Cosmetic Chemistry Legal Acts & Regulations

1 Legal acts ensuring the safety, quality and supply of cosmetic products to the market TOPIC 1. COSMETIC CHEMISTRY Presenter Dr. Lamees Hejazi ENT, Head, Neck and skin surgeon Basic concepts...

1 Legal acts ensuring the safety, quality and supply of cosmetic products to the market TOPIC 1. COSMETIC CHEMISTRY Presenter Dr. Lamees Hejazi ENT, Head, Neck and skin surgeon Basic concepts 2 ▶ Cosmetics ▶ Cosmetic chemistry ▶ Manufacturer ▶ Cosmetology ▶ Distributor ▶ Chemical ▶ Importer ▶ Mixture ▶ End user ▶ Cosmetic product ▶ (Serious) Adverse effects ▶ Presentation and supply to the market ▶ Responsible person Definitions of all terms are given in EB2009 (from page 3). Cosmetic products on the market 3 National Public Health Cosmetic product Center under the Safety, Ministry of Health Manufacturer, information, https://nvsc.lrv.lt/ responsible person labeling Supply to the Control market, free in the market movement of goods State Consumer Rights Protection Service Final https://www.vvtat.lt/ the user  Basic legal acts 4 ▶ REGULATION OF THE EUROPEAN PARLIAMENT AND COUNCIL No. 1223/2009 of 2009 November 30 on cosmetic products [hereinafter EC 2009] This regulation lays down the rules that all cosmetic products placed on the market must comply with in order to ensure the functioning of the internal market and a very good protection of human health. In order to achieve these goals, the production of cosmetic products should comply with the principles of good manufacturing practice. Cosmetic products supplied to the market must be safe for human health if used in accordance with the usual or implied requirements for use, especially with regard to: presentation, labeling; instructions regarding use and disposal; any other instructions or information provided by the responsible person. ▶ Decision of the Commission in 2005 February 9 amending Decision 96/335/EC establishing the inventory and common nomenclature of ingredients used in cosmetic products (2006/257/EC) [hereinafter EC 2006] supplemented by COMMISSION DECISION (EU) 2019/701 of 2019. April 5 establishing a glossary (list) of common ingredient names used in the labeling of cosmetic products. [hereinafter EB2019] This solution sets out the ingredients used in cosmetic products.  5 ▶ REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL (EC) No. 1907/2006 of 2006 December 18th on the Registration, Evaluation, Authorization and Restriction of Chemicals [hereinafter REACH] This regulation sets out measures for the production of chemicals, preparations or products, placing on the market and use. ▶ HN 117:2007 "HEALTH AND SAFETY REQUIREMENTS FOR BEAUTY SERVICES" (as amended) This hygiene standard establishes the basic health safety requirements for beauty services. This hygiene norm is mandatory for all legal and natural persons of the Republic of Lithuania, who design, build, equip, reconstruct buildings and premises where beauty services are provided, service providers and controlling institutions. ▶ Product Safety Law of the Republic of Lithuania 1999 June 1 No. VIII-1206 (as amended) The purpose of this law is to ensure that 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). All cosmetic products must be manufactured in accordance with this standard. Responsibilities of the responsible person 6 Notification of cosmetic products 7 Notification of cosmetic products – this is the submission of the necessary information about the cosmetic product through the Cosmetic Products Notification Portal (CPNP - Cosmetic Products Notification Portal). CPNP is a common, purpose-built online system of the European Union, used by manufacturers, importers, sellers and control bodies and organizations of cosmetic products. https://webgate.ec.europa.eu/cpnp/faq/index.cfm?event=faq.show Product information file administration 8 ▶ Safety report ▶ Product description ▶ Proof of product effectiveness - confirmation of the effect, nature ▶ Description of the manufacturing method - adherence to good manufacturing practice ▶ Animal testing ▶ Compliance with the instructions of the regulation The product information file is kept for 10 years from the date on which the last shipment of the cosmetic product was placed on the market. Safety report Part A 9 1. Quantitative and qualitative composition of the cosmetic product 2. Physical and chemical properties of the cosmetic product and its stability 3. Microbiological quality (results of retention tests) 4. Impurities, residues and information on packaging material 5. Normal or reasonably foreseeable use (warnings) 6. Effect of cosmetic product 7. Effects of substances 8. Toxicological data of substances 9. Adverse and serious adverse effects 10.Other information about the cosmetic product  Safety report Part B 10 1. Assessment conclusion 2. Warnings and instructions for use are on the label 3. Justification 4. Evaluator Qualification and Part B approval Good Manufacturing Practice Guide 11 Brief Contents ▶ Premises (furnishing of premises; protection against pests; ensuring sanitary conditions in premises; cleaning of premises; cleaning of equipment and cleaning of working surfaces; waste management). ▶ Training of employees (supervision of personnel hygiene; hygiene at workplaces; personnel hygiene control). ▶ Equipment (maintenance of operating equipment; maintenance of measuring devices). ▶ Raw materials (selection of suppliers; acceptance and inspection of raw materials). ▶ Production (manufacturing process traceability scheme; sampling). EC 2009 Contents 12 1. ch. Scope, definitions 2. ch. Safety, responsibility, free movement 3. ch. Safety assessment, product information file, notification 4. ch. Material restrictions 5. ch. Animal testing 6. ch. Consumer information 7. ch. Non-compliance, protective clause 8. ch. Cooperation of administrations 9. ch. Implementation measures EC 2009 annexes 13 1. Cosmetic product safety report 2. List of prohibited substances in cosmetic products (1611) 3. List of substances allowed to be used in the production of cosmetic products only in accordance with the established restrictions (312) 14  15 4. List of colorants permitted for use in cosmetic products (153) 5. List of preservatives allowed for use in cosmetic products (59) 6. List of UV filters that can be used in cosmetic products (31) 7. Symbols on packages and/or containers 8. List of approved alternative methods to animal testing 9. The Directive as amended is repealed 10. Correspondence table What CANNOT be In a cosmetic 16 product ▶ Prohibited substances ▶ Restricted substances (except Annex III, EC 2009) ▶ Dyes (except Annex IV, EC 2009) ▶ Preservatives (except Annex V, EC 2009) ▶ UV filters (except Annex VI, EC 2009) Abbreviations in legal acts: 17 INN - International non-proprietary recommended by the World Health Organization name. INCI - International Nomenclature of Cosmetic Ingredients - set of names. CAS No. - is a number compiled by the Chemical Substances Abbreviation Service, used to identify substances. EC no. – numbers corresponding to the numbers of the European List of Existing Commercial Chemical Substances (EINECS) or the numbers of the European List of New Chemical Substances (ELINCS) or according to Regulation (EC2006) No. 1907/2006 granted registration numbers. Ph.D. Eur. name is the name of the European Pharmacopoeia. Pharmacopoeia - a set of valid state standards defining the quality, production, quality and quantity control, storage conditions and names of medicinal substances. IUPAC - International Union of Theoretical and Applied Chemistry. Useful links 18 LEGISLATION: ▶ https://eur-lex.europa.eu/legal-content/LT/ALL/?uri=CELEX:02009R1223-20190617(EB 2009) ▶ http://eur-lex.europa.eu/legal-content/LT/TXT/?uri=CELEX%3A32006D0257(EB2006) ▶ https://eur-lex.europa.eu/legal-content/lt/TXT/?uri=CELEX%3A32019D0701 (EB2019) ▶ http://eur-lex.europa.eu/legal-content/LT/TXT/?uri=CELEX%3A02006R1907-20150601(REACH) ▶ https://www.e-tar.lt/portal/lt/legalAct/TAR.CE03E1D3329D (for beauty services) ▶ https://www.e-tar.lt/portal/lt/legalAct/TAR.A845E65C32A2/qeAjMkGLoC (product safety law) ▶ https://www.e-tar.lt/portal/lt/legalAct/TAR.D46F4F967055 (due to expired orders)