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COM reports under Article 16(2) of (EC) No 648/2004 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; the biodegradation of main non-surfactant organic detergent ingredients.
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. The Detergents meetings were attended also by Representatives of related industry associations such as:
AISE (Association de la Savonnerie, de la Dtergence et des Produits dEntretien),
The positions and submitted material by IND, MS and any other interested parties were carefully considered and were reflected in the COM reports
European Commission Enterprise 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) 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 environmental protection. 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 sewage sludge,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.
European Commission Enterprise and Industry
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)
European Commission Enterprise and Industry
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 <1 (surface water: 0.041, sediment: 0.316, sewage treatment plant: 0.007 and soil: 0.103). Any remaining uncertainties (e.g no consideration on AE-homologues) do not invalidate the main HERA conclusion for no environmental risks.
European Commission Enterprise and Industry
Recent environmental data seem to show a potential for degradation of LAS under 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
European Commission Enterprise and Industry
It can therefore be concluded that anaerobic biodegradability should not be used as an additional pass/fail criterion for environmental acceptability of 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 surfactants will 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.
European Commission Enterprise and Industry
COM reports under Article 16(2) of (EC) No 648/2004 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;
Formulation aids
Soil repellents/anti-redeposition agents Solvents
European Commission Enterprise and Industry
detergent ingredients
RPA study (2006) - detergent ingredients of potential concern 1. Builders, Complexing Agents and Ion Exchangers
Phosphonates: Slowly degradable.They may present a environmental risk due to potential aquatic chronic toxicity of HEDP (1- hydroxy ethane diphosphonic acid) and its salts to Daphnia. Polycarboxylates: Not readily biodegradable. As there are no available monitoring data, concentrations in sludge-treated soils may be significant. EDTA and its salts: 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.
Nitrilotriacetic acid (NTA): NTA is readily biodegradable using a range of standard tests although, in some cases, the formation of metal-NTA complexes may slow the rate of degradation.
European Commission Enterprise and Industry
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 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.
European Commission Enterprise and Industry
2007 SCHER opinion on the RPA study In December 2006, the Commission requested SCHER to assess the overall
scientific quality of the RPA report, and comment whether the RPA conclusions are valid and in agreement with existing literature. In June 2007, after considering
all 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 and
agreed that this constitutes a reliable factual basis concerning non-surfactant organic 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 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.
European Commission Enterprise and Industry
(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.
European Commission Enterprise and Industry
For polycarboxylates, a revision is ongoing (based on updated SCHER opinion 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. Consequently, the review of the Commission did not conclude a need for proposing further legislation at this point concerning non-surfactant organic ingredients in detergents.
European Commission Enterprise and Industry