How to Build a Cosmetic Raw Material Regulatory Dossier?
A cosmetic raw material without a usable regulatory dossier cannot be incorporated into a cosmetic product in accordance with European Cosmetic Regulation 1223/2009, even if it is innovative or natural
As an expert in cosmetic regulations, Toxi Plan gives you the key steps in the regulatory dossier for cosmetic raw materials.
The objectives of the "regulatory file for cosmetic raw materials"
The raw materials dossier plays a central role in the development of a cosmetic ingredient.
Indeed, it allows the manufacturer to precisely understand the composition of the material, assess its safety in use, and integrate this data into the Product Safety File (PSF).
Thus, this dossier is a key tool for demonstrating the conformity of the finished product and responding effectively to authorities in the event of an inspection.
It therefore represents the essential scientific and regulatory basis for any future use of the ingredient.
🧭 Overview of the process
The creation of a raw material dossier relies on a progressive and structured approach. First, the raw material must be precisely defined, and then its physicochemical properties must be characterized.
Next, compositional analysis identifies the constituents, leading to the study of associated toxicological data. Based on this information, the toxicologist can conduct a safety assessment and define appropriate conditions of use.
Finally, all of this information allows for the creation of a complete and usable supplier dossier. Thus, each step follows a coherent logic, as it directly influences the next.
1. First step: defining the raw material
This step involves precisely describing the ingredient:
- Proposed INCI name
- Cosmetic function
- Origin (plant-based, synthetic, biotechnological, etc.)
- Manufacturing process
- Solvents used
- Any additives
- Known impurities
This first step is essential because a poorly defined raw material cannot be toxicologically evaluated.
2. Second step: physico-chemical characterization
It allows for the identification of the ingredient’s key properties. This data is essential for formulation and the evaluation of skin exposure:
- appearance
- solubility
- pH
- molecular weight
- melting point
- stability
- purity
3. Third step: composition analysis
The toxicologist always assesses the actual composition:
The composition must be known both qualitatively and quantitatively. It includes:
- main constituents
- secondary constituents
- impurities
- solvent residues
- manufacturing by-products
- For natural ingredients:
- botanical variability
- chromatographic profiles
- naturally occurring substances
4. Fourth step: toxicological data of the constituents
Data is collected for each identified constituent and for relevant impurities.
The sources used are as follows:
- Scientific literature
- SCCS opinion
- Toxicological databases
- REACH data when available
- Supplier data
The parameters evaluated include:
- Systemic toxicity
- Genotoxicity
- Reproductive toxicity
- Skin irritation and sensitization
- Phototoxicity (if relevant)
5. Fifth step: toxicological evaluation of the raw material
This step requires the expertise of a toxicologist, as it allows for a thorough assessment of the raw material’s safety.
Specifically, the toxicologist identifies available NOAELs (No Observed Adverse Effect Levels), applies TTC (Total Consumption Testing) approaches when necessary, and calculates the margin of safety (MoS).
In parallel, they assess skin exposure, consider the target population, and analyze the cumulative risk. This comprehensive approach allows for a precise characterization of the risk level associated with the ingredient. Following this analysis, the toxicologist determines the safe use of the raw material, defines the maximum recommended concentrations, and identifies any known restrictions or incompatibilities.
6. Sixth step: defining the terms of use
Following the toxicological assessment, the essential elements for brands to establish their Product Safety Profile (PSP) are defined:
- maximum concentration of use
- types of cosmetic products concerned
- authorized areas of application
- target populations
- precautions for use
- applicable regulatory restrictions
7. Final step: compiling the supplier file
The supplier file is sent to the cosmetic manufacturers who are clients. This raw materials file generally includes:
- technical data sheet
- safety data sheet (SDS)
- description of the manufacturing process
- specifications
- qualitative and quantitative composition
- toxicological assessment
- conditions of use
- EU regulatory declarations
- allergens
- CMR status
🔬 The indispensable role of the toxicologist 🔬
The toxicologist plays a central role in ensuring the safety of a raw material, as they guarantee the scientific validity of its assessment. They interpret toxicological data, link it to skin exposure, and calculate safety margins to define safe conditions of use.
Furthermore, they anticipate European regulatory requirements and produce an assessment that can be directly integrated into a Product Safety Review (PSR). Thus, they transform raw data into a safety dossier that brands can use. Without this expertise, the raw material becomes difficult to use: it cannot be properly assessed, brands hesitate to incorporate it, and the regulatory risk shifts to the customer.
Consequently, the ingredient is often rejected in the early stages of development.
The benefits of a complete raw materials file
A comprehensive raw materials dossier is a true performance driver, as it brings clarity, security, and credibility to every stage of development.
For ingredient suppliers, it strengthens their credibility with brands while facilitating the integration of the raw materials into formulations. Furthermore, it reduces regulatory back-and-forth, promotes innovation, and secures access to the European market.
For cosmetic manufacturers, a well-structured dossier saves time during development because the data is directly usable. This ensures the accuracy of the CPSR (Product Safety Record), limits the risk of non-compliance, and accelerates product launches.
Creating the regulatory dossier for a cosmetic raw material is a structured and demanding process. It relies on a thorough understanding of the composition, reliable scientific data, and a rigorous toxicological assessment.
And you?
In this process, the toxicologist plays a central role in transforming an innovative raw material into a usable, safe, and compliant cosmetic ingredient. If you need a reliable expert, Toxi Plan can help you turn your regulatory requirements into a performance driver.
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.