Hazardous harmonization

Decision regarding a harmonized critena for dispensations from 96/82/EC on major accident hazards... 

On the basis of the EU labeling criteria according to the 12th Harmonization Directive 91/325/EEC, alkanesulfonates require no environmental hazard labeling. 

The United Nations Globally Harmonized System of Classification and Labelling of Chemicals (GHS) includes an internationally standardized guidance procedure on Transformation/Dissolution Protocol (T/DP) for metals and sparingly soluble metal compounds (United Nations, 2007), recently validated by the OECD (Organization for Economic Cooperation and Development). To establish the acute aquatic hazard classification level of a metal-bearing substance under the GHS, data from the T/DP are compared with an acute ecotoxicity reference value (ERV) derived under conditions similar to those of the T/DP. 

Felton FC, Oomen PA, Stevenson JH (1986) Toxicity and hazard of pesticides to honeybees harmonization of test methods. Bee World 67 114—124... 

ICSCs are a potential tool for the implementation of the Globally Harmonized System (GHS) for the labeling and classification of chemicals as they contain the necessary hazard data for this purpose. 

Other terms often used indiscriminately for the dose-response relationship include concentration-effect relationship and dose-effect relationship. According to the joint OECD/IPCS project (OECD 2003 a), which has developed internationally harmonized generic and technical terms used in chemical hazard and risk assessment, the following definitions have been provided although consensus was not achieved ... 

OECD has published a document on a Harmonised integrated classification system for human health and environmental hazards of chemical substances and mixtures (OECD 2001b). Chapter 2.1 addresses a harmonized system for the classification of chemicals which cause acute toxicity, and Chapter 2.8 addresses the chemicals which cause specific target organ oriented systemic toxicity following a single exposure. 

The approach to exposure assessment is not as internationally harmonized as hazard assessment. A synopsis of current activities regarding exposure assessment for industrial chemicals in a number of OECD Member countries has been published (OECD 2006). The executive summary of this document states that while there is a significant level of sharing of approaches used for hazard characterization for risk assessment, this is not the case for exposure characterization. Although broad consistency in the overall approaches used by different countries in conducting exposure assessment exists, there is variation in policy-related factors, including the regulatory context for assessment and the way that information is applied, as well as in the types of approaches and tools used. 

The basic idea of the CLH process is the transfer of responsibility for classification and labeling from industrial companies to authorities on a European Community level. In case of active substances in biocidal or plant protection products, all intrinsic properties including physicochemical properties, human health hazards, and environmental hazards are subject to the harmonization. By contrast, in the case of chemicals which are used in other application fields only some specific hazard classes are considered in the CLH procedure. According to Article 36 of the CLP Regulation, these are respiratory sensitization, carcinogenicity, germ cell mutagenicity, and reproductive toxicity. Consequently, these provisions have... 

OECD/IPCS (2001) Project on the harmonization of chemical hazard/risk assessment terminology Critical analysis of survey results. Organisation for Economic Co-operation and Development and World Health Organization, International Programme on Chemical Safety (in press). 

In Canada, the federal mandate for food control rests with four departments Health Canada, Agriculture and Agri-Eood Canada, Department of Fisheries and Oceans, and Industry Canada. A cooperative relationship exists among departments with the ultimate goal of creating a harmonized and streamlined national food control system. All four departments ensure the application of food safety standards in their areas of responsibility to prevent or eliminate human health and safety threats created through chemical, biological, physical, or other hazards. 

Other particularly controversial issues of hazard and risk assessment that urgently need harmonization refer to the potential impact of residues of antimicrobial drugs on the human gut flora, the impact of bound residues, and the impact of residues at injection site on the calculation of ADIs. 

The various national and international regulatory authorities have used different hazard classification systems in the past. In light of the importance of hazard classification, the Organisation for Economic Cooperation and Development (OECD) recently harmonized criteria for hazard classification for global use. For example, the five harmonized categories for acute oral toxicity (in mg/kg body weight) are 0-5, 5-50, 50-300, 300-2000, and 2000-5000. 

In Figure 5 we show an example decomposition of the security trust objective. We can notice some similarities between the structures presented in figures 4 and 5. This similarity suggests that the two domains (i.e. safety and security) have developed similar conceptual frameworks which possibly could be harmonized into a common one. To illustrate this, compare the notions of hazard and vulnerability or mishap and incident from figures 4 and 5 respectively. In particular, it suggests that the trust cases aiming at safety or security can have similar structures concerning their decomposition into more specific trust objectives. This in particular can lead to the concept of trust case patterns which will not be further discussed in this paper. 

Organisation for Economic Co-Operation and Development [OECD], 2001. Guidance document on the use of the harmonized system for the classification of chemicals which are hazardous for the aquatic environment. OECD Series on Testing and Assessment. No. 27 ENV/JM/MONO. Paris (France) Organization of Economic Cooperation and Development, 8 p. 

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