pif product information file

We maintain the PIF including all required documents and information for you! When a product is placed on the market, the responsible person shall keep a product information file (PIF) for a period of ten years following the date on which the cosmetic product has been placed on the market. Product Information / Technical File Compilation Product information file or technical file is type of cosmetic dossier and need to be in place before the product is placed in the market. Mitä Product Information File sisältää? What is a Voluntary Cosmetic Registration Program (VCRP)? For example, microbiological quality of the product, toxicological profile, exposure to the substance and cosmetic products, physical/chemical properties etc. The Product Information File (PIF) is one of the key elements for ensuring successful market entry of a cosmetic product in the European market. According to the EU Cosmetics Regulation 1223/2009/EC, the elements of the PIF include but are not limited to: Product Description; Safety Report: Part A: Cosmetic Product Safety Information. ASEAN PIF Guidelines 13 June, 2007 Page 3 of 7 1. The main objective of this ASEAN Product Information File (PIF) Guideline* is to provide companies placing a cosmetic product in the market recommendations on how to organize and compile the PIF based on a recommended PIF format. and is open for inspection by the Regulatory authority. Assessor’s credentials and approval – name, address, proof of qualification, date and signature. should be available to control officers at the … Data on Animal Testing. Consult our experts regarding authoring, compiling and submitting PIFs. Il nuovo regolamento CE 1223/2009 sui prodotti cosmetici parla per la prima volta di Product Information File (PIF) e valutazione della sicurezza. What are National, Mutual Recognition, Decentralized and Centralized Procedures? Hi, A Product Information File (PIF) is one of the most important legal requirements for placing a product in the market. A Product Information File (PIF) is one of the most important legal requirements for placing a product in the market. Though it’s not needed to submit complete PIF to health authority for approval, but all the documents need to be in place as health authority may request any time for information. These information could be the exe file path, the amount of memory used, as ell as the program window size. The European regulation (EC) No 1223/2009 on cosmetic products requires industry professionals to provide a Product Information File (PIF) for each product commercialized. What Is A Product Information File (PIF)? The Product Information File (PIF) is the mandatory set of technical documentation required for each cosmetic product to be placed on the EU market. The Product Information File (PIF) is the mandatory compilation of technical documentation required for each cosmetic product to be placed on the EU market. Need help to write one? Since the application of the new European Cosmetics Regulation 1223/2009 article 11 on cosmetic products sold in the European Union, industry professionals have to provide a Product Information File (PIF) for each of the product placed on the market and destined for consumption. http://www.ceway.eu This clip presents what is a cosmetics product information file (PIF) and which information it consists of. What is EU General Data Protection Regulation (EU GDPR), What is European Database on Medical Devices (EUDAMED). The Product Information File (PIF) is one of the key elements for ensuring successful market entry of a cosmetic product in the European market. The product information file is a collection of documents intended to describe a cosmetic product. https://www.lascom.com/solutions/plm-software-cosmetics/, Quantitive and qualitive composition of the product – exact percentage, Physical/chemical characteristics and stability of the product, Impurities, traces, information about the packaging, Statement on the safety of the cosmetic product, Statement on the need to label any particular warnings and instructions of use, Explanation of the scientific reasoning of the substances contained in the cosmetic product and on the Safety Information documentation, Justification of the consideration and non-consideration of the raw materials’ toxicological profiles. The PIF must be maintained by the Responsible person for at least 10 years post the date, on which the last batch of the product was distributed in the market. It is mandatory for the product cosmetic company to create and maintain the PIF to enable the product to be placed in the market. File (PIF) Compiling a Product Information . Panaracer No. What Is A Periodic Safety Update Report (PSUR)? What Is A Biologics License Application (BLA)? The PIF should include all the elements considered to be of primary importance to the consumer and its health: namely the identity of the product, the precaution of use, the list of ingredients and the possible negative effects. According to regulation 1223/2009 article 2.11, the product information file shall be kept at the disposal of the competent authorities at least ten years after the last product batch has … It also needs to contain company information including the street address of all distributors and the details of the ‘Responsible Person’. Regulation (EC) No 1223/2009 requires that a product information file (PIF) is kept for ten years for every cosmetic product placed onto the market within the European Union (EU). Quando un prodotto cosmetico è immesso sul mercato, la persona responsabile deve mantenere una accurata documentazione (PIF) informativa su di esso. Product Information File (PIF) – All You Need to Know. The PIF must also include the “Physical and chemical characteristics of the substances or mixtures, as well as of the cosmetic product.” which is covered in the raw materials’ MSDS sheets. As per the Cosmetic Regulation 1223/2009, a PIF helps the concerned authorities of the European Union (EU) to monitor the safety of cosmetic products available in the market. Readily accessible: The P.I.F. What is Certification of Suitability (CEP) and Sister CEP submissions? The bases that lead to the PIF already existed in the Directive 76/768. Since the application of the new European Cosmetics Regulation 1223/2009 article 11 on cosmetic products sold in the European Union, industry professionals have to provide a Product Information File (PIF) for each of the product placed on the market and destined for consumption. Sincerely, Each cosmetic product is required to have a PIF of its own containing information about the product such as CPSR (Cosmetic Product Safety Report), product description, methods of manufacture etc. Creating compliant packaging for a cosmetic product is a collaborative effort of various departments in an organization such as: Labeling, Artwork and Regulatory Affairs. What is Reference Safety Information (RSI)? Lascom CPG solution helps you to manage all your product data and information. Legal objective and justification related to animal testing, It should be kept in electronic or any other (example: paper) format as long as it is maintained, The information included should be easily understood by the verifier of the PIF, It should be in the national language of the country it is kept in, Any supporting documents such as laboratory reports, letters or publications should be retained in the original language they are written in. Nel PIF, in particolare, il valutatore della sicurezza dovrà effettuare e documentare verifiche su: Introduction and Objective The ASEAN Cosmetic Directive (ACD) requires persons or companies placing a product on the market to keep a product information file “readily According to the EU Cosmetics Regulation 1223/2009/EC, the elements of the PIF include but are not limited to: Proof of the effect claimed (where justified) Proof of the effect claimed (where justified) Data on Animal Testing. Nel PIF, in particolare, il valutatore della sicurezza dovrà effettuare e documentare verifiche su: Each cosmetic product is required to have a PIF of its own containing information about the product such as CPSR (Cosmetic Product Safety Report), product description, methods of manufacture etc. Unfortunately, we are unable to answer this specific question as we are not regulatory experts per se. The Legal basis EU Regulation No 1223/2009 as amended lays down the rules for cosmetic products on the EU market. about the cosmetics product information file (pif) The product information file is a cosmetic product dossier containing all the most important information about the finished product, ingredients which the product is made from, packaging in which the product is sold, manufacturing process and product labelling, which shows the product characteristics, its safety and efficacy. This is a legal requirement and the files are open to inspection by the competent authorities. The person responsible placing the cosmetic product on the market have to submit to competent authorities (ANSM, the Directorate General of Health or the DGCCRF) the PIF, as well as the Risk assessment of the product and keep those documents updated for at least 10 years. so I am looking for help to complete this if you can help. PIF – PRODUCT INFORMATION FILE NAPKIN GO 09 ‐ MAKE UP REMOVER CODICE FORMULA CH09 Rev 00 Data: 20/01/2015 Pagina 5 di 31 Dopo un periodo di … This tool provides you with the an indication of the key steps you will need to follow, without having to go through the whole Cosmetic Regulation … The main objective of this ASEAN Product Information File (PIF) Guideline* is to provide companies placing a cosmetic product in the market recommendations on how to organize and compile the PIF based on a recommended PIF format. Product Information File (PIF) Content . L’articolo 10 e 11 del nuovo regolamento CE 1223/2009 sui prodotti cosmetici inseriscono, per la prima volta nella terminologia cosmetica, termini quali Documentazione informativa sul Prodotto (P.I.F. What is the Product Information File (PIF)? What is a Marketing Authorization Application (MAA)? The health authorities can review the PIF at any time, and if they notice that a cosmetic product presents any non-conformity, they will require the immediate withdrawal of the product. CHIC TRADING s.r.l. What is Pregnancy and Lactation Labeling Rule? Below the list of documents that composed the PIF: If it appears that a cosmetic product placed on the market presents a risk to human health, the person responsible for placing it on the market must immediately inform the authorities and specify the preventive and corrective measures to be adopted. *This is not a legal document and as such, … ASEAN PIF Guidelines 13 June, 2007 Page 3 of 8 1. EU Regulation No 1223/2009 as amended lays down the rules for cosmetic products on the EU market. This document also provides guidance on who is responsible to keep the PIF and some guiding points for PIF audits. What is Software as a Medical Device (SaMD)? What Is Post-Authorisation Safety Study (PASS)? • PIF 5.0 2011 is designed to be filled out electronically after which it may This is a legal requirement and Cosmetic Product Information File (PIF) The responsible person must keep a Product Information File (PIF) at their address indicated on the label and make it available to supervisory authorities. - Product Information File ... PIF in TECHNICS is nothing more than the collection and organization of all informations memorized previously through research and development. Further guidance from Cosmetics Europe – Guidelines on Product Information File (PIF) Requirement. Express your needs and expectations; we will do our best to organize a meeting with our sales team. Our blog authors combine information freely available on the web with our teams’ experience to provide related best manufacturing practices. PIF (Product Information File) Regulation (EC) No 1223/2009 – PIF requirements. What Is FDA Unified Registration and Listing System (FURLS)? What is An Australian Public Assessment Report (AusPAR)? Therefore, it is crucial for cosmetic product manufacturers to file it compliantly by … Product Information File (PIF) Each cosmetic product must have its own Product Information File (though the term 'file' includes virtual records) containing a great deal of information about the product. A Product Information File (PIF) is one of the most important legal requirements for placing a product in the market. Who is A Mexican Registration Holder (MRH)? Compiling a Product Information . The product information file shall be kept for a period of ten years following the date on which the last batch of the cosmetic product was pla ced on the market. What is a Product Information File (PIF)? While label artwork must be validated by an artwork labeling team, it must combinedly be reviewed and approved by Regulatory Affairs team to ensure the compliance. Name and address of the responsible person, The country of origin if the product is imported from countries outside of the EU, Nominal content of the product, given by weight or volume, Date of minimum durability or period after opening. What is CFR (Code of Federal Regulations)? The product information file (PIF) demonstrates the safety of a cosmetic product for reasonably foreseeable use and must be in place before placing a cosmetic product on the market. What is The Center for Drug Evaluation and Research (CDER)? According to the … What is A Pharmacovigilance System Master File (PSMF)? This tool provides you with the an indication of the key steps you will need to follow, without having to go through the whole Cosmetic Regulation 1223/2009. For imported products, the importer is the responsible person. information on product composition and on undesirable effects to be made easily accessible to the public. I am slightly confused on how to create the PIF and what it should look like? It needs to be established before you start selling your products, as it is basically a record of how you made them. To talk to one of our PLM (Product Lifecycle Management) experts, please fill in a contact request and our teams will come back to you shortly! According to regulation 1223/2009 article 2.11, the product information file shall be kept at the disposal of the competent authorities at least ten years after the last product batch has … What Are Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE)? The PIF must be made available by the responsible person (RP) at the address displayed on the label of the cosmetic product in accordance with the Regulation. Date 03-001 2003.6.16 Product Information File (BTG-F) : ax-yu- USTIJL Y— BTG-F) : BTG-F ´Vaatimattomasti sanottuna Product Information File sisältää aivan kaiken kosmetiikkatuotteeseen liittyvän. The Product Information File (PIF) is the mandatory set of technical documentation required for each cosmetic product to be placed on the EU market. The product information file (PIF) is a collection of technical documentation for each cosmetic product to be introduced to the market. Cosmetics Product Information File (PIF) is compiled documentation with information about the cosmetic product. You will be able to automatically create the product information file and manage all the information related to your cosmetic products: physico-chemical specifications, microbiological, control plans, product formulation, constrained formulation (regulations and customers), nonconformity management, etc. What is the Product Information File (PIF)? Product Information File The Product Information File (PIF) is the mandatory compilation of technical documentation required for each cosmetic product to be placed on the EU market. Cosmetics product information file (PIF) 1. The P.I.F. Do you require a Product Information File – or PIF – for your cosmetic hair or skin product? For cosmetics manufactured in the European Union, the person who sells the product under their brand is the responsible person. shall be accessible to the competent authority of the Member State where the P.I.F. Artwork services for the current Consumer Healthcare/Food Supplements landscapes are divided as per the markets. Every product that falls under the definition of a cosmetic product and is placed in the European market, requires a PIF. Our blog authors combine information freely available on the web with our teams’ experience to provide related best manufacturing practices. However we work with regulatory partners when a customer project requires it. What Is TPD (Therapeutic Product Directorate)? The Product Information File (PIF) must contain five parts. is kept, in electronic or other format and in a language which can be easily understood by the competent authority.. For Compliance based markets, artworks are created by Freyr team and submitted to the client for finalizing the artwork/ label. What we will do: If you are selling your cosmetic products then one of the requirements is that you produce a Product Information File (PIF) for each recipe/product that you make. What Is Active Substance Master File (ASMF)? La documentazione informativa (o Product Information File) sul prodotto cosmetico dovrà essere conservata per un periodo di dieci anni dopo la data in cui l’ultimo lotto del prodotto cosmetico è stato immesso sul mercato.» The requirements for cosmetic products are set by the Regulation (EC) N° 1223/2009 on cosmetic products which replaced the Cosmetic Directive 76/768/EC. PIF stands for Program Information File, containing necessary instructions on how a DOS application should be executed in Windows. Who Is A Marketing Authorization Holder (MAH)? What is Regulated Product Submission (RPS)? In case any changes are made to the product, the PIF must be updated immediately. #1: Finished Product Information A PIF needs to start with the product name, its description and intended uses. PIF – Product Information File Il dossier cosmetico viene sostituito dal PIF ( Product Information File ) documento molto più articolato e meglio definito rispetto al passato. MS DOS programs originally use PIF files and they serve as executable file shortcuts like an .LNK file. Unfortunately, we are unable to answer this specific question as we are not regulatory experts per se. This dossier must contain information regarding the raw material, qualitative analysis, safety report, finished product etc. According to the Cosmetic Regulation (EC) No 1223/2009, when a cosmetic product is placed in the European market, the Responsible person for the product is required to maintain a Product Information File (PIF). The Regulation goes further with the introduction, for the first time, of the wording ^Product Information File (the P.I.F It needs to be established before you start selling your products, as it is basically a record of how you made them. ( I am using bases for my lip glosses which are available on the market already as well as oils and glitters so would all of this be simply states in the PIF? File (PIF) Compiling a Product Information File (PIF) is one of the key steps you need to comply with when it comes down to putting your cosmetic products on the European market. However, the Regulation 1223/2009, which is fully enforced since 11 July 2013 in lieu of the Directive, goes farther, by detailing the content of the Product Information File (PIF). The Product Information File (PIF) is a mandatory document that is necessary for every cosmetic product placed in the Association of Southeast Asian Nations (ASEAN) and European markets. Sincerely, What Is Corrective Action and Preventive Action (CAPA)? When a product is placed on the market, the responsible person shall keep a product information file (PIF) for a period of ten years following the date on which the cosmetic product has been placed on the market. Sacha Baïzet – Moderator. PIF – Product Information File Il dossier cosmetico viene sostituito dal PIF ( Product Information File ) documento molto più articolato e meglio definito rispetto al passato. It includes references of the person in charge, scientific reasoning, conclusion of the safety assessment, instructions displayed on the label. The product information file (PIF) is a collection of technical documentation for each cosmetic product to be introduced to the market. Product Information File (P.I.F. Article 11.1 of the EC regulation states: “When a cosmetic product is placed on the market, the responsible person shall keep a product information file for it.” A compliant product information file (PIF) therefore must be created from the date the cosmetic product is first sold and for a duration of 10 years from the date when the …

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