The Safety Report, identified as the Annex I of the EC 1223/2009, is one of the essential elements when building up the Product Information File of a Cosmetic product. 

The Safety Report always includes two parts:

• Part A: Safety Information
• Part B: Safety Assessment

Safety Information

The Safety Information, identified in the Annex I of the Regulation, is Part A of the Safety Report within the Product Information File of a Cosmetic product. 

Safety Information includes but is not limited to:

  ✓   The quantitative and qualitative composition of the cosmetic product;
  ✓   The physic-chemical characteristics, microbiological specifications and stability of the cosmetic product;
  ✓   The physic-chemical properties, microbiological and toxicological specifications of the raw materials;
  ✓   The impurities, traces, information about the packaging material;
  ✓   Normal and reasonably foreseeable use of the cosmetic product; 
  ✓   Exposure to the cosmetic product and substances; 
  ✓   Undesirable effects and serious undesirable effects

The safety information can be obtained through the suppliers of the raw materials and the producers of the finished product (easily accessible when producing according to Good Manufacturing Practices) or with the support of external testing laboratories;

Safety Assessment

The Safety Assessment, identified in the Annex I of the Regulation, is Part B of the Safety Report within the Product Information File of a Cosmetic product. 

Safety Assessment includes but is not limited to:

  ✓   Statement on the safety of the cosmetic product in relation to Article 3;
  ✓   Statement on the need to label any particular warnings and instructions of use in accordance with Article 19(1) (d);
  ✓   Explanation of the scientific reasoning leading to the assessment conclusion which is to be based on the possible interactions of the substances contained in the cosmetic product and also on the Safety Information;
  ✓   Justification of the consideration and non-consideration of the different toxicological profiles;
  ✓   Consideration of the impacts of the stability on the safety of the cosmetic product;
  ✓   Assessor’s credentials and approval (name and address proof of qualification, date and signature).

The safety assessment can be obtained through a qualified person with a European degree in Pharmacy, Medicine, Biology, Toxicology or a related discipline (and at least 3 years of experience in the field) otherwise known as a “Safety Assessor”.

In some cases, a special safety assessment needs to be issued:

  ✓   Products intended for use on children under 3 years old.
  ✓   Products intended exclusively for use in external intimate hygiene.

To find out more about the Safety Report, Contact Us. 

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