natgillin/translations-raw huggingface dataset:
Odlaganje, shranjevanje in uporaba obstoječih zalog biocidnih pripravkov z manjšim tveganjem, za katere pooblaščeni organi niso dovolili zadevne uporabe, so dovoljeni do dvanajst mesecev po datumu odločitve iz drugega pododstavka ali dvanajst mesecev po datumu iz tretjega pododstavka, odvisno od tega, kateri datum je poznejši.
Disposal, storage and use of existing stocks of low-risk biocidal products which are not authorised for the relevant use by the competent authority are allowed until twelve months after the date of the decision referred to in the second subparagraph or twelve months after the date referred to in the third subparagraph, whichever is the later.
Ta uredba velja za biocidne pripravke z manjšim tveganjem, kot so opredeljeni v točki (b) člena 2(1) Direktive 98/8/ES, od izteka registracije iz odstavka 1 tega člena.
This Regulation shall apply to low-risk biocidal products as defined in point (b) of Article 2(1) of Directive 98/8/EC as of the expiry of the registration referred to in paragraph 1 of this Article.
Vloge za dovoljenje snovi, mešanic in naprav, ki se obravnavajo kot biocidni pripravki v skladu z drugim stavkom točke (a) člena 3(1), ki so bili na voljo v prometu dne … * Datum začetka veljavnosti te uredbe.
Applications for the authorisation of substances, mixtures and devices considered as biocidal products in accordance with the second sentence of point (a) of Article 3(1) which were available on the market on ... * Date of entry into force of this Regulation.
, se vložijo najpozneje do 1. januarja 2017.
shall be submitted at the latest by 1 January 2017.
Če se dovoljenje za dajanje biocidnih pripravkov v promet zavrne, se takšen biocidni pripravek preneha dajati v promet v šestih mesecih po sprejetju te odločitve.
In the case of a refusal to grant an authorisation to place such biocidal product on the market, such biocidal product shall no longer be placed on the market within six months after such decision.
Odstranitev, skladiščenje in uporaba obstoječih zalog biocidnih pripravkov, ki jih pristojni organi ali Komisija niso dovolili za zadevno uporabo, se lahko izvaja do 12 mesecev od datuma odločitve iz prvega pododstavka ali 12 mesecev po datumu iz drugega pododstavka, odvisno kateri datum je poznejši.
Disposal, storage and use of existing stocks of biocidal products which are not authorised for the relevant use by the competent authority or the Commission are allowed until 12 months after the date of the decision referred to in the first subparagraph or 12 months after the date referred to in the second subparagraph, whichever is the later.
Če se dovoljenje za dajanje biocidnih pripravkov v promet zavrne, se tretirani izdelki in snovi, ki vsebujejo takšne biocidne pripravke, prenehajo dajati v promet v šestih mesecih po sprejetju takšne odločitve.
In the event of a refusal to grant an authorisation to place a biocidal product on the market, treated articles and materials that incorporate such biocidal product shall no longer be placed on the market within six months after such decision.
Odstranitev, skladiščenje obstoječih zalog biocidnih pripravkov, ki jih pristojni organi ali Komisija niso dovolili za zadevno uporabo, so dovoljeni do poteka 12 mesecev od datuma odločitve iz prvega pododstavka člena 85(2) ali 12 mesecev od datuma iz drugega pododstavka člena 80(2), kar je pozneje.
Disposal and storage of existing stocks of biocidal products which are not authorised for the relevant use by the competent authority or the Commission shall be allowed until 12 months after the date of the decision referred to in the first subparagraph of Article 85(2) or 12 months after the date referred to in the second subparagraph of Article 85(2), whichever is the later.
, se vložijo najpozneje 1. januarja 2017.
shall be submitted at the latest 1 January 2017.
Snovi, ki so v stiku z živili, ki so bile v prometu dne ...*, za katere je bila vložena vloga v skladu z odstavkom 1, se lahko še naprej dajejo v promet do dne, ko se dovoljenje podeli ali zavrne.
Food contact materials which were available on the market on ...* for which an application was submitted in accordance with paragraph 1 may continue to be placed on the market until the date of the decision granting the authorisation or refusing to grant the authorisation.
Če se dovoljenje za dajanje takšnega biocidnega pripravka v promet zavrne, se takšen biocidni pripravek preneha dajati v promet v šestih mesecih po sprejetju te odločitve.
In the event of a refusal to grant an authorisation to place such biocidal product on the market, such biocidal product shall no longer be placed on the market within six months after such decision.
Snovi, ki so v stiku z živili, ki so bile na voljo v prometu dne ...* in za katere vloga ni bila vložena v skladu z odstavkom 1, se lahko še naprej dajejo v promet do dne šest mesecev po datumu iz odstavka 1.
Food contact materials which were available on the market on ...* for which an application was not submitted in accordance with paragraph 1 may continue to be placed on the market until six months after the date referred to in paragraph 1.
Odstranitev, skladiščenje in uporaba obstoječih zalog biocidnih pripravkov, ki jih pristojni organi ali Komisija niso dovolili za zadevno uporabo, se lahko izvajajo 12 mesecev po datumu odločitve iz drugega pododstavka odstavka 1 ali 12 mesecev po datumu iz tretjega pododstavka odstavka 1, odvisno kateri datum je poznejši.
Disposal, storage and use of existing stocks of biocidal products which are not authorised for the relevant use by the competent authority or the Commission is allowed until 12 months after the date of the decision referred to in the second subparagraph of paragraph 1 or 12 months after the date referred to in the third subparagraph of paragraph 1, whichever is the later.
, ki izpolnjuje
which complies with
Vlagatelj, ki prosi za dovoljenje za biocidni pripravek z aktivno snovjo, za katero je bila predložena izjava o dostopu v skladu s pododstavkom 1, lahko to izjavo uporablja za namene člena 18(1).
The applicant for the authorisation of a biocidal product containing an active substance for which a letter of access has been submitted in accordance with subparagraph 1 shall be allowed to use that letter of access for the purposes of Article 18(1).
Biocidni pripravki,
Biocidal products
ki vsebujejo obstoječe aktivne snovi,
containing existing active substances
za katere
for which
za katere ni bila posredovana dokumentacija ali izjava o dostopu do nje v skladu s pododstavkom 1
a dossier or a letter of access to a dossier has not been submitted in accordance with paragraph 1
, je dovoljena do
is allowed until
Za namene odstavka 3 uradni nadzor v skladu s členom 54(3) izvajajo pristojni organi.
For the purpose of paragraph 3, competent authorities shall carry out official controls as required by Article 54(3).
Ne glede na člena 83 in 84 se Direktiva 98/8/ES s tem razveljavlja.
Without prejudice to Article 83 and 84, Directive 98/8/EC is hereby repealed.
Sklicevanje na razveljavljeno Direktivo se razume kot sklicevanje na to uredbo in se bere v skladu s korelacijsko tabelo iz Priloge VII.
References to the repealed Directive shall be construed as references to this Regulation and be read in accordance with the correlation table set out in Annex VII.
Člen 90
Article 90 Entry into force
Začetek veljavnosti
This Regulation shall enter into force on the 20th day following that of its publication in the
Uporablja se od 1. januarja 2013.
It shall apply from 1 January 2013.
SEZNAM AKTIVNIH SNOVI Z ZAHTEVAMI ZA UPORABO V BIOCIDNIH PRIPRAVKIH
LIST OF ACTIVE SUBSTANCES WITH REQUIREMENTS FOR INCLUSION IN BIOCIDAL PRODUCTS
Splošno ime
Common Name
Ime po IUPAC
IUPAC Name
Identifikacijske številke
Identification Numbers
Minimalna čistost aktivne snovi v biocidnem pripravku, kakor se daje v promet
Minimum purity of the active substance in the biocidal product as placed on the market
Datum vključitve
Date of inclusion
Rok za uskladitev s členom 82(3)
Deadline for compliance with Article 82(3)
(razen za pripravke, ki vsebujejo več kot eno aktivno snov, za katero je rok za uskladitev s členom 82(3) enak roku, določenemu v zadnji odločitvi o vključitvi aktivnih snovi)
(except for products containing more than one active substance, for which the deadline to comply with Article 82(3) shall be the one set out in the last of the inclusion decisions relating to its active substances)
Datum izteka veljavnosti vključitve
Expiry date of inclusion
Vrsta pripravka
Product type
Posebne določbe (*)
Specific provisions (*)
sulfuril fluorid
sulfuryl fluoride
sulfuril difluorid
sulfuryl difluoride
ES št.: 220-281-5
EC No: 220-281-5
(1) pripravek se lahko prodaja samo strokovnjakom, usposobljenim za njegovo uporabo, ki ga edini lahko uporabljajo;
(1) the product may only be sold to and used by professionals trained to use it;
(2) edvideni so ustrezni ukrepi za zmanjšanje tveganja za delavce/uporabnike in druge navzoče osebe;
(2) appropriate risk mitigation measures are included for operators and bystanders;
(3) nadzorujejo se koncentracije sulfuril fluorida v oddaljenem troposferskem ozračju.
(3) concentrations of sulfuryl fluoride in remote tropospheric air are monitored.
Imetniki dovoljenj pošljejo poročila o nadzoru iz točke (3) vsakih pet let, z začetkom 1. januarja 2009, neposredno Komisiji.
Reports of the monitoring referred to in point (3) are to be transmitted by authorisation holders directly to the Commission every fifth year starting from 1 January 2009.
ES št.: 214-118-7
EC No: 214-118-7
1. marec 2009
1 March 2009
(1) Pripravke, katerih uporaba je dovoljena v industriji in/ali v profesionalne namene, je treba uporabljati z ustrezno osebno zaščitno opremo.
(1) Products authorised for industrial and/or professional use must be used with appropriate personal protective equipment.
(2) Zaradi ugotovljenih tveganj za tla je treba za zaščito tega ekosistema sprejeti ustrezne ukrepe za zmanjšanje tveganja.
(2) In view of the risks identified for the soil compartment appropriate risk mitigation measures must be taken to protect that compartment.
(3) Na oznakah in/ali varnostnih listih pripravkov, katerih uporaba je dovoljena v industriji, se navede, da je treba sveže obdelani les po obdelavi hraniti na neprepustni trdni podlagi, da se prepreči neposredno spiranje pripravkov v tla in se omogoči njihovo zbiranje za ponovno uporabo ali odstranjevanje.
(3) Labels and/or safety-data sheets of products authorised for industrial use indicate that freshly treated timber must be stored after treatment on impermeable hard standing to prevent direct losses to soil and that any losses must be collected for re-use or disposal.
ES št.: 433-460-1
EC No: 433-460-1
Zaradi ugotovljenih tveganj za tla, površinske vode in predele s podzemno vodo se dovoljenja ne izdajo za pripravke za obdelavo lesa, namenjenega uporabi na prostem, razen če predloženi podatki ne pokažejo, da je pripravek v skladu z zahtevami člena 16 in Priloge VI, po potrebi z uporabo ustreznih ukrepov za zmanjšanje tveganja.
In view of the risk identified for the soil, surface water and groundwater compartments, products shall not be authorised for the treatment of wood that will be used outdoors unless data is submitted to demonstrate that the product will meet the requirements of Article 16 and Annex VI, if necessary by the application of appropriate risk mitigation measures.
Zlasti na oznakah in/ali varnostnih listih pripravkov, katerih uporaba je dovoljena v industriji, se navede, da se sveže obdelani les po obdelavi hrani na neprepustni trdni podlagi, da se prepreči neposredno spiranje pripravkov v tla in se omogoči njihovo zbiranje za ponovno uporabo ali odstranjevanje.
In particular, labels and/or safety-data sheets of products authorised for industrial use indicate that freshly treated timber shall be stored after treatment on impermeable hard standing to prevent direct losses to soil and that any losses shall be collected for reuse or disposal.
ES št.: ni na voljo
EC No: n/a
(1) Nazivna koncentracija aktivne snovi v pripravku ne sme presegati 0,0025 % m/m, registracija pa se izda samo za uporabo pripravljene vabe.
(1) The nominal concentration of the active substance in the products shall not exceed 0,0025 % w/w and only ready-for-use baits shall be authorised.
(4) Primarna in sekundarna izpostavljenost ljudi, neciljnih živali in okolja se zmanjšata z upoštevanjem in uporabo vseh primernih in razpoložljivih ukrepov za zmanjšanje tveganja.
(4) Primary as well as secondary exposure of humans, non-target animals and the environment are minimised, by considering and applying all appropriate and available risk mitigation measures.
Ti med drugim vključujejo omejitev pripravka za poklicno rabo, določitev največje velikosti embalaže ter določitev zahtev za uporabo vab, zaščitenih pred nedosegljivimi posegi
These include, amongst others, the restriction to professional use only, setting an upper limit to the package size and laying down obligations to use tamper resistant and secured bait boxes.
ES št.: 407-980-2
EC No: 407-980-2
Zaradi ugotovljenega tveganja za delavce se pripravki ne smejo uporabljati vse leto, razen če predloženi podatki o dermalni absorpciji ne pokažejo, da kronična izpostavljenost ne pomeni nesprejemljivih tveganj.
In view of the risk identified for workers, products cannot be used year round unless dermal absorption data is provided to demonstrate that there are no unacceptable risks from chronic exposure.
Poleg tega se pripravke, namenjene uporabi v industriji, uporablja z ustrezno osebno zaščitno opremo.
In addition, products intended for industrial use shall be used with appropriate personal protective equipment.
ES št.: 403-640-2
EC No: 403-640-2
31. marec 2012
31 March 2012
31. marec 2020
31 March 2020
Zaradi ugotovljenih tveganj za tla in vodo se za varovanje teh ekosistemov sprejmejo ustrezni ukrepi za zmanjšanje tveganja.
In view of the risks identified for the soil and aquatic compartments appropriate risk mitigation measures shall be taken to protect those compartments.
ogljikov dioksid
carbon dioxide
ES št.: 204-696-9
EC No: 204-696-9
ES št.: 262-104-4
EC No: 262-104-4
Glede na ugotovitve ocene tveganja se pripravke z dovoljenjem za industrijsko in/ali poklicno uporabo uporablja z ustrezno osebno zaščitno opremo, razen če ni v vlogi za izdajo dovoljenja dokazano, da se tveganja za industrijske in/ali poklicne uporabnike lahko zmanjšajo na sprejemljivo raven z drugimi sredstvi.
In view of the assumptions made during the risk assessment, products authorised for industrial and/or professional use shall be used with appropriate personal protective equipment, unless it can be demonstrated in the application for product authorisation that risks to industrial and/or professional users can be reduced to an acceptable level by other means.
ES št.: 259-978-4
EC No: 259-978-4
31. marec 2015
31 March 2015
Ti med drugim vključujejo omejitev pripravka za poklicno rabo, določitev največje velikosti embalaže ter določitev zahtev za uporabo vab, zaščitenih pred nedosegljivimi posegi.
These include, amongst others, the restriction to professional use only, setting an upper limit to the package size and laying down obligations to use tamper resistant and secured bait boxes.
Cikloheksilhidroksidiazen 1-oksid, kalijeva sol
Cyclohexylhydroxydiazene 1-oxide, potassium salt
(Ta vnos vključuje tudi hidratne oblike K-HDO).
(This entry also covers the hydrated forms of K-HDO)
30. junij 2012
30 June 2012
30. junij 2020
30 June 2020
(1) zaradi možnih tveganj za okolje in delavce se pripravkov v skladu s členom 16 in Prilogo VI ne sme uporabljati drugje kot samo v industrijskih, povsem avtomatiziranih in zaprtih sistemih, razen če ni v vlogi za izdajo dovoljenja dokazano, da se lahko tveganja zmanjšajo na sprejemljivo raven;
(1) in view of the possible risks for the environment and workers, products shall not be used in other systems than industrial, fully automated and closed ones unless the application for product authorisation demonstrates that risks can be reduced to acceptable levels in accordance with Article 16 and Annex VI;
(2) glede na ugotovitve ocene tveganja se pripravki uporabljajo z ustrezno osebno zaščitno opremo, razen če ni v vlogi za izdajo dovoljenja dokazano, da je tveganje za uporabnike mogoče zmanjšati na sprejemljivo raven z drugimi sredstvi;
(2) in view of the assumptions made during the risk assessment, products shall be used with appropriate personal protective equipment, unless the application for product authorisation demonstrates that risks to users can be reduced to acceptable levels by other means;
(3) zaradi ugotovljenih tveganj za majhne otroke pripravkov ni dovoljeno uporabljati za obdelavo lesa, ki bi lahko prišel v neposreden stik z majhnimi otroki.
(3) in view of the risk identified for infants, products shall not be used for the treatment of wood that may enter in direct contact with infants.
3-jodo-2-propinil butilkarbamat
3-iodo-2-propynyl butylcarbamate
ES št.: 259-627-5
EC No: 259-627-5
Glede na ugotovitve ocene tveganja se pripravke z dovoljenjem za industrijsko in/ali poklicno uporabo uporablja z ustrezno osebno zaščitno opremo, razen če ni v vlogi za izdajo dovoljenja dokazano, da se tveganja za industrijske in/ali poklicne uporabnike lahko zmanjšajo na sprejemljivo raven z drugimi sredstvi.
In view of the assumptions made during the risk assessment, products authorised for industrial and/or professional use, shall be used with appropriate personal protective equipment, unless it can be demonstrated in the application for product authorisation that risks to industrial and/or professional users can be reduced to an acceptable level by other means.
Zlasti se na oznakah in/ali varnostnih listih pripravkov, katerih uporaba je dovoljena v industriji, navede, da se sveže obdelani les po obdelavi hrani pod streho ali na neprepustni trdni podlagi, da se prepreči neposredno spiranje pripravkov v tla ali vodo in se omogoči njihovo zbiranje za ponovno uporabo ali odstranitev.
In particular, labels and/or safety data sheets of products authorised for industrial use shall indicate that freshly treated timber shall be stored after treatment under shelter or on impermeable hard standing to prevent direct losses to soil or water and that any losses shall be collected for reuse or disposal.
ES št.: 205-725-8
EC No: 205-725-8
Glede na ugotovitve ocene tveganja se pripravke z dovoljenjem za industrijsko in/ali poklicno uporabo med izvedbo postopkov dvojnega vakuuma in potapljanja uporablja z ustrezno osebno zaščitno opremo, razen če ni v vlogi za izdajo dovoljenja dokazano, da se tveganja za industrijske in/ali poklicne uporabnike lahko zmanjšajo na sprejemljivo raven z drugimi sredstvi.
In view of the assumptions made during the risk assessment, products authorised for industrial and/or professional use, with respect to the double-vacuum and dipping application tasks, shall be used with appropriate personal protective equipment, unless it can be demonstrated in the application for product authorisation that risks to industrial and/or professional users can be reduced to an acceptable level by others means.
Uporaba pripravkov se ne dovoli za obdelavo lesa na prostem na kraju samem ali za les, ki bo izpostavljen vremenskim vplivom, razen če se predložijo podatki, ki dokazujejo, da bo pripravek izpolnjeval zahteve iz člena 16 in Priloge VI, če je potrebno z izvajanjem ustreznih ukrepov za zmanjševanje tveganja.
Products shall not be authorised for the in situ treatment of wood outdoors or for wood that will be exposed to weathering, unless data is submitted to demonstrate that the product will meet the requirements of Article 16 and Annex VI, if necessary by the application of appropriate risk mitigation measures.
ES št.: 428-650-4
EC No: 428-650-4
(*) Za izvajanje splošnih načel Priloge VI so vsebina in sklepne ugotovitve poročil o oceni na voljo na spletni strani Komisije: http://ec.europa.eu/comm/environment/biocides/index.htm.
(*) For the implementation of the common principles of Annex VI, the content and conclusions of assessment reports are available on the Commission website: http://ec.europa.eu/comm/environment/biocides/index.htm
Zahtevani podatki za aktivne snovi
Data requirements for active substances
Dokumentacija za raven I vsebuje vse informacije, ki so potrebne za opredelitev lastnosti in tveganj aktivnih snovi v njihovem življenjskem ciklu, zlasti v skladu s členi 5, 9 in 17 te uredbe.
Dossiers for Tier 1 shall contain all information necessary for identifying the properties and risks of active substances over their life cycle, in particular pursuant to Article 5, 9 and 17 of this Regulation.
Informacij, ki niso potrebne zaradi lastnosti biocidnega pripravka ali njegove predlagane uporabe, ni treba navajati.
Information which is however not necessary owing to the nature of the biocidal product or of its proposed uses need not be supplied.
Vključi se podroben in popoln opis opravljenih raziskav ter uporabljenih metod ali bibliografska navedba teh postopkov.
A detailed and full description of the studies conducted and of the methods used or a bibliographical reference to those methods shall be included.
Dokumentacija mora biti predložena na obrazcih, ki so na voljo pri Komisiji.
The formats made available by the Commission must be used for submission of the dossiers.
Poleg tega je treba uporabiti posebno programsko opremo (IUCLID), ki jo da na voljo Komisija, za tiste dele dokumentacije, za katere se lahko uporablja IUCLID.
In addition, the special software package (IUCLID) made available by the Commission must be used for those parts of the dossiers to which IUCLID applies.
Obrazci in nadaljnje smernice glede zahtevanih podatkov in priprave dokumentacije so na voljo na spletni strani Agencije.
Formats and further guidance on data requirements and dossier preparation are available on the Agency homepage.
Vendar se, če je metoda neustrezna ali ni opisana, uporabijo druge metode, ki
However, if a method is inappropriate or not described, other methods shall be used which are
so zadostne z znanstvenega vidika, njihova veljavnost pa mora
scientifically satisfactory
v vlogi.
must be justified in the application.
Opravljeni preskusi bi morali biti v skladu z ustreznimi zahtevami za varstvo laboratorijskih živali iz Direktive Sveta 86/609/EGS z dne 24. novembra 1986 o približevanju zakonov in drugih predpisov držav članic o varstvu živali, ki se uporabljajo za poskuse in druge znanstvene namene UL L 358, 18.12.1986, str.
Tests performed should comply with the relevant requirements of protection of laboratory animals, set out in Council Directive 86/609/EEC of 24 November 1986 on the approximation of laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposes OJ L 358, 18.12.1986, p.
, ter v primeru ekotoksikoloških in toksikoloških preskusov dobro laboratorijsko prakso iz Direktive 2004/10/ES z dne 11. februarja 2004 Evropskega parlamenta in Sveta o usklajevanju zakonov in drugih predpisov o uporabi načel dobre laboratorijske prakse ter preverjanju njihove uporabe pri preskusih kemijskih snovi UL L 50, 20.2.2004, str.
, and, in the case of ecotoxicological and toxicological tests, good laboratory practice, set out in Directive 2004/10/EC of the European Parliament and of the Council of 11 February 2004 on the harmonisation of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their application for tests on chemical substances OJ L 50, 20.2.2004, p.
ali iz drugih mednarodnih standardov, ki sta jih Komisija ali Agencija priznali kot ustrezne.
or other international standards recognised as being equivalent by the Commission or the Agency.
Kadar se opravi preskus, je treba predložiti natančen opis (specifikacija) uporabljenega materiala in nečistot, ki jih vsebuje.
Where testing is done, a detailed description (specification) of the material used and its impurities must be provided.
Kadar obstajajo podatki o preskusih, pridobljeni pred
Where test data exist that have been generated before