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Brazil Anvisa to exclude obsolete active ingredients used in agrochemicals

The Brazilian National Health Surveillance Agency (Anvisa ) plans to begin a process to review the list of active ingredients in pesticides authorized throughout the country, and exclude substances already considered obsolete - that is, those that are not now used in the market.

A proposal has been submitted to exclude 34 monographs of pesticides - a list that includes data, such as type of product, degree of toxicity and crops in which its use is allowed.

In practice, the measure will prevent new pesticides with these substances from being registered and reused. With the exclusion, the use of these substances is now prohibited.

According to the general manager of toxicology, Carlos Alexandre Gomes, the proposal follows a survey made to identify the absence of products with these ingredients in the market.

This is the first time, since 2005, that Anvisa plans to revise the list of monographs based on these criteria. Until then, exclusion occurred only in cases where there was a reassessment of safety and possible health risks, noted Gomes.

Currently, 425 pesticide active ingredients make up the list of monographs authorized by Anvisa to register new products.

Besides the adequacy for the market, the proposal represents an attempt by the agency to minimize criticism about the existence of authorized agrochemicals in Brazil that have already been banned in other countries.

According to Gomes, 30 of the 34 monographs proposed for exclusion are no longer used in the United States and Europe. Over time, they have also had their use reduced here.

“We think it is ideal to do this 'cleaning' to harmonize with international decisions. They are products that already have substitutes, which do not represent a commercial attraction or that are not based on the international market,” said Gomes.

The proposal must still go through public consultations. Among the 34 active ingredients that can be excluded are azocyclotin, bromopropylate, edifenphos, oxasulfuron, and sulfonate, among others.

Further, according to Gomes, the expectation is that other active ingredients are to be reviewed this year. Among them are four substances in the process of toxicological reassessments since 2006 and 2008.

Upon completion of this process, a new list of substances that must undergo a safety reassessment should be released by May.

Increase in registrations

In addition to an attempt to minimize criticism about the endorsement of active ingredients banned in other countries, the proposal to revise the list of monographs also occurs within a context in which the release for sale in the market and industrial use of products related to agrochemicals in Brazil has grown.

Only in 2018, 450 records of this type of product were approved, the highest number in at least 13 years. For comparison, in 2005, there were 91 records, and in 2015, 139.

In the first three months of this year, the number has already reached 93 records, according to data from the Ministry of Agriculture.

The Agriculture Ministry said the records do not involve new active ingredients, but products known to the consumer. It also attributes the increase in releases to greater agility within Anvisa.

Anvisa affirms that a reorganization of work processes allowed a faster analysis, but that the volume of requests accumulated still makes it impossible for the deadline established in law for registration, up to 120 days, to be fulfilled.