2001D0607 — EN — 08.08.2001 — 000.001 — 1
This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents
►B COMMISSION DECISION
of 19 July 2001
establishing the ecological criteria for the award of the Community eco-label to hand dishwashing
detergents
(notified under document number C(2001) 1989)
(Text with EEA relevance)
(2001/607/EC)
(OJ L 214, 8.8.2001, p. 30)
Corrected by:
►C1 Corrigendum, OJ L 334, 18.12.2001, p. 34 (2001/607/EC)
▼B
COMMISSION DECISION
of 19 July 2001
establishing the ecological criteria for the award of the Community
eco-label to hand dishwashing detergents
(notified under document number C(2001) 1989)
(Text with EEA relevance)
(2001/607/EC)
THE COMMISSION OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Community,Having regard to Regulation (EC) No 1980/2000 of the European
Parliament and of the Council of 17 July 2000 on a revised Communityeco-label award scheme (
1), and in particular Articles 3, 4 and 6 thereof,
Whereas:
(1) Article 3 of Regulation (EC) No 1980/2000 provides that the eco-
label may be awarded to a product possessing characteristics
which enable it to contribute significantly to improvements inrelation to key environmental aspects.
(2) Article 4 of Regulation (EC) No 1980/2000 provides that specific
eco-label criteria shall be established according to product groups.
(3) The measures set out in this Decision have been developed and
adopted under the procedures for the setting of eco-label criteriaas laid down in Article 6 of Regulation (EC) No 1980/2000.
(4) The measures set out in this Decision are in accordance with theopinion of the committee set up under Article 17 of Regulation(EC) No 1980/2000,
HAS ADOPTED THIS DECISION:
Article 1
The product group ‘hand dishwashing detergents’ (hereinafter referred
to as 'the product group') shall mean:
All detergents intended to be used to wash by hand dishes, crockery,
cutlery, pots, pans and other kitchen utensils, etc.
Article 2
The environmental performance and the fitness for use of the product
group shall be assessed by reference to the criteria set out in the Annex.
Article 3
The product group definition and the criteria for the product group shall
be valid for three years from the date on which this Decision takeseffect. If revised ecological criteria have not been adopted before theend of this period, their validity shall be extended for a further year.
Article 4
For administrative purposes the code number assigned to the product
group shall be 019.
Article 5
This Decision is addressed to the Member States.2001D0607 — EN — 08.08.2001 — 000.001 — 2
(1) OJ L 237, 21.9.2000, p. 1.
▼B
ANNEX
FRAMEWORK
In order to qualify for the eco-label, a hand dishwashing detergent (hereinafter
referred to as ‘the product’ must fall within the product group as defined in
Article 1, and must comply with the criteria of this Annex, with tests carried out
on application as indicated in the criteria and the technical appendix. Where
appropriate, other test methods may be used if their equivalence is accepted by
the competent body or bodies assessing the application (hereinafter referred to as
the ‘competent body’). Where no tests are mentioned, or are mentioned as being
for use in verification or monitoring, competent bodies should rely, as
appropriate, on declarations and documentation provided by the applicant and/
or independent verifications. Where it is indicated that specific documentation
and/or declarations are required, these shall be provided by the applicant and/or
the manufacturer(s) and/or the supplier(s) as appropriate. Where ingredients are
referred to, this includes substances and preparations.
The competent bodies are recommended to take into account the implementation
of recognised environmental management schemes, such as EMAS or ISO 14001,
when assessing applications and monitoring compliance with the criteria in this
Annex ( Note: it is not required to implement such management schemes.)
These criteria aim in particular at promoting:
— the reduction of discharges of toxic or otherwise polluting substances into the
aquatic environment,
— the reduction or prevention of risks to health or the environment related to the
use of hazardous substances,
— the minimisation of packaging waste,— information that will enable the consumer to use the product in the way that is
efficient and minimises environmental impact.
The criteria are set at levels that promote the labelling of hand dishwashing
detergents that have a low environmental impact.
ECOLOGICAL CRITERIA
1.Toxicity to aquatic organisms
The critical dilution volume toxicity (CDV
tox) is calculated for each ingredient (i)
using the following equation:
where weight (i) is the weight of the ingredient per recommended dose for 1 l of
dishwashing water, LF is the loading factor and LTE is the long-term toxicity
effect concentration of the ingredient.
The values of the LF and LTE parameters shall be as given in the detergent
ingredient database list (DID list) in Appendix IA. If the ingredient in question is
not included in the DID list, the applicant shall estimate their values following the
approach described in Appendix IB. The CDVtoxis summed for each ingredient,
making the CDVtoxfor the product.
The CDVtoxof the recommended dose expressed for 1 l of dishwashing water
shall not exceed 170 l.
The exact formulation of the product shall be provided to the competent body,
together with the details of the CDVtoxcalculations showing compliance with this
criterion.
2.Biodegradabiltiy of surfactants
(a)Readybiodegradability(aerobic)
Each surfactant used in the product shall be readily biodegradable.The exact formulation of the product shall be provided to the competent body.
The DID list (see Appendix IA) indicates whether a specific surfactant is
aerobically biodegradable or not (i.e. those that have an entry of ‘Y’ in the
column on aerobic biodegradabiltiy shall not be used). For surfactants 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 biodegrad-
able shall be provided. The tests for ready biodegradabiltiy shall be as referred to
in Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws,
regulations and administrative provisions relating to the classification, packaging2001D0607 — EN — 08.08.2001 — 000.001 — 3
▼B
and labelling of dangerous substances (1), and its subsequent amendments, in
particular the methods detailed in Annex V.C4, or their equivalent OECD 301 A-
F test methods, or their equivalent ISO tests. The 10 days window principle shall
not apply. The pass levels shall be 70 % for the tests referred to in Annex V.C4-A
and C.4-B of Directive 67/548/EEC (and theirequivalent OECD 301 A and E tests
and ISO equivalent), and shall be 60 % for tests C4-C, D, E and F (and their
equivalent OECD 301 B, F, D and tests and ISO equivalents).
(b)Anaerobic biodegradability
Each surfactant used in the product shall be biodegradable under anaerobic
conditions.
The exact formulation of the product shall be provided. The DID list (see
Appendix IA) indicates whether a specific surfactant is anaerobically biodegrad-
able or not (i.e. those that have an entry of ‘Y’ in the column on anaerobic
biodegradability shall not be used). For surfactants which are not included in the
DID list, 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 ISO 11734, ECETOC No
28 (June 1988) or equivalent test method, with the requirement of a minimum of
60 % degradability under anaerobic conditions.
3.Dangerous, hazardous or toxic substances or preparations
(a) The following ingredients shall not be included in the product, either as part
of the formulation or as part of any preparation included in the formulation:
— alkyl phenol ethoxylates (APEOs)
— quaternary ammonium compounds— trichlorocarbon— EDTA (ethylene-diamine-tetra-acetate)
— NTA (nitrilo-tri-acetate)
— polyglycol solvents: polyethylene glycols— 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-dinitrotoluenemoskene: 1,1,3,3,5-pentamethyl-4,6-dinitroindanmusk 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).
(b) No ingredient shall be included in the product that is classified as:
R40 (limited evidence of a carcinogenic effect)
R45 (may cause cancer),
R46 (may cause heritable genetic damage),R49 (may cause cancer by inhalation),R68 (possible risks of irreversible effects)R50+53 (very toxic to aquatic organisms and may cause long-term adverse
effects in the aquatic environment),
R51+53 (toxic to aquatic organisms and may cause long-term adverse effects
in the aquatic environment),
R59 (dangerous to the ozone layer),R60 (may impair fertility),
R61 (may cause harm to the unborn child),
R62 (possible risk of impaired fertility),
R63 (possible risk of harm to the unborn child),
R64 (may cause harm to breastfed babies),
or any combination thereof, according to Directive 67/548/EEC and its
subsequent amendments, or according to Directive 1999/45/EC of the2001D0607 — EN — 08.08.2001 — 000.001 — 4
(1) OJ 196, 16.8.1967, p. 1.▼C1
▼B
▼B
European Parliament and of the Council of 31 May 1999 concerning the
approximation of the laws, regulations and administrative provisions of the
Member States relating to the classification, packaging and labelling of
dangerous preparations (1), and its subsequent amendments.
Each ingredient of any preparation used in the formulation that exceeds 0,1 %
by weight of the preparation shall also meet the above requirement.
Biocides that are used to preserve the product (as allowed under the criterion
on biocides below), and are classified as R50+53 or R51+53 are nevertheless
permitted, but only if they are not potentially bio-accumulative. In this
context, a biocide is considered to be potentially bio-accumulative if the log
Pow (log octanol/water partition coefficient) ≥3,0 (unless the experimen-
tally determined BCF ≤100).
The exact formulation of the product shall be provided to the competent
body, together with copies of the material safety data sheets of each
ingredient which shall indicate the classification or lack thereof of each
ingredient, as well as a declaration that none of the above substances have
been included in the product.
Similarly the suppliers of any preparation used in the formulation shall
provide a declaration that their preparation complies with the above
requirements.
4.Fragrances
(a) The product shall not contain perfumes containing nitro-musks or polycyclic
musks (as specified in the criterion above).
(b) If the product contains one or more of the following fragances, this shall be
clearly indicated on the packaging, mentioning the name or names of the
fragances concerned:
Common name CAS-No Common name CAS-No
Amyl Cinnamal 122-40-7 Amylcinnamyl
alcohol101-85-9
Benzyl alcohol 100-51-6 Benzyl salicylate 118-58-1
Cinnamyl alcohol 104-54-1 Cinnamal 104-55-2
Citral 5392-40-5 Coumarin 91-64-5
Eugenol 97-53-0 Geraniol 106-24-1
Hydroxycitronellal 107-75-5 Hydroxymethyl
penthylcyclohexe-
necarboxaldehyde31906-04-4
Isoeugenol 97-54-1
(c) Any ingredients added to the product as a fragance must have been
manufactured and/or handled following the code of practice of the
International Fragrance Association.
A declaration of compliance with each part of this criterion shall be provided to
the competent body.
5.Dyes or colouring agents
Any dyes or colouring agents used in the product must be permitted by Council
Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the
Member States relating to cosmetic products (2) and its subsequent amendments,
and must be permitted by Directive 94/36/EEC of the European Parliament and of
the Council of 30 June 1994 on colours for use in foodstuffs (3) and its subsequent
amendments.
A declaration of compliance with this criterion shall be provided to the competent
body, together with a full list of all dyes or colouring agents used.2001D0607 — EN — 08.08.2001 — 000.001 — 5
(1) OJ L 200, 30.7.1999, p. 1.
(2) OJ L 262, 27.9.1976, p. 169.
(3) OJ L 237, 10.9.1994, p. 13.
▼B
6.Biocides
(a) The product may only include biocides in order to preserve the product, and
in the appropriate dosage for this purpose alone. This does not refer to
surfactants which may also have biocidal properties.
The exact formulation of the product shall be provided, together with copies
of the material safety data sheets of any preservatives added, as well as
information on the dosage necessary to preserve the product. A declaration of
compliance with this criterion shall be provided.
(b) It is prohibited to claim or suggest on the packaging or by any other
communication that the hand dishwashing product has an antimicrobial
action.
The texts and layouts used on each type of packaging and/or an example of
each different type of packaging shall be provided to the competent body,
together with a declaration of compliance with this criterion.
7.Sensitising substances
The product shall not be classified as R42 (may cause sensitisation by inhalation)
and/or R43 (may cause sensitisation by skin contact) according to Directive 1999/
45/EC concerning the approximation of the laws, regulations and administrative
provisions of the Member States relating to the classification, packaging and
labelling of dangerous preparations.
The exact formulation of the product shall be provided to the competent body,
together, with copies of the material safety data sheets of each ingredient which
shall indicate the relevant classification or lack thereof of each ingredient, and
also a declaration of compliance with this criterion.
8.Limitation of the total surfactants per wash
The weight of total surfactants in the recommended dose for 1 l of dishwashing
water shall not exceed 0,4 g for dirty dishes.
Data on the total active matter per ml of product shall be provided to the
comeptent body, together with the recommended dosage in ml for 1l of
dishwashing water for dirty dishes that appears on the packaging. On the basis of
this data, compliance with this criterion shall be demonstrated.
9.Packaging requirements
(a) The primary packaging shall have a volumetric coefficient of packaging
(VCP) less than or equal to 1,9. This criterion does not apply if the primary
packaging is made up of 50 % or more recycled material.
VCP is equal to the volume of the smallest rectangular solid (rectangular
parallelepiped) that can contain the packaging divided by the volume of the
product contained in the packaging.
(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) The primary packaging parts shall be easily separable into mono-material
parts.
(d) Plastics shall be marked according to Directive 94/62/EC of the European
Parliament and of the Council of 20 December 1994 on packaging and
packaging waste (1), or DIN 6120 parts 1 and 2 in connection with DIN 7728
part 1.
Data on the packaging, and/or a sample thereof if appropriate, shall be provided
to the competent body, together with a declaration of compliance with this
criterion.
FITNESS FOR USE
10.Fitness for use
The product shall be fit for use, meeting the needs of the consumers.All relevant data shall be provided to the competent body. This shall at least
include the results of a performance test comparing the product (at the
recommended dosage, tested on dirty dishes, in realistic conditions) with water
and at least one other product (commonly available in the area where the eco-2001D0607 — EN — 08.08.2001 — 000.001 — 6
(1) OJ L 365, 31.12.1994, p. 10.
▼B
labelled product is to be marketed, and at its recommended dosage). The choice
of the reference product(s) and test protocol used for these comparisons shall be
justified. The applicant may use, for example, the test method entitled
‘Dishwashing’ established by the CTTN-IREN.
CONSUMER INFORMATION
11.User instructions
The product shall bear the following information on the packaging:
(a) ‘To wash your dishes in the most efficient way, to save water and energy, and
to protect the environment, do not use running water but immerse the dishes,
and use the recommended dosage. You can wash most efficiently without lots
of foam’ (or equivalent text).
(b) The pictogram and information below shall appear on the packaging in a
reasonably sufficient size and against a visible background:
where x, y, z and w have to be defined by the applicant and/or the
manufacturer.
The measure used in the above pictogram shall be mililitres. A second well-
known measure, such as teaspoons, shall additionally be given in brackets (asin the pictogram above). However, if the packaging has an efficient and
convenient dosing system that can provide an equally reliable dosage, an
alternative measure (e.g capfulls, squirts, or other) may be used.
(c) An indication of the approximate number of washes that the consumer can
perform with one bottle.
This is calculated by dividing the volume of the product by the dosage
required for 5 l of dishwashing water for dirty dishes (as indicated in the
pictogram above).
(d) Commission recommendation 89/542/EEC of 13 September 1989 for the
labelling of detergents and cleaning products (
1) shall be applied.
(e) If the product contains perfumes, this shall be indicated on the packaging.
(f) ‘For more information visit the EU eco-label website: http://europa.eu.int/
ecolabel’ (or equivalent text).
A sample of the product packaging, including the label, shall be provided to the
competent body, together with a declaration of compliance with each part of this
criterion.
12.Information appearing on the eco-label
Box 2 of the eco-label shall contain the following text:
— reduced impact on aquatic life,
— clear dosage instructions.2001D0607 — EN — 08.08.2001 — 000.001 — 7
(1) OJ L 291, 10.10.1989, p. 55.
Appendix I
DETERGENT INGREDIENTS DATABASE AND APPROACH TO BE FOLLOWED FOR INGREDIENTS NOT LISTED IN THE DATABASE
A.The data given below on the most commonly used detergent ingredients shall be used for the calculation of the ecological criteria
(Note: the parameters a NBO, SI, II, THOD as well as the CF-factors for an NBO are not used within this product group)
Detergent ingredients database (DID-list; version 29.9.1998)
DID-
NoIngredientsToxicity
Loading factor
(LF)Anaerobic non-
biodegradable
(a NBO)Aerobic non-
biodegradable
(a NBO)Soluble inor-
ganics
(SI)Insoluble inor-
ganics
(II)THODNOEC
measuredLTE
Anionic surfactants
1 C 10-13 LAS (Na Ø 11,5-11,8, C14 < 1 %) 0,3 0,3 0,05 Y, CF = 0,75 O O O 2,3
2 other LAS (C 14 > 1 %) 0,12 0,12 0,05 Y, CF = 1,5 O O O 2,3
3 C 14/17 Alk. sulphonate 0,27 0,27 0,03 Y, CF = 0,75 O O O 2,5
4 C 8/10 Alkylsulphate EC50 = 2,9 0,15 0,02 O O O O 1,9
5 C 12-15 AS 0,1 0,1 0,02 O O O O 2,2
6 C 12-18 AS LC50 = 3 0,15 0,02 O O O O 2,3
7 C 16/18 FAS 0,55 0,55 0,02 O O O O 2,5
8 C 12-15 A 1-3 EO sulphate 0,15 0,15 0,03 O O O O 2,1
9 C 16/18 A 3-4 EO sulphate no valid data 0,1 0,03 O O O O 2,2
10 C 8 Dialkylsulphosuccinate LC50 = 7,5 0,4 0,5 Y, CF = 1,5 O O O 2
11 C 12/14 sulpho-fat.-acid methylester EC50 = 5 0,25 0,05 Y, CF = 0,75 O O O 2,1
12 C 16/18 sulpho-fat.-acid methylester 0,15 0,15 0,05 Y, CF = 0,75 O O O 2,3
13 C 14/16 alpha olefine sulphonate LC50 = 2,5 0,13 0,05 Y, CF = 0,75 O O O 2,3
14 C 14-18 alpha olefine sulphonate LC50 = 1,4 0,07 0,05 Y, CF = 2,0 O O O 2,4
15 Soaps (C 12-22) EC0 = 1,6 1,6 0,05 O O O O 2,9
Nonionic surfactants
16 C 9/11 A > 3-6 EO lin. or mono br. EC50 = 3,3 0,7 0,03 O O O O 2,4
17 C 9/11 A > 6-9 EO lin. or mono br. EC50 = 5,4 1,1 0,03 O O O O 2,2
18 C 12-15 A 2-6 EO lin. or mono br. 0,18 0,18 0,03 O O O O 2,5▼B2001D0607 — EN — 08.08.2001 — 000.001 — 8
DID-
NoIngredientsToxicity
Loading factor
(LF)Anaerobic non-
biodegradable
(a NBO)Aerobic non-
biodegradable
(a NBO)Soluble inor-
ganics
(SI)Insoluble inor-
ganics
(II)THODNOEC
measuredLTE
19 C 12-15 (Avg. C < 14) A > 6-9 EO lin. or
mono br.0,24 0,24 0,03 O O O O 2,3
20 C 12-15 (Avg. C > 14) A > 6-9 EO 0,17 0,17 0,03 O O O O 2,3
21 C 12-15 A > 9-12 EO LC50 = 0,8 0,3 0,03 O O O O 2,222 C 12-15 A 20-30 EO EC50 = 13 0,65 0,05 O O O O 2
23 C 12-15 A > 30 EO LC50 = 130 6,5 0,75 O Y O O 0 (*)
24 C 12/18 A 0-3 EO no data 0,01 0,03 O O O O 2,9
25 C 12-18 A 9 EO 0,2 0,2 0,03 O O O O 2,4
26 C 16/18 A 2-6 EO 0,03 0,03 0,03 O O O O 2,6
27 C 16/18 A > 9-12 EO LC50 = 0,5 0,05 0,03 O O O O 2,3
28 C 16/18 A 20-30 EO EC50 = 18 0,36 0,05 O O O O 2,1
29 C 16/18 A > 30 EO LC50 = 50 2,5 0,75 O Y O O 0 (*)
30 C 12/14 glucose amide 4,3 4,3 0,03 O O O O 2,231 C 16/18 glucose amide 0,116 0,116 0,03 O O O O 2,5
32 C 12/14 alkylpolyglucoside 1 1 0,03 O O O O 2,3
Amphoteric surfactants
33 C 12-15 alkyl dimethylbetaine 0,03 0,03 0,05 Y, CF = 2,5 O O O 2,9
34 C 12-18 alkyl amidopropylbetaine 0,03 0,03 0,05 Y, CF = 2,5 O O O 2,8
Suds controllers
35 Silicone EC0 = 241 4,82 0,4 Y, CF = 0,75 Y O O 0,0
36 Paraffin no data 100 0,4 O Y O O 0 (*)
Fabric softening
37 Glycerol LC50 >5-10 gl 1 000 0,13 O O O O 1,2
Builders
38 Phosphate as sodium-tri-polyphosphate
(STPP)1 000 0,6 O O Y O 0,0▼B2001D0607 — EN — 08.08.2001 — 000.001 — 9
DID-
NoIngredientsToxicity
Loading factor
(LF)Anaerobic non-
biodegradable
(a NBO)Aerobic non-
biodegradable
(a NBO)Soluble inor-
ganics
(SI)Insoluble inor-
ganics
(II)THODNOEC
measuredLTE
39 Zeolite A 120 120 0,05 O O O Y 0,0
40 Citrate EC50 = 85 85 0,07 O O O O 0,6
41 Polycarboxylates and related derivates 124 124 0,4 Y, CF = 0,1 Y O O 0 (*)
42 Clay 1 000 0,05 O O O Y 0,0
43 Carbonate/bicarbonate LC50 = 250 250 0,8 O O Y O 0,0
44 Fatty acid (C ≥14) EC0 = 1,6 1,6 0,05 O O O O 2,9
45 Silicate/disilicate EC50 >1 000 1 000 0,8 O O Y O 0,0
46 NTA 19 19 0,13 O O O O 0,647 Polyaspartic acid. Na salt 125 12,5 0,13 Y, CF = 0,1 O O O 1,2
Bleaching
48 Perborate mono (as borate) 1-10 6 1 O O Y O 0,0
49 Perborate tetra (as borate) 1-10 6 1 O O Y O 0,0
50 percarbonate (see carbonate) LC50 = 250 250 0,8 O O Y O 0,0
51 TAED EC0 = 500 EC0 = 500 0,13 O O O O 2,0
Solvents
52 C 1-C 4 alcohols LC50 = 8 000 100 0,13 O O O O 2,3
53 Monoethanolamine 0,78 0,78 0,13 O O O O 2,4
54 Diethanolamine 0,78 0,78 0,13 O O O O 2,3
55 Triethanolamine 0,78 0,78 0,13 O O O O 2
Miscellaneous
56 Polyvinylpyrrolidon (PVP/PVNO/PVPVI) EC50 > 100 100 0,75 Y, CF = 0,1 Y O O 0 (*)
57 Phosphonates 7,4 7 0,4 Y, CF = 0,5 Y O O 0 (*)
58 EDTA LOEC = 11 11 1 Y, CF = 0,1 Y O O 0 (*)
59 CMC LC50 > 250 250 0,75 Y, CF = 0,1 Y O O 0 (*)
60 Na sulphate EC50 = 2 460 1 000 1 O O Y O 0,0
61 Mg sulphate EC50 = 788 800 1 O O Y O 0,0▼B2001D0607 — EN — 08.08.2001 — 000.001 — 10
DID-
NoIngredientsToxicity
Loading factor
(LF)Anaerobic non-
biodegradable
(a NBO)Aerobic non-
biodegradable
(a NBO)Soluble inor-
ganics
(SI)Insoluble inor-
ganics
(II)THODNOEC
measuredLTE
62 Na chloride EC50 = 650 650 1 O O Y O 0,0
63 Urea LC50 > 10 000 100 0,13 O O O O 2,1
64 Maleic acid LC50 = 106 2,1 0,13 O O O O 0,8
65 Malic acid LC50 = 106 2,1 0,13 O O O O 0,6
66 Ca formiate 100 0,13 O O O O 2,0
67 Silica 100 0,05 O O O Y 0,0
68 High MW polymers PEG > 4 000 100 0,4 O O O O 0 (*)
69 Low MW polymers PEG < 4 000 100 0,13 O O O O 1,170 Cumene sulphonate LC50 = 66 6,6 0,13 Y, CF = 0,25 O O O 1,7
71 Xylene sulphonate LC50 = 66 6,6 0,13 Y, CF = 0,25 O O O 1,6
72 Toluene sulphonates LC50 = 66 6,6 0,13 Y, CF = 0,25 O O O 1,4
73 Na-/Mg-/KOH 100 1 O O Y O 0,0
74 Enzymes LC50 = 25 25 0,13 O O O O 2,0
75 Perfume formulation as used LC50 = 2-10 0,02 0,1 Y, CF = 3,0 Y O O 0 (*)
76 Dyes LC50 = 10 0,1 0,4 Y, CF = 3,0 Y O O 0 (*)
77 Starch no data 250 0,1 O O O O 0,97
78 Zn phthalocyanine sulphonate 0,16 0,016 0,074 (**) Y, CF = 2,5 Y O O 0 (*)
79 Anionic polyester (soil release polymer) EC50 = 310 310 0,4 Y, CF = 0,1 Y O O 0 (*)
80 Iminodisuccinate 23 2,3 0,13 Y, CF = 0,25 O O O 1,1
Optical brighteners = (FWA)
81 FWA 1 (
1) LC0 = 10 1,0 0,4 Y, CF = 1,5 Y O O 0 (*)
82 FWA 5 (2) 3,13 3,13 0,4 Y, CF = 0,5 Y O O 0 (*)
Additional ingredients
83 Alkyl aminoxides (C 12-18) 0,08 0,08 0,05 Y, CF = 2,5 O O O 3,2
84 Glycereth (6-17EO) cocoate EC50 = 32 1,6 0,05 O O O O 2,1
85 Phosphate esters (C 12-18) EC50 = 38 1,9 0,05 Y, CF = 0,25 O O O 2,3▼B2001D0607 — EN — 08.08.2001 — 000.001 — 11
(1) FWA 1 = Disodium 4.4-bis (4-anilino-5-morpholino-1,3,5-triazin-2-yl)amino-stilbene-2.2-disulphonate.
(2) FWA 5 = Disodium 4.4-bis(2-sulfostryryl)biphenyl.
(*) THOD for aerobically non degradable organic substances is set to zero.
(**) rapid photodegradation.
NotesY = yes, criterion applies.
O = no, criterion does not apply.LTE = long-term effect concentration.NOEC = non-observed effect concentration.CF = correction factor for anaerobic non degradable organic substances.THOD = theoretical oxygen demand.▼B2001D0607 — EN — 08.08.2001 — 000.001 — 12
▼B
B.Approach for ingredients which are not included in the DID-list
For ingredients which are not included in the DID-list, the applicant shall, under
his own responsibility, find the appropriate values for the relevant parameters.
The reference for the relevant test methods shall be the appropriate Annexes to
Directive 67/548/EC.
The approach for estimating long-term-toxicity effect concentration (LTE) and
loading factors (LF) is given below.
1.How to estimate long-term-toxicity-effect concentration (LTE)
As LTE the lowest validated long-term toxicity concentration for fish, daphnia
magna or algae shall be considered.
In cases where data on homologues and/or QSARs (quantitative structure activity
relationships) are used, a correction could be considered for the finally selected
LTE. If long-term toxicity data (such as NOEC) for one or more of the three
species are missing, or only short-term toxicity data (such as LC50) are available,
the following uncertainty factors (UF) shall be used:
1.1. Uncertainty factors (UF) for non-surfactants
Data available UF to be used
3 NOEC on fish, daphnia or algae 1 (take lowest validated NOEC)
2 NOEC on fish or daphnia or algae 5
1 NOEC on fish or daphnia or algae 10
At least 2 acute LC50 on fish or
daphnia or algae100
Deviation from this rule may be admitted if evidence can be provided that lower
factors or data can be justified scientifically.
1.2. Uncertainity factors (UF) for surfactants
Data available UF to be used
At least 2 NOEC on fish or daphnia or
algae1 (lowest NOEC)
1 NOEC on fish or daphnia or algae 1 (if species is most sensitive in acute
toxicity)
10 (if species is not the most sensitive
in acute toxicity)
3 LC50 on fish or daphnia or algae 20 (lowest LC50)
At least 1 LC50 on fish, daphnia or
algae50 (lowest LC50) or 20 in specific
cases (*)
(*) In the last case referred to above, an uncertainty factor of 20 may be used instead of 50
only if 1-2 L(E)C50 (LC50 in case of fish toxicity, EC50 in case of daphnia magna and
algae toxicity) data are available and if it can be concluded from the information forother compounds that the most sensitive species have been tested. Such a rule can beapplied only within a group of homologues. It is emphasised that the LTEs used must beconsistent within a group of homologues with respect to the influence of, for examplelength of alkyl chain for LAS (linear alkylbenzene sulphonate) or number of EOs
(ethoxy groups) for alcohol-ethoxylate. Any deviation from the scheme described above
shall be well reasoned for the specific chemical.
2.How to estimate loading factors (LF)
The loading factors (LF) for calculating the critical dilution volume toxicity
(CDVtox) reflect the percentage of the substance which passes the sewage
treatment system and depends on biodegradability and sorption tendency of the
substance.2001D0607 — EN — 08.08.2001 — 000.001 — 13
▼B
2.1. Loading factors for organic substances
Degradability of substance Sorption Loading factor (LF)
Ready biodegradable Low 0,13
Medium 0,1
High 0,07
Inherent biodegradable Low 0,6
Medium 0,5
High 0,3
Non-biodegradable Low 1
Medium 0,75
High 0,4
Note: Sorption can be estimated by log Pow(partition coefficient octanol/water), where Pow< 2 is considered as ‘low sorption’, Pow< x < 4 is ‘medium sorption’ and Pow>4is
‘high sorption’. Where no sorption data are available, low sorption is assumed.
2.2. Special approach for readily degradable surfactants
Type of surfactant Loading factor (LF) to be used
Readily degradable surfactants in
general0,05
Alcohol ethoxylates (EO < 20) and
alcohol ethoxysulphates0,03
Alcohol sulphates 0,02
2.3. Special approach for inorganic substances
Type of inorganic substance loading factor (LF) to be used
Soluble inorganic substances 1
Insoluble inorganic substances 0,052001D0607 — EN — 08.08.2001 — 000.001 — 14