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How it works

Cosmedesk automates the PIF generation as required by EU regulation

Create/Add Ingredients

The Regulation lays down rules for ingredients selection, substances authorized, restricted and prohibited for use in cosmetics.

To ensure the safety of a cosmetic product, toxicological data on its ingredients must be completed, for all relevant toxicological endpoints, in order to calculate the Margin of Safety (MoS) and perform the safety assessment of the cosmetic product.

With Cosmedesk, you can create and manage your own cosmetic ingredients or we can provide you their toxicological analysis upon request.

Create/Add Raw Materials

Insert the data on the microbial and physico-chemical specifications, impurities and composition of the raw material, including information on the presence of allergens to guarantee quality control and product safety.

Upload your raw materials technical documents such as the Safety Data Sheet (SDS), the Technical File (TF), The International Fragrance Association (IFRA) certificate, etc., as provided by manufacturers to ensure traceability.

Store, manage and reuse all your raw materials´ information.

Create/Duplicate Products

  • Products Formulation

Throughout the life of a cosmetic product, some points need to be taken into account, including the careful ingredients and raw materials selection, adequate packaging and appropriate labelling.

Cosmedesk allows you not only to create and duplicate your products but also to manage them, from their formulation to the estimate of the exposure levels.

 

  • Label Review

The Regulation deliberates a set of strict requirements for labelling of cosmetic products and one of the legal obligations to guarantee consumer safety, is to ensure compliance with these rules. Without proper labelling, a product will not be allowed into the European market.

Cosmedesk allows you to upload your cosmetic product label and artwork and provides a checklist to help you make sure that it is compliant with the Regulation.

 

  • Safety Evaluation

In order to demonstrate the safety of a cosmetic product, a comprehensive safety evaluation must be completed.

A typical safety evaluation comprises the following steps:

  1. Hazard identification: based on the toxicological profile and the physical and chemical properties of the ingredients.
  2. Exposure Assessment: based on the declared functions and uses of a substance as cosmetic ingredient, the amount present in the respective cosmetic product categories and their frequency of use.
  3. Dose-response assessment: determination of a Point of Departure (POD) usually a No Observed Adverse Effect Level (NOAEL), to establish the relationship between the exposure and the toxic response.
  4. Risk characterization: calculation of the Margin of Safety (MoS), which is the ratio between a PODsystemic  and an estimate of the exposure, represented by a Systemic Exposure Dose (SED).

Cosmedesk automatically calculates the SED and the MoS for each cosmetic ingredient, according to SCCS Notes of Guidance for the Testing of Cosmetic Ingredients and their Safety Evaluation (11thRevision).

Generate Documents

  • PIF
The Product Information File (PIF) is the mandatory compilation information of the technical documentation required for every cosmetic product to be placed on the EU market. The PIF should be kept for 10 years after the last batch is placed on the market and shall include the following information:

Overview of Contents

  1. Description of the cosmetic product
  2. Cosmetic Product Safety Report (CPSR)
  3. Manufacturing method
  4. Proof of the alleged effects
  5. Data on animal testing

 

  • CPSR
The Cosmetic Product Safety Report (CPSR) is the most important part of the PIF and ensures that a safety assessment has been conducted. According to the Regulation, the CPSR shall contain the following information, organized in two sections:

  • Part A

    1. Product’s name and description
    2. Qualitative and quantitative composition of the product
    3. Physical and chemical characteristics and stability of the cosmetic product
    4. Microbiological quality
    5. Impurities, traces, information about the packaging material
    6. Normal and reasonably foreseeable use
    7. Exposure to the cosmetic product
    8. Exposure to the ingredient
    9. Toxicological profile of the substances
    10. Undesirable effects and serious undesirable effects
    11. Information on the cosmetic product
  • Part B

    1. Assessment conclusion
    2. Labelled warnings and instructions of use
    3. Reasoning
    4. Assessor’s credentials and approval of part B
    5. Bibliography 

     

 

  • Labelling Compliance

Cosmedesk provides a checklist with the label requirements to ensure labelling compliance and organizes the list of ingredients in descending order of their weight at the time they are added to the cosmetic product, also taking into account the allergen restrictions.

  • PaO Estimation

The Period after Opening (PaO) represents the period of time after opening for which the product is safe and can be used without any harm to the consumer. Cosmedesk can provide an additional document with the PaO estimation according to the guidelines “Recommandations relatives a l’estimation de la periode apres ouverture” from the Agence française de sécurité sanataire des produits de santé (ANSM).

  • Technical Data Sheet

Cosmedesk automatically generates the Technical Data Sheet, an additional document with an overview of your products more relevant information.

  • CPNP Data Sheet

Cosmedesk offers a document with necessary information regarding the formulation to upload during the registration of the product in the Cosmetic Product Notification Portal (CPNP).

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