Part A and Part B of the cosmetic safety report
The cosmetic safety report (CSRR) is actually based on two different but inseparable approaches: without reliable data, there can be no sound assessment—and without assessment, there is no guarantee of safety.
On the one hand, Part A gathers all the scientific data about the product.
On the other hand, Part B analyzes this data to determine whether the product is truly safe.
Understanding Regulatory Requirements and Securing Your Market Launch
Placing a cosmetic product on the European market is not improvised. Behind every soap, cream, or serum lies a structured, precise, and legally binding regulatory framework for the Responsible Person.
At the heart of this obligation is the Cosmetic Product Safety Report (CPSR), required under Regulation (EC) No 1223/2009.
The CPSR is composed of two complementary sections:
- Part A: Cosmetic Product Safety Information
- Part B: Cosmetic Product Safety Assessment
These two parts serve different but inseparable purposes:
Part A gathers the scientific data. Part B interprets that data to reach a safety conclusion. Understanding the distinction is essential to structuring a compliant file and avoiding costly mistakes.
1. The Regulatory Framework: A Foundational Obligation
Regulation (EC) No 1223/2009 requires that before placing a cosmetic product on the EU market, it must have:
- a Product Information File (PIF)
- a CPNP notification
- a Cosmetic Product Safety Report (Parts A and B) prepared by a qualified safety assessor
Consumer safety is the top priority and this is the responsibility of the Responsible Person (RP) who bears legal responsibility for it.
The quality of the safety report determines:
- regulatory compliance
- credibility during inspections
- and legal protection for your company
2. Part A: The Scientific Foundation of the Product
Definition : Part A gathers all the data necessary for the safety assessment. It is a factual and documented compilation. It does not yet contain a conclusion but provides the elements that the evaluator will analyze in Part B. Product information: Part A also includes Claims – Directions of use – Warning statements. Because the way the product is presented influences the safety analysis.
In summary: Part A is technical, structured, factual. It does not judge, it documents. But without a complete and solid Part A, Part B cannot be reliable.
2.1 Quantitative and Qualitative Composition
Transparency must be total because any imprecision weakens the evaluation. That is why the formula must be detailed with the:
- Complete INCI list
- Exact concentration of each ingredient
- Identification of regulated substances
- Presence of allergens
2.2 Physicochemical Characteristics
Some elements make it possible to anticipate the risks related to product degradation. They are:
- pH
- Stability data
- Packaging compatibility
- Raw material specifications
- Purity data
2.3 Microbiological Quality
Microbiology is a pillar of safety, which is why compliance with Good Manufacturing Practices (ISO 22716) is expected. Part A must include:
- Results of microbiological analyses
- Justification of the conservative system
- Challenge test if necessary
- Batch validation if applicable
2.4 Impurities, Traces, and Packaging
The evaluator must know all potential risks, even indirect ones. That is why the following elements must be documented:
- Possible presence of impurities
- Undesirable substances
- Possible migration from the packaging
2.5 Normal and Reasonably Foreseeable Use
The regulation requires that each product be evaluated in 👉🏼its normal use, as well as in 👉🏼its reasonably foreseeable use.
Example: A professional soap can be used more frequently than a consumer soap.
= This directly impacts the toxicological assessment.
2.6 Exposure to the Product
Some data feed the safety margin calculations. Part A must therefore specify them:
- Quantity applied
- Exhibition area
- Frequency of use
- Target population (adults, children, professionals…)
2.7 Toxicological Profile of Substances
This section constitutes the raw material of the evaluator. Each ingredient must be documented:
- Toxicological data
- NOAEL
- Potential irritant or sensitizing
- CMR data if relevant
2.8 Undesirable Effects
Adverse effects should never be left to chance: their traceability is a regulatory obligation. This involves centralizing and analyzing all the available information by integrating:
- Existing data
History if reformulation
Possible reports
3. Part B: Scientific Evaluation and Safety Conclusion
The expertise of the safety evaluator
Part B constitutes the core of RSPC’s expertise: where Part A collects data, it interprets them to conclude on product safety. Written by a qualified assessor (pharmacist, toxicologist, physician or equivalent), this step is based on an in-depth scientific analysis. Each ingredient is studied, the margin of safety (MoS) is calculated, the actual exposure is compared with toxicological data and compliance with regulatory requirements is verified.
But beyond simple control, the evaluator must argue and justify scientifically the safety of the product.
3.1 Special Cases
Part B must address:
- Regulated substances (Annexes II–VI)
- Allergens
- Nanomaterials
- Complex fragrance mixtures
- Professional-use exposure scenarios
3.2 Justification of Warnings
A product for professional use often requires more extensive analysis than a consumer product. The evaluator can therefore impose mandatory information, restrictions on use, specific recommendations.
3.3 Why Part B is the critical point
In practice, the authorities’ controls mainly concern scientific consistency, justification of calculations, regulatory compliance and robustness of safety margins. A weak Part B exposes to many inconveniences: request for supplements, product withdrawal, legal risk, etc… This is precisely where Toxi Plan comes in.
In conclusion...
The conclusion of Part B legally commits the placing on the market. It concludes with:
- A formal safety declaration
- The conditions of use
- The signature of the evaluator
- His qualifications
4. Strategic Difference Between Part A and Part B
Part A and Part B: an effective collaboration
Many companies choose to prepare Part A internally, outsource Part B to a specialist. Toxi Plan operates precisely within this collaborative model.
This approach allows:
- Better cost control
- Internal knowledge development
- Regulatory security
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Confusing the two part is a common mistake :
Part A prepares / Part B secures.
Part A | Part B |
Data collection | Scientific analysis and interpretation |
Technical and descriptive | Scientific and decision-making |
Can be prepared internally | Must be prepared by a qualifiedassessor |
Documentary foundation | Regulatory commitment |
5. Toxi Plan: Specialist in Part B Safety Assessments
Toxi Plan specializes in drafting and securing Part B of the Cosmetic Product Safety Report.
Our expertise is built on:
- In-depth toxicological analysis
- Mastery of regulatory annexes
- Strong knowledge of authority expectations
- A rigorous, fully documented approach
1. Strategic Formula Review
In order to avoid unnecessary tests as much as possible, we analyze the formulas upstream to:
- Identify potential risks
- Anticipate the requirements
- Optimize compliance
2. Accurate Margin of Safety Calculations
Each ingredient is assessed according to:
- Realistic exposure
- Toxicological profile
- SCCS recommendations
- The most up-to-date scientific data
3. Professional-Use Product Expertise
Products for professional use require the following specificities, perfectly mastered by Toxi Plan:
- A specific exposure analysis
A consideration of high frequencies
A strengthened justification
4. Robust and Defensible Reports
Our assessments are Structured – Reasoned – Compliant with European requirements.
The goal is not only to be compliant, but to be solid in case of control. Safety; yours, that of your products and that of the consumers; remains above all our priority.
6. Secure today to avoid blockages tomorrow
Cosmetic safety report (RSPC)
The regulatory landscape is evolving:
- Increased restrictions
- Heightened surveillance
- Growing authority expectations
A robust safety report is an investment. Compliance is not a burden. It is a credibility driver.
Common Field Mistakes
- Underestimating real exposure
- Overlooking regulated substances
- Misinterpreting toxicological data
- Submitting incomplete documentation
- Confusing the PIF with the CPSR
- These errors can be costly.
Part B is not a mere administrative formality. It is a scientific and legal commitment.
Part A gathers the data / Part B transforms them into scientific decision.
One without the other has no regulatory value. Understanding this distinction is essential for any company wishing to put cosmetic products on the European market safely. Toxi Plan supports manufacturers in drafting and securing Part B, with a rigorous, strategic approach and in compliance with European requirements.
Because safety is not a detail. It is the very foundation of marketing.
Disclaimer:
The information provided in this article is for informational and educational purposes only. It does not constitute legal advice nor a personalized regulatory consultation. Despite the care taken in drafting this article and verifying its sources, regulations evolve regularly and may be subject to differing interpretations depending on the specific context of each company, product, or market.
Toxi Plan®, its directors, and its employees shall not be held liable for any use made of the information contained in this article without further analysis tailored to a specific situation. Any regulatory or strategic decision should be based on a specific assessment carried out by a qualified professional, with due regard to the applicable regulations, including any provisions or regulatory practices entering into force after the date of publication.