The regulatory environment for cosmetics and personal care products in Latin America (LATAM) presents complex frameworks that vary from country to country. As Euromonitor International recently reported, the region’s beauty and personal care market is growing. It is valued at around $64 billion in 2022, so it is expected to reach $77 billion by 2026.
According to Latam Manager of Cemical Engineer & Cosmetic Chemist -Ce.way in Latam, regional harmony efforts such as the Andean Communities (CAN), including Colombia, Ecuador, Bolivia, Peru, and Mercosur, have been sought by Brazil, Argentina, Uruguay and Paraguay for approval. Label requirements and create challenges for manufacturers looking to enter multiple markets.
“Many countries require a homologation process before allowing national surveillance and management bodies to trade products freely,” Silva explained in detail.
She interviewed Silva about her insight into the current state of the LATAM cosmetics and personal care product space and gave advice to brands seeking to enter market share.
Market challenges
Differences in regulations are a major challenge for brands looking to enter multiple LATAM markets. Differences in registration processes, ingredient restrictions, and customs procedures can create barriers to seamless market access.
For example, Silva explained that brands can “have health notices as long as they are within a trade agreement, but ultimately they must register on each platform that corresponds to the institutions of each country.”
Furthermore, she explained, “It can be difficult to put a product into LATAM due to the lengthy process involved in document reviews in countries.”
She also pointed out that US-based cosmetics brands must simultaneously explain the additional complexities of dealing with various LATAM regulations.
“To nationalize and sell national products, we need to create external figures, such as establishing companies or partnering with local companies,” she said.
Country-specific regulations in Brazil and Mexico
Within the Ratam countries, Brazil’s regulatory framework under ANVISA is known for its strict standards. Anvisa, or Agêncianacional de Vigilância Sanitária, is Brazil’s national health monitor and maintains responsibility for the health of Brazil’s population, according to the regulator’s website.
“ANVISA divides products into two risk categories: Grade 1-low risk, only need notifications, Grade 2-high risk, pre-market approval and safety data,” Silva said.
“Compared to other Ratam countries, Brazil’s approval process is particularly extended and detailed, making compliance more resource intensive.”
In contrast, Mexico offers strategic advantages with access to North and South American markets. However, Silva said the country remains “a subject to several important regulatory elements.” [which] Include compliance NOM-141-SSA1/SCFI-2012strict national labeling standards, and requirements for local representatives with effective sanitation licenses for imports. ”
The US manufacturers looking to expand in Mexico, the Federal Commission for national regulatory alignment with Cofepris or protection against hygiene risks, and the FDA present both opportunities and challenges.
“Cofepris’ harmonious efforts with the FDA make Mexico an ideal place to manufacture products for the Latam and the US market,” Silva said, but “brands need to ensure full compliance with local standards, particularly around labeling and claims demonstration.”
New trends in Colombia and Peru
Colombia and Peru are adjusting regulations to global standards as part of their cans. “Strengthening GMP compliance, stricter ingredient safety assessments, and some of the key trends in these areas have strengthened the digitalized approval process,” Silva said.
“In addition, certain changes have been adopted in cosmetic communications, such as revisions to billing and labeling.”
She also said that regulatory changes in these markets could indicate wider changes in the LATAM region. “The rapid adaptation of changes in regulations regarding EU ingredients has also impacted Latam’s regulations,” she said.
“Companies considering entering these markets should prepare to renew their formulation and product claims accordingly.”
Latam vs. Global Markets
Compared to global markets such as the US and Europe, Latam’s regulations show significant differences. “Many Latam countries follow EU guidelines on ingredient restrictions, but the US is more generous,” Silva shared.
Specifically, “Brazil and Chile need more substantial scientific support for claims, but pre-market approvals differ.” “Europe requires pre-market notification, but “some Ratum markets, such as Brazil, Colombia and Chile, require pre-market certification.”
For US brands accustomed to post-market surveillance, these differences may require new compliance strategies. “Companies should plan their regulations in advance to avoid delays in entering the market,” he advised.
Labeling and product claims
Latam’s labeling requirements are strict and Spanish labeling is mandatory in all countries. “We can request Mercosur and Mexi Entries in descending order, but Mexico has strict labeling based on NOM-141-SSA1/SCFI-2012 to ensure consumer transparency,” emphasized Silva.
Different countries are conducting different levels of scrutiny regarding product claims. “Brazil needs scientific evidence of claims, particularly for anti-aging or SPF products,” she explained.
Additionally, she said, “Chile has strong consumer protection laws that require proven claims.”
US manufacturers considering placing their products in terms such as “clean”, “organic”, and “dermatologist test” should be aware of these country-specific variations.
“The terms of billing and marketing must be scientifically justified in tougher markets such as Brazil, Chile, soon Colombia, Ecuador and Peru,” Silva added. “This is an important consideration for US brands looking to maintain consistent messaging across the Latam market.”
Preparing for regulations changes
Like the US, Latam’s regulatory environment is evolving, with future changes poised to have a major impact on the industry.
“Among the challenge is the harmony of national laws, allowing for better marketing,” Silva said.
“In addition, implementation of good manufacturing practices (GMPs) remains a problem and requires gradual implementation to avoid economic disruptions, as compliance costs are high.”
She highlighted the growing importance of the Latam market for global beauty brands, including those in the US. “LATAM is experiencing strong growth in countries such as the United States due to the benefits of free trade agreements, residents of Latin American communities and quality of Latin American products,” Silva said.
Furthermore, she emphasized, “Brazil and Colombia stand out as leaders in the beauty market.” As a result, Silva advised: “This will require manufacturers and brands to enter the US with a new implementation of Mocra and change the laws of gaming on e-commerce platforms like Amazon.”
Strategic advice for expanding the market
Strategic planning is important for international brands looking to expand to LATAM while maintaining compliance. “It’s essential to understand market-specific regulations and not assume all-purpose compliance,” Silva advised.
“By leveraging local harmony efforts such as Can and Mercosur, it will help simplify registration and partnering with local experts can facilitate the approval process.”
As LATAM regulations evolve, active adaptation and collaboration with industry experts will be key to successfully navigating the dynamic cosmetics regulatory environment in the region.
“For US brands, understanding the LATAM-specific regulatory framework and staying ahead of future changes is important for long-term success,” concluded Silva.
