Safety Assessment in Cosmetic Products

Immediate effects and long-lasting effects of unsafe cosmetic products can cause irreversible results. Cosmetic products should be safe for both consumers and professionals to apply cosmetics on the consumer. Considering that they have been used extensively throughout human life, it is an important requirement to conduct safety assessments by the safety assessor for each cosmetic product before introducing them to the market.

A cosmetic product made avaliable on the market should have the characteristics of not being harmful to human health when applied under normal use and reasonable conditions foreseen by the manufacturer or in accordance with the terms of use proposed for the presentation, labelling and use of the product or the information provided by the manufacturer (Article 6 of the Cosmetics Regulation). Products having these characteristics and complying with the Cosmetics Legislation are considered to be “safe”.

With the Cosmetics Law No. 5324, which entered into force in our country on 24.3.2005, it is aimed to ensure that cosmetic products are offered to the public safely, effectively and in good quality. For this purpose, in paragraph “d” of Article 12 of the Regulation the matters on safety assessment in the finished product for human health are specified.

According to the Cosmetics Law, the manufacturer should ensure that this assessment is made for every product to be made avaliable on the market in order to protect human health and ensure product safety. This assessment should concern the toxicological character, chemical structure and exposure level of the product components, the specific exposure characteristics of the target consumer, in which the product is presented, or the area to which the product to be applied. Special safety assessment is required for products that are manufactured for children under the age of three and for personal hygiene products for the external genitalia. Information, documents and reports in relation to this assessment should be filed in the product information file under the heading of “Product Safety Assessment Report”.

The safety assessor to make this assessment should be a person with a pharmacy diploma or a person with medical, dentistry, biology, chemistry, biochemistry, microbiology or equivalent diploma and has completed the theoretical and applied curriculum program in the field of toxicology or in the field of cosmetic product safety assessment.

The duties of the safety assessor are as follows;

     (1) The Safety assessor prepares the cosmetic product safety report in accordance with this guideline by reviewing the available data that he/she has obtained from various sources.

     (2) In the light of the relevant additional information arise after the product is introduced to the market, he/she ensures that the safety assessment report is up-to-date in case of any changes occurring in the formula of the product, the source of the raw material or in the proposed use. In paragraph “d” of Article 12 of the Cosmetics Regulation, the matters specified for safety assessment for human health in the finished product have been manualized. “Guideline for Safety Assessment in Cosmetic Products” was published by the General Directorate of Pharmaceuticals and Pharmacy on 22.03.2012. “Guideline for Safety Assessment in Cosmetic Products” entered into force with the authority consent numbered 60443 and dated 26.06.2012. The current version is 2.0.

The Situation in Europe

Manufacturers exporting cosmetics to the EU before 2013 were in compliance with the EU Cosmetics Directive 76/768/EEC and the EU Cosmetics Regulation EC 1907/2006 after that.

The first practices of EC Cosmetic Regulation EC 1223/2009 started in January 2012. Together with the revisions made during the transition from directive to regulation, there have been significant changes in the obligations of companies exporting cosmetic products to the EU.

As of 11 July 2013, there has been a significant change in safety assessments for products already on the market or newly introduced to the market in terms of documentation and submitting of reasonings. A safety report is required to be created after the safety assessment.

The new regulation clarifies what information should the manufacturers have in the safety assessment of their product in order to prove the safety of the cosmetic products that they have introduced to the market. The old directive did not provide detailed information in this regard.

Product Safety Information and Assessment Report

The margin of safety (MoS) of product components should be calculated in the product safety assessment report. The highest application amount (NOAEL) of the substance, in which the UNDESIRABLEe effect is not observed, is used in MoS calculations. In addition, in order to be able to make an assessment for all toxicological routes of absorption and systemic effects, the amount of component expected to pass into the bloodstream – systemic exposure dose (SED) – will also be needed.

The safety assessment consists of two parts; where the product safety information is included, and the reporting part.

The first part contains the following information;

  1. Quantitative and qualitative composition of the cosmetic product
  2. Physical/chemical characteristics and stability of the cosmetic product
  3. Microbiological quality
  4. Impurities, traces, information about the packaging material
  5. Normal and reasonably foreseeable use
  6. Exposure to the cosmetic product
  7. Exposure to the substances
  8. Toxicological profile of the substances
  9. Undesirable effects and serious undesirable effects
  10. Relevant information on cosmetic products

Following information is included in the second part;

  1. Assessment conclusion
  2. Labelled warnings and instructions of use
  3. Reasoning
  4. Identity information and approval of the person performing the assessment