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Perfume Allergens in Cosmetic Products: A Guide to Compliance

Homecosmetic regulationsPerfume Allergens in Cosmetic Products: A Guide to Compliance
perfume allergens
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Perfume allergens, also known as ‘fragrance allergens’ or ‘sensitizers’, can cause problems for formulators and those responsible for compliance of cosmetics and personal care products. We’ve produced this article to provide some recommended best practices and to explain how to best set up perfumes/fragrances, essential oils and apply these correctly to your formulations.

Some countries do not require the declaration of specific perfume allergens. For example, the U.S. regulations require that fragrance ingredients are listed simply as “Fragrance”. The Food and Drugs Administration, states: “FDA does not have the same legal authority to require allergen labeling for cosmetics as for food.” 1

Even though your local regulations may not stipulate special requirements for perfume allergens, we recommend declaring these in the raw materials used in your formulations, in accordance with Article 19 (g) of Regulation (EC) N° 1223/2009. 2 It’s easy to then omit them from your label of ingredients if not required and ensures that your raw materials are set up by default for the EU market. This also provides flexibility in the future, should you wish to expand to other markets where perfume allergens must be declared.

According to the EU regulations, perfume allergens must be declared on the label of ingredients when they are present in concentrations exceeding 0.001 percent in leave-on products such as creams and lotions, and 0.01 percent in rinse-off products such as shampoos and soaps. There are currently 26 of these perfume allergens, which are listed in Annex III of CosIng.3

 

Download guide as PDF
Download the cosmetri Perfume Allergens Guide (PDF)

 

Use of the term ‘Parfum’ or ‘Fragrance’

 

Ingredients used in strictly necessary quantities as solvents, or as carriers, for perfume and aromatic compositions may be declared as the INCI ‘Parfum’ – providing protection of the intellectual property of perfume houses who wish not to disclose their exact formulations. Depending on your country, this ‘Parfum’ may alternatively be displayed as e.g. ‘Fragrance’ or ‘Aroma’ on your label of ingredients. Essential oils however should be entered with the oil’s main ingredient and any perfume allergens declared additional to this. Usually the main ingredient (the oil itself) would be entered at 100 %w/w. In cosmetri it does not matter that the total max. %w/w for the ingredients in the essential oil are > 100. It would be logically incorrect to say for example, that an allergen exists at 10% concentration in the oil and therefore the oil should be entered at 90%. If you sourced an oil that had no such allergen present, you would still use the oil @100%, rather than substituting the allergen for another ingredient. In other words, the perfume allergen is a property of the oil and is not separate to it, even though it must be ‘added’ as such to the raw material’s composition for the purpose of correctly calculating perfume allergen concentrations in the product’s formula.

 

Calculating Perfume Allergens in your Cosmetic Product

To calculate the percentage of each perfume allergen in your product, let’s take the following example of Myrtle Essential Oil, with some typical allergen concentrations in the product, based on adding this @0.5 %w/w and 0.1 %w/w:

 

  Coumarin Eugenol Geraniol Citronellol Limonene Linalool
Myrtle Oil 0.20000% 0.70000% 0.80000% 0.30000% 12.00000% 2.00000%
0.5 %w/w in product 0.01000% 0.03500% 0.04000% 0.01500% 0.60000% 0.10000%
RINSE-OFF 0.01% OK DECLARE DECLARE DECLARE DECLARE DECLARE
LEAVE-ON 0.001% DECLARE DECLARE DECLARE DECLARE DECLARE DECLARE
0.1 %w/w in product 0.00200% 0.00700% 0.00800% 0.00300% 0.12000% 0.02000%
RINSE-OFF 0.01% OK OK OK OK DECLARE DECLARE
LEAVE-ON 0.001% DECLARE DECLARE DECLARE DECLARE DECLARE DECLARE

 

 

Regulation (EC) N° 1223/2009 stipulates that the concentration of Coumarin @0.01000% in the 0.5 %w/w version ‘rinse-off’ example, would not require inclusion on the label because this concentration 'does not exceed 0.01000%', whereas all the other five perfume allergens must be declared.

The calculations of course become more of a headache when we must consider each instance of a perfume allergen that appears in your product formula – for example if more than one essential oil is used. Then we have also to consider the case of an ingredient such as Benzyl Alcohol, that may be used for a non-perfuming function e.g. as a preservative, but must still be included in any calculation of perfume allergens. In CosIng this can be confusing because this example ingredient exists as three different records in the database. Using cosmetri you can enter any of these three versions and each will be also classified as a perfume allergen so that the correct total allergen concentration for e.g. Benzyl Alcohol can be determined.

 

Variations in Concentration of Perfume Allergens Between Batches

If you’ve followed the logic so far, we have one more aspect to potentially complicate matters. Let’s take the example of Coumarin in our Myrtle essential oil, used @0.5 %w/w in our rinse-off product. Perfume allergen concentrations in essential oils tend to vary from batch to batch, so it’s important to check the documentation provided with the batch received form your supplier. You may have had your product labels printed and omitted Coumarin from the label of ingredients. But a small increase in Coumarin in a later batch of the essential oil would put this perfume allergen over the threshold, requiring it to be included on the label. Few companies have checks in place for such a case and can unwittingly fall foul of the regulations. Using cosmetri, you can calculate the expected perfume allergen concentrations when first designing your formula and easily check the concentrations for each batch of your product that you manufacture – even in the case that you manufacture using more than one batch of an essential oil, with different perfume allergen concentrations present in each batch.

If you are not using software capable of such calculations, we recommend identifying any ‘borderline’ allergens in your formula that risk exceeding the threshold required for declaration on your label of ingredients. This requires establishing the average percentage fluctuation of the allergen’s concentration form batch to batch of your raw material (such as a perfume or essential oil) and then adding a further ‘safety margin’ on top of this. For example, if your average level of Coumarin in your batches of Myrtle Oil is 0.20000%, but the maximum was 0.25000% it’s good practice to add a further say, 25% safety margin, so that the maximum assumed level will be 0.31250%. In the example calculation earlier, this would require declaring Coumarin in your product label, whereas previously it was not required. While you may wish to declare as few perfume allergens as possible on your label, it may be better to be on the safe side and thus avoid having to re-calculate the label of ingredients from batch to batch of your product.

 

 

Download guide as PDF
Download the cosmetri Perfume Allergens Guide (PDF)

 

 

Sources:

  1. https://www.fda.gov/cosmetics/productsingredients/ingredients/ucm388821.htm#labeling
  2. http://ec.europa.eu/health//sites/health/files/endocrine_disruptors/docs/cosmetic_1223_2009_regulation_en.pdf
  3. http://ec.europa.eu/growth/tools-databases/cosing/index.cfm?fuseaction=search.results&annex_v2=III&search