Directive European Commission

Food coloring is restricted by law to prevent misuse that may lead to deception of consumers related to reduced value or usability. For this purpose, the European Union implemented food colorant guidelines in 1994 based on the understanding that food coloration presents a technological need. While European Parliament and Council Directive 94/36/EC lists colors and their uses in food, the European Commission Directive 95/45/EC contains specific purity criteria for colors in foodstuffs, e.g., a maximal lead content of 20 ppm. " ... 

European Commission Directive 89/105 EEC. Relating to transparency of measures regulating the scope of national health insurance systems. Official Journal of the European Communities 1989. 

Injection-molded specimen 4 mm, barrier values 100 pm blown films [3] Measured using standard test method ASTM D 3985 Compliance with European Commission Directive 2002/72/EC Compliance with European Standard EN 13432... 

The European Commission Directive 77/535/EEC of 22 June 1977 on the approximation of the laws of the Member States relating to methods of sampling and analysis for fertilizers is obtainable at ... 

This methodology was a first approach to estimate population exposure, calculated as the total daily values above the thresholds recommended by the European Commission Directive for long- and short-term health effects. Obtained results revealed that in Lisbon city centre a large number of persons are exposed to PM levels exceeding the legislated daily limit value of 50 pg m 3. 

The Three Rs alternatives are the basic tenets of EU research and other policies concerning the use of animals in scientific testing and experimentation, and the present review by the European Commission (Directive 86/609/EEC) on the Protection of Animals Used for Experimental and other Scientific Purposes focuses on the implementation of the Three Rs [6]. 

European Union Guide to Directive 91/356/EEC (1991), European Commission Directive Laying Down the Principles of Good Manufacturing Practice for Medicinal Products for Human Use. 

Amendment to the European Commission directive 75/318/EEC would require manufacturers to provide a Certificate of Suitability or the underlying scientific information in the form of a marketing variation to attest that their pharmaceuticals are free of TSEs. 

Note, however, that amendments that are made to reduce an immediate clinical hazard to the trial participants may be implemented immediately, and remains the primary responsibility of the designated medical monitor for the study, without prior written approval from the ethics committee. However, the investigator is under obligation to inform the ethics committee, the sponsor must inform the RA, both as soon as possible and in any case within 72 h (see European Commission Directive 2003/94/EC, 2005/28/EC). 

The information on the IMP in the CTA is necessarily not as complete as in a MA, and the overall intent is that the extent of information should be proportional to the clinical phase of the protocol, while complying with the new Guidance document for Good Manufacturing Practices as they apply to IMPs (Annex 13, Rev 1 of the document). A further guideline is forthcoming on the requirements to the chemical and pharmaceutical quality documentation concerning IMPs in clinical trials (see European Commission Directive 2003/94/EC). 

Directive 2001/20 required that compliance with GMP guidelines was introduced into the national laws of all MS and (see European Commission Directive 2003/94/EC). GMP inspections have long been standard for all companies at the time of a MA application, but there had previously been no such requirement for IMPs. This gap has now been closed. 

Principles and guidelines of good manufacturing practice for medicinal products for human use. European Commission Directive 2003/94/EC. Official Journal, 14/10/2003, L 262 22-26. 

The municipal water supply is the same as tap water in the case of households, also referred to here as drinking water. Currently, Milan s water narrowly meets the EU standards as set by the 1980 European Commission Directive on Drinking Water Quality (80/778/EEC) and subsequently adopted in Italian law (DPR 236/88). The European Directive contains certain guidelines as well as maximum permissible concentrations for 71 parameters. The Italian interpretation includes conditions under which regional administrations can issue limited exemptions to water authorities regarding certain standards, in view of the extensive remedial measures and investment pressures created by the new standards (Funari et al.,... 

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