How to formulate hypoallergenic cosmetics

Is hypersensitivity the same as an allergy?

The answer is no. Sensitivity reactions commonly include redness, itching and dryness at the site of application, with at least some discomfort experienced by the consumer. Irritant reactions generally happen on the first and every exposure to the cosmetic ingredient/s in question, and will typically resolve when the product is discontinued. 

This is not the same as an allergy. A true allergy to a cosmetic ingredient involves the immune system and generally occurs only on the second and subsequent exposure to the allergen ingredient. An allergic reaction to a cosmetic ingredient will generally require the use of antihistamines to resolve, or could require stronger medications. Consumers with known allergens to cosmetic ingredients should avoid them completely, as allergic reactions will often become worse with every exposure. 

Learn more about cosmetic ingredient irritants, allergens and comedogens here. 

While more than 50% of personal care consumers claim they have sensitive skin, they will often misinterpret sensitivity as allergic reactions, claiming instead they have an allergy to certain cosmetic ingredients. This is often not the case, however hypoallergenic cosmetic formulas are usually quite appealing to consumers with highly sensitive skin as they often think they will be milder and better suited to their skin type. 

What are cosmetic ingredient allergens?

As Cosmetic Chemists, we typically use the EU ruling on cosmetic allergens to guide our hypoallergenic ingredient selections. The EU lists certain cosmetic ingredients in Annex III of the Cosmetic Regulations as allergens. When these specific cosmetic ingredients are present at more than 0.001% in leave on products, or more than 0.01% in wash off products, their presence must be listed on the label. These substances, commonly referred to as ‘allergens’, are found in many essential oils and fragrances. Visit this blog to see a full list of these materials. 

How to make a hypoallergenic cosmetic formula

From the Technical Document on Cosmetic Claims, used by EU Courts to determine if a claim is truthful, hypoallergenic formulas need to be:

• designed to minimize allergenic potential and
• with no known allergens or allergen precursors added or present.

Even if you are not developing a cosmetic formula to be sold in the EU, this guidance, and the EU allergens list, gives us essential parameters within which we should be working when creating hypoallergenic cosmetic formulas. 

In order to create hypoallergenic cosmetic formulas, you will need to avoid:

• all essential oils and fragrances that have even trace amounts of allergens present, or at the least ensure that any known allergens are below labelling requirements.
• since most essential oils and fragrances contain at least one allergen in a trace amount, it usually means avoiding essential oils and fragrances in your finished product. 

Remember, creating natural cosmetic formulas or using natural ingredients does not mean a product will be any safer than those with approved synthetic cosmetic ingredients; nor does it mean it will be naturally hypoallergenic. Most essential oils contain multiple components recognized as allergens, and many essential oils and some plant extracts are now considered allergens based on EU lists.  

You will also need to carefully check:

• the SDS sheets of all other ingredients, to see if there is any risk of allergen potential, and cross check their CAS numbers against the EU allergens list;
• medical and health journals for all other cosmetic ingredients used in the formula, to ensure they have not had any research or reports of allergenic potential. 

How to add fragrance to a hypoallergenic cosmetic formula 

Since almost all essential oils and fragrances contain at least one or more known allergens in quantities that would require listing on a cosmetic label, how can you add any sort of scent to your personal care formula?

You could:

• contact a fragrance house requesting an ‘allergen free’ fragrance be made. If you really want a fragrance present, remember to allow additional time and costs in the formulation development phase for the fragrance house to submit such samples. The aromatic possibilities can be quite limited when making such a request, and you may need to order at least 5kg or more of the selected fragrance to cover their costs of development and tests to ensure absence of known allergens. 
• use hydrosols for a milder scent - but remember with the latest expanded list of EU allergens, many of your intended selections may no longer be permitted. In any case, you would need to obtain hydrosols with tests and statements about any potential allergens present to confirm their suitability before using in your hypoallergenic cosmetic formula. 

Learn the difference between essential oils, hydrosols and floral waters with this video. 
 

Additional tips for hypoallergenic cosmetic formulas 

Consumers with true allergies will be avid readers of cosmetic ingredient lists, so make sure you get yours right! Additionally, consumers with sensitive skin (who often think they have allergies) will often seek out cosmetic formulas with little or no scent, as the essential oils, fragrances and preservatives are often believed to be the culprits. 

If you want to make a hypoallergenic product formula, then you are best to avoid fragrance and essential oils completely, along with all other known sensitizing and allergenic agents. If you look in the market place, most hypoallergenic products are fragrance (and essential oil) free for this reason. 

Remember also that hypoallergenic formula claims do not mean a product is absent of allergic risk, and the product must not imply that it does. It simply means no known allergens, so a reduced risk by avoiding known allergenic substances. This can impact other functional and active ingredient selections, and the products’ performance overall. 

Sometimes, your cosmetic brand may need to consider: is the claim ‘hypoallergenic formula’ really that important to your company? 

Make sure you either have the skills and knowledge as a Cosmetic Chemist, or seek someone who does, if you want to go down the path of developing hypoallergenic cosmetic formulas. 
 

Happy formulating!