Professional Documents
Culture Documents
9
SEPTEMBER 2005
EUROPEAN COMMITTEE OF ORGANIC SURFACTANTS AND THEIR INTERMEDIATES
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Foreword
Foreword
One year has elapsed since Christophe Sn joined CESIO as Senior Counsellor on technical and scientific areas to complete the team formed by Christianne Holvoet and the undersigned. This year has been used to establish our team, get to know and understand the surfactants industry but most of all to tackle without delay all the issues related to the implementation of the detergent regulation which takes up a substantial part of this newsletter (page 2). Within the Oleochemicals & Surfactants cluster, we have started developing some centres of expertise which APAG, CESIO & ECOSOL should benefit from. This, we have already experienced in the handling of the IMO reclassification of chemicals transported in bulk at sea issue (page 9). During the past year we have also tried to improve the circulation of information among the membership and overall communication. We hope to further optimise it by offering to all members of CESIO whether companies, national associations or members of the national associations an extranet (page 10). Next year, we shall attempt to consolidate the CESIO activities and further develop the interactions within the cluster in order to optimise the way our member companies and the Secretariat operates. Last but not least, an association is only as successful as its members make it. We depend upon your co-operation for effective and successful working groups, taskforces, etc. which we have enjoyed during the past year. We thank you for your trust in the Oleochemicals & Surfactants team and welcome any suggestions for our future work.
Chantal De Cooman Secretary General
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Anaerobic biodegradation of surfactants European ecolabel on detergents and cosmetics
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A.I.S.E. charter for sustainable cleaning
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ERASM OECD HPV chemical assessment programme
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HERA Transport in bulk at sea (IMO IBC code) Standardization
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CESIO extranet Forthcoming 7th surfactant world congress
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Future Events
This Cesio News(letter) has been designed so as to give an overview of the main issues managed by CESIO over the last 12 months. More details have been given on the Detergent Regulation for obvious reason. The other topics have been summarized; however more detailed information, notably on future actions, can be obtained by contacting CESIO Secretariat.
Christophe Sn Senior Counsellor
September 2005
2. Scope of regulation
The regulation applies to all ingredients of detergents; however the biodegradability requirements clearly apply to surfactants only. The EU Commission is to review this situation by April 2007, by reviewing the biodegradation requirements of non-surfactants organic detergents ingredients. Any substance or preparation (surfactant or not) intended for washing and cleaning fall under the scope of the regulation. For example, this is the case for most polishing agents since they have a cleaning function (even if the primary function is polishing) whereas paints do not fall within the scope of the regulation as they have nothing to do with cleaning or washing.
September 2005
CESIO strongly recommends using standardized declarations in the SDS document. For that purpose, a CESIO Guidance Document, available from CESIO secretariat, was issued with standardized sentences & translations in the different European languages. This document is also available on the EU Commission website at www.europa.eu.int/comm/enterprise/chemicals/legislation /detergents/index_en.htm
the properties of individual substances by readingacross from the properties of substances on either side in the same product family.
The EU Commission Tiered Approach Guidance document (Annex F), available from the EU Commission website at www.europa.eu.int/comm/enterprise/chemicals/legislation/ detergents/index_en.htm, and CESIO Guidance Document (Appendix E), available from CESIO or National Association secretariats, indicate how the read-across principle should be applied to the biodegradation data of surfactants. The surfactant manufacturer should be responsible for the correct performance of the relevant biodegradation tests and should also have available documentation on the testing carried out to demonstrate compliance with this regulation such as (i) test results, (ii) documents to support a read-across approach, or (iii) any appropriate technical reports (public information or not) of good scientific quality. Public information is acceptable but the level of scientific quality needs to be proven (e.g. Peerreviewed publication). For public information, access to for surfactants placed on the market after the entry into force of the GLP standard or en ISO/IEC 17025, industry needs to use laboratories which applied either good laboratory practice or en ISO/IEC 17025. for surfactants placed on the market before the entry into force of the GLP standard or en ISO/IEC 17025, biodegradation tests may be accepted on a case-bycase basis provided they are performed according to the best scientific practice (see CESIO guidance document for details). Using a tiered approach, derogation can be requested for surfactants which fail ultimate biodegradability, but meet the primary biodegradability requirements. It should be emphasized that derogation is granted on a temporary basis and only for surfactants in (i) institutional & industrial, (ii) low-dispersive and (iii) low-volume Under the regulation, there is an obligation on surfactant manufacturers to communicate efficiently on the compliance of their surfactant products. It was agreed upon by the European Commission, Member States, AISE and CESIO that the Material Safety Datasheet (SDS) was the most appropriate document for showing evidence of biodegradability, and that any additional certificate (letter of compliance) is unnecessary. A summary on how to apply for Derogation is described in CESIO Guidance Document. applications. Derogation can be granted in cases (i) when the surfactant is used in a closed system or (ii) the formation of recalcitrant metabolites can be excluded or (iii) a complementary risk assessment indicates no unacceptable risk. raw data or to the original report is considered as a definite advantage. It is important to note that the manufacturer should also be able to show that he is entitled to benefit from the property rights relating to the test results & documentation.
September 2005
6.1 The Tiered Approach of the Complementary Risk Assessment of surfactants as part of the derogation procedure1
A guidance document describing the methodology for obtaining the derogation using a tiered approach to testing in the context of Annex IV of Regulation (EC) No 648/2004 has been issued by the EU Commission. This guidance document can be obtained from: www.europa.eu.int/comm/enterprise/chemicals/legislation/ detergents/index_en.htm Surfactants failing the ultimate biodegradability criteria but meeting the application prerequisites for derogation will have to undergo a Complementary Risk Assessment in case that the formation of recalcitrant degradation intermediates cannot be excluded. This assessment that addresses the possible risks of recalcitrant metabolites for the aquatic environment is performed in a stepwise manner and is described in the European Commission Tiered Approach Guidance document. The risk assessment according to the Tiered Approach follows the basic principles of risk assessment, i.e. takes the environmental exposure and effects of the recalcitrant degradation products of the concerned surfactant into account. For passing the Complementary Risk Assessment it is necessary to show that the predicted environmental concentration (PEC) does not surpass the predicted noeffect concentration (PNEC) of the recalcitrant metabolites. The tiered approach allows deriving the PEC and PNEC in
a stepwise process starting with limited data but high safety margins up to comprehensive and specific data allowing a lower safety margin (Figure 1). The prediction of the environmental concentration of recalcitrant metabolites is essentially connected with socalled emission scenarios. They describe in a generic way the specific cleaning processes (work flow, state-of-the-art techniques for treatment of surfactant-containing cleaning solutions) applied in institutional and industrial areas potentially requiring surfactants subject to derogation (metal surface cleaning, bottle washing, cleaning-inplace/CI and membrane cleaning). The emission scenarios forming part of the Tiered Approach Guidance Document allow predicting the concentration of the concerned surfactant in the waste water leaving the Industrial & Institutional facility. Ultimately, the aquatic PEC of the surfactants recalcitrant metabolites is calculated on the basis of standard exposure assumptions according to the EU Technical Guidance Document on Risk Assessment (TGD) and taking biodegradation/ elimination test data of the parent surfactant into account (Figure 2). The prediction of the no-effect concentration (PNEC) of the recalcitrant metabolites is based in Tiers 1 and 2 of the tiered process on the existing ecotoxicity data of the parent surfactant. It depends on the availability of further information whether it must be assumed that the metabolites are considerably more toxic than the parent surfactant or can be considered equally toxic.
Derogation rejected
Evaluation: tier 3
Detailed Test Data
YES
Evaluation: tier 2
Estimates based on test a/o models Derogation granted
NO
PEC/PNEC < 1
YES
Derogation granted
Evaluation: tier 1
Worst case assumptions
NO
PEC/PNEC < 1
YES
Formation of persistant degradation metabolites can be excluded
YES
NO
Exposure assessment
September 2005
Proof for the latter assumption can be obtained from investigations into the ecotoxicity of recalcitrant metabolites present in biodegradation test liquors. In Tier 3, characterisation and ecotoxicity testing of the isolated metabolites would be required implying extremely high efforts (Figure 2).
Two types of consortia were created: 65% of the consortia had data to share while 35% had to co-generate data.
Effects assessment
Aquatic toxicity of metabolites is assumed to be 100x higher than that of parent surfactant Metabolite toxicity estimate based on study on toxicity of biodegradation test liquors/ QSAR / read-across Specific ecotoxicity studies with isolated and characterised metabolites
The tiered approach allows, in principle, to follow different options for obtaining a refinement of the PEC and PNEC which, ultimately, determine the outcome of the risk assessment. As the Competent Authority of the member state has the responsibility to examine and evaluate the provided information, it will remain a matter of discussion between the derogation applicant and the authority to agree on the most suitable strategy for obtaining the information needed to demonstrate the lack of an environmental risk.
September 2005
For these 3 levels, impurities should not be considered as ingredients and should not therefore be listed. INCI names are designed for cosmetic applications, and therefore not all surfactant placed on the market for detergent applications have INCI names. Regulation (EC) No 648/2004 on detergents gives no obligation to have INCI name for surfactants.
This SCHER opinion is legally non-binding, but the EU Commission cannot ignore this opinion when writing future legislation on surfactants and detergents. This Opinion may also have an impact on other schemes such as the European Ecolabel.
9. Additional information
Further information can be obtained in: CESIO Guidance Document (version 2) issued in June 2005 A.I.S.E. has issued a guideline to help industry with the implementation of the provisions on the biodegradability of surfactants and on the labelling of detergents under Regulation (EC) No 648/2004. The A.I.S.E. guideline can be obtained from the EU Commission website: www.europa.eu.int/comm/enterprise/chemicals/legislation/ detergents/index_en.htm The list of national competent authorities can be found on the EU Commission website: www.europa.eu.int/comm/enterprise/chemicals/legislation/ detergents/national_en.htm
Laundry Detergents.
September 2005
Specific logos have been designed to identify companies who belong to and have committed to the scheme: several detergent companies have already confirmed their commitment to the Charter; and logos will start appearing on the packs of soaps, detergents, and maintenance products from Sept. 2005. The Charter follows from the A.I.S.E. Code of Good Environmental Practice, the Wash Right campaign and the joint A.I.S.E./Cefic HERA address the agenda of sustainability and product information. This voluntary scheme will further strengthen our image as a responsible and proactive industry. As from 2006, A.I.S.E. will issue an annual sustainability report. Regular dialogue with all interested bodies and external stakeholders will further be organised with the implementation of the project. Further information can be obtained at www.sustainable-cleaning.com
Laundry
Dish
Cleaning
September 2005
ERASM
ERASM is a scientific based initiative funded at a level of 50% by CESIO and 50% by five detergent companies (Colgate, Henkel, P&G, Reckitt Benckiser and Unilever) whose objective is to run activities for enlarging knowledge about the risk assessment of detergent-based surfactants in environmental compartments. The ERASM projects call on contributions from senior industry and academic experts, and several ad hoc groups are working on matters of interest to the surfactant and detergent industries. Membership of ERASM projects is open to all CESIO members and new members are welcome. ERASM participates in conferences, and publications are regularly published in peer-reviewed journals and/or posted on the ERASM public website www.erasm.org. Six projects are currently active under ERASM: Anaerobic Biodegradability Monitoring of the activities of the Competent Authorities on the evaluation of the anaerobic biodegradability of surfactants as a basis for a future update of the Detergent Regulation. Biotransformation Feasibility study on the in vitro biotransformation of surfactants. Complex Substances Aquatic Risk Assessment (CSARA) Development of methods for monitoring-based, aquatic risk assessment of complex substances using alcohol ethoxylates (AE) as an example model development. A study on alcohol sourcing in surface waters and sediments is currently in progress.
Decentralised Sewage Treatment Plants (DeSeTPs) New project to assess the effectiveness of decentralised and small scale sewage treatment plants. Pristine Assessment of endocrine-disrupting potential of surfactants. Sediment Risk Assessment Environmental risk assessment of surfactants in sediments. The following projects have been completed this year: (1) Coastal vegetation, (2) Ecotoxicity Testing of Metabolites in Biodegradation Test Liquors, (3) Environmental Analysis and Monitoring, (4) Gammarus Study, (5) GREAT-ER (Geography-Referenced Regional Exposure Assessment Tool for European Rivers) www.great-er.org and (6) Terrestrial Toxicity Testing of Surfactants.
Forecast
Approved at SIAM 20 (Apr. 2005). SIAP published in Aug. 2005. SIAR to be published by 2005 end by OECD Most likely SIAM 23 (Oct. 2006) with a small chance for SIAM 22 (Apr. 2006) SIAM 22 (Apr. 2006) SIAM 22 (Apr. 2006) SIAM 21 (Oct. 2005) 2007 Sponsor country not selected yet, but preliminary work has started. Collaboration with APAG. 2007-2008 SIAM 22 (Apr. 2006)
CESIO/SDA Alkyl Sulfates Consortium (Alkyl Sulfates, Alkyl Sulfonates, Alpha Olefin Sulfonates) CESIO/SDA Amine Oxide Consortium CESIO/SDA Betaine Consortium CESIO/SDA Hydrotropes Consortium CLER-ECOSOL Coalition on LAB Alkylate Bottoms (benzene, alkyl derivatives, fractionation bottoms) CESIO/SDA Glycerides Consortium APAG/SDA Aliphatic Alcohol Consortium (not a CESIO consortium, FYI only)
September 2005
HERA
The Human and Environmental Risk Assessment (HERA) on ingredients of household cleaning products, a unique European partnership established in 1999 between the makers of household cleaning products (A.I.S.E.) and the chemical industry (Cefic) to which CESIO made a large contribution is coming to an end.
The HERA Risk Assessment programme for surfactants is as follows: Detailed information and reports are available at www.heraproject.com. With the exception of the Risk Assessments of three surfactants still to be finalized, future activities of HERA are under discussion. Activities, focused mainly around communication, are likely.
Date of publication
Feb. 2003 & June 2004 March 2002 & Dec. 2002 July 2005 (Human Health section only) Sept. 2005 May 2004 Apr. 2005
STANDARDIZATION
The CEN/TC 276, which is financed by CESIO, was We all know the importance of Standardization in our current world. It enables to have the necessary analytical tools to communicate in an objective and recognized manner on quality and specifications with customers but also gives credibility when discussing with the authorities. Indeed technical development of the sector largely depends upon the requirements in accordance with the regulation and the request of the industrial users of surface active agents who present new needs for new applications therefore introducing new types of products. Developing these standards at an industry and European level enables CESIO members to save development cost that each company would have borne. 43 standards on surfactants have already been developed and approved by CEN following the work of CEN/TC 276. established in 1990 to elaborate standards on surface active agents. The secretariat is currently held by AFNOR (France). It is made of two working groups (WG): (i) WG analysis examines problems relating to qualitative and quantitative determinations of constituents actives matters or impurities and (ii) WG Test Method deals with issues relating to physical properties. 6 projects are active under WG1 and 2 under WG2. The list is available from Cesio secretariat (and soon from CESIO extranet). A new process has been introduced for new projects: CESIO TRA will review the project proposals in term of technical background but also in term of relevance for Cesio members. Proposals for new projects are most welcome. Analytical experts willing to join the CEN/TC276 Working Groups are invited to contact CESIO secretariat.
September 2005
CESIO EXTRANET
A CESIO extranet is under construction and should be up and running by end 2005 (the address will be http://cesiomembers.cesio.eu). The CESIO extranet will be securely accessible by CESIO and National Association members only. It will be used as
a library for relevant documents (legislation, industry guidelines), to call for meetings or to provide access to up-to-date information on CESIO issues and activities including minutes and technical, statistical and financial information. The Extranet will also be used as an electronic platform for working groups to interact (review of draft documents).
September 2005
Future Events
The Soap and Detergent Association 80th Annual Meeting & Industry Convention, 31 Jan. - 4 Feb. 2006, Boca Raton, Florida, USA. www.cleaning101.com/meetings/ convention2006
CED in collaboration with AEPSAT, the Spanish Surfactant Association, is organizing the CED annual meeting in 29 and 30 March 2006 in Barcelona.
Issues on environmental regulation, packaging, storing and transport will be discussed. Technical and socioeconomic presentations are welcome. For further information, please go to www.jornadasced.com
97th AOCS Annual Meeting & Expo, April 30-May 3, 2006, America's Center, St. Louis, Missouri, USA. For further information, please visit www.aocs.org/meetings/annual_mtg
SETAC Europe 16th Annual Meeting, Controversies and Solutions in Environmental Sciences, 7 11 May 2006, The Hague, The Netherlands. www.setac.org
Environmental Chemistry Mechanistic toxicology Ecotoxicology & Stress Ecology Life Cycle Assessment Environmental Risk Assessment Contaminated Sediments Political & Socio-economic Aspects of Environmental Issues Environment and Human Health
Avenue E. Van Nieuwenhuyse 4 B - 1160 Brussels telephone +32 2 676 72 11 fax +32 2 676 73 00 http://www.cefic.org
Avenue E. Van Nieuwenhuyse 4 B - 1160 Brussels telephone +32 2 676 72 55 fax +32 2 676 73 47 http://www.cefic.org/cesio
Cefic, the European Chemical Industry Council, is the Brussels-based organisation representing national chemical federations and chemical companies of Europe. All together, Cefic represents, directly or indirectly, about 30,000 large, medium and small chemical companies in Europe, which employ about 2 million people and account for more than 30% of world chemicals production. CESIO (Comit Europen des Agents de Surface et de leurs Intermdiaires Organiques) is the Cefic sector group representing the European producers of surfactants. The aim of CESIO is to develop and promote surfactants, keeping in mind environment and health. CEFIC 2005