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The ABCs of Product Information Files and Safety Reports

Guest article by Mag. Dr. Doris Plank

In the production of cosmetics, the legislator also provides for certain measures under Article 11 of the EU Cosmetics Regulation to ensure that no product is placed on the market that could cause damage to health despite proper use. In the case of cosmetics, this is the creation of a Product Information File.

Your obligations as a cosmetics manufacturer

As a cosmetics manufacturer or responsible person, you know that you must create a Product Information File (PIF) for every cosmetic product. This must be prepared before you place the cosmetic product on the market and must be kept up to date.

Furthermore, the PIF must be kept at the address of the responsible person in electronic or other form for a period of 10 years after the last batch of the cosmetic product has been placed on the market. The responsible person is usually the one indicated on the product label. This is to ensure that authorities can quickly access all necessary information if required.

What does the Product Information File contain and who is allowed to create it?

With the exception of the safety report, the Product Information File may be created by you yourself and contains the following documents:

  1. Description of the cosmetic product,
  2. Manufacturing method and the statement of compliance with Good Manufacturing Practice,
  3. Evidence of the claimed effect,
  4. Data on animal testing performed (or not performed),
  5. Safety report.

Let's go through the individual points in more detail:

1.) Description of the cosmetic product

The description usually contains the following points:

  • Description of your product
    Basically, one sentence is sufficient for this.
  • Qualitative and quantitative description
    Presentation in a tabular form is best suited for this.
  • Physico-chemical and microbiological specifications of your product
  • Packaging information
    This usually refers to the certificate of safety/conformity for the packaging.
  • Label
    An image of the front and, if applicable, the back of the label.

2.) Manufacturing method and the statement of compliance with "Good Manufacturing Practice"

This sub-point contains your manufacturing instructions. In addition, the statement of compliance with "Good Manufacturing Practice" must be filed. This can be a simple document containing the product name, date, and your signature.

3.) Evidence of the claimed effect

If you advertise your product with a specific effect, corresponding evidence (e.g., dermatological tests) must be provided here.

4.) Data on animal testing performed (or not performed)

5.) Safety report

The main part of your Product Information File is the safety report. The safety report may only be written by you if you have the appropriate education (degree in medicine, pharmacy, chemistry, or a comparable qualification). Otherwise, the safety report is written by a safety assessor and you.

Some safety assessors will also create the entire PIF for you. It is important to be attentive here to ensure that you receive the optimal version for your needs.

Normally, you provide the safety assessor with the following information:

  • the current safety data sheet and certificate of analysis for every raw material used,
  • manufacturing proof (formula),
  • allergen data for essential oils/perfumes,
  • packaging information,
  • etc. (further information may also be requested).

The safety report for your cosmetic product is written from all this information.

What does a safety report contain?

The safety report is divided into two parts:

  • Part A: Safety information on the cosmetic product
  • Part B: Safety assessment.

Part A: Safety information

  1. Quantitative and qualitative composition of the product
    The following data for each raw material is usually recorded in a table:
    • INCI names,
    • CAS number (international number for substances),
    • ELINIC/EINECS number (EC number of European chemical law),
    • concentration, and
    • the intended function.
  2. Physical and chemical properties of the raw materials
    The physical and chemical properties of each raw material are summarized.
  3. Physical and chemical properties as well as information on the stability of the product
    In this section, the physical and chemical properties and information on the stability of the product are explained.
  4. Microbiological quality of the raw materials and the product
    This sub-point usually also contains the results of the preservative efficacy test.
  5. Information on packaging material, impurities in the raw materials.
  6. Normal and foreseeable use
  7. Exposure data and calculation
    From the exposure data: place of application, size of the affected surface area, how often the product is used, target group, how exposure is calculated. If applicable, so-called secondary exposures are also considered, such as the inhalation of sprays, unintentional ingestion of lip products, etc.
  8. Toxicological profiles of all raw materials and Margin of Safety (MoS)
    Calculation: Here, the following information is summarized, usually in tabular form:
    • acute toxicity,
    • irritation potential (skin & eye),
    • sensitization potential, and
    • carcinogenicity and mutagenicity.
    • The MoS (Margin of Safety) value is also calculated. This safety margin calculation is based on the NO(A)EL value and the exposure calculation from point 7.
  9. Undesirable side effects
    If side effects are known, these must be recorded here.
  10. Other relevant information
    These could be, for example, studies on volunteers.

Part B: Safety assessment

  1. Conclusion of the assessment
    The essential statements regarding the safety of the cosmetic product are recorded and described here.
  2. Label warnings and instructions for use
    Some substances require warnings and instructions for use. A distinction is made here between legally mandatory and voluntary ones. For example, all toothpastes containing sodium fluoride must be labeled with the statement "Contains sodium fluoride" (legally mandatory). Voluntarily, it can also be an advantage to write things like "Only remove with clean fingers" on cream jars.
  3. Reasoning
    Scientific considerations that led to the conclusion of the assessment are explained here.
  4. Qualification of the safety assessor
    The curriculum vitae of the safety assessor is usually integrated here.

As you can see, a safety report contains a lot of information about your product and the raw materials you use. Basically, the safety report is the evidence that the product complies with the Cosmetics Regulation (EU Cosmetics Regulation (EC) No. 1223/2009) regarding its composition and is safe for human health. Current legislation requires a safety report for every cosmetic product; no exceptions are permitted.

Since every safety assessor has their own style, the order of the chapters may vary, but all information must be included.

doris-plank

Mag. Dr. Doris Plank | + 43 650 311 38 33 | www.cosmetic-consulting.at | doris@cosmetic-consulting.at
As a chemist with a doctorate and experience in quality management, Doris deals intensively with the composition and (toxicological) effect of modern natural cosmetics and, among other things, creates Product Information Files (PIF) including safety reports for her clients for cosmetic products in accordance with the EU Cosmetics Regulation (EC) No. 1223/2009 and its supplementary provisions.

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