Sipcam to defend cyhexatin registrations
Date:08-22-2008
The Brazilian joint venture, Sipcam Isagro Brasil (Uberaba), is to contest the recommendation to cancel all registrations in Brazil of the acaricide, cyhexatin. The Ministry of Health’s national health surveillance agency, the Anvisa, made the proposal last month. The Italian agrochemical company, Sipcam-Oxon (Milan), is to defend all worldwide registrations of the active ingredient. The company has a 50% share of the joint venture, Sipcam Isagro Brasil.
The Italian company carried out teratogenic studies on cyhexatin in 1989 and submitted data on them to the WHO’s Joint Meeting on Pesticide Residues (Codex - JMPR), it says. That followed Dow AgroSciences‘ voluntary withdrawal of the ai from the market in the US and other countries due to teratogenic effects observed on rabbits. Cyhexatin was subsequently banned in several countries and placed on the prior informed consent (PIC) list under the Rotterdam Convention, Sipcam-Oxon explains. But, the JMPR reviewed toxicological data on the ai’s teratogenecity in 1994 and in 2005 and concluded that "after taking into consideration the results of all studies on teratogenicity in rabbits, cyhexatin is not teratogenic to this species".
The product has been re-registered in many countries since publication of the JMPR studies and was removed from the PIC list in 1996, Sipcam-Oxon says. The company adds that the PIC committee noted in 2005 that “the new internationally peer-reviewed information available calls into question the basis for further regulatory action based on the old data”. The WHO classifies it as “slightly hazardous”.
Sipcam-Oxon counters the reasoning behind the Anvisa’s recommendation. “The ban on cyhexatin in many countries persists due to no new registration processes being activated, and so the new [JMPR] studies have not been evaluated,” it says. The Anvisa cited the ai’s restriction or ban in several countries due to human health risks among its justifications to advise its cancellation. Furthermore, Sipcam-Oxon says that the imminent removal in the EU is the consequence of the voluntary withdrawal by it and the United Phosphorus subsidiary, Cerexagri, due to falling demand for the product in the EU.
Sipcam Isagro Brasil distributes five of the seven registered products that are based on the ai in Brazil.
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