REACH—The New European Chemicals Law - Environmental

VIEWPOINT

t

REACH — The

New

European Chemicals Law

U W E L A HL K ATRIN A NNE H AW X W ELL GERM A N FEDER AL MINISTRY FOR THE EN V IRONMENT, NATURE CONSERVATION, A ND NUCLE AR SA FET Y

A single piece of legislation is set to replace the multitude of laws that currently govern the use of chemicals in Europe.

© 2006 American Chemical Society

I

n all likelihood, European chemicals laws will be restructured in 2007 by the so-called REACH (Registration, Evaluation, and Authorisation of Chemicals) regulation. REACH is probably the EU’s most comprehensive and complex piece of legislation. In this paper, we explain why European chemicals laws needed to be restructured, present the key components of REACH, and predict the impacts that REACH will have on the global chemicalsmanagement situation.

The need for action Europe has had substance laws for decades. One important law is a European directive that dates back to 1967 (1). More than 40 additional laws at the community level also regulate chemical-safety issues. This diversity is one of the important reasons for REACH. The REACH regulation, a single piece of legislation, will supplant the current legal framework, which is complex, confusing, and difficult to implement and enforce. DECEMBER 1, 2006 / Environmental Science & Technology n 7115

Existing laws also have substantial shortcomings. For example, registration obligations and information requirements were not introduced until 1981, and those constraints apply only to substances introduced to the market since then. About 100,000 substances already on the market at the time that the legislation was introduced remain largely unreviewed. That lack of testing and review makes it difficult, or even impossible, to ensure that chemicals are being handled responsibly. Chemical producers know too little about the environmental and human safety of the substances they produce; thus, downstream users often receive inadequate information about the substances and their associated risks. This lack of information tends to lead to environmentaland health-protection problems. In general, the public believes that chemicals are responsible for causing numerous diseases. Current discussion has focused on bisphenol A, phthalates, brominated flame retardants, and perfluorooctanoic acid, to name just a few. A lack of pertinent information makes it very difficult to prove or refute alleged correlations, however. Moreover, the existing regulatory system is not particularly conducive to innovation because different rules apply to existing and new substances. Regulations for substances introduced to the market after 1981 are considerably stricter than those for substances that were already on the market in that year. REACH eliminates this discrepancy and establishes a unified legal framework for all substances.

Status of the legislative procedure At the end of the 1990s, the weaknesses of the current system sparked discussion about ways of restructuring laws on chemicals. Acting in response to a call from European environment ministers, as adopted under the German presidency of the Council of Ministers in 1999, the European Commission (EC) presented a White Paper on the Strategy for a Future Chemicals Policy in 2001 (2). The Commission followed up on that document by preparing a draft of the REACH regulation. After stakeholders were given an opportunity to comment on this draft, the Commission revised its proposal. In October 2003, it presented a formal proposal for the REACH regulation (3). That proposal was subsequently reviewed by a Council of Ministers working group that consisted of experts from the member states’ authorities. In December 2005, the Council of Ministers reached a political agreement on REACH. Beginning in September 2006, the European Parliament began deliberating REACH in its so-called second reading. In the legislation’s first reading, which was concluded in November 2005, the Parliament adopted a number of motions for amendment. Of these, only a few were incorporated within the Council’s common position. In the second reading, the Parliament can again adopt motions for amendment. Then, the Council of Ministers must consider the Parliament’s resolution. If it approves that resolution, the REACH regu7116 n Environmental Science & Technology / DECEMBER 1, 2006

lation will have been formally adopted. REACH will then take effect when it has been promulgated in the EU’s official journal. If the Council of Ministers does not approve the Parliament’s resolution, a conciliation procedure between the two institutions will ensue. Negotiations between the Parliament and the Council began in July 2006, after it became clear what aspects the Parliament considered especially relevant. Examples include greater protection for animal welfare via targeted support for alternative test methods and the introduction of a general duty of care. Compromises on both issues are emerging. The issue of substitution will also play an important role in any agreement in the second reading. The Council’s common position, in contrast to the Parliament’s first-reading resolution, does impose general obligations to find substitutes for substances of particular concern. It remains to be seen whether the Parliament and the Council will be able to reach agreement on this highly controversial issue, which could prove to be the trigger for a conciliation procedure. Regardless of how the legislative procedure is concluded, REACH is expected to take effect during 2007.

An overview of REACH REACH is often referred to as the EU’s largest legislative project. At ~700 pages, it certainly is one of the most extensive. It is also one of the most difficult to understand, and that difficulty is not primarily due to its length. The new regulation will create a unified regulatory framework for substances on the European market. The main purpose of REACH is to improve standards in the area of environmental and health protection. It should also be noted that industry is concerned about the high costs associated with REACH. The following section describes the main regulatory content of REACH. The descriptions are based on the common position of the Council of Ministers as of June 27, 2006 (4). Although the common position is expected to undergo minor changes in the current legislative procedure, such changes will not affect the core elements and basic principles of REACH. Registration. The centerpiece of REACH consists of a registration procedure that is designed to provide systematic information about the properties of relevant substances. The concept of “substance” has been very broadly defined; it includes chemical elements and their compounds in either natural or manufactured forms, including process-related impurities. Under REACH, a manufacturer or importer of a substance is required to submit a registration dossier to the new European Chemicals Agency in Helsinki if at least 1 tonne (1000 kg) per year (t/yr) of the substance is manufactured or imported. The regulations apply both to substances and to components of preparations. Substances in products are also subject to registration requirements when they are intended to be released from the products, for example, aroma substances in perfumed candles.

Certain substances and substance groups are exempted from the registration procedure. Exemptions apply, for example, to substances used in medications for humans or animals, or in foodstuffs or feeds, because such substances are already subject at the European level to special regulations that protect the environment and human health in equivalent ways. Furthermore, the annexes to the REACH regulation contain two lists of substances that are exempted from registration requirements. The first, in Annex IV, contains substances about which the available information suffices to indicate that they pose only a minimal risk. This list includes such substances as carbon, nitrogen, water, and sunflower oil. The second list, in Annex V, contains substances for which registration is considered irrelevant or unnecessary. This list includes substances such as minerals, ores, and noble gases. About 30,000 substances are expected to fall under the registration requirements. In their registration dossiers, manufacturers and importers must provide information about the chemical identity of the substance in question; its physical–chemical, toxic, and ecotoxic properties; its classification and labeling; and the ways in which it is used. Where quantities involved exceed 10 t/yr, a chemical safety report must also be provided. The relevant annual quantities of the substance manufactured or imported determine what data must be provided in the dossier. A total of 4 categories have been established: 1–10, 10–100, 100–1000, and >1000 t/yr. The largest group comprises ~20,000 substances produced or imported in quantities of 1–10 t/yr. The testing requirements that apply in each case are set forth in detail in the annexes to the REACH regulation. The greater the annual quantity in question, the more stringent the requirements. For substances that fall within the range of 1–10 t/ yr, only data on the substance’s physical–chemical properties and on a few acute impacts on the environment and human health must be submitted. When quantities of >1000 t/yr are involved, however, the substances must be tested extensively. Testing requirements are not rigid, however. The aim of the registration procedure is for manufacturers to be able to prove that their substances are safe in use. For this reason, under certain circumstances, tests can be waived—that is, the parties subject to registration requirements are not required to carry out testing. For example, if no relevant employee or consumer exposure is expected for a substance, then testing for chronic toxicity may be waived. The registration procedure imposes obligations on manufacturers and importers. They are responsible for the safety of their substances and must prove that their substances are safe to use; this responsibility leads to testing requirements. Findings obtained from testing will lead to the development of suitable risk-management measures for the safe use of substances along the supply chain. In the European discussion about REACH, this concept is often referred to as reversal of the burden of proof. Although this does not apply in a legal sense, it does illustrate a basic principle of REACH. Under the previous sys-

tem, state authorities were charged with determining the risks of substances, for purposes of justifying any measures for protection of human health and the environment. They had to determine whether a substance posed a risk to human health or the environment. In light of the number of substances involved and the limited staff capacities of authorities, that system had only limited effectiveness. REACH, on the other hand, will create a broad information base that will be of great value to all stakeholders. For example, the new findings will enable industrial producers of chemicals to improve their products and users of chemicals to improve their procedures. In the regulatory sphere, the new findings will also have impacts in legal areas outside of chemical laws. Examples include water-quality and soil-quality laws, because regulations pertaining to water and soil often focus on hazardousness criteria and the data obtained through REACH will facilitate authorities’ actions relative to such criteria. The situation is similar with laws for consumer protection and occupational health and safety.

Pulmonary edemas from use of sealing sprays—an example of insufficient communication in the supply chain A current example from Germany shows how important it is for pertinent information to be shared throughout supply chains. In spring 2006, several consumers incurred serious health problems, including pulmonary edemas, after using a so-called “sealing spray” designed to coat ceramic and glass surfaces with a thin waterproof and dirt-repelling film. The spray was then taken off the market. The relevant authorities subsequently encountered difficulties in finding the cause for the health damage, however, because the seller of the spray was unaware of the product’s composition and thus was unable to carry out any safety assessment. Considerable research was needed to determine which firms had supplied which ingredients of the spray. Under REACH, this problem would have been cleared up much more quickly.

Information provision within supply chains. Another core element of REACH involves the flow of information between stakeholders within supply chains. An example for shortcomings of the present system in this field is outlined in the box above. REACH introduces obligations for sharing of information about substance properties and risk-management measures throughout supply chains. Under these obligations, suppliers of a substance or a preparation must provide their customers with a pertinent safety data sheet if the substance or preparation is classified as dangerous; persistent, bioaccumulative, and toxic (PBT); or very persistent and very bioaccumulative (vPvB). As under previous requirements, safety data sheets must include information DECEMBER 1, 2006 / Environmental Science & Technology n 7117

about potential hazards; first-aid measures to be taken in case of exposure; measures to be taken in case of fires; requirements pertaining to handling, storage, disposal, and transport; physical–­chemical properties; and toxicological properties. Under REACH, safety data sheets must also pre­ sent so-called exposure scenarios. These are based on the uses identified by the relevant party subject to registration obligations. They include information about what types of exposure would be expected and about relevant risk-management measures. To prepare such exposure scenarios, a party subject to registration obligations needs access to information about experience gained with use of the respective substance or substances. For this reason, REACH introduces requirements whereby downstream users in the supply chain must provide information to manufacturers and others located upstream. In cases where downstream users do not wish to inform a manufacturer regarding their use of the manufacturer’s substance—for example, because they fear losing an advantage in know-how—they do not have to provide such information to the manufacturer. However, they must provide use information to the chemicals agency.

The example of perfluorooctane sulfonate (PFOS) Analysis of the intrinsic effects of PFOS provides a characteristic picture: • high polarity • high thermal and chemical stability • nonbiodegradability • concentrated toxicity In addition, PFOS has become ubiquitous and is very persistent in the human body. Application of PFOS in the open environment is currently prohibited. If registration has been required for PFOS, the manufacturer would have noticed the nonbiodegradability of this substance while establishing the registration documentation and would have been required to deal with this problem in the risk analysis, for example, in the case of applications in an open environment. The subsequent evaluation phase would have brought the other properties of PFOS to light.

Evaluation. The European Chemicals Agency will be a community institution responsible for the technical, scientific, and administrative aspects of REACH. Together with the pertinent national authorities, the agency will be responsible for evaluation. Two different procedures are distinguished—dossier evaluation and substance evaluation. In the dossier procedure, the European Chemicals Agency checks whether a registration dossier conforms to all applicable requirements, for example, whether it contains all necessary test data and whether the data are of adequate quality. Substances that provide reason for concern are assessed thoroughly by a state authority 7118 n Environmental Science & Technology / DECEMBER 1, 2006

from the relevant member state. Such evaluations can result in the issuing of substance prohibitions or restrictions by the EC. Authorization. REACH provides for an authorization procedure for substances of special concern. This group includes PBT and vPvB substances as well as those with carcinogenic, mutagenic, or reprotoxic properties. Additional substances can be subjected to this authorization procedure if scientific findings indicate that serious impacts on human health or the environment are likely. As an example, the regulation mentions endocrine-disrupting properties. In the coming years, under the aforementioned criteria, ~1000 substances could be subject to the authorization procedure. To reduce authorities’ workloads, only uses of those substances that are listed in a certain annex to the REACH regulation will be subject to authorization. At a time to be specified in each individual case, nonauthorized uses of substances on that list will be prohibited. The structure of the authorization procedure was one of the most controversial points in the discussion about REACH. Basically, the discussion focused on two issues—whether authorization decisions would be time-limited and whether substitution obligations should be introduced. The Council of Ministers found compromise solutions on both of these issues. As a result, authorizations will not be time-limited, but they will be regularly reviewed to determine whether the conditions for the authorization are still being fulfilled. In the framework of the authorization procedure, the question of substitution plays a role in two different ways. First, every application for authorization must include an analysis of possible substitute substances or procedures as well as an analysis of their technical and economic feasibility. Second, decisions on authorizations will take into account the possibilities for substitution. This aspect will be relevant to authorization only in the case of substances whose risks are not being adequately controlled. The concept of adequate control only applies to those substances for which a derived no-effect level (DNEL) or a predicted no-effect concentration (PNEC) value cannot be determined from Annex I of the REACH regulation. Thus, substitution obligations will not be imposed in all cases; a comparative analysis of substitution regulations in European law is provided by Herb and Hamer (5). The authorization procedure itself will also provide incentives for substitutions. After all, authorization procedures create costs and uncertainties for entrepreneurs. In addition, a manufacturer can incur negative publicity if a substance fails to be authorized or is authorized with heavy restrictions. On the other hand, alternatives that do not require authorization will lend themselves well to marketing. Thus, companies could certainly have incentives to make investments in this area. Restrictions. REACH also makes it possible to issue prohibitions on substances or restrictions on certain uses. This is not new; it was possible under the previous chemicals regime. However, REACH simplifies the procedure. The provisions pertaining

to restrictions are designed to function as a safety net: in cases where action is required at the European level, it will be possible to take action more quickly than in the past. Database. The important innovations introduced by REACH include the European Chemicals Agency’s database of substances. This Internet database will contain the substance information collected in the framework of the registration procedure, except for information that is confidential, and it will be publicly accessible. Published information for each substance will include its commercial designation, its physical–chemical properties, results of pertinent toxicological and ecotoxicological studies, and relevant DNEL or PNEC levels. Examples of the sorts of confidential information that will not be publicly accessible are complete details on composition of preparations and information about the relationships between manufacturers or importers and downstream users.

Impacts of REACH Environmental and health protection in Europe. Several studies of REACH’s potential impacts have been carried out. In most cases, such studies have considered the expected financial burdens on industry. Some studies have also considered the benefits for environmental and health protection. Pertinent studies carried out on behalf of the EC estimate that cost savings in the health-care sector will be ~¤50 billion over the next 30 yr (6, 7). Such savings are expected to result from decreasing rates of skin disorders, allergies, and cancer. The same studies determined that the resulting environmental benefits would be significant, although they did not attempt to quantify such benefits. Better regulation in Europe. In the past, certain chemicals were singled out as being dangerous and were subjected to special regulation as deemed necessary. Apparently, such selection was carried out virtually at random. For example, such selection was often triggered when chemicals were found— via some new, more sensitive testing method that became available—in environmental media or in samples taken from human beings. Singled-out substances suddenly became the “substance of the month” and dominated public discussion. Whether this substance-of-the-month approach always led to the right toxicological or ecotoxicological priorities is questionable, even though a focus on, and regulation of, chlorinated pollutants clearly did not lead to any wrong priorities. The availability of pertinent data provides the key basis for regulatory action. Along with studies of impacts, studies of exposure that use chemical analyses have always been important sources of findings. For example, reliable data on exposure to organic chlorine chemicals could not be obtained until the electron capture detector became available. It must be remembered that reliable detection of environmental pollutants depends not only on the availability of detection methods but also on the sensitivity of the methods. Historically, analytical chemists made the ini-

tial discoveries of environmental pollutants, which then prompted subsequent follow-up toxicity testing. This path made sense in the absence of a systematic approach. As described above, under REACH, testing of new and existing chemicals will take place systematically, on the basis of impacts-only criteria in conjunction with exposure as expected via modeling (the actual system reacts too late, see box on previous page). Past risk assessments depended on the availability of sufficiently sensitive detection methods; some had to be made without such methods. At the end of the overall REACH testing process, which will last ~15 yr, it will be clear whether those assessments were correct. We expect REACH to lead to the discovery of new problem substances that are currently not of significant concern. If the above analysis is correct, then such new substances will tend to be of purely organic composition or have only small shares of hetero atoms. Also, we can expect some surprises in the area of polar substances that are highly watersoluble. Having played an active role in the preparation of REACH, we are convinced of the following: REACH will put an end to the principle that substances should be regulated only when they have been proven to be a problem. REACH will provide instruments for a forward-looking approach; ideally, it will prevent the obvious problem cases from even arising. Science. For the science sector, the 15-yr testing process will be an ongoing challenge and source of findings. Its impacts will be felt especially in the fields of toxicology and ecotoxicology. In the coming years, impacts and exposure data worth ~¤10 billion will become available to the scientific sector. These data will revolutionize our understanding of the relevant structures. Animal experiments will be necessary for the new data to be obtained. REACH will therefore lead to a significant increase in animal testing in the implementation phase. On the other hand, REACH will also increase knowledge in the area of alternatives to animal experiments. REACH has opened up all avenues to the use of in silico (via computer simulation) and in vitro methods (8). However, the findings produced by such methods must be reliable. The coming years will show how the growing database can be applied in validation of alternative methods. We are aware that these methods have clear limitations and can only be used within a well-defined context. Clearly, research in support of REACH must be intensified (9). Both industry and state authorities should participate in such intensification. In Germany, preparations have already begun. Industry. Improved understanding of structures and impacts will also promote the development of safe chemicals and applications, in keeping with a central principle of green chemistry (10–12). Europe could become a leading region for green chemistry. Hard scientific data are needed for green chemistry to evolve from a scientist’s vision into a principle for industry. REACH will provide such data, and as DECEMBER 1, 2006 / Environmental Science & Technology n 7119

FIGURE 1

REACH authorization procedure step-by-step Substance that is produced, imported, or used

Substance subject to authorization

PBT or vPvB substance?

Carcinogenic, mutagenic, or reprotoxic substance or substance giving rise to similar concerns

Can an effects threshold be determined?

No

Do the socioeconomic benefits outweigh the risks for people and the environment?

No

Authorization denied

Yes

Yes Authorization issued

The substance may be produced, imported, and used

No

Yes Is the risk being adequately controlled?

Alternative substance not subject to authorization

No

Are suitable substitute substances or technologies available?

a result, European industry will be able to develop competitive advantages. In addition, the European Parliament’s discussions about REACH produced the concept of making REACH a “brand” for safe-chemical products. This plan will also give European industry competitive advantages, as long as regulators for North American and Asian markets do not follow suit. REACH will also facilitate the marketing of new chemicals and thus provide better perspectives for innovation. Moreover, REACH will significantly simplify the framework conditions under which new substances can move from the research sphere to actual applications. This claim holds up when REACH is compared with the substance laws of other countries. REACH’s enhancement of the possibilities for new substances is based on the realization that testing of new substances for negative effects and impacts should be carried out much more carefully and painstakingly than it was in the past. As described above, in the area of existing substances, REACH will lead to a broad range of prohibitions, restrictions, and conditional authorizations. This, in turn, will create substantial incentives and pressures to find substitutes, in keeping with the regulatory intent behind the new regulation. REACH will challenge industry’s innovators and lead to new solutions. The resulting solutions will generate international advantages for Europe’s chemical industry 7120 n Environmental Science & Technology / DECEMBER 1, 2006

Yes

and will lead to the creation of new jobs. Impact on non-EU countries. As a result of globalization and ultrafast information exchange via networked media and the Internet, the different legal systems in place increasingly influence one another. REACH will fundamentally reshape the European legal system and give new priority to environmental and health-protection concerns. REACH will lead to a wealth of new assessments of substances and relevant exposures on the basis of new scientific data. Such results will not fail to have an effect on other legal systems, because the information involved will often be publicly accessible. As a result, the regulatory state of affairs in the other relevant legal systems will either be adapted or not, with certain indirect effects felt in those systems. Liability laws could prove to be one avenue by which REACH enters into other legal systems. Although the details of liability differ widely around the world, the issue of the predictability of damage plays a key role in many different approaches to this issue. Of course, the criteria for assessing liability vary among legal systems. Where a legal system uses relatively strict criteria, the obligations it imposes on producers and users of chemicals could be influenced by REACH. Regarding the question of the predictability of damage, it could be argued that producers or users outside the EU should be expected to take into account, in product development or

with regard to work-safety aspects, the findings that REACH has collected and made available worldwide. When producers or users violate this obligation and damages occur, they would not be able to defend themselves against consumer or employee legal action by claiming that they were unaware of the dangerous properties involved. This will be especially true for substances or substance uses that REACH prohibits in Europe. After all, in relevant cases, a significant legal system will have ruled, after careful review, that a certain risk is not acceptable. Nonetheless, in light of the complexity of the various legal systems and the great differences among them, specific predictions about possible legal developments cannot be made in the present context. It remains to be seen whether the lines of argument suggested here will actually be adopted in legal practice. Emerging contaminants. How will REACH change our knowledge about contaminants, particularly emerging contaminants? As described previously, producers and importers of chemicals will be required to submit registration dossiers; in each case, the form and level of detail required will depend on the annual tonnages that apply to the relevant chemical. Dossiers will contain information about the types of exposures involved, list intrinsic properties of the relevant substances, and describe the risks of various intended uses (10–12). Via the registration dossier, a producer will be able to determine whether existing marketing has been acceptable. If not, it will need to be modified. The new European Chemicals Agency will check dossiers for completeness and quality. When grounds for concern exist, the agency will be able to arrange for more intensive toxicological and ecotoxicological testing and impose additional requirements on the producer. Evaluation will become a process by which unforeseen contaminants can emerge. An authorization procedure is expected for substances recognized to present a high level of risks. The Annex XIV to the REACH regulation contains a list of substances that are to be studied in the framework of the authorization procedure. In all likelihood, this (currently empty) list will ultimately contain ~1000 names. Eventually, the list will provide a basis for environmental analysis, for “voyages of discovery” into the various relevant environmental media. Ultimately, the findings emerging from this environmental analysis process will be used to change and enhance the list.

Implications of REACH In all probability, REACH will be adopted by the EU’s political decision-making bodies by the end of 2006. In actuality, the terms “chemicals law” or “substance law” are rather incomplete. REACH is really a readjustment of the relevant regulatory and industrial– political framework for Europe (13, 14). What will REACH accomplish? REACH will take work safety, environmental protection, and consumer protection in Europe to a new, higher level. REACH will turn Europe into a leading global market

for clean production—known as green chemistry in the U.S. This, in turn, will give Europe competitive advantages in global markets. For the science sector, REACH will provide an unprecedented degree of access to key data via the web-based database. Industry estimates that such access could be worth up to ¤10 billion in the next 15 years. In the context of European research, this database will help generate knowledge and innovations. Ultimately, it will also help to improve basic understanding of chemical structures and their effects. Uwe Lahl is a chemist and director general in the German Federal Ministry for the Environment, Nature Conservation, and Nuclear Safety. Katrin Anne Hawxwell is an environmental lawyer and legal adviser in this ministry. Address correspondence about this article to Lahl at [email protected].

References (1) Council Directive 67/548/EEC of 27 June 1967 on the Approximation of Laws, Regulations and Administrative Provisions Relating to the Classification, Packaging and Labeling of Dangerous Substances; http://ecb. jrc.it/Legislation/1967L0548EC.htm. (2) White Paper on the Strategy for a Future Chemicals Policy, COM/2001/88; European Commission: Brussels, 2001; http://ec.europa.eu/environment/chemicals/­ whitepaper.htm. (3) Proposal for a Regulation of the European Parliament and of the Council concerning the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH), Establishing a European Chemicals Agency and Amending Directive 1999/45/EC, COM/2003/0644 final; European Commission: Brussels, 2003; http:// ec.europa.eu/enterprise/reach/overview_en.htm. (4) Council Common Position, http://register.consilium.­ europa.eu/pdf/en/06/st07/st07524.en06.pdf. (5) Herb, G.; Hamer, J. The Substitution of Dangerous Substances in European Law (in German). Z. Stoffrecht 2005, 5, 198–203; 6, 262–272; 2006, 1, 58–66. (6) Extended Impact Assessment, COM 2002 (644); European Commission: Brussels, 2002; http://ec.europa. eu/enterprise/reach/eia_en.htm. (7) The Impact of the New Chemicals Policy on Health and the Environment; European Commission: Brussels, June 2003; http://ec.europa.eu/environment/chemicals/pdf/ envhlthimpact.pdf. (8) Lahl, U. Strategy for Minimising the Use of Animal Testing as Part of REACH. Presented at the Fifth World Congress on Alternatives & Animal Use in the Life Science, Aug 21–25, 2005, Berlin; www.bmu.de/files/pdfs/­allgemein/­ application/pdf/proceed_22.08.2005_en.pdf. (9) Hengsler, J. G.; et al. The REACH Concept and Its Impact on Toxicological Science. Toxicology 2006, 220, 232–239; Hettich, S.–H., Rothfuss A., Steger-Hartmann, T. Use of Computer-Assisted Prediction of Toxic Effects of Chemical Substances. Toxicology 2006, 224, 156–162. (10) Anastas, P. T.; Warner, J. C. Green Chemistry: Theory and Practice; Oxford University Press: New York, 1998; p 30. (11) Anastas, P. T., Williamson, T. C., Eds. Green Chemistry: Frontiers in Benign Chemical Synthesis and Processes; Oxford Science Publications: Oxford, U.K., 1998. (12) Tundo, P., Anastas, P., Eds. Green Chemistry: Challenging Perspectives; Oxford Science Publications: Oxford, U.K., 2000. (13) European Commission’s REACH Proposal Process description, http://ec.europa.eu/environment/chemicals/ preparing/rip1_process_descriptions.pdf. (14) Führ, M.; Lahl, U. REACH: Self-Responsibility as a Regulatory Concept, Oct 2005; www.bmu.de/english/­chemical_ safety/doc/36322.php. DECEMBER 1, 2006 / Environmental Science & Technology n 7121