Mexican Authorities Clarifies Guidelines for Cosmetics GMP

In a recent move to provide clear guidelines and dispel confusion in the cosmetics industry, Mexico's regulatory authority for health products, COFEPRIS (Federal Commission for Protection against Sanitary Risk), has published a special Circular addressing the implementation of the new standard on Good Manufacturing Practices (GMP) for cosmetics products, known as NOM-259-SSA1-2022. The circular aims to offer much-needed clarity and insights into the application of the new regulations to ensure a smoother transition for businesses in the cosmetics sector.

Streamlined Entry Process for Imported Cosmetics

One of the key highlights of the new Circular is the streamlining of the entry process for imported cosmetic products into Mexico. As per the guidelines, imported cosmetics will no longer require prior sanitary import permits from COFEPRIS, thereby simplifying the importation process and potentially reducing administrative burdens for businesses.

Voluntary Certificate of GMP for Cosmetics Products

The Circular clarifies that while compliance with the NOM-259 standard is mandatory for all cosmetics products in the Mexican market, obtaining a Certificate of GMP for Cosmetics Products is not obligatory. In other words, manufacturers are not compelled to obtain this certificate, though they have the option to do so voluntarily. This offers flexibility to businesses, allowing them to decide whether obtaining the certificate aligns with their objectives and strategies.

Long-Term Validity of Certificates for Export in Compliance with GMP

For those manufacturers who choose to pursue the Certificate of GMP for Cosmetics Products, the Circular provides reassurance as it states that such certificates will remain valid for a period of five (5) years. This long-term validity period ensures that businesses can plan for export activities with confidence and stability, reducing the need for frequent certificate renewals.

Protection of Pre-NOM-259 Certifications

The Circular clarifies that cosmetic products certified for export prior to the implementation of the NOM-259 standard will remain unaffected and need not undergo any modifications. This provision offers assurance to manufacturers who had previously obtained certifications, ensuring that their products can continue to be exported without disruption.

COFEPRIS' Focus on Mexican Standards

In a notable decision, COFEPRIS emphasizes that it will apply Mexican standards, including NOM-259 and others, for cosmetics regulations. The Circular clarifies that COFEPRIS will not use ISO 22716, a widely recognized international standard for cosmetics GMP, as it falls outside the agency's sphere of competence. This decision underscores COFEPRIS' commitment to adopting and enforcing locally relevant and tailored regulations.

With the provided this Circular, COFEPRIS aims to address various questions and uncertainties surrounding the new GMP standard for cosmetics products, ensuring clarity and streamlined processes for businesses operating in the cosmetics industry in Mexico.