Feb. 9, 2017
While the biggest companies in the world are in process of mergers and acquisitions, sharing more than 85% of Brazilian pesticide market, those who want to access it are facing one of the most difficult barriers ever since to have registration approvals, the true bottleneck.
Pesticide registration at the federal level in Brazil involves three agencies: ANVISA (health), IBAMA (environment) and MAPA (agriculture). The last one is in charge of registration approval. For technical product (TC) based on equivalency, the 3 Agencies work together. The waiting time in the queue for evaluation is between 5 to 6 years, but in some cases, an early evaluation could happen. Formulated product (FP) registration will be eligible for evaluation only after the respective TC is approved. With respect to FP, each Agency works independently. Thus, regardless of one Agency has approved it, another Agency can reject it. In addition, evaluations follow different timing by each Agency with a long gap. It means that even though one of the Agencies completes the evaluation, the registration cannot be issued until all Agencies conclude the evaluations. All these steps may totalize up to 10 years - depending on when the FP registration was submitted.
If the TC is not considered equivalent based on the comparison of the impurity profile and physical-chemical properties, it should go to Phase II and the evaluation is performed by ANVISA only. Additional studies will be required and it would take 1-2 years for evaluation. In 2016, 24% of the TC evaluated, that is, 53 of them were sent to Phase II.
“The year of 2016 was the record number of registration approvals”, said Dr. Julio de Britto, registration manager of the Ministry of Agriculture until last month.
Sources: Brazilian Ministry of Agriculture; ANVISA; AllierBrasil Consulting
The door for market access is definitely the FP registration. It is clear the unbalance between TC and FP approvals. Thus, expediting TC registrations do not result in directly market access. However, once the TC evaluation is concluded, the holders of registration should pay yearly fees to the government for maintenance, even without any sales.
Some companies have decided to withdrawn registration in order to avoid paying this maintenance fee. This opens an opportunity for registration certificate commerce for those who want to access the market quicker.
Besides the fact that Brazilian pesticide market is the most attractive in the world, the time for registration plus regulatory changes and unpredictability are the main reasons for potential players decide to not access it.
According to Federal regulation, Agencies should evaluate registration submission up to 120 days. Based on this, after several years waiting in the queue for evaluation, companies have been increasingly going to the court against the Agencies to demand that the registrations be evaluated. Considering ANVISA is the one that takes longer time for evaluation, it is the target of lawsuits. In 2016, there were 55 lawsuits against ANVISA. In order to avoid lawsuits, there is a possibility of government changes the rule, excluding 120-day term from the regulation.
The costs of pesticide registrations have been increased annually, not only because of regulatory requirements, but also because of Agencies fees. Nevertheless, it has been verified in the last 2 years that laboratory fees have decreased considerably in average. It can be explained because of the emergence of many new players mainly from China and India; more understanding by foreigner laboratories and registrants about Brazilian regulatory demands; and laboratory margins reduction due to competition.
Several regulation changes are already in place and many others are expected in 2017 and should affect all those who have registration submissions in progress and to be started. Some of changes already in place are the automatic EUP (RET) that approvals are in a couple of days, no fee, no cost; government has expedite post-registration demands, such as packaging and formulator inclusions, label expansion, FP composition change.
The access to the biggest pesticide market in the world has never been an easy task. As soon as the new players start the registration process, as earlier they could start business, even though it could take a decade. However, when they obtain their registrations, there is a risk that the product would not be in the market anymore. Registration, market access, distribution are the some of the important subjects of Forum AllierBrasil in Shanghai, Mumbai and Osaka, organized by AllierBrasil.