The concepts and methods used by regulatory agencies worldwide to assess the safety of flavouring additives were designed by and for the flavouring industry. They embody and embed, in routine regulatory practice, the industry’s commercial interests in minimising regulatory costs and the risk that the market for its products might be restricted. First sketched out by US flavouring company scientists in the early 1960s, this approach required almost no experimental data, and was highly permissive, relative to both our knowledge (and lack of it) about chemical toxicity, and to the ways other kinds of food additives are regulated. A ‘realist constructivist’ analysis illustrates how the industry’s approach was also anti-scientific and unscientific because it served to discourage scientific investigation of important aspects of the phenomena it purported to evaluate, and because it relied on assumptions and hypotheses that lacked any evidential basis. The industry approach was first used to assess flavourings in the USA, where the industry was allowed to design and run its own regulatory regime. In all other regulatory jurisdictions, the industry’s approach was rejected; expert advisors argued that it was incompatible with mandates to protect consumer health. Yet, the approach eventually prevailed everywhere. It did so in large part because of the collective refusal of the flavouring industry over three decades to provide the experimental data that had been requested by the regulatory authorities. This has been a form of regulatory capture, which was triggered by a remarkably effective tactic of non-cooperation with demands for data.

Autores: Patrick van Zwanenberg y Erik Millstone

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