2005/344/EC: Commission Decision of 23 March 2005 establishing ecological criteria for the award of the Community eco-label to all-purpose cleaners and cleaners for sanitary facilities (notified under document number C(2005) 1028)Text with EEA relevance.
Date: 2005-03-23
Institutions: European Commission
Subjects: European symbol, eco-label, polishing and scouring preparations, product quality

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COMMISSION DECISION

of 23 March 2005

establishing ecological criteria for the award of the Community eco-label to all-purpose cleaners
and cleaners for sanitary facilities

(notified under document number C(2005) 1028)

(Text with EEA relevance)

(2005/344/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

(6)

In the interests of clarity, Decision 2001/523/EC should
therefore be replaced.

Having regard to the Treaty establishing the European
Community,

Having regard to Regulation (EC) No 1980/2000 of
the
European Parliament and of the Council of 17 July 2000 on a
revised Community eco-label award scheme (1), and in
particular the second subparagraph of Article 6(1) thereof,

After consulting the European Union Eco-Labelling Board,

Whereas:

(1) Under Regulation (EC) No 1980/2000 the Community
eco-label may be awarded to a product possessing
characteristics which enable it to contribute significantly
to improvements
in relation to key environmental
aspects.

(2) Regulation (EC) No 1980/2000 provides that specific
eco-label criteria, drawn up on the basis of the criteria
drafted by the European Union Eco-Labelling Board, are
to be established according to product groups.

(3)

(4)

(5)

It also provides that the review of the eco-label criteria, as
well as of the assessment and verification requirements
related to the criteria, is to take place in goodtime before
the end of the period of validity of the criteria specified
for the product group concerned.

It is appropriate, in order to take account of scientific and
market developments, to revise the ecological criteria
established by Commission Decision 2001/523/EC of
27 June 2001 establishing the ecological criteria for the
award of
to all-purpose
cleaners and cleaners for sanitary facilities (2).

the Community eco-label

Furthermore, in order to specify that detergent products
for the routine cleaning of windows are to be regarded as
all-purpose cleaners, rather than as products for more
specific cleaning uses,
is necessary to modify the
definition of
the product group laid down in that
Decision.

it

(1) OJ L 237, 21.9.2000, p. 1.
(2) OJ L 189, 11.7.2001, p. 25.

(7) The revised ecological criteria should be valid for a

period of four years.

(8)

It is appropriate to allow a transitional period of not
more than twelve months for applicants whose products
have been awarded the eco-label before the date of
notification of this Decision or who have applied for
such an award before that date, so that
they have
sufficient time to adapt their products to comply with the
revised criteria and requirements.

(9) The measures provided for in this Decision are in
accordance with the opinion of the Committee instituted
by Article 17 of Regulation (EC) No 1980/2000,

HAS ADOPTED THIS DECISION:

Article 1

The product group ‘all-purpose cleaners and cleaners for
sanitary facilities’ shall be composed of the following three
subgroups:

(a)

cleaners

comprising detergent products
all-purpose
intended for
floors, walls,
the routine cleaning of
ceilings, windows and other fixed surfaces, and which
are dissolved or diluted in water prior to use. All purpose
cleaners must have water content ≤ 90 % (w/w).

(b) window cleaners comprising specific all-purpose cleaners
intended for the routing cleaning of windows, and which
are either diluted in water prior to use or used without
dilution. All window cleaners must have water content ≤
95 % (w/w).

(c)

for

sanitary facilities comprising detergent
cleaners
products intended for the routine removal,
including
by scouring, of dirt and/or deposits in sanitary facilities,
such as laundry rooms, bathrooms, showers, toilets and
kitchens. All cleaners for sanitary facilities must have
water content ≤ 90 % (w/w).

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The subgroup specified in point (c) of the first paragraph shall
not include the following:

(a)

products which are automatically used when a toilet is
flushed, such as ‘self-dosing-products’,
including toilet
blocks;

(b) products for use in a toilet cistern;

(c)

products, which have no cleaning effects other than the
removal of calcium carbonate (scale);

(d) disinfectants.

The product group shall not cover products for more specific
cleaning uses, such as oven cleaners, floor-strippers, polishes,
drain cleaners, and so on.

The product group shall cover products for both private and
professional use.

Article 2

In order to be awarded the Community eco-label, for all-
purpose cleaners and cleaners for sanitary facilities, under
Regulation (EC) No 1980/2000, a cleaner must fall within the
product group ‘all-purpose cleaners and cleaners for sanitary
facilities’ and must comply with the ecological criteria set out
in the Annex to this Decision.

Article 4

For administrative purposes the code number assigned to the
product group ‘all purpose cleaners and cleaners for sanitary
facilities’ shall be 020.

Article 5

Decision 2001/523/EC is repealed.

Article 6

Eco-labels awarded before the notification date of
this
Decision in respect of products falling within the product
group ‘all-purpose cleaners and cleaners for sanitary facilities’
may continue to be used until 31 March 2006.

Where applications have been submitted before the notifica-
tion date of this Decision for award of the eco-label in respect
of products falling within the product group ‘all-purpose
cleaners and cleaners for sanitary facilities’, those products
may be awarded the eco-label under the conditions laid down
in Decision 2001/523/EC. In such cases the eco-label may be
used until 31 March 2006.

Article 7

This Decision is addressed to the Member States.

Article 3

Done at Brussels, 23 March 2005.

The ecological criteria for the product group ‘all purpose
cleaners and cleaners for sanitary facilities’, as well as the
related assessment and verification requirements, shall be valid
until 31 December 2008.

For the Commission
Stavros DIMAS
Member of the Commission

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ANNEX

FRAMEWORK

In order to qualify for the eco-label, an all purpose cleaner or a cleaner for sanitary facilities (hereinafter referred to as
the product) must fall within the product group as defined in Article 1, and must comply with the criteria of this
Annex.

These criteria aim at promoting:

The aims of the criteria

— the reduction of environmental impact by limiting the quantity of harmful ingredients, by reducing the quantity

of detergent used and by reducing packaging waste,

— the reduction or prevention of risks for the environment and for human health related to the use of hazardous

substances,

— information that will enable the consumer to use the product in the way that is efficient and minimises

environmental impact.

The criteria are set at levels that promote the labelling of all-purpose cleaners and sanitary cleaners that have a low
environmental impact.

Assessment and verification requirements

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

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

Where no tests are mentioned, or are mentioned as being for use in verification or monitoring, competent bodies
should rely as appropriate on declarations and documentation provided by the applicant and/or independent
verifications.

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

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

Where ingredients are referred to, this includes substances and preparations.

Appendix I presents the new revised detergent ingredient database (DID list), version 30 June 2004, which contains
the most widely used ingredients in detergent formulations. Part-A of the DID list shall be used for deriving the data
for the calculations of CDVtox and for the assessment of the biodegradability of surfactants.

Where appropriate, the applicant may use subsequent revisions of the Detergent Ingredient Database as they become
available.

For ingredients which are not included in part-A of the DID list, the applicant shall, under his own responsibility,
apply the procedure as described in part-B of the Appendix I.

For ingredients, which are not listed in the DID-list, the applicant may use an approach to provide the necessary
documentation of anaerobic degradability described in Appendix II

The competent bodies are recommended to take into account the implementation of recognised environmental
management schemes, such as EMAS or ISO 14001, when assessing applications and monitoring compliance with the
criteria in this Annex (Note: It is not required to implement such management schemes.)

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FUNCTIONAL UNIT

For all-purpose cleaners the functional unit (used in the criteria below) is the dosage in grams of the product
recommended by the manufacturer for 1 litre of suds (washing water).

For window cleaners and cleaners for sanitary facilities, no functional unit is defined (the relevant criteria below being
calculated in relation to 100 g of the product).

ECOLOGICAL CRITERIA

1.

Toxicity to aquatic organisms

The critical dilution volume toxicity (CDVtox) is calculated for each ingredient (i) using the following equation:

CDVtox

(ingredien

i)t 

(cid:2)

(cid:1)

weight 
 TF

(i)
chronic

(i)DF
(i)

(cid:1)

1000

where weight (i) is the weight of the ingredient (in grams) per functional unit (for all-purpose cleaners) or per 100 g of
product (cleaners for sanitary facilities). DF (i) is the degradation factor and TF chronic (i) is the toxicity factor of the
ingredient (in milligram/litre).

The values of DF and TF chronic shall be as given in the detergent ingredient database list-part A (DID list-part A)
(Appendix I). If the ingredient in question is not included in the DID list-part A, the applicant shall estimate the values
following the approach described in the DID list-part B (Appendix 1). The CDVtox is summed for each ingredient,
making the CDVtox for the product.

For all-purpose cleaners, the CDVtox for the product shall not exceed 20 000 l/functional unit.

For cleaners for sanitary facilities, the CDVtox for the product shall not exceed 100 000 l per 100 g product.

For window cleaners, the CDVtox for the product shall not exceed 5 000 l per 100 g product.

Assessment and verification: the exact formulation of the product shall be provided to the competent body, together
with the details of the CDVtox calculations showing compliance with this criterion.

2.

Biodegradability of surfactants

(a)

Ready biodegradability (aerobic)

Each surfactant used in the product shall be readily biodegradable.

Assessment and verification: the exact formulation of the product as well as a description of the function of each
ingredient shall be provided to the competent body. The DID list-part A (Appendix I) indicates whether a specific
surfactant is aerobically biodegradable or not (the surfactants with an entry of ‘R’
in the column on aerobic
biodegradability are readily biodegradable). For surfactants which are not included in the DID list-part A, the relevant
information from literature or other sources, or appropriate test results, showing that
they are aerobically
biodegradable shall be provided. The tests for ready biodegradability shall be as referred to in Regulation (EC) No 648/
2004 of the European Parliament and of the Council of 31 March 2004 on detergents (1). Surfactants shall be
considered as readily biodegradable if the level of biodegradability (mineralisation) measured according to one of the
five following tests is at least 60 % within 28 days: CO2 headspace test (OECD 310), carbon dioxide (CO2) evolution
modified Sturm test (OECD 301B; Council Directive 67/548/EEC (2) Annex V.C.4-C), closed bottle test (OECD 301D;
Directive 67/548/EEC Annex V.C.4-E), manometric respirometry (OECD 301F; Directive 67/548/EEC Annex V.C.4-
D), or MITI (I) test (OECD 301C; Directive 67/548/EEC Annex V.C.4-F), or their equivalent ISO tests. Depending on

(1)
(2)

OJ L 104, 8.4.2004, p. 13.

Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions
relating to the classification, packaging and labelling of dangerous substances (OJ L 196, 16.8.1967, p. 1).

 
 
 
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the surfactant, one of

the following tests might be used to confirm ready
the physical characteristics of
biodegradability, if the level of biodegradability is at least 70 % within 28 days: dissolved organic carbon DOC die-
away (OECD 301A; Directive 67/548/EEC Annex V.C.4-A) or modified OECD screening DOC die-away (OECD 301E;
Directive 67/548/EEC Annex V.C.4-B), or their equivalent ISO tests. The applicability of test methods based on
measurement of dissolved organic carbon needs to be appropriately justified as these methods could give results on
to be used in tests for aerobic ready
the removal and not on the biodegradability. Pre-adaptation is not
biodegradability. The 10 days window principle shall not apply.

(b) Anaerobic biodegradability

Each surfactant used in the product shall be biodegradable under anaerobic conditions.

Assessment and verification: the exact formulation of the product as well as a description of the function of each
ingredient shall be provided to the competent body. The DID list-part A (Appendix I) indicates whether a specific
surfactant is anaerobically biodegradable or not (the surfactants with an entry of ‘Y’ in the column on anaerobic
biodegradability are biodegradable under anaerobic conditions). For surfactants which are not included in the DID
list-part A, the relevant information from literature or other sources, or appropriate test results, showing that they are
anaerobically biodegradable shall be provided. The reference test for anaerobic degradability shall be OECD 311, ISO
11734, ECETOC No 28 (June 1988) or an equivalent test method, with the requirement of a minimum of 60 %
ultimate degradability under anaerobic conditions. Test methods simulating the conditions in a relevant anaerobic
environment may also be used to document that 60 % ultimate degradability has been attained under anaerobic
conditions (see Appendix II).

3.

Dangerous, hazardous or toxic substances or preparations

(a)

The following ingredients shall not be included in the product, either as part of the formulation or as part of any preparation
included in the formulation:

— Alkyl phenol ethoxylates (APEOs) and derivatives thereof,

— EDTA (ethylene-diamine-tetra-acetate) and its salts,

— NTA (nitrilo-tri-acetate),

— Nitromusks and polycyclic musks, including for example:

Musk xylene: 5-tert-butyl-2,4,6-trinitro-m-xylene,

Musk ambrette: 4-tert-butyl-3-methoxy-2,6-dinitrotoluene,

Moskene: 1,1,3,3,5-pentamethyl-4,6-dinitroindan,

Musk tibetine: 1-tert-butyl-3,4,5-trimethyl-2,6-dinitrobenzene,

Musk ketone: 4’-tert-butyl-2’,6’-dimethyl-3’,5’-dinitroacetaphenone,

HHCB (1,3,4,6,7,8-Hexahydro-4,6,6,7,8,8-hexamethylcyclopenta(g)-2-benzopyran),

AHTN (6-Acetyl-1,1,2,4,4,7-hexamethyltetralin).

Assessment and verification: the applicant shall provide a declaration supported by declarations from manufacturers of
ingredients, as appropriate, confirming that the listed substances have not been included in the product.

(b) Quaternary ammonium salts that are not readily biodegradable shall not be used, either as part of the formulation or as

part of any preparation included in the formulation.

Assessment and verification: the applicant shall provide documentation showing the biodegradability of any quaternary
ammonium salt used.

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(c) No ingredient (substance or preparation) shall be included in the product that is classified, with any of the following risk
phrases, or any combination thereof, in accordance with Directive 67/548/EEC and its amendments or Directive 1999/45/
EC of the European Parliament and of the Council

(3) and its amendments:

R31 (contact with acid liberates toxic gas),

R40 (limited evidence of a carcinogenic effect),

R45 (may cause cancer),

R46 (may cause heritable genetic damage),

R49 (may cause cancer by inhalation),

R68 (possible risks of irreversible effects)

R50-53 (very toxic to aquatic organism and may cause long term adverse effects in the aquatic environment),

R51-53 (toxic to aquatic organism and may cause long term adverse effects in the aquatic environment),

R59 (dangerous to the ozone layer),

R60 (may impair fertility),

R61 (may cause harm to the unborn child),

R62 (possible risk of impaired fertility),

R63 (possible risk of harm to the unborn child),

R64 (may cause harm to breastfed babies).

Specific requirements are prescribed for biocides, either as part of the formulation or as part of any preparation included in the
formulation (see criterion on biocides below).

The above requirements shall apply to each ingredient (substance or preparation) that exceeds 0,01 % by weight of the
final product. This includes also each ingredient of any preparation used in the formulation that exceeds 0,01 % by
weight of the final product.

Assessment and verification: copies of the material safety data sheets shall be provided for all ingredients (whether
substances or preparations). A declaration prepared by the manufacturer of ingredients and showing compliance with
this criterion shall be provided by the applicant.

4.

Biocides

(a)

The product may only include biocides in order to preserve the product, and in the appropriate dosage for this
purpose alone. This does not refer to surfactants, which may also have biocidal properties.

Assessment and verification: copies of the material safety data sheets of any preservatives added shall be provided,
together with information on their exact concentration in the product. The manufacturer or supplier of the
preservatives shall provide information on the dosage necessary to preserve the product.

(3)

Directive 1999/45/EC of the European Parliament and of the Council of 31 May 1999 concerning the approximation of the
laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of
dangerous preparations (OJ L 200, 30.7.1999, p. 1).

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(b)

It is prohibited to claim or suggest on the packaging or by any other communication that the product has an
antimicrobial action.

Assessment and verification: the texts and layouts used on each type of packaging and/or an example of each
different type of packaging shall be provided to the competent body.

Biocides, either as part of the formulation or as part of any preparation included in the formulation, that are
used to preserve the product and that are classified with R50-53 or R51-53 risk phrases, in accordance with
Directive 67/548/EEC and its amendments or Directive 1999/45/EC, are permitted but only if they are not
potentially bioaccumulative. In this context, a biocide is considered to be potentially bioaccumulative if the log
Pow (log octanol/water partition coefficient) ≥3,0 (unless the experimentally determined BCF ≤100).

The concentration of biocides in the final product shall not exceed the maximum authorised concentration in
Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating
to cosmetic products and its subsequent amendments.

Assessment and verification: copies of the material safety data sheets shall be provided for all biocides, together
with a documentation of the concentrations of the biocides in the final product.

5.

Dyes or colouring agents

Any dyes or colouring agents used in the product must be permitted by Council Directive 76/768/EEC relating to
cosmetic products (4) and its subsequent amendments, or must be permitted by European Parliament and Council
Directive 94/36/EC of 30 June 1994 on colours for use in foodstuffs (5) and its subsequent amendments, or must be
characterised by environmental properties that do not imply classification with R50-53 or R51-53 risk phrases, in
accordance with Directive 67/548/EEC and its amendments.

Assessment and verification: a declaration of compliance with this criterion shall be provided to the competent body,
together with a full list of all dyes or colouring agents used.

6.

Fragrances

(a)

The product shall not contain perfumes containing nitro-musks or polycyclic musks (as specified in the
criterion 3(a).

(b) Any ingredients added to the product as a fragrance must have been manufactured and/or handled in

accordance with the code of practice of the International Fragrance Association.

Assessment and verification: a declaration of compliance with each part of this criterion shall be provided to the
competent body.

7.

Sensitising substances

The product shall not be classified with R42 (may cause sensitisation by inhalation) and/or R43 (may cause
sensitisation by skin contact) risk phrases, in accordance with Directive 1999/45/EC and its amendments.

The concentration of any substance or ingredient classified with R42 (may cause sensitisation by inhalation) and/or
R43 (may cause sensitisation by skin contact) risk phrases,
in accordance with Directive 67/548/EEC and its
amendments or Directive 1999/45/EC and its amendments, shall not exceed 0,1 % by weight of the final product.

Assessment and verification: the exact concentrations of all ingredients that are classified as R42 and/or R43 shall be
provided to the competent body, together with copies of the material safety data sheets.

8.

Volatile organic compounds

The product shall not contain more than 10 % (by weight) of volatile organic compounds with a boiling point lower
than 150 oC.

(4)
(5)

OJ L 262, 27.9.1976, p. 169.

OJ L 237, 10.9.1994, p. 13.

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Assessment and verification: copies of the material safety data sheets of each organic solvent together with details of the
calculations of the total volatile organic compounds with a boiling point lower than 150 oC shall be provided by the
applicant.

9.

Phosphorus

The total quantity of elemental phosphorous in the product shall be calculated per functional unit (for all-purpose
cleaners) or per 100 g of product (cleaners for sanitary facilities) taking into account all ingredients containing
phosphorus (e.g. phosphates and phosphonates).

For all-purpose cleaners, the total phosphorus content (P) shall not exceed 0,02 g/functional unit.

For cleaners for sanitary facilities, the total phosphorus content (P) shall not exceed 1,0 g/100 g of product.

Ingredients used in window cleaning products must not contain phosphorus.

Assessment and verification: the exact formulation of the product shall be provided to the competent body, together
with the details of the calculations showing compliance with this criterion.

(a)

Sprays containing propellants must not be used.

10.

Packaging requirements

(b)

(c)

Plastic materials that are used for the main container shall be marked according to European Parliament and
Council Directive 94/62/EC of 20 December 1994 on packaging and packaging waste (6), or DIN 6120 Parts 1
and 2 in connection with DIN 7728 part 1.

If the primary packaging is made of recycled material, any indication of this on the packaging shall be in
conformity with the ISO 14021 standard ‘Environmental labels and declarations — Self declared claims (type II
environmental labelling)’.

(d)

The primary packaging parts shall be easily separable into mono-material parts.

Assessment and verification: data on the packaging, and/or a sample thereof if appropriate, shall be provided to the
competent body, together with a declaration of compliance with each part of this criterion.

FITNESS FOR USE

11.

Fitness for use

The product shall be fit for use, meeting the needs of the consumers.

The cleaning ability must be equivalent to or better than a market-leading or generic reference product (see Appendix
III), approved by a competent body, as well as better than pure water.

For all-purpose cleaners and cleaning products for kitchens, only fat-removing effects must be documented. For
sanitary cleaning products and window cleaners, both calcium and fat-removing effects must be documented.

Assessment and verification: the performance of the product must either be tested by:

— an adequate and justifiable laboratory test, or

— an adequate and justifiable consumer test.

Both tests must be carried out and reported within specified parameters as stated in the framework described in
Appendix III.

(6)

OJ L 365, 31.12.1994, p. 10.

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CONSUMER INFORMATION

12.

User instructions

(a) Dosage instructions

For all-purpose cleaners, an exact dosage recommendation shall appear on the packaging in a reasonably sufficient
size and against a visible background. The use of a pictogram (such as a 5 1 tub and number of caps with ml) is
recommended but voluntary.

In the case of a concentrated cleaner for sanitary facilities, it shall be clearly indicated on the packaging that only a
small quantity of the product is needed compared to normal (i.e. diluted) products.

The following text (or equivalent text) shall appear on the packaging:

‘Proper dosage saves costs and minimises environmental impacts’.

(b)

Safety advice

The following safety advice (or equivalent text) shall appear on the product (in both text form and with an equivalent
pictogram):

‘Keep away from children’

‘Do not mix different cleaners’

‘Avoid inhaling sprayed product’ (only for products that are packaged as sprays).

(c)

Information and labelling of ingredients

Regulation (EC) No 648/2004 shall be applied.

(d)

Information about the eco-label

The following text (or equivalent text) shall appear on the packaging:

‘For more information visit the EU eco-label web-site: http://europa.eu.int/ecolabel’.

Assessment and verification: a sample of the product packaging, including the label, shall be provided to the competent
body, together with a declaration of compliance with each part of this criterion.

13.

Information appearing on the eco-label

Box 2 of the eco-label shall contain the following text:

— reduced impact on aquatic life,

— reduced use of hazardous substances,

— clear user instructions.

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14.

Professional training

For detergents, which are used by professional users, the producer, its distributor or a third party shall offer training or
training materials for cleaning staff. These shall include step-by-step instructions for proper dilution, use, disposal and
the use of equipment.

Assessment and verification: a sample of training material containing step-by-step instructions for proper dilution, use,
disposal and the use of equipment and a description of training courses shall be provided to the competent body.

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EN

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L 115/53

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EN

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EN

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EN

Official Journal of the European Union

4.5.2005

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EN

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4.5.2005

EN

Official Journal of the European Union

L 115/61

Part B. Critical dilution volume

The Critical Dilution Volume is calculated according to the following equation:

CDV = 1000 * Σdosage(i)*DF(i)/TF(i)

Dosage(i) = dosage of ingredient i, expressed in g/wash, or in some cases as g/100 g product.

DF(i) = degradation factor for ingredient i.

TF(i) = toxicity factor for ingredient i.

PROCEDURE FOR ESTABLISHING PARAMETER VALUES FOR INGREDIENTS NOT ON THE DID-LIST

As a general rule the listed parameter values must be used for all ingredients on the DID-list. An exception is made for
perfumes and dyes, where additional test results are accepted (see footnote in Part A).

The following approach applies for ingredients that are not listed on the DID-list.

Aquatic toxicity

In the European Eco-label scheme, the CDV is calculated based on the chronic toxicity and chronic safety factors. If no
chronic test results are available, the acute toxicity and safety factor must be used.

The chronic toxicity factor (TFchronic)

— Calculate the median value within each trophic level (fish, crustaceans or algae) using validated test results for
chronic toxicity. If several test results are available for one species within a trophic level, a median for the species
shall be calculated first, and these median values shall be used when calculating the median value for the trophic
level .

— The chronic toxicity factor (TFchronic) is the lowest median of the trophic levels calculated.

— The TFchronic shall be used when calculating the critical dilution volume criterion.

The acute toxicity factor (TFacute)

— Calculate the median value within each trophic level (fish, crustaceans or algae) using validated test results for
acute toxicity. If several test results are available for one species within a trophic level, a median for the species
shall be calculated first, and these median values shall be used when calculating the median value for the trophic
level .

— The acute toxicity factor (TFacute) is the lowest median of the trophic levels.

— The TFacute shall be used when calculating the critical dilution volume criterion.

L 115/62

EN

Official Journal of the European Union

4.5.2005

Safety factor:

The Safety factor (SF) is depending on how many trophic levels are tested, and whether chronic test results are
available or not. SF is determined as follows:

Data

Safety factor (SF)

Toxicity factor (TF)

1 short-term L(E)C50

2 short-term L(E)C50 from species representing two trophic levels
(fish and/or crustaceans and/or algae)

At least 1 short-term L(E)C50 from each of three trophic levels of
the base-set1

One long-term NOEC (fish or crustaceans)

Two long-term NOEC from species representing two trophic levels
(fish and/or crustaceans and/or algae)

Long-term NOEC from at
crustaceans and algae) representing three trophic levels

three species (normally fish,

least

10 000

5 000

Toxicity/10 000

Toxicity/5 000

1 000

Toxicity/1 000

100

50

10

Toxicity/100

Toxicity/50

Toxicity/10

The base set for testing the toxicity of substances towards aquatic organisms consists of acute tests with fish, daphnia
and algae.

Degradation factors

The degradation factor is defined as follows:

Table 1

Degradation factor (DF)

Readily biodegradable (*)

Readily biodegradable (**)

Inherently biodegradable

Persistent

DF

0,05

0,15

0,5

1

(*) All surfactants or other ingredients consisting of a series of homologues and fulfilling the final degradation
requirement of the test, shall be included in this class regardless of fulfilment of the 10-day window criterion.

(**) 10-day window criterion not fulfilled.

For inorganic ingredients the DF is set according to observed degradation rate. If the ingredient degrade within
five days: DF=0,05, within 15 days: DF=0,15 or within 50 days: DF=0,5.

Anaerobic biodegradability

The ingredient must be classified into one of the following classes of compounds:

Category

Anaerobically not biodegradable, i.e. tested and found not biodegradable.

Anaerobically biodegradable i.e.
demonstrated through analogy considerations etc.

tested and found biodegradable or not

tested but

Not tested for anaerobic biodegradability

Label

N

Y

0

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Aerobic biodegradability

The ingredient must be classified into one of the following classes of compounds:

Category

Readily biodegradable

Inherently biodegradable, but not readily biodegradable

Persistent

Not tested for aerobic biodegradability

Insoluble inorganic ingredients

Label

R

I

P

O

If an inorganic ingredient has a very low water-solubility, or is not soluble in water this must be indicated in the
submitted file.

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Appendix II

DOCUMENTATION OF ANAEROBIC BIODEGRADABILITY

The following approach may be used to provide the necessary documentation of anaerobic biodegradability in the
case of ingredients that are not listed in the DID list.

Apply reasonable extrapolation. Use test results obtained with one raw material to extrapolate the ultimate anaerobic
degradability of structurally related surfactants. If anaerobic biodegradability has been confirmed for a surfactant (or a
group of homologues) according to the DID list (Appendix I), it can be assumed that a similar type of surfactant is
also anaerobically biodegradable (for example, C 12-15 A 1-3 EO sulphate (DID No 8) is anaerobically biodegradable,
and a similar anaerobic biodegradability may also be assumed for C 12-15 A 6 EO sulphate).
If anaerobic
biodegradability has been confirmed for a surfactant by use of an appropriate test method, it can be assumed that a
similar type of surfactant is also anaerobically biodegradable (for example, literature data confirming the anaerobic
biodegradability of surfactants belonging to the group alkyl ester ammonium salts may be used as documentation for
a similar anaerobic biodegradability of other quaternary ammonium salts containing ester-linkages in the alkyl chain
(s)).

Perform screening test for anaerobic degradability. If new testing is necessary, perform a screening test by use of OECD 311,
ISO 11734, ECETOC No 28 (June 1988) or an equivalent method.

Perform low-dosage degradability test. If new testing is necessary, and in the case of experimental problems in the
screening test (for example, inhibition due to toxicity of test substance), repeat testing by using a low dosage of
surfactant and monitor degradation by 14C measurements or chemical analyses. Testing at low dosages may be
performed by use of OECD 308 (24 April 2002) or an equivalent method provided that strict anaerobic conditions
are applied. The testing and the interpretation of the test results should be conducted by an independent expert.

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Appendix III

FRAMEWORK FOR A PERFORMANCE TEST

The performance test can be either a laboratory test or a consumer test. The conditions for both types of test are
described in the following sections.

1.

Laboratory tests

The aim of the laboratory test is to confirm that the test product cleans as well as or better than a comparative
reference product and better than pure water, and to confirm that the test product does not damage the surfaces it is
intended for.

General framework requirements

— The test product and the reference product shall be of the same product category.

— The reference product may be either a market-leading product or a generic formulation.

— If a market-leading reference product is used, it shall be one of the three or four products with the highest sales
volume on the market in a region, where the eco-labelled product is to be marketed. Furthermore, the market-
leading reference product must be approved by the competent body, and the trade name must be available to
the public.

— If a generic reference product is used, it must have a composition which is representative for the products on the
market. Furthermore, the generic reference product must be approved by the Competent body and the exact
formulation must be publicly available free of charge.

— The dosages used shall be the recommended dosage for normal soil or normal use. If no recommended dosage
is stated for the reference product, the same dosage must be used for both the test product and the reference
product.

— If a dosage interval is given, the lowest recommended dosage must be used in the test.

— The soil mixture must be relevant for the use of the product, homogeneous and, if prepared artificially, based on

well-described substances. Enough soil for the whole test must be prepared in a single batch.

— For all-purpose cleaners and cleaning products for kitchens, only fat-removing effects shall be documented. For

sanitary cleaners and window cleaners, both calcium and fat removing effects shall be documented.

— The washing procedure must reflect realistic use conditions and can be manual or by machinery.

Testing requirements

— The assessment of cleanness must include testing and comparison of test product, reference product.

— Each product must be tested in at least five parallels (see documentation requirements). Additionally, one test

must be performed with water only, i.e. without any cleaning agent.

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— The quantity of soil applied to plates or another substrate must be the same for each plate or substrate-part,

weighed in grams to one decimal point.

— The order of testing of the two products shall be randomised.

— The test must be capable of generating results that provide a measure of the cleanness (fat and calcium removing
effects) according to the product tested. Cleanness can be measured visually, photometrically (e.g. measuring
reflectance), gravimetrically or by means of another relevant method. The method of measurement, including a
possible scoring system, must be decided in advance.

— Testing of fat and calcium removing effects may be done either separately or jointly.

Documentation requirements

A detailed test report shall be submitted to the competent body, including information on:

— The dosages used for the test product and the reference product.

— Common application area(s) for the test and the reference product.

— Justification of the choice of the reference product with respect to its position on the market and its function.

— Type(s) of surface used in the test, their relevance and whether the products are gentle on the chosen surface(s).

— Description of the soil mixture used in the test, together with an argumentation for its relevance in relation to

the testing of fitness for use.

— Description of the procedures for soiling, washing and measurement of cleaning performance.

— Calculation and statistical comparison procedures.

— All raw data used in the testing and calculations.

— For the test product to be considered to have fulfilled the performance requirements its results must be positive
in 100 % of the test rounds. If the result is less than 100 % positive, five new parallel tests must be performed.
Of these 10 parallel tests, 80 % must be positive.

As an alternative the applicant may use statistical methods and demonstrate with a one-sided 95 % confidence
range that the test product is as good as or better than the reference product in at least 80 % of the test rounds,
if more than 10 parallel tests are made.

— How it is shown that the product tested has a better performance than that of pure water.

Note on tests

The CTTN-IREN test ‘Washing of tiled floor and grease removal on kitchen surface’ fulfils the requirements for all-
purpose cleaners provided that the number of tests is increased, the same amount of soil is applied in all subtests, and
an assessment of the gentleness of the products on surfaces is included. The method described by the Danish
Consumer Information fulfils the requirements for all-purpose cleaners provided that the number of tests with each
product is increased (Testing of all-purpose cleaners, 2004; Danish title: ‘Sådan er universalrengøringsmidlerne testet’;
(www.forbrug.dk/test/testbasen/rengoering/universalrengoerings/saadan-er-de-testet/).

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The IKW-test ‘Empfehlung zur Qualitätsbewertung für Badezimmerreiniger’ (SÖFW-Journal, 129, Jahrgang 3, 2003)
fulfils the requirements for bathroom cleaners. The IKW-test ‘Recommendations for the quality assessment of acidic
toilet cleaners’ (SÖFW-Journal, 126, 11-2000) fulfils the requirements for sanitary cleaners. The method described by
the Danish Consumer Information fulfils the requirements for sanitary cleaners (Testing of sanitary cleaners, 2004;
Danish title: ‘Sådan er toiletrensemidlerne testet’;
(www.forbrug.dk/test/testbasen/rengoering/toiletrensemidler/saadan-er-de-testet/).

The CHELAB test ‘Detergents for hard surfaces: washing efficiency’ (CHELAB internal test method n. 0578) fulfils the
requirements for all-purpose cleaners provided that a test with pure water (without addition of detergent) is included
in the procedure (www.chelab.it/).

2.

Consumer tests

The aim of the consumer test is to show whether the test product cleans as good as or better than a comparative
reference product, and that the test product does not hurt the surfaces it is intended for.

General framework requirements

— For testing of consumer products, responses must be received from a minimum of 20 persons, randomly

selected in the sales region and normally using the reference product

— For testing of professional products, responses must be received from at least five professional users, randomly

selected in the sales region and normally using the reference product

— The test product and the reference product should be of the same product category. The reference products shall

be the products normally used by the test persons.

— The dosages used must be the dose recommended by the manufacturer

— The test must be performed on the type(s) of surface relevant in relation to the recommendations on the label

— The test period must allow for at least five uses of the test product

Testing requirements

— Effectiveness of all-purpose cleaners must be assessed by the following properties:

— The ability of the products to remove soil

— The gentleness of the products on the surface(s) on which it is used

— Effectiveness of sanitary cleaners must be assessed by the following properties:

— The ability to remove fat-based soil

— The ability to remove calcium deposits (not relevant for cleaning products for kitchens)

— The gentleness of the product on the surface(s) on which it is used

— The test persons must reply to the question ‘How effective do you consider the test product to be compared to
the product you normally use?’ — or equivalent. At least three possibilities for a response must be available, e.g.
‘poorer’, ‘as good as’ and ‘better’

— At least 80 % of the test persons must assess the product to be ‘as good as’ or ‘better’ than the reference product

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Documentation requirements

A detailed test report must be submitted to the competent body, including information/documentation on:

— The selection of the test persons

— The information provided by the test persons and a summary describing how the testing was performed

— The type of surface(s) the product was tested on.

— For each test person, the following information must be available, e.g. in the form of answers to a questionnaire:

— The dosage used by the test person

— The name of the reference product

— A statement declaring that the product has been tested at least five times

— The result of the comparison of the test product and the reference product

— Calculation and documentation showing that at least 80 % of the test persons assess the product to be as good

as or better than the reference product.