Understanding the CPSR Structure
The Cosmetic Product Safety Report (CPSR) is divided into two distinct parts as defined by Annex I of EU Regulation 1223/2009. Understanding this structure is essential for preparing compliant documentation.
Two Parts, Different Purposes
Part A: Cosmetic Product Safety Information
Part A is the data compilation section. According to Annex I, Section A, it must contain:
| Section | Contents | Who Provides |
|---|---|---|
| 1. Quantitative & qualitative composition | Complete formula with INCI names and concentrations | Manufacturer |
| 2. Physical/chemical characteristics | Appearance, pH, viscosity, stability data | Testing laboratory |
| 3. Microbiological quality | Specs, challenge test results, micro limits | Testing laboratory |
| 4. Impurities, traces, packaging info | Impurity profiles, packaging specs, compatibility | Supplier/Lab |
| 5. Normal & foreseeable use | Application area, method, frequency, target users | Brand/Manufacturer |
| 6. Exposure to the cosmetic product | Exposure calculations, amount used, body surface | Calculated data |
| 7. Exposure to substances | Per-ingredient exposure based on formula & use | Calculated data |
| 8. Toxicological profile | Tox data for each ingredient (NOAEL, ADI, etc.) | Literature/Suppliers |
| 9. Undesirable effects | Reported adverse events, consumer complaints | Internal records |
| 10. Other relevant information | Supporting studies, volunteer tests, etc. | Various sources |
Source: EU Regulation 1223/2009, Annex I
Part A Deep Dive: Key Sections
Section 1: Quantitative & Qualitative Composition
Formula Documentation Requirements
- List every ingredient by INCI name
- Provide exact weight percentages for all ingredients
- Include water content even if listed separately
- Identify fragrance components above allergen thresholds
- Note any nano-materials with [nano] designation
- Distinguish between active ingredients and excipients
Fragrance and Flavor Disclosure
Section 2: Physical/Chemical Characteristics & Stability
| Test Type | Conditions | Duration | Data Generated |
|---|---|---|---|
| Accelerated stability | 40°C/75% RH | 3-6 months | Shelf life prediction |
| Long-term stability | 25°C/60% RH | 12-36 months | Real-time confirmation |
| Photostability | Light exposure | As appropriate | Light sensitivity data |
| Freeze-thaw cycling | -10°C to 40°C | 5 cycles | Temperature resilience |
| In-use stability | Room temp, opened | PAO period | Open-product stability |
Section 3: Microbiological Quality
| Parameter | Standard Products | Eye Area/Infant Products |
|---|---|---|
| Total aerobic count | < 1,000 CFU/g | < 100 CFU/g |
| Yeasts and molds | < 100 CFU/g | < 10 CFU/g |
| Pseudomonas aeruginosa | Absent in 1g | Absent in 1g |
| Staphylococcus aureus | Absent in 1g | Absent in 1g |
| Candida albicans | Absent in 1g | Absent in 1g |
Source: Industry practice; see SCCS Notes of Guidance (12th revision, 2023)
Section 8: Toxicological Profile
This is often the most substantial part of Part A. As outlined by SCCS Notes of Guidance:
Toxicological Data for Each Ingredient
- Acute toxicity (oral, dermal, inhalation where relevant)
- Skin irritation/corrosion potential
- Eye irritation potential
- Skin sensitization potential
- Phototoxicity/photoallergenicity (if UV-absorbing)
- Mutagenicity/genotoxicity
- Repeated dose toxicity (subchronic, chronic)
- Carcinogenicity (if applicable)
- Reproductive/developmental toxicity
- Toxicokinetics (absorption, metabolism, excretion)
Note on Endocrine Disruption
Part B: Cosmetic Product Safety Assessment
Part B is the scientific evaluation conducted by a qualified safety assessor. According to Article 10, only persons meeting specific qualification requirements can sign Part B.
| Section | Content | Expert Input Required |
|---|---|---|
| 1. Assessment conclusion | Clear statement on product safety | Yes — final judgment |
| 2. Labeled warnings | Any mandatory warnings or precautions | Yes — based on risk assessment |
| 3. Reasoning | Scientific justification for conclusions | Yes — expert interpretation |
| 4. Assessor credentials | Name, qualifications, address, signature, date | Yes — personal declaration |
Source: EU Regulation 1223/2009, Annex I Part B
Part B: Assessment Conclusion
The assessor must provide an unambiguous statement. According to industry guidance:
Valid Conclusion Statements
Part B: Reasoning Section
The reasoning must address:
Assessor's Reasoning Requirements
- How Part A data was evaluated and interpreted
- Margin of Safety calculations for key ingredients
- Consideration of target population (including sensitive groups)
- Assessment of cumulative exposure from multiple products
- Evaluation of potential ingredient interactions
- Justification for any warnings or restrictions
- How gaps in data were addressed (if any)
Part A vs Part B: Key Differences
| Aspect | Part A | Part B |
|---|---|---|
| Purpose | Compile technical data | Scientific safety evaluation |
| Who prepares | Manufacturer, Responsible Person, or delegate | Qualified Safety Assessor only |
| Content type | Factual information, test results | Expert interpretation, conclusions |
| Signature required | No (data compilation) | Yes (assessor must sign) |
| Qualifications needed | Technical competence | Article 10(2) qualifications mandatory |
| Update frequency | Whenever data changes | When formulation or data significantly changes |
| Can be outsourced | Yes, to consultants or labs | Yes, but assessor takes personal responsibility |
Source: EU Regulation 1223/2009, Annex I
Common Mistakes in CPSR Preparation
Avoid These Errors
Part A Mistakes
| Issue | Problem | Solution |
|---|---|---|
| Incomplete formula | Missing ingredients or inaccurate percentages | Verify formula totals 100%, include all components |
| Missing stability data | No accelerated or long-term data | Complete full stability program before assessment |
| Generic tox data | Using data for similar (not identical) ingredients | Obtain supplier-specific safety data |
| Incomplete fragrance data | Allergens not quantified | Request full breakdown from fragrance supplier |
| Outdated information | Using old safety data for reviewed ingredients | Verify current regulatory status of all ingredients |
Part B Mistakes
| Issue | Problem | Solution |
|---|---|---|
| Vague conclusions | No clear safety statement | Explicit conclusion on safety under use conditions |
| Missing reasoning | Conclusions without scientific justification | Document how each data point supports conclusion |
| Ignored data gaps | No discussion of missing information | Explain how gaps were addressed or why acceptable |
| Boilerplate assessments | Generic text not product-specific | Tailor assessment to specific product characteristics |
| Unqualified assessor | Signed by person without Article 10(2) credentials | Verify assessor qualifications before engaging |
Practical Workflow: Preparing Your CPSR
CPSR Development Process
Finalize and Document Formula
Lock your formula and prepare the quantitative composition. Obtain all ingredient specifications and safety data sheets from suppliers.
Commission Required Testing
Engage testing laboratories for stability, PET (if applicable), and microbiological analysis. Start early — stability takes months.
Compile Part A Dossier
Gather all required data points. Organize systematically following Annex I structure. Fill any gaps before submitting to assessor.
Engage Safety Assessor
Select qualified assessor. Provide complete Part A dossier. Discuss any concerns or questions about the formulation.
Assessor Completes Part B
Assessor reviews Part A, performs safety calculations, and drafts Part B with conclusions and reasoning.
Review and Finalize
Review completed CPSR. Implement any assessor recommendations. Assessor signs and dates Part B.
Maintain and Update
Store CPSR with Product Information File. Update when formula changes or new safety data emerges.
Key Takeaways
Frequently Asked Questions
Technically yes, if that person has the Article 10(2) qualifications required for Part B. However, in practice, Part A is often prepared by the manufacturer or a regulatory consultant, while Part B is completed by a specialized safety assessor. The key requirement is that whoever signs Part B must have the appropriate toxicology/pharmacy/medical qualifications and cosmetic safety expertise.
The profile should include all relevant toxicological endpoints for each ingredient: acute toxicity, irritation, sensitization, mutagenicity, repeated dose toxicity, carcinogenicity (where relevant), and reproductive toxicity. For well-established ingredients with SCCS opinions or comprehensive supplier dossiers, referencing these sources is acceptable. For novel ingredients, more extensive original data may be required.
Data gaps must be addressed in the CPSR. The assessor has several options: use read-across from structurally similar substances, apply conservative default assumptions, rely on long history of safe use, or conclude that additional data is needed. The reasoning must be documented in Part B. Significant gaps may prevent the assessor from concluding the product is safe.
Annex I specifies the content requirements but not a mandatory format. However, most CPSRs follow the structure outlined in Annex I (Part A sections 1-10, Part B sections 1-4). Templates are available from industry associations and regulatory consultancies. The key is that all required elements are present and clearly organized.
Length varies significantly based on product complexity. A simple formula with well-characterized ingredients might be 30-50 pages. Complex products with novel ingredients, high-risk applications (baby, eye area), or extensive testing data can exceed 100 pages. Quality of content matters more than length — ensure all required information is present without excessive padding.
Minor Part A updates (adding a stability timepoint, correcting a typo) generally don't require Part B revision. However, if Part A changes affect the safety conclusion (new adverse event data, significant test result changes, updated tox data for key ingredients), Part B must be reviewed and potentially updated by the assessor. When in doubt, consult your safety assessor.