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Allergenic substances

Requirements of the 7th amendment 

Directive 2003-15-EC of 27 February 2003

The European Parliament and the Council of the European Union have considered that certain substances have been identified as an important cause of contact-allergy reactions in fragrance-sensitive consumers. In order to ensure that such consumers are adequately informed, it is therefore necessary to amend the provisions of Directive 76-768-EEC to require that the presence of these substances be mentioned in the list of ingredients. This information will improve the diagnosis of contact allergies among such consumers and will enable them to avoid the use of cosmetic products which they do not tolerate.

List of Allergenic substances possibly present in botanical species

Out of the 26 allergenic substances added to Annex III, Part I, of the Directive 76-768-EEC by the 7th amendment, only 16 can be found in plants and, therefore, concern botanical ingredients.

Among the 10 others:

  • 8 are synthetic,
  • 2 are botanic species themselves.

Summarized Results of the UNITIS studies

Following its philosophy OPTIMUM versus MAXIMUM, UNITIS applied to allergenic substances (concerned by the 7th amendment) a progressive determination of the realities through several steps:

  • Possible presence of allergens in botanicals,
  • Professional experience,
  • Scientific knowledge,
  • Internal or external dosages.

A special Task Force of UNITIS first studied 315 plants/parts of plants from which a practical tool was put at its members' disposal.

A scheme summarizes results as follows:


Addendum - June 2005
The UNITIS ad hoc Task Force is constantly working on the determination of allergenic substances of new plants so that an addendum to the initial list of 300 plants/parts of plants has been drawn.

Enquire at your suppliers to know more… Information is in their hands.

POSITION PAPER N° 2 - February 2004
For more than 300 plants, UNITIS Members have all elements on hand to assist the cosmetic industry in complying with its legal obligations.

POSITION PAPER N° 1 - June 2003
Considering the complexity of the problem raised by the 7th amendment of the European Cosmetic Directive about Allergenic Substances, UNITIS decided to implement an ad hoc working group to work on it.
UNITIS made public its decision through a first position paper published in June 2003.

Last update : 19/07/24

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