Cosmetic Safety Assessor

The Cosmetic Safety Assessor is the professional responsible for assessing the safety of a cosmetic product before it is placed on the market.

Regulation (EC) No 1223/2009 requires every cosmetic product placed on the European market to undergo a safety assessment and to have a Cosmetic Product Safety Report – CPSR prepared. The CPSR is an essential part of the PIF – Product Information File.

The safety assessment is not a simple formal review of the formulation. It is a technical and scientific evaluation that considers ingredients, concentrations, exposure, conditions of use, area of application, target consumers, microbiological quality, stability, packaging and any warnings to be included on the label.

What Does the Cosmetic Safety Assessor Do?

The role of the Cosmetic Safety Assessor is to determine whether the cosmetic product can be considered safe for human health under normal or reasonably foreseeable conditions of use.

In particular, the assessor:

• analyses the qualitative and quantitative formula;
• evaluates the toxicological profile of the ingredients;
• assesses exposure to the finished product and to individual substances;
• checks the presence of prohibited, restricted or regulated substances;
• evaluates allergens, impurities, traces and raw material documentation;
• considers stability, microbiological quality and packaging;
• identifies any warnings or instructions for use to be included on the label;
• justifies the absence of data, where applicable;
• signs the safety assessment.

The final conclusion must be based on adequate, relevant and documented data.

Requirements of the Cosmetic Safety Assessor

The Cosmetic Safety Assessor must hold a suitable qualification in pharmacy, toxicology, medicine or similar disciplines, as required by Regulation (EC) No 1223/2009.

In addition to the formal qualification, expertise in toxicology, cosmetology, regulatory affairs and formulation is required.

The safety of a cosmetic product does not depend only on the presence of certain ingredients, but on a combination of factors: concentration of use, exposure, frequency of application, body area involved, type of consumer and characteristics of the finished product.

Cosmetic Safety Assessor and Responsible Person

Regulation (EC) No 1223/2009 distinguishes between two key figures:

• the Responsible Person, who ensures the compliance of the cosmetic product placed on the market;
• the Cosmetic Safety Assessor, who provides the technical and scientific opinion on the safety of the product.

The Cosmetic Product Safety Report prepared or approved by the assessor becomes part of the PIF and must be kept available to the competent authorities.

Cosmetic Product Safety Report – CPSR

The CPSR is the document that contains the safety information on the cosmetic product and the conclusions of the Cosmetic Safety Assessor.

It is divided into two parts:

Part A – Cosmetic Product Safety Information

This part includes data relating to the formula, physical and chemical characteristics, stability, microbiological quality, impurities, packaging, intended use, exposure, toxicological profile of the ingredients and any undesirable effects.

Part B – Cosmetic Product Safety Assessment

This part contains the assessor’s conclusions, the scientific reasoning, any warnings to be included on the label, the assessor’s credentials and signature.

When Is the Safety Assessment Required?

The safety assessment is required before any cosmetic product is placed on the market.

It must also be updated when relevant changes occur, such as:

• formulation changes;
• replacement of a raw material;
• change of supplier;
• packaging changes;
• introduction of new claims;
• regulatory updates affecting ingredients;
• new toxicological data or new test results;
• reports of undesirable effects.

The CPSR must therefore remain consistent with the product actually placed on the market.

Support in Cosmetic Safety Assessment

The service may include:

• preliminary formula review;
• verification of prohibited or restricted ingredients;
• toxicological assessment of ingredients;
• exposure assessment;
• review of allergens, impurities and traces;
• assessment of available tests;
• definition of warnings to be included on the label;
• preparation of the Cosmetic Product Safety Report;
• signature of the assessment by the Cosmetic Safety Assessor;
• update of existing safety assessments.

A proper safety assessment helps prepare a complete PIF, reduce the risk of non-compliance and ensure that the cosmetic product placed on the market is safe for the final consumer.