Cosmetic Product Safety Report Requirements

Our previous blog post briefly explained what the Cosmetic Product Safety Report (CPSR) is and why do you need one to run a successful cosmetic business. In this post, we will explain in more detail the requirements and structure of the Cosmetic Product Safety Report.

Don't, worry, the Cosmetic Product Safety Report doesn't need to look like the picture below, nevertheless, there are certain elements that have to be included.

Cosmetic Product Safety Report Structure

The CPSR consists of Part A – Cosmetic product safety information and Part B – Cosmetic product safety assessment.

Part A aims to gather all the data necessary for the safety assessment of the product and must contain 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. Information on the cosmetic product.

Part B of the Cosmetic Product Safety Report sets out the reasons for drawing a conclusion regarding its safety.The following sections must be included: 1. The assessment conclusion. 2. The labelled warnings and instructions of use. 2. The reasoning. 3. The credentials of the safety assessor and their final approval.

Cosmetic Product Safety Report Requirements

The structure and content of CPSR are mandated by regulation and have to be followed. There are other important requirements for the safety report which are highlighted below.

The list is by no means exhaustive but provides useful pointers on preparation of a high-quality Cosmetic Product Safety Report.

• The cosmetic product safety report should be drawn up in a transparent way and should be well-argued and easily understood.

• The structure and content of the safety report should reflect the above requirements. However, if the report does not directly contain the required information, it should provide a reference to another readily available source, e.g. scientific literature, information provided by supplier of an ingedient.

• The data required for compilation of Part A can be drawn from any reliable source, e.g. scientific literature or experience with similar products.

• The CPSR must include a conclusion. The conclusion should state whether the product is safe, safe with restrictions or not safe for human health when used under normal or reasonably foreseeable conditions of use. The legal framework for the assessment should be explicitly mentioned.

• The qualified safety assessor remains the only professional allowed to carry out the Cosmetic Product Safety Assessment as described in Part B.

Watch this space for upcoming blog posts exploring further aspects of cosmetic regulations and how to make and sell your cosmetics in a safe and compliant way. We will make it simple!

CPSR is only one of many obligations under the current EU/UK cosmetic legislation. Please get in touch via info@moleculeregulatoryservices.co.uk for further information.

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