Understanding Regulatory Requirements for Cosmetics: USA vs Global


 April 19, 2019

Regulatory Requirements for Cosmetics and Personal Care Products: What Brands Need to Know

Keeping abreast with the different national regulatory requirements for cosmetics is essential for brands looking to compete globally. Around the world, definitions and requirements for cosmetics and personal care products vary by country. Yet, one thing they have in common is the goal of protecting consumers by ensuring the safety of the finished product. While different countries have more or less stringent requirements to achieve this goal, consumer safety remains their priority.

Let’s take a look at a few of the key differences between US vs global regulatory requirements for cosmetics and personal care products – and what that means for brands doing business in multiple countries.

US Regulations vs. Global Regulations for Cosmetics and Personal Care Brands Kinetik

US Regulations vs. Global Regulations for Cosmetics and Personal Care Brands

According to the U.S. Food & Drug Administration, “Among the important differences between requirements for cosmetics in the United States and various other countries are the legal definitions of drugs and cosmetics, restrictions on the use of color additives and other ingredients, and registration requirements.”


Definition of Cosmetics Kinetik

Definition of Cosmetics


United States

The Federal Food, Drug & Cosmetic Act (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.” This definition includes things like lotion, lipstick, eye and facial cosmetic preparations, hair care, toothpaste, deodorant, etc.


On the other hand, the European Union Cosmetics Directive defines a cosmetic as “any substance or preparation intended to be placed in contact with the various external parts of the human body (epidermis, hair system, nails, lips and external genital organs) 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.”


In Japan, the cosmetics industry is regulated through its Ministry of Health, Labor and Welfare (established in 1960). Products are broken down into cosmetics and quasi-drugs, with differing regulations for each. Deodorants, hair dyes and anti-aging products all fall within the quasi-drug category.


In Canada, cosmetics are regulated through the Health Canada’s Cosmetics Program and are defined as, “any substance or mixture of substances, manufactured, sold or represented for use in cleansing, improving or altering the complexion, skin, hair or teeth and includes deodorants and perfumes.”

As in the U.S., manufacturers in the European Union, Japan and Canada are responsible for ensuring that cosmetics and personal care products comply with the law before they are marketed. However, cosmetic registration in the USA is considered voluntary (although highly recommended). In other countries, brands may be required to register their establishment and list product ingredients. This may require different product labelling for each end market.

Products Classified as Cosmetics and OTC Drugs

It’s important to note that some products can be classified as both cosmetics and over-the-counter drugs in the US. These products must meet different — and more stringent requirements. Among these combinations are toothpaste that contains fluoride, antiperspirants, and any cosmetics and moisturizers that include claims about sun protection.

Supporting Requirements for Cosmetic Regulation

At Kinetik, we don’t just supply the innovative ingredients brands need to stay on top of trends. Our team helps you stay informed about essential regulatory requirements for cosmetics and personal care products in the countries where you operate. As standards and laws evolve, it’s essential for brands to stay abreast of updates and changes. Kinetik can help.


Some of Kinetik’s key ingredients to meet global regulations include:

  • Abysoft – Multitasking ingredient with original skin feel, cushion effect, soothing, moisturizing, regenerating. Pigment wetting properties. Long lasting effect. Can be used in multiple platforms like Skin Care, Make-Up, Hair Care, and Cleansers.
  • Berry Wax – Emollient wax with low-melting soft wax with velvet, powdery skin feel. Outstanding payoff enhancer for stick and pencil preparations. Gives O/W emulsions a whipped, mousse-like texture. MP: 48 – 54 °C
  • Dermosoft 1388 – Multifunctional patented blend of organic acids with broad antimicrobial activity. Optimal pH < 5.5.
  • Dermofeel Sensolv – Natural silicone replacement with elegant, dry and non-greasy skin feel. Highly polar, quick spreading emollient for skin care, sun care and decorative cosmetics.
  • GLB Essentials Green Wax S – 100% naturally-derived, high-performance O/W emulsifying. Creates “alcohol-free” emulsions in a wide range of viscosities.
  • GLB Standards Willowbark Extract AQ – Standardized extract to 10% Salicylic Acid. Increases cell turnover and effectively reduces reproduction of P. Acnes, the microorganism associated with acne.
  • Konjac Mannan Gel Powder – Powdered thickener, moisturizer and film former derived from the Amorphophallus konjac tuber. Forms highly stable gels at pH 2-7.
  • Myrica Fruit Wax – High quality, hard wax with low melting point. Excellent performance as natural hair conditioning agent. Provides medium hold when used in hair styling products, without flaking. Provides a rich skin feel and prolongs play time to emulsions. MP: 45 – 55 °C
  • Pantrofina Skin 360– Extracted from Mediterranian marine pine, this “universal skincare” active provides superior protection. Reduces the appearance of skin aging and combats damage from daily pollution.
  • Plantsil – Olive derived ester “Light and Dry” alternative to cyclomethicone. Rapidly absorbs into the skin.
  • Sucragel CF – Sugar based Emulsifier and oil thickener for esters and non-polar oils suitable for all skin types.


Are you maintaining compliance?

If you need support ensuring cosmetic product compliance with FDA regulatory requirements, contact us at (732) 335-5775. Kinetik is headquartered in the USA, but we work with clients and represent suppliers worldwide.