5 little known regulations every cosmetic brand & formulator should be aware of

1. Some essential oils have very strict limits on use.

Just because essential oils are natural, does not mean they are safe. Here are some essential oils with limits that you may not have been aware of, and already using in excess! 

• Angelica root, bergamot, bitter orange, grapefruit, lemon and lime are rich in furocoumarins - also known as bergapten, which can lead to permanent skin staining when applied to the skin that is exposed to the sun. 
• Lower amounts of furocoumarins can be found in cumin, parsley, petitgrain mandarin, tangerine and rue essential oils, and must be checked. 
• Ylang ylang, certain types of rose oil, tea tree, tuberose and verbena contain methyl eugenol which can cause dermal sensitization and systemic toxicity. 

It is essential that you check the content of furocoumarins or methyl eugenol carefully when using any of the above essential oils against the IFRA or other government listed limits to ensure you are complying with regulations and ultimately keeping your consumer safe from adverse events. 

Learn how to conduct these checks with our Diploma of Personal Care Formulation (11268NAT) or Certificate in Fragrance & Essential Oils. 

 

2. Sunscreens need test results and may not be cosmetics in certain countries.

A lot of smaller brands would love to have a sunscreen formula as part of their product range, but they don’t realise that full sunscreen compliance testing, for the regions in which the product will be sold, must be held by them specific to their formula. Watch: Should you add a sunscreen to your cosmetic brand?

It is not enough to ‘buy’ a sunscreen formula from a Cosmetic Chemist or contract manufacturer; the brand putting the sunscreen on to the market must hold the required testing evidence specific to the formula of their product. 

Another little-known fact is that sunscreens are not always regulated as cosmetics in different countries. Where a sunscreen is regulated as a therapeutic good, drug or special use cosmetic, which brings with it a whole new set of rules, testing, registration and even labelling requirements. Here is an example of how complicated sunscreen claims and regulations can be! 

Learn the difference for all types of personal care with our Diploma of Personal Care Formulation (11268NAT) or Certificate in Cosmetic Regulatory Essentials.  

3. Wash off limits apply to some ingredients.

What we wash down our drains can have a huge impact on our waterways, so it is no surprise that some cosmetic ingredients have special limits that apply when used in wash off formulas (such as shampoo and body wash specifically). These include:

• Microplastic beads: now largely banned, there are loads of environmentally and even sustainable alternatives that can be used in exfoliant formulas in their place. 
• Cyclomethicone: this is a volatile ingredient that is highly resistant to biological degradation. It is perfectly fine to use in leave on products, as it will mostly evaporate shortly after use. In wash off products, however, it can remain in water ways and buildup, affecting marine life. It’s main functional role is to provide a weightless finish to leave on skin and hair care formulas, so should not be used in wash off products anyway. 

Preservatives and allergen compounds in fragrances and essential oils are also subject to different limits when used in wash off formulations. Make sure you are aware of the differences, and how to check them, by studying our Diploma of Personal Care Formulation (11268NAT) or Certificate in Cosmetic Regulatory Essentials. 

4. The cosmetic brand is responsible and must have a recall procedure.

This is a little known item that usually quietens any conference room. If you are a cosmetic brand, you are responsible for the quality, compliance, claims and evidence of the cosmetic products you put into the market place, regardless if you have paid a Cosmetic Chemist to create the formulas or contract manufacturer to make the product. Watch: who’s responsible for faulty product?

While a contract manufacturer has obligations relating to the quality of their procedures, and Cosmetic Chemists have theoretical responsibility over ingredient selection, the safety, shelf life and performance of that product, including all evidence to support claims of its performance, shelf life and safety, is the BRAND’S responsibility.  

All cosmetic brands should also have a recall procedure in place to show a regulator if ever asked, because they are supposed to have responsible personnel, who are part of that brand, to action it if ever there is a need to. This recall procedure includes specific investigative, reporting and advertising activities that need to be followed in the case of a recall being instigated; and all associated product must be accounted for that is part of the recalled batch. 

Make sure you comply and protect your Brand’s best interests with our Diploma of Cosmetic Brand Management, Certificate in Cosmetic Regulatory Essentials or Certificate in Cometic Product Recalls. 

5. The brand must hold all evidence and not be misleading about safety or natural status.

Another shocker that many brands don’t realise is that they should not be making misleading claims about the safety or hazards of certain ingredients when permitted for use in cosmetic products; or how natural their cosmetic formulas truly are. 

While it was a growing trend in the 90’s and noughties (00’s), it is no longer okay to suggest that:

• Approved cosmetic ingredients, when used within regulatory limits, are in any way toxic or dangerous;
• The non-approved cosmetic ingredients may be found in cosmetic formulas thereby rendering them unsafe;
• Claim a product is ‘free from’ certain chemicals or ingredients where they are otherwise safe or not normally used in that product type;
• Suggest that synthetic chemicals are hazardous and/or natural/organic ingredients are safe. 

All of the above statements are considered misleading and deceptive and must not be used when trying to promote your cosmetic brand or its cosmetic formulas. Watch: ‘free from’ claims for cosmetics.  

In addition to this, if you are claiming your formula to be ‘all natural’ then you need to hold evidence to support this claim. Be careful, some natural sounding ingredients are not as natural as you may think - so investigate them properly or consult with a Cosmetic Chemist. Watch: cosmetic ingredients that aren’t as natural as you think.

All claims made about your cosmetic product must have evidence to support the statements you make. Watch: Cosmetic Claims and Evidence. 

Make sure you comply and protect your Brand’s best interests with our Diploma of Cosmetic Brand Management or Certificate in Cosmetic Regulatory Essentials.
 

What the regulators say…

Some of these items come as an unfortunate surprise to cosmetic brands. Even more of a shock is that saying ‘but I didn’t know’, or ‘other brands do the same thing’ is not an acceptable excuse as far as cosmetic regulators are concerned. 

We hope this article has been enlightening and given you tools to improve your compliance and protect your cosmetic brands’ best interests. We’re here to help teach you what you aren’t aware of and make the most of your cosmetic brand potential. 

Happy formulating!