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What is the purpose of the regulation EC 2009 regarding cosmetic products?
Which entity is responsible for the safety and labeling of cosmetic products in the market?
What principle should the production of cosmetic products comply with according to the regulations?
Which of the following roles is NOT directly mentioned in connection with cosmetic products?
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What does the term 'Serious Adverse effects' relate to in cosmetic products?
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Which of the following is a key aspect of the control of cosmetic products in the market?
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Who has the ultimate responsibility for the presentation and supply of a cosmetic product in the market?
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What is a major goal of cosmetic chemistry as indicated in the content?
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What substances are absolutely prohibited in cosmetic products?
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Which abbreviation represents a set of names used for cosmetic ingredients?
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Which of the following substances can be used in cosmetic products only with restrictions?
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What is indicated by the abbreviation CAS No.?
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Which list specifies the dye-related regulations for cosmetic products?
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What is the duration for which the product information file must be kept after the last shipment of a cosmetic product?
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What is the primary requirement for cosmetic products supplied to the market?
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Which of the following is NOT included in the Safety Report Part A?
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Which regulation specifically addresses the registration, evaluation, authorization, and restriction of chemicals?
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Which of the following aspects is primarily focused on during the 'Training of employees' in Good Manufacturing Practice?
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What does CPNP stand for in the context of cosmetic product notification?
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What is the main purpose of having a 'Product Description' in the product information file?
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Which of the following statements accurately reflects the contents of the Safety Report Part B?
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What standard must all cosmetic products comply with during manufacturing?
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What does the Product Safety Law of the Republic of Lithuania aim to achieve?
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What aspect is covered under the 'Equipment' section in Good Manufacturing Practice?
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Which entity is responsible for providing instructions regarding the use and disposal of cosmetic products?
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What is one of the main focuses of animal testing regulations?
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Which of the following is NOT an aspect covered by the health and safety requirements for beauty services?
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Which component of the product information file contains results of retention tests related to microbiological quality?
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What does the amended Decision 96/335/EC address in relation to cosmetic products?
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Study Notes
Cosmetic Products, Regulations, and Safety
- Cosmetic Products defined as substances or mixtures intended to be placed in contact with the external parts of the human body (skin, hair, nails, lips, external genital organs, teeth, oral cavity) for the purpose of cleaning, perfuming, changing their appearance, protecting them, or correcting body odors
- Cosmetic Chemistry is the study of the chemical properties of cosmetic products and their effects on the skin and hair.
- Key Players Involved: Manufacturer, Distributor, Importer, End User, and Responsible Person.
- Cosmetic Products Notification Portal (CPNP): Online system for manufacturers, importers, sellers, and control bodies of cosmetic products to submit information about their products.
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Important Legal Acts:
- Regulation (EC) No. 1223/2009 (EC 2009): Establishes rules for cosmetic products placed on the market to ensure safety and the functioning of the internal market.
- Commission Decision 2006/257/EC (EC 2006): Sets out the ingredients used in cosmetic products.
- Regulation (EC) No. 1907/2006 (REACH): Outlines measures for the production, placement on the market, and use of chemicals, preparations, and products.
- HN 117:2007 "HEALTH AND SAFETY REQUIREMENTS FOR BEAUTY SERVICES": Establishes basic health safety requirements for beauty services in Lithuania.
- Product Safety Law of the Republic of Lithuania (1999): Ensures only safe products are placed on the market.
- LST EN ISO 22716:2008 Cosmetic products.Good Manufacturing Practices.Guide to Good Manufacturing Practice (International Organization for Standardization, ISO 22716:2007): Sets standards for all cosmetic product manufacturing.
- Product Information File: Contains information about the cosmetic product, such as the safety report, product description, proof of effectiveness, manufacturing methods, animal testing information, and compliance with regulations. This file is retained for 10 years.
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The "Safety Report" is divided into two parts:
- Part A: Includes details like product composition, physical and chemical properties, microbiological quality, impurities, residues, packaging information, normal use, effects, and adverse effects.
- Part B: Contains the assessment conclusion, warnings and instructions for use, justification, and evaluator qualification.
- Good Manufacturing Practice (GMP): Covers essential aspects of production like premises, equipment, training, and raw materials.
- EC 2009 Contents: The regulation covers various aspects, including scope, definitions, safety, responsibility, free movement, safety assessment, product information file, notification, material restrictions, animal testing, consumer information, non-compliance, cooperation of administrations, and implementation measures.
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EC 2009 Annexes:
- Annex 1: Details the format of the cosmetic product safety report.
- Annexes 2-6: List prohibited substances and restricted ingredients, including dyes, preservatives, and UV filters.
- Annex 7: Provides information on symbols for packaging and containers.
- Annex 8: Lists approved alternative methods to animal testing.
- Annex 9: Contains information on repealed Directives.
- Annex 10: Includes a correspondence table.
- Prohibited substances cannot be used in cosmetic products.
- Restricted substances can only be used under specific conditions and limitations defined in Annex III of the EC 2009.
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Abbreviations used in legal acts:
- INN: International Non-proprietary Name (recommended by the World Health Organization).
- INCI: International Nomenclature of Cosmetic Ingredients.
- CAS No.: Chemical Abstract Service Number.
- EC No.: European List of Existing Commercial Chemical Substances (EINECS) or the European List of New Chemical Substances (ELINCS).
- Ph.D.Eur.: European Pharmacopoeia.
- IUPAC: International Union of Pure and Applied Chemistry.
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Description
This quiz explores the definitions, safety regulations, and chemistry behind cosmetic products. Learn about the key players in the industry and important legal acts that govern cosmetic safety and marketing. Test your knowledge on the crucial aspects of cosmetic product regulations.
