United Kingdom reporting requirements

LRNI, Lower Reference Nutrient Intake RNI, Reference Nutrient Intake Al, Adequate Intake RDA, Recommended Dietary Allowance. Sources UK Department of Health (1991) Dietary Reference Values for Food Energy and Nutrients for the United Kingdom, Report on Health and Social Subjects No. 41. London HMSO. USA Food and Nutrition Board, Institute of Medicine (2000) Dietary Reference Intakes for Vitamin C, Vitamin E, Selenium and Carotenoids. Washington, DC National Academy Press. WHO/FAO WHO/FAO (2002) Human Vitamin and Mineral Requirements. Report of a Joint FAO/WHO Expert Consultation, Bangkok, Thailand. Rome WHO/ FAO. 

The concept of a safety case comes from the requirements of the European Union/European Community (EU/EC) Seveso Directive (82/501/EC) and, in particular, regulations that the United Kingdom and other member states used to implement that directive. United Kingdom regulations (Control of Industrial Major Accident Hazards [CIMAH], 1984 replaced by Control of Major Accident Hazards Involving Dangerous Substances [COMAH] in 1999) require that major hazardous facilities produce a safety report or safety case.64 The requirement for a safety case is initiated by a list of chemicals and a class of flammables. Like the hazard analysis approach (Section 8.1.2), experts identify the reactive hazards of the process if analysis shows that the proposed process is safe, it may be excluded from additional regulatory requirements. 

At the present time, several countries have well-organised and experienced spontaneous reporting systems which contribute the bulk of ADE reports. In particular the United States, the United Kingdom, France and the Scandinavian countries have records going back several decades, and can claim to have in their possession data of reasonable quality. The section on p. 438 considers the various methods of causality assessment that are available and the data that are required for their application. 

The United Kingdom requires new cases of BSE to be reported and investigated, bans the feeding of ruminant-derived meat and bone meal protein (MBM) to ruminants, and introduces a mandatory slaughter and compensation plan for detected cases. 

This category includes applications for new products or variations to existing products which relate to goods having recent evaluation reports from acceptable countries (e.g., Canada, United States, United Kingdom, Sweden, Netherlands) that have independently evaluated and approved the identical product. They are required to be ... 

In the United Kingdom, regulation is derived from the Medicines Act of 1968, which provides a comprehensive system of licensing affecting most aspects of the sale of medicinal products. It also contains provisions on related matters, such as pharmacovigilance and the requirements for the reporting of adverse events (AEs). The Medicines Act encompasses measures contained in European Community Directives, including the first on the control of medicines, introduced in 1965. The Medicines Act led to the creation of various... 

Since October 1973, FDA regulations require that all U.S. ophthalmic ointments be sterile. This legal requirement was a result of several surveys on microbial contamination of ophthalmic ointments, and followed reports in Sweden and the United Kingdom of severe eye infections resulting from use of nonsterile ointments. In its survey published in 1973, the FDA found that of 82 batches of ophthalmic ointments tested from 27 manufacturers, 16 batches were contaminated, including 8 antibiotic-containing ointments. The contamination levels were low and were principally molds and yeasts... 

Omega-6 and omega-3 are essential fatty acids, but the body requires them in a ratio that is not normally achieved by the typical diet of today s developed nations. It is reported that the current average intakes of essential fatty acids expressed as ratios of fatty acids are 8 1 in United Kingdom, 10 1 in United States, and 12 1 in Australia (www. omega-3info.com). Health bulletins indicate that the proportion of ai-6 to (0-3 fatty acids should be equal or close to 5 for cardiovascular health (Simopoulos, 1999). 

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