RISK-BENEFIT REGULATION

The safety of a diet could be defined as the overall risk-benefit of consuming that diet over a lifetime. This concept is not one that is applied in determining the safety of a chemical in food. Safety is almost invariably considered as the absence, or minimisation, of risk and not as the maximisation of benefit. Consequently, the scientific basis for regulating food chemicals is based on principles that were developed for assessing the risks posed by pharmaceuticals and industrial chemicals, and minimising these, rather than for maximising the benefits. 

In US, AF products need a registration both at federal and at state level. Registration/regulation of AF paints is governed by the Federal Insecticide, Fungicide, and Rodenticide Act FIFRA (US, 2004) and administered by US Environmental Protection Agency. Extensive data packages need to be submitted by the biocide producers and the paint manufacturers. The decision for approval of products is based upon a risk benefit balance evaluation process. 

All these complexities, ways around regulations, and tendencies to emphasize benefits over risks make regulation of prescription drug advertising challenging. Companies and advertisers can more quickly come up with new methods of publicizing their products and new ways to attract users than the FDA can control the ads. 

Risk assessment is the definition of risks, potential risks, and the risk-benefit equations necessary for the regulation of toxic substances. Risk assessment is logically followed by risk communication and risk management. 

Ever since the ban of TBT containing paint for use on pleasure boats in 1989 (Council Directive 89/677/EEC), the regulations in Sweden have gradually been strengthened as several of the active substances have shown to constitute a risk to both human health and the aquatic environment. The approval of existing antifouling substances has been surveyed twice and after risk/benefit analysis new restrictions was adopted in 1992 (KemI 1992) and 1998 (KemI 1998a, b). 

Public perception appears to be focused on the risks rather than the benefits of chemicals production. A pan-European survey found that only 50% of the general public viewed the chemical industry as beneficial to society, whereas 93% consider that chemicals negatively affect human health [78]. Rarely do public debates on chemicals policy discuss the benefits that chemical products provide to society or how to best devise regulation that supports the competitiveness of EU chemical producers. The media eye sees only chemical risks and regulation responds with knee-jerk reactions. Society is faced with complex issues on the sustainability of the chemical industry, not just in terms of maintaining international competitiveness but maximising the potential for the application of innovative chemistry. 

For most products, the revised regulation foresees only one renewal based on a reevaluation of the risk-benefit balance, after which the validity of the MA is unlimited. However, at its discretion, national regulatory authorities can still require subsequent five-year renewals (article 24 of Directive 2004/27 and article 14 of Regulation 726/2004). 

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