Abstract: The product information file (PIF) is a crucial document for every cosmetics manufacturer and responsible person in the European Union to ensure compliance with legal requirements, and to ensure consumer safety. It serves as a comprehensive collection of information about a cosmetic product, including its identity, ingredients, safety assessment and intended use. The PIF must be created before the product is placed on the market and must be kept for ten years after the last batch has been placed on the market. While the PIF can be self-prepared, the cosmetic product safety report (CPSR), a critical element of the PIF, must be prepared by a qualified safety assessor. The CPSR contains a detailed scientific evaluation of a product’s safety based on available data and ensures that the product meets regulatory standards and does not pose unreasonable risks to consumers.
Plank D. The basics about the product information file (PIF) and cosmetic product safety report (CPSR) – What documentation you need for the registration of a cosmetic product. Cos ACTIVE J. 2025
BEHIND THE LABEL: YOUR RESPONSIBILITY FOR COSMETIC PRODUCTS
According to Regulation (EC) No 1223/2009 on cosmetic products, as a manufacturer of cosmetics or as a responsible person, you are obliged to create a product information file (PIF) for each cosmetic product before you place it on the market. In addition, the PIF must be kept in electronic or other form at the address of the responsible person for a period of ten years after the last batch has been placed on the market.
The responsible person is usually the person indicated on the label of the product. This may be a manufacturer based in the European Union. For products with a white label, this can also be a distributor (who sells a product under their own brand) or an importer if the product is manufactured outside the EU.
If changes are made to a product, the PIF and the cosmetic product safety report (CPSR) must be updated immediately. This may involve the alteration of a cosmetic product’s qualitative and quantitative formula, the alteration of packaging material and/or labelling, and an update or change in the applicable regulatory requirements for cosmetic products.

YOU MUST KNOW THE DETAILS: WHAT ARE THE PIF AND CPSR?
With the exception of the CPSR, which must be written by a qualified safety assessor, the PIF can be prepared by yourself, i.e. by you as a product manufacturer. It contains these five data sections:
1. Description of the cosmetic product
2. Manufacturing process and declaration of compliance with good manufacturing practices
3. Proof of the claimed effect
4. Declaration regarding animal testing
5. CPSR
Details of individual sections and the scope of the information they must contain are described below.
- Description of a cosmetic product
The description usually contains the following points:
– The description of your product, where one sentence is usually sufficient.
– This is followed by a qualitative and quantitative description. The ideal presentation is in tabular form.
– This is usually followed by the physical, chemical and microbiological specifications of your product.
– Next, the packaging information must be recorded. This usually refers to the Declaration of Conformity (DoC) of the packaging material.
– Photo of primary and secondary packaging.
- Manufacturing process and declaration of compliance with good manufacturing practices
This PIF subsection contains your manufacturing instructions. The declaration of compliance with good manufacturing practices (GMP) must also be entered here. This declaration can be a simple document with a product name, a statement that a product is manufactured in accordance with GMP, the date and your signature.
- Proof of the claimed effect
If you advertise a product with a special effect, you must provide evidence of this. Here are a few examples. If sun protection (performance claim) is claimed, a test must be carried out in accordance with the applicable ISO standard for SPF testing. In the case of a claim relating to an ingredient, the ingredient to which the claim refers should be present in an appropriate concentration. Hyperbolic claims, for example, “This perfume gives you wings.” require no evidence; in this case a consumer would never take the claim literally. Evidence may vary depending on the nature of the claim.
- Animal testing statement
Within the European Union, the test ban for finished cosmetic products has been in force since 11 September 2004. Later, on 11 March 2009, animal testing for cosmetic ingredients was banned, regardless of whether there are animal-free alternatives, and from 11 March 2013, the European Union completed the ban on the sale of cosmetics tested on animals anywhere in the world after this date. The ban applies to both cosmetic products and ingredients, again regardless of whether there are alternatives.
By providing an animal testing statement you comply with the regulation. This declaration can be a simple document with a product name, the date and a statement about the non-existence of animal testing, and your signature.
- Cosmetic product safety report
The CPSR is the most important part of your PIF. It may only be written by you if you have the appropriate training (i.e. a degree in medicine, pharmacy, chemistry or a comparable qualification). Otherwise, the safety report must be written by a safety assessor using the information you provide to them.
Normally, you must provide the following information: the safety data sheet and the certificate of analysis, the technical data sheet or the product data sheet and further information regarding every raw material. The manufacturing description and formulation of your cosmetic product (e.g. individual ingredients and their percentage content), proof of allergens for essential oils/perfumes and information on the packaging are also required. All this information is then used to create the safety report for your cosmetic product.

MORE ABOUT THE COSMETIC PRODUCT SAFETY REPORT
The CPSR is divided into two parts as is mandatory according to Regulation (EC) No 1223/2009 on cosmetic products:
– Part A – Safety information about a cosmetic product, and
– Part B – Safety assessment.
Part A, the safety information, contains the following ten sections:
- Product description, and quantitative and qualitative composition of a cosmetic product
First, there is a description of your product: product name and whether it is a leave-on or rinse-off product, as well as the intended use (e.g. bath salts, hand cream, body lotion, etc.). The quantitative and qualitative description is usually presented in tabular form. For each raw material, the INCI name, the CAS number (Chemical Abstracts Service for substances), the ELINIC/EINECS number (European List of Notified Chemical Substances/European Inventory of Existing Commercial Chemical Substances), the concentration and the intended function must be given.
- Physical and chemical properties of individual raw materials
This section represents a brief description of the specific physical/chemical characteristics and unique properties of each material.
- Physical and chemical properties, and information about the stability of a product
Data about the stability of the product is usually required. In some cases, data from other comparable products can be used. This is the case, for example, for soaps, shampoo bars and ointments. Physical and chemical characteristics primarily include appearance, colour, odour and pH value.
- Microbiological quality of raw materials and product
The microbiological characteristics of raw materials must be listed. In addition, the microbiological properties of a finished cosmetic product must also be specified. The evaluation of the microbiological quality of a product aims to ensure that the product is free from microorganisms that may affect its quality and the consumers’ health. This includes the total microbial count, moulds and yeasts, as well as the absence of pathogenic microorganisms. If a product is not a low-risk product according to ISO 29621, the results of the challenge test must be also included.
Low-risk products according to ISO 29621 are defined as products to which one of the following points applies: a pH value ≤3 or ≥10, the absence of water or an aw value (this is the value for the available water in the product) that is ≤0.60 or ≤0.75, or alcohol content (mass) of ≥20%.
- Information and specification of packaging material and the impurities of raw materials
In accordance with Article 17 of Regulation (EC) No 1223/2009 on cosmetic products, the unintentional presence of a small quantity of a prohibited substance in a cosmetic product due to impurities of natural or synthetic ingredients, the manufacturing process, storage or migration from the packaging is permitted, provided that this is technically unavoidable in good manufacturing practices and does not compromise the safety of a product. In this section, traces of prohibited substances in a cosmetic product are assessed. These can be, for example, traces of heavy metal that occur in mica, iron oxides or similar.
- Normal and foreseeable use
The normal usage of a product needs to be described here. For example, for a shampoo normal use is considered application on the scalp and hair and then rinsing-off the shampoo. Reasonably foreseeable use includes, for example, (diluted) contact with the eyes and body, while misuse means ingestion of the shampoo.
- Exposure: information and calculation
The so-called systemic exposure dose (SED) is calculated from the exposure values to a cosmetic product. If applicable, so-called secondary exposures are also taken into account, e.g. inhalation of sprays, unintentional ingestion of lip balm, etc. (3). Usually, data from literature are used.
- Toxicological profiles of all raw materials and calculation of the margin of safety (MoS)
The toxicological evaluation of a product is based on the assessment of the individual toxicological profile of each substance in the formulation. For each raw material, the following information is summarised, usually in a table: acute toxicity, irritation potential (skin and eyes), sensitisation potential, carcinogenicity (carcinogenic effect) and mutagenicity, reproductive toxicity and, if applicable, photo-induced toxicity.
The Margin of Safety (MoS) is also calculated. The MoS is a measure of the probability that a substance will cause harm to the human body. To be considered safe, an ingredient must have an MoS value of more than 100. This calculation of the MoS is based on the NO(A)EL value and the exposure calculation (SED) from point 3.
- Undesirable side effects
If side effects are known, they must be recorded here.
- Additional relevant information
For example, if studies on volunteers have been made, they are included in this part.
Part B of the safety assessment then follows with the below-described content.
- Conclusion from the assessment
Essential statements regarding the safety of a cosmetic product are recorded and described here.
- Warnings on the label and instructions for use
Some substances require warnings and instructions for use. If this is the case, these are recorded under this sub-item.
- Justification/reasoning
The scientific considerations that led to the conclusion of the assessment are explained here.
- Qualifications of the safety assessor
The curriculum vitae of the safety assessor is usually included in this point.

WRAPPING UP: KEY TAKEAWAYS ON THE PRODUCT INFORMATION FILE (PIF) AND COSMETIC PRODUCT SAFETY REPORT (CPSR) TO ENSURE PRODUCT COMPLIANCE
To summarise, the CPSR and the entire PIF contain complete information about your product and the raw materials used. The safety report part, in particular, is proof that the product complies with the cosmetics regulation in the European Union (Regulation (EC) No 1223/2009 on cosmetic products) in terms of its composition and is safe for human health. According to the current legal situation, the safety report is mandatory for every cosmetic product and no exceptions are permitted.
As each safety assessor has their own style, the order of the chapters may be different, but the information described in this article should all be included.
You should also be aware that some safety assessors will prepare the entire PIF, including the CPSR, for you, while others only offer preparation of the CPSR. It is thus important to pay attention when asking for this service, so that you get the best version for your needs.
Doris Plank, Ph.D.
Cosmetic Consulting, Graz, Austria

References
Please click on the references below for more information.
2. International Organization for Standardization. ISO 29621:2017 Cosmetics – Microbiology – Guidelines for the risk assessment and identification of microbiologically low risk products. Edition 2, 2017.
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