl
ishe
dfo
rpr
e-re
gist
ratio
nfie
ldte
stin
g
sam
edi
ffere
nt
mac
ro-o
rgan
ism
sA
us,
Aut
,H
un,
Jap,
Sw
eF
in,
Nor
Den
,G
er,
Ita,
Nth
,N
or,
NZ
,U
S,
EC
*
Can
Aus
,A
ut,
Can
,H
un,
Jap,
Sw
e,E
C*
Can
,H
un,
Nor
,E
C*
tran
sgen
icpl
ants
Aus
,D
en,
Hun
Aut
,C
an,
Den
,F
in,
Fra
,G
er,
Ita,
Nth
,N
or,
Sw
e
Ger
,N
th,
Nor
Aut
,N
Z,
US
Aus
,C
an,
Den
,F
ra,
Ger
,H
un,
Ita,
EC
Den
,F
ra,
Hun
,Ita
,N
or,
US
,E
C
addi
tiona
ltyp
eslis
ted
byco
untr
ies
met
abol
ites
ofm
icro
-or
gani
sms
Hun
Hun
Hun
anim
alto
xins
Hun
Hun
Hun
livin
gor
gani
sms
for
othe
rth
anco
ntro
l(p
ollin
atin
gin
sect
s)
Hun
Hun
Hun
nem
atod
es(b
utno
tot
her
mac
ro-
orga
nism
s)
Fra
,N
ZF
ra,
NZ
NZ
*Reg
istr
atio
nis
requ
ired
only
ifor
gani
sms
are
gene
tical
lym
odifi
ed.
41
TA
BLE
C:
RE
GIS
TR
AT
ION
OF
BIO
PE
ST
ICID
ES
FO
RN
ON
-PLA
NT
PR
OT
EC
TIO
NU
SE
S*
(HO
US
EH
OLD
,P
UB
LIC
HE
ALT
HA
ND
/OR
PR
OF
ES
SIO
NA
LP
ES
TC
ON
TR
OL)
pest
icid
ety
pe
regi
stra
tion
requ
ired
unde
rpe
stic
ide
law
(bio
logi
calo
rch
emic
al)
revi
ewre
quire
dun
der
othe
rla
wor
prog
ram
me
regi
stra
-tio
nno
tre
quire
d
regi
stra
tion
not
curr
ently
requ
ired
but
will
bein
futu
re
data
requ
irem
ents
for
regi
stra
tion
are
the
sam
eas
ordi
ffere
ntfr
omth
ose
for
chem
ical
pest
icid
es
data
requ
ire-
men
tses
tabl
ishe
dfo
rpr
e-re
gist
ratio
nfie
ldte
stin
g
sam
edi
ffere
nt
mic
ro-o
rgan
ism
s
natu
rally
occu
rrin
gvi
able
Aus
,C
an,
Fin
,F
ra,
Nth
,N
Z,
Sw
e,U
K,
US
Ger
,H
un,
Ita,
Nor
Aut
Den
,G
er,
EC
ItaA
us,
Fin
,F
ra,
Ger
,H
un,
Nth
,N
or,
NZ
,S
we,
US
,E
C
Fra
,H
un,
Nth
,U
S
non-
viab
leA
us,
Can
,D
en,
Fin
,F
ra,
Nth
,N
Z,
Sw
e,U
K,
US
Ger
,H
un,
Ita,
Nor
Aut
Ger
,E
CD
en,
Ger
,Ita
,S
we,
UK
,U
S
Aus
,F
in,
Fra
,H
un,
Nth
,N
or,
NZ
,E
C
Den
,H
un,
Nth
,U
K,
US
gene
tical
lym
odifi
edvi
able
Aus
,C
an,
Fin
,F
ra,
Nth
,N
Z,
Sw
e,U
S
Aus
,D
en,
Fra
,G
er,
Hun
,Ita
,N
th,
Nor
,N
Z,
EC
Aut
Den
,G
erA
us,
Den
,F
in,
Fra
,G
er,
Hun
,Ita
,N
th,
Nor
,N
Z,
Sw
e,U
S,
EC
Den
,F
ra,
Hun
,Ita
,N
th,
Nor
,U
S,
EC
non-
viab
leA
us,
Can
,D
en,
Fin
,F
ra,
Nth
,N
Z,
Sw
e,U
S
Aus
,F
ra,
Ger
,H
un,
Ita,
Nth
,N
or,
NZ
Aut
Ger
,E
CD
en,
Sw
e,U
S,
EC
Aus
,F
in,
Fra
,G
er,
Hun
,Ita
,N
th,
Nor
,N
Z
Den
,F
ra,
Hun
,Ita
,N
th,
Nor
,U
S,
EC
42
pest
icid
ety
pe
regi
stra
tion
requ
ired
unde
rpe
stic
ide
law
(bio
logi
calo
rch
emic
al)
revi
ewre
quire
dun
der
othe
rla
wor
prog
ram
me
regi
stra
-tio
nno
tre
quire
d
regi
stra
tion
not
curr
ently
requ
ired
but
will
bein
futu
re
data
requ
irem
ents
for
regi
stra
tion
are
the
sam
eas
ordi
ffere
ntfr
omth
ose
for
chem
ical
pest
icid
es
data
requ
ire-
men
tses
tabl
ishe
dfo
rpr
e-re
gist
ratio
nfie
ldte
stin
gsa
me
diffe
rent
othe
r
pher
omon
esm
onito
ring
Den
,S
we,
US
Hun
Aut
,F
in,
Ger
,Ita
,N
th,
NZ
,U
K
EC
Den
,G
er,
Nth
,S
we,
EC
Hun
,N
or,
US
Den
,H
un,
Nth
,U
S
othe
rus
esA
us,
Can
,D
en,
Fra
,N
th,
Sw
e,U
S
Ger
,H
unA
ut,
Fin
,Ita
,N
Z,
UK
Ger
,E
CA
us,
Den
,F
ra,
Ger
,N
th,
Sw
e,E
C
Can
,H
un,
Nor
,U
SC
an,
Den
,H
un,
Nth
,U
S
inse
ctgr
owth
regu
lato
rsA
us,
Can
,D
en,
Fin
,F
ra,
Nth
,N
Z,
Sw
e,U
K,
US
Ger
,H
unA
ut,
ItaG
er,
EC
Aus
,D
en,
Fra
,G
er,
Nth
,N
Z,
Sw
e,U
K,
EC
Hun
,N
or,
US
Den
,H
un,
Nth
,U
K,
US
plan
tex
trac
tsA
us,
Can
,D
en,
Fin
,F
ra,
Nth
,N
Z,
Sw
e,U
K,
US
Ger
,H
un,
ItaA
utN
or,
Ger
,E
CA
us,
Den
,F
in,
Fra
,G
er,
Ita,
Nth
,N
Z,
Sw
e,E
C
Hun
,N
or,
US
Den
,H
un,
Nth
,U
S
43
pest
icid
ety
pe
regi
stra
tion
requ
ired
unde
rpe
stic
ide
law
(bio
logi
calo
rch
emic
al)
revi
ewre
quire
dun
der
othe
rla
wor
prog
ram
me
regi
stra
-tio
nno
tre
quire
d
regi
stra
tion
not
curr
ently
requ
ired
but
will
bein
futu
re
data
requ
irem
ents
for
regi
stra
tion
are
the
sam
eas
ordi
ffere
ntfr
omth
ose
for
chem
ical
pest
icid
es
data
requ
irem
ents
esta
blis
hed
for
pre-
regi
stra
tion
field
test
ing
sam
edi
ffere
nt
addi
tiona
ltyp
eslis
ted
byco
untr
ies
othe
rliv
ing
orga
nism
s,e.
g.ne
mat
odes
Aus
,F
raF
ra
mac
ro-o
rgan
ism
sF
raG
erF
ra
pres
erva
tives
for
prod
ucts
EC
pres
erva
tives
for
proc
esse
sE
C
antif
oulin
gpr
oduc
tsE
C
*T
heor
igin
alqu
estio
nnai
rere
ques
ted
info
rmat
ion
sepa
rate
lyfo
rea
chof
the
thre
eus
es:
hous
ehol
d,pu
blic
heal
than
dpr
ofes
sion
alpe
stco
ntro
l.T
his
tabl
eco
mbi
nes
the
thre
egr
oups
beca
use
coun
trie
s’re
spon
ses
are
iden
tical
for
allt
hree
inne
arly
allc
ases
.E
xcep
tions
are
asfo
llow
s:H
unga
ry’s
resp
onse
appl
ies
only
topu
blic
heal
thus
es;
Nor
way
’sre
spon
sere
gard
ing
requ
irem
ents
for
field
test
ing
appl
ies
only
topu
blic
heal
than
dpr
ofes
sion
alpe
stco
ntro
luse
s;T
heU
K’s
requ
irem
ents
are
usua
lly,
but
not
alw
ays,
cons
iste
ntac
ross
the
thre
eca
tego
ries.
44
TA
BLE
DU
SE
OF
TIE
RT
ES
TIN
GIN
DA
TA
RE
QU
IRE
ME
NT
SF
OR
MIC
RO
-OR
GA
NIS
MS
*
Cou
ntry
Tie
rte
stin
gis
form
al(F
),ca
se-b
y-ca
se(C
),or
not
appl
ied
(N)
resi
dues
toxi
city
path
ogen
icity
infe
ctiv
ityec
otox
icity
envi
ronm
enta
lfat
e
Aus
tral
iaC
CC
CC
C
Aus
tria
CC
CC
CC
Can
ada
NN
NN
FF
Den
mar
kN
FF
FF
F
Fin
land
NC
CC
CC
Fra
nce
NC
CC
CC
Ger
man
yN
1C
1C
1C
1C
1C
1
Hun
gary
NF
CC
FN
Italy
NN
NN
NN
Japa
nN
NN
NN
N
Net
herla
nds
F2
F2
F2
F2
F2
F2
New
Zea
land
CC
CC
CC
Nor
way
CC
CC
CC
Sw
eden
CF
,CF
,CF
,CF
,CF
,C
UK
CC
CC
CC
US
FF
F
*T
heE
Cdi
dno
tan
swer
this
ques
tion,
sinc
eim
plem
enta
tion
ofre
quire
men
tsha
sno
tye
tbe
ensp
ecifi
ed.
1re
fers
only
tobi
opes
ticid
esau
thor
ised
upto
now
2fo
rmal
tiers
are
unde
rde
velo
pmen
t
45
TA
BLE
EP
OLI
CIE
S,
RE
QU
IRE
ME
NT
SF
OR
NO
N-I
ND
IGE
NO
US
OR
GA
NIS
MS
Cou
ntry
Def
initi
onof
Indi
geno
us/N
on-in
dige
nous
Spe
cial
Pol
icie
sor
Req
uire
men
ts
EC
none
none
Aus
tral
iano
ne
Aus
tria
none
yes
–de
cisi
onca
se-b
y-ca
se
Can
ada
Am
icro
-org
anis
mis
cons
ider
edin
dige
nous
ifit
has
been
isol
ated
from
orpr
evio
usly
used
inth
eec
ozon
eof
inte
nded
use.
Itis
curr
ently
prop
osed
that
any
gene
tical
lym
odifi
edor
gani
smbe
cons
ider
edno
n-in
dige
nous
for
envi
ronm
enta
lrev
iew
purp
oses
.D
efin
ition
san
dsp
ecia
lreq
uire
men
tsfo
rin
dige
nous
/non
-in
dige
nous
mac
ro-o
rgan
ism
sar
eun
der
deve
lopm
ent.
Env
ironm
enta
lfat
eda
taar
ere
quire
dfo
ral
lorg
anis
ms
iftie
rI
envi
ronm
enta
ltox
icol
ogy
effe
cts
are
unac
cept
able
.Li
fecy
cle
(tie
rIII
)st
udie
sar
ere
quire
dfo
rno
n-in
dige
nous
orga
nism
sif
tier
IIen
viro
nmen
talt
oxic
olog
yef
fect
sar
eun
acce
ptab
le.
Den
mar
kno
neM
ore
com
preh
ensi
vere
quire
men
tsfo
rda
taon
abili
tyof
non-
indi
geno
usor
gani
sms
tosu
rviv
e,sp
read
and
esta
blis
hin
the
envi
ronm
ent.
Fin
land
Def
initi
ons
ofin
dige
nous
/non
-indi
geno
usor
gani
sms
are
not
give
nin
legi
slat
ion.
Str
icte
rha
ndlin
gta
kes
plac
efo
rm
icro
-org
anis
ms
from
outs
ide
the
Fin
nish
envi
ronm
ent.
Mor
eco
mpr
ehen
sive
data
are
requ
este
don
envi
ronm
enta
lfat
eof
the
non-
indi
geno
usor
gani
sms
Fra
nce
none
none
Ger
man
yin
dige
nous
orga
nism
sar
eth
ose
that
occu
rna
tura
llyin
the
area
ofus
e,es
peci
ally
inG
erm
any
and
the
neig
hbou
ring
coun
trie
s
noad
ditio
nalp
olic
ies
orre
quire
men
ts
Hun
gary
Ano
n-in
dige
nous
mic
ro-o
rgan
ism
ison
eth
atha
sno
tbe
ende
tect
edin
the
coun
try
or,
ifit
occu
rs,
for
whi
chth
eci
rcum
stan
ces
ofits
inte
nded
intr
oduc
tion
are
know
n(d
ate,
plac
e,m
ode,
spre
ad,
etc.
)If
acci
dent
alin
trod
uctio
nis
susp
ecte
d,in
dire
ctev
iden
ces
(orig
inof
impo
rted
plan
t,pl
ant
mat
eria
leco
logy
and
biol
ogy
ofth
em
icro
-org
anis
m,
host
-spe
cies
)ar
eus
edfo
rde
cidi
ngw
heth
erth
em
icro
-org
anis
mis
fore
ign
and
wha
tits
orig
inis
.
Fur
ther
data
requ
irem
ents
are
orde
red
case
byca
seby
the
min
istr
ies
part
icip
atin
gin
the
regi
stra
tion
proc
edur
e:M
inis
try
ofA
gric
ultu
re,
Min
istr
yof
Wel
fare
,M
inis
try
ofE
nviro
nmen
talP
rote
ctio
nan
dR
egio
nalD
evel
opm
ent.
46
Cou
ntry
Def
initi
onof
Indi
geno
us/N
on-in
dige
nous
Spe
cial
Pol
icie
sor
Req
uire
men
ts
Italy
none
Gre
ater
atte
ntio
non
stud
ies
abou
ten
viro
nmen
tal
dist
ribut
ion
and
envi
ronm
enta
lfat
e.
Japa
ncu
rren
tlyun
der
inve
stig
atio
ncu
rren
tlyun
der
inve
stig
atio
n
Net
herla
nds
none
see
appe
ndic
es2
&3
(inD
utch
)
New
Zea
land
node
finiti
onN
on-in
dige
nous
orga
nism
sth
atar
epa
thog
enic
toor
are
pest
sof
anim
als,
plan
tsor
inse
cts
mus
tre
ceiv
e,in
addi
tion
tore
gist
ratio
n,cl
eara
nce
from
the
Min
istr
yof
Agr
icul
ture
and
Fis
herie
s,be
fore
they
can
beim
port
ed.
Nor
way
none
Ifno
n-in
dige
nous
,N
orw
ayw
illre
quire
clea
rst
atem
ents
ofth
epo
tent
ialf
orsp
read
inth
een
viro
nmen
t.
Sw
eden
An
indi
geno
usor
gani
smis
one
that
occu
rsna
tura
llyin
that
part
icul
arec
olog
ical
syst
emw
here
itm
aybe
used
asa
biol
ogic
alpe
stic
ide.
Ano
n-in
dige
nous
orga
nism
ison
eth
atdo
esno
toc
cur
natu
rally
inth
atpa
rtic
ular
ecol
ogic
alsy
stem
whe
reit
may
beus
edas
abi
olog
ical
pest
icid
e.
Info
rmat
ion
acco
rdin
gto
Tie
r2,
conc
erni
ngef
fect
son
the
envi
ronm
ent,
are
man
dato
ryfo
rno
n-in
dige
nous
orga
nism
s.F
orin
dige
nous
orga
nism
s,T
ier
1in
form
atio
nm
aybe
suffi
cien
t.
UK
–N
on-in
dige
nous
plan
tsan
dan
imal
sar
eco
vere
dby
the
Wild
life
and
Cou
ntry
side
Act
(198
1).
App
licat
ions
are
asse
ssed
ona
case
-by-
case
basi
s.
US
An
orga
nism
isco
nsid
ered
indi
geno
usif
itoc
curs
in:
a)th
eco
ntin
enta
lU.S
.in
clud
ing
Ala
ska,
and
the
imm
edia
tely
adjo
inin
gco
untr
ies,
i.e.
Can
ada
and
Mex
ico,
b)th
eH
awai
ian
isla
nds,
orc)
the
Car
ibbe
anIs
land
sin
clud
ing
Pue
rto
Ric
oan
dth
eU
.S.
Virg
inIs
land
s.
Not
ifica
tion
prio
rto
smal
l-sca
le(n
on-c
onta
ined
)te
stin
gis
requ
ired
for
non-
indi
geno
usm
icro
bial
pest
icid
esth
atha
veno
tbe
enac
ted
upon
byth
eU
SD
epar
tmen
tof
Agr
icul
ture
.
47
TA
BLE
FP
OLI
CIE
SA
ND
RE
QU
IRE
ME
NT
SF
OR
GE
NE
TIC
ALL
YM
OD
IFIE
DO
RG
AN
ISM
S
Cou
ntry
Pol
icie
s,re
quire
men
tsfo
rG
MO
s
EC
For
plan
tpr
otec
tion
prod
ucts
cons
istin
gof
orco
ntai
ning
GM
Os,
data
requ
irem
ents
ofD
irect
ive
90/2
20/E
EC
curr
ently
appl
yin
addi
tion
toth
ose
ofD
irect
ive
91/4
14/E
EC
.D
irect
ive
91/4
14/E
EC
will
bead
apte
din
the
futu
reto
cove
rth
ose
aspe
cts
now
cove
red
in90
/220
/EE
C.
For
non-
plan
tpr
otec
tion
prod
ucts
cons
istin
gof
orco
ntai
ning
GM
Os,
data
requ
irem
ents
ofD
irect
ive
90/2
20/E
EC
appl
yin
addi
tion
toth
ose
requ
ired
atth
ena
tiona
llev
elby
Mem
ber
stat
es.
Aus
tral
iaG
MO
sar
ecu
rren
tlyas
sess
edby
the
Gen
etic
Man
ipul
atio
nA
dvis
ory
Com
mitt
eepr
ior
toco
nsid
erat
ion
byre
gist
ratio
nau
thor
ities
.H
owev
er,
arra
ngem
ents
for
cons
ider
atio
nof
GM
Os
are
bein
gre
fined
,an
dit
islik
ely
that
GM
AC
will
bere
plac
edby
ane
wbo
dy.
Aus
tria
Add
ition
alre
quire
men
tsve
rysi
mila
rto
Dire
ctiv
e90
/220
/EE
C.
Can
ada
Aim
isto
regu
late
prod
ucts
rath
erth
anpr
oces
ses.
How
ever
,th
em
etho
dof
prod
uctio
nis
cons
ider
ed,
and
ifit
invo
lved
GM
Os
orth
eir
prod
ucts
,th
isw
ould
have
tobe
cite
din
the
appl
icat
ion,
and
any
chan
gein
prop
ertie
sor
pote
ntia
lhaz
ards
ofth
epr
oduc
tw
ould
beas
sess
ed.
Den
mar
kG
enet
ical
lym
odifi
edbi
olog
ical
pest
icid
esar
eco
vere
dby
the
Dan
ish
Act
no.
356
of6
June
1991
onen
viro
nmen
tan
dge
netic
engi
neer
ing
and
byth
est
atut
ory
orde
rno
.10
98of
11D
ecem
ber
1992
onth
eap
prov
alof
expe
rimen
talr
elea
sean
dm
arke
ting
ofG
MO
s,w
hich
cont
ains
data
requ
irem
ents
asla
iddo
wn
inth
eE
EC
Dire
ctiv
e90
/220
/EE
C.
GM
Ope
stic
ides
mos
tbe
regi
ster
edin
acco
rdan
cew
ithth
isre
gula
tion
asw
ella
sin
acco
rdan
cew
ithth
epe
stic
ide
regu
latio
n.
Fin
land
The
new
Gen
eT
echn
olog
yA
ctca
me
into
forc
e1
June
1995
and
itco
ntai
nsre
gula
tions
and
polic
ies
asla
iddo
wn
inth
eE
EC
dire
ctiv
es90
/220
/EE
Can
d90
/219
/EE
C.
Acc
ordi
ngto
91/4
14/E
EC
and
the
Fin
nish
Pes
ticid
eA
ct,
90/2
20/E
EC
appl
ies
also
toge
netic
ally
mod
ified
biop
estic
ides
.G
MO
sne
edtw
ose
para
tere
view
san
dap
prov
als,
ifth
eyar
ego
ing
tobe
used
aspe
stic
ides
.T
heC
omm
ittee
onG
ene
Tec
hnol
ogy
revi
ews
any
rele
ase
ofG
MO
san
dpr
oces
ses
ofge
netic
engi
neer
ing,
asth
eC
omm
ittee
onP
estic
ides
revi
ews
the
acce
ptab
ility
ofa
prod
uct
tobe
plac
edon
the
mar
ket
asa
pest
icid
e.T
heM
inis
try
ofS
ocia
lAffa
irsan
dH
ealth
ispr
epar
ing
ade
cisi
onco
ncer
ning
data
requ
irem
ents
for
GM
Os.
The
info
rmat
ion
isno
tye
tav
aila
ble,
and
cann
otbe
take
nin
toac
coun
tin
mor
ede
tail
inth
esu
rvey
.
Fra
nce
InF
ranc
eth
edo
ssie
rfo
rre
gist
ratio
nof
am
icro
bial
prep
arat
ion
volu
ntar
ilyre
leas
edin
the
envi
ronm
ent
isre
view
edby
thre
eco
mm
ittee
sas
follo
ws:
1.C
GB
(Com
mis
sion
duG
énie
Bio
mol
écul
aire
)an
alys
esth
eris
kslin
ked
toth
ein
trod
uctio
nof
anhe
tero
logo
usge
ne(v
ecto
r,ge
ne,
mar
kers
,re
com
bina
tion,
gene
diffu
sion
,et
c)2.
GE
OD
E(G
roup
ed’
Etu
dede
sO
rgan
ism
esdi
ssém
inés
dans
l’env
ironn
emen
t).
Thi
sgr
oup
isin
clud
edin
the
"Com
mis
sion
d’ét
ude
dela
toxi
cité
des
prod
uits
antip
aras
itaire
sà
usag
eag
ricol
e"w
hich
isre
spon
sibl
efo
rth
eto
xico
logi
calc
lass
ifica
tion
ofal
lphy
tosa
nita
ryan
dfe
rtili
zing
prod
ucts
.3.
Com
itéd’
hom
olog
atio
nw
hich
rule
son
the
effic
acy
ofth
epr
oduc
t.
48
Cou
ntry
Pol
icie
s,re
quire
men
tsfo
rG
MO
s
Ger
man
yG
enet
ical
lym
odifi
edor
gani
sms
for
plan
tpr
otec
tion,
like
allg
enet
ical
lym
odifi
edor
gani
sms,
are
subj
ect
toth
epr
escr
iptio
nsof
the
"Gen
tech
nikg
este
z"(G
ene
Tec
hnol
ogy
Act
).T
hus,
any
rele
ase
ofa
GM
Ofo
rfie
ldte
sts
(e.g
.fo
ref
ficac
yte
stin
g)is
regu
late
dby
the
Gen
tech
nikg
eset
z.T
hepl
acin
gon
the
mar
ket
ofa
prod
uct
cont
aini
nga
GM
O,
how
ever
,is
subj
ect
tobo
thG
ente
chni
kges
tez
and
Pla
ntP
rote
ctio
nA
ct.
Hun
gary
InH
unga
ryno
GM
Os
are
regi
ster
ed.
Thu
sth
eM
inis
try
ofA
gric
ultu
re,
invo
lvin
gth
eM
inis
try
ofW
elfa
rean
dM
inis
try
ofE
nviro
nmen
talP
rote
ctio
nan
dR
egio
nalD
evel
opm
ent,
deci
des
onsp
ecia
lreq
uire
men
tsin
ever
yca
se.
Italy
All
cate
gorie
sof
biol
ogic
alpe
stic
ides
that
are
gene
tical
lym
odifi
edar
ere
gula
ted
byth
ed.
lgs
ofth
e3/
3/93
n.92
inre
aliz
atio
nof
the
dire
ctiv
e90
/220
/CE
E.
Japa
nA
nyG
MO
sin
tend
edfo
rus
eas
pest
icid
esar
eco
ntro
lled
unde
r"t
heG
uide
lines
for
App
licat
ion
ofR
ecom
bina
ntD
NA
Org
anis
ms
inA
gric
ultu
re,
For
estr
y,F
ishe
ries,
the
Foo
dIn
dust
ryan
dO
ther
Rel
ated
Indu
strie
s."
Net
herla
nds
GM
Os
mus
tfir
stbe
appr
oved
for
rele
ase
toth
een
viro
nmen
tby
the
VC
OG
EM
,a
Dut
chor
gani
satio
nre
spon
sibl
efo
rev
alua
ting
risks
ofen
viro
nmen
talr
elea
se.
Aut
horiz
atio
nm
ust
then
begr
ante
dun
der
the
Pes
ticid
eA
ct.
New
Zea
land
Any
gene
tical
lym
odifi
edor
gani
sms
inte
nded
for
use
aspe
stic
ides
mus
tfir
stbe
clea
red
byan
inte
rdep
artm
enta
lsc
ient
ific
"Int
erim
Ass
essm
ent
Gro
up"
befo
rebe
ing
cons
ider
edfo
rre
gist
ratio
n.
Nor
way
Diff
eren
tre
quire
men
tsap
ply
toge
netic
ally
mod
ified
orga
nism
s,an
dth
eyar
eha
rmon
ized
with
the
EC
.
Sw
eden
Add
ition
alin
form
atio
nis
requ
ired
abou
tth
ege
netic
mod
ifica
tion.
Inal
loth
erre
spec
ts,
aG
MO
istr
eate
dth
esa
me
way
asa
non-
GM
O.
Thi
spo
licy
appl
ies
toal
lorg
anis
ms
nam
edin
the
Act
onP
relim
inar
yE
xam
inat
ion
ofB
iolo
gica
lP
estic
ides
(mic
ro-o
rgan
ism
s,vi
ruse
s,ne
mat
odes
,in
sect
sor
Ara
chni
da).
UK
GM
Os
and
tran
sgen
icpl
ants
are
cove
red
byth
eG
enet
ical
lyM
odifi
edO
rgan
ism
s(d
elib
erat
ere
leas
e)R
egul
atio
ns19
92.
US
The
rear
eno
spec
ific
diffe
renc
esin
polic
ies
orda
tare
quire
men
tsfo
rre
gist
ratio
nan
dla
rge
scal
ete
stin
g(E
xper
imen
talU
seP
erm
itsc
ale)
betw
een
natu
rally
occu
rrin
gan
dge
netic
ally
mod
ified
pest
icid
es.
Any
addi
tiona
lda
tare
quire
men
tsw
hich
mig
htbe
need
edfo
rge
netic
ally
mod
ified
prod
ucts
wou
ldbe
dete
rmin
edon
aca
se-s
peci
ficba
sis.
Apr
e-ex
perim
enta
luse
perm
itno
tific
atio
nru
leis
inpl
ace
whi
chre
quire
sth
atE
PA
beno
tifie
dbe
fore
smal
l-sca
le(u
ncon
tain
ed)
test
ing
ispe
rfor
med
with
am
icro
bial
pest
icid
ew
hose
pest
icid
alpr
oper
ties
have
been
impa
rted
oren
hanc
edby
the
addi
tion
ofge
netic
mat
eria
ltha
tha
sbe
ende
liber
atel
ym
odifi
ed.
The
requ
irem
ent
also
appl
ies
tono
n-in
dige
nous
mic
robi
alpe
stic
ides
that
are
not
acte
don
byth
eU
SD
epar
tmen
tof
Agr
icul
ture
.E
PA
iscu
rren
tlyde
velo
ping
apo
licy
and
asso
ciat
edre
gula
tions
for
the
over
sigh
tof
plan
tpe
stic
ides
,in
clud
ing
thos
eth
atha
vebe
ende
velo
ped
thro
ugh
gene
ticen
gine
erin
g.B
ecau
seth
ese
docu
men
tsar
est
illin
the
form
ativ
est
ages
,it
isno
tpo
ssib
leto
spec
ifyan
ydi
stin
ctio
nsm
ade
for
plan
tpe
stic
ides
that
have
been
gene
tical
lym
odifi
ed.
Annex 2
Biopesticides Registered in OECD Countriesfor Plant Protection and Other Uses
Note: This annex lists different types of biopesticides registered foruse in OECD countries and Hungary. It should be noted that someof the categories included – namely plant/insect growth regulators andplant extracts – are not considered to be biopesticides by somecountries (see Table A, page 32 ff). These countries therefore did notlist products in these categories, although they may indeed haveregistered such products, as chemical pests.
49
Annex 2 Contents
Micro-organisms registered for plant protection uses . . . . . . . . . . . . . . . . . . . . . . . . . . 51
Micro-organisms registered for uses other than plant protection . . . . . . . . . . . . . . . . . . 58
Pheromones registered for plant protection uses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59
Pheromones registered for uses other than plant protection . . . . . . . . . . . . . . . . . . . . . 63
Plant growth regulators registered for plant protection uses . . . . . . . . . . . . . . . . . . . . . 64
Insect growth regulators registered for plant protection uses . . . . . . . . . . . . . . . . . . . . 66
Insect growth regulators registered for uses other than plant protection . . . . . . . . . . . . 67
Macro-organisms registered for plant protection uses . . . . . . . . . . . . . . . . . . . . . . . . . 68
Plant extracts registered for plant protection uses . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70
Plant extracts registered for uses other than plant protection . . . . . . . . . . . . . . . . . . . . 72
Other biopesticides registered . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73
50
MICRO-ORGANISMS REGISTERED FOR PLANT PROTECTION USES
Active ingredient Registered uses (pest and/or crop) Country
BACTERIA
Agrobacterium radiobacter root dip against crown gall disease in non fruit-bearing plants
Canada
rose seedling Japan
seedling dip for prevention of crown gall inpeaches, bush fruit, kiwifruit, roses
New Zealand
crown gall disease US
Agrobacterium radiobacterStrain k1026
against crown gall disease on almond, peach,rose, stone fruit, walnut
Australia
Bacillus popilliae+ B.lentimorbus
Japanese beetle larvae US
Bacillus pumilis lucerne hay inoculant Australia
Bacillus subtilis damping off disease;seed treatment protection from Fusarium,Rhizoctonia, Alternaria, and Aspergillus; and foruse as a manufacturing-use product
US
Bacillus thuringiensis vegetable, maize, viticulture Austria
fruit crops Austria,Netherlands
cabbage Netherlands,UK
crops, vegetables that are botanically grown Netherlands
ornamental plants Netherlands,UK
forestry Netherlands
foliar insecticide for caterpillars in horticulture New Zealand
Norway (+)
lepidopteran larvae in: cabbages, cauliflower,tomato, vine, olive tree, pine tree, Quercus sp.
forestry, viticulture (caterpillars) Switzerland
brussels sprout, cauliflower, calabrese, broccoli,lettuce, French bean, pea, tomato, cucumber,pepper, strawberry, raspberry, apple, pear,cherry, vine
UK
B. thuringiensis and δ-endotoxin vegetable, tea, apple, cherry Japan
B. thuringiensis serotype 1+ piperonyl butoxyde+ pyrethrines
amateur gardens, treatments of aerial parts;insecticides
France
51
Active ingredient Registered uses (pest and/or crop) Country
B. thuringiensis serotype 3 general treatments, treatments of aerial parts,moths, olive tree, olive moth, apple tree,Capua, Pandemis, vine, Cochylis, Eudemis,Eulia, conifers, pine processionary caterpillar,broad-leaved trees, bombyx, seed treatments,soya, cabbage, tomatoes, amateur gardens;insecticides
France
B. thuringiensis serotype 3+ piperonyl butoxyde+ pyrethrines
amateur gardens, treatments of aerial parts;insecticides
France
B. thuringiensis subsp. aizawai lepidopteran larvae US
against Lobesia botrana and Eupoeciliaambiguella (viticulture);against Hibernia defoliara (Erannis defoliara)(horticulture)
Germany
B. thuringiensis subsp. aizawaistrain GC-91
lepidopteran larvae US
B. thuringiensissubsp. aizawai x kurstaki
cabbage butterfly (Pieris brassicae, P rapae),diamondback moth (Plutella xylostella)
Sweden
B. thuringiensis subsp. kurstaki cabbage moth, cabbage white butterfly onbrassica spp. or cole crop, broccoli, brusselssprout, cabbage and cauliflower. Light brownapple moth on fruit crop or tree, grapevine, kiwifruit and ornamental plant or annual.Grapevine moth on grape and grapevine.Cabbage moth and cabbage white butterfly onornamentals. Looper on ornamental plant orannual. Tobacco looper or looper caterpillar ontobacco. Cotton.
Australia
lepidopteran larvae Canada, US
Hyphantria, Lymantria in forestry; Ostrinianubilalis on maize
France,Hungary
lepidoptera in agriculture (Ostrinia nubilalis),viticulture (Lobesia botrana, Eupoeciliaambiguella), ornamentals (e.g. Euproctischrysorrhoea, Lymantria dispar), horticulture(e.g. Pieris brassicae, Plutella sp.), fruit-growing(e.g. L. dispar, C. chrysorrhoea), forestry
Germany
insecticide Italy
δ-endotoxin of Bacillusthuringiensis subsp kurstaki
hairy and hairless, free living butterflycaterpillars (lepidopteran pests), larva ofeuropean corn borer (Ostrinia nubilalis), GrapeBerry Moth on viticulture, leaf rollers on fruit,white butterfly (cabbage-white) on vegetables,cabbage moth caterpillars on vegetables
Austria
52
Active ingredient Registered uses (pest and/or crop) Country
Bacillus thuringiensis subsp.kurstaki vegetative cells andspores
hairy and hairless, free living butterflycaterpillars (lepidopteran pests), larva ofeuropean corn borer (Ostrinia nubilalis), GrapeBerry Moth on viticulture, leaf rollers on fruit,white butterfly (cabbage-white) on vegetables,cabbage moth caterpillars on vegetables
Austria
B. thuringiensis subsp. tenebrionis(= B. thuringiensis var. san diego)
Colorado potato beetle on potatoes andtomatoes - Leptinotarsa decemlineata
Canada,Germany,Hungary
coleopteran larvae US
B. thuringiensis var. tenebrionis Austria
insecticide France, Italy
Lactobacillus casei+ Lactobacillus plantarum+ hemicelulase+ amylase+ Pedlococcus pentosaceus
silage inoculant: maize France
Lactobacillus plantarum silage inoculant: maize France
Lactobacillus plantarum+ Pediococcus acidilactici
silage inoculant: maize France
Lactobacillus plantarum+ Pediococcus pentosaceus
silage inoculant: maize France
Lactobacillus plantarum+ Streptococcus faecium
silage inoculant: maize France
Lactobacillus plantarum+ cellulase+ Pediococcus acidilactici
silage inoculant: maize France
Lactobacillus plantarum+ enzymes+ Streptococcus faecium
silage inoculant: maize France
Lactobacillus plantarum+ Streptococcus faecium+ Pediococcus acidilactici
silage inoculant: maize France
Lactobacillus plantarum+ hemicellulase+ amylase+ Lactobacillus casei+ Pediococcus pentosaceus
silage inoculant: maize France
Pediococcus acidilactici+ Lactobacillus plantarum
silage inoculant: maize France
Pediococcus acidilactici+ cellulase+ Lactobacillus plantarum
silage inoculant: maize France
Pediococcus acidilactici+ Lactobacillus plantarum+ Streptococcus faecium
silage inoculant: maize France
Pediococcus pentosaceus silage inoculant: maize France
53
Active ingredient Registered uses (pest and/or crop) Country
Pediococcus pentosaceus+ Lactobacillus plantarum
silage inoculant: maize France
Pediococcus pentosaceus+ Lactobacillus plantarum+ hemicellulase+ amylase+ Lactobacillus casei
silage inoculant: maize France
Pseudomonas fluorescens against bacterial spot/blotch on mushroom Australia
antagonist to mushroom blotch in mushroombeds
New Zealand
Pseudomonas fluorescensEG1053
Pythium, Rhizoctonia seedling disease complex US
Pseudomonas fluorescens A 506 frost inhibition by competition US
Pseudomonas fluorescens 162RS frost inhibition by competition US
Pseudomonas syringae 742RS frost inhibition by competition US
Pseudomonas cepacia typeWisconsin
damping off disease, and nematodes US
Rhizobium japonicum silage inoculant: soya, seed treatment France
Rhizobium melilotti silage inoculant: leguminous fodder plant, seedtreatments
France
Serratia entomophila soil applied insecticide for grass grub in pasture New Zealand
Streptococcus faecium+ Lactobacillus plantarum
silage inoculant: maize France
Streptococcus faecium+ Lactobacillus plantarum+ enzymes
silage inoculant: maize France
Streptococcus faecium+ Lactobacillus plantarum+ Pediococcus acidilactici
silage inoculant: maize France
54
Active ingredient Registered uses (pest and/or crop) Country
PROTOZOA
Nosema locustae (protozoa) grasshoppers US
VIRUSES
Apfelwicklergranulosevirus (CPGV)(Cydia-pomonella-granulosis-virus)
apple tree, treatments of aerial parts, apples,pearsCydia pomonella
France
Cydia pomonella, apples, pears Germany,Switzerland
Borrelinavirus diprionis in forestry against neodiprion sertifer Finland
Dendrolimus Cytoplasmic-polyhedrois Virus (DCV)
pine tree Japan
Nuclear polyhedrosis virus(Mamestra brassicae)
cabbage, treatment of aerial parts, defoliatingmoths
France
Polyhedral inclusion bodies ofDouglas fir tussock moth nuclearpolyhedrosis virus (NPV)
Douglas fir tussock moth Canada, US
Polyhedral inclusion bodies of pinesawfly NPV
pine sawfly in forests Canada, US
Polyhedral inclusion bodies ofHeliothis NPV
cotton bollworm, budworm US
Polyhedral inclusion bodies ofgypsy moth NPV
gypsy moth larvae US
Polyhedral inclusion bodies of thebeet armyworm NPV
Beet armyworm larvae US
Polyhedral inclusion bodies ofAutographa californica (Alfalfalooper)
Alfalfa looper larvae US
Schalenwicklergranulose virus(Capua granulosis virus)
Switzerland
Spodoptora exigua nuclearpolyhedrosis virus
against Spodoptora exigua on flower cropsunder glass
Netherlands
FUNGI
Achersonia aleyrodis White flies (Trialeurodes vaporatriorum, Beisatabaci)
Sweden
Beauveria brongniartii cockchafer May beetle grub Switzerland
Colletotrichum gloeosporioides control of round leaf mallow (herbicide) Canada
Colletotrichum gloeosporioides f.sp. aeschynomene ATCC 203 58
northern joint vetch US
Endothia parasitica strains chestnut tree, treatment of aerial parts, barkcanker
France
Gliocladium virens G-21 Pythium, Phizoctonia US
Metarhizium anisopliae Otiorhynchus sulcatus, Hepialus sp. Germany
Monacrosporium phymatapagam tobacco Japan
55
Active ingredient Registered uses (pest and/or crop) Country
Paecilomyces fumosoroseus white flies (Trialeurodes vaporatriorum, Beisatabaci)
Sweden
Phlebia gigantea forestry, against Fomes annosus Finland
Norway (+)
rot: Pine tree and spruce Sweden
Phytophthora citrophthoraStrangler vine race
citrus strangler vine US
Puccinia canaliculate (Schweinitz)Langerheim
yellow nutsedge control US
Spores of Beauveria bassiana 147 maize, treatments of aerial parts, pyrale France
Spores of Beauveria tenella 96 general treatments, soil treatment, May beetlegrub (Hoplochelus marginalis), sugar cane;insecticide
France
Streptomyces sp. soilborne diseases in ornamental Sweden
Streptomyces griseoviridis seed treatment in horticulture; spray treatmentfor ornamentals and cucumber
Finland
Fusarium on carnation, gerbera, potted/cutflowers
Hungary
Norway (+)
withered state of cyclamen, gerbera, carnation Switzerland
control of Fusarium, Alternariu, Phemopsis andsuppression of Botrytis, Pythium, andPhytophthora
US
Trichoderma sp soil borne fungal diseases Sweden
Trichoderma harzianum (ATCC20476) (always sold and used withTrichoderma polysporum)
tree wound decay France, US
soil borne fungal diseases Sweden
Trichoderma polysporum (ATCC20475) (always sold and used withTrichoderma harzianum)
wood rot US
Trichoderma harzianum Rifai strainKRL-AG2
damping off disease US
Trichoderma lignorum tobacco Japan
Trichoderma viride antagonist to silverleaf in pip and stonefruit New Zealand
plum, apple, pear, cherry, forestry UK
56
Active ingredient Registered uses (pest and/or crop) Country
Verticillium lecanii insects on tomatoes, cucumbers Netherlands,Switzerland
aphids, mites Norway
aphids (Macrosiphum euphorbiae, Aulacothumsolani)
Sweden
thrips of tobacco, aphids, T. urticae Switzerland
ornamental, flower(cut), cucumber, pepper,aubergine, lettuce, bean
UK
Verticillium dahliae against elm disease on elms Netherlands
weak stem of the tomatomozaikvirus
on tomato plants for protection againstmozaikvirus
Netherlands
NON-VIABLE MICROBIALPESTICIDES
B. thuringiensis toxin vine, treatment of aerial parts, Cochylis,Eudemis, Eulia, conifers, pine processionarycaterpillar
France
Delta endotoxin of Bacillusthuringiensis var kurstakiencapsulated in killedPseudomonas fluorescens
leptidopteran larvae US
Delta endotoxin of Bacillusthuringiensis var San Diegoencapsulated in killedPseudomonas fluorescens
coleopteran larvae US
(+) Not approved yet
57
MICRO-ORGANISMS REGISTEREDFOR USES OTHER THAN PLANT PROTECTION
Active ingredient Registered uses (pest and/or crop) Country
BACTERIA
Bacillus licheniformis products against microorganisms in chemicaltoilets
Sweden
Bacillus sphaericus mosquitoes, larvae France
dipteran larvae control US
Bacillus subtilis products against microorganisms in chemicaltoilets
Sweden
B. thuringiensis subsp. aizawai pet housing; insecticide; storage premises France
B. thuringiensis subsp. israelensis mosquito control in fresh and salt water:brown house mosquito, common Australianmosquito, common banded mosquito, saltmarshmosquito
Australia
control of mosquito and blackfly larvae inponds, lakes and rivers
Canada
against flies in different places Finland
public health: vs larvae of mosquitoes France,Germany
dipteran larvae (blackflies and mosquitoes nearwater)
France, US
mosquito control Hungary
household insecticide Italy
against larvae of mosquitoes in crawlspacesunder buildings
Netherlands
fungus gnats (Bradysia spp) Sweden
control of blackfly / flies in sewage treatmentworksbeehive (empty brood and honeycombs)
UK
dipteran larvae control US
VIRUSES
FUNGI
Lagenidium giganteum dipteran (mosquito) larvae control US
Metarhizium anisopliaestrain ESF1
fly + cockroach control US
58
PHEROMONES REGISTERED FOR PLANT PROTECTION USES
Active ingredient(trade/common name)
Target Pest Uses Country
ALCOHOLS (only)
(E,E)-8,10-dodecadien-1-ol(Australia: Cydiapomonella pheromone)(Austria: Codlemon)
Cydia pomonella Hungary
Cydia pomonella on apple and pear Australia
fruit growing Austria
1-tetradecanol;(E,E)-8,10-dodecadien-1-ol;1-dodecanol (US: Isomate C)
Codling Moth in apple and pearorchards: control bymating disruption
Canada, US
3,7,11-trimethyl-2,6,10-dodecatriene-1-ol (Farnesol)
Tetranychid mite US
3,7,11-trimethyl-1,6,10-dodecatriene-3-ol (Nerolidol)
Tetranychid mite US
ESTER ACETATES
[10, 1x=]Decen- acetates
(E)-5-decen-1-ol acetate;(E)-5-decen-1-ol
Anarsia lineatella Hungary
[12, 1x=]Dodecen- acetates
(Z)-8-dodecen-1-ol acetate Cydia molesta Hungary
(E)-8-dodecen-1-ol acetate;(Z)-8-dodecen-1-ol acetate(Rak-5)
Oriental Fruit Moth on peach trees France
(E)-8-dodecen-1-ol acetate /96.5%;(Z)-8-dodecen-1-ol acetate / 3.5%
Cydia funebrana Hungary
(E)-8-dodecen-1-yl acetate;(Z)-8-dodecen-1-yl acetate;(Z)-8-dodecen-1-ol
(US: Isomate M)(France: Confusaline)(Australia: Oriental fruitmoth pheromone)
Oriental Fruit Moth on peach trees Australia,France, US
(E)-8-dodecenyl acetate;(Z)-8-dodecenyl acetate;(Z)-8-dodecen-1-ol(Checkmate OFM)
Oriental Fruit Moth US
(Z,E)-8-dodecen-1-ol acetate;(Z,E)-9-dodecen-1-ol acetate
Enarmonia formosana Hungary
(E)-9-dodecenyl acetate Grape Berry Moth US
(Z)-9-dodecenyl acetate(Switz.: Bocep Viti)
Eupoecilia ambiguella viticulture Germany,Switzerland
59
Active ingredient(trade/common name)
Target Pest Uses Country
(Z)-9-dodecenyl acetate viticulture Austria
Grape Berry Moth,Endopiza viteana
in vineyards: controlby mating disruption
Canada, US
(Z)-9-dodecen-1-ol acetate Eupoecilia ambiguella Hungary
(E,Z)-9-dodecen-1-ol acetate Western Pine ShootBorer
US
(E)-9-dodecen-1-ol acetate /80-90%;(E)-9-dodecen-1-ol / 10-20%
Sparganothispilleriana;Leucoptera malifoliella
Hungary
[13, 1x=]Tridecen- acetates
(E)-4-tridecen-1-yl acetate Tomato Pinworm US
(Z)-4-tridecen-1-yl acetate Tomato Pinworm US
[14, 1x=]Tetradecen- acetates
(E)-11-tetradecenyl acetate Grape Berry Moth;Tufted Apple Budmoth
US
(Z)-9-tetradecen-1-ol acetate;(Z)-11-tetradecen-1-ol acetate
Adoxophyesreticulana, orana
Hungary
[16, 1x=]Hexadecen- acetates
(E)-11-hexadecen-1-ol acetate;(Z)-11-hexadecen-1-ol acetate;(Z)-11-hexadecen-1-ol;
Plutella xylostella Hungary
[12, 2x=]Dodecadien- acetates
(E)-7-(Z)-9-dodecadienylacetate Lobesia botrana viticulture Germany
(Z,E)-7,9-dodecadien-1-ol acetate Lobesia botrana Hungary
60
Active ingredient(trade/common name)
Target Pest Uses Country
[16, 2x=]Hexadecadien- acetates
(Z,E)-7-11-hexadecadien-1-ylacetate;(Z,Z)-7-11-hexadecadien-1-ylacetate(MEC Gossyplure)
Pink Bollworm US
[18, 2x=]Octadecadien- acetates
(E,Z)-3,13-octadecadien-1-olacetate;(Z,Z)-3,13-octadecadien-1-olacetate
Peachtree Borer US
ESTER FORMATES
[10, 2x=]Decadien- formates
Decadienoic acid, methyl ester Pityogeneschalcographus
monitoring and controlin forestry
Switzerland
[12, 3x=]Dodecatrien-yl formates
(Z,E)-7,9,11-dodecatrien-1-ylformate (Ectomyform)
Carob Moth US
UNSATURATED COMPOUNDS
7-11-dimethyl-3-methylene-1-(E)-6,10-dodecatriene(ß-Farnesene)
Aphid US
2,6,6-trimethylbicyclo[3.1.1]-hept-2-ene (α-Pinene or Pinene);5-cis-verbenol (Lineatin);(Linoprax Agro)
Trypodendronlineatum
monitoring and controlin forestry
Switzerland
ALDEHYDES (also in mixtures)
(Z)-9-tetradecenal Tomato Budworm,Cotton Bollworm
US
(Z)-11-hexadecenal Artichoke Plume Moth US
(Z)-2-(3,3-dimethylcyclohexylidene) ethanol;(E)-(3,3-dimethylcyclohexylidene)acetaldehyde;(Z)-(3,3-dimethylcyclohexylidene)acetaldehyde;(1R-Cis)-1-methyl-2-(1-methylethenyl)cyclo butaneethanol; ("Grandlure")
Cotton boll weevil US
61
Active ingredient(trade/common name)
Target Pest Uses Country
EPOXY
Cis-7,8-epoxy-2-methyloctadecane
Gypsy Moth US
(Z)-7,8-epoxy-2-methyloctadien Lymatria dispar Hungary
HETEROCYCLIC COMPOUNDS
(R,Z)-5-(1-decenyl)dihydro-2-(3)-furanone (Nuranone Japonilure)
Japanese Beetle US
OTHERS (unclassified)
Ips dianol Switzerland
Notes:
→ Chemicals are arranged in ascending order of carbon chain and number of double bonds of thefirst ingredient[length of the carbon chain, nb. of double bonds]
62
PHEROMONES REGISTERED FOR USES OTHER THAN PLANT PROTECTION
Active ingredient(trade/common name)
Registered uses (pest and/or crop) Country
(Z)-9-tricosene(Canada: Muscalure)
(Hungary: Muscamone)
fly attractant in farm buildings US, Canada
housefly control Hungary
[1R-(1R), 2R, 5S, 6E, 10R]-(+)-8-methylene-5-(1-methylethyl)spiro[11-oxabicyclo [8.1.0]undec-6-ene-2,2-oxiran]-3-one(Periplanone B)
American cockroach US
63
PLANT GROWTH REGULATORS REGISTEREDFOR PLANT PROTECTION USES
Active ingredient Registered uses (pest and/or crop) Country
ALCOHOLS
n-decanol Tobacco succer inhibition Hungary
ALCENES
Ethylene Fruit trees: hastens fruit ripening and maturity,enhances color, loosens nut hulls, and is afloral stimulantControls witch weed
US
ACIDS
Indole acetic acid (IAA)+ naphthylacetic acid
Acceleration of root development growth androoting induction (bowling green, cutting, golfcourse/green turf, lawn, sugar cane)
Australia
Indole acetic acid+ Gibberellic acid+ Zeatins(Biozyme: Nat. plant Ext.)
Not specified US
4-indol-3-yl butanoic acid Australia
Root promotion in plant cuttings HungaryNew Zealand
Indole-3-butanoic acid Assists fruit set, is a root stimulant, hastensmaturity, increases fruit set, size, yield,vegetative growth and sugar content,stimulates germination and is a fruit abscissionretardantControls fungal rot, decay and fungi
US
Gibberellic acid (GA) Currant grape and Sultana grape for drying:bunch elongation, fruit thinning, fruit sizeincreasing, fruit maturity promotion or delay;Navel orange: advance or delay maturity,storage quality;Malting barley: germination period reduction;Mandarin: fruit quality improvement
Australia
Cherry: spur and fruit development;Rhubarb: breaking dormancy
Canada
Fruit russet, general plant growth regulator US
Gibberellic acid+ Gibberellin A4/A7
Growth promotants for pipfruit, stonefruit, citrus New Zealand
General US
Gibberellic acid+ boronacid (chemical)
Wheat, barley, sugar beet: enhancement ofgermination
Hungary
64
Active ingredient Registered uses (pest and/or crop) Country
Gibberellic acid, monopotassiumsalt
General US
Gibberellic acid+ naphtoxi-acetic acid (chemical)
Cherry, sour cherry: fruit setting Hungary
PURINES
Benzyladenine(also called: N-6-Benzyladenine or6-benzylaminopurine)(US: Cytokinin B)
Apple, pear: budding and shooting promotion Hungary
Bud breaking in cherries and fruit elongation inapples
New Zealand
General US
Benzyladenine+ Gibberellins A4/A7
Enhancing fruit shape of Delicious apples Canada
6-furfural(amino)purine;1H-purin-6-amine;N-(2-furanylmethyl)-(9CI)(US: Cytokinin)
General US
Purine related derivative(US: Keatine)
US
OTHERS
1,4-dimethylnaphtalene Sprout inhibitor US
Aminoethoxy Vinyl Glycine (AVG -Streptomyces product)
Ornamental plants (apples) US
Na-nitrophenolate;Na-nitroguajacolate
Tomato, pepper: yield enhancement Hungary
Na-nitrophenolate;Na-nitroguajacolate;Na-naphtilacetate
Apple, plum: dropping inhibition Hungary
5-nitroguaiacolate;ortho-nitrophenol;para-nitrophenol (US: Atonik)
Not specified US
65
INSECT GROWTH REGULATORS REGISTEREDFOR PLANT PROTECTION USES
Active ingredient Registered uses (pest and/or crop) Country
Trimethyl-dodecadien-
Isopropyl (2E,4E)-11-methoxy-3,7,11-trimethyl-2,4-dodecadienoate (Methoprene)
fly control on mushrooms Canada
2-propynyl(S-(E,E))-3,7,1-trimethyl-2,4-dodecadienate(US: S-kinoprene)
gnats, aphids (fungus) US
2-propynyl(S-(E,E))-3,7,1-trimethyl-2,4-dodecadienoate(Kinoprene)
insect control for ornamental plants grown ingreenhouses
Canada
US
OTHERS
1-(4-chlorophenyl)-3-(2,6-difluorobenzoyl) urea(diflubenzuron, Dimilin)
Gypsy moth larvae on forest lands Canada
Azadirachtin (Neem seed extract) US
Tetraazadirachtin US
66
INSECT GROWTH REGULATORS REGISTEREDFOR USES OTHER THAN PLANT PROTECTION
Active ingredient Registered uses (pest and/or crop) Country
Trimethyl-dodecadienoates
Ethyl(2E,4E)-3,7,11-trimethyl-2,4-dodecadienoate (Hydroprene) (*)+ S-ethyl(2E,4E)-3,7,11-trimethyl-2,4-dodecadienoate(S-hydroprene)
roaches New ZealandUS
2-propynyl(S-(E,E))-3,7,1-trimethyl-2,4-dodecadienoate(Kinoprene)
US
Isopropyl (2E,4E)-11-methoxy-3,7,11-trimethyl-2,4-dodecadienoate (Methoprene) (*)
mosquito larvicide; insect control in storedtobacco
Canada
flea control in houses, buildings CanadaNew Zealand
Isopropyl (2E,4E)-11-methoxy-3,7,11-trimethyl-2,4-dodecadienoate(Methoprene) (*)+ Isopropyl (2E,4E, 7S)-11-methoxy-3,7,11-trimethyl-2,4-dodecadienoate(S-Methoprene) (*)
dipteran larvae, fleas, mosquitoes New ZealandUS
OTHERS
1-(4-chlorophenyl)-3-(2,6-difluorobenzoyl) urea(diflubenzuron, Dimilin)
control of mosquito larvae Canada
insecticide in public health and professionalpest control
Germany
(*) Not considered to be "biological pesticides" in New Zealand
67
MACRO-ORGANISMS REGISTERED FOR PLANT PROTECTION USES
Active ingredient Registered uses (pest and/or crop) Country
INSECTS
Aphelinus abdominalis Aphids (Macrosiphum euphorbiae, Aulacothumsolani) on vegetables under glass
Austria,Sweden
Greenhouse: aphids on potatoes, tomatoes,green pepper, aubergines
Switzerland
Aphidius colemani Aphids (except Macrosiphum sp.), on vegetablesunder glass
Austria
Aphids (Macrosiphum euphorbiae, Aulacothumsolani)
Sweden
Aphidius matricariae Aphids (except Macrosiphum sp.), on vegetablesunder glass
Austria
Aphids on peach trees and melon Switzerland
Aphidoletes aphidimyza Aphids (Macrosiphum euphorbiae, Aulacothumsolani) on vegatables (e.g. cucumbers, tomatoes,pepperonis, aubergines)
Austria,Sweden,Switzerland
Chrysoperla carnea Sucking insects and spider mites on vegetablesand ornamentals under glass; mealybugs onornamentals under glass
Austria
Cryptolaemus montrouzieri Mealy bug, scale insects (Coccoidea) onornamentals
Austria,Sweden
Pseudococines Switzerland
Dacnusa sibirica Borer; diptera France,Switzerland
Leafminers (Liriomyza pusilla) Sweden
Dacnusa+ Diglyphus
Borer Switzerland
Diglyphus isaea Borer; diptera France,Switzerland
Leafminers (Agromyzidae e.g. Liriomyza pusilla,Phytomyza) on vegetables under glass
Austria,Sweden
Encarsia formosa White flies (Trialeurodes vaporatriorum, Bemisiatabaci) on vegetables and ornamentals underglass
Austria,Sweden
Tomato, treatment of aerial parts France
Vegetables, ornamentals under glass:Trialeurodes vapor
Hungary
Switzerland
Leptomastidea abnormis Mealybugs (Planococcus citri) on ornamentalsunder glass
Austria
Leptomastix dactylopii Mealybugs (Planococcus citri) on ornamentalsunder glass and ornamentals
Austria
Orius insidiosus California thrips, tobacco thrips on paprika Switzerland
68
Active ingredient Registered uses (pest and/or crop) Country
Orius laevigatus Thrips (Trips tabaci, Franklinella occidentalis) Sweden
California thrips, tobacco thrips on paprika Switzerland
Orius majusculus Thrips (Trips tabaci, Franklinella occidentalis) onvegetables and ornamentals under glass
Austria
California thrips, tobacco thrips on paprikaAcarid: T. urticae
Switzerland
Trichogramma Maize, treatment of aerial parts, France
Trichogramma brassicae Maize Switzerland
Trichogramma maidis France
Typhlodromus pyri Scheuten(Mikulov)
Red spider mite on fruit and viticulture, acarinosisof vine, apple rust mite on fruit farming
Austria
NEMATODES
Heterorhabditis spp. Otiorhynchus spec. (broad-nosed weevils) Germany
Larvae on strawberry plant, fruit tree, vine Switzerland
Heterorhabditis bacteriophora Weevil larvae on ornamental plants New Zealand
Steinernema spp. Scaria spec. (moth fly in greenhouses) Germany
Steinernema carpocapsae Otiorhynchus spec. (broad-nosed weevils) Germany
insecticide on turf Japan
Weevils (Othiorynchus sulcatus) Sweden
Larvae on strawberry plant, fruit tree, vine Switzerland
Steinernema feltiae Fungus gnats (Bradysia spp)Weevils (Othiorynchus sulcatus,Othio. singularius)
Sweden
SPIDERS/MITES
Amblyseius cucumeris Thrips (Trips tabaci, Franklinella occidentalis) onvegetables and ornamentals under glass
Austria,Sweden
Amblyseius cucumeris+ Amblyseius barkeri
Tobacco thrips, California thrips on cucumbers,tomatoes, pepperonis and aubergines underglassOnion thrips
Switzerland
Amblyseius mackenziei Tobacco thrips, California thrips on cucumbers,tomatoes, pepperonis and aubergines (underglass)
Switzerland
Hypoaspis miles Fungus gnats (Bradysia spp) Sweden
Phytoseiulus persimilis Vegetables, berries, ornamentals under glass:spinning mites (Tetranychus urticae)
Austria,France,Hungary,Sweden,Switzerland
69
PLANT EXTRACTS REGISTERED FOR PLANT PROTECTION USES
Active ingredient Registered uses (pest and/or crop) Country
Abamectin Switzerland
Artemisia vulgaris+ Pastinaca sativa+ Solidago gigantea
orchid, vegetables, ornamentals: Aphididae Hungary
Capsicum (pepper) insect, dog, bird US
Castor oil attractant/repellant (moles, dogs, cats) US
Cedar leaf oil attractant/repellant (blowflies, screw-worm) US
Cedar wood oil attractant/repellant (fleas, moths) US
Cinnamaldehyde+ Indole+ Benzenepropanol+ 3-phenyl-2-propenol+ 4-methoxybenzenethanol+ 3-(4-methoxyphenyl)2-propenal+ 1,2,4-trimethyoxybenzene
Corn Rootworm US
Cinnamon roaches US
Corn Rootworm Bait diabroticine beetle US
Eugenol Japanese Beetle US
Garlic extract birds US
Garlic oil/Pyrethrin extract fruit tree, indoor plants, vegetables Australia
Geraniol Japanese beetle US
Marigold extract (calendulaofficinalis)
insects US
Methyl Anthranilate birds US
Nicotine Switzerland
2-phenylethyl propionate Japanese Beetle US
Pyrethrins/pip. butoxide vegetables, citrus, fruit tree, indoor plants,ornamental plants
Australia
Pyrethrin (*) agriculture Finland,Norway
70
Active ingredient Registered uses (pest and/or crop) Country
Pyrethrum insect control on ornamentals, fruit growing,vegetables
AustriaCanada
insecticide Germany
foliar insecticide for aphids and caterpillars inhorticulture
New Zealand
Quassia tree extract Switzerland
Rape seed oil ornamental plants; horticulture (against spidermites)
Germany
Switzerland
Rotenone against: aphid, cabbage moth, cabbage whitebutterfly, cutworm, European earwig, jassid orleafhopper, rutherglen bug, thrip, vegetableweevilon: broccoli, Brussels sprout, cabbage,cauliflower, turnip
Australia
fruit growing Austria
insect control on vegetable, berry andornamental crops
Canada
foliar insecticide for caterpillars in horticulture New Zealand
Switzerland
Urtica extract+ farnezen
tomato, paprika, ornamentals: Aphididae Hungary
71
PLANT EXTRACTS REGISTERED FOR USES OTHER THAN PLANT PROTECTION
Active ingredient Registered uses (pest and/or crop) Country
Cinnamon Cockroach control (repellent) US
Citronella oil (*) Topical and candle insect repellent (forhumans and horses);Dog and cat repellent
US
Mosquito repellent Finland
Cedarwood oil Flea and moth repellent US
Garlic extract Bird and insect repellent US
Geraniol Dog and cat repellent US
Grapefruit seed extract House dust mite control New Zealand
Nicotine (*) Non-agriculture Finland
Pyrethrin (*) Personal insect repellent Australia
Against insects indoors Finland
Pyrethrum Control of many insects (e.g.: home andgarden, commercial livestock and pet careproducts)
Canada
Insect control Hungary
Public health and professional pest controlunder the Federal Epedemics Act
Germany
Rotenone Insect control on livestock;control of unwanted fishes in lakes and rivers
Canada
Soybean lecithin Public health and professional pest controlunder the Federal Epedemics Act
Germany
(*) Considered and handled as chemical pesticides in Finland
72
OTHER BIOPESTICIDES REGISTERED
Active ingredient Registered uses (pest and/or crop) Country
Dially disulfide+ N-propyl disulfide
fungicide US
Dried blood rabbit, dog and deer repellent US
Grapefruit seed extract control of dust mites in carpets New Zealand
Neem oil(free fatty acid, glycerides)
insects US
Nicotine (*) non-agriculture Finland
Phosphoric acid fungicide US
Polyoxins B grape, raspberry, strawberry: Botrytis cinerea Hungary
Putrescent whole egg solids deer and big game repellent US
Repellent oil Daphne (*) game repellent Finland
Sodium carboxymethylcellulose insects, mites US
Soybean oil miticide US
Traps for insects aphids, caterpillar Switzerland
(*) Considered and handled as chemical pesticides in Finland
73
74
Annex 3
Individual Countries’ Responses to Part 2of the Questionnaire
Key to Abbreviations Used
A Always required for registration of plant protection products.
F Frequently required: These data are required in more than 80 per centof registration submissions.
L Less frequently required: These data are required in less than 80 per centof registration submissions.
X Required at an unknown rate: These data are required in an undeterminednumber of cases.
AI Active ingredient
FM Formulation
* Good Laboratory Practice is required.
g Guidance for the study is available.
c A comment was provided in the country’s questionnaire response.
75
76
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DIT
ION
AL
DA
TA
LIS
TE
DB
YC
OU
NT
RIE
S
Way
ofpr
oduc
tion
AI
AA
AA
FM
A
Nam
eof
prod
uct
AI
FM
AA
A
Pur
pose
ofsu
bmis
sion
AI
A
FM
AA
Cla
ims
for
use
AI
FM
AA
A
Dra
ftla
bela
nd/o
rus
epa
ttern
AI
A
FM
AA
A
For
mul
atin
gpl
ant
AI
A
FM
AA
g
Pat
ent
stat
usan
dnu
mbe
rA
IA
c
FM
Ac
Sou
rce
ofac
tive
ingr
edie
ntA
IA
A
FM
AA
A
IDE
NT
ITY
OF
MIC
RO
-OR
GA
NIS
M(b
oth
natu
rally
occu
rrin
gan
dge
netic
ally
mod
ified
)
Sci
entif
icna
me
AI
XA
AA
AA
Ag
Ac
AA
gA
AA
Ag
A
FM
AA
gA
AA
g
77
TY
PE
OF
DA
TA
/INF
OR
MA
TIO
NE
CD
EN
FR
GE
RIT
AN
LU
KA
US
AU
TC
AN
FIN
HU
NN
OR
NZ
SW
EU
S
Com
mon
nam
eA
IX
cA
AA
AA
gA
cA
Ag
AA
AA
A
FM
AA
gA
F
Syn
onym
sA
IX
AA
LA
AA
gA
cA
Ag
AA
AA
A
FM
AA
gA
L
Sub
spec
ies
AI
XA
AA
AA
Ag
Ac
AA
gA
AA
AA
*
FM
AA
gA
Str
ain
AI
Xc
AA
AA
AA
gA
cA
Ag
AA
AA
A*
FM
AA
gA
Ser
otyp
eA
IL
Ac
AA
AA
gA
cA
Acg
AF
AA
L* c
FM
AA
cgF
For
gene
tical
lym
odifi
edor
gani
sms
only
:
Info
rmat
ion
onth
edo
nor
orga
ism
(s):
scie
ntifi
cna
me,
subs
peci
es,
stra
in,
etc.
AI
XA
AA
Ac
X? c
cA
Ag
cA
cX
cA
cA
FM
Ac
Ag
A
Info
rmat
ion
onth
ein
sert
edge
netic
mat
eria
l
Des
crip
tion
ofin
sert
edM
ater
ial
AI
XA
AA
Ac
X?
cA
Ag
cA
Xc
cA
*
FM
AA
gA
Gen
eco
ntro
lreg
ion(
s)A
IX
cA
AA
Ac
X?
cA
Ag
cA
Xc
cA
*
FM
AA
gA
Sile
ntge
netic
mat
eria
lA
IX
cA
AA
Ac
X?
cA
Ag
cA
Xc
AA
*
FM
AA
gA
Phe
noty
pic
trai
tsga
ined
orlo
stA
IX
cA
AA
Ac
X?
cA
Ag
cA
Xc
AA
*
FM
AA
gA
Info
rmat
ion
onth
eve
ctor
(s)
Iden
tity
AI
XA
AA
Ac
X?
cA
Ag
cA
Xc
AA
*
FM
AA
Ag
AA
Pro
pert
ies
AI
Xc
AA
AA
cX
?c
AA
gc
AX
cA
A*
FM
AA
Ag
AA
78
TY
PE
OF
DA
TA
/INF
OR
MA
TIO
NE
CD
EN
FR
GE
RIT
AN
LU
KA
US
AU
TC
AN
FIN
HU
NN
OR
NZ
SW
EU
S
Info
rmat
ion
onth
eho
st
Nam
eA
IX
AA
AA
cX
?c
AA
gc
AX
cA
A*
FM
AA
Ag
AA
Tax
onom
icpo
sitio
nA
IX
AA
AA
cX
?c
AA
gc
AX
cA
A*
FM
AA
Ag
AA
Info
rmat
ion
onth
ege
netic
ally
mod
ified
orga
nism
itsel
f
Mod
ifica
tion
tech
niqu
eA
IX
AA
AA
cX
?c
AA
gc
AX
cA
*
FM
AA
Ag
A
Site
ofne
wge
netic
mat
eria
lA
IA
AA
Ac
X?
cA
Ag
cA
A*
FM
AA
Ag
A
AD
DIT
ION
AL
DA
TA
LIS
TE
DB
YC
OU
NT
RIE
S
Col
lect
ion
and
cultu
rere
fere
nce
num
ber
whe
reth
ecu
lture
isde
posi
ted
AI
XA
L
FM
L
Tes
tpr
oced
ures
and
crite
riafo
rid
entif
icat
ion
(e.g
.m
orph
olog
y,bi
oche
mis
try,
sero
logy
)A
IX
AA
FM
A
Wha
tki
ndof
gene
ticm
odifi
catio
nha
sbe
enm
ade?
Has
any
gene
ticm
ater
ialb
een
rem
oved
orad
ded,
etc.
?A
IA
AA
FM
A
BIO
LOG
ICA
LP
RO
PE
RT
IES
OF
TH
EM
ICR
O-O
RG
AN
ISM
For
natu
rally
occu
rrin
gor
gani
sms
only
:
His
tory
ofth
eor
gani
sman
dits
uses
AI
XA
Ac
AA
AA
Ag
AA
AA
Ac
FM
AA
gA
A
Rel
atio
nshi
psto
know
npl
ant
orm
amm
alia
npa
thog
ens
AI
Xc
AA
cA
FA
AA
Ag
AA
AA
Ac*
FM
AA
gA
F
Nat
ural
occu
rren
cean
dge
ogra
phic
dist
ribut
ion
ofth
eor
gani
smA
IX
AA
cF
AA
AA
AA
gA
AA
AA
c*
FM
FA
gA
Info
rmat
ion
onbi
olog
ical
prop
ertie
san
dho
stsp
ecifi
city
rang
eA
IX
AA
cF
AA
AA
AA
cgA
AA
Ag
Ac*
FM
FA
cgA
Ag
Gen
etic
stab
ility
and
fact
ors
affe
ctin
git
AI
Xc
LA
cF
AA
AA
Fg
LA
AA
Ac
FM
FF
gL
F
79
TY
PE
OF
DA
TA
/INF
OR
MA
TIO
NE
CD
EN
FR
GE
RIT
AN
LU
KA
US
AU
TC
AN
FIN
HU
NN
OR
NZ
SW
EU
S
Gen
eral
info
rmat
ion
onsu
rviv
abili
ty,
phys
ical
stab
ility
AI
Xc
AA
AA
AA
AF
gA
AA
AF
MA
AF
gA
AA
AD
DIT
ION
AL
DA
TA
LIS
TE
DB
YC
OU
NT
RIE
SE
ffect
son
non-
targ
etsp
ecie
sA
IX
cA
AF
MA
Pre
senc
e,ab
senc
eor
prod
uctio
nof
toxi
ns(n
atur
e,id
entit
y,ch
emic
alst
ruct
ure
(ifap
prop
riate
)an
dst
abili
ty)
AI
XA
AA
AF
MId
entif
icat
ion
test
for
mic
ro-o
rgan
ism
AI
AA
FM
Sel
ectio
nan
dm
utat
ion;
stat
eif
the
activ
eor
gani
smw
asse
lect
edor
was
mut
ated
AI
AF
MM
etho
dsto
prev
ent
the
activ
eor
gani
smfr
omlo
sing
itsab
ility
toel
imin
ate
the
targ
etor
gani
smA
IA
FM
Des
crip
tion
ofth
elif
ecy
cle
ofth
eac
tive
orga
nism
AI
AA
FM
Com
petit
ors
and
natu
rale
nem
ies
ofth
eac
tive
orga
nism
AI
AF
ME
xten
tto
whi
chve
ctor
orm
odifi
edge
nes
may
betr
ansf
erre
dam
ong
orin
corp
orat
edby
othe
ror
gani
sms
AI
AF
MF
orge
netic
ally
mod
ified
orga
nism
son
ly:
His
tory
and
uses
ofth
epa
rent
orga
nism
(s)
incl
udin
gbo
thdo
nor
and
host
AI
Xc
Ac
Ac
X? c
cA
Ag
cA
Xc
cA
c
FM
AA
Rel
atio
nshi
pof
the
pare
ntor
gani
sm(s
)to
any
plan
tpa
thog
ens
orto
path
ogen
sof
vert
ebra
esp
ecie
sA
IX
cA
cA
cX
? cc
AA
gc
AX
cc
A*
FM
AF
Nat
ural
occu
rren
cean
dge
ogra
phic
dist
ribut
ion
ofth
epa
rent
orga
nism
(s)
AI
Xc
Ac
Ac
X? c
cA
Ag
cA
Xc
cA
*
FM
AA
Pro
pert
ies
ofpa
rent
orga
nism
(s)
Pat
hoge
nici
tyA
IX
cc
Ac
X?
cA
Ag
cA
Xc
cA
*
FM
AA
Infe
ctiv
ityA
IX
cc
Ac
X?
cA
cA
Xc
cA
*
FM
AA
Tox
icity
,in
clud
ing
alle
rgen
icity
AI
Xc
cA
cX
?c
Ac
AX
cc
A*
FM
AA
AIn
form
atio
non
biol
ogic
alpr
oper
ties
and
host
spec
ifici
tyra
nge
ofth
epa
rent
orga
nism
(s)
AI
Xc
cc
X?
cA
Ag
cA
Xc
cA
*
FM
A
80
TY
PE
OF
DA
TA
/INF
OR
MA
TIO
NE
CD
EN
FR
GE
RIT
AN
LU
KA
US
AU
TC
AN
FIN
HU
NN
OR
NZ
SW
EU
S
Gen
etic
stab
ility
ofth
epa
rent
orga
nism
(s)
and
fact
ors
affe
ctin
git
AI
Xc
Lc
Ac
X?
AA
Xc
A
FM
AA
Gen
eral
info
rmat
ion
onsu
rviv
abili
tyof
the
pare
ntor
gani
sm(s
),ph
ysic
alst
abili
tyA
IX
cc
Ac
X?
AF
gA
Xc
FM
AA
A
AD
DIT
ION
AL
DA
TA
LIS
TE
DB
YC
OU
NT
RIE
S
Pot
entia
lof
mod
ified
orga
nism
totr
ansf
erge
netic
mat
eria
lto
othe
ror
gani
sms
AI
AX
?A
A*
FM
Rel
ativ
een
viro
nmen
talc
ompe
titiv
enes
sof
mod
ified
orga
nism
AI
LA
A*
FM
PU
RIT
Y
Mic
robi
olog
ical
purit
yA
IX
cA
AA
cA
AA
gA
AA
gA
AA
Ag
A*
FM
AA
gA
cA
gA
Ag
AA
AA
Ag
A*
Iden
tity
ofan
yun
inte
nded
toxi
cby
-pro
duct
s,al
lerg
ens,
orim
purit
ies
prod
uced
byth
em
icro
-org
anis
mor
inth
ein
cuba
tion
proc
ess;
info
rmat
ion
onth
ena
ture
and
prop
ertie
sof
such
impu
ritie
s
AI
Xc
AA
cA
AA
gA
AA
gA
AA
Ag
A*
FM
AA
cA
gA
AA
AA
gA
*
IDE
NT
ITY
OF
FO
RM
ULA
TIO
N
Tra
dena
me
and
man
ufac
ture
r’sde
velo
pmen
tco
denu
mbe
rA
IA
Ac
Ag
FM
L cA
AA
AA
AA
cA
Ag
AA
AA
Ag
A*
Com
posi
tion
ofth
epr
oduc
t:id
entit
yan
dco
ncen
trat
ion
ofac
tive
orga
nism
(s),
iner
tco
mpo
nent
s,ex
tran
eous
orga
nism
s,et
c.
AI
AA
cA
FM
XA
AA
AA
AA
cA
AA
AA
AA
gA
*
Iden
tity
ofto
xic
by-p
rodu
cts,
alle
rgen
s,or
othe
rim
purit
ies
prod
uced
byth
em
icro
-org
anis
mor
inth
ein
cuba
tion
orm
anuf
actu
ring
proc
ess;
info
rmat
ion
onth
ena
ture
and
prop
ertie
sof
such
impu
ritie
s
AI
AA
cA
Ag
FM
Xc
AA
AA
Ac
AA
gA
AA
AA
gA
*
Nat
ure
ofth
epr
oduc
t(e
.g.
emul
sifia
ble
conc
entr
ate,
wet
tabl
epo
wde
r,et
c.)
AI
FM
XA
AA
AA
AA
cA
Ag
AA
AA
Ag
A
81
TY
PE
OF
DA
TA
/INF
OR
MA
TIO
NE
CD
EN
FR
GE
RIT
AN
LU
KA
US
AU
TC
AN
FIN
HU
NN
OR
NZ
SW
EU
S
AD
DIT
ION
AL
DA
TA
LIS
TE
DB
YC
OU
NT
RIE
S
Spe
cific
grav
ity/d
ensi
tyA
I
FM
AA
g
Rhe
olog
ical
prop
ertie
s(s
uspe
ndab
ility
,w
etta
bilit
y,et
c.)
AI
FM
AA
g
Iden
tity
and
purp
ose
ofno
n-ac
tive
ingr
edie
nts
AI
FM
AA
c
Rel
evan
tph
ase
ofde
velo
pmen
tof
activ
eor
gani
smw
hen
the
prod
uct
isso
ld(e
.g.
spor
es)
AI
FM
A
82
MA
TR
IX2.
FU
NC
TIO
N,
MO
DE
OF
AC
TIO
NA
ND
HA
ND
LIN
G
TY
PE
OF
DA
TA
/INF
OR
MA
TIO
NE
CD
EN
FR
GE
RIT
AN
LU
KA
US
AU
TC
AN
FIN
HU
NN
OR
NZ
SW
EU
S
Fun
ctio
n(e
.g.
fung
icid
e,he
rbic
ide,
inse
ctic
ide,
repe
llant
,gr
owth
regu
lato
r,an
ti-vi
rala
gent
)A
IX
AA
AA
Ag
AA
Acg
A
FM
XA
AA
AA
AA
Ag
AA
AA
Ac
A
Mod
eof
actio
nto
targ
etpe
st,
infe
ctiv
edo
se,
tran
smis
sibi
lity
AI
Xc
AF
AA
AA
Acg
AA
Ac
A
FM
AA
AA
Acg
AA
AA
Fie
ldof
use
(e.g
.fie
ld,
glas
shou
se,
food
crop
)A
IX
AA
cgA
gA
FM
XA
AA
AA
AA
cgA
Ag
AA
AA
Acg
A
Det
ails
ofin
tend
edus
e(e
.g.
targ
etor
gani
sman
dpl
ants
orpl
ant
prod
ucts
tobe
prot
ecte
d)A
IX
AA
gA
gA
FM
XA
AA
AA
AA
gA
Ag
AA
AA
Acg
A
App
licat
ion
rate
AI
AA
cgA
Ag
A
FM
XA
AA
AA
AA
cgA
Ag
AA
AA
Acg
A
Con
ditio
nsun
der
whi
chth
esu
bsta
nce
may
not
beus
ed(a
gric
ultu
ral,
plan
the
alth
oren
viro
nmen
tal)
AI
Xc
Acg
Ag
FM
XA
AA
Acg
AA
gA
AA
AA
cg
Met
hod
ofap
plic
atio
nA
IA
cgA
gA
FM
XA
AA
AA
AA
cgA
Ag
AA
AA
Acg
A
Num
ber
and
timin
gof
appl
icat
ions
AI
Acg
Ag
A
FM
XA
AA
AA
AA
cgA
Ag
AA
AA
Acg
A
Pro
pose
din
stru
ctio
nsfo
rus
eA
IA
gA
gA
FM
XA
AA
AA
AA
gA
Ag
AA
AA
Acg
A
Re-
entr
yin
terv
als
AI
Ag
A
FM
XA
AA
AL
Fc
AA
gL c
AA
A
Pre
-har
vest
inte
rval
s(w
aitin
gpe
riod
betw
een
last
trea
tmen
tan
dha
rves
tor
cons
umpt
ion)
AI
Ag
Acg
A
FM
XA
AA
AL
Fcg
AA
gA
cA
AA
cA
Typ
eof
pack
agin
gA
IA
cgA
gA
FM
Xc
AA
AA
AA
gA
Ag
AA
AA
Acg
A
Pro
cedu
res
for
clea
ning
appl
icat
ion
equi
pmen
tA
IA
g
FM
XA
LA
AL
Fcg
AA
gL c
AA
Acg
83
TY
PE
OF
DA
TA
/INF
OR
MA
TIO
NE
CD
EN
FR
GE
RIT
AN
LU
KA
US
AU
TC
AN
FIN
HU
NN
OR
NZ
SW
EU
S
Pro
cedu
res
for
dest
ruct
ion
orde
cont
amin
atio
nof
the
prod
uct
and
itspa
ckag
ing
AI
Fcg
Ag
FM
XA
AA
AA
LF
gA
Ag
AA
AF
Acg
Rec
omm
ende
dm
etho
dsan
dpr
ecau
tions
conc
erni
ngha
ndlin
g,st
orag
e,tr
ansp
ort
orfir
eA
IX
AA
cgA
g
FM
Xc
AA
AA
AL
Ag
AA
gA
AA
FA
cg
Em
erge
ncy
mea
sure
sin
case
ofan
acci
dent
AI
Acg
Ag
FM
XA
AL
AA
LA
gA
Ag
AA
AF
Acg
Met
hods
topr
even
tlo
ssof
viab
ility
ofse
edst
ock
AI
XA
FA
gL
AA
cgA
c
FM
Ag
LA
Ac
AA
Acg
AD
DIT
ION
AL
DA
TA
LIS
TE
DB
YC
OU
NT
RIE
S
Pos
sibi
lity
ofre
nder
ing
the
orga
nism
sun
infe
ctiv
eor
non-
infe
cted
AI
XL
FM
Met
hods
topr
even
tlo
ssof
viru
lenc
eA
IL
FM
Sel
ectiv
ityof
actio
nA
IA
FM
End
-use
prod
uct:
stab
ility
,m
aint
enan
ceof
purit
yan
dpo
tenc
yA
I
FM
AA
cg
With
hold
ing
orst
orag
epe
riods
inth
eca
seof
post
-har
vest
use
(cou
ldsu
bstit
ute
for
pre-
harv
est
inte
rval
s)
AI
FM
X
84
MA
TR
IX3.
PH
YS
ICA
L-C
HE
MIC
AL
PR
OP
ER
TIE
S
TY
PE
OF
DA
TA
/INF
OR
MA
TIO
NE
CD
EN
FR
GE
RIT
AN
LU
KA
US
AU
TC
AN
FIN
HU
NN
OR
NZ
SW
EU
S
App
eara
nce
AI
AA
g*A
AA
gA
cA
FM
XA
AA
Ac*
Ag*
AA
gA
cA
cA
LA
g
Phy
sica
lsta
teA
IA
Ag*
AA
Ag
AA
A*
FM
XA
AA
A*
Ag*
AA
gA
Ac
AL
Ag
A*
Den
sity
AI
LF
g*A
Ag
L cA
A*
FM
AA
*F
g*A
AA
g(F
)L c
AL
Ag
A*
pHA
IF
g*F
L cA
A*
FM
AF
g*L
AA
L cA
LA
gA
*
Sta
bilit
yw
hen
used
acco
rdin
gto
prop
osed
met
hod
(e.g
effe
cts
ofsu
nlig
ht,
wat
er,
chan
ges
inpH
and
tem
pera
ture
)
AI
XF
AA
g*A
AL c
AA
*
FM
AA
*A
g*F
AA
Ac
AF
Sto
rage
stab
ility
AI
AA
gA
L cA
A*
FM
Xc
AA
AA
*A
Ag*
AA
Ag
AA
cA
AA
gA
*
Sus
pend
abili
tyan
dsu
spen
sion
stab
ility
AI
L
FM
AA
F*
Fg*
LA
FA
cA
LA
g
Siz
edi
strib
utio
nof
the
orga
nism
AI
Ag*
FA
FM
AF
L*A
g*F
FL c
AL
Con
tent
ofac
tive
ingr
edie
ntin
oron
bait
part
icle
s,gr
anul
esor
trea
ted
seed
AI
Fg*
Ag
AA
c
FM
AA
LL*
Fg*
LA
Ag
L cA
AA
gA
c
Flo
wab
ility
,po
urab
ility
,du
stab
ility
AI
Fg*
Ag
L
FM
LA
F*
Fg*
LF
Ag
AA
cA
LA
g
AD
DIT
ION
AL
DA
TA
LIS
TE
DB
YC
OU
NT
RIE
S
Met
hods
for
esta
blis
hing
stor
age
and
shel
f-lif
est
abili
tyA
I
FM
XA
Tec
hnic
alch
arac
teris
tics
ofth
epr
epar
atio
nA
I
FM
Xc
A
Phy
sica
land
chem
ical
com
patib
ility
with
othe
rpr
oduc
tsin
clud
ing
plan
tpr
otec
tion
prod
ucts
who
seus
eis
tobe
auth
oris
ed
AI
FM
XA
TY
PE
OF
DA
TA
/INF
OR
MA
TIO
N
85
EC
DE
NF
RG
ER
ITA
NL
UK
AU
SA
UT
CA
NF
INH
UN
NO
RN
ZS
WE
US
Wet
ting,
adhe
renc
ean
ddi
strib
utio
nto
targ
etpl
ants
AI
FM
XA
Com
pata
bilit
yw
ithot
her
prod
ucts
AI
FM
AA
*
Sam
ple
for
anal
ysis
AI
A
FM
AA
Mis
cibi
lity
AI
Ag
FM
Ag
A*
Odo
urA
IA
g
FM
Ag
Cor
rosi
vech
arac
ter
AI
Ag
FM
Ag
A*
Col
our
AI
FM
Ag
For
mat
ion
ofae
roso
lsA
I
FM
A
Vis
cosi
tyA
I
FM
AA
*
86
MA
TR
IX4.
MA
NU
FA
CT
UR
ING
,Q
UA
LIT
YC
ON
TR
OL
AN
DA
NA
LYT
ICA
LM
ET
HO
DS
TY
PE
OF
DA
TA
/INF
OR
MA
TIO
NE
CD
EN
FR
GE
RIT
AN
LU
KA
UA
UC
AN
FIN
HU
NN
OR
NZ
SW
EU
S
Met
hod
ofpr
oduc
tion:
desc
riptio
nof
tech
niqu
esus
edto
ensu
rea
unifo
rmpr
oduc
tan
das
say
met
hods
for
stan
dard
izat
ion
AI
Xc
Ag
LA
*A
Ag*
AA
Acg
AA
cA
Ag
Ac
FM
XA
Ag
A*
Ag*
AA
Acg
AF
cA
AA
gA
c
Met
hods
toes
tabl
ish
the
iden
tity
and
purit
yof
seed
stoc
kfr
omw
hich
batc
hes
are
prod
uced
and
resu
ltsob
tain
ed,
incl
udin
gin
form
atio
non
varia
bilit
y
AI
XA
gF
F*
AA
g*F
AA
cgA
Ac
AA
gA
*
FM
AA
gF
AA
cgA
AF
Ag
A*
Met
hods
tosh
owm
icro
biol
ogic
alpu
rity,
incl
udin
gva
riabi
lity
and
leve
lsof
cont
amin
ants
AI
XA
gA
A*
AA
g*F
AA
cgA
Ac
AA
gA
*
FM
XA
Ag
FA
*A
g*A
AA
cgA
Ac
AA
Ag
A*
Met
hods
tosh
owth
ere
are
nokn
own
hum
anor
othe
rm
amm
alia
npa
thog
ens
asco
ntam
inan
tsA
IX
cA
gA
A*
AA
g*A
cA
Acg
AA
cA
cA
*
FM
Xc
AA
gA
*A
g*A
AA
cgA
Ac
AF
cA
*
Met
hods
tode
tect
and
quan
tify
resi
dues
inor
ontr
eate
dpl
ants
,pr
oduc
ts,
food
,fe
ed,
anim
alan
dhu
man
body
fluid
san
dtis
sues
,so
il,w
ater
and
air
Via
ble
resi
dues
AI
XA
*A
Ag*
AA
cgA
Ac
L c*
FM
Xc
AA
A*
AF
Acg
AA
cA
Fc
Non
-via
ble
resi
dues
AI
XA
*A
Ag*
AA
cgA
Ac
L c*
FM
Xc
AA
A*
AF
Acg
AA
cA
Fc
Mic
robi
alto
xins
AI
XA
*A
Ag*
AA
cgA
Ac
L c*
FM
Xc
AA
A*
AL
Acg
AA
cA
F
Met
hods
tode
tect
the
orga
nism
inth
een
viro
nmen
tA
IA
Ac
Ag*
AL c
gA
A
FM
AL c
gA
Ac
AF
Met
hods
for
dete
rmin
ing
the
com
posi
tion
ofth
efo
rmul
atio
nA
I
FM
XA
AA
*A
Ag*
LA
L cg
AA
cF
A*
For
gene
tical
lym
odifi
edor
gani
sms:
met
hods
tode
tect
the
inse
rted
gene
ticm
ater
ial
AI
XA
A*
X?
AF
cX
cA
FM
A*
X?
Fc
Ac
A
87
MA
TR
IX5.
RE
SID
UE
S
TY
PE
OF
DA
TA
/INF
OR
MA
TIO
NE
CD
EN
FR
GE
RIT
AN
LU
KA
US
AU
TC
AN
FIN
HU
NN
OR
NZ
SW
EU
S
GE
NE
RA
L
Like
lihoo
dof
mul
tiplic
atio
nor
pers
iste
nce
ofth
eac
tive
subs
tanc
ein
/on
crop
sor
food
MO
Xc
AA
AA
Ag
Fc
AA
cgA
AA
Fc
AA
MT
AA
AA
Ag
Fc
AA
cgA
AA
Fc
AA
NA
TU
RE
OF
TH
EM
AT
ER
IAL.
..
In/o
ntr
eate
dpl
ants
orpr
oduc
tsM
OX
cA
AA
Ag
FA
Ac
AA
AF
cA
L*
MT
Xc
AA
AA
gF
AA
cA
AA
Fc
AL*
Inliv
esto
ck,
ifre
sidu
esre
mai
non
crop
used
for
feed
MO
Fc
FA
gF
AA
cA
AL
Fc
AL*
MT
Fc
FA
gF
AA
cA
AA
Fc
AL*
PR
ES
EN
CE
&M
AG
NIT
UD
EO
FT
HE
MA
TE
RIA
LIN
...
Foo
dcr
ops
MO
AF
AA
Ag
FA
Ac
AA
AF
cA
L*
MT
AF
AA
Ag
FA
Ac
AA
AF
cA
L*
Mea
t,da
irypr
oduc
ts,
poul
try,
eggs
MO
AF
cF
Ag
FA
Ac
AL
LF
AL*
MT
L cA
Fc
FA
gF
AA
cA
AL
FA
L*
Pro
cess
edfo
od/fe
edM
OA
LA
gF
FA
cL c
LF
AL*
MT
L cA
LA
gF
FA
cL c
AF
AL*
Pot
able
wat
erM
OA
AA
gF
cF
AL
FA
L*
MT
AA
Ag
Fc
FA
LF
AL*
Fis
hM
OA
LL
L gF
cF
LF
AL*
MT
AL
LL g
Fc
FA
FA
L*
AD
DIT
ION
AL
CO
UN
TR
IES
LIS
TE
DB
YC
OU
NT
RIE
S
Bird
san
dra
tsM
OF
MT
F
OT
HE
RR
EQ
UIR
EM
EN
TS
Effe
cts
ofpr
oces
sing
orco
okin
gon
resi
dues
MO
F/L
LL
Ag
LL
Acg
LL
AL*
MT
F/L
LL
Ag
LF
Acg
LA
AL*
Pro
pose
dm
axim
umre
sidu
ele
vels
MO
AA
Ac
Ag
AA
Acg
(A)F
cF
Fc
AL*
MT
Xc
AL
AA
cA
gA
AA
cg(A
)Fc
FF
cA
cA
L*
88
TY
PE
OF
DA
TA
/INF
OR
MA
TIO
NE
CD
EN
GE
RIT
AN
LU
KA
US
AU
TC
AN
FIN
HU
NN
OR
NZ
SW
EU
S
Sum
mar
yan
dev
alua
tion
ofre
sidu
ebe
havi
our
MO
XA
AA
Ag
FA
Acg
AA
FF
Ac
L*
MT
XA
AA
Ag
FA
Acg
AA
FF
Ac
L*
AD
DIT
ION
AL
DA
TA
LIS
TE
DB
YC
OU
NT
RIE
S
Effe
cts
onco
lour
,sm
ell,
tast
ean
dot
her
qual
ityas
pect
sM
OA
MT
X(L
)A
Res
idue
data
insu
ccee
ding
orro
tatio
nalc
rops
MO
A
MT
XA
Res
idue
sin
anim
als
that
com
ein
cont
act
with
trea
ted
crop
mat
eria
lM
OA
MT
A
Fre
ezer
stab
ility
(sto
rage
befo
rean
alys
is)
MO
Acg
MT
Acg
Met
abol
ism
MO
L c
MT
L c
89
MA
TR
IX6.
EF
FIC
AC
Y
TY
PE
OF
DA
TA
/INF
OR
MA
TIO
NE
CD
EN
FR
GE
RIT
AN
LU
KA
US
AU
TC
AN
FIN
HU
NN
OR
NZ
SW
EU
S
Pre
limin
ary
rang
e-fin
ding
test
sA
IA
FM
XA
AA
AF
LA
Fcg
AA
cgF
LA
gA
*
Fie
ldte
sts
AI
FM
XA
AA
AA
cgA
AA
cgA
Acg
Ac
AA
gA
*
Dos
e/ef
ficac
yre
latio
nshi
psA
IF
cg
FM
AA
LA
cA
AF
cgA
Ac
AF
Ag
A*
Use
inin
tegr
ated
pest
man
agem
ent
syst
ems
AI
FM
FA
Fc
FA
Fcg
AA
cF
FA
g
Info
rmat
ion
onth
epo
ssib
lede
velo
pmen
tof
resi
stan
cean
dap
prop
riate
man
agem
ent
stra
tegi
esA
IA
cA
c
FM
Xc
AL
AA
cF
AL c
gA
AL
Ag
Effe
cts
onqu
ality
and
yiel
dof
trea
ted
plan
tsA
I
FM
XA
AL
AA
Ac
FL
Acg
AF
cA
AA
gA
*
Effe
cts
onqu
ality
oftr
eate
dpl
ant
prod
ucts
AI
FM
XA
AA
AA
Fc
LL
Acg
AA
cA
AA
gA
*
Phy
toto
xici
tyto
targ
etpl
ants
AI
L cF
MX
cA
FL
AA
Ac
AA
Acg
AA
cA
AA
g
Phy
toto
xici
tyto
rota
tiona
lcro
psA
IL c
Ag
FM
AF
FL
Fc
LA
Acg
AA
cF
FA
g
Obs
erva
tions
ofun
desi
rabl
eor
unin
tend
edsi
deef
fect
sA
IL c
FM
XA
AA
Ac
AA
Acg
AA
cF
AA
cA
*
AD
DIT
ION
AL
DA
TA
LIS
TE
DB
YC
OU
NT
RIE
S
Sum
mar
yan
dev
alua
tion
AI
FM
X
Met
hods
,tim
ing
and
equi
pmen
tfo
rap
plic
atio
nA
I
FM
Ag
Val
ueas
sess
men
tA
I
FM
Acg
Sta
teel
emen
tsw
hich
coul
daf
fect
effic
acy,
such
asot
her
pest
icid
es,
resi
stan
cefo
rmat
ion,
and
clim
ate
cond
ition
sA
I
FM
A
Phy
topa
thog
enic
ityA
I
FM
X
90
MA
TR
IX7.
TO
XIC
OLO
GY
,P
AT
HO
GE
NIC
ITY
AN
DIN
FE
CT
IVIT
Y
TY
PE
OF
DA
TA
/INF
OR
MA
TIO
NE
CD
EN
FR
GE
RIT
AN
LU
KA
US
AU
TC
AN
FIN
HU
NN
OR
NZ
SW
EU
S
AC
UT
ET
OX
ICIT
YT
ES
TIN
G
Ora
lA
IX
cA
g*A
gA
*A
*A
g*F
g*A
AA
cg*
Ac
Ag
A*
Ac*
Ag
FM
Xc
Ag*
AA
*A
*L g
*F
g*A
AA
cg*
Ac
Ag
A*
Ag
A*
Der
mal
AI
Xc
Ag
F*
A*
L g*
Fg*
AA
Acg
*A
cA
gA
*
FM
Xc
Ag*
FF
*A
*L g
*F
g*A
AA
cg*
Ac
Ag
A*
Ac*
Ag
A*
Inha
latio
nA
IX
cA
g*A
gF
*A
*L g
*A
AA
cg*
Ac
L gA
*A
c*A
g
FM
Xc
Ag*
FF
*A
*F
g*L g
*A
AA
cg*
Ac
A*
Ag
A*
Eye
irrita
tion
AI
LL g
*A
gA
*A
*F
cg*
L g*
AA
Ac
Fg
A*
(A) c
FM
LA
g*F
A*
A*
Fcg
*F
g*A
AA
cg*
Ac
Ag
A*
Ac*
Ac
A*
Ski
nirr
itatio
nA
IX
L g*
Ag
A*
A*
Acg
*L g
*A
AA
cF
gA
*(A
) cF
MX
Ag*
FA
*A
*A
cg*
Fg*
AA
Acg
*A
cA
gA
*A
cA
*
Ski
nse
nsiti
zatio
nA
IX
L g*
Ag
A*
A*
Ag*
L g*
AA
cF
gA
*A
c
FM
XA
g*F
A*
A*
Fg*
Ac
AA
cg*
Ac
Ag
A*
Ac*
Ac
A*
Intr
aper
itone
alor
intr
aven
ous
AI
Xc
Acg
*A
gL*
A*
Ag*
L g*
cA
cg*
Ac
L gF
*A
c*A
c
FM
FL g
*A
cL g
Ac
AD
DIT
ION
AL
DA
TA
LIS
TE
DB
YC
OU
NT
RIE
S
Ran
gefin
ding
test
for
case
sw
here
asi
ngle
dose
isno
tap
prop
riate
toas
sess
path
ogen
icity
AI
XL
FM
Ava
ilabl
eto
xico
logi
cald
ata
rela
ting
tono
n-ac
tive
subs
tanc
esA
IX
FM
XF
X
Intr
acer
ebra
ltes
tsfo
rne
urot
ropi
cag
ents
AI
cA
cg*
FM
c
Sta
tean
yad
ditio
nals
tudi
espe
rfor
med
AI
LX
FM
X
Tis
sue
cultu
re;
appl
ies
mai
nly
tovi
rus
AI
AX
FM
X
91
TY
PE
OF
DA
TA
/INF
OR
MA
TIO
NE
CD
EN
FR
GE
RIT
AN
LU
KA
US
AU
TC
AN
FIN
HU
NN
OR
NZ
SW
EU
S
Sum
mar
yA
IX
FM
X
RE
PE
AT
ED
DO
SE
TO
XIC
ITY
,P
AT
HO
GE
NIC
ITY
AN
DIN
FE
CT
IVIT
Y(s
tudi
esle
ssth
anon
em
onth
)
Ora
lA
IF
/Lg
Ac
L cg*
Fg*
cL
L cg*
cL c
*A
*
FM
L cF
cg*
L g*
cc
Der
mal
AI
L cL c
g*L g
*c
Lc
L c*
A*
FM
L cF
cg*
L g*
cc
Inha
latio
nA
IF
/Lg*
L cL g
*c
Lc
L c*
A*
FM
L cF
g*L g
*c
c
Intr
aper
itone
alA
IL g
*c
cA
*
FM
L g*
cc
Intr
aven
ous
AI
L g*
cL
cA
*
FM
L g*
cc
AD
DIT
ION
AL
DA
TA
LIS
TE
DB
YC
OU
NT
RIE
S
Pat
hoge
nici
tyA
IA
*F
g*c
AA
L c*
FM
L*L g
*c
A
Infe
ctiv
ityA
IF
/Lg*
A*
AF
g*c
AA
Fc
FM
L*L g
*c
A
SU
BC
HR
ON
ICT
OX
ICIT
Y(s
tudi
eslo
nger
than
one
mon
th)
Ora
lA
IX
cF
/LF
Ac*
A*
Fg*
L cA
L cg
L cA
gF
c*L c
*X
cL c
*
FM
LL c
gc
Ag
Der
mal
AI
Xc
L c*
A*
L g*
L cL
L cg
cA
gX
cL c
*
FM
LL g
*L c
gc
Ag
Inha
latio
nA
IX
cF
/LL c
*A
*L g
*L c
LL g
cX
cL c
*
FM
LL g
*L g
c
GE
NE
TIC
TO
XIC
ITY
Gen
em
utat
ion
AI
XA
FF
*A
*L c
L g*
Ac
Ac
Fcg
Fc
Ag
A*
Ac*
Xc
FM
L g*
Fc
Chr
omos
omal
aber
ratio
ns/c
ytot
oxic
ityA
IX
AF
F*
A*
L cL g
*A
cA
cF
cgc
Ag
A*
Xc
FM
L g*
c
92
TY
PE
OF
DA
TA
/INF
OR
MA
TIO
NE
CD
EN
FR
GE
RIT
AN
LU
KA
US
AU
TC
AN
FIN
HU
NN
OR
NZ
SW
EU
S
DN
Aal
tera
tions
/gen
etic
dam
age
AI
XF
/LF
F*
A*
L cL g
*A
cA
cc
Ag
F/L
Xc
FM
L g*
c
AD
DIT
ION
AL
ST
UD
IES
Onc
ogen
icity
AI
L g*
L c*
L cg*
L g*
Fc
Ag
AL c
*
FM
L cg*
c
Long
-ter
mto
xici
ty(≥
six
mon
ths)
AI
Xc
L g*
L c*
A*
L g*
Fc
Ag
L c*
A
FM
L cc
Dev
elop
men
talt
oxic
ityA
IX
cL g
*L c
*L c
g*L g
*F
cA
gL c
*c
FM
L cg*
c
Fer
tility
/rep
rodu
ctio
nA
IX
cL g
*L*
A*
L cg*
L g*
Fc
Ag
L c*
AL*
FM
L cg*
c
Der
mal
pene
trat
ion/
perc
utan
eous
abso
rptio
nA
IL*
L*L
LL g
FM
XA
*L
L*L
Imm
unot
oxic
ityA
IX
F*
A*
L cg*
L*F
FL g
AL c
FM
L cg*
F
Alle
rgen
icity
AI
XL g
*F
*A
*L c
*L*
FA
L gA
c*A
FM
Ag*
L c*
A
Prim
ate
infe
ctiv
ityA
IA
*L*
LA
FM
LA
Cel
lor
tissu
ecu
lture
(viru
ses
only
)A
IX
cA
g*F
c*A
*A
c*L*
FA
Ac*
AL*
FM
L c*
Hyp
erse
nsiti
vity
–la
bora
tory
test
sA
IL
Fc*
L*F
A
FM
Acg
*L
Ac
A
Est
imat
esof
occu
patio
nale
xpos
ure
AI
F*
L*A
cA
FA
FM
XA
g*L
L*A
cA
FF
g
AD
DIT
ION
AL
DA
TA
LIS
TE
DB
YC
OU
NT
RIE
S
Met
abol
icst
udie
s–
abso
rptio
n,di
strib
utio
nan
dex
cret
ion
inm
amm
als
incl
udin
gel
ucid
atio
nof
met
abol
icpa
thw
ays
AI
XX
FM
Neu
roto
xici
tyst
udie
sin
clud
ing
whe
reap
prop
riate
dela
yed
neur
otox
icity
test
ing
inad
ult
hens
AI
XL c
*X
FM
93
TY
PE
OF
DA
TA
/INF
OR
MA
TIO
NE
CD
EN
FR
GE
RIT
AN
LU
KA
US
AU
TC
AN
FIN
HU
NN
OR
NZ
SW
EU
S
Pat
hoge
nici
tyan
din
fect
ivity
unde
rim
mun
osup
pres
sion
AI
XX
X
FM
Tox
icok
inet
ics
tobe
stud
ied
inca
seof
onco
geni
city
,ge
neto
xici
ty,
orre
prot
oxic
effe
cts
caus
edby
toxi
ns
AI
X
FM
ME
DIC
AL
DA
TA
App
licat
orex
posu
reA
IX
cA
LF
AA
cF
Fc
AA
*F
AA
g
FM
FA
Ac
FF
cA
A*
FF
LA
g
Hyp
erse
nsiti
vity
/alle
rgen
icity
inci
dent
sA
IL c
AL
Fc
LA
cF
Fc
AA
*A
AA
gA
FM
Fc
Ac
FF
cA
A*
AF
LA
g
Hea
lthre
cord
sfr
omin
dust
ry,
agric
ultu
reA
IX
cA
LA
cF
Ac
FF
cA
Ac*
LA
Ag
FM
Ac
Ac
FF
cA
Ac*
LA
FL
Ag
Firs
tai
dtr
eatm
ents
AI
L cA
LL
AA
FA
Acg
AA
g
FM
LA
FA
Acg
AA
gA
L
AD
DIT
ION
AL
DA
TA
LIS
TE
DB
YC
OU
NT
RIE
S
Obs
erva
tions
onex
posu
reof
the
gene
ral
popu
latio
nan
dep
idem
iolo
gica
ldat
a,if
appr
opria
te
AI
XF
c
FM
Fc
Dia
gnos
isof
pois
onin
g,sp
ecifi
csi
gns
ofpo
ison
ing,
chem
ical
test
s,if
appr
opria
teA
IX
A
FM
Pro
gnos
isof
expe
cted
effe
cts
ofpo
ison
ing,
ifap
prop
riate
AI
X
FM
Viru
ses:
toxi
cef
fect
son
lives
tock
and
pets
AI
XX
FM
Ope
rato
rpr
otec
tion
AI
LA
c
FM
AA
c
Sum
mar
yan
dev
alua
tion
ofm
amm
alia
nto
xico
logy
and
conc
lusi
ons
AI
XX
FM
TE
ST
ING
OF
MIC
RO
BIA
LT
OX
INS
Do
you
requ
irese
para
teda
ta/in
form
atio
non
mic
robi
alto
xins
?Y
ES
Xc
Xc
XX
cX
XX
cX
cX
XX
c
NO
XX
XX
X
Are
data
requ
irem
ents
sim
ilar
toth
ose
for
conv
entio
nalc
hem
ical
pest
icid
esY
ES
XX
cX
XX
cX
cX
XX
Xc
X
NO
XX
cX
94
MA
TR
IX8.
EC
OT
OX
ICO
LOG
Y
TY
PE
OF
DA
TA
/INF
OR
MA
TIO
NE
CD
EN
FR
GE
RIT
AN
LU
KA
US
AU
TC
AN
FIN
HU
NN
OR
NZ
SW
EU
S
AC
UT
ET
OX
ICIT
Y,
PA
TH
OG
EN
ICIT
Y,
INF
EC
TIV
ITY
Bird
oral
–sp
ecie
s1
AI
XF
cg*
AA
c*A
*F
cg*
Fcg
*F
cF
Ac
Lc
Ac
A*
FM
cg*
L c*
A*
L cg*
AA
/Fc
Ac
Acg
c
Bird
oral
–sp
ecie
s2
AI
L c*
L c*
F*
Fcg
*F
cg*
Fc
FL
cA
*
FM
c*L c
*F
*L c
g*A
A/F
cA
cgc
Wild
mam
mal
AI
L cA
c*L c
FL
cL*
FM
cL*
Ac
L cg
c
Hon
eybe
eA
IX
Fc
AA
*F
cg*
Fcg
Fc
FA
cL
cA
A*
FM
Lc
A*
A*
L cg*
L cg
AF
cA
cF
cgc
Oth
erbe
nefic
iali
nsec
tsA
Ic
FF
*F
cg*
Fcg
*L c
FF
cL
cA
A*
FM
Xc
A*
F*
L cg*
L cg*
AF
cF
cL c
gc
Ear
thw
orm
AI
Xc
FA
*L c
g*F
cg*
Fc
FA
cL
c
FM
Xc
F*
A*
L cg*
AL c
Ac
L cg
c
Oth
erso
ilfa
una
AI
cL*
L cg*
L cF
Lc
FM
Xc
L*A
L cL c
c
Oth
erno
n-ta
rget
orga
nism
sbe
lieve
dto
beat
risk
AI
Xc
L*L c
*L c
FL c
cA
cL*
FM
Xc
L*L*
AA
cL c
L cc
Ext
ent
ofin
dire
ctco
ntam
inat
ion
ofad
jace
ntno
n-ta
rget
crop
s,w
ildpl
ants
,so
ilan
dw
ater
AI
Xc
LF
*L c
*L c
FL c
cA
c
FM
cL c
*A
L cc
Fre
shw
ater
fish
–sp
ecie
s1
AI
Xc
Fc
AL*
A*
Fcg
*F
cg*
Fc
FA
cL
Ac
A
FM
Xc
cF
*A
*L c
g*F
cg*
AA
cA
c
Fre
shw
ater
fish
–sp
ecie
s2
AI
LL*
F*
Fcg
*L c
g*F
cF
LA
FM
cF
*F
*L c
g*L c
g*A
Ac
Fre
shw
ater
inve
rteb
rate
AI
XF
cA
A*
Fcg
*F
cg*
Fc
FA
cL
Ac
A
FM
Xc
A*
A*
L cg*
Fcg
*A
Fc
Ac
Est
uarin
ean
dm
arin
ean
imal
AI
LL
L cg*
L cL
L*
FM
cL c
g*c
Effe
cts
onal
galg
row
thA
IX
L cL
A*
Fcg
*L c
g*L c
FA
cL
Ac
L*
FM
Xc
L*L c
g*A
Fc
Ac
95
TY
PE
OF
DA
TA
/INF
OR
MA
TIO
NE
CD
EN
FR
GE
RIT
AN
LU
KA
US
AU
TC
AN
FIN
HU
NN
OR
NZ
SW
EU
S
AD
DIT
ION
AL
DA
TA
LIS
TE
DB
YC
OU
NT
RIE
SIm
port
ant
para
site
san
dpr
edat
ors
ofta
rget
spec
ies;
acut
eto
xici
tyan
d/or
path
ogen
icity
and
infe
ctiv
ity
AI
XA
Xc
FM
Xc
Fc
Sum
mar
yan
dev
alua
tion
AI
XX
c
FM
XX
c
Non
-tar
get
plan
tsA
IL*
FM
Fc
LON
G-T
ER
MS
TU
DIE
SA
vian
chro
nic
repr
oduc
tion
AI
Xc
cL c
A*
L cg*
LL
cc
cL*
FM
cL
L cg
cc
cA
quat
icin
vert
ebra
tera
nge
test
ing
AI
cA
*F
cg*
Lc
cc
L*
FM
cF
cc
cF
ish
life
cycl
eA
Ic
L*A
*L c
g*L
Lc
cc
L*
FM
cL*
LL c
cc
cA
quat
icec
osys
tem
AI
Xc
cL
cc
cL*
FM
cL*
LL c
cc
cN
on-t
arge
tpl
ants
AI
Xc
LF
*L c
*L
cc
cL*
FM
cL
F*
L cc
cc
Mic
ro-o
rgan
ism
s,in
clud
ing
soil
oraq
uatic
mic
roflo
raA
IX
cc
L cA
*L
LA
cc
c
FM
Xc
cL c
A*
LA
cc
c
AD
DIT
ION
AL
DA
TA
LIS
TE
DB
YC
OU
NT
RIE
SM
ore
exte
nsiv
eaq
uatic
stud
ies
inca
ses
whe
reto
xins
are
prod
uced
AI
XF
MF
ish
chro
nic
toxi
city
AI
L cg*
FM
L cg*
Bee
/ben
efic
ialr
epro
duct
ion,
bee
broo
dte
stA
IL c
g*
FM
L cg*
L cg
Infe
ctiv
ityof
mic
ro-o
rgan
ism
sto
bird
s,fis
h,be
es,
eart
hwor
ms
and
othe
rbe
nefic
ialo
rgan
ism
sA
IA
FM
L
FIE
LDT
ES
TS
-S
IMU
LAT
ED
OR
AC
TU
AL
Ter
rest
rials
peci
esA
IX
cc
Lc
Lc
cL*
FM
cL*
L c*
LL c
cL c
gc
cA
quat
icsp
ecie
sA
IX
cc
Lc
Lc
cL*
FM
cL*
L cg*
LL c
cc
c
96
TY
PE
OF
DA
TA
/INF
OR
MA
TIO
NE
CD
EN
FR
GE
RIT
AN
LU
KA
US
AU
TC
AN
FIN
HU
NN
OR
NZ
SW
EU
S
Pol
linat
ors
AI
Xc
cL
cL
cc
L*
FM
cL
L*L c
gL
cL c
cc
Ben
efic
iali
nsec
tsA
IX
cc
Lc
Lc
cL*
FM
cL
L*L c
g*L
L cc
Lc
c
AD
DIT
ION
AL
DA
TA
LIS
TE
DB
YC
OU
NT
RIE
S
Ear
thw
orm
sA
I
FM
L cg
Fis
hA
I
FM
L cS
ecun
der
toxi
city
test
AI
FM
L cg
TE
ST
ING
OF
MIC
RO
BIA
LT
OX
INS
c
Do
you
requ
irese
para
teda
ta/in
form
atio
non
mic
robi
alto
xins
?Y
ES
Xc
XX
XX
cX
Xc
XX
cX
c
NO
XX
XX
XX
Are
data
requ
irem
ents
sim
ilar
toth
ose
for
conv
entio
nalc
hem
ical
pest
icid
esY
ES
XX
cX
XX
XX
XX
XX
cX
NO
97
MA
TR
IX9.
EN
VIR
ON
ME
NT
AL
FA
TE
TY
PE
OF
DA
TA
/INF
OR
MA
TIO
NE
CD
EN
FR
GE
RIT
AN
LU
KA
US
AU
TC
AN
FIN
HU
NN
OR
NZ
SW
EU
S
LAB
OR
AT
OR
Y/M
ICR
OC
OS
MT
ES
TIN
G
Spr
ead,
mob
ility
,m
ultip
licat
ion
and
pers
iste
nce
inth
een
viro
nmen
tS
oil
AI
Xc
(F) c
LA
*A
c*F
cg*
Ag*
FF
Ac
AA
cc
cL*
FM
Xc
L c*
AL c
Ac
Wat
erA
IX
c(F
) cL
A*
Ac*
Fcg
*A
g*F
FA
cA
Ac
cc
L*
FM
Xc
L c*
AL c
Ac
Air
AI
Xc
(F) c
LA
*A
c*L c
g*A
g*L
FA
cL
Ac
cc
L*
FM
Xc
L c*
AA
c
Ifge
netic
ally
mod
ified
:ge
ne-t
rans
fer
rate
sA
IX
cA
Ac*
FA
Ac
cc
A*
FM
L c
Ifge
netic
ally
mod
ified
:co
mpe
titiv
enes
sre
lativ
eto
dono
rst
rain
s,in
...S
oil
AI
cA
A*
Ac*
cF
AA
cc
cA
*
FM
Wat
erA
Ic
LA
*A
c*c
FA
Ac
cc
A*
FM
Air
AI
cL
A*
Ac*
cF
FL
cc
cA
*
FM
Info
rmat
ion
conc
erni
ngpo
ssib
lefa
tein
food
chai
nsA
IX
cL
L c*
L cg*
Ag
LA
Ac
FM
AD
DIT
ION
AL
DA
TA
LIS
TE
DB
YC
OU
NT
RIE
S
Pur
ecu
lture
test
ing
AI
FM
L c
Con
clud
ing
eval
uatio
nof
the
prod
uct’s
effe
cts
onth
een
viro
nmen
tA
IX
c
FM
Xc
GR
EE
NH
OU
SE
TE
ST
ING
Spr
ead,
mob
ility
,m
ultip
licat
ion
and
pers
iste
nce
inth
een
viro
nmen
tS
oil
AI
Xc
Lc
Ag*
LL
cL
Fc
c
FM
Wat
erA
IX
cL
cA
g*L
Lc
Fc
c
FM
Air
AI
Xc
Lc
Ag*
LL
cL
Fc
c
FM
98
TY
PE
OF
DA
TA
/INF
OR
MA
TIO
NE
CD
EN
FR
GE
RIT
AN
LU
KA
US
AU
TC
AN
FIN
HU
NN
OR
NZ
SW
EU
S
Ifge
netic
ally
mod
ified
:ge
ne-t
rans
fer
rate
sA
IX
cF
Ac
Lc
FM
Ifge
netic
ally
mod
ified
:co
mpe
titiv
enes
sre
lativ
eto
pare
ntal
stra
ins,
in...
Soi
lA
IX
cc
FA
cL
cc
c
FM
Wat
erA
IX
cc
FA
cL
cc
c
FM
Air
AI
Xc
cF
Lc
Lc
cc
FM
Info
rmat
ion
conc
erni
ngpo
ssib
lefa
tein
food
chai
nsA
IA
gL
Lc
Lc
c
FM
FIE
LDT
ES
TIN
G
Spr
ead,
mob
ility
,m
ultip
licat
ion
and
pers
iste
nce
inth
een
viro
nmen
tS
oil
AI
Xc
cL
L g*
LL
LF
cc
L*
FM
LL c
c
Wat
erA
IX
cc
L g*
LL
LF
cc
L*
FM
LL c
c
Air
AI
Xc
cL g
*L
LL
Fc
cL*
FM
Lc
Ifge
netic
ally
mod
ified
:co
mpe
titiv
enes
sre
lativ
eto
pare
ntal
stra
ins
in...
Soi
lA
IX
cc
FA
Lc
cc
L*
FM
Wat
erA
IX
cc
FA
Lc
cc
L*
FM
Air
AI
Xc
cF
LL
cc
cL*
FM
TE
ST
ING
OF
MIC
RO
BIA
LT
OX
INS
Do
you
requ
irese
para
teda
ta/in
form
atio
non
mic
robi
alto
xins
?Y
ES
(X) c
XX
XX
Xc
Xc
XX
c
NO
XX
XX
Are
data
requ
irem
ents
sim
ilar
toth
ose
for
conv
entio
nalc
hem
ical
pest
icid
es?
YE
SX
(X) c
Xc
XX
XX
XX
X
NO
Sum
mar
yan
dev
alua
tion
YE
SX
NO
Annex 4
Summary of Responsesto Part 2 of the Questionnaire
Key to Abbreviations Used
A Always required for registration of plant protection products.
F Frequently required: These data are required in more than 80 per cent ofregistration submissions.
L Less frequently required: These data are required in less than 80 per cent ofregistration submissions.
X Required at an unknown rate: These data are required in an undeterminednumber of cases.
AI Active ingredient
FM Formulation
( ) Numbers in parentheses (below double lines) refer to number of EU Membercountries who listed the corresponding data element.
99
100
SU
MM
AR
YM
AT
RIX
1.ID
EN
TIT
YA
ND
BIO
LOG
ICA
LP
RO
PE
RT
IES
TY
PE
OF
DA
TA
/INF
OR
MA
TIO
NA
ctiv
eIn
gred
ient
For
mul
atio
n
AF
LX
AF
LX
GE
NE
RA
LIN
FO
RM
AT
ION
App
lican
t(n
ame,
addr
ess,
etc.
)5
129
12
Man
ufac
ture
r(n
ame,
addr
ess,
faci
lity
loca
tion)
712
912
AD
DIT
ION
AL
DA
TA
LIS
TE
DB
YC
OU
NT
RIE
S
Way
ofpr
oduc
tion
1(3)
1
Nam
eof
prod
uct
(3)
Pur
pose
ofsu
bmis
sion
11(
1)
Cla
ims
for
use
1(2)
Dra
ftla
bela
nd/o
rus
epa
ttern
12(
1)
For
mul
atin
gpl
ant
(1)
1(1)
Pat
ent
stat
usan
dnu
mbe
r1
1
Sou
rce
ofac
tive
ingr
edie
nt1(
1)2(
1)
IDE
NT
ITY
OF
MIC
RO
-OR
GA
NIS
M(b
oth
natu
rally
occu
rrin
gan
dge
netic
ally
mod
ified
)
Sci
entif
icna
me
812
4
Com
mon
nam
e8
122
1
Syn
onym
s8
122
1
Sub
spec
ies
812
2
Str
ain
812
2
Ser
otyp
e6
11
11
For
gene
tical
lym
odifi
edor
gani
sms
only
:
Info
rmat
ion
onth
edo
nor
orga
nism
(s):
scie
ntifi
cna
me,
subs
peci
es,
stra
in,
etc.
513
2
Info
rmat
ion
onth
ein
sert
edge
netic
mat
eria
l
Des
crip
tion
ofin
sert
edm
ater
ial
413
2
Gen
eco
ntro
lreg
ion(
s)4
132
Sile
ntge
netic
mat
eria
l5
132
Phe
noty
pic
trai
tsga
ined
orlo
st5
132
Info
rmat
ion
onth
eve
ctor
(s)
Iden
tity
513
3
Pro
pert
ies
513
3
101
TY
PE
OF
DA
TA
/INF
OR
MA
TIO
NA
ctiv
eIn
gred
ient
For
mul
atio
n
AF
LX
AF
LX
Info
rmat
ion
onth
eho
stN
ame
513
3
Tax
onom
icpo
sitio
n5
133
Info
rmat
ion
onth
ege
netic
ally
mod
ified
orga
nism
itsel
f
Mod
ifica
tion
tech
niqu
e4
132
Site
ofne
wge
netic
mat
eria
l4
2
AD
DIT
ION
AL
DA
TA
LIS
TE
DB
YC
OU
NT
RIE
S
Col
lect
ion
and
cultu
rere
fere
nce
num
ber
whe
reth
ecu
lture
isde
posi
ted
(1)
112
1
Tes
tpr
oced
ures
and
crite
riafo
rid
entif
icat
ion
(e.g
.m
orph
olog
y,bi
oche
mis
try,
sero
logy
)1(
1)12
1
Wha
tki
ndof
gene
ticm
odifi
catio
nha
sbe
enm
ade?
Has
any
gene
ticm
ater
ialb
een
rem
oved
orad
ded,
etc?
2(1)
1
BIO
LOG
ICA
LP
RO
PE
RT
IES
OF
TH
EM
ICR
O-O
RG
AN
ISM
For
natu
rally
occu
rrin
gor
gani
sms
only
:
His
tory
ofth
eor
gani
sman
dits
uses
712
3
Rel
atio
nshi
psto
know
npl
ant
orm
amm
alia
npa
thog
ens
812
21
Nat
ural
occu
rren
cean
dge
ogra
phic
dist
ribut
ion
ofth
eor
gani
sm8
122
Info
rmat
ion
onbi
olog
ical
prop
ertie
san
dho
stsp
ecifi
city
rang
e8
123
Gen
etic
stab
ility
and
fact
ors
affe
ctin
git
51
112
21
Gen
eral
info
rmat
ion
onsu
rviv
abili
ty,
phys
ical
stab
ility
61
124
1
AD
DIT
ION
AL
DA
TA
LIS
TE
DB
YC
OU
NT
RIE
S
Effe
cts
onno
n-ta
rget
spec
ies
1(1)
121
Pre
senc
e,ab
senc
eor
prod
uctio
nof
toxi
ns(n
atur
e,id
entit
y,ch
emic
alst
ruct
ure
(ifap
prop
riate
)an
dst
abili
ty)
2(2)
12
Iden
tific
atio
nte
stfo
rm
icro
-org
anis
m(2
)
Sel
ectio
nan
dm
utat
ion;
stat
eif
the
activ
eor
gani
smw
asse
lect
edor
was
mut
ated
1
Met
hods
topr
even
tth
eac
tive
orga
nism
from
losi
ngits
abili
tyto
elim
inat
eth
eta
rget
orga
nism
1
Des
crip
tion
ofth
elif
ecy
cle
ofth
eac
tive
orga
nism
1(1)
Com
petit
ors
and
natu
rale
nem
ies
ofth
eac
tive
orga
nism
1
Ext
ent
tow
hich
vect
oror
mod
ified
gene
sm
aybe
tran
sfer
red
amon
gor
inco
rpor
ated
byot
her
orga
nism
s1
For
gene
tical
lym
odifi
edor
gani
sms
only
:
His
tory
and
uses
ofth
edo
nor
orga
nism
(s)
413
1
Rel
atio
nshi
pof
the
dono
ror
gani
sm(s
)to
any
plan
tpa
thog
ens
orto
path
ogen
sof
vert
ebra
esp
ecie
s4
131
102
TY
PE
OF
DA
TA
/INF
OR
MA
TIO
NA
ctiv
eIn
gred
ient
For
mul
atio
n
AF
LX
AF
LX
Nat
ural
occu
rren
cean
dge
ogra
phic
dist
ribut
ion
ofth
edo
nor
orga
nism
(s)
413
1
Pro
pert
ies
ofdo
nor
orga
nism
(s)
Pat
hoge
nici
ty4
131
Infe
ctiv
ity3
131
Tox
icity
,in
clud
ing
alle
rgen
icity
313
2
Info
rmat
ion
onbi
olog
ical
prop
ertie
san
dho
stsp
ecifi
city
rang
eof
the
dono
ror
gani
sm(s
)4
131
Gen
etic
stab
ility
ofth
edo
nor
orga
nism
(s)
and
fact
ors
affe
ctin
git
313
1
Gen
eral
info
rmat
ion
ofsu
rviv
abili
tyof
the
dono
ror
gani
sm(s
),ph
ysic
alst
abili
ty2
113
2
AD
DIT
ION
AL
DA
TA
LIS
TE
DB
YC
OU
NT
RIE
S
Pot
entia
lof
mod
ified
orga
nism
totr
ansf
erge
netic
mat
eria
lto
othe
ror
gani
sms
2(1)
(1)?
Rel
ativ
een
viro
nmen
talc
ompe
titiv
enes
sof
mod
ified
orga
nism
s2
(1)
PU
RIT
Y
Mic
robi
olog
ical
purit
y8
128
Iden
tity
ofan
yun
inte
nded
toxi
cby
-pro
duct
s,al
lerg
ens,
orim
purit
ies
prod
uced
byth
em
icro
-org
anis
mor
inth
ein
cuba
tion
proc
ess;
info
rmat
ion
onth
ena
ture
and
prop
ertie
sof
such
impu
ritie
s
812
7
IDE
NT
ITY
OF
FO
RM
ULA
TIO
N
Tra
dena
me
and
man
ufac
ture
r’sde
velo
pmen
tco
denu
mbe
r2
912
Com
posi
tion
ofth
epr
oduc
t:id
entit
yan
dco
ncen
trat
ion
ofac
tive
orga
nism
(s),
iner
tco
mpo
nent
s,ex
tran
eous
orga
nism
s,et
c.2
912
Iden
tity
ofto
xic
by-p
rodu
cts,
alle
rgen
s,or
othe
rim
purit
ies
prod
uced
byth
em
icro
-or
gani
smor
inth
ein
cuba
tion
orm
anuf
actu
ring
proc
ess;
info
rmat
ion
onth
ena
ture
and
prop
ertie
sof
such
impu
ritie
s
39
12
Nat
ure
ofth
epr
oduc
t(e
.g.
emul
sifia
ble
conc
entr
ate,
wet
tabl
epo
wde
r,et
c.)
912
AD
DIT
ION
AL
DA
TA
LIS
TE
DB
YC
OU
NT
RIE
S
Spe
cific
grav
ity/d
ensi
ty1(
1)
Rhe
olog
ical
prop
ertie
s(s
uspe
ndab
ility
,w
etta
bilit
y,et
c.)
1(1)
Iden
tity
and
purp
ose
ofno
n-ac
tive
ingr
edie
nts
1(1)
Rel
evan
tph
ase
ofde
velo
pmen
tof
activ
eor
gani
smw
hen
the
prod
uct
isso
ld(e
.g.
spor
es)
1
103
SU
MM
AR
YM
AT
RIX
2.F
UN
CT
ION
,M
OD
EO
FA
CT
ION
AN
DH
AN
DLI
NG
TY
PE
OF
DA
TA
/INF
OR
MA
TIO
NA
ctiv
eIn
gred
ient
For
mul
atio
n
AF
LX
AF
LX
Fun
ctio
n(e
.g.
fung
icid
e,he
rbic
ide,
inse
ctic
ide,
repe
llant
,gr
owth
regu
lato
r,an
ti-vi
rala
gent
)6
128
12
Mod
eof
actio
nto
targ
etpe
st,
infe
ctiv
edo
se,
tran
smis
sibi
lity
612
6
Fie
ldof
use
(e.g
.fie
ld,
glas
shou
se,
food
crop
)3
129
12
Det
ails
ofin
tend
edus
e,e.
g.ta
rget
orga
nism
and
plan
tsor
plan
tpr
oduc
tsto
bepr
otec
ted
312
912
App
licat
ion
rate
49
12
Con
ditio
nsun
der
whi
chth
esu
bsta
nce
may
not
beus
ed(a
gric
ultu
ral,
plan
the
alth
oren
viro
nmen
tal)
212
812
Met
hod
ofap
plic
atio
n3
912
Num
ber
and
timin
gof
appl
icat
ions
39
12
Pro
pose
din
stru
ctio
nsfo
rus
e3
912
Re-
entr
yin
terv
als
25
11
12
Pre
-har
vest
inte
rval
s(w
aitin
gpe
riod
betw
een
last
trea
tmen
tan
dha
rves
tor
cons
umpt
ion)
37
112
Typ
eof
pack
agin
g3
912
Pro
cedu
res
for
clea
ning
appl
icat
ion
equi
pmen
t1
51
112
Pro
cedu
res
for
dest
ruct
ion
orde
cont
amin
atio
nof
the
prod
uct
and
itspa
ckag
ing
11
62
12
Rec
omm
ende
dm
etho
dsan
dpr
ecau
tions
conc
erni
ngha
ndlin
g,st
orag
e,tr
ansp
ort
orfir
e2
127
112
Em
erge
ncy
mea
sure
sin
case
ofan
acci
dent
27
112
Met
hods
topr
even
tlo
ssof
viab
ility
ofse
edst
ock
31
125
1
AD
DIT
ION
AL
DA
TA
LIS
TE
DB
YC
OU
NT
RIE
S
Pos
sibi
lity
ofre
nder
ing
the
orga
nism
sno
n-in
fect
ive
orno
n-in
fect
ed(1
)12
Met
hods
topr
even
tlo
ssof
viru
lenc
e(1
)
Sel
ectiv
ityof
actio
n(1
)
End
-use
prod
uct:
stab
ility
,m
aint
enan
ceof
purit
yan
dpo
tenc
y1(
1)
With
hold
ing
orst
orag
epe
riods
inth
eca
seof
post
-har
vest
use
(cou
ldsu
bstit
ute
for
pre-
harv
est
inte
rval
s)12
104
SU
MM
AR
YM
AT
RIX
3.P
HY
SIC
AL-
CH
EM
ICA
LP
RO
PE
RT
IES
TY
PE
OF
DA
TA
/INF
OR
MA
TIO
NA
ctiv
eIn
gred
ient
sF
orm
ulat
ion
AF
LX
AF
LX
App
eara
nce
56
112
Phy
sica
lsta
te6
71
12
Den
sity
41
61
2
pH2
11
53
Sta
bilit
yw
hen
used
acco
rdin
gto
prop
osed
met
hod
(e.g
.ef
fect
sof
sunl
ight
,w
ater
,ch
ange
sin
pHan
dte
mpe
ratu
re)
41
124
2
Sto
rage
stab
ility
51
912
Sus
pend
abili
tyan
dsu
spen
sion
stab
ility
14
12
Siz
edi
strib
utio
nof
the
orga
nism
11
12
2
Con
tent
ofac
tive
ingr
edie
ntin
oron
bait
part
icle
s,gr
anul
esor
trea
ted
seed
36
2
Flo
wab
ility
,po
urab
ility
,du
stab
ility
11
51
2
AD
DIT
ION
AL
DA
TA
LIS
TE
DB
YC
OU
NT
RIE
S
Met
hods
for
esta
blis
hing
stor
age
and
shel
f-lif
est
abili
ty12
Tec
hnic
alch
arac
teris
tics
ofth
epr
epar
atio
n12
Phy
sica
land
chem
ical
com
patib
ility
with
othe
rpr
oduc
tsin
clud
ing
plan
tpr
otec
tion
prod
ucts
who
seus
eis
tobe
auth
oris
ed12
Wet
ting,
adhe
renc
ean
ddi
strib
utio
nto
targ
etpl
ants
12
Com
patib
ility
with
othe
rpr
oduc
ts(2
)
Sam
ple
for
anal
ysis
(1)
(2)
Mis
cibi
lity
12
Odo
ur1
1
Cor
rosi
vech
arac
ter
12
Col
our
1
For
mat
ion
ofae
roso
ls1
Vis
cosi
ty1(
1)
105
SU
MM
AR
YM
AT
RIX
4.M
AN
UF
AC
TU
RIN
G,
QU
ALI
TY
CO
NT
RO
LA
ND
AN
ALY
TIC
AL
ME
TH
OD
S
TY
PE
OF
DA
TA
/INF
OR
MA
TIO
NA
ctiv
eIn
gred
ient
For
mul
atio
n
AF
LX
AF
LX
Met
hod
ofpr
oduc
tion:
desc
riptio
nof
tech
niqu
esus
edto
ensu
rea
unifo
rmpr
oduc
tan
das
say
met
hods
for
stan
dard
izat
ion
812
81
12
Met
hods
toes
tabl
ish
the
iden
tity
and
purit
yof
seed
stoc
kfr
omw
hich
batc
hes
are
prod
uced
and
resu
ltsob
tain
ed,
incl
udin
gin
form
atio
non
varia
bilit
y
71
126
2
Met
hods
tosh
owm
icro
biol
ogic
alpu
rity,
incl
udin
gva
riabi
lity
and
leve
lsof
cont
amin
ants
71
129
12
Met
hods
tosh
owth
ere
are
nokn
own
hum
anor
othe
rm
amm
alia
npa
thog
ens
asco
ntam
inan
ts7
127
112
Met
hods
tode
tect
and
quan
tify
resi
dues
inor
ontr
eate
dpl
ants
,pr
oduc
ts,
food
,fe
ed,
anim
alan
dhu
man
body
fluid
san
dtis
sues
,so
il,w
ater
and
air
Via
ble
resi
dues
41
124
212
Non
-via
ble
resi
dues
41
124
212
Mic
robi
alto
xins
41
124
11
12
Met
hods
tode
tect
the
orga
nism
inth
een
viro
nmen
t3
13
11
Met
hods
for
dete
rmin
ing
the
com
posi
tion
ofth
efo
rmul
atio
n4
12
12
For
gene
tical
lym
odifi
edor
gani
sms:
met
hods
tode
tect
the
inse
rted
gene
ticm
ater
ial
21
122
1
106
SU
MM
AR
YM
AT
RIX
5.R
ES
IDU
ES
TY
PE
OF
DA
TA
/INF
OR
MA
TIO
NM
icro
-org
anis
mM
icro
bial
Tox
in
AF
LX
AF
LX
GE
NE
RA
L
Like
lihoo
dof
mul
tiplic
atio
nor
pers
iste
nce
ofth
eac
tive
subs
tanc
ein
/on
crop
sor
food
72
127
2
NA
TU
RE
OF
TH
EM
AT
ER
IAL.
..
In/o
ntr
eate
dpl
ants
orpr
oduc
ts6
21
126
21
12
Inliv
esto
ck,
ifre
sidu
esre
mai
non
crop
used
for
feed
52
26
21
PR
ES
EN
CE
&M
AG
NIT
UD
EO
FT
HE
MA
TE
RIA
LIN
...
Foo
dcr
ops
62
16
21
Mea
t,da
irypr
oduc
ts,
poul
try,
eggs
42
35
214
Pro
cess
edfo
od/fe
ed2
33
33
2
Pot
able
wat
er2
32
23
2
Fis
h1
32
23
1
AD
DIT
ION
AL
DA
TA
LIS
TE
DB
YC
OU
NT
RIE
S
Bird
san
dra
ts1
1
OT
HE
RR
EQ
UIR
EM
EN
TS
Effe
cts
ofpr
oces
sing
orco
okin
gon
resi
dues
25
31
3
Pro
pose
dm
axim
umre
sidu
ele
vels
43
15
31
12
Sum
mar
yan
dev
alua
tion
ofre
sidu
ebe
havi
our
53
112
53
112
AD
DIT
ION
AL
DA
TA
LIS
TE
DB
YC
OU
NT
RIE
S
Effe
cts
onco
lour
,sm
ell,
tast
ean
dot
her
qual
ityas
pect
s1
112
Res
idue
data
insu
ccee
ding
orro
tatio
nalc
rops
11
12
Res
idue
sin
anim
als
that
com
ein
cont
act
with
trea
ted
crop
mat
eria
l1
1
Fre
ezer
stab
ility
(sto
rage
befo
rean
alys
is)
11
Met
abol
ism
11
107
SU
MM
AR
YM
AT
RIX
6.E
FF
ICA
CY
TY
PE
OF
DA
TA
/INF
OR
MA
TIO
NA
ctiv
eIn
gred
ient
For
mul
atio
n
AF
LX
AF
LX
Pre
limin
ary
rang
e-fin
ding
test
s1
52
212
Fie
ldte
sts
912
Dos
e/ef
ficac
yre
latio
nshi
ps1
72
Use
inin
tegr
ated
pest
man
agem
ent
syst
ems
44
Info
rmat
ion
onth
epo
ssib
lede
velo
pmen
tof
resi
stan
cean
dap
prop
riate
man
agem
ent
stra
tegi
es1
41
212
Effe
cts
onqu
ality
and
yiel
dof
trea
ted
plan
ts6
21
12
Effe
cts
onqu
ality
oftr
eate
dpl
ant
prod
ucts
72
12
Phy
toto
xici
tyto
targ
etpl
ants
18
12
Phy
toto
xici
tyto
rota
tiona
lcro
ps1
15
21
Obs
erva
tions
ofun
desi
rabl
eor
unin
tend
edsi
deef
fect
s1
81
12
AD
DIT
ION
AL
DA
TA
LIS
TE
DB
YC
OU
NT
RIE
S
Sum
mar
yan
dev
alua
tion
12
Met
hods
,tim
ing
and
equi
pmen
tfo
rap
plic
atio
n1
Val
ueas
sess
men
t1
Sta
teel
emen
tsw
hich
coul
daf
fect
effic
acy,
such
asot
her
pest
icid
es,
resi
stan
cefo
rmat
ion,
and
clim
ate
cond
ition
s1
Phy
topa
thog
enic
ity12
108
SU
MM
AR
YM
AT
RIX
7.T
OX
ICO
LOG
Y,
PA
TH
OG
EN
ICIT
YA
ND
INF
EC
TIV
ITY
TY
PE
OF
DA
TA
/INF
OR
MA
TIO
NA
ctiv
eIn
gred
ient
For
mul
atio
n
AF
LX
AF
LX
AC
UT
ET
OX
ICIT
YT
ES
TIN
G
Ora
l8
128
12
Der
mal
612
92
12
Inha
latio
n7
112
712
Eye
irrita
tion
51
1212
912
Ski
nirr
itatio
n5
112
812
Ski
nse
nsiti
zatio
n4
112
912
Intr
aper
itone
alor
intr
aven
ous
41
112
21
AD
DIT
ION
AL
DA
TA
LIS
TE
DB
YC
OU
NT
RIE
S
Ran
gefin
ding
test
for
case
sw
here
asi
ngle
dose
isno
tap
prop
riate
toas
sess
path
ogen
icity
(1)
12
Ava
ilabl
eto
xico
logi
cald
ata
rela
ting
tono
n-ac
tive
subs
tanc
es1
(1)
13
Intr
acer
ebra
ltes
tsfo
rne
urot
ropi
cag
ents
1
Sta
tean
yad
ditio
nals
tudi
espe
rfor
med
(1)
11
Tis
sue
cultu
re;
appl
ies
mai
nly
tovi
rus
(1)
11
Sum
mar
y1
1
RE
PE
AT
ED
DO
SE
TO
XIC
ITY
,P
AT
HO
GE
NIC
ITY
AN
DIN
FE
CT
IVIT
Y(s
tudi
esle
ssth
an1
mon
th)
Ora
l1
3
Der
mal
12
Inha
latio
n1
2
Intr
aper
itone
al1
Intr
aven
ous
11
AD
DIT
ION
AL
DA
TA
LIS
TE
DB
YC
OU
NT
RIE
S
Pat
hoge
nici
ty2(
1)(1
)1
1(2
)
Infe
ctiv
ity2(
2)1(
2)1
1(2
)
SU
BC
HR
ON
ICT
OX
ICIT
Y(s
tudi
eslo
nger
than
1m
onth
)
Ora
l2
15
131
1
Der
mal
14
131
1
Inha
latio
n4
131
109
TY
PE
OF
DA
TA
/INF
OR
MA
TIO
NA
ctiv
eIn
gred
ient
For
mul
atio
n
AF
LX
AF
LX
GE
NE
TIC
TO
XIC
ITY
Gen
em
utat
ion
52
131
Chr
omos
omal
aber
ratio
ns/c
ytot
oxic
ity4
113
DN
Aal
tera
tions
/gen
etic
dam
age
31
113
AD
DIT
ION
AL
ST
UD
IES
Onc
ogen
icity
21
1
Long
-ter
mto
xici
ty(≥
six
mon
ths)
21
112
Dev
elop
men
talt
oxic
ity1
11
12
Fer
tility
/rep
rodu
ctio
n2
12
12
Der
mal
pene
trat
ion/
perc
utan
eous
abso
rptio
n3
121
12
Imm
unot
oxic
ity1
22
121
Alle
rgen
icity
31
112
1
Prim
ate
infe
ctiv
ity1
13
1
Cel
lor
tissu
ecu
lture
(viru
ses
only
)3
11
12
Hyp
erse
nsiti
vity
–la
bora
tory
test
s1
12
Est
imat
esof
occu
patio
nale
xpos
ure
31
22
12
AD
DIT
ION
AL
DA
TA
LIS
TE
DB
YC
OU
NT
RIE
S
Met
abol
icst
udie
s–
abso
rptio
n,di
strib
utio
nan
dex
cret
ion
inm
amm
als
incl
udin
gel
ucid
atio
nof
met
abol
icpa
thw
ays
12(1
)
Neu
roto
xici
tyst
udie
sin
clud
ing
whe
reap
prop
riate
dela
yed
neur
otox
icity
test
ing
inad
ult
hens
(1)
13
Pat
hoge
nici
tyan
din
fect
ivity
unde
rim
mun
osup
pres
sion
13(1
)
Tox
icok
inet
ics
tobe
stud
ied
inca
seof
onco
geni
city
,ge
noto
xici
ty,
orre
prod
uctiv
eef
fect
sca
used
byto
xins
1
ME
DIC
AL
DA
TA
App
licat
orex
posu
re4
212
33
1
Hyp
erse
nsiti
vity
/alle
rgen
icity
inci
dent
s6
112
42
1
Hea
lthre
cord
sfr
omin
dust
ry,
agric
ultu
re4
11
124
22
Firs
tai
dtr
eatm
ents
412
51
110
TY
PE
OF
DA
TA
/INF
OR
MA
TIO
NA
ctiv
eIn
gred
ient
For
mul
atio
n
AF
LX
AF
LX
AD
DIT
ION
AL
DA
TA
LIS
TE
DB
YC
OU
NT
RIE
S
Obs
erva
tions
onex
posu
reof
the
gene
ralp
opul
atio
nan
dep
idem
iolo
gica
ldat
a,if
appr
opria
te1
121
Dia
gnos
isof
pois
onin
g,sp
ecifi
csi
gns
ofpo
ison
ing,
chem
ical
test
s,if
appr
opria
te(1
)12
Pro
gnos
isof
expe
cted
effe
cts
ofpo
ison
ing,
ifap
prop
riate
12
Viru
ses:
toxi
cef
fect
son
lives
tock
and
pets
12(1
)
Ope
rato
rpr
otec
tion
1(1
)1(
1)
Sum
mar
yan
dev
alua
tion
ofm
amm
alia
nto
xico
logy
and
conc
lusi
ons
13
TE
ST
ING
OF
MIC
RO
BIA
LT
OX
INS
YE
SN
O
Do
you
requ
irese
para
teda
ta/in
form
atio
non
mic
robi
alto
xins
?7
14
Are
data
requ
irem
ents
sim
ilar
for
conv
entio
nalc
hem
ical
pest
icid
es?
182
111
SU
MM
AR
YM
AT
RIX
8.E
CO
TO
XIC
OLO
GY
TY
PE
OF
DA
TA
/INF
OR
MA
TIO
NA
ctiv
eIn
gred
ient
For
mul
atio
n
AF
LX
AF
LX
AC
UT
ET
OX
ICIT
Y,
PA
TH
OG
EN
ICIT
Y,
INF
EC
TIV
ITY
Bird
oral
–sp
ecie
s1
32
112
31
Bird
oral
–sp
ecie
s2
12
12
1
Wild
mam
mal
13
11
Hon
eybe
e3
21
122
212
Oth
erbe
nefic
iali
nsec
ts2
22
12
112
Ear
thw
orm
12
112
22
12
Oth
erso
ilfa
una
12
12
12
Oth
erno
n-ta
rget
orga
nism
sbe
lieve
dto
beat
risk
11
312
22
12
Ext
ent
ofin
dire
ctco
ntam
inat
ion
ofad
jace
ntno
n-ta
rget
crop
s,w
ildpl
ants
,so
ilan
dw
ater
11
212
11
Fre
shw
ater
fish
–sp
ecie
s1
32
112
312
Fre
shw
ater
fish
–sp
ecie
s2
12
12
Fre
shw
ater
inve
rteb
rate
32
112
21
12
Est
uarin
ean
dm
arin
ean
imal
3
Effe
cts
onal
galg
row
th2
13
122
112
AD
DIT
ION
AL
DA
TA
LIS
TE
DB
YC
OU
NT
RIE
S
Impo
rtan
tpa
rasi
tes
and
pred
ator
sof
targ
etsp
ecie
s;ac
ute
toxi
city
and/
orpa
thog
enic
ityan
din
fect
ivity
(1)
12(1
)1
(1)
Sum
mar
yan
dev
alua
tion
12(1
)12
(1)
Non
-tar
get
plan
ts1
1
LON
G-T
ER
MS
TU
DIE
S
Avi
anch
roni
cre
prod
uctio
n3
122
Aqu
atic
inve
rteb
rate
rang
ete
stin
g2
1
Fis
hlif
ecy
cle
32
Aqu
atic
ecos
yste
m2
122
Non
-tar
get
plan
ts2
121
Mic
ro-o
rgan
ism
s,in
clud
ing
soil
oraq
uatic
mic
roflo
ra1
212
11
12
112
TY
PE
OF
DA
TA
/INF
OR
MA
TIO
NA
ctiv
eIn
gred
ient
For
mul
atio
n
AF
LX
AF
LX
AD
DIT
ION
AL
DA
TA
LIS
TE
DB
YC
OU
NT
RIE
S
Mor
eex
tens
ive
aqua
ticst
udie
sin
case
sw
here
toxi
nsar
epr
oduc
ed12
Fis
hch
roni
cto
xici
ty(1
)(1
)
Bee
/ben
efic
ialr
epro
duct
ion,
bee
broo
dte
st(1
)1(
1)
Infe
ctiv
ityof
mic
ro-o
rgan
ism
sto
bird
s,fis
h,be
es,
eart
hwor
ms
and
othe
rbe
nefic
ial
orga
nism
s(1
)(1
)
FIE
LDT
ES
TS
–S
IMU
LAT
ED
OR
AC
TU
AL
Ter
rest
rials
peci
es3
123
Aqu
atic
spec
ies
312
2
Pol
linat
ors
312
2
Ben
efic
iali
nsec
ts3
123
AD
DIT
ION
AL
DA
TA
LIS
TE
DB
YC
OU
NT
RIE
S
Ear
thw
orm
s(1
)
Fis
h1
Sec
unde
rto
xici
tyte
st1
TE
ST
ING
OF
MIC
RO
BIA
LT
OX
INS
YE
SN
O
Do
you
requ
irese
para
teda
ta/in
form
atio
non
mic
robi
alto
xins
?6
15
Are
data
requ
irem
ents
sim
ilar
toth
ose
for
conv
entio
nalc
hem
ical
pest
icid
es?
18
113
SU
MM
AR
YM
AT
RIX
9.E
NV
IRO
NM
EN
TA
LF
AT
E
TY
PE
OF
DA
TA
/INF
OR
MA
TIO
NA
ctiv
eIn
gred
ient
For
mul
atio
n
AF
LX
AF
LX
LAB
OR
AT
OR
Y/M
ICR
OC
OS
MT
ES
TIN
G
Spr
ead,
mob
ility
,m
ultip
licat
ion
and
pers
ista
nce
inth
een
viro
nmen
tS
oil
32
112
21
12
Wat
er3
21
122
112
Air
21
312
212
Ifge
netic
ally
mod
ified
:ge
ne-t
rans
fer
rate
s3
112
1
Ifge
netic
ally
mod
ified
:co
mpe
titiv
enes
sre
lativ
eto
pare
ntal
stra
ins,
in...
Soi
l3
1
Wat
er3
1
Air
12
1
Info
rmat
ion
conc
erni
ngpo
ssib
lefa
tein
food
chai
ns2
112
AD
DIT
ION
AL
DA
TA
LIS
TE
DB
YC
OU
NT
RIE
S
Pur
ecu
lture
test
ing
1
Con
clud
ing
eval
uatio
nof
the
prod
uct’s
effe
cts
onth
een
viro
nmen
t1
1
GR
EE
NH
OU
SE
TE
ST
ING
Spr
ead,
mob
ility
,m
ultip
licat
ion
and
pers
iste
nce
inth
een
viro
nmen
tS
oil
13
121
Wat
er1
212
1
Air
13
12
Ifge
netic
ally
mod
ified
:ge
ne-t
rans
fer
rate
s1
11
12
Ifge
netic
ally
mod
ified
:co
mpe
titiv
enes
sre
lativ
eto
pare
ntal
stra
ins,
in...
Soi
l1
11
12
Wat
er1
11
12
Air
12
12
Info
rmat
ion
conc
erni
ngpo
ssib
lefa
tein
food
chai
ns3
FIE
LDT
ES
TIN
G
Spr
ead,
mob
ility
,m
ultip
licat
ion
and
pers
iste
nce
inth
een
viro
nmen
tS
oil
14
121
Wat
er1
412
1
Air
14
12
Ifge
netic
ally
mod
ified
:co
mpe
titiv
enes
sre
lativ
eto
pare
ntal
stra
ins
in...
Soi
l1
12
12
Wat
er1
12
12
Air
13
12
114
TY
PE
OF
DA
TA
/INF
OR
MA
TIO
NA
ctiv
eIn
gred
ient
For
mul
atio
n
AF
LX
AF
LX
TE
ST
ING
OF
MIC
RO
BIA
LT
OX
INS
YE
SN
O
Do
you
requ
irese
para
teda
ta/in
form
atio
non
mic
robi
alto
xins
?4
3
Are
data
requ
irem
ents
sim
ilar
toth
ose
for
conv
entio
nalc
hem
ical
pest
icid
es?
16
Sum
mar
yan
dev
alua
tion
12
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No. 14, Final Report of the Expert Group on Model Forms of Agreement for the Exchange ofConfidential Data on Chemicals (1988)F
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Users Guide to Hazardous Substance Data Banks Available in OECD Member Countries,OCDE/GD(91)102 (1991)F
[Also translated into Spanish by the United Nations Environment Programme’s Industry andEnvironment Office (UNEP IE).]
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No. 70, Occupational and Consumer Exposure Assessments (1993)
118
No. 73, The Application of the GLP Principles to Short-term Studies (1993)F, GLP
No. 74, The Role and Responsibilities of the Study Director in GLP Studies (1993)F, GLP
No. 76, OECD Series on the Test Guidelines Programme No. 1: Guidance Document for theDevelopment of OECD Guidelines for Testing of Chemicals (1993; reformatted 1995)F
No. 77, Data Requirements for Pesticide Registration in OECD Member Countries: SurveyResults (1993)
No. 81, Health Aspects of Chemical Accidents: Guidance on Chemical Accident Awareness,Preparedness and Response for Health Professionals and Emergency Responders (1994)F
[Four international organisations collaborated in the preparation of this publication: theInternational Programme on Chemical Safety (IPCS), OECD, UNEP IE, and the World HealthOrganization – European Centre for Environment and Health (WHO-ECEH).]
No. 88, US EPA/EC Joint Project on the Evaluation of (Quantitative) Structure ActivityRelationships (1994)
No. 90: Ottawa ’92: The OECD Workshop on Methods for Monitoring Organisms in theEnvironment (1994)*
No. 91: Compendium of Methods for Monitoring Organisms in the Environment (1994)*
[*Monographs No. 90 and 91 are companion documents.]
No. 92, Guidance Document for Aquatic Effects Assessment (1995)
No. 93, Report of the OECD Workshop on Chemical Safety in Port Areas (1994)
[This Workshop was co-sponsored by OECD, the International Maritime Organization (IMO)and UNEP.]
No. 94, Report of the OECD Special Session on Chemical Accident Prevention, Preparednessand Response at Transport Interfaces (1995)
No. 95, Report of the OECD Workshop on Small and Medium-sized Enterprises in Relationto Chemical Accident Prevention, Preparedness and Response (1995)
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No. 98, OECD Series on the Test Guidelines Programme No. 2: Detailed Review Paper onBiodegradability Testing (1995)
No. 99, Commercialisation of Agricultural Products Derived through Modern Biotechnology:Survey Results (1995)
No. 100, Analysis of Information Elements Used in the Assessment of Certain Products ofModern Biotechnology (1995)
No. 101, Risk Reduction Monograph No. 2: Methylene Chloride (1994)
No. 102, Risk Reduction Monograph No. 3: Selected Brominated Flame Retardants (1994)
No. 103, Risk Reduction Monograph No. 4: Mercury (1994)
No. 104, Risk Reduction Monograph No. 5: Cadmium (1994)
No. 105, Report of the OECD Workshop on Environmental Hazard/Risk Assessment (1995)
No. 106, Data Requirements for Biological Pesticides (1996)
No. 107, Report of the OECD Workshop on the Commercialisation of Agricultural ProductsDerived through Modern Biotechnology (1995)
No. 108, Final Report on the OECD Pilot Project to Compare Pesticide Data Reviews (1995)
No. 110, Revised Guides for Compliance Monitoring Procedures for Good Laboratory Practice(1995)F, GLP
No. 111, Revised Guidance for the Conduct of Laboratory Inspections and Study Audits(1995)F, GLP
No. 115, Guidance for the Preparation of GLP Inspection Reports (1995)F, GLP
No. 116, The Application of the Principles of GLP to Computerised Systems (1995)F, GLP
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No. 117, Industrial Products of Modern Biotechnology Intended for Release to theEnvironment: The Proceedings of the Fribourg Workshop (1996)
Priced Publications:
OECD Guidelines for Testing of Chemicals (updated 1995)F
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Safety Evaluation of Foods Derived by Modern Biotechnology: Concepts and Principles(1993)F
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Environmental Impacts of Aquatic Biotechnology (December 1995)(OECD No. 97 95 14 1) ISBN 92-64-14666-0 171 pagesPrice in France: FF 170Price in other countries: contact the OECD Publications Service
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