ANNEX

FRAMEWORK

The aims of the criteria

The criteria aim, in particular, at promoting products that have a reduced impact on aquatic ecosystems, contain a limited amount of hazardous substances and whose performance has been tested.

CRITERIA

Criteria are set for each of the following aspects:

1.	Toxicity to aquatic organisms: Critical Dilution Volume (CDV)

2.	Biodegradability

3.	Excluded or limited substances and mixtures

4.	Packaging requirements

5.	Washing performance (fitness for use)

6.	Automatic dosing systems

7.	User information — Information appearing on the EU Ecolabel

(1)   Assessment and verification

(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 detergent ingredient database (DID list) which contains the most widely used ingoing substances 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 ingoing substances. 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

Compliance with the ecological criteria is required for substances intentionally added, as well as for by-products and impurities from raw materials, the concentration of which equals or exceeds 0,010 % by weight of final formulation.

For biocides and colouring agents compliance with the criteria is required regardless of their concentration.

Substances meeting the threshold limit as listed above are hereby referred to as ‘Ingoing substances’.

(2)   Functional unit

The functional unit for this product group shall be expressed in g/l washing solution (grams per litre washing solution).

Requirements relating to assessment and verification of the functional unit:

The full formulation indicating trade name, chemical name, CAS No, DID No (*1), the ingoing quantity including and excluding water, the function and the form of all the ingoing substances (regardless of concentration) in the product must be submitted to the competent body. A sample of the artwork including dosage recommendations must be submitted to the competent body.

Safety data sheets for each ingoing substance shall be submitted to the competent body in accordance with Regulation (EC) No 1907/2006 of the European Parliament and of the Council (1).

Parts A and B of the DID list can be found on the EU Ecolabel website:

http://ec.europa.eu/environment/ecolabel/documents/did_list/didlist_part_a_en.pdf

http://ec.europa.eu/environment/ecolabel/documents/did_list/didlist_part_b_en.pdf

EU ECOLABEL CRITERIA

Criterion 1 —   Toxicity to aquatic organisms: Critical Dilution Volume (CDV)

The Critical Dilution Volume (CDVchronic) of a single or multi-component system must not exceed the following limits (at the highest recommended dose):

CDV at the highest recommended dosage	Soft	Medium	Hard
Product type	0-6 °dH	7-13 °dH	> 14 °dH
Pre-soaks	2 000	2 000	2 000
Dishwasher detergents	3 000	5 000	10 000
Multi-component system	3 000	4 000	7 000
Rinse aids	3 000	3 000	3 000

The Critical Dilution Volume (CDVchronic) is calculated for all ingoing substances (i) in the product using the following equation:

Where:

weight	=	the weight of the ingoing substance per recommended dose
DF	=	the degradation factor
TF	=	the chronic toxicity factor of the substance as stated in the DID list.

Biocides and colouring agents present in the product shall also be included in the CDV calculation even if the concentration is lower than 0,010 % (100 ppm).

Because of the degradation of the substances in the wash process, separate rules apply to the following substances:

—	Hydrogen Peroxide (H2O2) — not to be included in calculation of CDV,

—	Peracetic acid — to be included in the calculation as acetic acid.

Assessment and verification: the applicant shall provide the calculation of the CDVchronic of the product. A spreadsheet for calculation of the CDV value is available on the EU Ecolabel website.

The values of the DF and TF parameters shall be as given in the Detergent Ingredient Database list (DID list). If the substance is not found on the DID list, the parameters shall be calculated using the guidelines in Part B of the DID list and attaching the associated documentation.

Criterion 2 —   Biodegradability

(a)   Biodegradability of surfactants

All surfactants must be biodegradable under aerobic and anaerobic conditions.

(b)   Biodegradability of organic substances

The content of all organic substances in the product that are aerobically non-biodegradable (not readily biodegradable) (aNBO) and anaerobically non-biodegradable (anNBO) shall not exceed the following limits:

aNBO

Product type (g/l washing solution)	Soft	Medium	Hard
	0-6 °dH	7-13 °dH	> 14 °dH
Pre-soaks	0,4	0,4	0,4
Dishwasher detergents/Multi-component system	0,4	0,4	0,4
Rinse aids	0,04	0,04	0,04

anNBO

Product type (g/l washing solution)	Soft	Medium	Hard
	0-6 °dH	7-13 °dH	> 14 °dH
Pre-soaks	0,4	0,4	0,4
Dishwasher detergents/Multi-component system	0,6	1,0	1,5
Rinse aids	0,04	0,04	0,04

Assessment and verification: the applicant shall provide documentation for the degradability of surfactants as well as the calculation of aNBO and anNBO for the product. A spreadsheet for use in calculating aNBO and anNBO values is available on the EU Ecolabel website.

For both surfactants and aNBO and anNBO values reference should be done to the DID List. For ingoing substances which are not included in the DID list, the relevant information from literature or other sources, or appropriate test results, showing that they are aerobically and anaerobically biodegradable shall be provided as described in Appendix I.

Note that TAED should be considered anaerobically biodegradable.

In the absence of documentation in accordance with the above requirements, a substance other than a surfactant may be exempted from the requirement for anaerobic degradability if one of the following three alternatives is fulfilled:

1.	Readily degradable and has low adsorption (A < 25 %); or

2.	Readily degradable and has high desorption (D > 75 %); or

3.	Readily degradable and non-bioaccumulating.

Testing for adsorption/desorption may be conducted in accordance with OECD guidelines 106.

Criterion 3 —   Excluded or limited substances and mixtures

(a)   Specified excluded ingoing substances

The following ingoing substances must not be included in the product, neither as part of the formulation nor as part of any mixture included in the formulation:

—	EDTA (ethylenediamine tetraacetate),

—	Fragrances,

—	Reactive chlorine compounds,

—	APEO (Alkyl phenol ethoxylates) and APD (Alkylphenols and derivatives thereof).

Assessment and verification: the applicant shall provide a completed and signed declaration of compliance.

(b)   Hazardous substances and mixtures

According to the Article 6(6) of Regulation (EC) No 66/2010 on the EU Ecolabel, the product or any component of it shall not contain substances 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 (2) or Council Directive 67/548/EEC (3) nor shall it contain substances referred to in Article 57 of Regulation (EC) No 1907/2006. The risk phrases below generally refer to substances. However, if information on substances cannot be obtained, the classification rules for mixtures apply.

List of hazard statements:

Hazard Statement (4)	Risk Phrase (5)
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	R23/26
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	R60/61/60-61
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	R39/23/24/25/26/27/28
H371 May cause damage to organs	R68/20/21/22
H372 Causes damage to organs through prolonged or repeated exposure	R48/25/24/23
H373 May cause damage to organs through prolonged or repeated exposure	R48/20/21/22
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

Note that this criterion also applies to known degradation products such as formaldehyde from formaldehyde releasers.

Substances or mixtures which change their properties through processing (e.g. become no longer bioavailable, or undergo chemical modification in a way that removes the previously identified hazard) are exempted from the above requirement.

The final product must not be labelled according to the hazard statements above.

Derogations

The following substances are specifically exempted from this requirement:

Surfactants < 15 % in the final product	H400: Very toxic to aquatic life	R50
Biocides for preservation purpose (*2) (only for liquids with pH between 2 and 12 and maximum 0,10 % w/w of active material)	H331: Toxic if inhaled	R23
	H334: May cause allergy or asthma symptoms or breathing difficulties if inhaled	R42
	H317: May cause allergic skin reaction	R43
	H400: Very toxic to aquatic life	R50
Enzymes (*3)	H334: May cause allergy or asthma symptoms or breathing difficulties if inhaled	R42
	H317: May cause allergic skin reaction	R43
	H400: Very toxic to aquatic life	R50
NTA as in impurity in MGDA and GLDA (*4)	H351: Suspected of causing cancer	R40

Assessment and verification: the applicant shall demonstrate compliance with this criterion by providing a declaration on the non-classification of each ingoing substance into any of the hazard classes associated to the hazard statements referred to in the above list in accordance with Regulation (EC) No 1272/2008, as far as this can be determined, as a minimum, from the information meeting the requirements listed in Annex VII to Regulation (EC) No 1907/2006. This declaration shall be supported by summarised information on the relevant characteristics associated to the hazard statements referred to in the above list, to the level of detail specified in Sections 10, 11 and 12 of Annex II to Regulation (EC) No 1907/2006 (Requirements for the Compilation of Safety Data Sheets).

Information on intrinsic properties of substances may be generated by means other than tests, for instance through the use of alternative methods such as in vitro methods, by quantitative structure activity models or by the use of grouping or read-across in accordance with Annex XI to Regulation (EC) No 1907/2006. The sharing of relevant data is strongly encouraged.

The information provided shall relate to the forms or physical states of the substance or mixtures as used in the final product.

For substances listed in Annexes IV and V to REACH, exempted from registration obligations under Article 2(7)(a) and (b) of Regulation (EC) No 1907/2006 REACH, a declaration to this effect will suffice to comply with the requirements set out above.

(c)   Substances listed in accordance with Article 59(1) of Regulation (EC) No 1907/2006

No derogation from the exclusion in Article 6(6) of the Regulation (EC) No 66/2010 shall 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 > 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. The applicant shall provide the exact formulation of the product to the competent body. The applicant shall also provide a declaration of compliance with this criterion, together with related documentation, such as declarations of compliance signed by the material suppliers and copies of relevant Safety Data Sheets for substances or mixtures.

(d)   Specified limited ingoing substances — 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 biocides added, together with information on their exact concentration in the product. The manufacturer or supplier of the biocides 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 or disinfecting effect. 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)

The product may contain biocides provided that they are not bioaccumulating. A biocide is not considered bioaccumulating if BCF < 100 or logKow < 3,0. If both BCF and logKow values are available, the highest measured BCF value shall be used. Assessment and verification: the applicant shall provide copies of the material safety data sheets of any biocide added, together with information on their BCF and/or logKow values.

(e)   Colouring agents

Colouring agents allowed in the product must not be bioaccumulating. In the case of colouring agents approved for use in foodstuffs it is not necessary to submit documentation of bioaccumulation potential. A colouring agent is considered not bioaccumulating if BCF < 100 or logKow < 3,0. If both BCF and logKow values are available, the highest measured BCF value shall be used.

Assessment and verification: the applicant shall provide copies of the material safety data sheets of any colouring agents added, or documentation to ensure that the colouring agent is approved for use in foodstuff.

(f)   Enzymes

Enzymes must be in liquid form or dust-free granulate. Enzymes must be free from micro-organism remnants from manufacture.

Assessment and verification: the applicant shall provide copies of the material safety data sheets of any enzyme added, together with documentation to ensure that the enzyme is free from micro-organism remnants.

(g)   Phosphorous

The total quantity of phosphates and other phosphorous compounds must not exceed the limit values specified in table, calculated in grams of phosphorous per litre water.

The highest recommended dosage shall be used for the phosphorous calculations.

Product type Phosphorous (g P/l water)	Soft	Medium	Hard
	0-6 °dH	7-13 °dH	> 14 °dH
Pre-soaks	0,08	0,08	0,08
Detergents	0,15	0,30	0,50
Rinse aids	0,02	0,02	0,02
Multi-component systems	0,17	0,32	0,52

Assessment and verification: the applicant shall provide documentation to ensure that the limit in the above table is fulfilled.

Criterion 4 —   Packaging requirements

(a)   Weight/utility ratio (WUR)

The weight/utility ratio (WUR) of the product shall not exceed the following values:

Product type	WUR
	0-6 °dH	7-13 °dH	> 14 °dH
Powders [g/l washing solution]	0,8	1,4	2,0
Liquids [g/l washing solution]	1,0	1,8	2,5

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

Where:

Wi	=	the weight (g) of the packaging component (i) including the label if applicable.
Ui	=	the weight (g) of non-recycled (virgin) material in the packaging component (i). If the proportion of recycled material in the packaging component is 0 % then Ui = Wi.
Di	=	the number of functional units contained in the packaging component (i). The functional unit = dosage in g/l washing solution.
ri	=	recycling figure, i.e. the number of times the packaging component (i) is used for the same purpose through a return or refill system. r = 1, if the packaging is not reused for the same purpose. If the packaging is reused r is set to 1 unless the applicant can document a higher number.

Exceptions

Plastic/paper/cardboard packaging containing more than 80 % recycled material or more than 80 % plastic from renewable origin is exempted from this requirement.

Packaging is regarded as recycled if the raw material used to make the packaging has been collected from packaging manufacturers at the distribution stage or at the consumer stage. Where the raw material is industrial waste from the material manufacturer’s own production process, then the material will not be regarded as recycled.

Assessment and verification: the applicant shall provide the calculation of the WUR of the product. A spreadsheet for this calculation is available on the EU Ecolabel website. The applicant shall provide a completed and signed declaration for the content of recycled or material from renewable origin in the packaging. For approval of refill packaging, the applicant and/or retailer shall document that the refills will be/are available for purchase on the market.

(b)   Plastic packaging

Only phthalates that at the time of application have been risk assessed and have not been classified according to criterion 3(b) (and combinations hereof) may be used in the plastic packaging.

In order to allow for identification of different parts of the packaging for recycling, plastic parts in the primary packaging must be marked in accordance with DIN 6120, Part 2 or the equivalent. Caps and pumps are exempted from this requirement.

Assessment and verification: the applicant shall provide completed and signed declaration of compliance.

Criterion 5 —   Washing performance (fitness for use)

The performance and efficiency of the product must be satisfactory. The product must satisfy the requirements for the user test or internal testing in accordance with Appendix II.

Assessment and verification: the applicant shall submit a detailed test report to the Competent Body, including information/documentation. See Appendix II.

Criterion 6 —   Automatic dosing systems

Multi-component systems shall be offered together with an automatic and controlled dosing system.

In order to ensure correct dosage in the automatic dosing systems, customer visits must be incorporated as a normal routine for manufacturers/suppliers. These customer visits are performed at all premises at least once a year during the license period; they must include calibration of the dosage equipment. Also, a third party can perform customer visits.

In exceptional cases, customer visits may be dispensed with if the distance and method of delivery makes the visit impracticable.

Assessment and verification: the applicant shall provide a written description of responsibility for, frequency and content of customer visits.

Criterion 7 —   User information — Information appearing on the EU Ecolabel

(a)   Information on the packaging/product information sheet

The following recommendations must appear on the packaging, and/or on product information sheet or equivalent:

—	Dose according to the degree of soil, and the water hardness. Follow the dosing instructions.

—	Using this EU Ecolabelled product according to the dosage instructions will contribute to the reduction of water pollution and waste production.

(b)   Information appearing on the EU Ecolabel

The logo should be visible and legible. The use of the EU Ecolabel logo is protected in primary EU law. The EU Ecolabel registration/licence number must appear on the product, it must be legible and clearly visible.

The optional label with text box shall contain the following text:

—	reduced impact on aquatic ecosystems,

—	limited hazardous substances,

—	performance tested.

The guidelines for the use of the optional label with text box can be found in the ‘Guidelines for use of the Ecolabel logo’ on the website: http://ec.europa.eu/environment/ecolabel/documents/logo_guidelines.pdf

Assessment and verification (a-b): the applicant shall provide a sample of the product label and/or product sheet, together with a declaration of compliance with this criterion. Product claims shall be documented through appropriate test reports.

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(*1)  DID No is the number of the ingoing substance on the DID list (‘Detergent Ingredient Database’ list), and is used in determining compliance with criteria 1 and 2.

(1)   OJ L 396, 30.12.2006, p. 1.

(2)   OJ L 353, 31.12.2008, p. 1.

(3)   OJ 196, 16.8.1967, p. 1.

(4)  Regulation (EC) No 1272/2008.

(5)  Directive 67/548/EEC with adjustment to REACH according to Directive 2006/121/EC and Directive 1999/45/EC as amended.

(*2)  Derogation is only for criterion 3(b). Biocides shall comply with criterion 3(d).

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

(*4)  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 %.