Report from the Commission to the European Parliament and the Council Pursuant to Article 16 of Regulation (EC) No 648/2004 of the European Parliament and of the Council of 31 March 2004 on detergents, concerning the biodegradation of main non-surfactant organic detergent ingredients (Text with EEA relevance)
Date: 2009-05-04
Institutions: European Commission
Subjects: activity report, biodegradability, free movement of goods, market approval, polishing and scouring preparations

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COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 4.5.2009 
COM(2009) 208 final 

REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND 
THE COUNCIL 

Pursuant to Article 16 of Regulation (EC) No 648/2004 of the European Parliament and 
of the Council of 31 March 2004 on detergents, concerning the biodegradation of main 
non-surfactant organic detergent ingredients 

(Text with EEA relevance) 

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REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND 
THE COUNCIL 

Pursuant to Article 16 of Regulation (EC) No 648/2004 of the European Parliament and 
of the Council of 31 March 2004 on detergents, concerning the biodegradation of main 
non-surfactant organic detergent ingredients 

(Text with EEA relevance) 

1. 
INTRODUCTION TO NON-SURFACTANT ORGANIC INGREDIENTS 
Article  16(2)  of  Regulation  (EC)  No  648/2004  on  detergents1  lays  down  that:  “by  8  April 
2009, the Commission shall carry out a review of the application of this Regulation, paying 
particular regard to the biodegradability of surfactants, and shall evaluate, submit a report 
on, and, where justified, present legislative proposals relating to: 

–  anaerobic biodegradation; 

–  the biodegradation of main non-surfactant organic detergent ingredients”. 

This report will present the results of the Commission's review on the biodegradation of the 
main non-surfactant organic ingredients in detergents. 

Apart  from  surfactants  and  builders  (water-softening  agents),  detergent  products  contain  a 
number of non-surfactant organic and inorganic ingredients. Table-1 lists the main groups of 
non-surfactant chemicals together with an outline of their role in detergents. 

Table 1: Non-surfactant Detergent Ingredients (RPA, 2006)2 

Chemical ingredient 

Acids-Bases 
Bleaching agents, Activators and 
Stabilisers 
Builders, complexing agents and Ion 
exchangers 

Corrosion inhibitors 
Dyes 
Dye transfer inhibitors 
Enzymes 
Fluorescent whitening agents 
Foam regulators 
Formulation aids 
Soil repellents/anti-redeposition 

Purpose 

To ensure optimal pH of wash water 
Enhanced cleaning performance 

Water-softening to maximise cleaning 
efficiency (i.e. removing dirt and keeping it 
in suspension) 
To prevent corrosion of washing machines 
To add colour to detergents 
To prevent loss of garment dyes 
‘Biological’ cleaning 
Optical brightening 
To limit foam generation (machine washing) 
To improve detergent performance 
To prevent re-deposition of dirt during 

1 
2 

OJ L104, 8.4.2004, p. 1 
RPA report available at: http://ec.europa.eu/enterprise/chemicals/legislation/detergents/index_en.htm 

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agents 

Solvents 

washing 
To keep ingredients in solution (particularly 
in liquid detergents) 

Inorganic  ingredients  (e.g  inorganic  bases  or  bleaching  agents)  for  which  biodegradation  is 
not applicable are not further considered in this report. 

For  the  most  important  and  commonly  used  non-surfactant  organic  ingredients  a  brief 
overview  of  their  uses,  the  quantities  used  and  their  biodegradation  characteristics  is  given 
below in Table 2. 

Table 2: Overview of main non-surfactant organic detergent ingredients 

Group of 
substances 
Acids  

Builders, 
Complexing 
Agents and 
Ion 
Exchangers 

Main ingredients 

Acetic, Citric, Adipic 

EU Consumption in 
detergents (tonnes/year) 
Citric acid: 100 000 t/year3  Readily 

Biodegradation 

(a) Phosphonates 

(b) Polycarboxylates  

~ 30 000t/y4 (AISE input 
for 2007) 

~ 80.000 t/y (AISE input 
for 2007) 

(c) Ethylendiammine 
tetra acetate (EDTA) and 
salts 

~ 11 600 and 1 800 t/y (in 
I&I and household 
detergent respectively)5 

biodegradable 

Biodegradation 
aspects of these are 
analysed in sections 
2 and 3 

Nitrilotriacetic-acid 
(NTA) 
Polyvinylpyrrolidone-
(PVP) is the most 
commonly used dye 
transfer inhibitor 
Proteases, α-amylases, 
(lipase, cellulases in 
small quantities) 
FWA-1 (CAS No: 273444-41-8  
FWA-5 (CAS No: 16090-02-1)  

> 20 000 t/y mainly in I&I 
detergents6 
~ 100 t/y  

Not readily 
biodegradable 

Protease: ~ 1 000 t/y 
α-amylase: 150 t/y7 

Readily 
biodegradable 

2100 t/y 
600 t/y8 

FWA-5 not readily 
biodegradable  

n-paraffins 

5 000 t/y 

n-paraffins readily 
biodeagradable 

Dye transfer 
inhibitors 

Enzymes 

Fluorescent 
Whitening 
Agents 
(FWAs) 
Foam 
Regulators 

3 
4 
5 
6 

7 
8 

http://www.heraproject.com/files/37-F-05-HERA_citricacid_version1_April05.pdf 
http://www.heraproject.com/files/30-F-04-%20HERA%20Phosphonates%20Full%20web%20wd.pdf 
http://www.baua.de/nn_8874/de/Chemikaliengesetz-Biozidverfahren/Dokumente/RAR__062.pdf 
http://ecb.jrc.ec.europa.eu/documents/Existing-
Chemicals/RISK_ASSESSMENT/SUMMARY/ntaENVsum307.pdf 
http://www.heraproject.com/files/38-F-Hera_Bridging_document_28.10.05.pdf 
http://www.heraproject.com/files/11-F-04-HERA%20FWA5%20Full%20web%20wd.pdf 

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Formulation 
Aids 

Anti-
Redeposition 
Agents 
Solvents 

Polydimethyl siloxane 
(PDMS) 
Toluene 

7 200 t/y9 

17 000 t/year10 

Carboxymethyl cellulose 
(CMC) 

20 000 t/year 

Various alcohols 
(ethanol, isopropanol, 2-
butoxy ethanol, 1-
decanol, glycerol) and 
triethanolamine (TEA) 

PDMS classified as 
very persistent 
Rapidly degrade 
under aerobic 
conditions 
Poorly 
biodegradable 

Readily 
biodegradable with 
exceptions of TEA 

The  Commission’s  Scientific  Committee  on  Toxicity,  Ecotoxicity  and  the  Environment 
(SCTEE) gave an opinion11 in March 2003 concluding, amongst others, that more information 
was  needed  on  the  health  and  environmental  risks  associated  with  the  co-builders  in 
detergents.  The  SCTEE  considered  that  although  considerable  progress  has  been  made  in 
relation  to  surfactants,  and  in  particular  with  regard  to  their  biodegradibility,  through  the 
implementation of the Detergents Regulation there remain some concern over other chemical 
ingredients in detergents, in particular with regard to certain organic compounds. 

2. 

STUDY ON NON-SURFACTANT DETERGENT ORGANIC INGREDIENTS 

2.1.  Main  findings  concerning  “Non-surfactant  organic  ingredients  and  zeolite-

based detergents” 

In 2005, the Commission services contracted a study to RPA (Risk & Policy Analysts Ltd) in 
order to fill the data gaps identified in the CSTEE opinion concerning the use, properties and 
environmental  impacts  for  a  representative  range  of  non-surfactant  organic  detergent 
ingredients.  The  final  report  entitled  “Non-surfactant  organic  ingredients  and  zeolite-based 
detergents”12,  was  delivered  in  June  2006,  and  served  as  the  basis  for  the  Commission  to 
review  the  biodegradation  of  the  main  non-surfactant  organic  ingredients  in  detergent 
formulations. 

The RPA study examined the properties of about 50 representative detergent ingredients that 
belong  to  the  groups  of  substances  presented  in  Table  1.  The  substances  which  are  readily 
biodegradable  with  no  other  properties  of  potential  concern  (such  as  high  aquatic  toxicity) 
were  considered  unlikely  to  present  significant risks  to  human  health  or  to  the  environment 
and  were  not  analysed  further.  The  substances  or  groups  of  substances  retained  for  further 
analysis  were  those  that  are  not  readily  biodegradable  or  that  have  properties  of  potential 
concern. 

9 

10 
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12 

Environmental  Risk  Assessment  of  Polydimethylsiloxane  used  in  Detergent  Applications,  report 
prepared for the Centre Européen des Silicones, dated 15 March 2006 
http://www.heraproject.com/files/24-F-HERA%20Hydrotropes%20Sept%202005.pdf 
http://ec.europa.eu/health/ph_risk/committees/sct/sct_opinions_en.htm 
available at: http://ec.europa.eu/enterprise/chemicals/legislation/detergents/index_en.htm 

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The screening exercise of RPA resulted in a list of specific substances and substance groups 
being selected for further analysis, based on scientific evidence available from the various risk 
assessments. The findings were: 

(1) 

Builders, Complexing Agents and Ion Exchangers 

(a) 

(b) 

(c) 

(d) 

Phosphonates:  There  is  a  broad  consensus  that  phosphonates  degrade  slowly 
and may present a risk to the environment with concern being focused on the 
potential  aquatic  chronic  toxicity  of  HEDP  (1-  hydroxy  ethane  diphosphonic 
acid) and its salts to Daphnia. 

Polycarboxylates: Polycarboxylates do not readily biodegrade, and while there 
are no available monitoring data, concentrations in sludge-treated soils may be 
significant. 

EDTA and its salts: Available data indicate that EDTA and its salts may be of 
concern  to  the  environment  with  regard  to  their  use  in  industrial  and 
institutional (I&I) cleaning - but not for household detergents where their use is 
limited. (ECB, 2004)13. 

is  readily 
Nitrilotriacetic  acid  (NTA):  There 
biodegradable  using  a  range  of  standard  tests  –  although,  in  some  cases,  the 
formation  of  metal-NTA  complexes  may  slow  the  rate  of  degradation  (ECB, 
2005)14. 

is  consensus 

that  NTA 

(2) 

(3) 

(4) 

13 

14

More  information  on  the  environmental  effects  of  phosphonates,  polycarboxylates, 
EDTA and NTA are given in section 3 below. 

Polyvinylpyrrolidone  (PVP):  PVP  does  not  pose  a  risk  for  human  health  and  there 
appears  to  be  a  general  consensus  that  this  is  of  limited  environmental  concern. 
Nevertheless,  further  data  would  be  desirable  to  demonstrate  that  PVP  presents  no 
significant environmental risks. 

Fluorescent  whitening  agent  FWA-5:  The  reported  concentrations  of  FWA-5  in  the 
environment  are  more  than  an  order  of  magnitude  below  the  Predicted  No  Effect 
Concentration (PNEC). On this basis, FWA-5 is unlikely to present a significant risk 
to human health or to the environment. However, there remains the possibility that the 
degradation products are of potential concern. 

Foam  regulators  –  in  particular  paraffins  (assumed  to  be  C10-C16  n-paraffins)  and 
polydimethyl siloxane (PDMS): For n-paraffins, it is unlikely that significant amounts 
will  reach  the  environment  due  to  a  combination  of  rapid  biodegradation  and  waste 
water treatment. Nevertheless, available data on properties such as aquatic toxicity and 
bioaccumulation  are  highly  uncertain  which  make  it  difficult  to  conclude  with 
confidence that there are no risks to the environment. For PDMS, although considered 

http://ecb.jrc.it/DOCUMENTS/Existing-
Chemicals/RISK_ASSESSMENT/SUMMARY/edtasum061.pdf 

http://ecb.jrc.ec.europa.eu/documents/ExistingChemicals/RISK_ASSESSMENT/SUMMARY/

ntaENVsum307. 

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to  be  persistent,  it  degrades  in  the  environment  –  particularly  in  dry,  clay  soils. 
Furthermore,  there  are  few  concerns  over  the  risks  associated  with  the  higher 
molecular weight PDMS compounds used in detergents. 

Anti-redeposition agents – in particular carboxymethyl-cellulose (CMC): It is unlikely 
that the use of CMC in detergents presents significant risks to human health or to the 
environment  due  to  its  low  toxicity.  However,  further  data  on  levels  found  in  the 
environment would be needed to properly substantiate this view. 

Solvents  -  in  particular  1-decanol  and  triethanolamine:  It  is  unlikely  that  the  use  of 
1-decanol  in  detergents  presents  significant  risks  to  human  health  or  to  the 
environment due to its rapid biodegradation. Further data are required to reach a firm 
conclusion on whether triethanolamine is likely to be of concern. 

(5) 

(6) 

Overall,  the  analysis  conducted  by  RPA  on  non-surfactant  organic  detergents  ingredients 
concluded  that  even  persistent  ingredients  may  not  pose  risks  for  the  environment  (i.e.  the 
PEC/PNEC ratio is less than one) due to environmental degradation and/or low environmental 
toxicity.  Sufficient  information  on  the  biodegradability  of  particular  ingredients  is  available 
and further testing is not deemed necessary. 

2.2. 

Aspects on biodegradation and waste-water treatment of non-surfactant organic 
ingredients 

The regulatory approach adopted in the EU for surfactants as organic ingredients of detergents 
is  that  they  must  be  aerobically  biodegradable.  Organic  substances  that  biodegrade  under 
aerobic conditions are likely to be broken down in waste water treatment plants. The two key 
parameters  in  biodegradation  are  the  degree  to  which  the  ingredients  will  ultimately 
biodegrade and the rate of biodegradation. 

According to the findings of the study conducted by RPA, the primary and secondary phases 
of  waste  water  treatment  are  likely  to  result  in  the  substantial  removal  of  many  of  the 
ingredients  of  potential  concern  which  will  limit  discharges  to  the  aquatic  environment. 
However,  EDTA  is  not  removed  by  waste  water  treatment  and  TEA  may  be  only  partially 
removed. Furthermore, there is insufficient data to comment on whether detergent dyes will 
be  removed  by  waste  water  treatment.  Although  there  were  insufficient  monitoring  data  to 
provide  confirmation,  RPA  considered  that  it  is  likely  that  PVP  and  CMC  will  be  removed 
during waste water treatment due to adsorption to the sludge. 

3. 

3.1. 

OPINIONS  OF  THE  SCIENTIFIC  COMMITTEE  ON  HEALTH  AND 
ENVIRONMENTAL RISKS (SCHER) 

2007  SCHER  opinion  on  RPA  report  concerning  non-surfactant  organic 
ingredients 

In  December  2006,  the  Commission  requested  the  Scientific  Committee  on  Health  and 
Environmental Risks (SCHER) to assess the overall scientific quality of the RPA report and 
to comment on  the methodology and the  assumptions used.  SCHER  was asked to  comment 
whether the RPA conclusions concerning the reviewed non-surfactant detergents ingredients 
are valid and in agreement with existing literature. Particular consideration should be given to 
the  results  concerning  the  health  and  environmental  risks  of  the  following  co-builders  in 
detergents formulations, for which the analysis by RPA indicated that either concern or some 

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uncertainties existed: (i) EDTA and EDTA tetrasodium salts (ii) Nitrilotriacetic acid (NTA), 
(iii) Phosphonates, and (iv) Polycarboxylates. 

In June 2007, after considering all the available evidence on non-surfactant detergent organic 
ingredients,  SCHER  published  a  scientific  opinion15  entitled  “Non-surfactant  Organic 
Ingredients  and  Zeolite-based  Detergents”.  The  opinion  considered  that  most  of  the 
assumptions used in the RPA study were acceptable and that the overall quality of the report 
was good. SCHER agreed that the RPA study constituted a reliable factual basis concerning 
non-surfactant  organic  ingredients  in  detergent formulations.  Concerning  the  biodegradation 
properties and subsequent environmental risks of each of the four above-mentioned categories 
of detergent builders, the SCHER opinion concluded: 

(1) 

(2) 

(3) 

(4) 

EDTA  and  tetrasodium  EDTA:  SCHER  confirmed  the  earlier scientific opinion of 
SCTEE16, that there is no risk from the use of EDTA in household detergents, whilst 
for some other applications (industrial detergents, paper mills, circuit board producers 
etc) a more precise exposure assessment is needed to exclude potential risks. 

Nitrilotriacetic Acid (NTA and salts): SCHER endorsed the conclusion of its earlier 
opinion17  that  there  are  no  environmental  risks  for  all  production  and  use  patterns. 
Furthermore, SCHER underlined that in terms of health risks, although there is a clear 
evidence of carcinogenicity in rats and mice, no human carcinogenic data or evidence 
of teratogenicity and mutagenicity is available. 

Phosphonates:  Based  on  preliminary  assessments  and  mainly  considering  the  RPA 
and HERA reports, SCHER concluded that a potential risk for phosphonates used in 
zeolite-based (“phosphate-free”) compact powders has been identified for the aquatic 
and terrestrial (agricultural soil) compartments. SCHER underlined that the persistence 
of  phosphonates  and  the  inconsistencies  regarding  its  bioaccumulation  potential 
recommend a further assessment of long-term and secondary poisoning. 

Polycarboxylates:  SCHER  concluded  that  a  potential  risk  may  exist  due  to 
polycarboxylates used in zeolite-based detergent formulations for aquatic organisms as 
the validity of data for chronic NOEC could not be confirmed, while uncertainties also 
exist  for  terrestrial  organisms  as  there  were  not  enough  information  for  estimating  a 
PNEC. 

3.2. 

2008 SCHER opinion on anaerobic biodegradation and polycarboxylates 

New scientific information on polycarboxylates (including its homo- & copolymers) became 
available  in  2007  in  the  form  of  a  targeted  risk  assessment  report  prepared  by  HERA.  In 
March 2008, the Commission mandated SCHER to produce an updated scientific opinion and 
to  comment  whether  it  agreed  with  the  main  conclusion  of  the  HERA  report  on 
polycarboxylates  in  detergents18,  i.e.  that  the  use  of  polycarboxylates  in  detergents  does  not 
pose risks for environmental compartments with the exception of the soil local compartment 
for P-AA/MA (a copolymer of acrylic and maleic acids or its sodium salt). In November 2008, 

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available at: http://ec.europa.eu/health/ph_risk/committees/04_scher/docs/scher_o_057.pdf 
available at: http://ec.europa.eu/health/ph_risk/committees/sct/documents/out194_en.pdf 
available at: http://ec.europa.eu/health/ph_risk/committees/04_scher/docs/scher_o_001.pdf 
available at: http://www.heraproject.com/files/32-F-HERA_polycarboxylates_final_Sept07.pdf 

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SCHER  adopted  a  scientific  opinion19  indicating  that  the  changes  in  the  PNEC  for  aquatic 
organisms that were proposed by HERA for P-AA/MA have consequences for the outcome of 
the  risk  assessment.  However,  SCHER  could  not  provide  a  final  answer  on  the  potential 
environmental risk (a) due to the lack of information on the reliability of fish chronic studies 
and  (b)  considering  that  information  on  soil  microbial  functions  is  essential  for  the  risk 
assessment of these chemicals. 

Overall, SCHER concluded that additional information is required before it can be concluded 
that  these  chemicals  are  of  low  environmental  concern.  SCHER  did  not  find  any  additional 
information  on  phosphonates,  therefore  the  conclusion  of  its  2007  opinion  on  potential 
environmental risks remained unchanged. 

4. 

CONSULTATION WITH STAKEHOLDERS 

The  findings  of  the  RPA  and  HERA  studies  as  well  as  their  evaluation  by  the  Scientific 
Committees have been discussed at several meetings of the Working Group of the Competent 
Authorities  responsible  for  the  implementation  of  the  Detergents  Regulation  in  June  2007, 
July  2008,  and  February  2009.  Those  meetings  were  attended  by  representatives  of  the 
Member  States,  and  various  industry  associations  such  as:  Association  Internationale  de  la 
Savonnerie,  de  la  Détergence  et  des  Produits  d’Entretien  (AISE),  and  European  Chemical 
Industry Council (CEFIC). 

Overall, Member States agreed that the RPA report served as a useful basis in particular for 
reviewing the environmental risks of non-surfactant detergent organic ingredients and that it 
should  be  the  responsibility  of  industry  to  collect  further  available  information  on  certain 
detergent  ingredients  of  potential  concern.  The  HERA  project  has  been  a  good  example  of 
such  a  voluntary  action  from  industry.  Furthermore,  Member  States  noted  that  in  the  near 
future, industry will be subjected to such responsibility under the registration procedure of the 
REACH  Regulation  (EC)  1907/200620,  where  detailed  information  on  the  chemicals 
ingredients used in detergents formulations will have to be provided. 

AISE  contested  some  conclusions  made  by  RPA  concerning  triethanolamine  and  the 
complexing agents EDTA and NTA for which there are EU Risk Assessment Reports (RARs) 
with more recent information. AISE stressed that information and conclusions of these RARs 
have  not  been  consistently  recognised  in  the  RPA  report,  which  thereby  raises  unnecessary 
concerns. Finally, AISE stressed that the Industrial & Institutional (I&I) sector is using these 
materials as they provide specific technical functionalities required for difficult professional 
cleaning conditions. EDTA has also been included in Annex III of Directive 2008/105/EC21 
and is subject to review for possible identification as priority substance or priority hazardous 
substance in the Water Framework Directive. The Commission will report the outcome of its 
review to the European Parliament and to the Council by 13 January 2011. 

In  January  2009,  AISE  provided  some  updated  information  concerning  the  consumption  of 
polycarboxylates in the EU, which was estimated at 80.000 for 2007, out of which 10 % were 
used  in  the  I&I  sector.  The  observed  increase  in  the  consumption  of  polycarboxylates 

19 
20 
21 

available at: http://ec.europa.eu/health/ph_risk/committees/04_scher/docs/scher_o_109.pdf 
OJ L 396, 30.12.2006, p.1 
Directive  2008/105/EC  of  the  European  Parliament  and  of  the  Council  of  16  December  2008  on 
environmental quality standards in the field of water policy, OJ L 348, 24.12.2008, p. 84 

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(compared  to  the  RPA  2006  report  value  of  ~  50  000  t/y)  is  linked  to  the  increasing  move 
towards  the  use  of  phosphate-free  laundry  detergents  and  the  associated  product  re-
formulation. 

Furthermore,  the  Commission  received  from  BASF  Company  (January,  2009)  data  from 
recently performed studies regarding the terrestrial toxicity of polycarboxylates. According to 
BASF,  these  data  demonstrate  that  for  P-AA/MA  the  PEC/PNEC  for  all  environmental 
compartments  is  below  1,  showing  that  there  is  no  risk  from  P-AA/MA  for  terrestrial 
organisms. It was agreed that the 2007 HERA report on polycarboxylates will be updated by 
inserting  this  new  data  and  that  the  revised  HERA  report  will  be  forwarded  to  SCHER  in 
April  2009  for  further  evaluation  and  an  opinion  as  to  whether  the  identified  uncertainties 
have been cleared. 

5. 

SUMMARY AND CONCLUSIONS 

The  Commission  has  taken  a  number  of  steps  to  establish  the  knowledge  base  needed  to 
conduct  a  review  of  the  “biodegradability  of  the  main  non-surfactant  organic  detergent 
ingredients” as required by Article 16 (2) of Regulation 648/2004. 

in  2004, 

the  Detergents  Regulation  was  adopted 

the  criterion  of  ultimate 
When 
biodegradability  was  considered  to  be  an  effective  and  proportionate  way  of  ensuring  that 
detergent  surfactants  do  not  pose  a  risk  to  the  environment.  Biodegradability  was  used  as  a 
proxy for environmental toxicity because insufficient direct data on the environmental toxicity 
of  surfactants  was  available  at  that  time.  However,  in  the  meantime,  and  in  preparation  for 
REACH,  much  effort  has  gone  into  carrying  out  targeted  risk  assessments  on  detergent 
ingredients.  The  Commission  has  therefore  been  able  to  go  further  than  required  by  Article 
16(2) and has been able to evaluate not only the biodegradability, but also the risk posed by 
those substances. 

A study conducted for the Commission in 2006 reviewed the biodegradability and ecotoxicity 
of  the  main  non-surfactant  organic  detergent  ingredients.  The  findings  of  the  study  together 
with  the  related  opinions  of  the  Commission’s  Scientific  Committee  in  June  2007  and 
November 2008 were discussed with delegates from Member States and industry associations 
in a number of meetings of the Commission Detergents Working Group. 

No risk to the environment has been identified for any of the non-surfactant organic detergent 
ingredients.  Although,  risk  cannot  be  definitely  excluded  for  a  few  of  those  substances,  as 
information on them is incomplete, the amount of additional data needed for a complete risk 
assessment  is  now  relatively  small.  It  is,  therefore,  not  considered  appropriate  to  propose 
legislation to impose a requirement of ultimate biodegradability on the non-surfactant organic 
ingredients. In fact, many of the non-surfactant organic ingredients for which data is complete 
are  not  ultimately  biodegradable,  but  are  neither  toxic  to  human  health  nor  to  the 
environment. Applying a surrogate risk indicator such as ultimate biodegradability to the non-
surfactant organic ingredients would therefore ban a number of them where it is known that 
they do not pose risks. It would therefore be more proportionate, as well as more scientifically 
robust, to complete instead the risk assessments on the few outstanding substances. 

Uncertainties  remain  concerning  the  environmental  fate  of:  (a)  polycarboxylates  and 
phosphonates,  both  of  which  are  used  in  considerable  tonnages  in  household  detergent 
formulations  and  (b)  EDTA  and  its  salts  (mainly  used  in  I&I  detergents),  triethanolamine, 

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FWA-5 and paraffins for which existing data are not yet sufficient to exclude the possibility 
of environmental risk. 

The information requirements of the REACH registration dossiers will ensure that for most of 
these substances, comprehensive data on hazard properties and possible risks to human health 
or the environment will be submitted by industry to the European Chemical Agency (ECHA). 
In  fact,  for  substances  manufactured  or  imported  in  quantities  of  1  000  tonnes  or  more  per 
year  registrations  are  due  by  December  2010  and  chemical  safety  reports  as  part  of  the 
registration dossiers will need to demonstrate the safe use throughout their life cycle. 

Therefore,  the  REACH  registration  information  should  be  sufficient  to  decide  whether 
restrictions  on  the  above-mentioned  detergent  organic  ingredients  are  needed  on  grounds  of 
environmental  risk,  and  if  so,  the  restriction  procedure  of  REACH  would  be  the  most 
appropriate  instrument  to  impose  such  restrictions.  Concerning  polycarboxylates,  for  which 
according  to  REACH  only  the  monomers  need  to  be  registered,  a  revised  HERA  risk 
assessment is foreseen in the near future which should clarify the remaining uncertainties with 
regard  to  potential  environmental  risks.  The  revised  report  will  by  submitted  to  SCHER  in 
April 2009. Furthermore EDTA will be also reviewed by the Commission by 2011 in view of 
a possible identification as a priority substance under the Water Framework Directive. 

Consequently,  the  Commission  does  not  intend  to  propose  legislation  concerning  the 
biodegradability of non-surfactant organic ingredients. The concept of using biodegradability 
as  an  acceptance  criterion  for  detergent  ingredients  has  become  redundant  in  light  of 
comprehensive risk assessment data on the environmental toxicity of the substances. 

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6. 

LIST OF ABBREVIATIONS 

AISE:  Association  Internationale  de  la  Savonnerie,  de  la  Détergence  et  des  Produits 

d’Entretien 

CEFIC:  European Chemical Industry Council 

CMC:  Carboxymethyl cellulose 

ECB:  European Chemical Bureau 

EDTA:  Ethylendiammine tetra acetate 

FWAs:  Fluorescent whitening agents 

HEDP 1: Hydroxy ethane diphosphonic acid 

HERA:  Human and Environmental Risk Assessment (AISE-CEFIC cooperative project) 

I&I: 

Industrial and institutional 

NOEC:  No Observed Effect Concentration 

NTA:  Nitrilotriacetic acid 

P(AA-MA): Copolymer of acrylic acid and maleic acid 

PDMS:  Polydimethyl siloxane 

PEC: 

Predicted Environmental Concentration 

PNEC:  Predicted No-Effect Concentration 

PVP: 

Polyvinylpyrrolidone 

RAR:  Risk Assessment Report 

REACH: Registration Evaluation Authorisation of Chemicals 

RCR:  Risk characterization ratios 

RPA:  Risk & Policy Analysts 

SCHER: Scientific Committee on Health and Environmental Risks 

SCTEE: Scientific Committee on Toxicity, Ecotoxicity and the Environment 

TAED:  Tetra acetyl ethylene diamine 

TEA:  Triethanolamine 

WFD:  Water Framework Directive 

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