Can the same person prepare both Part A and Part B?

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.

How detailed must the toxicological profile in Part A be?

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.

What happens if there are gaps in the toxicological data?

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.

Is there a standard format for the CPSR?

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.

How long should a CPSR be?

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.

Can Part A be updated without changing Part B?

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.

CPSR Part A vs Part B: Complete Structure Guide

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 compiles all the technical data and information about your product. Part B is the scientific safety assessment conducted by a qualified expert. Both parts are mandatory — you cannot have a valid CPSR without both.

Part A: Cosmetic Product Safety Information

Part A is the data compilation section. According to Annex I, Section A, it must contain:

Part A Required Elements
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

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

While 'parfum' or 'aroma' may appear as single entries on labels, Part A must include a detailed breakdown from your fragrance supplier showing all individual components, especially the 80+ declarable allergens and any restricted substances.

Section 2: Physical/Chemical Characteristics & Stability

Typical Stability Program for Part A
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

Microbiological Specifications by Product Type
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

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

Endocrine disrupting properties are a distinct hazard concern under increasing regulatory scrutiny. While not yet a mandatory toxicological endpoint under Regulation 1223/2009, safety assessors should be aware that the European Commission is progressively identifying and restricting substances with endocrine-disrupting properties. The SCCS has developed specific criteria for assessing endocrine activity. Substances flagged as potential endocrine disruptors (e.g., certain UV filters, preservatives) warrant enhanced evaluation.

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.

Part B Required Elements
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

Part B: Assessment Conclusion

The assessor must provide an unambiguous statement. According to industry guidance:

Valid Conclusion Statements

- "The product is safe for human health when used under normal or reasonably foreseeable conditions of use." - Or identification of specific conditions under which the product is safe (e.g., "safe when used as directed on intact skin, not exceeding [frequency]").

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

Part A vs Part B Comparison
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

Common Mistakes in CPSR Preparation

Avoid These Errors

Many CPSRs are rejected or require revision due to these common issues:

Part A Mistakes

Common Part A Deficiencies
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

Common Part B Deficiencies
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

Part A is the data compilation (formula, testing, tox profiles) — can be prepared by manufacturer or consultant

Part B is the scientific assessment with conclusions — must be prepared by qualified assessor per Article 10(2)

Part A has 10 required sections covering everything from formula to adverse events

Part B requires an explicit safety conclusion, reasoning, and assessor signature

Common Part A issues: incomplete formulas, missing stability data, generic tox profiles

Common Part B issues: vague conclusions, missing reasoning, boilerplate assessments

Both parts must be complete before the product is placed on the EU market