Required Data

Institute Dr. Schrader

Required Data

What documents are required for a safety assessment?

To create safety reports including safety assessments for your products, we require the following documents in German or English:

  • Qualitative and quantitative formulation
  • Manufacturing procedure
  • Filling material instruction
  • Toxicological data of the used raw materials:
    including testing for acute toxicity (cytotoxicity)
    Testing of skin, mucous and eye irritation
    Testing for sensitization (contact allergy)
    Testing of skin penetration
    Mutagenicity study
  • Product and safety data sheets and certificates of analysis of the raw materials used, information about impurities
  • INCI declaration- listing ingredients
  • Results of the chemico-physical testing (test specification) of the final product
  • Results of the storage stability tests
  • Results of the microbiological tests (Preservative challenge test; in-use studies)
  • Dermatological tolerance tests on the finished product
  • Certificate of conformity of the perfume oil (separate safety assessment of the manufacturer) as far as contained
  • Details of packing materials
  • Original sample or product label and product claims
  • Complaints Statistics (if available)

In order to create a safety assessment, we need numerous documents. Should not all toxicological data be available, the documents can be completed by database searches of us.

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