natgillin/translations-raw huggingface dataset:
The Netherlands have informed the Commission that the CAS number for the pentahydrate form in the original report was incorrect, and submitted a revised report to the Commission according to which the correct CAS number for this form is 12179-04-3.
Nizozemska je obvestila Komisijo, da je številka CAS za pentahidrat v originalnem poročilu napačna in ji je predložila revidirano poročilo, v skladu s katerim je pravilna številka CAS za to obliko 12179-04-3.
The revised report was endorsed by the Standing Committee on Biocidal Products on 25 May 2012.
Revidirano poročilo je Stalni odbor za biocidne popravke potrdil 25. maja 2012.
Annex I to Directive 98/8/EC should therefore be corrected accordingly.
Prilogo I k Direktivi 98/8/ES je zato treba ustrezno spremeniti.
Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 31 March 2013 at the latest.
Države članice sprejmejo zakone in druge predpise, potrebne za uskladitev s to direktivo, najpozneje do 31. marca 2013.
In Annex I to Directive 98/8/EC, the third column of entry No 24 is replaced by the following:
V Prilogi I k Direktivi 98/8/ES se tretji stolpec vnosa št. 24 nadomesti z naslednjim:
‘disodium tetraborate
„dinatrijev tetraborat
EC No: 215-540-4
Št. EC: 215-540-4
CAS No (anhydrous): 1330-43-4
Št. CAS (brezvoden): 1330-43-4
CAS No (pentahydrate): 12179-04-3
Št. CAS (pentahidrat): 12179-04-3
CAS No (decahydrate): 1303-96-4’
Št. CAS (dekahidrat): 1303-96-4“
Commission Directive 2012/41/EU
Direktiva Komisije 2012/41/EU
amending Directive 98/8/EC of the European Parliament and of the Council to extend the inclusion in Annex I thereto of the active substance nonanoic acid to product type 2
o spremembi Direktive 98/8/ES Evropskega parlamenta in Sveta za razširitev vključitve aktivne snovi nonanojske kisline v Prilogi I k Direktivi na 2. vrsto izdelkov
Commission Directive 2011/13/EU of 8 February 2011 amending Directive 98/8/EC of the European Parliament and of the Council to include nonanoic acid as an active substance in Annex I thereto [3] included nonanoic acid as an active substance in Annex I to Directive 98/8/EC for use in product type 19, repellents and attractants, as defined in Annex V to Directive 98/8/EC.
Z Direktivo Komisije 2011/13/EU z dne 8. februarja 2011 o spremembi Direktive 98/8/ES Evropskega parlamenta in Sveta za vključitev nonanojske kisline kot aktivne snovi v Prilogo I k Direktivi [3] je bila nonanojska kislina vključena kot aktivna snov v Prilogo I k Direktivi 98/8/ES za uporabo v 19. vrsti izdelkov (repelenti in sredstva za privabljanje (atraktanti)), kot je opredeljena v Prilogi V k Direktivi 98/8/ES.
Pursuant to Regulation (EC) No 1451/2007, nonanoic acid has now been evaluated in accordance with Article 11(2) of Directive 98/8/EC for use in product type 2, private area and public health area disinfectants and other biocidal products, as defined in Annex V to that Directive.
Na podlagi Uredbe (ES) št. 1451/2007 je bila v skladu s členom 11(2) Direktive 98/8/ES opravljena presoja nonanojske kisline glede uporabe v 2. vrsti izdelkov (razkužila in drugi biocidni pripravki za zasebne površine in površine, namenjene javnemu zdravstvu), kot je opredeljena v Prilogi V k navedeni direktivi.
Austria was designated as Rapporteur Member State and submitted the competent authority report, together with a recommendation, to the Commission on 6 August 2010 in accordance with Article 14(4) and (6) of Regulation (EC) No 1451/2007.
Avstrija, ki je bila imenovana za državo članico poročevalko, je 6. avgusta 2010 v skladu s členom 14(4) in (6) Uredbe (ES) št. 1451/2007 Komisiji poslala poročilo pristojnega organa in priporočilo.
In accordance with Article 15(4) of Regulation (EC) No 1451/2007, the findings of the review were incorporated, within the Standing Committee on Biocidal Products on 25 May 2012, in an assessment report.
V skladu s členom 15(4) Uredbe (ES) št. 1451/2007 so bile ugotovitve pregleda v Stalnem odboru za biocidne pripravke z dne 25. maja 2012 vključene v poročilo o oceni.
It appears from the evaluations that biocidal products used as private area and public health area disinfectants and other biocidal products as defined in Annex V to Directive 98/8/EC and containing nonanoic acid may be expected to satisfy the requirements laid down in Article 5 of Directive 98/8/EC.
Iz presoje je razvidno, da je za biocidne pripravke, ki se uporabljajo kot razkužila in drugi biocidni pripravki za zasebne površine in površine, namenjene javnemu zdravstvu, opredeljeni v Prilogi V k Direktivi 98/8/ES, in ki vsebujejo nonanojsko kislino, mogoče sklepati, da izpolnjujejo zahteve iz člena 5 Direktive 98/8/ES.
It is therefore appropriate to extend the inclusion of nonanoic acid in Annex I to that Directive to product type 2.
Zato je primerno razširiti vključitev nonanojske kisline v Prilogi I k navedeni direktivi na 2. vrsto izdelkov.
It is therefore appropriate to require that Member States assess those uses or exposure scenarios and those risks to human populations and to environmental compartments that have not been representatively addressed in the Union level risk assessment and, when granting product authorisations, ensure that appropriate measures are taken or specific conditions imposed in order to reduce the identified risks to acceptable levels.
Zato je primerno od držav članic zahtevati, da ocenijo možnosti uporabe oziroma primere izpostavljenosti ter tista tveganja za populacije ljudi in dele okolja, ki v oceni tveganja na ravni Unije niso bili reprezentativno obravnavani, ter da pri izdajanju dovoljenj za pripravke zagotovijo, da se sprejmejo ustrezni ukrepi ali določijo posebni pogoji za zmanjšanje ugotovljenih tveganj na sprejemljivo raven.
In view of the irritant properties of the substance, it is appropriate to require that exposure during non-professional use is minimised through the design of the packaging, unless it can be demonstrated in the application for product authorisation that risks for human health can be reduced to acceptable levels by other means.
Glede na dražilne lastnosti snovi je ustrezno zahtevati, da se izpostavljenost med nepoklicno uporabo zmanjša z ustrezno oblikovano embalažo, razen če v vlogi za izdajo dovoljenja ni dokazano, da se tveganja za človeško zdravje lahko zmanjšajo na sprejemljivo raven z drugimi sredstvi.
The provisions of this Directive should be applied simultaneously in all Member States in order to ensure equal treatment on the Union market of biocidal products of product type 2 containing the active substance nonanoic acid and also to facilitate the proper operation of the biocidal products market in general.
Določbe te direktive bi se morale uporabljati hkrati v vseh državah članicah, da se tako na trgu Unije zagotovi enaka obravnava biocidnih pripravkov iz 2. vrste izdelkov, ki vsebujejo aktivno snov nonanojsko kislino, in omogoči ustrezno delovanje trga biocidnih pripravkov na splošno.
A reasonable period should be allowed to elapse before an active substance is included in Annex I to Directive 98/8/EC, in order to permit Member States and interested parties to prepare themselves to meet the new requirements entailed and to ensure that applicants who have prepared dossiers can benefit fully from the 10-year period of data protection, which, in accordance with Article 12(1)(c)(ii) of Directive 98/8/EC, starts from the date of inclusion.
Pred vključitvijo aktivne snovi v Prilogo I k Direktivi 98/8/ES bi bilo treba zagotoviti ustrezno obdobje, ki bo državam članicam in zainteresiranim stranem omogočilo, da se pripravijo na izpolnjevanje novih zahtev, prijaviteljem, ki so pripravili dokumentacijo, pa zagotovilo, da lahko povsem izkoristijo desetletno obdobje za varstvo podatkov, ki se v skladu s členom 12(1)(c)(ii) Direktive 98/8/ES začne z dnem vključitve.
In accordance with the Joint Political Declaration of Member States and the Commission on explanatory documents of 28 September 2011 [4], Member States have undertaken to accompany, in justified cases, the notification of their transposition measures with one or more documents explaining the relationship between the components of a directive and the corresponding parts of national transposition instruments.
Države članice so se v skladu s skupno politično deklaracijo držav članic in Komisije o obrazložitvenih dokumentih z dne 28. septembra 2011 [4] zavzele, da bodo v utemeljenih primerih uradnemu obvestilu o svojih ukrepih za prenos priložile enega ali več dokumentov, ki bodo pojasnjevali razmerje med sestavnimi deli direktive in ustreznimi deli nacionalnih instrumentov za prenos.
The following is added to entry ‘No 41’ in Annex I to Directive 98/8/EC:
V Prilogo I k Direktivi 98/8/ES se vstavi naslednji vnos „št. 41“:
‘1 October 2014
„1. oktober 2014
Member States shall ensure that authorisations of products for non-professional use are subject to the packaging being designed to minimise user exposure, unless it can be demonstrated in the application for product authorisation that risks for human health can be reduced to acceptable levels by other means.’
Države članice zagotovijo, da je izdaja dovoljenja za pripravek za nepoklicno uporabo odvisna od ustreznosti embalaže, oblikovane za zmanjšanje izpostavljenosti uporabnika, razen če v vlogi za izdajo dovoljenja ni dokazano, da se tveganja za človeško zdravje lahko zmanjšajo na sprejemljivo raven z drugimi sredstvi.“
Commission Directive 2012/42/EU
Direktiva Komisije 2012/42/EU
amending Directive 98/8/EC of the European Parliament and of the Council to include hydrogen cyanide as an active substance in Annex I thereto
o spremembi Direktive 98/8/ES Evropskega parlamenta in Sveta za vključitev vodikovega cianida kot aktivne snovi v Prilogo I k Direktivi
That list includes hydrogen cyanide.
Navedeni seznam vključuje vodikov cianid.
Pursuant to Regulation (EC) No 1451/2007, hydrogen cyanide has been evaluated in accordance with Article 11(2) of Directive 98/8/EC for use in the following product types, as defined in Annex V to that Directive: product type 8, wood preservatives, product type 14, rodenticides, and product type 18, insecticides, acaricides and products to control other arthropods.
Na podlagi Uredbe (ES) št. 1451/2007 je bila v skladu s členom 11(2) Direktive 98/8/ES opravljena presoja vodikovega cianida glede uporabe v naslednjih vrstah izdelkov, kot so opredeljene v Prilogi V k navedeni direktivi: 8. vrsta izdelkov (pripravki za zaščito lesa), 14. vrsta izdelkov (rodenticidi) in 18. vrsta izdelkov (insekticidi, akaricidi in pripravki za nadzor drugih členonožcev).
The Czech Republic was designated as Rapporteur Member State and submitted three competent authority reports, including recommendations, to the Commission on 24 January 2008 in accordance with Article 14(4) and (6) of Regulation (EC) No 1451/2007.
Češka republika, ki je bila imenovana za državo članico poročevalko, je 24. januarja 2008 v skladu s členom 14(4) in (6) Uredbe (ES) št. 1451/2007 Komisiji poslala poročilo pristojnega organa in priporočila.
In accordance with Article 15(4) of Regulation (EC) No 1451/2007, the findings of the review were incorporated, within the Standing Committee on Biocidal Products on 25 May 2012, in three assessment reports.
V skladu s členom 15(4) Uredbe (ES) št. 1451/2007 so bile ugotovitve pregleda v Stalnem odboru za biocidne pripravke z dne 25. maja 2012 vključene v tri poročila o oceni.
It appears from the evaluations that biocidal products used as wood preservatives, rodenticides, insecticides, acaricides and products to control other arthropods and containing hydrogen cyanide may be expected to satisfy the requirements laid down in Article 5 of Directive 98/8/EC.
Iz presoje je razvidno, da je za biocidne pripravke, ki se uporabljajo kot pripravki za zaščito lesa, rodenticidi, insekticidi, akaricidi in pripravki za nadzor drugih členonožcev ter vsebujejo vodikov cianid, mogoče sklepati, da izpolnjujejo zahteve iz člena 5 Direktive 98/8/ES.
It is therefore appropriate to include hydrogen cyanide in Annex I to that Directive.
Zato je vodikov cianid primerno vključiti v Prilogo I k navedeni direktivi.
In view of the highly toxic and flammable properties of the active substance and the assumptions made during the risk assessment, it is appropriate to require that products are only authorised for use by professionals adequately trained to use them and that safe operational procedures during fumigation and venting are established for operators and bystanders, including the following requirements: products shall be used with adequate personal protective equipment including, where appropriate, self-contained breathing apparatus and gas-tight clothing; re-entry into fumigated spaces shall be prohibited until the air concentration has reached safe levels for operators and bystanders by ventilation; exposure during and after ventilation shall be prevented from exceeding safe levels for operators and bystanders by the establishment of a supervised exclusion zone; prior to fumigation, any food and any porous material with a potential to absorb the active substance, except wood intended to be treated, shall either be removed from the space to be fumigated or protected from absorption by adequate means, and the space to be fumigated shall be protected against accidental ignition.
Glede na zelo strupene in vnetljive lastnosti aktivne snovi in ugotovitve ocene tveganja je primerno zahtevati, da smejo pripravke uporabljati samo poklicni uporabniki, ki so za njihovo uporabo ustrezno usposobljeni, in da se med zaplinjevanjem in prezračevanjem za uporabnike in druge navzoče osebe določijo postopki varnega ravnanja, vključno z naslednjimi zahtevami: pripravki se uporabljajo z ustrezno osebno zaščitno opremo, ki po potrebi vključuje aparat za samostojno dihanje in obleko, nepropustno za plin; ponovni vstop v zaplinjene prostore je prepovedan, dokler se s prezračevanjem ne doseže varna raven koncentracije v zraku za uporabnike in druge navzoče osebe; izpostavljenost uporabnikov in drugih navzočih oseb prekoračitvi varne ravni med prezračevanjem in po njem se prepreči z vzpostavitvijo nadzorovanega zaprtega območja; pred začetkom zaplinjevanja se kakršna koli hrana in porozni material, ki lahko absorbira aktivno snov, razen lesa, namenjenega za obdelavo, odstrani iz prostora, ki se zaplinjuje, ali zaščiti pred absorpcijo na primeren način, prostor, ki se zaplinjuje, pa se zaščiti pred slučajnim vžigom.
The provisions of this Directive should be applied simultaneously in all Member States in order to ensure equal treatment on the Union market of biocidal products of product types 8, 14 and 18 containing the active substance hydrogen cyanide and also to facilitate the proper operation of the biocidal products market in general.
Določbe te direktive bi se morale uporabljati hkrati v vseh državah članicah, da se tako na trgu Unije zagotovi enaka obravnava biocidnih pripravkov v 8., 14. in 18. vrsti izdelkov, ki vsebujejo aktivno snov vodikov cianid, in omogoči ustrezno delovanje trga biocidnih pripravkov na splošno.
In accordance with the Joint Political Declaration of Member States and the Commission on explanatory documents of 28 September 2011 [3], Member States have undertaken to accompany, in justified cases, the notification of their transposition measures with one or more documents explaining the relationship between the components of a directive and the corresponding parts of national transposition instruments.
Države članice so se v skladu s skupno politično deklaracijo držav članic in Komisije o obrazložitvenih dokumentih z dne 28. septembra 2011 [3] zavzele, da bodo v utemeljenih primerih uradnemu obvestilu o svojih ukrepih za prenos priložile enega ali več dokumentov, ki bodo pojasnjevali razmerje med sestavnimi deli direktive in ustreznimi deli nacionalnih instrumentov za prenos.
hydrogen cyanide
vodikov cianid
EC No: 200-821-6
Št. ES: 200-821-6
CAS No: 74-90-8
Št. CAS: 74-90-8
Member States shall ensure that authorisations of products for use as a fumigant are subject to the following conditions:
Države članice zagotovijo, da so pri izdajanju dovoljenj za pripravke, namenjene za zaplinjevanje, izpolnjeni naslednji pogoji:
product shall only be supplied to and used by professionals adequately trained to use them;
pripravki se lahko dobavijo le ustrezno usposobljenim poklicnim uporabnikom, ki jih edini lahko uporabljajo;
safe operational procedures during fumigation and venting shall be established for operators and bystanders;
med zaplinjevanjem in prezračevanjem se za uporabnike in druge navzoče osebe določijo postopki varnega ravnanja;
products shall be used with adequate personal protective equipment including, where appropriate, self-contained breathing apparatus and gas-tight clothing;
pripravki se uporabljajo z ustrezno osebno zaščitno opremo, ki po potrebi vključuje aparat za samostojno dihanje in obleko, nepropustno za plin;
re-entry into fumigated spaces shall be prohibited until the air concentration has reached safe levels for operators and bystanders by ventilation;
ponovi vstop v zaplinjene prostore je prepovedan, dokler se s prezračevanjem ne doseže varna raven koncentracije v zraku za uporabnike in druge navzoče osebe;
exposure during and after ventilation shall be prevented from exceeding safe levels for operators and bystanders by the establishment of a supervised exclusion zone;
izpostavljenost uporabnikov in drugih navzočih oseb prekoračitvi varne ravni med prezračevanjem in po njem se prepreči z vzpostavitvijo nadzorovanega zaprtega območja;
prior to fumigation, any food and any porous material with a potential to absorb the active substance, except wood intended to be treated, shall either be removed from the space to be fumigated or protected from absorption by adequate means, and the space to be fumigated shall be protected against accidental ignition.’
pred začetkom zaplinjevanja se kakršna koli hrana in porozni material, ki lahko absorbira aktivno snov, razen lesa, namenjenega za obdelavo, odstrani iz prostora, ki se zaplinjuje, ali zaščiti pred absorpcijo na primeren način, prostor, ki se zaplinjuje pa se zaščiti pred slučajnim vžigom.“
Commission Directive 2012/43/EU
Direktiva Komisije 2012/43/EU
amending certain headings of Annex I to Directive 98/8/EC of the European Parliament and of the Council
o spremembi nekaterih naslovov stolpcev v Prilogi I k Direktivi 98/8/ES Evropskega parlamenta in Sveta
Having regard to Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market [1], and in particular Articles 11(4) and 16(2) thereof,
ob upoštevanju Direktive 98/8/ES Evropskega parlamenta in Sveta z dne 16. februarja 1998 o dajanju biocidnih pripravkov v promet [1] ter zlasti člena 11(4) in člena 16(2) Direktive,
Commission Regulation (EC) No 1451/2007 of 4 December 2007 on the second phase of the 10-year work programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market [2] provides detailed rules for the evaluations of existing active substances.
Uredba Komisije (ES) št. 1451/2007 z dne 4. decembra 2007 o drugi fazi desetletnega delovnega programa iz člena 16(2) Direktive 98/8/ES Evropskega parlamenta in Sveta o dajanju biocidnih pripravkov v promet [2] določa podrobna pravila za presojo obstoječih aktivnih snovi.
Article 15(2) of the Regulation provides for peer reviews by experts from the Member States prior to the Commission decisions on inclusion in Annex I.
Člen 15(2) Uredbe določa, da se pred odločitvami Komisije o vključitvi v Prilogo I opravijo posvetovanja s strokovnjaki iz držav članic.
Pursuant to Article 10(2)(i) of Directive 98/8/EC, inclusion of an active substance in Annex I shall, where appropriate, be subject to requirements on the minimum degree of purity and the nature and maximum content of certain impurities.
V skladu s členom 10(2)(i) Direktive 98/8/ES veljajo za vključitev aktivne snovi v Prilogo I, kadar je to primerno, zahteve glede najmanjše stopnje čistosti ter vrste in najvišje vsebnosti nekaterih nečistot.
The first inclusion in Annex I was decided in Commission Directive 2006/140/EC of 20 December 2006 amending Directive 98/8/EC of the European Parliament and of the Council to include sulfuryl fluoride as an active substance in Annex I thereto [3].
O prvi vključitvi v Prilogo I je bila odločitev sprejeta v Direktivi Komisije 2006/140/ES z dne 20. decembra 2006 o spremembi Direktive 98/8/ES Evropskega parlamenta in Sveta za vključitev sulfuril fluorida kot aktivne snovi v Prilogo I k Direktivi [3].
That Directive defined the headings of Annex I to Directive 98/8/EC.
Zadevna direktiva je opredelila naslove stolpcev v Prilogi I k Direktivi 98/8/ES.
Those headings include ‘Minimum purity of the active substance in the biocidal product as placed on the market’.
Eden od teh naslovov je „Minimalna čistost aktivne snovi v biocidnem pripravku, kakor se daje v promet“.
In the context of the peer reviews provided for by Article 15(2) of Regulation (EC) No 1451/2007, Member States experts have developed a method for establishing the similarity of the chemical compositions and the hazard profiles, known as ‘technical equivalence’, of substances falling within the same definition but being produced from different sources or manufacturing processes.
V okviru posvetovanj s strokovnjaki iz člena 15(2) Uredbe (ES) št. 1451/2007 so strokovnjaki držav članic oblikovali metodo za določitev podobnosti kemičnih sestav in stopenj nevarnosti, znane kot „tehnična enakovrednost“, snovi z enako opredelitvijo, ki pa se proizvajajo iz različnih virov ali z različnimi proizvodnimi postopki.
For this establishment, the degree of purity is only one of the factors that can be decisive.
Za navedeno določitev je stopnja čistosti zgolj eden od dejavnikov, ki so lahko odločilnega pomena.
Furthermore, lower purity of an active substance does not necessarily compromise its hazard profile.
Poleg tega nižja čistost aktivne snovi ne vpliva nujno na njeno stopnjo nevarnosti.
It is therefore appropriate to replace the existing reference to minimum purity in the headings of Annex I to Directive 98/8/EC by a reference to the minimum degree of purity of the active substance used for the evaluation made in accordance with Article 11 of the Directive, and indicate that, in the product placed on the market, the active substance may be of a different purity provided that it has been proven technically equivalent with the evaluated substance.
Zato je primerno obstoječi naslov v zvezi z minimalno čistostjo v Prilogi I k Direktivi 98/8/ES nadomestiti z naslovom v zvezi z minimalno stopnjo čistosti aktivne snovi, ki se uporablja za presojo v skladu s členom 11 Direktive, in navesti, da je lahko v pripravku, ki se daje v promet, čistost aktivne snovi drugačna, če je dokazano tehnično enakovredna ocenjeni snovi.
The first row of Annex I to Directive 98/8/EC established by Commission Directive 2006/140/EC also contains the heading ‘Deadline for compliance with Article 16(3) (except for products containing more than one active substance, for which the deadline to comply with Article 16(3) shall be the one set out in the last of the inclusion decisions relating to its active substances)’.
Prva vrstica Priloge I k Direktivi 98/8/ES, ki je bila določena z Direktivo 2006/140/ES, vsebuje tudi naslov „Rok za uskladitev s členom 16(3) (razen za pripravke, ki vsebujejo več kot eno aktivno snov, za katere je rok za uskladitev s členom 16(3) enak roku, določenemu v zadnji odločbi o vključitvi njegove aktivne snovi)“.
According to Article 4(1) of Directive 98/8/EC, a Member State receiving an application for mutual recognition of an existing authorisation has a period of 120 days to authorise the product through mutual recognition.
V skladu s členom 4(1) Direktive 98/8/ES ima država članica, ki prejme vlogo za medsebojno priznavanje obstoječega dovoljenja, na voljo 120 dni, da izda dovoljenje za pripravek z uporabo medsebojnega priznavanja.