Europe safety data required

Nevertheless, events during the past 35 years have directed public and government scrutiny on the chemical industry and its unintended impacts on the environment and society. For instance, despite evidence of health effects linked to chemical exposure, a great majority of the chemicals found in our air, water, food, and everyday products lack basic safety data for human and ecosystem health, particularly that of developing organisms. Of the 100,000 chemicals in common use, 30,000 are used in volumes of one ton or more. Of these, 95 percent have little or no environmental or human health data, simply because prior to 1980 no data were required before marketing in the United States or Europe (Thorpe, Chapter 3, Section 3.2 of this volume). 

Worldwide hazard communication of chemicals requires a change from the existing systems to a more harmonized one. This gave rise to the elaboration of a Globally Harmonized System of Classification and Labeling of Chemicals (GHS) by the United Nations Economic Commission for Europe (UNECE, 2002). This system proposes harmonized hazard communication elements, including labels and safety data sheets. 

Within the United States, the OSHA Hazard Communication Standard (HCS) requires that a Material Safety Data Sheet (MSDS) be prepared for chemicals that are hazardous according to the criteria described within the HCS. An American National Standards Institute (ANSI) Standard has been prepared by the Chemical Manufacturers Association (CMA) with the aim of assisting the compilation of these MSDSs. This Standard [13], in final draft form, recommends the same 16 data elements, outlined above, as those applying within the European Union, and gives detailed advice on the compilation of each section, together with an analysis of the regulatory requirements in the United States, Canada and Europe. Example MSDSs are also included. 

The decision to approve a new drug is made by a national regulatory body (Food Drug Administration in the U.S.A., the Health Protection Branch Drugs Directorate in Canada, UK Europe, Australia) to which manufacturers are required to submit their appUca-tions. AppUcants must document by means of appropriate test data (from predinical and clinical trials) that the criteria of efficacy and safety have been met and that product forms (tablet, capsule, etc.) satisfy general standards of quality control. 

For example, once implemented, the European Commission s new chemicals policy REACH (Registration, Evaluation and Authorization of Chemicals) -endorsed in 2003 - would require manufacturers and importers of over one ton per year of any chemical substance to gather information on the properties, hazards, and use of that substance, and submit the data to the European Chemicals Agency. The Agency would then determine if the chemical substance needed to be further regulated, restricted, or banned from use. It is estimated that about 30,000 existing chemicals produced in or imported into Europe would be subject to REACH. Key objectives of the European Commission s initiative on the reformulation of chemicals policy are to raise human and environmental safety levels as well as to simplify and standardize the current legislation. 

All member states of the EC were similarly required to review the quality, safety and efficacy data of products on their market. Various dates were set for the completion of such national reviews, and the time schedule had to be revised on a number of occasions due to slow progress of the exercise. The various national review processes have not led to harmonized marketing approvals for these older products within Europe. 

New directives and regulations covering the use and safety requirements of protective gloves have come into force in Europe. Obtaining information on quality requirements and performance data, as well as an acceptable level of exposure to hazards and problems in glove usage is necessary before gloves are selected, purchased or used (Mellstrom and Boman 1997). 

The European Union s chemical management law known as REACH requires chemical manufacturers and importers to assess risks and describe conditions under which their chemical substances can be safely used. Although REACH is required in Europe, data generated under the law has global impact. Among the data generated for a chemical substance is a Chemical Safety Assessment, Derived No Effect Level (DNEL),... 

Chemical manufacturer s position. When this company generated the data for the powder required by REACH, it was probably told by lawyers it had an obligation to pass the safety information along to all downstream users, even those located outside of Europe. 

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