2001/607/EC: Commission Decision of 19 July 2001 establishing the ecological criteria for the award of the Community eco-label to hand dishwashing detergents (Text with EEA relevance) (notified under document number C(2001) 1989)
Date: 2001-07-19
Institutions: European Commission
Subjects: European standard, eco-label, environmental protection, household article, polishing and scouring preparations, quality label

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II

(Acts whose publication is not obligatory)

COMMISSION

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 Euro-
pean Parliament and of the Council of 17 July 2000 on a
revised Community eco-label award scheme (1), and in partic-
ular Articles 3, 4 and 6 thereof,

Whereas:

(1)

(2)

(3)

(4)

Article 3 of Regulation (EC) No 1980/2000 provides
the eco-label may be awarded to a product
that
possessing characteristics which enable it to contribute
significantly to improvements in relation to key environ-
mental aspects.

Article 4 of Regulation (EC) No 1980/2000 provides
that
specific eco-label criteria shall be established
according to product groups.

The measures set out in this Decision have been devel-
oped and adopted under the procedures for the setting
of eco-label criteria as laid down in Article 6 of Regula-
tion (EC) No 1980/2000.

The measures set out in this Decision are in accordance
with the opinion 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 takes effect. If revised ecological criteria have not been
adopted before the end 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.

Done at Brussels, 19 July 2001.

For the Commission

Margot WALLSTRÖM

Member of the Commission

(1) OJ L 237, 21.9.2000, p. 1.

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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 manage-
ment 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 (CDVtox) 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
for the product.
approach described in Appendix IB. The CDVtox

is summed for each ingredient, making the CDV

tox

The CDVtox

of 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 CDVtox
calculations showing compliance with this criterion.

2. Biodegradabiltiy of surfactants

(a) Ready biodegradability (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 biodegradable 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, packaging 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 their

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

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equivalent 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 biodegradable 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-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(cid:1)-tert-butyl-2(cid:1),6(cid:1)-dimethyl-3(cid:1),5(cid:1)-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),

R62 (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 the European Parliament and of the Council of 31 May 1999 concerning the approximation
of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging
and labelling of dangerous preparations (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.

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

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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 experimentally 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

Benzyl alcohol

Cinnamyl alcohol

Citral

Eugenol

Hydroxycitronellal

Isoeugenol

122-40-7

Amylcinnamyl alcohol

100-51-6

Benzyl salicylate

104-54-1

Cinnamal

5392-40-5

Coumarin

97-53-0

Geraniol

101-85-9

118-58-1

104-55-2

91-64-5

106-24-1

107-75-5

97-54-1

Hydroxymethyl
penthylcyclohexenecarboxaldehyde

31906-04-4

(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 (1) 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 (2) 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.

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.

(1) OJ L 262, 27.9.1976, p. 169.
(2) OJ L 237, 10.9.1994, p. 13.

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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 adminis-
trative 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-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).

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

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(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 (as in 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.

(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-No

Ingredients

Anionic surfactants

C 10-13 LAS (Na Ø 11,5-11,8, C14 < 1 %)

other LAS (C 14 > 1 %)

C 14/17 Alk. sulphonate

C 8/10 Alkylsulphate

C 12-15 AS

C 12-18 AS

C 16/18 FAS

C 12-15 A 1-3 EO sulphate

Toxicity

NOEC
measured

0,3

0,12

0,27

EC50 = 2,9

0,1

LC50 = 3

0,55

0,15

C 16/18 A 3-4 EO sulphate

no valid data

C 8 Dialkylsulphosuccinate

C 12/14 sulpho-fat.-acid methylester

C 16/18 sulpho-fat.-acid methylester

C 14/16 alpha olefine sulphonate

C 14-18 alpha olefine sulphonate

Soaps (C 12-22)

LC50 = 7,5

EC50 = 5

0,15

LC50 = 2,5

LC50 = 1,4

EC0 = 1,6

1

2

3

4

5

6

7

8

9

10

11

12

13

14

15

Loading factor
(LF)

Anaerobic
non-biodegradable
(a NBO)

Aerobic
non-biodegradable
(a NBO)

Soluble
inorganics
(SI)

Insoluble
inorganics
(II)

THOD

0,05

0,05

0,03

0,02

0,02

0,02

0,02

0,03

0,03

0,5

0,05

0,05

0,05

0,05

0,05

Y, CF = 0,75

Y, CF = 1,5

Y, CF = 0,75

O

O

O

O

O

O

Y, CF = 1,5

Y, CF = 0,75

Y, CF = 0,75

Y, CF = 0,75

Y, CF = 2,0

O

O

O

O

O

O

O

O

O

O

O

O

O

O

O

O

O

O

O

O

O

O

O

O

O

O

O

O

O

O

O

O

O

O

O

O

O

O

O

O

O

O

O

O

O

O

2,3

2,3

2,5

1,9

2,2

2,3

2,5

2,1

2,2

2

2,1

2,3

2,3

2,4

2,9

LTE

0,3

0,12

0,27

0,15

0,1

0,15

0,55

0,15

0,1

0,4

0,25

0,15

0,13

0,07

1,6

L

2
1
4
/
3
6

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
C
o
m
m
u
n
i
t
i
e
s

.

.

8
8
2
0
0
1

DID-No

Ingredients

Nonionic surfactants

C 9/11 A > 3-6 EO lin. or mono br.

C 9/11 A > 6-9 EO lin. or mono br.

C 12-15 A 2-6 EO lin. or mono br.

C 12-15 (Avg. C < 14) A > 6-9 EO lin. or
mono br.

C 12-15 (Avg. C > 14) A > 6-9 EO

C 12-15 A > 9-12 EO

C 12-15 A 20-30 EO

C 12-15 A > 30 EO

C 12/18 A 0-3 EO

C 12-18 A 9 EO

C 16/18 A 2-6 EO

C 16/18 A > 9-12 EO

C 16/18 A 20-30 EO

C 16/18 A > 30 EO

C 12/14 glucose amide

C 16/18 glucose amide

C 12/14 alkylpolyglucoside

Amphoteric surfactants

C 12-15 alkyl dimethylbetaine

C 12-18 alkyl amidopropylbetaine

Suds controllers

Silicone

Paraffin

16

17

18

19

20

21

22

23

24

25

26

27

28

29

30

31

32

33

34

35

36

Toxicity

NOEC
measured

EC50 = 3,3

EC50 = 5,4

0,18

0,24

0,17

LC50 = 0,8

EC50 = 13

LC50 = 130

no data

0,2

0,03

LC50 = 0,5

EC50 = 18

LC50 = 50

4,3

0,116

1

0,03

0,03

EC0 = 241

no data

LTE

0,7

1,1

0,18

0,24

0,17

0,3

0,65

6,5

0,01

0,2

0,03

0,05

0,36

2,5

4,3

0,116

1

0,03

0,03

4,82

100

Fabric softening

37

Glycerol

LC50 >5-10 gl

1 000

0,13

Loading factor
(LF)

Anaerobic
non-biodegradable
(a NBO)

Aerobic
non-biodegradable
(a NBO)

Soluble
inorganics
(SI)

Insoluble
inorganics
(II)

THOD

.

.

8
8
2
0
0
1

0,03

0,03

0,03

0,03

0,03

0,03

0,05

0,75

0,03

0,03

0,03

0,03

0,05

0,75

0,03

0,03

0,03

0,05

0,05

0,4

0,4

O

O

O

O

O

O

O

O

O

O

O

O

O

O

O

O

O

Y, CF = 2,5

Y, CF = 2,5

Y, CF = 0,75

O

O

O

O

O

O

O

O

O

Y

O

O

O

O

O

Y

O

O

O

O

O

Y

Y

O

O

O

O

O

O

O

O

O

O

O

O

O

O

O

O

O

O

O

O

O

O

O

O

O

O

O

O

O

O

O

O

O

O

O

O

O

O

O

O

O

O

O

O

O

2,4

2,2

2,5

2,3

2,3

2,2

2

0 (*)

2,9

2,4

2,6

2,3

2,1

0 (*)

2,2

2,5

2,3

2,9

2,8

0,0

0 (*)

1,2

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
C
o
m
m
u
n
i
t
i
e
s

L

2
1
4
/
3
7

DID-No

Ingredients

Builders

Phosphate as sodium-tri-polyphosphate (STPP)

Zeolite A

Citrate

Polycarboxylates and related derivates

Clay

Carbonate/bicarbonate

Fatty acid (C ≥ 14)

Silicate/disilicate

NTA

Polyaspartic acid. Na salt

Bleaching

Perborate mono (as borate)

Perborate tetra (as borate)

TAED

Solvents

C 1-C 4 alcohols

Monoethanolamine

Diethanolamine

Triethanolamine

Miscellaneous

38

39

40

41

42

43

44

45

46

47

48

49

50

51

52

53

54

55

56

57

58

Toxicity

NOEC
measured

120

EC50 = 85

124

LC50 = 250

EC0 = 1,6

LTE

1 000

120

85

124

1 000

250

1,6

EC50 >1 000

1 000

19

125

1-10

1-10

19

12,5

6

6

LC50 = 8 000

0,78

0,78

0,78

100

0,78

0,78

0,78

100

7

11

Loading factor
(LF)

Anaerobic
non-biodegradable
(a NBO)

Aerobic
non-biodegradable
(a NBO)

Soluble
inorganics
(SI)

Insoluble
inorganics
(II)

THOD

0,6

0,05

0,07

0,4

0,05

0,8

0,05

0,8

0,13

0,13

1

1

0,8

0,13

0,13

0,13

0,13

0,13

0,75

0,4

1

O

O

O

Y, CF = 0,1

O

O

O

O

O

Y, CF = 0,1

O

O

O

O

O

O

O

O

Y, CF = 0,1

Y, CF = 0,5

Y, CF = 0,1

O

O

O

Y

O

O

O

O

O

O

O

O

O

O

O

O

O

O

Y

Y

Y

Y

O

O

O

O

Y

O

Y

O

O

Y

Y

Y

O

O

O

O

O

O

O

O

O

Y

O

O

Y

O

O

O

O

O

O

O

O

O

O

O

O

O

O

O

O

0,0

0,0

0,6

0 (*)

0,0

0,0

2,9

0,0

0,6

1,2

0,0

0,0

0,0

2,0

2,3

2,4

2,3

2

0 (*)

0 (*)

0 (*)

L

2
1
4
/
3
8

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
C
o
m
m
u
n
i
t
i
e
s

.

.

8
8
2
0
0
1

Polyvinylpyrrolidon (PVP/PVNO/PVPVI)

EC50 > 100

Phosphonates

EDTA

7,4

LOEC = 11

percarbonate (see carbonate)

LC50 = 250

250

EC0 = 500

EC0 = 500

DID-No

Ingredients

Loading factor
(LF)

Anaerobic
non-biodegradable
(a NBO)

Aerobic
non-biodegradable
(a NBO)

Soluble
inorganics
(SI)

Insoluble
inorganics
(II)

Toxicity

NOEC
measured

LC50 > 250

LTE

250

EC50 = 2 460

1 000

EC50 = 788

EC50 = 650

LC50 > 10 000

LC50 = 106

LC50 = 106

LC50 = 66

LC50 = 66

LC50 = 66

LC50 = 25

LC50 = 2-10

LC50 = 10

no data

0,16

800

650

100

2,1

2,1

100

100

100

100

6,6

6,6

6,6

100

25

0,02

0,1

250

CMC

Na sulphate

Mg sulphate

Na chloride

Urea

Maleic acid

Malic acid

Ca formiate

Silica

High MW polymers PEG > 4 000

Low MW polymers PEG < 4 000

Cumene sulphonate

Xylene sulphonate

Toluene sulphonates

Na-/Mg-/KOH

Enzymes

Perfume formulation as used

Dyes

Starch

Zn phthalocyanine sulphonate

59

60

61

62

63

64

65

66

67

68

69

70

71

72

73

74

75

76

77

78

79

80

0,75

Y, CF = 0,1

1

1

1

0,13

0,13

0,13

0,13

0,05

0,4

0,13

0,13

0,13

0,13

1

0,13

0,1

0,4

0,1

O

O

O

O

O

O

O

O

O

O

Y, CF = 0,25

Y, CF = 0,25

Y, CF = 0,25

O

O

Y, CF = 3,0

Y, CF = 3,0

O

Y

O

O

O

O

O

O

O

O

O

O

O

O

O

O

O

Y

Y

O

Y

Y

O

O

Y

Y

Y

O

O

O

O

O

O

O

O

O

O

Y

O

O

O

O

O

O

O

O

O

O

O

O

O

O

O

Y

O

O

O

O

O

O

O

O

O

O

O

O

O

Anionic polyester (soil release polymer)

EC50 = 310

Iminodisuccinate

23

0,016

0,074 (**)

Y, CF = 2,5

310

2,3

0,4

0,13

Y, CF = 0,1

Y, CF = 0,25

THOD

0 (*)

0,0

0,0

0,0

2,1

0,8

0,6

2,0

0,0

0 (*)

1,1

1,7

1,6

1,4

0,0

2,0

0 (*)

0 (*)

0,97

0 (*)

0 (*)

1,1

.

.

8
8
2
0
0
1

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
C
o
m
m
u
n
i
t
i
e
s

L

2
1
4
/
3
9

DID-No

Ingredients

Optical brighteners = (FWA)

FWA 1 (1)

FWA 5 (2)

Additional ingredients

Alkyl aminoxides (C 12-18)

Glycereth (6-17EO) cocoate

Phosphate esters (C 12-18)

81

82

83

84

85

Toxicity

NOEC
measured

LC0 = 10

3,13

0,08

EC50 = 32

EC50 = 38

LTE

1,0

3,13

0,08

1,6

1,9

Loading factor
(LF)

Anaerobic
non-biodegradable
(a NBO)

Aerobic
non-biodegradable
(a NBO)

Soluble
inorganics
(SI)

Insoluble
inorganics
(II)

THOD

0,4

0,4

0,05

0,05

0,05

Y, CF = 1,5

Y, CF = 0,5

Y, CF = 2,5

O

Y, CF = 0,25

Y

Y

O

O

O

O

O

O

O

O

O

O

O

O

O

0 (*)

0 (*)

3,2

2,1

2,3

FWA 1 = Disodium 4.4-bis (4-anilino-5-morpholino-1,3,5-triazin-2-yl)amino-stilbene-2.2-disulphonate.
FWA 5 = Disodium 4.4-bis(2-sulfostryryl)biphenyl.

(1)
(2)
(*) THOD for aerobically non degradable organic substances is set to zero.
(**) rapid photodegradation.

= yes, criterion applies.
= no, criterion does not apply.
= long-term effect concentration.

Notes
Y
O
LTE
NOEC = non-observed effect concentration.
CF
THOD = theoretical oxygen demand.

= correction factor for anaerobic non degradable organic substances.

L

2
1
4
/
4
0

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
C
o
m
m
u
n
i
t
i
e
s

.

.

8
8
2
0
0
1

8.8.2001

EN

Official Journal of the European Communities

L 214/41

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. U n c e r t a i n t y f a c t o r s ( U F )

f o r n o n - s u r f a c t a n t s

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

1 NOEC on fish or daphnia or algae

At least 2 acute LC50 on fish or daphnia or algae

5

10

100

Deviation from this rule may be admitted if evidence can be provided that lower factors or data can be justified
scientifically.

1.2. U n c e r t a i n i t y f a c t o r s ( U F )

f o r s u r f a c t a n t s

Data available

UF to be used

At least 2 NOEC on fish or daphnia or algae

1 (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 algae

50 (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 for other
compounds that the most sensitive species have been tested. Such a rule can be applied only within a group of homologues. It is
emphasised that the LTEs used must be consistent within a group of homologues with respect to the influence of, for example length 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 (CDV
) reflect the percentage of the substance
which passes the sewage treatment system and depends on biodegradability and sorption tendency of the substance.

tox

2.1. L o a d i n g f a c t o r s f o r o r g a n i c s u b s t a n c e s

Degradability of substance

Sorption

Loading factor (LF)

Ready biodegradable

Low

Medium

High

0,13

0,1

0,07

L 214/42

EN

Official Journal of the European Communities

8.8.2001

Degradability of substance

Sorption

Loading factor (LF)

Inherent biodegradable

Non-biodegradable

Low

Medium

High

Low

Medium

High

0,6

0,5

0,3

1

0,75

0,4

Note: Sorption can be estimated by log Pow (partition coefficient octanol/water), where Pow < 2 is considered as ‘low
> 4 is ‘high sorption’. Where no sorption data are available, low

< x < 4 is ‘medium sorption’ and P

ow

sorption’, P
sorption is assumed.

ow

2.2. Sp e c i a l a p p r o a c h f o r

r e a d i l y d e g r a d a b l e s u r f a c t a n t s

Type of surfactant

Loading factor (LF) to be used

Readily degradable surfactants in general

Alcohol ethoxylates (EO < 20) and alcohol ethoxysulphates

Alcohol sulphates

0,05

0,03

0,02

2.3. Sp e c i a l a p p r o a c h f o r

i n o r g a n i c s u b s t a n c e s

Type of inorganic substance

loading factor (LF) to be used

Soluble inorganic substances

Insoluble inorganic substances

1

0,05