Brazilian pesticides legislation is one of the strictest in the world, where registration submissions have a very careful and detailed evaluation by government authorities. The Brazilian system has become a model for many countries, mainly in Latin America. As from the end of 2004, when the new regulation regarding equivalents, or me-too registrations was approved, many foreign companies, mainly from China, India and Germany, began to focus on the Brazilian market. The introduction of equivalence approvals ushered a unique race to register generic pesticides in an attempt to grab a share of the US$7 billion market.

 

Although registrations are widely considered the biggest barrier to access this market, they are just the first step in a convoluted system of distribution, collections, quality control and post-registration, to name a few. That reality became clear in 2009, when officials from the three ministries involved in product registration conducted unannounced inspections of formulation facilities and offices. The National Health Surveillance Agency (ANVISA), Brazilian Institute of Environment and Renewable Natural Resources (IBAMA), and the Ministry of Agriculture (MAPA) worked actively in the inspection of the manufacturing and formulation sites of already registered products.

 

Some of the inspections were caused by complaints, and others were routine. The inspections performed by MAPA through officials spread throughout all the Brazilian territory and boarders are typical, including manufacturing and formulation sites, toll formulators, as well as companies’ headquarters. It was intensified between July and September, just prior to harvesting months. MAPA actions aimed to combat counterfeiting and smuggling, two frequent crimes in this field; labeling and packaging; and origin of the products (such as products registered with a specific source and actually imported from another). In addition to federal agencies, the states also intensified surveillances and inspections.

 

Inspections and Product Seizures in Brazil*
Federal Agency/ Departments	Month	Company	Active ingredient
ANVISA and Federal Police	July	Milenia (Makhteshim Agan)	Atrazine+Simazine Glyphosate Atrazine Flumetralin Chlorpyrifos
ANVISA and Federal Police	August	Ihara	Thiophanate-methyl Chlorothalonil + Thiophanate-methyl Bispyribac-sodium Fenitrothion
ANVISA and Federal Police	September	Bayer	Cyproconazole + Trifloxystrobin Imidacloprid + Thiodicarb Iprodione Tebuconazole Methamidophos Prochloraz Metribuzin
ANVISA and Federal Police	October	Syngenta	Difenoconazole Thiamethoxam + Cyproconazole Cyhexatin Azoxystrobin + Cyproconazole Cyproconazole
IBAMA	October	BASF	Phorate
ANVISA and Federal Police	November	Nufarm	Methamidophos Endosulfan Tebuconazole Glyphosate Malathion Nonyl phenol ethoxylate
Source: ANVISA, IBAMA. *This is a partial list.

  According to ANVISA, some of the irregularities were: unauthorized changes of the formulation recipe and in the production; no impurity analysis of impurity controlled products; and product with more hazardous toxicological effects than the approved toxicological classification of its registration. In case of the complaints, they occurred prior to the inspection, and the product was collected in the market and sent for analysis in the Federal Police and in a state government research institution. The results of the analysis showed that the analyzed product had extreme toxicity characteristics in opposition to the approved toxicological classification of the registration “moderately toxic” (Toxicological Class I versus Class III, where the first is the most hazardous).

 

The fined companies were given the legal deadline for their defenses. Penalties could reach up to US$830,000, in addition to possible penalties for criminal investigation. Toxicological classification report of Evidence, one of Bayer’s imidacloprid formulations was canceled; importation and production were suspended, and consequently registration shall be canceled.

 

The increase of the number of new players in the market since 2005, most of which are from China and India, is forcing Brazilian government authorities to seek proximity to the regulatory agencies of these countries that stand out as major suppliers. Thus regulatory authorities are planning to make official visits to the foreign manufacturing sites — initially to China, whose companies supply to Brazil — with the clear objective to check in local quality control, traceability, location and address of manufacturing site. This proceeding is routine in other segments, such as the frequent surveillances from the European Community representatives to Brazilian pastures to verify cattle hoof and mouth disease, for example, resulting in the release or prohibition of animal and meat export to those countries.

 

It is expected that inspections will be continued in Brazil with more attention in the coming years, as already confirmed by the authorities. This should face up to, not only products quality and safety, but quality of registrations that include stated manufacturers and formulators, recipe, labeling and packaging, for example. Being complex, costly and the longest hurdle, product registration itself is just one of the many steps to go through the long, winding road to market access. Taking into account the results of inspections in 2009, it confirms that access to and competition in this market is difficult, costly and complex.