Cosmetics SB 2020
7 likes662 views
This document discusses cosmetics, including their definition, common materials used, classification, microbiological aspects, product formulation, safety and toxicology, and legislation and regulations. It defines cosmetics as any article intended to be applied to the human body to cleanse, beautify or alter appearance. Common materials used include water, preservatives, oils and colors. Cosmetics are classified based on the area of the body they are used on, such as skin, hair, eyes and nails. Microbiological aspects and preventing contamination during manufacturing are also covered. The safety and toxicology section discusses irritation, sensitization and systemic effects. Legislation and regulations in India such as the Drugs and Cosmetics
![Regulation in India
• The Objective of a Drug Regulatory in India are to ensure the
Medicinal, Medical Devices and Cosmetics products are acceptable on
their Quality, Safety and Efficacy.
• Drug Controller General of India is the head of Central Drug Standard
Control Organisation.[CDSCO] He Regulates Cosmetics, Devices &
Drugs in India.
• The Drugs & Cosmetics Act and Rules are the governing regulations
in India.](https://image.slidesharecdn.com/cosmeticssb2020-201101032158/85/Cosmetics-SB-2020-34-320.jpg)
Cosmetics SB 2020
- 1. Cosmetics Presented by- Prof. Salman Baig Assistant Professor in Pharmaceutics
- 2. Definition “Any article intended to be rubbed, poured, sprinkled or sprayed on, or introduced into, or otherwise applied to, the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance is known as cosmetic.”
- 3. Common material used In cosmetics • Water • Preservatives: Anti-microbial agents • Anti-oxidants • Humectants • Surfactants • Oils, fats & waxes • Perfumes • Colors • Some functional raw materials (active ingredients) • Herbal or plant materials
- 4. Classification of Cosmetic Products Cosmetics for skin: • Skin cream • Skin bleach cream • Sunscreen cream • Body powder (talcum powder) • Antiperspirants & deodorants
- 5. Cosmetics for face: • Face powders • Compact powders • Foundation • Lipsticks • Astringents & skin tonics • For the rapid coagulation of blood from a flesh wound, skin healing, the promotion of tissue growth and other, more subjective sensations such as a refreshing or invigorating Classification of Cosmetic Products
- 6. Cosmetics for hair: • Shampoos • Depilatories • Shaving soaps & creams • Hair dyes • Anti dandruff products • Hair tonics & conditioners • Hair wave sets • Hair grooming preparations • Hair bleaches & hair colorants Classification of Cosmetic Products
- 7. Cosmetics for eye: • Eye shadows • Eyebrow pencils • Mascara • Eye liners Classification of Cosmetic Products
- 8. Cosmetics for nails: • Cuticle creams (for dry cuticles, nails) • Nail Polish • Nail lacquers & removers Classification of Cosmetic Products
- 9. According to their function: • Curative or therapeutic • Antiperspirants • Hair preparations • Protective • Sunscreen cream • Corrective • Face powder • Decorative • Lipstick • Nail polishes • Eye lashes Classification of Cosmetic Products (Antiperspirants: A substance that is applied to the skin, especially under the arms, to prevent or reduce perspiration)
- 11. Microbiological aspects of cosmetics • Many cosmetics, particularly emulsion-type formulations, provide good media for the growth of bacteria and fungi (the latter group includes moulds and yeasts). • Means of inhibiting their growth are therefore essential to prevent deterioration of the product and to ensure the safety of the consumer during its use. • Spoilage of product in time by the formation of bad odours, changes of colour or texture and separation of phases quite often indicates contamination.
- 12. Microbiological aspects of cosmetics • Presence of microorganisms is not readily apparent, but it can be demonstrated by sampling and growing on enriched culture media • Counting the colonies so formed, the original numbers can be assessed.
- 13. Pathogen • Pathogen can give rise to disease, most often under the following circumstances • If broken or abraded, skin allows invasion through to the underlying tissue, as when Staphylococcus aureus gives rise to septicaemia. • During illness when general resistance may be lowered. • If the skin is delicate, as in the very young whose immunity is undeveloped, or in the elderly where it is impaired or weakened by age. • The eyes are especially vulnerable, mainly because they are so moist; Pseudomonas aeruginosa flourishes in moist conditions. • If the consumer is undergoing antibiotic or steroid therapy.
- 17. Sterilization • Sterilization is an absolute term indicating the complete destruction or removal of all microorganisms including the most resistant bacterial spores • Moist heat: Autoclaving is the application of steam heat for 15-20min. It is useful for culture media, glassware, distilled water and instruments. At a pressure of 10 Pa (15 Ib in~2) water boils at 1210C and both spores and vegetative organisms are destroyed. • Dry heat: Some materials such as cotton wool and paper can be sterilized in a hot-air oven, thermostatically controlled, and maintained at 1800C for 1 h. All open-ended apparatus should be plugged with cotton wool to prevent aerial contamination before sterilization and plugged again immediately after use. Heating to 1400C for 3 h may be used in some cases. Dry heat kills by oxidation.
- 18. Sterilization • Membrane filtration Vegetating organisms and spores may be physically removed from liquids by filtration. This is useful for culture media, enzyme preparations, water and solutions of antibiotics. • Several types of filter are available and all are used over slight negative pressure achieved by means of a vacuum pump. • They must be changed frequently or sanitized with water containing 200 ppm of chlorine, or 2% formalin with a final flushing with sterile water which should be tested for sterility.
- 19. Sterilization • Hygiene in the microbiological laboratory • After contact with microorganisms every piece of disposable equipment, including used Petri dishes containing discarded media, must be disinfected, e.g. with 2% phenol, before being destroyed. • Aseptic precautions to take are as follows: • 1. The external neck of the receiver, when samples are taken, should be wiped • with ethanol; for example, batch samples. • 2. Disposable plastic gloves should be used once only when testing samples. • 3. Distilled, freshly sterilized water must be used in preparing media and whenever • water is called for in a test.
- 20. Product formulation and development Choice of raw materials. • If the raw materials are of natural origin there is a possibility that they will be heavily contaminated; suspect ingredients are talc, bentonite, kaolin, pigments and natural gums Choice of preservatives: • For example, hexachlorophane is active against the Gram-positive Staphylococcus spp. but less so against Gram-negative spp. • A mixture of methyl, ethyl, propyl and butyl /7-hydroxybenzoates is effective against a wide range of fungi and some bacteria since their different solubilities enable them to be well distributed between the various phases in an emulsion
- 21. Prevention of contamination during manufacture • Control of environment of manufacturing premises • Control of personal hygiene • Development of an effective cleaning & sterilization programme • Monitoring of quality of water supply • Observation of quality of water supply • Use of adequate preservatives • Monitoring of microbial quality of cosmetics during manufacturing stages.
- 22. Safety & Toxicology aspect of cosmetics
- 23. Safety & Toxicology • Skin irritation • Irritation can be likened to a direct chemical attack on the skin. This may either be directly on the surface horny layer resulting in dry, flaky or rough skin or the material may penetrate into the skin and cause inflammation and reddening. A secondary process may result in a disturbance of keratinization so that the new horny layer is affected and becomes dry, flaky or rough. • There is normally a threshold concentration below which the product is safe. It is clearly important for an estimate of this threshold concentration to be available for risk assessment, and it follows that more irritant materials may be acceptable as minor ingredients in a product, while the major ingredients must have a low irritation threshold. • Methods of determining skin irritation are in general comparative, with the objective being to show whether or not a new ingredient is more irritant than existing ingredients with the same degree of exposure to the skin. A conclusion that a new ingredient is of less or equal irritancy can be used directly in the risk assessment procedure.
- 24. Safety & Toxicology • Eye irritation • Damage to the eye is of course a potentially greater hazard than skin irritation because of possible effects on vision. Great care must be taken particularly with cosmetics intended for use around the eyes. • There is an increasing pressure on the cosmetic industry to avoid testing on animals. An increasing number of alternative testing methods are under development and coming into use within the industry. • HET CAM instead of Draize test
- 25. Safety & Toxicology • Mucous membrane irritation • The area around the eye and the ano-genital region have mucous membrane tissues which cosmetic products may contact either accidentally • Mucous membranes do not have the protective horny layer of the skin and are therefore more susceptible to irritants. • Some ingredients may be acceptable for use on skin but not for use in products which are likely to contact mucous membranes. • Again the principles of concentration limits and comparison with existing ingredients are used in risk assessment procedures for mucous membrane contact.
- 26. Safety & Toxicology • Skin sensitization • One of the adverse effects of cosmetics is that of skin sensitization or allergy. • Allergy differs from irritation not in the reaction itself but in the mechanism that produces the reaction. The immune system is involved • Chemicals differ in their allergenic potential and vary from materials such as poison ivy or chemicals • Sensitization is concentration-dependent • It is frequently said that any chemical will sensitize someone somewhere, and the object of cosmetic safety evaluation is to reduce the number of sensitized people to a minimum because Zero reactions are impossible target. • The available test methods aim to determine the relative potential to sensitization.
- 27. Safety & Toxicology • The effect of ultraviolet light • Some chemicals cause skin irritation or allergy only in the presence of ultraviolet light, known as photoirritation • It has become routine to consider all new ingredients for their potential to cause of photoirritation • Ingredients which do not absorb ultraviolet light are not considered to show a problem • Particular care is therefore required in the safety evaluation of sunscreen agents as they are a potential problem and new ones are thoroughly evaluated before use
- 28. Safety & Toxicology • Miscellaneous skin reactions • Occasionally there are skin reactions which do not fit neatly into any of the categories outlined above. • The first is known as an urticarial response (nettle rash) and is characterized by a direct release of histamine, and possibly other mediators of inflammation, into the skin. • Some ingredients used in cosmetics, e.g. cinammic aldehyde, have been shown to have this effect. • The second phenomenon is that of skin stinging. A small (around 10%) proportion of people suffer a severe stinging sensation
- 29. Safety & Toxicology • Systemic effects • Cosmetic ingredient may enter the body through the skin or mucous membranes, by swallowing or by inhalation. Almost any chemical in contact with the skin can penetrate to some extent and enter the bloodstream so that effects anywhere in the body are possible • There can be several types of systemic toxicity which need to be considered during safety evaluation, and information on each needs to be available. • Specific effects such as cancer (carcinogenicity), birth defects (teratology) or toxic effects on the nervous system (neurotoxicity)
- 31. BIS Bureau of Indian Standards • BIS –The National Standards Body Of India Functioning Under Ministry Of Consumer Affairs and leaders in all matters concerning standardization, certification & quality. • OBJECTIVES: • Harmonious development of activities of standardization, marking and quality certification • Providing new thrust to standardization and quality control • Evolving the national strategy for according recognition to standards and integrating them with growth and development of industrial production and exports • Product specification, method of test, codes of practices, terminologies, basic standards (17000 standards )
- 32. BIS • MAIN ACTIVITIES • Standards Formulation Certification Product Hallmarking of Gold Jewelry Quality Management System Environmental Management Systems Occupational Health and Safety Management System Hazard Analysis and Critical Control Points Imported Products FMCS Laboratory Management International Activities Training Services Others Information Services Consumer Affairs & Standards Promotion Sale of Standards
- 33. ICH • The complete name of ICH is the "International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use“ April 1990 in Brussels ICH is a joint initiative involving both regulators and research-based industry representatives of the European Union, Japan and the USA in scientific and technical discussions of the testing procedures required to assess and ensure the safety, quality and efficacy of medicines. The objective of ICH is to increase international harmonisation of technical requirements to ensure that safe, effective, and high quality medicines are developed and registered in the most efficient and cost-effective manner
- 34. Regulation in India • The Objective of a Drug Regulatory in India are to ensure the Medicinal, Medical Devices and Cosmetics products are acceptable on their Quality, Safety and Efficacy. • Drug Controller General of India is the head of Central Drug Standard Control Organisation.[CDSCO] He Regulates Cosmetics, Devices & Drugs in India. • The Drugs & Cosmetics Act and Rules are the governing regulations in India.
- 35. Cosmetic • Drugs & Cosmetic Act defines “cosmetic” means any article intended to be rubbed, poured, sprinkled or sprayed on, or introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and includes any article intended for use as a component of cosmetic.
- 36. Import of cosmetics • Domestic Manufacturing of Cosmetic already regulated in India As per Notification GSR 426(E) in 2010 the Drugs & • Cosmetics Act amended required Registration prior to importation of Cosmetics to India. • Though it is extended for some time now it is mandatory from 1st April 2013
- 37. Documents • Other Documents required are Manufacturing License, GMP if any, Free Sale Certificate, etc. • The products should not contain prohibited items (such as mercury, lead & prohibited colors) & it should comply to the standards of either Bureau of Indian Standards or of International Cosmetics Standards. • Government Fee by TR Challan as applicable
- 38. Documents • Documents To be submitted by Indian agent • Form 42- It should be signed and stamped by Indian agent. • Documents To be submitted by Manufacturer: • POA- Power of attorney should be Appostilised or Consularized from • Indian embassy of the country of the origin and should be co-jointly signed by both the parties i.e. Manufacturer and Indian Agent in the given format. • Schedule DIII- They should be signed and stamped by Manufacturer in the given format.
- 39. Labels and inserts • Product labels should show the address of manufacturer, manufacturing & expiry date, importer name and address, import license no., indications & cautions or contra-indications (if any) • Product inserts should describe the brief description of the product and its intended use. • Company Profile • Product specification and testing protocol • List of Ingredients with details of strength of each ingredient used in the products to be registered
- 40. Timeline • After ensuring all documents correctly as per the requirements of FDA, they are submitted. It generally takes about 2-3 months to scrutinize these documents by Technical Data Associates/Drug inspectors of CDSCO. • During this period clarification if any, required by them are answered and thereafter we get the Registration Certificate (RC) in Form 43
- 41. Timeline • State Drug authorities of Respective States are responsible to issue manufacturing Licenses. • Application in Form 31 with Govt. Fees …... • List of Equipment • Manufacturing Facility details with minimum area of 15 Sq. Meters, • Technical Competent personnel details, • Relevant Sops are required for obtaining manufacturing permissions. • The specifications should comply the BIS standards if applicable or else acceptable International Standards. • Presently Trials are not required. A proposal to include the definition of • New cosmetics are on cards.
- 42. Thank You Ref.: Poucher's Cosmetics