Regulations on Registration of Plant Protection Products in the Republic of Latvia

ANNEI RecuJations on Recistration of Plant Protection Products in Republic of Latvia 5-th January. 1995 The Reclster of Plant Protection Products in Republic of Latvia Part PREPARATIONS j IReCistration . Prepara- The sub- The Trade naae The Crop Haraful The Appli- Pre tion is .itter aanufa- of prepara- recls- orcanisa dose cation harvest HI' Date reciste- of the cturer tion. type. tration rate frequ- Inter red till ppplica- fira. active sub- class ensy val tion on State. stance kc. per I (year) recistr- address l/ha season (days)at-ion kC. I (Naae, lit I address) I I 1 I 1 2 3 4 5 6 7 8 9 10 11 12 , G\ The Register of Plant Protection Products in Republic of Latvia Part II BIOLOGICAL PREPARATIONS Recistration The submit- The Trade Taxonomic Crop Harmful The Appli- Pre teI' of the manufac- name name. stl'ain orcanis. dose cation harvest Nr Date application turer of fol' bactel'ia rate frequ- inter on I'ecist- fira. prepa- protozoa and ency va1 ration State. ration funci; for kc. per address vil'uses tax- Ilha season (days) (Name. onoaic desi- kC. address) gnation of lIt the acent. serotype 1 2 3 4 5 6 7 8 9 10 11 ~ The Reeister of Plant Protection Products in Rep,ubllc of Latvia Part III ACTIVE SUBSTANCES r-r-r Registration The subait- The Co.mon Chemical name Empiri- Hole- Hanu- CAS Sphe- The active tel" of the manufac- nalle pro- cal cular factu and re of substance HI" Date application'turer posed or (IUPAC nomen- formula mass rer"s EFC appli reclstered on reclstr- fir. ISO - ac- clature) code catl- In Europe ation (name, cepted. Nr on (Name. address) and Nr (State. addresg) synonyms year) 1 2 3 4 5 6 7 8 9 10 11 12 ~ ANNEX II Regulation on Registration of Plant Protection Products In Republic of Latvia •• 199 • REQUIREMENTS FOR THE DOSSIER TO BE SUBMITTED FOR THE AUTHORIZATION OF PLANT PROTECTION PRODUCTS PART Chemical substances Active Ingredients 1. 1.1 r. 2. i , 3. 1. 4. 1. 5. 1. 6. 1. 7. 1. 6. 1. 9. 1.10. 2. 2.1. 2.2. 2.3. 2.4. 2.5 2.6. Identity of the active substance Applicant (name. address. etc.) Manufacturer (name. address. including location of plant) Common name proposed or ISO-accepted. and synonyms Chemical name (IUPAC nomenclature) Manufacturer's development code number(s) CAS and EEC numbers (If available) Empirical and structural formula~ molecular mass Method of manufacture (synthesis pathway) of the active substance SpecificatIon of purIty of the actIve substance In c/kg or gIl as appropriate Identity of isomers. Impurities and additIves (e.g. stabilizers). together with the structural formula and the possible range expressed as g/kg or gIl as approprIate Physical and chemical properties of the active substance Melting point. boilinc point. relative density (I) Vapour pressure (in Pal at 20 D C. volatility (e.g. Henry's law constant) (I) Apperance (physical state. colour and odour; If appropriate. thres·hold concentratIons for substances wIth intense odour or taste In water (2) Absorption spectra i UV / VIS. IR. NMR. MS ). molecular extinction at relevant wavelengths (I) Solubility in water Including effect of pH (5 to 9) and temperature on solubilIty (I) Solubility In organic solvents including effect of temperature on solubtlity (I) (I) These data must be subai t ted for the purified active substance of stated specification. I') H,esl! data must be submitted for the active substance and the purified active subslance of stated specification. • TAT! ~ LAN T ~"OTIt:CTION .TATION L AT 1/ I A • " I • A 2 2.7. 2.8. 2.9. 2.10. 2. 11. 2.12. 2.13. 2. 14. 2.15. 2.16. 2.17. 3. 3.1. 3.2. 3.3. 3.4. 3.5. 3.6. 3.7. 3.8. 3.9. PartitIon coefficIent N-octanol/water includine effect of pH C5 to 9) and temperature (I) StabilIty In water, hydrolysis rate, photochemIcal deeradatIon, quantum yield and identIty of breakdown productCs), dissocIation constant Inciudine effect of pH C5 to 9) (I) StabilIty In air, photochemical deeradatIon, Identity of breakdown product(s) (2) StabilIty In oreanic solvents used In preparations (2) Thermal stabIlity, identIty of breakdown products FlammabilIty Includine auto-flammability and identity of combustion products Flash point Surface tension Explosive propertIes Oxidizine properties Reactivity towards container material Further informatIon on the actIve substance Function, e.c. funeicide, herbicide, insectIcide, repellant, erowth reculator Effects on harmful orcanisas, e.c. contact poison, inhalation poison, stomach poison, funcitoxic or funci static, etc., systemic or not In plants Field of use envisaced, e.c. field, classhouse, food or feed storace, home carden Where necessary, in the licht of the test results, any specific acricultural. plant health or environmental conditions under which· the active substance mayor may not be used. Harmful orcanisms controlled and crops or products protected or treated ,",ode of action Information on the occurrence or possible occurrence of the development of resistance and appropriate manacement stratecles Recommended methods and precautions concerninc handline storace. tran~port or fire In case of fire. nature of reaction product. combustIon cases, etc. 3.10. 3.10.1. 3.10.2. 3.10.3. 3.10.4. 3.10.5. 3. 10.6. 3.10.7. 4. 4. 1. Emergency measures in the case of an accident Procedures for destruction or decontamination of the active substance Possibility of recovery Possibility of neutralization Controlled discharce Controlled incineration Water purification Others Analytical methods Analytical methods for the determinatIon of pure active substance and, where appropriate. for relevant breakdown products, isomers and ImpuritIes of the actIve substance and addItIves (e.c. stabllizerg) II TAT I ~ LA" T ~1I0TICTION .20 IITATION 1\ I II A 3 4.2. 4.2.1. 4.2.2. 4.2.3. 4.2.4. 4.2.5. 5. 5.1. 5.1.1. 5.1.2. 5.1.3. 5.1.4. 5.1.5. 5.1.6. 5.2. 5.2.1. 5.2.2. 5.2.3. 5.3. 5.3.1. 5.4. 5.5. 5.5.1. 5.5.2. 5.6. 5.6.1. 5.6.2. 5.7. 5.8. 5. 0.1. Analytical methods includine recovery rates and the limits of determination for residues in, and where relevant on, the followine : Treated plants. plant products, foodstuffs, feedinestuffs So il Water lincludin& drlnkine water) Air Animal and human body fluids and tissues Toxicolo~ical and metabolism studies on the active substance Acute toxicity Oral Percutaneous Inhalation Intraperitoneal Skin and where appropriate eye irritation Skin sensitization Short-term toxicity Oral cumulative toxicity ( 28-day study ) Oral administration - two species, one rodent (preferably rat) and one non-rodent, usually OO-day study Other routes (inhalation, percutaneous as appropriate) Chronic toxicity Oral long-term toxicity and carcinocenicity (rat and other mammalian species) - other routes as appropriate Mutagenicity - test battery to assess ~ene mutations, chromosomal aberrations and DNA perturbations Reproductive toxicity Terato~enicity studies - rabbit and one rodent species, oral and when appropriate percutaneous Multi~eneration studies in mammals (at least two generations) Metabolism studies in mammals •Absorption, distribution and excretion studies followin~ both o~al and percutaneous administration Elucidation of metabolic pathways Neurotoxicity studies - includin~ where appropriate delayed neurotoxicity tests in adult hens Supplementary studie9 Toxic effects of metabolites from treated pl~nt9 In case where different from those identified in animal studies • TAT E ~ l ANT ITATION " I • A 4 5.8.2. 5.9. 5.10. 5.10.1. 5.10.2. 5.10.3. 5.10.4. 5.10.5. 5.10.6. 5.10.7. 5.10.8. 5.11. 6. 6. 1. 6.2. 6.3. 6.4. 6.5. 6.6. 6.7. Any mechanIstIc studIes needed to clarIfy effects reported In toxIcIty studIes ToxIc effects on livestock and pets Medical dat.a Medical surveillance on manufacturinc plant personnel Direct observation, e.C. clinical cases and poisoning incidents Health records, both from industry and acriculture Observations on exposure of the general population and epidemiological studIes if approprIate DiagnosIs of poisonIng (determinatIon of active substance, metabolites), specIfIc sIcns of poisoning, clInIcal tests Sensitization/allercenlcityobservations Proposed treatment: first aId measures, antidotes, medical treatment Prognosis of expected effects of poisonIng Summary of mammalian toxicology and conclusions (including no observable adverse effect level INOAEL), no observable effect level (NOEL), acceptable daily intake (ADI) ). Overall evaluation with regard to all toxicological data, and other information concerning the active substance Residues in or on treated products, food and feed Identification of breakdown and reaction products and of metabolites in treated plants or products Behaviour of residue of the active substance and its metabolites from the time of applicatIon until harvest or outloadinc of stored products - uptake and distribution in, and where relevant on, plants, kinetics of disappearance, binding to plant constituents, etc. Overall material balance for the active substance. SufficIent residue data supervised trials to demons trate that residues likely to arise from the proposed treatments would not be of concern for human and animal health Estimation of the potential and actual exposure throuch diet and other means, such as residue monitoring data for products in the distribution chain. or such as data concerninc exposure via air, water,etc. Feeding and metabolIsm studies In livestock (if residues remain in or on crops or parts of crops used for feed) to permit evaluation of residues In foodstuffs of animal origin Effects of industrial processing and/or household preparation on the nature and magnitude of resIdues Summary and evaluation of residue behaviour resultlnt: from data submitted pursuant to points 6.1 to 6.6 • TAT f. ,. tAN T aTATION ~ 1 a" 5 7. 7.1. 7.1.1. 7.1.2. 7.1.3. 7.1.4. 7.2. 7.2.1. 7.2.2. 7.2.3. 8. 8.1. 8.1.1. 8.1.2. 8.1.3. 6.2. 8.2. 1. 8.2.2. 8.2.3. 8.2.4. 8.2.5. 6.2.6. 8.2.7. 8.3. 6.3.1. 8.3.2. 8.3.3. 8.~.4. 8.3.5. Fate and behaviour in the environment Fate and behavoir in soil Rate and route of decradation (to 90 per cent decradation) includin£ identification of the process involved and identification of metabolites and breakdown products in at least three soil types under appropriate conditions. Adsorption and desorption in at least three soil types and where relevant adsorption and desorption of metabolites and breakdown products Mobility in at least three soil types and where relevant mobil tty of metabolites and breakdown products Extent and nature of bound residues Fate and behaviour in water and air Rate and route of de£radation in aquatic systems biodeeradation, hydrolysis, photolysis (as far as not covered by point 2.8), including identification of metabolites and breakdown products Adsorbtion and desorption in water (sedimentation) and where relevant adsorption and desorption of metabolites and breakdown products Rate and route of deeradatlon in air (for fuaicants and other volatile active substances) (as far as not covered by point 2.9) Ecotoxicoiocicai studies on the active substance Effects on birds Acute oral toxlc!t~ Short-term toxicity - eight-day dietary study In at least one species (other than chicken) Effects on reproduction Effects on aquatic organisms Acute toxicity to fish Chronic toxicity to fish Effects on fish reproduction and growth rate Bioaccuaulation in fish Acute toxicity for Daphnia magna Daphnia macna reproduction and growth rate Effects on algal growth Effects on other non-target organisms Acute toxicity to honeybees and other beneficial arthropods (e.c. predators) Toxicity to earthworms and to other soil non-target macro-organisms Effects on soil non-target micro organisms Effects on other non-target organisms (flora and fauna) believed to be at risk Effects on biological methods for sewage treatment I TilT I ~ L II " T ~"OTILCTIO" ITIITION L A T V 1 " • 6 9. 10. 11. 1. 1.1. 1. 2. 1. 3. 1. 4. 1. 5. 1. 6. 1. 7. 2. 2.1. 2.2. 2.3. 2.4. 2.5. Summary and evaluation of points 7 and 8 Proposals including justification for the proposals for the classification and label inc of the active substance according to Council Directive 67/548/EEC Hazard sy.bol(s) Indications of danger Risk phrases Safety phrases A dossier as referred to in part 3, for a representative plant protection product PART 2 Micro-orcanisms and viruses Identity of the or~anism Applicant (name. address. etc.) Manufacturer (name. address. includine location of plant) Common name or alternatIve and superseded names Taxonomic name and strain for bacteria. protozoa and fun&i. indIcation whether it is a stock variant or a mutant strain; for viruses the taxonomic desienation of the aeent. serotype. strain or mutant Collection and culture reference number where the culture is deposited The appropriate test procedures and criteria used for identification (e.g. morpholoey. biochemistry, seroloey) CompositIon - microbiologIcal purity. nature. identity. properties, content of any I.purities and extraneous oreanisms Bioloeical properties qf the oreanism Tareet oreanism. PathogenicIty or kind of antaeonls. to host. InfectIve dose. transmissIbility and information on mode of action History of the oreanism and its uses. Natural occurrence and eeoeraphical distribution Host specificity range and effects on specIes other than the tareet harmful oreanis. includine species most closely related to the tareet species - to Include infectivity, p~thoeenicity and transmissibility InfectIvity and physical stability when used accordin~ to the proposed method. Effect of temperature. exposure to air radiation. etc. Persistance under the likely envIronmental conditions of use Whether the organism Is closely related to & rdant pathoeen or to a pa t h o z e n of a ve r t e b ra t a Specl(-!!;l (I, ,. l .. N T ~"OT~CTIO" II TAT I a " LATVIA, " I SA 7 2.6. 2.7. 3. 3.1. 3.2. 3.3. 3.4. 3.5. 3.6. 3.7. 3.8. 3.9. 4. 4.1. 4.2. 4.3. 4.4. Laboratory evidence of £enetic stability (I.e. mutatIon rate) under envIronmental conditIons of proposed use Presence. absence or p~oduction of toxins as well as their nature. Identity. chemical structure (if appropriate) and stabilIty Further informatIon on the or£anism Function. e. e. funelcide. herbicide. insecticide. repellant. £rowth re£ulator Effects on harmful oreanisms. e.£. contact poison. inhalatIon poison. stomach polson. fun£itoxic or funeistatic. etc •• systemic or not In plants Field of use envisa£ed. e.e. field. £lasshouse. food or feed storaee. home earden Where necessary. in the l I z h t. of the test resul t s . any specific a£ricultural. plant health or environmental conditions under which the actIve substance mayor may not be used Harmful or£anisms controlled and crops or products protected or treated Method of production with descriptions of the techniques used to ensure a uniform product and of assay methods for its standardization. In the case of a mutant. detailed information should be provided on Its production and isolation. to£ether with all known differences between the mutant and the parent wild strains. Methods to prevent loss of virulence of seed stock Recommended methods and precautions. concernin£ handling, storage. transport or fIre PossibIlity of renderin£ the or£anism uninfective Analytical methods Methods for estabiishin£ the Identity and purity of seed stock from which batches are produced and results obtained. Includln£ information on variability Methods to show microbiolo£ical purity of the final product and showin£ that contaminants have been controlled to an acceptable level, results obtained and information on variability Methods used to show that there are no human or other mammalian patho£ens,as contaminants in the active agent. inc Iud i n£ in the case of protozoa and fune t , the effects of temperature (35 a C and other relevant temperatures; Methods to determine viable and non-viable (e.£. toxins) residues in or on treated products. foodstuffs. f e e d l n z s t uf f s , animal and h urnn n body fluldg and S TAT e ~ LAN T ~IIOTECTION STATION LATYIA. II I S A 8 5. 5.1. 5.1.1. 5.1.1.1. 5.1.1.2. 5.1.1.3. 5.1.1.4. 5.1.1.5. 5.1.1.6. 5.1.1.7. tissues, soil, water and air, where relevant Toxicolo~ical, patho~enicity and infectivity studies Bacteria, fun&i, protozoa and mycoplasma Toxicity and/or patho&enicity and infectivity Oral sin~le dose In cases where a sin&le dose is not appropriate to assess patho~enicity, a set of ran~e-findine texts must be carried out to reveal hi&hly toxic a~ents and infectivity Percutaneous sln~le dose Inhalation sin&le dose Intraperitoneal sin&le dose Skin and, where necessary, eye irritation Skin sensitization 5.1.2. Short-term toxicIty (90 days exposure) 5.1.2.1. Oral administration 5.1.2.2. Other routes (inhalation, percutaneous as appropriate) 5.1.3. 5.1.3.1. 5.1.3.2. 5.1.3.3. 5.1.3.4. 5.1.3.5. 5.1.3.6. 5.1.3.7. 5.1.3.8. 5.2. 5.2. L 5.2.2. 5.2.3. 5.3. 5.4. 5.4. L 5.4.2 5.4.3. 5.4.4. Supplementary toxicolo~ical and/or pathoeenicity and infectivity studies Oral lon&-term toxicity and carclno~enicity Muta~eniclty - (tests as refered to under point 5.4 of part I) Terato~eniclty studies Multigeneration study In mammals (at least two ~enerations) Metabolic studies - absorption, distribution and excretion in mammals includin& elucidation of metabolic pathways Neurotoxicity studies, includin~ where appropriate delayed neurotoxicity tests in adult hens Immunotoxicity, e.&. aller&enicity Patho&enicity and infectivity under immunosuppression Viruses, virolds Acute toxicity and/or patho&enicity and infectivity. Data as outlined under point 5.1.1 and cell culture studies usin& purified infective virus and primary cell cultures of mammalian, avian and fish cells Short term toxicity Data as outlined under point 5.1.2 and tests for infectivity carried out by bio-assay or on a suitable cell culture at least seven days after the lagt administration to the test animals Supplementary toxicolo~ical and/or pathoeenicity and infectivity studies as outlined under point 5.1.3 Toxic effects dn livestock and pets Medical data Medical surveillance on manufacturlne plant personnel Health records, both from industry and agriculture Observations on exposure of the eeneral population &oJ e p Ld em I o l o g Lca l data, If appropriate D i a Ii: nos I ~> a f poi son I n f:. , s p e c I fie 9 i e n 9 0 f p u I ,.l G n t l\ £: , ,. LAN f 26 eTATIOH LATYIA. " r e A 9 5.4. S. 5.4.6. S.h.7. 6. 6. 1. 6.2 6.3. 6.4. 7. 7. L 7.2. 7.3. 8. 8.1. 8.2. 8.3. 8.4. 8.5. 8.6. 8.7. 8.A. 8.9. 8.10. clInIcal tests, If appropriate Sensltizatlon/allereenIclty observations, If approprIate Proposed treatment: first aId measures, antidotes, me dLca l treatment, If appropriate Pro~noDJg of expected effects of polsonIn~, If ilpprnprlate Summary of mammalian toxicolo~y and conclusions t Lnc l ud Ln a NOAEL, NOEL and ADI, If appropriate). Overall evaluation with re~ard to all toxicoioeical patho~eniclty and Infectivity data, and infectIvity and other information concernine the active substance Residues In or on treated products, food and feed Identification of viable and non-viable (e.~. toxins) residues in or on treated plants or products, the viable residue by culture or blo-assay and the non-viable by appropriate techniques Likelihood of multiplication of the active substance in or on crops or food tocether wIth a report on any effect on food quality In cases where residues of toxins remain in or on an edible plant product, data as outlined under points 4.2.1 and 6 of part I are required Summary and evaluation of residue behaviour resultinc from data submitted under points 6.1 to 6.3 Fate and behaviour in the environment Spread, mobility. multiplication and persistance in air, water, 5011 Information concerninc possible fate in food chains In cases where toxins are produced. data as outlined under part I, point 7 are required. where relevant Ecotoxicoloeical studIes Birds - acute oral toxicity and/or pathocenicity and infectivity Fish - acute toxicity and/or pathocenicity and infectivity Toxicity - Daphnia macna (If appropriate) Effects on alcal crowth . Important parasites and predators of tarcet species; acute toxicity and~or pathocenicity and infectivity Honey-bees: acute toxIcity and/or pathocenicity and infectivity Earthworms: acute toxicity and/or pathocenicity and infectivity Other non-tarcet orcanisms believed to be at risk: acute toxicity and/or pathocenicity and infectivity Extent of indirect contamination on adjacent non-tar~et crops, wild plants, ~oil and water Effects on other flora and fnuna a TAT ~ ~ LAN T ~1I0TICTI0" aTATION " 1 • ~ 10 8.11. 9. 10. 11. 1. 1.1. 1. 2. 1. 3. 1. 4. 1. 5. 1. 6. 2.1. 2.2. 2.3. In cases where toxins are produced. data as outlined under Part I, points 8.1.2, 8.1.3, 8.2.2, 8.2.3, 8.2.4, 8.2.5, 8.2.6, 8.2.7 and 8.3.3 are required, where relevant Sumaary and evaluation of points 7 and 8 Proposals includine justification of the classification and label lIne of the active substance in accordance with Directive 67/548/EEC Hazard symbol(s) Indications of daneer Risk phrases Safety phrases A d09sier as referred to in part 4, for a representative plant protection product. PART 3 Chemical preparations Identity of. the plant protection product Applicant (name, address. etc.) Manufacturer of the preparation and active substance(g) (name. address. etc. includine location of plantg) Trade name or proposed trade name, and manufacturer's development code number for the preparation. if appropriate Detailed quantitative and qualitati~e information on the composition (active substance(s), impurities, adjuvants, inert components, etc.) Physical state and lJature of the preparation (emulsifiable concentrate, wettable powder, solution etc. ) Use cateeory (herbicide, insectIcide, etc.) Physical, chemical and technical propertIes of the plant protection product Appearance (colour and odour) Explosivity and oxidizine propertIes Flush point and other indIcations of flamm~bll ILy or spontaneous i~nitlon eTA T I! ~ LA" T ~"DTECTID" II TAT I 0 " " I II A 11 2.4. 2.5. 2.6. 2.7. 2.8. 2.8.1. 2.8.2. 2.8.3. 2.8.4. 2.8.5. 2.8.6. 2.8.7. 2.8.8. 2.8.9. 2.9. 2. 10. 3. 3. 1. 3.2. 3.3 3.4. 3.5. 3.6. 3.7. 3.8. 3.9. 3. 10. Acidity/alkalinity and if necessary pH value (1 % in water) Viscosity, surface tension Relative density Storace stability - stability and shelf-life. Effects of licht. temperature and humidity on technical characteristics of the plant protection product Technical characteristics of the plant health product Yettability Persistent foaminc Suspensibility and suspension stability Yet sieve test and dry sieve test Particle size distribution, content of dust/fines. attrition and friability In the case of cranules: sieve test and indication of weicht distribution of the cranules, at least of the fraction with partIcle sIzes biccer than 1 m. Content of active substance in or on bait particles. granules or treated seed Emulsifibility, re-emulsifiability, emulsion stability Flowability, pourability and dustability Physical and chemical compatibility with other products includlnc plant protection products with which its use Is to be authorized \Jettinc, adherence and distribution to tarcet plants Data on applicatlDn Field of use, e.c. field, classhouse, food or feed storace, home carden Effects on harmful orcanisms, e.c. contact poison, inhalation poison or stomach poison, funcitoxic or funcistatic, etc., systemic or not in plants Details of intended use, e.c. types of harmful orcanisms controlled and/or plants or plants products to be protected Yhere necessary, in the licht of the test results, any specific acrlcultural, plant health and/or environmential conditIons under which the orcanism may or may not be used Application rate Concentration of active substance in material used (e. c. in the d I I uted spray, bai t or treated seed) Method of applIcation Number and timlnc of applications and duration of protection Necessary waitinc periods or other precautions to avoid phytotoxic effects on succeed inc crops Proposed instructions for use a TAT E ,. LAN T ""OTECTION aTATION LATVIA. 1\ I • A 12 4. 4. 1. 4.2. 4.3. 4.4. 4.5. 4.6. 4.7. 4.7.1. 4.7.2. 4.7.3. 4.7.4. 4.7.5. 5. 5.1. 5.2. 5.2. 1. 5.2.2. 5.2.3. 5.2.4. 5.2.5. 6. 6.1. 6.2. 6.3. 6.4. 6.5. 6.6. 6.7. Further information on the plant protection product Packa~in~ (type, materials, size, etc. I, compatibility of the preparation with proposed packa~in~ materials Procedures for cleanin~ application equipment Re-entry periods, necessary waitin~ periods or other precausions to protect humans and animals Recommended methods and precautions concernin~ handlin~, stora~e, transport or fire Emercency measures in case of an accident Identity of combustion products relevant to cases of fire Procedures for destruction or decontamination of the plant protection product and its packacin~ Possibility of neutralization Controlled discharce Controlled incineration Water purification Others Analytical methods Analytical methods for deter.ininc the composition of the plant protection product In so far as not covered by Annex I, Part I, point 4.2, analytical methods includinc recover rates and the limits of determination for residues in and where relevant on, the followinc : Treated plants, plant products, foodstuffs, feedlncstuffs Soil Water (includinc drinkinc waterl Air Animal and human body fluids and tissues Efficacy data Preliminary rance-findinc tests Field experimentation Information on the possible occurrence of the development of resistance Effects on the quality and where appropriate on the yield of treated plants or effects on the quality of treated plant products Phytotoxicity to target plants (includinc different cultivarsl, or to target plant products Observations on undesirable or unintended side-effecl~, e.g. on beneficial and other non-tarcet organisms, on succeeding crops, other plants or parts of treatod plants used for propagating purposes (e.g. seeds, cut tines, runners) Summary and evaluation of dat.a presented under p()lnt~ I'" r,. ANT "R[JT~r.IIO~ l AT" 1 A • 13 7 • 7. 1. 7 .. t , 1. 7 . t . 2. 7.1.:3. 7. L 4. 7. L 5. 7.1. G. 7.2. 7.2.1. 7.2.2. ? .2.3. 8. 8. 1. 8.2. 8.3. 8.4. 8.5. 8.6. 8.7. ~.o. 6.1 to 6.6 Toxicological studies Acut.e toxicity Oral p.", r c u t a n e o u s Inhalation Skin and, where relevant. eye Irritation SkIn scngitization Where apPlopriate, acute dermal toxicity, skin and eye irritation for combinations of plant protection products for which authorIzation Is sought for use In such combinations Operator exposure Dermal absorption LIkely operator exposure under fIeld conditions. includIng where relevant quantitative analysis of operQtor axposure AvaIlable toxicologIcal data relatIng to non-active r ub s t a n c e a Residues In or on treated products, food and feed Data frollJ supervised trials In crops, food or feedlngstuffs, for which authorized use is sought.£lvlne all experimental conditions and details, Includln~ residue data concernln. the active substance, relevant metabolites and relevant other constItuents of the plant protection product, from time of application untIl h a r v e s t , or in the case of post-harvest treatment, breakdown ~f ~~sldueg durln£ 9to r a e e and levels of residues at time of release from storaEe for marketIng. Data should be available for the ran~e of climatic and n~ronomlc conditions likely to he encoun tered in the proposed area of use Effects of IndustrIal processln~ and/or household preparation on the nature and magnitude of residues Effects on taint. odour. taste or other quality aspectg due to ~esidueg In or on fresh or processed products EstimatIon of residues in products of animal oriein resultln~ from ingestion of feedingstuffs or resulting from contact with hedding, on the hasis of residue data referred to in point 8.1 and studies in livestock referred to in Arm e x I, Part I. point 6.5 Residue data In succedine or rotatIonal crops where presence of resIdues mIght be expected Proposed pre-harvest intervals for envisaged uses, or wlthoiding perIods or storage perIods, in the case of post-harvest uses Proposed maximum residue levels (MRLs) and justification of the acceptability of these residues Summary and ovaluation of the residue behaviour on the basis of the data submitted under points 8.1 to 8.7 " TAT e ,. LAN T ~"OTECTION IlTATION lilT V I II • " I II A 14 9. 9. i , 9.2. 9.3. 10. 10. i , 10.1.!. 10. i . 2. 10. i . 3. 10.2. 10.2. 1 10.2.2. 10.2.3. 10.2.4. Fate and behaviour In the environment The information provided must, where relevant, include that referred to in Annex I. Part I, point 7. and Testing for distribution and dissipation in solI Testing for distribution and dissipation in water Testin~ for distribution and dissipation in all' Ecotoxlcological studies Effects on birds Acute oral toxicity Supervised trials to assess risks to avian species under field conditions If appropriate, studies on acceptance of bait, granules. or treated seeds b~ birds Effects on aquatic organisms Acute toxicity to fish Acute toxicity to Daphnia magna Overspray study (if toxic to fish or other aquatic organisms and persistent in water) to assess risks to aquatic organisms under field conditions In case of application in/at surface waters 10.2.4.1. 10.2.4.2. 10.2.5. 10.3. 10.3.1 10.3.2. 10.3.3. 10.3.4. 10.3.5. 10.3.6. 10.3.7. 11. 12. 12. 1. 12.2. Particular studies with fish and other aquatic organisms Residue data in fish concerning the active substance and including toxicologically relevant metabolites The studies referred to in Annex I, Part I points 8.2.2, 8.2.3. 8.2.4. ,8.2.6, and 8.2.7 may be required for particular plant protection products Effects on other non-target organisms Effects on terrestrial vertebrates other than birds Toxicity to honey-bees Toxicity to foraging bees under field conditions Effects on beneficial arthropods other than bees Effects on earthworms and other soil non-target macro-organisms. believed to be at risk Effects on soil non-target micro-organisms Available data from biological primary screening In summary form Summary and evaluation of points 9 and 10 Further information l n f o r ma t Lo n on authorizations in o t h e r c o u o t rf e s Information on established mal<imWD r e e t d ue 11m! t.:::. <HRLl in other c o u n t r Le s ~ LA" l 32 illATION ft I " A 15 12.3. 12.4. 12.5. 1. 1.1. 1. 2. 1. 3. 1. 4. 1. 5. 1. 6. 2. 2. 1. 2.2. 2.3. 2.4. 2.4.1. 2.4.2. 2.4.3. 2.4.4. 2.4.5. 2.4.6. 2.4.7 Proposals includin~ justification for the classIfication and labellin~ proposed in accordance with Directive 67/548/EEC and Directive 78/631/EEC Ha%ard sy.boICs) Indications of dan~er Risk phrases Safety phrases Proposals for risk and safety phrases and proposed label Speci.ents of proposed packa~In~ PART 4 Preparations of micro-or~anisms or viruses Identity of the plant protection product Applicant (name, address. etc.) Manufacturer of the preparation and the active a~ent(s) Cnames. addresses, etc•• includinc location of plants) Trade name or proposed trade name and manufaoturer's development code number/or the plant protection product, if appropriate Detailed quantitatIve and qualItative informatIon on the compositIon of the plant protection product (active orcanIsm(s). inert components. extraneous or~anisllls, etc.) Physical state and nature of the plant protection product (emulsifiable concentrate, wettable powder. etc. ) Use cate~ory (Insecticide, funcicide. etc.) Technical properties of the plant protection product Appearance (colour and odour) Storace stability - stability and shelf-life. Effects of temperature, method of paoka~in~ and ~torace, etc. -on retention of bioloe:ical activity Methods for establishlnc storae:e and shelf-lIfe s tabUi ty TechnIcal characteristics of the preparation Wettabllity Persistent foaminc SU9pensibility and suspension stability Wet sieve test and dry sieve test PartIcle sl%e distrIbutIon. content of dust/fines, attrItion and frIability In the case of ~ranule9, sieve test and indications of weicht distribution of the cranules. at least of the fraction with particle sI%e9 biccer than 1 mill Content of active substance In or on baIt particles, granules or treated seed ~"OTECTION STATION L A T \I I A • ,. I a A 16 .. ---- . 2.4.8 2.4.9. 2.5. 2.6. 3. 3.1. 3.2. 3.3. 3.4. 3.5. 3.6. 3.7. 3.8. 3.9. 4. 4.1. 4.2. 4.3. 4.4. 4.5. 4.6. 5. 5. 1. 5.2. 5.3. 5.4. 5.5. Emulsifiability, re-emulsiflability, emulsion stability Flowability, pourability and dustability Physical and chemical compatibility with other products includin~ plant protection products with which its use is to be authorized Wettin~, adh~rence and distribution to tar~et [llants Data on application Field of use. e.~. field. ~lasshouse, food or feed stora~e, home carden Details of intended use. e.c. types of harmful or~anism controlled and/or plants or plant products to be protected Application rate Where necessary, in the li~ht of the test results, any specific acricultural. plant health and/or environmental conditions under which the product may or may not be used. Concentration of active substance in material used (e.~. % concentration in the diluted spray) Method of application Number and timin~ of applications Phytopathocenicity Proposed instructions for use Further information on the preparation Packacin~ (type. materials, size, e t c c t , compatibLlity of the preparation with proposed packa~in~ materials Procedures for cleanin~ application equipment Re-entry periods. necessary waitin~ periods or other precautions to protect humans and animals Recommended.methods and precautions concern!", handlin~. storace. transport Emercency measures in case of an accident Procedures for destruction or decontamination of the plant protection product Analytical methods Analytical methods for determininc the cowputlitiof\ of the plant protection product Methods for determinin~ residues In or on lrealed plants or in or on plant products (e.c. biotostJ Methods used to show microbIolo~ical purity of lhe plant protection product Methods used to show the plant protection p r o o uc t to be free from any human and other mammalian pathogens or, if need be. frOID honey-bee pat.ho~erl~j Techniques used to ensure a uniform product and as~&y methods for its standardization ,.. tAN T "TATJD" " I e " 17 6. 6.1 6.2. u.3. 6.4. u.5. A.6. 6.7. "7. '.1 7.2. 7.3. 7.4. 7.5. 7.6. 'r . 7. 7.7.1 7.7.2. 8. 8.1. 8.2. 8.3. 8. ~. El.5. EffIcacy data PrelImInary ran~e-findIn~ tests FIeld experImentatIon InformatIon on the possible occurrence of the develop ment of resIstance Effects on the qualIty and where approprIate on the yield of treated plants or effects on the quality of treated plant products PhytotoxIcity to tar~et plants (includtn~ dIfferent cuitivars), or to tar~et plant products Observations concernin& undesIrable or unintended side-effects, e.~. on benefIcial and other non-tar~et organisms, on succeedin~ crops, other plants or parts of treated plants used for propagation purposes le.g. seeds, c u t t Ln z s , runners) Summa ry and eva I ua t I on of da t.a presented under po i nts 6.1 to 6.6 ToxicIty and/or patho~enicity and Infectivity studIes Oral sIngle dose Percutaneous sIn~le dose InhalatIon Skin and where relevant eye Irritation Skin sensItizatIon Available toxlcolo~Ical data relating to non-active substances Operator exposure Percutaneous absorptIon Likely operator exposure under field condItions, includln~ where relevant quantitative analysis of operator exposure. Residues in or on treated products, food and feed Residue data concernIn~ the active substance incJudln~ data from supervIsed trIals In crops, food or feedingstuffs for whIch autorlzation for use Is sou~ht, ~iving all experimental conditIons and details. Data should be available for the ran~e of different climatic and a~ronomlc conditions encountered in the proposed area of use. I t is aJ so necessary to identify viable and non-viable resIdues In treated crops Effects of industrial processin~ and/or household preparatIon on the nature and ma~nltude of resIdues, if appropriate Effects on taint; odour, taste or other quality ~5pects due to residues on or in fresh or processed product., If approprIate Reslrlue dat.a In products of AnImal orl~in result.lng from Ineestinn of feedln£stufFs or contact wIth hf~(I(llne. If approprIate Rp.sldlW data In s uo c e e d t n z or rotatIonal crops where • TilT r. ~ L II H T LilT Y I II • " 1 " H 18 8.6. 8.7. 8.8. 9. presence of residues aicht be expected Proposed pre-harvest intervals for envlsaced uses or wltholdin~ periods, or stora~e periods, in the case of post-harvest uses Proposed maxiaum residue levels (HRLs) and the justification of the acceptability of these levels (for toxins), if ap~ropriate Summary and evaluation of the residue behaviour on the basis of the data subaitted under points 8.1 to 0.7 Fate and behaviour in the environment 9.1. 10. In cases where toxins are produced, under Part I, point 9 are required, Ecotoxicolo~ical studies data as outlined if appropriate 10.1. 10.1.1. 10.1.2. 10.1.3. 10.2. 10.2.1. 10.2.2. 10.2.3. 10.2.4. 10.2.5. 10.2.6. 11. 12. 12.1. 12.2. 12.3. 12.4. 12.5. Effects on aquatic or~anisms Fish Studies in Daphnia ma~na and in species closely related to the tarcet or&anisms Studies in aquatic micro-or&anisms Effects on beneficial and other non-tarcet orcanlsms Effects on honey-bees, if appropriate Effects on other beneficial orcanlsm8 Effects on earthworms Effects on other soil fauna Effects on other non-tarcet or~anisms believed to be at risk Effects on soil microflora Summary and evaluation of points 9 and 10 Further information Information on authorizations in other countries Information on established maximum residue limits (HRLs) in other countries Proposals/includinc justification for the classification and labellinc proposed In accordance with Directives 67/548/EEC and 78/631/EEC Hazard symbol(s) Indications of dancer Risk phrases Safety phrases Proposals for risk and safety phrases and prupoged label Speciments of Proposed packacinc ew t A H T 06' .. T ,. T 1 Q N 19 . - . . . REQUIREMENTS FOR LABELS AND LEAFLETS OF PLANT PROTECTION PRODUCTS IN LATVIA LABEL FOR OVERPACKS 1. Trade name of the plant protection product 2. Type of preparation (e.~. wettable powder. emulsifiable concentrate etc.) 3. Type of action (e.~. insecticide. ~rowth reculator. etc.) 4. Hazard symbols 5. Name and address of holder of the authorization 6. Name and address of manufacturer. distributor or acent 7. Recistration number. 8. Ba tch number 9. Date of formulation 10. Net weicht 11. Stora~e conditions 12. Safety statements LABEL FOR INSIDE CONTAINERS : 1. Trade name of the plant protection product 2. Active in~redient(s) and amount of each 3. The type of preparation (e.~. wettable powder, emuls~fiable concentrate. etc.) 4. The type of action (e.c. insecticide. ~rowth re~ulator. etc. ) 5. Hazard symbo 19 6. Name and address of holder of the authorization 7. Name and address of manufacturer. distributor or acent 8. Re~istration number 9. Distribution ~roup 10. Batch number 11. Date of for.ulation 12. Net weicht 13. Storace conditions i4. Shelf life 15. Safety precautions for the protection of humans, animals or the environment in the forll of standart phrases 16. Infor ation on first aid and advise to medical doctors 17. Summary of uses for which the plant protection product has been authorized. 18. Directions for safe disposal of the plant protection product and of the packacinc P LAN 1 PROTl:CTIO" :/7 .j • alAT10 ... 20 19. Directions for use crop, pests. diseases, weeds controlled, dose rates, timinc, frequency, re - entry period, method of application. application conditions, use restrictions, pre - harvest interval, mixinc instructions. warninc statement for cood acricultural practice: where necessary, the safety interval for each use between application and sowinc or plantinc of the crop to be protected, sowinc or plantinc of succedinc crops, access by humans or animals, harvestinc, use or consumption; partic~lars of possible phytoxicity, varietal susceptibility, and any other direct or indirect adverse side effects on plants or products of plant oricin tocether with the intervals to be observed between application and sowinc or plantlne of the crop in question, or subsequent crops. 20. Lecal responsibilities 21. If accompanied a leaflet, the sentence wRead accompanyine instructions before use REQUIREMENTS FOR LEAFLET If the space available on the packace Is too slIIall, re&ulations permit that requirements in para&raph 19, 20 may be printed on leaflet. Such a leaflet shall be recarded as part of the label. The leaflet should contain information provided in para~raphs 1, 2,3,4,13,15,16,17.18. ANNEX 4 Reculations on Recistration of Plant Protection Products in Republic of Latvia 5-th January. 1995 (Coat of Arms) The Ministry of Acriculture of Latvian Republic The State Plant Protection Station Re2:1stra.t:10rl Cert:1£:1oa.te of the Plant Protection Product Nr This Certificate Is handed out that accordin£ to the ·Reeulatlons on Reclstratlon aT Plant Protection Products in Republic of Latvia· is recistered the preparation with the active substance (es) •.•••.•••.••.•••••..••.••••.• Re C • Nr ...•.. , ••.•••.••••.•.••••••• Rec. Nr •••••• is reclstered in •••• class. l~,.nl ItI"D,eCllon .,.Aoue" The term of action of this Certificate is till •••••••••••••• • • • lo •••••••••••••• (date) Director •..•••.••