International Regulation of Chemicals — Implications for Organic Colorants

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Abstract
Following the enactment of the Toxic Substances Control Act (USA), 6th Amendment (EEC) and similar legislation elsewhere, the problems of over‐regulation have become particularly serious for the dye‐making industry, with its multitude of widely‐used but usually small‐tonnage products. Apart from the heavy administrative burden imposed by these regulations, the problems are aggravated by the emotionalism which abounds concerning carcinogenic risk, and the lack of consensus on how animal tests at excessively high dose levels be interpreted in terms of risk to man from trace exposure. A further problem is posed by the incorporation of short‐term testing requirements in the laws before their relevance is fully understood.This situation leads to the imposition of ultra‐conservative safeguards against risks which are probably insignificant when viewed in the perspective of the total risk situation. The lack of harmonization in requirements between countries creates trade barriers and leads to the anomalous situation where a dye which is a permitted food additive in one country has to be labelled as a carcinogenic textile dye in another.Inadequate recognition of the importance of confidentiality to the specialised industries poses additional problems as authorities are now establishing computer data banks of ecological and toxicological data. Whilst hazards should not be concealed, the dissemination of costly data and know‐how gratis to competitors can only further penalize the innovator.These and other problems currently facing the dye‐making industry are explored and the current ecological and toxicological studies are summarized to ensure that, properly handled and used, synthetic organic colorants do not present an unreasonable risk to man or the environment.

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