EU CHEMICAL RISK MANAGEMENT

Judging from previous EU chemical risk management decision-making, the choice of control instrument, scope and detail of regulatory action proposed by a Member State depends on its national regulatory approach and administrative structure [31, 32]. This affects inclusion of different actors in decision-making... 

In a book on EU chemical risk management, Calow identified four approaches to risk management suspicion, hazard, technical, and risk-benefit [256]. These are categorised according to the amount of scientific evidence and the amount of caution involved in decisionmaking (Figure 2.8) ... 

The relevance of REACH goes beyond the transformation of EU chemicals safety management. Internally, REACH S institutional design and procedural sequences may well become a model for EU risk regulation generally (Pesendorfer 2006). 

Any regulatory or corporate decision on chemical risk management will have knock-on effects through the manufacturing supply chains (Section 2.2.1). From past experience, chemicals regulation has caused some losses in the industrial competitiveness of EU firms... 

EU chemical risk assessment and management decision-making processes appear to be separated into five or more Techmcal Committees and Working Groups attended by different regulators and overseen by at least three Directorate-Generals of the European Commission. 

Interviews were the primary method for data collection. In the four subject Member States, key regulatory officials and stakeholder organisation representatives were asked questions on national chemical risk management and their views of EU regulation1. When analysing national policy and practice, interview data needed to be supplemented and validated by incorporating literature references relating to (Section 2.3.3) ... 

A product lifecycle ranges from resource extraction through manufacture to use and final waste disposal or processing. Under the current EU chemical risk assessment procedure, lifecycle thinking considers the risks at each stage of a substance s lifecycle, with the possible summation of multiple sources of exposures to a single substance [144], LCA that quantitatively evaluate the overall environmental and health impacts of processes, services or products can complement risk assessment as a useful decision-support tool for chemical risk management [183, 188, 536]. 

The harmonised EU safety data sheet is designed to describe systematically the hazardous properties of chemicals and to inform users about suitable and effective risk management measures. For some years this safety data sheet also has to state what (eco)toxicological standard effects have not been verified for a specific substance. The EU instrument has now been in existence for thirteen years, while the corresponding DIN predecessor had already been introduced in the 1980s. Nevertheless, many safety data sheets still indicate extensive quality shortcomings. 

Within the EU the chemical control directives are based on three steps (1) Hazard assessment, (2) Risk assessment, and (3) Risk management. 

The aims of the proposed new regulations are to improve the protection of human health and the environment while maintaining the competitiveness and enhancing the innovative capability of the EU chemicals industry. REACH would furthermore give greater responsibility to industry to manage the risks from chemicals and to provide safety information on the substances. This information would be passed down the chain of production. 

The latter deadline is set nearly 20 years after the ministerial call for a new chemicals policy in the EU. Above 10 t, a Chemical Safety Report with data on a relatively large set of parameters, including data on intrinsic properties, exposure scenarios and risk management measures, is to be included in the registration (Article 14, Annex 1). For substances in quantities of 1-10 t, a technical dossier with more basic data (Article 10) is stated to be sufficient. Concerning so-called non-phase-in substances , i.e. basically those not being produced or marketed before REACH, the registration provisions entered into force on 1 June, 2008 (Article 141). 

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