Key Takeaways

  • Product Safety Substantiation has always been a requirement under the Food, Drug, and Cosmetic Act. 
  • The Modernization of Cosmetics Regulation Act (MoCRA) has strengthened these requirements, making safety substantiation even more critical than before.
  • A robust Safety evaluation system helps identify and address gaps in the substantiation process.
  • Continuous monitoring of Safety substantiation will help keep up with ever changing Regulations.

What is this article about:

Ensuring the safety of cosmetic products is more than a regulatory obligation. It is a very important aspect to brand reputation and earning the customer trust. This was always part of requirements but since the Modernization of Cosmetics Regulation Act (MoCRA) came into effect, the cosmetic safety standards have become stringent. Here is a deep dive into what is needed to fully proof your Cosmetic Safety Substantiation.

What You Need to Know:

  • Manufacturers and marketers of cosmetics are responsible for ensuring the safety of their products prior to being placed on the market.
  • The Safety of cosmetic products starts at the ideation stage in the New product development process. It is always a good practice to include any restricted ingredient lists, required testing, and clinical safety considerations in the lab briefs.
  • Ingredient/Raw materials safety is the building block of a safe final product. Manufacturers can rely on existing safety data for individual ingredients or similar product formulations.
  • Cosmetic ingredient suppliers often provide safety data for their materials. Certificates of Analysis (COAs), Safety data sheets (SDS) are essential to verify purity and safety. 
  • In addition, published studies from scientific journals and reputable sources such as the Cosmetic Ingredient Review (CIR), PubMed, and TOXNET can also support Safety Substantiation. 
  • A thorough review of toxicological profiles, justification of ingredient concentrations for their intended use, and assessment of impurities such as heavy metals or residual solvents should be included in establishing the safety conclusion for the final product. 
  • Exposure assessment is also a key factor in evaluating the safety of the final product product and should be based on
  • Frequency and duration of use.
  • Application area and recommended amount.
  • Leave or rinse-off.
  • User group- adult vs. children.
  • Safety Testing on the final approved formula should be robust and conducted at Testing Facilities which are well equipped.
  • Stability testing: to ensure safety over the product’s shelf life. 
  • Microbiological testing: to confirm preservative efficacy and microbial limits.
  • Patch testing (HRIPT): to assess skin compatibility, especially for leave-on products. 
  • Ophthalmology test: product intended for the eye area.
  • Other tests such as Comedogenicity test, Acnegenicity test, Lactic acid sting test (LAST) should be considered for Safety Substantiation based on products intended for the user group.

Definitions

MOCRA: Modernization of Cosmetics Regulation Act of 2022

Patch testing/Human Repeat Insult Patch Test (HRIPT): A clinical test used to evaluate whether a product causes skin irritation or allergic reactions after repeated application.

Timeline

In effect since Dec 2023.

Impacts

  • The FDA can take enforcement action against companies that fail to comply with Safety Substantiation requirements or fail to provide this safety substantiation upon request.
  • Inadequate safety documentation increases the risk of regulatory audits and may trigger investigations in related areas, such as Adverse Event reporting.
  • Manufacturers and marketers may face legal consequences, including lawsuits, if products cause harm due to lack of safety.
  • Regulatory actions, product recalls, or safety concerns can severely damage a brand’s credibility and consumer trust.
  • Global market access may be restricted, as Safety Substantiation is a critical requirement in many international regulations.

Our Expert Advice

Ithos expert advice
Need help understanding these requirements?

Contact Ithos today have our regulatory team help in your next review!

  • Integrate safety planning at the ideation and formulation stage.
  • Define your safety substantiation needs, documentation, and process and complete all requirements prior to placing a product on the market.
  • Set up a robust Safety Substantiation System capturing the safety of ingredients and the final formula.
  • Perform relevant Final Product Safety Testing.
  • Maintain all the Safety Substantiation records.
  • Keep your Safety file up to date with regulatory changes, formula updates, and new safety data. Set a schedule for periodic reviews.
  • Monitor evolving regulations to respond swiftly and stay compliant.

How the Ithos Regulatory Team can help

  • Our regulatory team can act as your representative, collaborating with raw material suppliers and manufacturers to collect and evaluate all necessary Safety Substantiation documents.
  • Ithos software can extract and maintain ingredient level information.
  • Ithos software can manage and securely store all the supporting documentation in the Ithos software (IIN).
  • We closely monitor regulatory changes and can help you to adapt quickly.
Reference links

FDA Website: Modernization of Cosmetics Regulation Act of 2022 (MoCRA)
https://www.fda.gov/cosmetics/cosmetics-laws-regulations/modernization-cosmetics-regulation-act-2022-mocra

FDA Website: Product Testing of Cosmetics
https://www.fda.gov/cosmetics/cosmetics-science-research/product-testing-cosmetics#Who_s_responsible

CFR Reference:
https://www.ecfr.gov/current/title-21/chapter-I/subchapter-G

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