Cosmetic regulations: EU and China Belinda Carli Director, Institute of Personal Care Science
Overview EU searches Product Information File (PIF) Safety evaluations Chinese regulations
EU searches www.personalcarescience.com.au CosIng: http://ec.europa.eu/growth/toolsdatabases/cosing/index.cfm?fuseaction=search.simple
EU searches Search: Phenoxyethanol (a common preservative) www.personalcarescience.com.au
EU searches
Product Information File (PIF) All cosmetic products must have responsible person within EU enters information on CPNP ensure product conformity provide necessary information notify authorities of safety risks, provide details of noncompliance and advise of corrective actions taken cooperate with authorities to eliminate risks identify distributors and supply chain (3 yrs per batch) Address indicated on label: Art.19(1)a BusName Street Suburb (Town) Country
Product Information File (PIF) Basic product information: name and description of product normal and reasonably foreseeable use general marketing/claims information on the cosmetic product exposure to the cosmetic product impurities, traces, information about the packaging material
Product Information File (PIF) Full formulation showing: quantity of ingredients all INCI names CAS numbers function of ingredients name, code number and identity of fragrance suppliers
Product Information File (PIF) Test results: physical and chemical characteristics of the product o SG, viscosity, ph, form, appearance, aroma stability of product o minimum 9 months accelerated (40 C)/30 months real time (20-25 C) microbiological standards and PET
Product Information File (PIF) www.personalcarescience.com.au Statements required: method of manufacture and statement of compliance with GMP details of any animal testing or statement that it has not been conducted no CMR Safety assessment by safety assessor Additional information where relevant: proof of efficacy (if claimed) particle size distribution curve (nanomaterials) purity statements and evidence (colourants)
Product Information File (PIF) Submit with PIF: SDS of finished product www.personalcarescience.com.au SDS of all raw materials and TDS o INCI names, declarations and CAS numbers MUST match PIF and MUST match label o incidental ingredients become an issue o should list any allergens present (essential oils/fragrances) stability protocol and results full PET results evidence for claims label safety calculations and assessment
Safety evaluations Daily application and exposure levels
Chinese regulations Check ingredients first: Inventory of Existing Chemical Substances Produced or Imported in China (IECSC) Need responsible agent to conduct registration
Chinese regulations Testing reports provided by SFDA designated labs mandatory - even if they have been tested abroad and assessed. Ordinary cosmetics: hygiene safety tests = physiochemical, microbiological and toxicological studies Special use cosmetics: hygiene safety tests + human safety tests If product contains a risk substances i.e. components (impurities or additives) that may cause potential harm to human health = additional tests required.
Chinese regulations Ordinary cosmetics: application form + all info in EU PIF, PLUS: Chinese product name and nomenclature; Original packaging of products (including product label and product information sheet); Testing report and data; Stamped copies of power of attorney and business license of Chinese responsible agent; Letter of commitment stating that the cosmetic ingredients meet the restriction requirements of high-risk substances from regions with high incidence of mad cow disease; Certificate of free sale at production country (region) or country (region) of origin; Diagram of production process
Chinese regulations Once approved, a certificate will be issued by the SFDA - required for customs clearance. The certificate number must appear on Chinese product label. Normal time: 4-6 months ordinary use ; 7-13 months special use Testing fee is charged by the SFDA designated labs; typically: 10,000 16,000 RMB Ordinary cosmetics 19,000 80,000 RMB Special use
Questions? Comments? belinda@personalcarescience.com.au www.personalcarescience.com.au LEADERS in DISTANCE and ON-LINE training Certificate and Diploma level We bring the training to YOU Flexible study at your home or work