Presentation SK TAIEX Commission Reports

7/30/2019 Presentation SK TAIEX Commission Reports

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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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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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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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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:PDF


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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.
http://ec.europa.eu/enterprise/sectors/chemicals/documents/competitiveness/anaerobic_en.htmhttp://ec.europa.eu/enterprise/sectors/chemicals/documents/competitiveness/anaerobic_en.htm


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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.pdf


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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=4


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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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(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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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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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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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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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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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.
http://ec.europa.eu/enterprise/chemicals/legislation/detergents/index_en.htmhttp://ec.europa.eu/enterprise/chemicals/legislation/detergents/index_en.htm


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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.pdf


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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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European Commission

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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European Commission


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



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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