EC Guidelines on Product Information File

On November 25th 2013, the European Commission has published the Implementing Decision 2013/674/UE on Guidelines on Annex I to Regulation (EC) No 1223/2009, towards supporting the cosmetic industry to achieve compliance with the Regulation requirements.

The Guidelines list the data that should be available “as a minimum” with a cosmetic Product Information File – to be made readily available at the EU address of the Responsible Person:

PART A of the Cosmetic Product Safety Report (CPSR) – SAFETY INFORMATION

  1. Quantitative & Qualitative composition of the cosmetic product
  • Each raw material of the composition is to be identified and quantified
  1. Physical/chemical characteristics and stability of the cosmetic product
  • Physical/chemical characteristics of substances or mixtures
  • Physical/chemical characteristics of the finished product
  • Stability of the cosmetic product under reasonably foreseeable storage conditions
  • The methodology used to determine the product’s minimum durability
  1. Microbiological quality
  • Microbiological quality of substances and mixtures
  • Microbiological quality of the finished cosmetic product
  1. Impurities, traces, information about packaging material
  • Purity of substances and mixtures. Impurities: unintended substances in raw materials
  • Evidence of the technical unavoidability of traces of prohibited substances
  • The relevant characteristics of the packaging material in direct contact with the product
  1. Normal and reasonably foreseeable use
  • Section essential to determine a relevant exposure scenario
  • Warning and other explanations on the labeling should be consistent with the identified normal and reasonably foreseeable use
  1. Exposure to the cosmetic product
  • To quantify the amount of cosmetic product coming into contact with the external part of the human body or the teeth and the mucous membranes of the oral cavity
  1. Exposure to the substances
  • To quantify the amount of each substance coming into contact with the external part of the human body or the teeth and the mucous membranes of the oral cavity
  1. Toxicological profile of the substances
  • To describe the toxicological hazard of each of the substances in the finished product
  • To determine the potential exposure
  • To draw up a risk characterization
  1. Undesirable effects and serious undesirable effects
  2. Information on the cosmetic product

PART B of the Cosmetic Product Safety Report (CPSR) – SAFETY ASSESSMENT

  1. Assessment conclusion
  • A product can be assessed as: ‘safe’, ‘safe with restrictions’ or ‘not safe
  1. Reasoning leading to the Assessment conclusion
  • This must cover:
    • Safety Evaluation of substances & mixtures
    • Safety Evaluation of the Cosmetic product
  1. Warning & Precautions of use
  • Must appear on the Cosmetic product label
  1. Assessor’s credentials
  • Name and address, proof of qualification, date and signature

Future Expectations

Manufacturers and Responsible Persons should cooperate together to achieve complete and compliant product information files taking into consideration that EU Member state Authorities will rely on the above guidelines when conducting post market surveillanceactivities.

If you would like to know more on the Guidelines on the Product Information File, please contact us.

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