Cosmetic Product Safety Report (CPSR)
Our certified professional prepares reports with certificates on the safety of cosmetic products, following the requirements of the National Health Surveillance Agency (ANVISA) and European Regulations for cosmetic products.
The holder of the cosmetic product regularization at ANVISA must, in accordance with RDC No. 752/2022, guarantee that the product does not pose a risk to consumer health when used in accordance with the instructions for use and other measures contained in the product's sales packaging during its validity period. There are a total of 11 technical requirements necessary to notify or register a product with ANVISA, including a summary of data proving safety of use, which can be part of the safety assessment prepared by SF Safety Consulting & Innovation.
Regulation (EC) No. 1223/2009 of the European Parliament and the Council of 30 November 2009 on cosmetic products (the “European Cosmetics Regulation”) was published in the Official Journal of the European Union on 22 December 2009.
https://eur-lex.europa.eu/legal-content/en/ALL/?uri=CELEX%3A32009R1223.
This regulation governs the composition, labeling, packaging and placing on the market of final cosmetics in Europe and was fully effective from 11 July 2013, when all provisions of the regulation became enforceable. The regulation introduces, for the first time, the requirement for a Product Information File (P.I.F.), under its Article 11. The regulation restructures some of its information, including the safety assessment for a Regulatory Cosmetic Product Safety (CPSR), which is detailed in Annex 1 of the Regulation. The Annex consists of the Cosmetic Product Safety Information (Part A) and the Cosmetic Product Safety Assessment (Part B).
To export to countries that are part of the European Commission, in accordance with (EC) 1223/2009, the Responsible Person must, before placing a cosmetic product on the market, ensure that the cosmetic product is subjected to a safety assessment based on the relevant information and that a CPSR is prepared in accordance with Annex I of regulation (EC) 1223/2009. The responsible person must ensure that:
a) The intended use of the cosmetic product and the anticipated systemic exposure to individual ingredients in a final formulation are taken into account in the safety assessment;
(b) An appropriate weight-of-evidence approach is used in the security assessment for reviewing data from all existing sources;
c) The CPSR is kept up to date taking into account additional relevant information generated after the product is placed on the market;
d) That no animal testing has been carried out to evaluate the safety and effectiveness of the ingredients used in the product formulation or in the final cosmetic product.
The safety assessment of cosmetic products, as set out in Annex I, Part B, must be carried out by a person holding a diploma or other document proving formal qualifications awarded on completion of a university course of theoretical and practical studies in pharmacy, toxicology, medicine or a similar discipline, or a course recognized as equivalent by a Member State.
Contact SF to prepare the CPSR for your company.