**7735/11 MS/fp 1**  **DG I 1A** 

## EN COUNCIL OF THE EUROPEAN UNION Brussels, 16 March 2011

7735/11

ENV 201

COVER NOTE **from: European Commission date of receipt: 4 March 2011**  **to: General Secretariat of the Council Subject: Draft Commission Decision of [...] on establishing the ecologica**  **l criteria for**

**the award of the EU Ecolabel to lubricants**

**Delegations will find attached Commission document D012687/02.**

**________________________**

**Encl. : D012687/02** 

# EN EN EUROPEAN COMMISSION

**Brussels D012687/02** 

**Draft**

COMMISSION DECISION

of [...] on establishing the ecological criteria for the award of the EU Ecolabel to lub ricants (Text with EEA relevance)

# EN **2** 

# EN **Draft**

COMMISSION DECISION

of establishing the ecological criteria for the award of the EU Ecolabel to lub ricants

**THE EUROPEAN COMMISSION, Having regard to the Treaty on the Functioning of the European Union,**  **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, After consulting the European Union Ecolabelling Board,**  **Whereas: (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 cyc le.**  **(2) Regulation (EC) No 66/2010 provides that specific EU Ecolabel crit**  **eria are to be established according to product groups.**  **(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. (4)**  **Those criteria have been further reviewed in light of technologic al developments. The**  **new criteria, as well as the related assessment and verifi cation requirements, should be**  **valid for four years from the date of adoption of this Decision (5)**  **Decision 2005/360/EC should be replaced for reasons of clarity. (6)**  **A transitional period should be allowed for producers whose products have been**  **awarded the EU Ecolabel for lubricants on the basis of the cr iteria set out in Decision**  **2005/360/EC, so that they have sufficient time to adapt their product s to comply with**  **the revised criteria and requirements. Producers should also be al lowed 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. (7)**  **The measures provided for in this Decision are in accordance wit h the opinion of the**  **Committee established by Article 16 of Regulation (EC) No 66/2010,**

**1 OJ L 27, 30.1.2010, p. 1.**  **2 OJ L 118, 05.05.2005** 

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**HAS ADOPTED THIS DECISION:**

Article 1 **The product group "lubricants" shall comprise the following categori es:**  **Category 1: hydraulic fluids and tractor transmission oils Category 2: greases and stern tube greases**  **Category 3: chainsaw oils, concrete release agents, wire rope lubricants, stern tube oils and** 

**other total loss lubricants Category 4: two-stroke oils**  **Category 5: industrial and marine gear oils.**

Article 2 **For the purpose of this Decision, the following definitions shall apply: (1)**  lubricant

**means a preparation consisting of base fluids and additives. (2)**  basefluid

**means a lubricating fluid whose flow, ageing, lubricity an d anti-wear**  **properties, as well as its properties, regarding contamina nt suspension, have not been**  **improved by the inclusion of additive(s). (3)**  substance **means a chemical element and its compounds in the natural stat e or obtained by**  **any production process, including any additive necessary to preserv e the stability of the**  **products and any impurity deriving from the process used, but exc luding any solvent**  **which may be separated without affecting the stability of the substance or changing its**  **composition**

**. (4)**  thickener **means one or more substances in the base fluid used to thicken or modify the rheology of a lubricating fluid or grease.**  **(5)** main component

**means any substance accounting for more than 5 % by weight of the**  **lubricant. (6)**  additive **means a substance or mixture whose primary functions are the improvement**  **of the flow, ageing, lubricity, anti-wear properties or of contaminant suspe nsion.**  **(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 lubr**  **icant.**

Article 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 Articl e 1 of this Decision and shall** 

# EN **4** 

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**comply with the criteria as well as the related assessment and veri fication requirements set out**  **in the Annex to this Decision.**

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

Article 5 **For administrative purposes, the code number assigned to the product group "lubricants" shall**  **be "027".**

Article 6 **Decision 2005/360/EC is repealed.**

Article 7
**1. By derogation from Article 6, applications for the EU Ecolabel**  **for products falling within the product group "lubricants" submitted before the da**  **te of adoption of this Decision shall be evaluated in accordance with the conditions laid dow**  **n in Decision 2005/360/EC.** 
**2. Where the EU Ecolabel is awarded on the basis of an application evaluated ac**  **cording to the criteria set out in Decision 2005/360/EC, that EU Ecolabel m**  **ay be used for 12 months from the date of adoption of this Decision.** 

Article 8 **This Decision is addressed to the Member States. Done at Brussels,** 

For the Commission Janez POTOČNIK Member of the Commission

# EN **5** 

# EN ANNEX
FRAMEWORK
The aims of the criteria **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.**

CRITERIA

**1. Excluded or limited substances and mixtures** 
**2. Exclusion of specific substances** 
**3. Additional aquatic toxicity requirements** 
**4. Biodegradability and bioaccumulative potential** 
**5. Renewable raw materials** 
**6. Minimum technical performance** 
**7. Information appearing on the EU Ecolabel**  Assessment and verification requirements (a) Requirements **The specific assessment and verification requirements are indicated wi thin each criterion.**  **Where the applicant is required to provide declarations, documentati on, analyses, test reports,**  **or other evidence to show compliance with the criteria to the comp etent body, it is understood**  **that these may originate from the applicant and/or his supplier( s) and/or their supplier(s), etc.,**  **as appropriate.**
**The supplier of the additive, thickener or base fluid may provide t he relevant information**  **directly to the competent body.**
**Where possible, the testing should be performed by laboratories that meet the general**  **requirements of EN ISO 17025 or equivalent. Where appropriate, test methods other than those indicated for each**  **criterion may be used if the competent body assessing the application accepts their equivalence.**  **Where appropriate, competent bodies may require supporting document ation and may carry**  **out independent verifications.**

# EN **6** 

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**The general scheme for the assessment of any constituent sub stance in a lubricant product is**  **given in Table 1.**
(b) Measurement thresholds **All constituent substances that are present above 0.010% (w/w) a nd 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 conce ntrations in which they**  **are present and where applicable, their CAS Registry and EC registr y number.**  **The criteria shall apply as follows:**

• **to the applied lubricant for criteria 1a, 6 and 7**

• **to each stated substance intentionally added or formed above 0.010% (w/ w) for criterion**  **1b and 2,**

• **to each stated substance intentionally added or formed above 0.10% (w/ w) for criteria 3, 4**  **and 5. In addition the total fraction of the stated substances where t**  **he formulated criteria 3 and 4 do not apply shall remain below 0.5% (w/w).** 
EU ECOLABEL CRITERIA

Criterion 1 – Excluded or limited substances and mixtures a) Hazardous substances and mixtures **According to the Article 6(6) of Regulation (EC) No 66/2010 on the EU E colabel, the product**  **or any part of it shall not contain substances (in any forms, i ncluding nanoforms) meeting the**  **criteria for classification with the hazard statements or r isk phrases specified below in**  **accordance with Regulation (EC) No 1272/2008 or Directive 67/548/EC nor shal l it contain**  **substances referred to in Article 57 of Regulation (EC) No 1907/2006. T he risk phrases below**  **generally refer to substances. Nanoforms intentionally added t o the product shall prove**  **compliance with this criterion for any concentration.** List of hazard statements and risk phrases:
Hazard Statement 1 Risk Phrase 2
**H300 Fatal if swallowed R28**
**H301 Toxic if swallowed R25 H304 May be fatal if swallowed and enters airways R65** 
**H310 Fatal in contact with skin R27**
**H311 Toxic in contact with skin R24**

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# EN

**H330 Fatal if inhaled R26**
**H331 Toxic if inhaled R23 H340 May cause genetic defects R46**  **H341 Suspected of causing genetic defects R68 H350 May cause cancer R45**  **H350i May cause cancer by inhalation R49 H351 Suspected of causing cancer R40**  **H360F May damage fertility R60 H360D May damage the unborn child R61**  **H360FD May damage fertility. May damage the unborn child**  **R60; R61; R60-61**
**H360Fd May damage fertility. Suspected of damaging the unborn child**  **R60-R63**
**H360Df May damage the unborn child. Suspected of damaging fertility**  **R61-R62**
**H361f Suspected of damaging fertility R62 H361d Suspected of damaging the unborn child R63**  **H361fd Suspected of damaging fertility. Suspected of damaging the unborn child**  **R62-63**
**H362 May cause harm to breast fed children R64 H370 Causes damage to organs R39/23; R39/24; R39/25;**  **R39/26; R39/27; R39/28 H371 May cause damage to organs R68/20; R68/21; R68/22**  **H372 Causes damage to organs through prolonged or repeated exposure**  **R48/25; R48/24; R48/23**
**H373 May cause damage to organs through prolonged or repeated exposure**  **R48/20; R48/21; R48/22**
**H400 Very toxic to aquatic life R50 H410 Very toxic to aquatic life with long-lasting effects R50-53**  **H411 Toxic to aquatic life with long-lasting effects R51-53**

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**H412 Harmful to aquatic life with long-lasting effects R52-53 H413 May cause long-lasting harmful effects to aquatic life**  **R53 EUH059 Hazardous to the ozone layer R59**  **EUH029 Contact with water liberates toxic gas R29 EUH031 Contact with acids liberates toxic gas R31**  **EUH032 Contact with acids liberates very toxic gas R32 EUH070 Toxic by eye contact R39-41**  1 As provided for in Regulation (EC) No 1272/2008 of the European Parliament and of the Council 2 As provided for in Council Directive 67/548/EC **This criterion shall also apply to the following hazard statements and risk p hrases:** 
Hazard Statement 1 Risk Phrase 2 **H334: May cause allergy or asthma symptoms or breathing difficulties if inhaled**  **R42**
**H317: May cause allergic skin reaction R43 H314 Causes severe skin burns and eye damage R34; R35**  **H319 Causes serious eye irritation R36**
**H315 Causes skin irritation R38 EUH066 Repeated exposure may cause skin dryness or**  **cracking R66** 
**H336 May cause drowsiness and dizziness R67** 1 As provided for in Regulation (EC) No 1272/2008 of the European Parliament and of the Council 2 As provided for in Council Directive 67/548/EC **Substances or mixtures which change their properties upon proc essing (e.g., become no**  **longer bioavailable, undergo chemical modification) so that the i dentified hazard no longer**  **applies are exempted from the above requirement. Concentration limits for substances meeting criteria of Art**  **icle 57 (a), (b) or (c) of Regulation (EC) No 1907/2006 shall not exceed 0.010% (w/w). If specific concentrati**  **on 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).**  **Derogations from Criterion 1a are listed in Table 1.** Assessment and verification of criterion: the applicant shall provide the exact formulation of the product to the competent body. The applicant shall demonstrate comp liance with this

# EN **9** 

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criterion for substances in the product on the basis of information c onsisting as a minimum of that specified in Annex VII of the Regulation (EC) No 1907/2006. Such infor mation shall be specific to the particular form of the substance, including nanofor ms, used in the product. For that purpose, the applicant shall provide a declaration of compliance w ith 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 subst ances 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. Sufficient data shall be available to allow for the evaluation of the env ironmental 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 Council Directives 67/548/EC and 1999/45/EC of the European Parliament and of the Council 3

. The evaluation of a product for hazards to the environment shall be perf ormed 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 b y part C of Annex III to Directive 1999/45/EC or by section 4.1.3.3 of Regulati on (EC) No 1272/2008, the results of testing the preparation (either the product prep aration 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.
b) Substances listed in accordance with Article 59(1) of Regulation 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 pres ent in mixtures, in**  **concentrations higher than 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 R egulation (EC) No 1907/2006 can be found here: 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. Concentration limits shall be specified in the safety data sheets ac cording to Annex II, paragraph 3.2.1(c) of Regulation (EC) No 453/2010. Criterion 2 – Exclusion of specific substances **The following stated substances are not allowed in quantities exc eeding 0.010% (w/w) of the**  **final product:**

**– Substances appearing in the Union List of priority substance**  **s in the field of water policy in Annex X to Directive 2000/60/EC as amended by laid in D**  **ecision 2455/2001/EC**  **4 and the OSPAR List of Chemicals for Priority Action** 

**3 OJ L 200, 30.7.1999, p.1.**  **4 OJ L 331 15.12.2001** 

# EN **10** 

# EN **( http://www.ospar.org/content/content.asp?menu=00950304450000_000000_000**  **000 )** 

**– Organic halogen compounds and nitrite compounds** 

**– Metals or metallic compounds with the exception of sodium, potassi**  **um, magnesium and calcium. In the case of thickeners, also lithium a**  **nd/or aluminium compounds may be used up to concentrations limited by the other cr**  **iteria included in the Annex to this Decision.**  Assessment and verification: conformance with these requirements shall be stated in writing and signed by the applicant. Criterion 3 - Additional aquatic toxicity requirements **The applicant shall demonstrate compliance by meeting the requir ements of either criterion**  **3.1 or criterion 3.2.** Criterion 3.1 - Requirements for the lubricant and its main components **Acute aquatic toxicity data of the main components and the mixture shall be pr ovided.**  **Acute aquatic toxicity data for each main component shall be sta ted on each of the following**  **two trophic levels: algae and daphnia 5**  **. The critical concentration for the acute aquatic toxicity for each main component shall be at least 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 conce ntration for the acute aquatic**  **toxicity for a lubricant in Category 1 and 5 shall be at leas t 100 mg/l and for a lubricant in**  **Category 2, 3 and 4 at least 1000 mg/l. Table 2 summarises the requirements for the different lubrica**  **nt categories according to Criterion 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 ment ioned in the following guidelines: ISO/DIS 10253 or OECD 201 or Part C.3. of the Annex to Commis sion Regulation (EC) No 440/2008 6 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. o f the Annex to Regulation (EC) No 440/2008 for fish. Equivalent test methods as agreed with a competent body are also permitted. Only (72hr) E r C50 for algae, (48hr)EC50 for daphnia and (96hr)LC50 for fish are accepted. Criterion 3.2 - Requirements for each stated substance present above 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 a nd fish.**  **In case chronic toxicity test results are missing, acute aquat ic toxicity tests results shall be**  **provided for each of the following two trophic levels; algae and daphnia** 

. **One or more**

**5 Crustacean can substitute for daphnia throughout t**  **his Decision where marine data is submitted.**

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**substances exhibiting a certain degree of aquatic toxicity are allowed in each of the five**  **lubricant categories for a cumulative mass concentration as indicated i n Table 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 re spectively, or equivalent test methods as agreed with a competent body. Either marine or freshwater acute toxicity data are accepted on alg ae 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 Commission Regulation (EC) No 440/2008 6 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)E r C50 for algae and (48hr)EC50 for daphnia are accepted.

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 re quirements set out for the aquatic toxicity in Table 1. In the case of slightly soluble substances or preparations (< 10 mg/l) the method of the wateraccommodated fraction (WAF) can be used in the aquatic toxicity determ ination. The established loading level, sometimes referred to as LL50 and relate d to the lethal loading, may be used directly in the classification criteria. The prep aration 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 OE CD 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 Int erpretation 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 criter ion. An aquatic toxicity study does not need to be conducted when:

**–** the classification of the substance, base fluid or additive is alr eady stated on the Lubricant Substance Classification list or

**–** a valid letter of compliance from a competent body can be submitted or

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

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

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

**6 OJ L 142, 31.5.2008, p.1.** 

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

. The water solubility of substances shall be determined where appropriate ac cording to OECD 105 or equivalent test methods. The molecular weight fraction below 1000 g/mol of a polymer shall be dete rmined according to Part A.19. of the Annex to Regulation (EC) No 440/2008 or equivalent test methods.

Criterion 4 - Biodegradability and bioaccumulative potential **Requirements for the biodegradability and bioaccumulative potential shall be fulfilled for**  **each stated substance present above 0.10% (w/w). The lubricant shall not contain substances that are both: non-biode**  **gradable and (potentially) bioaccumulative.**  **However, the lubricant may contain one or more substances with a certain degree of**  **degradability and potential or actual bioaccumulation up to a cumul ative mass concentration**  **as indicated in Table 1.** Assessment and verification: conformity shall be demonstrated by providing the following information: High quality test reports or literature data (testing according t o acceptable protocols and GLP) including the references on the biodegradability and when required on t he (potential) bioaccumulation of each constituent substance.
4.1 Biodegradation

A substance is considered ultimately biodegradable (aerobic) if: 1. In a 28-day biodegradation study according Part C.4. of the Annex to Regul ation (EC) No 440/2008, OECD 306, OECD 310 the following levels of biodegradation are achieved: — in the ultimately biodegradable tests based upon dissolved organic carbon ≥ 70 %, — in the ultimately biodegradable tests based upon oxygen depletion or carbon dioxide generation ≥ 60 % of the theoretical maxima. In these ultimately biodegradable tests the 10-day window principle w ill not necessarily apply. If the substance reaches the biodegradation pass level within 28 days but not wi thin the 10-day time-window, a slower degradation rate is assumed. 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 440/2008 or equival ent methods while the COD shall be assessed according to Part C.6. of the Annex to Regulation 440/2008 or equivalent methods.

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A substance is considered inherently biodegradable if it shows: — 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 — 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. The biodegradation test does not need to be conducted when: the classification of the substance, base fluid or additive is already stated on t he Lubricant Substance Classification list or a valid letter of compliance from a compete nt body can be submitted A substance is non-biodegradable if it fails the criteria for ultimate and inherent biodegradability. The applicant may also use read-across data to estimate the biodegradabi lity of a substance. ‘Read-across’ for the assessment of the biodegradability of a subs tance shall be acceptable if the reference substance differs by only one functional group or fra gment from the substance applied in the product. If the reference substance is readily or inhe rently 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. Func tional groups or fragments with a positive effect on the biodegradation are: aliphati c and aromatic alcohol [- OH], aliphatic and aromatic acid [-C(=O)-OH], aldehyde [-CHO], E ster [-C(=O)-O-C], amide [-C(=O)–N or -C(=S)–N]. Adequate and reliable documentation of t he 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 pr ovided on the positive effect of the functional group on the biodegradation of structurally similar substances.
4.2 Bioaccumulation The (potential) bioaccumulation does not need to be established when the substance: - has a MM > 800 g/mol, or - has a molecular diameter > 1,5 nm (> 15 Å), or - has an octanol-water partition coefficient, log Kow, value of < 3 or > 7, or - has a measured BCF of ≤ 100 L/kg, or - is a polymer and its molecular weight fraction below 1000 g/mol is less than 1%. Since most substances used in lubricants are quite hydrophobic the BC F-value should be based on the lipid weight content and care must be shown to ensure a su fficient exposure time. 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. The log octanol/water partition coefficient (log K ow ) 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 K ow values by any of these calculation methods < 3 or >7 indicates that the substance is not expected to bioaccumulate

.

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Log K

ow values are applicable to organic chemicals only. To assess the bioaccumul ation potential of non-organic compounds, surfactants, and some organo-metallic c ompounds, BCF measurements shall be carried out.
Criterion 5 - Renewable raw materials **The formulated product shall have a carbon content derived from renew able raw materials**  **that shall be: ≥ 50 % (m/m) for Category 1,**  **≥ 45 % (m/m) for Category 2, ≥ 70 % (m/m) for Category 3,**  **≥ 50 % (m/m) for Category 4, ≥ 50 % (m/m) for Category 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 fr om (vegetable) oils**  **or (animal) fats divided by the total number of C-atoms in compone nt A] plus mass**  **percentage of component B × [number of C-atoms in component B, whi ch 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. The applicant shall indicate on the application form the type (**  **s), source(s) and origin of the renewable material(s) of the main components.**  Assessment and verification : the applicant shall provide the competent body with a declaration of compliance with this criterion. Criterion 6 - Minimum technical performance
**(a) For Hydraulic fluids : at least the technical performance criteria as laid down i**  **n the current ISO 15380, Tables 2 to 5. The supplier shall list on his pr**  **oduct information sheet which 2 elastomers have been tested.**  **(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. (c) For chainsaw oils**  **: at least the technical performance criteria as laid down in the RAL**  **UZ 48 of the 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.**  **(e) For two-stroke oils for terrestrial applications : at least meet the EGD level of**  **technical performance criteria laid down in ISO 13738:2000.**

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**(f) For all other lubricants : fit for purpose.**  Assessment and verification: the applicant shall provide the competent body with a declaration of compliance with this criterion, together with related documentati on.
Criterion 7: Information appearing on the eco-label **Optional label with text box shall contain the following text: “- Reduced harm for water and soil during use**  **- Contain a large fraction of biobased material”.**
**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**  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.

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Table 1: Criteria for the lubricant and each stated substance

# EN **17** 

# EN Category 1 Category 2 Category 3 Category 4 Categor y 5 Category

Criteria **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**

Hazard statements and R-phrases indicating environmental and human health hazards (Derogation for Criterion 1a) Category 1 Category 2 Category 3 Category 4 Category 5

**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**  **Council Directive 99/45/EC)**  **None**

**(Lowest classification**  **limit in Regulation (EC)**  **No 1272/2008 or Council**  **Directive 99/45/EC)**  **None**

**(Lowest classification limit**  **in Regulation (EC) No 1272/2008 or**  **Council Directive 99/45/EC)**  **None**

**(Lowest classification**  **limit in Regulation**  **(EC) No 1272/2008 or**  **Council Directive**  **99/45/EC) None** 

**(Lowest classification limit**  **in Regulation (EC) No 1272/2008 or**  **Council Directive 99/45/EC)** 

Exclusion of specific substances (Criterion 1b and 2) Category 1 Category 2 Category 3 Category 4 Categor y 5

**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); Annex XIV to Regulation (EC)** 

**No 1907/2006; < 0.010% < 0.010% < 0.010% < 0.010% < 0.010%** 

Cumulative mass percentages (% w/w) of substances p resent in Aquatic toxicity (Criterion 3.2 only) Category 1 Category 2 Category 3 Category 4 Categor y 5 **Not toxic**  **(D) Acute toxicity > 100 mg/L** 

**or NOEC > 10 mg/L**  **Not limited**

**Harmful (E)**  **10 mg/L < Acute toxicity** ≤ **100**

**mg/L**

**or 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**

**Very toxic**  **(G) Acute toxicity**  ≤ **1 mg/L**

**or NOEC**  ≤ **0.1 mg/L** ≤ **0.1/M** **(*)** ≤ **0.1/M** **(*)** ≤ **0.1/M** **(*)** ≤ **0.1/M** **(*)** ≤ **1/M** **(*)**

Cumulative mass percentages (%w/w) of substances pr esent in Biodegradation and Bioaccumulation

(Criterion 4) Category 1 Category 2 Category 3 Category 4 Categor y 5 **Ultimately aerobically biodegradable (A) > 90 > 75 > 90 > 75 > 90**  **Inherently aerobically biodegradable (B)** ≤ **5** ≤ **5** ≤ **20** ≤ **5 Non-biodegradable AND non-bioaccumulative** 

**(C)** ≤ **5** ≤ **25**
≤ **5** ≤ **10** ≤ **5**
**Non-biodegradable AND bioaccumulative (X)** ≤ **0.1** ≤ **0.1** ≤ **0.1** ≤ **0.1** ≤ **0.1** Cumulative mass percentages (%w/w) of substances pr esent in Fraction not assessed on aquatic toxicity

(Criterion 3.2) or biodegradation/bioaccumulation (Criterion

4) Category 1 Category 2 Category 3 Category 4 Categor y 5

**< 0.5 < 0.5 < 0.5 < 0.5 < 0.5**

# EN **18** 

# EN

**(*) M is the multiplication factor of 10 for substances that** **are very toxic to the aquatic environment as from Table 1b in Directive 2006/8/EC.** 

**multiplication factor (M)**  **LC50 or EC50 value (“L(E)C50”) of**

**substance 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).** Table 2: Aquatic toxicity requirements for the different l ubricant categories – Data requirements for the lubricant and its main components. Criterion 3.1 Category 1 Category 2 Category

3 Category 4 Category 5
**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** 

**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**  Cumulative mass percentages (%w/w) of substances pr esent in Renewability (Criterion 5) Category 1 Category 2 Category 3 Category 4 Categor y 5 **Based on carbon** ≥ **50%** ≥ **45%** ≥ **70%** ≥ **50%** ≥ **50%**

Category 1 Category 2 Category 3 Category 4 Catego ry 5 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**