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COMMISSION DIRECTIVE 94/37/EC of 22 July 1994 amending Council Directive 91/414/EEC concerning the placing of plant protection products on the market
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KOMMISSIONENS DIREKTIV 94/37/EF af 22. juli 1994 om aendring af Raadets direktiv 91/414/EOEF om markedsfoering af plantebeskyttelsesmidler
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THE COMMISSION OF THE EUROPEAN COMMUNITIES,
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KOMMISSIONEN FOR DE EUROPAEISKE FAELLESSKABER HAR -
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Having regard to the Treaty establishing the European Community,
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under henvisning til traktaten om oprettelse af Det Europaeiske Faellesskab,
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Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (1), as last amended by Commission Directive 93/71/EEC (2), and in particular Article 18 (2) thereof,
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under henvisning til Raadets direktiv 91/414/EOEF af 15. juli 1991 om markedsfoering af plantebeskyttelsesmidler (1), senest aendret ved Kommissionens direktiv 93/71/EOEF (2), saerlig artikel 18, stk. 2, og
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Whereas Annexes II and III to Directive 91/414/EEC lay down the requirements for the dossier to be submitted by applicants respectively for the inclusion of an active substance in Annex I and for the authorization of a plant protection product;
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ud fra foelgende betragtninger:
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Whereas it is necessary to indicate in Annexes II and III to the applicants, as precisely as possible, any details on the required information, such as the circumstances, conditions and technical protocols under which certain data have to be generated; whereas these provisions should be introduced as soon as available in order to permit applicants to use them in the preparation of their dossier;
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Bilag II og III til direktiv 91/414/EOEF fastsaetter kravene til det dossier, som ansoegerne skal indsende med henblik paa henholdsvis optagelse af et aktivt stof i bilag I og godkendelse af et plantebeskyttelsesmiddel;
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Whereas greater precision can now be given to the data requirements concerning the identity, physical and chemical properties and further on the active substance, provided for in sections 1, 2 and 3 of Part A of Annex II;
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det er noedvendigt i bilag II og III saa praecist som muligt for ansoegerne at anfoere alle detaljer vedroerende de kraevede oplysninger saasom omstaendigheder, betingelser og tekniske protokoller, hvorunder visse data skal fremskaffes; disse bestemmelser boer indfoeres, saa snart de foreligger, for at ansoegerne kan anvende dem ved udarbejdelsen af deres dossierer;
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Whereas greater precision can now be given to the data requirements concerning the identity, physical, chemical and technical properties and other general information on the plant protection product, provided for in sections 1 to 4 of Part of Annex III;
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det er nu muligt yderligere at praecisere de data, der kraeves med hensyn til identitet, fysiske og kemiske egenskaber samt andre generelle oplysninger vedroerende det aktive stof, der er omhandlet i sektion 1, 2 og 3 i del A i bilag II;
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Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Plant Health,
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det er ogsaa nu muligt yderligere at praecisere de data, der kraeves for identitet, fysiske, kemiske og tekniske egenskaber samt andre generelle oplysninger vedroerende det plantebeskyttelsesmiddel, der er omhandlet i sektion 1 til 4 i del A i bilag III;
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HAS ADOPTED THIS DIRECTIVE:
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de i dette direktiv fastsatte foranstaltninger er i overensstemmelse med udtalelse fra Den Staaende Komité for Plantesundhed -
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UDSTEDT FOELGENDE DIREKTIV:
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Article 1
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Directive 91/414/EEC is amended as follows:
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Artikel 1
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1. In Part A of Annex II, the sections headed '1. Identity of the active substance', '2. Physical and chemical properties of the active substance' and '3. Further information on the active substance' are replaced by Annex I hereto;
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I direktiv 91/414/EOEF foretages foelgende aendringer:
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2. In Part A of Annex III, the sections headed '1. Identity of the plant protection product', '2. Physical, chemical and technical properties of the plant protection product', '3. Data on application' and '4. Further information on the plant protection product' are replaced by Annex II hereto.
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1) I del A i bilag II affattes sektionerne »1. Det aktive stofs identitet«, »2. Det aktive stofs fysiske og kemiske egenskaber« og »3. Yderligere oplysninger om det aktive stof« som angivet i bilag I til naervaerende direktiv.
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2. I del A i bilag III affattes sektionerne »1. Plantebeskyttelsesmidlets identitet«, »2. Plantebeskyttelsesmidlets fysiske, kemiske og tekniske egenskaber«, »3. Anvendelsesdata« og »4. Yderligere oplysninger om plantebeskyttelsesmidlet« som angivet i bilag II til naervaerende direktiv.
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Article 2
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Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 31 July 1995. They shall immediately inform the Commission thereof.
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Artikel 2
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When Member States adopt these measures, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States.
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Medlemsstaterne saetter de noedvendige love og administrative bestemmelser i kraft for at efterkomme dette direktiv senest den 31. juli 1995. De underretter straks Kommissionen herom.
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Naar medlemsstaterne vedtager disse bestemmelser, skal de indeholde en henvisning til dette dirketiv, eller de skal ved offentliggoerelsen ledsages af en saadan henvisning. De naermere regler for denne henvisning fastsaettes af medlemsstaterne.
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Article 3
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This Directive shall enter into force on 1 August 1994.
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Artikel 3
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Done at Brussels, 22 July 1994.
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Dette direktiv traeder i kraft den 1. august 1994.
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For the Commission
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Udfaerdiget i Bruxelles, den 22. juli 1994.
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René STEICHEN
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Paa Kommissionens vegne
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Member of the Commission
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René STEICHEN
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Medlem af Kommissionen
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(1) OJ No L 230, 19. 8. 1991, p. 1.
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(2) OJ No L 221, 31. 8. 1993, p. 27.
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(1) EFT nr. L 230 af 19. 8. 1991, s. 1.
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(2) EFT nr. L 221 af 31. 8. 1993, s. 27.
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ANNEX I
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1. Identity of the active substance
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BILAG I
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The information provided must be sufficient to identify with precision each active substance, to define it in terms of its specification and to characterize it as to its nature. The information and data referred to, unless otherwise specified, are required for all active substances.
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1. Det aktive stofs identitet
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1.1. Applicant (name, address, etc.)
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De afgivne oplysninger skal vaere tilstraekkelige til, at hvert enkelt aktivt stof kan identificeres noejagtigt, defineres ved sine specifikationer og karakteriseres ved sine egenskaber. De omhandlede oplysninger og data kraeves for alle aktive stoffer, medmindre andet er anfoert.
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The name and address of the applicant (permanent Community address) must be provided as must the name, position, telephone and telefax number of the appropriate person to contact.
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1.1. Ansoeger (navn, adresse mv.)
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Where, in addition, the applicant has an office, agent or representative in the Member State to which the application for inclusion in Annex I is submitted, and if different, in the Rapporteur Member State appointed by the Commission, the name and address of the local office, agent or representative must be provided, as must the name, position, telephone and telefax number of the appropriate person to contact.
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Ansoegerens navn og adresse (fast adresse i EF) skal oplyses tillige med navn, stilling og telefon- og telefaxnummer for en kontaktperson.
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1.2. Manufacturer (name, address, including location of plant)
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Har ansoegeren desuden et kontor, en agent eller en repraesentant i den medlemsstat, som ansoegningen om optagelse i bilag I er sendt til, og hvis denne medlemsstat er en anden end den rapporterende medlemsstat - i den medlemsstat, som Kommissionen har udpeget som rapporterende medlemsstat, skal navn og adresse paa det lokale kontor, den lokale agent eller den lokale repraesentant oplyses tillige med navn, stilling og telefon- og telefaxnummer for en kontaktperson.
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The name and address of the manufacturer or manufacturers of the active substance must be provided as must the name and address of each manufacturing plant in which the active substance is manufactured. A contact point (preferably a central contact point, to include name, telephone and telefax number) must be provided, with a view to providing updating information and responding to queries arising, regarding manufacturing technology, processes and the quality of product (including where relevant, individual batches). Where following inclusion of the active substances in Annex I, there are changes in the location or number of manufacturers, the information required must again be notified to the Commission and the Member States.
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1.2. Fabrikant (navn og adresse, herunder produktionsanlaeggenes beliggenhed)
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1.3. Common name proposed or ISO-accepted, and synonyms
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Navn og adresse paa fabrikanten (fabrikanterne) af det aktive stof skal opgives tillige med navn og adresse paa hvert enkelt produktionsanlaeg, hvor det aktive stof fremstilles. Der skal oplyses en kontaktmulighed (helst en central kontaktmulighed omfattende navn og telefon- og telefaxnummer) med henblik paa ajourfoering af oplysninger og besvarelse af eventuelle forespoergsler vedroerende fremstillingsteknologien og -processerne og produktets kvalitet (herunder af eventuelle bestemt batcher). Hvis der efter optagelse af det aktive stof i bilag I sker aendringer i antallet af fabrikanter eller deres beliggenhed, skal de kraevede oplysninger atter meddeles Kommissionen og medlemsstaterne.
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The ISO common name, or proposed ISO common name and where relevant, other proposed or accepted common names (synonyms), including the name (title) of the nomenclature authority concerned, must be provided.
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1.3. Foreslaaet eller accepteret ISO-faellesnavn, samt synonymer
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1.4. Chemical name (IUPAC and CA nomenclature)
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Der skal anfoeres ISO-faellesnavn eller foreslaaet ISO-faellesnavn og eventuelle andre foreslaaede eller accepterede faellesnavne (synonymer), herunder navnet (titlen) paa den paagaeldende nomenklaturinstans.
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The Chemical name as given in Annex I to Directive 67/548/EEC, or, if not included in this Directive, in accordance with both IUPAC and CA nomenclature, must be provided.
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1.4. Kemisk navn (IUPAC- og CA-nomenklatur)
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1.5. Manufacturer's development code number(s)
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Det kemiske navn skal anfoeres som angivet i bilag I til direktiv 67/548/EOEF, og hvis det ikke er medtaget i direktivet, i overensstemmelse med saavel IUPAC- som CA-nomenklaturen.
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Code numbers used to identify the active substance, and where available, formulations containing the active substance, during development work, must be reported. For each code number reported, the material to which it relates, the period for which it was used, and the Member States or other countries in which it was used and is being used, must be stated.
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1.5. Fabrikantens udviklingskodenummer (-numre)
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1.6. CAS, EEC and CIPAC numbers (if available)
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Det skal oplyses, hvilke kodenumre der er benyttet til at identificere det aktive stof og eventuelle midler indeholdende stoffet under udviklingsarbejdet. For hvert kodenummer skal oplyses, hvilket teststof det henviser til, i hvilken periode det er anvendt, og i hvilken medlemsstat eller hvilket andet land det har vaeret eller blive anvendt.
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Chemical Abstracts, EEC (EINECS or ELINCS), and CIPAC numbers, where they exist, must be reported.
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1.6. CAS-, EF- og CIPAC-numre (hvis de foreligger)
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1.7. Molecular and structural formula, molecular mass
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Der oplyses eventuelt foreliggende numre i henhold til Chemical Abstracts, EF-fortegnelserne (EINECS eller ELINCS) eller CIPAC.
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The molecular formula, molecular mass and structural formula of the active substance, and where relevant, the structural formula of each stereo and optical isomer present in the active substance, must be provided.
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1.7. Molekylformel og strukturformel samt molekylmasse
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1.8. Method of manufacture (synthesis pathway) of the active substance
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Der anfoeres molekylformel, molekylmasse og strukturformel for det aktive stof samt strukturformel for eventuelle stereoisomerer og optiske isomerer, der er til stede i det aktive stof.
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The method of manufacture, in terms of the identity of the starting materials, the chemical pathways involved, and the identity of by-products and impurities present in the final product, must be provided, for each manufacturing plant. Generally process engineering information is not required.
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1.8. Metoden til fremstilling (syntesevejen) af det aktive stof
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Where the information provided relates to a pilot plant production system, the information required must again be provided once industrial scale production methods and procedures have stabilized.
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Fremstillingsmetoden skal for hvert produktionsanlaeg angives i form af, hvilke udgangsstoffer der benyttes, hvilke kemiske reaktioner der er involveret, og identiteten af de biprodukter og urenheder, der findes i det faerdige produkt. Produktionstekniske oplysninger kraeves i almindelighed ikke.
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1.9. Specification of purity of the active substance in g/kg
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Hvis de givne oplysninger vedroerer et pilotanlaeg, skal oplysningerne gives paa ny, naar metoder og procedurer for den industrielle produktion er blevet stabile.
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The minimum content in g/kg of pure active substance (excluding inactive isomers) in the manufactured material used for production of formulated products, must be reported.
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1.9. Specifikation af renheden af det aktive stof, udtrykt i g/kg
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Where the information provided relates to a pilot plant production system, the information required must again be provided to the Commission and the Member States once industrial scale production methods and procedures have stabilized, if production changes result in a changed specification of purity.
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Mindsteindholdet af rent aktiv stof (inaktive isomerer ikke medregnet) i den tekniske vare, der benyttes til fremstilling af formulerede midler, skal oplyses i g/kg. Hvis de givne oplysninger vedroerer et pilotanlaeg, skal oplysningerne gives paa ny til baade Kommissionen og medlemsstaterne, naar metoder og procedurer for den industrielle produktion er blevet stabile, dog kun hvis produktionsaendringer har medfoert aendringer i renhedsgraden.
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1.10. Identity of isomers, impurities and additives (e.g. stabilizers), together with the structural formula and the content expressed as g/kg
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1.10. Identitet af isomerer, urenheder og tilsaetningsstoffer (f.eks. stabilisatorer) tillige med strukturformel og indhold udtrykt i g/kg
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The maximum content in g/kg of inactive isomers as well as the ratio of the content of isomers/diastereo-isomers, where relevant, must be provided. In addition, the maximum content in g/kg of each further component other than additives, including by-products, and impurities, must be provided. In the case of additives the content in g/kg must be provided.
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Det maksimale indhold af inaktive isomerer skal oplyses i g/kg tillige med forholdet mellem indholdet af eventuelle forskellige isomerer/diastereomerer. Derudover skal det maksimale indhold af alle andre bestanddele end tilsaetningsstoffer, herunder biprodukter, og urenheder oplyses i g/kg. For tilsaetningsstoffer skal indholdet i g/kg oplyses.
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For each component, present in quantities of 1 g/kg or more, the following information, where relevant, must be provided:
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For hver af de komponenter, der findes i en maengde paa mindst 1 g/kg, skal foelgende oplysninger gives, hvor det er relevant:
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- chemical name according to IUPAC and CA nomenclature,
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- kemisk navn ifoelge IUPAC- og CAS-nomenklaturen
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- ISO common name or proposed common name if available,
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- foreslaaet eller accepteret ISO-faellesnavn, hvis det foreligger
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- CAS number, EEC (EINECS or ELINCS) number, and CIPAC number if available,
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- CAS-nummer, EF-nummer (EINECS- eller ELINCS-nummer) og CIPAC-nummer, hvis det foreligger
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- molecular and structural formula,
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- molekylformel og strukturformel
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- molecular mass, and
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- molekylmasse
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- maximum content in g/kg.
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- maksimalt indhold i g/kg.
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Where the manufacturing process is such that impurities and by-products which are particularly undesirable because of their toxicological, ecotoxicological or environmental properties could be present in the active substance, the content of each such compound must be determined and reported. In such cases, the analytical methods used and the limits of determination, which must be sufficiently low, for each compound of concern, must be reported. Additionally the following information, where relevant, must be provided:
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Hvis fremstillingsprocessen er af en saadan art, at der i det aktive stof kan forekomme urenheder og biprodukter, der er saerligt uoenskede som foelge af deres toksikologiske, oekotoksikologiske eller miljoemaessige egenskaber, skal indholdet af samtlige saadanne forbindelser bestemmes og oplyses. I saadanne tilfaelde skal der for hver enkelt af disse forbindelser gives oplysning om, hvilken analysemetode der benyttes, og om bestemmelsesgraensen, der skal vaere passende lav. Derudover skal foelgende oplysninger gives, hvor det er relevant:
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- chemical name according to IUPAC and CA nomenclature,
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- kemisk navn ifoelge IUPAC- og CAS-nomenklaturen
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- ISO common name or proposed common name if available,
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- foreslaaet eller accepteret ISO-faellesnavn, hvis det foreligger
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- CAS number, EEC (EINECS or ELINCS) number, and CIPAC number if available,
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- CAS-nummer, EF-nummer (EINECS- eller ELINCS-nummer) og CIPAC-nummer, hvis det foreligger
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- molecular and structural formula,
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- molekylformel og strukturformel
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- molecular mass, and
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- molekylmasse
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- maximum content in g/kg.
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- maksimalt indhold i g/kg.
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Where the information provided relates to a pilot plant production system, the information required must again be provided once industrial scale production methods and procedures have stabilized, if production changes result in a changed specification of purity.
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Hvis de givne oplysninger vedroerende et pilotanlaeg, skal oplysningerne gives paa ny, naar metoder og procedurer for den industrielle produktion er blevet stabile, dog kun hvis produktionsaendringer har medfoert aendringer i renhedsgraden.
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Where the information provided does not fully identify a component viz. condensates, detailed information on the composition must be provided for each such component.
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Hvis de afgivne oplysninger ikke giver en fuldstaendig identifikation af en bestanddel, f.eks. kondensationsprodukter, skal der anfoeres detaljerede oplysninger om hver enkelt bestanddels sammensaetning.
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The trade name of components added to the active substance, prior to manufacture of formulated product, to preserve stability and facilitate ease of handling, where they are used, must also be provided. Additionally the following information, where relevant, must be provided for such additives:
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Der skal ligeledes give oplysning om handelsnavn for eventuelle bestanddele, der tilsaettes til det aktive stof inden fremstillingen af formulerede produkter for at holde det stabilt eller goere det lettere at haandtere. Desuden skal der for saadanne tilsaetningsstoffer gives foelgende oplysninger, hvor det er relevant:
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- chemical name according to IUPAC and CA nomenclature,
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- kemisk navn ifoelge IUPAC- og CAS-nomenklaturen
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- ISO common name or proposed common name if available,
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- foreslaaet eller accepteret ISO-faellesnavn, hvis det foreligger
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- CAS number, EEC (EINECS or ELINCS) number, and CIPAC number if available,
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- CAS-nummer, EF-nummer (EINECS- eller ELINCS-nummer) og CIPAC-nummer, hvis det foreligger
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- molecular and structural formula,
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- molekylformel og strukturformel
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- molecular mass, and
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- molekylmasse
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- maximum content in g/kg.
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- maksimalt indhold i g/kg.
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For added components, other than active substance and other than impurities resulting from the manufacturing process, the function of the component (additive) must be given:
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For bestanddele, der tilsaettes, dvs. andre bestanddele end det aktive stof og urenheder, der dannes under fremstillingsprocessen, skal det oplyses, hvilken funktion disse bestanddele (tilsaetningsstoffer) har:
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- antifoaming agent,
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- skumdaempende middel
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- antifreeze,
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- frostsikringsmiddel
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- binder,
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- bindemiddel
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- other (specify),
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- buffer
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- buffer,
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- dispergeringsmiddel
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- dispersing agent,
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- stabilisator
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- stabilizer.
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- andet (anfoer naermere).
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1.11. Analytical profile of batches
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1.11 Batchernes analyseprofil
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Representative samples of the active substance must be analysed for content of pure active substance, inactive isomers, impurities and additives, as appropriate. The analytical results reported must include quantitative data, in terms of g/kg content, for all components present in quantities of more than 1 g/kg and typically should account for at least 98 % of the material analysed. The actual content of components which are particularly undesirable because of their toxicological, ecotoxicological or environmental properties, must be determined and reported. Data reported must include the results of the analysis of individual samples and a summary of that data, to show the minimum or maximum and typical content of each relevant component, as appropriate.
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Repraesentative proever af det aktive stof skal analyseres for indhold af rent aktivt stof, inaktive isomerer, urenheder og tilsaetningsstoffer. Analysen skal for hver af de bestanddele, der findes i en maengde paa over 1 g/kg, vaere kvantitativ, og der skal typisk goeres rede for mindst 98 % af det analyserede stof. Det noejagtige indhold af bestanddele, der er saerligt uoenskede som foelge af deres toksikologiske, oekotoksikologiske eller miljoemaessige egenskaber, skal bestemmes og oplyses. Baade resultaterne af analyser af enkeltproever og en sammenfatning af disse data, hvoraf hoejeste eller laveste og typiske indhold af hver relevant bestanddel fremgaar, skal gives.
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Where an active substance is produced in different plants this information must be provided for each of the plants separately.
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Fremstilles et aktivt stof paa forskellige anlaeg, skal disse oplysninger gives for hvert enkelt anlaeg.
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In addition, where available and relevant, samples of the active substance produced in laboratory scale or pilot production systems, must be analyzed, if such material was used in generating toxicological or ecotoxicological data.
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Derudover skal eventuelle relevante proever af det aktive stof, der er fremstillet i laboratorium eller paa pilotproduktionsanlaeg, analyseres, hvis dette stof er blevet brugt til at frembringe toksikologiske eller oekotoksikologiske data.
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2. Physical and chemical properties of the active substance
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2. Det aktive stofs fysiske og kemiske egenskaber
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(i) The information provided, must describe the physical and chemical properties of active substances and together with relevant information, must serve to characterize them. In particular, the information provided must permit:
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i) De angivne oplysninger skal beskrive de aktive stoffers fysiske og kemiske egenskaber, og de skal sammen med anden relevant information kunne karakterisere stofferne. Navnlig skal oplysningerne give mulighed for
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- physical, chemical, and technical hazards associated with active substances, to be identified,
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- at identificere, hvilke fysiske, kemiske og tekniske farer der maatte vaere forbundet med de aktive stoffer
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- classification of active substance as to harzard,
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- at klassificere de aktive stoffer efter farlighed
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- appropriate restrictions and conditions to be associated with inclusions in Annex I to be selected, and
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- at fastsaette passende begraensninger og betingelser i forbindelse med optagelse i bilag I
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- appropriate risk and safety phrases to be specified.
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- at specificere passende risiko- og sikkerhedssaetninger.
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The information and data referred to are required for all active substances, except where otherwise specified.
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Oplysninger og data kraeves for samtlige aktive stoffer, medmindre andet er anfoert.
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(ii) The information provided, taken together with that provided for relevant preparations, must permit the physical, chemical hazards associated with preparations, to be identified, permit preparations to be classified, and permit establishment that preparations can be used without unnecessary difficulty, and be such that exposure of man, animals, and the environment is minimized, taking account of manner of use.
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ii) De angivne oplysninger skal sammen med oplysninger, der gives for relevante praeparater, give mulighed for at identificere, hvilke fysiske, kemiske og tekniske farer der maatte vaere forbundet med praeparaterne, at klassificere praeparaterne, og at godtgoere, at praeparaterne kan anvendes uden unoedige vanskeligheder og paa en saadan maade, at mennesker, dyr og miljoe eksponeres mindst muligt under hensyn til anvendelsesmaaden.
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(iii) The extent to wich active substances of which inclusion in Annex I is sought, comply with relevant FAO specifications, must be stated. Divergences from FAO specifications must be described in detail, and justified.
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iii) Det skal angives, i hvilket omfang aktive stoffer, der soeges optaget i bilag I, opfylder relevante FAO-specifikationer. Afvigelser fra FAO-specifikationer skal beskrives detaljeret og begrundes.
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(iv) In certain specified instances, tests must be conducted using purified active substance of stated specification. In such cases the principles of the method(s) of purification must be reported. The purity of such test material, which must be as high as can be achieved using the best available technology, must be reported. A reasoned justification must be provided in cases where the degree of purity achieved is less than 980 g/kg.
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iv) I visse naermere angivne tilfaelde skal proever udfoeres paa kemisk rent stof med angivet specifikation. I saadanne tilfaelde skal den eller de benyttede oprensningsmetoders principper oplyses. Saadant teststofs renhed, som skal vaere saa hoej, som den bedste tilgaengelige teknologi tillader, skal oplyses. Der skal gives en udfoerlig begrundelse i de tilfaelde, hvor den opnaaede renhed er mindre end 980 g/kg.
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Such justification must demonstrate that all technically feasible and reasonable possibilities for the production of the pure active substance have been exhausted.
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I begrundelsen skal det godtgoeres, at alle teknisk gennemfoerlige og rimelige muligheder for at fremstille det rene aktive stof er udnyttet.
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2.1. Melting point and boiling point
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2.1. Smeltepunkt og kogepunkt
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2.1.1. The melting point or where appropriate the freezing or solidification point of purified active substance must be determined and reported according to EEC method A 1. Measurements should be taken up to 360 °C.
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2.1.1. Smeltepunkt eller hvis relevant fryse/stoerkningspunkt for det rene aktive stof skal bestemmes og oplyses efter EOEF-metode A.1.
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2.1.2. Where appropriate the boiling point of purified active substances must be determined and reported according to EEC method A 2. Measurements should be taken up to 360 °C.
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Der boer foretages maalinger op til 360 °C.
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2.1.3. Where melting point and/or boiling point cannot be determined because of decomposition or sublimation, the temperature at which decomposition or sublimation occurs, must be reported.
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2.1.2. Hvis det er relevant, skal kogepunktet for det rene aktive stof bestemmes og oplyses efter EOEF-metode A.2.
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2.2. Relative density
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Der boer foretages maalinger op til 360 °C.
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In the case of active substances which are liquids or solids, the relative density of the purified active substance must be determined and reported according to EEC method A 3.
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2.1.3. Hvis smeltepunkt og/eller kogepunkt ikke kan bestemmes paa grund af dekomponering eller sublimation, oplyses den temperatur, hvor der sker dekomponering eller sublimation.
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2.3. Vapour pressure (in Pa), volatility (e.g. Henry's law constant)
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2.2. Relativ massefylde
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2.3.1. The vapour pressure of purified active substance must be reported according to EEC method A 4. Where vapour pressure is less than 10-5 Pa, the vapour pressure at 20 or 25 °C may be estimated by a vapour pressure curve.
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For flydende eller faste aktive stoffer skal det rene aktive stofs relative massefylde bestemmes og oplyses efter EOEF-metode A 3.
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2.3.2. In the case of active substances which are solids or liquids, volatility (Henry's law constant) of purified active substance must be determined or calculated from its water solubility and vapour pressure and be reported (in Pa × m3 × mol 1).
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2.3. Damptryk (i Pa), flygtighed (f.eks. Henrys lov konstant)
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2.4. Appearance (physical state, colour and odour; if known)
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2.3.1. Damptrykket for det rene aktive stof skal oplyses efter EOEF-metode A.4. Hvis damptrykket er lavere end 10 5 Pa, kan damptrykket ved 20 eller 25 °C skoennes ved hjaelp af en damptrykskurve.
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2.4.1. A description of both the colour, if any, and the physical state of both the active substance as manufactured and purified active substance, must be provided.
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2.3.2. For flydende eller faste aktive stoffer skal flygtigheden (Henrys lov konstant) af det rene aktive stof bestemmes eller beregnes ud fra dets vandoploeselighed og damptryk og oplyses (i Pa × m3 × mol 1).
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2.4.2. A description of any odour associated with the active substance as manufactured and purfied active substance, noted when handling the materials in laboratories or production plants, must be reported.
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2.4. Udseende (fysisk tilstand, farve og lugt, hvis kendt)
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2.5. Spectra (UV/VIS, IR, NMR, MS), molecular extinction at relevant wavelengths
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2.4.1. Der skal gives en beskrivelse af baade eventuel farve og fysisk tilstandsform af det aktive stof, baade som teknisk vare og som rent stof.
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2.5.1. The following specta including a table of signal characteristica needed for interpretation must be determined and reported: Ultraviolet/Visible (UV/VIS), infrared (R), nuclear magnetic resonance (NMR), and mass spectra (MS) of purified active substance and molecular extinction at relevant wavelengths, must be determined and reported.
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2.4.2. Der skal gives en beskrivelse af enhver lugt, som forbindes med det aktive stof, baade som teknisk vare og som rent stof, og som bemaerkes ved haandtering af materialet i laboratoriet eller i produktionsanlaegget.
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The wavelengths at which UV/visible molecular extinction occurs are to be determined and reported and must include where appropriate a wavelength at the highest absorption value above 290 nm.
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2.5. Spektre (UV/VIS, IR, NMR, MS) molaer ekstinktion ved relevante boelgelaengder
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In the case of active substances which are resolved optical isomers their optical purity must be measured and reported.
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2.5.1. Der skal for rene aktive stoffer optages og oplyses foelgende spektre vedlagt en tabel over de karakteristiske signaler, der er noedvendige for fortolkningen; ultraviolet/synligt lys (UV/VIS), infraroed (IR), kernemagnetisk resonans (NMR) og massespektrum (MS); desuden skal den molaere ekstinktion bestemmes ved relevante boelgelaengder og oplyses.
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2.5.2. The UV/visible absorption spectra, IR, NMR and MS spectra, where necessary for the identification of the impurities considered to be of toxicological, ecotoxicological or environmental significance must be determined and reported.
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De boelgelaengder, ved hvilken den molaere UV/VIS-ekstinktion sker, skal bestemmes og oplyses og skal, hvis det er relevant, inkludere den boelgelaengde over 290 nm med den hoejeste absorbans.
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2.6. Solubility in water including effect of pH (4 to 10) on solubility
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For aktive stoffer, der er adskilte optiske isomerer, skal den optiske renhed maales og oplyses.
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The water solubility of purified active substances under atmospheric pressure must be determined and reported according to EEC method A 6. These water solubility determinations must be made in the neutral range (i.e. in distilled water in equilibrium with atmospheric carbon dioxide). Where the active substance is capable of forming ions, determinations must also be made in the acidic range (pH 4 to 6) and in the alkaline range (pH 8 to 10), and be reported. Where the stability of the active substance in aqueous media is such that water solubility cannot be determined, a justification based on test data must be provided.
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2.5.2. Der skal optages og oplyses UV/VIS-absorptionsspektre, IR-, NMR- og MS-spektre, hvis det er noedvendigt til identifikation af urenheder, der anses for at vaere af toksikologisk, oekotoksikologisk eller miljoemaessig betydning.
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2.7. Solubility in organic solvents
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2.6. Oploeselighed i vand, herunder pH-vaerdiens (4 til 10) indvirkning paa oploeseligheden
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The solubility of the active substances as manufactured in the following organic solvents at 15 to 25 °C must be determined and reported if less than 250 g/kg; the temperature applied must be specified:
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Det rene aktive stofs vandoploeselighed under atmosfaerisk tryk skal bestemmes og oplyses efter EOEF-metode A.6. Disse bestemmelser af vandoploeseligheden skal foretages i det neutrale omraade (dvs. i destilleret vand i ligevaegt med luftens kuldioxid). Hvis det aktive stof kan danne ioner, skal der ogsaa bestemmes og oplyses vaerdier for det sure (pH 4 til 6) og det basiske (pH 8 til 10) omraade. Hvis det aktive stof har en saa ringe stabilitet i vandigt medium, at vandoploeseligheden ikke kan bestemmes, skal der gives en begrundelse, der underbygges med analysedata.
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- Aliphatic hydrocarbon: preferably n-heptane,
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2.7. Oploeselighed i organiske oploesningsmidler
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- Aromatic hydrocarbon: preferably xylene,
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Oploeseligheden ved 15 til 25 °C af det aktive stof som teknisk vare i foelgende organiske oploesningsmidler skal bestemmes og oplyses, hvis den er mindre end 250 g/kg med angivelse af den anvendte temperatur:
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- Halogenated hydrocarbon: preferably 1,2-dichlorethane,
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- alifatisk kulbrinte: helst n-heptan
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- Alcohol: preferably methanol or isopropyl alcohol,
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- aromatisk kulbrinte: helst xylen
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- Ketone: preferably acetone,
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- halogeneret kulbrinte: helst 1,2-dichlorethan
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- Ester: preferably ethyl acetate.
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- alkohol: helst methanol eller isopropylalkohol
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If for a particular active substance, one or more of these solvents is unsuitable (e.g. reacts with test material), alternative solvents can be used instead. In such cases, choices made must be justified in terms of their structure and polarity.
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- keton: helst aceton
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2.8. Partition coefficient n-octanol/water including effect of pH (4 to 10)
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- ester: helst ethylacetat.
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The n-octanol/water partition coefficient of purified active substance must be determined and reported according to EEC method A 8. The effect of pH (4 to 10) must be investigated when the substance is acidic or basic as defined by its pKa value (< 12 for acids, >2 for bases).
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Hvis et eller flere af disse oploesningsmidler er uegnet for et bestemt aktivt stof (f.eks. fordi det reagerer med stoffet), kan der benyttes andre oploesningsmidler i stedet for. I saa fald skal valget begrundes ud fra struktur- og polaritetshensyn.
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2.9. Stability in water, hydrolysis rate, photochemical degradation, quantum yield and identity of breakdown product(s), dissociation constant including effect of pH (4 to 9)
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2.8. Fordelingskoefficient n-octanol/vand, herunder pH-vaerdiens (4 til 10) indvirkning herpaa
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2.9.1. The hydrolysis rate of purified active substances (usually radiolabelled active substance, >95 % purity), for each of the pH values 4, 7 and 9, under sterile conditions, in the absence of light, must be determined and report according to EEC method C 7. For substances with a low rate of hydrolysis, the rate can be determined at 50 °C, or another appropriate temperature.
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Det rene aktive stofs fordelingskoefficient n/octanol/vand skal bestemmes og oplyses efter EOEF-metode A.8. pH-vaerdiens (4 til 10) indvirkning herpaa skal undersoeges, hvis stoffet er surt eller basisk (pKa< 12 for syrer, pKa >2 for baser).
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If degradation is observed at 50 °C, degradation rate at another temperature must be determined, and an Arrhenius plot must be constructed to permit an estimate to be made of hydrolysis at 20 °C. The identity of hydrolysis products formed and the rate constantly observed, must be reported. The estimated DT 50 value must also be reported.
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2.9. Stabilitet i vand, hydrolysehastighed, fotokemisk nedbrydning, kvanteudbytte og nedbrydningsprodukters identitet, dissociationskonstant, herunder pH-vaerdiens (4 til 9) indvirkning herpaa
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2.9.2. For compounds with a molar (decadic) absorption coefficient (e) > 10 (1 × mol 1 × cm 1) at a wavelength l & ge; 290 nm, direct phototransformation in purified (e.g. distilled) water at 20 to 25 °C, of purified active substance usually radio labelled using artificial light under sterile conditions, if necessary using a solubilizer, must be determined and reported. Sensitizers such as acetone must not be used as a cosolvent or solubilizer. The light source must simulate sunlight and be equipped with filters to exclude radiation at wavelengths l < 290 nm. The identity of breakdown products formed which at any time during the study are present in quantities & ge; 10 % of the active substance added, a mass balance to account for at least 90 % of the applied radioactivity, as well as photochemical halflife must be reported.
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2.9.1. Hydrolysehastigheden for det rene aktive stof (normalt radioaktivt maerket aktivt stof af >95 % renhed) skal bestemmes og oplyses efter EOEF-metode C.7. ved 20 ± 0,5 °C, under sterile forhold og i moerke ved pH 4, 7 og 9. For stoffer med lav hydrolysehastighed kan denne bestemmes ved 50 °C eller en anden passende temperatur. Hvis der iagttages nedbrydning ved 50 °C, skal nedbrydningshastigheden bestemmes ved en anden temperatur, og der skal optegnes et Arrhenius-diagram, saa hydrolysen ved 20 °C kan skoennes. Hydrolyseprodukternes identitet og den iagttagne hastighedskonstant skal oplyses. Den anslaaede DT50-vaerdi skal ogsaa oplyses.
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2.9.3. Where necessary to investigate direct phototrans-formation, the quantum yield of direct photodegradation in water must be determined and reported, together with calculations to estimate theoretical lifetime of the active substance in the top layer of aqueous systems and the real lifetime of the substance.
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2.9.2. For forbindelser med en molaer (dekadisk) absorptionskoefficient > 10 (1 × mol 1 × cm 1) ved en boelgelaengde & ge; 290 nm skal den direkte fotonedbrydning i rent (f.eks. destilleret) vand af det rene aktive stof, normalt radioaktivt maerket bestemmes ved 20 til 25 °C ved hjaelp af kunstigt lys under sterile forhold, om noedvendigt ved hjaelp af et oploesende stof, og oplyses. Sensitizers saasom acetone maa ikke benyttes som cosolvent eller oploesende stof. Lyskilden skal simulere sollys og vaere forsynet med filtre, som udelukker for straaling med boelgelaengder < 290 nm. Der skal endvidere gives oplysning om identiteten af dannede nedbrydningsprodukter, der paa noget tidspunkt findes i en maengde paa & ge; 10 % af det tilsatte aktive stof, en massebalance, som goer rede for mindst 90 % af den tilsatte radioaktivitet, samt den fotokemiske halveringstid.
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The method is described in the FAO Revised Guidelines on Environmental Criteria for the Registration of Pesticides .
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2.9.3. Hvis det er paakraevet at undersoege direkte fotoomdannelse, skal kvanteudbytte ved direkte fotonedbrydning i vand bestemmes og oplyses tillige med beregnede skoen over det aktive stofs teoretiske halveringstid i de oevre lag i vandige systemer og stoffets faktiske halveringstid.
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2.9.4. Where dissociation in water occurs, the dissociation constant(s) (pKa values) of the purified active substance must be determined and reported according to OECD Test Guideline 112. The identity of the dissociated species formed, based on theoretical considerations, must be reported. If the active, substance is a salt, the pKa value of the active principle must be given.
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Metoden er beskrevet i FAO Revised Guidelines on Environmental Criteria for the Registration of Pesticides.
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2.10. Stability in air, photochemical degradation, identity of breakdown product(s)
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2.9.4. Hvis der sker dissociation i vand, skal det oprensede aktive stofs dissociationskonstant (-konstanter) pKa-vaerdier) bestemmes og oplyses efter OECD Test Guideline 112. Identiteten af dissociationsprodukterne ifoelge teoretiske overvejelser skal oplyses. Hvis det aktive stof er et salt, skal det aktive stofs pKa-vaerdi oplyses.
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An estimation of the photochemical oxidative degradation (indirect hototransformation) of the active substance, must be submitted.
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2.10. Stabilitet i luft, fotokemisk nedbrydning, nedbrydningsprodukters identitet
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2.11. Flammability including auto-flammability
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Der skal fremlaegges et skoen over det aktive stofs fotokemiske oxidative nedbrydning (indirekte fotoomdannelse).
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2.11.1. The flammability of active substances as manufactured, which are solids, gases, or are substances which evolve highly flammable gases, must be determined and reported according to EEC method A 10, A 11 or A 12 as as appropriate.
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2.11. Antaendelighed, herunder selvantaendelighed
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2.11.2. The auto-flamability of active substances as manufactured must be determined and reported according to EEC method A 15 or A 16 as appropriate, and/or, where necessary according to the UN-Bowes-Cameron-Cage-Test (UN-Recommendations on the Transport of Dangerous Goods, Chapter 14, No 14.3.4).
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2.11.1. Antaendeligheden af aktive stoffer, der som teknisk vare foreligger som fast stof, gas eller et stof, der udvikler let antaendelige gasarter, skal bestemmes og oplyses efter EOEF-metode A.10, A.11 eller A.12.
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2.12. Flash point
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2.11.2. Selvantaendeligheden af aktive stoffer som teknisk vare skal bestemmes og oplyses efter EOEF-metode A.15 eller A.16 og/eller, hvis det er relevant, efter UN-Bowes-Cameron-Cage-Test (UN-Recommendations on the Transport of Dangerous Goods, Chapter 14, Nr. 14.3.4).
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The flash point of active substances as manufactured with a melting point below 40 °C, must be determined and reported according to EEC method A 9; only closed cup methods should be used.
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2.12. Flammepunkt
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2.13. Explosive properties
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Flammepunktet for aktive stoffer som teknisk vare med smeltepunkt under 40 °C skal bestemmes og oplyses efter EOEF-metode A.9; der boer kun anvendes metoder med lukket digel.
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The explosive properties of active substances as manufactured, must be determined and reported according to EEC method A 14 where necessary.
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2.13. Eksplosive egenskaber
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2.14. Surface tension
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De eksplosive egenskaber af aktive stoffer som teknisk vare skal bestemmes og oplyses efter EOEF-metode A.14, hvis det er relevant.
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The surface tension has to be determined and reported according to EEC method A 5.
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2.14. Overfladespaendingen skal bestemmes og oplyses efter EOEF-metode A.5.
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2.15 Oxidizing properties
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2.15 Oxiderende egenskaber
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The oxidizing properties of active substances as manufactured, must be determined and reported according to EEC method A 17, except where examination of its sturctural formula, establishes beyond reasonable doubt that the active substance is incapable of reacting exothermically with a combustible material. In such cases, it is sufficient to provide that information as justification for not determining the oxidizing properties of the substance.
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De oxiderende egenskaber af aktive stoffer som teknisk vare skal bestemmes og oplyses efter EOEF-metode A.17, undtagen hvis det paa grundlag af stoffets strukturformel er haevet over enhver rimelig tvivl, at stoffet ikke kan reagere exotermt med braendbart materiale. I saadanne tilfaelde er det tilstraekkeligt at fremlaegge denne oplysning som begrundelse for, at stoffets oxiderende egenskaber ikke er bestemt.
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3. Further information on the active substance
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3. Yderligere oplysninger om det aktive stof
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(i) The information provided must describe the intended purposes for which preparations containing the active substance are used, or are to be used and the dose and manner of their use or proposed use.
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i) De givne oplysninger skal beskrive det formaal, som praeparater indeholdende det aktive stof anvendes til eller agtes anvendt til, samt i hvilken dosis og paa hvilken maade de anvendes eller skal anvendes.
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(ii) The information provided must specify the normal methods and precautions to be followed, in the handling, storage and transport of the active substance.
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ii) De givne oplysninger skal omfatte en beskrivelse af, hvilke metoder og forholdsregler der normalt skal foelges ved haandtering, oplagring og transport af det aktive stof.
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(iii) The studies, data and information submitted, together with other relevant studies, data and information, must both specify and justify the methods and precautions to be followed in the event of fire. The possible products of combustion in the event of fire should be estimated, based on the chemical structure and the chemical and physical properties of the active substance.
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iii) De fremlagte undersoegelser, data og oplysninger skal sammen med andre relevante undersoegelser, data og oplysninger omfatte en beskrivelse af og en begrundelse for, hvilke metoder og forholdregler der skal foelges i tilfaelde af brand. Det boer vurderes, hvilke forbraendningsprodukter der eventuelt kan udvikles ved brand paa grundlag af det aktive stofs kemiske struktur og kemiske og fysiske egenskaber.
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(iv) The studies, data and information submitted, together with other relevant studies, data and information, must demonstrate the suitability of measures proposed for use in emergency situations.
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iv) De fremlagte undersoegelser, data og oplysninger skal sammen med andre relevante undersoegelser, data og oplysninger godtgoere, at de foreslaaede noedforanstaltninger er hensigtsmaessige.
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(v) The informaton and data referred to are reqired for all active substances, except where otherwise specified.
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v) Oplysninger og data kraeves for samtlige aktive stoffer, medmindre andet er anfoert.
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3.1. Function, e.g. fungicide, herbicide, insecticide, repellant, growth regulator
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3.1. Funktion, f.eks. fungicid, herbicid, insecticid, afskraekningsmiddel eller vaekstreguleringsmiddel
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The function must be specified from among the following:
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Funktionen skal angives ved et af foelgende udtryk:
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- acaricide
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- acaricid
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- bactericide
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- bactericid
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- fungicide
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- fungicid
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- herbicide
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- herbicid
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- insecticide
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- insecticid
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- molluscicide
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- molluscicid
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- nematicide
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- nematicid
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- plant growth regulator
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- plantevaekstreguleringsmiddel
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- repellant
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- afskraekningsmiddel (repellant)
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- rodenticide
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- rodenticid
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- semio-chemicals
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- semiokemikalier
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- talpicide
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- talpicid
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- viricide
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- viricid
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- other (must be specified)
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- andet (anfoer naermere).
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3.2. Effects on harmful organisms, e.g. contact poison, inhalation poison, stomach poison, fungitoxic, etc. systematic or not in plants
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3.2. Virkninger paa skadelige organismer, f.eks. ved kontakt, indaanding eller som mavegift, fungitoksisk eller fungistatisk middel osv., evt. systemisk i planter
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3.2.1. The nature of the effects on harmful organisms must be stated:
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3.2.1. Arten af virkningerne paa skadelige organismer skal anfoeres:
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- contact action
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- virkning ved kontakt
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- stomach action
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- virkning via maven
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- inhalation action
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- virkning ved indaanding
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- fungitoxic action
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- fungitoksisk virkning
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- fungistatic action
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- fungistatisk virkning
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- desiccant
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- udtoerrende virkning
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- reproduction inhibitor
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- reproduktionshaemmende virkning
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- other (must be specified)
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- andet (anfoer naermere).
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3.2.2. It must be stated whether or not the active substance is translocated in plants and where relevant whether such translocation is apoplastic, symplastic or both.
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3.2.2. Det skal angives, om det aktive stof translokerer i planter, og i givet fald om translokationen er apoplastisk eller symplastisk eller begge dele.
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3.3. Field of use envisaged, e.g. field, protected crops, storage of plant products, home gardening
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3.3. Paataenkte anvendelsesomraader, f.eks. markanvendelse, beskyttede afgroeder, oplagring af planteprodukter, private haver
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The field(s) of use, existing and proposed, for preparations containing the active substance must be specified from among the following:
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Eksisterende og paataenkte anvendelsesomraader for praeparater, der indeholder det aktive stof, skal specificeres blandt foelgende:
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- Field use, such as agriculture, horticulture, forestry and viticulture
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Markanvendelse, saasom landbrug, gartneri, skovbrug og vindyrknig:
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- Protected crops
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- beskyttede afgroeder
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- Amenity
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- rekreative omraader
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- Weed control on non-cultivated areas
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- ukrudtsbekaempelse paa udyrkede arealer
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- Home gardening
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- private haver
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- House plants
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- stueplanter
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- Plant products storage practice
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- oplagring af planteprodukter
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- Other (specify)
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- andet (anfoer naermere).
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3.4. Harmful organisms controlled and crops or products protected or treated
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3.4. Skadevoldende organismer, som skal bekaempes, og afgroeder eller produkter, som oenskes beskyttet eller behandlet
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3.4.1. Details of existing and the intended use in terms of crops, groups of crops, plants, or plant products treated and where relevant protected, must be provided.
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3.4.1. Der skal gives detaljerede oplysninger om eksisterende og paataenkt anvendelse i form af, hvilke afgroeder, afgroedegrupper, planter eller planteprodukter der oenskes behandlet eller beskyttet.
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3.4.2. Where relevant, details of harmful organisms against which protection is afforded, must be provided.
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3.4.2. Der skal gives oplysning om, hvilke eventuelle skadevoldende organismer der ydes beskyttelse mod.
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3.4.3 Where relevant, effects achieved e.g. sprout suppression, retardation of ripening, reduction in stem length, enhanced fertilization etc., must be reported.
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3.4.3 Der skal hvor relevant oplyses om opnaaede virkninger, saasom spiringshaemning, modningsforsinkelse, straaforkortning og foroeget frugtbarhed.
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3.5. Mode of action
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3.5. Virkemaade
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3.5.1. To the extent that is has elucidated, a statement must be provided as to the mode of action of the active substance in terms, where relevant, of the biochemical and physiological mechanism(s) and biochemical pathway(s) involved. Where availble, the results of relevant experimental studies must be reported.
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3.5.1. Der skal afgives en udtalelse om, hvordan det aktive stof virker, udtrykt ved de involverede biokemiske og fysiologiske mekanismer og den biokemiske vej, i det omfang, disse er kendt. Resultaterne af eventuelle relevante eksperimentelle undersoegelser skal oplyses.
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3.5.2. Where it is known that to exert its intended effect, the active substance must be converted to a metabolite or degradation product following application or use of preparations containing it, the following information, cross referenced to and drawing on information provided in the context of paragraphs 5.6, 5.11, 6.1, 6.2, 6.7, 7.1, 7.2 and 9, where relevant, must be provided for active metabolite or degradation product:
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3.5.2. Hvis det vides, at det aktive stof for at udoeve sin tilsigtede virkning skal omdannes til en metabolit eller et nedbrydningsprodukt efter udbringning eller brug af praeparater, som indeholder stoffet, skal nedenstaaende oplysninger opgives for den aktive metabolit eller det aktive nedbrydningsprodukt, idet der i relevante tilfaelde krydshenvises til og bygges paa oplysninger, der gives i punkt 5.6, 5.11, 6.1, 6.2, 6.7, 7.1, 7.2 og 9
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- chemical name according to IUPAC and CA nomenclature,
|
- kemisk navn ifoelge IUPAC- og CAS-nomenklaturen
|
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- ISO common name or porposed common name,
|
- foreslaaet eller accepteret ISO-faellesnavn
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- CAS EEC-number EEC (EINECS or ELINCS) number, and CIPAC number if available,
|
- CAS-nummer, EF-nummer (EINECS- eller ELINCS-nummer) og CIPAC-nummer, hvis det foreligger
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- empirical and structural formula, and
|
- molekylformel og strukturformel
|
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- molecular mass.
|
- molekylmasse.
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3.5.3. Available information relating to the formation of active metabolites and degradation products, must be provided, to include:
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3.5.3. Der skal opgives foreliggende oplysninger om dannelse af aktive metabolitter eller nedbrydningsprodukter, herunder
|
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- the processes, mechanisms and reactions involved,
|
- involverede processer, mekanismer og reaktioner
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- kinetic and other data concerning the rate of conversion and if known the rate limiting step,
|
- kinetikdata og andre oplysninger om omdannelseshastigheden, og det hastighedsbegraensende trin, hvis det er kendt
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- environmental and other factors effecting the rate and extent of conversion.
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- miljoefaktorer og andre faktorer, der indvirker paa omdannelseshastighed og -grad.
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3.6. Information on the occurrence or possible occurrence of the development of resistance and appropriate management strategies
|
3.6. Oplysning om forekomst eller mulig forekomst af resistensudvikling samt om forholdsregler i saa fald
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Where available information on possible occurrence of the development of resistance or cross-resistance must be provided.
|
Eventuelt foreliggende oplysninger om forekomst eller udvikling af krydsresistens skal opgives.
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3.7. Recommended methods and precautions concerning handling, storage, transport or fire
|
3.7. Anbefalede metoder og forholdsregler vedroerende haandtering, oplagring, transport eller brand
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A safety data sheet pursuant to Article 27 of Council Directive 65/548/EEC (1) must be provided for all active substances.
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Der skal forelaegges et sikkerhedsdatablad for alle aktive stoffer, udformet i henhold til artikel 27 i Raadets direktiv 67/548/EOEF (1).
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3.8. Procedures for destruction or decontamination
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3.8. Fremgangsmaader ved destruktion eller dekontaminering
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3.8.1. Controlled incineration
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3.8.1. Kontrolleret forbraending
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In many cases the preferred or sole means to safely dispose of active substances, contaminated materials, or contaminated packaging, is through controlled incineration in a licensed incinerator.
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I mange tilfaelde er den foretrukne eller eneste metode til sikker bortskaffelse af aktive stoffer, kontaminerede materialer eller kontamineret emballage kontrolleret forbraending i et godkendt forbraendingsanlaeg.
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Where the content of halogens of the active substance is greater than 60 %, the pyrolytic behaviour of the active substance under controlled conditions (including where relevant supply of oxygen and defined residence time), at 800 °C and the content of polyhalogenated dibenzo-p-dioxins and dibenzo-furans in the products of pyrolysis must be reported. The application must provide detailed instructions for safe disposal.
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Hvis halogenindholdet i det aktive stof er over 60 %, skal stoffets opfoersel ved pyrolyse under kontrollerede betingelser (med, hvis det er relevant, ilttilfoersel og kendt opholdstid) ved 800 °C samt indholdet af polyhalogenerede dibenzo-p-dioxiner og dibenzo-furaner i pyrolyseprodukterne oplyses. Ansoegeren skal give detaljerede anvisninger om sikker bortskaffelse.
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3.8.2. Others
|
3.8.2. Andet
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Other methods to dispose of the active substance, contaminated packaging and contaminated materials, where proposed, must be fully described. Data must be provided for such methods, to establish their effectiveness and safety.
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Hvis der foreslaas andre metoder til bortskaffelse af det aktive stof, kontaminerede materialer og kontamineret emballage, skal der gives en fuldstaendig beskrivelse af dem. Der skal fremlaegges data for saadanne metoder til dokumentation af, at de er effektive og sikre.
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3.9. Emergency measures in case of an accident
|
3.9. Noedforholdsregler i ulykkestilfaelde
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Procedures for the decontamination of water in case of an accident must be provided.
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Der skal gives procedurer for dekontaminering af vand i ulykkestilfaelde.
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(1) OJ No L 196, 16. 8. 1967, p. 1.
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(1) EFT nr. L 196 af 16. 8. 1967, s. 1.
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ANNEX II
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BILAG II
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1. Identity of the plant protection product
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1. Plantebeskyttelsesmidlets identitet
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The information provided, taken together with that provided for the active substance(s), must be sufficient to precisely identify preparations and define them in terms of their specification and nature. The information and data referred to, unless otherwise specified, are required for all plant protection products.
|
Den indleverede information skal sammen med informationen om de aktive stoffer vaere tilstraekkelig til, at det er muligt praecist at identificere praeparater og definere dem efter art og specifikke egenskaber. De omhandlede oplysninger og data kraeves for alle plantebeskyttelsesmidler, medmindre andet er anfoert.
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1.1. Applicant (name and address, etc.)
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1.1. Ansoeger (navn, adresse mv.)
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The name and address of the applicant (permanent community address) must be provided as must the name, position, telephone and telefax number of the appropriate person to contact.
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Ansoegerens navn og adresse (fast adresse i EF) skal oplyses. Det samme gaelder navn, stilling og telefon- og telefaxnummer for kontaktperson.
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Where in addition, the applicant has an office, agent or representative in the Member State in which the authorization is being sought, the name and address of the local office agent or representative should be provided, as should the name, position, telephone and telefax number of the appropriate person to contact.
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Har ansoegeren desuden et kontor, en agent eller en repraesentant i den medlemsstat, hvori der soeges om godkendelse, skal navn og adresse paa det lokale kontor, den lokale agent eller den lokale repraesentant oplyses tillige med navn, stilling og telefon- og telefaxnummer for en kontaktperson.
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1.2. Manufacturer of the preparation and the active substance(s) (names and addresses etc. including location of plants)
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1.2. Fabrikanten af praeparatet og de(t) aktive stof(fer) (nanv og adresse mv., herunder produktionsanlaeggenes beliggenhed)
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The name and address of the manufacturer of the preparation and of each active substance in the preparation must be provided as must the name and address of each manufacturing plant in which the preparation and active substance are manufactured.
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Navn og adresse paa fabrikanten af praeparatet og af hvert af de aktive stoffer i praeparatet skal oplyses tillige med navn og adresse paa hvert enkelt produktionsanlaeg hvor praeparatet og det aktive stof fremstilles. I hvert enkelt tilfaelde oplyses en kontaktmulighed (helst en central kontaktmulighed omfattende navn og telefon- og telefaxnummer).
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A contact point (preferable a central contact point, to include name, telephone and telefax numbers) must be provided for each.
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Hvis det aktive stof hidroerer fra en fabrikant, som ikke tidligere har indsendt data i henhold til bilag II, skal der fremlaegges detaljerede oplysninger om dets renhed og indhold af urenheder som kraevet i bilag II.
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If the active substance originates from a manufacturer from which data according to Annex II had not been submitted previously, a statement of purity and detailed information on the impurities in Annex II have to be provided.
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1.3. Handelsnavn eller foreslaaet handelsnavn samt fabrikantens eventuelle udviklingskodenummer for praeparatet
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1.3. Trade name or proposed trade name, and manufacturer's development code number of the preparation if appropriate
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Alle tidligere og nuvaerende handelsnavne og foreslaaede handelsnavne samt udviklingskodenumre for praeparatet saavel som de nuvaerende navne og numre skal oplyses. Hvor de paagaeldende handelsnavne og kodenumre har relation til lignende, men forskellige (eventuelt foraeldede) praeparater, oplyses alle enkeltheder vedroerende forskellene. (Det foreslaaede handelsnavn maa ikke give anledning til forveksling med allerede registrerede plantebeskyttelsesmidlers handelsnavn.)
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All former and current trade names and proposed trade names and development code numbers of the preparation as well as the current names and numbers must be provided. Where trade names and code numbers referred to, relate to similar but different preparations (possibly absolete), full details of the differences, must be provided. (The proposed trade name may not give rise to confusion with the trade name of already registered plant protection products.)
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1.4. Detaljerede kvantitative og kvalitative oplysninger om praeparatets sammensaetning (aktivt(-e) stof(fer), hjaelpestoffer)
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1.4. Detailed quantitative and qualitative information on the composition of the preparation (active substance(s), and formulants)
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1.4.1. For praeparater skal foelgende oplysninger gives:
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1.4.1. For preparations the following information must be reported:
|
- indholdet af aktivt stof, baade teknisk kvalitet og i ren form
|
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- the content of both technical active substance(s) and pure active substance(s);
|
- indholdet af hjaelpestoffer.
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- the content of formulants.
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Koncentrationerne boer angives som omhandlet i artikel 6, stk. 2, i direktiv 78/631/EOEF.
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The concentrations should be expressed in terms as provided for in Article 6 (2) of Directive 78/631/EEC.
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1.4.2. For aktive stoffer angives deres ISO-faellesnavn eller foreslaaede ISO-faellessnavn og deres CIPAC-nummer og, hvis de foreligger, deres EOEF-numre (EINECS eller ELINCS). Hvor det er relvant, oplyses, hvilket salt eller hvilken ester, anion eller kation der er tale om.
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1.4.2. For active substances their ISO common names or proposed ISO common names and their CIPAC numbers, and, where available, the EEC (EINECS or ELINCS) numbers must be provided. Where relevant it must be stated which salt, ester, anion or cation is present.
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1.4.3. Hjaelpestoffer skal, hvor det er muligt, identificeres ved deres kemiske navn som anfoert i bilag I til direktiv 67/548/EOEF, eller, hvis dette ikke er medtaget i direktivet, i henhold til baade IUPAC-reglerne og CAS-nomenklaturen. Deres struktur eller strukturformel anfoeres. For hver bestanddel af hjaelpestofferne skal dens eventuelle EOEF-nummer (EINECS eller ELINCS) og CAS-nummer anfoeres. Hvor de anfoerte oplysninger ikke giver fuldstaendig identifikation af et hjaelpestof, skal der anfoeres en passende specifikation. Et eventuelt handelsnavn for hjaelpestoffer skal ligeledes oplyses.
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1.4.3. Formulants must where possible, be identified both by their chemical name as given in Annex I to Directive 67/548/EEC, or, if not included in this Directive, in accordance with both IUPAC and CA nomenclature. Their structure or structural formula must be provided. For each component of the formulants the relevant EEC (EINECS or ELINCS) number and CAS number where they exist, must be provided. Where the information provided does not fully identify a formulant, an appropriate specification must be provided. The trade name of formulants, where they exist, must also be provided.
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1.4.4. For hjaelpestoffer skal funktionen oplyses:
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1.4.4. For formulants the function must be given:
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- adsorbant (klaebemiddel)
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- adhesive (sticker),
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- skumdaempende middel
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- antifoaming agent,
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- frostsikringsmiddel
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- antifreeze,
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- bindemiddel
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- binder,
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- buffer
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- buffer,
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- baerestof
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- carrier,
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- deodorant
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- deodorant,
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- dispergeringsmiddel
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- dispersing agent,
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- farve
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- dye,
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- braekmiddel
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- emetic,
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- emulgator
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- emulsifier,
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- goedning
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- fertilizer,
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- konserveringsmiddel
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- preservative,
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- duftstof
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- odourant,
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- parfume
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- perfume,
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- drivmiddel
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- propellant,
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- afskraekningsmiddel (repellant)
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- repellent,
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- »safener«
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- safener,
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- oploesningsmiddel
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- solvent,
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- stabilisator
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- stabilizer,
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- synergist
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- synergist,
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- fortykningsmiddel
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- thickener,
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- befugtningsmiddel
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- wetting agent,
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- andet (anfoer naermere).
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- miscellaneous (specify).
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1.5. Praeparatets fysiske tilstandsform og art (emulsionskoncentrat; vanddispergerbart pulver; oploesning osv.)
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1.5. Physical state and nature of the preparation (emulsifiable concentrate, wettable powder, solution etc).
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1.5.1. Praeparatets type og kode skal angives i overensstemmelse med »Catalogue of pesticide formulation types and international coding system (GIFAP Technical Monograph no 2, 1989)«.
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1.5.1. The type and code of preparation must be designated according to the 'Catalogue of pesticide formulation types and international coding system (GIFAP Technical Monograph No 2. 1989)'.
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Hvor et bestemt praeparat ikke er praecist defineret i denne publikation, skal der gives en fuldstaendig beskrivelse af praeparatets fysiske art og tilstandsform tillige med et forslag til en egnet beskrivelse af praeparatets type og et forslag til definition af det.
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Where a particular preparation is not defined precisely in this publication a full description of the physical nature and state of the preparation must be provided, together with a proposal for a suitable description of the type of preparation and a proposal for its definition.
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1.6. Funktion (herbicid, insecticid, m.v.)
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|
1.6. Function (herbicide, insecticide, etc.)
|
Funktionen skal anfoeres ved et af foelgende udtryk:
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The function must be specified from among the following:
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- acaricid
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- acaricide,
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- bactericid
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- bactericide,
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- fungicid
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|
- fungicide,
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- herbicid
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- herbicide
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- insecticid
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- insecticide,
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- molluscicid
|
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- molluscicide,
|
- nematicid
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- nematicide,
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- vaekstreguleringsmiddel
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- plant growth regulator,
|
- afskraekningsmiddel (repellant)
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- repellant,
|
- rodenticid
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- rodenticide,
|
- semiokemikalier
|
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- semio-chemicals,
|
- talpicid
|
|
- talpicide,
|
- viricid
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|
- viricide,
|
- andet (anfoer naermere).
|
|
- other (must be specified).
|
2. Plantebeskyttelsesmidlets fysiske, kemiske og tekniske egenskaber
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|
2. Physical, chemical and technical properties of the plant protection product
|
Det angives, i hvilken udstraekning plantebeskyttelsesmidler, som der ansoeges om godkendelse af, opfylder relvante FAO-specifikationer som vedtaget i gruppen for pesticidspecifikationer under FAO-ekspertpanelet for pesticidspecifikationer, registreringskrav og anvendelsesstandarder. Afvigelser fra FAO-specifikationer skal beskrives detaljeret og begrundes.
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|
The extent to which plant protection products for which authorization is sought, comply with relevant FAO specifications as agreed by the Group of Experts on Pesticide Specifications, of the FAO Panel of Experts on Pesticide Specifications, Registration Requirements and Application Standards, must be stated. Divergences from FAO specifications must be described in detail, and justified.
|
2.1. Udseende (farve og lugt)
|
|
2.1. Appearance (colour and odour)
|
Der gives en beskrivelse af baade farve og eventuel lugt samt af praeparatets fysiske tilstansform.
|
|
A description of both the colour and odour, if any, and the physical state of the preparation, must be provided.
|
2.2. Eksplosive og oxiderende egenskaber
|
|
2.2. Explosivity and oxidizing properties
|
2.2.1. Praeparatets eksplosive egenskaber skal oplyses i henhold til EOEF-metode A.14. Hvor det ud fra de foreliggende termodynamiske oplysninger er haevet over enhver rimelig tvivl, at en exotermisk reaktion i praeparatet er udelukket, er det tilstraekkeligt at oplyse dette som begrundelse for, at praeparatets eksplosive egenskaber ikke er bestemt.
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|
2.2.1. The explosive properties of preparations must be reported according to EEC method A 14. Where available thermodynamic information establishes beyond reasonable doubt that the preparation is incapable of exothermic reaction, it is sufficient to provide that information as a justification for not determining the explosive properties of the preparation.
|
2.2.2. Oxiderende egenskaber hos praeparater, som er i fast form, skal bestemmes og oplyses efter EOEF-metode A.17. For andre praeparater skal den anvendte metode begrundes. Det er ikke noedvendigt at fastslaa de oxiderende egenskaber, hvis det paa grundlag af termodynamiske oplysninger er haevet over enhver rimelig tvivl, at praeparatet ikke kan reagere exotermt med braendbare materialer.
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|
2.2.2. Oxidizing properties of preparations which are solids must be determined and exported according to EEC method A 17. For other preparations the method used must be justified. The oxidizing properties do not have to be determined if it can be shown without reasonable doubt on the basis of thermodynamic information, that the preparation is incapable of reacting exothermically with combustible materials.
|
2.3. Flammepunkt og andre angivelser af antaendelighed eller selvantaendelighed
|
|
2.3. Flash point and other indications of flammability or spontaneous ignition
|
Flammepunktet for vaesker, som indeholder antaendelige oploesningsmidler skal bestemmes og oplyses efter EOEF-metode A.9. Fast praeparaters og gassers antaendelighed skal bestemmes og oplyses efter EOEF-metode A.10, A.11, eller A.12. Praeparaternes selvantaendelighed skal bestemmes og oplyses efter EOEF-metode A. 15 eller A.16 og/eller, hvis det er relevant efter UN-Bowes-Cameron-Cage-Test (UN-Recommendations on the Transport of Dangerous Goods, Chapter 14, no 14.3.4).
|
|
The flash point of liquids which contain flammable solvents, must be determined and reported according to EEC Method A 9. The flammability of solid preparations and gases must be determined and reported according to EEC methods A 10, A 11 and A 12 as appropriate. The auto-flammability of preparations must be determined and reported in accordance with EEC methods A 15 or A 16 as appropriate, and or, where necessary, according to the UN-Bowes-Cameron-Cage-Test (UN-Recommendations on the Transport of Dangerous Goods, Chapter 14, No 14.3.4).
|
2.4. Aciditet/alkalinitet, i relevante tilfaelde pH-vaerdi
|
|
2.4. Acidity/alkalinity and if necessary pH value
|
2.4.1. For praeparater, som er sure (pH < 4) eller basiske (pH > 10), skal syre- eller baseegenskaberne og pH-vaerdien bestemmes og oplyses efter CIPAC-metode MT 31 og MT 75.
|
|
2.4.1. In the case of preparations which are acidic (pH < 4) or alkaline (pH > 10) the acidity or alkalinity and the pH value must be determined and reported according to CIPAC Method MT 31 and MT 75 respectively.
|
2.4.2. Hvor det er relevant (ved anvendelse som vandig fortynding), bestemmes og oplyses pH for en 1 % vandig oploesning, emulsion eller dispersion af praeparatet efter CIPAC-metode MT 75.
|
|
2.4.2. Where relevant (if to be applied as aqueous dilution) the pH of a 1 % aqueous dilution, emulsion or dispersion of the preparation, must be determined and reported according to CIPAC Method MT 75.
|
2.5. Viskositet og overfladespaending
|
|
2.5. Viscosity and surface tension
|
2.5.1. Hvor der er tale om flydende praeparater til Ultra Low Volume- (ULV) anvendelse, skal den kinematiske viskositet bestemmes og oplyses efter OECD Test Guidelines 114.
|
|
2.5.1. In the case of liquid preparations for Ultra Low Volume use (ULV) the kinematic viscosity must be determined and reported according to OECD Test Guideline 114.
|
2.5.2. For ikke-newtonske vaesker skal viskositeten bestemmes og oplyses med angivelse af testbetingelserne.
|
|
2.5.2. For non newtonian liquids the viscosity must be determined and reported together with the test conditions.
|
2.5.3. For flydende praeparater skal overfladespaendingen bestemmes og oplyses efter EOEF-metode A.5.
|
|
2.5.3. In the case of liquid preparations the surface tension has to be determined and reported according to EEC method A 5.
|
2.6. Relativ massefylde og bulk-massefylde
|
|
2.6. Relative density and bulk density
|
2.6.1. Den relative massefylde af flydende praeparater skal bestemmes og oplyses efter EOEF-metode A.3 eller CIPAC-metode MT 3.
|
|
2.6.1. The relative density of liquid preparations must be determined and reported according to EEC Method A 3.
|
2.6.2. Bulk-massefylden for praeparater, som er pulvere eller granulater, skal bestemmes og oplyses efter CIPAC-metode MT 33, MT 159 eller MT 169.
|
|
2.6.2. The bulk (tap) density of preparations which are powders or granules, must be determined and reported according to CIPAC Methods MT 33, MT 159 or MT 169 as appropriate.
|
2.7. Lagringsstabilitet - stabilitet og holdbarhed samt virkningen af lys, temperatur og fugtighed paa plantebeskyttelsesmidlets tekniske karakteristika
|
|
2.7. Storage - stability and shelf-life: Effects of light, temperature and humidity on technical characteristics of the plant protection product
|
2.7.1. Praeparatets stabilitet efter oplagring i 14 dage ved 54 °C skal bestemmes og oplyses efter CIPAC-metode MT 46.
|
|
2.7.1. The stability of the preparation after storage for 14 days at 54 °C must be determined and reported according to CIPAC Method MT 46.
|
Der kan vaere behov for anden varighed og/eller temperatur (f.eks. otte uger ved 40 °C, 12 uger ved 35 °C eller 18 uger ved 30 °C), hvis praeparatet er varmefoelsomt.
|
|
Other times and/or temperatures may be needed (e.g. eight weeks at 40 °C or 12 weeks at 35 °C or 18 weeks at 30 °C) if the preparation is heat sensitive.
|
Hvis indholdet af aktivt stof efter varmestabilitetsproeven er faldet med mere end 5 % af det oprindelige indhold, deklareres minimumsindholdet, og denne deklaration suppleres med oplysninger om nedbrydningsprodukterne.
|
|
If the active substance content after the heat stability test has decreased by more than 5 % of the initially found content, the minimum content shall be declared and information on the degradation products shall be supplied.
|
2.7.2. Herudover skal indvirkningen af lave temperaturer paa stabiliteten bestemmes op oplyses efter CIPAC-metode MT 39, MT 48, MT 51 eller MT 54 for flydende praeparater.
|
|
2.7.2. Additionally in the case of liquid preparations, the effect of low temperatures on stability, must be determined and reported according to CIPAC Methods MT 39, MT 48, MT 51 or MT 54 as appropriate.
|
2.7.3. Praeparatets holdbarhed ved stuetemperatur skal oplyses. Er holdbarheden mindre end to aar, skal holdbarheden i maaneder med tilhoerende temperaturspecifikationer oplyses, jf. GIFAP Monograph No 17 for naermere oplysninger.
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|
2.7.3. The shelf life of the preparation at ambient temperature must be reported. Where shelf life is less than two years, the shelf life in months, with appropriate temperature specifications, must be reported. Useful information is given in GIFAP Monograph No. 17.
|
2.8. Plantebeskyttelsesmidlets tekniske karakteristika
|
|
2.8. Technical characteristics of the plant protection product
|
Praeparatets tekniske karakteristika skal bestemmes, saa der kan traeffes beslutning om, hvorvidt det kan accepteres.
|
|
The technical characteristics of the preparation must be determined to permit a decision to be made as to its acceptability.
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2.8.1. Fugtningsmulighed
|
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2.8.1. Wettability
|
Fugtningsmuligheden hos faste praeparater, der fortyndes foer brug, (f.eks. vanddispergerbare pulvere, vandoploeselige pulvere, vandoploeselige granulater og vanddispergerbare granulater) skal bestemmes og oplyses efter CIPAC-metode MT 53.3.
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|
The wettability of solid preparations which are diluted for use (e.g. wettable powders, water soluble powders, water soluble granules and water dispersible granules), must be determined and reported according to CIPAC Method MT 53.3.
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2.8.2. Persistent skumdannelse
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|
2.8.2. Persistent foaming
|
Persistensen af skumdannelse hos praeparater til fortynding med vand skal bestemmes og oplyses efter CIPAC-metode MT 47.
|
|
The persistence of foaming of preparations to be diluted with water, must be determined and reported according to CIPAC Method MT 47.
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2.8.3. Dispersionsevne og dispersionsstabilitet
|
|
2.8.3. Suspensibility and suspension stability
|
- Dispersionsevnen af vanddispergerbare produkter (f.eks. vanddispergerbare pulvere, vanddispergerbare granulater, suspensionskoncentrater) skal bestemmes og oplyses efter CIPAC-metode MT 15, MT 161 eller MT 168.
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|
- The suspensibility of water dispersible products (e.g. wettable powders, water dispersible granules, suspension concentrates) must be determined and reported according to CIPAC Method MT 15, MT 161 or MT 168 as appropriate.
|
- For suspensionskoncentrater og vanddispergerbare granulater skal evnen til spontan dispersion bestemmes og oplyses efter CIPAC-metode MT 160 eller MT 174.
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|
- The spontaneity of dispersion of water dispersible products (e.g. suspension concentrates and water dispersible granules) must be determined and reported according to CIPAC Methods MT 160 or MT 174 as appropriate.
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2.8.4. Oploesningsstabilitet
|
|
2.8.4. Dilution stability
|
Oploesningsstabiliteten af vandoploeselige produkter skal bestemmes og oplyses efter CIPAC-metode MT 41.
|
|
The dilution stability of water soluble products must be determined and reported according to CIPAC Method MT 41.
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2.8.5. Toersigtningstest og vaadsigtningstest
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2.8.5. Dry sieve test and wet sieve test
|
For at sikre at puddere har en for anvendelsen passende partikelstoerrelsesfordeling, skal der gennemfoeres og gives oplysning om en toersigtningstest efter CIPAC-metode MT 59.1. For vanddispergerbare produkter skal der gennemfoeres og gives oplysning om en vaadsigtningstest efter CIPAC-metode MT 59.3 eller MT 167.
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|
In order to ensure that dustable powders have a suitable particle size distribution for ease of application, a dry sieve test must be conducted and reported according to CIPAC Method MT 59.1.
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2.8.6. Partikelstoerrelsesfordeling (puddere og vanddispergerbare pulvere, granulater), indhold af stoev/fint pulver (granulater) samt slid ved gnidning og tendens til smuldring (granulater)
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|
In the case of water dispersible products, a wet sieve test must be conducted and reported according to CIPAC Method MT 59.3 or MT 167 as appropriate.
|
2.8.6.1. Partikelstoerrelsesfordelingen for pulvere skal bestemmes og oplyses efter OECD-metode 110.
|
|
2.8.6. Particle size distribution (dustable and wettable powders, granules), content of dust/fines (granules), attrition and friability (granules)
|
Det nominelle stoerrelsesomraade for granulater til direkte anvendelse bestemt efter CIPAC MT 58.3 og for vanddispergerbare granulater bestemt efter CIPAC MT 170 skal oplyses.
|
|
2.8.6.1. The size distribution of particles in the case of powders, must be determined and reported according to OECD Method 110.
|
2.8.6.2. Stoevindholdet i granulatpraeparater skal bestemmes og oplyses efter CIPAC-metode MT 171. Stoevets partikelstoerrelse skal bestemmes og oplyses efter OECD-metode 110, hvis det er relevant for brugereksponering.
|
|
The nominal size range of granules for direct application must be determined and reported in accordance with CIPAC MT 58.3, for water dispersible granules in accordance with CIPAC MT 170.
|
2.8.6.3. Granulaters karakteristika med hensyn til slid og smuldring skal bestemmes og oplyses, naar der foreligger internationalt vedtagne metoder hertil. Hvor data allerede foreligger, skal disse oplyses tillige med den benyttede metode.
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2.8.6.2. The dust content of granular preparations, must be determined and reported according CIPAC Method MT 171. If relevant for operator exposure the particle size of dust must be determined and reported according to OECD Method 110.
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2.8.7. Emulsionsevne, reemulsionsevne, emulsionsstabilitet
|
|
2.8.6.3. The friability and attrition characteristics of granules, must be determined and reported once internationally agreed methods are available. Where already data are available they must be reported together with the method used.
|
2.8.7.1. Emulsionsevnen, emulsionsstabiliteten og reemulsionsevnen for praeparater, som danner emulsioner, skal bestemmes og oplyses efter CIPAC-metode MT 36 eller MT 173.
|
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2.8.7. Emulsifiability, Re-emulsifiability, emulsion stability
|
2.8.7.2. Stabiliteten af fortyndede emulsioner og af praeparater i emulsionsform skal bestemmes og oplyses efter CIPAC-metode MT 20 eller MT 173.
|
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2.8.7.1. The emulsifiability, emulsion stability and re-emul-sifiability of preparations which form emulsions, must be determined and reported according to CIPAC Methods MT 36 or MT 173 as appropriate.
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2.8.8. Flydeevne, haeldbarhed (skylbarhed) og »dustability«
|
|
2.8.7.2. The stability of dilute emulsions and of preparations which are emulsions, must be determined and reported according to CIPAC Method MT 20 or MT 173.
|
2.8.8.1. Granulaters flydeevne skal bestemmes og oplyses efter CIPAC-metode MT 172.
|
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2.8.8. Flowability, pourability (rinsability) and dustability
|
2.8.8.2. Haeldbarheden (inklusive skyllerester) af suspensioner (f.eks. suspensionskoncentrater og suspoemulsioner) skal bestemmes og oplyses efter CIPAC-metode MT 148.
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2.8.8.1. The flowability of granular preparations must be determined and reported according to CIPAC Mehtod MT 172.
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2.8.8.3. Pudderes »dustability« efter en accelereret lagring som beskrevet i 2.7.1 skal bestemmes og oplyses efter CIPAC-metode MT 34 eller en anden egnet metode.
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2.8.8.2. The pourability (including rinsed residue) of suspensions (e.g. suspension concentrates, suspo-emulsions), must be determined and reported according to CIPAC Method MT 148.
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2.9. Fysisk og kemisk forenelighed med andre midler, herunder plantebeskyttelsesmidler, som det skal tillades benyttet sammen med
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|
2.8.8.3. The dustability of dustable powders following accelerated storage according 2.7.1 must be determined and reported according to CIPAC Method MT 34 or another suitable method.
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2.9.1. Den fysiske forenelighed af tankblandinger skal oplyses baseret paa firmaets egne testmetoder. En praktisk test vil vaere et acceptabelt alternativ.
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2.9. Physical and chemical compatibility with other products including plant protection products with which its use is to be authorized
|
2.9.2. Den kemiske forenelighed af tankblandinger skal bestemmes og oplyses, undtagen hvor det ud fra en undersoegelse af praeparaternes individuelle egenskaber er haevet over al rimelig tvivl, at en reaktion ikke vil kunne finde sted. I saadanne tilfaelde er det tilstraekkeligt at oplyse dette som begrundelse for, at den kemiske forenelighed ikke er bestemt i praksis.
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2.9.1. The physical compatibility of tank mixes must be reported based on in-house test methods. A practical test would be an acceptable alternative.
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2.10. Vedhaeftning til og fordeling paa froe
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2.9.2. The chemical compatibility of tank mixes must be determined and reported except where examination of the individual properties of the preparations would establish beyond reasonable doubt that there is no possibility of reaction taking place. In such cases it is sufficient to provide that information as justification for not practically determining the chemical compatibility.
|
For praeparater til bejdsning af froe skal baade fordeling og vedhaeftning undersoeges og oplyses; med hensyn til fordeling foelges CIPAC-metode MT 175.
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2.10. Adherence and distribution to seeds
|
2.11. Resumé og evaluering af data fremlagt under punkt 2.1 til 2.10
|
|
In the case of preparations for seed treatment, both distribution and adhesion must be investigated and reported; in the case of distribution according to CIPAC Method MT 175.
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3. Anvendelsesdata
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|
2.11. Summary and evaluation of data presented under points 2.1. to 2.10
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3.1. Anvendelsesomraade, f.eks. markanvendelse, beskyttede afgroeder, oplagring af planteprodukter private haver
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|
3. Data on application
|
Eksisterende og paataenkte anvendelsesomraader for praeparater, der indeholder det aktive stof, skal specificeres blandt foelgende:
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3.1. Field of use envisaged, e.g. field, protected crops, storage of plant products, home gardening
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Markanvendelse, saasom landbrug, gartneri, skovbrug og vindyrkning:
|
|
The field(s) of use, existing and proposed, for preparations containing the active substance must be specified from among the following:
|
- beskyttede afgroeder
|
|
- field use, such as agriculture, horticulture, forestry and viticulture,
|
- rekreative omraader
|
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- protected crops,
|
- ukrudtsbekaempelse paa udyrkede omraader
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- amenity,
|
- private haver
|
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- weed control on non-cultivated areas,
|
- stueplanter
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- home gardening,
|
- oplagring af planteprodukter
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- house plants,
|
- andet (anfoer naermere).
|
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- plant products storage practice,
|
3.2. Virkninger paa skadelige organismer, f.eks. ved kontakt, indaanding eller som mavegift, fungitoksisk eller fungistatisk middel osv., eventuelt systemisk i planter
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- other (specify).
|
Arten af virkningerne paa skadelige organismer skal anfoeres:
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3.2. Effects on harmful organisms, e.g. contact, inhalation or stomach poison, fungitoxic or fungistatic, etc., systemic or not in plants
|
- virkning ved kontakt
|
|
The nature of the effects on harmful organisms must be stated:
|
- virkning via maven
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|
- contact action,
|
- virkning ved indaanding
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|
- stomach action,
|
- fungitoksisk virkning
|
|
- inhalation action,
|
- fungistatisk virkning
|
|
- fungitoxic action,
|
- udtoerrende virkning
|
|
- fungistatic action,
|
- reproduktionshaemmende virkning
|
|
- desiccant,
|
- andet (anfoer naermere).
|
|
- reproduction inhibitor,
|
Det skal angives, om stoffet translokerer i planter.
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|
- other (must be specified).
|
3.3. Enkeltheder vedroerende den paataenkte anvendelse, f.eks. arter af skadelige organismer, som skal bekaempes, og/eller planter eller planteprodukter, som oenskes beskyttet
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|
It must be stated whether or not the product is translocated in plants.
|
Enkeltheder vedroerende den paataenkte anvendelse skal oplyses.
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|
3.3. Details of intended use e.g. types of harmful organisms controlled and/or plants or plant products to be protected
|
Hvor det er relevant, skal der oplyses om opnaaede virkninger som f.eks. spiringshaemning, modningsforsinkelse, straaforkortning, foroeget frugtbarhed osv.
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|
Details of the intended use must be provided.
|
3.4. Dosering
|
|
Where relevant, effects achieved e.g. sprout suppression, retardation of ripening, reduction in stem length, enhanced fertilization etc. must be reported.
|
For hver enkelt anvendelsesmetode og for hvert enkelt anvendelsesomraade skal den anvendte maengde pr. behandlet enhed (ha, m2 m3) oplyses i gram eller kilogram af baade praeparat og aktivt stof.
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|
3.4. Application rate
|
Doseringen skal normalt udtrykkes i g eller kg/ha eller kg/m3 og i relevante tilfaelde g eller kg/t; for beskyttede afgroeder og private haver anvendes g eller kg/100 m2 eller g eller kg/m3.
|
|
For each method of application and each use, the rate of application per unit (ha, m2, m3) treated, in terms of g or kg of both preparation and active substance, must be provided.
|
3.5. Koncentration af det aktive stof i det brugsfaerdige middel (f.eks. i fortyndet sproejtemiddel, lokkemad eller bejdsede froe)
|
|
Application rates shall normally be expressed in g or kg/ha or in kg/m3 and where appropriate in g or kg/tonne; for protected crops and home gardening use rates shall be expressed in g or kg/100 m2 or g or kg/m3.
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Indholdet af det aktive stof skal angives i g/l, g/kg, mg/kg eller g/ton.
|
|
3.5. Concentration of active substance in material used (e.g. in the diluted spray, baits or treated seed)
|
3.6. Udbringningsmetode
|
|
The content of active substance shall be reported, as appropriate, in g/l, g/kg, mg/kg or in g/tonne.
|
Den paataenkte udbringingsmetode skal beskrives fuldt ud med angivelse af den type udstyr, der eventuelt skal benyttes, saavel som art og rumfang af det fortyndingsmiddel, der skal anvendes, per areal- eller rumfangsenhed.
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|
3.6. Method of application
|
3.7. Udbringningshyppighed og -tidspunkt samt beskyttelsens varighed
|
|
The method of application proposed must be described fully, indicating the type of equipment to be used, if any, as well as the type and volume of diluent to be used per unit of area or volume.
|
Det maksimale antal udbringninger samt udbringningstidspunkterne skal oplyses. Hvor det er relevant, angives vaekststadierne af den afgroede eller de planter, der skal beskyttes, og de skadegoerende organismers udviklingsstadier. Hvor det er muligt, oplyses tidsintervallet mellem udbringningerne i dage.
|
|
3.7. Number and timing of applications and duration of protection
|
Varigheden af den beskyttelse, som baade den enkelte udbringning og det maksimale antal udbringninger giver, skal oplyses.
|
|
The maximum number of applications to be used and their timing, must be reported. Where relevant the growth stages of the crop or plants to be protected and the development stages of the harmful organisms, must be indicated. Where possible the interval between applications, in days, must be stated.
|
3.8. Noedvendige venteperioder eller andre forholdsregler for at undgaa fytotoksiske virkninger paa efterfoelgende afgroeder
|
|
The duration of protection afforded both by each application and by the maximum number of applications to be used, must be indicated.
|
Hvor det er relevant, skal de minimale venteperioder mellem sidste anvendelse og saaning eller udplantning af efterfoelgende afgroeder, som er noedvendige for at undgaa fytotoksiske virkninger paa efterfoelgende afgroeder, oplyses og foelge af de i afsnit 6.6 anfoerte data.
|
|
3.8. Necessary waiting periods or other precautions to avoid phytotoxic effects on succeeding crops
|
Eventuelle begraensninger i valg af efterfoelgende afgroeder skal angives.
|
|
Where relevant, minimum waiting periods between last application and sowing or planting of succeeding crops, which are necessary to avoid phytotoxic effects on succeeding crops, must be stated, and follow from the data provided under paragraph 6.6.
|
3.9. Paataenkt brugsanvisning
|
|
Limitations on choice of succeeding crops, if any, must be stated.
|
Den paataenkte brugsanvisning for praeparatet, som skal trykkes paa etiketter og foelgeblade, skal oplyses.
|
|
3.9. Proposed instructions for use
|
4. Yderligere oplysninger om plantebeskyttelsesmidlet
|
|
The proposed instructions for use of the preparation, to be printed on labels and leaflets, must be provided.
|
4.1. Emballage (type, materialer, stoerrelse mv.), praeparatets forenelighed med de foreslaaede emballagematerialer
|
|
4. Further information on the plant protection product
|
4.1.1. Den emballage, der skal anvendes, skal beskrives fuldstaendigt, og materialer, konstruktion (f.eks. ekstruderet, svejset osv.), stoerrelse og rumindhold, aabningsstoerrelse samt luknings- og forseglingstype skal specificeres. Den skal vaere udformet efter de kriterier og retningslinjer, der er angivet i FAO's »Guidelines for the Packaging of Pesticides«.
|
|
4.1. Packaging (type, materials, size etc.), compatibility of the preparation with proposed packaging materials
|
4.1.2. Emballagens, herunder dens lukningers, egnethed med hensyn til styrke, taethed og modstandsdygtighed ved normal transport og haandtering skal bestemmes og oplyses efter ADR-metode 3552, 3553, 3560, 3554, 3555, 3556, 3558 eller relevante ADR-metoder for mellemstore fragtcontainere til transport af massegods (IBC's) og efter ISO-standard 8317, hvis der kraeves boernesikre lukninger til praeparatet.
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|
4.1.1. Packaging to be used must be fully described and specified in terms of the materials used, manner of construction (e.g. extruded, welded etc.), size and capacity, size of opening, type of closure and seals. It must be designed in accordance with the criteria and guidelines specified in the FAO 'Guidelines for the Packaging of Pesticides'.
|
4.1.3. Emballagematerialets modstandsdygtighed over for indholdet skal oplyses efter GIAP Monograph No 17.
|
|
4.1.2. The suitability of the packaging, including closures, in terms of its strength, leakproofness and resistance to normal transport and handling, must be determined and reported according to ADR Methods 3552, 3553, 3560, 3554, 3555, 3556 3558, or appropriate ADR Methods for intermediate bulk containers, and, where for the preparation child-resistant closures are required, according to ISO standards 8317.
|
4.2. Fremgangsmaade ved rengoering af anvendt udstyr
|
|
4.1.3. The resistance of the packaging material to its contents must be reported according to GIFAP Monograph No 17.
|
Fremgangsmaader for rengoering af baade anvendt udstyr og vaernemidler skal beskrives i enkeltheder. Effektiviteten af rengoeringen skal vaere fuldt undersoegt og skal oplyses.
|
|
4.2. Procedures for cleaning application equipment
|
4.3. Re-entry perioder, noedvendige venteperioder eller andre forholdsregler for at beskytte mennesker og husdyr
|
|
Cleaning procedures for both application equipment and protective clothing must be described in detail. The effectiveness of the cleaning procedure, must be fully investigated and reported.
|
De anfoerte oplysninger skal foelge af og underbygges af de data, der er givet for de(t) aktive stof(fer), og dem, der er anfoert i afsnit 7 og 8.
|
|
4.3. Re-entry periods, necessary waiting periods or other precautions to protect man, livestock and the environment
|
4.3.1. Hvor det er relevant, skal behandlingsfrister, re-entry perioder eller tilbageholdelsesfrister, som er noedvendige for, at forekomsten af rester i eller paa afgroeder, planter og planteprodukter eller i behandlede omraader bliver mindst mulig, saaledes at mennesker og husdyr beskyttes, specificeres, f.eks:
|
|
The information provided must follow from and be supported by the data provided for the active substance(s) and that provided under sections 7 and 8.
|
- behandlingsfrist (i dage) for hver relevant afgroede
|
|
4.3.1. Where relevant pre-harvest intervals, re-entry periods or withholding periods necessary to minimize the presence of residues in or on crops, plants and plant products, or in treated areas or spaces, with a view to protecting man or livestock, must be specified e.g.:
|
- re-entry periode (i dage) for husdyr til graesningsarealer
|
|
- pre-harvest interval (in days) for each relevant crop,
|
- re-entry periode (i timer eller dage) for mennesker til behandlede afgroeder, bygninger eller omraader
|
|
- re-entry period (in days) for livestock, to areas to be grazed,
|
- tilbageholdelsesfrist (i dage) for foderstoffer
|
|
- re-entry period (in hours or days) for man to crops, buildings or spaces treated,
|
- venteperiode (i dage) mellem udbringning og haandtering af behandlede produkter
|
|
- withholding period (in days) for animal feedingstuffs,
|
- venteperiode (i dage) mellem sidste udbringning og saaning eller udplantning af efterfoelgende afgroeder.
|
|
- waiting period (in days), between application and handling treated products, or
|
4.3.2. Hvor det er relevant, skal der paa baggrund af testresultaterne gives oplysning om, under hvilke specielle landbrugsmaessige, plantesundhesmaessige eller miljoemaessige forhold praeparatet maa eller ikke maa anvendes.
|
|
- waiting period (in days), between last application and sowing or planting succeeding crops.
|
4.4. Anbefalede metoder og forholdsregler vedroerende haandtering, oplagring, transport eller brand
|
|
4.3.2. Where necessary, in the light of the test results, information on any specific agricultural, plant health or environmental conditions under which the preparation may or may not be used must be provided.
|
De anbefalede metoder og forholdsregler med hensyn til haandteringsmaader (detaljerede) for oplagring baade i lagerbygninger og hos bruger af plantebeskyttelsesmidler samt for transport og i tilfaelde af brand skal anfoeres. Foreliggende information om forbraendingsprodukter skal fremlaegges. De farer, der kan forventes at opstaa, og metoder og fremgangsmaader til at goere disse farer mindst mulige skal specificeres. Fremgangsmaader, der hindrer, at der fremkommer affald eller rester, eller goer maengden heraf mindst mulig, skal anfoeres.
|
|
4.4. Recommended methods and precautions concerning: handling, storage, transport or fire
|
Hvor det er relevant, skal vurdering ske efter ISO - TR 9122.
|
|
The recommended methods and precautions concerning handling procedures (detailed) for the storage, at both warehouse and user level of plant protection products, for their transport and in the event of fire must be provided. Where available information on combustion products must be provided. The risks likely to arise and the methods and procedures to minimize the hazards arising, must be specified. Procedures to preclude or minimize the generation of waste or leftovers must be provided.
|
Hvor det er relevant, skal arten af og karakteristika ved de vaernemidler og det udstyr, der foreslaas anvendt, anfoeres. De anfoerte data skal vaere tilstraekkelige til, at egnetheden og effektiviteten kan bedoemmes under realtistiske anvendelsesforhold (f.eks. i marken eller i vaeksthus).
|
|
Where relevant assessment has to be done according to ISO - TR 9122.
|
4.5. Noedforholdsregler i ulykkestilfaelde
|
|
Where appropriate the nature and characteristics of protective clothing and equipment proposed must be provided. The data provided must be sufficient to evaluate the suitability and effectiveness under realistic conditions of use (e.g. field or glasshouse circumstances).
|
Hvad enten situationen opstaar under transport, oplagring eller anvendelse, skal der gives detaljerede anvisninger for, hvilke forholdsregler der skal traeffes i ulykkestilfaelde, herunder vedroerende:
|
|
4.5. Emergency measures in the case of an accident
|
- indeslutning af udslip og spild
|
|
Whether arising during transport, storage or use, detailed procedures to be followed in the event of an emergency, must be provided; and include:
|
- dekontaminering af omraader, koeretoejer og bygninger
|
|
- containment of spillages,
|
- bortskaffelse af beskadiget emballage, adsorbenter og andre materialer
|
|
- decontamination of areas, vehicles and buildings,
|
- beskyttelse af redningsmandskab og tilskuere
|
|
- disposal of damaged packaging, adsorbents and other materials,
|
- foerstehjaelp i ulykkestilfaelde.
|
|
- protection of emergency workers and bystanders,
|
4.6. Fremgangsmaade ved destruktion eller dekontaminering af plantebeskyttelsesmidlet og emballagen
|
|
- first aid measures.
|
Der skal vaere udviklet fremgangsmaader for destruktion og dekontaminering for baade smaa maengder (paa brugerplan) og store maengder (lagerbygninger). Fremgangsmaaderne skal overholde de lokale bestemmelser vedroerende bortskaffelse af affald og giftigt affald. De paataenkte bortskaffelsesmetoder maa ikke have nogen uacceptabel indflydelse paa miljoeet og skal vaere saa omkostningseffektive og praktisk gennemfoerlige som muligt.
|
|
4.6. Procedures for destruction or decontamination of the plant protection product and its packaging
|
4.6.1. Mulighed for neutralisering
|
|
Procedures for destruction and decontamination must be developed for both small quantities (user level) and large quantities (warehouse level). The procedures must be consistent with provisions in place relating to the disposal of waste and of toxic waste. The means of disposal proposed should be without unacceptable influence on the environment and be the most cost effective and practical means of disposal feasible.
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Neutraliseringsmetoder (f.eks. ved reaktion med alkali, saa der dannes mindre giftige forbindelser) til brug i tilfaelde af udslip ved uheld skal beskrives, hvor saadanne metoder er gennemfoerlige. Sammensaetningen af det neutraliserede middel boer vurderes i praksis eller teoretisk og oplyses.
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4.6.1. Possibility of neutralization
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4.6.2. Kontrolleret forbraending
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Neutralization procedures (e.g by reaction with alkali to form less toxic compounds) for use in the event of accidental spillages, must where they are feasible, be described. The products produced after neutralization should be practically or theoretically evaluated and reported.
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I mange tilfaelde er den foretrukne eller eneste metode til sikker bortskaffelse af aktive stoffer og de plantebeskyttelsesmidler, der indeholder det, samt kontaminerede materialer eller kontamineret emballage kontrolleret forbraending i et godkendt forbraendingsanlaeg.
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4.6.2. Controlled incineration
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Hvor halogenindholdet af de(t) aktive stof(fer) i praeparatet er over 60 %, skal stoffets opfoersel ved pyrolyse under kontrollerede betingelser (med, hvis det er relevant, ilttilfoersel og kendt opholdstid) ved 800 °C samt indholdet af polyhalogenerede dibenzo-p-dioxiner og dibenzo-furaner i pyrolyseprodukterne oplyses. Ansoegeren skal give detaljerede anvisninger om sikker bortskaffelse.
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In many cases the preferred or sole means to safely dispose of active substances as well as plant protection products containing it, contaminated materials, or contaminated packaging, is through controlled incineration in a lincensed incinerator.
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4.6.3. Andet
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Where the content of halogens of the active substance(s) in the preparation is greater than 60 %, the pyrolytic behaviour of the active substance under controlled conditions (including where relevant supply of oxygen and defined residence time) at 800 °C and the content of polyhalogenated dibenzo-p-dioxins and dibenzo-furans in the products of pyrolysis must be reported. The applicant must provide detailed instructions for safe disposal.
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Hvis der foreslaas andre metoder til bortskaffelse af plantebeskyttelsesmidler, emballage og kontaminerede materialer, skal der gives en fuldstaendig beskrivelse af dem. Der skal fremlaegges data for saadanne metoder til dokumentation af, at de er effektive og sikre.
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4.6.3. Others
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Other methods to dispose of plant protection products, packaging and contaminated materials, where proposed, must be fully described. Data must be provided for such methods, to establish their effectiveness and safety.
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