Abstract: In order to carry out a safety assessment for a cosmetic product, comprehensive information on the raw materials used as ingredients in its composition is required, which unfortunately is all too often not easily accessible. This article summarises the most important information about cosmetic raw materials, which can also help you to evaluate the quality of the ingredient you are purchasing. Material Safety Data Sheet (MSDS or SDS), Certificate of Analysis (CoA), Technical Data Sheet (TDS or TS) and Product Data Sheet (PDS) are the mandatory documents that you and your safety assessor will need to evaluate the ingredients used in a cosmetic product. These documents are discussed in detail in this article. In addition, information on self-made extracts and raw materials from the supermarket, as well as basic information on packaging will also be covered.
Plank D. Documentation about cosmetic ingredients. Cos ACTIVE J. 2025;3:9–14
THE RAW TRUTH: NAVIGATING INGREDIENT DOCUMENTATION FOR SAFE AND COMPLIANT COSMETICS
From a technical point of view, cosmetic ingredients are considered raw materials for the manufacture of cosmetic products that are placed on the market for use by the end consumers. Cosmetics regulations and the cosmetics industry must follow certain rules and guidelines both in the manufacturing process and in the preparation of the Product Information File/Cosmetic Product Safety Report (PIF/CPSR) to ensure that cosmetics are of the highest quality and safety. This includes the use of raw materials for which appropriate data on their quality, i.e. physico-chemical properties, composition, safety, etc., is available. Such documentation is required not only to demonstrate the safety of a cosmetic product, but also to ensure compliance with Good Manufacturing Practice (GMP) guidelines.
Apart from the Material Safety Data Sheet (also known as MSDS) or, for short, Safety Data Sheet (SDS) and the Certificate of Analysis (also called CoA), there are unfortunately no standardised names for these documents. It may also be that all the information is available in a single document, the Technical Data Sheet (TDS) or the shorter Technical Sheet (TS) or the Product Data Sheet (PDS), or you may receive many individual documents; this varies from manufacturer to manufacturer (or supplier to supplier). It should also be noted that sometimes more information is required. For example, this may be the particle size for glitter, pigments, polymers and nanomaterials, and for aerosols the Particle Size Distribution (PSD), which is relevant for assessing the risk of inhalation of the particles. A statement on the absence of nanoparticles may also be required. It should also be noted that, depending on the specific raw material or product type, the safety assessor may require additional data beyond the standard documentation. In such cases, it is usual for the assessor to consult the cosmetics manufacturer to obtain the missing or product-specific information. This may include, for example, information on particle size (e.g. for glitter, pigments, polymers, or nanomaterials), or— especially for aerosol formulations — the detailed particle size distribution (PSD) relevant for the inhalation risk assessment. Depending on the regulatory context and intended use, a formal statement confirming the absence of nanoparticles may also be required.
Considering how complex and challenging the raw material step can be when purchasing or preparing information for the PIF/CPSR, especially without sufficient background knowledge of cosmetics, it is advisable to purchase raw materials from a specialised cosmetic raw material supplier, as all the necessary documentation is usually available there. This applies both to those who are involved in the manufacturing of cosmetics for sale and to those formulating as do-it-yourself.
MSDS: IDENTIFICATION OF THE RAW MATERIAL
The identification of a raw material is the basis for all further safety assessments that a person manufacturing a cosmetic product needs before placing a product on the market. MSDS should be available for every raw material, with the exception of raw materials purchased at the grocery store, and the manufacturer of the raw material (or the supplier) should be able to provide it to you. The MSDS contains the most important information about an ingredient in 16 sections. In section 1 you will find information about the manufacturer of the raw material, the name of the substance, the chemical formula and the CAS number. The name of the raw material is unique and uniquely identifies the raw material. The chemical formula indicates the chemical composition of the raw material. The CAS number is a globally unique identifier for chemical compounds.
CoA: CHEMICAL AND PHYSICAL PROPERTIES OF THE RAW MATERIAL
The chemical and physical properties of a raw material have a significant impact on your formulation and should be carefully checked in the CoA. The CoA should be available for each batch of a raw material, except for raw materials purchased at the grocery store. Key information includes molecular weight, melting point, boiling point, solubility, pH and content or purity.
The molecular weight indicates the relative molecular mass of the raw material. The melting point is the temperature at which the raw material changes from a solid to a liquid state. The boiling point is the temperature at which the raw material changes from a liquid to a gaseous state. The solubility indicates the extent to which the raw material is soluble in a particular solvent; this can be crucial information for your formulation. The pH value indicates the acidity of a solution is. In terms of content or purity, it should be mentioned that some cosmetic ingredients are in the form of diluted solutions. For example, D-panthenol is also available as a 75% aqueous solution or vitamin E as a 70% solution in a vegetable oil. As a rule, you will find the assay parameter in a CoA, in which the content of an active ingredient (D-panthenol or vitamin E) is specified. For colourants, the total pigment content must be indicated, and the indication of purity is mandatory.
There are other properties that are characteristic for specific raw materials. In the case of vegetable oils, for example, the iodine value serves as a measure of the degree of unsaturation (the higher the iodine value, the more unsaturated bonds the oil contains) and the peroxide value as a measure of the oxidation state (the peroxide value increases with oxidative spoilage). The ash content is the value of the inorganic content of a material. In plant extracts, the content of cosmetically active ingredients is of great importance but is not always specified. In an extract of Bosswellia serata (Olibanum), for example, you should find the content of boswellic acids and the content of the extraction solvent (ethanol, water). In a curcuma dry extract, the content of curcuminoids and, if applicable, excipients such as maltodextrin should be stated. Why is this important for cosmetic scientists and safety assessors? Because knowing the percentage of a cosmetically active ingredient makes it possible to use the raw material in a concentration that has been proven to have clinically relevant cosmetic effects, while ensuring the safety of a cosmetic product.
TDS or PDS: INFORMATION ABOUT THE COMPOSITION
A composition sheet is a document that contains information about the composition of a cosmetic raw material. This information can sometimes also be part of the CoA. In general, this is required at least for all raw materials that contain more than one ingredient. The composition sheet contains the following information:
1. Product name: This is the name of the product as it appears on the label.
2. INCI names: These are the international cosmetic names of the ingredients.
3. Ingredient concentrations: These are the amounts of each ingredient in the product, usually expressed in ranges.
DESCRIPTION OF MANUFACTURING METHOD
The manufacturing method for complex raw materials used in cosmetics is an important piece of information that should be included in the CPSR. It provides information about the manufacturing process and ensures that the raw materials are produced in a safe and controlled environment. This information is crucial for evaluating the overall safety of the cosmetic product.
The description of a manufacturing method includes:
– Raw material sourcing: indicating the source of the raw material, the country of origin and any specific details.
– Extraction or processing: the description of specific procedures used to extract or process the raw material such as distillation, extraction or purification; this is particularly important for obtaining certificates for natural cosmetics. Purification or standardization: an explanation of the methods used to purify or standardize the raw material, to ensure consistency and quality.
REGULATORY STATEMENT
A regulatory statement for cosmetic raw materials is a declaration that confirms the safety and suitability of a raw material for use in cosmetic products in accordance with Cosmetic Regulation EC 1223/2009 (valid in the European Union) or any other regulation.
INFORMATION ON MICROBIOLOGICAL SPECIFICATIONS
A microbiological statement is a declaration that confirms the safety and suitability of a raw material for use in cosmetic products regarding its microbial contamination. This information is required at least for all raw materials containing water, as aqueous raw materials can be a major cause of microbial contamination of cosmetic products. Manufacturers should therefore ensure that raw materials have a low level of microbial contamination and are free from harmful microorganisms or their toxins. It is best if all raw materials and primary packaging have the same microbiological specifications as the cosmetic product itself.
INFORMATION ABOUT HEAVY METALS
Some raw materials (especially those originating from the earth’s crust, such as clays, iron oxides, dyes, mica, illite, etc.) are susceptible to heavy metal contamination. In order to include these impurities in the CPSR, data on their presence must be available. Why is this important?
Impurities, even if present in trace amounts, can have a significant impact on the toxicological profile of a cosmetic product. Some impurities may have hazardous properties even at low concentrations, e.g. genotoxic, carcinogenic or sensitizing. Without reliable data on their identity and concentration, the potential risks to the end user may be underestimated in the overall safety assessment. In addition, certain impurities are specifically regulated or restricted in the EU Cosmetics Regulation (e.g. substances listed in Annex II or III), and their unintended presence must be evaluated against the relevant legal thresholds.
From a regulatory and scientific perspective, transparency on impurities is essential for the credibility of the safety assessment and to ensure that the product complies with applicable legislation, including the precautionary principle embedded in Regulation (EC) No 1223/2009.
INFORMATION ON IMPURITIES AND RESIDUAL SOLVENTS
Some raw materials contain impurities or solvent residues that can be traced back to the manufacturing process. In order to include these impurities in the safety assessment, it is necessary to obtain information about them.
This is essential as certain solvent residues, even in small quantities, may be of toxicological concern, e.g. in terms of neurotoxicity, reproductive toxicity or carcinogenicity. Without data on their presence and concentration, potential health risks may be underestimated. In addition, several solvent residues are subject to specific restrictions under cosmetic and pharmaceutical regulations, and their inclusion in the toxicological evaluation is crucial for regulatory compliance.
INFORMATION ON PESTICIDES
Some raw materials (especially plant substances) may contain pesticide residues. To include these residues in the safety assessment, information about them must be obtained. It should be noted that this is sometimes only a sentence stating that the raw material is within the legal limits.
INFORMATION ON PARTICLE SIZE
This is only required for all powdery raw materials such as colourants and bulking agents (e.g. kaolin, mica, iron oxides, etc.).
INFORMATION ABOUT IONISING RADIATION, GENETICALLY MODIFIED ORGANISMS AND BOVINE SPONGIFORM ENCEPHALOPATHY/TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHIES
This is usually a sentence statement that declares:
– The raw material has not been treated with ionizing radiation.
– The raw material does not contain any material of genetically modified origin (GMO).
– The raw material is not at risk of bovine spongiform encephalopathy (BSE) or transmissible spongiform encephalopathy (TSE).
IFRA CERTIFICATE
The International Fragrance Association (IFRA) is a self-regulatory organization that promotes safety and sustainability in the fragrance industry. The IFRA standards are recognised by the scientific community.
An IFRA certificate is a document for the safe use of fragrances (perfume oils and essential oils) in cosmetic products. The certificate contains information on the following points:
– The name of the fragrance blend and the permitted use levels, i.e. the maximum permitted concentrations of the fragrance in various cosmetic products.
– A list of restricted components should also be included.
It is recommended to check the current IFRA certificate before formulating your product.
DECLARATION OF ALLERGENS – ALLERGEN CERTIFICATE
For perfumes and essential oils, information on the allergenic substances listed in Annex III of Regulation 1223/2009 is mandatory. It should be noted that the list of allergenic substances was renewed in 2023 with Regulation (EU) 2023/1545 amending Regulation (EC) No 1223/2009 as regards the labelling of fragrance allergens in cosmetic products.
The new regulation introduces 56 additional fragrance allergens. This is done through new/amended entries in Annex III of the Cosmetics Regulation. These substances must be labelled if their concentration exceeds 0.001% in leave-on products and 0.01% in rinse-off products. Labelling takes place via the list of ingredients analogous to the existing labelling requirements. The extended labelling requirement also applies to many essential oils (natural extracts), e.g. Atlas cedar, neroli, cinnamon, bergamot, sweet orange, lemongrass, eucalyptus, clove, lemon, lavender, peppermint, rose geranium, patchouli, rose, sandalwood, ylang-ylang essential oils and others.
Perfume oils and essential oils
The following information is mandatory for perfume oils and essential oils: MSDS, CoA, IFRA Certificate and Allergen Certificate. If it is possible to obtain a safety assessment from the perfume oil manufacturer, it is always welcome. For homemade essential oils, a GC-MS analysis report on their allergen content is required. In some cases, this may also be recommended for homemade hydrosols.
RAW MATERIALS OBTAINED IN A FOOD STORE
A photo of the front and back of the label is usually sufficient for the safety assessment. Vegetable oils, butters, spices and herbal teas can usually be used without any problems. Please note, however, that all other raw materials, such as food colours, should be discussed with your safety assessor in advance.
HOMEMADE COSMETIC RAW MATERIALS
For homemade extracts (macerates, tinctures, essential oils, hydrolates, etc.), the information described above must be provided for each raw material used to make an extract. This means that if you use olive oil from the grocery store, you usually provide a photo of the label or documentation, if available. For botanicals such as marigold flowers purchased from a specialty store, provide the MSDS, CoA and any other data sheets you can get, and if you are using tea grade botanicals, provide a photo of the packaging (front and back). The next step is the formulation (composition), information about the detailed manufacture process and quality control. You can write these documents yourself. If you do not have experience in writing such documents, ask your safety assessor how to do this at an early stage. It is important that every step is well documented.
PACKAGING
Finally, information about your packaging material is also required. The easiest way is to obtain a Declaration of Compliance (DoC) for food contact materials/food packaging. If you are using baking paper, lunch bags or similar that you purchase from a grocery store, a photo of the fork/knife symbol is usually sufficient for the safety assessment. If you are unable to obtain a DoC, discuss this with your safety assessor at an early stage.
Doris Plank, Ph.D.
Cosmetic Consulting, Graz, Austria
References
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