The regulatory landscape for cosmetics and personal care products in Latin America (LATAM) presents a complex framework that varies across different countries. As recently reported by Euromonitor International, the region’s beauty and personal care market is growing: valued at approximately $64 billion in 2022, projections are expected to reach $77 billion by 2026.
According to Laura Silva, Chemical Engineer & Cosmetic Chemist – Latam Manager for CE.way in LATAM, while regional harmonization efforts such as the Andean Community (CAN), comprising Colombia, Ecuador, Bolivia, and Peru, and Mercosur, representing Brazil, Argentina, Uruguay, and Paraguay seek to streamline regulations, significant differences remain in approval processes, ingredient restrictions, and labeling requirements, creating challenges for manufacturers looking to enter multiple markets.
“Many countries require homologation processes before each country’s surveillance and control entities can allow products to be traded freely,” Silva elaborated, “which often ends up being a process of several months and a lot of documentation.”
We interviewed Silva for her insights into the current landscape of the LATAM cosmetic and personal care product space and advice for brands seeking entry into the market share.
Challenges in market entry
Regulatory divergence poses a significant 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 illustrated that a brand can “have homologated health notifications as long as they are within the trade agreement, but in the end, must register on each platform corresponding to each country’s institution.”
Additionally, “getting products into LATAM can be challenging because of the lengthy processes involved in document reviews in each country,” she explained, as “they often require specialists endorsed and certified by the overseeing institution as the only authorized person in charge.”
She also pointed out that US-based cosmetic brands must simultaneously account for the added complexity of dealing with various LATAM regulations.
“It is necessary to create external figures, such as setting up companies or making alliances with a local company, to nationalize the products in the country and market them,” she said.
Country-specific regulations in Brazil and Mexico
Among LATAM countries, Brazil’s regulatory framework under ANVISA is known for its rigorous standards. ANVISA, or Agência Nacional de Vigilância Sanitária, is Brazil’s National Health Surveillance Agency, and according to the regulatory agency’s website, it maintains responsibility for the health of the Brazilian population.
“ANVISA classifies products into two risk categories: Grade One – low-risk, requiring only notification, and Grade 2 – high-risk, needing pre-market approval and safety data,” Silva noted.
“Compared to other LATAM countries, the approval process in Brazil is notably more extended and detailed, making compliance more resource-intensive.”
In contrast, Mexico offers a strategic advantage due to its access to North and South American markets. However, Silva noted, the country is still subject to “some key regulatory elements, [which] include compliance with NOM-141-SSA1/SCFI-2012, a strict national labeling standard, and the requirement for a local representative with a valid sanitary license for imports.”
For US manufacturers seeking to expand in Mexico, the country’s regulatory alignment with COFEPRIS, or the Federal Commission for Protection against Sanitary Risks, and the FDA, presents both opportunities and challenges.
“Harmonization efforts with COFEPRIS and FDA make Mexico an ideal location for manufacturing products destined for LATAM and US markets,” Silva said, but “brands must still ensure full compliance with local standards, particularly around labeling and claims substantiation.”
Emerging trends in Colombia and Peru
Colombia and Peru, as part of the CAN, are aligning their regulations with global standards. “Strengthened GMP compliance enforcement, stricter ingredient safety evaluations, and faster digitalized approval processes are some of the key trends” in these areas, Silva stated.
“Additionally, specific changes are being adopted in the communication of cosmetic products, such as revising claims and labeling.”
She also noted that regulatory shifts in these markets could signal broader changes for the LATAM region. “The rapid adaptation of regulatory changes regarding ingredients in the EU is also influencing LATAM regulations,” she said.
“Companies looking to enter these markets should be prepared to update formulations and product claims accordingly.”
LATAM vs. global markets
Compared to global markets like the US and Europe, LATAM regulations exhibit notable differences. “Many LATAM countries follow EU guidelines for ingredient restrictions, while the US is more lenient” overall, Silva shared.
Specifically, “Brazil and Chile require more substantial scientific backing for claims, whereas pre-market approvals vary,” and while “Europe requires pre-market notification,” only “some LATAM markets, such as Brazil, Colombia, and Chile, require pre-market authorization.”
For US brands accustomed to post-market surveillance, these differences could necessitate new compliance strategies: “Companies need to plan regulatory submissions well in advance to avoid delays in market entry,” she advised.
Labeling and product claims
Labeling requirements in LATAM are stringent, with Spanish-language labeling mandatory in all countries. “Mercosur and CAN require ingredient lists in descending order, while Mexico has strict labeling under NOM-141-SSA1/SCFI-2012, ensuring consumer transparency,” Silva highlighted.
Regarding product claims, different countries enforce varying levels of scrutiny. “Brazil requires scientific evidence for claims, particularly for anti-aging or SPF products,” she explained.
Additionally, “Chile has strong consumer protection laws that require substantiated claims,” she said, “while Mexico enforces truthful advertising with looser claim requirements.”
US manufacturers looking to position products with terms such as “clean,” “organic,” or “dermatologist-tested” should be mindful of these country-specific variations.
“Claims and marketing terms must be scientifically justified in stricter markets like Brazil, Chile, and soon Colombia, Ecuador, and Peru,” Silva added. “This is an important consideration for US brands looking to maintain consistent messaging across LATAM markets.”
Preparing for regulatory changes
Like the US, LATAM’s regulatory environment is evolving, with upcoming changes poised to impact the industry significantly.
“Among the challenges is the harmonization of laws between countries, allowing for better marketing,” Silva said.
“Additionally, the implementation of Good Manufacturing Practices (GMP) remains an issue, with high compliance costs making gradual implementation necessary to avoid economic disruption.”
She emphasized the growing importance of LATAM markets for global beauty brands, including those in the US. “LATAM is experiencing strong growth in countries such as the US due to the advantages of free trade agreements, the residents of Latin American communities, and the quality of Latin American products,” Silva noted.
Furthermore, “Brazil and Colombia stand out as leaders in the beauty market,” she highlighted. As a result, Silva advised, “this demands an accompaniment for manufacturers and brands to enter the US with the new implementation of MoCRA, changing the laws of the game for e-commerce platforms like Amazon.”
Strategic advice for market expansion
Strategic planning is crucial for international brands looking to expand into LATAM while maintaining compliance. “Understanding market-specific regulations and not assuming one-size-fits-all compliance is essential,” Silva advised.
“Leveraging regional harmonization efforts, such as CAN and Mercosur, can help simplify registrations, and partnering with local experts can facilitate approval processes.”
As LATAM regulations evolve, proactive adaptation and collaboration with industry experts will be key to successfully navigating the region’s dynamic cosmetic regulatory landscape.
“For US brands, understanding LATAM-specific regulatory frameworks and staying ahead of upcoming changes will be crucial for long-term success,” Silva concluded.
