FAQ

Regulatory Landscape

  • 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) has 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. 

Why do you need a CPSR?

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.

What is the CPSR?

The CPSR (Cosmetic Product Safety Report) is a dossier containing all the information required to demonstrate that a particular cosmetic product is safe. It will form part of the Product Information File (PIF).

While there is no set format as to how the CPSR should look, it must follow the minimum requirements detailed in Annex I to the UK and the EU Cosmetics Regulations, under each of the headings of Part A and Part B.

Part A is a collection of all the cosmetic product safety information necessary for the safety assessment of the product, while Part B provides the safety assessment conclusion with the assessors reasoning, any labelling/warnings required, and the safety assessor's credentials.

How are products 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:

  • the general toxicological profile of each ingredient used;
  • the chemical structure of each ingredient;
  • the level of exposure of each ingredient;
  • the specific exposure characteristics of the areas on which the cosmetic product will be applied;
  • the specific exposure characteristics of the class of individuals for whom the cosmetic product is intended; and
  • any impurities, traces, as well as the packaging material.

What needs to be covered by the safety assessor is listed in Annex I of both the EU and the UK cosmetic regulations.

Does Natural Products also require a CPSR?

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.

What information is the Safety Assessor likely to ask you?

  • product formulation (list of ingredients and their concentrations, totalling to 100%);
  • supplier documentation: Safety Data Sheets (SDS), Certificate of Analysis (CoA) and other relevant documentation related to each cosmetic ingredient in the finished product;
  • for fragrance materials: the IFRA Conformity Certificate, list of fragrance allergens with concentrations and any preservatives or other stabilisers;
  • results from preservative challenge test, stability/compatibility test reports;
  • information about the Good Manufacturing Practice (GMP) system that you use (GMP can be demonstrated through compliance with the ISO standard ISO22716);
  • information about the packaging, its material composition, and any other relevant technical information available from the packaging supplier;
  • how the product is used (leave-on/rinse-off, site of application, amount of product per use, use frequency, as examples);
  • any clinical studies, if available;
  • if the product has got cosmetovigilance data (for example, history of Undesirable Effects or Serious Undesirable Effects); this may be asked by the safety assessor prior to, or after, the product is placed on the market. This can provide supporting evidence to the overall risk profile of the product.

Who can be a Cosmetic Safety Assessor?

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.

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