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Europaudvalget 2000-01
EUU Alm.del Bilag 1042
Offentligt

Modtaget via elektronisk post. Der tages forbehold for evt. fejl

Europaudvalget

(Alm. del - bilag 1042)

miljøministerråd

(Offentligt)

Medlemmerne af Folketingets

Europaudvalg og deres stedfortrædere

Bilag

Journalnummer

400.C.2-0

Kontor

EU-sekr.

3. april 2001

Til underretning for Folketingets Europaudvalg vedlægges Miljø- og Energiministeriets notat samt grundnotat om forslag til

Kommissionens beslutning om miljøkriterier for tildeling af EU-miljømærke til håndopvaskemidler.

MILJØstyrelsen

Den 30. marts 2001

Internationalt kontor J.nr M 1034-0051

OK/6

NOTAT TIL FOLKETINGETS EUROPAUDVALG

Om forslag til Kommissionens beslutning om miljøkriterier for tildeling af EU-miljømærke til håndopvaskemidler.

Kommissionen har fremlagt et forslag om miljøkriterier for tildeling af EU-miljømærke til håndopvaskemidler.

Formålet med den frivillige positive miljømærkeordning er at fremme udformningen, fremstillingen, markedsføringen og anvendelsen af

produkter, som har mindsket indvirkning på miljøet gennem hele deres livscyklus samt give forbrugerne bedre information om produktets

indvirkning på miljøet.

Det sker gennem fastlæggelse af en række kriterier, som skal overholdes for at kunne anvende miljømærket.

Beslutningsforslaget indeholder kriterier for tildeling af miljømærket Blomsten til håndopvaskemidler. Kommissionen har, med Frankrig som

ledende kompetent organ, udarbejdet forslaget.

Forslaget har været til høring i EF-specialudvalget for miljø.

Der stemmes om forslaget den 6.april 2001.

Danmark agter at stemme for forslaget, idet der dog lægges afgørende vægt på kriterieforslagets

Krav om anaerob nedbrydelighed bibeholdes, som der er foreslået i udkastet.

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MILJØstyrelsen

30. marts 2001

Kontoret for Renere Produkter J. nr. M 1034-0051

BHC/10

Grundnotat

om forslag til Kommissionens beslutning om miljøkriterier for tildeling af EU-miljømærket til håndopvaskemidler

1. Indledning

Kommissionen har den 28. februar 2001 fremsendt endeligt forslag til Kommissionens beslutning om etablering af miljøkriterier for

tildeling af EU-miljømærket til håndopvaskemidler (Dok. ENV/2001/0043, draft 21 February 2001, engelsk udgave foreligger og er

vedlagt).

Forslaget udgør en opfølgning af artikel 4 og 6 i Europa-Parlamentets og Rådets forordning nr. 1980/2000 af 17. juli 2000 om en

revideret ordning for tildeling af EF-miljømærke. I disse artikler bestemmes det, at der fastsættes specifikke miljømærkekriterier for hver

produktgruppe for en given gyldighedsperiode. Kriterier og gyldighedsperiode fastlægges i overensstemmelse med fremgangsmåden i art.

17, som er en forskriftsudvalgsprocedure, ef ter høring af Det Europæiske Miljømærkenævn.

Det er planlagt at Forskriftsudvalget skal stemme om sagen d. 6. april 2001. Det er dog endnu uklart om der vil blive truffet en endelig

afgørelse på denne dag. Der er udeståender omkring afstemningsproceduren i den nyligt reviderede forordning nr. 1980/2000 af 17. juli

2000.

2. Formål og indhold

Formålet med den frivillige positive miljømærkeordning er at fremme udformningen, fremstillingen, markedsføringen og anvendelsen af

produkter, som har mindsket indvirkning på miljøet gennem hele deres livscyklus samt give forbrugerne bedre information om produkters

indvirkning på miljøet.

Nærværende beslutningsforslag indeholder kriterier for tildeling af miljømærket Blomsten til håndopvaskemidler. Kommissionen har,

med Frankrig som ledende kompetent organ, udarbejdet forslaget. Undervejs i processen har repræsentanter for medlemslandene og

interesseorganisationerne været hørt.

Definition af produktgruppen

Produktgruppen defineres som: Alle detergenter (opvaskemidler) som er beregnet til opvask i hånden af fade, porcelæn,

bestik, skåle og andet køkkenudstyr.

Definitionen af produktgruppen og kriterierne for produktgruppen foreslås at gælde for en periode på 5 år regnet fra den

første dag i den måned, der følger efter kommissionsbeslutningens ikrafttræden. Kommissionen ønsker nye kriterier fastsat 1

år før gyldigheden af de eksisterende ophører. Det vil i givet fald sige, at der skal foreligge nyt kriterieforslag igen om 4 år.

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Kriterier

Der er kriterier for nedennævnte områder. De detaljerede krav kan ses i det vedlagte engelsksprogede kriterieforslag. "Nr." henviser til

kriterieforslagets nummer.

Nr. Dansk

Bionedbrydelighed af overfladeaktive

stoffer", opdelt på 2a aerob og 2b anaerob

nedbrydelighed,

Farlige og giftige stoffer

Mangler (fejl i nummerering)

Parfumestoffer, opdelt på 5a Moskus-

forbindelser og 5b Udvalgte parfumer

Farvestoffer

Biocider

Hud sensibilisering (overfølsomhed)

Engelsk

Biodegradability of surfactants

2a Ready biodegradability (aerobic), 2b

Anaerobic biodegradability

Dangerous, hazardous or toxic components

Fragrances, 5a Musk, 5b Fragrances

concerned

Dyes or colouring agents

Biocides

Skin sensitisation

Packaging requirements

Fitness for use

User instructions

Giftighed overfor vandlevende organismer Toxicity to aquatic organisms

Mængde af overfladeaktive stoffer pr. vask Limitation of the total surfacatants per wash

10 Emballage

11 Brugsegnethed

12 Forbrugerinformation

3. Nærheds- og proportionalitetsprincippet

Kommissionen har ikke redegjort for nærheds- og proportionalitetsprincippet. Der er tale om en gennemførelsesforanstaltning af en

allerede vedtaget rådsretsakt.

4. Forslagets konsekvenser for Danmark.

Lovgivningsmæssige konsekvenser

Forslaget medfører ingen lovgivningsmæssige konsekvenser for Danmark.

Økonomiske konsekvenser

Den europæiske miljømærkningsordning er frivillig. Erhvervelse af miljømærket indebærer udgifter for producenter og importører, men

disse udgifter forventes opvejet af de konkurrencemæssige fordele ved anvendelsen af miljømærket. Forslaget forventes ikke at medføre

statsfinancielle eller administrative konsekvenser.

Miljømæssige konsekvenser

Forslaget er første generation af kriterier for produktgruppen.

Miljøbelastningen fra de produkter, der kan tildeles licens, vil på grund af kravene være mindre end gennemsnittet for tilsvarende

produkter. Forslaget forventes derfor at få miljøbeskyttelsesmæssigt positive konsekvenser, såfremt de miljømærkede produkter udbredes

på markedet.

5. Høring

Forslaget har været i høring i Miljømærkenævnet. Her sidder repræsentanter for Dansk Industri, Det Danske Handelskammer, Dansk

Handel & Service, Danmarks Naturfredningsforening, Forbrugerrådet, WWF Verdensnaturfonden i Danmark, LO, HK Industri,

Forbrugerstyrelsen, Statens og Kommunernes Indkøbsservice, , Direktoratet for Arbejdstilsynet, to udvalgte detailhandelsrepræsentanter

samt Miljø- og Energiministeriet v. Miljøst yrelsen. Nævnet var delt med hensyn til spørgsmålet om parfumestoffer. NGO{{PU2}}erne

ønskede ikke parfumestoffer tilladt, industri- og handelsrepræsentanterne ønskede parfumestoffer tilladt.

Forslaget har desuden været i høring i EF-miljøspecialudvalget. Her indkom høringssvar fra Miljøkontrollen, SiD, Greenpeace.

Miljøkontrollen har ingen bemærkninger.

SiD mener at parfumestoffer (kriterie 5) ikke skal være tilladt i håndopvaskemidler.

Greenpeace har følgende bemærkninger:

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Kriterie 3 Farlige og giftige stoffer: Ordlyden i forbudet mod "trichlorcarbon" bør bestemt formuleres bredere til "stoffer der indeholder

aktivt chlor".

Kriterie 5b: Parfumestoffer bør ikke være tilladt. Greenpeace fremfører, at forbrugere, der køber miljømærkede produkter netop køber

dem for at få noget, der er bedre for miljø og sundhed.

Kriterie 7 Biocider: Det er uacceptabelt at biocider, der er "meget giftige for organismer der lever i vand, samt kan forårsage uønskede

langtidsvirkninger i vandmiljøet samt er giftige for organismer, der lever i vand" bliver tilladt i miljømærkede produkter.

Kriterie 8 Overfølsomhed: Hudsensibiliserende stoffer bør ikke tillades i mængder op til 1% i et miljømærket produkt.

Kriterie 10 Emballage: Det er uacceptabelt at der ikke er et direkte mod PVC i emballagen. PVC er forbudt i andre miljømærkede

produkter. Dn fortsat aktiv fravælgelse af PVC hos producenterne bør fremmes.

ENV/2001/0043, draft 21 February 2001

COMMISSION DECISION ../{{NEL}}/EC

establishing the ecological criteria for the award of the Community eco-label to hand dishwashing detergents

COMMISSION DECISION ../{{NEL}}/EC

establishing the ecological criteria for the award of the Community eco-label to hand dishwashing detergents

(Text with EEA relevance)

(2001/--/---)

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 Community

Eco-label award scheme, and in particular Articles 3, 4 and 6 thereof,

Whereas:

• 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 in relation to key environmental 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 developed and adopted under the procedures for the setting of eco-label criteria as laid

down in Article 6 of Regulation (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 {{PU1}}hand dishwashing detergents{{PU2}} (hereinafter referred to as {{PU1}}the product group{{PU2}}) 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 five years from the date on which this Decision takes

effect.

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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,

For the Commission

Margot WALLSTRÖM

Member of the Commission

ANNEX

FRAMEWORK

In order to qualify for an eco-label, the product as defined in Article 1 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 assessing the application. Where no tests are mentioned, or are mentioned as being for use in verification or

monitoring, Competent Bodies should rely as appropriate on decla rations 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.

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 environmental 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 litre 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 I A. If the

ingredient in question is not included in the DID list, the applicant shall estimate their values following the approach described in appendix I

B. The CDV

tox

is summed for each ingredient, making the CDV

tox

for the product.

The CDV

tox

of the recommended dose expressed for 1 litre of dishwashing water shall not exceed 130 litre.

The exact formulation of the product shall be provided, together with the details of the CDV

tox

calculations showing compliance with this criterion.

2. Biodegradability of Surfactants

Ready biodegradability (aerobic)

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Each surfactant used in the product shall be readily biodegradable.

The tests for ready biodegradability shall be as referred to in Council Directive 67/548/EEC on the approximation of laws, regulations and administrative provisions

relating to the classification, packaging and labelling of dangerous substances, 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 te sts

referred to in Annex V.C4-A and C.4-B of Directive 67/548/EEC (and their 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 C tests and ISO equivalents).

The exact formulation of the product shall be provided. For each surfactant, the results of the above-mentioned tests, or equivalent documentation from established

literature, shall be provided.

Anaerobic Biodegradability

Each surfactant used in the product shall be biodegradable in anaerobic conditions.

The exact formulation of the product shall be provided. For each surfactant, the relevant information from the literature or other sources, or appropriate test results, shall

be provided. The reference test for anaerobic degradability shall be ISO 11734, ECETOC N°. 28 (June 1988) or equivalent test method, with the requirement of a

minimum of 60% degradability under anaerobic conditions.

3. Dangerous, hazardous or toxic components

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

- formaldehyde

- 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{{PU2}}-tert-butyl-2{{PU2}},6{{PU2}}-dimethyl-3{{PU2}},5{{PU2}}-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 (possible risks of irreversible effects),

R45 (may cause cancer),

R46 (may cause heritable genetic damage),

R49 (may cause cancer by inhalation),

R50+53 (very toxic to aquatic organism and may cause long term adverse effects in the aquatic environment),

R 51+53 (toxic to aquatic organism 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),

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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 Council Directive 67/548/EEC

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 as to preserve the product (as allowed under the criterion on biocides below), and that are classified as R50+53 or

R51+53 are nevertheless permitted.

The exact formulation of the product shall be provided, 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.

5. 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 fragrances, this shall be clearly indicated on the packaging, mentioning

the name or names of the fragrances concerned:

Common name CAS n° Common name CAS n°

Amyl cinnamal 122-40-7 Amylcinnamyl alcohol 101-85-9

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 31906-04-4

Isoeugenol 97-54-1 penthylcyclohexenrcarboxaldehyde

c) Any ingredients added to the product as a fragrance 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.

6. Dyes or colouring agents

Any dyes or colouring agents used in the product must be permitted by Council Directive 76/768/EEC of on the approximation of the laws

of the Member States relating to cosmetic products and its subsequent amendments, and must be permitted by European Parliament and

Council Directive 94/36/EEC of 30 June 1994 on colours for use in foodstuffs and its subsequent amendments.

A declaration of compliance with this criterion shall be provided, together with a full list of all dyes used.

7. 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 packaging and/or an example of each different packaging shall be provided, together with a declaration of compliance with this

criterion.

8. Skin sensitisation

No ingredient classified as R42 (may cause sensitization by inhalation) and/or R43 (may cause sensitization by skin contact) according to

Council Directive 67/548/EEC and its subsequent amendments shall exceed 1% by weight of the total undiluted product.

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The exact formulation of the product shall be provided, together with copies of the Material Safety Data Sheets of each ingredient which shall indicate the classification or

lack thereof of each ingredient. A declaration of compliance with this criterion shall also be provided.

9. Limitation of the total surfacatants per wash

The weight of total surfactants in the recommended dose for 1 litre 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, 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.

10. 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 {{SPA}} Self declared claims (type II environmental labelling)".

c) The primary packaging parts shall be easily separable into mono-material parts.

Data on the packaging, and/or a sample thereof if appropriate, shall be provided, together with a declaration of compliance with this criterion.

FITNESS FOR USE

11. Fitness for use

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

All relevant data shall be provided. This shall at least include the results of a performance test comparing the product (at the recommended dosage, tested on dirty dishes)

with water and with 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.

CONSUMER INFORMATION

12. 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:

Recommended dosage for 5 litres of dishwashing water :

not very dirty x ml (y tea spoons) of product

dirty z ml (w tea spoons) of product

where x, y, z and w have to be defined by the applicant and/or the manufacturer.

The metric used in the above pictogram shall be millilitres. A second well-known metric, 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 metric (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 5l of dishwashing detergent 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 shall to be applied.

e) If the product contains perfumes, this shall be indicated on the packaging.

f) "For more information visit the EU Eco-label web-site: http://europa.eu.int/ecolabel" (or equivalent text).

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A sample of the product packaging, including the label, shall be provided, together with a declaration of compliance with each part of this criterion.

13. Information appearing on the eco-label

Box 2 of the eco-label shall contain the following text:

* reduced environmental impact

* clear dosage instructions

Appendix i

Detergents Ingredients database and approach to be follwed for ingredients not listed in the database

A. Detergent Ingredients Database (DID-list; version 29.09.98)

DID

Ingredients

NOEC

measured

Anionic surfactants

C 10-13 LAS (Na ø 11.5-11.8. C14<1 %)

other LAS (C14 > 1 %)

C 14/17 alk. sulfonate

C 8/10 Alkylsulfate

C 12-15 AS

C 12-18 AS

C 16/18 FAS

C 12-15 A 1-3 EO sulphate

C 16/18 A 3-4 EO sulphate

C 8 -Dialkylsulfosuccinate

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 (C12 - 22)

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

C12-18 Alkyl amidopropylbetaine

Sud controllers

silicone

paraffin

EC0 = 241

no data

4.82

100

0.4

Y,CF = 0.75

0.0

0.03

0.05

Y, CF= 2.5

Y,CF = 2.5

2.9

2.8

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

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

0.03

0.05

0.75

0.03

0.05

0.75

0.03

2.4

2.2

2.5

2.3

2.2

2.9

2.4

2.6

2.3

2.1

2.2

2.5

2.3

0.3

0.12

0.27

EC50= 2.9

0.1

LC50 = 3

0.55

0.15

no valid data

LC50 = 7.5

EC50 = 5

0.15

LC50 = 2.5

LC50 = 1.4

EC0 = 1.6

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

0.05

0.03

0.02

0.03

0.5

0.05

Y, CF = 0.75

Y, CF = 1.5

Y, CF = 0.75

Y, CF = 1.5

Y, CF = 0.75

Y, CF = 2.0

2.3

2.5

1.9

2.2

2.3

2.5

2.1

2.2

2.1

2.3

2.4

2.9

Toxicity

LTE

factor (LF)

Anaerobic Non-Bio-

degradable (an NBO)

Aerobic Non-Bio-

degradable (a NBO)

Soluble

Inorganics (SI)

Insoluble

Inorganics ( II)

THOD

Fabric Softening

Glycerol

Builders

phosphate as STPP

zeolite A

citrate

polycarboxylates and related derivates

clay

carbonate /bicarbonate

fatty acid (C >=14)

LC50 = 250

EC0=1.6

120

EC50 = 85

124

1000

120

124

1000

250

1.6

0.6

0.05

0.07

0.4

0.05

0.8

0.05

Y, CF = 0.1

0.0

0.6

0.0

2.9

LC50 > 5-10 gl

1000

0.13

1.2

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silicate

NTA

Polyaspartic acid. Na salt

Bleaching

EC50 > 1000

125

1000

12.5

0.8

0.13

Y,. CF=0.1

0.0

0.6

1.2

perborate mono (as borate)

perborate tetra (as borate)

percarbonate (see carbonate)

TAED

Solvents

1 - 10

LC50 = 250

EC0 = 500

250

EC0 = 500

0.8

0.13

0.0

2.0

C 1-C4 alcohols

Monoethanolamine

Diethanolamine

Triethanolamine

Miscellaneous

LC50 = 8000

0.78

100

0.78

0.13

2.3

2.4

2.3

Polyvinylpyrrolidon PVP / PVNO / PVPVI

Phosphonates

EDTA

CMC

Na sulphate

Mg Sulphate

Na chloride

urea

maleic acid

malic acid

Ca formiate

Silica

High MW polymers PEG > 4000

Low MW polymers PEG < 4000

cumenesulfonate

xylenesulfonate

toluene sulfonates

Na-/Mg-/KOH

enzymes

perfume formulation as used

dyes

Starch

Zn Phthalocyanine Sulfonate

Anionic Polyester (Soil release polymer)

Iminodisuccinate

Optical brighteners = FWA

EC50 > 100

7.4

LOEC = 11

LC50 > 250

EC50 = 2460

EC50 = 788

EC50 = 650

LC50>10000

LC50 = 106

100

250

1000

800

650

100

2.1

100

0.75

0.4

0.75

0.13

0.05

0.4

0.13

0.1

0.4

0.1

0.07**

0.4

0.13

Y, CF = 0.1

Y, CF = 0.5

Y, CF = 0.1

Y, CF = 0.25

Y, CF = 3.0

Y, CF=2.5

Y,CF=0.1

Y,CF=0.25

0.0

2.1

0.8

0.6

2.0

0.0

1.1

1.7

1.6

1.4

0.0

2.0

0.97

1.1

LC50 = 66

6.6

100

LC50 = 25

LC50 = 2-10

LC50 = 10

no data

0.16

EC50=310

0.02

0.1

250

0.016

310

2.3

FWA 1

FWA 5

LC0 = 10

3.13

1.0

3.13

0.4

Y, CF = 1.5

Y, CF = 0.5

Additional ingredients

C12-18 Alkyl Aminoxides

Glycereth (6-17EO) cocoate

C12-18 Phosphate esters

0.08

EC50=32

EC50=38

0.08

1.6

1.9

0.05

Y,CF = 2.5

Y,CF = 0.25

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'-disulfonate.

FWA 5 = Disodium 4.4'-bis(2-sulfostryryl)biphenyl.

THOD for aerobically non degradable organic substances is set to zero.

rapid photodegradation

Notes:

NOEC = non observed effect concentration CF = correction factor for anaerobic non degradable substances

LTE = long term toxicity effect concentration THOD = Theoretical oxygen demand Remark:

Y = yes, criterion applies a NBO, SI, II, THOD are not used in the criteria for this product group

0 = no, criterion does not apply

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 assess the data for criteria calculating in own responsibility. The

reference for the relevant tests shall be the appropriate annexes of council directive 67/548/EC. For assessing data for ingredients which are

not in the DID-list the applicant may use existing Chemical Databases such as IUCLD (International Uniform Chemical Database for the

Implementation of Council Regulat ion EEC 793/93).

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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 data. 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 algae 100

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

1-2) Uncertainity factors (UF) for surfactants

data available UF to be used

At least 2 NOECs 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 (LC 50 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

(long-term effects) used must be consistent within a group of homologues with respect to the influence of e.g. 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

tox

) reflect the bio-degradability of the substance.

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 P

(Partition Coefficient Octanol/Water), where P

<2 is seen as "low sorption, P

2<x<4 is

"medium sorption" and P

> 4 is "high sorption". In the case that no sorption data are available, low sorption is assumed.

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2-2) Special approach for readily degradable surfactants

Type of surfactant Loading factor (LF) to be used

Readily degradable surfactants in general 0.05

Alcohol ethoxylates (EO < 20) & Alcohol ethoxysulfates 0.03

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 0.05