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Survey and health assesment of chemicals substances in pleasure gel

4 Legislation

• 4.1 Introduction
• 4.2 Classification of products
• 4.3 Requirement from the Statutory Order on cosmetics

4.1 Introduction

The regulations governing special products such as pleasure gels etc. are not always obvious. The products are regulated by the law on chemical substances and products (LBK nr. 21 af 16/01/1996 om kemiske stoffer og produkter). Due this the pleasure gels are also regulated by the general Statutory Order on classification and labelling of chemical substances and products (Klassificering, 2005). Some of the substances in the products are required to have a warning label and therefore, all the products are assessed with respect also to classification and labelling.

The Statutory Order on cosmetics (Cosmetics, 2006), however, does not regulate pleasure gels, although the exposure route seems a like, §2^[4]. Section 4.3 describes the requirements to labelling of ingredients, restrictions, etc. if the products were regulated by the Statutory Order on cosmetics.

4.2 Classification of products

In the assessment of which products should be classified only substances detected in more than 0.01 percent (100 mg/kg) have been considered.

A table for each of the 22 samples is shown below. For substances included in the EU-list on allergic fragrances (SCCNFP, 1999) is stated “potential R43” and the substance and its effect are included in the classification for the product. Substances included on the Danish advisory list for classification (Vejledende liste ) are marked with an *.

Table 4.1 Classification for Pleasure-gel number 1

Table 4.2 Classification for pleasure-gel number 2

In sample no. 3, no problematic substances have been detected in amounts exceeding 100 mg/kg.

Table 4.3 Classification for pleasure-gel number 4

Table 4.4 Classification for pleasure-gel number 6

Table 4.5 Classification for pleasure-gel number 7

Table 4.6 Classification for pleasure-gel number 8

In sample no. 9, no problematic substances have been detected in amounts exceeding 100 mg/kg.

Table 4.7 Classification for pleasure-gel number 11

Table 4.8 Classification for pleasure-gel number 12

Table 4.9 Classification for pleasure-gel number 13

In samples 15, 18, 21, and 22, no problematic substances have been detected in amounts exceeding 100 mg/kg.

Table 4.10 Classification for pleasure-gel number 23

Table 4.11 Classification for pleasure-gel number 24

In or sample no. 25 no problematic substances have been detected in amounts exceeding 100 mg/kg.

Table 4.12 Classification for pleasure-gel number 27

Table 4.13 Classification for pleasure-gel number 29

Table 4.14 Classification for pleasure-gel number 30

Table 4.15 Classification for pleasure-gel number 32

Conclusion

As it can be seen from tables above more products contains substances which by the scientific committee are evaluated as sensitizing, and 5 product contains one or more of these substances in concentrations above 0.1 %. 6 should be classified because of the relative high content of cinnamal and eugenol.

For substances that are not included at ”the list of dangerous substances” it is required that the producers of products must perform an evaluation and selfclassification of the substances. If this evaluation shows that the substance is sensitizing (allergy-causing) the products containing this must be labelled according to the concentration of the substance in the product. If the product contains 0.1-1 % of the sensitizing substance the product must be labelled with the sentence "Contains (substance). Allergic reaction can arise". If the product contains mire the 1 % of the substance the product has to be classified.

4.3 Requirement from the Statutory Order on cosmetics

The Statutory Order on cosmetics (Cosmetics, 2006), does not regulate pleasure gels, although the exposure route seems a like. Here it is described which requirements to labelling of content of perfume; the products were regulated by if covered by the Statutory Order on cosmetics.

The basic requirements in the Statutory Order on cosmetics are:

• some substances are prohibited; none of the these which were analysis were identified in the qualitative analysis
• some substances can be used in limited quantities; a few substances of this category have been identified
• some substances like perfume and flavours must be declared by name on the package if the content exceeds the limit value. If the content is below the limit value it shall only be specified that the product contains perfume or flavour.

A number of perfume substances have to be declared on the package if the content is more than 0.001% (10 mg/kg) for products which are not meant to be cleaned off the skin again (“Leave on products”). Substances in pleasure-gels are assumed not to be cleaned off the skin.

In the following all the products are assessed with respect to content of substances that has to be declared. Only substances determined at higher amounts than 0.001% (10 mg/kg) are considered.

Sample no. 1

None of substances have to be declared with respect to appendix 3 in the Statutory Order on cosmetics.

Sample no. 2

Linalool                 0.14 w% has to be declared

The product declaration did not include the required substance.

Sample no. 3

None of the substances have to be declared according to appendix 3 in the Statutory Order on cosmetics.

Sample no. 4

Benzyl alcohol               0.004 w% has to be declared

Cinnamal                      0.620 w% has to be declared

Cinnalmyl alcohol        0.001 w% has to be declared

D-Limonene         0.005 w% has to be declared

Eugenol                 0.050 w% has to be declared

Linalool                 0.020 w% has to be declared

The product declaration did not include the required substances.

Sample no. 6

Benzyl alcohol               0.014 w% has to be declared

Cinnamal                      1.700 w% has to be declared

D-Limonene         0.040 w% has to be declared

Eugenol                 1.800 w% has to be declared

Isoeugenol             0.050 w% has to be declared

Linalool                        0.120 w% has to be declared

The product declaration did not include the required substances.

Sample no. 7

Citral                     0.004 w% has to be declared

Cinamal                0.027 w% has to be declared

Citronellol             0.018 w% has to be declared

D-Limonene         0.002 w% has to be declared

Eugenol                 1.800 w% has to be declared

Isoeugenol             0.002 w% has to be declared

With respect to the declaration on the product the name Eugenia was included. This may be the same as Eugenol. The other substances were not mentioned.

Sample no. 8, 9, 11, 12, and 13

None of substances have to be declared according to appendix 3 in the Statutory Order on cosmetics.

Sample no. 15

Coumarin                      0.004 w% has to be declared

Linalool                 0.004 w% has to be declared

The product declaration did not include the required substances.

Sample no. 18, 21, 22, and 23

None of substances have to be declared according to appendix 3 in the Statutory Order on cosmetics.

Sample no. 24

The content of 2-phenoxyethanol is 10% and the maximal allowed concentration in cosmetics is 1%

Sample no. 25

None of substances have to be declared according to appendix 3 in the Statutory Order on cosmetics.

Sample no. 27

Benzyl alcohol               0.002 w% has to be declared

Citronellol             0.034 w% has to be declared

Coumarin                      0.019 w% has to be declared

D-limonene           0.015 w% has to be declared

Eugenol                 0.083 w% has to be declared

Linalool                 0.130 w% has to be declared

The declaration included all required substances according to appendix 3 in the Statutory Order of cosmetics.

Sample no. 29

D-limonene           0.005 w% has to be declared

Linalool                 0.010 w% has to be declared

The declaration included all required substances according to appendix 3 in the Statutory Order of cosmetics. The product declaration included also substances present in amounts less than 1 mg/kg; for instance Citronellol.

Sample no. 30

D-Limonene         0.022 w% has to be declared

Linalool                 0.140 w% has to be declared

The declaration included all required substances according to appendix 3 in the Statutory Order of cosmetics. The product declaration included also substances present in amounts less than 1 mg/kg; for instance Citronello and Coumarin.

Sample no. 32

Benzyl alcohol               0.002 w% has to be declared

Citronello                      0.021 w% has to be declared

Coumarin                      0.046 w% has to be declared

D-Limonene         0.002 w% has to be declared

Linalool                 0.034 w% has to be declared

The product declaration did not include the required substances.

Conclusion

For 8 of the 22 products the declaration did not meet the requirements in the Statutory Order on cosmetics.

In one product a content of 10 times the allowed amount of the preservative

2-ethoxyethanol was detected.

Footnotes

^[4] §2 The statutory order is not applicable for products which have to be applied to humans or animals to prevent, realise, ease, treat or cure sickness, sickness symptoms or pain or to affect the functions of the body. §3 Cosmetic products means any substance or preparation intended for placing in contact with the various external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with the view exclusively or principally to cleaning them, perfuming them or protecting them in order to keep them in good condition, change their appearance or correct body odours. Statutory Order on cosmetic products No.422  of 4 May, 2006. Ministry of the Environment, Denmark.

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Version 1.0 September 2006, © Danish Environmental Protection Agency