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Cosmetic Regulations Round-Up: Impact of Claims

Belinda Carli – Jun 20, 2017

Cosmetic RegulationsWhen it comes to cosmetic regulations, anywhere in the world, there are 2 elements that have the biggest impact on how regulators view cosmetic products and the ingredients they contain:

  1. The claims made about the product - Discussed in this article
  2. The ingredients used in the product - Subject of Part II of this series

You’ll need to make sure that at the very start of development, your product will comply with at least these two items. What does this mean? To answer this, we first need to look at the definition of cosmetics, which thankfully is remarkably similar around the world. This is, however, where the similarities end!

What can a cosmetic product claim?

Cosmetic products are defined using different words by various regulators around the world, but in general, their use is based on:

  • Appearance or odor based changes that are transient. Example, they clean or moisturize the skin, but if you stop using the product their effect also stops.
  • Topical applications to unbroken skin. It may also include applications to the teeth and oral mucosa to keep them clean.

This means claims should be reflective of the visible or odor based changes they make, for example:

  • Visibly brightens the skin/complexion
  • Reduces the appearance of fine lines and wrinkles
  • Eliminates/masks body odor
Cosmetic Claims

Products also need to be packed with suitable dispensers and directions to ensure safe use. For products like creams and lotions, special precautions may not be necessary. But, this becomes important when the product is designed to have a specialty function. For e.g. highly acidic products designed for chemical exfoliation of the skin.

In these cases, the ingredients and the formula itself are subject to additional restrictions. Even, when the ingredient inputs and formula have been carefully checked, claims about the product, its directions for use and expected performance results must still be compliant with the local countries’ definition and permitted use of cosmetics.

What is NOT allowed to be said about cosmetics?

In general, cosmetics must not claim to provide a therapeutic effect, changes to physiological systems, cells or for treatment of a diagnosed skin condition or other disease. General non-compliances we all too often see include:

  • Products claiming to be suitable for eczema, dermatitis or other skin disease - These are diagnosable skin conditions and require medical consultation, prescription, monitoring and treatment.

  • Product claiming to reduce inflammation - To reduce inflammation is to alter a physiological reaction, and is not an allowed claim for a cosmetic.

  • Traditional use’ claims. For example, an herbal extract or essential oil may have been used to treat certain skin conditions in the past, but this claim is not allowed on a cosmetic. Even if you have the evidence to prove traditional use, a claim about ‘treatment’ of a named skin condition, sleep, emotional effects or other disease (e.g. arthritis or muscular aches) does not meet the definition of a cosmetic. It is not appearance based and implies a therapeutic effect!

  • Links to external sites - Some companies think that if they don’t say it on their site, but link to another site where their product is not displayed, makes it okay. It doesn’t - any links you provide to other sites must also provide claims that are compliant with cosmetic regulations. In other words, do not link to other sites when promoting your product!

  • Claims for topical application that have an internal effect, for example, menopause creams. Even if the product is applied topically, to imply that it has a physiological effect means the product is no longer meeting the definition of a cosmetic.

  • Products cannot claim to have a ‘whiteningeffect or talk about changes to melanin synthesis etc. Even if the ingredient has in vitro evidence that it alters melanin synthesis, you can’t make this claim as it is then considered physiological. If you want to create a lightening product using an approved cosmetic ingredient, keep your claims to appearance based, for example, ‘visibly brightens the skin/complexion by x% in 28 days’. Do not mention HOW it brings about this effect.

There are many other examples not mentioned in this article. Just because we haven’t mentioned it here doesn’t mean you can say it! It is up to the individual brand to ensure compliance in its marketing and claims. So, be careful not to imply a therapeutic benefit or purpose for your product!

When a cosmetic product is NO LONGER considered a cosmetic?

There are many products that ‘fall’ at the interface between a cosmetic and therapeutic good / drug in other regions. Also they have additional regulatory restrictions. How they are treated is different around the world; common examples appear in the table below.

(must not imply medical/prescription use; ‘anti-inflammatory’ or named bacteria)
Cosmetic Cosmetic Cosmetic Cosmetic Quasi-drug Drug
(no named bacteria or condition permitted)
Cosmetic Cosmetic Cosmetic Cosmetic Quasi-drug Drug
(claims about cleansing only; no named cause)
Cosmetic Special Use Cosmetic Cosmetic Quasi-drug Drug
Anti-perspirant Cosmetic Special Use Cosmetic Cosmetic Quasi-drug Drug
Fluoridated Oral Care
(fluoride within limits)
Cosmetic Cosmetic Cosmetic Cosmetic Quasi-drug Drug
Hair dye Cosmetic Special Use Cosmetic Cosmetic Quasi-drug Cosmetic
Skin whitening
(brightening appearance based claims)
Cosmetic Special Use Cosmetic Cosmetic Quasi-drug Cosmetic
(includes SPF in personal care and/or make-up)
Cosmetic (Secondary function and SPF 15 or less)

Therapeutic (Primary function and SPF >15)
Special Use Cosmetic Cosmetic Cosmetic Drug

Definitions of Products in Different Countries

Note: This table assumes that ingredients are used within local country limits for cosmetic use and claims are compliant with local definitions of cosmetics.

In addition to this:

  • ASEAN countries and South Africa follow EU regulations
  • New Zealand can follow either Australian or EU regulations
  • Soap in the USA needs special treatment; refer to Consumer Product Safety Commission for more information

Different regulators around the world have different restrictions and prohibitions on both ingredients that are used and the claims products make. While, you may have a product that is compliant. For example, in America, it does not mean you can legally sell it in England without:

  • Making label
  • Ingredient changes
  • Compiling significant paperwork
  • Having it assessed, and registering it

Individual customers can often purchase a ‘personal’ amount of product on-line and have it delivered. This is generally considered to be 1-3 months’ supply according to pack directions. However, this does not apply to full shipments of product being exported for wholesale or retail sale in another country. Before exporting full shipments to another country, your company will need to make sure they comply with all regulatory conditions of the country they are trying to enter.

But I Saw Another Company Doing The Wrong Thing…

Don't Risk the Brand ImageJust because another company does or says the wrong thing, or includes a material they shouldn’t, doesn’t mean you can. If a regulator finds something wrong with your product, they won’t consider it suitable for you to use a non-compliant example as an excuse. Regulators hold individual companies responsible for ensuring compliance of the products they put on the market. So, if your product comes under scrutiny, you’ll need to provide suitable evidence to show compliance or remove it from the market and make changes.

Removing a product from the market can be disastrous for a brand’s image, not to mention expensive! So make sure you comply from the start to avoid issues later

Remember: if you have gotten away with being non-compliant in the past, count yourself lucky. But, as your brand build awareness, you are more likely to be reported by a competitor and/or noticed by a regulator if you are doing the wrong thing. It’s just not worth the risk. So if you see non-compliance by a competitor, report them. It makes a more level playing field for all companies that way; and protects consumer best interests and safety.

What else do you need to know?

Additional compliance requirements your product needs to have before it goes onto the market could include one or more (or sometimes all!) of the following:

  • All required label information - Including:

    • Weights/measures information
    • Address of the company or responsible person
    • Ingredient list using correct names for the region, and
    • Font size

  • Full product dossier - Required in many countries but especially stringent control over what is needed for export throughout EU, England and China

  • Registration - Required in many countries

  • Warnings or directions to ensure safe use

  • New chemicals’ often require notification and registration before they can be introduced

  • If your product is making insect repellent claims, you may have other regulatory authorities to comply with e.g. pesticides

  • If your product is making ‘organic’ claims then you should also check to comply with organic certification regulations

  • Claims on a product should not be misleading or deceptive, so any claims you make about the product, even if they comply with cosmetic regulations, should also be true for the products performance. Your company must hold appropriate evidence to support any claims it makes about the performance of a product
Learn to Check Compliance

It is important to remember that regulations can (and often do) change and to be truly compliant. And before proceeding too far into development, you should either:

  • Learn how to check and comply with local regulations properly - Which means more training than just this article!), or
  • Ask a consultant to review your ingredients and claims for compliance

While compliance checks are all too often considered an ‘expense’, it is really an investment in protecting your brand and its future. Factor in Regulatory costs as part of your Research and Development budget and conduct regulatory checks early in the development stages of a product to avoid costly and unexpected surprises later!

Disclaimer: The information in this article has been provided as a general overview and should not be considered specific guidance for any one situation. Persons reading this article on behalf of themselves or their organizations should seek proper regulatory advice specific to their situation and products before placing a product into the market.

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