Risk assessment under REACH

Application of the principles of risk assessment will be important in the successful implementation of REACH, particularly during its authorization phase. Exposure factors such as whether industrial workers or consumers are exposed, and what production volumes are anticipated, should be taken into account along with a determination of the potential for unintended but catastrophic releases such as in the Bhopal incident. Other factors, including economic effect and whether a suitable replacement for the chemical exists, should be considered before reaching a decision that a substance must be completely banned. 

Charlie Auer, former Director of the EPA s Office of Pollution Prevention and Toxics, made a presentation in Ottawa, Ontario, Canada, on 30 October 2006 (Air and Waste Management Association) titled US Experience in Applying Informed Substitution as a Component of Risk Reduction and Alternative Analysis. In his presentation, Auer cited the use of highly fluorinated substances such as perfluorooctyl sulfonate (PFOS) and perfluorooctanoic acid (PFOA). He suggested that these substances 

What remains to be seen is the extent to which the European Chemicals Agency (ECHA) will recognise exposure factors and economic and societal benefits, and not simply ban a substance based on toxicity. It is the responsibility of the companies participating in REACH to provide ECHA with adequate information and data to convince ECHA to allow certain uses and conditions for continuing manufacture of SVHC substances. 

December 1st 2007. Available at http //canadagazette.gc.ca/ partI/2007/20071201/html/notice-e.htmltH5 

Priority Substances List, Statement of the Science Report 

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REACH. In 2003 the EU Commission proposed a new chemicals policy -REACH (Registration, Evaluation, and Authorisation of Chemicals). The biocides used in AF products are still registered through the BPD, but the other paint constituents as with all other chemical constituents produced or imported > 1 ton/year on the European market will need to be partly or fully risk assessed under REACH. The legislation is expected to enter into force in 2007 (EU, 2003b). 

Persistence and the related property of bioaccumulation were not previously considered in risk assessments under EU legislation, but do have to be considered in CSAs carried out under REACH. Persistence and bioaccumulation do not in themselves denote adverse effects, so a chemical cannot be said to pose a risk simply by virtue of it having these properties. However, persistence and bioaccumulation of organic chemicals render those chemicals more risky in that they increase the magnitude of harmful effects, if any are caused. 

There is now discussion as to whether more substances, including other flame-retardants, should be added to the RoHS Directive. The history of the RoHS Directive and potential additions raises some very real concerns over the fundamental relationship between results of risk assessments under regulation 793/93, REACH registrations and evaluations, and the RoHS Directive. Consistency is needed between the REACH Regulation and the other EU directives. REACH evaluations will determine whether restrictions are necessary in all applications including electronic applications, and where authorization for use is necessary. 

Flame-retardants that have gone through a EU Risk Assessment under Regulation 793/93/EC should be some of the first substances registered under the REACH. Several flame-retardants have already been tested by the EU and found to be compatible with the strict safety criteria of REACH, such as PBT and CMR criteria. 

Combes R, Barratt M, and Balls M (2003) An overall strategy for the testing of chemicals for human hazard and risk assessment under the EU REACH system. Alternatives to Laboratory Animals ATLA 31 7-19. Hanway RH and Evans PE (2000) Read-across of toxicological data in the notification of new chemicals. Toxicology Letters 116(Suppl. 1) 61. 

Notification under the Sixth Amendment (and related risk assessments under the Seventh Amendment as described above for Navy Blue) continued until 1 June 2008. On that date the notification scheme was revoked and replaced by Regulation (EC) No 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH). ELINCS then contained 8,433 notifications, representing 5,292 substances in total [91]. 

Exposure assessment is one of the most important steps in risk assessment. It is the process that predicts or estimates the amount of the substance under study that reaches the human body. To assess the exposure, it is necessary to define in detail the exposure pathway, the route of exposure, the concentration of the pollutant in the particular media, the contact rate, the frequency of exposure, and the population exposed (age, gender, and vulnerable population, among others). A general equation (Eq. 1) to determine the exposure dose is as follows ... 

Risk Assessment Technical Guidance Document (a. 16), which will presumably apply to registration under REACH. The adequacy of each test can be defined by two basic elements ... 

Substances that are used only to formulate cosmetics or to manufacture food-packaging materials are dual regulated they still have to be registered under REACH, although they are subject to separate EU measures that involve an evaluation of their safety to humans. Hence, in order to avoid duplication of work, the REACH CSR only has to include an environmental risk assessment. 

The EPA makes decisions about clean-up of abandoned hazardous waste sites under the so-called Superfund law. Risk assessment outcomes are one guide to the decision process. The agency has declared that, for carcinogenic contaminants, clean-up must reach lifetime risks somewhere in the range of one in 10 000 to one-in-one million most decisions seem to aim at risks of one in 100 000 or lower. Hazard index values for non-carcinogens are not expected to exceed one. Costs and technical feasibility figure heavily in these decisions. 

In order to reduce animal testing under REACH, and also because of the ban on the marketing of cosmetic products/ingredients tested on animals, a broader strategy for risk assessment has been suggested. One element suggested in this strategy is the TTC concept. 

Hazard and Risk Assessment of Teratogenic Chemicais Under REACH... 

The second objective of the hazard assessment concerns characterization of the identified hazards of a particular substance. Under REACH this means that the registrant must define so-called derived no-effect levels., abbreviated DNELs. With respect to human health, these values constitute exposure levels above which humans should not be exposed and below which risks for humans are considered controlled. The DNEL derivation is a complex process which comprises several conversion steps and the application of different assessment factors. In the case of reproductive toxicity, the registrant derives separate DNELs with respect to developmental toxicity on the one hand and to impairment of sexual function and fertility on the other hand. 

The U.S. EPA and many other organizations point out that, when information about potential risks is incomplete, basing decisions to avoid unnecessary health risks is potentially the best option.8 When a good set of scientific data is available on a material, then the Precautionary Principle is not appropriate. Scientific data generated in the EU Risk Assessments or under risk assessment programs, such as REACH, that deem materials safe for continued use should effectively rule out the use of Precautionary Principle. 

The SCHER Opinion was considered, but the risk assessment was not changed and finalized under the old existing chemicals regulation before June 1, 2008, when this regulation was superseded by REACH. For TCPP, TDCP, TCEP, and V-6, SCHER is not finished. 

There is little doubt that the identification and control of hazardous chemicals is necessary to protect human health and the environment. An assessment of the occupational health benefits of REACH estimates that improved chemical risk assessment and risk management can reduce compensation for worker-related illness by between 18 and 54 billion over a 30-year period [190]. The long-term benefits of improved environmental protection resulting from the identification of hazardous chemicals under REACH (e.g., avoided costs for carrying out environmental remediation) can readily result in savings of hundreds of million Euro per substance [190]. Based on World Bank estimates that chemicals and chemical pollution causes between 0.6% and 2.5% of diseases in developed countries, the European Commission calculated a saving of 50 billion on health and medical care within the EU over 30 years could result if REACH can reduce the occurrence of disease by 0.1% [282]. 

A study that examines how REACH could be devised or implemented to promote innovation in the chemical sector is lacking. Decisionmaking under REACH will need to address this lack of company-and sector-specific business impact assessment data. In particular, regulators will need to account for the distribution of business management risk between companies, across sectors and through supply chains. Otherwise the financial and management hurdles... 

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