Safety Assessment Report and Product Information File for Cosmetics

In the different cosmetics regulations worldwide a cosmetic safety assessment for human health is completed for cosmetic products. In addition, cosmetic products should be correctly labelled and packaged with appropriate INCI (International Nomenclature for Cosmetic Ingredients) ingredients listing and warnings.

A Cosmetic safety assessment is an approach mandated in the EU, but also widely requested by buyers and authorities in North America, ASEAN Cosmetics Directive, Saudi Arabia and other countries like China considerated as an alternative method.

Our experts offer different types of service as required by various cosmetic legislations:

EU Regulation 1223/2009 applies to all cosmetics on sale in the EU – in the UK this regulation is enforced through the Cosmetics Enforcement Regulation 2013

Our EU services include: Safety Assessments, Packaging Approval, Claims Approval, Product Information Files, Dossiers, Registrations, EU Responsible Person Duties according to Turkish and EU regulations

The documents need for Product Information File

• Information of manufacturer or importers  (Adress, Contact information)
• A description of the cosmetic product that enables the product information file
• Formulation of the product (INCI names and concentrations)
• SDS/MSDS of the Product and Raw materials
• The cosmetic product safety assessment report
• A description of the method of manufacturing and a statement on compliance with good manufacturing practice (GMP). GMP is covered in Article 8 of the Regulation
• GMP Declaration or Certificate
• Artwork/Image of the product package/product
• Where justified by the nature or the effect of the cosmetic product, proof of the effect claimed for the cosmetic product
• Cosmetic Stability, Microbial, Physical-Chemical, Challenge and Dermatological Tests
• Data on any animal testing performed by the manufacturer, his agents or suppliers, relating to the development or safety assessment of the cosmetic product or its ingredients, including any animal testing performed to meet the legislative or regulatory requirements of countries outside the EU

The cosmetic product safety report shall, as a minimum, contain the following:

PART A – Cosmetic product safety 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. Information on the cosmetic product

PART B – Cosmetic product safety assessment

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

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