EU CHEMICALS CONTROL

Current EU Chemical Control Legislation for New and Existing Chemicals... 

On 13 February 2001 the European Commission adopted the much-discussed White Paper Strategy for a Future Chemicals Policy (a. 10). The current EU chemical control measures were considered to result in too great a disparity between new and existing substances, with the high cost of new substance notification stifling innovation. Furthermore, although existing substances account for >99% by volume of chemicals in commerce, they were considered to be relatively poorly assessed and controlled in comparison with new substances. 

Although REACH involved a revision of most EU chemical control legislation, one existing directive that was not incorporated into REACH is the Solvent Emissions Directive [26]. The aim of this Directive is to prevent or reduce the effects of volatile organic compounds (VOCs) on the environment (mainly via the atmosphere) and reduce the potential human health risks from solvent-based activities. Most of the provisions of the directive relate to emission and inventory control, but one part of the directive has potentially negative consequences in terms of Green Chemistry. 

The main EU directives governing chemical control are summarized in Table 23-2. Table 23-2 Overview of EU chemical control directives and regulations. 

Table 23.2 Overview of EU chemical control directives and regulations.

In the EU, the current chemical control measures, based on a network of legislation for hazard communication and safety assessment, are soon to be dramatically revised. To set the scene for this forthcoming fundamental change to chemical control in the EU, the key facets of the existing measures are described briefly i.e., notification of new chemical substances, the relatively-limited measures to evaluate existing substances and hazard communication. There have been problems with the current scheme, principally the disparity between the safety data on new and existing substances. 

The standardized testing methods play a central role in the EU policy on chemicals control and they are referred to in many other pieces of EU legislation (e.g., those related to dangerous preparations, pesticides, cosmetics, and biocides also refer to these methods). The methods are based on those recognized and recommended by competent international bodies, in particular OECD (Section 2.2). When such methods were not available, national standards or scientific consensus methods have been adopted. 

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

The reform process, kick-started in 1997 with broad Commission consultation on the strengths and weaknesses of the key EU legal instruments for chemical control,15 culminated in December 2006 in the adoption of the REACH Regulation.16 The Regulation demands registration of all chemical substances, on their own, in preparations, or in articles, that are produced, traded, or imported onto the EU market. The Regulation sets a standard of no data, no market . Chemicals for which technical data have not been submitted, should be taken out of circulation. The technical data submitted in the course of registration are used to identify chemicals that may pose... 

The Toxic Substance Control Act is a nearly perfect realisation of the old approaches and is clearly outdated. The EPA has been somewhat successful with stimulating voluntary action, but that is far from sufficient, judging from the results in relation to expectations. Previous EU chemicals legislation was permeated by many of the same problems, and it is obvious that the designers of REACH have learned important lessons from the past.33... 

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... 

REACH introduces the concept of adequate control in EU chemical law. Traditionally, the term adequate control has been used to refer to good practice in the workplace. REACH now redefines adequate control in the form of risk management measures detailed in an exposure scenario necessary for the control of hazardous properties. Through a set of systematic procedures, risk management measures must be selected to reduce exposure below which adverse effects to human health or the environment are likely to occur (i.e., a DNEL, DMEL or PNEC). There is debate as to whether a concept of a safe level of exposure reduction, similar to adequate control, can apply to non-threshold carcinogens and mutagens, endocrine disruptors, persistent, bioaccumulative and toxic (PBT) or VPVB substances (e.g., [270]). Industry may need to demonstrate that exposure to these substances is always avoided or minimised, as specified in Annex I of the REACH Regulation. 

Inevitably, there will be a need to carry out a regulatory impact assessment on the resources needed to implement REACH. Not only does this have implications on ensuring a level playing field for business across the EU, it may also affect regulatory resources available for promoting international action on chemical control. 

A.W. van der Widen, Acceptable Risk Assessments by Industry Lessons from Experience and Challenge for Future, 23rd Annual Chemical Control Conference - The EU Draft Chemical Control Regulations, Charles Simeons Conferences, London, UK, 2002. 

EEC ° as last amended by Directive 97/48/EC sets requirements (time temperature conditions, selection of simulants) for testing of plastic materials and articles with food simulants. Directive 85/572/EEC indicates the simulants that shall be used for specified foods or groups of foods. See Chapter 5 for further details on these controls. Regulation of chemical migration from plastics into food and drink has developed over many years. EU regulatory control of active and intelligent packaging will therefore have to fit in with this well-established system of controls. 

European Union Directives require the evaluation and control of the risks to the environment and/or public health of both existing and new chemicals. The European Chemicals Bureau (ECB) located in Ispra, Italy provides technical support for the development of EU chemicals policy and its website34 provides information on both existing and new chemicals. The Existing Substances Regulation35 provides for the evaluation and control of risks posed by existing chemicals in four steps ... 

Revisions are being made to chemical control measures by describing the key facts and objectives of future chemicals policy in EU legislation through the Registration, Evaluation and Authorisation of Chemicals (REACH) regulation, which will be effective in 2007. REACH is expected to have major implications for European chemical producers and downstream users, since it is anticipated that around 30,000 chemicals will need to be screened for their health and environmental impact [8, 33, 34, 35]. 

Hetero Diels-Alder reactions are a good entry for the preparation of intermediates for total synthesis of sugars. The lanthanide catalysts allow to work with labile reactants and adducts with an excellent stereo-chemical control. Moreover Danishefsky found (56) that a chiral europium shift reagent (Eu(hfc) ) is able to catalyze asymmetric cycloaddition (eq. 40] ). ... 

The European Commission, with a staff of about 15 000 people, is the largest of the EU institutions. It is organized into 36 directorates-general and specialized services. The directorates-general of most importance to chemical control requirements are listed in Table 23-1. 

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