Cosmetics safety assessment (CPSR)

WHAT IS THE COSMETICS SAFETY ASSESSMENT, WHY DO YOU NEED IT AND HOW IS IT PERFORMED?

Cosmetics Regulation 1223/2009 aims to ensure the safety of cosmetic product consumers. This means that each cosmetic product must be the subject of a safety assessment performed by a qualified person, before the product can be placed on the EU market.

Safety assessment forms part B of the cosmetic product safety report (CPSR), and therefore is a vital part of the product information file. Cosmetic product safety assessment is conducted based on part A of the CPSR, which gives cosmetic product safety information and includes documents such as:

• the cosmetic product formula (the qualitative and quantitative composition of the product),
• raw material specifications and toxicological profiles of the substances used,
• physical and chemical specifications of the finished product,
• microbiological quality and the results of the preservation challenge test (if relevant),
• stability of the cosmetic product and its compatibility with the packaging,
• information about the packaging material,
• information about the normal and reasonably foreseeable use of the product,
• exposure to the cosmetic product and the substances and
• any other information on the cosmetic product that may be available to the product manufacturer.

The safety assessor reviews these documents, checks whether the ingredients used in the product are restricted or banned in the EU, checks that the other information about the cosmetic product is in order and checks that the tests were conducted properly. Based on the no observed adverse effects level (NOAEL), he or she then calculates the margins of safety (MoS) and prepares the cosmetics safety assessment report.

In order to demonstrate that a cosmetic product complies with Article 3, the responsible person shall, prior to placing a cosmetic product on the market, ensure that the cosmetic product has undergone a safety assessment on the basis of the relevant information and that a cosmetic product safety report is set up in accordance with Annex I. (EU Regulation 1223/2009, Article 10.1)

The cosmetic product safety assessment must include the following.

• Conclusion as to whether the product is safe and in conformity with the EU cosmetics regulation or not
• The safety assessor’s scientific reasoning that led to such a conclusion
• A list of any warnings and precautions for use that must appear on the label
• The assessor’s credentials and approval.

It is worth mentioning that the same, or very similar, cosmetic safety assessments are also required in many other countries or regions around the world. These include, among others, Turkey, Israel, the ASEAN region, some South American countries and South Africa.

SAFETY ASSESSOR REQUIREMENTS

The EU cosmetics regulation also lists requirements for the safety assessors. The safety assessor should firstly, of course, be knowledgeable about the EU cosmetics regulation, but that is not sufficient. The regulation also stipulates some additional requirements. It states that the cosmetics safety assessment must be carried out by a person in possession of a diploma or other evidence of formal qualifications awarded on completion of a university course of theoretical and practical study in pharmacy, toxicology, medicine or a similar discipline, from the EU, or a course recognized as equivalent in the EU.

CE.WAY COSMETICS SAFETY ASSESSMENT SERVICES

CE.way’s safety assessors are highly skilled and fulfil the criteria mentioned above. They have degrees in pharmacy or cosmetology, they have completed the ‘Safety Assessment of Cosmetics in the EU’ course in Brussels and have years of experience in conducting cosmetic product safety assessments. Therefore, you can be sure that their cosmetics safety assessments will be accepted by the competent authorities.

As well as the quality of our services, we are also proud of the speed at which we provide them. Due to CE.way’s extensive database of toxicological profiles of the substances commonly used in cosmetic products, together with the software that we have developed, we can guarantee that cosmetic product safety assessments will be completed in up to three days from the time when we receive all of the documents from part A of the cosmetic product safety report.