Commission Decision

Sklep Komisije

of 24 June 2011

z dne 24. junija 2011

on establishing the ecological criteria for the award of the EU Ecolabel to lubricants

o določitvi okoljskih meril za podeljevanje znaka EU za okolje mazivom

(notified under document C(2011) 4447)

(notificirano pod dokumentarno številko C(2011) 4447)

(Text with EEA relevance)

(Besedilo velja za EGP)

(2011/381/EU)

THE EUROPEAN COMMISSION,

EVROPSKA KOMISIJA JE –

Having regard to the Treaty on the Functioning of the European Union,

ob upoštevanju Pogodbe o delovanju Evropske unije,

Having regard to Regulation (EC) No 66/2010 of the European Parliament and of the Council of 25 November 2009 on the EU Ecolabel [1], and in particular Article 8(2) thereof,

ob upoštevanju Uredbe (ES) št. 66/2010 Evropskega parlamenta in Sveta z dne 25. novembra 2009 o znaku EU za okolje [1] in zlasti člena 8(2) Uredbe,

After consulting the European Union Ecolabelling Board,

po posvetovanju z Odborom Evropske unije za znak za okolje,

Whereas:

ob upoštevanju naslednjega:

(1) Under Regulation (EC) No 66/2010, the EU Ecolabel may be awarded to those products with a reduced environmental impact during their entire life cycle.

(1) V skladu z Uredbo (ES) št. 66/2010 se lahko znak EU za okolje podeli proizvodom z manjšim vplivom na okolje v njihovem celotnem življenjskem krogu.

(2) Regulation (EC) No 66/2010 provides that specific EU Ecolabel criteria are to be established according to product groups.

(2) Uredba (ES) št. 66/2010 določa, da se uvedejo posebna merila za podelitev znaka EU za okolje glede na skupine proizvodov.

(3) Commission Decision 2005/360/EC [2] has established the ecological criteria and the related assessment and verification requirements for lubricants which are valid until 30 June 2011.

(3) Odločba Komisije 2005/360/ES [2] je določila okoljska merila in z njimi povezane zahteve za ocenjevanje in preverjanje za maziva, ki veljajo do 30. junija 2011.

(4) Those criteria have been further reviewed in light of technological developments. The new criteria, as well as the related assessment and verification requirements, should be valid for 4 years from the date of adoption of this Decision

(4) Ta merila so bila dodatno spremenjena v skladu s tehnološkim razvojem. Nova merila in z njimi povezane zahteve za ocenjevanje in preverjanje veljajo štiri leta od datuma sprejetja te odločbe.

(5) Decision 2005/360/EC should be replaced for reasons of clarity.

(5) Odločbo 2005/360/ES je treba nadomestiti zaradi jasnosti.

(6) A transitional period should be allowed for producers whose products have been awarded the EU Ecolabel for lubricants on the basis of the criteria set out in Decision 2005/360/EC, so that they have sufficient time to adapt their products to comply with the revised criteria and requirements. Producers should also be allowed to submit applications based on the criteria set out in Decision 2005/360/EC or on the criteria set out in this Decision until the lapse of validity of that Decision.

(6) Proizvajalcem, ki so za svoje proizvode dobili znak EU za okolje za maziva na podlagi meril iz Odločbe 2005/360/ES, je treba omogočiti prehodno obdobje, da bodo imeli dovolj časa za prilagoditev svojih proizvodov tako, da bodo ustrezali spremenjenim merilom in zahtevam. Proizvajalcem je treba še dovoliti, da vložijo vloge na podlagi meril, navedenih v Odločbi 2005/360/ES, ali na podlagi meril v tej odločbi do prenehanja veljavnosti navedene odločbe.

(7) The measures provided for in this Decision are in accordance with the opinion of the Committee established by Article 16 of Regulation (EC) No 66/2010,

(7) Ukrepi iz tega sklepa so v skladu z mnenjem Odbora, ustanovljenega s členom 16 Uredbe (ES) št. 66/2010 –

HAS ADOPTED THIS DECISION:

SPREJELA NASLEDNJI SKLEP:

Article 1

Člen 1

The product group "lubricants" shall comprise the following categories:

Skupina proizvodov "maziva" zajema naslednje kategorije:

Category 1 : hydraulic fluids and tractor transmission oils

Kategorija 1 : hidravlične tekočine in olje za prenose za traktorje

Category 2 : greases and stern tube greases

Kategorija 2 : masti in masti za grodnične cevi

Category 3 : chainsaw oils, concrete release agents, wire rope lubricants, stern tube oils and other total loss lubricants

Kategorija 3 : olja za verižne žage, sredstva za razkalupljanje betona, maziva za žičnate vrvi, olja za grodnične cevi in druga maziva, ki gredo v celoti v izgubo

Category 4 : two-stroke oils

Kategorija 4 : olja za dvotaktni motor

Category 5 : industrial and marine gear oils.

Kategorija 5 : olja za industrijsko ali pomorsko opremo.

Article 2

Člen 2

For the purpose of this Decision, the following definitions shall apply:

V tem sklepu se uporabljajo naslednje opredelitve pojmov:

(1) "lubricant" means a preparation consisting of base fluids and additives;

1. "mazivo" pomeni pripravek, ki ga sestavljajo bazna olja in dodatki;

(2) "basefluid" means a lubricating fluid whose flow, ageing, lubricity and anti-wear properties, as well as its properties regarding contaminant suspension, have not been improved by the inclusion of additive(s);

2. "bazno olje" pomeni mazalno tekočino, katere tekočnost, staranje, mazivnost in lastnosti preprečevanja obrabe, kot tudi njene lastnosti preprečevanja onesnaževanja, niso bile izboljšane z dodatkom(-ki);

(3) "substance" means a chemical element and its compounds in the natural state or obtained by any production process, including any additive necessary to preserve the stability of the products and any impurity deriving from the process used, but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition;

3. "snov" pomeni kemični element in njegove spojine v naravnem stanju ali pridobljene v kakršnem koli proizvodnem postopku, vključno z vsemi dodatki, potrebnimi za ohranitev obstojnosti izdelkov, in vsemi nečistočami, ki nastanejo zaradi uporabljenega postopka, ne vključujejo pa topila, ki ga je mogoče izločiti, ne da bi se tako vplivalo na obstojnost snovi ali da bi se spremenila njena sestava;

(4) "thickener" means one or more substances in the base fluid used to thicken or modify the rheology of a lubricating fluid or grease;

4. "sredstvo za zgoščevanje" pomeni eno ali več snovi v baznem olju, ki se uporabljajo za zgostitev ali spremembo reologije mazalne tekočine ali masti;

(5) "main component" means any substance accounting for more than 5 % by weight of the lubricant;

5. "glavna komponenta" pomeni vsako snov, ki zavzema več kot 5 % teže maziva;

(6) "additive" means a substance or mixture whose primary functions are the improvement of the flow, ageing, lubricity, anti-wear properties or of contaminant suspension;

6. "dodatek" pomeni snov ali zmes, katere glavne funkcije so izboljšanje tekočnosti, staranja, mazivnosti, preprečevanja obrabe ali preprečevanje onesnaževanja;

(7) "grease" means a solid to semi-solid mixture which consists of a "thickener" and may include other ingredients imparting special properties in a liquid lubricant.

7. "mast" pomeni trden do poltrden pripravek, ki je sestavljen iz zgoščevalnega sredstva v tekočem mazivu, in lahko vsebuje katero koli sestavino, ki daje posebne lastnosti.

Article 3

Člen 3

In order to be awarded the EU Ecolabel under Regulation (EC) No 66/2010 a product shall fall within the product group "lubricants" as defined in Article 1 of this Decision and shall comply with the criteria as well as the related assessment and verification requirements set out in the Annex to this Decision.

Za podelitev znaka EU za okolje v okviru Uredbe (ES) št. 66/2010 mora proizvod spadati v skupino proizvodov "maziva", kakor je opredeljeno v členu 1 tega sklepa in mora biti v skladu z merili in z njimi povezanimi zahtevami za ocenjevanje in preverjanje, določenimi v Prilogi k temu sklepu.

Article 4

Člen 4

The ecological criteria for the product group "lubricants", as well as the related assessment and verification requirements shall be valid for 4 years from the date of the adoption of this Decision.

Okoljska merila za skupino proizvodov "maziva" ter s tem povezane zahteve za ocenjevanje in preverjanje veljajo štiri leta od datuma sprejetja tega sklepa.

Article 5

Člen 5

For administrative purposes, the code number assigned to the product group "lubricants" shall be "027".

Za administrativne namene se skupini proizvodov "maziva" dodeli kodna številka "027".

Article 6

Člen 6

Decision 2005/360/EC is repealed.

Odločba 2005/360/ES se razveljavi.

Article 7

Člen 7

1. By derogation from Article 6, applications for the EU Ecolabel for products falling within the product group "lubricants" submitted before the date of adoption of this Decision shall be evaluated in accordance with the conditions laid down in Decision 2005/360/EC.

1. Z odstopanjem od člena 6 se vloge za podelitev znaka EU za okolje za proizvode, ki spadajo v skupino proizvodov "maziva", za katere je bil vložen zahtevek pred datumom sprejetja tega sklepa, ocenjujejo v skladu s pogoji iz Odločbe 2005/360/ES.

2. Applications for the EU Ecolabel for products falling within the product group "lubricants" submitted from the date of adoption of this Decision but by 30 June 2011 at the latest may be based either on the criteria set out in Decision 2005/360/EC or on the criteria set out in this Decision. Those applications shall be evaluated in accordance with the criteria on which they are based.

2. Vloge za pridobitev znaka EU za okolje za proizvode iz skupine proizvodov "maziva", predložene po datumu sprejetja tega sklepa, vendar najpozneje do 30. junija 2011, lahko temeljijo na merilih iz Odločbe 2005/360/ES ali na merilih iz tega sklepa. Te vloge se obravnavajo skladno z merili, na podlagi katerih so pripravljene.

3. Where the EU Ecolabel is awarded on the basis of an application evaluated according to the criteria set out in Decision 2005/360/EC, that EU Ecolabel may be used for 12 months from the date of adoption of this Decision.

3. Če se znak EU za okolje podeli na podlagi vloge, ocenjene po merilih iz Odločbe 2005/360/ES, se lahko ta znak EU za okolje uporablja 12 mesecev od datuma sprejetja tega sklepa.

Article 8

Člen 8

This Decision is addressed to the Member States.

Ta sklep je naslovljen na države članice.

Done at Brussels, 24 June 2011.

V Bruslju, 24. junija 2011

For the Commission

Za Komisijo

Janez Potočnik

Member of the Commission

Član Komisije

[1] OJ L 27, 30.1.2010, p. 1.

[1] UL L 27, 30.1.2010, str. 1.

[2] OJ L 118, 5.5.2005, p. 26.

[2] UL L 118, 5.5.2005, str. 26.

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ANNEX

PRILOGA

FRAMEWORK

OKVIR

The aims of the criteria

Cilji meril

These criteria aim in particular at promoting products that have a reduced impact on the water and soil during its use and contain a large fraction of biobased material.

Cilj teh meril je predvsem pospeševanje takih proizvodov, ki ob uporabi manj škodujejo vodi in tlom in vsebujejo velik delež snovi na biološki osnovi.

CRITERIA

MERILA

1. Excluded or limited substances and mixtures

1. Izključene ali omejene snovi in zmesi

2. Exclusion of specific substances

2. Izločitev posebnih snovi

3. Additional aquatic toxicity requirements

3. Dodatne zahteve glede strupenosti za vodno okolje

4. Biodegradability and bioaccumulative potential

4. Biološka razgradljivost in biološki akumulativni potencial

5. Renewable raw materials

5. Obnovljive surovine

6. Minimum technical performance

6. Minimalna tehnična zmogljivost

7. Information appearing on the EU Ecolabel

7. Informacije na znaku EU za okolje.

Assessment and verification requirements

Zahteve za ocenjevanje in preverjanje

(a) Requirements

(a) Zahteve

The specific assessment and verification requirements are indicated within each criterion.

Pri vsakem merilu so navedene posebne zahteve za ocenjevanje in preverjanje.

Where the applicant is required to provide declarations, documentation, analyses, test reports, or other evidence to show compliance with the criteria to the competent body, it is understood that these may originate from the applicant and/or his supplier(s) and/or their supplier(s), etc. as appropriate.

Kadar se od vlagatelja zahteva, da pristojnemu organu zagotovi izjave, dokumentacijo, analize, poročila o testih ali druga dokazila o skladnosti z merili, se razume, da lahko ti izvirajo od vlagatelja in/ali njegovega(-ih) dobavitelja(-ev) in/ali njihovega(-ih) dobavitelja(-ev), kakor je ustrezno.

The supplier of the additive, thickener or base fluid may provide the relevant information directly to the competent body.

Dobavitelj dodatka, zgoščevalnega sredstva ali baznega olja lahko zagotovi ustrezne informacije neposredno pristojnemu organu.

Where possible, the testing should be performed by laboratories that meet the general requirements of EN ISO 17025 or equivalent.

Kadar je mogoče, morajo preskuse opraviti laboratoriji, ki izpolnjujejo splošne zahteve EN ISO 17025 ali enakovrednega standarda.

Where appropriate, test methods other than those indicated for each criterion may be used if the competent body assessing the application accepts their equivalence.

Kadar je to primerno, se lahko poleg preskusnih metod, navedenih za vsako posamezno merilo, uporabijo tudi druge, če njihovo enakovrednost sprejme pristojni organ, ki ocenjuje vlogo.

Where appropriate, competent bodies may require supporting documentation and may carry out independent verifications.

Po potrebi lahko pristojni organi zahtevajo dokazno dokumentacijo in izvedejo neodvisna preverjanja.

The general scheme for the assessment of any constituent substance in a lubricant product is given in Table 1.

Splošna shema za oceno katere koli sestavine v mazivu je predstavljena v preglednici 1.

(b) Measurement thresholds

(b) Zgornje meje pri meritvah

All constituent substances that are present above 0,010 % (w/w) and which are intentionally added and/or are formed intentionally after any chemical reaction in the applied lubricant shall be unambiguously stated giving their names and the mass concentrations in which they are present and where applicable, their CAS Registry and EC registry number.

Sestavine, ki jih mazivo vsebuje več kot 0,010 % (m/m) in so dodane namerno in/ali nastanejo namerno po kateri koli kemijski reakciji v uporabljenem mazivu, se jasno navedejo z nazivi in masnimi koncentracijami, v kateri so, ter, kjer je to ustrezno, z njihovo registrsko številko po CAS in ES.

The criteria shall apply as follows:

Merila se uporabljajo, kot sledi:

- to the applied lubricant for criteria 1(a), 6 and 7,

- za merila 1a, 6 in 7 za uporabljena maziva,

- to each stated substance intentionally added or formed above 0,010 % (w/w) for criterion 1(b) and 2,

- za merili 1b in 2 za vsako navedeno sestavino, ki je bila dodana ali je nastala namerno in je proizvod vsebuje več kot 0,010 % (m/m),

- to each stated substance intentionally added or formed above 0,10 % (w/w) for criteria 3, 4 and 5.

- za merila 3, 4 in 5 za vsako navedeno sestavino, ki je bila dodana ali je nastala namerno in je proizvod vsebuje več kot 0,10 % (m/m).

In addition the total fraction of the stated substances where the formulated criteria 3 and 4 do not apply shall remain below 0,5 % (w/w).

Poleg tega skupni delež navedenih snovi, za katere se ne uporabljata merili 3 in 4, ne sme presegati 0,5 % (m/m).

EU ECOLABEL CRITERIA

MERILA ZA PODELJEVANJE ZNAKA EU ZA OKOLJE

Criterion 1 – Excluded or limited substances and mixtures

Merilo 1 – Izključene ali omejene snovi in zmesi

(a) Hazardous substances and mixtures

(a) Nevarne snovi in zmesi

According to the Article 6(6) of Regulation (EC) No 66/2010 on the EU Ecolabel, the product or any part of it shall not contain substances (in any forms, including nanoforms) meeting the criteria for classification with the hazard statements or risk phrases specified below in accordance with Regulation (EC) No 1272/2008 of the European Parliament and of the Council [1] or Council Directive 67/548/EEC [2] nor shall it contain substances referred to in Article 57 of Regulation (EC) No 1907/2006 of the European Parliament and of the Council [3]. The risk phrases below generally refer to substances. Nanoforms intentionally added to the product shall prove compliance with this criterion for any concentration.

V skladu s členom 6(6) Uredbe (ES) št. 66/2010 o znaku EU za okolje proizvod ali kateri koli njegov del ne sme vsebovati snovi (v kateri koli obliki, vključno z nanooblikami), ki izpolnjujejo merila za razvrstitev v stavke o nevarnosti ali opozorilne stavke, navedene spodaj, v skladu z Uredbo (ES) št. 1272/2008 Evropskega parlamenta in Sveta [1] ali Direktivo Sveta 67/548/EGS [2], ali snovi iz člena 57 Uredbe (ES) št. 1907/2006 Evropskega parlamenta in Sveta [3]. Spodaj navedeni opozorilni stavki se na splošno nanašajo na snovi. Nanooblike, ki so bile namerno dodane proizvodu, morajo izpolnjevati to merilo, ne glede na koncentracijo.

List of hazard statements and risk phrases:

Seznam stavkov o nevarnosti in opozorilnih stavkov:

Hazard Statement [4] | Risk Phrase [5] |

Stavek o nevarnosti [4] | Opozorilni stavek [5] |

H300 Fatal if swallowed | R28 |

H300 Smrtno pri zaužitju | R28 |

H301 Toxic if swallowed | R25 |

H301 Strupeno pri zaužitju | R25 |

H304 May be fatal if swallowed and enters airways | R65 |

H304 Pri zaužitju in vstopu v dihalne poti je lahko smrtno | R65 |

H310 Fatal in contact with skin | R27 |

H310 Smrtno v stiku s kožo | R27 |

H311 Toxic in contact with skin | R24 |

H311 Strupeno v stiku s kožo | R24 |

H330 Fatal if inhaled | R26 |

H330 Smrtno pri vdihavanju | R26 |

H331 Toxic if inhaled | R23 |

H331 Strupeno pri vdihavanju | R23 |

H340 May cause genetic defects | R46 |

H340 Lahko povzroči genetske okvare | R46 |

H341 Suspected of causing genetic defects | R68 |

H341 Sum povzročitve genetskih okvar | R68 |

H350 May cause cancer | R45 |

H350 Lahko povzroči raka | R45 |

H350i May cause cancer by inhalation | R49 |

H350i Lahko povzroči raka pri vdihavanju | R49 |

H351 Suspected of causing cancer | R40 |

H351 Sum povzročitve raka | R40 |

H360F May damage fertility | R60 |

H360F Lahko škoduje plodnosti | R60 |

H360D May damage the unborn child | R61 |

H360D Lahko škoduje nerojenemu otroku | R61 |

H360FD May damage fertility. May damage the unborn child | R60; R61; R60-61 |

H360FD Lahko škoduje plodnosti. Lahko škoduje nerojenemu otroku | R60; R61; R60-61 |

H360Fd May damage fertility. Suspected of damaging the unborn child | R60-R63 |

H360Fd Lahko škoduje plodnosti. Sum škodljivosti za nerojenega otroka | R60–R63 |

H360Df May damage the unborn child. Suspected of damaging fertility | R61-R62 |

H360Df Lahko škoduje nerojenemu otroku. Sum škodljivosti za plodnost | R61–R62 |

H361f Suspected of damaging fertility | R62 |

H361f Sum škodljivosti za plodnost | R62 |

H361d Suspected of damaging the unborn child | R63 |

H361d Sum škodljivosti za nerojenega otroka | R63 |

H361fd Suspected of damaging fertility. Suspected of damaging the unborn child | R62-63 |

H361fd Sum škodljivosti za plodnost. Sum škodljivosti za nerojenega otroka | R62-63 |

H362 May cause harm to breast fed children | R64 |

H362 Lahko škoduje dojenim otrokom | R64 |

H370 Causes damage to organs | R39/23; R39/24; R39/25; R39/26; R39/27; R39/28 |

H370 Škoduje organom | R39/23; R39/24; R39/25; R39/26; R39/27; R39/28 |

H371 May cause damage to organs | R68/20; R68/21; R68/22 |

H371 Lahko škoduje organom | R68/20; R68/21; R68/22 |

H372 Causes damage to organs through prolonged or repeated exposure | R48/25; R48/24; R48/23 |

H372 Škoduje organom pri dolgotrajni ali ponavljajoči se izpostavljenosti | R48/25; R48/24; R48/23 |

H373 May cause damage to organs through prolonged or repeated exposure | R48/20; R48/21; R48/22 |

H373 Lahko škoduje organom pri dolgotrajni ali ponavljajoči se izpostavljenosti | R48/20; R48/21; R48/22 |

H400 Very toxic to aquatic life | R50 |

H400 Zelo strupeno za vodne organizme | R50 |

H410 Very toxic to aquatic life with long-lasting effects | R50-53 |

H410 Zelo strupeno za vodne organizme, z dolgotrajnimi učinki | R50-53 |

H411 Toxic to aquatic life with long-lasting effects | R51-53 |

H411 Strupeno za vodne organizme, z dolgotrajnimi učinki | R51-53 |

H412 Harmful to aquatic life with long-lasting effects | R52-53 |

H412 Škodljivo za vodne organizme, z dolgotrajnimi učinki | R52-53 |

H413 May cause long-lasting harmful effects to aquatic life | R53 |

H413 Lahko ima dolgotrajne škodljive učinke na vodne organizme | R53 |

EUH059 Hazardous to the ozone layer | R59 |

EUH059 Nevarno za ozonski plašč | R59 |

EUH029 Contact with water liberates toxic gas | R29 |

EUH029 V stiku z vodo se sprošča strupen plin | R29 |

EUH031 Contact with acids liberates toxic gas | R31 |

EUH031 V stiku s kislinami se sprošča strupen plin | R31 |

EUH032 Contact with acids liberates very toxic gas | R32 |

EUH032 V stiku s kislinami se sprošča zelo strupen plin | R32 |

EUH070 Toxic by eye contact | R39-41 |

EUH070 Strupeno ob stiku z očmi | R39-41 |

This criterion shall also apply to the following hazard statements and risk phrases:

To merilo se uporablja tudi za naslednje stavke o nevarnosti in opozorilne stavke:

Hazard Statement [6] | Risk Phrase [7] |

Stavek o nevarnosti [6] | Opozorilni stavek [7] |

H334: May cause allergy or asthma symptoms or breathing difficulties if inhaled | R42 |

H334: Lahko povzroči simptome alergije ali astme ali težave z dihanjem pri vdihavanju | R42 |

H317: May cause allergic skin reaction | R43 |

H317: Lahko povzroči alergijski odziv kože | R43 |

H314 Causes severe skin burns and eye damage | R34; R35 |

H314 Povzroča hude opekline kože in poškodbe oči | R34; R35 |

H319 Causes serious eye irritation | R36 |

H319 Povzroča hudo draženje oči | R36 |

H315 Causes skin irritation | R38 |

H315 Povzroča draženje kože | R38 |

EUH066 Repeated exposure may cause skin dryness or cracking | R66 |

EUH066 Ponavljajoča izpostavljenost lahko povzroči nastanek suhe ali razpokane kože | R66 |

H336 May cause drowsiness and dizziness | R67 |

H336 Lahko povzroči zaspanost in omotico | R67 |

Substances or mixtures which change their properties upon processing (e.g. become no longer bioavailable, undergo chemical modification) so that the identified hazard no longer applies are exempted from the above requirement.

Snovi ali zmesi, katerih lastnosti se pri obdelavi spremenijo (na primer niso več biološko razpoložljive ali se kemično spremenijo) tako, da ugotovljena nevarnost ni več upoštevna, so izvzete iz zgoraj navedene zahteve.

Concentration limits for substances meeting criteria of Article 57(a), (b) or (c) of Regulation (EC) No 1907/2006 shall not exceed 0,010 % (w/w). If specific concentration limits are referred to for substances meeting criteria of Article 57(a), (b) or (c) they should remain below one tenth (1/10) of the lowest specific concentration value indicated unless this value falls below 0,010 % (w/w).

Mejne vrednosti za snovi, ki izpolnjujejo merila iz člena 57(a), (b) ali (c) Uredbe (ES) št. 1907/2006, ne smejo presegati 0,010 % (m/m). Če se posebne mejne vrednosti nanašajo na snovi, ki izpolnjujejo merila iz člena 57(a), (b) ali (c), njihova koncentracija ne sme presegati desetine (1/10) navedene najnižje posebne mejne vrednosti, razen če ta vrednost ne presega 0,010 % (m/m).

Derogations from Criterion 1(a) are listed in Table 1.

Odstopanja od merila 1a so navedena v preglednici 1.

Assessment and verification of criterion: the applicant shall provide the exact formulation of the product to the competent body. The applicant shall demonstrate compliance with this criterion for substances in the product on the basis of information consisting as a minimum of that specified in Annex VII to the Regulation (EC) No 1907/2006. Such information shall be specific to the particular form of the substance, including nanoforms, used in the product. For that purpose, the applicant shall provide a declaration of compliance with this criterion, together with a list of ingredients and related Safety Data Sheets in accordance with Annex II to Regulation (EC) No 1907/2006 for the product as well as for all substances listed in the formulation(s). Concentration limits shall be specified in the Safety Data Sheets in accordance with Article 31 of Regulation (EC) No 1907/2006.

Ocenjevanje in preverjanje merila: Vlagatelj pristojnemu organu predloži natančno sestavo proizvoda. Vlagatelj dokaže skladnost s tem merilom za snovi v proizvodu na podlagi podatkov, ki vključujejo vsaj podatke, navedene v Prilogi VII k Uredbi (ES) št. 1907/2006. Ti podatki ustrezajo posamezni obliki snovi, vključno z nanooblikami, uporabljenimi v proizvodu. Vlagatelj v ta namen predloži izjavo o skladnosti s tem merilom, skupaj s seznamom sestavin in ustrezne varnostne liste v skladu s Prilogo II k Uredbi (ES) št. 1907/2006 za izdelek in vse snovi, navedene v sestavi(-ah). Mejne vrednosti se navedejo v varnostnih listih v skladu s členom 31 Uredbe (ES) št. 1907/2006.

Sufficient data shall be available to allow for the evaluation of the environmental hazards (indicated by the hazard statements H400 – H413 or R-phrases: R 50, R 50/53, R 51/53, R 52, R 52/53, R 53), of the product in accordance with Regulation (EC) No 1272/2008 or Directive 67/548/EEC and Directive 1999/45/EC of the European Parliament and of the Council [8].

Zagotoviti je treba zadostno količino podatkov, da se omogoči ovrednotenje nevarnosti proizvoda za okolje (označene s stavki o nevarnosti H400–H413 ali stavki R: R 50, R 50/53, R 51/53, R 52, R 52/53, R 53) v skladu z Uredbo (ES) št. 1272/2008 ali Direktivo 67/548/EGS in Direktivo Evropskega parlamenta in Sveta 1999/45/ES [8].

The evaluation of a product for hazards to the environment shall be performed by the conventional method as indicated in Annex III to Directive 1999/45/EC or by the summation method in Section 4.1.3.5.2 of Regulation (EC) No 1272/2008. However, as defined by Part C of Annex III to Directive 1999/45/EC or by Section 4.1.3.3 of Regulation (EC) No 1272/2008, the results of testing the preparation (either the product preparation or the additive package) as such can be used to modify the classification concerning the aquatic toxicity that would have been obtained using the conventional or summation method.

Ovrednotenje nevarnosti proizvoda za okolje se izvede z običajno metodo, kakor je navedena v Prilogi III k Direktivi 1999/45/ES, ali z metodo seštevanja iz razdelka 4.1.3.5.2 Uredbe (ES) št. 1272/2008. Vendar, kakor je navedeno v delu C Priloge III k Direktivi 1999/45/ES ali v razdelku 4.1.3.3 Uredbe (ES) št. 1272/2008, se lahko rezultati testiranja pripravka (bodisi pripravka proizvoda ali tovorka dodatkov) kot takega uporabijo za spremembo razvrstitve glede strupenosti za vodno okolje, ki bi bili pridobljeni z običajno metodo ali metodo seštevanja.

(b) Substances listed in accordance with Article 59(1) of Regulation (EC) No 1907/2006

(b) Snovi, razvrščene v skladu s členom 59(1) Uredbe (ES) št. 1907/2006

No derogation from the exclusion in Article 6(6) of Regulation (EC) No 66/2010 may be given concerning substances identified as substances of very high concern and included in the list foreseen in Article 59 of Regulation (EC) No 1907/2006, when present in mixtures, in concentrations higher than 0,010 % (w/w).

Za snovi, opredeljene kot snovi, ki vzbujajo veliko zaskrbljenost in so vključene na seznam iz člena 59 Uredbe (ES) št. 1907/2006, odstopanje od izključitve iz člena 6(6) Uredbe (ES) št. 66/2010 ni mogoče v zmeseh in koncentracijah, ki presegajo 0,010 % (m/m).

Assessment and verification: the list of substances identified as substances of very high concern and included in the candidate list in accordance with Article 59 of Regulation (EC) No 1907/2006 can be found here:

Ocenjevanje in preverjanje: Seznam snovi, opredeljenih kot snovi, ki vzbujajo veliko skrb in so vključene na seznam kandidatnih snovi v skladu s členom 59 Uredbe (ES) št. 1907/2006, je na voljo na naslovu:

http://echa.europa.eu/chem_data/authorisation_process/candidate_list_table_en.asp

Reference to the list shall be made on the date of application.

Sklicevanje na seznam se opravi na datum vloge.

Concentration limits shall be specified in the Safety Data Sheets according to Annex II, paragraph 3.2.1(c) of Commission Regulation (EU) No 453/2010 [9].

Mejne vrednosti se navedejo v varnostnih listih v skladu z odstavkom 3.2.1(c) Priloge II k Uredbi Komisije (EU) št. 453/2010 [9].

Criterion 2 – Exclusion of specific substances

Merilo 2 – Izločitev posebnih snovi

The following stated substances are not allowed in quantities exceeding 0,010 % (w/w) of the final product:

Končni proizvod ne sme vsebovati naslednjih navedenih snovi v količinah, ki presegajo 0,010 % (m/m):

- substances appearing in the Union List of priority substances in the field of water policy in Annex X to Directive 2000/60/EC of the European Parliament and of the Council [10] as amended by laid in Decision No 2455/2001/EC of the European Parliament and of the Council [11] and the OSPAR List of Chemicals for Priority Action (http://www.ospar.org/content/content.asp?menu=00950304450000_000000_000000),

- snovi, ki se pojavljajo na seznamu Unije prednostnih snovi na področju vodne politike v Prilogi X k Direktivi 2000/60/ES Evropskega parlamenta in Sveta [10], kakor je bil spremenjen s seznamom kemikalij za prednostno delovanje, navedenim v Odločbi št. 2455/2001/ES Evropskega parlamenta in Sveta [11] in dokumentu OSPAR (http://www.ospar.org/content/content.asp?menu=00950304450000_000000_000000),

- organic halogen compounds and nitrite compounds,

- organskih halogenskih spojin in nitritnih spojin,

- metals or metallic compounds with the exception of sodium, potassium, magnesium and calcium. In the case of thickeners, also lithium and/or aluminium compounds may be used up to concentrations limited by the other criteria included in the Annex to this Decision.

- kovin ali kovinskih spojin, z izjemo natrija, kalija, magnezija in kalcija. V primeru sredstev za zgoščevanje se lahko uporabljajo tudi litij in/ali litijeve spojine do koncentracij, omejenih z drugimi merili iz Priloge k temu sklepu.

Assessment and verification: conformance with these requirements shall be stated in writing and signed by the applicant.

Ocenjevanje in preverjanje: Za skladnost s temi zahtevami vlagatelj predloži pisno podpisano izjavo.

Criterion 3 – Additional aquatic toxicity requirements

Merilo 3 – Dodatne zahteve glede strupenosti za vodno okolje

The applicant shall demonstrate compliance by meeting the requirements of either criterion 3.1 or criterion 3.2.

Vlagatelj dokaže skladnost z zahtevami po merilu 3.1 ali merilu 3.2.

Criterion 3.1. – Requirements for the lubricant and its main components

Merilo 3.1 – Zahteve za mazivo in njegove glavne sestavine

Acute aquatic toxicity data of the main components and the mixture shall be provided.

Navedejo se podatki o akutni strupenosti glavnih sestavin in zmesi na vodno okolje.

Acute aquatic toxicity data for each main component shall be stated on each of the following two trophic levels: algae and daphnia [12]. The critical concentration for the acute aquatic toxicity for each main component shall be at least 100 mg/L.

Podatki o akutni strupenosti za vodno okolje za vsako glavno sestavino se navedejo za vsako od naslednjih dveh prehranjevalnih ravni: alge in vodne bolhe [12]. Kritična koncentracija akutne strupenosti vsake glavne sestavine za vodno okolje je najmanj 100 mg/l.

Acute aquatic toxicity data for the applied lubricant shall be stated on each of the following three trophic levels: algae, daphnia and fish. The critical concentration for the acute aquatic toxicity for a lubricant in Category 1 and 5 shall be at least 100 mg/L and for a lubricant in Category 2, 3 and 4 at least 1000 mg/L.

Podatki o akutni strupenosti za vodno okolje za uporabljeno mazivo se navedejo za vsako od naslednjih treh prehranjevalnih ravni: alge, vodne bolhe in ribe. Kritična koncentracija akutne strupenosti maziva iz kategorij 1 in 5 za vodno okolje je najmanj 100 mg/l, maziva iz kategorij 2, 3 in 4 pa najmanj 1000 mg/l.

Table 2 summarises the requirements for the different lubricant categories according to criterion 3.1.

Preglednica 2 povzema zahteve za različne kategorije maziv v skladu z merilom 3.1.

Assessment and verification: either marine or freshwater toxicity data are accepted. The tests are carried out according to and using relevant test species mentioned in the following guidelines: ISO/DIS 10253 or OECD 201 or Part C.3 of the Annex to Council Regulation (EC) No 440/2008 [13] for algae, ISO TC 147/SC5/WG2 or OECD 202 or Part C.2 of the Annex to Regulation (EC) No 440/2008 for daphnia and OECD 203 or Part C.1 of the Annex to Regulation (EC) No 440/2008 for fish. Equivalent test methods as agreed with a competent body are also permitted. Only (72hr)ErC50 for algae, (48hr)EC50 for daphnia and (96hr)LC50 for fish are accepted.

Ocenjevanje in preverjanje: Sprejmejo se podatki o strupenosti za morsko okolje ali celinske vode. Preskusi se izvajajo glede na ustrezne preskusne vrste in s temi vrstami, navedenimi v naslednjih smernicah: ISO/DIS 10253, OECD 201 ali del C.3 Priloge k Uredbi Sveta (ES) št. 440/2008 [13] za alge, ISO TC 147/SC5/WG2 ali OECD 202 ali del C.2 Priloge k Uredbi (ES) št. 440/2008 za vodne bolhe in OECD 203 ali del C.1 Priloge k Uredbi (ES) št. 440/2008 za ribe. Po dogovoru s pristojnim organom so dovoljene so tudi enakovredne preskusne metode. Sprejmejo se samo vrednosti ErC50 za alge (72 ur), EC50 za vodne bolhe (48 ur) in LC50 za ribe (96 ur).

Criterion 3.2. – Requirements for each stated substance present above 0,10 % (w/w)

Merilo 3.2 – Zahteve za vsako navedeno snov, ki je v koncentraciji nad 0,10 % (m/m)

Chronic toxicity test results in the form of No Observed Effect Concentration (NOEC) data shall be stated on each of the following two aquatic trophic levels: daphnia and fish.

Rezultati preskusa za kronično strupenost v obliki vrednosti neopaženega učinka (NOEC) se navedejo za vsako od naslednjih dveh vodnih prehranjevalnih ravni: vodne bolhe in ribe.

In case chronic toxicity test results are missing, acute aquatic toxicity tests results shall be provided for each of the following two trophic levels; algae and daphnia. One or more substances exhibiting a certain degree of aquatic toxicity are allowed in each of the five lubricant categories for a cumulative mass concentration as indicated in Table 1.

Če ni potrjenih rezultatov preskusa za kronično strupenost, se predložijo rezultati preskusov o akutni strupenosti za vodno okolje za vsako od naslednjih dveh prehranjevalnih ravni: alge in vodne bolhe. Ena ali več snovi, ki izkazujejo določeno stopnjo strupenosti za vodno okolje, so v vsaki od petih kategorij maziv dovoljene za kumulativno masno koncentracijo v mazivu, kakor je navedeno v preglednici 1.

Assessment and verification: No Observed Effect Concentration (NOEC) data on the two trophic levels, daphnia and fish, are established by the following test methods: Part C.20 and Part C.14 of the Annex to Regulation (EC) No 440/2008 for daphnia and fish respectively, or equivalent test methods as agreed with a competent body.

Ocenjevanje in preverjanje: Podatka o vrednosti neopaženega učinka (NOEC) za dve prehranjevalni ravni, vodne bolhe in ribe, se določita na podlagi naslednjih preskusnih metod: metod iz dela C.20 in dela C.14 Priloge k Uredbi Komisije (ES) št. 440/2008 za vodne bolhe in ribe ali enakovrednih preskusnih metod po dogovoru s pristojnim organom.

Either marine or freshwater acute toxicity data are accepted on algae and daphnia. The tests in marine water are carried out according to and using relevant test species mentioned in the following guidelines: ISO/DIS 10253 or OECD 201 or Part C.3 of the Annex to Regulation (EC) No 440/2008 for algae, ISO TC 147/SC5/WG2 or OECD 202 or Part C.2 of the Annex to Regulation (EC) No 440/2008 for daphnia and OECD 203 or Part C.1 of the Annex to Regulation (EC) No 440/2008 for fish. Equivalent test methods as agreed with a competent body are also permitted. Only (72hr)ErC50 for algae and (48hr)EC50 for daphnia are accepted.

Za alge in vodne bolhe se sprejmejo podatki o akutni strupenosti za morsko okolje ali celinske vode. Preskusi v morski vodi se izvajajo glede na ustrezne preskusne vrste in s temi vrstami, navedenimi v naslednjih smernicah: ISO/DIS 10253, OECD 201 ali del C.3 Priloge k Uredbi (ES) št. 440/2008 za alge, ISO TC 147/SC5/WG2, OECD 202 ali del C.2 Priloge k Uredbi Komisije (ES) št. 440/2008 za vodne bolhe in OECD 203 ali del C.1 Priloge k Uredbi Komisije (ES) št. 440/2008 za ribe. Po dogovoru s pristojnim organom so dovoljene so tudi enakovredne preskusne metode. Sprejmejo se samo vrednosti ErC50 za alge (72 ur) in EC50 za vodne bolhe (48 ur).

Assessment and verification for Criteria 3.1 and 3.2: high quality test reports or literature data (testing according to acceptable protocols and GLP) including the references shall be submitted to the competent body demonstrating compliance with the requirements set out for the aquatic toxicity in Table 1.

Ocenjevanje in preverjanje za merili 3.1 in 3.2: Pristojnemu organu se predložijo visoko kakovostna poročila o preskusih ali podatki iz literature (preskušanje se opravi v skladu s sprejemljivimi protokoli in dobro laboratorijsko prakso), vključno z referencami, s katerimi se dokaže skladnost z zahtevami o strupenosti za vodno okolje v preglednici 1.

In the case of slightly soluble substances or preparations (< 10 mg/L) the method of the water-accommodated fraction (WAF) can be used in the aquatic toxicity determination. The established loading level, sometimes referred to as LL50 and related to the lethal loading, may be used directly in the classification criteria. The preparation of a water-accommodated fraction shall follow the recommendations set out according to one of the following guidelines: ECETOC Technical Report No 20 (1986), Annex III to OECD 1992 301 or the ISO Guidance document ISO 10634, or ASTM D6081-98 (Standard practice for Aquatic Toxicity Testing for Lubricants: Sample Preparation and Results Interpretation or equivalent methods). In addition, demonstration of the absence of toxicity for a substance at its limit of water solubility shall be deemed to have met the requirements of this criterion.

V primeru rahlo topljivih snovi ali pripravkov (< 10 mg/l) se za določitev strupenosti za vodno okolje lahko uporabi metoda Water Accommodated Fraction (WAF). Za merila razvrščanja se lahko neposredno uporabi uveljavljena dozirna stopnja, ki se včasih navaja kot LL50 in se nanaša na smrtno stopnjo. Pripravek Water Accommodated Fraction sledi priporočilom, določenim v skladu z eno od naslednjih smernic; tehnično poročilo ECETOC št. 20 (1986), Priloga III k OECD 1992 301 ali smernica ISO dokument ISO 10634 ali ASTM D6081-98 (Standardna praksa za testiranje strupenosti maziv na vodno okolje: Priprava vzorcev in tolmačenje rezultatov ali enakovrednih metod). Poleg tega se šteje, da dokaz o nestrupenosti snovi na njeni mejni vrednosti topnosti v vodi izpolnjuje zahteve tega merila.

An aquatic toxicity study does not need to be conducted when:

Študije o strupenosti za vodno okolje ni treba opraviti, če:

- the classification of the substance, base fluid or additive is already stated on the Lubricant Substance Classification list, or

- je razvrstitev snovi, baznega olja ali dodatka že navedena na razvrstitvenem seznamu mazalnih snovi ali

- a valid letter of compliance from a competent body can be submitted, or

- je mogoče predložiti veljavno izjavo o skladnosti, ki jo izda pristojni organ, ali

- the substance is unlikely to cross biological membranes MM > 800 g/mol or molecular diameter > 1,5 nm (> 15 Å), or

- snov po vsej verjetnosti ne bo prekoračila bioloških membran MM > 800 g/mol ali molekularnega premera > 1,5 nm (> 15 Å) ali

- the substance is a polymer and its molecular weight fraction below 1000 g/mol is less than 1 %, or

- je snov polimer in delež njene molske mase pod 1000 g/mol je manjši od 1 % ali

- the substance is highly insoluble in water (water solubility < 10 μg/l),

- je snov zelo netopna v vodi (topnost v vodi < 10 μg/l),

as such substances are not regarded as toxic for algae and daphnia in the aquatic system.

kot take se snovi ne štejejo za strupene za alge in vodne bolhe v vodnem sistemu.

The water solubility of substances shall be determined where appropriate according to OECD 105 or equivalent test methods.

Topnost snovi v vodi se določi, kjer je primerno, v skladu z OECD 105 ali enakovrednimi preskusnimi metodami.

The molecular weight fraction below 1000 g/mol of a polymer shall be determined according to Part A.19 of the Annex to Regulation (EC) No 440/2008 or equivalent test methods.

Delež molske mase polimera pod 1000 g/mol se določi v skladu z delom A.19 Priloge k Uredbi (ES) št. 440/2008 ali enakovrednimi preskusnimi metodami.

Criterion 4 – Biodegradability and bioaccumulative potential

Merilo 4 – Biološka razgradljivost in biološki akumulativni potencial

Requirements for the biodegradability and bioaccumulative potential shall be fulfilled for each stated substance present above 0,10 % (w/w).

Zahteve za biološko razgradljivost in biološki akumulativni potencial morajo biti izpolnjene za vsako navedeno snov, ki je nad 0,10 % (m/m).

The lubricant shall not contain substances that are both: non-biodegradable and (potentially) bioaccumulative.

Mazivo ne sme vsebovati snovi, ki: niso biološko razgradljive in so (potencialno) bioakumulativne.

However, the lubricant may contain one or more substances with a certain degree of degradability and potential or actual bioaccumulation up to a cumulative mass concentration as indicated in Table 1.

Vendar mazivo lahko vsebuje eno ali več snovi z določeno stopnjo razgradljivosti in potencialno ali dejansko bioakumulacijo do kumulativne masne koncentracije, kakor je navedeno v preglednici 1.

Assessment and verification: conformity shall be demonstrated by providing the following information:

Ocenjevanje in preverjanje: Skladnost se dokazuje s predložitvijo naslednjih podatkov:

High quality test reports or literature data (testing according to acceptable protocols and GLP) including the references on the biodegradability and when required on the (potential) bioaccumulation of each constituent substance.

visoko kakovostnih poročil o preskusih ali podatkov iz literature (preskušanje se opravi v skladu s sprejemljivimi protokoli in dobro laboratorijsko prakso), vključno z navedbami biološke razgradljivosti in, kadar je to potrebno, (možne) bioakumulacije vsake sestavine.

4.1. Biodegradation

4.1 Biološka razgradljivost

A substance is considered ultimately biodegradable (aerobic) if:

Snov se šteje za popolnoma biološko razgradljivo (aerobno) v naslednjih primerih:

1. In a 28-day biodegradation study according Part C.4 of the Annex to Regulation (EC) No 440/2008, OECD 306, OECD 310 the following levels of biodegradation are achieved:

1. Če se v 28-dnevni študiji o biološki razgradljivosti v skladu z delom C.4 Priloge k Uredbi (ES) št. 440/2008, OECD 306, OECD 310 dosežejo naslednje stopnje biološke razgradljivosti:

- in the ultimately biodegradable tests based upon dissolved organic carbon ≥ 70 %,

- v preskusih končne biološke razgradljivosti na podlagi raztopljenega organskega ogljika ≥ 70 %,

- in the ultimately biodegradable tests based upon oxygen depletion or carbon dioxide generation ≥ 60 % of the theoretical maxima.

- v preskusih končne biološke razgradljivosti na podlagi izčrpanosti kisika ali ustvarjanja ogljikovega dioksida ≥ 60 % teoretičnih maksimumov.

In these ultimately biodegradable tests the 10-day window principle will not necessarily apply. If the substance reaches the biodegradation pass level within 28 days but not within the 10-day time-window, a slower degradation rate is assumed.

Pri teh preskusih končne biološke razgradljivosti ni nujno, da se uporablja načelo desetdnevnega okna. Če snov doseže stopnjo praga biorazgradljivosti v 28 dneh in ne v desetdnevnem časovnem oknu, se predvideva počasnejša stopnja razgradljivosti.

2. The BOD5/ThOD or BOD5/COD ratio ≥ 0,5. The BOD5/(ThOD or COD) ratio can only be used if no data based on Part C.4 of the Annex to Regulation (EC) No 440/2008, OECD 306 or OECD 310 or any other equivalent test methods are available. The BOD5 shall be assessed according to Part C.5 of the Annex to Regulation (EC) No 440/2008 or equivalent methods while the COD shall be assessed according to Part C.6 of the Annex to Regulation (EC) No 440/2008 or equivalent methods.

2. Če je količnik med BOD5/ThOD ali BOD5/COD ≥ 0,5. Količnik BOD5/(ThOD ali COD) se lahko uporablja samo, če ni na razpolago podatkov na podlagi dela C.4 Priloge k Uredbi (ES) št. 440/2008, OECD 306 ali OECD 310 ali kakršnih koli drugih enakovrednih preskusnih metod. BOD5 se oceni v skladu z delom C.5 Priloge k Uredbi (ES) št. 440/2008 ali enakovrednimi metodami, medtem ko se COD oceni v skladu z delom C.6 Priloge k Uredbi (ES) št. 440/2008 ali enakovrednimi metodami.

A substance is considered inherently biodegradable if it shows:

Snov se šteje za inherentno biološko razgradljivo, če kaže:

- a biodegradation > 70 % in the Part C.9 of the Annex to Regulation (EC) No 440/2008 or OECD 302 C test for inherent biodegradation or equivalent methods, or

- biološko razgradljivost > 70 % pri preskusu za inherentno biološko razgradljivost v skladu z delom C.9 Priloge k Uredbi (ES) št. 440/2008 ali OECD 302 C ali po enakovrednih metodah ali

- a biodegradation > 20 % but < 60 % after 28 days in Part C.4 of the Annex to Regulation (EC) No 440/2008, OECD 306, OECD 310 tests based on oxygen depletion or carbon dioxide generation or equivalent methods.

- biološko razgradljivost > 20 % vendar < 60 % po 28 dneh pri preskusih na podlagi izčrpanosti kisika ali ustvarjanja ogljikovega dioksida v skladu z delom C.4 Priloge k Uredbi (ES) št. 440/2008, OECD 306, OECD 310 ali po enakovrednih metodah.

The biodegradation test does not need to be conducted when:

Preskusa za biološko razgradljivost ni treba opraviti, kadar:

- the classification of the substance, base fluid or additive is already stated on the Lubricant Substance Classification list or a valid letter of compliance from a competent body can be submitted,

- je razvrstitev snovi, baznega olja ali dodatka že navedena na razvrstitvenem seznamu mazalnih snovi ali je mogoče predložiti veljavno izjavo o skladnosti, ki jo izda pristojni organ.

- a substance is non-biodegradable if it fails the criteria for ultimate and inherent biodegradability.

- Snov biološko ni razgradljiva, če ne izpolnjuje meril za popolno in inherentno biorazgradljivost.

The applicant may also use read-across data to estimate the biodegradability of a substance. "Read-across" for the assessment of the biodegradability of a substance shall be acceptable if the reference substance differs by only one functional group or fragment from the substance applied in the product. If the reference substance is readily or inherently biodegradable and the functional group has a positive effect on the aerobic biodegradation then the applied substance may also be regarded as readily or inherently biodegradable. Functional groups or fragments with a positive effect on the biodegradation are: aliphatic and aromatic alcohol [-OH], aliphatic and aromatic acid [-C(=O)-OH], aldehyde [-CHO], Ester [-C(=O)-O-C], amide [-C(=O)–N or -C(=S)–N]. Adequate and reliable documentation of the study on the reference substance should be provided. In case of a comparison with a fragment, not included here above, adequate and reliable documentation of the studies should be provided on the positive effect of the functional group on the biodegradation of structurally similar substances.

Za oceno biološke razgradljivosti snovi vlagatelj lahko uporabi tudi podatke o referenčni snovi. Za oceno biološke razgradljivosti snovi so "podatki o referenčni snovi" sprejemljivi, če se referenčna snov razlikuje samo za eno funkcionalno skupino ali fragment od snovi, uporabljene v proizvodu. Če je referenčna snov hitro ali inherentno biorazgradljiva in ima funkcionalna skupina pozitivni učinek na aerobno biorazgradljivost, potem se tudi uporabljena snov lahko šteje za hitro ali inherentno biorazgradljivo. Funkcionalne skupine ali fragmenti s pozitivnim učinkom na biorazgradljivost so: alifatski in aromatski alkohol [-OH], alifatske in aromatske kisline [-C(=O)-OH], aldehidi [-CHO], estri [-C(=O)-O-C], amidi [-C(=O)-N ali -C(=S)-N]. Treba je zagotoviti ustrezno in zanesljivo dokumentacijo študije o referenčni snovi. V primeru primerjave s fragmentom, ki ni vključen zgoraj, je treba zagotoviti ustrezno in zanesljivo dokumentacijo študij o pozitivnih učinkih funkcionalne skupine na biorazgradljivost strukturno podobnih snovi.

4.2. Bioaccumulation

4.2 Bioakumulacija

The (potential) bioaccumulation does not need to be established when the substance:

Preskusa za (možno) bioakumulacijo ni treba opraviti, kadar ima/je snov:

- has a MM > 800 g/mol, or

- molsko maso > 800 g/mol ali

- has a molecular diameter > 1,5 nm (> 15 Å), or

- molekularni premer > 1,5 nm (> 15 Å) ali

- has an octanol-water partition coefficient, log Kow, value of < 3 or > 7, or

- koeficient porazdelitve oktanol/voda log Kow vrednost < 3 ali > 7 ali

- has a measured BCF of ≤ 100 L/kg, or

- izmerjeno vrednost BCF ≤ 100 l/kg ali

- is a polymer and its molecular weight fraction below 1000 g/mol is less than 1 %.

- polimer, delež njene molske mase pod 1000 g/mol pa je manjši od 1 %.

Since most substances used in lubricants are quite hydrophobic the BCF-value should be based on the lipid weight content and care must be shown to ensure a sufficient exposure time.

Ker je večina snovi v mazivih precej hidrofobnih, mora vrednost BCF temeljiti na vsebnosti teže lipidov in paziti se mora na to, da se zagotovi zadostni čas izpostavljenosti.

The bioconcentration factor (BCF) shall be assessed according to Part C.13 of the Annex to Regulation (EC) No 440/2008 or equivalent test methods.

Biokoncentracijski faktor (BCF) se oceni v skladu z delom C.13 Priloge k Uredbi (ES) št. 440/2008 ali z enakovrednimi preskusnimi metodami.

The log octanol/water partition coefficient (log Kow) shall be assessed according to Part A.8 of the Annex to Regulation (EC) No 440/2008 or OECD 123 or equivalent test methods. In case of an organic substance other than a surfactant where no experimental value is available, a calculation method can be used. The following calculation methods are allowed: CLOGP, LOGKOW, (KOWWIN) and SPARC. Estimated log Kow values by any of these calculation methods < 3 or > 7 indicates that the substance is not expected to bioaccumulate.

Koeficient porazdelitve oktanol/voda log (log Kow) se oceni v skladu z delom A.8 Priloge k Uredbi (ES) št. 440/2008 ali OECD 123 ali z enakovrednimi preskusnimi metodami. Pri organskih snoveh, ki niso površinsko aktivne snovi in pri katerih preskusna vrednost ni na voljo, je mogoče uporabiti računsko metodo. Dovoljene so naslednje metode izračuna: CLOGP, LOGKOW, (KOWWIN) in SPARC. Pričakovana vrednost log Kow < 3 ali > 7, pridobljena s katero koli od teh računskih metod, kaže, da se snov po pričakovanjih ne bo bioakumulirala.

Log Kow values are applicable to organic chemicals only. To assess the bioaccumulation potential of non-organic compounds, surfactants, and some organo-metallic compounds, BCF measurements shall be carried out.

Vrednosti log Kow se uporabljajo samo za organske kemikalije. Za oceno bioakumulacijskega potenciala anorganskih spojin, površinsko aktivnih snovi in nekaterih organsko-kovinskih spojin se izvedejo merjenja BCF.

Criterion 5 – Renewable raw materials

Merilo 5 – Obnovljive surovine

The formulated product shall have a carbon content derived from renewable raw materials that shall be:

Sestavljen proizvod mora imeti vsebnost ogljika, ki izvira iz obnovljivih surovin, ki je:

- ≥ 50 % (m/m) for Category 1,

- ≥ 50 % (m/m) za kategorijo 1,

- ≥ 45 % (m/m) for Category 2,

- ≥ 45 % (m/m) za kategorijo 2,

- ≥ 70 % (m/m) for Category 3,

- ≥ 70 % (m/m) za kategorijo 3,

- ≥ 50 % (m/m) for Category 4,

- ≥ 50 % (m/m) za kategorijo 4,

- ≥ 50 % (m/m) for Category 5.

- ≥ 50 % (m/m) za kategorijo 5.

Carbon content derived from renewable raw material means the mass percentage of component A × [number of C-atoms in component A, which are derived from (vegetable) oils or (animal) fats divided by the total number of C-atoms in component A] plus mass percentage of component B × [number of C-atoms in component B, which are derived from (vegetable) oils or (animal) fats divided by the total number of C-atoms in component B] plus the mass percentage of component C × [number of C-atoms in component C, which are derived from (vegetable) oils or (animal) fats divided by the total number of C-atoms in component C], and so on.

Vsebnost ogljika, ki izvira iz obnovljivih surovin, pomeni odstotni delež mase sestavine A × [število C-atomov v sestavini A, ki so derivati iz (rastlinskih) olj ali (živalskih) maščob, deljeno s skupnim številom C-atomov v sestavini A] plus odstotni delež mase sestavine B × [število C-atomov v sestavini B, ki so derivati iz (rastlinskih) olj ali (živalskih) maščob, deljeno s skupnim številom C-atomov v sestavini B] plus odstotni delež mase sestavine C × [število C-atomov v sestavini C, ki so derivati iz (rastlinskih) olj ali (živalskih) maščob, deljeno s skupnim številom C-atomov v sestavini C] in tako dalje.

The applicant shall indicate on the application form the type (s), source(s) and origin of the renewable material(s) of the main components.

Vlagatelj na vlogi navede vrsto(-e), vir(-e) in izvor obnovljive(-ih) snovi glavnih sestavin.

Assessment and verification: the applicant shall provide the competent body with a declaration of compliance with this criterion.

Ocenjevanje in preverjanje: Vlagatelj pristojnemu organu predloži izjavo o skladnosti proizvoda s tem merilom.

Criterion 6 – Minimum technical performance

Merilo 6 – Minimalna tehnična zmogljivost

(a) For Hydraulic fluids: at least the technical performance criteria as laid down in the current ISO 15380, Tables 2 to 5. The supplier shall list on his product information sheet which 2 elastomers have been tested.

(a) Za hidravlične tekočine: vsaj merila za tehnično zmogljivost, določena v najnovejšem standardu ISO 15380, v razpredelnicah 2–5. Dobavitelj na svojem informacijskem listu proizvoda navede, katera dva elastomera sta bila preskušena.

(b) For Industrial and marine gear oils: at least the technical performance requirements as in the DIN 51517. The supplier shall list on his product information sheet which Section (I, II or III) was selected.

(b) Za olja za menjalnike za industrijsko ali pomorsko uporabo: vsaj merila za tehnično zmogljivost, določena v standardu DIN 51517. Dobavitelj na svojem informacijskem listu proizvoda navede, kateri razdelek (I, I ali III) je bil izbran.

(d) For two-stroke oils for marine applications: at least the technical performance criteria laid down in "NMMA Certification for Two-Stroke Cycle Gasoline Engine Lubricants" of NMMA TC-W3.

(d) Za olja za dvotaktne motorje za pomorsko uporabo: vsaj merila za tehnično zmogljivost, določena z "NMMA-potrdilom za maziva za dvotaktne bencinske motorje" v okviru NMMA TC-W3.

(e) For two-stroke oils for terrestrial applications: at least meet the EGD level of technical performance criteria laid down in ISO 13738:2000.

(e) Za olja za dvotaktne motorje za uporabo na kopnem: vsaj merila za tehnično zmogljivost za stopnjo EGD, določeno v ISO 13738:2000.

(f) For all other lubricants: fit for purpose.

(f) Za vsa druga maziva: prilagojenost za predvideno uporabo.

Assessment and verification: the applicant shall provide the competent body with a declaration of compliance with this criterion, together with related documentation.

Ocenjevanje in preverjanje: Vlagatelj pristojnemu organu predloži izjavo, skupaj s pripadajočo dokumentacijo o skladnosti proizvoda s tem merilom.

Criterion 7 – Information appearing on the eco-label

Merilo 7 – Informacije, prikazane na znaku za okolje

Optional label with text box shall contain the following text:

Neobvezna oznaka z besedilnim poljem vsebuje naslednje besedilo:

- "— Reduced harm for water and soil during use

- "— Med uporabo zmanjšana nevarnost za vodo in tla

- — Contain a large fraction of biobased material".

- — Vsebujejo velik delež snovi na biološki osnovi".

The guidelines for the use of the optional label with text box can be found in the "Guidelines for the use of the EU Ecolabel logo" on the website: http://ec.europa.eu/environment/ecolabel/promo/logos_en.htm

Navodila za uporabo neobvezne oznake z besedilnim poljem so na voljo v "Navodilih za uporabo logotipa znaka za okolje EU" na spletni strani: http://ec.europa.eu/environment/ecolabel/promo/logos_en.htm

Assessment and verification: the applicant shall provide the competent body with a sample of the product packaging showing the label, together with a declaration of compliance with this criterion.

Ocenjevanje in preverjanje: Vlagatelj pristojnemu organu zagotovi vzorec embalaže proizvoda z nalepko in izjavo o skladnosti s tem merilom.

Table 1

Preglednica 1

Criteria for the lubricant and each stated substance

Merila za mazivo in vsako navedeno snov

CategoryCriteria | Hydraulic fluids, tractor transmission oils | Greases, stern tube greases | Chain saw oils, concrete release agents, wire rope lubricants and other total loss lubricants | Terrestrial and marine two-stroke oils | Industrial and marine gear oils |

Razredmerila | Hidravlične tekočine, olje za prenose za traktorje | Masti, masti za grodnične cevi | Olja za verižne žage, sredstva za razkalupljanje betona, maziva za žičnate vrvi in druga maziva, ki gredo v celoti v izgubo | Olja za dvotaktne motorje za uporabo na kopnem ali pomorsko uporabo | Olja za industrijsko ali pomorsko opremo |

Health or Environmental Hazard statement or R-phrase of the lubricant at the time of application | None (Lowest classification limit in Regulation (EC) No 1272/2008 or Directive 1999/45/EC) | None (Lowest classification limit in Regulation (EC) No 1272/2008 or Directive 1999/45/EC) | None (Lowest classification limit in Regulation (EC) No 1272/2008 or Directive 1999/45/EC) | None (Lowest classification limit in Regulation (EC) No 1272/2008 or Directive 1999/45/EC) | None (Lowest classification limit in Regulation (EC) No 1272/2008 or Directive 1999/45/EC) |

Stavki o nevarnosti za zdravje ali okolje ali stavek R za mazivo med uporabo | Nič (Najnižja omejitev za razvrstitev v Uredbi (ES) št. 1272/2008 ali Direktivi 1999/45/ES) | Nič (Najnižja omejitev za razvrstitev v Uredbi (ES) št. 1272/2008 ali Direktivi 1999/45/ES) | Nič (Najnižja omejitev za razvrstitev v Uredbi (ES) št. 1272/2008 ali Direktivi 1999/45/ES) | Nič (Najnižja omejitev za razvrstitev v Uredbi (ES) št. 1272/2008 ali Direktivi 1999/45/ES) | Nič (Najnižja omejitev za razvrstitev v Uredbi (ES) št. 1272/2008 ali Direktivi 1999/45/ES) |

OSPAR-listed; the Union list of priority substances in the field of water policy; organic halogens; nitrites; metals and metallic compounds except Na, K, Mg, Ca and for thickeners Li, Al; CMR cat 1,2 (R45, R46, R49, R60 or R61); the candidate list for Annex XIV to Regulation (EC) No 1907/2006 | < 0,010 % | < 0,010 % | < 0,010 % | < 0,010 % | < 0,010 % |

Navedeno v OSPAR; seznamu Unije prednostnih snovi na področju vodne politike; organski halogeni; nitriti; kovine in kovinske spojine, razen Na, K, Mg, Ca in pri sredstvih za zgoščevanje Li, Al; v CMR kat 1,2 (R45, R46, R49, R60 ali R61); seznam kandidatnih snovi za Prilogo XIV k Uredbi (ES) št. 1907/2006 | < 0,010 % | < 0,010 % | < 0,010 % | < 0,010 % | < 0,010 % |

Aquatic toxicity (Criterion 3.2 only) | Cumulative mass percentages (% w/w) of substances present in |

Strupenost za vodno okolje (samo merilo 3.2) | Kumulativni masni deleži (% m/m) prisotnih snovi |

Not toxic (D) | Acute toxicity > 100 mg/L or NOEC > 10 mg/L | Not limited |

Nestrupeno (D) | Akutna strupenost > 100 mg/l ali NOEC > 10 mg/l | Neomejeno |

Harmful (E) | 10 mg/L < Acute toxicity ≤ 100 mg/L or 1 mg/L < NOEC ≤ 10 mg/L | ≤ 20 | ≤ 25 | ≤ 5 | ≤ 25 | ≤ 20 |

Škodljivo (E) | 10 mg/l < akutna strupenost ≤ 100 mg/l ali 1 mg/l < NOEC ≤ 10 mg/l | ≤ 20 | ≤ 25 | ≤ 5 | ≤ 25 | ≤ 20 |

Toxic (F) | 1 mg/L < Acute toxicity ≤ 10 mg/L or 0,1 mg/L < NOEC ≤ 1 mg/L | ≤ 5 | ≤ 1 | ≤ 0,5 | ≤ 1 | ≤ 5 |

Strupeno (F) | 1 mg/l < akutna strupenost ≤ 10 mg/l ali 0,1 mg/l < NOEC ≤ 1 mg/l | ≤ 5 | ≤ 1 | ≤ 0,5 | ≤ 1 | ≤ 5 |

Very toxic (G) | Acute toxicity ≤ 1 mg/L or NOEC ≤ 0,1 mg/L | ≤ 0,1/M [14] | ≤ 0,1/M [14] | ≤ 0,1/M [14] | ≤ 0,1/M [14] | ≤ 1/M [14] |

Zelo strupeno (G) | Akutna strupenost ≤ 1 mg/l ali NOEC ≤ 0,1 mg/l | ≤ 0,1/M [14] | ≤ 0,1/M [14] | ≤ 0,1/M [14] | ≤ 0,1/M [14] | ≤ 1/M [14] |

Biodegradation and Bioaccumulation (Criterion 4) | Cumulative mass percentages (%w/w) of substances present in |

Biološka razgradljivost in bioakumulacija (merilo 4) | Kumulativni masni deleži (% m/m) prisotnih snovi |

Ultimately aerobically biodegradable (A) | > 90 | > 75 | > 90 | > 75 | > 90 |

Popolnoma aerobno biološko razgradljivo (A) | > 90 | > 75 | > 90 | > 75 | > 90 |

Inherently aerobically biodegradable (B) | ≤ 5 | ≤ 25 | ≤ 5 | ≤ 20 | ≤ 5 |

Inherentno aerobno biološko razgradljivo (B) | ≤ 5 | ≤ 25 | ≤ 5 | ≤ 20 | ≤ 5 |

Non-biodegradable AND non-bioaccumulative (C) | ≤ 5 | ≤ 5 | ≤ 10 | ≤ 5 |

Ni biološko razgradljivo IN ni bioakumulativno (C) | ≤ 5 | ≤ 5 | ≤ 10 | ≤ 5 |

Non-biodegradable AND bioaccumulative (X) | ≤ 0,1 | ≤ 0,1 | ≤ 0,1 | ≤ 0,1 | ≤ 0,1 |

Ni biološko razgradljivo IN bioakumulativno (X) | ≤ 0,1 | ≤ 0,1 | ≤ 0,1 | ≤ 0,1 | ≤ 0,1 |

Fraction not assessed on aquatic toxicity (Criterion 3.2) or biodegradation/bioaccumulation (Criterion 4) | Cumulative mass percentages (%w/w) of substances present in |

Frakcija ni ocenjena za strupenost na vodno okolje (merilo 3.2) ali biološko razgradljivost/bioakumulacijo (merilo 4) | Kumulativni masni deleži (% m/m) prisotnih snovi |

| < 0,5 | < 0,5 | < 0,5 | < 0,5 | < 0,5 |

Renewability (Criterion 5) | Cumulative mass percentages (%w/w) of substances present in |

Obnovljivost (merilo 5) | Kumulativni masni deleži (% m/m) prisotnih snovi |

Based on carbon | ≥ 50 % | ≥ 45 % | ≥ 70 % | ≥ 50 % | ≥ 50 % |

Na podlagi ogljika | ≥ 50 % | ≥ 45 % | ≥ 70 % | ≥ 50 % | ≥ 50 % |

Minimal Technical performance (Criterion 6) | Hydraulic fluids: ISO 15380 Tables 2 to 5 Tractor transmission oils: fit for purpose | Fit for purpose | Chain saw oils: as in RAL UZ 48 Others: fit for purpose | Marine 2T-oils: as in NMMA TC-W3. Terrestrial 2T-oils: as the EGD level in ISO 13738:2000 | Industrial and marine gear oils DIN 51517 |

Minimalna tehnična zmogljivost (merilo 6) | Hidravlične tekočine: ISO 15380, razpredelnice 2–5 Olja za prenose za traktorje: prilagojenost za predvideno uporabo | Prilagojenost za predvideno uporabo | Olja za verižne žage: kot v RAL UZ 48. Drugo: prilagojenost za predvideno uporabo | Olja za dvotaktne motorje za pomorsko uporabo: kot v NMMA TC-W3 Olja za dvotaktne motorje za uporabo na kopnem: kot za stopnjo EGD v ISO 13738:2000 | Olja za menjalnike za industrijsko ali pomorsko rabo DIN 51517 |

multiplication factor (M) | LC50 or EC50 value ("L(E)C50") of substance |

Množilni faktor (M) | Vrednost LC50 ali EC50 ("L(E)C50") za snov |

1 | 0,1 < L(E)C50 ≤ 1 |

10 | 0,01 < L(E)C50 ≤ 0,1 |

100 | 0,001 < L(E)C50 ≤ 0,01 |

1000 | 0,0001 < L(E)C50 ≤ 0,001 |

For substances with a lower LC50 or EC50 value than 0,0001 mg/L, the corresponding concentration limits are calculated accordingly (in factor 10 intervals). |

Za snovi z nižjo vrednostjo LC50 ali EC50 kakor 0,0001 mg/l, se ustrezne mejne vrednosti izračunajo skladno s to vrednostjo (v faktorju 10 intervalov). |

Table 2

Preglednica 2

Aquatic toxicity requirements for the different lubricant categories — Data requirements for the lubricant and its main components

Zahteve glede strupenosti za vodno okolje za različne kategorije maziv – Zahteve za podatke za mazivo in njegove glavne sestavine

Acute aquatic toxicity for the freshly prepared lubricant on three trophic levels, algae, daphnia and fish | > 100 mg/L | > 1000 mg/L | > 1000 mg/L | > 1000 mg/L | > 100 mg/L |

Akutna strupenost za vodno okolje za sveže pripravljeno mazivo na treh prehranjevalnih ravneh: alge, vodne bolhe in ribe | > 100 mg/l | > 1000 mg/l | > 1000 mg/l | > 1000 mg/l | > 100 mg/l |

Acute aquatic toxicity for each main component on each of two trophic levels, algae and daphnia | > 100 mg/L | > 100 mg/L | > 100 mg/L | > 100 mg/L | > 100 mg/L |

Akutna strupenost za vodno okolje za vsako glavno sestavino na vsaki od dveh prehranjevalnih ravni: alge, vodne bolhe in rake | > 100 mg/l | > 100 mg/l | > 100 mg/l | > 100 mg/l | > 100 mg/l |

[1] OJ L 353, 31.12.2008, p. 1.

[1] UL L 353, 31.12.2008, str. 1.

[2] OJ 196, 16.8.1967, p. 1.

[2] UL 196, 16.8.1967, str. 1.

[3] OJ L 396, 30.12.2006, p. 1.

[3] UL L 396, 30.12.2006, str. 1.

[4] As provided for in Regulation (EC) No 1272/2008.

[4] Kakor je določeno v Uredbi (ES) št. 1272/2008.

[5] As provided for in Directive 67/548/EEC.

[5] Kakor je določeno v Direktivi 67/548/EGS.

[6] As provided for in Regulation (EC) No 1272/2008.

[6] Kakor je določeno v Uredbi (ES) št. 1272/2008.

[7] As provided for in Directive 67/548/EEC.

[7] Kakor je določeno v Direktivi 67/548/EGS.

[8] OJ L 200, 30.7.1999, p. 1.

[8] UL L 200, 30.7.1999, str. 1.

[9] OJ L 133, 31.5.2010, p. 1.

[9] UL L 133, 31.5.2010, str. 1.

[10] OJ L 327, 22.12.2000, p. 1.

[10] UL L 327, 22.12.2000, str. 1.

[11] OJ L 331, 15.12.2001, p 1.

[11] UL L 331, 15.12.2001, str. 1.

[12] Crustacean can substitute for daphnia throughout this Decision where marine data is submitted.

[12] V tem sklepu lahko pri predložitvi podatkov za morsko okolje vodno bolho nadomestijo raki.

[13] OJ L 142, 31.5.2008, p. 1.

[13] UL L 142, 31.5.2008, str. 1.

[] M is the multiplication factor of 10 for substances that are very toxic to the aquatic environment as from Table 1b in Commission Directive 2006/8/EC (OJ L 19, 24.1.2006, p. 12).

[] M je množilni faktor 10 za snovi, ki so zelo strupene za vodno okolje v skladu s preglednico 1b v Direktivi Komisije 2006/8/ES (UL L 19, 24.1.2006, str. 12).

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