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:
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
NOW YOU CAN ALSO PUBLISH YOUR ARTICLE ONLINE.
SUBMIT YOUR ARTICLE/PROJECT AT articles@pharmatutor.org
Subscribe to Pharmatutor Job Alerts by Email
FIND OUT MORE ARTICLES AT OUR DATABASE
5. FACTORS CONSIDERED IN SAFETY EVALUATION OF COSMETICS
Cosmetics and personal care products companies utilize a multi-tiered scientific approach to extensively evaluate the safety of products and ingredients. Key components of this strict and methodical safety process include:
5.1. Reviews of Latest, Up-To-Date Safety Research
As part of the scientific product evaluation process, numerous scientific research sources are examined for all the latest, most up-to-date ingredient safety information. These sources include extensive scientific reviews by the Cosmetic Ingredient Review, an expert panel of independent scientists, as well as reviews of cosmetic ingredients by other sources; information and data from cosmetic ingredient suppliers; published data in the scientific literature; and government sources, including the U.S. Food and Drug Administration, the National Toxicology Program, the National Cancer Institute, and other government databases.
5.2. Determinations of Potential Ingredient Toxicology
Safety evaluations take into consideration a number of key factors including cosmetic ingredient function and use concentration; degree of chemical purity and stability; and potential for ingredients to be absorbed through the skin and/or mucous membranes, or via oral ingestion or inhalation. Assessment for potential adverse effects includes: evaluation of exposure to ingredients for short, intermediate or long periods of time (acute, subchronic, and chronic systemic toxicity); skin irritation; skin allergy; photoirritation; photoallergy; and determination of the potential for ingredients to adversely affect the body´s genetic material (genotoxicity), cause cancer (carcinogenicity), or negatively effect reproduction and fetal development.
5.3. Evaluation & Testing of Human Health Impacts
Following a thorough review of each ingredient in a cosmetic formulation, additional safety data on the finished product are reviewed. These may include cell culture (in vitro) and clinical (human) tests conducted on the final product and on products similar in composition to the product being evaluated. The potential for ingredient interactions within the product leading to unexpected adverse effects also is evaluated. Confirmatory testing of product compatibility and acceptability on human volunteers (clinical testing) is often undertaken with informed consent and with the appropriate safeguards to detect any undesirable effects that could occur.
5.4. Examination of Cumulative Exposure to the Human Body
Typical consumers use multiple cosmetic and personal care products each day. Therefore, assessment of cumulative exposure to product ingredients from multiple sources is an important component in the overall assessment of product safety. In this regard, it is also important to take into account inadvertent (secondary) exposures (e.g. inhalation with hair spray use or ingestion from lipsticks, etc.). Factors to be considered in determining exposure levels for products and ingredients include product type, amount used per application, frequency of application, site of body contact, duration of product contact, concentration of individual ingredients in the final product, use by sensitive subpopulations (i.e., babies, the elderly, pregnant women), method of application, external factors (i.e., sunlight exposure, variation in use related to weather, local or temporal habits and trends, and cultural considerations), and possible conditions of foreseeable misuse.
5.5. Testing & Evaluation Performed by Scientists Trained in Product Safety
In order to ensure the reliability of testing, product safety studies are designed and monitored, and the results interpreted and evaluated by scientists who are specially trained and experienced in toxicology and safety evaluation. These scientists have a fundamental understanding of cosmetic, personal care and fragrance products and of the tests being used.9
6. SAFETY MONITORING CONTINUES ONCE PRODUCT IS ON MARKET:
Safety reassurance does not end once a product is placed in the market place. Once a product is launched, companies engage in ongoing, active monitoring of consumer experience to confirm product safety. Cosmetic and personal care product manufacturers have established post-market surveillance processes for the identification of potential safety issues related to their products. Such systems help to identify consumer use patterns, such as alternate uses or product combinations that may contribute to adverse events. These processes include regular surveys of consumer contacts received by a marketer or manufacturer either through toll-free 1-800 numbers on packages or direct correspondence. Trend analyses of contact data, including evaluations of frequency and severity of adverse events, as well as comparison of these trends with historical information for other comparable products, represent valuable mechanisms for identification of safety-related concerns. Although adverse reactions that are both serious and unexpected are extremely rare for cosmetic and personal care products, manufacturers must report knowledge of any instances of serious product reactions to the Federal Food and Drug Administration.
6.1. The Scientists Behind Product Safety:
Scientists that are specially trained in many different disciplines are involved in the design, development, and manufacture of cosmetic and personal care products, including chemistry and biochemistry, microbiology, molecular modeling, engineering, formulation science, technical packaging, and toxicology. While the activity of each of these scientists contributes to the safety profile of cosmetic and personal care products, it is the specific role of the toxicologist to design and interpret the tests that assess the safety of cosmetic and personal care products and their ingredients.
Some of the scientists involved in the product development and safety process, and their roles, include:
- Toxicologists, who evaluate ingredients and finished products to establish their safety for consumers during usage.
- Microbiologists, who establish product preservation requirements and monitor manufacturing to ensure finished product integrity.
- Analytical Chemists, who perform chemical evaluations of ingredients and finished products, to determine purity and other properties
- Formulators, who develop new and improved products and set product standards and specifications
- Science Information Specialists, who retrieve information, including scientific articles and patents, relevant to product development and safety
- Manufacturing engineers, who develop manufacturing procedures and oversee production of the final product
- Technical Packaging Specialists, who create improved ways of applying, dispensing and packaging products
- Quality Assurance Professionals, who test components and products to meet ingredient and finished product specifications
- Regulatory Specialists, who ensure that a product meets all labeling requirements and is in compliance with all governmental regulations
Consumer Affairs Professionals, who conduct consumer research and testing prior to product marketing and track issues that may arise following product marketing.9
7. SAFETY ASSESSMENT
It is recommended that this should generally be in the form of a signed statement of opinion by an appropriately qualified and suitably experienced person or persons. This should give reassurance that the product is safe in its intended cosmetic use and takes account of foreseeable use. A specific safety assessment is also required for cosmetic products intended for use on children under the age of three and for cosmetic products intended exclusively for use in external intimate hygiene.
The safety assessor should take into account all support information such as:
• The general toxicological profile of each ingredient used;
• The chemical structure of each ingredient;
• The level of exposure of each ingredient;
• The specific exposure characteristics of the areas on which the cosmetic product will be applied; and
• The specific exposure characteristics of the class of individuals for whom the cosmetic product is intended.
In the case of perfumery raw materials, the composition may not be known because of confidentiality. If so, it is necessary to obtain a relevant safety assessment from the supplier.9
NOW YOU CAN ALSO PUBLISH YOUR ARTICLE ONLINE.
SUBMIT YOUR ARTICLE/PROJECT AT articles@pharmatutor.org
Subscribe to Pharmatutor Job Alerts by Email
FIND OUT MORE ARTICLES AT OUR DATABASE
8. SAFETY ASSESSMENT AND PRODUCT INFORMATION PACK
Every cosmetic product placed on the market requires a safety assessment carried out by a suitably European qualified professional. The website for the Cosmetic Toiletry and Perfumery Association at ctpa.org.uk has a link to the Regulations and can provide a list of safety assessors.
The assessment will form part of the product information pack which should also include details of the qualitative and quantitative composition of the product, specifications of raw materials and finished products and the purity and microbiological controls, details of 2 methods of manufacture in accordance with good manufacturing practice, data on undesirable effects on human health, and where appropriate, proof of any claimed effect.
8.1 Restrictions on Ingredients
All ingredients, natural or not, need to be in line with the Regulations (which are the same as EU Council Directive 76/768 EEC). Any restrictions on ingredients will also showup on the EU Cosmetics database at https://ec.europa.eu/enterprise/cosmetics/cosing/ There are lists of banned substance which may not be used in any cosmetic product, lists of products which are restricted by percentage use in a particular product, and also positive lists for colours, uv-filters and preservatives – meaning only those on the list may be used.
Labelling There are very specific requirements for labelling, which must include an address within the European Union from where the product information is available, and a full ingredients listing amongst other items. A product manufactured outside of the EU must also include country of origin.
Notification Once the safety assessment has been carried out and before you place the product on the UK market, if the UK is the first market in the EU, please notify by email cosmeticnotification@bis.gsi.gov.uk of the type of product you are supplying, together with your name, company and address details, or if importing from outside of the EU, the details of the importing company in the UK. You are also advised to contact your local Trading Future Regulation Regulation (ec) no 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products will come into force in full on 11 July 2013.9,10
8.2 Cosmetic ingredient
A cosmetic ingredient is any substance or preparation of synthetic or natural origin used in the composition of a cosmetic product. Note, however, that for ingredient labelling purposes perfume and aromatic compositions, i.e. flavours, are subject to special rules and these are explained in the paragraphs dealing with ingredients listings.
Common ingredient nomenclature
*The labelling nomenclature referred to in Regulation 12(2)(a) is published by the European Commission as part of the inventory of cosmetic ingredients. This nomenclature shall be used for products supplied in European Union. There are over 7000 ingredients on the current list published in 1996, amended in 2006, and it must be used for ingredient labelling purposes. This nomenclature, developed by a Colipa (European Cosmetics Association) working group, has been approved by Member States and will be updated from time to time. It is now known as the INCI nomenclature (International Nomenclature of Cosmetic Ingredients) with the objective of satisfying the need for a truly international system of labelling. For example: water is known as aqua
A product must be safe not only under normal but also under reasonably foreseeable conditions of use. Regulation 4 also stipulates that, in determining which conditions of use are “reasonably foreseeable”, all the circumstances, including the presentation of the product, which includes warnings, instructions for use and disposal, and any other information, is to be taken into account. The safety requirement does not cover misuse of a cosmetic product (except where it is a reasonably foreseeable misapplication of the product).
For example A hair dye product for general use (i.e. not professional use), contains comprehensive and clear instructions together with warnings regarding the safe use of the product. The warnings include the statement Do not use to dye eyelashes or eyebrows. Rinse eyes immediately if product comes into contact with them. The manufacturer has recognised that the product may irritate the eyes and has warned against applying the product in the vicinity of the eyes. If a consumer chooses to ignore the warnings, the manufacturer cannot be held responsible These refer to the various groups of ingredients contained in Schedules 3 to 7 of the Regulations that list prohibitions and restrictions.
*Schedule 3, Part I lists ingredients prohibited in all cosmetics unless otherwise specified.
*Schedule 4, Part I lists ingredients that may only be used subject to the restrictions specified. It includes certain ingredients commonly but not exclusively used in fragrances and which must be labelled individually if they exceed a certain threshold level regardless of the function they perform in the product. This labelling requirement is in addition to normal perfume labelling requirements and does not replace them.
A number of these ingredients are also found in natural essential oils. In order to check the levels of these ingredients in their products, companies need to obtain information from their suppliers of essential oils and perfume compounds.
Schedule 4, Part II contains provisionally allowed ingredients, subject to the listed restrictions, but cosmetic products containing any of these ingredients may only be placed on the market up until the dates specified.8
8.3Ban on animal testing
The Cosmetics Directive banned the testing of finished cosmetic products on animals in any territory of the EU from 11th September 2004 and the testing of ingredients, or combinations of ingredients, from 11th March 2009, where the testing is undertaken in order to satisfy the requirements of the Directive. The UK Government already had a ban in place for a number of years that has a similar effect.
The Directive also aims to eliminate all safety testing of cosmetic ingredients involving the use of animals, except in extenuating circumstances that are subject to pre-approval. Where alternative test methods exist, and have been validated and accepted by the European Community, these methods must be used in place of testing on animals.
The Regulations contain a ban on the testing of finished cosmetic products on animals where the testing is undertaken to ensure compliance with Directive 76/768/EEC or with the Regulations. This prohibition had effect from 11th September 2004. The Regulations also maintain a 2-stage ban on the testing of cosmetic ingredients on animals. This applies to any test undertaken to ensure compliance with the Cosmetics Directive or with the Regulations and operates as follows:
Ban on Supply of Cosmetic Products which have been Tested on Animals
The Regulations ban the supply of cosmetic products, and cosmetic products containing ingredients, that have been tested on animals in order to ensure compliance with the Cosmetics Directive or the Regulations, where a validated alternative method exists.
• Until 11th March 2009 (or 2013 in the case of tests concerning repeated dose toxicity, reproductive toxicity or toxicokinetics) it is illegal to supply any cosmetic product which contains any ingredient or combination of ingredients which have been tested on animals (using a method other than an alternative method) in order to satisfy any requirement of the Regulations wherean alternative test method existed and had been validated at Community level at the time of testing. Where such an alternative test method exists, it will be listed in the Commission Regulation on test methods as specified in article 13 (2) of Regulation (EC) No. 1907/2006 and in Annex IX of the Cosmetic Directive.
After 11th March 2009 (or 2013 in the case of tests concerning repeated dose toxicity, reproductive toxicity or toxicokinetics) it is illegal to supply any cosmetic product which contains any ingredient or combination of ingredients which have been tested on animals using a method other than an alternative test method irrespective of whether an appropriate alternative test method exists.
• “No animal tests have been carried out” means that no animal tests whatsoever were carried out in relation to the development of a cosmetic product.” Only the full replacement of the animal tests by an alternative method allows the claim to be made. The claim only refers to the replacement, and not the reduction or refinement, of animal tests. Furthermore, it does not matter where the test, including retesting, is performed, whether in the European Union or in third countries, or when the test was performed.
• “The manufacturer and his suppliers have not carried out or commissioned any animal tests…” means that the manufacturer and his suppliers:
- should not have directly carried out animal tests;
- Should not have commissioned animal tests. They should not have requested, or paid for, animal tests by means, for instance, of sponsorship of research by academic institutions.
• “Manufacturer and his suppliers should not have…used any ingredients that have been tested on animals by others for the purpose of developing new cosmetic products” means that:
- The manufacturer and his suppliers should not have used ingredients for which data resulting from animal tests made by others for the purpose of developing a new cosmetic product are available, for instance, in scientific literature.
The Regulations require all cosmetic products to be marked with:
• list of ingredients paragraphs
• name and address of manufacturer or supplier paragraphs
• country of origin paragraph
• date of minimum durability (best before date) paragraphs
• warning statements and precautionary information paragraphs
• batch number or lot code paragraphs
• product function, when appropriate paragraph
• the following must be in English for products supplied in the UK but the additional use of other languages is allowed
- warning statements;
- precautionary information;
- “Best before” when used to indicate the date of minimum durability;
- “months” and “years” when used to indicate “Period After Opening”;
-- It is important that all ingredients used in the European Community have a European INCI name. If their ingredients do not have one, manufacturers of ingredients should apply to the International Nomenclature Committee, on the standard forms, to have an INCI name allocated. Further information can be obtained from the CTPA.4,8
8.4List of ingredients -
A full list of ingredients must be given on the outer packaging headed or preceded by the word INGREDIENTS. Where there is no outer packaging, the list must appear on the container (see also paragraphs 64 to 80 on Labelling Difficulties). This listing must:
• Show all ingredients added to the product;
• Use the name given in the Common Ingredients Nomenclature known as the INCI name (International Nomenclature for Cosmetic Ingredients). See paragraph 13. There is no requirement to use either upper or lower case text;
• In the absence of an INCI name10, use an alternative as listed in Appendix 1 of this guidance note;
• For colouring agents, use the INCI names as detailed above;
• Perfume compositions and their raw materials do not need to be declared and can be simply described by the use of the word perfume. However, in order to achieve a harmonised European label, European industry, with the support of the European Commission and Member States, has agreed a convention to use the harmonised term parfum. See also paragraph 23 concerning certain ingredients that must be labelled individually even if they form part of a perfume composition or essential oil;
• Aromatic compositions and their raw materials do not need to be declared and can be simply described by the use of the word aroma. See also paragraph 23 concerning certain ingredients that must be labelled individually even if they form part of a flavour composition or essential oil;
• Show ingredients in descending order of weight, the weight determined at the time the ingredients are added to the product.
For the purposes of labelling, the following are not regarded as cosmetic ingredients and do not need to be shown:
• Impurities in the raw materials
• Subsidiary technical materials used in the preparation of the cosmetic product but not present in the final product. For example, alkalis used to adjust the pH at any stage of preparation would not be declared. Similarly, solvents used for extraction purposes but subsequently “driven off” would not be listed;
• Materials used in strictly necessary quantities as solvents or as carriers for perfumes and aromatic compositions.6,8
8.5Name and address
The name and address required are those of the manufacturer or supplier established within a Member State of the Community or European Economic Area.
The name and address must be sufficient to identify the undertaking. The address may be abbreviated to a well-known city or town such that the normal postal service will deliver a letter to that address. A full postcode is also sufficient for an address within the Community. For example, London, being a major city, is sufficient for a product sold within the Community but Ipswich will require a postcode such as IP65 3TS UK. If space allows and a full address will not detract from the product, it is better to give as full an address as possible. The information must be given on both the primary container and the outer packaging.
8.6 Best before date A product which is likely to deteriorate up to and including 30 months from the date of manufacture so that it:
• Ceases to satisfy the general safety requirement in Regulation 4; or
• Ceases to fulfill its intended function;
must have a date of minimum durability using the words “Best before” immediately followed by either:
• The earliest date, in the form month, year, in which one of these may occur; or
• An indication of where that date appears on the labelling.
The minimum durability date must appear on both the primary container and outer packaging in English. Best before November 2010, Best before Nov 10 and Best before 11/10 are all acceptable forms. It is generally accepted practice to be able to abbreviate the words Best before to Exp. and Best Before End to BBE.8
“Period After Opening” (PAO)
Any cosmetic product, subject to certain exceptions detailed below, that does not require a date of minimum durability must be marked with a “Period After Opening” (PAO). It must appear on both the primary container and outer packaging.
The “Period After Opening” is the time after which the cosmetic product may cease to comply with the general safety requirement in Regulation 4.
• Opening of the product may be considered as occurring when the consumer opens the product for use for the first time.
• According to the Commission Guidance, the PAO symbol will not be necessary where:
– No physical opening of the product as is the case for products presented in containers where there is no possibility of contact between the product in the container and the external environment (e.g. aerosols);
– No period after opening as is the case for single-use products, which are designed to be used only once;
– No risk of harm to the consumer as there is no risk of deterioration that could lead to, in accordance with Article 2 of the Cosmetics Directive, damage to human health.
Warning statements and precautionary information
Information must be provided on both the primary container and outer packaging in English if the product is supplied in the UK. Conditions of use and warnings for a range of ingredients are specified in the Schedules to the Regulations as follows:
• Chemical substances - Schedule 4, column 6;
• Preservatives - Schedule 6, column 6; and
• UV filters - Schedule 7, column 5.8
8.7Batch number or lot codes
A code which enables the manufacturer or supplier to identify the batch in which the product was manufactured must be marked on both the primary container and outer packaging. If the product is not made in a batch, then the code should enable the date and place of manufacture to be identified.
Where it is impossible for reasons of size for the lot code to appear on both the primary container and outer packaging, it may appear on the outer packaging alone.
It is good practice to identify a batch or lot in as precise a way as possible. If a problem should arise, this will limit the quantities of product which have to be recalled or “held” in stock pending further investigations.8
8.8Language
The following must be in English for products supplied in the UK, but the additional use of other languages is allowed:
• Any warnings or information required
• Precautionary information;
• “Best before” when used to indicate the date of minimum durability;
• “Months” and “years” when used to indicate “Period After Opening”;
• Product function.,
It is recognised that the variety and nature of cosmetic products and their packaging will pose difficulties when trying to include all of the information specified in the Regulations. Certain provisions have, therefore, been made to take into account the practical difficulties.
Warning statements and precautionary information
Information relating to substances, preservatives and UV filters, and any particular precautions to be observed in use will normally appear on both the primary container and outer packaging. Where this is impossible for practical reasons, the information may be given on a leaflet, label, tag, tape or card enclosed with the cosmetic product or attached to it.
When the information is given in an enclosed leaflet, label, tag, tape or card, the consumer must be referred to it, either by abbreviated information or by a special symbol, given in Part of the Regulations (the hand and book symbol), which must be on both the container and outer packaging. This symbol is reproduced in Appendix 3 of these Guidelines.8
8.9 Batch code
Where it is impossible, for reasons of size, for details of the batch code to appear on both the primary container and outer packaging, the details may be given on the outer packaging.
Ingredient listing
An ingredient listing is required on the outer packaging only or, in its absence, on the primary container. Where it is impossible for practical reasons for the list to appear on the packaging (or container), it must be given on a leaflet, label, tag, tape or card enclosed with the product or attached to it. The consumer must be referred to the text either by abbreviated information or by the hand and book symbol, which must appear on the outer packaging. This symbol is reproduced of these Guidelines.
Ingredient listing for difficult shapes and small products
Where it is impracticable for reasons of size or shape for a list of ingredients to be given, the list of ingredients must be displayed on a notice in the immediate 20
proximity to the container in which the product is being sold, so as to be visible to the intending purchaser. The hand and book symbol is not required.
Ingredient listing - Variable Ingredients
The Regulations make provision for the listing of all colouring agents used in a decorative range of cosmetics although each product would only contain a selection of those colours. The intention is to simplify manufacture by allowing all of the colouring agents to be listed on one label in a market where fashions and colours change frequently. However, there is no specific provision made for other ingredients which are subject to change.
For example, minor formulation changes of non-colour ingredients are usually necessary to accommodate the different characteristics of colour pigments used within a range of colour cosmetics.8
8.10 Ingredient labelling - colours and associated ingredients
Colour ingredients which do not have a CI number, as listed in Schedule 5 to the Regulations, but are closely associated with colour might only be present in some products within the decorative range. The industry interpretation is to list these items under the +/- (may contain) section of the ingredient listing. Examples are mica and tin oxide, both used as opacifiers.
Hotels
Cosmetic products made available to customers in their hotel rooms are subject to all of the requirements of the Cosmetic Products (Safety) Regulations 2008. However, full use can be made of the exemptions to ingredient labelling given for difficult shapes and small packs. For example, it is acceptable for the ingredient information to be given on a leaflet or card which can be placed close to the product where the Regulations allow this.
Vending machines
The labelling requirements in the Regulations apply equally to products dispensed from vending machines.
8.11 Free samples
Free samples, whether they are provided in-store, by direct mail or in magazines e.g. shampoo samples, are considered to be within the definition of supply contained in the Regulations. Compliance with all of the requirements of the Regulations is, therefore, required.
Off-Pack Labelling - Responsibilities of Manufacturers, Retailers & Suppliers
There are occasions when ingredients information will need to be displayed near to the products. The respective responsibilities of manufacturers, retailers and suppliers are as follows.
Manufacturers must provide a list of ingredients relating to the products in question. It is advisable to include information which refers to the retailer’s responsibility, for example ‘To comply with the Cosmetic Products (Safety) Regulations 2008, a list of ingredients as given above must be displayed in immediate proximity to the container in which the product is exposed for sale’.
Retailers or suppliers must not supply the cosmetic product unless the ingredient labelling information for that product is displayed in accordance with the Regulations.
Toilet soap - labelling difficulties
In the case of the impracticability of enclosing a leaflet with the product or attaching a label, tag, tape or card to the product, the ingredient listing may be displayed in close proximity to the product when offered for sale.
‘Coconut oil’ and ‘Palm kernel oil’ are both obtained from the kernels of palm trees. When saponified in the production of soap they become a form of ‘sodium palm kernelate’. The UK Cleaning Products Industry Association (UKCPI)12 recommends the use of this term, listed in the INCI nomenclature, to cover the use of either of these raw materials in the ingredients listing.8
Toilet soap supplied in a container or wrapper The normal requirements apply.
The name and address of the manufacturer or supplier and the batch code are required to be given on either:
• The soap itself (but only required to be indelible until it has been put into use); or
• The packaging in which it is exposed for supply; or
• The container in which it was packed before being exposed for supply.
8.12Contents of the Product Information
The information which must be present in the PI is detailed in the following sections. It may be the case that a competent authority would like to see supporting documentation, in which event adequate time is likely to be given to the company for this to be obtained. Supporting documentation may be in a language of the Community which is not English. However, companies should be prepared to provide an English translation, if needed.
Product composition
This should be a statement of the complete quantitative composition of the product covering all raw materials added. This will also meet the specified requirement for qualitative composition. In the case of perfumes and perfume compositions used as ingredients, only the name and code number of the composition and the identity of the supplier have to be provided.
Physico-chemical and microbiological specifications of raw materials and finished product
The specifications (and any related control criteria) of both raw materials and finished products will be determined by the type and use of the raw material concerned and the product type in which it will be used. The level of detail will obviously vary according to those criteria and the professional judgement of those involved in formulating and manufacturing the product. The standards adopted will reflect regulatory requirements and generally accepted industry practice. Full specifications for the finished product must be provided.
Method of manufacture
This should include a brief overview of the method of manufacture including storage and filling, and applicable to the manufacturing site(s) concerned. There should be a summary of the process and a cross-reference to the detailed manufacturing documentation within any specific manufacturing site. Manufacture – and also (it is generally recognised) packaging and storage - of cosmetic products should be carried out to cosmetic Good Manufacturing Practice (GMP) and the guidance documents published by Colipa15, the Council of Europe16 and the European Commission on GMP are recommended as a reference.8
Proof of the effect
The provision of information is required to support claimed effects, where justified by the nature of the effect or product. This is only required where a claimed effect is in addition to that which is obvious from the formula and product presentation. For example, the basic effect of a shampoo is clear and there is no need to include performance data on its ability to wash hair. A sunscreen, however, would require performance data such as information to support its Sun Protection Factor (SPF).
REFERENCES
1. Balsam S.M. & Gerhson S.D. at al Cosmetics, science & technology ,vol-3,willey –intersciences A division of John willey & sons Inc. , Neew York ,London ,Sydney ,Toronto P.No:-336-339
2. Consumer Protection, The Cosmetics Product (Safety) Regulation 2008, P. No. 3-6, accessed on 28-07-11
3. Health Sciences Authority, Regulatory Guideline on control of cosmetic products, revised in feb. 2011, P. No. 3-5, accessed on 28-07-11
4. Howard I. Maibach “Cosmeceuticals – Drugs Vs. Cosmetics” 2000 ,Marcel Decker Inc. New York Baser. P.No:- 245-247
5. James Swarbrick, “Encyclopedia of Pharmaceutical technology”, 3rd edition, Volume-1, P.No. 803
6. M.M. Breuer “Cosmetic Science” Volume 1,Academic Press ,London New York ,San Francisco ,P. No:-28-33
7. Mithal B.M. & Saha R.N. “A handbook of cosmetics”-2007, Vallabh Prakashan Delhi, P. No;-36-38,58-60,191-193
8. Product Safety bis.gov.uk/policies/consumer-issues/product-safety/cosmetic-products-safety-regulations-2008-as-amended,March-2010 P. No. 1,7-18, 25-28 accessed on 28-07-11
9. Product safety cosmeticsinfo.org/product_safety.php accessed on 28-07-11
10. Regulation of cosmetics alchemycompliance.com/cosmetic-regulation-safety-assessment.html accessed on 28-07-11
11. Sharma P.P. “Formulation, manufacturing & Q.C. 4th edition 2008 ,Vandana Publications Pvt.Ltd. delhi 110088 P.NO:- 770-780
12. Vijay Malik “Law relating to drugs & cosmetics” 19’th edition 2006, Eastern Book company ,Lucknow P.No;- 16-22
NOW YOU CAN ALSO PUBLISH YOUR ARTICLE ONLINE.
SUBMIT YOUR ARTICLE/PROJECT AT articles@pharmatutor.org
Subscribe to Pharmatutor Job Alerts by Email
FIND OUT MORE ARTICLES AT OUR DATABASE
.png)
