How to get PIF
(Regulation 1223/2009 )
You need PIF?
Do you want to places your cosmetic product on the Serbian, EU or other markets?
We can help you!
MAKING A PIF AND SAFETY ASSESSMENT (CPSR)
Safety assessment is the main part of the mandatory documentation for placing a cosmetic product on the market. Our team of experts performs, for you, safety assessment, as well as the entire development of PIF (Product Information File). In accordance with European regulations, a cosmetic product should meet high standards in terms of quality, efficiency, but most importantly, in terms of safety for human use, when used under normal, reasonably foreseeable circumstances. Particular attention should be paid to: the presentation of the cosmetic product including compliance with Directive 87 / 357EEC, the declaration, the instructions for use and disposal and other relevant information that the Responsible Person considers relevant.
Efficiency, as well as the safety of cosmetic products, is a priority requirement for the manufacturer. The manufacturer must prove the effectiveness of the product before placing it on the market. We offer consulting services related to the assessment of the effectiveness of cosmetic products and assistance in defining claims in accordance with regulations
The stability of a cosmetic product means that the product retains its physical, chemical and microbiological characteristics in accordance with the specification for the declared shelf life. Our team will be able to help you in the phase of product stability control.
CLASSIFICATION OF COSMETIC PRODUCT
The cosmetic product should comply with the requirements of EU Regulation 1223/2009. We can help you assess whether the product you plan to place on the market is a cosmetic product or belongs to another area.
CLAIMS AND PRECAUTIONS
Claims and precautions for cosmetic products are essential elements of labeling and are an integral part of the declaration. They must comply with regulations. Claims must be in line with the definition of cosmetic products in the EU. Precautions indicate the safe use of a cosmetic product.
NOTIFICATION TO CPNP PORTAL
Notification to the CPNP portal is in accordance with European Union regulations, a mandatory step for placing a cosmetic product on the market. The application is done electronically by the Responsible Person, with the aim of market surveillance and consumer protection.
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Frequently Asked Questions
PIF (Product Information File) is a technical documentation of a cosmetic product that is placed on the market. PIF means the documentation that is necessary for a certain cosmetic product to be placed on the market. The PIF presents detailed data and information on the cosmetic product, which are provided exclusively to the inspector upon request.
GMP is the English abbreviation for “Good Manufacturing Practice”.
GMP (ISO 22716 recommendation) is a set of procedures that ensure that a cosmetic product is manufactured under the highest standards that allow complete traceability (monitoring of the product throughout the manufacturing process). Applies to raw materials, premises, personnel, equipment, control and monitoring of the finished product, environment, production processes, quality control, storage, waste, subcontractors, complaints, internal audits, documentation…
The goal of GMP is to ensure that every manufactured cosmetic product that is placed on the market complies with the specification.
GMP is a “tool” that documents and demonstrates to the Authority that the Responsible Person has placed on the market a series of cosmetic products that in all respects correspond to the "ideal" product that the Safety Assessor assessed in the PIF.
How do we know that our product is a cosmetic product??
Cosmetic product means a substance or mixture intended to come into contact with various external parts of the human body (epidermis, hair, nails, lips and external genital organs) or with the teeth and mucous membranes of the oral cavity in order to clean, perfume or beautify them exclusively or mainly. cosmetics), removes unpleasant odors, protects and maintains in good condition.
There are three basic questions to consider when deciding whether a product can be legally classified as a cosmetic product:
1. Purpose: whether the purpose of the product is entirely or mainly cosmetic, ie. whether it is intended to cleanse, perfume, beautify, correct unpleasant body odors, protect and maintain in good condition (care). If the main purpose of the product is not one of these functions, it is unlikely that the product will be cosmetic.
2. Place of application: whether the product is intended for: epidermis, hair, nails, lips, oral cavity, external genital organs If not, it is unlikely that the product will be cosmetic.
3. Composition: whether the composition of the product is in accordance with the Regulations and regulations on cosmetics.
The cosmetic safety assessment shall be performed by a person holding a diploma or other evidence of formal qualifications obtained after completing a university course in theoretical and practical studies in pharmacy, toxicology, medicine or similar disciplines, or a course recognized as equivalent by a Member State. Assessor).