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Context - More than 2,500 fragrance ingredients are used in perfumes and perfumed consumer goods such as cosmetics, detergents, fabric softeners and other household products. to give them a specific, usually pleasant smell. They can sometimes cause skin irritations or allergic reactions.

A list of 26 substances that have to be identified on products to inform consumers was established in 1999.

Is this list sufficient, or is it necessary for additional fragrance ingredients be added to the list?

The answers to these questions are a faithful summary of the scientific opinion produced in 2012 by Scientific Committee on Consumer Safety (SCCS): " Opinion on Fragrance allergens in cosmetic products" Learn more...

GreenFacts was contracted to prepare this summary by the DG Health and Consumers of the European Commission, which authorised its publication. See this publication on europa.eu.
Text copyright© DG Health and Consumers of the European Commission.

  • Source document:SCCS (2012)
  • Summary & Details: GreenFacts
Latest update: 15 June 2013

1. Introduction

Fragrance ingredients are found in cosmetics and other consumer
								products.
Fragrance ingredients are found in cosmetics and other consumer products. Source: Lilieks

Fragrance substances can be derived from natural sources or chemical synthesis. They are organic compounds with a characteristic, usually pleasant smell, which are used in perfumes and perfumed consumer goods such as cosmetics, detergents, fabric softeners and other household products. Fragrances provide the consumer with a desired fresh smell or mask unpleasant odours. Fragrance substances are also used in aromatherapy and are sometimes present in herbal products. More...

2. What kind of skin problems are known to be caused by fragrance ingredients?

Skin rashes can be caused by fragrance ingredients, but are usually
								not allergic reactions.
Skin rashes can be caused by fragrance ingredients, but are usually not allergic reactions.
Source: James Heilman

The most common problems observed with fragrance ingredients, either through use of a perfume or a fragranced consumer product, are skin allergies and skin irritations. Many people complain about intolerance or rashes to perfumes or perfumed products. However, the majority of complaints commonly described as ‘skin rash’ are believed to be irritant reactions and not skin allergies. A key difference is that allergic reactions typically occur with a delay of about one day after using the perfume or cosmetic product, while irritant reactions develop immediately after use.

Skin allergy to fragrance ingredients occurs when an individuals skin has been exposed to a certain minimum dose of a fragrance allergen. For example through regular use of a fragranced cosmetic product. Once an allergy has developed, it is a life-long condition. The symptoms are redness, swelling and vesicles that are commonly described as ‘skin rash’ and may occur upon re-exposure to the fragrance allergen in question. Skin allergies to fragrance ingredients are most commonly caused by fragranced cosmetic products and frequently involve the skin of the face, hands or armpits.

Fragrances in perfumes and cosmetic products may also cause irritant reactions. However, skin irritant reactions cannot necessarily be attributed alone to the fragrance ingredients contained in the product. This effect also depends on the irritation potential of the other ingredients and their levels in the cosmetic product. More...

3. How can fragrance substance become skin allergens?

To cause a skin allergy, a certain minimum amount of the fragrance substance must penetrate the skin and attach to a skin protein. Only once the fragrance substance is attached to a skin protein can it provoke a cascade of events in our immune system which ultimately ends in allergy symptoms.

Whilst there are fragrance substances that directly bind to skin proteins, we also know that there are other types of fragrance substances which have to be chemically transformed before they can bind to skin proteins. This transformation occurs on the skin, for example in the presence of air or sunlight, or under the skin after reacting with skin enzymes (‘bio-activation’). Such transformation processes may turn a non- or weakly- allergenic substances into potent skin allergens. More...

4. What fragrance substances can be classified as skin allergens?

Depending on the quality of the available information and the strength of the evidence, dermatologists and other scientists distinguish between established (in humans or animals), likely, or possible contact allergens. In their evaluations, they consider information available on the fragrance substance from human studies (for example clinical or epidemiological studies), data from experimental animal studies or chemical structure information that, based on historical experience with similar type of chemicals, suggest the potential of a fragrance substance to cause skin allergies.

Following their review and data evaluation, the Scientific Committee on Consumer Safety identified a total of 54 individual fragrance substances and 28 natural extracts (essential oils) as ‘established contact allergens in humans’. The scientific committee also considered 18 individual chemicals and 1 natural extract as ‘established contact allergens in animals’, 26 individual chemicals categorised as ‘likely contact allergens’ and 35 individual chemicals plus 13 natural extracts categorised as ‘possible contact allergens’.

Category Number of individual fragrences Number of natural extracts Lists of substances Conclusion concerning labelling of consumer products
Established in humans 54 28 82 substances (13.1) Labelling recommended
(see conclusion)
Established in animals 18 1 19 substances (13.2) Labelling recommended
(see conclusion)
Likely 26   26 Substances (13.3) Labelling recommended
(see conclusion)
Possible 35 13 48 substances (13.4) -

(For the 127 established and likely contact allergens labelling of consumer products that contain them is recommended) More...

5. How is the general public exposed to fragrance allergens?

The general public is exposed to fragrance substances via their use in perfumes and perfumed consumer products such as cosmetics detergents, fabric softeners and other household products. In the latter product types, fragrances may be used to provide the consumer with a fresh smell or to mask unpleasant odours from raw materials. Fragrance substances are also used in aromatherapy and may be present in herbal products. Fragrances or ‘perfumes’ are complex mixtures which may contain up to several hundreds of different fragrance ingredients. Special databases list more than 2,500 fragrance ingredients that are used for perfuming consumer products. More...

6. What are the gaps in the current knowledge about perfume allergies?

Although science has progressed in recent years, gaps in knowledge remain regarding;

  • which specific fragrance substances cause allergies in humans,
  • to what extent susceptible population groups run a greater risk of developing allergies compared to the rest of the population,
  • what exposure levels can be considered to be safe for the general population and susceptible groups and
  • how consumers are using perfumed cosmetic products as well as how much and how often.

A better understanding of these aspects will improve the risk assessment of fragranced products containing fragrance allergens and allow better risk management of the products. More...

7. Conclusion : are the current European regulations on fragrance allergens adequate?

In 1999, a set of 26 fragrance allergens with a well-recognised potential to cause allergy had been ifentified, for which information should be provided to consumers about their presence in cosmetic products.

On this basis, the Cosmetics directive required that the presence any of these 26 substances be indicated in the list of ingredients when its concentration exceeds 0,001 % in leave-on products and 0,01 % in rinse-off products. These limits had been set in a pragmatic administrative decision in the absence of known thresholds for these allergens.

Such labelling allows patients who are allergic to one or more of these 26 fragrance chemicals to avoid products containing them.

The Scientific Committee on Consumer Safety now identified more than 100 additional individual substances and natural extracts as established contact allergens or likely contact allergens by combination of evidence. In its conclusions, the scientific committee recommends that the consumer be made aware of the presence of all known and likely fragrance allergens in cosmetic products and not only the 26 currently listed.

While a general safe exposure level that would apply to all individual fragrance allergens can still not be established, it is considered that a level of 0.01% of a fragrance allergen in a cosmetic product (refered to in the Cosmetics directive) could be tolerated by most consumers with contact allergy to the respective fragrance allergen. This maximum allowable level does not, however, preclude that the most sensitive segment of the population may develop a skin allergy upon exposure. Hence, having a maximum allowable product level does not remove the necessity for providing information to the consumer concerning the presence of the fragrance substance in cosmetics. More...


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