Marine-derived compounds, such as those from algae, fish, and coastal plants, have diverse applications in food supplements, medicines, and cosmetics. Both food supplements and medicines are heavily regulated, and products must meet stringent safety, efficacy, and quality standards based on their intended application. Manufacturers must carefully categorize their products and ensure compliance with relevant regulations.

Regulatory Requirement for Marine-Derived Compounds in Cosmetics, Food Supplements, and Medicines

Interesting News . Sep 10, 2024

Marine-derived compounds, such as those from algae, fish, and coastal plants, have diverse applications in food supplements, medicines, and cosmetics. Both food supplements and medicines are heavily regulated, and products must meet stringent safety, efficacy, and quality standards based on their intended application. Manufacturers must carefully categorize their products and ensure compliance with relevant regulations.

The cosmetic industry, which is dynamic and fast-paced, also requires strict regulation. Regulatory frameworks worldwide are quite similar, though differences exist between regions. Below is an overview of key regulatory bodies and laws governing cosmetic products across different countries.

Country/Region Regulatory Bodies Key Laws/Regulations
United States Food and Drugs Administration (FDA) Federal Food, Drug, and Cosmetic Act (FD&C Act), Fair Packaging and Labeling Act (FPLA) (1)
Canada Health Canada Cosmetic Regulation Act (1977), Food and Drugs Act (1985) (2)
Brazil Ministry of Health, ANVISA, GHCOS Various regulations overseeing cosmetic safety and quality (3)
Japan Ministry of Health, Labor, and Welfare Pharmaceutical and Medical Devices Law (PMDL) (4)
China SAMR, NMPA, GAC Cosmetic Supervision and Administration Regulation (CSAR), replacing CHSR in 2021 (5)
European Union European Commission Regulation (EC) N° 1223/2009 (6)

European Cosmetic Regulations (EC) N° 1223/2009

In the European Union, Regulation (EC) N° 1223/2009 (6) is the primary regulatory framework governing cosmetic products. It mandates that all cosmetics placed on the market must be safe for human health when used under normal or foreseeable conditions. This regulation focuses on ensuring product safety and setting guidelines for manufacturers, including the preparation of a Cosmetic Product Safety Report (CPSR).

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Safety Requirements

Cosmetic Product Safety Report (CPSR):The CPSR includes two key parts:

  • Part A: Cosmetic product safety information (e.g., toxicological profile, chemical structure, exposure).
  • Part B:Cosmetic product safety assessment.

The CPSR, along with the Product Information File (PIF), must be kept updated by manufacturers and available for authorities if required.

Animal Testing and Alternative Methods

Animal testing for cosmetics has been banned in many countries, including the EU. Therefore, raw material safety is evaluated using alternative validated methods such as:

  • In vitro tests:
    • Skin/Eye Irritation: EpiDerm (OECD 439) and EpiOcular (OECD 492).
    • Mutagenicity/Genotoxicity: Ames Test (OECD 471) and Chromosome Aberration Test (OECD 473).
    • Photo-toxicity: 3T3 NRU.
  • In vivo tests:
    • Human Repeated Insult Patch Test (HRIPT).

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REACH Regulation for Chemicals

Any chemical, whether macro-, micro-, or nano scale, introduced into the EU market must comply with the REACH regulation (Regulation (EC) No 1907/2006). This ensures a thorough assessment of hazards and exposure risks.

Good Manufacturing Practices (GMP)

Regulation N° 1223/2009 requires that all cosmetics must be produced in accordance with Good Manufacturing Practices (GMP). GMP ensures a clean production environment and guarantees that products are free from contamination during manufacturing.

Ingredient Declaration and Labeling

  • INCI Compliance: Ingredients must be listed using the International Nomenclature of Cosmetic Ingredients (INCI) on the product packaging or in an enclosed leaflet if space is limited.
  • Cosmetic Products Notification Portal (CPNP): Before products can be sold in the European market, they must be listed in the CPNP database. This allows authorities (e.g., poison centers) to access cosmetic product information for market surveillance and safety planning.

Cosmetic Claims and Labeling

The EU Cosmetics Regulation has specific requirements regarding the labeling of products. This includes the name of the product, list of ingredients, expiration dates, and any special precautions for use. Labels must also adhere to rules governing claims made about the product’s effectiveness and characteristics.

Cosmetic Ingredient Dossier (CID)

A Cosmetic Ingredient Dossier (CID) must be compiled for each ingredient used in a cosmetic product. This dossier typically includes:

Conclusion

Marine-derived compounds hold significant potential in cosmetics, food supplements, and medicines. However, the development of such products requires strict adherence to various national and international regulatory frameworks. Manufacturers must ensure their products are safe, comply with established guidelines, and are properly labelled and marketed.

The full potential of marine-derived compounds with FRL has expertise formulation services for cosmeceuticals. Our team ensures products meet standard regulatory requirements across global markets, including quires and compliance with EU regulations. We help you with the process of complexities of ingredient verification, Cosmetic Product Safety Reports (CPSR), and Good Manufacturing Practices (GMP), ensuring efficiency, safety with market upgrades.