Introduction to Cosmetic Product Safety Report (CPSR)

Understanding the requirements for selling cosmetic products in Europe and the UK is crucial for compliance. Our comprehensive guide, “How to Gain EU Compliance in Three Steps,” highlights the necessity of the Cosmetic Product Safety Report (CPSR) along with other key elements:

1. CPSR and Product Information File (PIF): Dive deeper into the specifics by reading our detailed article on CPSR.
2. Compliant Labeling: Ensure your product labels and claims meet all CPSR stipulations for compliance.
3. Notification Process: Register your products with the European portal CPNP and the UK portal SCPN, as required by CPSR guidelines for UK sales.
4. Legal Representation: Appoint a Responsible Person in both the EU and the UK, as mandated by CPSR regulations.

Absence of any of these CPSR components results in non-compliance, barring market access.

Biorius and CPSR Compliance

Biorius assists throughout the CPSR compliance process, from preliminary steps to final approval. Learn more about our five-step approach and CPSR expertise on EU regulations.

Detailed Explanation of CPSR

The Cosmetic Product Safety Report (CPSR) is essential and typically located within the Product Information File (PIF) of each cosmetic product. The PIF, an electronic folder, includes CPSR documents usually formatted as PDFs.

Importance of CPSR and Regulatory Scrutiny

CPSR is pivotal for legally placing cosmetics on the market in Europe and the UK. It is the primary focus during inspections by national authorities. Failure to properly prepare or update the CPSR can lead to severe penalties, immediate withdrawal of products, and notifications to RAPEX, the EU’s regulatory oversight system.

CPSR Content Requirements

According to Annex I of REGULATION (EC) No 1223/2009, the CPSR comprises two essential parts:

• Part A: Details on the safety information of cosmetic products including composition, stability, and exposure.
• Part B: Provides the safety assessment conclusions, warnings, and the scientific basis for these findings, specifically tailored for vulnerable groups such as children under three or products for intimate use.

Common Errors in CPSR Documentation

Frequent CPSR errors include incorrect ingredient listing, overlooked impurities, insufficient packaging evaluations, and incomplete safety data. These mistakes can significantly impact CPSR compliance.

Choose Biorius for Reliable CPSR Assessment

Biorius offers expert CPSR assessment services, ensuring your cosmetic products meet all safety and regulatory standards. Our Safety Assessors are highly qualified to endorse Part B of the CPSR, ensuring your compliance is comprehensive and current.

For more information about CPSR assessments and other services offered by Biorius, please contact us.

If a cosmetics brand that wants to sell in Europe and the UK is missing one of the 4 requirements listed above, we can undoubtedly say that trade is not possible: No market / Unauthorized market / No authorized trade / Pas de Marché / kein Markt / Ningún Mercado / ノーマーケット.

Don’t forget that Biorius can assist you in this process from start to finish, you can find more information about the 5 steps and BIORIUS’ expertise on the EU Regulation here.

Cosmetic Product Safety Report Explanation (CPSR)

This article is intended to provide more clarity and additional information about the Cosmetic Product Safety Report (CPSR). In English, CPSR is also commonly referred to as ‘Safety Assessment‘.

Where can We Find the CPSR?

First, it’s important to know that this document can be found within the PIF of each cosmetic product. Don’t forget that, in practice, the Product Information File is an electronic folder consisting of several subfolders, which contains files, usually PDFs, including also the CPSR.

The Importance of the CPSR and the Inspection of the National Authorities

We might even say that the CPSR is the most important report when placing a cosmetic on the European and UK market. However, we don’t want to take away the importance of the other documents of the PIF. The label and compliant formula, the notifications to the portals and the Responsible Person are also essential elements for full compliance with the European and UK Regulations.

In addition, the CPSR is undoubtedly the document most inspected by the competent national authorities, which is why if there is no trace of the CPSR in the PIF or if you have been negligent in preparing it, this can lead to very severe financial penalties, an immediate withdrawal, and notification to RAPEX. For those who don’t yet know, RAPEX is the EU national Authorities’ supervisory system. Once your cosmetic brand is mentioned to RAPEX, you can expect a systematic and meticulous inspection of all your products…

Which Kind of Information the CPSR must Contain?

In practice, the CPSR consists of two parts, PART A and PART B: the Annex I of REGULATION (EC) No 1223/2009 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 30 November 2009 on cosmetic products clearly mentions all information that has to be collected and processed by the Safety Assessor in order to identify and quantify the hazards that the cosmetic product may present for human health. In Annex I we find in detail which elements the two parts must contain, namely:

PART A contains cosmetic product safety information, such as:

1. Quantitative and qualitative composition of the cosmetic product;
2. Physical/chemical characteristics and stability of the cosmetic product;
3. Microbiological quality;
4. Impurities, traces, information about the packaging material;
5. Normal and reasonably foreseeable use;
6. Exposure to the cosmetic product;
7. Exposure to the substances;
8. Toxicological profile of the substances;
9. Undesirable effects and serious undesirable effects;
10. Information on the cosmetic product.

While PART B includes the cosmetic product safety assessment, namely:

1. Assessment conclusion: statement on the safety of the cosmetic product in relation to Article 3;
2. Labelled warnings and instructions of use: statement on the need to label any particular warnings and instructions of use in accordance with Article 19(1)(d);
3. Reasoning: Explanation of the scientific reasoning leading to the assessment conclusion set out under Section 1 and the statement set out under Section 2. This explanation shall be based on the descriptions set out under Part A. Where relevant, margins of safety shall be assessed and discussed. There shall be inter alia a specific assessment for cosmetic products intended for use on children under the age of three and for cosmetic products intended exclusively for use in external intimate hygiene. Possible interactions of the substances contained in the cosmetic product shall be assessed. The consideration and non-consideration of the different toxicological profiles shall be duly justified. Impacts of the stability on the safety of the cosmetic product shall be duly considered.
4. Assessor’s credentials and approval of part B.

Common Mistakes Encountered about CPSR

We would also like to highlight some examples of what common mistakes can be and we may encounter when talking about CPSR:

• The CPSR is only based on the formula composition in ingredients (and not rebuilt from the raw materials breakdown);
• Impurities are not properly identified;
• Nature and evaluation of the packaging material is very limited or even absent;
• Important raw materials documents are missing (e.g., IFRA Certificate of a fragrance);
• Quality of tests is very insufficient or negative test results are ignored or underestimated;
• Toxicological data on individual ingredients is absent or very limited;
• Exposure to the cosmetic product is too optimistic or even completely wrong;
• Only systemic toxicity is evaluated quantitatively (not always well) and no consideration for other toxicological endpoints such as skin sensitization, skin irritation, etc.;
• The Safety Assessor does not have the right qualifications;
• The CPSR is not maintained, made once for all, while it should evolve with the product.

That’s why it’s important to rely on an honest and reliable consultant like Biorius: our Safety Assessors are highly qualified and have obtained the required degrees to fulfill this role and to be able to sign the Part B of the CPSR.

For more information about the CPSR and the services offered by Biorius, please do not hesitate to contact us.