Collection of cosmetics raw materials and ingredients laid out in plates and bowls on white background.
Author

Jaclyn Bellomo

Senior Director of Cosmetic Science and Regulatory Affairs

Raw Materials & Their Ingredients for Cosmetic Quality & Compliance

Jun 5, 2024

Your raw materials and their ingredients are what create your finished cosmetic product. It’s impossible to produce a quality cosmetic that complies with government regulations without managing its components correctly.

Proactivity is the key, and companies should develop systems to check for compliance during the entire product lifecycle. These compliance checks should start with evaluating the ingredients in raw materials.

Your evaluation should provide assurances that raw materials are properly vetted, handled, and maintained. Prioritizing quality and compliance at the raw material level will help you avoid costly errors and will prevent products going to market that are not compliant.

Here are things to remember when formulating cosmetics to comply with EU regulations.

Checking Raw Materials for Quality   

Raw materials should meet quality standards and have documentation to ensure their safety is easily traceable.

Here are some things to include in your workflow when managing raw materials:

  • Keep raw materials well organized and clearly labeled
  • Include batch/lot information on labels so you can trace materials
  • Regularly take stock of inventory and investigate discrepancies

Your product’s raw materials aren’t just important during the initial formulation. They also play a significant role in reformulating cosmetics.

Companies may need to reformulate a product based on various factors. For example, a shift in consumer demands or supply chain constraints may be causes for reformulation.

When this happens, it’s imperative that formulators incorporate replacements that do not cause the product to fall out of quality standards. Developing a method to manage your raw material quality prevents these unintended mishaps.

Checking Ingredients for Compliance

Companies should be familiar with ingredient regulations for regions they want to sell their products in. You should only include ingredients allowed in your target markets.

Your company’s Responsible Person (RP) should act as the gatekeeper of your cosmetics. The RP must be vigilant about monitoring your product’s ingredients, assuring the cosmetic’s intended use and exposure to ingredients are safe. 


REGULATION (EC) No 1223/2009 catalogues whether cosmetics on the EU market can contain certain ingredients.

Annex II of the regulation includes an extensive list of prohibited ingredients. Conversely, Annex VI provides a list of allowed color additives.   


Though the regulations are explicit, they are subject to revision. Companies should stay abreast of regulatory changes to assure they adjust ingredients when regulations shift.   

For example, France recently announced its intention to initiate proceedings that could prohibit Cannabidiol (CBD) in cosmetics marketed in Europe. Companies currently marketing CBD-containing cosmetics would need to adjust their formulas to continue selling those products in the EU.

Developing a System for Formulation Compliance Checks

It can be easy to overlook small details when bringing a cosmetic product from formulation to market. Unfortunately, minor infractions with your raw materials or their ingredients could cause major issues. These issues could prevent your product from landing into consumers’ hands.

This is why taking a methodological approach to compliance is so important.

One way to systematize compliance is to employ software that automates the process, reducing the likelihood of human error. You can use a platform like Product Manager to monitor compliance at the raw material stage. You can also store and manage associated documentation for your raw materials and ingredients.

Incorporating automation into your compliance strategy can help you remain confident that your cosmetic’s raw materials and their ingredients align with applicable regulations in the EU and beyond.

Confidently research, develop, and produce effective, safe, and compliant products   

Discover Product Manager’s powerful solutions for streamlining cosmetic compliance.

Get a Demo 

Author


Jaclyn Bellomo

Senior Director of Cosmetic Science and Regulatory Affairs

A seasoned expert on the cosmetic industry, Jaclyn's deep understanding and insights on cosmetic regulations brought on with the passage of the Modernization of Cosmetics Regulation Act (MoCRA) are unmatched. Her experience and reputation throughout the global cosmetic industry helps companies worldwide meet the newly enacted FDA regulations under MoCRA.

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