Safety data, European requirements

Appendix 9.1 - European Union and US material safety data sheet requirements... 

Health and Safety Data Sheet This document is required to provide anyone who comes into contact with the material with sufficient information needed to react to a spillage or breakage. The labelling and health and safety sheet regulations are not yet consistent through out the world and at the time of writing there is no way to label a product so that it conforms to US, Canadian, European and Australian requirements The Safety data sheet issue is less confused, the U S OSHA and EU forms of the so called material safety data sheet are moving to conform with an I SO Standard. 

International Conference on Harmonisation (ICH) of Technical Requirements of Pharmaceuticals for Human Use. Topic 2 A Note for Guidance on Clinical Safety Data Management Definitions and Standards for Expedited Teporting, CPMPIICHI377I95. London European Agency for the Evaluation of Medicinal Products, 1994. 

Exposure scenarios specify the conditions in which the chemical is to be used (including the protective equipment to be used, working practices, products it is incorporated into, how consumers use those products and how these are disposed), limiting the range of the conditions that must be considered in the exposure assessment. The exposure scenario is annexed to the chemical safety data sheet that is passed to downstream users of the chemical. Those downstream users are required to pass information back to their suppliers about their use of the substance, the exposure to the substance involved in that use and the practicality of specified risk reduction measures. If a use is significantly different from those identified in the CSA, the user must report this to the European Chemicals Agency and prepare its own CSA, or ask the manufacturer to revise the CSA to include that use. 

The European Union (EU) withdrawal of strychnine marks its end as a method of mole control. The EU Directive 91/414/EEC is midway through an ambitious program to review all pesticides used within Member States. This requires manufacturers to provide health and safety data to... 

Guidance on the preparation of SDS s under the requirements of the GHS can be found in Annex 4. It has been developed by the GHS Sub-Committee after consideration of the main internationally-recognized standards which provided guidance in the preparation of an SDS, including the ILO Standard under the Recommendation 177 on Safety in the Use of Chemicals at Work, the International Standard 11014 of the International Standard Organization (ISO), the European Union Safety Data Sheet Directive 91/155/EEC and the American National Standard Institute (ANSI) standard Z 400.1. 

At the beginning of 1995 the MEB changed its policy with regard to precliniccil safety data of the SPC. The MEB had previously followed the practice that in this item animal experimental toxicity data are included only if these data are relevant for the prescriber. There is a discrepancy here with other European Member States. In order to remove this discrepcmcy the MEB has proposed the following requirement regcirding the inclusion of animal experimental data ... 

However, none of these statutes were so directly focused on the chemical industry as the 1976 Toxic Substances Control Act (TSCA) in the United States and the Sixth Amendment to the Dangerous Substances Directive enacted by the European Parliament in 1979. These statutes did not focus on the industry s wastes, pollution or occupational exposures as much as on the intrinsic hazards - the toxicity, chemical stability, and bioavailability - of the industry s chemical products as they were used in commerce. These laws were intended to provide government agencies with the authority to collect relevant health and safety data on chemical products, require testing where data were missing, and condition and restrict the use of chemical substances so as to reduce unreasonable risks to the public and environment. 

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. 

R-Phrases Standardized risk phrases that are required on labels and safety data sheets for hazardous chemicals in the European Union. They appear as a letter followed by one or more numbers. 

For nonpharmacopeial materials a full specification should be included in the application. This should include appropriate tests and requirements for physical characteristics, identification, relevant purity tests, and performance-related tests. Characteristics likely to influence bioavailability of the finished product should be controlled. Routine tests and specifications should be described. Methods should be validated. The material should be fully characterized, with full data on the chemistry concerned and including consideration of the safety of the excipient. Any relevant European Directive requirements or other international specifications should be met, but additional requirements might apply depending on the intended use of the product—e.g., for materials to be used in sterile products. 

Medical grade plastics are discussed with reference to biocompatibility and the tests that the end-product manufacturer should perform in order to ensure the safety of the material. Regulatory requirements are described, and tabulated data is presented on mostly European suppliers of medical grade plastics. The data shows that most companies rely onUSP Class VI certificates to demonstrate the suitability of their materials for the medical industry. However, it is argued that most manufacturers of medical devices would benefit more from tests carried out according to ISO 10993. 6 refs. 

There are slight differences in the requirements for the European Union, the United States, and Japan. Duration to support Phase III trials in the EU, when they differ from the other data, is given in parentheses. Readers are referred to Guidance for Industry M3 Nonclinical Safety Studies for the Conduct of Human Clinical Trials for Pharmaceuticals, EDA, Rockville, MD, 1997. http //www.fda.gov/cder/guidance/1855fnl.pdf [accessed September 20,2007]. 

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