natgillin/translations-raw huggingface dataset:
Product-type 21: Antifouling products
Vrsta proizvodov 21: antivegetacijska sredstva
Products used to control the growth and settlement of fouling organisms (microbes and higher forms of plant or animal species) on vessels, aquaculture equipment or other structures used in water.
Proizvodi za preprečevanje rasti in naselitve neželenih organizmov (mikrobov in rastlinskih ali živalskih vrst) na plovilih, opremi za vodno kulturo in drugih objektih in konstrukcijah, ki se uporabljajo v vodi.
Product-type 22: Embalming and taxidermist fluids
Vrsta proizvodov 22: tekočine za balzamiranje in prepariranje
Products used for the disinfection and preservation of human or animal corpses, or parts thereof.
Proizvodi, ki se uporabljajo za razkuževanje in ohranjanje človeških ali živalskih trupel ali njihovih delov.
COMMON PRINCIPLES FOR THE EVALUATION OF DOSSIERS FOR BIOCIDAL PRODUCTS
SPLOŠNA NAČELA ZA OCENJEVANJE DOKUMENTACIJE ZA BIOCIDNE PROIZVODE
Terms and definitions
Izrazi in opredelitve pojmov
Effects on human and animal health
Učinki na zdravje človeka in živali
Effects on the environment
Vplivi na okolje
Effects on target organisms
Učinki na ciljne organizme
Conclusions
Ugotovitve
Overall integration of conclusions
Povezovanje ugotovitev v celoto
Correspondence with the criteria set out in Article 19(1)(b)
Skladnost z merili iz člena 19(1)(b)
The subheadings ‘Effects on human and animal health’, ‘Effects on the Environment’, ‘Effects on Target Organisms’ and ‘Efficacy’ used in the Sections ‘Assessment’ and ‘Conclusions’ correspond to the four criteria set out in Article 19(1)(b) as follows:
Podnaslovi „Učinki na zdravje človeka in živali“, „Vplivi na okolje“, „Učinki na ciljne organizme“ in „Učinkovitost“ iz oddelkov „Ocena“ in „Ugotovitve“ ustrezajo naslednjim štirim merilom iz člena 19(1)(b):
‘Efficacy’ corresponds to criterion (i): ‘is sufficiently effective’.
„Učinkovitost“ ustreza merilu (i): „je dovolj učinkovit“.
‘Effects on target organisms’ corresponds to criterion (ii): ‘has no unacceptable effects on the target organisms, in particular unacceptable resistance or cross resistance or unnecessary suffering and pain for vertebrates’.
„Učinki na ciljne organizme“ ustreza merilu (ii): „nima nesprejemljivih učinkov na ciljne organizme, predvsem nesprejemljive odpornosti ali navzkrižne odpornosti ali nepotrebnega trpljenja in bolečine pri vretenčarjih“.
‘Effects on human and animal health’ corresponds to criterion (iii): ‘has no immediate or delayed unacceptable effects itself, or as a result of its residues, on human health, including that of vulnerable groups [1], or animal health, directly or through drinking water, food, feed, air, or through other indirect effects’.
„Učinki na zdravje človeka in živali“ ustreza merilu (iii): „sam po sebi ali njegovi ostanki nimajo takojšnjih ali zapoznelih nesprejemljivih učinkov na zdravje človeka, vključno z ranljivimi skupinami [1], ali zdravje živali neposredno ali prek pitne vode, hrane, krme, zraka ali prek drugih posrednih učinkov“.
‘Effects on the environment’ corresponds to criterion iv: ‘has no unacceptable effects itself, or as a result of its residues, on the environment, having particular regard to the following considerations:
„Vplivi na okolje“ ustreza merilu (iv): „sam po sebi ali njegovi ostanki nimajo nesprejemljivih vplivov na okolje, pri čemer je treba predvsem upoštevati naslednje:
its fate and distribution in the environment,
njegovo usodo in porazdelitev v okolju,
its impact on non-target organisms,
njegov vpliv na neciljne organizme,
its impact on biodiversity and the ecosystem’.
njegov vpliv na biotsko raznovrstnost in ekosistem“.
Technical definitions
Tehnične opredelitve
The identification of the adverse effects which a biocidal product has an inherent capacity to cause.
Je ugotavljanje neželenih učinkov, ki jih biocidni proizvod lahko povzroči zaradi svojih lastnosti.
Dose (concentration) — response (effect) assessment
Ocena razmerja med odmerkom (koncentracijo) in odzivom (učinkom)
The estimate of the relationship between the dose, or level of exposure, of an active substance or substance of concern in a biocidal product and the incidence and severity of an effect.
Je ocena razmerja med odmerkom ali stopnjo izpostavljenosti aktivne snovi ali pogojno nevarne snovi v biocidnem proizvodu ter resnostjo učinka.
The determination of the emissions, pathways and rates of movement of an active substance or a substance of concern in a biocidal product and its transformation or degradation in order to estimate the concentration/doses to which human populations, animals or environmental compartments are or may be exposed.
Je opis emisij, poti in hitrosti prehajanja aktivne snovi ali pogojno nevarne snovi v biocidnem proizvodu ter njene preobrazbe ali razgradnje, da se oceni razmerje med koncentracijo in odmerki, ki so jim ali so jim lahko izpostavljene populacije ljudi, živali ali ekosistemi.
Risk characterisation
Opis tveganja
The estimation of the incidence and severity of the adverse effects likely to occur in a human population, animals or environmental compartments due to actual or predicted exposure to any active substance or substance of concern in a biocidal product.
Je ocena pojava in resnosti neželenih učinkov, za katere obstaja verjetnost, da bi se pojavili pri populaciji ljudi, živali ali v ekosistemih zaradi dejanske ali predvidene izpostavljenosti aktivni snovi ali pogojno nevarni snovi v biocidnem proizvodu.
This may include ‘risk estimation’, i.e. the quantification of that likelihood.
Ta ocena lahko zajema „oceno tveganja“, torej količinsko oceno verjetnosti.
Water, including sediment, air, soil, wild species of fauna and flora, and any interrelationship between them, as well as any relationship with living organisms.
Voda, vključno z usedlinami, zrak, zemlja, prosto živeče vrste živali in rastline ter vsa medsebojna razmerja med njimi kot tudi vsa razmerja z živimi organizmi.
This Annex sets out the common principles for the evaluation of dossiers for biocidal products referred to in Article 19(1)(b).
V tej prilogi so določena splošna načela za ocenjevanje dokumentacije za biocidne proizvode iz člena 19(1)(b).
A decision by a Member State or the Commission to authorise a biocidal product shall be taken on the basis of the conditions set down in Article 19, taking account of the evaluation carried out according to this Annex.
Država članica ali Komisija sprejme sklep o izdaji dovoljenja za biocidni proizvod na podlagi pogojev, določenih v členu 19, ob upoštevanju ocene, opravljene v skladu s to prilogo.
Detailed technical guidance regarding the application of this Annex is available on the website of the Agency.
Podrobne tehnične smernice o uporabi te priloge so na voljo na spletnem mestu Agencije.
The principles set out in this Annex can be applied in their entirety to the evaluation of biocidal products comprised of chemical substances.
Načela iz te priloge se lahko v celoti uporabljajo za ocenjevanje biocidnih proizvodov, ki jih sestavljajo kemične snovi.
For biocidal products containing micro-organisms, these principles should be further developed in technical guidance taking into account practical experience gained, and be applied taking into account the nature of the product and the latest scientific information.
Za biocidne proizvode, ki vsebujejo mikroorganizme, bi morali ta načela bolj podrobno opisati v tehničnih smernicah, pri čemer bi bilo treba upoštevati pridobljene praktične izkušnje, ter jih uporabljati ob upoštevanju narave proizvoda in najnovejših znanstvenih dognanj.
In the case of biocidal products containing nanomaterials, the principles set out in this Annex will also need to be adapted and elaborated in technical guidance to take account of the latest scientific information.
Tudi za biocidne proizvode, ki vsebujejo nanomateriale, bo treba načela iz te priloge prilagoditi in podrobneje opredeliti v tehničnih smernicah, da bi upoštevali najnovejša znanstvena dognanja.
In order to ensure a high and harmonised level of protection of human health, animal health and the environment, any risks arising from the use of a biocidal product shall be identified.
Da se zagotovi visoka in usklajena raven varovanja zdravja človeka, zdravja živali in okolja, se opredelijo vsa tveganja, ki izhajajo iz uporabe biocidnega proizvoda.
To achieve this, a risk assessment shall be carried out to determine the acceptability or otherwise of any risks that are identified.
Da se to doseže, se opravi ocena tveganja, s katero se ugotovi sprejemljivost ali nesprejemljivost vseh ugotovljenih tveganj.
This is done by carrying out an assessment of the risks associated with the relevant individual components of the biocidal product, taking into account any cumulative and synergistic effects.
To se opravi z oceno tveganj, povezanih z ustreznimi posameznimi sestavinami biocidnega proizvoda, ob upoštevanju kakršnih koli kumulativnih in sinergijskih učinkov.
A risk assessment on the active substance(s) present in the biocidal product is always required.
Ocena tveganja je vedno obvezna za aktivno snov ali snovi, ki so prisotne v biocidnem proizvodu.
This risk assessment shall entail hazard identification, and, as appropriate, dose (concentration) - response (effect) assessment, exposure assessment and risk characterisation.
Po takšni oceni tveganja se opredeli nevarnost in opravi, če je primerno, ocena razmerja med odmerkom (koncentracijo) in odzivom (učinkom) ter ocena izpostavljenosti in pripravi opis tveganja.
Where a quantitative risk assessment cannot be made a qualitative assessment shall be produced.
Če kvantitativna ocena tveganja ni mogoča, se pripravi kvalitativna ocena.
Additional risk assessments shall be carried out, in the same manner as described above, on any substance of concern present in the biocidal product.
Na enak način, kot je opisano zgoraj, se izvedejo dodatne ocene tveganja za vse pogojno nevarne snovi, ki so prisotne v biocidnem proizvodu.
Information submitted in the framework of Regulation (EC) No 1907/2006 shall be taken into account where appropriate.
Po potrebi se upoštevajo podatki, predloženi v okviru Uredbe (ES) št. 1907/2006.
In order to carry out a risk assessment, data are required.
Za oceno tveganja so potrebni podatki.
These data are detailed in Annexes II and III and take account of the fact that there are a wide variety of applications as well as different product-types and that this has an impact on the associated risks.
Za oceno tveganja so potrebni podatki, ki so podrobno opisani v prilogah II in III in pri katerih se upošteva dejstvo, da obstajajo različne vrste uporabe in proizvodov, kar vpliva na tveganja, povezana z njimi.
The data required shall be the minimum necessary to carry out an appropriate risk assessment.
Zahtevajo se vsaj minimalni podatki, potrebni za pripravo primerne ocene tveganja.
The evaluating body shall take due consideration of the requirements of Articles 6, 21 and 62 in order to avoid duplication of data submissions.
Organ za ocenjevanje upošteva zahteve iz členov 6, 21 in 62, da bi se izognil podvajanju predloženih podatkov.
Data may also be required on a substance of concern present in a biocidal product.
Zahtevajo se lahko tudi podatki za pogojno nevarne snovi v biocidnem proizvodu.
For in-situ generated active substances, the risk assessment includes also the possible risks from the precursor(s).
Za aktivne snovi, nastale na kraju samem, ocena tveganja vključuje tudi morebitna tveganja predhodne oziroma predhodnih sestavin (prekurzorja(-ev)).
The results of the risk assessments carried out on the active substance and on the substances of concern present in the biocidal product shall be integrated to produce an overall assessment for the biocidal product itself.
Rezultate ocen tveganja, ki se opravijo za aktivno snov in pogojno nevarne snovi v biocidnem proizvodu, je treba združiti v skupno oceno za biocidni proizvod.
When making evaluations of a biocidal product the evaluating body shall:
Organ za ocenjevanje pri ocenjevanju biocidnega proizvoda:
take into consideration other relevant technical or scientific information which is reasonably available to them with regard to the properties of the biocidal product, its components, metabolites, or residues;
upošteva druge primerne tehnične informacije ali znanstvena dognanja, ki so na voljo v zvezi z lastnostmi biocidnega proizvoda, njegovimi sestavinami, metaboliti ali ostanki;
evaluate, where relevant, justifications submitted by the applicant for not supplying certain data.
po potrebi oceni utemeljitve, ki jih je vlagatelj predložil, kadar ni priskrbel določenih podatkov.
The application of these common principles shall, when taken together with the other conditions set out in Article 19, lead to the competent authorities or the Commission deciding whether or not a biocidal product can be authorised.
Uporaba teh splošnih načel, kadar so povezani z drugimi pogoji iz člena 19, pristojne organe ali Komisijo vodi pri odločanju, ali se lahko izda dovoljenje za biocidni proizvod ali ne.
Such authorisation may include restrictions on use or other conditions.
V takem dovoljenju so lahko tudi omejitve glede uporabe ali drugi pogoji.
In certain cases the competent authorities may conclude that more data are required before an authorisation decision can be made.
V določenih primerih država članica lahko sklene, da potrebuje več podatkov, preden lahko sprejme odločitev o izdaji dovoljenja.
In the case of biocidal products containing active substances covered by the exclusion criteria in Article 5(1), the competent authorities or the Commission shall also evaluate whether the conditions of Article 5(2) can be satisfied.
V primeru biocidnih proizvodov z aktivnimi snovmi, ki so zajete v merilih za izključitev v členu 5(1), pristojni organi ali Komisija prav tako ocenijo, ali je mogoče izpolniti pogoje iz člena 5(2).
During the process of evaluation, applicants and the evaluating bodies shall cooperate in order to resolve quickly any questions on the data requirements, to identify at an early stage any additional studies required, to amend any proposed conditions for the use of the biocidal product, or to modify its nature or its composition in order to ensure full compliance with the requirements of Article 19 and of this Annex.
Vlagatelji in organi za ocenjevanje v postopku ocenjevanja sodelujejo, da hitro razrešijo kakršna koli vprašanja v zvezi z zahtevami glede podatkov ali da v zgodnji fazi določijo kakršne koli potrebne dodatne raziskave ali dopolnijo vse predlagane pogoje za uporabo biocidnega proizvoda ali spremenijo njegovo vrsto ali sestavo, da bi zagotovili popolno upoštevanje zahtev iz člena 19 in te priloge.
The administrative burden, especially for SMEs, shall be kept to the minimum necessary without prejudicing the level of protection afforded to humans, animals and the environment.
Upravno breme, zlasti za MSP, naj bi bilo čim manjše, pri tem pa se ne sme posegati v stopnjo zaščite, namenjene ljudem, živalim in okolju.
The judgments made by the evaluating body during the evaluation must be based on scientific principles, preferably recognised at international level, and must be made with the benefit of expert advice.
Presoje, ki jih sprejmejo organi za ocenjevanje v postopku ocenjevanja, morajo temeljiti na znanstvenih načelih, po možnosti priznanih na mednarodni ravni, in upoštevati nasvete strokovnjakov.
The data submitted in support of an application for authorisation of a biocidal product shall be validated by the evaluating or receiving competent authority in accordance with the relevant articles of the Regulation.
Podatke, ki jih vlagatelj predloži v vlogi za izdajo dovoljenja za biocidni proizvod, organi, pristojni za ocenjevanje ali prejem vlog, potrdijo v skladu z ustreznimi členi uredbe.
After validation of these data the competent authorities shall utilise them by carrying out a risk assessment based on the proposed use.
Po potrditvi podatkov jih pristojni organi uporabijo za oceno tveganja, ki temelji na predlagani uporabi.
A risk assessment on the active substance present in the biocidal product shall always be carried out.
Za aktivno snov v biocidnem proizvodu se vedno pripravi ocena tveganja.
If there are, in addition, any substances of concern present in the biocidal product then a risk assessment shall be carried out for each of these.
Če so poleg tega v biocidnem proizvodu tudi druge pogojno nevarne snovi, se ocena tveganja pripravi tudi za vsako od njih.
The risk assessment shall cover the proposed normal use of the biocidal product, together with a realistic worst-case scenario including any relevant production and disposal issue.
Ocena tveganja zajema predlagano običajno uporabo biocidnega proizvoda, skupaj z realno najslabšim možnim primerom, v katerem so zajeti vsi pomembni problemi proizvodnje in odstranjevanja.
The assessment shall also take account of how any ‘treated articles’ treated with or containing the product may be used and disposed of.
V oceni je prav tako upoštevano, kako se uporabljajo vsi „tretirani izdelki“, ki so tretirani s takšnim proizvodom ali ga vsebujejo, ter kako se jih odstranjuje.
Active substances that are generated in-situ and the associated precursors shall also be considered.
V poštev pridejo tudi aktivne snovi, nastale na kraju samem, in z njimi povezane predhodne sestavine.
In carrying out the assessment, the possibility of cumulative or synergistic effects shall also be taken into account.
Pri ocenjevanju se upoštevajo tudi možni kumulativni ali sinergijski učinki.
The Agency shall, in collaboration with the Commission, Member States and interested parties, develop and provide further guidance on the scientific definitions and methodologies for the assessment of cumulative and synergistic effects.
Agencija v sodelovanju s Komisijo, državami članicami in zainteresiranimi stranmi oblikuje in zagotavlja dodatne smernice glede znanstvenih opredelitev in metodologije za oceno kumulativnih in sinergijskih učinkov.
For each active substance and each substance of concern present in the biocidal product, the risk assessment shall entail hazard identification and the establishment of appropriate reference values for dose or effect concentrations such as NOAEL or Predicted No Effect Concentrations (PNEC), where possible.
Za vsako aktivno in vsako pogojno nevarno snov, ki je v biocidnem proizvodu, oceni tveganja, kadar je to mogoče, sledi določitev nevarnosti in ustreznih referenčnih vrednosti za odmerek ali učinek koncentracij, kot je NOAEL, oziroma predvidenih koncentracij brez učinka (PNEC).
It shall also include, as appropriate, a dose (concentration) — response (effect) assessment, together with an exposure assessment and a risk characterisation.
Ocena prav tako vsebuje, kot je primerno, oceno razmerja med odmerkom (koncentracijo) in odzivom (učinkom), skupaj z oceno izpostavljenosti in opisom tveganja.
The results arrived at from a comparison of the exposure to the appropriate reference values for each of the active substances and for any substances of concern shall be integrated to produce an overall risk assessment for the biocidal product.
Rezultati, pridobljeni s primerjavo izpostavljenosti ustreznim referenčnim vrednostim za vsako aktivno snov ali za pogojno nevarno snov, se združijo v skupno oceno tveganja biocidnega proizvoda.
Where quantitative results are not available the results of the qualitative assessments shall be integrated in a similar manner.
Če kvantitativni rezultati niso na voljo, je treba združiti rezultate kvalitativnih ocen.
The risk assessment shall determine:
Ocena tveganja določa:
the hazards due to the physico-chemical properties,
nevarnosti zaradi fizikalno-kemijskih lastnosti;
the risk to humans and animals,
tveganje za ljudi in živali;
the risk to the environment,
tveganje za okolje;
the measures necessary to protect humans, animals and the environment, both during the proposed normal use of the biocidal product and in a realistic worst-case situation.
potrebne ukrepe za zaščito ljudi, živali in okolja tako med predlagano običajno uporabo biocidnega proizvoda kot v realnem najslabšem možnem primeru.
In certain cases it may be concluded that further data are required before a risk assessment can be finalised.
V določenih primerih se lahko sklene, da so pred končno oceno tveganja potrebni dodatni podatki.
Any such additional data requested shall be the minimum necessary to complete such a risk assessment.
Vsi zahtevani dodatni podatki so minimalni podatki, potrebni za dokončno oceno tveganja.
The information provided on the biocidal product family shall permit the evaluating body to reach a decision on whether all the products within the biocidal product family comply with the criteria under Article 19(1)(b).
Organ za ocenjevanje bo lahko na podlagi podatkov o družini proizvodnega proizvoda odločil, ali vsi proizvodi iz družine biocidnega proizvoda ustrezajo merilom iz člena 19(1)(b).
Where relevant the technical equivalence for every active substance contained in the biocidal product shall be established with reference to active substances already included in the list of approved active substances.
Po potrebi se za vsako aktivno snov, ki jo vsebuje biocidni proizvod, določi tehnična ekvivalenca glede na aktivne snovi, ki so že na seznamu odobrenih aktivnih snovi.
Effects on human health
Učinki na človekovo zdravje
The risk assessment shall take account of the following potential effects arising from the use of the biocidal product and the populations liable to exposure.
Ocena tveganja upošteva spodaj navedene možne učinke, ki nastanejo zaradi uporabe biocidnega proizvoda, in populacije, ki bodo verjetno izpostavljene temu proizvodu.
The effects previously mentioned result from the properties of the active substance and any substance of concern present.
Prej navedeni vplivi nastanejo zaradi lastnosti aktivne snovi in vseh pogojno nevarnih snovi v biocidnem proizvodu.
They are:
Ti vplivi so:
acute toxicity,
akutna toksičnost,
irritation,
draženje,
corrosivity,
jedkost,
repeated dose toxicity,
toksičnost pri ponovljenih odmerkih,
mutagenicity,
mutagenost,
carcinogenicity,
rakotvornost,
reproductive toxicity,
toksičnost za razmnoževanje,
neurotoxicity,
nevrotoksičnost,
immunotoxicity,
imunotoksičnost,
disruption of the endocrine system,
motnje endokrinega sistema,
any other special properties of the active substance or substance of concern,
vse druge posebne lastnosti aktivne snovi ali pogojno nevarne snovi,
other effects due to physico-chemical properties.
drugi učinki zaradi fizikalno-kemijskih lastnosti.
The populations previously mentioned are:
Zgoraj navedene populacije so:
professional users,
poklicni uporabniki,
non-professional users,
nepoklicni uporabniki,
humans exposed directly or indirectly via the environment.
osebe, ki so neposredno ali posredno izpostavljene preko okolja.
In considering these populations, particular attention should be given to the need to protect vulnerable groups within these populations.
Pri obravnavi teh populacij bi bilo treba posebno pozornost nameniti potrebi po zaščiti ranljivih skupin med njimi.
The hazard identification shall address the properties and potential adverse effects of the active substance and any substances of concern present in the biocidal product.
Pri določanju nevarnosti je treba preučiti lastnosti in morebitne neželene vplive aktivne snovi in vseh pogojno nevarnih snovi v biocidnem proizvodu.
The evaluating body shall apply points 27 to 30 when carrying out a dose (concentration) - response (effect) assessment on an active substance or a substance of concern present in a biocidal product.
Organ za ocenjevanje uporabi točke 27 do 30 pri ocenjevanju razmerja med odmerkom (koncentracijo) in odzivom (učinkom) za aktivno snov ali za pogojno nevarno snov v biocidnem proizvodu.
For repeated dose toxicity and reproductive toxicity the dose-response relationship shall be assessed for each active substance or substance of concern and, where possible, a NOAEL identified.
Pri toksičnosti zaradi ponovljenih odmerkov in toksičnosti za razmnoževanje se oceni razmerje med odmerkom in odzivom za vsako aktivno snov ali pogojno nevarno snov in, kadar je to mogoče, ugotovi NOAEL.