Cross-border products: the regulatory landscape in LATAM

04-Jul-2018 - Last updated on 04-Jul-2018 at 10:55 GMT

With a more globally-aligned industry only set to strengthen, what areas of regulation in LATAM do formulators elsewhere need to know about?

Claudia de Lucca Mano, industry consultant and director of DLM, will be speaking at the upcoming Cosmetics Consultants Europe (CCE) Open Academy in Barcelona in October.

Full details of the CCE are available here, and details so far available for this year’s Open Academy programme are here.

What are the LATAM cosmetics regulations that international brands need to be aware of?

Brazil has specific requirements on company licensing, classification of cosmetics products and roots for their clearance (registration or notification), as well as local ingredient lists.

These include restricted ingredients, ultraviolet filters, colorants, preservatives, and forbidden ingredient (the lists are harmonized in Mercosur - a LATAM trade block of Argentina, Brazil, Paraguay and Uruguay).

Are there any special quirks to LATAM cosmetics regulation?

In 2015 Brazilian ANVISA (the Brazilian Health Regulatory Agency) started charging government fees even for notification of Risk 1 products.

Animal testing ban is still an ongoing discussion here. New regulation on child cosmetics were published on 2015.

What are your top tips for companies looking be compliant with LATAM and Brazil regulation?

The following actions are important for companies looking to be compliant:

Understand the variety of local regulations
Plan ahead
Select the appropriate business model for the market
Offer a product line that appeals to local consumers.

Should the industry push for ever greater regulatory alignment/cooperation internationally? Why, and if so, how can this be done?

Honestly, it’s hard enough to harmonize regulations within Mercosur countries.

Amongst all the areas of sanitary surveillance covered by Brazilian Anvisa, cosmetics is well advanced, in terms of Mercosur harmonization.

Usually government officials resist on blindly adopting international regulations, claiming a concern for national sovereignty.

Subsidiary to local regulations, Anvisa adopts European or US test methods as a reference (for example, water resistant and SPF claims are proven through FDA and COLIPA regulations).