The cosmetic product safety report is a scientific document with legal powers. Is a document, prepared and signed by a Qualified Cosmetic Safety Assessor, that confirms whether or not a particular product complies with UK and EU cosmetic regulation, therefore, safe for human use.
In the EU, cosmetic products are governed by the Cosmetic Regulation 1223/2009. This regulation also extends to Iceland, Liechtenstein and Norway.
As of 2021, Great Britain (England, Scotland and Wales) hasp introduced a distinct regulation for cosmetic products known as Regulation 2009/2013 on Cosmetic Products as amended by the Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019.
The PIF (Product Information File) is s technical dossier that gathers all necessary and relevant information and documentation available for each cosmetic product being sold. “When a cosmetic product is placed on the market, the Responsible Person shall keep a product information file for it.”
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A Cosmetic product MUST be safe for human use before it can be placed in the market. The CPSR is the way that Responsible Persons must demonstrate the safety of their products. The CPSR is mandatory, every cosmetic product in the EU and the UK markets must be safely assessed.
According to the requirements of article 10 of the EU and the UK Cosmetic Regulations, the CPSR should be performed by a qualified assessor, called the Cosmetic Safety Assessor.
The safety assessor will consider the following:
What needs to be covered by the safety assessor is listed in Annex I of both the EU and the UK cosmetic regulations.
The qualifications of the Cosmetic Safety Assessor are stated in article 10 of the EU and the UK cosmetic regulations:
"The cosmetic product safety assessment, as set out in Part B of Annex I shall 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, or a course recognised as equivalent by a Member State (EU) / by the Secretary of State (UK)."
If the manufacturing company has a qualified person internally, the CPSR can be performed in-house, otherwise, a third-party qualified assessor should be used.
YES!
The origin of a raw material (synthetic or natural) doesn’t speak for its safety. The annexes of the EU and the UK cosmetic regulations (INGREDIENTS PROHIBITED OR RESTRICTED DUE TO SAFETY REASONS) contain several natural ingredients, as well as synthetic ingredients, which means that any raw material can have a toxicological profile of concern.
The CPSR is required for ALL cosmetic products, regardless of their origin, so a product containing only natural ingredients must also be safely assessed.
The CPSR is performed based on documentation, the safety assessor does not need to see the finished product. To allow the safety assessor to formulate an assessment conclusion, the product must be stability and compatibility tested, and its preservative system must be challenged.
The results of these tests are essential for the safety assessor job.
Part A Cosmetic Product Safety Information
Part B – Cosmetic Product Safety Assessment
*Some products are exempt of Microbiological and Preservative Challenge test.
Article 11 sets out the requirements relating to the Product Information File (PIF), and the detail of the information and data that should be contained concerning:
The PIF must be kept for a period of ten years after the date the last batch of the cosmetic product was placed on the market.
The Responsible Person must make the PIF readily accessible to a competent authority at the address notified, in accordance with Article 13.
The PIF should be a ‘living document’ and should be updated as necessary. For instance, it should be updated when changes are made to the CPSR, such as the addition of new test data.
Adiato Baldé is a Pharmaceutical Scientist, Regulatory Affairs Expert, and a Cosmetic Safety Assessor.
Adiato has a post-graduation in Regulation and Evaluation of Medicines and Healthcare Products, and for the last decade, she has been in the industry (Pharmaceutical, Medical Devices, Biocides, Food/Feed and Cosmetics) involved always with Regulatory, Compliance and Quality fields.
Adiato started performing cosmetic product safety assessments in 2020, since then she has been actively updating her knowledge in the Toxicology and Dermato-Cosmetic Science fields.
Adiato is member of the Royal Pharmaceutical Society, Society of Cosmetic Scientists, and the Chemical Hazard Communication Society, where she also supports the members by becoming a Course Module Deputy Tutor for the Cosmetic Regulations course.
Adiato currently works as a Regulatory Manager being responsible for the technical / regulatory and compliance aspects of personal care products, while focusing on the safety assessment of cosmetic ingredients.
If you are considering bringing a cosmetic product to the EU and/or the UK markets, please don’t hesitate to contact me for further information. I can provide support by assessing the safety of your cosmetic product or by compiling your product information file.
You can find real examples of a CPSR, a PIF and other technical documents in the COMPLIANCE DOCUMENTS section, you just need to create an account to have access to them.
Adiato Baldé
Adiato Baldé
Cosmetic safety Assessor | Regulatory Affairs Expert
Understanding the intricate world of regulations can be challenging, even for industry experts. This mini guide aims to simplify compliance process and provide valuable insights for aspiring new brand owners or anyone looking to understand this topic a bit more.