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Panama’s drug safety regulator has indicated it will apply certain EU cosmetic standards to products on the market as it strengthens its surveillance of the sector.
The move suggests that Panama, and potentially other Central American countries, may expect companies to comply with international safety standards without specifically changing their own cosmetics rules.
Earlier this month, Panama’s Ministry of Health (MINSA)'s National Directorate of Pharmacy and Drugs (DNFD) published a resolution cancelling the registration of a perfume containing a substance prohibited under the EU Cosmetic Products Regulation (CPR). It separately issued a safety notice indicating it would apply the EU’s expanding fragrance allergen labelling requirements to cover some 81 substances.
Based on these actions, companies should presume that Panama will apply EU requirements regarding certain cosmetics standards, Melissa Owen, founder of the law practice AMBIENTELEGAL, told Chemical Watch News & Insight.
"It’s not just that standards are getting harmonised," Owen said. "It’s that countries are taking safety measures that impact products on the market, at times without even changing their standards by direct action, citing broad authority to protect public health," she said.
In a resolution (No 104) published in Panama’s Gaceta Oficial on 13 August, the DNFD cited its statutory authority over the quality and safety of drug products as the basis for withdrawing from Panama’s market a perfume that contained 2-(4-tert-butylbenzyl) propionaldehyde (BMHCA), a synthetic fragrance also known as lilial that has been banned in the EU since early 2022.
The European Commission's "Safety Gate" rapid alert system specifically mentioned the perfume in a November 2025 alert, according to the resolution.
"In light of the foregoing, the Health Authority is authorised to issue the provisional or preventive measures necessary to safeguard the life, health, physical integrity and other interests of consumers," the DNFD said.
In a separate statement announcing the strengthening of surveillance of cosmetic products, Uriel Pérez, the national director of Pharmacy and Drugs, said that his office is "verifying that the formulations do not contain components prohibited on international lists, mainly European ones".
His office is also reviewing products that were already registered, he said in a 14 August announcement.
"As a regulatory authority, our responsibility is to act on changes to international lists and prevent products that pose a potential risk from remaining on the market," Pérez said.
Application in other Central American countries?
The DNFD's separate safety notice on fragrance allergen labelling, issued on 3 August, set out a specific legal basis for applying the EU’s requirements in Panama, articulating a rationale that could be similarly applied in other Central American countries.
The August safety notice on fragrance allergens pointed to Panama’s adoption of the Central American Technical Regulation on cosmetic labelling (RTCA 71.03.36:21), which requires labelling information to comply with certain international standards like the EU CPR "and its updates".
The notice also cited EU Regulation 2023/1545, which updated the CPR to expand the number of fragrance allergens that must be labelled on cosmetics to 81 substances. That update "constitutes a mandatory standard for products marketed in the country", according to the notice.
By that logic, Owen said, Panama "and presumably other member countries in Central America" – which include Costa Rica, El Salvador, Guatemala, Honduras and Nicaragua – could be expected to take the same stance that updates to the regulations in the EU apply in Central America, per the terms of the RTCA regulation.
"Safety signals cross the pond at lightning speed these days," Owen said. EU requirements may be applied in some countries by relying on existing authorities, without even adopting new rules, she said.