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As of July 11, 2013, the previous Cosmetics Directive has been replaced with the new European Union (EU) Cosmetic Regulation 1223/2009. The new regulation’s intent is to ensure that the health of consumers’ is protected and that EU agencies are well informed of the composition, labeling, and safety of cosmetic and personal care products marketed within the EU. This involves several changes, most of which are summarized below:

Responsible person

“Only cosmetic products for which a legal or natural person is designated within the Community as ‘responsible person’ shall be placed on the market.” In order to demonstrate that a cosmetic product complies with the new regulations, a “responsible person”, typically the manufacturer, must be selected and assigned to each product to ensure that it has undergone the necessary safety assessment and that all required information is included in the Product Information File (PIF). The manufacturer may designate another qualified person as the responsible person in writing and upon their acceptance (i.e. regulatory consultant). Microchem maintains a list of Regulatory Consultants that can assist cosmetic and personal care companies in designating a Responsible Person and in putting together the necessary information for the PIF.

The Product Information File

The new European Union Cosmetic legislation states that all cosmetics must have a product information file (PIF) which is to include the following:

PART A – Cosmetic product safety information

  1. Quantitative and qualitative composition of the cosmetic product
  2. Physical/chemical characteristics and stability of the cosmetic product
  3. Microbiological quality
  4. Impurities, traces, information about the packaging material
  5. Normal and reasonably foreseeable use
  6. Exposure to the cosmetic product
  7. Exposure to the substances
  8. Toxicological profile of the substances
  9. Undesirable effects and serious undesirable effects
  10. Information on the cosmetic product

PART B – Cosmetic product safety assessment

  1. Assessment conclusion
  2. Labeled warnings and instructions of use
  3. Reasoning for the conclusion
  4. Assessor’s credentials and approval of part B

The Microbiological Quality, listed as #3 above, is to include the microbiological specifications of the raw materials and the finished product, including a preservative efficacy test (“challenge test”). Preservatives are antimicrobial substances added to cosmetic and personal care formulations to inhibit the growth and reduce the level of microorganisms in the cosmetic product.

The preservation system in cosmetic and personal care products should be broad spectrum, covering a wide range of bacteria (Gram-positive and Gram-negative), yeasts, and molds. An effective preservative will inhibit the growth of the microorganisms and significantly reduce a microbial population within the proposed shelf-life. Acceptable preservative efficacy test methods include the following:

  • Compendial Methods such as United States Pharmacopoeia method (USP <51>) and European Pharmacopoeia (EP) method;
  • Trade association methods, such as the Personal Care Product Council (PCPC), formerly the Cosmetic, Toiletry, and Fragrance Association (CTFA), methods for preservation testing.

It is also a regulatory requirement within the EU that consumers be informed of the date until which the cosmetic product will continue to fulfill its initial function and remain safe. Therefore, it is also important to assess the preservative efficacy of the product following the shelf-life and stability testing regimen. Microchem specializes in preservative efficacy and microbiological quality test methods. Please contact us or get a same-day price quote for more information.

Animal testing

Animal testing must be replaced by alternative methods where possible. The new Regulation prohibits the use of animals for testing in the EU for all finished products and ingredients. It also prohibits the sale of any products that have already been subjected to animal testing. Alternative in vitro methods for skin and eye irritation, sensitization and corrosion are available to reduce the need for in vivo animal testing.

Product Labeling

Cosmetic and personal care products intended to be marketed in the EU must contain the following information either on the immediate product package where possible and in easily legible format: the name or registered name and the address of the responsible person; the country of origin for imported products; the weight or volume of the content at the time of packaging; a use-by date for products kept in appropriate conditions; precautions for use, including cosmetics for professional use; the batch number of manufacture or the reference for identifying the cosmetic product; the list of ingredients, i.e. any substance or mixture intentionally used in the product during the process of manufacturing.

For more information regarding microbiological quality testing, Shelf-life and Stability Testing or non-animal toxicity testing, for products to be marketed in the EU, please contact Microchem.


  1. Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products.
  2. The Safety Factor in Preservative Efficacy Testing By: Donald S. Orth, Neutrogena; David C. Steinberg, Steinberg & Associates Posted: May 6, 2003, from the April 2003 issue of Cosmetics & Toiletries.