Regulatory Affairs: BIOCIDES IN BRAZIL: REGULATORY ASPECTS

Biocidal products are known worldwide for its function and efficiency characteristic to inactivate microorganisms in several areas. However, Brazil does not have a relevant and specific legislation for this product, not even a definition provided by the law, which leaves us at a disadvantage in relation to other countries that dominate it and carry out a strict regulatory control as the production, distribution and marketing of biocidal products.

Biocides compounds are present in the production of various products, from pesticides to agronomist application, through the cosmetics area as preservatives, even in the composition of sanitizing products for mold appearance prevention. This information shows in the urgency of drawing up a specific regulatory environment for biocides, taking into account also the risks that this compound may entail for human health and the environment, since their action is strong enough to prevent microbial growth.

The absence of normative basis for this framework creates confusion and delay in the regulation of biocidal products, delaying the market for the consumer and consequently the economic sector. Some countries like the EU and the US are specific laws holders to biocides, which enables and facilitates the production, distribution and marketing of the product safely and effectively. In Europe, for example, biocides are regulated by directives. The Directive 98/8 EC of the European Union organized the products into the rating application (disinfectant for water, wood preservatives, human hygiene etc.), and was repealed in 2012 by EU Regulation No 528/2012, which provides for the security assurance of human, animal and environmental on exposure to microorganisms that may pose health risks by applying active chemical compounds present in biocidal products.

Because we have no specific legislation for biocides, in individual cases, ANVISA applies some international laws, such as the use of substances with antimicrobial activity (biocides) in food manufacturing and the like, which follows the positive list of Code of Federal Regulation No 21 (FDA - USA) and Directive No. 98/8 / EC (European Union). Besides, ANVISA applies a generic control of products to be inserted in the market or biocidal compounds containing biocidal function in the formulation. This control is based on the evaluation purpose and use of the product and the direction the same to specific organ, if not of the Agency.

In the cosmetic context, for example, biocides are represented by the preservative action substances which have equivalent functions, but are not called by the term biocide. They are regulated by ANVISA through RDC No. 29/2012 which regulates the positive list of substances into preservatives in cosmetic formulations.

Other biocidal chemicals are framed by the pesticide classification and regulated by the Pesticides Act No. 7802/1989. In the case of this classification, the relevant bodies for the evaluation and regulation are three:MAPA (Ministério da Agricultura, Pecuária e Abastecimento - Ministry of Agriculture, Livestock and Food Supply),MS/ANVISA (Ministério da Saúde - Ministry of Health/Agência Nacional de Vigilância Sanitária - Brazilian Health Surveillance Agency) and the MMA (Ministério do Meio Ambiente – Brazilian Ministry of Environment). The control of pesticides is more stringent because of its application: they are products used in plantations to the inactivation of microbial growth. Are applied in large amounts, exposing the plantation (jurisdiction of the MAPA), the worker/consumer and being released into the environment (MS/ANVISA racing) (jurisdiction of the MMA).

Biocides can also be framed in the sanitizing classification as an inhibitor of microbial growth both on the product itself, such as after application. In this context, the products are regulated by ANVISA through Law No. 6.360/1976. These products may be subject to registration or notification, according to the risk grade that this presents (grade 1 and grade 2). The active ingredients used in these formulations are allowed concentrations established by RDC No. 14/2007 and RDC No. 35/2010, considering the type of product and the application to limit the use of assets and establish other requirements to products and labeling and technical reports for the completion of the registration process. Already RDC No. 35/2010 states that it is prohibited to use substances with proven potential carcinogenic, mutagenic and teratogenic to human health.

All active ingredients that will be applied to products subject to health surveillance should necessarily follow the specific legislation in force and in the case of absence in the legislation, may be used in Brazilian territory all products with antimicrobial function/biocide prescribed in the laws of the EPA, FDA and the European Community. ANVISA follows the Directive n° 98/8 together with the European Community Regulation No 1451/2007 to determine the substances with antimicrobial activity (biocides) that can be used in Brazil. If the asset is absent in any of those laws, must be made a new active ingredient inclusion process following valuation principles outlined in the RDC Annex II No. 14/2007.

Against this background, we emphasize the urgency of developing a specific and clear legislation to the scope of the biocides. The absence of regulation creates huge problems, including the difficulty of registration of biocidal products in Brazil, impacting the trade and economic sector of the country, and not to disclose and prevent the occurrence of risks and their consequences. 

Referências

POLLUTION ENGINEERING. Biocidas no Brasil. Available in: Access: 24/set/2015.

PUBLIC HEALTH. Biocides. Available in:   Access:  24/set/2015.

PUBLIC HEALTH. Effects of Biocides. Available in: <http://ec.europa.eu/health/opinions/en/biocides-antibiotic-resistance/l-3/1-definition-antimicrobials.htm> Access: 24/set/2015.

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