CPSR & Cosmetic Safety Assessment

ToxWriter supports cosmetic manufacturers, brand owners, importers and private-label companies with product-specific safety assessments and technical documentation. For products intended for the EU and Great Britain, this may include preparation of a Cosmetic Product Safety Report (CPSR). For India and the United States, the deliverable is scoped to the applicable national requirements rather than assuming that an EU-format CPSR is mandatory.

What is a CPSR?

A CPSR is a product-specific safety report required for cosmetics placed on the EU market under Regulation (EC) No 1223/2009. Corresponding requirements apply in Great Britain under its cosmetics framework. It has two parts.

Part A — Cosmetic Product Safety Information

Part A assembles the information needed to assess the finished product, including:

• Qualitative and quantitative composition.
• Physical and chemical characteristics and product stability.
• Microbiological quality.
• Impurities, traces and packaging-related information.
• Normal and reasonably foreseeable use and exposure to the product and its ingredients.
• Toxicological profiles of ingredients.
• Available information on undesirable and serious undesirable effects.
• Other relevant product-specific safety information.

Part B — Cosmetic Product Safety Assessment

Part B records the safety assessor’s evaluation and conclusion. It includes:

• The assessment conclusion.
• Warnings and instructions for use that should appear on the label.
• The scientific reasoning supporting the conclusion.
• The required assessor details, qualifications and approval.

The report must be specific to the formulation and intended use. A generic ingredient list or Safety Data Sheet alone is not sufficient to demonstrate the safety of a finished cosmetic product.

What is the Product Information File (PIF)?

The Product Information File (PIF) is the wider regulatory file maintained for a cosmetic product. The CPSR is one component of the PIF—not a substitute for the complete file.

Under Article 11 of the EU Cosmetics Regulation, the PIF contains:

1. A clear description of the cosmetic product.
2. The CPSR (Part A and Part B).
3. A description of the manufacturing method and a statement of Good Manufacturing Practice (GMP) compliance.
4. Evidence supporting product claims where justified by the nature or effect of the product.
5. Relevant animal-testing data required by the legislation, where applicable.

The EU PIF must be kept for 10 years after the last batch was placed on the market and made readily accessible to competent authorities at the Responsible Person’s address. Great Britain has corresponding PIF requirements under its applicable framework. The Responsible Person/manufacturer remains responsible for maintaining the complete PIF and meeting other market obligations.

Official reference: Regulation (EC) No 1223/2009 — Articles 10 and 11 and Annex I

Documents and information required for CPSR preparation

The list below is a practical client checklist. The exact documents needed depend on the product, available evidence and intended market; not every test or certificate is mandatory for every cosmetic.

Product composition and use

• Complete quantitative formulation: INCI/chemical names, ingredient percentages, functions and identifiers where available. The composition should total 100% or explain the formulation basis.
• Manufacturing method: process description or detailed manufacturing information.
• Product-use information: product category, application site, leave-on/rinse-off status, amount and frequency of use, target users and foreseeable conditions of use.

Finished-product quality

• Physicochemical properties and finished-product specifications.
• Finished-product Certificate of Analysis (CoA).
• Product stability report.
• Microbiological analysis report.
• Preservative efficacy/challenge-test report, where relevant.
• Heavy-metal or other contaminant analysis, where relevant to the product and applicable requirements.

Ingredient safety and fragrance

• Raw-material CoAs and specifications for all ingredients.
• Safety Data Sheets, technical data sheets and available ingredient toxicological information. CoAs and SDSs alone may not provide sufficient toxicological data.
• IFRA Certificate of Conformity, where fragrance is used and applicable.
• Fragrance composition and allergen information sufficient for safety and labelling review.
• Information on relevant impurities, restricted ingredients, botanical extracts or nanomaterials, where applicable.

Manufacturing, packaging and supporting evidence

• GMP compliance statement and manufacturing documentation; ISO 22716 certificate or audit evidence, where available.
• Proposed/final product label and packaging artwork for the target market.
• Packaging material specifications and compatibility information; migration/extractables data where relevant.
• Animal-testing history and supporting information where relevant under the applicable framework.
• Available clinical, dermatological or consumer-use studies; product claims and supporting evidence where applicable.
• Previous safety assessments and known undesirable-effect/complaint information, where available.

Relevant regulations, guidance and standards

European Union (EU)

• Regulation (EC) No 1223/2009 — Cosmetic Products Regulation: safety assessment, CPSR, PIF, Responsible Person, ingredients and labelling.
• Commission Implementing Decision 2013/674/EU: guidance on Annex I and CPSR preparation.
• SCCS Notes of Guidance, 12th revision: ingredient toxicology, exposure and safety evaluation.
• Commission Regulation (EU) No 655/2013: common criteria for cosmetic claims.
• Commission Regulation (EU) 2023/1545: fragrance allergen labelling amendments.
• ISO 22716 (GMP), ISO 11930 (preservative efficacy) and ISO 17516:2014 (published microbiological-limits edition; the ISO 2026 second edition is under publication), and ISO 29621:2017 (microbiologically low-risk products), as applicable. Check current editions and amendments before use.

United Kingdom (UK)

• GOV.UK — Making cosmetic products available to consumers in Great Britain: safety report, PIF, Responsible Person, notification and labelling.
• GOV.UK — Consumer products: cosmetics: Great Britain requirements and business responsibilities.
• Cosmetic Products Enforcement Regulations 2013: UK enforcement framework. Check the relevant provisions and current guidance for Great Britain or Northern Ireland.

India

• CDSCO — Cosmetics Rules, 2020 and related documents.
• Official PDF — Cosmetics Rules, 2020.
• Bureau of Indian Standards (BIS) — Know Your Standard: use the official portal to check current product-specific standards and amendments.
• BIS Standards portal: searchable standards, including IS 4011:2018 on methods of test for safety evaluation of cosmetics and relevant IS 4707 parts.

India has its own requirements under the Drugs and Cosmetics Act, 1940, the Cosmetics Rules, 2020 and applicable BIS standards. Do not describe an EU-format CPSR as universally mandatory for Indian cosmetics; scope the safety assessment and dossier to the applicable Indian requirements.

United States (USA)

• FDA — Modernization of Cosmetics Regulation Act (MoCRA): safety substantiation records and other applicable obligations.
• FDA — Cosmetics and US Law: overview of the legal framework.
• FDA — Product Testing of Cosmetics: safety testing and substantiation.
• FDA — Summary of Cosmetic Labelling Requirements.

FDA does not prescribe a universal EU-style CPSR format or a specific set of tests for every cosmetic. MoCRA requires the responsible person to ensure and maintain records supporting adequate safety substantiation, alongside other applicable requirements. The US deliverable should therefore be described as a cosmetic safety assessment or safety-substantiation dossier.

How ToxWriter approaches the assessment

1. Review product information: composition, intended use, label and supporting documentation.
2. Confirm the market framework: applicable legislation, ingredient restrictions and standards.
3. Evaluate ingredient toxicology: available data, relevant endpoints and evidence gaps.
4. Assess consumer exposure: use amount, frequency, application site and retention/rinse-off characteristics.
5. Evaluate safety: calculate systemic exposure and margin of safety where appropriate; assess local endpoints separately.
6. Document the conclusion: explain the reasoning, assumptions, limitations and any warnings or further data needs.

For systemic endpoints, the margin of safety may be calculated as MoS = NOAEL / SED, where NOAEL is a suitable no-observed-adverse-effect level and SED is the systemic exposure dose. An MoS of 100 is a common starting point where its assumptions apply, not a universal pass/fail rule for every ingredient or endpoint.

Frequently asked questions

Is a CPSR required in India or the United States?

India and the US have their own cosmetic regulatory frameworks. They should not automatically be described as requiring the EU statutory CPSR format. The assessment documentation should match the applicable market requirements.

Is an IFRA certificate sufficient for a fragranced product?

No. It may support the fragrance-use assessment but does not replace the overall finished-product safety assessment or all fragrance allergen and labelling information.

Are all documents on the checklist mandatory?

No. The checklist identifies commonly useful evidence. The assessor determines which documents and tests are necessary for the specific product, applicable requirements and available evidence.

Does CPSR preparation include laboratory testing?

Not automatically. Reports from stability, microbiological, preservative efficacy or other studies may be needed, but laboratory testing should be scoped separately when required.

Regulations and standards may change. Confirm the current requirements for the target market at the time of assessment. This page describes the service scope and does not guarantee regulatory acceptance.