Abstract
Background: Cosmetics are products meant for cleaning, perfuming, beautifying, promoting attractiveness or altering the appearance on application to human body, without involving any physiological activity. In general, the term cosmetic includes a vast range of products mainly used for external care of the human body. To safeguard consumer’s health, each country has its guidance or regulations for cosmetic products. These regulations are legal tools for simplifying and reducing administrative work and ambiguities.
Methods: We undertook a structured search of regulations available for cosmetic products in major countries. All countries have been selected basis their well developed and highly recommended regulations and guidance documents. All regulations have been studied and presented here in a comparative manner for their regulatory framework for cosmetics in Canada, United States, European Union and India. All information was collected from mentioned countries regulatory databases maintained and updated by authority of these countries and appropriate review literatures available online.
Results: Regulations and guidelines have been studied thoroughly and appropriate information was included in the review through regulatory Authority website available on the internet. Majority of regulatory information for Canada, United States, European Union and India were available at website maintained by their respective authorities. In addition few review articles have been also consulted for introductory part of the manuscript. As per respective country regulations, Import, manufacture and sale procedures of cosmetics must be compliant with legislative regulatory system of respective country. Health Canada regulations on cosmetic products are mentioned in Food and Drugs Act and the Cosmetics Regulations. Cosmetics Notification, essential minimum labeling for consumers are few basic requirements that must be followed by manufacturers for Canadian market. Except for colour additives, United States, Food and Drug Administration (FDA) do not require cosmetic products and ingredients premarket approval. However, manufacturers are always advised to carry out necessary tests and establish safety of their product and all ingredients used in the preparation. New European Community Cosmetics Regulation 1223/2009 has replaced earlier Cosmetics Directive 76/768/EEC and other national provisions that were applicable to cosmetics. The Objective of new Regulation is to have a harmonized rule for all EU member countries. In India, cosmetics are regulated under the scope of Drugs and Cosmetics (D&C) Act 1940 and Rules 1945.
Conclusion: The finding of this review is to conclude the comparative regulatory framework for cosmetic products with respect to applicable acts, regulations, ingredients, heavy metals, labeling, notification procedures etc. for different countries. Despite of many differences among these regulations, the availability of quality products in market is the prime objective of each country’s laws and regulations.
Keywords: Code of federal regulations, cosmetic notification form, cosmetics, drugs and cosmetics act & rules, international nomenclature for cosmetic ingredients, principal display panel, product information file, responsible person.
27
2