Cosmetic product safety report
The Cosmetic product safety report is a document constituting certified product safety and toxicological analysis summarizing the individual components. Cosmetic product safety report is issued before each product is placed on the EU market.
Cosmetic product safety report must be drawn out in compliance with Regulation issued on the 11th July 2013, the European Union (EU) Cosmetics Directive 76/768/EEC which was replaced by Regulation (EC) No 1223/2009 (the “Cosmetic Products Regulation”), which harmonizes and simplifies the cosmetics regulations across the EU member states. The aim of the Regulation is to simplify procedures, streamline terminology and strengthen the regulatory framework for cosmetics with a view to ensuring a high level of protection of human health.
Cosmetic product safety report refers to the assessment of product safety. So as to meet EU Regulations the CPDR report must be created of appropriate levels of exposure, taking into account the use parameters, such as the area of application, the amount used in the cosmetic single application, duration and frequency of application and target groups exposed to the cosmetic. Safety assessment refers to the normal and reasonably foreseeable use of the product.
Cosmetic Product Safety is an official document which has to have two parts:
- Part A Cosmetic Product Safety Information
This section requires product information and test data. Cosmetic product safety report is set up in accordance with Annex I Regulation (EC) No 1223/2009 of The European Parliament and of The Council of 30 November 2009 on cosmetic products. This set is described in detail in Commission Implementing Decision on 25 of November 2013 in reference to the guidelines contained in Annex I Regulation (EC) No 1223/2009 of The European Parliament and of The Council of 30 November 2009 on cosmetic products.
- Part B Cosmetic Product Safety Assessment
A Safety Assessor’s expert opinion as to why the product is safe to be placed on the market. Safety Assessor is operational personnel, that the safety requirements for the system are appropriate and adequate for the planned cosmetic product and that the system satisfies those safety requirements. A person who carries out assessment in compliance Regulation (EC) No 1223/2009. A Safety Assessor must be 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 recognized as equivalent by a Member State. Part B should present all available information, which led to the conclusion with regard to product safety. The person conducting the safety evaluation can approve, reject or approve under certain conditions, product formulation that is the subject of evaluation. Product not in compliance with Regulation (EC) No 1223/2009 must be rejected and shall not be placed on the market. Follow the recommendations of the Safety Assessor for the safe use of the product.
A person who is responsible for updating cosmetic safety report shall ensure that the cosmetic product safety report is kept up to date in view of additional relevant information generated subsequent to placing the product on the market.
The safety report updating is required in case of:
- any changes in regulatory requirements (e.g. restrictions of the one of the substances)
- the emergence of new scientific findings and toxicological data on the substance, which could change the result of the existing safety assessment
- occurrence of changes in the recipe or specification of raw materials
- any changes in the conditions of use
- any an upward trend in the nature, severity and frequency of adverse reaction
The safety report is created in close cooperation of the manufacturer and Safety Assessor and is subject to verification by authorities. Supervision of safety of cosmetic products in Poland performed by the State Sanitary Inspection.