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Understanding Brazilian regulatory issues
Dec. 14, 2015
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Brazil
Brazilian Minister of Agriculture, Mrs. Katia Abreu, have announced last week that she declined with the idea to create a sole pesticide regulatory Agency in place of today three agencies, ANVISA, IBAMA and MAPA. The idea of this new Agency was to speed up product registrations, that is taking about 5-7 years to register one technical and one formulated products.
Each of these Agencies works independently and it is very often the cases that one of them approves the requested registration meanwhile the other rejects it. The exception is for technical product based on equivalency where the three Agencies work should together. In this case, they all have to agree about considering the technical product is equivalent or not, reject or approve.
Nevertheless, with or without this sole regulatory Agency, product registration applicants are facing most diverse difficulties to have granted their registrations. It is mainly because when the registration dossier goes for evaluation, the rules have changed so many times, that in many cases the submitted dossier is no longer in compliance. It is explained by the fact the timing to go for evaluation is very long, about 4 to 5 years after the dossier is elaborated and submitted for registration, according to Mr. Flavio Hirata, MBA, regulatory expert and consultant from AllierBrasil.
According to the Brazilian regulatory authorities, the delays or long term for a submission to have its evaluation started is because the large number of “clones” submission requests. Such large number of registrations demands a lot of time from Agencies for the evaluations, and when approved, in many cases, these “clones” will not be market, according to them. “Clone” is the same registration dossier for a different brand name.
On the other hand, players want different brand names to position their products with different distributors or different markets/crops. This could be a successful strategy for foreign new players. In such big market, more and more players are considering the alternative to have regional distributors, ie, per State/region or per crop, instead of a Brazil wide distributor. This is explained by the fact that there are not so many large distributors interested in distribution having only one supplier; regional distributors are eager to enlarge their product portfolio; considering the purchased volumes by regional distributors are much less than the larger distributors, the margins for the suppliers may be considered more attractive as well as payment terms.
It also happens in the market companies that register “clones” to sell it in the future. Nevertheless, this is more exception than rule.
The long time in the queue and consequently for the dossiers to have their evaluations started brings an unresonable dilema. Rules changes or even different interpretation of the same rules, in many cases result in registration rejetions. An important example is the new interpretation of the law by the regulatory Agencies that is not considered eligeable for registration a more toxic product than already registered one. It means if there is a specific type formulation of an active igredient classified as low toxic, it will not be allowed to register other product with same type of formulation, same concentration and same active ingredient. This was first defined by ANVISA, in charge of health evaluation. More recently it was also defined by IBAMA, in charge of environmental evaluation. Thus in both Agencies registration requests are rejected, said Mr. Hirata.
Other important issue to be addressed is the registration dossier elaboration. Laboratory reports with missing information or data, wrong results, lack of required documents or annexes, active ingredient concentration, …, may also result in rejections depending on the gravity of the mistake. If the registration is not rejected, at least the evaluation will demand additonal time that may take several months to be concluded.
In addition to these above, there are the environmental and health re-registrations or re-evaluations. Last week ANVISA issued its final decision to ban Parathion-methyl. Paraquat status is the most critical by now. In case of environmental re-registrations, once it is started, all registrations that have the same active ingredient are “frozen”, ie, shall not be evaluated until the re-registration is positively concluded. This is happening with imidacloprid for more than 3 years. More recently with thiamethoxam and soon it will be fipronil.
To better understand Brazilian regulatory steps and issues, and much more about Brazilian agribusiness, AllierBrasil is organizing the 8th Forum AllierBrasil in Shanghai, China in the EverBright Hotel, on January 7th and 8th, 2016. For enrollment and information: allierbrasil@allierbrasil.com.br
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