A PRIMER ON QUALITY AND SAFETY OF COSMETICS

Pharma Admission

pharma admission

 

About Author:
Tarun Patel, Prof. Dr. Vipin Kukkar, Amit Patel

Seth G.L. Bihani S.D. College of Technical Education,
Institute of Pharmaceutical Sciences and Drug Research,
Sri Ganganagar, Rajasthan, INDIA

ABSTRACT:
It is a product which is used for improvement of appearance of human body by applying it externally on human body. For better results and minimizing risk of adverse reaction of cosmetic products on human body we have to check out and maintain quality of cosmetic products during its manufacturing.  And  also required some safety parameters for manufacturing of cosmetic products. In this review article we discussed briefly about quality and safety parameters during manufacturing of cosmetic products.

Reference Id: PHARMATUTOR-ART-1248

1. INTRODUCTION
What is a cosmetic product?
Any substance or preparation intended to be placed in contact with the various external parts of the human body with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, correcting body odours, protecting them, or keeping them in good condition.8

IMPORTANT IN THIS ARTICLE:

* FACTORS CONSIDERED IN SAFETY EVALUATION OF COSMETICS

* SAFETY ASSESSMENT AND PRODUCT INFORMATION PACK

WHAT IS QUALITY ?
Quality is the sum of
*         Knowing customer’s requirements
*         Designing to meet those requirements
*         Faultless manufacture or service
*         Reliable bought in component & assemblies
*         Certified performance & safety
*         Clear instruction manuals
*         Punctual delivery
*         Efficient back up service
*         Feedback of field experience

To control quality product the international organization of standardization in ISO:9000 has defined Quality control system as under.

Quality control: The operational techniques & activities that are used to fulfill requirements for quality.12

2.TYPES OF COSMETIC PRODUCTS
• Creams, emulsions, lotions, gels and oils for the skin (hands, face, feet, etc)
• Face masks
• Tinted bases (liquids, pastes, powders)
• Make-up powders, after-bath powders, hygiene powders etc
• Toilet soaps, deodorant soaps, etc
• Perfumes, toilet waters and eau de Cologne
• Bath and shower preparations (salts, foams, oils, gels, etc)
• Depilatories
• Deodorants and anti-perspirants
• Hair care products
Ø  Hair tints and bleaches
Ø  Products for waving, straightening or fixing
Ø  Setting products
Ø  Cleansing products (lotions, powders, shampoos)
Ø  Conditioning products (lotions, creams, oils)
Hairdressing products (lotions, lacquers, brilliantines)
• Shaving products (creams, foams, lotions, etc)
• Products for making-up and removing make-up from the face and the eyes
• Products intended for the application to the lips and around the eyes
• Products for care of the teeth and the mouth
• Products for nail care and make-up (manicure and pedicure products)
• Products for external intimate hygiene
• Sunbathing products
• Products for tanning without sun
• Skin whitening products
• Anti-wrinkle products
• Wipes

Product forms and types not listed above should be considered against the definition of a cosmetic product.10

3. QUALITY CONTROL OF COSMETICS:

3.1 Compact Powder :-
Shade control & lighting:
  This is to control & determine the variation of color shade from batch to batch & with the standard One such method is comparison of the appearance of the body of the powder with a standard when it is spread out & flattened on a white paper background. The other method of evaluation is comparison of sample with the standard by skin tone or under tone. Powders should be applied by same puff that is to be used for finished pack.  Artificial lighting is used for color evaluation.

Dispersion of color:  Color should be homogenously distributed in the powder base. There should be no segregation or bleeding of the color. Spreading the powder on a white paper & checking it with magnifying glass can test this. 

Pay-off:  The pay-off character, i.e.adhesion with the puff, of a compact or pressed powder should be tested on the skin. High pressure will make cake so hard that the powder will not rub off the cake easily enough & thus there will be insufficient adhesion of the material to the puff. To low pressure will make the cake soft & thus have a tendency to crumble & break.

Pressure testing:  Pressure applied to compact powder should be uniform to prevent air pocket & thus breaking or cracking. Uniformity of hardness can be tested by penetrometer. Reading of hardness is checked at various points of compact tablet to see the uniformity of hardness.

Breaking test:  This is carried out by dropping tablet of powder on a wooden surface several times from a height 8-10 inches & checking the breakage or clipping of the compact. If the cake is unbroken it is indication of the resistance against travel & normal handling. 

Flow property:This is very important, particularly for body powders, as they should come out easily from the container for easy application. Measuring the angle of repose of powder product by allowing falling on a plate from a funnel & measuring the height radius of heap formed can study this.

 Particle size & abrasiveness: Particle size can be determined by microscope, sieve analysis or by using sophisticated instruments & techniques.  Rubbing the powder on a smooth surface & then studying the effect on the surface-using microscope can study abrasiveness.

Moisture content & limits for color:These can be estimated by using suitable analytical methods.7

Physical Parameters:

Color:The color of the powder should be near to the skin tone to provide covering of blemishes of skin without its visibility.

PH:1gm of product with 9gm of water & shake vigorously then determine pH by glass or low range pH paper in aqueous solution.

Adhesiveness:It is a characteristic of particle size & shape & checked by simply rubbing the powder on skin. If there is no eruption & rashes, then consider it free from grittiness.

3.2  Lipsticks

Melting point:Determination of melting Point & is determined by capillary tube method by keeping the size of capillary length of fill & rate of heating constant.

Breaking point:This test is done to determine the strength of the lipstick. To carry out test lipstick is held horizontally in a socket filling over about ½ inch of its base and weight is applied at measured distance from the edge of support. The weight applied is increased every 30 second by predetermined increment(10 gms) until the lipstick break.  

Thixotropy character:  This is done by using penetrometer. Standard needle of specific diameter is allow to penetrate for 5 sec. under a 50 gm load at 25?c. the depth of penetration is a measurement of the thixotropic structure. Penetration of 9 to 10.5 mm is indicative of a soft and thixotropic structure.   

Force of application: This is a test of comparative measurement of force to be applied for application. Two lipsticks, end cut to get flat surface, are kept opposite way by mechanical holder. Lower lipstick standing upright and fixed. Upper lipsticks move downward, by mechanical means under a given weight, to the flat surface of lower lipstick. A stripe of smooth paper is attached to a dynamometer and is drawn between two lipstick ends at constant speed. A force required to pull the paper again a given specific weight is measured and compared with those made on other sticks of same diameter.

Perfume stability:How much time the fragrance long lasted is measured.

Oxidative stability: It us predicted by standard determination of peroxide value   after exposure to oxygen under given condition.

Accelerated stability test:It can be studied at higher temperature or alternatively keeping at 45c and 0c and observing the changes.

3.3 Nail lacquers and removers

Non-volatile content:This can be done by taking known amount of lacquers and applying on a plate of flat surface. Weight of the residual film after evaporation of solvent will indicate the non- volatile content.

Drying rate:This can be done by taking the product on a flat surface and touching the tip of finger at short intervals of time of feel the tackiness. Time taken for disappearance of tackiness is noted. The time by IS –6 min (minimum)

Smoothness:The film is applied on a surface and the surface characteristics of the film  are studied microscopically

Hardness:Film is applied on flat surface and the hardness is measured by applying pressure mechanically.

Adhesion:This is done by applying the film and then measuring the adhesion character by trying to remove the film mechanically and the force required for that.

Water resistance:This is done by applying a continuous film on a surface and  immersing in weight, is calculated. Higher the increase in weight lower the resistance.

Viscosity:Can be studied by any viscometer.

Gloss:Comparision against a standard should be made by using the flow pour described above, this is a general visual observation. More critical determination of gloss can be made on a gardner or other similar instrument.

3.4 Shampoos :

Foam & foam Stability:Test for foam stability:- 200ml. of a surfactant solution is dropped into a glass column containing 50 ml of same solution.  The height of the foam generated is measured immediately and again after specific time interval. It is measured in  volume

Detergency & coloring action:Cleaning action of shampoo is find out by “ wool yarn in grease”.  Place 5gms of wool yarn in grease in 200ml of water containing 1gms of shamppo in flask. Temperature of water should be 35c. Shake the f1ask for 4 min. at the rate of 50 times a min. remove the solution and take out the sample. Dry the sample and weight it. Calculate amount of soil removed under experimental condition.

Eye Irritation:0.1 ml of test solution is instilled in eye of rabbit. Keep one eye for control test. After 4sec both eye are washed with saline and observation made after 1 hour.

Oral toxicity:It is given in terms of LD50 .if LD50 is 5 or more the toxicity is considered as low. Lower the LD50, the greater the toxicity.1,7,11

4. SAFETY ASSESSMENT FOR COSMETICS:-
With a broad experience in chemical supply legislation (notification, classification, risk assessment, etc.), and regulatory chemistry and toxicology we are also able to produce dossiers to support inclusion of colouring agents, preservatives, and UV filters in Annexes IV, VI and VII of the Cosmetics directive. We can advise on testing strategies and laboratories to conduct studies, and liaise with authorities to expedite the application.
Alchemy Compliance can register finished cosmetic products with appropriate national authorities and poison information centres, particularly in the UK, France, Sweden, and Germany.
Unlike other chemical products (new industrial chemicals, biocides, medicines, etc.), the CD achieves this aim without a pre-market procedure (authorisation, registration, or notification), although there are provisions  for informing the authority of the place of manufacture, or importation, and some national requirements to file the composition with Poison Information Centres. Instead, a competent person, the safety assessor, must perform a safety assessment for each finished cosmetic product before it is placed on the EU market.
The safety assessment is part of a package of information, the TIF (or PIP), which the manufacturer or importer must keep up-to-date and available for inspection by the Authorities. The content of the TIF is as follows :

  • Composition of the cosmetic product
  • Physico-chemical and microbiological specifications of raw materials and finished product
  • Method of manufacture
  • Cosmetic safety assessment, and details of the safety assessor
  • Existing data on the undesirable effects on human health (eg from customer complaints)
  • Proof of the effect (only for certain products, such as sunscreens)
  • Data on animal testing performed by the manufacturer, his agents, or suppliers relating to the development or safety evaluation of the product or its ingredients

Data on undesirable effects, the qualitative composition, and the amount of dangerous ingredients (according to 67/54/EEC) in the cosmetic product should available to the public on request.
The cosmetic safety assessment has to be carried out by a suitably qualified person, such as a chartered toxicologist, dermatologist, or chemist. The safety assessment uses available test reports, literature data, structure–activity relationships, and regulatory texts to determine safe levels of cosmetic ingredients in a new formulation. Combined with exposure values for particular types of cosmetic use, this risk assessment process can give margins of safety for individual components and an overall conclusion regarding the safety of the new cosmetic product.9
Users know that, as a rule, Rx drugs are more likely to cause adverse side effects than OTC drugs. This is an obvious result of the nature and of the distribution system for these products. Prescription drugs are administered under the supervision of a physician, who has the responsibility and moral obligation to monitor the patient’s progress. However, OTC drugs may be used ad lib by the uninformed, who may not always be competent to diagnose the underlying disease or to recognize adverse side effects. In this respect, cosmetics resemble OTC drugs except that cosmetics are used repeatedly and over extended periods of time. Thus, the requirements for the safety of cosmetics should be, in fact, much more stringent then those for many drugs. The level of side effects or adverse effects that can be tolerated by manufacturers of cosmetics is virtually nil. Of particular concern is the sensitizing potential of components during prolonged and repeated use. Photosensitization is another phenomenon that has led to the removal of some cosmetic ingredients from the list of routinely employed substances.5

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