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Survey and safety assessment of Chemical substances in artificial nails and nail hardeners

5 Legislation

• 5.1 Demands on labelling of products
  • 5.1.1 Evaluation of labelling
• 5.2 Classification of ingredients
  • 5.2.1 Classification of formaldehyde
  • 5.2.2 Classification of acrylic compounds
  • 5.2.3 5.2.3 Classification of screened ingredients in products for manufacture of artificial nails

Artificial nails and nail hardeners are comprised by the Statutory Order on Cosmetic Products (BEK no 422 of 4/05/2006) (1). With respect to marketing of cosmetic products, the marketing responsible person in the EU is responsible for labelling of the products in accordance with the regulations for cosmetic products. The products must not contain ingredients which are not allowed in cosmetic products; the final cosmetic product should not cause a risk to the consumers by normal use or use that can be reasonably anticipated.

5.1 Demands on labelling of products

The products must be labelled as follows on box and packing.

• Name of company and address or head office of the company responsible for marketing the product.
• Weight/volume of the product
• Expiry date, if validity of the product unopened is less than 30 months.
• If the validity is more than 30 months, validity after opening with indication of symbol for open box is indicated.
• Safety declarations for correct use of the cosmetic product – including special considerations with respect to cosmetic products used professionally.
• The manufacturing number (batch number), possibly only on box.
• Function of the cosmetic product
• List of ingredients. The ingredients must be stated with INCI (International Nomenclature of Cosmetic Ingredients) name and listed by decreasing weight in the product.
• Scenting and aromatic compounds and their raw materials must be named “perfume” or “aroma”.

5.1.1 Evaluation of labelling

The purchased products have been reviewed for possible lack of labelling. Generally, the labelling showed many discrepancies, especially the acrylic artificial nail products. The following discrepancies were recurred on many of the purchased products.

-   Missing information of durability

-   Directions for use

-   The labelling is often in other languages than Danish (English, German, French)

-   Missing batch number

-   Wrong or no INCI list

The functioning of most of the products was unclear, and the list of ingredients did not comply with the rules in the Statutory Order on Cosmetic Products. In the labelling of the nail hardeners were observed fewer discrepancies than in that of artificial nails.

5.2 Classification of ingredients

The classification of ingredients in the purchased and analysed nail products has been investigated in accordance with the chemicals legislation and the demands stipulated in the cosmetics legislation. It is important to emphasize that this classification applies to products that are marketed in accordance with the chemicals legislation and not the cosmetics legislation. However, the classification may indicate if the products contain hazardous substances. Glues for fixing artificial nails belong under a so-called “borderline” area meaning that they are either classified as cosmetic products or as chemical products depending on the purpose, the application, and how the product is presented to the consumer. The Danish Environmental Protection Agency has assessed the glues for fixing the nail tips (see Chapter 3.3.1) to be chemicals. Therefore, they must be labelled in accordance with the chemical legislation.

5.2.1 Classification of formaldehyde

The content of formaldehyde in the nail hardeners is shown in the analyses of 6 different nail hardeners on the Danish market. The classification of formaldehyde is shown in table 5.1.

Table 5.1 Classification of formaldehyde in nail hardeners

In accordance with the Statutory Order on Cosmetic Products (1), the allowed content of formaldehyde in nail hardeners is up to 5% total formaldehyde. In addition, all final products containing formaldehyde or substances from which formaldehyde can be decomposed (see Chapter 3.4.2) can be labelled with the text “contains formaldehyde”, if the concentration of formaldehyde in the final product exceeds 0.05%. The analyses of the 6 nail hardeners products illustrate that none of the products exceeds this limit of 5%, whereas a product (product number 20) does not declare formaldehyde, even the concentration exceeds the limit of declaration of 0.005%.

If formaldehyde has been added as a preservative, the maximum permitted concentration is 0.2%.

5.2.2 Classification of acrylic compounds

Acrylic compounds are found in a selection of products for manufacture of artificial nails purchased on the Danish market. In order to find indications of the toxic effects of the substances, information on the classification of the acrylic compounds has been collected from the list of hazardous compounds. Furthermore, information on the regulation of the ingredients in cosmetic products was found.

Table 5.2 Classification of the analysed acrylates

^a Number of products containing the acrylic compound

As shown in table 5.2, 5 out of 6 of the analysed acrylic compounds are classified. The 5 substances have been classified for ´sensitisation by skin contact (R43). This classification must appear in the labelling of the product, if the products are labelled in accordance with the chemicals legislation, but not if the product is covered by the cosmetics legislation. However, all ingredients except perfume and aromatic substances must be included in the list of ingredients of cosmetic products.

5.2.3 Classification of screened ingredients in products for manufacture of artificial nails

Information of the classification of the identified ingredients has been searched. This information has been searched in the List of Hazardous Substances and in the consultative list for self classification of the Danish Environmental Protection Agency. The data collected from the consultative list are marked with ‘*’. Also, data on the permitted use of the ingredients in cosmetic products have been identified.

Table 5.3 Classification of the ingredients identified through GC-MS SCAN of 21 nail products. Data are collected from the consultative list of the Danish Environmental Protection Agency marked with ‘*’. Also, data on the permitted use of the ingredients in cosmetic products have been identified

^a Number of products with the GC-MS SCAN ingredient identification.

^* Data from guide for self classification

As it appears from table 5.3, many of the screened ingredients of the products for manufacture of artificial nails are classified in accordance with the chemicals legislation. Several substances are also regulated by the cosmetics legislation – for instance with respect to declaration. For instance, d-limonene is not declared on product no. 30, benzyl benzoate not on product no. 12

More of the substances are probably found in the products as impurities. With cosmetic products is distinguished between ingredients and impurities. Ingredients are actively added substances that must be declared on the packing. The substances to be added legally, and in which the concentrations are regulated in accordance with the Statutory Order on Cosmetic Products (1). Contrary to ingredients, impurities are not actively added. Impurities are present in low concentrations in the used raw materials, or they can be introduced during the industrial manufacturing of the product. Such impurities are not to be declared, however they should be avoided, and it is always the responsibility of the producer to ensure that the final product is not hazardous to human health.

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Version 1.0 July 2008, © Danish Environmental Protection Agency