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Product Information File (PIF) for the European Union

All cosmetics placed on the European market must have a complete PIF, which includes safety evaluation and laboratory tests.

What does the Cosmetic Product Information File consist of?

Having an expert advisor to ensure product compliance with applicable regulations will avoid future problems with authorities.


Description and Classification

Product description and classification in accordance with applicable regulations.

Ingredient evaluation

Detection of restricted and prohibited ingredients in products according to the market

Security Assessment

Toxicological study of ingredients and calculation of the safety margin effectively

Labeling Compliance

Verification of legal information, method of use, precautions, languages and waste treatment.

Lab tests

Challenge Test, specifications, microbiology, stability, HRIPT, etc.

Substantiation of claims

Justification of product claims, SPF tests among others.

Find out about the PIF and the cosmetic dossier

In the world of cosmetics, it is important to know the meaning of certain terms and concepts related to safety and legislation in the sector.

We are going to delve into the PIF and the cosmetic dossier, two fundamental elements to guarantee that our product is safe and complies with established standards. We will also cover the difference between cosmetic and cosmeceutical, how to know if a cosmetic is toxic or not, and the difference between a cosmetic and a medication.

What is the PIF of a cosmetic?

The PIF (Cosmetic Product Information Product) is a mandatory document that must be provided by the manufacturer or the person responsible for marketing a cosmetic.

This document contains all the information necessary to guarantee the safety of the product, such as its composition, its method of use, the results of the tests carried out, among other relevant data. The preparation of the PIF is essential to ensure that the product is safe and complies with current legislation.

What is the difference between a cosmetic and a cosmeceutical?

Cosmetics and cosmeceuticals are skin care products that have different properties. Cosmetics are primarily used to improve the appearance of the skin, as well as to cleanse and moisturize. Cosmeceuticals, on the other hand, contain active ingredients that penetrate the deeper layers of the skin and have therapeutic properties.

Cosmeceuticals are more effective than cosmetics in treating specific skin problems, such as acne or wrinkles.

When does the European Union indicate that a cosmetic is not toxic?

The European Union establishes a list of substances that are prohibited in the manufacture of cosmetics due to their high risk to health, and establishes maximum limits of use for other substances that are considered safe in small quantities.

When a cosmetic complies with European regulations, the European Union indicates that it is safe for use, and may include the mention “Non-toxic.”

What is the difference between a cosmetic and a medicine?

The difference between a cosmetic and a medicine is that the latter is designed to treat diseases or health problems, while a cosmetic has a purely aesthetic or personal care purpose.

Medications require additional authorization and may have side effects or contraindications. Cosmetics, on the other hand, do not have these types of restrictions, but must comply with current legislation.

What is a cosmetic dossier and what is it for?

The cosmetic dossier, also known as “Cosmetics Master Registration File”, is a document that contains all the necessary information about a cosmetic product. This document includes the PIF, manufacturer data, product name, a detailed description of the product, the tests performed, among other relevant details.

The cosmetic dossier is an essential document for the marketing of the product and to ensure its safety. The dossier acts as a legal file for your product and can be requested by the EU at any time in the event of an audit or in the event of a security investigation.

What is the dossier like?

The dossier will include a complete description of the product, a complete list of ingredients and their function, an evaluation of the safety of the ingredients, a description of the production process, information on labeling and packaging, including instructions for use, and the analysis of the results of microbiology, stability and efficacy tests.

What does quality dossier mean?

The quality dossier is a detailed record of a product, including all the ingredients and materials used for its production, as well as the manufacturing process. The dossier may also include stability and microbiology testing, risk analysis, efficacy test results, and a safety evaluation of each ingredient.

Belab Services offers a comprehensive service for preparing the Cosmetic Product Information Dossier that includes laboratory tests and substantiation of claims.

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