The Winds of Change in Brazil’s Regulatory Agency

Angel Lizárraga, Diretor de Novos Negócios, Laboratórios Ecolyzer Ltda.

In publishing the regulatory guideline RDC 4 on 30 January 2014, ANVISA (Brazil’s National Health Surveillance Agency) breathed new and innovatory life into Brazil’s regulatory system for the cosmetics sector and showed its willingness to join the computer age and the age of globalization.

Trying to free itself of the shackles of heavy bureaucracy, common to almost all Brazil’s official bodies, is without doubt a significant step forward. Adopting an end-to-end on-line system to standardize cosmetics products is a huge plus for the sector.

This movement toward innovation began with the publication of RDC 343 of 13 December 2005. With this, ANVISA began the completely electronic notification system for Grade 1 Toiletries, Cosmetics and Perfume Products (products with a minimum health risk). This was undoubtedly a very real change for the sector in that Grade 1 products make up around 70% of the cosmetics products on the market. The need to physically register Grade 2 products on hard copy remained unchanged, however. Registering Grade 2 products is subject to a technical product analysis and registration must be carried at the main ANVISA headquarters in Brasilia (DF) to begin the lengthy regularization process.

Another innovation brought by RDC 4 is the granting of autonomy to companies. The segmentation of Risk Grade 2 products into products subject to registration and products subject to simplified registration is proof of this. Thirty products do not need technical analysis to achieve a health registration. With this change, ANVISA stands to make huge strides in efficiency and flexibility and companies will gain one of life’s most valuable and precious benefits: time.

The sector’s expectations are great and the changes have been well received. Any change, however, and especially one of this dimension, needs time for companies to bed-in with the new system, from the filling-out of forms to the scanning of documents. As there is no longer any paper trail, the process is a digital one for e-sending.

This ‘weaning’ period isn’t limited solely to companies: it includes ANVISA’s own operational system which initially (as might be expected) experienced some teething troubles and will need adjustments to work perfectly. It is, of course, a matter of time.

The publication of RDC 4/2014 is a further step in ANVISA’s path of modernization and technical partnership with the cosmetics sector.

The road is a long one with much distance yet to run. It is not a straight road, nor a smooth one, but rather a winding road whose bends must be negotiated or overcome. Yet, as with everything in life, the important thing is the first step, the kick-start, and this has been taken.

The mutual understanding which has always existed between the regulatory sector and that which it regulates will certainly be a springboard for considering global technical and scientific advances so that Brazilian cosmetics products continue to be recognized and respected by the world market.

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