CPSR (Cosmetic Product Safety Report)
What is a CPSR and why is it important?
A Cosmetic Product Safety Report (CPSR) is a mandatory document in the European Union, the United Kingdom and other regions to ensure the safety of cosmetic products before they are placed on the market. It must be included in the PIF.
What is a CPSR?
The Cosmetic Product Safety Report is a detailed report that assesses the safety of a cosmetic product before it is launched on the market. This report is divided into two main parts:
Part A: Cosmetic Product Safety Information
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All relevant technical and scientific information about the product is collected, such as the list of ingredients, their purity and stability.
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Analyzes potential health risks based on the toxicity of ingredients and interactions between them.
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Includes identification of the skin type or specific area of the body for which the product is intended.
Part B: Cosmetic Product Safety Assessment
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This is where the safety assessor, a qualified professional in toxicology or related sciences, makes his or her judgment on the safety of the product.
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The evaluator confirms whether the product is safe for its intended use, based on the expected exposure and toxicological profile of the ingredients.
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The document concludes with a signature from the evaluator, who certifies the safety of the product.
CPSR as an essential part of the PIF
The CPSR is a mandatory component of the PIF (Product Information File) , a complete file of product information that must be available at all times to the authorities. The PIF is kept in the country of marketing and contains all documentation related to the safety, testing and formulation of the product. In addition to the CPSR , the PIF usually includes:
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Product Description
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Efficacy test report (if performed)
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Stability testing
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Information on Good Manufacturing Practices (GMP)
This structure ensures that any product on the market is backed by a thorough safety assessment, ensuring consumer protection and manufacturer transparency.
Where is CPSR mandatory besides the EU and UK?
In addition to the European Union and the United Kingdom , other regions have also adopted similar regulations, albeit with some variations:
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Switzerland – Although not part of the EU, Switzerland maintains similar safety regulations for cosmetic products. Products must meet the standards of the European Cosmetics Association and a CPSR is recommended for market entry.
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United States - Although CPSR is not mandatory in the US in the same way as in the EU, the FDA (Food and Drug Administration) recommends that safety assessments be conducted for cosmetic products under the Federal Food, Drug, and Cosmetic Act . In addition, many US retailers require CPSR as a safety guarantee for imported products.
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Australia - Australia follows strict regulations on cosmetics, administered by the Australian Industrial Chemicals Introduction Scheme (AICIS). While the CPSR is not strictly mandatory, manufacturers are required to thoroughly assess the safety of the product and document these studies, which is very similar to a CPSR.
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Canada - Through the Health Canada Cosmetic Regulations, safety assessments are mandatory. Health Canada suggests comprehensive documentation supporting product safety, leading many manufacturers to adopt the CPSR as part of their dossier.
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Mercosur (South America) - In countries such as Argentina, Brazil, and other Mercosur members, there are regulations that are to some extent aligned with EU regulations, and although the CPSR is not explicitly mandatory, some security requirements are similar and extensive documentation is required.
What is a CPSR for?
CPSR is essential for:
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Ensure product safety: Ensures that the cosmetic product is safe for use under normal or foreseeable conditions of use.
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Compliance with regulations: This is a legal requirement to be able to market cosmetic products in many countries, such as those in the European Union.
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Prevent legal problems: Avoid possible sanctions, fines or product withdrawal from the market for non-compliance with regulations.
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Protecting the consumer: The certificate offers a layer of security to the end user, guaranteeing that there will be no serious adverse effects from using the product.
The CPSR is not only a key part of the PIF but also a sign of social responsibility and transparency on the part of cosmetics manufacturers. Although regulations in each region may vary, the CPSR represents a standard that ensures that cosmetic products are safe for their intended use and remain in compliance with local and international regulations.
Purpose of CPSR
The main purpose of the CPSR is to ensure the health and safety of consumers by providing a comprehensive evaluation of the product's ingredients and properties. In addition, it is key to:
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Transparency in the cosmetics industry: Allows companies to demonstrate compliance with regulations, ensuring that their products are reliable and safe.
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Risk control: Identifies possible risks in the composition of the product, allowing modifications to be made before its launch.
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Access to new markets: Obtaining a CPSR allows cosmetic products to be marketed in international markets, as it is a standard recognized by many regulatory authorities around the world.
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