Survey of Chemical Substances in Consumer Products, 53 – Survey of chemical substances in dandruff shampoo

Survey of chemical substances in dandruff shampoo

2 Legislation

2.1 Dandruff shampoo subject to regulations under the Statutory Order on cosmetic products
2.2 Labelling of dandruff shampoo
2.3 List of ingredients
2.4 Limitations on use of chemical substances in dandruff shampoo
2.5 Dandruff shampoo subject to regulation under the Statutory Order on labelling etc. of drugs

2.1 Dandruff shampoo subject to regulations under the Statutory Order on cosmetic products

Dandruff shampoos which are not declared as products for medical treatment are subject to regulation under the Statutory Order on cosmetic products – Statutory Order no. 489 of 12 June 2003, ^[2] which implements European provisions concerning cosmetics.

In Danish legislation, dandruff shampoo is categorised under "Hair-Care Preparations - hair-washing agents (lotion, dry shampoo, and shampoo)". ^[3].

The Statutory Order on cosmetic products lays down rules concerning product composition and use, in addition to containing a number of provisions pertaining to labelling.

According to section 9 of the Statutory Order on cosmetic products, cosmetic products marketed in the EU must not pose a harm to human health when used under normal conditions. The Statutory Order on cosmetic products stipulates a number of limitations on the use of chemical substances in cosmetic products.

The person or enterprise marketing a cosmetic product is responsible for complying with the regulations as they are stipulated in the Statutory Order.

2.2 Labelling of dandruff shampoo

Cosmetic products, including dandruff shampoo, must be labelled with the following information:

Company name and address of the manufacturer responsible for marketing the product within the EU (section 17).
Ingredients by weight or volume (if more than 5 g or more than 5 ml (section 18)).
Use-by date (if the durability is less than 30 months (section 19)).
Safety instructions for use (section 20).
Manufacture serial/batch number or reference, so that the time and place of manufacture can be identified (section 21).
Function (unless this is clear from the presentation of the product (section 22)).
List of ingredients; that is, a list of product ingredients in descending order of weight at the time the ingredients were added to the cosmetic product (section 23).

2.3 List of ingredients

The following special terms apply to the list of ingredients for cosmetic products (Statutory Order no. 594, section 23, 2000):

Impurities are not considered ingredients.
Fragrant (perfuming) and aromatic compounds must be referred to by the words "parfume" (or "parfum") or "aroma".
Ingredients present in concentrations of less than 1% can be listed in any order after those in concentrations of more than 1%.
As a main rule, colourants should be listed by their Colour Index Numbers in any order after the other ingredients.
Ingredients must be stated by common names in accordance with the common nomenclature for cosmetic ingredients (INCI name).

INCI is short for ”International Nomenclature of Cosmetic Ingredients", a common nomenclature for declaration of ingredients in cosmetic products within the EU. An INCI name can denote a single chemical substance or mixtures, extracts etc. The INCI list is indicative, which means it is not a list of approved ingredients in cosmetics, but a list indicative of the ingredients normally used in cosmetics. In the absence of an INCI name for the ingredient, the ingredient must be identified by its chemical name, and application for an INCI name must be made (Statutory Order no. 594, 2000).

2.4 Limitations on use of chemical substances in dandruff shampoo

As described above, the Statutory Order on cosmetic products sets up a number of limitations on the use of chemical substances in cosmetic products, including limitations as to which substances are allowed in cosmetic products, which substances are allowed only under certain conditions (e.g. allowed max. concentration), and which of the substances within certain groups are allowed in cosmetic products (positive lists concerning e.g. colourants and preservatives).

Substances not allowed in dandruff shampoo

According to section 10 of the Statutory Order on cosmetic products, substances that are listed in Annex 2 of the Statutory Order are not permitted as ingredients in cosmetic products.

Colourants allowed in dandruff shampoo

According to section 12 of the Statutory Order on cosmetic products (with the exception of cosmetic products containing colourants intended solely for colouring hair), cosmetic products may only contain colourants as well as lakes, salts and pigments thereof, which are included in the lists in Annexes 3 and 4 of the Statutory Order, and in accordance with the limitations and terms set out in said Annexes.

Preservatives allowed in dandruff shampoo

According to section 13 of the Statutory Order on cosmetic products, cosmetic products must not contain preservatives other than those listed in Annex 5 of the Statutory Order.

2.5 Dandruff shampoo subject to regulation under the Statutory Order on labelling etc. of drugs

As this project exclusively reviews and assesses the ingredients of dandruff shampoo, clarification of legislation pertaining to medical dandruff shampoo will only concentrate on regulation and declaration requirements pertaining to these. Therefore, the following does not include an assessment of the pharmacological properties of the products, nor of their clinical information, requirements for handling etc.

The review of relevant legislation will concentrate on the Statutory Order on labelling etc. of drugs (Statutory Order no. 7 of 8 January 2002). According to sections 16-17, labelling must include a quantitative declaration of the active substance, on the inner as well as the outer packaging of the product. In the case of dandruff shampoo, this means that labelling must contain a description in terms of quantity of the agent added to the product in order to treat dandruff. This description must be visible on the container as well as on any packaging.

Sections 33-34 moreover prescribe that ancillary substances are declared qualitatively on an enclosed information leaflet (section 34(2)). If one or more of the ancillary substances are included in Annex 1 of the Statutory Order on labelling etc. of drugs, these must in addition bear a quantitative declaration (section 34(3)).

Other relevant legislation on regulation of medical dandruff shampoo include Lov om lægemidler (the Danish Medicines Act), cf. Consolidated Act no. 656 of 28 July 1995, the Act to ammend the Medicines Act (Act no. 297 of 15 May 2002), and bekendtgørelse om bivirkningsovervågning af lægemidler (the Statutory Order on adverse effects of medicinal products; Statutory Order no. 567 of 28 June 2002).

Footnotes

[2] Statutory Order no. 489 replaces Statutory Order no. 594, in force at the time of procurement of products for this project. In january 2005 statutory order no. 489 was repalced by no. 74 of 14. of January 2005

[3] Annex 1 of the Statutory Order on cosmetic products, item 10) d).