Regulating teratogenicity as a health risk

The development of scientific knowledge and regulatory policy with respect to teratogenicity is reviewed. The current debate on the definition of teratogenicity and on perceived risks, as illustrated by the Dutch Health Council report on teratogenicity, originates from the increased regulatory demands and from incoherent development of teratology as a scientific discipline. Barriers in the development of knowledge are discussed with respect to their consequences for regulatory policy. Special emphasis is given to behavioural effects, to the rise of monitoring and registration systems, and to epidemiological research. From a regulatory perspective, knowledge on the public perception of teratogenicity as a health risk is inadequate. It is concluded that the present situation is ambivalent and poses a real problem for regulatory policy. The positions vary from refining the original and very strict definition stressing severity and low risk, to stressing the need for a more comprehensive definition; in the latter case teratogenicity is seen as a top of the iceberg problem to be treated as part of the reproductive toxicity health issue.