BHAVIK M PATELM.PHARM 1ST YEAR

DEPARTMENT OF QASHREE DEVI COLLEGE OF PHARMACY

QUALITY SAFETY AND LEGISLATION FOR COSMETICS

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Introduction

Quality and Safety of cosmetics Current legislation of cosmetics in different countries

introduction:

The quality of marketed products is generally not an issue with conventional medicines but, at present, for some complementary medicines, this is a real concern.

Manufacturers of licensed medicines are required to demonstrate to the MCA that their products meet standards for pharmaceutical quality (as well as safety and efficacy).

The use of ineffective, poor quality, harmful medicines can result in therapeutic failure, exacerbation of disease, resistance to medicines and sometimes death.

In 2000, the MCA set up an Ethnic Medicines Forum which aims to achieve improvements to safety and quality standards and to raise awareness of medicines legislation among some operators within the sector.

Governments need to establish strong national regulatory authorities (NRAs), to ensure that the manufacture, trade and use of medicines are regulated effectively, to protect and promote public health.

Licensing of the manufacture, import, export, distribution, promotion and advertising of medicines.

Assessing the safety, efficacy and quality of medicines, and issuing marketing wholesalers and dispensers of medicines.

Controlling and monitoring the quality of medicines

on the market

Controlling promotion and advertising of medicines.

Monitoring adverse reactions to medicines.

Providing independent information on medicines to professionals and the public. Medicines regulatory function

A drug is defined as being safe if it causes no known or potential harm to users. There are three categories of safety that need to be considered, as these would dictate the nature of the safety requirements that would have to be ensured.

Category 1 : safety established by use over long time

Category 2 : safe under specific conditions of use

Category 3 : herbal medicines of uncertain safety

Legislation concerning cosmetic products in the main markets worldwide, such as the Drug and cosmetic act of india, European Union (EU), the Unites States (US) and Japan, demand the assurance of three very important features, namely safety , efficacy and quality of cosmetic products.

Both safety and quality have to be considered under the following conditions:

1) The final product must accord with the composition designed by the manufacturer and be in a perfect state.

2) The cosmetic has to be applied by the user under the normal given conditions

important feature of cosmetic products is their quality and this requires thorough control .

quality control requires the manufacturing laboratory (or an external laboratory) to:

1) Use appropriate chemical, physicochemical, biological or microbiological analytical procedures to control production. Precision and accuracy of the applied procedure have to be known. These methods must be modified according to new scientific research and advances.

2) Assure stability and good preservation of the final product through the necessary assays. Expiry date of the product must also be considered.

Cosmetics represent a global industry with their main markets to be found in the D&C act of India, European Union (EU), the Unites States (US) and Japan with a value of 34.3, 25.7 and 11.9 billion euros , respectively, in 2004, according to data compiled by COLIPA.

To ensure safety and efficacy, cosmetic products are

regulated and controlled worldwide.

Avoidance of time-consuming and expensive pre-market licensing/registration of products.

The company responsible for placing the cosmetic on the market is also responsible for the regulatory compliance, for the safety and efficacy of the product.

In case of non-compliance there can be penalties. It encourages companies to ensure product safety

and therefore it offers better health protection benefits.

It increases the competitiveness of the market. It ensures that new products will be available to

consumers more quickly.

Registration time delays the launch of cosmetics that change quickly in line with developments in technology and/or fashion.

It restricts the availability of new products on the market.

Time-consuming procedures and high-registration costs imply higher cost for companies and consequently more expensive products

Legal authority and manufacture of cosmetics for sale

In India the Drugs and Cosmetic Act (1940) operates the regulations of cosmetics.

For the manufacture of cosmetics for sale or distribution the manufacturer should build the factory premises according to the Schedule M-II and application for license in the form 31 and along with license fee of Rs. 2500/- and an inspection fee of Rs.1000/- for every inspection to the licensing authority of the state government where in the manufacturing unit is located. And the information is reviewed by (local state) licensing authority and shall be granted in the form 32.

According to D&C act in India the labeling requirements for cosmetics are:

Name of cosmetics and name and manufacturing address should carry on the both inner and outer labels. For small size containers on the label instead of mfg address the principle place of mfg and pin code are sufficient. The outer label should contain the amount of net contents of ingredients used in the manufacturing. The inner label addresses the direction of safe use and any warning indication or names and quantities of the ingredients those are hazardous or poisonous in nature. The label should carry a distinctive batch number and it indicated by the letter “B” and for soaps the month and year of the manufacturing shall be given instead of “B” and this is not apply to cosmetics which are having 10grams or less for solids or semisolids and 25ml or less for liquid state products. On the label the letter “M” is indicate the manufacturing license number.

Regarding the safety information of cosmetics the manufacturer or his agent or the person responsible for placing an imported cosmetic product on the Community market should have the data about the assessment of safety of human health of finished cosmetic product.

For safety data manufacturers should take into consideration the general toxicological profile of the ingredient, its chemical structure and its level of exposure. Should the same product be manufactured at several places within Community territory, the manufacturer may choose a single place of manufacture where that information will be kept available.

In this connection, and when so requested for monitoring purposes, he shall be obliged to indicate the place so chosen to the monitoring authority/authorities concerned.

I. The ingredients should be declared in the descending order of their concentrations down to 1% and in any order below 1%.

II. Use before date instead of best use before date which was earlier declared as xx months/year from the date of packaging.

Recently cdsco published the Gazette Notification regarding Import & Registration of Cosmetics .it is further to amend the D&C act about the rules for import of cosmetics. Previously there was no legislation for the registration of cosmetics in India. Now this rule says “no cosmetic shall be imported into India unless the product is registered under these rules by thelicensing authority appointed by Central government”. The amendment comes into force with the effect from 1st day of April 2011.

The EU Cosmetics Directive, was adopted on 27 July 1976 and published in the Official Journal of the European Communities L 262 on 27 September 1976.

The European Commission has overall responsibility for cosmetics legislation within the EU, while a competent authority that enforces the legislation is designated in each of the 25 Member States.

The main objective of the EU Cosmetics Directive

1) to ensure a high level of consumer protection

2) a safety assessment of each cosmetic by a qualified professional as part of product development.

In recent years the EU Cosmetics Directive has become the model of modern cosmetic regulations worldwide, representing a dynamic legislation that allows for continuous adaptation to technical progress

Article 1 of the EU Cosmetics Directive defines a cosmetic product as, “ any substance or preparation intended to be placed in contact with the various external parts of the human body or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance and/or correcting body odours and/or protecting them or keeping them in good condition”.

Safety of cosmetics and consumer protection are primarily addressed in Article 2 of the EU Cosmetics Directive, “A cosmetic product put on the market within the Community must not cause damage to human health when applied under normal or reasonably foreseeable conditions of use.”

According to Articles 3, 4 and 5, Member States will have to take all necessary measures to ensure that only cosmetic products that conform to the provision of the Cosmetics Directive are put in market

Member States will therefore prohibit the marketing of cosmetics containing,

1) banned substances

2) products containing colouring agents intended solely to colour hair

3) preservatives

Concerning the labelling of cosmetics (Article 6), “Member States shall take all measures necessary to ensure that cosmetic products may be marketed only if the container and packaging bear the following information (...)”

a) the name and the address or registered office of the manufacturer or the person responsible for marketing the cosmetic product inside the EU.

b) the nominal content at the time of packaging, given by weight or by volume, free samples and single application packs.

c) the date of minimum durability needs to be indicated by the words ‘best used before the end of’ followed by either the date itself (month and year or day, month and year) or details of where it appears on the packaging.

d) the batch number of manufacture; f) the function of the product; g) a list of ingredients preceded by the word

ingredients

Article 7a indicates further obligations by manufacturers and importers towards safety and efficacy. They are responsible to keep the following information accessible to the competent authorities of the Member State:

The qualitative and quantitative composition of the product.

The physicochemical and microbiological specifications of the raw materials and the finished product and the purity and microbiological control criteria of the cosmetic product.

The manufacturing method must comply with the GMP. Assessment of the safety for human health of the finished

product. The name and address of the qualified person or persons

responsible for the assessment. Existing data on undesirable effects on human health. Data on any animal testing performed, related to the

development or safety evaluation of the product or its ingredients

Cosmetics manufactured or imported in the US must comply with the provisions of the FD&C Act, the Fair Packaging and Labelling Act (FPLA) dated 1967 and the regulations published under the authority of these laws.

The complete regulations published by the Food and Drug Administration (FDA) can be found in Title 21 of CFR.

The FD&C Act defines cosmetics as “articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance

in the US, some products considered as cosmetics in the EU are classified as OTC drugs.

Many products may qualify both as cosmetics and as OTC drugs when they have two intended uses.

An anti-dandruff shampoo, Fluoride-containing toothpastes, deodorants that are also anti- perspirants , moisturizers and make-up products with sunscreen claims are examples of cosmetic/drug.

A cosmetic may be deemed misbranded for reasons of:

--- False or misleading labeling . --- Failure to state prominently and conspicuously any information required by or under

authority of this act---Misleading container presentation or fil

A cosmetic may be deemed adulterated for essentially four reasons, namely:

1) It may be injurious to users under conditions of customary use because it contains, or its container is composed of, a potentially harmful substance.

2) It contains filth.

3) It contains a non-permitted, or in some instances non-certified, color additive.

4) It is manufactured or held under insanitary conditions

CONTENTS

AUTHORITY FDA EMEA CDSCO

RULES AND REGULATIONS

FOOD,DRUG ANDCOSMETIC Act

COUNCILDIRECTIVE 76/768/EEC

DRUGS AND COSMETICSAct

PRE-MARKET APPROVAL Not required Not required by CosmeticDirective

Required under state governmentlicensing

LABELLING Should comply with the FD&Cand FP&LNo date required

Based on CouncilDirective 76/768/EEC

Should comply with part XV ofD&C rules 1945

EXPIRY DATE No date required Date of minimum durability ifdurability is <30 months.Period after opening if durabilityis >30 months

Indicated as “Use before date”

POST MARKETINGREPORTING SYSTEM

Yes. (Voluntary CosmeticRegistration Program)

N/A N/A

Summary of cosmetic regulations

http://www.authorstream.com/Presentation/urmikantaria-1010767-urmi/

www.scholarsresearchlibrary.com

A comparative view on cosmetic regulations: USA, EU and INDIA.By Srikanth.T, Anand Abha