Cosmetics and Personal Care Regulatory Compliance

Understanding the ever-changing cosmetic regulatory compliance landscape is crucial to achieving and maintaining conformity. Local and global rules are particularly harsh and varied in the industry.

Consumer safety

Consumer safety is a priority for cosmetic and personal care products companies. In the U.S., manufacturers are committed to keeping strict FDA regulations as required by the FD&C Act. The law requires that every cosmetic and personal care product and its ingredients be tested for safety before going to market, and that they contain no prohibited ingredients. Complicating this business challenge is a cosmetic regulatory compliance that involves extensive testing and data to substantiate marketing claims.

Cosmetic regulatory compliance and product labeling

Cosmetic regulatory compliance also regulates product labeling. Cosmetic product labeling and claims must comply with the regulations stipulated in the Food, Drugs and Cosmetics Act and the Fair Packaging and Labeling Act. Misbranded cosmetics products are illegal and may be the result of false or misleading labeling, failure to provide required information, improper display of label information, or violation of the Poison Prevention Packaging Act.

E.U. regulatory compliance example

In the E.U., the Cosmetics Regulation (EC) No. 1223/2009 sets out labeling requirements in order to provide consumers with access to the information they need. Cosmetic regulatory compliance on labeling includes:

  • Manufacturer, importer or distributor’s name and address
  • Nominal content by weight or volume
  • Date of minimum durability, or period after opening (PAO)
  • Precautions to be observed in use
  • Goods identification reference – batch number or manufacturing code
  • The function of the product
  • Ingredients in INCI nomenclature

The Cosmetics Regulation (EC) No. 1223/2009 also requires the national governments to have surveillance systems that monitor compliance with all requirements. For instance, an official body in each country carries out in-market control inspections. These bodies have powers to analyze samples for cosmetic regulatory compliance with requirements for labeling, ingredients and microbiological quality.

As of 11 July 2013, cosmetic products manufactured / distributed in the E.U. must conform to the Good Manufacturing Practices (GMP). One way to demonstrate compliance with GMP is to implement the international standard ISO 22716:2007.

Global cosmetic regulatory compliance

International ISO 22716 introduces a personal care regulation management systems approach to documenting and regulating the production, control, storage, and shipment of cosmetic products. The standard’s guidelines provide business with practical methods for managing the many factors that can affect product quality. ISO 22716 standards achieve both consumer safety and environmental protection.

Cosmetic regulatory compliance also requires that each cosmetics marketed product goes through a challenge test (CT), an effective solution to evaluate contamination risks, and avoid bacteria, mold, or yeast proliferation. However, CT is expensive and laborious. Without an effective preservative system, proliferation of microorganisms can cause health hazards, skin infections, pH changes and degradations (odour, color, general appearance). Personal care regulation management is crucial for personal care businesses. It assists quality teams in cosmetic regulatory compliance and daily tasks. It smoothes continuous improvement processes too.

Lascom suite to improve personal care regulation management

Personal care regulation management is essential for businesses to effectively conform to cosmetic regulatory compliance. Companies with a loose personal care regulation management process or with a lack of visibility on it risk significant issues such as slower time to market, increased volume of recalls, sales bans, etc.

Effective personal care regulation management avoids losing revenue, wasting time and money and preserve brand image on the market.

Success Stories

  • Lascom PLM solution for all Eili/Lilly European factories