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Izvedbena uredba Komisije (EU) 2019/1844 z dne 22. oktobra 2019 o izdaji dovoljenja Unije za družino biocidnih proizvodov BPF_Iodine_VET (Besedilo velja za EGP) Izvedbena uredba Komisije (EU) 2019/1844 z dne 22. oktobra 2019 o izdaji dovoljenja Unije za družino biocidnih proizvodov BPF_Iodine_VET (Besedilo velja za EGP) C/2019/7446
OJ L 283, , str. 1–37
(BG, ES, CS, DA, DE, ET, EL, EN, FR, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)
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Commission Implementing Regulation (EU) 2019/1844 of 22 October 2019 granting a Union authorisation for the biocidal product family BPF_Iodine_VET (Text with EEA relevance) Commission Implementing Regulation (EU) 2019/1844 of 22 October 2019 granting a Union authorisation for the biocidal product family BPF_Iodine_VET (Text with EEA relevance) C/2019/7446
OJ L 283, , pp. 1–37
(BG, ES, CS, DA, DE, ET, EL, EN, FR, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)
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| 5.11.2019 | SL | Uradni list Evropske unije | L 283/1 | 5.11.2019 | EN | Official Journal of the European Union | L 283/1 |
| IZVEDBENA UREDBA KOMISIJE (EU) 2019/1844 | COMMISSION IMPLEMENTING REGULATION (EU) 2019/1844 |
| z dne 22. oktobra 2019 | of 22 October 2019 |
| o izdaji dovoljenja Unije za družino biocidnih proizvodov „BPF_Iodine_VET“ | granting a Union authorisation for the biocidal product family ‘BPF_Iodine_VET’ |
| (Besedilo velja za EGP) | (Text with EEA relevance) |
| EVROPSKA KOMISIJA JE – | THE EUROPEAN COMMISSION, |
| ob upoštevanju Pogodbe o delovanju Evropske unije, | Having regard to the Treaty on the Functioning of the European Union, |
| ob upoštevanju Uredbe (EU) št. 528/2012 Evropskega parlamenta in Sveta z dne 22. maja 2012 o dostopnosti na trgu in uporabi biocidnih proizvodov (1) ter zlasti prvega pododstavka člena 44(5) Uredbe, | Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (1), and in particular the first subparagraph of Article 44(5) thereof, |
| ob upoštevanju naslednjega: | Whereas: |
| (1) | Družba Applied Biocide GmbH je 7. avgusta 2015 v skladu s členom 43(1) Uredbe (EU) št. 528/2012 vložila vlogo za izdajo dovoljenja za družino biocidnih proizvodov z imenom „BPF_Iodine_VET“ vrste proizvodov 3, kot je opredeljena v Prilogi V k navedeni uredbi, pri čemer je predložila pisno potrdilo pristojnega organa Avstrije, da se strinja, da bo ocenil vlogo. Vloga je bila v registru biocidnih proizvodov evidentirana pod številko zadeve BC-XJ019074-33. | (1) | On 7 August 2015, Applied Biocide GmbH submitted an application in accordance with Article 43(1) of Regulation (EU) No 528/2012 for authorisation of a biocidal product family named ‘BPF_Iodine_VET’ of product-type 3, as described in Annex V to that Regulation, providing written confirmation that the competent authority of Austria had agreed to evaluate the application. The application was recorded under case number BC-XJ019074-33 in the Register for Biocidal Products. |
| (2) | „BPF_Iodine_VET“ vsebuje jod kot aktivno snov, ki je vključena na seznam odobrenih aktivnih snovi Unije iz člena 9(2) Uredbe (EU) št. 528/2012. Ob upoštevanju intrinzičnih lastnosti aktivne snovi in znanstvenih meril za ugotavljanje lastnosti motilcev endokrinega sistema iz Delegirane uredbe Komisije (EU) 2017/2100 (2) bo Komisija proučila potrebo po pregledu odobritve joda, vključno s polivinilpirolidon jodom, v skladu s členom 15 Uredbe (EU) št. 528/2012. Glede na izid navedenega pregleda bo Komisija nato proučila, ali je treba dovoljenja Unije za proizvode, ki vsebujejo aktivno snov, pregledati v skladu s členom 48 Uredbe (EU) št. 528/2012. | (2) | ‘BPF_Iodine_VET’ contains iodine, as the active substance, which is included in the Union list of approved active substances referred to in Article 9(2) of Regulation (EU) No 528/2012. Taking into account the intrinsic properties of the active substance, and the scientific criteria for the determination of endocrine-disrupting properties set out in Commission Delegated Regulation (EU) 2017/2100 (2), the Commission will consider the need to review the approval of iodine, including polyvinylpyrrolidone iodine, in accordance with Article 15 of Regulation (EU) No 528/2012. Depending on the outcome of that review, the Commission will then consider whether the Union authorisations for products containing the active substance have to be reviewed in accordance with Article 48 of Regulation (EU) No 528/2012. |
| (3) | Ocenjevalni pristojni organ je 22. avgusta 2018 v skladu s členom 44(1) Uredbe (EU) št. 528/2012 predložil poročilo o oceni in zaključke ocenjevanja Evropski agenciji za kemikalije (v nadaljnjem besedilu: Agencija). | (3) | On 22 August 2018, the evaluating competent authority submitted, in accordance with Article 44(1) of Regulation (EU) No 528/2012, an assessment report and the conclusions of its evaluation to the European Chemicals Agency (‘the Agency’). |
| (4) | Agencija je 4. aprila 2019 Komisiji predložila mnenje (3), vključno z osnutkom povzetka značilnosti biocidnega proizvoda (v nadaljnjem besedilu: SPC) „BPF_Iodine_VET“ in končnim poročilom o oceni družine biocidnih proizvodov v skladu s členom 44(3) Uredbe (EU) št. 528/2012. V mnenju je ugotovljeno, da je „BPF_Iodine_VET“ družina biocidnih proizvodov v smislu člena 3(1)(s) Uredbe (EU) št. 528/2012, da je upravičena do dovoljenja Unije v skladu s členom 42(1) navedene uredbe in da ob upoštevanju skladnosti z osnutkom SPC izpolnjuje pogoje iz člena 19(1) in (6) navedene uredbe. | (4) | On 4 April 2019, the Agency submitted to the Commission an opinion (3), including the draft summary of the biocidal product characteristics (‘SPC’) of ‘BPF_Iodine_VET’ and the final assessment report on the biocidal product family in accordance with Article 44(3) of Regulation (EU) No 528/2012. The opinion concludes that ‘BPF_Iodine_VET’ is a biocidal product family within the meaning of Article 3(1)(s) of Regulation (EU) No 528/2012, that it is eligible for Union authorisation in accordance with Article 42(1) of that Regulation and that subject to compliance with the draft SPC, it meets the conditions laid down in Article 19(1) and (6) of that Regulation. |
| (5) | Agencija je 4. junija 2019 v skladu s členom 44(4) Uredbe (EU) št. 528/2012 Komisiji predložila osnutek SPC v vseh uradnih jezikih Unije. | (5) | On 4 June 2019, the Agency transmitted to the Commission the draft SPC in all the official languages of the Union in accordance with Article 44(4) of Regulation (EU) No 528/2012. |
| (6) | Komisija se strinja z mnenjem Agencije, zato meni, da je primerno izdati dovoljenje Unije za „BPF_Iodine_VET“. | (6) | The Commission concurs with the opinion of the Agency and considers it therefore appropriate to grant a Union authorisation for ‘BPF_Iodine_VET’. |
| (7) | Ukrepi iz te uredbe so v skladu z mnenjem Stalnega odbora za biocidne proizvode – | (7) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products, |
| SPREJELA NASLEDNJO UREDBO: | HAS ADOPTED THIS REGULATION: |
| Člen 1 | Article 1 |
| Družbi Applied Biocide GmbH se izda dovoljenje Unije s številko dovoljenja EU-0020540-0000 za dostopnost na trgu in uporabo družine biocidnih proizvodov „BPF_Iodine_VET“ v skladu s povzetkom značilnosti biocidnega proizvoda iz Priloge. | A Union authorisation with authorisation number EU-0020540-0000 is granted to Applied Biocide GmbH for the making available on the market and use of the biocidal product family ‘BPF_Iodine_VET’, in accordance with the summary of the biocidal product characteristics set out in the Annex. |
| Dovoljenje Unije velja od 25. novembra 2019 do 31. oktobra 2029. | The Union authorisation is valid from 25 November 2019 until 31 October 2029. |
| Člen 2 | Article 2 |
| Ta uredba začne veljati dvajseti dan po objavi v Uradnem listu Evropske unije. | This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. |
| Ta uredba je v celoti zavezujoča in se neposredno uporablja v vseh državah članicah. | This Regulation shall be binding in its entirety and directly applicable in all Member States. |
| V Bruslju, 22. oktobra 2019 | Done at Brussels, 22 October 2019. |
| Za Komisijo | For the Commission |
| Predsednik | The President |
| Jean-Claude JUNCKER | Jean-Claude JUNCKER |
| (1) UL L 167, 27.6.2012, str. 1. | (1) OJ L 167, 27.6.2012, p. 1. |
| (2) Delegirana uredba Komisije (EU) 2017/2100 z dne 4. septembra 2017 o določitvi znanstvenih meril za ugotavljanje lastnosti endokrinih motilcev v skladu z Uredbo (EU) št. 528/2012 Evropskega parlamenta in Sveta (UL L 301, 17.11.2017, str. 1). | (2) Commission Delegated Regulation (EU) 2017/2100 of 4 September 2017 setting out scientific criteria for the determination of endocrine-disrupting properties pursuant to Regulation (EU) No 528/2012 of the European Parliament and Council (OJ L 301, 17.11.2017, p. 1). |
| (3) Mnenje ECHA z dne 27. februarja 2019 o dovoljenju Unije za „BPF_Iodine_VET“ (ECHA/BPC/219/2019). | (3) ECHA opinion of 27 February 2019 on the Union authorisation of ‘BPF_Iodine_VET’ (ECHA/BPC/219/2019). |
| PRILOGA | ANNEX |
| Povzetek lastnosti družine biocidnega proizvoda | Summary of product characteristics for a biocidal product family |
| BPF_Iodine_VET | BPF_Iodine_VET |
| Vrsta proizvodov 3 – Veterinarska higiena (Razkužila) | Product type 3 - Veterinary hygiene (Disinfectants) |
| Številka dovoljenja: EU-0020540-0000 | Authorisation number: EU-0020540-0000 |
| Številka proizvoda R4BP: EU-0020540-0000 | R4BP asset number: EU-0020540-0000 |
| DEL I | PART I |
| PRVA INFORMACIJSKA RAVEN | FIRST INFORMATION LEVEL |
| 1. UPRAVNE INFORMACIJE | 1. ADMINISTRATIVE INFORMATION |
| 1.1 Ime družine | 1.1. Family name |
| Ime | BPF_Iodine_VET | Name | BPF_Iodine_VET |
| 1.2 Vrsta(-e) proizvoda(-ov) | 1.2. Product type(s) |
| Vrsta(-e) proizvoda(-ov) | Vrsta proizvodov 03 – Veterinarska higiena (razkužila) | Product type(s) | PT03 — Veterinary hygiene (Disinfectants) |
| 1.3 Imetnik dovoljenja | 1.3. Authorisation holder |
| Ime in naslov imetnika dovoljenja | Ime in priimek | Applied Biocide GmbH | Name and address of the authorisation holder | Name | Applied Biocide GmbH |
| Naslov | Sprl 31, Rue Jules Melotte, 4350, Remicourt, Belgija | Address | Sprl 31, Rue Jules Melotte, 4350, Remicourt, Belgium |
| Številka dovoljenja | EU-0020540-0000 | Authorisation number | EU-0020540-0000 |
| Številka proizvoda R4BP | EU-0020540-0000 | R4BP asset number | EU-0020540-0000 |
| Datum dovoljenja | 25. november 2019 | Date of the authorisation | 25 November 2019 |
| Datum izteka veljavnosti dovoljenja | 31. oktober 2029 | Expiry date of the authorisation | 31 October 2029 |
| 1.4 Proizvajalec(-ci) biocidnih proizvodov | 1.4. Manufacturer(s) of the biocidal products |
| Ime proizvajalca | Ewabo Chemikalien GmbH & Co KG | Name of manufacturer | Ewabo Chemikalien GmbH & Co KG |
| Naslov proizvajalca | Kolpingstrasse 4, 49835 Wietmarschen Nemčija | Address of manufacturer | Kolpingstrasse 4, 49835 Wietmarschen Germany |
| Lokacije proizvodnje | Kolpingstrasse 4, 49835 Wietmarschen Nemčija | Location of manufacturing sites | Kolpingstrasse 4, 49835 Wietmarschen Germany |
| Ime proizvajalca | FINK TEC GmbH | Name of manufacturer | FINK TEC GmbH |
| Naslov proizvajalca | Oberster Kamp 23, 59069 Hamm Nemčija | Address of manufacturer | Oberster Kamp 23, 59069 Hamm Germany |
| Lokacije proizvodnje | Oberster Kamp 23, 59069 Hamm Nemčija | Location of manufacturing sites | Oberster Kamp 23, 59069 Hamm Germany |
| Ime proizvajalca | IRCASERVICE | Name of manufacturer | IRCASERVICE |
| Naslov proizvajalca | S.S. Cremasca 591 no. 10, 24040 Fornovo S. Giovanni (BG) Italija | Address of manufacturer | S.S. Cremasca 591 no. 10, 24040 Fornovo S. Giovanni (BG) Italy |
| Lokacije proizvodnje | S.S. Cremasca 591 no. 10, 24040 Fornovo S. Giovanni (BG) Italija | Location of manufacturing sites | S.S. Cremasca 591 no. 10, 24040 Fornovo S. Giovanni (BG) Italy |
| Ime proizvajalca | Laboratorios Maymo SA | Name of manufacturer | Laboratorios Maymo SA |
| Naslov proizvajalca | Via Augusta, 302, 08017 Barcelona Španija | Address of manufacturer | Via Augusta, 302, 08017 Barcelona Spain |
| Lokacije proizvodnje | Via Augusta, 302, 08017 Barcelona Španija | Location of manufacturing sites | Via Augusta, 302, 08017 Barcelona Spain |
| 1.5 Proizvajalec(-ci) aktivne(-ih) snovi | 1.5. Manufacturer(s) of the active substance(s) |
| Aktivna snov | Jod | Active substance | Iodine |
| Ime proizvajalca | Cosayach S.A. Compania de Salitre y Yodo | Name of manufacturer | Cosayach S.A. Compania de Salitre y Yodo |
| Naslov proizvajalca | Amunátegui 178, 7th Floor, 8320000 Santiago Čile | Address of manufacturer | Amunátegui 178, 7th Floor, 8320000 Santiago Chile |
| Lokacije proizvodnje | S.C.M. Cosayach Cala Cala, 1180000 Pozo Almonte Chile Čile | Location of manufacturing sites | S.C.M. Cosayach Cala, 1180000 Pozo Almonte Chile Chile |
| Aktivna snov | Jod | Active substance | Iodine |
| Ime proizvajalca | ACF Minera S.A. | Name of manufacturer | ACF Minera S.A. |
| Naslov proizvajalca | San Martin 499, 1100000 Iquique Čile | Address of manufacturer | San Martin 499, 1100000 Iquique Chile |
| Lokacije proizvodnje | Lagunas mine, 1180000 Pozo Almonte Čile | Location of manufacturing sites | Lagunas mine, 1180000 Pozo Almonte Chile |
| Aktivna snov | Jod | Active substance | Iodine |
| Ime proizvajalca | Sociedad Quimica y Minera SA | Name of manufacturer | Sociedad Quimica y Minera SA |
| Naslov proizvajalca | Los Militares 4290, 7550000 Las Condes Čile | Address of manufacturer | Los Militares 4290, 7550000 Las Condes Chile |
| Lokacije proizvodnje | Nueva Victoria, 1180000 Pozo Almonte Čile | Pedro de Valdivia, 1240000 Antofagasta Čile | Location of manufacturing sites | Nueva Victoria, 1180000 Pozo Almonte Chile | Pedro de Valdivia, 1240000 Antofagasta Chile |
| 2. SESTAVA IN FORMULACIJA DRUŽINE PROIZVODOV | 2. PRODUCT FAMILY COMPOSITION AND FORMULATION |
| 2.1 Kvalitativni in kvantitativni podatki o sestavi družine | 2.1. Qualitative and quantitative information on the composition of the family |
| Splošno ime | Ime IUPAC | Funkcija | Številka CAS | Številka EC | Vsebnost (%) | Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| Najmanj | Največ | Min | Max |
| Jod | | Aktivna snov | 7553-56-2 | 231-442-4 | 0,1 | 3,0 | Iodine | | Active Substance | 7553-56-2 | 231-442-4 | 0,1 | 3,0 |
| fosforjeva kislina | ortofosforjeva kislina | Neaktivna snov | 7664-38-2 | 231-633-2 | 0,0 | 10,0 | Phosphoric Acid | Trihydroxidooxidophosphorus phosphoric acid | Non-active substance | 7664-38-2 | 231-633-2 | 0,0 | 10,0 |
| Poli(oks-1,2-etandiil).alfa.-tridecil-.omega.-hidroksi-, razvejan | Poli(oks-1,2-etandiil).alfa.-tridecil-.omega.-hidroksi-, razvejan | Neaktivna snov | 69011-36-5 | 500-241-6 | 0,0 | 31,8 | Poly(oxy-1,2-ethanediyl).alpha.-tridecyl-.omega.-hydroxy-,branched | Poly(oxy-1,2-ethanediyl).alpha.-tridecyl-.omega.-hydroxy-,branched | Non-active substance | 69011-36-5 | 500-241-6 | 0,0 | 31,8 |
| Izotridekanol, etoksiliran 90 %, C 9-11 alkohol etoksilat | Izotridekanol, etoksiliran 90 %, C 9-11 alkohol etoksilat | Neaktivna snov | 68439-46-3 | 614-482-0 | 0,0 | 31,8 | Isotridecanol, ethoxylated 90 %, C 9-11 Alcohol Ethoxylate | Isotridecanol, ethoxylated 90 %, C 9-11 Alcohol Ethoxylate | Non-active substance | 68439-46-3 | 614-482-0 | 0,0 | 31,8 |
| 2.2 Vrsta(-e) formulacije | 2.2. Type(s) of formulation |
| Formulacija(-e) | meta SPC 1–5: AL – druge tekočine | meta SPC 6–8: SL – topni koncentrat | Formulation(s) | meta SPC 1-5: AL — any other liquid | meta SPC 6-8: SL — soluble concentrate |
| DEL II | PART II |
| DRUGA INFORMACIJSKA RAVEN – META SPC(-ji) | SECOND INFORMATION LEVEL — META SPC(S) |
| META SPC 1 | META SPC 1 |
| 1. UPRAVNE INFORMACIJE O META SPC 1 | 1. META SPC 1 ADMINISTRATIVE INFORMATION |
| 1.1 Identifikator meta SPC 1 | 1.1. Meta SPC 1 identifier |
| Identifikator | Meta SPC 1 | Identifier | Meta SPC 1 |
| 1.2 Pripona k številki dovoljenja | 1.2. Suffix to the authorisation number |
| Številka | 1-1 | Number | 1-1 |
| 1.3 Vrsta(-e) proizvoda(-ov) | 1.3. Product type(s) |
| Vrsta(-e) proizvoda(-ov) | Vrsta proizvodov 03 – Veterinarska higiena (razkužila) | Product type(s) | PT03 - Veterinary hygiene (Disinfectants) |
| 2. SESTAVA META SPC 1 | 2. META SPC 1 COMPOSITION |
| 2.1 Kvalitativne in kvantitativne informacije o sestavi meta SPC 1 | 2.1. Qualitative and quantitative information on the composition of the meta SPC 1 |
| Splošno ime | Ime IUPAC | Funkcija | Številka CAS | Številka EC | Vsebnost (%) | Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| Najmanj | Največ | Min | Max |
| Jod | | Aktivna snov | 7553-56-2 | 231-442-4 | 0,15 | 0,15 | Iodine | | Active Substance | 7553-56-2 | 231-442-4 | 0,15 | 0,15 |
| fosforjeva kislina | ortofosforjeva kislina | Neaktivna snov | 7664-38-2 | 231-633-2 | 0,0 | 0,0 | Phosphoric Acid | Trihydroxidooxidophosphorus phosphoric acid | Non-active substance | 7664-38-2 | 231-633-2 | 0,0 | 0,0 |
| Poli(oks-1,2-etandiil).alfa.-tridecil-.omega.-hidroksi-, razvejan | Poli(oks-1,2-etandiil).alfa.-tridecil-.omega.-hidroksi-, razvejan | Neaktivna snov | 69011-36-5 | 500-241-6 | 0,0 | 0,0 | Poly(oxy-1,2-ethanediyl).alpha.-tridecyl-.omega.-hydroxy-,branched | Poly(oxy-1,2-ethanediyl).alpha.-tridecyl-.omega.-hydroxy-,branched | Non-active substance | 69011-36-5 | 500-241-6 | 0,0 | 0,0 |
| Izotridekanol, etoksiliran 90 %, C 9-11 alkohol etoksilat | Izotridekanol, etoksiliran 90 %, C 9-11 alkohol etoksilat | Neaktivna snov | 68439-46-3 | 614-482-0 | 0,0 | 0,0 | Isotridecanol, ethoxylated 90 %, C 9-11 Alcohol Ethoxylate | Isotridecanol, ethoxylated 90 %, C 9-11 Alcohol Ethoxylate | Non-active substance | 68439-46-3 | 614-482-0 | 0,0 | 0,0 |
| 2.2 Vrste formulacije meta SPC 1 | 2.2. Type(s) of formulation of the meta SPC 1 |
| Formulacija(-e) | AL – druge tekočine | Formulation(s) | AL — any other liquid |
| 3. STAVKI O NEVARNOSTI IN PREVIDNOSTNI STAVKI ZA META SPC 1 | 3. Hazard and precautionary statements of the meta SPC 1 |
| Stavki o nevarnosti | Lahko je jedko za kovine. | Hazard statements | May be corrosive to metals. |
| Previdnostni stavki | Hraniti samo v originalni posodi. | Odpraviti razlitje, da se prepreči materialna škoda. | Hraniti v posodi odporni proti koroziji z odporno notranjo oblogo. | Precautionary statements | Keep only in original packaging. | Absorb spillage to prevent material damage. | Store in corrosive resistant container with a resistant inner liner. |
| 4. DOVOLJENE UPORABE META SPC 1 | 4. AUTHORISED USE(S) OF THE META SPC 1 |
| 4.1 Opis uporabe | 4.1. Use description |
| Preglednica 1 | Table 1 |
| Uporaba # 1 – Veterinarska higiena – živinoreja – razkužilo za seske – profesionalno – za uporabo v zaprtih prostorih – pršenje (po molži) | Use # 1 — Veterinary hygiene — animal husbandry — teat disinfectant — professional — indoors — spraying (post milking) |
| Vrsta proizvoda | Vrsta proizvodov 03 – Veterinarska higiena (razkužila) | Product type | PT03 — Veterinary hygiene (Disinfectants) |
| Natančen opis dovoljene uporabe, kjer je to potrebno | — | Where relevant, an exact description of the authorised use | — |
| Ciljni organizem(-mi) (vključno z razvojno stopnjo) | Bakterije | Kvasovke | Target organism(s) (including development stage) | Bacteria | Yeasts |
| Področje uporabe | Notranjost, znotraj | Field(s) of use | Indoor |
| Način(-i) uporabe | Odprt sistem: pršenje | Pršenje: Ročno in avtomatizirano nemedicinsko razkuževanje seskov z razpršilom, pripravljenim za uporabo (na kravah, po molži) | Application method(s) | Open system: spray treatment | Spraying: Manual and automated non-medical disinfection of teats with a ready-to-use spray (on cows, post-milking) |
| Odmerki in pogostost uporabe | Stopnja uporabe: 10–15 ml na kravo | Pogostost uporabe: | V obdobju laktacije: | — | ročno: 2x dnevno (po molži) | — | samodejno: 3x dnevno (po molži) | Ob koncu izločanja mleka: 1x dnevno | Application rate(s) and frequency | Application rate: 10-15 ml per cow | Application frequency: | During lactation period: | — | manual: 2 applications per day (post-milking) | — | automated: 3 applications per day (post-milking) | During dry period: 1 application per day |
| Skupina(-e) uporabnikov | Poklicni | Category(ies) of users | Professional |
| Velikosti in material embalaže | Plastenka iz polietilena z visoko gostoto (HDPE): 1 liter, pokrovček je narejen iz polipropilena | Pločevinka HDPE: 5–60 litrov | Sod HDPE: 200 litrov | Vsebnik IBC: HDPE : 600–1 000 litrov | Pack sizes and packaging material | Bottle high-density polyethylene (HDPE): 1 liter, cap is made of PP | Jerry can HDPE: 5-60 liters | Drum HDPE: 200 liters | IBC HDPE: 600-1 000 liters |
| 4.1.1 Uporba – posebna navodila za uporabo | 4.1.1. Use-specific instructions for use |
| - - - | --- |
| 4.1.2 Uporaba – posebni ukrepi za zmanjšanje tveganja | 4.1.2. Use-specific risk mitigation measures |
| - - - | --- |
| 4.1.3 Kjer je specifična uporaba, možni direktni ali indirektni učinki, navodila za prvo pomoč in nujni okrepi za zaščito okolja | 4.1.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment |
| - - - | --- |
| 4.1.4 Kjer je specifična uporaba, navodila za varno odstranjevanje proizvoda in njegove embalaže | 4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging |
| - - - | --- |
| 4.1.5 Kjer je specifična uporaba, pogoji skladiščenja in rok uporabnosti proizvoda v običajnih pogojih skladiščenja | 4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage |
| - - - | --- |
| 5. SPLOŠNE SMERNICE ZA UPORABO (1) META SPC 1 | 5. GENERAL DIRECTIONS FOR USE (1) OF THE META SPC 1 |
| 5.1 Navodila za uporabo | 5.1. Instructions for use |
| Pred uporabo vedno preberite etiketo ali navodila za uporabo in upoštevajte vsa navodila. | Always read the label or leaflet before use and follow all the instructions provided. |
| Izdelek je treba pred uporabo segreti na temperaturo nad 20 °C. | The product must be brought to a temperature above 20 °C before use. |
| Za polnjenje izdelka v opremo za nanašanje je priporočena uporaba dozirne črpalke. | The use of a dosing pump for filling the product into the application equipment is recommended. |
| Takoj po molži vsake krave celotno površino vsakega seska napršite z raztopino. Izdelka ne odstranite do naslednje molže. Seskov ne čistite neposredno po razkuževanju. | Immediately after each cow has been milked, spray the entire surface of each teat with the solution. Leave the product until next milking. Do not clean the teats directly after disinfection. |
| Krave naj stojijo, dokler se izdelek ne posuši (najmanj 5 minut). | Keep the cows standing until the product has dried (at least 5 minutes). |
| Izdelek se lahko nanese ročno ali s pomočjo samodejnega pršila za seske. | Product can be applied manually or by means of automatic teat sprayer. |
| Pred naslednjo molžo je treba seske očistiti, po možnosti s po eno novo, mokro krpo na kravo. | Before the next milking the teats have to be cleaned, preferably with one new wet cloth per cow. |
| Pogostost uporabe ne sme presegati dveh nanosov na kravo in dan glede na ročno oz. treh nanosov na kravo in dan glede na samodejno pršilo za seske (po molži). | Application frequency must not exceed two applications per cow and day considering manual spraying and must not exceed three applications per cow and day considering automatic teat sprayer (post-milking). |
| 5.2 Ukrepi za zmanjšanje tveganja | 5.2. Risk mitigation measures |
| Hraniti izven dosega otrok. | Keep out of reach of children. |
| Nosite zaščitne rokavice, odporne na kemikalije, hlače z oprsnikom in škornje med rokovanjem z izdelkom in fazo uporabe (material določi imetnik dovoljenja v okviru informacij o izdelku). | Wear protective chemical resistant gloves, coated coverall and boots during product handling and application phase (material to be specified by the authorisation holder in the product information). |
| Če je potrebna kombinacija razkuževanja pred in po molži, je treba pri razkuževanju pred molžo uporabiti drugi proizvod, ki ne vsebuje joda. | In case a combination of pre- and post-milking disinfection is necessary, using another product not containing Iodine has to be considered for pre-milking disinfection. |
| 5.3 Značilnosti verjetnih direktnih ali indirektnih učinkov, navodila za prvo pomoč in nujni ukrepi za zaščito okolja | 5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment |
| Po vdihovanju: Zagotovite dotok svežega zraka; v primeru težav se posvetujte z zdravnikom. | After inhalation: Supply fresh air; consult doctor in case of complaints. |
| Po stiku s kožo: Kožo temeljito sperite. | After skin contact: Wash skin thoroughly. |
| Po stiku z očmi: Sperite odprte oči, odstranite kontaktne leče in nekaj minut izpirajte pod tekočo vodo. Nato se posvetujte z zdravnikom. | After eye contact: Rinse opened eye, remove contact lenses, keep rinsing for several minutes under running water. Then consult a doctor. |
| Po zaužitju: Sperite usta in nato spijte nekaj vode. Ne izzivajte bruhanja; takoj pokličite zdravniško pomoč. | After swallowing: Rinse out mouth and then drink some water. Do not induce vomiting; call for medical help immediately. |
| Ko iščete zdravniško pomoč, imejte embalažo ali etiketo pri roki in pokličite na številko 112 – klic v sili. | When asking for medical advice keep packaging or label at hand and call your local poison control center [insert local number here]. |
| Okoljevarstveni ukrepi: | Environmental emergency measures: |
| Obvestite pristojne organe, če je izdelek povzročil onesnaženje okolja (kanalizacije, plovne poti, tla ali zrak). Da bi preprečili nepravilno delovanje posamezne komunalne čistilne naprave, je treba morebitne ostanke, ki vsebujejo izdelek, odložiti na odlagališče za gnojila (za raztros na kmetijskih zemljiščih ali fermentacijo v bioplinarnah) ali v komunalni kanalizacijski sistem, če je to zakonsko dovoljeno. | Inform the relevant authorities if the product has caused environmental pollution (sewers, waterways, soil or air). To prevent malfunctioning of an individual wastewater treatment plant, possible residues containing the product must be discharged to the manure storage (for spreading on agricultural soils or fermentation into biogas installation) or to the municipal sewer if legally allowed. |
| 5.4 Navodila za varno odstranjevanje proizvoda in njegove embalaže | 5.4. Instructions for safe disposal of the product and its packaging |
| Na koncu obdelave odstranite neuporabljeni izdelek in embalažo v skladu z lokalnimi zahtevami. Uporabljeni izdelek se lahko splakne v komunalni kanalizacijski sistem ali zavrže na odlagališče za gnojila, odvisno od lokalnih predpisov. Ne spuščajte v posamezno komunalno čistilno napravo. | At the end of the treatment, dispose unused product and the packaging in accordance with local requirements. Used product can be flushed to the municipal sewer or disposed to the manure deposit depending on local requirements. Avoid release to an individual waste water treatment plant. |
| Evropski seznam odpadkov: 200130 – detergenti razen tistih, ki niso navedeni pod 20 01 29. | European Waste Catalogue: 200130-detergents other than those mentioned in 20 01 29. |
| 5.5 Pogoji za shranjevanje in rok uporabnosti proizvoda pri običajnih pogojih skladiščenja | 5.5. Conditions of storage and shelf-life of the product under normal conditions of storage |
| Izdelek hranite pri sobni temperaturi, stran od neposredne sončne svetlobe in v neprozornih posodah. Zaščitite pred zmrzaljo. Posodo hranite tesno zaprto. | Store the product at room temperature, away from direct sunlight and in opaque containers. Protect from frost. Keep container tightly closed. |
| Rok uporabnosti: 12 mesecev v HDPE. | Shelf-life: 12 months in HDPE. |
| 6. DRUGE INFORMACIJE | 6. OTHER INFORMATION |
| 7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 1 | |
| 7. TRETJA INFORMACIJSKA RAVEN:POSAMEZNI PROIZVODI V META SPC 1 | 7.1. Trade name(s), authorisation number and specific composition of each individual product |
| 7.1 Trgovsko(-a) ime(-na), številka avtorizacije in specifična sestava za vsak posamezni proizvod | Trade name(s) | FINK — Io Spray 15 | FINK — Euter-DIP PVP-S | FINK Pattedyp PVP | IOSpray 15 PVP |
| Trgovsko ime | FINK - Io Spray 15 | FINK - Euter-DIP PVP-S | FINK Pattedyp PVP | IOSpray 15 PVP | Authorisation number | EU-0020540-0001 1-1 |
| Številka dovoljenja | EU-0020540-0001 1-1 | Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| Splošno ime | Ime IUPAC | Funkcija | Številka CAS | Številka EC | Vsebnost (%) | Iodine | | Active Substance | 7553-56-2 | 231-442-4 | 0,15 |
| Jod | | Aktivna snov | 7553-56-2 | 231-442-4 | 0,15 | META SPC 2 |
| META SPC 2 | 1. META SPC 2 ADMINISTRATIVE INFORMATION |
| 1. UPRAVNE INFORMACIJE O META SPC 2 | 1.1. Meta SPC 2 identifier |
| 1.1 Identifikator meta SPC 2 | Identifier | Meta SPC 2 |
| Identifikator | Meta SPC 2 | 1.2. Suffix to the authorisation number |
| 1.2 Pripona k številki dovoljenja | Number | 1-2 |
| Številka | 1-2 | 1.3. Product type(s) |
| 1.3 Vrsta(-e) proizvoda(-ov) | Product type(s) | PT03 — Veterinary hygiene (Disinfectants) |
| Vrsta(-e) proizvoda(-ov) | Vrsta proizvodov 03 – Veterinarska higiena (razkužila) | 2. META SPC 2 COMPOSITION |
| 2. SESTAVA META SPC 2 | 2.1. Qualitative and quantitative information on the composition of the meta SPC 2 |
| 2.1 Kvalitativne in kvantitativne informacije o sestavi meta SPC 2 | Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| Splošno ime | Ime IUPAC | Funkcija | Številka CAS | Številka EC | Vsebnost (%) | Min | Max |
| Najmanj | Največ | Iodine | | Active Substance | 7553-56-2 | 231-442-4 | 0,3 | 0,5 |
| Jod | | Aktivna snov | 7553-56-2 | 231-442-4 | 0,3 | 0,5 | Phosphoric Acid | Trihydroxidooxidophosphorus phosphoric acid | Non-active substance | 7664-38-2 | 231-633-2 | 0,0 | 0,0 |
| fosforjeva kislina | ortofosforjeva kislina | Neaktivna snov | 7664-38-2 | 231-633-2 | 0,0 | 0,0 | Poly(oxy-1,2-ethanediyl).alpha.-tridecyl-.omega.-hydroxy-,branched | Poly(oxy-1,2-ethanediyl).alpha.-tridecyl-.omega.-hydroxy-,branched | Non-active substance | 69011-36-5 | 500-241-6 | 0,0 | 0,0 |
| Poli(oks-1,2-etandiil).alfa.-tridecil-.omega.-hidroksi-, razvejan | Poli(oks-1,2-etandiil).alfa.-tridecil-.omega.-hidroksi-, razvejan | Neaktivna snov | 69011-36-5 | 500-241-6 | 0,0 | 0,0 | Isotridecanol, ethoxylated 90 %, C 9-11 Alcohol Ethoxylate | Isotridecanol, ethoxylated 90 %, C 9-11 Alcohol Ethoxylate | Non-active substance | 68439-46-3 | 614-482-0 | 0,0 | 0,0 |
| Izotridekanol, etoksiliran 90 %, C 9-11 alkohol etoksilat | Izotridekanol, etoksiliran 90 %, C 9-11 alkohol etoksilat | Neaktivna snov | 68439-46-3 | 614-482-0 | 0,0 | 0,0 | 2.2. Type(s) of formulation of the meta SPC 2 |
| 2.2 Vrste formulacije meta SPC 2 | Formulation(s) | AL — any other liquid |
| Formulacija(-e) | AL – druge tekočine | 3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 2 |
| 3. STAVKI O NEVARNOSTI IN PREVIDNOSTNI STAVKI ZA META SPC 2 | Hazard statements | May be corrosive to metals. | Harmful to aquatic life with long lasting effects. |
| Stavki o nevarnosti | Lahko je jedko za kovine. | Škodljivo za vodne organizme, z dolgotrajnimi učinki. | Precautionary statements | Keep only in original packaging. | Avoid release to the environment. | Absorb spillage to prevent material damage. | Store in corrosive resistant container with a resistant inner liner. | Dispose of contents to/container in accordance with the local/national regulations. |
| Previdnostni stavki | Hraniti samo v originalni posodi. | Preprečiti sproščanje v okolje. | Odpraviti razlitje, da se prepreči materialna škoda. | Hraniti v posodi odporni proti koroziji z odporno notranjo oblogo. | Odstraniti vsebino posodo skladno z lokalnimi / nacionalnimi predpisi. | 4. AUTHORISED USE(S) OF THE META SPC 2 |
| 4. DOVOLJENE UPORABE META SPC 2 | 4.1. Use description |
| 4.1 Opis uporabe | Table 2 |
| Preglednica 2 | Use # 1 — Veterinary hygiene — animal husbandry — teat disinfectant — professional — indoors — spraying (post milking) |
| Uporaba # 1 – Veterinarska higiena – živinoreja – razkužilo za seske – profesionalno – za uporabo v zaprtih prostorih – pršenje (po molži) | Product-type | PT03 — Veterinary hygiene (Disinfectants) |
| Vrsta proizvoda | Vrsta proizvodov 03 – Veterinarska higiena (razkužila) | Where relevant, an exact description of the authorised use | — |
| Natančen opis dovoljene uporabe, kjer je to potrebno | - | Target organism(s) (including development stage) | Bacteria | Yeasts |
| Ciljni organizem(-mi) (vključno z razvojno stopnjo) | Bakterije | Kvasovke | Field(s) of use | Indoor |
| Področje uporabe | Notranjost, znotraj | Application method(s) | Open system: spray treatment | Spraying: Manual and automated non-medical disinfection of teats with a ready-to-use spray (on cows, post-milking) |
| Način(-i) uporabe | Odprt sistem: pršenje | Pršenje: Ročno in avtomatizirano nemedicinsko razkuževanje seskov z razpršilom, pripravljenim za uporabo (na kravah, po molži) | Application rate(s) and frequency | Application rate: 10-15 ml per cow | Application frequency: | During lactation period: | — | manual: 2 applications per day (post-milking) | — | automated: 3 applications per day (post-milking) | During dry period: 1 application per day |
| Odmerki in pogostost uporabe | Stopnja uporabe: 10–15 ml na kravo | Pogostost uporabe: | V obdobju laktacije: | — | ročno: 2x dnevno (po molži) | — | samodejno: 3x dnevno (po molži) | Ob koncu izločanja mleka: 1x dnevno | Category(ies) of users | Professional |
| Skupina(-e) uporabnikov | Poklicni | Pack sizes and packaging material | Bottle HDPE: 1 liter, cap is made of PP | Jerry can HDPE: 5-60 liters | Drum HDPE: 200 liters | IBC HDPE: 600-1 000 liters |
| Velikosti in material embalaže | Plastenka HDPE: 1 liter, pokrovček je narejen iz polipropilena | Pločevinka HDPE: 5–60 litrov | Sod HDPE: 200 litrov | Vsebnik IBC: HDPE : 600–1 000 litrov | 4.1.1. Use-specific instructions for use |
| 4.1.1 Uporba - posebna navodila za uporabo | -- |
| -- | 4.1.2. Use-specific risk mitigation measures |
| 4.1.2 Uporaba - posebni ukrepi za zmanjšanje tveganja | -- |
| -- | 4.1.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment |
| 4.1.3 Kjer je specifična uporaba, možni direktni ali indirektni učinki, navodila za prvo pomoč in nujni okrepi za zaščito okolja | -- |
| -- | 4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging |
| 4.1.4 Kjer je specifična uporaba, navodila za varno odstranjevanje proizvoda in njegove embalaže | -- |
| -- | 4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage |
| 4.1.5 Kjer je specifična uporaba, pogoji skladiščenja in rok uporabnosti proizvoda v običajnih pogojih skladiščenja | -- |
| -- | 5. GENERAL DIRECTIONS FOR USE (2) OF THE META SPC 2 |
| 5. SPLOŠNE SMERNICE ZA UPORABO (2) META SPC 2 | 5.1. Instructions for use |
| 5.1 Navodila za uporabo | Always read the label or leaflet before use and follow all the instructions provided. |
| Pred uporabo vedno preberite etiketo ali navodila za uporabo in upoštevajte vsa navodila. | The product must be brought to a temperature above 20 °C before use. |
| Izdelek je treba pred uporabo segreti na temperaturo nad 20 °C. | The use of a dosing pump for filling the product into the application equipment is recommended. |
| Za polnjenje izdelka v opremo za nanašanje je priporočena uporaba dozirne črpalke. | Immediately after each cow has been milked, spray the entire surface of each teat with the solution. Leave the product until next milking. Do not clean the teats directly after disinfection. |
| Takoj po molži vsake krave celotno površino vsakega seska napršite z raztopino. Izdelka ne odstranite do naslednje molže. Seskov ne čistite neposredno po razkuževanju. | Keep the cows standing until the product has dried (at least 5 minutes). |
| Krave naj stojijo, dokler se izdelek ne posuši (najmanj 5 minut). | Product can be applied manually or by means of automatic teat sprayer. |
| Izdelek se lahko nanese ročno ali s pomočjo samodejnega pršila za seske. | Before the next milking the teats have to be cleaned, preferably with one new wet cloth per cow. |
| Pred naslednjo molžo je treba seske očistiti, po možnosti s po eno novo, mokro krpo na kravo. | Application frequency must not exceed two applications per cow and day considering manual spraying and must not exceed three applications per cow and day considering automatic teat sprayer (post-milking). |
| Pogostost uporabe ne sme presegati dveh nanosov na kravo in dan glede na ročno oz. treh nanosov na kravo in dan glede na samodejno pršilo za seske (po molži). | 5.2. Risk mitigation measures |
| 5.2 Ukrepi za zmanjšanje tveganja | Keep out of reach of children. |
| Hraniti izven dosega otrok. | Wear protective chemical resistant gloves, coated coverall and boots during product handling and application phase (material to be specified by the authorisation holder in the product information). |
| Nosite zaščitne rokavice, odporne na kemikalije, hlače z oprsnikom in škornje med rokovanjem z izdelkom in fazo uporabe (material določi imetnik dovoljenja v okviru informacij o izdelku). | In case a combination of pre- and post-milking disinfection is necessary, using another product not containing Iodine has to be considered for pre-milking disinfection. |
| Če je potrebna kombinacija razkuževanja pred in po molži, je treba pri razkuževanju pred molžo uporabiti drugi proizvod, ki ne vsebuje joda. | 5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment |
| 5.3 Značilnosti verjetnih direktnih ali indirektnih učinkov, navodila za prvo pomoč in nujni ukrepi za zaščito okolja | After inhalation: Supply fresh air; consult doctor in case of complaints. |
| Po vdihovanju: Zagotovite dotok svežega zraka; v primeru težav se posvetujte z zdravnikom. | After skin contact: Wash skin thoroughly. |
| Po stiku s kožo: Kožo temeljito sperite. | After eye contact: Rinse opened eye, remove contact lenses, keep rinsing for several minutes under running water. Then consult a doctor. |
| Po stiku z očmi: Sperite odprte oči, odstranite kontaktne leče in nekaj minut izpirajte pod tekočo vodo. Nato se posvetujte z zdravnikom. | After swallowing: Rinse out mouth and then drink some water. Do not induce vomiting; call for medical help immediately. |
| Po zaužitju: Sperite usta in nato spijte nekaj vode. Ne izzivajte bruhanja; takoj pokličite zdravniško pomoč. | When asking for medical advice keep packaging or label at hand and call your local poison control center [insert local number here]. |
| Ko iščete zdravniško pomoč, imejte embalažo ali etiketo pri roki in pokličite na številko 112 – klic v sili. | Environmental emergency measures: |
| Okoljevarstveni ukrepi: | Inform the relevant authorities if the product has caused environmental pollution (sewers, waterways, soil or air). To prevent malfunctioning of an individual wastewater treatment plant, possible residues containing the product must be discharged to the manure storage (for spreading on agricultural soils or fermentation into biogas installation) or to the municipal sewer if legally allowed. |
| Obvestite pristojne organe, če je izdelek povzročil onesnaženje okolja (kanalizacije, plovne poti, tla ali zrak). Da bi preprečili nepravilno delovanje posamezne komunalne čistilne naprave, je treba morebitne ostanke, ki vsebujejo izdelek, odložiti na odlagališče za gnojila (za raztros na kmetijskih zemljiščih ali fermentacijo v bioplinarnah) ali v komunalni kanalizacijski sistem, če je to zakonsko dovoljeno. | 5.4. Instructions for safe disposal of the product and its packaging |
| 5.4 Navodila za varno odstranjevanje proizvoda in njegove embalaže | At the end of the treatment, dispose unused product and the packaging in accordance with local requirements. Used product can be flushed to the municipal sewer or disposed to the manure deposit depending on local requirements. Avoid release to an individual waste water treatment plant. |
| Na koncu obdelave odstranite neuporabljeni izdelek in embalažo v skladu z lokalnimi zahtevami. Uporabljeni izdelek se lahko splakne v komunalni kanalizacijski sistem ali zavrže na odlagališče za gnojila, odvisno od lokalnih predpisov. Ne spuščajte v posamezno komunalno čistilno napravo. | European Waste Catalogue: 200130-detergents other than those mentioned in 20 01 29. |
| Evropski seznam odpadkov: 200130 – detergenti razen tistih, ki niso navedeni pod 20 01 29. | 5.5. Conditions of storage and shelf-life of the product under normal conditions of storage |
| 5.5 Pogoji za shranjevanje in rok uporabnosti proizvoda pri običajnih pogojih skladiščenja | Store the product at room temperature, away from direct sunlight and in opaque containers. Protect from frost. Keep container tightly closed. |
| Izdelek hranite pri sobni temperaturi, stran od neposredne sončne svetlobe in v neprozornih posodah. Zaščitite pred zmrzaljo. Posodo hranite tesno zaprto. | Shelf-life: 12 months in HDPE. |
| Rok uporabnosti: 12 mesecev v HDPE. | 6. OTHER INFORMATION |
| 6. DRUGE INFORMACIJE | 7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 2 |
| 7.1. Trade name(s), authorisation number and specific composition of each individual product | |
| 7. TRETJA INFORMACIJSKA RAVEN: POSAMEZNI PROIZVODI V META SPC 2 | Trade name(s) | Fink Io Spray - 30 | ST-Io Spray | DESINTEC MH Iodine S | DESINTEC MH Raidip plus | Iodine Spray 3000 | Iodine Spray |
| 7.1 Trgovsko(-a) ime(-na), številka avtorizacije in specifična sestava za vsak posamezni proizvod | Authorisation number | EU-0020540-0002 1-2 |
| Trgovsko ime | Fink Io Spray – 30 | ST-Io Spray | DESINTEC MH Iodine S | DESINTEC MH Raidip plus | Iodine Spray 3000 | Iodine Spray | Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| Številka dovoljenja | EU-0020540-0002 1-2 | Iodine | | Active Substance | 7553-56-2 | 231-442-4 | 0,3 |
| Splošno ime | Ime IUPAC | Funkcija | Številka CAS | Številka EC | Vsebnost (%) | 7.2. Trade name(s), authorisation number and specific composition of each individual product |
| Jod | | Aktivna snov | 7553-56-2 | 231-442-4 | 0,3 | Trade name(s) | Fink — Io Spray 50 | DESINTEC MH Raidip 5000 | Iodine Spray 5000 |
| 7.2 Trgovsko(-a) ime(-na), številka avtorizacije in specifična sestava za vsak posamezni proizvod | Authorisation number | EU-0020540-0003 1-2 |
| Trgovsko ime | Fink - Io Spray 50 | DESINTEC MH Raidip 5000 | Iodine Spray 5000 | Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| Številka dovoljenja | EU-0020540-0003 1-2 | Iodine | | Active Substance | 7553-56-2 | 231-442-4 | 0,5 |
| Splošno ime | Ime IUPAC | Funkcija | Številka CAS | Številka EC | Vsebnost (%) | META SPC 3 |
| Jod | | Aktivna snov | 7553-56-2 | 231-442-4 | 0,5 | 1. META SPC 3 ADMINISTRATIVE INFORMATION |
| META SPC 3 | 1.1. Meta SPC 3 identifier |
| 1. UPRAVNE INFORMACIJE O META SPC 3 | Identifier | Meta SPC 3 |
| 1.1 Identifikator meta SPC 3 | 1.2. Suffix to the authorisation number |
| Identifikator | Meta SPC 3 | Number | 1-3 |
| 1.2 Pripona k številki dovoljenja | 1.3. Product type(s) |
| Številka | 1-3 | Product type(s) | PT03 — Veterinary hygiene (Disinfectants) |
| 1.3 Vrsta(-e) proizvoda(-ov) | 2. META SPC 3 COMPOSITION |
| Vrsta(-e) proizvoda(-ov) | Vrsta proizvodov 03 – Veterinarska higiena (razkužila) | 2.1. Qualitative and quantitative information on the composition of the meta SPC 3 |
| 2. SESTAVA META SPC 3 | Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| 2.1 Kvalitativne in kvantitativne informacije o sestavi meta SPC 3 | Min | Max |
| Splošno ime | Ime IUPAC | Funkcija | Številka CAS | Številka EC | Vsebnost (%) | Iodine | | Active Substance | 7553-56-2 | 231-442-4 | 0,5 | 0,5 |
| Najmanj | Največ | Phosphoric Acid | Trihydroxidooxidophosphorus phosphoric acid | Non-active substance | 7664-38-2 | 231-633-2 | 0,0 | 0,0 |
| Jod | | Aktivna snov | 7553-56-2 | 231-442-4 | 0,5 | 0,5 | Poly(oxy-1,2-ethanediyl).alpha.-tridecyl-.omega.-hydroxy-,branched | Poly(oxy-1,2-ethanediyl).alpha.-tridecyl-.omega.-hydroxy-,branched | Non-active substance | 69011-36-5 | 500-241-6 | 0,0 | 0,0 |
| fosforjeva kislina | ortofosforjeva kislina | Neaktivna snov | 7664-38-2 | 231-633-2 | 0,0 | 0,0 | Isotridecanol, ethoxylated 90 %, C 9-11 Alcohol Ethoxylate | Isotridecanol, ethoxylated 90 %, C 9-11 Alcohol Ethoxylate | Non-active substance | 68439-46-3 | 614-482-0 | 0,0 | 0,0 |
| Poli(oks-1,2-etandiil).alfa.-tridecil-.omega.-hidroksi-, razvejan | Poli(oks-1,2-etandiil).alfa.-tridecil-.omega.-hidroksi-, razvejan | Neaktivna snov | 69011-36-5 | 500-241-6 | 0,0 | 0,0 | 2.2. Type(s) of formulation of the meta SPC 3 |
| Izotridekanol, etoksiliran 90 %, C 9-11 alkohol etoksilat | Izotridekanol, etoksiliran 90 %, C 9-11 alkohol etoksilat | Neaktivna snov | 68439-46-3 | 614-482-0 | 0,0 | 0,0 | Formulation(s) | AL — any other liquid |
| 2.2 Vrste formulacije meta SPC 3 | 3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 3 |
| Formulacija(-e) | AL – druge tekočine | Hazard statements | May be corrosive to metals. | Harmful to aquatic life with long lasting effects. |
| 3. STAVKI O NEVARNOSTI IN PREVIDNOSTNI STAVKI ZA META SPC 3 | Precautionary statements | Keep only in original packaging. | Avoid release to the environment. | Absorb spillage to prevent material damage. | Store in corrosive resistant container with a resistant inner liner. | Dispose of contents to/container in accordance with the local/national regulations. |
| Stavki o nevarnosti | Lahko je jedko za kovine. | Škodljivo za vodne organizme, z dolgotrajnimi učinki. | 4. AUTHORISED USE(S) OF THE META SPC 3 |
| Previdnostni stavki | Hraniti samo v originalni posodi. | Preprečiti sproščanje v okolje. | Odpraviti razlitje, da se prepreči materialna škoda. | Hraniti v posodi odporni proti koroziji z odporno notranjo oblogo. | Odstraniti vsebino posodo skladno z lokalnimi / nacionalnimi predpisi. | 4.1. Use description |
| 4. DOVOLJENE UPORABE META SPC 3 | Table 3 |
| 4.1 Opis uporabe | Use # 1 – Veterinary hygiene - animal husbandry - teat disinfectant - professional - indoors – spraying (post milking) |
| Preglednica 3 | Product type | PT03 — Veterinary hygiene (Disinfectants) |
| Uporaba # 1 – Veterinarska higiena – živinoreja – razkužilo za seske – profesionalno – za uporabo v zaprtih prostorih – pršenje (po molži) | Where relevant, an exact description of the authorised use | — |
| Vrsta proizvoda | Vrsta proizvodov 03 – Veterinarska higiena (razkužila) | Target organism(s) (including development stage) | Bacteria | Yeasts |
| Natančen opis dovoljene uporabe, kjer je to potrebno | - | Field(s) of use | Indoor |
| Ciljni organizem(-mi) (vključno z razvojno stopnjo) | Bakterije | Kvasovke | Application method(s) | Open system: spray treatment | Spraying: Manual and automated non-medical disinfection of teats with a ready-to-use spray (on cows, post-milking) |
| Področje uporabe | Notranjost, znotraj | Application rate(s) and frequency | Application rate: 10-15 ml per cow | Application frequency: | During lactation period: | — | manual: 2 applications per day (post-milking) | — | automated: 3 applications per day (post-milking) | During dry period: 1 application per day |
| Način(-i) uporabe | Odprt sistem: pršenje | Pršenje: Ročno in avtomatizirano nemedicinsko razkuževanje seskov z razpršilom, pripravljenim za uporabo (na kravah, po molži) | Category(ies) of users | Professional |
| Odmerki in pogostost uporabe | Stopnja uporabe: 10–15 ml na kravo | Pogostost uporabe: | V obdobju laktacije: | — | ročno: 2x dnevno (po molži) | — | samodejno: 3x dnevno (po molži) | Ob koncu izločanja mleka: 1x dnevno. | Pack sizes and packaging material | Bottle HDPE: 1 liter, cap is made of PP | Jerry can HDPE: 5-60 liters | Drum HDPE: 200 liters | IBC HDPE: 600-1 000 liters |
| Skupina(-e) uporabnikov | Poklicni | 4.1.1. Use-specific instructions for use |
| Velikosti in material embalaže | Plastenka HDPE: 1 liter, pokrovček je narejen iz polipropilena | Pločevinka HDPE: 5–60 litrov | Sod HDPE: 200 litrov | Vsebnik IBC: HDPE : 600–1 000 litrov | -- |
| 4.1.1 Uporba – posebna navodila za uporabo | 4.1.2. Use-specific risk mitigation measures |
| -- | --- |
| 4.1.2 Uporaba – posebni ukrepi za zmanjšanje tveganja | 4.1.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment |
| --- | -- |
| 4.1.3 Kjer je specifična uporaba, možni direktni ali indirektni učinki, navodila za prvo pomoč in nujni okrepi za zaščito okolja | 4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging |
| -- | --- |
| 4.1.4 Kjer je specifična uporaba, navodila za varno odstranjevanje proizvoda in njegove embalaže | 4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage |
| --- | --- |
| 4.1.5 Kjer je specifična uporaba, pogoji skladiščenja in rok uporabnosti proizvoda v običajnih pogojih skladiščenja | 5. GENERAL DIRECTIONS FOR USE (3) OF THE META SPC 3 |
| --- | 5.1. Instructions for use |
| 5. SPLOŠNE SMERNICE ZA UPORABO (3) META SPC 3 | Always read the label or leaflet before use and follow all the instructions provided. |
| 5.1 Navodila za uporabo | The product must be brought to a temperature above 20 °C before use. |
| Pred uporabo vedno preberite etiketo ali navodila za uporabo in upoštevajte vsa navodila. | The use of a dosing pump for filling the product into the application equipment is recommended. |
| Izdelek je treba pred uporabo segreti na temperaturo nad 20 °C. | Immediately after each cow has been milked, spray the entire surface of each teat with the solution. Leave the product until next milking. Do not clean the teats directly after disinfection. |
| Za polnjenje izdelka v opremo za nanašanje je priporočena uporaba dozirne črpalke. | Keep the cows standing until the product has dried (at least 5 minutes). |
| Takoj po molži vsake krave celotno površino vsakega seska napršite z raztopino. Izdelka ne odstranite do naslednje molže. Seskov ne čistite neposredno po razkuževanju. | Product can be applied manually or by means of automatic teat sprayer. |
| Krave naj stojijo, dokler se izdelek ne posuši (najmanj 5 minut). | Before the next milking the teats have to be cleaned, preferably with one new wet cloth per cow. |
| Izdelek se lahko nanese ročno ali s pomočjo samodejnega pršila za seske. | Application frequency must not exceed two applications per cow and day considering manual spraying and must not exceed three applications per cow and day considering automatic teat sprayer (post-milking). |
| Pred naslednjo molžo je treba seske očistiti, po možnosti s po eno novo, mokro krpo na kravo. | 5.2. Risk mitigation measures |
| Pogostost uporabe ne sme presegati dveh nanosov na kravo in dan glede na ročno oz. treh nanosov na kravo in dan glede na samodejno pršilo za seske (po molži). | Keep out of reach of children. |
| 5.2 Ukrepi za zmanjšanje tveganja | Wear protective chemical resistant gloves, coated coverall and boots during product handling and application phase (material to be specified by the authorisation holder in the product information). |
| Hraniti izven dosega otrok. | In case a combination of pre- and post-milking disinfection is necessary, using another product not containing Iodine has to be considered for pre-milking disinfection. |
| Nosite zaščitne rokavice, odporne na kemikalije, hlače z oprsnikom in škornje med rokovanjem z izdelkom in fazo uporabe (material določi imetnik dovoljenja v okviru informacij o izdelku). | 5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment |
| Če je potrebna kombinacija razkuževanja pred in po molži, je treba pri razkuževanju pred molžo uporabiti drugi proizvod, ki ne vsebuje joda. | After inhalation: Supply fresh air; consult doctor in case of complaints. |
| 5.3 Značilnosti verjetnih direktnih ali indirektnih učinkov, navodila za prvo pomoč in nujni ukrepi za zaščito okolja | After skin contact: Wash skin thoroughly. |
| Po vdihovanju: Zagotovite dotok svežega zraka; v primeru težav se posvetujte z zdravnikom. | After eye contact: Rinse opened eye, remove contact lenses, keep rinsing for several minutes under running water. Then consult a doctor. |
| Po stiku s kožo: Kožo temeljito sperite. | After swallowing: Rinse out mouth and then drink some water. Do not induce vomiting; call for medical help immediately. |
| Po stiku z očmi: Sperite odprte oči, odstranite kontaktne leče in nekaj minut izpirajte pod tekočo vodo. Nato se posvetujte z zdravnikom. | When asking for medical advice keep packaging or label at hand and call your local poison control center [insert local number here]. |
| Po zaužitju: Sperite usta in nato spijte nekaj vode. Ne izzivajte bruhanja; takoj pokličite zdravniško pomoč. | Environmental emergency measures: |
| Ko iščete zdravniško pomoč, imejte embalažo ali etiketo pri roki in pokličite na številko 112 – klic v sili. | Inform the relevant authorities if the product has caused environmental pollution (sewers, waterways, soil or air). To prevent malfunctioning of an individual wastewater treatment plant, possible residues containing the product must be discharged to the manure storage (for spreading on agricultural soils or fermentation into biogas installation) or to the municipal sewer if legally allowed. |
| Okoljevarstveni ukrepi: | 5.4. Instructions for safe disposal of the product and its packaging |
| Obvestite pristojne organe, če je izdelek povzročil onesnaženje okolja (kanalizacije, plovne poti, tla ali zrak). Da bi preprečili nepravilno delovanje posamezne komunalne čistilne naprave, je treba morebitne ostanke, ki vsebujejo izdelek, odložiti na odlagališče za gnojila (za raztros na kmetijskih zemljiščih ali fermentacijo v bioplinarnah) ali v komunalni kanalizacijski sistem, če je to zakonsko dovoljeno. | At the end of the treatment, dispose unused product and the packaging in accordance with local requirements. Used product can be flushed to the municipal sewer or disposed to the manure deposit depending on local requirements. Avoid release to an individual waste water treatment plant. |
| 5.4 Navodila za varno odstranjevanje proizvoda in njegove embalaže | European Waste Catalogue: 200130-detergents other than those mentioned in 20 01 29. |
| Na koncu obdelave odstranite neuporabljeni izdelek in embalažo v skladu z lokalnimi zahtevami. Uporabljeni izdelek se lahko splakne v komunalni kanalizacijski sistem ali zavrže na odlagališče za gnojila, odvisno od lokalnih predpisov. Ne spuščajte v posamezno komunalno čistilno napravo. | 5.5. Conditions of storage and shelf-life of the product under normal conditions of storage |
| Evropski seznam odpadkov: 200130 – detergenti razen tistih, ki niso navedeni pod 20 01 29. | Store the product at room temperature, away from direct sunlight and in opaque containers. Protect from frost. Keep container tightly closed. |
| 5.5 Pogoji za shranjevanje in rok uporabnosti proizvoda pri običajnih pogojih skladiščenja | Shelf-life: 12 months in HDPE. |
| Izdelek hranite pri sobni temperaturi, stran od neposredne sončne svetlobe in v neprozornih posodah. Zaščitite pred zmrzaljo. Posodo hranite tesno zaprto. | 6. OTHER INFORMATION |
| Rok uporabnosti: 12 mesecev v HDPE. | 7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 3 |
| 6. DRUGE INFORMACIJE | 7.1. Trade name(s), authorisation number and specific composition of each individual product |
| Trade name(s) | Fink — Io Spray 50 (Jodophor) | Fink — Io Spray 50 (Iodophor) | |
| 7. TRETJA INFORMACIJSKA RAVEN:POSAMEZNI PROIZVODI V META SPC 3 | Authorisation number | EU-0020540-0004 1-3 |
| 7.1 Trgovsko(-a) ime(-na), številka avtorizacije in specifična sestava za vsak posamezni proizvod | Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| Trgovsko ime | Fink - Io Spray 50 (Jodophor) | Fink - Io Spray 50 (Iodophor) | Iodine | | Active Substance | 7553-56-2 | 231-442-4 | 0,5 |
| Številka dovoljenja | EU-0020540-0004 1-3 | META SPC 4 |
| Splošno ime | Ime IUPAC | Funkcija | Številka CAS | Številka EC | Vsebnost (%) | 1. META SPC 4 ADMINISTRATIVE INFORMATION |
| Jod | | Aktivna snov | 7553-56-2 | 231-442-4 | 0,5 | 1.1. Meta SPC 4 identifier |
| META SPC 4 | Identifier | Meta SPC 4 |
| 1. UPRAVNE INFORMACIJE O META SPC 4 | 1.2. Suffix to the authorisation number |
| 1.1 Identifikator meta SPC 4 | Number | 1-4 |
| Identifikator | Meta SPC 4 | 1.3. Product type(s) |
| 1.2 Pripona k številki dovoljenja | Product type(s) | PT03 — Veterinary hygiene (Disinfectants) |
| Številka | 1-4 | 2. META SPC 4 COMPOSITION |
| 1.3 Vrsta(-e) proizvoda(-ov) | 2.1. Qualitative and quantitative information on the composition of the meta SPC 4 |
| Vrsta(-e) proizvoda(-ov) | Vrsta proizvodov 03 – Veterinarska higiena (razkužila) | Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| 2. SESTAVA META SPC 4 | Min | Max |
| 2.1 Kvalitativne in kvantitativne informacije o sestavi meta SPC 4 | Iodine | | Active Substance | 7553-56-2 | 231-442-4 | 0,1 | 0,15 |
| Splošno ime | Ime IUPAC | Funkcija | Številka CAS | Številka EC | Vsebnost (%) | Phosphoric Acid | Trihydroxidooxidophosphorus phosphoric acid | Non-active substance | 7664-38-2 | 231-633-2 | 0,0 | 0,0 |
| Najmanj | Največ | Poly(oxy-1,2-ethanediyl).alpha.-tridecyl-.omega.-hydroxy-,branched | Poly(oxy-1,2-ethanediyl).alpha.-tridecyl-.omega.-hydroxy-,branched | Non-active substance | 69011-36-5 | 500-241-6 | 0,0 | 0,0 |
| Jod | | Aktivna snov | 7553-56-2 | 231-442-4 | 0,1 | 0,15 | Isotridecanol, ethoxylated 90 %, C 9-11 Alcohol Ethoxylate | Isotridecanol, ethoxylated 90 %, C 9-11 Alcohol Ethoxylate | Non-active substance | 68439-46-3 | 614-482-0 | 0,0 | 0,0 |
| fosforjeva kislina | ortofosforjeva kislina | Neaktivna snov | 7664-38-2 | 231-633-2 | 0,0 | 0,0 | 2.2. Type(s) of formulation of the meta SPC 4 |
| Poli(oks-1,2-etandiil).alfa.-tridecil-.omega.-hidroksi-, razvejan | Poli(oks-1,2-etandiil).alfa.-tridecil-.omega.-hidroksi-, razvejan | Neaktivna snov | 69011-36-5 | 500-241-6 | 0,0 | 0,0 | Formulation(s) | AL — any other liquid |
| Izotridekanol, etoksiliran 90 %, C 9-11 alkohol etoksilat | Izotridekanol, etoksiliran 90 %, C 9-11 alkohol etoksilat | Neaktivna snov | 68439-46-3 | 614-482-0 | 0,0 | 0,0 | 3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 4 |
| 2.2 Vrste formulacije meta SPC 4 | Hazard statements | May be corrosive to metals. |
| Formulacija(-e) | AL – druge tekočine | Precautionary statements | Keep only in original packaging. | Absorb spillage to prevent material damage. | Store in corrosive resistant container with a resistant inner liner. |
| 3. STAVKI O NEVARNOSTI IN PREVIDNOSTNI STAVKI ZA META SPC 4 | 4. AUTHORISED USE(S) OF THE META SPC 4 |
| Stavki o nevarnosti | Lahko je jedko za kovine. | 4.1. Use description |
| Previdnostni stavki | Hraniti samo v originalni posodi. | Odpraviti razlitje, da se prepreči materialna škoda. | Hraniti v posodi odporni proti koroziji z odporno notranjo oblogo. | Table 4 |
| 4. DOVOLJENE UPORABE META SPC 4 | Use # 1 – Veterinary hygiene — animal husbandry — teat disinfectant — professional — indoors — dipping (post milking) |
| 4.1 Opis uporabe | Product type | PT03 — Veterinary hygiene (Disinfectants) |
| Preglednica 4 | Where relevant, an exact description of the authorised use | — |
| Uporaba # 1 – Veterinarska higiena – živinoreja – razkužilo za seske – profesionalno – za uporabo v zaprtih prostorih – namakanje (po molži) | Target organism(s) (including development stage) | Bacteria | Yeasts |
| Vrsta proizvoda | Vrsta proizvodov 03 – Veterinarska higiena (razkužila) | Field(s) of use | Indoor |
| Natančen opis dovoljene uporabe, kjer je to potrebno | - | Application method(s) | Open system: dip treatment | Teat-dipping: Manual non-medical disinfection of teats with a ready-to-use liquid (on cows, post-milking) |
| Ciljni organizem(-mi) (vključno z razvojno stopnjo) | Bakterije | Kvasovke | Application rate(s) and frequency | Application rate: 5-10 ml per cow | Application frequency: | During lactation period: 2 applications per day (post-milking) | During dry period: 1 application per day |
| Področje uporabe | Notranjost, znotraj | Category(ies) of users | Professional |
| Način(-i) uporabe | Odprt sistem: pomakanje | Namakanje seskov: Ročno nemedicinsko razkuževanje seskov s tekočino, pripravljeno za uporabo (na kravah, po molži) | Pack sizes and packaging material | Bottle HDPE: 1 liter, cap is made of PP | Jerry can HDPE: 5-60 liters | Drum HDPE: 200 liters | IBC HDPE: 600-1 000 liters |
| Odmerki in pogostost uporabe | Stopnja uporabe: 5–10 ml na kravo | Pogostost uporabe: | V obdobju laktacije: 2x dnevno (po molži) | Ob koncu izločanja mleka: 1x dnevno | 4.1.1. Use-specific instructions for use |
| Skupina(-e) uporabnikov | Poklicni | --- |
| Velikosti in material embalaže | Plastenka HDPE: 1 liter | Pločevinka HDPE: 5–60 litrov | Sod HDPE: 200 litrov | IBC HDPE: 600–1 000 litrov | 4.1.2. Use-specific risk mitigation measures |
| 4.1.1 Uporba – posebna navodila za uporabo | --- |
| --- | 4.1.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment |
| 4.1.2 Uporaba – posebni ukrepi za zmanjšanje tveganja | --- |
| --- | 4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging |
| 4.1.3 Kjer je specifična uporaba, možni direktni ali indirektni učinki, navodila za prvo pomoč in nujni okrepi za zaščito okolja | --- |
| --- | 4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage |
| 4.1.4 Kjer je specifična uporaba, navodila za varno odstranjevanje proizvoda in njegove embalaže | --- |
| --- | 5. GENERAL DIRECTIONS FOR USE (4) OF THE META SPC 4 |
| 4.1.5 Kjer je specifična uporaba, pogoji skladiščenja in rok uporabnosti proizvoda v običajnih pogojih skladiščenja | 5.1. Instructions for use |
| --- | Always read the label or leaflet before use and follow all the instructions provided. |
| 5. SPLOŠNE SMERNICE ZA UPORABO (4) META SPC 4 | The product must be brought to a temperature above 20 °C before use. |
| 5.1 Navodila za uporabo | The use of a dosing pump for filling the product into the application equipment is recommended. |
| Pred uporabo vedno preberite etiketo ali navodila za uporabo in upoštevajte vsa navodila. | Fill up a teat dipping cup with 2/3 of product. Immediately after each cow has been milked, dip each teat manually in the solution. Ensure that at least two thirds of the teats, preferably the entire teats, come in contact with the solution. |
| Izdelek je treba pred uporabo segreti na temperaturo nad 20 °C. | Do not clean the teats directly after disinfection. Leave the product until next milking. Keep the cows standing until the product has dried (at least 5 minutes). |
| Za polnjenje izdelka v opremo za nanašanje je priporočena uporaba dozirne črpalke. | Refill the cup as necessary. |
| Napolnite posodo za namakanje seskov z 2/3 izdelka. Takoj po posamezni molži krave vsak sesek potopite ročno v raztopino. Prepričajte se, da sta vsaj dve tretjini seskov oz. da so po možnosti celotni seski v stiku z raztopino. | Teat dipping cups should be emptied after milking and washed before re-use. Before the next milking the teats have to be cleaned, preferably with one new wet cloth per cow. |
| Seskov ne čistite neposredno po razkuževanju. Izdelka ne odstranite do naslednje molže. Krave naj stojijo, dokler se izdelek ne posuši (najmanj 5 minut). | Application frequency must not exceed two applications per cow and day (post-milking). |
| Po potrebi ponovno napolnite posodo. | 5.2. Risk mitigation measures |
| Posode za namakanje seskov je treba po molži izprazniti in pred ponovno uporabo oprati. Pred naslednjo molžo je treba seske očistiti, po možnosti s po eno novo, mokro krpo na kravo. | Keep out of reach of children. |
| Pogostost uporabe ne sme presegati dveh nanosov na kravo in dan (po molži). | In case a combination of pre- and post-milking disinfection is necessary, using another product not containing Iodine has to be considered for pre-milking disinfection. |
| 5.2 Ukrepi za zmanjšanje tveganja | 5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment |
| Hraniti izven dosega otrok. | After inhalation: Supply fresh air; consult doctor in case of complaints. |
| Če je potrebna kombinacija razkuževanja pred in po molži, je treba pri razkuževanju pred molžo uporabiti drugiproizvod, ki ne vsebuje joda. | After skin contact: Wash skin thoroughly. |
| 5.3 Značilnosti verjetnih direktnih ali indirektnih učinkov, navodila za prvo pomoč in nujni ukrepi za zaščito okolja | After eye contact: Rinse opened eye, remove contact lenses, keep rinsing for several minutes under running water. Then consult a doctor. |
| Po vdihovanju: Zagotovite dotok svežega zraka; v primeru težav se posvetujte z zdravnikom. | After swallowing: Rinse out mouth and then drink some water. Do not induce vomiting; call for medical help immediately. |
| Po stiku s kožo: Kožo temeljito sperite. | When asking for medical advice keep packaging or label at hand and call your local poison control center [insert local number here]. |
| Po stiku z očmi: Sperite odprte oči, odstranite kontaktne leče in nekaj minut izpirajte pod tekočo vodo. Nato se posvetujte z zdravnikom. | Environmental emergency measures: |
| Po zaužitju: Sperite usta in nato spijte nekaj vode. Ne izzivajte bruhanja; takoj pokličite zdravniško pomoč. | Inform the relevant authorities if the product has caused environmental pollution (sewers, waterways, soil or air). To prevent malfunctioning of an individual wastewater treatment plant, possible residues containing the product must be discharged to the manure storage (for spreading on agricultural soils or fermentation into biogas installation) or to the municipal sewer if legally allowed. |
| Ko iščete zdravniško pomoč, imejte embalažo ali etiketo pri roki in pokličite na številko 112 – klic v sili. | 5.4. Instructions for safe disposal of the product and its packaging |
| Okoljevarstveni ukrepi: | At the end of the treatment, dispose unused product and the packaging in accordance with local requirements. Used product can be flushed to the municipal sewer or disposed to the manure deposit depending on local requirements. Avoid release to an individual waste water treatment plant. |
| Obvestite pristojne organe, če je izdelek povzročil onesnaženje okolja (kanalizacije, plovne poti, tla ali zrak). Da bi preprečili nepravilno delovanje posamezne komunalne čistilne naprave, je treba morebitne ostanke, ki vsebujejo izdelek, odložiti na odlagališče za gnojila (za raztros na kmetijskih zemljiščih ali fermentacijo v bioplinarnah) ali v komunalni kanalizacijski sistem, če je to zakonsko dovoljeno. | European Waste Catalogue: 200130-detergents other than those mentioned in 20 01 29. |
| 5.4 Navodila za varno odstranjevanje proizvoda in njegove embalaže | 5.5. Conditions of storage and shelf-life of the product under normal conditions of storage |
| Na koncu obdelave odstranite neuporabljeni izdelek in embalažo v skladu z lokalnimi zahtevami. Uporabljeni izdelek se lahko splakne v komunalni kanalizacijski sistem ali zavrže na odlagališče za gnojila, odvisno od lokalnih predpisov. Ne spuščajte v posamezno komunalno čistilno napravo. | Store the product at room temperature, away from direct sunlight and in opaque containers. Protect from frost. Keep container tightly closed. |
| Evropski seznam odpadkov: 200130 – detergenti razen tistih, ki niso navedeni pod 20 01 29. | Shelf-life: 12 months in HDPE. |
| 5.5 Pogoji za shranjevanje in rok uporabnosti proizvoda pri običajnih pogojih skladiščenja | 6. OTHER INFORMATION |
| Izdelek hranite pri sobni temperaturi, stran od neposredne sončne svetlobe in v neprozornih posodah. Zaščitite pred zmrzaljo. Posodo hranite tesno zaprto. | 7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 4 |
| Rok uporabnosti: 12 mesecev v HDPE. | 7.1. Trade name(s), authorisation number and specific composition of each individual product |
| 6. DRUGE INFORMACIJE | Trade name(s) | FINK — Io Dip 10 | IODip 10 PVP |
| Authorisation number | EU-0020540-0005 1-4 | |
| 7. TRETJA INFORMACIJSKA RAVEN:POSAMEZNI PROIZVODI V META SPC 4 | Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| 7.1 Trgovsko(-a) ime(-na), številka avtorizacije in specifična sestava za vsak posamezni proizvod | Iodine | | Active Substance | 7553-56-2 | 231-442-4 | 0,1 |
| Trgovsko ime | FINK - Io Dip 10 | IODip 10 PVP | 7.2. Trade name(s), authorisation number and specific composition of each individual product |
| Številka dovoljenja | EU-0020540-0005 1-4 | Trade name(s) | FINK — Io Dip Protect | DESINTEC MH Iodine Barrier | TvP — Barrier Dip |
| Splošno ime | Ime IUPAC | Funkcija | Številka CAS | Številka EC | Vsebnost (%) | Authorisation number | EU-0020540-0006 1-4 |
| Jod | | Aktivna snov | 7553-56-2 | 231-442-4 | 0,1 | Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| 7.2 Trgovsko(-a) ime(-na), številka avtorizacije in specifična sestava za vsak posamezni proizvod | Iodine | | Active Substance | 7553-56-2 | 231-442-4 | 0,15 |
| Trgovsko ime | FINK - Io Dip Protect | DESINTEC MH Iodine Barrier | TvP - Barrier Dip | META SPC 5 |
| Številka dovoljenja | EU-0020540-0006 1-4 | 1. META SPC 5 ADMINISTRATIVE INFORMATION |
| Splošno ime | Ime IUPAC | Funkcija | Številka CAS | Številka EC | Vsebnost (%) | 1.1. Meta SPC 5 identifier |
| Jod | | Aktivna snov | 7553-56-2 | 231-442-4 | 0,15 | Identifier | Meta SPC 5 |
| META SPC 5 | 1.2. Suffix to the authorisation number |
| 1. UPRAVNE INFORMACIJE O META SPC 5 | Number | 1-5 |
| 1.1 Identifikator meta SPC 5 | 1.3. Product type(s) |
| Identifikator | Meta SPC 5 | Product type(s) | PT03 — Veterinary hygiene (Disinfectants) |
| 1.2 Pripona k številki dovoljenja | 2. META SPC 5 COMPOSITION |
| Številka | 1-5 | 2.1. Qualitative and quantitative information on the composition of the meta SPC 5 |
| 1.3 Vrsta(-e) proizvoda(-ov) | Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| Vrsta(-e) proizvoda(-ov) | Vrsta proizvodov 03 – Veterinarska higiena (razkužila) | Min | Max |
| 2. SESTAVA META SPC 5 | Iodine | | Active Substance | 7553-56-2 | 231-442-4 | 0,3 | 0,45 |
| 2.1 Kvalitativne in kvantitativne informacije o sestavi meta SPC 5 | Phosphoric Acid | Trihydroxidooxidophosphorus phosphoric acid | Non-active substance | 7664-38-2 | 231-633-2 | 0,35 | 0,4 |
| Splošno ime | Ime IUPAC | Funkcija | Številka CAS | Številka EC | Vsebnost (%) | Poly(oxy-1,2-ethanediyl).alpha.-tridecyl-.omega.-hydroxy-,branched | Poly(oxy-1,2-ethanediyl).alpha.-tridecyl-.omega.-hydroxy-,branched | Non-active substance | 69011-36-5 | 500-241-6 | 0,0 | 0,0 |
| Najmanj | Največ | Isotridecanol, ethoxylated 90 %, C 9-11 Alcohol Ethoxylate | Isotridecanol, ethoxylated 90 %, C 9-11 Alcohol Ethoxylate | Non-active substance | 68439-46-3 | 614-482-0 | 0,0 | 0,0 |
| Jod | | Aktivna snov | 7553-56-2 | 231-442-4 | 0,3 | 0,45 | 2.2. Type(s) of formulation of the meta SPC 5 |
| fosforjeva kislina | ortofosforjeva kislina | Neaktivna snov | 7664-38-2 | 231-633-2 | 0,35 | 0,4 | Formulation(s) | AL — any other liquid |
| Poli(oks-1,2-etandiil).alfa.-tridecil-.omega.-hidroksi-, razvejan | Poli(oks-1,2-etandiil).alfa.-tridecil-.omega.-hidroksi-, razvejan | Neaktivna snov | 69011-36-5 | 500-241-6 | 0,0 | 0,0 | 3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 5 |
| Izotridekanol, etoksiliran 90 %, C 9-11 alkohol etoksilat | Izotridekanol, etoksiliran 90 %, C 9-11 alkohol etoksilat | Neaktivna snov | 68439-46-3 | 614-482-0 | 0,0 | 0,0 | Hazard statements | May be corrosive to metals. | Harmful to aquatic life with long lasting effects. |
| 2.2 Vrste formulacije meta SPC 5 | Precautionary statements | Keep only in original packaging. | Avoid release to the environment. | Absorb spillage to prevent material damage. | Store in corrosive resistant container with a resistant inner liner. | Dispose of contents to / container in accordance with the local/national regulations. |
| Formulacija(-e) | AL – druge tekočine | 4. AUTHORISED USE(S) OF THE META SPC 5 |
| 3. STAVKI O NEVARNOSTI IN PREVIDNOSTNI STAVKI ZA META SPC 5 | 4.1. Use description |
| Stavki o nevarnosti | Lahko je jedko za kovine. | Škodljivo za vodne organizme, z dolgotrajnimi učinki. | Table 5 |
| Previdnostni stavki | Hraniti samo v originalni posodi. | Preprečiti sproščanje v okolje. | Odpraviti razlitje, da se prepreči materialna škoda. | Hraniti v posodi odporni proti koroziji z odporno notranjo oblogo. | Odstraniti vsebino posodo skladno z lokalnimi / nacionalnimi predpisi. | Use # 1 — Veterinary hygiene — animal husbandry — teat disinfectant — professional — indoors — dipping (post milking) |
| 4. DOVOLJENE UPORABE META SPC 5 | Product type | PT03 — Veterinary hygiene (Disinfectants) |
| 4.1 Opis uporabe | Where relevant, an exact description of the authorised use | — |
| Preglednica 5 | Target organism(s) (including development stage) | Bacteria | Yeasts |
| Uporaba # 1 – Veterinarska higiena – živinoreja – razkužilo za seske – profesionalno – za uporabo v zaprtih prostorih – namakanje (po molži) | Field(s) of use | Indoor |
| Vrsta proizvoda | Vrsta proizvodov 03 – Veterinarska higiena (razkužila) | Application method(s) | Open system: dip treatment | Teat-dipping: Manual non-medical disinfection of teats with a ready-to-use liquid (on cows, post-milking) |
| Natančen opis dovoljene uporabe, kjer je to potrebno | - | Application rate(s) and frequency | Application rate: 5-10 ml per cow | Application frequency: | During lactation period: 2 applications per day (post-milking) | During dry period: 1 application per day |
| Ciljni organizem(-mi) (vključno z razvojno stopnjo) | Bakterije | Kvasovke | Category(ies) of users | Professional |
| Področje uporabe | Notranjost, znotraj | Pack sizes and packaging material | Bottle HDPE: 1 liter, cap is made of PP | Jerry can HDPE: 5-60 liters | Drum HDPE: 200 liters | IBC HDPE: 600-1 000 liters |
| Način(-i) uporabe | Odprt sistem: pomakanje | Namakanje seskov: Ročno nemedicinsko razkuževanje seskov s tekočino, pripravljeno za uporabo (na kravah, po molži) | 4.1.1. Use-specific instructions for use |
| Odmerki in pogostost uporabe | Stopnja uporabe: 5–10 ml na kravo | Pogostost uporabe: | V obdobju laktacije: 2x dnevno (po molži) | Ob koncu izločanja mleka: 1x dnevno | --- |
| Skupina(-e) uporabnikov | Poklicni | 4.1.2. Use-specific risk mitigation measures |
| Velikosti in material embalaže | Plastenka HDPE: 1 liter | Pločevinka HDPE: 5–60 litrov | Sod HDPE: 200 litrov | IBC HDPE: 600–1 000 litrov | --- |
| 4.1.1 Uporba – posebna navodila za uporabo | 4.1.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment |
| --- | --- |
| 4.1.2 Uporaba – posebni ukrepi za zmanjšanje tveganja | 4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging |
| --- | --- |
| 4.1.3 Kjer je specifična uporaba, možni direktni ali indirektni učinki, navodila za prvo pomoč in nujni okrepi za zaščito okolja | 4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage |
| --- | --- |
| 4.1.4 Kjer je specifična uporaba, navodila za varno odstranjevanje proizvoda in njegove embalaže | 5. GENERAL DIRECTIONS FOR USE (5) OF THE META SPC 5 |
| --- | 5.1. Instructions for use |
| 4.1.5 Kjer je specifična uporaba, pogoji skladiščenja in rok uporabnosti proizvoda v običajnih pogojih skladiščenja | Always read the label or leaflet before use and follow all the instructions provided. |
| --- | The product must be brought to a temperature above 20 °C before use. |
| 5. SPLOŠNE SMERNICE ZA UPORABO (5) META SPC 5 | The use of a dosing pump for filling the product into the application equipment is recommended. |
| 5.1 Navodila za uporabo | Fill up a teat dipping cup with 2/3 of product. Immediately after each cow has been milked, dip each teat manually in the solution. Ensure that at least two thirds of the teats, preferably the entire teats, come in contact with the solution. |
| Pred uporabo vedno preberite etiketo ali navodila za uporabo in upoštevajte vsa navodila. | Do not clean the teats directly after disinfection. Leave the product until next milking. |
| Izdelek je treba pred uporabo segreti na temperaturo nad 20 °C. | Keep the cows standing until the product has dried (at least 5 minutes). |
| Za polnjenje izdelka v opremo za nanašanje je priporočena uporaba dozirne črpalke. | Refill the cup as necessary. |
| Napolnite posodo za namakanje seskov z 2/3 izdelka. Takoj po posamezni molži krave vsak sesek potopite ročno v raztopino. Prepričajte se, da sta vsaj dve tretjini seskov oz. da so po možnosti celotni seski v stiku z raztopino. | Teat dipping cups should be emptied after milking and washed before re-use. Before the next milking the teats have to be cleaned, preferably with one new wet cloth per cow. |
| Seskov ne čistite neposredno po razkuževanju. Izdelka ne odstranite do naslednje molže. | Application frequency must not exceed two applications per cow and day (post-milking). |
| Krave naj stojijo, dokler se izdelek ne posuši (najmanj 5 minut). | 5.2. Risk mitigation measures |
| Po potrebi ponovno napolnite posodo. | Keep out of reach of children. |
| Posode za namakanje seskov je treba po molži izprazniti in pred ponovno uporabo oprati. Pred naslednjo molžo je treba seske očistiti, po možnosti s po eno novo, mokro krpo na kravo. | In case a combination of pre- and post-milking disinfection is necessary, using another product not containing Iodine has to be considered for pre-milking disinfection. |
| Pogostost uporabe ne sme presegati dveh nanosov na kravo in dan (po molži). | 5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment |
| 5.2 Ukrepi za zmanjšanje tveganja | After inhalation: Supply fresh air; consult doctor in case of complaints. |
| Hraniti izven dosega otrok. | After skin contact: Wash skin thoroughly. |
| Če je potrebna kombinacija razkuževanja pred in po molži, je treba pri razkuževanju pred molžo uporabiti drugiproizvod, ki ne vsebuje joda. | After eye contact: Rinse opened eye, remove contact lenses, keep rinsing for several minutes under running water. Then consult a doctor. |
| 5.3 Značilnosti verjetnih direktnih ali indirektnih učinkov, navodila za prvo pomoč in nujni ukrepi za zaščito okolja | After swallowing: Rinse out mouth and then drink some water. Do not induce vomiting; call for medical help immediately. |
| Po vdihovanju: Zagotovite dotok svežega zraka; v primeru težav se posvetujte z zdravnikom. | When asking for medical advice keep packaging or label at hand and call your local poison control center [insert local number here]. |
| Po stiku s kožo: Kožo temeljito sperite. | Environmental emergency measures: |
| Po stiku z očmi: Sperite odprte oči, odstranite kontaktne leče in nekaj minut izpirajte pod tekočo vodo. Nato se posvetujte z zdravnikom. | Inform the relevant authorities if the product has caused environmental pollution (sewers, waterways, soil or air). To prevent malfunctioning of an individual wastewater treatment plant, possible residues containing the product must be discharged to the manure storage (for spreading on agricultural soils or fermentation into biogas installation) or to the municipal sewer if legally allowed. |
| Po zaužitju: Sperite usta in nato spijte nekaj vode. Ne izzivajte bruhanja; takoj pokličite zdravniško pomoč. | 5.4. Instructions for safe disposal of the product and its packaging |
| Ko iščete zdravniško pomoč, imejte embalažo ali etiketo pri roki in pokličite na številko 112 – klic v sili. | At the end of the treatment, dispose unused product and the packaging in accordance with local requirements. Used product can be flushed to the municipal sewer or disposed to the manure deposit depending on local requirements. Avoid release to an individual waste water treatment plant. |
| Okoljevarstveni ukrepi: | European Waste Catalogue: 200130-detergents other than those mentioned in 20 01 29. |
| Obvestite pristojne organe, če je izdelek povzročil onesnaženje okolja (kanalizacije, plovne poti, tla ali zrak). Da bi preprečili nepravilno delovanje posamezne komunalne čistilne naprave, je treba morebitne ostanke, ki vsebujejo izdelek, odložiti na odlagališče za gnojila (za raztros na kmetijskih zemljiščih ali fermentacijo v bioplinarnah) ali v komunalni kanalizacijski sistem, če je to zakonsko dovoljeno. | 5.5. Conditions of storage and shelf-life of the product under normal conditions of storage |
| 5.4 Navodila za varno odstranjevanje proizvoda in njegove embalaže | Store the product at room temperature, away from direct sunlight and in opaque containers. Protect from frost. Keep container tightly closed. |
| Na koncu obdelave odstranite neuporabljeni izdelek in embalažo v skladu z lokalnimi zahtevami. Uporabljeni izdelek se lahko splakne v komunalni kanalizacijski sistem ali zavrže na odlagališče za gnojila, odvisno od lokalnih predpisov. Ne spuščajte v posamezno komunalno čistilno napravo. | Shelf-life: 12 months in HDPE. |
| Evropski seznam odpadkov: 200130 – detergenti razen tistih, ki niso navedeni pod 20 01 29. | 6. OTHER INFORMATION |
| 5.5 Pogoji za shranjevanje in rok uporabnosti proizvoda pri običajnih pogojih skladiščenja | 7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 5 |
| Izdelek hranite pri sobni temperaturi, stran od neposredne sončne svetlobe in v neprozornih posodah. Zaščitite pred zmrzaljo. Posodo hranite tesno zaprto. | 7.1. Trade name(s), authorisation number and specific composition of each individual product |
| Rok uporabnosti: 12 mesecev v HDPE. | Trade name(s) | Jodofilm 75/5 4 500 ppm |
| 6. DRUGE INFORMACIJE | Authorisation number | EU-0020540-0007 1-5 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) | |
| 7. TRETJA INFORMACIJSKA RAVEN:POSAMEZNI PROIZVODI V META SPC 5 | Iodine | | Active Substance | 7553-56-2 | 231-442-4 | 0,45 |
| 7.1 Trgovsko(-a) ime(-na), številka avtorizacije in specifična sestava za vsak posamezni proizvod | Phosphoric Acid | Trihydroxidooxidophosphorus phosphoric acid | Non-active substance | 7664-38-2 | 231-633-2 | 0,4 |
| Trgovsko ime | Jodofilm 75/5 4500 ppm | 7.2. Trade name(s), authorisation number and specific composition of each individual product |
| Številka dovoljenja | EU-0020540-0007 1-5 | Trade name(s) | Jodofilm 75/5 3 000 ppm |
| Splošno ime | Ime IUPAC | Funkcija | Številka CAS | Številka EC | Vsebnost (%) | Authorisation number | EU-0020540-0008 1-5 |
| Jod | | Aktivna snov | 7553-56-2 | 231-442-4 | 0,45 | Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| fosforjeva kislina | ortofosforjeva kislina | Neaktivna snov | 7664-38-2 | 231-633-2 | 0,4 | Iodine | | Active Substance | 7553-56-2 | 231-442-4 | 0,3 |
| 7.2 Trgovsko(-a) ime(-na), številka avtorizacije in specifična sestava za vsak posamezni proizvod | Phosphoric Acid | Trihydroxidooxidophosphorus phosphoric acid | Non-active substance | 7664-38-2 | 231-633-2 | 0,35 |
| Trgovsko ime | Jodofilm 75/5 3000 ppm | META SPC 6 |
| Številka dovoljenja | EU-0020540-0008 1-5 | 1. META SPC 6 ADMINISTRATIVE INFORMATION |
| Splošno ime | Ime IUPAC | Funkcija | Številka CAS | Številka EC | Vsebnost (%) | 1.1. Meta SPC 6 identifier |
| Jod | | Aktivna snov | 7553-56-2 | 231-442-4 | 0,3 | Identifier | Meta SPC 6 |
| fosforjeva kislina | ortofosforjeva kislina | Neaktivna snov | 7664-38-2 | 231-633-2 | 0,35 | 1.2. Suffix to the authorisation number |
| META SPC 6 | Number | 1-6 |
| 1. UPRAVNE INFORMACIJE O META SPC 6 | 1.3. Product type(s) |
| 1.1 Identifikator meta SPC 6 | Product type(s) | PT03 — Veterinary hygiene (Disinfectants) |
| Identifikator | Meta SPC 6 | 2. META SPC 6 COMPOSITION |
| 1.2 Pripona k številki dovoljenja | 2.1. Qualitative and quantitative information on the composition of the meta SPC 6 |
| Številka | 1-6 | Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| 1.3 Vrsta(-e) proizvoda(-ov) | Min | Max |
| Vrsta(-e) proizvoda(-ov) | Vrsta proizvodov 03 – Veterinarska higiena (razkužila) | Iodine | | Active Substance | 7553-56-2 | 231-442-4 | 1,75 | 2,4 |
| 2. SESTAVA META SPC 6 | Phosphoric Acid | Trihydroxidooxidophosphorus phosphoric acid | Non-active substance | 7664-38-2 | 231-633-2 | 3,0 | 10,0 |
| 2.1 Kvalitativne in kvantitativne informacije o sestavi meta SPC 6 | Poly(oxy-1,2-ethanediyl).alpha.-tridecyl-.omega.-hydroxy-,branched | Poly(oxy-1,2-ethanediyl).alpha.-tridecyl-.omega.-hydroxy-,branched | Non-active substance | 69011-36-5 | 500-241-6 | 0,0 | 25,6 |
| Splošno ime | Ime IUPAC | Funkcija | Številka CAS | Številka EC | Vsebnost (%) | Isotridecanol, ethoxylated 90 %, C 9-11 Alcohol Ethoxylate | Isotridecanol, ethoxylated 90 %, C 9-11 Alcohol Ethoxylate | Non-active substance | 68439-46-3 | 614-482-0 | 0,0 | 31,8 |
| Najmanj | Največ | 2.2. Type(s) of formulation of the meta SPC 6 |
| Jod | | Aktivna snov | 7553-56-2 | 231-442-4 | 1,75 | 2,4 | Formulation(s) | SL — soluble concentrate |
| fosforjeva kislina | ortofosforjeva kislina | Neaktivna snov | 7664-38-2 | 231-633-2 | 3,0 | 10,0 | 3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 6 |
| Poli(oks-1,2-etandiil).alfa.-tridecil-.omega.-hidroksi-, razvejan | Poli(oks-1,2-etandiil).alfa.-tridecil-.omega.-hidroksi-, razvejan | Neaktivna snov | 69011-36-5 | 500-241-6 | 0,0 | 25,6 | Hazard statements | May be corrosive to metals. | Harmful if swallowed. | Causes severe skin burns and eye damage. | Causes serious eye damage. | May cause damage to thyroid gland through prolonged or repeated exposure. | Harmful to aquatic life with long lasting effects. |
| Izotridekanol, etoksiliran 90 %, C 9-11 alkohol etoksilat | Izotridekanol, etoksiliran 90 %, C 9-11 alkohol etoksilat | Neaktivna snov | 68439-46-3 | 614-482-0 | 0,0 | 31,8 | Precautionary statements | Keep only in original packaging. | Do not breathe mist. | Do not breathe spray. | Avoid release to the environment. | Wear protective gloves. | Wear protective clothing. | Wear face protection. | IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water. | IF IN EYES: Rinse cautiously with water for several minutes. | Remove contact lenses, if present and easy to do. Continue rinsing. | Absorb spillage to prevent material damage. | Store locked up. | Keep out of reach of children. |
| 2.2 Vrste formulacije meta SPC 6 | 4. AUTHORISED USE(S) OF THE META SPC 6 |
| Formulacija(-e) | SL – topni koncentrat | 4.1. Use description |
| 3. STAVKI O NEVARNOSTI IN PREVIDNOSTNI STAVKI ZA META SPC 6 | Table 6 |
| Stavki o nevarnosti | Lahko je jedko za kovine. | Zdravju škodljivo pri zaužitju. | Povzroča hude opekline kože in poškodbe oči. | Povzroča hude poškodbe oči. | Lahko škoduje organom ščitnica pri dolgotrajni ali ponavljajoči se izpostavljenosti. | Škodljivo za vodne organizme, z dolgotrajnimi učinki. | Use # 1 — Veterinary hygiene — animal husbandry — hard surface disinfectant — professional — indoors — spraying |
| Previdnostni stavki | Hraniti samo v originalni posodi. | Ne vdihavati meglice. | Ne vdihavati razpršila. | Preprečiti sproščanje v okolje. | Nositi zaščitne rokavice. | Nositi zaščitno obleko. | Nositi zaščito za obraz. | PRI STIKU S KOŽO (ali lasmi): Takoj sleči vsa kontaminirana oblačila. Kožo izprati z vodo. | PRI STIKU Z OČMI: Previdno izpirati z vodo nekaj minut. | Odstranite kontaktne leče, če jih imate in če to lahko storite brez težav. Nadaljujte z izpiranjem. | Odpraviti razlitje, da se prepreči materialna škoda. | Hraniti zaklenjeno. | Hraniti zunaj dosega otrok. | Product type | PT03 — Veterinary hygiene (Disinfectants) |
| 4. DOVOLJENE UPORABE META SPC 6 | Where relevant, an exact description of the authorised use | — |
| 4.1 Opis uporabe | Target organism(s) (including development stage) | Bacteria | Yeasts | Viruses |
| Preglednica 6 | Field(s) of use | Indoor |
| Uporaba # 1 – Veterinarska higiena – živinoreja – razkužilo za trde površine – profesionalno – za uporabo v zaprtih prostorih – pršenje | Application method(s) | Open system: spray treatment | Disinfectant for hard surfaces in stables (excluding hatcheries). Spraying of diluted concentrate by means of a hand-held knapsack sprayer (4-7 bar) |
| Vrsta proizvoda | Vrsta proizvodov 03 – Veterinarska higiena (razkužila) | Application rate(s) and frequency | 100 ml/m2— Concentration of Iodine in application solution: 750 ppm (0,075 % w/w). | Application frequency per year: | Dairy cows: 1 | Beef cattle: 1 | Veal calves: 4 | Sows, in individual pens: 5 | Sows in groups: 5 | Fattening pigs: 3 | Laying hens in battery cages without treatment: 1 | Laying hens in battery cages with aeration (belt drying): 1 | Laying hens in battery cages with forced drying (deep pit, high rise): 1 | Laying hens in compact battery cages: 1 | Laying hens in free range with litter floor (partly litter floor, partly slatted): 1 | Broilers in free range with litter floor: 7 | Laying hens in free range with grating floor (aviery system): 1 | Parent broilers in free range with grating floor: 1 | Parent broilers in rearing with grating floor: 3 | Turkeys in free range with litter floor: 2 | Ducks in free range with litter floor: 13 | Geese in free range with litter floor: 6 |
| Natančen opis dovoljene uporabe, kjer je to potrebno | - | Category(ies) of users | Professional |
| Ciljni organizem(-mi) (vključno z razvojno stopnjo) | Bakterije | Kvasovke | Virusi | Pack sizes and packaging material | Bottle HDPE: 1 liter, cap is made of PP | Jerry can HDPE: 5-60 liters | Drum HDPE: 200 liters | IBC HDPE: 600-1 000 liters |
| Področje uporabe | Notranjost, znotraj | 4.1.1. Use-specific instructions for use |
| Način(-i) uporabe | Odprt sistem: pršenje | Razkužilo za trde površine v hlevih (razen valilnic). Razprševanje razredčenega koncentrata s pomočjo ročne nahrbtne škropilnice (4–7 barov) | Iodosan 30: Mix 29 ml product with 971 ml water to obtain 1 l application solution. |
| Odmerki in pogostost uporabe | 100 ml/m2 – Koncentracija joda v nanašalni raztopini: 750 ppm (0,075 % m/m). | Pogostost uporabe na leto: | Krave molznice: 1 | Klavno govedo: 1 | Klavna teleta: 4 | Svinje, v posameznih boksih: 5 | Svinje v skupinah: 5 | Pitovni prašiči: 3 | Kokoši nesnice v baterijskih kletkah brez obdelave: 1 | Kokoši nesnice v baterijskih kletkah s prezračevanjem (trakovi za sušenje): 1 | Kokoši nesnice v baterijskih kletkah z umetnim sušenjem (globoka jama, visok porast): 1 | Kokoši nesnice v kompaktnih baterijskih kletkah: 1 | Kokoši nesnice v prosti reji z nastlanimi tlemi (delno nastlana tla, delno rešetkasta tla): 1 | Pitovni piščanci v prosti reji z nastlanimi tlemi: 7 | Kokoši nesnice v prosti reji s talnimi rešetkami (ptičnica): 1 | Matični pitovni piščanci v prosti reji s talnimi rešetkami: 1 | Matični pitovni piščanci v vzreji s talnimi rešetkami: 3 | Purani v prosti reji z nastlanimi tlemi: 2 | Race v prosti reji z nastlanimi tlemi: 13 | Gosi v prosti reji z nastlanimi tlemi: 6 | Iodosan 18: Mix 40 ml product with 960 ml water to obtain 1 l application solution. |
| Skupina(-e) uporabnikov | Poklicni | 4.1.2. Use-specific risk mitigation measures |
| Velikosti in material embalaže | Plastenka HDPE: 1 liter, pokrovček je narejen iz polipropilena | Pločevinka HDPE: 5–60 litrov | Sod HDPE: 200 litrov | IBC HDPE: 600–1 000 litrov | --- |
| 4.1.1 Uporba – posebna navodila za uporabo | 4.1.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment |
| Iodosan 30: Zmešajte 29 ml izdelka z 971 ml vode, da dobite 1 l nanašalne raztopine. | --- |
| Iodosan 18: Zmešajte 40 ml izdelka z 960 ml vode, da dobite 1 l nanašalne raztopine. | 4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging |
| 4.1.2 Uporaba – posebni ukrepi za zmanjšanje tveganja | --- |
| - - - | 4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage |
| 4.1.3 Kjer je specifična uporaba, možni direktni ali indirektni učinki, navodila za prvo pomoč in nujni okrepi za zaščito okolja | --- |
| - - - | 5. GENERAL DIRECTIONS FOR USE (6) OF THE META SPC 6 |
| 4.1.4 Kjer je specifična uporaba, navodila za varno odstranjevanje proizvoda in njegove embalaže | 5.1. Instructions for use |
| - - - | Always read the label or leaflet before use and follow all the instructions provided. |
| 4.1.5 Kjer je specifična uporaba, pogoji skladiščenja in rok uporabnosti proizvoda v običajnih pogojih skladiščenja | To prepare the disinfectant solution, mix the liquid product with water. Always pour in water first and then carefully stir in the product. |
| - - - | Use max. 100 ml application solution per m2 treated area. Do not prepare more fluid than strictly necessary. |
| 5. SPLOŠNE SMERNICE ZA UPORABO (6) META SPC 6 | The product shall only be applied in empty (unpopulated) animal houses after surfaces have been thoroughly cleaned with a suitable cleaner. |
| 5.1 Navodila za uporabo | Pre-cleaning is mandatory. Rinse or wipe the surfaces which will be treated afterwards. Leave them to dry for about 24 up to 36 h before disinfection to obtain earth-moist surfaces. Soak installations and equipment thoroughly with a thin layer of the prepared solution by spraying, using suitable devices (4 to 7 bar). During the process and for the duration of contact time (min. 30 minutes), all openings have to be closed and the ventilation has to be switched off. |
| Pred uporabo vedno preberite etiketo ali navodila za uporabo in upoštevajte vsa navodila. | 5.2. Risk mitigation measures |
| Za pripravo raztopine za razkuževanje tekoči izdelek zmešajte z vodo. Najprej vedno nalijte vodo in nato previdno dodajte izdelek. | Keep out of reach of children. |
| Uporabite največ 100 ml nanašalne raztopine na m2 obdelane površine. Ne pripravljajte več tekočine, kot je nujno potrebno. | The form of the bottle of the product should minimise risk for splashes in order to prevent eye and skin exposure during diluting the product. |
| Izdelek uporabljajte samo v praznih (nenaseljenih) hišicah za živali, potem ko so površine temeljito očiščene s primernim čistilom. | During the mixing and loading phase: The use of a face shield and protection gloves (glove material to be specified by the authorisation holder in the product information) is mandatory. |
| Predhodno čiščenje je obvezno. Sperite ali obrišite površine, ki bodo naknadno obdelane. Pustite, da se pred dezinfekcijo sušijo 24 do 36 ur, da površine ostanejo zemeljsko vlažne. Instalacije in opremo s pršenjem temeljito namočite s tanko plastjo pripravljene raztopine, in sicer tako, da uporabite primerne naprave (4 do 7 barov). Med postopkom in v času trajanja stika (najm. 30 minut) morajo biti vse odprtine zaprte in prezračevanje izklopljeno. | During the application phase of the in use dilution by spraying: Gloves and a protective coverall (at least type X, EN XXXXX) which is impermeable for the biocidal product shall be worn (glove and coverall material to be specified by the authorisation holder in the product information). Use new gloves for each work shift. |
| 5.2 Ukrepi za zmanjšanje tveganja | Professionals must not carry out animal house disinfection more than 3 times per month. These professionals should not use Iodine products for additional purposes. |
| Hraniti izven dosega otrok. | Only use one kind of Iodine-containing product per day. |
| Oblika steklenice izdelka naj bi zmanjšala tveganje brizganja, da se prepreči izpostavljenost oči in kože med redčenjem izdelka. | Stable disinfection should not be carried out more than once per year or once per lifetime for calf and pigs. Feeding troughs must be covered during application. |
| Med fazo mešanja in polnjenja: Uporaba zaščite za obraz in rokavic (material rokavic določi imetnik dovoljenja v okviru informacij o izdelku) je obvezna. | 5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment |
| Med fazo uporabe razredčene raztopine s pršenjem: Nositi je treba rokavice in zaščitne hlače z oprsnikom (vsaj tip X, EN XXXXX), ki so neprepustne za biocidne pripravke (material rokavic in hlač z oprsnikom določi imetnik dovoljenja v okviru informacij o izdelku). Za vsako delovno izmeno uporabite nove rokavice. | After inhalation: Supply fresh air; consult doctor in case of complaints. |
| Strokovnjaki ne smejo izvajati razkuževanja hišice za živali več kot trikrat na mesec. Ti strokovnjaki prav tako ne smejo uporabljati jodovih izdelkov za dodatne namene. | After skin contact: Immediately take off contaminated clothing and wash skin thoroughly. |
| Uporabite samo en izdelek, ki vsebuje jod na dan. | After eye contact: Immediately rinse opened eye, remove contact lenses, keep rinsing for several minutes under running water. Then consult a doctor. |
| Razkuževanje hlevov se ne sme izvajati več kot enkrat na leto ali enkrat v življenjski dobi telet in prašičev. Krmilna korita morajo biti med nanašanjem pokrita. | After swallowing: Rinse out mouth and then drink some water. Do not induce vomiting; call for medical help immediately. |
| 5.3 Značilnosti verjetnih direktnih ali indirektnih učinkov, navodila za prvo pomoč in nujni ukrepi za zaščito okolja | In case of unconsciousness place patient stably in left side position for transportation. Never give anything by mouth to an unconscious individual |
| Po vdihovanju: Zagotovite dotok svežega zraka; v primeru težav se posvetujte z zdravnikom. | When asking for medical advice keep packaging or label at hand and call your local poison control center [insert local number here]. |
| Po stiku s kožo: Takoj slecite kontaminirana oblačila in kožo temeljito umijte. | Environmental emergency measures: |
| Po stiku z očmi: Nemudoma sperite odprte oči, odstranite kontaktne leče in nekaj minut izpirajte pod tekočo vodo. Nato se posvetujte z zdravnikom. | Inform the relevant authorities if the product has caused environmental pollution (sewers, waterways, soil or air). To prevent malfunctioning of an individual wastewater treatment plant, possible residues containing the product must be discharged to the manure storage (for spreading on agricultural soils or fermentation into biogas installation) or to the municipal sewer if legally allowed. |
| Po zaužitju: Sperite usta in nato spijte nekaj vode. Ne izzivajte bruhanja; takoj pokličite zdravniško pomoč. | Methods and material for containment and cleaning up: |
| V primeru nezavesti pacienta stabilno postavite v levi položaj za prevoz. Nezavestnemu posamezniku nikoli ne dajajte ničesar v usta. | Stop leak if safe to do so. Absorb spillage with liquid-binding material (sand, earth, diatomite, acid binders, universal binders, sawdust) and place in container for disposal according to local / national regulations. |
| Ko iščete zdravniško pomoč, imejte embalažo ali etiketo pri roki in pokličite na številko 112 – klic v sili. | 5.4. Instructions for safe disposal of the product and its packaging |
| Okoljski ukrepi v nujnih primerih: | At the end of the treatment, dispose unused product and the packaging in accordance with local requirements. Used product can be flushed to the municipal sewer or disposed to the manure deposit depending on local requirements. Avoid release to an individual waste water treatment plant. |
| Obvestite pristojne organe, če je izdelek povzročil onesnaženje okolja (kanalizacije, plovne poti, tla ali zrak). Da bi preprečili nepravilno delovanje posamezne komunalne čistilne naprave, je treba morebitne ostanke, ki vsebujejo izdelek, odložiti na odlagališče za gnojila (za raztros na kmetijskih zemljiščih ali fermentacijo v bioplinarnah) ali v komunalni kanalizacijski sistem, če je to zakonsko dovoljeno. | European Waste Catalogue: 200130-detergents other than those mentioned in 20 01 29. |
| Metode in materiali za zadrževanje in čiščenje: | 5.5. Conditions of storage and shelf-life of the product under normal conditions of storage |
| Ustavite uhajanje, če je to varno. Vpijte z materialom, ki na sebe veže tekočino (pesek, zemlja, diatomit, kislo vezivo, univerzalno vezivo, žagovina) in ga odložite v posodo za odstranjevanje v skladu z lokalnimi/nacionalnimi predpisi. | Store the product away from direct sunlight and in opaque containers. Protect from frost. Keep container tightly closed. |
| 5.4 Navodila za varno odstranjevanje proizvoda in njegove embalaže | Shelf-life: 24 months in HDPE |
| Na koncu obdelave odstranite neuporabljeni izdelek in embalažo v skladu z lokalnimi zahtevami. Uporabljeni izdelek se lahko splakne v komunalni kanalizacijski sistem ali zavrže na odlagališče za gnojila, odvisno od lokalnih predpisov. Ne spuščajte v posamezno komunalno čistilno napravo. | 6. OTHER INFORMATION |
| Evropski seznam odpadkov: 200130 – detergenti razen tistih, ki niso navedeni pod 20 01 29. | 7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 6 |
| 5.5 Pogoji za shranjevanje in rok uporabnosti proizvoda pri običajnih pogojih skladiščenja | 7.1. Trade name(s), authorisation number and specific composition of each individual product |
| Izdelek hranite stran od neposredne sončne svetlobe in v neprozornih posodah. Zaščitite pred zmrzaljo. Posodo hranite tesno zaprto. | Trade name(s) | IODOSAN 30 | IODOSAN | IODAT | DESINTEC FL-JODES | ROTIE-SOL J | Disinfect Jod | FINK — Jodophos 15 | Jod-Reiniger sauer | Tankrein extra |
| Rok uporabnosti: 24 mesecev v HDPE. | Authorisation number | EU-0020540-0009 1-6 |
| 6. DRUGE INFORMACIJE | Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| Iodine | | Active Substance | 7553-56-2 | 231-442-4 | 2,4 | |
| 7. TRETJA INFORMACIJSKA RAVEN:POSAMEZNI PROIZVODI V META SPC 6 | Phosphoric Acid | Trihydroxidooxidophosphorus phosphoric acid | Non-active substance | 7664-38-2 | 231-633-2 | 10,0 |
| 7.1 Trgovsko(-a) ime(-na), številka avtorizacije in specifična sestava za vsak posamezni proizvod | Poly(oxy-1,2-ethanediyl).alpha.-tridecyl-.omega.-hydroxy-,branched | Poly(oxy-1,2-ethanediyl).alpha.-tridecyl-.omega.-hydroxy-,branched | Non-active substance | 69011-36-5 | 500-241-6 | 25,6 |
| Trgovsko ime | IODOSAN 30 | IODOSAN | IODAT | DESINTEC FL-JODES | ROTIE-SOL J | Disinfect Jod | FINK - Jodophos 15 | Jod-Reiniger sauer | Tankrein extra | 7.2. Trade name(s), authorisation number and specific composition of each individual product |
| Številka dovoljenja | EU-0020540-0009 1-6 | Trade name(s) | IODOSAN 18 |
| Splošno ime | Ime IUPAC | Funkcija | Številka CAS | Številka EC | Vsebnost (%) | Authorisation number | EU-0020540-0010 1-6 |
| Jod | | Aktivna snov | 7553-56-2 | 231-442-4 | 2,4 | Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| fosforjeva kislina | ortofosforjeva kislina | Neaktivna snov | 7664-38-2 | 231-633-2 | 10,0 | Iodine | | Active Substance | 7553-56-2 | 231-442-4 | 1,75 |
| Poli(oks-1,2-etandiil).alfa.-tridecil-.omega.-hidroksi-, razvejan | Poli(oks-1,2-etandiil).alfa.-tridecil-.omega.-hidroksi-, razvejan | Neaktivna snov | 69011-36-5 | 500-241-6 | 25,6 | Phosphoric Acid | Trihydroxidooxidophosphorus phosphoric acid | Non-active substance | 7664-38-2 | 231-633-2 | 3,0 |
| 7.2 Trgovsko(-a) ime(-na), številka avtorizacije in specifična sestava za vsak posamezni proizvod | Isotridecanol, ethoxylated 90 %, C 9-11 Alcohol Ethoxylate | Isotridecanol, ethoxylated 90 %, C 9-11 Alcohol Ethoxylate | Non-active substance | 68439-46-3 | 614-482-0 | 31,8 |
| Trgovsko ime | IODOSAN 18 | META SPC 7 |
| Številka dovoljenja | EU-0020540-0010 1-6 | 1. META SPC 7 ADMINISTRATIVE INFORMATION |
| Splošno ime | Ime IUPAC | Funkcija | Številka CAS | Številka EC | Vsebnost (%) | 1.1. Meta SPC 7 identifier |
| Jod | | Aktivna snov | 7553-56-2 | 231-442-4 | 1,75 | Identifier | Meta SPC 7 |
| fosforjeva kislina | ortofosforjeva kislina | Neaktivna snov | 7664-38-2 | 231-633-2 | 3,0 | 1.2. Suffix to the authorisation number |
| Izotridekanol, etoksiliran 90 %, C 9-11 alkohol etoksilat | Izotridekanol, etoksiliran 90 %, C 9-11 alkohol etoksilat | Neaktivna snov | 68439-46-3 | 614-482-0 | 31,8 | Number | 1-7 |
| META SPC 7 | 1.3. Product type(s) |
| 1. UPRAVNE INFORMACIJE O META SPC 7 | Product type(s) | PT03 — Veterinary hygiene (Disinfectants) |
| 1.1 Identifikator meta SPC 7 | 2. META SPC 7 COMPOSITION |
| Identifikator | Meta SPC 7 | 2.1. Qualitative and quantitative information on the composition of the meta SPC 7 |
| 1.2 Pripona k številki dovoljenja | Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| Številka | 1-7 | Min | Max |
| 1.3 Vrsta(-e) proizvoda(-ov) | Iodine | | Active Substance | 7553-56-2 | 231-442-4 | 3,0 | 3,0 |
| Vrsta(-e) proizvoda(-ov) | Vrsta proizvodov 03 – Veterinarska higiena (razkužila) | Phosphoric Acid | Trihydroxidooxidophosphorus phosphoric acid | Non-active substance | 7664-38-2 | 231-633-2 | 10,0 | 10,0 |
| 2. SESTAVA META SPC 7 | Poly(oxy-1,2-ethanediyl).alpha.-tridecyl-.omega.-hydroxy-,branched | Poly(oxy-1,2-ethanediyl).alpha.-tridecyl-.omega.-hydroxy-,branched | Non-active substance | 69011-36-5 | 500-241-6 | 31,8 | 31,8 |
| 2.1 Kvalitativne in kvantitativne informacije o sestavi meta SPC 7 | Isotridecanol, ethoxylated 90 %, C 9-11 Alcohol Ethoxylate | Isotridecanol, ethoxylated 90 %, C 9-11 Alcohol Ethoxylate | Non-active substance | 68439-46-3 | 614-482-0 | 0,0 | 0,0 |
| Splošno ime | Ime IUPAC | Funkcija | Številka CAS | Številka EC | Vsebnost (%) | 2.2. Type(s) of formulation of the meta SPC 7 |
| Najmanj | Največ | Formulation(s) | SL — soluble concentrate |
| Jod | | Aktivna snov | 7553-56-2 | 231-442-4 | 3,0 | 3,0 | 3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 7 |
| fosforjeva kislina | ortofosforjeva kislina | Neaktivna snov | 7664-38-2 | 231-633-2 | 10,0 | 10,0 | Hazard statements | May be corrosive to metals. | Harmful if swallowed. | Causes severe skin burns and eye damage. | Causes serious eye damage. | May cause damage to thyroid gland through prolonged or repeated exposure. | Toxic to aquatic life with long lasting effects. |
| Poli(oks-1,2-etandiil).alfa.-tridecil-.omega.-hidroksi-, razvejan | Poli(oks-1,2-etandiil).alfa.-tridecil-.omega.-hidroksi-, razvejan | Neaktivna snov | 69011-36-5 | 500-241-6 | 31,8 | 31,8 | Precautionary statements | Keep only in original packaging. | Do not breathe mist. | Do not breathe spray. | Avoid release to the environment. | Wear protective gloves. | Wear protective clothing. | Wear face protection. | IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water. | IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. | Absorb spillage to prevent material damage. | Store locked up. | Keep out of reach of children. |
| Izotridekanol, etoksiliran 90 %, C 9-11 alkohol etoksilat | Izotridekanol, etoksiliran 90 %, C 9-11 alkohol etoksilat | Neaktivna snov | 68439-46-3 | 614-482-0 | 0,0 | 0,0 | 4. AUTHORISED USE(S) OF THE META SPC 7 |
| 2.2 Vrste formulacije meta SPC 7 | 4.1. Use description |
| Formulacija(-e) | SL – topni koncentrat | Table 7 |
| 3. STAVKI O NEVARNOSTI IN PREVIDNOSTNI STAVKI ZA META SPC 7 | Use # 1 — Veterinary hygiene — animal husbandry — hard surface disinfectant — professional — indoors — spraying |
| Stavki o nevarnosti | Lahko je jedko za kovine. | Zdravju škodljivo pri zaužitju. | Povzroča hude opekline kože in poškodbe oči. | Povzroča hude poškodbe oči. | Lahko škoduje organom ščitnica pri dolgotrajni ali ponavljajoči se izpostavljenosti. | Strupeno za vodne organizme, z dolgotrajnimi učinki. | Product type | PT03 — Veterinary hygiene (Disinfectants) |
| Previdnostni stavki | Hraniti samo v originalni posodi. | Ne vdihavati meglice. | Ne vdihavati razpršila. | Preprečiti sproščanje v okolje. | Nositi zaščitne rokavice. | Nositi zaščitno obleko. | Nositi zaščito za obraz. | PRI STIKU S KOŽO (ali lasmi): Takoj sleči vsa kontaminirana oblačila. Kožo izprati z vodo. | PRI STIKU Z OČMI: Previdno izpirati z vodo nekaj minut. Odstranite kontaktne leče, če jih imate in če to lahko storite brez težav. Nadaljujte z izpiranjem. | Odpraviti razlitje, da se prepreči materialna škoda. | Hraniti zaklenjeno. | Hraniti zunaj dosega otrok. | Where relevant, an exact description of the authorised use | — |
| 4. DOVOLJENE UPORABE META SPC 7 | Target organism(s) (including development stage) | Bacteria | Yeasts | Viruses |
| 4.1 Opis uporabe | Field(s) of use | Indoor |
| Preglednica 7 | Application method(s) | Open system: spray treatment | Disinfectant for hard surfaces in stables (excluding hatcheries). Spraying of diluted concentrate by means of a hand-held knapsack sprayer (4-7 bar) |
| Uporaba # 1 – Veterinarska higiena – živinoreja – razkužilo za trde površine – profesionalno – za uporabo v zaprtih prostorih – pršenje | Application rate(s) and frequency | 100 ml/m2 - Concentration of Iodine in application solution: 750 ppm (0,075 % w/w). | Application frequency per year: | Dairy cows: 1 | Beef cattle: 1 | Veal calves: 4 | Sows, in individual pens: 5 | Sows in groups: 5 | Fattening pigs: 3 | Laying hens in battery cages without treatment: 1 | Laying hens in battery cages with aeration (belt drying): 1 | Laying hens in battery cages with forced drying (deep pit, high rise): 1 | Laying hens in compact battery cages: 1 | Laying hens in free range with litter floor (partly litter floor, partly slatted): 1 | Broilers in free range with litter floor: 7 | Laying hens in free range with grating floor (aviery system): 1 | Parent broilers in free range with grating floor: 1 | Parent broilers in rearing with grating floor: 3 | Turkeys in free range with litter floor: 2 | Ducks in free range with litter floor: 13 | Geese in free range with litter floor: 6 |
| Vrsta proizvoda | Vrsta proizvodov 03 – Veterinarska higiena (razkužila) | Category(ies) of users | Professional |
| Natančen opis dovoljene uporabe, kjer je to potrebno | - | Pack sizes and packaging material | Bottle HDPE: 1 liter, cap is made of PP | Jerry can HDPE: 5-60 liters | Drum HDPE: 200 liters | IBC HDPE: 600-1 000 liters |
| Ciljni organizem(-mi) (vključno z razvojno stopnjo) | Bakterije | Kvasovke | Virusi | 4.1.1. Use-specific instructions for use |
| Področje uporabe | Notranjost, znotraj | Iodosan 30 plus: Mix 23 ml product with 977 ml water to obtain 1 l application solution. |
| Način(-i) uporabe | Odprt sistem: pršenje | Razkužilo za trde površine v hlevih (razen valilnic). Razprševanje razredčenega koncentrata s pomočjo ročne nahrbtne škropilnice (4–7 barov) | 4.1.2. Use-specific risk mitigation measures |
| Odmerki in pogostost uporabe | 100 ml/m2 – Koncentracija joda v nanašalni raztopini: 750 ppm (0,075 % m/m). | Pogostost uporabe na leto: | Krave molznice: 1 | Klavno govedo: 1 | Klavna teleta: 4 | Svinje, v posameznih boksih: 5 | Svinje v skupinah: 5 | Pitovni prašiči: 3 | Kokoši nesnice v baterijskih kletkah brez obdelave: 1 | Kokoši nesnice v baterijskih kletkah s prezračevanjem (trakovi za sušenje): 1 | Kokoši nesnice v baterijskih kletkah z umetnim sušenjem (globoka jama, visok porast): 1 | Kokoši nesnice v kompaktnih baterijskih kletkah: 1 | Kokoši nesnice v prosti reji z nastlanimi tlemi (delno nastlana tla, delno rešetkasta tla): 1 | Pitovni piščanci v prosti reji z nastlanimi tlemi: 7 | Kokoši nesnice v prosti reji s talnimi rešetkami (ptičnica): 1 | Matični pitovni piščanci v prosti reji s talnimi rešetkami: 1 | Matični pitovni piščanci v vzreji s talnimi rešetkami: 3 | Purani v prosti reji z nastlanimi tlemi: 2 | Race v prosti reji z nastlanimi tlemi: 13 | Gosi v prosti reji z nastlanimi tlemi: 6 | --- |
| Skupina(-e) uporabnikov | Poklicni | 4.1.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment |
| Velikosti in material embalaže | Plastenka HDPE: 1 liter, pokrovček je narejen iz polipropilena | Pločevinka HDPE: 5–60 litrov | Sod HDPE: 200 litrov | IBC HDPE: 600–1 000 litrov | --- |
| 4.1.1 Uporba – posebna navodila za uporabo | 4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging |
| Iodosan 30 plus: Zmešajte 23 ml izdelka z 977 ml vode, da dobite 1 l nanašalne raztopine. | --- |
| 4.1.2 Uporaba – posebni ukrepi za zmanjšanje tveganja | 4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage |
| - - - | --- |
| 4.1.3 Kjer je specifična uporaba, možni direktni ali indirektni učinki, navodila za prvo pomoč in nujni okrepi za zaščito okolja | 5. GENERAL DIRECTIONS FOR USE (7) OF THE META SPC 7 |
| - - - | 5.1. Instructions for use |
| 4.1.4 Kjer je specifična uporaba, navodila za varno odstranjevanje proizvoda in njegove embalaže | Always read the label or leaflet before use and follow all the instructions provided. |
| - - - | To prepare the disinfectant solution, mix the liquid product with water. Always pour in water first and then carefully stir in the product. |
| 4.1.5 Kjer je specifična uporaba, pogoji skladiščenja in rok uporabnosti proizvoda v običajnih pogojih skladiščenja | Use max. 100 ml application solution per m2 treated area. Do not prepare more fluid than strictly necessary. |
| - - - | The product shall only be applied in empty (unpopulated) animal houses after surfaces have been thoroughly cleaned with a suitable cleaner. |
| 5. SPLOŠNE SMERNICE ZA UPORABO (7) META SPC 7 | Pre-cleaning is mandatory. Rinse or wipe the surfaces which will be treated afterwards. Leave them to dry for about 24 up to 36 h before disinfection to obtain earth-moist surfaces. Soak installations and equipment thoroughly with a thin layer of the prepared solution by spraying, using suitable devices (4 to 7 bar). During the process and for the duration of contact time (min. 30 minutes), all openings have to be closed and the ventilation has to be switched off. |
| 5.1 Navodila za uporabo | 5.2. Risk mitigation measures |
| Pred uporabo vedno preberite etiketo ali navodila za uporabo in upoštevajte vsa navodila. | Keep out of reach of children. |
| Za pripravo raztopine za razkuževanje tekoči izdelek zmešajte z vodo. Najprej vedno nalijte vodo in nato previdno dodajte izdelek. | The form of the bottle of the product should minimise risk for splashes in order to prevent eye and skin exposure during diluting the product. |
| Uporabite največ 100 ml nanašalne raztopine na m2 obdelane površine. Ne pripravljajte več tekočine, kot je nujno potrebno. | During the mixing and loading phase: The use of a face shield and protection gloves (glove material to be specified by the authorisation holder in the product information) is mandatory. |
| Izdelek uporabljajte samo v praznih (nenaseljenih) hišicah za živali, potem ko so površine temeljito očiščene s primernim čistilom. | During the application phase of the in use dilution by spraying: Gloves and a protective coverall (at least type X, EN XXXXX) which is impermeable for the biocidal product shall be worn (glove and coverall material to be specified by the authorisation holder in the product information). Use new gloves for each work shift. |
| Predhodno čiščenje je obvezno. Sperite ali obrišite površine, ki bodo naknadno obdelane. Pustite, da se pred dezinfekcijo sušijo 24 do 36 ur, da površine ostanejo zemeljsko vlažne. Instalacije in opremo s pršenjem temeljito namočite s tanko plastjo pripravljene raztopine, in sicer tako, da uporabite primerne naprave (4 do 7 barov). Med postopkom in v času trajanja stika (najm. 30 minut) morajo biti vse odprtine zaprte in prezračevanje izklopljeno. | Professionals must not carry out animal house disinfection more than 3 times per month. These professionals should not use Iodine products for additional purposes. |
| 5.2 Ukrepi za zmanjšanje tveganja | Only use one kind of Iodine-containing product per day. |
| Hraniti izven dosega otrok. | Stable disinfection should not be carried out more than once per year or once per lifetime for calf and pigs. Feeding troughs must be covered during application. |
| Oblika steklenice izdelka naj bi zmanjšala tveganje brizganja, da se prepreči izpostavljenost oči in kože med redčenjem izdelka. | 5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment |
| Med fazo mešanja in polnjenja: Uporaba zaščite za obraz in rokavic (material rokavic določi imetnik dovoljenja v okviru informacij o izdelku) je obvezna. | After inhalation: Supply fresh air; consult doctor in case of complaints. |
| Med fazo uporabe razredčene raztopine s pršenjem: Nositi je treba rokavice in zaščitne hlače z oprsnikom (vsaj tip X, EN XXXXX), ki so neprepustne za biocidne pripravke (material rokavic in hlač z oprsnikom določi imetnik dovoljenja v okviru informacij o izdelku). Za vsako delovno izmeno uporabite nove rokavice. | After skin contact: Immediately take off contaminated clothing and wash skin thoroughly. |
| Strokovnjaki ne smejo izvajati razkuževanja hišice za živali več kot trikrat na mesec. Ti strokovnjaki prav tako ne smejo uporabljati jodovih izdelkov za dodatne namene. | After eye contact: Immediately rinse opened eye, remove contact lenses, keep rinsing for several minutes under running water. Then consult a doctor. |
| Uporabite samo en izdelek, ki vsebuje jod na dan. | After swallowing: Rinse out mouth and then drink some water. Do not induce vomiting; call for medical help immediately. |
| Razkuževanje hlevov se ne sme izvajati več kot enkrat na leto ali enkrat v življenjski dobi telet in prašičev. Krmilna korita morajo biti med nanašanjem pokrita. | In case of unconsciousness place patient stably in left side position for transportation. Never give anything by mouth to an unconscious individual. |
| 5.3 Značilnosti verjetnih direktnih ali indirektnih učinkov, navodila za prvo pomoč in nujni ukrepi za zaščito okolja | When asking for medical advice keep packaging or label at hand and call your local poison control center [insert local number here]. |
| Po vdihovanju: Zagotovite dotok svežega zraka; v primeru težav se posvetujte z zdravnikom. | Environmental emergency measures: |
| Po stiku s kožo: Takoj slecite kontaminirana oblačila in kožo temeljito umijte. | Inform the relevant authorities if the product has caused environmental pollution (sewers, waterways, soil or air). To prevent malfunctioning of an individual wastewater treatment plant, possible residues containing the product must be discharged to the manure storage (for spreading on agricultural soils or fermentation into biogas installation) or to the municipal sewer if legally allowed. |
| Po stiku z očmi: Nemudoma sperite odprte oči, odstranite kontaktne leče in nekaj minut izpirajte pod tekočo vodo. Nato se posvetujte z zdravnikom. | Methods and material for containment and cleaning up: |
| Po zaužitju: Sperite usta in nato spijte nekaj vode. Ne izzivajte bruhanja; takoj pokličite zdravniško pomoč. | Stop leak if safe to do so. Absorb spillage with liquid-binding material (sand, earth, diatomite, acid binders, universal binders, sawdust) and place in container for disposal according to local / national regulations. |
| V primeru nezavesti pacienta stabilno postavite v levi položaj za prevoz. Nezavestnemu posamezniku nikoli ne dajajte ničesar v usta. | 5.4. Instructions for safe disposal of the product and its packaging |
| Ko iščete zdravniško pomoč, imejte embalažo ali etiketo pri roki in pokličitena številko 112 – klic v sili. | At the end of the treatment, dispose unused product and the packaging in accordance with local requirements. Used product can be flushed to the municipal sewer or disposed to the manure deposit depending on local requirements. Avoid release to an individual waste water treatment plant. |
| Okoljski ukrepi v nujnih primerih: | European Waste Catalogue: 200130-detergents other than those mentioned in 20 01 29. |
| Obvestite pristojne organe, če je izdelek povzročil onesnaženje okolja (kanalizacije, plovne poti, tla ali zrak). Da bi preprečili nepravilno delovanje posamezne komunalne čistilne naprave, je treba morebitne ostanke, ki vsebujejo izdelek, odložiti na odlagališče za gnojila (za raztros na kmetijskih zemljiščih ali fermentacijo v bioplinarnah) ali v komunalni kanalizacijski sistem, če je to zakonsko dovoljeno. | 5.5. Conditions of storage and shelf-life of the product under normal conditions of storage |
| Metode in materiali za zadrževanje in čiščenje: | Store the product away from direct sunlight and in opaque containers. Protect from frost. Keep container tightly closed. |
| Ustavite uhajanje, če je to varno. Vpijte z materialom, ki na sebe veže tekočino (pesek, zemlja, diatomit, kislo vezivo, univerzalno vezivo, žagovina) in ga odložite v posodo za odstranjevanje v skladu z lokalnimi/nacionalnimi predpisi. | Shelf-life: 24 months in HDPE |
| 5.4 Navodila za varno odstranjevanje proizvoda in njegove embalaže | 6. OTHER INFORMATION |
| Na koncu obdelave odstranite neuporabljeni izdelek in embalažo v skladu z lokalnimi zahtevami. Uporabljeni izdelek se lahko splakne v komunalni kanalizacijski sistem ali zavrže na odlagališče za gnojila, odvisno od lokalnih predpisov. Ne spuščajte v posamezno komunalno čistilno napravo. | 7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 7 |
| Evropski seznam odpadkov: 200130 – detergenti razen tistih, ki niso navedeni pod 20 01 29. | 7.1. Trade name(s), authorisation number and specific composition of each individual product |
| 5.5 Pogoji za shranjevanje in rok uporabnosti proizvoda pri običajnih pogojih skladiščenja | Trade name(s) | IODOSAN 30 Plus | YODO CONTROL | YODIVEN |
| Izdelek hranite stran od neposredne sončne svetlobe in v neprozornih posodah. Zaščitite pred zmrzaljo. Posodo hranite tesno zaprto. | Authorisation number | EU-0020540-0011 1-7 |
| Rok uporabnosti: 24 mesecev v HDPE. | Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| 6. DRUGE INFORMACIJE | Iodine | | Active Substance | 7553-56-2 | 231-442-4 | 3,0 |
| Phosphoric Acid | Trihydroxidooxidophosphorus phosphoric acid | Non-active substance | 7664-38-2 | 231-633-2 | 10,0 | |
| 7. TRETJA INFORMACIJSKA RAVEN: POSAMEZNI PROIZVODI V META SPC 7 | Poly(oxy-1,2-ethanediyl).alpha.-tridecyl-.omega.-hydroxy-,branched | Poly(oxy-1,2-ethanediyl).alpha.-tridecyl-.omega.-hydroxy-,branched | Non-active substance | 69011-36-5 | 500-241-6 | 31,8 |
| 7.1 Trgovsko(-a) ime(-na), številka avtorizacije in specifična sestava za vsak posamezni proizvod | META SPC 8 |
| Trgovsko ime | IODOSAN 30 Plus | YODO CONTROL | YODIVEN | 1. META SPC 8 ADMINISTRATIVE INFORMATION |
| Številka dovoljenja | EU-0020540-0011 1-7 | 1.1. Meta SPC 8 identifier |
| Splošno ime | Ime IUPAC | Funkcija | Številka CAS | Številka EC | Vsebnost (%) | Identifier | Meta SPC 8 |
| Jod | | Aktivna snov | 7553-56-2 | 231-442-4 | 3,0 | 1.2. Suffix to the authorisation number |
| fosforjeva kislina | ortofosforjeva kislina | Neaktivna snov | 7664-38-2 | 231-633-2 | 10,0 | Number | 1-8 |
| Poli(oks-1,2-etandiil).alfa.-tridecil-.omega.-hidroksi-, razvejan | Poli(oks-1,2-etandiil).alfa.-tridecil-.omega.-hidroksi-, razvejan | Neaktivna snov | 69011-36-5 | 500-241-6 | 31,8 | 1.3. Product type(s) |
| META SPC 8 | Product type(s) | PT03 - Veterinary hygiene (Disinfectants) |
| 1. UPRAVNE INFORMACIJE O META SPC 8 | 2. META SPC 8 COMPOSITION |
| 1.1 Identifikator meta SPC 8 | 2.1. Qualitative and quantitative information on the composition of the meta SPC 8 |
| Identifikator | Meta SPC 8 | Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| 1.2 Pripona k številki dovoljenja | Min | Max |
| Številka | 1-8 | Iodine | | Active Substance | 7553-56-2 | 231-442-4 | 1,5 | 1,5 |
| 1.3 Vrsta(-e) proizvoda(-ov) | Phosphoric Acid | Trihydroxidooxidophosphorus phosphoric acid | Non-active substance | 7664-38-2 | 231-633-2 | 3,0 | 3,0 |
| Vrsta(-e) proizvoda(-ov) | Vrsta proizvodov 03 – Veterinarska higiena (razkužila) | Poly(oxy-1,2-ethanediyl).alpha.-tridecyl-.omega.-hydroxy-,branched | Poly(oxy-1,2-ethanediyl).alpha.-tridecyl-.omega.-hydroxy-,branched | Non-active substance | 69011-36-5 | 500-241-6 | 18,0 | 18,0 |
| 2. SESTAVA META SPC 8 | Isotridecanol, ethoxylated 90 %, C 9-11 Alcohol Ethoxylate | Isotridecanol, ethoxylated 90 %, C 9-11 Alcohol Ethoxylate | Non-active substance | 68439-46-3 | 614-482-0 | 0,0 | 0,0 |
| 2.1 Kvalitativne in kvantitativne informacije o sestavi meta SPC 8 | 2.2. Type(s) of formulation of the meta SPC 8 |
| Splošno ime | Ime IUPAC | Funkcija | Številka CAS | Številka EC | Vsebnost (%) | Formulation(s) | SL - soluble concentrate |
| Najmanj | Največ | 3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 8 |
| Jod | | Aktivna snov | 7553-56-2 | 231-442-4 | 1,5 | 1,5 | Hazard statements | May be corrosive to metals. | Causes severe skin burns and eye damage. | Causes serious eye damage. | May cause damage to thyroid gland through prolonged or repeated exposure. | Harmful to aquatic life with long lasting effects. |
| fosforjeva kislina | ortofosforjeva kislina | Neaktivna snov | 7664-38-2 | 231-633-2 | 3,0 | 3,0 | Precautionary statements | Keep only in original packaging. | Do not breathe mist. | Do not breathe spray. | Avoid release to the environment. | Wear protective gloves. | Wear protective clothing. | Wear face protection. | IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water. | IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. | Absorb spillage to prevent material damage. | Store locked up. | Keep out of reach of children. |
| Poli(oks-1,2-etandiil).alfa.-tridecil-.omega.-hidroksi-, razvejan | Poli(oks-1,2-etandiil).alfa.-tridecil-.omega.-hidroksi-, razvejan | Neaktivna snov | 69011-36-5 | 500-241-6 | 18,0 | 18,0 | 4. AUTHORISED USE(S) OF THE META SPC 8 |
| Izotridekanol, etoksiliran 90 %, C 9-11 alkohol etoksilat | Izotridekanol, etoksiliran 90 %, C 9-11 alkohol etoksilat | Neaktivna snov | 68439-46-3 | 614-482-0 | 0,0 | 0,0 | 4.1. Use description |
| 2.2 Vrste formulacije meta SPC 8 | Table 8 |
| Formulacija(-e) | SL – topni koncentrat | Use # 1 — Veterinary hygiene — animal husbandry — hard surface disinfectant — professional — indoors — spraying |
| 3. STAVKI O NEVARNOSTI IN PREVIDNOSTNI STAVKI ZA META SPC 8 | Product type | PT03 — Veterinary hygiene (Disinfectants) |
| Stavki o nevarnosti | Lahko je jedko za kovine. | Povzroča hude opekline kože in poškodbe oči. | Povzroča hude poškodbe oči. | Lahko škoduje organom ščitnica pri dolgotrajni ali ponavljajoči se izpostavljenosti. | Škodljivo za vodne organizme, z dolgotrajnimi učinki. | Where relevant, an exact description of the authorised use | — |
| Previdnostni stavki | Hraniti samo v originalni posodi. | Ne vdihavati meglice. | Ne vdihavati razpršila. | Preprečiti sproščanje v okolje. | Nositi zaščitne rokavice. | Nositi zaščitno obleko. | Nositi zaščito za obraz. | PRI STIKU S KOŽO (ali lasmi): Takoj sleči vsa kontaminirana oblačila. Kožo izprati z vodo. | PRI STIKU Z OČMI: Previdno izpirati z vodo nekaj minut. Odstranite kontaktne leče, če jih imate in če to lahko storite brez težav. Nadaljujte z izpiranjem. | Odpraviti razlitje, da se prepreči materialna škoda. | Hraniti zaklenjeno. | Hraniti zunaj dosega otrok. | Target organism(s) (including development stage) | Bacteria | Yeasts | Viruses |
| 4. DOVOLJENE UPORABE META SPC 8 | Field(s) of use | Indoor |
| 4.1 Opis uporabe | Application method(s) | Open system: spray treatment | Disinfectant for hard surfaces in stables (excluding hatcheries). Spraying of diluted concentrate by means of a hand-held knapsack sprayer (4-7 bar) |
| Preglednica 8 | Application rate(s) and frequency | 100 ml/m2— Concentration of Iodine in application solution: 750 ppm (0,075 % w/w). | Application frequency per year: | Dairy cows: 1 | Beef cattle: 1 | Veal calves: 4 | Sows, in individual pens: 5 | Sows in groups: 5 | Fattening pigs: 3 | Laying hens in battery cages without treatment: 1 | Laying hens in battery cages with aeration (belt drying): 1 | Laying hens in battery cages with forced drying (deep pit, high rise): 1 | Laying hens in compact battery cages: 1 | Laying hens in free range with litter floor (partly litter floor, partly slatted): 1 | Broilers in free range with litter floor: 7 | Laying hens in free range with grating floor (aviery system): 1 | Parent broilers in free range with grating floor: 1 | Parent broilers in rearing with grating floor: 3 | Turkeys in free range with litter floor: 2 | Ducks in free range with litter floor: 13 | Geese in free range with litter floor: 6 |
| Uporaba # 1 – Veterinarska higiena – živinoreja – razkužilo za trde površine – profesionalno – za uporabo v zaprtih prostorih – pršenje | Category(ies) of users | Professional |
| Vrsta proizvoda | Vrsta proizvodov 03 – Veterinarska higiena (razkužila) | Pack sizes and packaging material | Bottle HDPE: 1 liter, cap is made of PP | Jerry can HDPE: 5-60 liters | Drum HDPE: 200 liters | IBC HDPE: 600-1 000 liters |
| Natančen opis dovoljene uporabe, kjer je to potrebno | - | 4.1.1. Use-specific instructions for use |
| Ciljni organizem(-mi) (vključno z razvojno stopnjo) | Bakterije | Kvasovke | Virusi | Iodosan 15: Mix 46 ml product with 954 ml water to obtain 1 l application solution. |
| Področje uporabe | Notranjost, znotraj | 4.1.2. Use-specific risk mitigation measures |
| Način(-i) uporabe | Odprt sistem: pršenje | Razkužilo za trde površine v hlevih (razen valilnic). Razprševanje razredčenega koncentrata s pomočjo ročne nahrbtne škropilnice (4–7 barov) | --- |
| Odmerki in pogostost uporabe | 100 ml/m2 – Koncentracija joda v nanašalni raztopini: 750 ppm (0,075 % m/m). | Pogostost uporabe na leto: | Krave molznice: 1 | Klavno govedo: 1 | Klavna teleta: 4 | Svinje, v posameznih boksih: 5 | Svinje v skupinah: 5 | Pitovni prašiči: 3 | Kokoši nesnice v baterijskih kletkah brez obdelave: 1 | Kokoši nesnice v baterijskih kletkah s prezračevanjem (trakovi za sušenje): 1 | Kokoši nesnice v baterijskih kletkah z umetnim sušenjem (globoka jama, visok porast): 1 | Kokoši nesnice v kompaktnih baterijskih kletkah: 1 | Kokoši nesnice v prosti reji z nastlanimi tlemi (delno nastlana tla, delno rešetkasta tla): 1 | Pitovni piščanci v prosti reji z nastlanimi tlemi: 7 | Kokoši nesnice v prosti reji s talnimi rešetkami (ptičnica): 1 | Matični pitovni piščanci v prosti reji s talnimi rešetkami: 1 | Matični pitovni piščanci v vzreji s talnimi rešetkami: 3 | Purani v prosti reji z nastlanimi tlemi: 2 | Race v prosti reji z nastlanimi tlemi: 13 | Gosi v prosti reji z nastlanimi tlemi: 6 | 4.1.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment |
| Skupina(-e) uporabnikov | Poklicni | --- |
| Velikosti in material embalaže | Plastenka HDPE: 1 liter, pokrovček je narejen iz polipropilena | Pločevinka HDPE: 5–60 litrov | Sod HDPE: 200 litrov | IBC HDPE: 600–1 000 litrov | 4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging |
| 4.1.1 Uporba – posebna navodila za uporabo | --- |
| Iodosan 15: Zmešajte 46 ml izdelka z 954 ml vode, da dobite 1 l nanašalne raztopine. | 4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage |
| 4.1.2 Uporaba – posebni ukrepi za zmanjšanje tveganja | --- |
| - - - | 5. GENERAL DIRECTIONS FOR USE (8) OF THE META SPC 8 |
| 4.1.3 Kjer je specifična uporaba, možni direktni ali indirektni učinki, navodila za prvo pomoč in nujni okrepi za zaščito okolja | 5.1. Instructions for use |
| - - - | Always read the label or leaflet before use and follow all the instructions provided. |
| 4.1.4 Kjer je specifična uporaba, navodila za varno odstranjevanje proizvoda in njegove embalaže | To prepare the disinfectant solution, mix the liquid product with water. Always pour in water first and then carefully stir in the product. |
| - - - | Use max. 100 ml application solution per m2 treated area. Do not prepare more fluid than strictly necessary. |
| 4.1.5 Kjer je specifična uporaba, pogoji skladiščenja in rok uporabnosti proizvoda v običajnih pogojih skladiščenja | The product shall only be applied in empty (unpopulated) animal houses after surfaces have been thoroughly cleaned with a suitable cleaner. |
| - - - | Pre-cleaning is mandatory. Rinse or wipe the surfaces which will be treated afterwards. Leave them to dry for about 24 up to 36 h before disinfection to obtain earth-moist surfaces. Soak installations and equipment thoroughly with a thin layer of the prepared solution by spraying, using suitable devices (4 to 7 bar). During the process and for the duration of contact time (min. 30 minutes), all openings have to be closed and the ventilation has to be switched off. |
| 5. SPLOŠNE SMERNICE ZA UPORABO (8) META SPC 8 | 5.2. Risk mitigation measures |
| 5.1 Navodila za uporabo | Keep out of reach of children. |
| Pred uporabo vedno preberite etiketo ali navodila za uporabo in upoštevajte vsa navodila. | The form of the bottle of the product should minimise risk for splashes in order to prevent eye and skin exposure during diluting the product. |
| Za pripravo raztopine za razkuževanje tekoči izdelek zmešajte z vodo. Najprej vedno nalijte vodo in nato previdno dodajte izdelek. | During the mixing and loading phase: The use of a face shield and protection gloves (glove material to be specified by the authorisation holder in the product information) is mandatory. |
| Uporabite največ 100 ml nanašalne raztopine na m2 obdelane površine. Ne pripravljajte več tekočine, kot je nujno potrebno. | During the application phase of the in use dilution by spraying: Gloves and a protective coverall (at least type X, EN XXXXX) which is impermeable for the biocidal product shall be worn (glove and coverall material to be specified by the authorisation holder in the product information). Use new gloves for each work shift. |
| Izdelek uporabljajte samo v praznih (nenaseljenih) hišicah za živali, potem ko so površine temeljito očiščene s primernim čistilom. | Professionals must not carry out animal house disinfection more than 3 times per month. These professionals should not use Iodine products for additional purposes. |
| Predhodno čiščenje je obvezno. Sperite ali obrišite površine, ki bodo naknadno obdelane. Pustite, da se pred dezinfekcijo sušijo 24 do 36 ur, da površine ostanejo zemeljsko vlažne. Instalacije in opremo s pršenjem temeljito namočite s tanko plastjo pripravljene raztopine, in sicer tako, da uporabite primerne naprave (4 do 7 barov). Med postopkom in v času trajanja stika (najm. 30 minut) morajo biti vse odprtine zaprte in prezračevanje izklopljeno. | Only use one kind of Iodine-containing product per day. |
| 5.2 Ukrepi za zmanjšanje tveganja | Stable disinfection should not be carried out more than once per year or once per lifetime for calf and pigs. Feeding troughs must be covered during application. |
| Hraniti izven dosega otrok. | 5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment |
| Oblika steklenice izdelka naj bi zmanjšala tveganje brizganja, da se prepreči izpostavljenost oči in kože med redčenjem izdelka. | After inhalation: Supply fresh air; consult doctor in case of complaints. |
| Med fazo mešanja in polnjenja: Uporaba zaščite za obraz in rokavic (material rokavic določi imetnik dovoljenja v okviru informacij o izdelku) je obvezna. | After skin contact: Immediately take off contaminated clothing and wash skin thoroughly. |
| Med fazo uporabe razredčene raztopine s pršenjem: Nositi je treba rokavice in zaščitne hlače z oprsnikom (vsaj tip X, EN XXXXX), ki so neprepustne za biocidne pripravke (material rokavic in hlač z oprsnikom določi imetnik dovoljenja v okviru informacij o izdelku). Za vsako delovno izmeno uporabite nove rokavice. | After eye contact: Immediately rinse opened eye, remove contact lenses, keep rinsing for several minutes under running water. Then consult a doctor. |
| Strokovnjaki ne smejo izvajati razkuževanja hišice za živali več kot trikrat na mesec. Ti strokovnjaki prav tako ne smejo uporabljati jodovih izdelkov za dodatne namene. | After swallowing: Rinse out mouth and then drink some water. Do not induce vomiting; call for medical help immediately. |
| Uporabite samo en izdelek, ki vsebuje jod na dan. | In case of unconsciousness place patient stably in left side position for transportation. Never give anything by mouth to an unconscious individual. |
| Razkuževanje hlevov se ne sme izvajati več kot enkrat na leto ali enkrat v življenjski dobi telet in prašičev. Krmilna korita morajo biti med nanašanjem pokrita. | When asking for medical advice keep packaging or label at hand and call your local poison control center [insert local number here]. |
| 5.3 Značilnosti verjetnih direktnih ali indirektnih učinkov, navodila za prvo pomoč in nujni ukrepi za zaščito okolja | Environmental emergency measures: |
| Po vdihovanju: Zagotovite dotok svežega zraka; v primeru težav se posvetujte z zdravnikom. | Inform the relevant authorities if the product has caused environmental pollution (sewers, waterways, soil or air). To prevent malfunctioning of an individual wastewater treatment plant, possible residues containing the product must be discharged to the manure storage (for spreading on agricultural soils or fermentation into biogas installation) or to the municipal sewer if legally allowed. |
| Po stiku s kožo: Takoj slecite kontaminirana oblačila in kožo temeljito umijte. | Methods and material for containment and cleaning up: |
| Po stiku z očmi: Nemudoma sperite odprte oči, odstranite kontaktne leče in nekaj minut izpirajte pod tekočo vodo. Nato se posvetujte z zdravnikom. | Stop leak if safe to do so. Absorb spillage with liquid-binding material (sand, earth, diatomite, acid binders, universal binders, sawdust) and place in container for disposal according to local / national regulations. |
| Po zaužitju: Sperite usta in nato spijte nekaj vode. Ne izzivajte bruhanja; takoj pokličite zdravniško pomoč. | 5.4. Instructions for safe disposal of the product and its packaging |
| V primeru nezavesti pacienta stabilno postavite v levi položaj za prevoz. Nezavestnemu posamezniku nikoli ne dajajte ničesar v usta. | At the end of the treatment, dispose unused product and the packaging in accordance with local requirements. Used product can be flushed to the municipal sewer or disposed to the manure deposit depending on local requirements. Avoid release to an individual waste water treatment plant. |
| Ko iščete zdravniško pomoč, imejte embalažo ali etiketo pri roki in pokličite na številko 112 – klic v sili. | European Waste Catalogue: 200130-detergents other than those mentioned in 20 01 29. |
| Okoljski ukrepi v nujnih primerih: | 5.5. Conditions of storage and shelf-life of the product under normal conditions of storage |
| Obvestite pristojne organe, če je izdelek povzročil onesnaženje okolja (kanalizacije, plovne poti, tla ali zrak). Da bi preprečili nepravilno delovanje posamezne komunalne čistilne naprave, je treba morebitne ostanke, ki vsebujejo izdelek, odložiti na odlagališče za gnojila (za raztros na kmetijskih zemljiščih ali fermentacijo v bioplinarnah) ali v komunalni kanalizacijski sistem, če je to zakonsko dovoljeno. | Store the product away from direct sunlight and in opaque containers. Protect from frost. Keep container tightly closed. |
| Metode in materiali za zadrževanje in čiščenje: | Shelf-life: 24 months in HDPE. |
| Ustavite uhajanje, če je to varno. Vpijte z materialom, ki na sebe veže tekočino (pesek, zemlja, diatomit, kislo vezivo, univerzalno vezivo, žagovina) in ga odložite v posodo za odstranjevanje v skladu z lokalnimi/nacionalnimi predpisi. | 6. OTHER INFORMATION |
| 5.4 Navodila za varno odstranjevanje proizvoda in njegove embalaže | 7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 8 |
| Na koncu obdelave odstranite neuporabljeni izdelek in embalažo v skladu z lokalnimi zahtevami. Uporabljeni izdelek se lahko splakne v komunalni kanalizacijski sistem ali zavrže na odlagališče za gnojila, odvisno od lokalnih predpisov. Ne spuščajte v posamezno komunalno čistilno napravo. | 7.1. Trade name(s), authorisation number and specific composition of each individual product |
| Evropski seznam odpadkov: 200130 – detergenti razen tistih, ki niso navedeni pod 20 01 29. | Trade name(s) | IODOSAN 15 |
| 5.5 Pogoji za shranjevanje in rok uporabnosti proizvoda pri običajnih pogojih skladiščenja | Authorisation number | EU-0020540-0012 1-8 |
| Izdelek hranite stran od neposredne sončne svetlobe in v neprozornih posodah. Zaščitite pred zmrzaljo. Posodo hranite tesno zaprto. | Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| Rok uporabnosti: 24 mesecev v HDPE. | Iodine | | Active Substance | 7553-56-2 | 231-442-4 | 1,5 |
| 6. DRUGE INFORMACIJE | Phosphoric Acid | Trihydroxidooxidophosphorus phosphoric acid | Non-active substance | 7664-38-2 | 231-633-2 | 3,0 |
| Poly(oxy-1,2-ethanediyl).alpha.-tridecyl-.omega.-hydroxy-,branched | Poly(oxy-1,2-ethanediyl).alpha.-tridecyl-.omega.-hydroxy-,branched | Non-active substance | 69011-36-5 | 500-241-6 | 18,0 | |
| 7. TRETJA INFORMACIJSKA RAVEN:POSAMEZNI PROIZVODI V META SPC 8 | (1) Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 1. |
| 7.1 Trgovsko(-a) ime(-na), številka avtorizacije in specifična sestava za vsak posamezni proizvod | (2) Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 2. |
| Trgovsko ime | IODOSAN 15 | (3) Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 3. |
| Številka dovoljenja | EU-0020540-0012 1-8 | (4) Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 4. |
| Splošno ime | Ime IUPAC | Funkcija | Številka CAS | Številka EC | Vsebnost (%) | (5) Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 5. |
| Jod | | Aktivna snov | 7553-56-2 | 231-442-4 | 1,5 | (6) Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 6. |
| fosforjeva kislina | ortofosforjeva kislina | Neaktivna snov | 7664-38-2 | 231-633-2 | 3,0 | (7) Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 7. |
| Poli(oks-1,2-etandiil).alfa.-tridecil-.omega.-hidroksi-, razvejan | Poli(oks-1,2-etandiil).alfa.-tridecil-.omega.-hidroksi-, razvejan | Neaktivna snov | 69011-36-5 | 500-241-6 | 18,0 | (8) Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 8. |
| (1) Navodila za uporabo, ukrepi za zmanjšanje tveganj in druge smernice za uporabo iz tega oddelka veljajo za vse dovoljene uporabe v okviru meta SPC 1. | |
| (2) Navodila za uporabo, ukrepi za zmanjšanje tveganj in druge smernice za uporabo iz tega oddelka veljajo za vse dovoljene uporabe v okviru meta SPC 2. | |
| (3) Navodila za uporabo, ukrepi za zmanjšanje tveganj in druge smernice za uporabo iz tega oddelka veljajo za vse dovoljene uporabe v okviru meta SPC 3. | |
| (4) Navodila za uporabo, ukrepi za zmanjšanje tveganj in druge smernice za uporabo iz tega oddelka veljajo za vse dovoljene uporabe v okviru meta SPC 4. | |
| (5) Navodila za uporabo, ukrepi za zmanjšanje tveganj in druge smernice za uporabo iz tega oddelka veljajo za vse dovoljene uporabe v okviru meta SPC 5. | |
| (6) Navodila za uporabo, ukrepi za zmanjšanje tveganj in druge smernice za uporabo iz tega oddelka veljajo za vse dovoljene uporabe v okviru meta SPC 6. | |
| (7) Navodila za uporabo, ukrepi za zmanjšanje tveganj in druge smernice za uporabo iz tega oddelka veljajo za vse dovoljene uporabe v okviru meta SPC 7. | |
| (8) Navodila za uporabo, ukrepi za zmanjšanje tveganj in druge smernice za uporabo iz tega oddelka veljajo za vse dovoljene uporabe v okviru meta SPC 8. |