SAFETY ASSESSMENT OF COSMETIC PRODUCTS, Lecture notes of Cosmetology

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SAFETY ASSESSMENT OF COSMETIC PRODUCTS PRODUCT INFORMATIOM FILE FDA CIRCULAR NO. 2018-001 - Reiterating the Mandatory Implementation of Article 8 of the ASEAN Cosmetic Directive “Product Information” Requirements for Industry - The company or Person placing a cosmetic product in the market shall: ● Notify the regulatory authorities before the product is put in the market (Article 1-3) ● Ensure that they will not cause damage to human health under normal or reasonably foreseeable conditions of use (Article 3) ● Keep the product information file readily accessible to the regulatory authorities (Article 8) ● Must have adequate knowledge or experience (Article 8-d) PIF ● Must be at the address of the Company responsible for placing the product in the market (as specified on the label); manufacturer, importer or distributor ● PIF must be in the Local Language or English ● Must be “readily accessible” ● Must be kept UPDATED of all modifications 1. Qualitative and quantitative composition of the product: name of percentage of ingredients (for perfumes: name of supplier, code of perfume and percentage) 2. Specifications of the raw materials and SAFETY ASSESSMENT OF COSMETIC PRODUCTS finished product (physico-chemical and microbiological) 3. Manufacturing method complying with ASEAN GMP Guidelines 4. Assessment of the safety for human health of the finished product, its ingredients, their chemical structure and level of exposure 5. Existing data on undesirable effects on human health resulting form the use of the product 6. Supporting data for claimed benefits (efficacy assessment) 7. Available methods used to check the ingredients corresponding with the certificate of analysis (Article 9, i.e. upon request) and 8. Criteria used for microbiological control; chemical purity of ingredients and/or methods for checking compliance with those criteria HOW TO ORGANIZE A PIF? PIF GUIDELINES RECOMMENDATIONS Part I: Administrative documents and product summary Part II: Quality data of Raw Materials Part III: Quality data of Finished Product Part IV: Safety and Efficacy data Part I : Administrative Documents and Product Summary A. Administrative documentation - Copy of the Notification form bearing the acknowledgement receipt from the Authorities; this will include the identity of the product, the address of the manufacturer, assembler, SAFETY ASSESSMENT OF COSMETIC PRODUCTS B. Manufacturing: - Manufacturer contact details; name, country and address of manufacturer, assembler and packager - Summary of the Manufacturing Process; - Additional detailed information on the manufacturing process, quality controls and related manufacturing documents should be made available upon request by the Authority C. Specifications and test methods of the finished product: - The criteria used for microbiological control of cosmetic products and chemical purity of ingredients of cosmetic products; - Method of Analysis corresponding to the specifications for checking compliance; D. Product Stability Summary Report, for product durability below 30 months: - The stability testing data and report or stability assessment to support the expiry date; Part IV : Safety and Efficacy of Data A. Safety Assessment - Signed assessment report of the safety for human health of the finished product based on its ingredients, their chemical structure and level of exposure; - Curriculum Vitae of the safety assessor; B. The latest comppiled report on confirmed or recorded adverse events or undesirable effects on human health resulting from use of the cosmetic product: - The adverse event report in the PIF is expected to be updated by the company on a regular basis; C. On-pack product claim support: - Full signed report of the Efficacy Assessment of the product, based on its composition or on tests performed; - Supporting data including literature review for claimed benefits of cosmetic products should be made available to justify the nature of its effect WHERE TO KEEP THE PIF? Article 8 states clearly that the PIF must be at the address of the company placing the product in the market ● This is the address printed on the label whether importer, manufacturer or distributor ● Recommendation is to keep the PIF for 3 years minimum after the last product is placed in the market 2 Types of Audit ROUTINE - Recommendation is for the Authorities to announce these audits at least 1 month in advance for the company to prepare AD-HOC - Triggered by results found on samples from the market, by consumer complaints, etc - Recommendation is to announce SAFETY ASSESSMENT OF COSMETIC PRODUCTS 48h in advance, except if urgent AUDIT DOCUMENTS ASEAN GUIDELINES FOR THE SAFETY ASSESSMENT OF A COSMETIC PRODUCT SAFETY ASSESSMENT OF COSMETIC PRODUCTS ● Part I should be available immediately ● Upon specific request, any other document should be made available to the Authorities within an agreed timeframe i.e. 15 to 60 calendar days (can be shorter depending on the urgency) Proprietary information ● Noting that due to trade secrets, the product owner may not disclose some of the product information in any part of the PIF, to the distributor/importer, the person or company placing the product in the market will need to make their own arrangements with the product owner to provide the relevant and necessary information directly to the authorities upon request OBJECTIVE: - The purpose of this Guideline is to help the Cosmetic Industry in assessing the safety of the product as well as the Regulators in auditing the data contained in the Product Information File (PIF) - This guideline serves to highlight some of the important considerations in the safety assessment of cosmetic product in line with Article 8 of the ASEAN Cosmetics Directive which requires an “Assessment of the safety for human health of the finished product, its ingredients, its chemical structure and its level of exposure” - This safety assessment is to be performed by a qualified professional defined as the “Safety Assessor” SAFETY ASSESSMENT OF COSMETIC PRODUCTS ingredient is used; ● Method of application (e.g. rubbed-in, sprayed, applied and washed off, etc.); ● Concentration of ingredient in product; ● Quantity of product used for each application; ● Frequency or product used for each application, ● Frequency of application; ● Total area of skin contact; ● Site of contact (e.g. mucous membrane, sunburnt skin); ● Duration of contact (e.g. rinse-off products, leave on products); ● Reasonably foreseeable miuse which may increase exposure; ● Type of consumers (e.g. children, people with sensitive skin); ● Projected number of consumers; ● Application to skin areas exposed to sunlight; ● Quantity likely to enter the body SAFETY CLAIMS If a safety claim is to be made, e.g., “dermatologically tested”, it has to be supported by adequate evidence. In most cases, appropriate human testing on the finished product will be necessary rather than animal testing SAFETY ASSESSMENT OF COSMETIC PRODUCTS PRECAUTION ● Consideration must be taken in special situations/patient groups CONTRAINDICATION ● Should not be used in a specific situation because risk is much greater than the possible benefit WARNING ● Serious adverse events that have been observed and potential safety hazards SAFETY ASSESSOR The person in charge of assessing the safety of the product is called the safety assessor The safety assessor should possess qualification is relevant fields for example a diploma in the field of pharmacy, toxicology, dermatology, medicine or a similar discipline and be suitably trained in the safety assessment of cosmetics. RESPONSIBILITIES OF THE SAFETY ASSESSOR The safety assessor is responsible for determining: ● Whether or not the ingredients present in the formula meet the requirements of the legislation ● Whether or not particular endpoint(s) have to be considered for a given ingredient; ● Whether the data available are relevant and sufficient; ● Whether or not interactions of toxicological relevance and/or modifications to penetration are likely to occur ● Whether or not complementary data are needed either on ingredients or on the finished product In respect of the concentration for authorised substances, absence of substances prohibited by SAFETY ASSESSMENT OF COSMETIC PRODUCTS the law and, more generally, in respect of all legal requirements RAW MATERIAL SUPPLIER RESPONSIBILITIES ● CHEMICALS ● BOTANICAL EXTRACTS ● ANIMAL EXTRACTS ● FRAGRANCES AND FLAVOURS CHEMICALS Provide its customers with adequate information as to the safety of the ingredients supplied ● Physical/ Chemical/ Microbiological specifications- purity ● Absence of Annex II ingredients beyond unavoidable traces (e.g. heavy metals) ● Toxic studies ○ Acute toxicity ○ Dermal absorption ○ Skin (and eye) irritation ○ Mucous membrane irritation (if necessary) ○ Skin sensitisation ○ Sub-chronic toxicity ○ Mutagenicity ○ Photo toxicity and photo mutagenicity (if necessary) ○ Human data (if available) BOTANICAL EXTRACTS Provide its customers with adequate information as to the safety of the ingredients supplied: ● Proper identification of the plant/part used ● Physical/Chemical/ microbiological specifications-purity ● Pesticide level ● Absence of Annex II ingredients beyond unavoidable traces (e.g, heavy metals) ● Toxicity studies: SAFETY ASSESSMENT OF COSMETIC PRODUCTS FRAGRANCES AND ANNEX: Definition of IFRA Categories SAFETY EVALUATION OF FINISHED PRODUCTS The assessment of the safety of any cosmetic product clearly relates to the manner of use. This factor is most important since it determines the amount of substance which may be absorbed through the skin or mucous membranes, or ingested or inhaled. SAFETY EVALUATION ● In general, the potential of a cosmetic product for sensitisation, genotoxicity and all other types of systemic (toxic) effects will be evaluated on the basis of the properties of the ingredients. ● For assessing the safety-in-use of a finished product, especially the local tolerance, it can be very useful to compare it with other formulae successfully marketed by the company. ● Skin compatibility or tolerance may be checked using reconstructed skin models and/or ethically conducted trials on human volunteers ● In vitro testing may be carried out to complement available information with the necessary use of appropriate benchmarks. For ocular safety, methods such as those listed below are available: ○ BCOP - Bovine Cornea Opacity and Permeability Test; ○ FLT or TEP - Fluorescein Leakage Test or Trans Epithelial Permeability ○ HET-CAM - hen’s Egg Test - Chorioallantoic Membrane; ○ RBC- Red Blood Cell test ○ TEA - Tissue Equivalent Assay. Clinical trials in man should be based on the principles of Good Clincial Practice (GCP) such as that of the EU - The following type of tests may be performed: ● Open epicutaneous application (single or repeated); ● Closed epicutaneous application (single or repeated); ● Controlled application tets; ● Further testing may involve SAFETY ASSESSMENT OF COSMETIC PRODUCTS in-use tests and/or market tests. SAFETY ASSESSMENT OF COSMETIC PRODUCTS ○ Controlled Use Test - Performed under normal or slightly exaggerated use conditions. ■ Exposure/ application conditions (which may vary widely for different product types) and evaluations are controlled and standardized Open Epicutaneous Application Apply product, usually to the arm, for exposure periods of up to 60 minutes (or at any time in case of adverse effects) Evaluate visually ; redness, scaling during and following the exposure period. Closed Epicutaneous Application Comparative assessment of several formulations on the same individual, generally including one or more reference preparations. Evaluation: Visually: redness, scaling Objective measurements: TEWL, redness intensity What will you do in case you experience an adverse reaction when using a cosmetic product? ● If you develop an adverse reaction such as allergic reaction or skin irritation, itchiness, redness or swelling, stop using the product immediately. ● Wash away the cosmetic product from the applied area of your skin. ● Inform the company whose name and address appear on the label. Bring the suspected cosmetic product and see a doctor if condition does not go away or worsens. ● You are encouraged to report the serious adverse reaction to the NRA/Company by providing the details of the product used and the type of reaction occured GUIDANCE FORMAT OF THE SAFETY ASSESSMENT