To the editor

I read with interest the articles by Anna Meldolesi published in the September issue (Nat. Biotechnol. 18, 919, 2000) that discuss the “rejection” on 16 December 1999 of three oils derived from GM oilseed rape and four products derived from GM corn by the Italian National Institute of Health (Istituto Superiore di Sanità, ISS). I would like to clarify what exactly happened.

The ISS statement issued in December 1999 was based on a specific legal interpretation of the relevant European Union directive, equating the words “substantive equivalence” with “identical chemical composition.” Given the sensitivity surrounding GM products, the Italian minister of health, during July 2000, asked the ISS to produce “a more in-depth and better documented opinion” on the subject. The ISS responded with a formal statement, sent to the minister on 28 July 2000, in which it stated that “it was the duty of the Ministry's Legal Office to correctly interpret the EU directive.” ISS then prepared a document providing a purely technical and scientific opinion regarding the substantive equivalence of the seven GM products compared with their “natural” counterparts. This new document concluded that “in terms of micro- and macro-nutrients, the seven GM products presented a substantive identity with their traditional counterparts,” although for some microconstituents the documentation received did not contain a comparative evaluation between the GM and the natural product. ISS also evaluated in detail the safety of the products in question, concluding, “there is no reason to believe that a risk for human or animal health could ensue from the consumption of products derived from the GM plants in question.” The end of the document also stated “the Institute feels that it should not comment on the possible risks associated with the 'release into the environment' of these GM organisms or products derived from them.”

On 4 August 2000 the prime minister of Italy issued a decree that, after citing extensively the formal opinion provided by the ISS, concluded: “the commercialization and utilization of GM products Mais BT 11, Mais MON 810, Mais MON 809 and MAIS T25 is suspended, in accordance with what is in the premise.” In support of his decision, the prime minister wrote that “the formal statement of the Istituto Superiore di Sanità does not express an opinion on risks arising from the possible 'release into the environment' of the GM products, in spite of the proven permanence of residues of modified components in the product”; the lack of this information meant “a clear breach in the principle of precaution, generally agreed in this matter.”

It seems self-evident that this inference is devoid of any scientific basis, as the “release into the environment” could relate only to the products, not the plants or seeds.