# L_2011169EN.01005201.xml

| 29.6.2011 | EN | Official Journal of the European Union | L 169/52 |
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29.6.2011

EN

Official Journal of the European Union

L 169/52

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COMMISSION DECISION

of 28 June 2011

on establishing the ecological criteria for the award of the EU Ecolabel to all-purpose cleaners and sanitary cleaners

(notified under document C(2011) 4442)

(Text with EEA relevance)

(2011/383/EU)

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 Eco-labelling 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 cycle. |
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(1)

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

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

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

| (3) | Commission Decision 2005/344/EC (2) has established the ecological criteria and the related assessment and verification requirements for all-purpose cleaners and cleaners for sanitary facilities which are valid until 30 June 2011. |
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(3)

Commission Decision 2005/344/EC (2) has established the ecological criteria and the related assessment and verification requirements for all-purpose cleaners and cleaners for sanitary facilities which are valid until 30 June 2011.

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

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

| (5) | Decision 2005/344/EC should be replaced for reasons of clarity. |
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(5)

Decision 2005/344/EC should be replaced for reasons of clarity.

| (6) | A transitional period should be allowed for producers whose products have been awarded the Ecolabel for all-purpose cleaners and sanitary cleaners on the basis of the criteria set out in Decision 2005/344/EC, so that they have sufficient time to adapt their products to comply with the revised criteria and requirements. Producers should also be allowed to submit applications based on the criteria set out in Decision 2005/344/EC or on the criteria set out in this Decision until the lapse of validity of that Decision. |
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(6)

A transitional period should be allowed for producers whose products have been awarded the Ecolabel for all-purpose cleaners and sanitary cleaners on the basis of the criteria set out in Decision 2005/344/EC, so that they have sufficient time to adapt their products to comply with the revised criteria and requirements. Producers should also be allowed to submit applications based on the criteria set out in Decision 2005/344/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 with the opinion of the Committee established by Article 16 of Regulation (EC) No 66/2010, |
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(7)

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

HAS ADOPTED THIS DECISION:

Article 1

The product group ‘All-purpose cleaners and sanitary cleaners’ shall comprise: all-purpose cleaners, window cleaners, and sanitary cleaners.

| (a) | All-purpose cleaners comprising detergent products intended for the routine cleaning of floors, walls, ceilings, windows and other fixed surfaces, and which are either diluted in water prior to use or used without dilution. All-purpose cleaners shall mean products intended for indoor use in buildings which include domestic, commercial and industrial facilities. |
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(a)

All-purpose cleaners comprising detergent products intended for the routine cleaning of floors, walls, ceilings, windows and other fixed surfaces, and which are either diluted in water prior to use or used without dilution. All-purpose cleaners shall mean products intended for indoor use in buildings which include domestic, commercial and industrial facilities.

| (b) | Window cleaners comprising specific cleaners intended for the routine cleaning of windows, and which are used without dilution. |
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(b)

Window cleaners comprising specific cleaners intended for the routine cleaning of windows, and which are used without dilution.

| (c) | Sanitary cleaners comprising detergent products intended for the routine removal, including by scouring, of dirt and/or deposits in sanitary facilities, such as laundry rooms, toilets, bathrooms, showers and kitchens. This subgroup thus contains bathroom cleaners and kitchen cleaners. |
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(c)

Sanitary cleaners comprising detergent products intended for the routine removal, including by scouring, of dirt and/or deposits in sanitary facilities, such as laundry rooms, toilets, bathrooms, showers and kitchens. This subgroup thus contains bathroom cleaners and kitchen cleaners.

The product group shall cover products for both private and professional use. The products shall be mixtures of chemical substances and must not contain micro-organisms that have been deliberately added by the manufacturer.

Article 2

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

| 1. | ‘substance’ means a chemical element and its compounds in the natural state or obtained by any production process, including any additive necessary to preserve the stability of the product and any impurity deriving from the process used but excluding any solvent, which may be separated without affecting the stability of the substance or changing its composition; |
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1.

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

| 2. | ‘product’ (or ‘mixture’) means a mixture or solution of two or more substances, which do not react. |
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2.

‘product’ (or ‘mixture’) means a mixture or solution of two or more substances, which do not react.

Article 3

In order to be awarded the EU Ecolabel under Regulation (EC) No 66/2010, an item of all-purpose cleaner, window cleaner or sanitary cleaner shall fall within the product group ‘all-purpose cleaners and sanitary cleaners’ as defined in Article 1 of this Decision and shall comply with the criteria as well as the related assessment and verification requirements set out in the Annex to this Decision.

Article 4

The criteria for the product group ‘all-purpose cleaners and sanitary cleaners’, as well as the related assessment and verification requirements, shall be valid for 4 years from the date of adoption of this Decision.

Article 5

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

Article 6

Decision 2005/344/EC is repealed.

Article 7

1.   By derogation from Article 6, applications for the EU Ecolabel for products falling within the product group ‘all-purpose cleaners and sanitary cleaners’ submitted before the date of adoption of this Decision shall be evaluated in accordance with the conditions laid down in Decision 2005/344/EC.

2.   Applications for the EU Ecolabel for products falling within the product group ‘all-purpose cleaners and sanitary cleaners’ submitted from the date of adoption of this Decision but by 30 June 2011 at the latest may be based either on the criteria set out in Decision 2005/344/EC or on the criteria set out in this Decision.

Those applications shall be evaluated in accordance with the criteria on which they are based.

3.   Where the Ecolabel is awarded on the basis of an application evaluated in accordance with the criteria set out in Decision 2005/344/EC, that Ecolabel may 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, 28 June 2011.

For the Commission

Janez POTOČNIK

Member of the Commission

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(1)  
  OJ L 27, 30.1.2010, p. 1.

1

(2)  
  OJ L 115, 4.5.2005, p. 42.

2

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ANNEX

FRAMEWORK

The aims of the criteria

The criteria aim, in particular, at promoting products that have a reduced environmental impact by limiting the quantity of harmful substances, by reducing the quantity of detergent used and by reducing packaging waste. The criteria furthermore aim at reducing or preventing of risks for the environment and for human health related to the use of hazardous substances, minimising packaging waste, providing information that will enable the consumer to use the product in the way that is efficient and minimising environmental impact.

CRITERIA

| 1. | Toxicity to aquatic organisms |
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1.

| 2. | Biodegradability of surfactants |
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2.

| 3. | Excluded or limited substances and mixtures |
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3.

| 4. | Fragrances |
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4.

| 5. | Volatile organic compounds |
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5.

| 6. | Phosphorus |
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6.

| 7. | Packaging requirements |
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7.

| 8. | Fitness for use |
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8.

| 9. | User instructions |
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9.

| 10. | Information appearing on the EU Ecolabel |
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10.

| 11. | Professional training |
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11.

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, it is understood that these may originate from the applicant and/or his supplier(s) and/or their supplier(s) etc., as appropriate.

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.

Appendix I makes reference to the Detergents Ingredients Database (DID) list which contains the most widely used ingredients used in detergent formulations. It shall be used for deriving the data for the calculations of the Critical Dilution Volume (CDV) and for the assessment of the biodegradability of the ingredients. For substances not present on the DID list, guidance is given on how to calculate or extrapolate the relevant data. The latest version of the DID list is available from the EU Ecolabel website or via the websites of the individual competent bodies.

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

(b)   Measurement thresholds

All substances in the product, including additives (e.g. preservatives or stabilisers) in the ingredients, of which the concentration exceeds 0,010 % by weight of the final formulation shall comply with the EU Ecolabel criteria, except for Criterion 1, where each intentionally added substance should be included, irrespective of its weight. Impurities resulting from the production of the ingredients which are present in concentrations > 0,010 % by weight of the final formulation shall also comply with the criteria.

(c)   Reference dosage

For all-purpose cleaners which are diluted in water prior to use the dosage in grams of the product recommended by the manufacturer for preparing 1 litre of washing water for cleaning of normally soiled surfaces is taken as the reference dosage for the calculations aiming at documenting compliance with the EU Ecolabel criteria and for testing of cleaning ability.

EU ECOLABEL CRITERIA

Criterion 1 —   Toxicity to aquatic organisms

The critical dilution volume (CDVchronic) is calculated for each substance (i) using the following equation:

Formula

where weight(i) is the weight of the substance (in grams) contained in the dosage recommended by the manufacturer for 1 litre of washing water (for all-purpose cleaners which are diluted in water prior to use) or per 100 grams of product (all-purpose cleaners, window cleaners and sanitary cleaners which are used without dilution). DF(i) is the degradation factor and TFchronic(i) is the toxicity factor of the substance (in milligrams/litre).

The values of DF and TFchronic shall be as given in the detergent ingredient database list-Part A (DID list-Part A) (Appendix I). If the substance 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 I). The CDVchronic is summed for each substance, making the CDVchronic for the product.

For all-purpose cleaners which are diluted in water prior to use, the CDVchronic shall be calculated on the basis of the dosage in grams of the product recommended by the manufacturer for preparing 1 litre of washing water for cleaning of normally soiled surfaces. The CDVchronic of the recommended dose expressed for 1 litre of washing water shall not exceed 18 000 litres.

For all-purpose cleaners which are used without dilution, the CDVchronic for 100 g of the product shall not exceed 52 000 litres.

For window cleaners, the CDVchronic for 100 g of the product shall not exceed 4 800 litres.

For sanitary cleaners, the CDVchronic for 100 g of the product shall not exceed 80 000 litres.

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

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 substance 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 in accordance with 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 Regulation (EC) No 440/2008 (2) method C.4-C), Closed Bottle test (OECD 301D; Regulation (EC) No 440/2008 method C.4-E), Manometric Respirometry (OECD 301F; Regulation (EC) No 440/2008 method C.4-D), or MITI (I) test (OECD 301C; Regulation (EC) No 440/2008 method C.4-F), or their equivalent ISO tests. Depending on the physical characteristics of the surfactant, one of the following tests might be used to confirm ready biodegradability, if the level of biodegradability is at least 70 % within 28 days: Dissolved Organic Carbon DOC Die-Away (OECD 301A; Regulation (EC) No 440/2008 method C.4-A) or Modified OECD Screening DOC Die-Away (OECD 301E; Regulation (EC) No 440/2008 method 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 the removal and not on the biodegradability. Pre-adaptation is not to be used in tests for aerobic ready biodegradability. The 10 days window principle shall not apply.

(b)   Anaerobic biodegradability

Surfactants that are not biodegradable under anaerobic conditions may be used in the product within specified limitations provided that the surfactants are not classified with H400/R50 (Very toxic to aquatic life) within the limit specified below.

For all-purpose cleaners to be diluted with water prior to use, the total weight of anaerobically non-biodegradable surfactants must not exceed 0,40 g of the recommended dose expressed for 1 litre of washing water.

For all-purpose cleaners to be used without dilution, the total weight of anaerobically non-biodegradable surfactants must not exceed 4,0 g per 100 g product.

For sanitary cleaners, the total weight of anaerobically non-biodegradable surfactants must not exceed 2,0 g per 100 g product.

For window cleaners, the total weight of anaerobically non-biodegradable surfactants must not exceed 2,0 g per 100 g product.

Assessment and verification: the exact formulation of the product as well as a description of the function of each substance 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.

Criterion 3 —   Excluded or limited substances and mixtures

The requirements stated in (a), (b) and (c) below shall apply to each substance, including biocides, colouring agents and fragrances, that exceeds 0,010 % by weight of the final product. This includes also each substance of any mixture used in the formulation that exceeds 0,010 % by weight of the final product. Nanoforms intentionally added to the product shall prove compliance with the Criterion 3(c) for any concentration.

(a)   Specified excluded substances

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

| — | Alkyl phenol ethoxylates (APEOs) and derivatives thereof |
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—

Alkyl phenol ethoxylates (APEOs) and derivatives thereof

| — | EDTA (ethylene-diamine-tetra-acetic-acid) and its salts |
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—

EDTA (ethylene-diamine-tetra-acetic-acid) and its salts

| — | 5-Bromo-5-nitro-1,3-dioxane |
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—

5-Bromo-5-nitro-1,3-dioxane

| — | 2-Bromo-2-nitropropane-1,3-diol |
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—

2-Bromo-2-nitropropane-1,3-diol

| — | Diazolinidylurea |
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—

Diazolinidylurea

| — | Formaldehyde |
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—

Formaldehyde

| — | Sodium hydroxy methyl glycinate |
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—

Sodium hydroxy methyl glycinate

| — | Nitromusks and polycyclic musks, including for example:






  — | Musk xylene: 5-Tert-butyl-2,4,6-trinitro-m-xylene, |
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—

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, |
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—

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

| — | Moskene: 1,1,3,3,5-Pentamethyl-4,6-dinitroindan, |
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—

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

| — | Musk tibetine: 1-Tert-butyl-3,4,5-trimethyl-2,6-dinitrobenzene, |
| --- | --- |

—

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

| — | Musk ketone: 4′-Tert-butyl-2′,6′-dimethyl-3′,5′-dinitroacetaphenone, |
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—

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), |
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—

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). |
| --- | --- |

—

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 substances, as appropriate, confirming that the listed substances have not been included in the product.

(b)   Quaternary ammonium salts

Quaternary ammonium salts that are not readily biodegradable shall not be used, either as part of the formulation or as part of any mixture included in the formulation.

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

(c)   Hazardous substances and mixtures

According to the Article 6(6) of Regulation (EC) No 66/2010, the product or any part of it shall not contain substances (in any forms, including nanoforms) meeting 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 (3) or Council Directive 67/548/EEC (4) nor shall it contain substances referred to in Article 57 of Regulation (EC) No 1907/2006 of the European Parliament and of the Council (5). The risk phrases below generally refer to substances. However, for mixtures of enzymes and fragrances, where information on substances cannot be obtained, the classification rules for mixtures shall be applied.

List of hazard statements and risk phrases:

| Hazard Statement (6) | Risk Phrase (7) |
| --- | --- |
| 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 | R23; 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 | R60-61 |
| H360Fd May damage fertility. Suspected of damaging the unborn child | R60-63 |
| H360Df May damage the unborn child. Suspected of damaging fertility | R61-62 |
| 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 |
| 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 |
| Sensitising substances |
| H334: May cause allergy or asthma symptoms or breathing difficulties if inhaled | R42 |
| H317: May cause allergic skin reaction | R43 |

Hazard Statement (6)

Risk Phrase (7)

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

R23; 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

R60-61

H360Fd May damage fertility. Suspected of damaging the unborn child

R60-63

H360Df May damage the unborn child. Suspected of damaging fertility

R61-62

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

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

Sensitising substances

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

R42

H317: May cause allergic skin reaction

R43

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.

Derogations: the following substances or mixtures are specifically exempted from this requirement:

| Surfactants
  In concentrations < 25 % in the product (*1) | H400 Very toxic to aquatic life | R50 |
| --- | --- | --- |
| Fragrances | H412 Harmful to aquatic life with long-lasting effects | R52-53 |
| Enzymes (*2) | H334: May cause allergy or asthma symptoms or breathing difficulties if inhaled | R42 |
| Enzymes (*2) | H317: May cause allergic skin reaction | R43 |
| NTA as an impurity in MGDA and GLDA (*3) | H351 Suspected of causing cancer | R40 |

Surfactants

In concentrations < 25 % in the product (*1)

H400 Very toxic to aquatic life

R50

Fragrances

H412 Harmful to aquatic life with long-lasting effects

R52-53

Enzymes (*2)

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

R42

Enzymes (*2)

H317: May cause allergic skin reaction

R43

NTA as an impurity in MGDA and GLDA (*3)

H351 Suspected of causing cancer

R40

Assessment and verification: 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.

(d)   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 present in mixtures in concentrations higher than 0,010 %.

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 in accordance with Article 31 of Regulation (EC) No 1907/2006.

(e)   Biocides

| (i) | 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: the applicant shall provide copies of the material safety data sheets of any preservatives added, 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. |
| --- | --- |

(i)

Assessment and verification: the applicant shall provide copies of the material safety data sheets of any preservatives added, 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.

| (ii) | 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 applicant shall provide the texts and layouts used on each type of packaging and/or an example of each different type of packaging to the competent body. |
| --- | --- |

(ii)

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

| (iii) | Biocides, either as part of the formulation or as part of any mixture included in the formulation, that are used to preserve the product and that are classified H410/R50-53 or H411/R51-53 in accordance with Directive 67/548/EEC, Directive 1999/45/EC of the European Parliament and of the Council (8) or Regulation (EC) No 1272/2008, are permitted but only if their bioaccumulation potentials are characterised by log Pow (log octanol/water partition coefficient) < 3,0 or an experimentally determined bioconcentration factor (BCF) ≤ 100.

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

(iii)

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

Criterion 4 —   Fragrances

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

(a)

| (b) | Any substance 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. The code can be found on IFRA website: http://www.ifraorg.org |
| --- | --- |

(b)

| (c) | Fragrance substances subject to the declaration requirement provided for in Regulation (EC) No 648/2004 (Annex VII) and which are not already excluded by Criterion 3(c) and (other) fragrance substances classified H317/R43 (May cause allergic skin reaction) and/or H334/R42 (May cause allergy or asthma symptoms or breathing difficulties if inhaled) shall not be present in quantities ≥ 0,010 % (≥ 100 ppm) per substance. |
| --- | --- |

(c)

Assessment and verification: the applicant shall provide a declaration of compliance with each part of Criteria (a) and (b). For Criterion (c), the applicant shall provide a signed declaration of compliance indicating the amount of fragrances in the product. The applicant shall also provide a declaration from the fragrance manufacturer specifying the content of each of the substances in the fragrances which are listed in Annex III, Part I to Council Directive 76/768/EEC (9) as well as the content of (other) substances which have been assigned the risk phrases R43/H317 and/or R42/H334.

Criterion 5 —   Volatile organic compounds

The final products of all-purpose cleaners and sanitary cleaners (as sold) shall not contain more than 6 % (by weight) of volatile organic compounds with a boiling point lower than 150 °C. Alternatively, for concentrated products to be diluted in water, the total concentration of volatile organic compounds with a boiling point lower than 150 °C shall not exceed 0,2 % (by weight) in the washing water.

The final products of window cleaners (as sold) shall not contain more than 10 % (by weight) of volatile organic compounds with a boiling point lower than 150 °C.

Assessment and verification: the applicant shall provide copies of the material safety data sheets of each organic solvent together with details of the calculations of the total concentration of volatile organic compounds with a boiling point lower than 150 °C.

Criterion 6 —   Phosphorus

The total quantity of elemental phosphorous in the product shall be calculated on the basis of the dosage of the product recommended by the manufacturer for preparing 1 litre of washing water for cleaning of normally soiled surfaces (for products diluted in water prior to use) or per 100 g of product (for products used without dilution) taking into account all substances containing phosphorus (e.g. phosphates and phosphonates).

For all-purpose cleaners, which are diluted in water prior to use, the total phosphorus content (P) shall not exceed 0,02 g of the dosage of the product recommended by the manufacturer for 1 litre of washing water.

For all-purpose cleaners, which are used without dilution, the total phosphorus content (P) shall not exceed 0,2 g per 100 g of product.

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

Substances used in window cleaners must not contain phosphorus.

Assessment and verification: the applicant shall provide the exact formulation of the product to the competent body, together with the details of the calculations showing compliance with this Criterion.

Criterion 7 —   Packaging requirements

| (a) | Sprays containing propellants must not be used. |
| --- | --- |

(a)

| (b) | Plastic materials that are used for the main container shall be marked in accordance with the European Parliament and Council Directive 94/62/EC of 20 December 1994 on packaging and packaging waste (10), or DIN 6120 Parts 1 and 2 in connection with DIN 7728 Part 1. |
| --- | --- |

(b)

| (c) | 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)’. |
| --- | --- |

(c)

| (d) | Products packaged in trigger sprays must be sold as a part of a refillable system. |
| --- | --- |

(d)

| (e) | Only phthalates that at the time of application have been risk assessed and have not been classified according to Criterion 3(c) may be used in the plastic packaging. |
| --- | --- |

(e)

| (f) | The weight utility ratio (WUR) of the primary packaging must not exceed the following values:






  Product type | WUR |
| --- | --- | --- |
| Concentrated products, including liquid concentrates and solids, that are diluted in water prior to use | 1,20 gram packaging per litre use solution (washing water) |
| Ready-to-use products, i.e. products used without further dilution | 150 gram packaging per litre use solution (washing water) |

(f)

Product type

WUR

Concentrated products, including liquid concentrates and solids, that are diluted in water prior to use

1,20 gram packaging per litre use solution (washing water)

Ready-to-use products, i.e. products used without further dilution

150 gram packaging per litre use solution (washing water)

WUR is calculated only for the primary packaging (including caps, stoppers and hand pumps/spraying devices) by using the formula below:

Formula
  ,

where

| Wi | = | The weight (g) of the primary packaging (i) including label if applicable. |
| --- | --- | --- |
| Ui | = | The weight (g) of non-recycled (virgin) material in the primary packaging (i). If the proportion of recycled material in the primary packaging is 0 %, then Ui = Wi. |
| Di | = | The number of functional doses (= number of the dosage volume which is recommended by the manufacturer for 1 litre of washing water) contained in the primary packaging (i). In the case of ready-to-use products that are sold pre-diluted, Di = product volume (in litres). |
| ri | = | Recycling figure, i.e. the number of times the primary packaging (i) is used for the same purpose through a return or refill system (ri = 1, if the packaging is not reused for the same purpose. If the packaging is reused, ri is set to 1 unless the applicant can document a higher number. |

Wi

=

The weight (g) of the primary packaging (i) including label if applicable.

Ui

=

The weight (g) of non-recycled (virgin) material in the primary packaging (i). If the proportion of recycled material in the primary packaging is 0 %, then Ui = Wi.

Di

=

The number of functional doses (= number of the dosage volume which is recommended by the manufacturer for 1 litre of washing water) contained in the primary packaging (i). In the case of ready-to-use products that are sold pre-diluted, Di = product volume (in litres).

ri

=

Recycling figure, i.e. the number of times the primary packaging (i) is used for the same purpose through a return or refill system (ri = 1, if the packaging is not reused for the same purpose. If the packaging is reused, ri is set to 1 unless the applicant can document a higher number.

Assessment and verification: the applicant shall provide a calculation of the WUR of the product to the competent body, together with a declaration of compliance with each part of this Criterion. For Criterion (e) the applicant shall provide completed and signed declaration of compliance.

Criterion 8 —   Fitness for use

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

(a)   All-purpose cleaners and window cleaners

For all-purpose cleaners, only fat-removing effects must be documented. For window cleaners, stripe-less drying must be documented.

The cleaning ability must be equivalent to or better than that of a market-leading or generic reference product, approved by a competent body.

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

| — | an adequate and justifiable laboratory test, or |
| --- | --- |

—

an adequate and justifiable laboratory test, or

| — | an adequate and justifiable consumer test. |
| --- | --- |

—

an adequate and justifiable consumer test.

Both tests must be carried out and reported within specified parameters as stated in the framework described in ‘Framework for testing the performance of all-purpose cleaners, window cleaners and sanitary cleaners’ that can be found here:

http://ec.europa.eu/environment/ecolabel/ecolabelled_products/categories/purpose_cleaners_en.htm

(b)   Sanitary cleaners

Sanitary cleaners include bathroom cleaners, toilet cleaners and kitchen cleaners. For bathroom cleaners, both limesoap and limescale removal shall be documented. For acidic toilet cleaners, only limescale removal shall be documented. For kitchen cleaners fat removing effects shall be documented.

The cleaning ability must be equivalent to or better than that of the generic reference detergent specified below.

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

| — | an adequate and justifiable laboratory test, or |
| --- | --- |

—

an adequate and justifiable laboratory test, or

| — | an adequate and justifiable consumer test. |
| --- | --- |

—

an adequate and justifiable consumer test.

Both tests must be carried out and reported within specified parameters as stated in the framework described in ‘Framework for testing the performance of all-purpose cleaners, window cleaners and sanitary cleaners’. The generic reference detergent shall be the one prescribed in IKW performance test ‘Recommendation for the quality assessment of acidic toilet cleaners’ (SÖFW-Journal, 126, 11, pp. 50-56, 2000). The reference detergent is applicable for toilet cleaners and bathroom cleaners; however the pH must be reduced to 3,5 for the testing of bathroom cleaners.

The IKW performance test ‘Recommendation for the quality assessment of acidic toilet cleaners’ (SÖFW-Journal, 126, 11, pp. 50-56, 2000) can be downloaded from

http://www.ikw.org/pdf/broschueren/EQ_WC_Reiniger_Englisch.pdf

Criterion 9 —   User instructions

(a)   Dosage instructions

Information on the recommended dosage of all-purpose cleaners and sanitary cleaners shall appear on the packaging in a reasonably sufficient size and against a visible background. In the case of a concentrated product, 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’.

The following text (or equivalent text) shall appear on the packaging of ready-to-use all-purpose cleaners: ‘The product is not intended for large-scale cleaning’.

(b)   Safety advice

The following safety advice (or equivalent) shall appear on the product in text or as pictogram:

| — | ‘Keep away from children’, |
| --- | --- |

—

‘Keep away from children’,

| — | ‘Do not mix different cleaners’, |
| --- | --- |

—

‘Do not mix different cleaners’,

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

—

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

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

Assessment and verification:

Criterion 10 —   Information appearing on the EU Ecolabel

Criterion 10 —

Information appearing on the EU Ecolabel

Optional label with text box shall contain the following text:

| ‘— | reduced impact on aquatic life, |
| --- | --- |

‘—

reduced impact on aquatic life,

| — | reduced use of hazardous substances, |
| --- | --- |

—

reduced use of hazardous substances,

| — | reduced packaging waste, |
| --- | --- |

—

reduced packaging waste,

| — | clear user instructions.’ |
| --- | --- |

—

clear user instructions.’

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 a sample of the label, together with a declaration of compliance with this Criterion.

Assessment and verification:

Criterion 11 —   Professional training

Criterion 11 —

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.

Assessment and verification:

---

(1)  
  OJ L 104, 8.4.2004, p. 1.

1

(2)  
  OJ L 142, 31.5.2008, p. 1.

2

(3)  
  OJ L 353, 31.12.2008, p. 1.

3

(4)  
  OJ 196, 16.8.1967, p. 1.

4

(5)  
  OJ L 396, 30.12.2006, p. 1.

5

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

6

(7)  As provided for in Directive 67/548/EEC.

7

(*1)  The percentage must be divided by the M-factor established in accordance with the Regulation (EC) No 1272/2008.

*1

(*2)  Including stabilisers and other auxiliary substances in the preparations.

*2

(*3)  In concentrations lower than 1,0 % in the raw material as long as the total concentration in the final product is lower than 0,10 %.

*3

(8)  
  OJ L 200, 30.7.1999, p. 1.

8

(9)  
  OJ L 262, 27.9.1976, p. 169.

9

(10)  
  OJ L 365, 31.12.1994, p. 10.

10

Appendix I

Detergents Ingredients Database (DID) list

The DID list (Part A) is a list containing information of the aquatic toxicity and biodegradability of ingredients typically used in detergent formulations. The list includes information on the toxicity and biodegradability of a range of substances used in washing and cleaning products. The list is not comprehensive, but guidance is given in Part B of the DID list concerning the determination of the relevant calculation parameters for substances not present on the DID list (e.g. the Toxicity Factor (TF) and degradation factor (DF), which are used for calculation of the critical dilution volume). The list is a generic source of information and substances present on the DID list are not automatically approved for use in EU Ecolabelled products. The DID list (Parts A and B) can be found on the EU Ecolabel website: http://ec.europa.eu/environment/ecolabel/ecolabelled_products/categories/did_list_en.htm

For substances with no data regarding aquatic toxicity and degradability, structure analogies with similar substances may be used to assess the TF and DF. Such structure analogies shall be approved by the competent body granting the EU Ecolabel license. Alternatively, a worst case approach shall be applied, using the parameters below:

Worst case approach:

| | Acute toxicity | Chronic toxicity | Degradation |
| --- | --- | --- | --- |
| Ingredient | LC50/EC50 | SF(acute) | TF(acute) | NOEC (*1) | SF(chronic)
   (*1) | TF(chronic) | DF | Aerobic | Anaerobic |
| ‘Name’ | 1  mg/l | 10 000 | 0,0001 | | | 0,0001 | 1 | P | N |

Acute toxicity

Chronic toxicity

Degradation

Ingredient

LC50/EC50

SF(acute)

TF(acute)

NOEC (*1)

SF(chronic)
   (*1)

TF(chronic)

DF

Aerobic

Anaerobic

‘Name’

1  mg/l

10 000

0,0001

0,0001

1

P

N

Documentation of ready biodegradability

The following test methods for ready biodegradability shall be used.

| (1) | Until 1 December 2010 and during transition period from 1 December 2010 to 1 December 2015: | The test methods for ready biodegradability provided for in Directive 67/548/EEC, in particular the methods detailed in Annex V.C4 to that Directive, or their equivalent OECD 301 A-F test methods, or their equivalent ISO tests. |
| --- | --- | --- |

(1)

Until 1 December 2010 and during transition period from 1 December 2010 to 1 December 2015:

The test methods for ready biodegradability provided for in Directive 67/548/EEC, in particular the methods detailed in Annex V.C4 to that Directive, or their equivalent OECD 301 A-F test methods, or their equivalent ISO tests.

| | The 10-days window principle shall not apply for surfactants. The pass levels shall be 70 % for the tests referred to in Regulation (EC) No 440/2008 method C.4-A and C4-B (and their equivalent OECD 301 A and E tests and ISO equivalents), and shall be 60 % for methods C4-C, D, E and F (and their equivalent OECD 301 B, C, D and F tests and ISO equivalents). |
| --- | --- |

The 10-days window principle shall not apply for surfactants. The pass levels shall be 70 % for the tests referred to in Regulation (EC) No 440/2008 method C.4-A and C4-B (and their equivalent OECD 301 A and E tests and ISO equivalents), and shall be 60 % for methods C4-C, D, E and F (and their equivalent OECD 301 B, C, D and F tests and ISO equivalents).

| (2) | After 1 December 2015 and during transition period from 1 December 2010 to 1 December 2015:
  The test methods provided for in Regulation (EC) No 1272/2008. |
| --- | --- |

(2)

After 1 December 2015 and during transition period from 1 December 2010 to 1 December 2015:

The test methods provided for in Regulation (EC) No 1272/2008.

Documentation of anaerobic biodegradability

The reference test for anaerobic degradability shall be EN ISO 11734, ECETOC No 28 (June 1988), OECD 311 or an equivalent test method, with the requirement 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.

Extrapolation for substances not listed in the DID list

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

| 1. | Apply reasonable extrapolation. Use test results obtained with one raw material to extrapolate the ultimate anaerobic degradability of structurally related surfactants. Where anaerobic biodegradability has been confirmed for a surfactant (or a group of homologues) in accordance with the DID list, it can be assumed that a similar type of surfactant is also anaerobically biodegradable (e.g. C12-15 A 1-3 EO sulphate [DID No 8] is anaerobically biodegradable, and a similar anaerobic biodegradability may also be assumed for C12-15 A 6 EO sulphate). Where 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 (e.g. 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)). |
| --- | --- |

1.

Apply reasonable extrapolation. Use test results obtained with one raw material to extrapolate the ultimate anaerobic degradability of structurally related surfactants. Where anaerobic biodegradability has been confirmed for a surfactant (or a group of homologues) in accordance with the DID list, it can be assumed that a similar type of surfactant is also anaerobically biodegradable (e.g. C12-15 A 1-3 EO sulphate [DID No 8] is anaerobically biodegradable, and a similar anaerobic biodegradability may also be assumed for C12-15 A 6 EO sulphate). Where 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 (e.g. 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)).

| 2. | Perform screening test for anaerobic degradability. If new testing is necessary, perform a screening test by use of EN ISO 11734, ECETOC No 28 (June 1988), OECD 311 or an equivalent method. |
| --- | --- |

2.

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

| 3. | Perform low-dosage degradability test. If new testing is necessary, and in the case of experimental problems in the screening test (e.g. 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 (August 2000) or an equivalent method. |
| --- | --- |

3.

Perform low-dosage degradability test. If new testing is necessary, and in the case of experimental problems in the screening test (e.g. 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 (August 2000) or an equivalent method.

---

(*1)  If no acceptable chronic toxicity data are found, these columns are empty. In that case TF(chronic) is defined as equal to TF(acute).

---