natgillin/translations-raw huggingface dataset:
Informacije o izpostavljenosti okolja, povezani s proizvodnjo in formulacijo, predlagano/pričakovano uporabo in odstranjevanjem
Information on environmental exposure associated with production and formulation, proposed/expected uses and disposal
Informacije o drugih proizvodih, skupaj s katerimi se bo proizvod verjetno uporabljal, zlasti navedba aktivnih snovi v teh proizvodih, če pomembno, in verjetnost morebitnega medsebojnega delovanja.
Information regarding other products that the product is likely to be used together with, in particular the identity of the active substances in these products, if relevant, and the likelihood of any interactions
TOKSIKOLOŠKI PROFIL PRI ČLOVEKU IN ŽIVALIH
TOXICOLOGICAL PROFILE FOR HUMANS AND ANIMALS
Jedkost za kožo ali draženje kože
Skin corrosion or skin irritation
Ocena te končne točke se izvede v skladu s strategijo zaporednega preskušanja za draženje kože in jedkost, določeno v Dodatku k smernici za preskušanje B.4.
The assessment of this endpoint shall be carried out according to the sequential testing strategy for dermal irritation and corrosion set out in the Appendix to Test Guideline B.4.
Akutna toksičnost: dermalna dražilnost/jedkost (Priloga B.4. k Uredbi (ES) št. 440/2008).
Acute Toxicity-Dermal Irritation/Corrosion (Annex B.4. to Regulation (EC) No 440/2008)
Preskus proizvoda/zmesi ni potreben, če:
Testing on the product/mixture does not need to be conducted if:
- so na voljo veljavni podatki o vsaki od sestavin v zmesi, ki so zadostni, da je možna razvrstitev zmesi v skladu s pravili iz Direktive 1999/45/ES in Uredbo (ES) št. 1272/2008 (CLP), sinergijski učinki med katero koli od sestavin pa niso pričakovani.
- there is valid data available on each of the components in the mixture sufficient to allow classification of the mixture according to the rules laid down in Directive 1999/45/EC and Regulation (EC) No 1272/2008 (CLP) and synergistic effects between any of the components are not expected.
Ocena te končne točke se izvede v skladu s strategijo zaporednega preskušanja za draženje oči in jedkost, določeno v dodatku k smernici za preskušanje B.5.
Eye irritation Eye-irritation test shall not be necessary where the biocidal product has been shown to have potential corrosive properties.
Akutna toksičnost: očesna dražilnost/jedkost (Priloga B.5. k Uredbi (ES) št. 440/2008).
The assessment of this endpoint shall be carried out according to the sequential testing strategy for eye irritation and corrosion as set down in the Appendix to Test Guideline B.5.Acute Toxicity: Eye Irritation/Corrosion (Annex B.5. to Regulation (EC) No 440/2008)
- so na voljo veljavni podatki o vsaki od sestavin zmesi, ki omogočajo razvrstitev zmesi v skladu s pravili iz Direktive 1999/45/ES in Uredbo (ES) št. 1272/2008 (CLP), sinergijski učinki med katero koli od sestavin pa niso pričakovani.
- there is 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/ECand 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 in Uredbo (ES) št. 1272/2008 (CLP), sinergijski učinki med katero koli od sestavin pa niso pričakovani.
- there is 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 and Regulation (EC) No 1272/2008 (CLP) and synergistic effects between any of the components are not expected.
- razpoložljive informacije kažejo, da bi moral biti proizvod razvrščen glede preobčutljivosti kože ali jedkosti za kožo ali
- the available information indicates that the product should be classified for skin sensitisation or corrosivity; or
- je snov močna kislina (pH < 2,0) ali baza (pH > 11,5).
- the substance is a strong acid (pH < 2.0) or base (Ph > 11.5)
- Privzeti pristop je razvrstitev na podlagi stopenjskega pristopa za razvrstitev zmesi za akutno strupenost iz Uredbe (ES) št. 1272/2008.
- Classification using the tiered approach to classification of mixtures for acute toxicity in Regulation (EC) No 1272/2008 is the default approach
Pri biocidnih proizvodih, za katere je predvidena izdaja dovoljenja za uporabo z drugimi biocidnimi proizvodi,
For biocidal products that are intended to be authorised for use with other biocidal products
se ocenijo tveganja za človekovo zdravje in okolje, ki izvirajo iz uporabe teh kombinacij proizvodov
the risks to human health and the environment arising from the use of these product combinations shall be assessed
Kot alternativa študijam akutne toksičnosti se lahko uporabijo izračuni.
As an alternative to acute toxicity studies calculations can be used.
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.
In some cases, for example where there is 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 out using combinations of the products.
Preskus zmesi proizvodov ni potreben, če:
Testing on the mixture of products does not need to be conducted if:
Podatki o dermalni absorpciji
Information on dermal absorption
Informacije o dermalni absorpciji pri izpostavljenosti biocidnemu proizvodu.
Information on dermal absorption when exposure occurs to the biocidal product.
Ta končna točka se oceni s stopenjskim pristopom.
The assessment of this endpoint shall proceed using a tiered approach
- pomožne snovi v formulaciji (tj. pogojno nevarne snovi) ali
- co-formulants (i.e. substance(s) of concern), or
- zmes, katere del je pogojno nevarna snov,
- a mixture that a substance(s) of concern is a component of
- so na voljo veljavni podatki o vsaki od sestavin zmesi, ki omogočajo razvrstitev zmesi v skladu s pravili iz Direktive 1999/45/ES in Uredbo (ES) št. 1272/2008 (CLP).
- there is 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 and Regulation (EC) No 1272/2008 (CLP).
Študije hrane in krme
Food and feedingstuffs studies
Če ostanejo ostanki biocidnega proizvoda na krmi dalj časa, so potrebne študije krme in študije metabolizma pri živini, da bi lahko ocenili ostanke v hrani živalskega izvora.
If residues of the biocidal product remain on feedingstuffs for a significant period of time, then feeding and metabolism studies in livestock shall be required to permit evaluation of residues in food of animal origin
Učinki industrijske predelave in/ali domačega pripravka na vrsto in količino ostankov biocidnega proizvoda
Effects of industrial processing and/or domestic preparation on the nature and magnitude of residues of the biocidal product
Za biocidni proizvod se zahtevajo ustrezni preskusi in primer z utemeljitvijo.
Suitable test(s) and a reasoned case will be required for the biocidal product
Poleg tega bi lahko bile potrebne študije ostankov za nekatere biocide, ki se uporabljajo neposredno na živini (vključno s konji) ali v njihovi okolici.
In addition, for certain biocides which are applied directly or around livestock (including horses) residue studies might be needed.
Na voljo mora biti dovolj informacij glede ekotoksičnosti biocidnega proizvoda, da omogočajo odločitev o razvrstitvi proizvoda.
Sufficient information relating to the ecotoxicity of the biocidal product such as to enable a decision to be made concerning the classification of the product is required.
- Kadar so na voljo veljavni podatki o vsaki od sestavin zmesi, sinergijski učinki med katero koli od sestavin pa niso pričakovani, je mogoče zmes razvrstiti v skladu s pravili iz Direktive 1999/45/ES, Uredbo (ES) št. 1907/2006 (REACH) in Uredbo (ES) št. 1272/2008 (CLP).
- Where there is valid data available on each of the components in the mixture and synergistic effects between any of the components are not expected, classification of the mixture can be made according to the rules laid down in Directive 1999/45/EC, Regulation (EC) No 1907/2006 (REACH) and Regulation (EC) No 1272/2008 (CLP)
- Kadar veljavnih podatkov o sestavinah ni na voljo ali kadar je mogoče pričakovati sinergijske učinke, je morda treba opraviti preskuse sestavin in/ali samega biocidnega proizvoda.
- Where valid data on the components is not available or where synergistic effects may be expected then testing of components and/or the biocidal product itself may be necessary.
Nadaljnje ekotoksikološke študije
Further Ecotoxicological studies
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 9 Priloge II, za pomembne sestavine biocidnega proizvoda ali sam biocidni proizvod.
Further studies chosen from among the endpoints referred to in section 9 of Annex II 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
Če je biocidni proizvod v obliki vabe ali zrnc, so lahko potrebne naslednje študije:
If the biocidal product is in the form of bait or granules the following studies may be required:
Drugotni ekološki vpliv, npr. ob tretiranju velikega dela specifičnega habitata.
Secondary ecological effect e.g. when a large proportion of a specific habitat type is treated.
Spodnje zahteve za preskuse se uporabljajo le za pomembne sestavine biocidnega proizvoda.
The test requirements below are applicable only to the relevant components of the biocidal product
Nadaljnje študije usode in obnašanja v okolju
Further studies on fate and behaviour in the environment
Lahko so potrebne nadaljnje študije, izbrane med končnimi točkami iz oddelka 10 Priloge II, za pomembne sestavine biocidnega proizvoda ali sam biocidni proizvod.
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.
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.
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.
Potrebni so podatki, razen če je znanstveno utemeljeno, da podatki, navedeni za aktivno snov in druge pogojno nevarne snovi, zajemajo usodo sestavin v proizvodu.
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
Preskusi glede širjenja in razpada v:
Testing for distribution and dissipation in the following:
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 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 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.
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
UKREPI, KI JIH JE TREBA SPREJETI ZA ZAŠČITO ČLOVEKA, ŽIVALI IN OKOLJA
MEASURES TO BE ADOPTED TO PROTECT HUMANS, ANIMALS AND THE ENVIRONMENT
Priporočene metode in previdnostni ukrepi v zvezi z ravnanjem, uporabo, shranjevanjem, odstranjevanjem, prevozom ali ob požaru
Recommended methods and precautions concerning handling, use, storage, disposal, transport or fire
Podrobnosti glede zdravljenja ob nesrečah, na primer prva pomoč, protistrupi, medicinsko zdravljenje, če je na voljo; nujni ukrepi za zaščito okolja
Specific treatment in case of an accident, e.g. first-aid measures, antidotes, medical treatment if available; emergency measures to protect the environment
Postopki za ravnanje z odpadnimi biocidnimi proizvodi in njihovo embalažo, ki veljajo za industrijsko uporabo, uporabo s strani usposobljenih strokovnjakov, poklicne ali nepoklicne uporabnike (na primer možnosti recikliranja, nevtralizacije, pogoji za nadzorovan izpust in sežig)
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 čiščenje opreme za nanašanje, kjer je to potrebno
Procedures for cleaning application equipment where relevant
Navesti repelente ali ukrepe za nadzorovanje stopnje toksičnosti, vključene v proizvod, za preprečevanje delovanja proizvoda na neciljne organizme
Specify any repellents or poison control measures included in the product that are present to prevent action against non-target organisms
RAZVRŠČANJE, OZNAČEVANJE IN PAKIRANJE
CLASSIFICATION, LABELLING, AND PACKAGING
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.
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.
Predložijo se vzorčne oznake, navodila za uporabo in varnostni list.
Example labels, instructions for use and safety data sheets shall be provided
Po potrebi se navedejo predlogi za varnostne liste
Proposals for safety-data sheets should be provided, where appropriate
Embalaža (vrsta, material, velikost itd.), združljivost proizvoda s predlaganimi materiali za embalažo
Packaging (type, materials, size, etc.), compatibility of the product with proposed packaging materials to be included
OCENA IN POVZETEK
EVALUATION AND SUMMARY
NASLOV 2 MIKROORGANIZMI ZBIRKA OSNOVNIH PODATKOV IN ZBIRKA DODATNIH PODATKOV
TITLE 2 MICRO-ORGANISMS CORE DATA SET AND ADDITIONAL DATA SET
Proizvajalec in formulator biocidnega proizvoda in mikroorganizma(-ov) (imena, naslovi, vključno s krajem proizvodnih obrata(-ov))
Manufacturer and formulator of the biocidal product and the micro-organism(s) (names, addresses, including location of plant(s))
OPIS BIOCIDNIH PROIZVODOV
IDENTITY OF THE BIOCIDAL PRODUCTS
Po potrebi proizvajalčeva razvojna koda in številka biocidnega proizvoda
Manufacturer's development code and number of the biocidal product, if appropriate
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(-ih) snovi, pomožnih snovi v formulaciji proizvoda in vseh drugih pomembnih sestavin.
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 co-formulants and any other relevant components.
Navedejo se tudi vse pomembne informacije o posameznih sestavinah in končna sestava biocidnega proizvoda.
All relevant information on individual ingredients and the final composition of the biocidal product shall be given.
Vrsta formulacije in narava biocidnega proizvoda
Formulation type and nature of the biocidal product
BIOLOŠKE, FIZIKALNE, KEMIJSKE IN TEHNIČNE LASTNOSTI BIOCIDNEGA PROIZVODA
BIOLOGICAL, PHYSICAL, CHEMICAL AND TECHNICAL PROPERTIES OF THE BIOCIDAL PRODUCT
Biološke lastnosti mikroorganizma v biocidnem proizvodu
Biological properties of the micro-organism in the biocidal product
Kislost, bazičnost in vrednost pH
Acidity, alkalinity and pH value
Učinki svetlobe
Effects of light
Učinki temperature in vlažnosti
Effects of temperature and humidity
Reaktivnost na embalažo
Reactivity towards the container
Razporeditev delcev po velikosti, vsebnost prahu/drobnih delcev, drobljivost in krušljivost
Particle size distribution content of dust/ fines, attrition and friability
Hitrost gorenja – generatorji dima
Burning rate - smoke generators
Popolnost zgorevanja – generatorji dima
Burning completeness - smoke generators
Sestava dima – generatorji dima
Composition of smoke - smoke generators
Vzorci razprševanja – aerosoli
Spraying patterns - aerosols
Fizikalna, kemijska in biološka združljivost z drugimi proizvodi, vključno z biocidnimi proizvodi, s katerimi se proizvod uporablja po izdaji dovoljenja ali registracije
Physical, chemical and biological compatibility with other products including biocidal products with which its use is to be authorised or registered
FIZIKALNE NEVARNOSTI IN USTREZNE ZNAČILNOSTI
PHYSICAL HAZARDS AND RESPECTIVE CHARACTERISITICS
4.7 Vnetljive trdne snovi
4.7 Flammable solids
Drugi fizikalni znaki nevarnosti
Other physical indications of hazard
Relativna temperatura samovžiga za trdne snovi
Relative self-ignition temperature for solids
Analitska metoda za določanje koncentracije mikroorganizmov in pogojno nevarnih snovi v biocidnem proizvodu
Analytical method for determining the concentration of the micro-organism(s) and substances of concern in the biocidal product
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)
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)
Uporaba in način nadziranja
Function and mode of control
Reprezentativni škodljivi organizmi, ki jih je treba nadzirati, in proizvodi, organizmi ali predmeti, ki jih je treba zaščititi
Representative pest organism(s) to be controlled and products, organisms or objects to be protected
Verjetna koncentracija, v kateri bo uporabljena aktivna snov
Likely concentration at which micro-organism will be used
Predlagano besedilo na oznaki proizvoda
The proposed label claims for the product
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.
Efficacy data to support these claims, including any available standard protocols, laboratory tests, or field trials used including performance standards, where appropriate and relevant
Opažanja o nezaželenih ali nenačrtovanih stranskih učinkih
Observations on undesirable or unintended side effects
Podroben opis predvidene uporabe
Detailed description of intended use
Odmerek in po potrebi končna koncentracija biocidnega proizvoda ali mikroorganizma in aktivne snovi v tretiranem izdelku ali sistemu, v katerem bo proizvod uporabljen (na primer v napravi za uporabo ali vabi)
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)
Število in časovni razpored uporabe in trajanje varstva.
Number and timing of applications and duration of protection
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 in živali ter okolja
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 and animal health and the environment
Podatki o izpostavljenosti
Exposure data
Informacije o izpostavljenosti ljudi, povezani s predlagano/pričakovano uporabo in odstranjevanjem
Information on human exposure associated with the proposed/expected uses and disposal
Informacije o izpostavljenosti okolja, povezani s predlagano/pričakovano uporabo in odstranjevanjem
Information on environmental exposure associated with the proposed/expected uses and disposal
- 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.
- there is 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
Jedkost za kožo ali draženje kože
Skin corrosion or irritation
Dodatne študije akutne toksičnosti
Additional acute toxicity studies
Po potrebi podatki o dermalni absorpciji
Information on dermal absorption if required
iz Priloge II za pomožne snovi v
for a coformulant(s) and cannot be inferred through read-across or other accepted non-testing approaches
snovi ali zmes, katere del je pogojno nevarna snov
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.
Nadaljnje ekotoksikološke študije
Further ecotoxicological studies
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.
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
Učinki na druge specifične neciljne organizme (floro in favno), ki naj bi bili ogroženi
Effects on any other specific non-target organisms (flora and fauna) believed to be at risk
Če je biocidni proizvod v obliki vabe ali zrnc:
If the biocidal product is in the form of bait or granules
Po potrebi je morda treba za proizvod navesti vse informacije, ki se zahtevajo v oddelku 9 Priloge II, Mikroorganizmi.
Where relevant, all the information required in section 9 of Annex II ‘Micro-organisms’ may be required for the product
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.
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
UKREPI, KI JIH JE TREBA SPREJETI ZA ZAŠČITO ČLOVEKA, ŽIVALI IN OKOLJA
MEASURES TO BE ADOPTED TO PROTECT MAN, ANIMAL AND THE ENVIRONMENT