European Economic Community regulation

European Regulations. Regulations for cosmetics differ from country to country but, in general, are similar to or patterned after U.S. regulation. Thus, the identification of a cosmetic in the European Community differs only marginally from that in the United States. A 1991 European Economic Community (EEC) directive defines a cosmetic as ... 

The following countries also have evaporative emission regulations Canada, European Economic Community (EEC), Japan, Brazil, Mexico, Australia, South Korea. Regulations in these countries have requirements that are typically less stringent than the U.S. imperatives. Table 1 depicts the chronology of evaporative emission regulation developments in the United States. 

Harmonizing the Regulation of New Chemicals in the United States and in the European Economic Community... 

The Good Manufacturing Practice (GMP) regulations, FDA, and European Economic Community (EEC) guidelines on aseptic processing, and other documents provide comprehensive details on facility requirements for sterile drag production. The facility must... 

Currently there is relatively little guidance for the use of QSARs to predict the toxicity and fate (especially in the environment) of chemicals. Some guidance is provided within the European Union (EU) where a comprehensive technical guidance document (TGD) was produced to support the Directive on New Substances and the Regulation on Existing Substances (European Economic Community, 1996). This document includes a substantial chapter providing guidance on the use of QSARs in environmental risk assessments. 

European Economic Community, Technical Guidance Document in Support of Commission Directive 93/67/EEC on Risk Assessment for New Notified Substances and Commission Regulation (EC) No 1488/94 on Risk Assessment for Existing Substances, European Commission, Office for Official Publications of the European Communities, Luxembourg, 1996. 

Although comprehensive regulatory legislation was developed first and most extensively in the United States, all the technically developed nations of the World now regulate the manufacture, sale, and use of agricultural chemicals. The criteria used are not unlike those which were developed over the past several years in the United States. In Europe, the European Economic Community (EEC) in 1991 adopted Directive 91/414/EEC which, included the following goals. ... 

Figure 12-5 The Consultative Process Used in the Development of EU Food Legislation. Source Reprinted with permission from R. Haigh and P. Deboyser, Food Additives and the European Economic Community, in International Food Regulation Handbook, R.D. Middlekauff and P. Shubik, eds., 1989, by courtesy of Marcel Dekker, Inc.

A system of classification is given in the Classification, Packaging and Labelling of Dangerous Substances, Regulations, 1984 (United Kingdom), which is based on European Economic Community (EEC) guidelines for example ... 

In Canada, the use of antioxidants is regulated under the Food and Drug Act (Heath Canada), and in United States, it is regulated by the Federal Drug Administration and the U.S. Department of Agriculture. When it comes to the European Economic Community, directives regulate the use of antioxidants however, individual member countries stiU have the control of usage levels. In Japan, the Food Sanitation Law specifies the use of antioxidants (48). 

The use of emulsifiers in foods is regulated in nearly all countries. Table 4 lists emulsifiers approved in the United States (by the Food and Drug Administration) and in Europe (by the European Economic Community). Several emulsifiers that have FDA sanction are not legally usable in Europe and vice versa. In some cases, specific limits are placed on the amount of emulsifier that a manufacturer may include in a food in other instances the limitation is that amount sufficient to produce the intended functional effect. If there is any question the appropriate regulation (in the United States, chapter 21 of the Code of Federal Regulations, 21 CFR) should be consulted. (See also Ref. 41.)... 

European Economic Community. Council Directive 86/609/EEC of 24 November on the approximation of laws, regulations, and administrative provisions of the Member States regarding the protection of animals used for experimental and other purposes. Off J EurCommun L352 1-29,1986. 

With the Drug Law of 1961, Germany— for the first time in its history—introduced modern legislation regulating the medicines industry. This law was amended in 1976 to bring it into line with the guidelines issued by the Commission of the European Economic Community (EEC) requiring the adaptation of national laws to the Treaty of Rome for the creation of a common market. 

Good manufacturing practice (GMP) is that part of QA that is aimed at ensuring that radiopharmaceuticals are consistently manufactured or prepared and handled in hospitals to a quality appropriate to their intended use (Kristensen 1979 Nordic Council on Medicines 1989). It is concerned -with both manufacture or preparation in hospitals, and quality control (QC). The principles and guidelines of GMP for medicinal products have been laid do-wn in Council Directive 91/356/EEC, presented in volume IV of the European Regulations (European Economic Community 1997). 

European Economic Community (1998 a) Notice to applicants procedures for marketing authorization. Medicinal products for human use. (Directive 75/318/EEC Regulation (EEC) No 2309/93). Eudralex, vol. IIA. European Economic Community, Luxembourg... 

Currently regulation ECE R15-04 is in force (ref. 7) and has been adopted by the European Economic Community (EEC) and by most other European States. The requirements of this regulation are lax relative to contemporary US and Japanese limits. 

EEC-European Economic Community (1989) Council Directive 89/106/EEC of 21 December 1988 on the Approximation of Laws, Regulations and Administrative Provisions of the Member States Relating to Construction Products. O.J.N0 L 40, 11.02.98, pp 12-25. 

Although it still may take a long time mtil a central pesticide registration becomes a practical reality in the European Economic Community, the initiated activities will certainly speed up the harmonization of regulations and decision making in the member states. 

Alone among the international organisations reviewed in this section, the European Economic Community is able to pass legislation and introduce regulations which become binding on member states. This power has been both a strength and a weakness for the Community in its response to the Chernobyl accident. 

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