ANNEX

FRAMEWORK

The aims of the criteria

These criteria aim, in particular, at promoting products that have a reduced discharges of toxic or otherwise polluting substances into the aquatic environment, reducing or preventing risks to health or the environment 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

2.

Biodegradability of surfactants

3.

Excluded or limited substances and mixtures

4.

Fragrances

5.

Corrosive properties

6.

Packaging requirements

7.

Fitness for use

8.

User instructions

9.

Information appearing on the EU Ecolabel

Assessment and verification requirements

(a)   Requirements

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

Where the applicant is required to provide declarations, documentation, analyses test reports, or other evidence to show compliance with the criteria, 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 hand dishwashing detergents, the dosage in grams of the product recommended by the manufacturer for preparing 1 litre of dishwashing water for cleaning of normally soiled dishes 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:

where weight(i) is the weight of the substance (in grams) contained in the dosage recommended by the manufacturer for 1 litre of dishwashing water. DF(i) is the degradation factor and TFchronic(i) is the toxicity factor of the substance (in milligrams/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 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.

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 dishwashing water for cleaning of normally soiled dishes. The CDVchronic of the recommended dose expressed for 1 litre of dishwashing water shall not exceed 3 800 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 provided that the surfactants are not classified with H400/R50 (Very toxic to aquatic life) within the limit specified below.

The total weight of such anaerobically non-biodegradable surfactants must not exceed 0,20 gram of the recommended dose expressed for 1 litre of dishwashing water.

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 (OJ L 115, 4.5.2005, p. 18 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).

Criterion 3 —   Excluded or limited substances and mixtures

The requirements stated in (a), (b) and (c) below shall apply to each substance or mixture, 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

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

—	5-Bromo-5-nitro-1,3-dioxane

—	2-Bromo-2-nitropropane-1,3-diol

—	Diazolinidylurea

—	Formaldehyde

—	Sodium hydroxy methyl glycinate

—

Nitro-musks 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, 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 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 on the EU Ecolabel, the product or any part of it shall not contain substances (in any forms, including nanoforms) meeting the criteria for classification with the hazard statements or risk phrases specified below in accordance with Regulation (EC) No 1272/2008 of the European Parliament and of the Council (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

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	R 50
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.

(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.

(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.

Criterion 4 —   Fragrances

(a)

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

(b)

Any substances 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

(c)

Fragrance substances subject to the declaration requirement provided for in Regulation (EC) No 648/2004 on detergents (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.

(d)

Fragrances shall not be used in hand dishwashing detergents for professional use.

Assessment and verification: a declaration of compliance with each part of criterion (a), (b) and (d). 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 —   Corrosive properties

The product shall not be classified as a ‘Corrosive’ (C) mixture with R34 or R35 in accordance with Directive 1999/45/EC, or as a ‘Skin Category 1’ mixture in accordance with Regulation (EC) No 1272/2008.

Assessment and verification: the applicant shall provide the exact concentrations of all substances used in the product, either as part of the formulation or as part of any mixture included in the formulation, that are classified as ‘Corrosive’ (C) with R34 or R35 in accordance with Directive 1999/45/EC, or as a ‘Skin Category 1’ mixture in accordance with Regulation (EC) No 1272/2008 to the competent body, together with copies of the material safety data sheets.

Criterion 6 —   Packaging requirements

(a)

Plastics 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 part 1 and 2 in connection with DIN 7728 part 1.

(b)

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)

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.

(d)

The weight utility ratio (WUR) of the primary packaging must not exceed the following values: Product type WUR Hand dishwashing detergents that are diluted in water prior to use 1,20 gram packaging per litre use solution (dishwashing water) WUR is calculated only for the primary packaging (including caps, stoppers and hand pumps/spraying devices) by using the formula below: , 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). 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 re-used for the same purpose. If the packaging is re-used, 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 (c) the applicant shall provide completed and signed declaration of compliance.

Criterion 7 —   Fitness for use

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

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

Assessment and verification: the cleaning ability and cleaning capacity must be tested by means of an adequate and justifiable laboratory performance test carried out and reported within specified parameters as stated in the framework described in ‘Framework for testing the performance of hand dishwashing detergents’ that can be found here:

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

The generic reference detergent shall be the one prescribed in IKW performance test ‘Recommendation for the quality assessment of the cleaning performance of hand dishwashing detergents’ (SÖFW-Journal, 128, 5, pp. 11-15, 2002) with the adaptation that the dosage applied in the performance test is set at 2,5 millilitres of the reference detergent per 5 litres of water.

The IKW performance test ‘Recommendation for the quality assessment of the cleaning performance of hand dishwashing detergents’ (SÖFW-Journal, 128, 5, pp. 11-15, 2002) method may be applied with the mentioned adaptation and can be downloaded from: http://www.ikw.org/pdf/broschueren/EQ_Handgeschirr_e.pdf

Criterion 8 —   User instructions

The product shall bear the following information on the packaging:

(a)	‘Do not use running water but immerse the dishes, and use the recommended dosage’ (or equivalent text);

(b)	information on the recommended dosage shall appear on the packaging in a reasonably sufficient size and against a visible background. The information shall be provided in millilitres (and tea spoons) of product for 5 litres of dishwashing water suitable for ‘dirty’ and ‘less dirty’ dishes;

(c)	an indication of the approximate number of washes that the consumer can perform with one bottle is recommended but voluntary.

This is calculated by dividing the volume of the product by the dosage required for 5 litres of dishwashing water for dirty dishes.

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.

Criterion 9 —   Information appearing on the EU Ecolabel

Optional label with text box shall contain the following text:

‘—	reduced impact on aquatic life,

—	reduced use of hazardous substances,

—	reduced packaging waste,

—	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.

---

(1)   OJ L 104, 8.4.2004, p. 1.

(2)   OJ L 142, 31.5.2008, p. 1.

(3)   OJ L 353, 31.12.2008, p. 1.

(4)   OJ 196, 16.8.1967, p. 1.

(5)   OJ L 396, 30.12.2006, p. 1.

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

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

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

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

(*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 %.

(8)   OJ L 200, 30.7.1999, p. 1.

(9)   OJ L 262, 27.9.1976, p. 169.

(10)   OJ L 365, 31.12.1994, p. 10.