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«Emission estimation and REACH – data sources and their use Dirk Bunke1, Andreas Ahrens2, Antonia Reihlen2, Hans-Peter Schenck3, Marcus Oenicke3, ...»

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Matrix_ESPR February 2007 Date: 1. February 2007

Emission estimation and REACH – data sources and their use

Dirk Bunke1, Andreas Ahrens2, Antonia Reihlen2, Hans-Peter Schenck3, Marcus Oenicke3, David Faubel1,

Burkhard Otto Wagner4, Silke Müller4

Öko-Institut e.V., Geschäftstelle Freiburg, Tel: 00-49-(0)761 – 45 295 46, E-Mail: d.bunke@oeko.de

Ökopol, Hamburg, Tel: 00-49-(0)40 - 3910020, E-Mail: reihlen@oekopol.de, ahrens@oekopol.de Chemie Daten, Strachau, Tel: 00-49-(0)38- 845-40 100, E-Mail: hps@chemiedaten.de, m.oenicke@chemiedaten.de German Federal Environment Agency, Tel: 00-49-(0)340 – 2103 - 3223, E-Mail silke.mueller@uba.de, bo.wagner@t-online.de February 01, 2007 Goal, Scope and Background. Emission estimation is an essential prerequisite for exposure assessment and risk characterisation. REACH, the future European regulation for industrial chemicals, requires for certain substances exposure scenarios as a main element of the chemical safety assessment. According to the present discussion, for most producers and importers of substances and preparations (not been involved so far in the assessment of new substances) emission estimation as well as exposure assessment seem to be completely new tasks.

Materials and Methods: To facilitate the use of already-existing data for exposure assessment under REACH, an emission estimation tool accompanied with an instruction manual is considered to be a welcome supplement for both industry and authorities. A project called “Branch- and product-related emission estimation tool for manufacturers, importers, and downstream users within the REACH-system” aimed to develop such emission estimation tools – on the basis of a documentation of existing data on emission estimation. Therefore a survey on available emission data in central documents has been made. This article presents main findings of the phase of this project referring to the analysis of existing emission estimation data.

Results: The references found have been documented by using a specific kind of matrix. In addition, a guidance how to find the appropriate emission data has been developed. For two industrial branches, stand-alone emission estimation IT tools have been developed.

Discussion: There is an impressive documentation about branch-specific emission situations publicly available in emission scenario documents (ESD) from several sources. They can be used as valuable data sources for the development of quantitative exposure scenarios for REACH. At present, there is only limited awareness about these data in the supply chains.

Conclusions: Emission scenario documents have been developed as support for the risk assessment of existing and new chemicals done by authorities. In order to use them for the registration duties under REACH by manufacturers, importers and downstream users, they have to be adapted tothe specific structure of the supply chains. In addition, they need to be “translated” into the branch-specific terminology.

Recommendations: The transfer of existing knowledge into the REACH system requires communication and exchange with the actors in these branches. This can be supported by authorities, but should be done mainly by the actors of the supply chains. A structured communication of safe conditions of use will become one of the central elements of a successful implementation of REACH.

Perspectives: The results from the work on plastic additives and photochemicals in the matrix project might be useful as a blueprint for similar tool developments in other supply chains. Calculation tools for emission estimation which have been elaborated together with the actors of the industrial branches can become an important element for a successful implementation of REACH.

Key words: emission estimation, emission scenario documents, emission estimation module, ESD matrix, OECD, REACH, sustainable chemistry, sustainable management of chemicals, supply chains, communication.

Emission estimation and REACH Emission estimation is an essential prerequisite for exposure assessment and risk characterisation. REACH, the future European regulation for the registration, evaluation, authorisation and restriction of chemicals, requires for certain substances exposure scenarios as a main element of the chemical safety assessment. According to the present discussion, for most producers and importers of substances and preparations (not been involved so far in the assessment of new substances) emission estimation as well as exposure assessment seem to be completely new tasks (even if they could be known at least partly from the management of dangerous substances already today).

There is an impressive documentation about branch-specific emission situations publicly available in emission scenario documents (ESD) from several sources. They can be used as valuable data sources for the development of quantitative exposure scenarios for REACH.

Matrix_ESPR February 2007 Date: 1. February 2007 At present, there is only limited awareness about these data in the supply chains. The EU TGD and the OECD ESDs are rarely known or used in the existing supply chains – in spite of the fact, that the OECD ESDs have been developed in cooperation with companies and industry associations. Therefore the use of this information by the actors of REACH requires intensive communication work.

Emission scenario documents have been developed as support for the risk assessment of existing and new chemicals done by authorities. In order to use them for the registration duties under REACH by manufacturers, importers and downstream users, they have to be adapted to the specific structure of the supply chains. In addition, they need to be “translated” into the branch-specific terminology. This requires communication and exchange with the actors in these branches.





The OECD Matrix project

In order to support the use of already-existing emission estimation data for the exposure assessment required under REACH, the OECD matrix project has been performed. It has the overall objective to develop technical guidance documents (manual and software tools) for emission and subsequent exposure estimation. Such guidance has to be robust and easy to use by manufacturers, importers and downstream users of substances. The conceptual approach has been based on the methodology laid down in EU TGD on Risk Assessment of New and Existing Substances (2003) and the OECD Emission Scenario Documents (ESD).

Within the project part B1, a survey on available emission data in central documents has been made. The references found have been documented by using a specific kind of matrix. In addition, a guidance how to find the appropriate emission data has been developed. For two industrial branches, stand-alone emission estimation IT tools have been developed. The results of the project have been worked out in intense exchange with RIVM (National Institute of Public Health and the Environment, Bilthoven, The Netherlands). RIVM has developed a guidance how to find the appropriate emission scenarios (see final report of the matrix project, Umweltbundesamt 2006).

This article presents the main findings of the survey on publicly available emission data. The additional results from the other parts of the project have been published in the project report (Umweltbundesamt 2006).

1 Publicly available data on emissions of chemicals Branch-specific data on emissions of chemicals are documented in several publications. The following two chapters describe in brief information, which were developed to support the risk assessment of chemicals (existing chemicals and new chemicals) and scenarios from the US EPA. Further sources are mentioned in chapter 1.3.

1.1 The EU Technical Guidance Document (TGD) and the OECD Emission Scenario Documents (ESDs).

The EU Technical Guidance Document (TGD) on Environmental and Human Health risk assessment (TGD

2003) and the OECD emission scenario documents contain a large amount of branch-specific emission data.

The general principles for risk assessment as laid down in Directives 93/67, 1488/94 and 98/8 do not include technical details on how to actually carry out the different steps of the risk assessment. Therefore the TGD provide extensive supplementary details from the hazard identification up to the risk characterisation. This includes description of exposure estimation. The TGD is issued by the European Commission, Joint Research Centre (DG JRC), Institute for Health and Consumer Protection, European Chemical Bureau.

The TGD is the official reference document for preparing comprehensive and detailed risk assessment reports of chemicals following the current EU legislation. At present, this is done by the Member States Competent Authorities. Under REACH, chemical safety reports will have to be prepared by manufacturers and importers of substances. A description of the methodology used for this purpose is actually developed in the REACH implementation project (RIP) 3.2-2. The methodology is mainly based on the principles laid down in the TGD.

The A-tables of the EU TGD contain release factors for 16 industrial categories regarding the different life cycle stages (mainly production, formulation and industrial use, some information for professional and private use as well as service life, waste disposal and recovery. The B-tables of the EU TGD give default values for the size of a local source (fraction of the main source) and the number of release days per year. In total, the EU TGD contains 31 A-tables and 47 B-tables. The following table 1 lists the industrial categories and examples for chemical products used in the respective branches.

Table 1: Industrial categories with examples (TGD 2003).

Industrial category Examples IC1 Agricultural industry Plant protection products; fertilisers.

IC2 Chemical industry: basic chemicals Solvents; pH-regulating agents (acids, alkalis).

IC3 Chemical industry: chemicals used in synthesis Intermediates (including monomers); process regulators.

Matrix_ESPR February 2007 Date: 1. February 2007

–  –  –

Supplementary to the EU TGD, the OECD Task Force on Environmental Exposure Assessment (TFEEA) develops Emission Scenario Documents (“ESDs”) since 1998. An Emission Scenario Document is defined as a description of sources, production processes, pathways and use patterns with the aim of quantifying the emissions (or releases) of a chemical from production, formulation, use (industrial use, professional use, private use of chemical substances/preparations), service life (use in articles) and recovery/disposal into water, air, soil and/or solid waste. It has been discussed to prepare ESDs only for selected life cycle stages.

The OECD Emission Scenario Documents published so far contain a lot of branch-specific data on processes, chemicals used and emission patterns. These documents focus on emissions to the environment. Only in a few cases, emissions and exposures of humans (occupational health) are considered, too1. Information on ESDs used in national or regional context is compiled in the OECD Database on Use and Releases of Chemicals (http://www.oecd.org).



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