natgillin/translations-raw huggingface dataset:
CAS No: 55406-53-6
ES: 259-627-5
For professional users, safe operational procedures and appropriate organizational measures shall be established.
Pri oceni proizvoda je treba posebno pozornost nameniti vidikom izpostavljenosti, tveganja in učinkovitosti, povezanim s katero koli uporabo, zajeto v vlogi za izdajo dovoljenja, ki pa ni bila obravnavana v oceni tveganja aktivne snovi na ravni Unije.
Products shall be used with appropriate personal protective equipment where exposure cannot be reduced to an acceptable level by other means,.
Za biocidne proizvode se dovoljenja izdajo pod naslednjima pogojema:
In view of the risks to the professional users, loading of the products into metal working fluids shall be semi-automated or automated, unless it can be demonstrated that risks can be reduced to an acceptable level by other means.
za poklicne uporabnike se vzpostavijo postopki varnega ravnanja in primerni organizacijski ukrepi.
The placing on the market of treated articles is subject to the following condition:
Če izpostavljenosti ni mogoče zmanjšati na sprejemljivo raven z drugimi načini, se proizvodi uporabljajo z ustrezno osebno zaščitno opremo;
The person responsible for the placing on the market of a treated article treated with or incorporating IPBC shall ensure that the label of that treated article provides the information listed in the second subparagraph of Article 58(3) of the Regulation (EU) No 528/2012.
dodajanje proizvodov v tekočine, ki se uporabljajo v kovinski industriji, se zaradi tveganj za poklicne uporabnike izvede polavtomatsko ali avtomatsko, razen če je mogoče dokazati, da je tveganje mogoče zmanjšati na sprejemljivo raven z drugimi načini.
The active substance in the product placed on the market can be of equal or different purity if it has been proven technically equivalent with the evaluated active substance.
oseba, ki je odgovorna za dajanje izdelka, ki je tretiran z IPBC ali ga vsebuje, v promet, zagotovi, da so na oznaki tega tretiranega izdelka navedene informacije iz drugega pododstavka člena 58(3) Uredbe (EU) št. 528/2012.
Commission Implementing Regulation (EU) 2015/1729
Izvedbena uredba Komisije (EU) 2015/1729
approving potassium sorbate as an existing active substance for use in biocidal products for product-type 8
o odobritvi kalijevega sorbata kot obstoječe aktivne snovi za uporabo v biocidnih proizvodih 8. vrste proizvodov
That list includes potassium sorbate.
Navedeni seznam vključuje kalijev sorbat.
Potassium sorbate has been evaluated in accordance with Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council [3] for use in product-type 8, wood preservatives, as defined in Annex V to that Directive, which corresponds to product-type 8, as defined in Annex V to Regulation (EU) No 528/2012.
V skladu s členom 16(2) Direktive 98/8/ES Evropskega parlamenta in Sveta [3] je bila opravljena ocena kalijevega sorbata glede uporabe v 8. vrsti proizvodov (pripravki za zaščito lesa), kot je opredeljena v Prilogi V k navedeni direktivi, ki ustreza 8. vrsti proizvodov, kot je opredeljena v Prilogi V k Uredbi (EU) št. 528/2012.
Germany was designated as evaluating competent authority and submitted the assessment report, together with its recommendations, to the Commission on 10 October 2010 in accordance with paragraphs 4 and 6 of Article 14 of Commission Regulation (EC) No 1451/2007 [4].
Nemčija, ki je bila imenovana za pristojni ocenjevalni organ, je 10. oktobra 2010 v skladu z odstavkoma 4 in 6 člena 14 Uredbe Komisije (ES) št. 1451/2007 [4] Komisiji predložila poročilo o oceni skupaj s svojimi priporočili.
According to that opinion, biocidal products used for product-type 8 and containing potassium sorbate may be expected to satisfy the requirements laid down in Article 5 of Directive 98/8/EC provided that certain conditions concerning its use are complied with.
Iz tega mnenja je razvidno, da je za biocidne proizvode, ki se uporabljajo za 8. vrsto proizvodov in vsebujejo kalijev sorbat, mogoče pričakovati, da izpolnjujejo zahteve iz člena 5 Direktive 98/8/ES, če so izpolnjeni določeni pogoji glede njihove uporabe.
It is therefore appropriate to approve potassium sorbate for use in biocidal products for product-type 8 subject to compliance with certain specifications and conditions.
Zato je primerno kalijev sorbat odobriti za uporabo v biocidnih proizvodih 8. vrste proizvodov, pod pogojem, da je to v skladu z določenimi specifikacijami in pogoji.
Potassium sorbate is approved as an active substance for use in biocidal products for product-type 8, subject to the specifications and conditions set out in the Annex.
Kalijev sorbat se odobri kot aktivna snov za uporabo v biocidnih proizvodih 8. vrste proizvodov, pri čemer se upoštevajo specifikacije in pogoji iz Priloge.
2,4-Hexadienoic acid, potassium salt (1:1), (2E, 4E)
2,4-heksadienojska kislina, kalijeva sol (1:1), (2E, 4E)
EC No: 246-376-1
št.
CAS No: 24634-61-5
ES: 246-376-1
Appropriate risk mitigation measures shall be taken to protect the groundwater.
Za industrijske ali poklicne uporabnike se vzpostavijo postopki varnega ravnanja in primerni organizacijski ukrepi.
In particular labels and, where provided, safety data sheets of products shall indicate that:
Če izpostavljenosti ni mogoče zmanjšati na sprejemljivo raven z drugimi načini, se proizvodi uporabljajo z ustrezno osebno zaščitno opremo.
a. industrial application shall be conducted within a contained area or on impermeable hard standing with bunding;
Sprejmejo se ustrezni ukrepi za zmanjšanje tveganja za zaščito podtalnice.
b. freshly treated timber shall be stored after treatment under shelter or on impermeable hard standing, or both, to prevent direct losses to soil or water;
Zlasti se na oznakah in, če so na voljo, varnostnih listih proizvodov se navede, da se:
c. any losses from the application of the product shall be collected for reuse or disposal.
industrijska uporaba izvaja na zaprtem območju ali na neprepustni trdni podlagi z ogrado;
The purity indicated in this column was the minimum degree of purity of the active substance used for the evaluation made in accordance with Article 16(2) of Directive 98/8/EC.
sveže obdelani les po obdelavi hrani pod streho ali na neprepustni trdni podlagi ali oboje, da se prepreči neposredno spiranje proizvodov v tla ali vodo;
The active substance in the product placed on the market can be of equal or different purity if it has been proven technically equivalent with the evaluated active substance.
vse izgube pri uporabi proizvoda zbirajo za ponovno uporabo ali odstranitev.
Commission Implementing Regulation (EU) 2015/1730
Izvedbena uredba Komisije (EU) 2015/1730
approving hydrogen peroxide as an existing active substance for use in biocidal products for product-types 1, 2, 3, 4, 5 and 6
o odobritvi vodikovega peroksida kot obstoječe aktivne snovi za uporabo v biocidnih proizvodih 1., 2., 3., 4., 5. in 6. vrste proizvodov
That list includes hydrogen peroxide.
Navedeni seznam vključuje vodikov peroksid.
Hydrogen peroxide has been evaluated in accordance with Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council [3] for use in product-type 1, human hygiene biocidal products, product-type 2, private area and public health area disinfectants and other biocidal products, product-type 3, veterinary hygiene biocidal products, product-type 4, food and feed area disinfectants, product-type 5, drinking water disinfectants, and product-type 6, in-can preservatives, as defined in Annex V to that Directive, which correspond respectively to product-types 1, 2, 3, 4, 5 and 6, as defined in Annex V to Regulation (EU) No 528/2012.
V skladu s členom 16(2) Direktive 98/8/ES Evropskega parlamenta in Sveta [3] je bila opravljena ocena vodikovega peroksida glede uporabe v 1. vrsti proizvodov (biocidni pripravki za človekovo osebno higieno), 2. vrsti proizvodov (razkužila in drugi biocidni pripravki za zasebne površine in površine, namenjene javnemu zdravstvu), 3. vrsti proizvodov (veterinarsko higienski biocidni pripravki), 4. vrsti proizvodov (dezinfekcijska sredstva za območja s hrano in krmo), 5. vrsti proizvodov (sredstva za razkuževanje pitne vode) ter 6. vrsti proizvodov (sredstva za konzerviranje v vsebnikih), kot so opredeljene v Prilogi V k navedeni direktivi, ki ustrezajo 1., 2., 3., 4., 5. in 6 vrsti proizvodov, kot so opredeljene v Prilogi V k Uredbi (EU) št. 528/2012.
Finland was designated as evaluating competent authority and submitted the assessment reports, together with its recommendations, to the Commission on 2 August 2013 in accordance with paragraphs 4 and 6 of Article 14 of Commission Regulation (EC) No 1451/2007 [4].
Finska, ki je bila imenovana za ocenjevalni pristojni organ, je 2. avgusta 2013 v skladu z odstavkoma 4 in 6 člena 14 Uredbe Komisije (ES) št. 1451/2007 [4] Komisiji predložila poročila o oceni skupaj s svojimi priporočili.
In accordance with Article 7(1)(b) of Delegated Regulation (EU) No 1062/2014, the opinions of the European Chemicals Agency were formulated on 2 February 2015 by the Biocidal Product Committee, having regard to the conclusions of the evaluating competent authority.
V skladu s členom 7(1)(b) Delegirane uredbe (EU) št. 1062/2014 je Odbor za biocidne pripravke Evropske agencije za kemikalije 2. februarja 2015 ob upoštevanju ugotovitev ocenjevalnega pristojnega organa pripravil svoja mnenja.
According to those opinions, biocidal products used for product-types 1, 2, 3, 4, 5 and 6 and containing hydrogen peroxide may be expected to satisfy the requirements laid down in Article 5 of Directive 98/8/EC, provided that certain conditions concerning its use are complied with.
Iz navedenih mnenj je razvidno, da je za biocidne proizvode, ki se uporabljajo za 1., 2., 3., 4., 5. in 6. vrsto proizvodov in vsebujejo vodikov peroksid, mogoče pričakovati, da izpolnjujejo zahteve iz člena 5 Direktive 98/8/ES, če so izpolnjeni nekateri pogoji glede njihove uporabe.
It is therefore appropriate to approve hydrogen peroxide for use in biocidal products for product-types 1, 2, 3, 4, 5 and 6 subject to compliance with certain specifications and conditions.
Zato je primerno vodikov peroksid odobriti za uporabo v biocidnih proizvodih 1., 2., 3., 4., 5. in 6. vrste proizvodov, pod pogojem, da je ta v skladu z nekaterimi specifikacijami in pogoji.
For the use in product-type 4, the evaluation did not address the incorporation of biocidal products containing hydrogen peroxide in materials and articles intended to come into contact directly or indirectly with food within the meaning of Regulation (EC) No 1935/2004 of the European Parliament and of the Council [5].
Glede uporabe v 4. vrsti proizvodov v oceni ni bila obravnavana vključitev biocidnih proizvodov, ki vsebujejo vodikov peroksid, v materiale in izdelke, namenjene za neposreden ali posreden stik z živili v smislu Uredbe Evropskega parlamenta in Sveta (ES) št. 1935/2004 [5].
Such materials may require the establishment of specific limits on the migration into food, as referred to in Article 5(1)(e) of Regulation (EC) No 1935/2004.
Taki materiali lahko zahtevajo določitev posebnih mejnih vrednosti migracij v živila, kot je določeno v členu 5(1)(e) Uredbe (ES) št. 1935/2004.
Regulation (EU) No 98/2013 of the European Parliament and of the Council [6] on the marketing and use of explosive precursors applies to hydrogen peroxide.
Uredba (EU) št. 98/2013 Evropskega parlamenta in Sveta [6] o trženju in uporabi predhodnih sestavin za eksplozive velja za vodikov peroksid.
Hydrogen peroxide is approved as an active substance for use in biocidal products for product-types 1, 2, 3, 4, 5 and 6, subject to the specifications and conditions set out in the Annex.
Vodikov peroksid se odobri kot aktivna snov za uporabo v biocidnih proizvodih 1., 2., 3., 4., 5. in 6. vrste proizvodov, pri čemer se upoštevajo specifikacije in pogoji iz Priloge.
EC No: 231-765-0
Št.
CAS No: 7722-84-1
ES: 231-765-0
The active substance as manufactured is an aqueous solution containing 350 - < 700 g/kg (35 - < 70 % by weight) hydrogen peroxide.
Št.
1 February 2017
Aktivna snov, kot je proizvedena, je vodna raztopina s 350–< 700 g/kg (35–< 70 masnih %) vodikovega peroksida.
31 January 2027
Teoretična (izračunana) specifikacija suhe snovi: minimalna čistost vodikovega peroksida je 995 g/kg (99,5 masnih %).
The product assessment shall pay particular attention to the exposures, the risks and the efficacy linked to any uses covered by an application for authorisation, but not addressed in the Union level risk assessment of the active substance.
1. februar 2017
The authorisations of biocidal products are subject to the following conditions:
31. januar 2027
Authorisations of biocidal products shall be without prejudice to Regulation (EU) No 98/2013 on the marketing and use of explosive precursors.
Pri oceni proizvoda je treba posebno pozornost nameniti vidikom izpostavljenosti, tveganja in učinkovitosti, povezanim s katero koli uporabo, zajeto v vlogi za izdajo dovoljenja, ki pa ni bila obravnavana v oceni tveganja aktivne snovi na ravni Unije.
For professional users, safe operational procedures and appropriate organisational measures shall be established for the handling of concentrated products.
Za biocidne proizvode se dovoljenja izdajo pod naslednjimi pogoji:
For professional users, safe operational procedures and appropriate organisational measures shall be established.
Dovoljenja za biocidne proizvode ne posegajo v Uredbo (EU) št. 98/2013 o trženju in uporabi predhodnih sestavin za eksplozive.
Products shall be used with appropriate personal protective equipment where exposure cannot be reduced to an acceptable level by other means.
Za poklicne uporabnike se vzpostavijo postopki varnega ravnanja s koncentriranimi proizvodi in primerni organizacijski ukrepi.
Products shall not be incorporated in materials and articles intended to come into contact with food within the meaning of Article 1(1) of Regulation (EC) No 1935/2004, unless the Commission has established specific limits on the migration of hydrogen peroxide into food or it has been established pursuant to that Regulation that such limits are not necessary.
Za poklicne uporabnike se vzpostavijo postopki varnega ravnanja in primerni organizacijski ukrepi.
The purity indicated in this column was the minimum degree of purity of the active substance used for the evaluation made in accordance with Article 16(2) of Directive 98/8/EC.
Proizvodi se uporabljajo z ustrezno osebno zaščitno opremo, če izpostavljenosti ni mogoče zmanjšati na sprejemljivo raven z drugimi načini.
The active substance in the product placed on the market can be of equal or different purity if it has been proven technically equivalent with the evaluated active substance.
Proizvodi se ne vključijo v materiale in izdelke, namenjene za stik z živili v smislu člena 1(1) Uredbe (ES) št. 1935/2004, razen če je Komisija določila posebne mejne vrednosti o migraciji vodikovega peroksida v živila ali če je bilo v skladu z navedeno uredbo določeno, da takšne mejne vrednosti niso potrebne.
Commission Implementing Regulation (EU) 2015/1731
Izvedbena uredba Komisije (EU) 2015/1731
approving medetomidine as an active substance for use in biocidal products for product-type 21
o odobritvi medetomidina kot aktivne snovi za uporabo v biocidnih proizvodih 21. vrste proizvodov
The United Kingdom received on 27 April 2009 an application, in accordance with Article 11(1) of Directive 98/8/EC of the European Parliament and of the Council [2], for the inclusion of the active substance medetomidine in its Annex I for use in product-type 21, antifouling products, as defined in Annex V to that Directive, which corresponds to product-type 21 as defined in Annex V to Regulation (EU) No 528/2012.
Združeno kraljestvo je 27. aprila 2009 v skladu s členom 11(1) Direktive 98/8/ES Evropskega parlamenta in Sveta [2] prejelo vlogo za vključitev aktivne snovi medetomidin v Prilogo I za uporabo v 21. vrsti proizvodov (pripravki za preprečevanje naselitve organizmov na površini, ki je v stiku z vodo – antivegetacijska sredstva), kot je opredeljena v Prilogi V k navedeni direktivi, kar ustreza 21. vrsti proizvodov, kot je opredeljena v Prilogi V k Uredbi (EU) št. 528/2012.
Medetomidine was not on the market on 14 May 2000 as an active substance of a biocidal product.
Medetomidin dne 14. maja 2000 ni bil na trgu kot aktivna snov v biocidnih proizvodih.
The United Kingdom submitted an assessment report, together with its recommendations, to the European Chemicals Agency on 12 March 2014 in accordance with Article 8(1) of Regulation (EU) No 528/2012.
Združeno kraljestvo je 12. marca 2014 v skladu s členom 8(1) Uredbe (EU) št. 528/2012 Evropski agenciji za kemikalije predložilo poročilo o oceni skupaj s svojimi priporočili.
The opinion of the European Chemicals Agency was formulated on 3 February 2015 by the Biocidal Product Committee, having regard to the conclusions of the evaluating competent authority.
Odbor za biocidne pripravke je ob upoštevanju ugotovitev pristojnega ocenjevalnega organa 3. februarja 2015 oblikoval mnenje Evropske agencije za kemikalije.
According to that opinion, biocidal products used for product-type 21 and containing medetomidine may be expected to satisfy the requirements laid down in Article 19(1)(b) of Regulation (EU) No 528/2012, provided that certain conditions concerning its use are complied with.
Iz tega mnenja je razvidno, da je za biocidne proizvode, ki se uporabljajo za 21. vrsto proizvodov in vsebujejo medetomidin, mogoče pričakovati, da izpolnjujejo zahteve iz člena 19(1)(b) Uredbe (EU) št. 528/2012, če so izpolnjeni nekateri pogoji glede njihove uporabe.
It is therefore appropriate to approve medetomidine for use in biocidal products for product-type 21 subject to compliance with certain specifications and conditions.
Zato je primerno odobriti medetomidin za uporabo v biocidnih proizvodih 21. vrste proizvodov, pod pogojem, da je ta v skladu z določenimi specifikacijami in pogoji.
The opinion concludes that the characteristics of medetomidine render it very persistent (vP) and toxic (T) in accordance with the criteria laid down in Annex XIII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council [3].
Iz mnenja je razvidno tudi, da je medetomidin v skladu z merili iz Priloge XIII k Uredbi (ES) št. 1907/2006 Evropskega Parlamenta in Sveta [3] zaradi svojih značilnosti zelo obstojen (vP) in strupen (T).
In addition, the opinion concludes that the active substance contains a significant proportion of non-active isomers or impurities.
Poleg tega je v mnenju navedeno, da aktivna snov vsebuje precejšnji delež neaktivnih izomerov ali nečistoč.
Medetomidine meets the conditions set out in points (d) and (f) of Article 10(1) of Regulation (EU) No 528/2012 and should therefore be considered a candidate for substitution.
Medetomidin izpolnjuje pogoje, določene v točkah (d) in (f) člena 10(1) Uredbe (EU) št. 528/2012, in bi ga bilo zato treba obravnavati kot možno snov za zamenjavo.
Pursuant to Article 10(4) of Regulation (EU) No 528/2012, the approval of an active substance that is considered as a candidate for substitution should be for a period not exceeding seven years.
V skladu s členom 10(4) Uredbe (EU) št. 528/2012 je treba odobritev aktivne snovi, ki se šteje kot možna snov za zamenjavo, podati za obdobje največ sedem let.
Since medetomidine meets the criteria for being very persistent (vP) according to Annex XIII to Regulation (EC) No 1907/2006, treated articles treated with or incorporating medetomidine should be appropriately labelled when placed on the market.
Ker medetomidin izpolnjuje kriterije za lastnost „zelo obstojen“ (vP – very peristent) v skladu s Prilogo XIII k Uredbi (ES) št. 1907/2006, bi bilo treba tretirane izdelke, ki so tretirani z medetomidinom ali ga vsebujejo, ustrezno označiti, ko se dajo na trg.
Medetomidine is approved as an active substance for use in biocidal products for product-type 21, subject to the specifications and conditions set out in the Annex.
Medetomidin se odobri kot aktivna snov za uporabo v biocidnih proizvodih 21. vrste proizvodov, pri čemer se upoštevajo specifikacije in pogoji iz Priloge.
EC No: not available
Št.
CAS No: 86347-14-0
ES: ni na voljo
99,5 % w/w.
Št.
Medetomidine is manufactured as a racemic mixture of R and S enantiomers: dexmedetomidine and levomedetomidine.
CAS: 86347-14-0
1 January 2016
99,5 mas. %.
31 December 2022
Medetomidin se proizvaja kot racemna zmes R- in S- enantiomerov: deksmedetomidina in levomedetomidina.
Medetomidine is considered a candidate for substitution in accordance with Article 10(1)(d) and (f) of Regulation (EU) No 528/2012.
1. januar 2016
The product assessment shall pay particular attention to the exposures, the risks and the efficacy linked to any uses covered by an application for authorisation, but not addressed in the Union level risk assessment of the active substance.
31. december 2022
The authorisations of biocidal products are subject to the following conditions:
Medetomidin se šteje kot možna snov za zamenjavo v skladu s členom 10(1)(d) in (f) Uredbe (EU) št. 528/2012.
For industrial or professional users, safe operational procedures and appropriate organisational measures shall be established.
Pri oceni proizvoda je treba posebno pozornost nameniti vidikom izpostavljenosti, tveganja in učinkovitosti, povezanim s katero koli uporabo, zajeto v vlogi za izdajo dovoljenja, ki pa ni bila obravnavana v oceni tveganja aktivne snovi na ravni Unije.
Persons making products containing medetomidine available on the market for non-professional users shall make sure that the products are supplied with appropriate gloves.
Za industrijske ali poklicne uporabnike se vzpostavijo postopki varnega ravnanja in primerni organizacijski ukrepi.
Labels and, where provided, instructions for use shall indicate whether other personal protective equipment shall be used.
Proizvodi se uporabljajo z ustrezno osebno zaščitno opremo, če izpostavljenosti ni mogoče zmanjšati na sprejemljivo raven z drugimi načini.
Labels and, where provided, instructions for use shall indicate that children shall be kept away until treated surfaces are dry.
Osebe, ki dajejo proizvode, ki vsebujejo medetomidin, na trg za nepoklicne uporabnike, zagotovijo, da so proizvodom priložene ustrezne rokavice.
Labels and, where provided, safety data sheets of products authorised shall indicate that application, maintenance and repair activities shall be conducted within a contained area, on an impermeable hard standing with bunding or on soil covered with an impermeable material to prevent direct losses and minimise emissions to the environment, and that any losses or waste containing medetomidine shall be collected for reuse or disposal.
Na nalepkah in po potrebi v navodilih za uporabo se navede, ali je treba uporabiti drugo osebno zaščitno opremo.
For products that may lead to residues in food or feed, the need to set new or to amend existing maximum residue levels (MRLs) in accordance with Regulation (EC) No 470/2009 of the European Parliament and of the Council [2] or Regulation (EC) No 396/2005 of the European Parliament and of the Council [3] shall be verified, and any appropriate risk-mitigation measures shall be taken to ensure that the applicable MRLs are not exceeded.
Na nalepkah in po potrebi v navodilih za uporabo se navede, da je treba otrokom preprečiti dostop, dokler obdelane površine niso suhe.
The placing on the market of treated articles is subject to the following condition:
Na nalepkah in po potrebi na varnostnih listih dovoljenih proizvodov se navede, da uporaba, vzdrževanje in popravila potekajo v zaprtem prostoru, na neprepustni trdni podlagi z ogrado ali na tleh, prekritih z neprepustnim materialom, da bi se s tem preprečile neposredne izgube in zmanjšale emisije v okolje, ter da se vse izgube ali odpadki, ki vsebujejo medetomidin, zbirajo za ponovno uporabo ali odstranitev.