safety assessment of cosmetic products

 

Chemila spol. s r.o., offers the elaborating of the cosmetic product safety assessment in conformity with the Part B of Annex I of Regulation (EC) No 1223/2009 and on the basis of documents provided by the manufacturer.
Dossier must be completed according the requirements of the Part A (Cosmetic product safety information) of Annex I of Regulation (EC) No 1223/2009 and shall, as a minimum, contain the following:

  • Quantitative and qualitative composition of the cosmetic product
  • Physical/chemical characteristic and stability of the cosmetic products (of substances or mixtures and finished product)
  • Microbiological quality (of substances and mixtures and finished product )
  • Impurities, traces, information about the packaging material
  • Normal and reasonably foreseeable use
  • Exposure to the cosmetic product
  • Exposure to substances
  • Toxicological profile of the substances
  • Undesirable effects and serious undesirable effects
  • Information on the cosmetic product

 

Complete structure of required documentation is at disposal here:  

Structure of the product information file.pdf

 

laboratory testing of cosmetic products

Based on the requirements resulting from the Part A (Cosmetic product safety information) of Annex I of Regulation (EC) No 1223/2009 offers Chemila spol., s r.o.  following laboratory tests:

 

sensorial

  • appearance, fragrance, color, consistency

 

physical and chemical

  • pH, dry matter, determination of acid number, dose volume, packaging leakage, humidity, viscosity

 

stability testing

  • it  is monitored in the course of various time intervals of storage of the product (the 0th, 1st, 3rd, 6th, 12th ... month) the influence of temperature (5°C, 25°C, 30°C, 40°C .. .) and humidity (75%, 60% ...) on physical, chemical and sensorial parameters (appearance, fragrance, color, consistency, pH, dry matter, determination of acid number, dose volume, packaging leakage, humidity, viscosity) and microbial safety (detection of specific and nonspecific microorganisms, enumeration of microorganisms).

    For each time interval is used the unopened container with the product, so the number of products stored at the beginning of the experiment at the appropriate temperature and humidity is identical to the total number of intervals.

    The basic generall accepted assays include for our climate zone accelerated tests (1, 3, 6 months / 40°C ± 2°C / 75% ± 5% humidity) and long-term tests (1, 6, 12 months / 25°C or 30°C ± 2°C / 60% ± 5% humidity). Accelerated tests of above mentioned parameters allow the declaration of minimum durability 2 years, however they must be always accompanied by a long-term test.

    Setting the parameters of stability testing depends on the composition of the product, on manufacturing experience, previous experience with similar products and it is up to manufacturer what conditions will require.

 

microbiological

  • proof of specific microorganisms (Pseudomonas aeruginosa, Staphyloccoccus aureus, Candida albicans, Escherichia coli),
  • determination of number and identity of non-specific microorganisms (mesophilic bacteria and yeasts),
  • challenge test (testing of efficacy of the preservation of cosmetic products) according ISO 11930: Cosmetics - Microbiology - Evaluation of the antimicrobial protection of cosmetic product

 

toxicological

  • in vitro testing of cytotoxicity according ISO 10993-5: Biological evaluation of medical devices - Part 10: Tests for in vitro cytotoxicity
  • in vitro testing of skin irritation (EpiDerm SIT_EPI-200 Irritation Test according OECD TG 439)
  • testing of skin irritation on human volunteers according ISO 10993-10: Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization