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European CommissionEnterprise and Industry
European CommissionEnterprise and Industry
Anaerobic biodegradation of surfactants and
non-surfactant organic ingredients in detergents(Commission reports under the Detergents Regulation (EC) No 648/2004)
TAIEX Workshop on the Implementation of EU Detergents RegulationBucharest, 21 - 22 September 2009
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European CommissionEnterprise and Industry
Article 16(2) of Regulation (EC) No 648/2004 on detergents
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:
COM reports under Article 16(2) of (EC) No 648/2004
anaerobic biodegradation of surfactants;
the biodegradation of main non-surfactant organicdetergent ingredients.
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European CommissionEnterprise and Industry
Consultation with stakeholders on the COM reports
The various COM studies on both anaerobic biodegradationand
non surfactant organic ingredientswere performed by external contractors.
The final studies were evaluated by the Commissions Scientific Committeeon Health and Environmental Risks (SCHER), the scientific opinions of
which served as the basis of the COM reports.
The Detergents meetings were attended also by Representatives of relatedindustry associations such as:
AISE (Association de la Savonnerie, de la Dtergence et des Produits dEntretien),
CESIO(Comit Europen des Agents de Surface et de leurs Intermdiares Organiques)
The positions and submitted material by IND, MS and any other interestedparties were carefully considered and were reflected in the COM reports
The findings of both COM studies and SCHER opinions were discussed at
several meetings (2006-2008) of the COM Detergents Working Group(MS representatives)responsible for implementation of Detergents Regulation.
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European CommissionEnterprise and Industry
Detergents Regulation sets ultimate aerobic biodegradabilityas the main criterion for use of surfactants in detergents.
Anaerobic biodegradation of surfactants in sludge andsediment produces CH4 (in contrast to the CO2 produced underaerobic conditions found in waste and surface water).
COM (2009)230 report on Anaerobic biodegradation
The COM report on anaerobic biodegradation of detergent
surfactants focus on linear alkylbenzene sulphonate (LAS)which is a widely-used, poorly biodegradable surfactant under
anaerobic conditions.
A review of anaerobic testing methodology is also given.
COM (2009)230 report available at:http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=COM:2009:0230:FIN:en:PDF)
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=COM:2009:0230:FIN:en:PDFhttp://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=COM:2009:0230:FIN:en:PDFhttp://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=COM:2009:0230:FIN:en:PDFhttp://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=COM:2009:0230:FIN:en:PDF7/30/2019 Presentation SK TAIEX Commission Reports
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European CommissionEnterprise and Industry
Background studies on Anaerobic biodegradation
The Fraunhofer report (2003) assessed the environmental impact in the EU resulting
from the incomplete biodegradation of detergent surfactants under anaerobic
conditions. (http://ec.europa.eu/enterprise/sectors/chemicals/documents/competitiveness/anaerobic_en.htmThe Fraunhofer study mainly concluded that:
The surfactants must be ultimately and readily biodegradable underaerobic conditions in order to prevent adverse environmental impacts.
The poor biodegradability of some surfactants (e.g. LAS) under anaerobicconditions may sometimes result in a significant surfactant content in sewage
sludge, especially after treatment in waste water treatment plants (WWTP)
employing an anaerobic sludge stabilisation process.
With regard to sediments, no accumulation of aerobically ready biodegradablesurfactants has been observed, (such as of LAS over a period of decades.
Aerobic (rather than anaerobic) biodegradation plays the main role in
elimination of organic compounds.
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European CommissionEnterprise and Industry
The Fraunhofer study was evaluated by SCHER that published an opinion in
November 2005 (http://ec.europa.eu/health/ph_risk/committees/04_scher/docs/scher_o_021.pdf)
2005 SCHER opinion on Anaerobic biodegradation
SCHER agreed with the main Fraunhofer conclusion that:
The requirement for ready and ultimate biodegradability of surfactants under
anaerobic conditions is not by itself regarded as an effective measure for
environmentalprotection.
However, SCHER expressed concerns about:(a) a potential for risk from LAS in sludge in certain applications of worst case
environmental conditions (PEC/PNEC values slightly above 1)
(b) the relatively high measured levels (0.5-1 g/kg) of other surfactants in sewagesludge,including some anaerobically biodegradable, such as:
alcohol ethoxylates (AE) and alkyl phenol ethoxylates (APE).
(c) the fact that a single test is not sufficient to evaluate anaerobic biodegradability.
A combination of several tests is more appropriate.
http://ec.europa.eu/health/ph_risk/committees/04_scher/docs/scher_o_021.pdfhttp://ec.europa.eu/health/ph_risk/committees/04_scher/docs/scher_o_021.pdf7/30/2019 Presentation SK TAIEX Commission Reports
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European CommissionEnterprise and Industry
Latest scientific evidence on Anaerobic biodegradation
In reaction to the concerns expressed in the 2005 SCHER opinion, European
Surfactant Industry (CESIO) funded additional soil toxicity studies, the results of
which were published on an updated 2007 HERA report on LAS
(http://www.heraproject.com/RiskAssessment.cfm?SUBID=4) which concluded that:
the risk characterisation for LAS as expressed by the PEC/PNEC ratio was < 1 for all
environmental compartments, considering the recently reported PNEC values
(~35 mg/kg versus 4.6 mg/kg in previous assessments)
so that lower PEC/PNEC ratios would indicate no adverse environmental risks
Concerning AE, a HERA report was produced in May 2007
(http://www.heraproject.com/RiskAssessment.cfm?SUBID=34) according to which:
AE usage in laundry cleaners and household cleaning products is not a
cause for concern for the environment (in particular surface water, sediment,
sewage treatment facilities, and soil).
In parallel, additional scientific findings on LAS and anaerobic biodegradation
were published by several researchers such as: Temnik and. Klapwijk (2004,
Krogh et al., (2007), Jensen et al., (2007) Schowanek (2007), and Berna (2007)
http://www.heraproject.com/RiskAssessment.cfm?SUBID=4http://www.heraproject.com/RiskAssessment.cfm?SUBID=34http://www.heraproject.com/RiskAssessment.cfm?SUBID=34http://www.heraproject.com/RiskAssessment.cfm?SUBID=47/30/2019 Presentation SK TAIEX Commission Reports
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European CommissionEnterprise and Industry
2008 SCHER opinion on anaerobic biodegradation
In March 2008, the Commission (DG Enterprise & Industry) requested SCHER:
(1) to assess recent HERA reports on LAS and AE and comment on their conclusions
concerning the environmental risks;
(2) in the light of all available scientific evidence, to reconfirm the key statements of 2005
SCHER opinion on anaerobic biodegradation of surfactants/environmental protection;
(3) to review the issue of anaerobic test methodology for surfactants.
In November 2008, SCHER published its opinion concerning anaerobic
degradation of surfactants(available at:http://ec.europa.eu/health/ph_risk/committees/04_scher/docs/scher_o_109.pdf)
(I)SCHER evaluation of HERA report on alcohol-ethoxylates (AEs)
The SCHER considered the exposure assessment as generally acceptable.
The PEC/PNEC-ratios for AE are sufficiently lower
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European CommissionEnterprise and Industry
(II) 2008 SCHER evaluation of HERA report on LAS
Overall, SCHER agreed with the proposed PNEC values for aquatic organismsand sediments.
However, SCHER considered that a proper evaluation of the relevance of LAS
effects on microbial activity is essential for a proper PNEC soil derivation.Unless additional justification can be provided,it is suggested to maintain theprevious PNECsoil of 4.6 mg/kg (and not the PNEC value of 35 mg/kg, recentlyproposed by HERA ).
Recent environmental data seem to show a potential for degradation of LASunder anaerobic conditions in the environment.
Furthermore, due to lack of new evidence, SCHER did not change the
conclusion of its 2005 opinion that:
Poor biodegradability under anaerobic conditions is not expected to produce
substantial modifications in the risk for freshwater ecosystems as the surfactant
removal in the WWTP seems to be determined by its aerobic biodegradability
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European CommissionEnterprise and Industry
The SCHER reviewed the existing screening and simulation test methods todetermine ultimate anaerobic biodegradability of organic substances. (screeningtest OECD 311 & simulation tests-TG 307,308 ).
Overall, SCHER believes that the existing OECD methods for anaerobicbiodegradation together provide an appropriate methodology for theassessment of the anaerobic biodegradability of organic compounds.
However, due to stringent (methanogenic) conditions used in the laboratory tests,inhibitory effects cannot be excluded therefore that a poor result may not be a final
proof of anaerobic recalcitrance.
(III) 2008 SCHER opinion onAnaerobic testing methodology
In February 2009, CESIO (+ERASM) informed of their initiative to
undertake further research in order:- to develop an improved method for measuring the anaerobic biodegradability
under sludge digester condition, and
-to evaluate the LAS degradation in sediments and review any scientificevidence in order to precisely estimate the PEC value for LAS.
The COM (2009)230 reportnotes that:Once sufficient, published evidence (e.g in a HERA report or in literature) will
be available, an updated SCHER opinion would be requested in the future.
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European CommissionEnterprise and Industry
Conclusions of COM report on Anaerobic biodegradation
The lack of anaerobic degradation of surfactants in various anaerobic compartments
does not seem to be correlated with any apparent environmental risk.
It can therefore be concluded that anaerobic biodegradability should not
be used as an additional pass/fail criterion for environmental acceptabilitof surfactants such as LAS which are readily biodegradable under
aerobic conditions.
The remaining concerns focus on the possible environmental toxicity of surfactants,
rather than on their biodegradability (e.g calculations for new PNECsoil for LAS)
At present, there is no evidence to justify legislative measures at EU level,such as regulatory limit values for LAS or other surfactants in sludge.However, once further, sufficient, published evidence (e.g a HERA report or in literature)
will be available, an updated SCHER opinion would be requested in the future.
The information requirements of the REACH registration dossiers will ensure that
comprehensive data on the health and environmental effects of detergents surfactantswill be submitted by industry to the European Chemical Agency by December 2010.
The REACH registration information should be sufficient to decide
whether restrictions on certain surfactants in detergents are needed on
environmental grounds, others than already imposed by (EC) 648/2004.
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European CommissionEnterprise and Industry
Article 16(2) of Regulation (EC) No 648/2004 on detergents
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 of surfactants;
COM reports under Article 16(2) of (EC) No 648/2004
the biodegradation of main non-surfactant organicdetergent ingredients.
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European CommissionEnterprise and Industry
COM (2009)208 - Non-surfactant organic detergent ingredients
This report presents the results of the Commission's review on the
biodegradation of the main non-surfactant organic detergent ingredients
Table 1: Non-surfactant Detergent Ingredients
Chemical ingredient Purpose
Acids-Bases To ensure optimal pH of wash water
Bleaching agents, activators and stabilisers Enhanced cleaning performance
Builders, complexing agents and ion
exchangers
Water-softening to maximise cleaning efficiency (i.e. removing
dirt and keeping it in suspension)
Corrosion inhibitors To prevent corrosion of washing machines
Dyes To add colour to detergents
Dye transfer inhibitors To prevent loss of garment dyes
Enzymes Biological cleaning
Fluorescent whitening agents Optical brightening
Foam regulators To limit foam generation (machine washing)
Formulation aids To improve detergent performance
Soil repellents/anti-redeposition agents To prevent re-deposition of dirt during washing
Solvents To keep ingredients in solution
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European CommissionEnterprise and Industry
RPA study (2006) - Non-surfactant organic detergent ingredients
Risk & Policy Analysts Ltd (RPA) was contracted by the Commission in order
to fill the data gaps concerning properties and environmental impacts for the
main non-surfactant organic detergent ingredients.The final RPA report was delivered in June 2006(accessible at: http://ec.europa.eu/enterprise/chemicals/legislation/detergents/index_en.htm)
The RPA study examined the properties of about 50 representative
detergent ingredients
The substances which are readily biodegradable with no other properties ofpotential concern (such as high aquatic toxicity) were not analysed further;
The substances (or groups) retained for further analysis were those that are
not readily biodegradable (or they have properties of potential concern).The screening exercise of RPA resulted in a list of specific substances
and substance groups of potential concern being selected for further
analysis, based on scientific evidence from the various risk assessments.
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European CommissionEnterprise and Industry
RPA study (2006) - detergent ingredients of potential concern
Phosphonates:Slowly degradable.They may present a environmental riskdue to potential aquatic chronic toxicity ofHEDP (1- hydroxy ethane
diphosphonic acid) and its salts to Daphnia.
Polycarboxylates: Not readily biodegradable. As there are no availablemonitoring data, concentrations in sludge-treated soils may be significant.
EDTA and its salts: EDTA and its salts may be of concern to theenvironment with regard to their use in industrial and institutional (I&I)
cleaning - but not for household detergents where their use is limited.
Nitrilotriacetic acid (NTA): NTA is readily biodegradable using a range ofstandard tests although, in some cases, the formation of metal-NTA
complexes may slow the rate of degradation.
1. Builders, Complexing Agents and Ion Exchangers
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RPA study (2006) - detergent ingredients of potential concern
2. Dye transfer inhibitors. Polyvinylpyrrolidone(PVP): Further data would be
desirable to demonstrate that PVP presents no significant environmental risks.
3. Fluorescent whitening agent. FWA-5: On basis of its PNEC value, FWA-5
is unlikely to present significant environmental risks. However, there remains
the possibility that the degradation products are of potential concern.
4. Foam regulators.(a) For n-paraffins: available data on aquatic toxicity and
bioaccumulation highly uncertain- difficult to conclude for enviromental risks
(b) For PDMS: Few concerns over the risks associated with HMW-PDMS.
5. Anti-redeposition agents.Carboxymethyl-cellulose (CMC): Further data
on its environmental levels would be needed to exclude potential risks.
6. Solvents. 1-decanol and triethanolamine: Further data are required to
reach a firm conclusion on whether triethanolamine is likely to be of concern.
Overall, RPA analysis concluded that even persistent ingredients may notpose risks for the environment (i.e. the PEC/PNEC ratio is less than one)due to environmental degradation and/or low environmental toxicity.
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2007 SCHER opinion on the RPA study
In December 2006, the Commission requested SCHER to assess the overallscientific quality of the RPA report, and comment whether the RPA conclusions
are valid and in agreement with existing literature. In June 2007, after consideringall the available evidence SCHER published an opinion(available at: http://ec.europa.eu/health/ph_risk/committees/04_scher/docs/scher_o_057.pdf)
SCHER concluded that the overall quality of the RPA study was good andagreed that this constitutes a reliable factual basis concerning non-surfactantorganic ingredients in detergent formulations. Concerning the biodegradation
properties and environmental risks of the most important builders:
(1) EDTA and salts: SCHER confirmed that there is no risk from the use ofEDTA 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.
http://ec.europa.eu/health/ph_risk/committees/04_scher/docs/scher_o_057.pdfhttp://ec.europa.eu/health/ph_risk/committees/04_scher/docs/scher_o_057.pdf7/30/2019 Presentation SK TAIEX Commission Reports
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European CommissionEnterprise and Industry
2007 SCHER opinion on the RPA study
(3) Phosphonates: SCHER concluded that a potential risk for phosphonates
used in zeolite-based (phosphate-free) compact powers has been identified
for the aquatic and terrestrial (agricultural soil) compartments. SCHER
underlined that the persistence of phosphonates and the inconsistenciesregarding its bioaccumulation potential recommend a further assessment of
long-term and secondary poisoning.
(4) 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 is no enough
information for estimating a PNEC.
(2) Nitrilotriacetic Acid (NTA and salts): SCHER concluded that there are no
environmental risks for all production and use patterns. Although there is an
evidence of carcinogenicity in rats and mice, no such human data is available.
F th i ti ti l b l t
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Enterprise and Industry
Further investigation on polycarboxylates
According to AISE, an increased consumption of polycarboxylates (PCXs) in the EU
(to 80.000 in 2007 from 50 000 t/y in 2004) is linked to the increasing move towards the
use of phosphate-free laundry detergents and the associated product re-formulation.
New scientific information on PCxs (including its homo- & copolymers P(AA-MA) of
acrylic-maleic acid) became available towards end of 2007 in the form of a targeted
HERA report (not considered by 2007 SCHER opinion), concluding that the use of
PCxs in detergents does not pose environmental risks(excepting P-AA/MA in soil-local)
In November 2008, SCHER adopted a new opinion indicating that the changes in
the PNECaquatic proposed by HERA for P-AA/MA have consequences for the outcomeof the risk assessment. However, SCHER could not provide a final answer on the
potential environmental risk due to the lack of information on the reliability of fish
chronic studies and on soil microbial functions, essential for the RA of the PCXs.
Based on new data from BASF Company demonstrating that for P-AA/MA the
PEC/PNEC for all environmental compartments is below 1, and that there is no risk fromP-AA/MA for terrestrial organisms, an updated 2009 HERA report was produced and
resubmitted to SCHER in April 2009.SCHER is in the process of finalising an
updated scientific opinion on PCXs, though it seems that some of their concerns
for the environmental fate of these compounds are maintained.
C l i f COM t i d t t i di t
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Enterprise and Industry
Consequently, the review of the Commission did not conclude aneed for proposing further legislation at this point concerning
non-surfactant organic ingredients in detergents.
Conclusions of COM report on organic detergent ingredients
Although no significant risks to the environment have been identifiedfor any of the non-surfactant organic detergent ingredients, uncertainties dueto insufficient data, remain concerning the environmental fate of: (a)polycarboxylates and phosphonates, (b) EDTA and its salts (mainly in I&Idetergents), triethanolamine, FWA-5 and paraffins.
The REACH registration information should be sufficient to decide whetherrestrictions on the above-mentioned detergent organic ingredients are neededon environmental grounds at EU level, and if so, these could be imposed underthe REACH restriction procedures.
For polycarboxylates, a revision is ongoing (based on updated SCHERopinion and identified needs for further investigation that IND may undertake ).
In addition, EDTA as a priority substance in Annex III of Directive 2008/105
would be further evaluated within WFD framework by 2011.
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European Commission
Enterprise and Industry
European CommissionEnterprise and Industry
Anaerobic biodegradation of surfactants andnon-surfactant organic ingredients in detergents
(Commission reports under the Detergents Regulation (EC) No 648/2004)
TAIEX Workshop on the Implementation of EU Detergents RegulationBucharest, 21 - 22 September 2009
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