Commission Decision

Deċiżjoni tal-Kummissjoni

of 24 June 2011

tal- 24 ta’ Ġunju 2011

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

dwar l-istabbiliment tal-kriterji ekoloġiċi għall-għoti tal-Ekotikketta tal-UE għal-lubrikanti

(notified under document C(2011) 4447)

(notifikata bid-dokument numru C(2011) 4447)

(Text with EEA relevance)

(Test b’relevanza għaż-ŻEE)

(2011/381/EU)

(2011/381/UE)

THE EUROPEAN COMMISSION,

IL-KUMMISSJONI EWROPEA,

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

Wara li kkunsidrat it-Trattat dwar il-Funzjonament tal-Unjoni Ewropea,

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,

Wara li kkunsidrat ir-Regolament (KE) Nru 66/2010 tal-Parlament Ewropew u tal-Kunsill tal- 25 ta’ Novembru 2009 dwar skema ta’ Ekotikketta tal-UE [1], u b'mod partikolari l-Artikolu 8(2) tiegħu,

After consulting the European Union Ecolabelling Board,

Wara li ġie kkonsultat il-Bord tal-Ekotikkettar tal-Unjoni Ewropea,

Whereas:

Billi:

(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) Skont ir-Regolament (KE) Nru 66/2010, l-Ekotikketta tal-UE tista' tingħata lil dawk il-prodotti b'impatt ambjentali mnaqqas tul iċ-ċiklu kollu ta’ ħajjithom.

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

(2) Ir-Regolament (KE) Nru 66/2010 jipprovdi li kriterji speċifiċi tal-Ekotikketta tal-UE għandhom jiġu stabbiliti skont il-gruppi tal-prodotti.

(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) Id-Deċiżjoni tal-Kummissjoni 2005/360/KE [2] stabbilixxiet il-kriterji ekoloġiċi u r-rekwiżiti relatati tal-valutazzjoni u l-verifika għal-lubrikanti li huma validi sat- 30 ta’ Ġunju 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) Dawk il-kriterji ġew analizzati aktar fil-fond fid-dawl tal-iżviluppi teknoloġiċi. Il-kriterji l-ġodda, kif ukoll ir-rekwiżiti relatati tal-valutazzjoni u l-verifika, għandhom ikunu validi għal erba’ snin mid-data tal-adozzjoni ta’ din id-Deċiżjoni.

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

(5) Id-Deċiżjoni 2005/360/KE għandha tiġi ssostitwita għal raġunijiet ta’ ċarezza.

(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) Għandu jingħata perjodu ta’ tranżizzjoni għall-produtturi li l-prodotti tagħhom ingħataw l-Ekotikketta tal-UE għal-lubrikanti abbażi tal-kriterji stabbiliti fid-Deċiżjoni 2005/360/KE, sabiex ikollhom żmien suffiċjenti biex jadattaw il-prodotti tagħhom biex isiru konformi mal-kriterji u r-rekwiżiti riveduti. Il-produtturi għandhom ukoll ikunu jistgħu jissotomettu l-applikazzjonijiet abbażi tal-kriterji stabbiliti fid-Deċiżjoni 2005/360/KE jew skont il-kriterji stabbiliti f'din id-Deċiżjoni sakemm tiskadi l-validità ta’ dik id-Deċiżjoni.

(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) Il-miżuri pprovduti f'din id-Deċiżjoni huma skont l-opinjoni tal-Kumitat stabbilit permezz tal-Artikolu 16 tar-Regolament (KE) Nru 66/2010,

HAS ADOPTED THIS DECISION:

ADOTTAT DIN ID-DEĊIŻJONI:

Article 1

Artikolu 1

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

Il-grupp ta’ prodotti "lubrikanti" għandu jinkludi l-kategoriji li ġejjin:

Category 1 : hydraulic fluids and tractor transmission oils

Kategorija 1 : fluwidi idrawliċi u żjut tat-trażmissjoni tat-tratturi

Category 2 : greases and stern tube greases

Kategorija 2 : griżijiet u griżijiet tat-tubu tal-istern

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

Kategorija 3 : żjut tas-serrieq mekkaniku tal-katina, aġenti tar-rilaxx tal-konkrit, lubrikanti tal-ħbula tal-wajer, żjut tat-tubu tal-istern u lubrikanti oħrajn ta’ telf totali

Category 4 : two-stroke oils

Kategorija 4 : żjut two-stroke

Category 5 : industrial and marine gear oils.

Kategorija 5 : żjut industrijali u tat-tagħmir tal-baħar.

Article 2

Artikolu 2

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

Għall-fini ta’ din id-Deċiżjoni, għandhom japplikaw id-definizzjonijiet li ġejjin:

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

(1) "lubrikant" tfisser preparazzjoni magħmula minn fluwidi bażiċi u addittivi;

(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) "fluwidu bażiku" tfisser fluwidu lubrikanti li l-proprjetajiet tiegħu tal-fluss, kemm jibqa’ tajjeb matul iż-żmien, il-lubriċità u r-reżistenza għall-kedd, kif ukoll il-proprjetajiet tiegħu fir-rigward tas-sospensjoni tal-kontaminanti ma ġewx imtejba permezz tal-inklużjoni ta’ addittiv(i);

(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) "sustanza" tfisser element kimiku u l-komposti tiegħu fl-istat naturali jew miksuba bi kwalunkwe proċess tal-produzzjoni, inkluż kwalunkwe addittiv meħtieġ biex jippreżerva l-istabbiltà tal-prodotti u kwalunkwe impurità li tirriżulta mill-proċess użat, iżda li jeskludi kwalunkwe solvent li jista' jiġi sseparat mingħajr ma jeffettwa l-istabbiltà tas-sustanza jew jibdel il-kompożizzjoni tagħha;

(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) "sustanza li tgħaqqad" tfisser sustanza waħda jew aktar fil-fluwidu bażiku użata biex tgħaqqad jew timmodifika r-rejoliġija ta’ fluwidu jew griż lubrikanti;

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

(5) "komponent ewlieni" tfisser kwalunkwe sustanza li ssarraf għal aktar minn 5 % tal-piż tal-lubrikant;

(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) "addittiv" tfisser sustanza jew taħlita li l-funzjonijiet ewlenin tagħha huma t-titjib tal-proprjetajiet tal-fluss, kemm jibqa’ tajjeb matul iż-żmien, il-lubriċità u r-reżistenza għall-kedd jew is-sospensjoni tal-kontaminanti;

(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) "griż" tfisser taħlita solida għal semisolida li tikkonsisti f'sustanza li tgħaqqad u tista' tinkludi ingredjenti oħrajn li jagħtu proprjetajiet speċjali f'lubrikant likwidu.

Article 3

Artikolu 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.

Sabiex prodott jingħata l-Ekotikketta tal-UE skont ir-Regolament (KE) Nru 66/2010, għandu jaqa’ fil-grupp tal-prodotti "lubrikanti" kif definit fl-Artikolu 1 ta’ din id-Deċiżjoni u għandu jkun konformi mal-kriterji kif ukoll mar-rekwiżiti tal-valutazzjoni u l-verifika relatati stabbiliti fl-Anness għal din id-Deċiżjoni.

Article 4

Artikolu 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.

Il-kriterji ekoloġiċi għall-grupp ta’ prodotti "lubrikanti", kif ukoll ir-rekwiżiti tal-valutazzjoni u l-verifika relatati, għandhom ikunu validi għal erba’ snin mid-data tal-adozzjoni ta’ din id-Deċiżjoni.

Article 5

Artikolu 5

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

Għall-finijiet amministrattivi, in-numru tal-kodiċi assenjat lill-grupp tal-prodotti "lubrikanti" għandu jkun "027".

Article 6

Artikolu 6

Decision 2005/360/EC is repealed.

Id-Deċiżjoni 2005/360/KE hija rrevokata.

Article 7

Artikolu 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. B’deroga mill-Artikolu 6, l-applikazzjonijiet għall-Ekotikketta tal-UE għal prodotti li jaqgħu taħt il-grupp tal-prodotti "lubrikanti" sottomessi qabel id-data tal-adozzjoni ta’ din id-Deċiżjoni għandhom jiġu evalwati skont il-kundizzjonijiet stabbiliti fid-Deċiżjoni 2005/360/KE.

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. L-applikazzjonijiet għall-Ekotikketta tal-UE għal prodotti li jaqgħu taħt il-grupp tal-prodotti "lubrikanti" sottomessi mid-data tal-adozzjoni ta’ din id-Deċiżjoni iżda sat- 30 ta’ Ġunju 2011 l-aktar tard jistgħu jkunu bbażati fuq il-kriterji stipulati fid-Deċiżjoni 2005/360/KE jew fil-kriterji stipulati f'din id-Deċiżjoni. Dawk l-applikazzjonijiet għandhom jiġu evalwati skont il-kriterji li fuqhom huma bbażati.

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. Fejn l-Ekotikketta tal-UE tingħata abbażi ta’ applikazzjoni evalwata skont il-kriterji stabbiliti fid-Deċiżjoni 2005/360/KE, dik l-Ekotikketta tal-UE tista' tintuża għal 12-il xahar mid-data tal-adozzjoni ta’ din id-Deċiżjoni.

Article 8

Artikolu 8

This Decision is addressed to the Member States.

Din id-Deċiżjoni hija indirizzata lill-Istati Membri.

Done at Brussels, 24 June 2011.

Magħmul fi Brussell, l- 24 ta’ Ġunju 2011.

For the Commission

Għall-Kummissjoni

Janez Potočnik

Member of the Commission

Membru tal-Kummissjoni

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

[1] ĠU L 27, 30.1.2010, p. 1.

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

[2] ĠU L 118, 5.5.2005, p. 26.

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ANNEX

ANNESS

FRAMEWORK

QAFAS

The aims of the criteria

Għanijiet tal-kriterji

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.

Dawn il-kriterji jimmiraw b’mod partikolari lejn il-promozzjoni ta’ prodotti li għandhom impatt imnaqqas fuq l-ilma u l-ħamrija matul l-użu tagħhom u fihom frazzjoni kbira ta’ materjal b’bażi bijoloġika.

CRITERIA

KRITERJI

1. Excluded or limited substances and mixtures

1. Sustanzi u taħlitiet esklużi jew limitati

2. Exclusion of specific substances

2. Esklużjoni ta’ sustanzi speċifiċi

3. Additional aquatic toxicity requirements

3. Rekwiżiti addizzjonali għat-tossiċità akkwatika

4. Biodegradability and bioaccumulative potential

4. Bijodegradabbiltà u potenzjal bijoakkumulattiv

5. Renewable raw materials

5. Materja prima rinnovabbli

6. Minimum technical performance

6. Prestazzjoni teknika minima

7. Information appearing on the EU Ecolabel

7. Informazzjoni li tidher fuq l-Ekotikketta tal-UE

Assessment and verification requirements

Rekwiżiti tal-valutazzjoni u l-verifika

(a) Requirements

(a) Rekwiżiti

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

Ir-rekwiżiti speċifiċi tal-valutazzjoni u l-verifika huma indikati f’kull kriterju.

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.

Meta l-applikant ikun meħtieġ jipprovdi dikjarazzjonijiet, dokumentazzjoni, analiżi, rapporti tat-testijiet jew evidenza oħra biex juri l-konformità mal-kriterji lill-korp kompetenti, huwa mifhum li dawn jistgħu joriġinaw mill-applikant u/jew mill-fornitur(i) tiegħu u/jew il-fornitur(i) tagħhom, eċċ., kif jixraq.

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

Il-fornitur tal-addittiv, is-sustanza li tgħaqqad jew il-fluwidu bażiku jista’ jipprovdi l-informazzjoni rilevanti direttament lill-korp kompetenti.

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

Fejn possibbli, it-testijiet għandhom jitwettqu minn laboratorji li jissodisfaw ir-rekwiżiti ġenerali tal-EN ISO 17025 jew ekwivalenti.

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

Fejn jixraq, jistgħu jintużaw metodi tal-ittestjar differenti minn dawk indikati għal kull kriterju jekk il-korp kompetenti li qed jivvaluta l-applikazzjoni jaċċetta l-ekwivalenza tagħhom.

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

Fejn jixraq, il-korpi kompetenti jistgħu jitolbu dokumentazzjoni ta’ appoġġ u jistgħu jwettqu verifiki indipendenti.

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

L-iskema ġenerali għall-valutazzjoni ta’ kwalunkwe sustanza konstitwenti fi prodott lubrikant qed tingħata fit-Tabella 1.

(b) Measurement thresholds

(b) Limiti tal-kejl

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.

Is-sustanzi konstitwenti kollha li huma preżenti b’aktar minn 0 010 % (w/w) u li huma miżjuda intenzjonalment u/jew iffurmati intenzjonalment wara xi reazzjoni kimika fil-lubrikant applikat, għandhom jiġu imsemmija b’mod ċar b’isimhom u l-konċentrazzjonijiet tal-massa li fihom huma preżenti u fejn applikabbli, in-numri tagħhom tar-Reġistru tal-CAS u tar-Reġistru tal-KE.

The criteria shall apply as follows:

Il-kriterji għandhom japplikaw kif ġej:

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

- għal-lubrikant applikat għal kriterji 1a, 6 u 7,

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

- għal kull sustanza imsemmija miżjuda jew ffurmata intenzjonalment b’aktar minn 0 010 % (w/w) għall-kriterji 1b u 2,

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

- għal kull sustanza imsemmija miżjuda jew ffurmata intenzjonalment b’aktar minn 0.10 % (w/w) għall-kriterji 3, 4 u 5.

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).

Barra minn hekk, il-frazzjoni totali tas-sustanzi msemmija fejn ma japplikawx il-kriterji fformulati 3 u 4 għandha tibqa’ anqas minn 0,5 % (w/w).

EU ECOLABEL CRITERIA

KRITERJI TAL-EKOTIKKETTA TAL-UE

Criterion 1 – Excluded or limited substances and mixtures

Kriterju 1 – Sustanzi jew taħlitiet esklużi jew limitati

(a) Hazardous substances and mixtures

(a) Sustanzi u taħlitiet perikolużi

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.

Skont l-Artikolu 6(6) tar-Regolament (KE) Nru 66/2010, dwar l-Ekotikketta tal-UE, il-prodott jew kwalunkwe parti minnu ma għandux ikollu sustanzi (fi kwalunkwe forma, inkluż forma nano) li jissodisfaw il-kriterji għal klassifikazzjoni bid-dikjarazzjonijiet ta’ periklu jew il-frażijiet ta’ riskju speċifikati hawn taħt skont ir-Regolament (KE) Nru 1272/2008 tal-Parlament Ewropew u tal-Kunsill [1], jew id-Direttiva tal-Kunsill 67/548/KEE [2] u l-anqas ma għandu jkun fih is-sustanzi msemmija fl-Artikolu 57 tar-Regolament (KE) Nru 1907/2006 tal-Parlament Ewropew u tal-Kunsill [3]. Il-frażijiet tar-riskju hawn taħt ġeneralment jirreferu għal sustanzi. Il-forom nano miżjuda mal-prodott intenzjonalment iridu jagħtu prova tal-konformità ma’ dan il-kriterju għal kwalunkwe konċentrazzjoni.

List of hazard statements and risk phrases:

Lista ta’ dikjarazzjonijiet ta’ periklu u frażijiet ta’ riskju:

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

Dikjarazzjoni ta’ Periklu [4] | Frażi ta’ Riskju [5] |

H300 Fatal if swallowed | R28 |

H300 Fatali jekk jinbela’ | R28 |

H301 Toxic if swallowed | R25 |

H301 Tossiku jekk jinbela’ | R25 |

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

H304 Jista’ jkun fatali jekk jinbela’ u jidħol fil-pajpijiet tan-nifs | R65 |

H310 Fatal in contact with skin | R27 |

H310 Fatali jekk jiġi f’kuntatt mal-ġilda | R27 |

H311 Toxic in contact with skin | R24 |

H311 Tossiku jekk jiġi f’kuntatt mal-ġilda | R24 |

H330 Fatal if inhaled | R26 |

H330 Fatali jekk jinġibed man-nifs | R26 |

H331 Toxic if inhaled | R23 |

H331 Tossiku jekk jinġibed man-nifs | R23 |

H340 May cause genetic defects | R46 |

H340 Jista’ jikkawża difetti ġenetiċi | R46 |

H341 Suspected of causing genetic defects | R68 |

H341 Suspettat li jikkawża difetti ġenetiċi | R68 |

H350 May cause cancer | R45 |

H350 Jista’ jikkawża l-kanċer | R45 |

H350i May cause cancer by inhalation | R49 |

H350i Jista’ jikkawża l-kanċer meta jinġibed man-nifs | R49 |

H351 Suspected of causing cancer | R40 |

H351 Suspettat li jikkawża l-kanċer | R40 |

H360F May damage fertility | R60 |

H360F Jista’ jagħmel ħsara lill-fertilità | R60 |

H360D May damage the unborn child | R61 |

H360D Jista’ jagħmel ħsara lit-tarbija li għadha fil-ġuf. | R61 |

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

H360FD Jista’ jagħmel ħsara lill-fertilità Jista’ jagħmel ħsara lit-tarbija li għadha fil-ġuf. | R60; R61; R60-61 |

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

H360Fd Jista’ jagħmel ħsara lill-fertilità Suspettat li jagħmel ħsara lit-tarbija li għadha fil-ġuf. | R60-R63 |

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

H360Df Jista’ jagħmel ħsara lit-tarbija li għadha fil-ġuf. Suspettat li jagħmel ħsara lill-fertilità | R61-R62 |

H361f Suspected of damaging fertility | R62 |

H361f Suspettat li jagħmel ħsara lill-fertilità | R62 |

H361d Suspected of damaging the unborn child | R63 |

H361d Suspettat li jagħmel ħsara lit-tarbija li għadha fil-ġuf. | R63 |

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

H361fd Suspettat li jagħmel ħsara lill-fertilità. Suspettat li jagħmel ħsara lit-tarbija li għadha fil-ġuf. | R62-63 |

H362 May cause harm to breast fed children | R64 |

H362 Jista’ jikkawża ħsara lit-tfal imreddgħa | R64 |

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

H370 Jikkawża ħsara lill-organi | 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 Jista’ jikkawża ħsara lill-organi | R68/20; R68/21; R68/22 |

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

H372 Jikkawża ħsara lill-organi wara espożizzjoni għal żmien twil jew ripetuta | R48/25; R48/24; R48/23 |

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

H373 Jista’ jikkawża ħsara lill-organi wara espożizzjoni għal żmien twil jew ripetuta | R48/20; R48/21; R48/22 |

H400 Very toxic to aquatic life | R50 |

H400 Tossiku ħafna għall-ħajja akkwatika | R50 |

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

H410 Tossiku ħafna għall-ħajja akkwatika b’effetti għall-żmien twil | R50-53 |

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

H411 Tossiku għall-ħajja akkwatika b’effetti għall-żmien twil | R51-53 |

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

H412 Jagħmel ħsara lill-ħajja akkwatika b’effetti għall-żmien twil | R52-53 |

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

H413 Jista’ jikkawża effetti ta’ ħsara għall-żmien twil lill-ħajja akkwatika | R53 |

EUH059 Hazardous to the ozone layer | R59 |

EUH059 Perikoluż għas-saff tal-ożonu | R59 |

EUH029 Contact with water liberates toxic gas | R29 |

EUH029 Meta jmiss mal-ilma jarmi gass tossiku | R29 |

EUH031 Contact with acids liberates toxic gas | R31 |

EUH031 Meta jmiss mal-aċidi jarmi gass tossiku | R31 |

EUH032 Contact with acids liberates very toxic gas | R32 |

EUH032 Meta jmiss mal-aċidi jarmi gass tossiku ħafna | R32 |

EUH070 Toxic by eye contact | R39-41 |

EUH070 Tossiku meta jmiss mal-għajnejn | R39-41 |

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

Dan il-kriterju għandu japplika wkoll għad-dikjarazzjonijet ta’ periklu u l-frażijiet tar-riskju li ġejjin:

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

Dikjarazzjoni ta’ Periklu [6] | Frażi tar-Riskju [7] |

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

H334: Jista’ jikkawża sintomi ta’ allerġija jew ta’ ażma jew diffikultajiet biex jittieħed in-nifs jekk jinġibed man-nifs | R42 |

H317: May cause allergic skin reaction | R43 |

H317: Jista’ jikkawża reazzjoni allerġika tal-ġilda | R43 |

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

H314 Jikkawża ħruq kbir fil-ġilda u ħsara fl-għajnejn | R34; R35 |

H319 Causes serious eye irritation | R36 |

H319 Jikkawża irritazzjoni serja fl-għajnejn | R36 |

H315 Causes skin irritation | R38 |

H315 Jikkawża irritazzjoni fil-ġilda | R38 |

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

EUH066 Espożizzjoni ripetuta tista’ twassal għal tnixxif jew qsim fil-ġilda | R66 |

H336 May cause drowsiness and dizziness | R67 |

H336 Jista’ jikkawża n-ngħas u sturdament | 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.

Sustanzi jew taħlitiet li mal-ipproċessar jibdlu l-proprjetajiet tagħhom (eż. ma jibqgħux aktar bijodisponibbli, jgħaddu minn modifika kimika) b’mod li l-periklu identifikat ma japplikax aktar, huma eżentati mir-rekwiżit ta’ hawn fuq.

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).

Il-limiti ta’ konċentrazzjoni għal sustanzi li jissodisfaw il-kriterji tal-Artikolu 57(a), (b) jew (c) tar-Regolament (KE) Nru 1907/2006 ma għandhomx jaqbżu l-0 010 % (w/w). Jekk jiġu imsemmija limiti speċifiċi ta’ konċentrazjoni għal sustanzi li jissodisfaw il-kriterji tal-Artikolu 57 (a), (b) jew (c), dawn għandhom jibqgħu anqas minn wieħed f’għaxra (1/10) tal-valur l-iżjed baxx tal-konċentrazzjoni speċifika indikata sakemm dan il-valur ma jaqax taħt il-0,010 % (w/w).

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

Derogi mill-Kriterju 1a huma elenkati fit-Tabella 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.

Valutazzjoni u verifika tal-kriterju: l-applikant għandu jipprovdi l-formulazzjoni eżatta tal-prodott lill-korp kompetenti. L-applikant għandu juri l-konformità ma’ dan il-kriterju għal sustanzi fil-prodott abbażi ta’ informazzjoni li tikkonsisti minimalment għal dak speċifikat fl-Anness VII għar-Regolament (KE) Nru 1907/2006. Tali informazzjoni għandha tkun speċifika għal forma partikolari tas-sustanza, inkluż il-forom nano, użati fil-prodott. Għalhekk, l-applikant għandu jipprovdi stqarrija tal-konformità ma’ dan il-kriterju, flimkien ma’ lista tal-ingredjenti u l-Iskedi tad-Dejta tas-Sikurezza relatati skont l-Anness II għar-Regolament (KE) Nru 1907/2006 għal prodott kif ukoll għas-sustanzi kollha elenkati fil-formulazzjoni(jiet). Il-limiti ta’ konċentrazzjoni għandhom jiġu speċifikati fl-Iskedi tad-Dejta tas-Sikurezza skont l-Artikolu 31 tar-Regolament (KE) Nru 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].

Għandu jkun hemm biżżejjed dejta disponibbli li tippermetti l-evalwazzjoni tal-perikli ambjentali (indikati permezz tad-dikjarazzjonijiet tal-periklu H400 – H413 jew il-frażijiet tar-riskju: R 50, R 50/53, R 51/53, R 52, R 52/53, R 53), tal-prodott skont ir-Regolament (KE) Nru 1272/2008 jew id-Direttiva 67/548/KEE u d-Direttiva 1999/45/KE tal-Parlament Ewropew u tal-Kunsill [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.

L-evalwazzjoni ta’ prodott għall-perikli għall-ambjent għandha ssir permezz ta’ metodu konvenzjonali kif indikat fl-Anness III għad-Direttiva 1999/45/KE jew permezz tal-metodu ta’ addizzjoni fit-taqsima 4.1.3.5.2 tar-Regolament (KE) Nru 1272/2008. Madankollu, kif imfisser fil-parti C tal-Anness III għad-Direttiva 1999/45KE jew permezz tat-taqsima 4.1.3.3 tar-Regolament (KE) Nru 1272/2008, ir-riżultati tal-ittestjar tal-preparazzjoni (il-preparazzjoni tal-prodott jew il-pakkett ta’ addittivi) bħala tali jistgħu jintużaw biex jimmodifikaw il-klassifika fir-rigward tat-tossiċità akkwatika li kienet tinkiseb kieku ntuża l-metodu konvenzjonali jew tal-addizzjoni.

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

(b) Sustanzi elenkati skont l-Artikolu 59(1) tar-Regolament (KE) Nru 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).

Ma għandha tingħata l-ebda deroga mill-esklużjoni fl-Artikolu 6(6) tar-Regolament (KE) Nru 66/2010 fir-rigward ta’ sustanzi identifikati bħala sustanzi ta’ tħassib serju ħafna u inklużi fil-lista prevista fl-Artikolu 59 tar-Regolament (KE) Nru 1907/2006, meta preżenti f’taħlitiet, f’konċentrazzjonijiet ogħla minn 0,010 % (w/w).

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:

Valutazzjoni u verifika: il-lista ta’ sustanzi identifikati bħala sustanzi ta’ tħassib serju ħafna u inklużi fil-lista tal-kandidati skont l-Artikolu 59 tar-Regolament (KE) Nru 1907/2006 tinsab hawn:

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.

Fid-data tal-applikazzjoni għandha ssir referenza għal-lista.

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].

Il-limiti ta’ konċentrazzjoni għandhom ikunu speċifikati fl-Iskedi tad-Dejta tas-Sikurezza skont l-Anness II, il-paragrafu 3.2.1(c) għar-Regolament tal-Kummissjoni (UE) Nru 453/2010 [9].

Criterion 2 – Exclusion of specific substances

Kriterju 2 – Esklużjoni ta’ sustanzi speċifiċi

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

Is-sustanzi msemmija li ġejjin ma jistgħux ikunu fi kwantitajiet li jaqbżu l-0 010 % (w/w) tal-prodott finali:

- 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),

- Sustanzi li jidhru fil-Lista tal-Unjoni tas-sustanzi ta’ prijorità fil-qasam tal-politika tal-ilma fl-Anness X għad-Direttiva 2000/60/KE tal-Parlament Ewropew u tal-Kunsill [10] kif emendata permezz tad-Deċiżjoni 2455/2001/KE [11] u l-Lista OSPAR tal-Kimiċi għall-Azzjoni Prijoritarja (http://www.ospar.org/content/content.asp?menu = 00950304450000_000000_000000)

- organic halogen compounds and nitrite compounds,

- Komposti tal-aloġenu organiku u komposti tan-nitrit

- 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.

- Metalli jew komposti metalliċi bl-eċċezzjoni tas-sodju, il-potassju, il-magneżju u l-kalċju. Fil-każ tas-sustanzi li jgħaqqdu, jistgħu jintużaw ukoll komposti tal-litju u/jew tal-aluminju sa livelli ta’ konċentrazzjoni limitati mill-kriterji l-oħrajn inklużi fl-Anness għal din id-Deċiżjoni.

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

Valutazzjoni u verifika: il-konformità ma’ dawn ir-rekwiżiti għandha tiġi msemmija bil-miktub u ffirmata mill-applikant.

Criterion 3 – Additional aquatic toxicity requirements

Kriterju 3 – Rekwiżiti addizzjonali dwar it-tossiċità akkwatika

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

L-applikant għandu juri l-konformità billi jissodisfa r-rekwiżiti tal-kriterju 3.1 jew tal-kriterju 3.2.

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

Kriterju 3.1. – Rekwiżiti għal-lubrikant u l-komponenti ewlenin tiegħu

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

Għandha tiġi pprovduta dejta dwar it-tossiċità akkwatika akuta tal-komponenti ewlenin u t-taħlita.

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.

Għandha tiġi imsemmija dejta dwar it-tossiċità akkwatika akuta għal kull komponent ewlieni dwar kull wieħed miż-żewġ livelli trofiċi li ġejjin: alka u dafnja [12]. Il-konċentrazzjoni kritika għat-tossiċità akkwatika akuta għal kull komponent ewlieni għandha tkun mill-inqas 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.

Għandha tiġi msemmija dejta dwar it-tossiċità akkwatika akuta għal-lubrikant applikat fuq kull wieħed mit-tliet livelli trofiċi li ġejjin: alka, dafnja u ħut. Il-konċentrazzjoni kritika għat-tossiċità akkwatika akuta għal lubrikant fil-Kategorija 1 u 5 għandha tkun mill-inqas 100 mg/l u għal lubrikant fil-Kategorija 2, 3 u 4 mill-inqas 1000 mg/l.

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

It-Tabella 2 fiha sommarju tar-rekwiżiti għall-kategoriji differenti ta’ lubrikant skont il-Kriterju 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.

Valutazzjoni u verifika: huma aċċettati kemm dejta tat-tossiċità tal-baħar kif ukoll tal-ilma ħelu. It-testijiet isiru skont, u bl-użu ta’ speċijiet rilevanti għat-test, imsemmija fil-linji gwida li ġejjin: ISO/DIS 10253 jew OECD 201 jew Parti C.3. tal-Anness għar-Regolament tal-Kunsill (KE) Nru 440/2008 [13] għall-alka, ISO TC 147/SC5/WG2 jew OECD 202 jew Parti C.2. tal-Anness għar-Regolament (KE) Nru 440/2008 għad-dafnja u OECD 203 jew Parti C.1 tal-Anness għar-Regolament (KE) Nru 440/2008 għall-ħut. Huma permessi wkoll metodi tal-ittestjar ekwivalenti kif maqbula ma’ korp kompetenti. Huma aċċettati biss (72 siegħa) ErC50 għall-alka, (48 siegħa) EC50 għad-dafnja u (96 siegħa) LC50 għall-ħut.

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

Kriterju 3.2. – Rekwiżiti għal kull sustanza msemmija preżenti b’aktar minn 0,10 % (w/w)

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.

Għal kull wieħed miż-żewġ livelli trofiċi akkwatiċi li ġejjin għandha tissemma dejta dwar ir-riżultati tat-test tat-tossiċità kronika fil-forma ta’ Konċentrazzjoni ta’ Effett Mhux Osservat (NOEC - No Observed Effect Concentration): dafnja u ħut.

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.

Jekk ir-riżultati tat-testijiet tat-tossiċità kronika jkunu neqsin, għandhom jiġu pprovduti r-riżultati tat-testijiet tat-tossiċità akkwatika akuta għal kull wieħed miż-żewġ livelli trofiċi li ġejjin; alka u dafnja. Sustanza waħda jew aktar li juru ċertu grad ta’ tossiċità akkwatika huma permessi f’kull waħda mill-ħames kategoriji ta’ lubrikanti għal konċentrazzjoni kumulattiva tal-massa kif indikat fit-Tabella 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.

Valutazzjoni u verifika: Dejta dwar Konċentrazzjoni ta’ Effett Mhux Osservat (NOEC) għaż-żewġ livelli trofiċi, dafnja u ħut, huma stabbiliti permezz tal-metodi tal-ittestjar li ġejjin: Parti C.20 u Parti C.14 tal-Anness għar-Regolament (KE) Nru 440/2008 għal dafnja u ħut rispettivament, jew metodi tal-ittestjar ekwivalenti kif maqbul mal-korp kompetenti.

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.

Kemm dejta dwar it-tossiċità akuta tal-baħar jew tal-ilma ħelu huma aċċettati dwar l-alka u d-dafnja. It-testijiet fl-ilma baħar isiru skont, u bl-użu ta’, speċijiet rilevanti għat-test, imsemmija fil-linji gwida li ġejjin: ISO/DIS 10253 jew OECD 201 jew Parti C.3. tal-Anness għar-Regolament (KE) Nru 440/2008 għall-alka, ISO TC 147/SC5/WG2 jew OECD 202 jew Parti C.2 tal-Anness għar-Regolament (KE) Nru 440/2008 għad-dafnja u OECD 203 jew Parti C.1 tal-Anness għar-Regolament (KE) Nru 440/2008 għall-ħut. Huma permessi wkoll metodi ekwivalenti tat-test kif maqbul mal-korp kompetenti. Jiġu aċċettati biss (72 siegħa)ErC50 għall-alka u (48 siegħa)EC50 għad-dafnja.

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.

Valutazzjoni u verifika għall-Kriterji 3.1 u 3.2: għandhom jiġu sottomessi lill-korp kompetenti rapporti ta’ testijiet ta’ kwalità għolja jew dejta mill-letteratura (ittestjar skont protokolli aċċettabbli u l-GLP) inkluż ir-referenzi, u li juru konformità mar-rekwiżiti stabbiliti għat-tossiċità akkwatika fit-Tabella 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.

Fil-każ ta’ sustanzi jew preparazzjonijiet li jinħallu ftit (< 10 mg/l) jista’ jintuża l-metodu tal-Frazzjoni Akkomodata mill-Ilma (WAF — water-accommodated fraction) għad-determinazzjoni tat-tossiċità akkwatika. Il-livell ta’ tagħbija stabbilit, xi drabi magħruf bħala LL50 u marbut mat-tagħbija letali, jista’ jintuża direttament fil-kriterji tal-klassifikazzjoni. Il-preparazzjoni ta’ Frazzjoni Akkomodata mill-Ilma għandha ssegwi r-rakkomandazzjonijiet stabbiliti skont waħda mil-linji gwida li ġejjin; ECETOC Rapport Tekniku Nru 20 (1986), l-Anness III għall-OECD 1992 301 jew id-Dokument ta’ Gwida ISO 10634, jew l-ASTM D6081-98 (Prattika standard għall-Ittestjar tat-Tossiċità Akkwatika għal-Lubrikanti: (Standard practice for Aquatic Toxicity Testing for Lubricants:) Preparament tal-Kampjun u Interpretazzjoni tar-Riżultati jew metodi ekwivalenti (Sample Preparation and Results Interpretation or equivalent methods)). Barra minn hekk, id-demostrazzjoni tan-nuqqas ta’ tossiċità għal sustanza fil-limiti tagħha ta’ kemm tinħall fl-ilma għandha titqies li ssodisfat ir-rekwiżiti ta’ dan il-kriterju.

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

Studju tat-tossiċità akkwatika mhux meħtieġ li jsir meta:

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

- il-klassifika tas-sustanza, fluwidu bażiku jew addittiv diġà tissemma fil-lista tal-Klassifikazzjoni tas-Sustanza tal-Lubrikant jew

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

- tista’ tiġi sottomessa ittra valida ta’ konformità minn korp kompetenti jew

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

- mhux probabbli li s-sustanza taqsam membrani bijoliġiċi MM > 800 g/mol jew dijametru molekulari > 1,5 nm (> 15 Å) jew,

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

- is-sustanza hija polimeru u l-frazzjoni tal-piż molekulari anqas minn 1000 g/mol tkun inqas minn 1 % jew

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

- is-sustanza ftit li xejn tinħall fl-ilma (solubbiltà fl-ilma < 10 μg/l),

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

għaliex tali sustanzi mhumiex meqjusa tossiċi għall-alka u d-dafnja fis-sistema akkwatika.

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

Is-solubbiltà tas-sustanzi fl-ilma għandha tiġi determinata, fejn jixraq skont l-OECD 105 jew metodi ta’ testijiet ekwivalenti.

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.

Il-frazzjoni tal-piż molekulari inqas minn 1000 g/mol ta’ polimeru għandha tiġi determinata skont il-Parti A.19 tal-Anness għar-Regolament (KE) Nru 440/2008 jew metodi ta’ testijiet ekwivalenti.

Criterion 4 – Biodegradability and bioaccumulative potential

Kriterju 4 – Bijodegradibbiltà u potenzjal bijoakkumulattiv

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

Ir-rekwiżiti għall-potenzjal tal-bijodegradabbiltà u l-bijoakkumulattività għandhom jiġu sodisfatti għal kull sustanza imsemmija preżenti ‘l fuq minn 0,10 % (w/w).

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

Il-lubrikant ma għandux ikun fih sustanzi li huma kemm: mhux bijodegradabbli u (potenzjalment) bijoakkumulattivi.

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.

Madankollu, il-lubrikant jista’ jkun fih sustanza waħda jew aktar b’ċertu grad ta’ degradibbiltà jew bijoakkumulazzjoni potenzjali jew attwali sa konċentrazzjoni kumulattiva tal-massa kif indikat fit-Tabella 1.

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

Valutazzjoni u verifika: il-konformità għandha tintwera billi tiġi pprovduta l-informazzjoni li ġejja:

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.

Rapporti ta’ testijiet ta’ kwalità għolja jew dejta mill-letteratura (ittestjar skont protokolli aċċettabbli u l-GLP) inkluż ir-referenzi dwar il-bijodegradabbiltà u meta meħtieġ dwar il-bijoakkumulazzjoni (potenzjali) ta’ kull sustanza konstitwenti.

4.1. Biodegradation

4.1. Bijodegradazzjoni

A substance is considered ultimately biodegradable (aerobic) if:

Sustanza titqies li hija finalment bijodegradabbli (aerobika) jekk:

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. Fi studju tal-bijodegradabbiltà ta’ 28 jum skont il-Parti C.4 tal-Anness għar-Regolament (KE) Nru 440/2008, OECD 306, OECD 310 jinkisbu l-livelli li ġejjin tal-bijodegradazzjoni:

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

- fit-testijiet tal-bijodegradabbiltà finali bbażati fuq il-karbonju organiku maħlul ≥ 70 %;

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

- fit-testijiet tal-bijodegradabbiltà finali bbażati fuq it-tnaqqis tal-ossiġnu jew il-ġenerazzjoni tad-dijossidu tal-karbonju ≥ 60 % tal-massimu teoretiku.

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.

F’dawn it-testijiet tal-bijodegradabbiltà finali l-prinċipju ta’ apertura ta’ għaxart ijiem (10) mhux neċessarjament japplika. Jekk is-sustanza tilħaq il-livell rikjest ta’ bijodegradazzjoni fi żmien 28 jum iżda mhux fl-apertura ta’ għaxart ijiem (10), tiġi assunta rata ta’ bijodegradazzjoni aktar bil-mod.

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. Il-BOD5/ThOD jew il-proporzjon BOD5/COD ≥ 0,5. Il-proporzjon BOD5/(ThOD jew COD) jista’ jintuża biss jekk l-ebda dejta abbażi tal-Parti C.4 tal-Anness għar-Regolament (KE) Nru 440/2008, OECD 306 jew OECD 310 jew kwalunkwe metodu ieħor ta’ test ekwivalenti ma jkunu disponibbli. Il-BOD5 għandu jiġi vvalutat skont il-Parti C.5. tal-Anness għar-Regolament (KE) Nru 440/2008 jew metodi ekwivalenti filwaqt li l-COD għandu jiġi vvalutat skont il-Parti C.6. tal-Anness għar-Regolament (KE) Nru 440/2008 jew metodi ekwivalenti.

A substance is considered inherently biodegradable if it shows:

Sustanza titqies li hija bijodegradabbli b’mod inerenti jekk turi:

- 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

- bijodegradazzjoni > 70 % fil-Parti C.9. tal-Anness għar-Regolament (KE) Nru 440/2008 jew test tal-OECD 302 C għall-bijodegradazzjoni b’mod interenti jew metodi ekwivalenti, jew

- 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.

- bijodegradazzjoni > 20 % imma < 60 % wara 28 jum fil-Parti C.4. tal-Anness għar-Regolament (KE) Nru 440/2008, testijiet tal-OECD 306, l-OECD 310 ibbażati fuq it-tnaqqis tal-ossiġnu jew il-ġenerazzjoni tad-dijossidu tal-karbonju jew metodi ekwivalenti.

The biodegradation test does not need to be conducted when:

It-test tal-bijodegradazzjoni ma hemmx għalfejn isir meta:

- 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,

- il-klassifikazzjoni tas-sustanza, fluwidu bażiku jew addittiv tissemma diġà fil-lista tal-Klassifikazzjoni tas-Sustanzi Lubrikanti jew tista’ tiġi sottomessa ittra valida ta’ konformita minn korp kompetenti

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

- Sustanza mhix bijodegradabbli jekk ma tissodisfax il-kriterji tal-bijodegradabbiltà finali jew b’mod inerenti.

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.

L-applikant jista’ juża wkoll dejta read-across biex jistima l-bijodegradabbiltà ta’ sustanza. "Read-across" għall-valutazzjoni tal-bijodegradabbiltà ta’ sustanza għandha tkun aċċettabbli jekk is-sustanza ta’ referenza tkun differenti bi grupp funzjonali wieħed biss jew framment mis-sustanza applikata fil-prodott. Jekk is-sustanza ta’ referenza tkun bijodegradabbli diġà jew b’mod inerenti u l-grupp funzjonali jkollu effett pożittiv fuq il-bijodegradabbiltà aerobika, allura s-sustanża applikata tista’ wkoll tiġi kkunsidrata li hija faċilment bijodegradabbli jew b’mod inerenti. Gruppi funzjonali jew frammenti b’effett pożittiv fuq il-bijodegradazzjoni huma: l-alkoħol alifatiku u aromatiku [-OH], l-aċidu alifatiku u aromatiku [-C(= O)-OH], l-aldeid [-CHO], l-ester [-C(= O)-O-C], l-amidu [-C(= O)-N jew –C(= S)-N]. Għandha tiġi pprovduta dokumentazzjoni adegwata u affidabbli dwar l-istudju fuq is-sustanza ta’ referenza. Fil-każ ta’ tqabbil ma’ framment mhux inkluż hawn fuq, għandha tiġi pprovduta dokumentazzjoni adegwata u affidabbli dwar l-istudji fuq l-effetti pożittivi tal-grupp funzjonali fuq il-bijodegradazzjoni ta’ sustanzi strutturalment simili.

4.2. Bioaccumulation

4.2. Bijoakkumulazzjoni

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

Il-bijoakkumulazzjoni (potenzjali) ma hemmx għalfejn tkun stabbilita meta s-sustanza:

- has a MM > 800 g/mol, or

- għandha MM > 800 g/mol, jew

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

- għandha dijametru molekulari > 1,5 nm (> 15 Å), jew

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

- għandha koeffiċjent tal-parti oktanol-ilma, log Kow, valur ta’ < 3 jew > 7, jew

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

- għandha BCF imkejjel ta’ 100 L/kg, jew

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

- hija polimeru u l-frazzjoni tal-piż molekulari anqas minn 1000 g/mol tkun inqas minn 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.

Billi l-biċċa l-kbira tas-sustanzi użati fil-lubrikanti huma idrofobiċi b’mod sinifikanti, il-valur BCF għandu jkun ibbażat fuq il-kontentut tal-piż lipidu u għandha tingħata attenzjoni biex ikun hemm żmien ta’ espożizzjoni suffiċjenti.

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.

Il-fattur tal-bijokonċentrazzjoni (BCF) għandu jiġi vvalutat skont il-Parti C.13 tal-Anness għar-Regolament (KE) Nru 440/2008 jew metodi tal-ittestjar ekwivalenti.

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.

Il-koeffiċjent tal-parti oktanol-ilma (log Kow) għandu jiġi vvalutat skont il-Parti A.8 tal-Anness għar-Regolament (KE) Nru 440/2008 jew OECD 123 jew metodi tal-ittestjar ekwivalenti. Fil-każ ta’ sustanza organika differenti minn aġent tensjoattiv fejn mhuwiex disponibbli valur esperminentali, jista’ jintuża metodu ta’ kalkulazzjoni. Huma permessi il-metodi tal-kalkulazzjoni li ġejjin: CLOGP, LOGKOW, (KOWWIN) u SPARC. Valuri log Kow stmati minn kwalunkwe minn dawn il-metodi ta’ kalkulazzjoni < 3 or > 7 jindikaw li s-sustanza mhijiex mistennija li tagħmel bijoakkumulazzjoni.

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.

Il-valuri Log Kow huma applikabbli biss għal kimiċi organiċi. Sabiex jiġi vvalutat il-potenżjal ta’ bijoakkumulazzjoni ta’ komposti mhux organiċi, aġenti tensjoattivi u xi komposti organometalliċi, għandu jsir kejl BCF.

Criterion 5 – Renewable raw materials

Kriterju 5 – Materji primi rinnovabbli

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

Il-prodott formulat għandu jkun fih kontenut tal-karbonju miksub minn materji primi rinnovabbli li għandhom ikunu:

- ≥ 50 % (m/m) for Category 1,

- ≥ 50 % (m/m) għall-Kategorija 1,

- ≥ 45 % (m/m) for Category 2,

- ≥ 45 % (m/m) għall-Kategorija 2,

- ≥ 70 % (m/m) for Category 3,

- ≥ 70 % (m/m) għall-Kategorija 3,

- ≥ 50 % (m/m) for Category 4,

- ≥ 50 % (m/m) għall-Kategorija 4,

- ≥ 50 % (m/m) for Category 5.

- ≥ 50 % (m/m) għall-Kategorija 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.

Kontenut tal-karbonju miksub minn materji primi rinnovabbli jfisser il-persentaġġ tal-massa tal-komponent A × [għadd ta’ atomi-C fil-komponent A, li huma miksuba minn żjut (veġetali) jew xaħmijiet (mill-annimali) diviż bl-għadd totali ta’ atomi-C fil-komponernt A] flimkien mal-persentaġġ tal-massa tal-komponent B × [għadd ta’ atomi-C fil-komponent B, li huma miksuba minn żjut (veġetali) jew xaħmijiet (mill-annimali) diviż bl-għadd totali ta’ atomi-C fil-komponernt B] flimkien mal-persentaġġ tal-massa tal-komponent C × [għadd ta’ atomi-C fil-komponent C, li huma miksuba minn żjut (veġetali) jew xaħmijiet (mill-annimali) diviż bl-għadd totali ta’ atomi-C fil-komponernt C] u jkompli hekk.

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

L-applikant għandu jindika fuq l-applikazzjoni it-tip(i), is-sors(i) u l-oriġini tal-materjal(i) rinnovabbli tal-komponenti ewlenin.

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

Valutazzjoni u verifika: l-applikant għandu jipprovdi lill-korp kompetenti dikjarazzjoni ta’ konformità ma’ dan il-kriterju.

Criterion 6 – Minimum technical performance

Kriterju 6 – Prestazzjoni teknika minima

(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) Għal Fluwidi idrawliċi: tal-inqas il-kriterji tal-prestazzjoni teknika kif stabbilit fl-ISO 15380 attwali, it-Tabelli 2 sa 5. Il-fornitur għandu jelenka liema 2 elastomers ġew ittestjati fuq l-iskeda tal-informazzjoni tal-prodott tiegħu.

(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) Għal Żjut industrijali u tat-tagħmir tal-baħar: tal-inqas ir-rekwiżiti tal-prestazzjoni teknika kif stabbilit f’DIN 51517. Il-fornitur għandu jelenka liema taqsima intgħażlet (I, II jew III) fuq l-iskeda tal-informazzjoni tal-prodott tiegħu.

(c) Għal żjut tas-serrieq mekkaniku tal-katina: tal-inqas il-kriterji tekniċi tal-prestazzjoni kif stabbiliti fil-RAL UZ 48 tal-Blue Angel.

(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) Għaż-żjut two-stroke għall-applikazzjonijiet tal-baħar: tal-inqas il-kriterji tekniċi tal-prestazzjoni stabbiliti fin-"NMMA Certification for Two-Stroke Cycle Gasoline Engine Lubricants" tal-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) Għaż-żjut two-stroke għall-applikazzjonijiet terrestri: tal-inqas jissodisfaw il-livell EGD tal-kriterji tekniċi tal-prestazzjoni stabbiliti f’ISO 13738:2000.

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

(f) Għal lubrikanti l-oħrajn kollha: tajbin biżżejjed għall-iskop tagħhom.

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

Valutazzjoni u verifika: l-applikant għandu jipprovdi lill-korp kompetenti dikjarazzjoni ta’ konformità ma’ dan il-kriterju, flimkien mad-dokumentazzjoni relatata.

Criterion 7 – Information appearing on the eco-label

Kriterju 7 – Informazzjoni li tidher fuq l-Ekotikketta

Optional label with text box shall contain the following text:

It-tikketta fakultattiva b’kaxxa tat-test għandha tinkludi t-test li ġej:

- "— Reduced harm for water and soil during use

- "— Inqas ħsara għall-ilma u l-ħamrija waqt l-użu

- — Contain a large fraction of biobased material".

- — Fih frazzjoni kbira ta’ materjal b’bażi bijoloġika".

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

Il-linji gwida għall-użu tat-tikketta fakultattiva bil-kaxxa tat-test jinsabu fil-"Guidelines for the use of the EU Ecolabel logo (Linji gwida għall-użu tal-logo tal-Ekotikketta tal-UE)" fuq is-sit tal-Internet: 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.

Valutazzjoni u verifika: l-applikant għandu jipprovdi lill-korp kompetenti kampjun tal-imballaġġ tal-prodott li juri t-tikketta, flimkien ma’ dikjarazzjoni ta’ konformità ma’ dan il-kriterju.

Table 1

Tabella 1

Criteria for the lubricant and each stated substance

Kriterji għal-lubrikant u għal kull sustanza msemmija

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 |

KategorijaKriterji | Fluwidi idrawliċi u żjut tat-trażmissjoni tat-tratturi | Griżijiet u griżijiet tat-tutbu tal-istern | Żjut tas-serrieq mekkaniku tal-katina, aġenti tar-rilaxx tal-konkrit, lubrikanti tal-ħbula tal-wajer u lubrikanti oħrjan ta’ telf totali | Żjut terrestri u tal-baħar two-stroke | Żjut industrijali u tat-tagħmir tal-baħar |

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) |

Dikjarazzjoni ta’ periklu Ambjentali jew għas-Saħħa jew Frażi tar-Riskju tal-lubrikant fi żmien l-applikazzjoni | Xejn (L-iżjed limitu baxx tal-klassifikazzjoni fir-Regolament (KE) Nru 1272/2008 jew id-Direttiva 1999/45/KE) | Xejn (L-iżjed limitu baxx tal-klassifikazzjoni fir-Regolament (KE) Nru 1272/2008 jew id-Direttiva 1999/45/KE) | Xejn (L-iżjed limitu baxx tal-klassifikazzjoni fir-Regolament (KE) Nru 1272/2008 jew id-Direttiva 1999/45/KE) | Xejn (L-iżjed limitu baxx tal-klassifikazzjoni fir-Regolament (KE) Nru 1272/2008 jew id-Direttiva 1999/45/KE) | Xejn (L-iżjed limitu baxx tal-klassifikazzjoni fir-Regolament (KE) Nru 1272/2008 jew id-Direttiva 1999/45/KE) |

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 % |

Elenkati fl-OSPAR, il-lista tal-Unjoni tas-sustanzi ta’ prijorità fil-qasam tal-politika tal-ilma; aloġeni organiċi; nitriti; metalli u komposti metalliċi bl-eċezzjoni ta’ Na, K, Mg, Ca au għas-sustanzi li jgħaqqdu Li, Al; CMR cat 1,2 (R45, R46, R49, R60 jew R61); il-lista tal-kandidati għall-Anness XIV għar-Regolament (KE) Nru 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 |

Tossiċità akkwatika (Criterion 3.2 only) | Perċentwali kumulattivi tal-massa (% w/w) tas-sustanzi preżenti fi |

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

Mhux tossiku (D) | Tossiċità akuta > 100 mg/L jew NOEC > 10 mg/L | Mhux limitat |

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

Jagħmel il-ħsara (E) | 10 mg/L < Tossiċità akuta ≤ 100 mg/L jew 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 |

Tossiku (F) | 1 mg/L < Tossiċità akuta ≤ 10 mg/L jew 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] |

Tossiku ħafna (G) | Tossiċità akuta ≤ 1 mg/L jew 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 |

Bijodegredazzjoni u Bijoakkumulazzjoni (Kriterju 4) | Perċentwali kumulattivi tal-massa (% w/w) tas-sustanzi preżenti fi |

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

Finalment bijodegradabbli aerobikament (A) | > 90 | > 75 | > 90 | > 75 | > 90 |

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

Bijodegradabbli aerobikament b’mod interenti (B) | ≤ 5 | ≤ 25 | ≤ 5 | ≤ 20 | ≤ 5 |

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

Mhux bijodegradabbli U mhux bijoakkumulattiv (C) | ≤ 5 | ≤ 5 | ≤ 10 | ≤ 5 |

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

Mhux bijodegradabbli U bijoakkumulattiv (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 |

Frazzjoni mhux ivvalutata għat-tossiċità akkwatika (Kriterju 3.2) jew bijodegredazzjoni/bijoakkumulazzjoni (Kriterju 4) | Perċentwali kumulattivi tal-massa (% w/w) tas-sustanzi preżenti fi |

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

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

Rennovabbiltà (Kriterju 5) | Perċentwali kumulattivi tal-massa (% w/w) tas-sustanzi preżenti fi |

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

Ibbażat fuq il-karbonju | ≥ 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 |

Prestazzjoni teknika minima (Kriterju 6) | Fluwidi idrawliċi: ISO 15380 Tabelli 2 sa 5 Żjut tat-tra’missjoni tat-tratturi tajbin biżżejjed għall-iskop tagħhom. | Tajbin biżżejjed għall-iskop tagħhom. | Żjut tas-serrieq mekkaniku tal-katina: Bħal RAL UZ 48. Oħrajn: tajbin biżżejjed għall-iskop tagħhom. | Żjut-2T tal-baħar: Bħal f’NMMA TC-W3. Żjut-2T terrestri: bħal-livell EGD f’ISO 13738:2000 | Żjut industrijali u tat-tagħmir tal-baħar DIN 51517 |

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

fattur tal-multiplikazzjoni (M) | Valur LC50 jew EC50 ("L(E)C50") ta’ sustanza |

1 | 0,1 < L(E)C50 ≤ 1 |

10 | 0,01 < L(E)C50 ≤ 0,1 |

10 | 0,01 < L(E)C50 ≤ 0.1 |

100 | 0,001 < L(E)C50 ≤ 0,01 |

100 | 0,001 < L(E)C50 ≤ 0.01 |

1000 | 0,0001 < L(E)C50 ≤ 0,001 |

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). |

Għal sustanzi li għandhom valur LC50 jew EC50 iktar baxx minn 0,0001 mg/l, il-limiti ta’ konċentrazzjoni korrispondenti huma kkalkulati kif xieraq (f’intervalli ta’ fattur ta’ 10). |

Table 2

Tabella 2

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

Rekwiċiti tat-tossiċità akkwatika għall-kategoriji differenti tal-lubrikanti – Rekwiżiti tad-dejta u l-komponenti ewlenin tiegħu

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 |

Tossiċità akkwatika akuta għal-lubrikant ippreparat frisk fuq tliet livell trofiċi, alka dafnja u ħut | > 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 |

Tossiċità akkwatika akuta għal kull komponent ewlieni fuq iż-żewġ livelli trofiċi alka u dafnja | > 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] ĠU L 353, 31.12.2008, p. 1.

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

[2] ĠU 196, 16.8.1967, p. 1.

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

[3] ĠU L 396, 30.12.2006, p. 1.

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

[4] Kif ipprovdut fir-Regolament (KE) Nru 1272/2008.

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

[5] Kif ipprovdut fid-Direttiva 67/548/KEE.

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

[6] Kif ipprovdut fir-Regolament (KE) Nru 1272/2008.

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

[7] Kif ipprovdut fid-Direttiva 67/548/KEE.

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

[8] ĠU L 200, 30.7.1999, p. 1.

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

[9] ĠU L 133, 31.5.2010, p. 1.

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

[10] ĠU L 327, 22.12.2000, p. 1.

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

[11] ĠU L 331, 15.12.2001, p. 1.

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

[12] Krustaċju jista’ jissostitwixxi dafnja f’din id-Deċiżjoni meta tiġi sottomessa dejta dwar il-baħar

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

[13] ĠU L 142, 31.5.2008, p. 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 huwa l-fattur tal-multiplikazzjoni ta’ 10 għal sustanzi li huma tossiċi ħafna għall-ambjent akkwatiku bħal fit-Tabella 1b fid-Direttiva 2006/8/KE (ĠU L 19, 24.1.2006, p. 12).

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