natgillin/translations-raw huggingface dataset:
If the biocidal product is in the form of bait or granules the following studies may be required:
Če je biocidni proizvod v obliki vabe ali zrnc, so lahko potrebne naslednje študije:
Supervised trials to assess risks to non-target organisms under field conditions
Nadzorovani preskusi za oceno tveganja za neciljne organizme v razmerah na prostem
Studies on acceptance by ingestion of the biocidal product by any non-target organisms thought to be at risk
Študije o tem, ali in kako ogroženi neciljni organizmi zaužijejo biocidni proizvod
Secondary ecological effect e.g. when a large proportion of a specific habitat type is treated
Drugotni ekološki vpliv, npr. ob tretiranju velikega dela specifičnega habitata
The test requirements below are applicable only to the relevant components of the biocidal product
Spodnje zahteve za preskuse se uporabljajo le za pomembne sestavine biocidnega proizvoda.
Foreseeable routes of entry into the environment on the basis of the use envisaged
Predvidene poti vstopa v okolje na podlagi predvidene uporabe
Further studies on fate and behaviour in the environment
Nadaljnje študije usode in obnašanja v okolju
Further studies chosen from among the endpoints referred to in Section 10 of Annex II for relevant components of the biocidal product or the biocidal product itself may be required.
Lahko so potrebne nadaljnje študije, izbrane med končnimi točkami iz oddelka 10 Priloge II, za pomembne sestavine biocidnega proizvoda ali sam biocidni proizvod.
For products that are used outside, with direct emission to soil, water or surfaces, the components in the product may influence the fate and behaviour (and ecotoxicity) of the active substance.
Pri proizvodih, ki se uporabljajo na prostem in prihajajo v neposreden stik s tlemi, vodo ali površinami, lahko sestavine vplivajo na usodo in obnašanje (in ekotoksičnost) aktivne snovi.
Data are required unless it is scientifically justified that the fate of the components in the product is covered by the data provided for the active substance and other identified substances of concern
Potrebni so podatki, razen če je znanstveno utemeljeno, da podatki, navedeni za aktivno snov in druge pogojno nevarne snovi, zajemajo usodo sestavin v proizvodu.
Leaching behaviour
Izpiranje
Testing for distribution and dissipation in the following:
Preskusi glede širjenja in razpada v:
Water and sediment
Vodi in usedline
If the biocidal product is to be sprayed near to surface waters then an overspray study may be required to assess risks to aquatic organisms or plants under field conditions
Če se biocidni proizvod razpršuje v bližini površinskih voda, se lahko zahteva študija o zanašanju, da se oceni tveganje za vodne organizme in rastline v razmerah na prostem.
If the biocidal product is to be sprayed outside or if potential for large scale formation of dust is given then data on overspray behaviour may be required to assess risks to bees and non-target arthropods under field conditions
Če se biocidni proizvod razpršuje na prostem ali če obstaja možnost nastajanja velike količine prahu, se lahko zahtevajo podatki o zanašanju, da se oceni tveganje za čebele in neciljne členonožce v razmerah na prostem.
MEASURES TO BE ADOPTED TO PROTECT HUMANS, ANIMALS AND THE ENVIRONMENT
UKREPI, KI JIH JE TREBA SPREJETI ZA ZAŠČITO LJUDI, ŽIVALI IN OKOLJA
Recommended methods and precautions concerning handling, use, storage, disposal, transport or fire
Priporočene metode in previdnostni ukrepi v zvezi z ravnanjem, uporabo, shranjevanjem, odstranjevanjem, prevozom ali ob požaru
Identity of relevant combustion products in cases of fire
Opis produktov zgorevanja v primeru požara
Specific treatment in case of an accident, e.g. first-aid measures, antidotes, medical treatment if available; emergency measures to protect the environment
Podrobnosti glede zdravljenja ob nesrečah, na primer prva pomoč, protistrupi, medicinsko zdravljenje, če je na voljo; nujni ukrepi za zaščito okolja
Water, including drinking water
Vodo, vključno s pitno vodo
Procedures for waste management of the biocidal product and its packaging for industrial use, use by trained professionals, professional users and non-professional users (e.g. possibility of reuse or recycling, neutralisation, conditions for controlled discharge, and incineration)
Postopki za ravnanje z odpadnimi biocidnimi proizvodi in njihovo embalažo, ki veljajo za industrijsko uporabo, uporabo s strani usposobljenih strokovnjakov, poklicne ali nepoklicne uporabnike (npr. možnosti recikliranja, nevtralizacije, pogoji za nadzorovan izpust in sežig)
Procedures for cleaning application equipment where relevant
Postopki za čiščenje opreme za nanašanje, kjer je to potrebno
Specify any repellents or poison control measures included in the product that are present to prevent action against non-target organisms
Navesti repelente ali ukrepe za nadzorovanje stopnje toksičnosti, vključene v proizvod, za preprečevanje delovanja proizvoda na neciljne organizme
CLASSIFICATION, LABELLING, AND PACKAGING
RAZVRŠČANJE, OZNAČEVANJE IN PAKIRANJE
As established in point (b) of Article 20(1), proposals including justification for the hazard and precautionary statements in accordance with the provisions set in Directive 1999/45/EC and Regulation (EC) No 1272/2008 must be submitted.
V skladu s točko (b) člena 20(1) je treba skupaj z vlogo predložiti utemeljitev izjave o nevarnosti in previdnostnih izjav v skladu z določbami Direktive 1999/45/ES in Uredbe (ES) št. 1272/2008.
Example labels, instructions for use and safety data sheets shall be provided
Predložijo se vzorčne oznake, navodila za uporabo in varnostni list.
Proposals for safety-data sheets should be provided, where appropriate
Po potrebi bi se morali podati predlogi za varnostne liste
Packaging (type, materials, size, etc.), compatibility of the product with proposed packaging materials to be included
Embalaža (vrsta, material, velikost itd.), vključno z združljivostjo proizvoda s predlaganimi materiali za embalažo
EVALUATION AND SUMMARY
OCENA IN POVZETEK
Core data set and additional data set
Zbirka osnovnih podatkov in zbirka dodatnih podatkov
Manufacturer and formulator of the biocidal product and the micro-organism(s) (names, addresses, including location of plant(s))
Proizvajalec in formulator biocidnega proizvoda in mikroorganizma oziroma mikroorganizmov (imena, naslovi, vključno s krajem proizvodnega obrata(-ov))
IDENTITY OF THE BIOCIDAL PRODUCTS
OPIS BIOCIDNIH PROIZVODOV
Manufacturer’s development code and number of the biocidal product, if appropriate
Po potrebi proizvajalčeva razvojna koda in številka biocidnega proizvoda
Detailed quantitative (g/kg, g/l or % w/w (v/v)) and qualitative information on the constitution, composition and function of the biocidal product, e.g. micro-organism, active substance(s) and product non-active substances and any other relevant components.
Podrobne kvantitativne (v g/kg, g/l ali % m/m (v/v)) in kvalitativne informacije o zgradbi, sestavi in funkciji biocidnega proizvoda, tj. mikroorganizma, aktivne oziroma aktivnih snovi in neaktivnih snovi proizvoda ter vseh drugih pomembnih sestavin.
All relevant information on individual ingredients and the final composition of the biocidal product shall be given
Navedejo se tudi vse pomembne informacije o posameznih sestavinah in končna sestava biocidnega proizvoda.
Formulation type and nature of the biocidal product
Vrsta formulacije in narava biocidnega proizvoda
BIOLOGICAL, PHYSICAL, CHEMICAL AND TECHNICAL PROPERTIES OF THE BIOCIDAL PRODUCT
BIOLOŠKE, FIZIKALNE, KEMIJSKE IN TEHNIČNE LASTNOSTI BIOCIDNEGA PROIZVODA
Biological properties of the micro-organism in the biocidal product
Biološke lastnosti mikroorganizma v biocidnem proizvodu
Acidity, alkalinity and pH value
Kislost, bazičnost in vrednost pH
Effects of light
Učinki svetlobe
Effects of temperature and humidity
Učinki temperature in vlažnosti
Reactivity towards the container
Reaktivnost na embalažo
Particle size distribution content of dust/fines, attrition and friability
Razporeditev delcev po velikosti, vsebnost prahu/drobnih delcev, drobljivost in krušljivost
Spraying patterns — aerosols
Vzorci razprševanja – aerosoli
Physical, chemical and biological compatibility with other products including biocidal products with which its use is to be authorised or registered
Fizikalna, kemijska in biološka združljivost z drugimi proizvodi, vključno z biocidnimi proizvodi, s katerimi se proizvod uporablja po izdaji dovoljenja ali registracije
PHYSICAL HAZARDS AND RESPECTIVE CHARACTERISITICS
FIZIKALNE NEVARNOSTI IN USTREZNE ZNAČILNOSTI
Other physical indications of hazard
Drugi fizikalni znaki nevarnosti
Analytical method for determining the concentration of the micro-organism(s) and substances of concern in the biocidal product
Analitska metoda za določanje koncentracije mikroorganizma oziroma mikroorganizmov in pogojno nevarnih snovi v biocidnem proizvodu
Analytical methods for monitoring purposes including recovery rates and the limit of quantification and detection for the active substance, and for residues thereof, in/on food of plant and animal origin or feeding stuffs and other products where relevant (not necessary if neither the active substance nor the article treated with it does not come into contact with food-producing animals, food of plant and animal origin or feeding stuffs)
Analitske metode za namene spremljanja, vključno z odstotki izkoristka ter mejo količinske opredelitve in določitve aktivne snovi in njenih ostankov, v/na živilih rastlinskega in živalskega izvora ali krme in po potrebi drugih proizvodih (ni potrebno, če niti aktivna snov niti izdelek, tretiran z njimi, ne pridejo v stik z živalmi za proizvodnjo živil, živili rastlinskega in živalskega izvora ali krmo)
Function and mode of control
Uporaba in način nadziranja
Representative pest organism(s) to be controlled and products, organisms or objects to be protected
Reprezentativni škodljivi organizem oziroma organizmi, ki jih je treba nadzirati, in proizvodi, organizmi ali predmeti, ki jih je treba zaščititi
Likely concentration at which micro-organism will be used
Verjetna koncentracija, v kateri bo uporabljena aktivna snov
The proposed label claims for the product
Predlagano besedilo na oznaki proizvoda
Efficacy data to support these claims, including any available standard protocols, laboratory tests, or field trials used including performance standards, where appropriate and relevant
Podatki o učinkovitosti, ki utemeljujejo te navedbe, vključno z vsemi razpoložljivimi uporabljenimi standardnimi protokoli, laboratorijskimi preskusi ali preskusi na prostem, vključno s standardi učinkovitosti, kadar je primerno
Any other known limitations on efficacy including resistance
Druge znane omejitve glede učinkovitosti, vključno z odpornostjo
Detailed description of intended use
Podroben opis predvidene uporabe
Application rate and if appropriate the final concentration of the biocidal product or the micro-organism active substance in a treated article or the system in which the product is to be used (e.g. in the application device or bait)
Odmerek in po potrebi končna koncentracija biocidnega proizvoda ali mikroorganizma in aktivne snovi v tretiranem izdelku ali sistemu, v katerem bo proizvod uporabljen (npr. v napravi za uporabo ali vabi)
Number and timing of applications and duration of protection
Število in časovni razpored uporabe in trajanje varstva.
Any particular information relating to the geographical location or climatic variations including necessary waiting periods for re-entry or necessary withdrawal period or other precautions to protect human health, animal health and the environment
Podrobne informacije o zemljepisni legi ali podnebnih nihanjih, vključno z delovno karenco za ponovni dostop, potrebno karenco ali drugimi previdnostnimi ukrepi za zaščito zdravja človeka, zdravja živali in okolja
Exposure data
Podatki o izpostavljenosti
Information on human exposure associated with the proposed/expected uses and disposal
Informacije o izpostavljenosti ljudi, povezani s predlagano/pričakovano uporabo in odstranjevanjem
Information on environmental exposure associated with the proposed/expected uses and disposal
Informacije o izpostavljenosti okolja, povezani s predlagano/pričakovano uporabo in odstranjevanjem
there are valid data available on each of the components in the mixture to allow classification of the mixture according to the rules laid down in Directive 1999/45/EC, Regulation (EC) No 1907/2006 (REACH) and Regulation (EC) No 1272/2008 (CLP) and synergistic effects between any of the components are not expected
so na voljo veljavni podatki o vsaki od sestavin zmesi, ki omogočajo razvrstitev zmesi v skladu s pravili iz Direktive 1999/45/ES, Uredbo (ES) št. 1907/2006 (REACH) in Uredbo (ES) št. 1272/2008 (CLP), sinergijski učinki med katero koli od sestavin pa niso pričakovani.
Skin corrosion or irritation
Jedkost za kožo ali draženje kože
Inhalation
Z vdihavanjem
Dermal
Dermalna
Additional acute toxicity studies
Dodatne študije akutne toksičnosti
Information on dermal absorption if required
Po potrebi podatki o dermalni absorpciji
If insufficient data are available for a non-active substance(s) and cannot be inferred through read-across or other accepted non-testing approaches, targeted test(s) described in Annex II, shall be carried out for the substance(s) of concern or a mixture that a substance(s) of concern is a component of
Če podatki za neaktivno oziroma neaktivne snovi ne zadostujejo in jih ni mogoče povzeti z navzkrižnim branjem ali drugimi sprejetimi pristopi, ki ne temeljijo na preskušanju, se izvede ciljni preskus oziroma preskusi iz Priloge II za pogojno nevarno snov oziroma snovi ali zmes, katere del je pogojno nevarna snov oziroma snovi.
there are valid data available on each of the components in the mixture to allow classification of the mixture according to the rules laid down in Directive 1999/45/EC, Regulation (EC) No 1907/2006 (REACH) and Regulation (EC) No 1272/2008 (CLP), and synergistic effects between any of the components are not expected
so na voljo veljavni podatki o vsaki od sestavin zmesi, ki omogočajo razvrstitev zmesi v skladu s pravili iz Direktive 1999/45/ES, Uredbo (ES) št. 1907/2006 (REACH) in Uredbo (ES) št. 1272/2008 (CLP), sinergijski učinki med katero koli od sestavin pa niso pričakovani.
Supplementary studies for combinations of biocidal products
Dopolnilne študije za kombinacije biocidnih proizvodov
For biocidal products that are intended to be authorised for use with other biocidal products, the risks to humans, animals and the environment arising from the use of these product combinations shall be assessed.
Pri biocidnih proizvodih, za katere je predvidena izdaja dovoljenja za uporabo z drugimi biocidnimi proizvodi, se ocenijo tveganja za ljudi, živali in okolje, ki izvirajo iz uporabe teh kombinacij proizvodov.
In some cases, for example where there are no valid data available of the kind set out in column 3, this may require a limited number of acute toxicity studies to be carried using combinations of the products
V nekaterih primerih, na primer kadar ni na voljo veljavnih podatkov takšne vrste, kot je določeno v stolpcu 3, bo morda treba z uporabo kombinacij teh proizvodov izvesti omejeno število študij akutne toksičnosti.
Further ecotoxicological studies
Nadaljnje ekotoksikološke študije
Further studies chosen from among the endpoints referred to in Section 8 of Annex II ‘Micro-organisms’ for relevant components of the biocidal product or the biocidal product itself may be required if the data on the active substance cannot give sufficient information and if there are indications of risk due to specific properties of the biocidal product
Kadar podatki o aktivni snovi ne morejo dati zadostnih informacij in kadar obstajajo znaki tveganja zaradi posebnih lastnosti biocidnega proizvoda, so lahko potrebne nadaljnje študije, izbrane med končnimi točkami iz oddelka 8 Priloge II, Mikroorganizmi, za pomembne sestavine biocidnega proizvoda ali sam biocidni proizvod.
Effects on any other specific non-target organisms (flora and fauna) believed to be at risk
Učinki na druge specifične neciljne organizme (floro in favno), ki naj bi bili ogroženi
If the biocidal product is in the form of bait or granules
Če je biocidni proizvod v obliki vabe ali zrnc:
Where relevant, all the information required in Section 9 of Annex II ‘Micro-organisms’ may be required for the product
Po potrebi je morda treba za proizvod navesti vse informacije, ki se zahtevajo v oddelku 9 Priloge II, Mikroorganizmi.
If the biocidal product is to be sprayed outside or if potential for large scale formation of dust is given then data on overspray behaviour may be required to assess risks to bees under field conditions
Če se biocidni proizvod razpršuje na prostem ali če obstaja možnost nastajanja velike količine prahu, se lahko zahtevajo podatki o zanašanju, da se oceni tveganje za čebele v razmerah na prostem.
Recommended methods and precautions concerning: handling, storage, transport or fire
Priporočene metode in varnostni ukrepi za: upravljanje, skladiščenje, prevoz ali požar
Procedures for destruction or decontamination of the biocidal product and its packaging
Postopki za uničenje ali dekontaminacijo biocidnega proizvoda in njegove embalaže
Packaging and compatibility of the biocidal product with proposed packaging materials
Embalaža in skladnost biocidnega proizvoda s predlaganimi materiali za pakiranje
Monitoring plan to be used for the active micro-organism and other micro-organism(s) contained in the biocidal product including handling, storage, transport and use
Načrt spremljanja, ki se uporabi za aktivne mikroorganizme in drug mikroorganizem oziroma mikroorganizme, ki jih vsebuje biocidni proizvod, vključno s shranjevanjem, upravljanjem, prevozom in uporabo
Indication on the need for the biocidal product to carry the biohazard sign specified in Annex II to Directive 2000/54/EC
Opozorilo, da mora biocidni proizvod nositi znak za biološko nevarnost iz Priloge II k Direktivi 2000/54/ES
Eye-irritation test shall not be necessary where the biocidal product has been shown to have potential corrosive properties.
Preskus draženja oči ni potreben, kadar je dokazano, da ima biocidni proizvod možne jedke lastnosti.
GENERAL RULES FOR THE ADAPTATION OF THE DATA REQUIREMENTS
SPLOŠNA PRAVILA ZA PRILAGODITEV ZAHTEV GLEDE PODATKOV
This Annex sets out rules to be followed when the applicant proposes to adapt the data requirements set out in Annexes II and III in accordance with Article 6(2) and (3) or Article 21(1) and (2), without prejudice to the specific rules set out in Annex III on the use of the calculation methods for classification of mixtures to avoid testing on vertebrates.
V tej prilogi so navedena pravila, ki jih je treba upoštevati, ko vlagatelj predlaga prilagoditev zahtev glede podatkov, določenih v prilogah II in III, v skladu s členom 6(2) in (3) ali členom 21(1) in (2), brez poseganja v posebna pravila iz Priloge III o uporabi metod izračunavanja za razvrščanje zmesi, da bi preprečili preskuse na vretenčarjih.
The reasons for such adaptations to the data requirements must be clearly stated under the appropriate heading of the dossier referring to the specific rule(s) of this Annex.
Razloge za tako prilagoditev zahtev glede podatkov je treba jasno navesti pod ustreznim naslovom dokumentacije, in sicer s sklicevanjem na posebno pravilo oziroma pravila iz te priloge.
TESTING DOES NOT APPEAR SCIENTIFICALLY NECESSARY
PRESKUSI SE Z ZNANSTVENEGA VIDIKA NE ZDIJO POTREBNI
Data on physical-chemical properties from experiments not carried out according to GLP or the relevant test methods.
Podatki o fizikalno-kemijskih lastnostih iz poskusov, ki niso izvedeni v skladu z dobro laboratorijsko prakso (DLP) ali ustreznimi preskusnimi metodami.
Data shall be considered to be equivalent to data generated by the corresponding test methods if the following conditions are met:
Podatki se upoštevajo kot enakovredni podatkom, pridobljenim z ustreznimi poskusnimi metodami, če so izpolnjeni naslednji pogoji:
adequacy of the data for the purpose of classification and labelling and risk assessment;
primernost podatkov za namen razvrščanja in označevanja ter ocene tveganja;
sufficient adequate and reliable documentation is provided to assess the equivalency of the study; and
zagotovljena je zadostna primerna in zanesljiva dokumentacija za oceno enakovrednosti študije in
the data are valid for the endpoint being investigated and the study is performed using an acceptable level of quality assurance.
podatki so veljavni za končno točko, ki se preiskuje, študija pa je opravljena na sprejemljivi ravni zagotovitve kakovosti.
Data on human health and environmental properties from experiments not carried out according to GLP or the relevant test methods.
Podatki o človekovem zdravju in okoljskih lastnostih iz poskusov, ki niso izvedeni v skladu z dobro laboratorijsko prakso (DLP) ali ustreznimi poskusnimi metodami.
adequate and reliable coverage of the key parameters/endpoints foreseen to be investigated in the corresponding test methods;
primerna in zanesljiva zajetost ključnih parametrov/končnih točk, predvidenih za raziskavo v ustrezni preskusni metodi;
exposure duration comparable to or longer than the corresponding test methods if exposure duration is a relevant parameter;
trajanje izpostavljenosti, ki je primerljivo z ustreznimi preskusnimi metodami ali je od njih daljše, če je trajanje izpostavljenosti relevanten parameter;
adequate and reliable documentation of the study is provided; and
zagotovljena je primerna in zanesljiva dokumentacija študije in
the study is performed using a system of quality assurance.
študija se izvede z uporabo sistema zagotovitve kakovosti.
Historical human data
Zgodovinski podatki o ljudeh
As a general rule, in accordance with Article 7(3) of Regulation (EC) No 1272/2008, tests on humans shall not be performed for the purposes of this Regulation.
Kot splošno pravilo in v skladu s členom 7(3) Uredbe (ES) št. 1272/2008 se preskusi na ljudeh za namene te uredbe ne izvajajo.
However, existing historical human data, such as epidemiological studies on exposed populations, accidental or occupational exposure data, biomonitoring studies, clinical studies and human volunteer studies performed in accordance with internationally accepted ethical standards shall be considered.
Upoštevajo pa se obstoječi zgodovinski podatki o ljudeh, kot so epidemiološke študije na izpostavljenih populacijah, podatki o nezgodni ali poklicni izpostavljenosti, študije biološkega monitoringa, klinične študije in študije na prostovoljcih, izvedene v skladu z mednarodno sprejetimi etičnimi standardi.
Data collected on humans shall not be used to lower the safety margins resulting from tests or studies on animals.
Podatki, pridobljeni v okviru raziskav, opravljenih na ljudeh, se ne smejo uporabiti za znižanje mej varnosti, ki so posledica preskusov ali študij na živalih.
The strength of the data for a specific human health effect depends, among other things, on the type of analysis and the parameters covered, and on the magnitude and specificity of the response and consequently the predictability of the effect.
Vrednost podatkov o posebnem učinku na človekovo zdravje je med drugim odvisna od vrste analize, zajetih parametrov, obsega in specifičnosti odziva ter posledično od predvidljivosti učinkov.
Criteria for assessing the adequacy of the data include:
Merila za oceno primernosti podatkov vključujejo:
the proper selection and characterisation of the exposed and control groups;
pravilno izbiro in opredelitev izpostavljenih in nadzornih skupin;
proper consideration of bias and confounding factors; and
pravilno obravnavanje pristranskosti in zavajajočih dejavnikov in
There may be sufficient weight of evidence from several independent sources of information leading to the assumption/conclusion that a substance has or does not have a particular dangerous property, while the information from each single source alone is considered insufficient to support this notion.
Iz več neodvisnih virov podatkov je mogoče dovolj zanesljivo domnevati/sklepati, da ima snov določene nevarne lastnosti ali pa teh nima, informacije le iz vsakega posameznega vira pa štejejo kot nezadostne za podporo temu mnenju.