2011年6月24日委员会决定,为判定润滑油欧盟生态标签制定生态标准(通报文件号C(2011) 4447)?(1)
技术法规类型:欧盟Eurlex法规 来源:tbtmap
EURLEX ID:32011D0381
OJ编号:OJ L 169, 29.6.2011, p. 28-39
中文标题:2011年6月24日委员会决定,为判定润滑油欧盟生态标签制定生态标准(通报文件号C(2011) 4447)?(1)
原文标题:2011/381/EU: Commission Decision of 24 June 2011 on establishing the ecological criteria for the award of the EU Ecolabel to lubricants (notified under document C(2011) 4447) Text with EEA relevance
分类:15.10.10_通则与程序;15.20.30_健康与安全保护
文件类型:二级立法 Decision|决定
废止日期:2058-12-31
法规全文:查看欧盟官方文件
EN
Official Journal of the European Union
29.6.2011
COMMISSION DECISION
of 24 June 2011
on establishing the ecological criteria for the award of the EU Ecolabel to lubricants
(notified under document C(2011) 4447)
(Text with EEA relevance)
(2011/381/EU)
THE EUROPEAN COMMISSION,
(7) The
measures
provided
for
in
this
Decision
are
in
accordance with the opinion of the Committee estab
lished by Article 16 of Regulation (EC) No 66/2010,
Having regard to the Treaty on the Functioning of the European
Union,
HAS ADOPTED THIS DECISION:
Having regard to Regulation (EC) No 66/2010 of the European
Parliament and of the Council of 25 November 2009 on the EU
Article 1
Ecolabel ( 1 ), and in particular Article 8(2) thereof,
The product group ‘lubricants’ shall comprise the following
categories:
After consulting the European Union Ecolabelling Board,
Category 1: hydraulic fluids and tractor transmission oils
Whereas:
Category 2: greases and stern tube greases
(1) Under
Regulation
(EC)
No
66/2010,
the
EU
Ecolabel
may
be awarded to those products with a reduced environ
Category 3: chainsaw oils, concrete release agents, wire rope
mental impact during their entire life cycle.
lubricants, stern tube oils and other total loss
lubricants
(2) Regulation
(EC)
No
66/2010
provides
that
specific
EU
Ecolabel criteria are to be established according to
Category 4: two-stroke oils
product groups.
Category 5: industrial and marine gear oils.
(3) Commission
Decision
2005/360/EC
( 2 ) has established
the ecological criteria and the related assessment and
verification requirements for lubricants which are valid
Article 2
until 30 June 2011.
For the purpose of this Decision, the following definitions shall
apply:
(4) Those
criteria
have
been
further
reviewed
in
light
of
technological developments. The new criteria, as well as
(1) ‘lubricant’ means a preparation consisting of base fluids and
the related assessment and verification requirements,
additives;
should be valid for 4 years from the date of adoption
of this Decision
(2) ‘basefluid’ means a lubricating fluid whose flow, ageing,
lubricity and anti-wear properties, as well as its properties
(5) Decision
2005/360/EC
should
be
replaced
for
reasons
of
regarding contaminant suspension, have not been improved
clarity.
by the inclusion of additive(s);
(6) A
transitional
period
should
be
allowed
for
producers (3) ‘substance’ means a chemical element and its compounds in
whose products have been awarded the EU Ecolabel for
the natural state or obtained by any production process,
lubricants on the basis of the criteria set out in Decision
including any additive necessary to preserve the stability
2005/360/EC, so that they have sufficient time to adapt
of the products and any impurity deriving from the
their products to comply with the revised criteria and
process used, but excluding any solvent which may be
requirements. Producers should also be allowed to
separated without affecting the stability of the substance
submit applications based on the criteria set out in
or changing its composition;
Decision 2005/360/EC or on the criteria set out in this
Decision until the lapse of validity of that Decision.
(4) ‘thickener’ means one or more substances in the base fluid
( 1 ) OJ L 27, 30.1.2010, p. 1.
used to thicken or modify the rheology of a lubricating fluid
( 2 ) OJ L 118, 5.5.2005, p. 26.
or grease;
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(5) ‘main component’ means any substance accounting for
Article 7
more than 5 % by weight of the lubricant;
1. By
derogation
from
Article
6,
applications
for
the
EU
Ecolabel for products falling within the product group
(6) ‘additive’ means a substance or mixture whose primary
‘lubricants’ submitted before the date of adoption of this
functions are the improvement of the flow, ageing, lubricity,
Decision shall be evaluated in accordance with the conditions
anti-wear properties or of contaminant suspension;
laid down in Decision 2005/360/EC.
(7) ‘grease’ means a solid to semi-solid mixture which consists
2. Applications
for
the
EU
Ecolabel
for
products
falling
of a ‘thickener’ and may include other ingredients imparting
within the product group ‘lubricants’ submitted from the date
special properties in a liquid lubricant.
of adoption of this Decision but by 30 June 2011 at the latest
may be based either on the criteria set out in Decision
Article 3
2005/360/EC or on the criteria set out in this Decision.
Those applications shall be evaluated in accordance with the
In order to be awarded the EU Ecolabel under Regulation (EC)
criteria on which they are based.
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
3. Where the EU Ecolabel is awarded on the basis of an
verification requirements set out in the Annex to this Decision.
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.
Article 4
The ecological criteria for the product group ‘lubricants’, as well
as the related assessment and verification requirements shall be
Article 8
valid for 4 years from the date of the adoption of this Decision.
This Decision is addressed to the Member States.
Article 5
For administrative purposes, the code number assigned to the
Done at Brussels, 24 June 2011.
product group ‘lubricants’ shall be ‘027’.
For the Commission
Article 6
Janez POTONIK
Decision 2005/360/EC is repealed.
Member of the Commission
L 169/30
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Official Journal of the European Union
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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 within each criterion.
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.
The supplier of the additive, thickener or base fluid may provide the 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 documentation and may carry out independent verifi
cations.
The general scheme for the assessment of any constituent substance in a lubricant product is given in Table 1.
(b) Measurement thresholds
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.
The criteria shall apply as follows:
— to the applied lubricant for criteria 1(a), 6 and 7,
— to each stated substance intentionally added or formed above 0,010 % (w/w) for criterion 1(b) 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 the formulated criteria 3 and 4 do not apply shall remain
below 0,5 % (w/w).
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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 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.
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
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
( 1 ) OJ L 353, 31.12.2008, p. 1.
( 2 ) OJ 196, 16.8.1967, p. 1.
( 3 ) OJ L 396, 30.12.2006, p. 1.
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Hazard Statement ( 1 ) Risk
Phrase
( 2 )
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
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.
( 2 ) As provided for in Directive 67/548/EEC.
This criterion shall also apply to the following hazard statements and risk phrases:
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.
( 2 ) As provided for in Directive 67/548/EEC.
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.
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).
Derogations from Criterion 1(a) 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 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.
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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 ( 1 ).
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.
(b) Substances listed in accordance with Article 59(1) of Regulation (EC) No 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).
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:
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 according to Annex II, paragraph 3.2.1(c) of Commission
Regulation (EU) No 453/2010 ( 2 ).
Criterion 2 – Exclusion of specific substances
The following stated substances are not allowed in quantities exceeding 0,010 % (w/w) of the final product:
— 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 ( 3 ) as amended by laid in Decision
No 2455/2001/EC of the European Parliament and of the Council ( 4 ) and the OSPAR List of Chemicals for
Priority Action (http://www.ospar.org/content/content.asp?menu=00950304450000_000000_000000),
— organic halogen compounds and nitrite compounds,
— 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.
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 requirements 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 provided.
Acute aquatic toxicity data for each main component shall be stated 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 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 1 000 mg/L.
Table 2 summarises the requirements for the different lubricant categories according to criterion 3.1.
( 1 ) OJ L 200, 30.7.1999, p. 1.
( 2 ) OJ L 133, 31.5.2010, p. 1.
( 3 ) OJ L 327, 22.12.2000, p. 1.
( 4 ) OJ L 331, 15.12.2001, p 1.
( 5 ) Crustacean can substitute for daphnia throughout this Decision where marine data is submitted.
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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 ( 1 ) 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,
(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 and fish.
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.
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.
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)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 requirements 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 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.
An aquatic toxicity study does not need to be conducted when:
— 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, or
— the substance is unlikely to cross biological membranes MM > 800 g/mol or molecular diameter > 1,5 nm (> 15 ),
or
— the substance is a polymer and its molecular weight fraction below 1 000 g/mol is less than 1 %, or
— the substance is highly insoluble in water (water solubility < 10 μg/l),
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 according to OECD 105 or equivalent test
methods.
The molecular weight fraction below 1 000 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.
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-biodegradable and (potentially) bioaccumulative.
( 1 ) OJ L 142, 31.5.2008, p. 1.
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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.
Assessment and verification: conformity shall be demonstrated by providing the following information:
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.
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 Regulation (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 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.
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.
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 the Lubricant Substance Classification list
or a valid letter of compliance from a competent 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 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 biode
gradation 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 ), or
— has an octanol-water partition coefficient, log K ow , value of < 3 or > 7, or
— has a measured BCF of ≤ 100 L/kg, or
— is a polymer and its molecular weight fraction below 1 000 g/mol is less than 1 %.
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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.
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.
Log K ow 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.
Criterion 5 – Renewable raw materials
The formulated product shall have a carbon content derived from renewable 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 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.
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 in the current ISO 15380, Tables 2 to 5.
The supplier shall list on his product 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 Certifi
cation 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.
(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 documentation.
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’.
EN
29.6.2011 Official
Journal
of
the
European
Union L
169/37
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.
Table 1
Criteria for the lubricant and each stated substance
Category 1 Category
2 Category
3 Category
4 Category
5
Category
Chain saw oils,
Hydraulic fluids,
concrete release
Terrestrial and
tractor
Greases, stern tube agents, wire rope marine two-stroke Industrial and
transmission oils
greases
lubricants and
marine gear oils
other total loss
oils
Criteria
lubricants
Hazard statements and R-phrases
indicating environmental and
human health hazards
Category 1 Category
2 Category
3 Category
4 Category
5
(Derogation for Criterion 1(a))
Health or Environmental
None
None
None
None
None
Hazard statement or R-phrase
of the lubricant at the time of
(Lowest
(Lowest
(Lowest
(Lowest
(Lowest
application
classification
classification
classification
classification
classification
limit in
limit in
limit in
limit in
limit in
Regulation (EC) Regulation (EC) Regulation (EC) Regulation (EC) Regulation (EC)
No 1272/2008 No 1272/2008 No 1272/2008 No 1272/2008 No 1272/2008
or Directive
or Directive
or Directive
or Directive
or Directive
1999/45/EC)
1999/45/EC)
1999/45/EC)
1999/45/EC)
1999/45/EC)
Exclusion of specific substances
Category 1 Category
2 Category
3 Category
4 Category
5
(Criterion 1(b) and 2)
OSPAR-listed; the Union list
< 0,010 % <
0,010
% <
0,010
% <
0,010
% <
0,010
%
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
Aquatic toxicity
Cumulative mass percentages (% w/w) of substances present in
(Criterion 3.2 only)
Category 1 Category
2 Category
3 Category
4 Category
5
Not toxic (D) Acute
toxicity
> 100 mg/L
or
Not limited
NOEC
> 10 mg/L
Harmful (E) 10
mg/L
<
≤ 20
≤ 25
≤ 5
≤ 25
≤ 20
Acute toxicity
≤ 100 mg/L
or
1 mg/L
< NOEC
≤ 10 mg/L
L 169/38
EN
Official Journal of the European Union
29.6.2011
Aquatic toxicity
Cumulative mass percentages (% w/w) of substances present in
(Criterion 3.2 only)
Category 1 Category
2 Category
3 Category
4 Category
5
Toxic (F) 1
mg/L
<
≤ 5
≤ 1
≤ 0,5
≤ 1
≤ 5
Acute toxicity
≤ 10 mg/L
or
0,1 mg/L
< NOEC
≤ 1 mg/L
Very toxic (G) Acute
toxicity ≤ 0,1/M (*)
≤ 0,1/M (*)
≤ 0,1/M (*)
≤ 0,1/M (*)
≤ 1/M (*)
≤ 1 mg/L
or
NOEC
≤ 0,1 mg/L
Biodegradation and Bioaccumu
Cumulative mass percentages (%w/w) of substances present in
lation
(Criterion 4)
Category 1 Category
2 Category
3 Category
4 Category
5
Ultimately aerobically biode
> 90 >
75 >
90 >
75 >
90
gradable (A)
Inherently aerobically biode
≤ 5
≤ 25
≤ 5
≤ 20
≤ 5
gradable (B)
Non-biodegradable AND non-
≤ 5
≤ 5
≤ 10
≤ 5
bioaccumulative (C)
Non-biodegradable AND
≤ 0,1
≤ 0,1
≤ 0,1
≤ 0,1
≤ 0,1
bioaccumulative (X)
Fraction not assessed on aquatic
Cumulative mass percentages (%w/w) of substances present in
toxicity (Criterion 3.2) or biode
gradation/bioaccumulation
(Criterion 4)
Category 1 Category
2 Category
3 Category
4 Category
5
< 0,5 <
0,5 <
0,5 <
0,5 <
0,5
Renewability
Cumulative mass percentages (%w/w) of substances present in
(Criterion 5)
Category 1 Category
2 Category
3 Category
4 Category
5
Based on carbon
≥ 50 %
≥ 45 %
≥ 70 %
≥ 50 %
≥ 50 %
Category 1 Category
2 Category
3 Category
4 Category
5
Minimal Technical
Hydraulic
Fit for purpose Chain
saw
oils: Marine 2T-oils: Industrial and
performance
fluids: ISO
as in RAL
as in NMMA marine gear oils
15380 Tables
UZ 48
TC-W3.
DIN 51517
(Criterion 6)
2 to 5
Others: fit for
Terrestrial
Tractor trans
purpose
2T-oils: as the
mission oils: fit
EGD level in
for purpose
ISO
13738:2000
(*) 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).
EN
29.6.2011 Official
Journal
of
the
European
Union L
169/39
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
1 000 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 lubricant 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
> 100 mg/L >
1
000
mg/L >
1
000
mg/L >
1
000
mg/L >
100
mg/L
freshly prepared lubricant on
three trophic levels, algae,
daphnia and fish
Acute aquatic toxicity for
> 100 mg/L >
100
mg/L >
100
mg/L >
100
mg/L >
100
mg/L
each main component on
each of two trophic levels,
algae and daphnia
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