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Survey and health risk assessment of products for treatment of sports injuries and pains
4 Legislation
4.1 Introduction
Due to the way these sport products are used there might be some doubts regarding which regulations are covering the sport products. 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 sport products 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) does not regulate sports products, although the exposure route seems a like. Sports products are not covered by the definition of cosmetic products, which states:
§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.
A number of perfume substances have to be declared on for products which are not meant to be cleaned off the skin. Substances in sports products are assumed not to be cleaned off the skin.
The 26 perfume substances analysed here must be declared on stay-on cosmetic products, if the content is more than 0.001% (10 mg/kg). 9 of the 12 analysed products contains more than 0.001% of one or more of the 26 perfume substances but since the sport products as described above are not covered by these declaration demand, the users of the products do not have access to this information about the content of the allergic perfume substances.
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 12 samples is shown below. For substances included in the EU-list on allergic fragrances (SCCNFP, 1999) are stated “potential sensitizer” and the substance and its effect are stated in the classification for the product. Substances included on the Danish advisory list for self-classification (Vejledende liste) are marked with an *.
Table 4.1 Classification for sports product number 1
| Sample number: 1 |
| Substance |
Amount (w%) |
Classification |
| Methyl salicylate |
5.10 |
- |
| 2-phenoxyethanol |
0.04 |
Xn;R22 Xi;R36 |
| Product classification |
None |
Table 4.2 Classification for sports product number 2
| Sample number: 2 |
| Substance |
Amount (w%) |
Classification |
| Benzaldehyde |
0.42 |
Xn;R 22 |
| α-Pinene |
1.2 |
N;R50/53* |
| d-Limonene |
1.9 |
R10 Xi;R38 R43 N;R50/53 |
| Linalool |
0.19 |
Potential R43 |
| Camphor |
7.7 |
None |
| Methyl salicylate |
0.53 |
None |
| Cinnamal |
10.00 |
R43 * |
| Eugenol |
2.7 |
Xn;R22 Mut3;R68 R43* |
| Isoeugenol |
0.16 |
Xn;R22 R43* |
| Product classification |
Xi R43 |
The product contains substances which may be hazardous to the environment. This aspect is not covered by the project.
Table 4.3 Classification for sports product number 3
| Sample number: 3 |
| Substance |
Amount (w%) |
Classification |
| α-Pinene |
0.06 |
N;R50/53* |
| d-Limonene |
0.04 |
R10 Xi;R38 R43 N;R50/53 |
| Camphor |
0.51 |
None |
| 2-Phenoxyethanol |
0.90 |
Xn;R22 Xi;R36 |
| Product classification |
None |
The product contains substances which may be hazardous to the environment. This aspect is not covered by the project.
Table 4.4 Classification for sports product number 4
| Sample number: 4 |
| Substance |
Amount (w%) |
Classification |
| Ethanol |
52.00 |
F;R11 |
| α-Pinene |
0.17 |
N;R50/53* |
| Camphene |
0.03 |
N;R50/53* |
| d-Limonene |
0.15 |
R10 Xi;R38 R43 N;R50/53 |
| Linalool |
0.10 |
Potential R43 |
| Camphor |
0.10 |
None |
| Product classification |
None |
| To be labelled for allergens |
Contains d-limonene. May cause allergic reactions. |
The product contains substances which may be hazardous to the environment. This aspect is not covered by the project.
The flashpoint of product number 4 was measured to below 45°C meaning that the product should be labelled with R10 (21-55°C) or R11 (flashpoint<21°C). However, a product having a flash point equal to or greater than 21° C and less than or equal to 55° C need not be classified as flammable if the product could not in any way support combustion and only so long as there is no reason to fear risks to those handling these products or to other persons. Due to this it is assessed that product 4 do not have to labelled for flammability.
Table 4.5 Classification for sports product number 5
| Sample number: 5 |
| Substance |
Amount (w%) |
Classification |
| Ethanol |
2.20 |
F;R11 |
| 2-Phenoxyethanol |
0.49 |
Xn;R22 Xi;R36 |
| Product classification |
None |
Table 4.6 Classification for sports product number 8
| Sample number: 8 |
| Substance |
Amount (w%) |
Classification |
| α-Pinene |
2.70 |
N;R50/53* |
| d-Limonene |
0.10 |
R10 Xi;R38 R43 N;R50/53 |
| Linalool |
0.01 |
Potential R43 |
| Methyl salicylate |
5.00 |
None |
| 2-Phenoxyethanol |
0.07 |
Xn;R22 Xi;R36 |
| Product classification |
None |
| To be labelled for allergens |
Contains d-limonene. May cause allergic reactions. |
The product contains substances which may be hazardous to the environment. This aspect is not covered by the project.
Table 4.7 Classification for sports product number 12
| Sample number: 12 |
| Substance |
Amount (w%) |
Classification |
| 2-propanol |
27.00 |
F; R11 Xi; R36 R67 |
| Camphor |
0.25 |
None |
| Product classification |
Xi; R36 R67 |
As shown in Table 4.7 product number 12 should be labelled irritant.
The flashpoint of product 12 was measured to be between 45-50°C. This means that the product should be labelled with R10. However, a product having a flash point equal to or greater than 21° C and less than or equal to 55° C need not be classified as flammable if the product could not in any way support combustion and only so long as there is no reason to fear risks to those handling these products or to other persons. Due to this it is assessed that product 12 do not have to labelled with R10.
Table 4.8 Classification for sports product number 13
| Sample number: 13 |
| Substance |
Amount (w%) |
Classification |
| Dimethyl sulphone |
0.82 |
None |
| 2-Phenoxyethanol |
0.04 |
Xn;R22 Xi;R36 |
| Product classification |
None |
Table 4.9 Classification for sports product number 15
| Sample number: 15 |
| Substance |
Amount (w%) |
Classification |
| α-Pinene |
1.90 |
N;R50/53* |
| d-Limonene |
0.02 |
R10 Xi;R38 R43 N;R50/53 |
| Methyl salicylate |
4.500 |
None |
| Product classification |
None |
The product contains substances which may be hazardous to the environment. This aspect is not covered by the project.
Table 4.10 Classification for sports product number C
| Sample number: C |
| Substance |
Amount (w%) |
Classification |
| Acetone |
1.90 |
F; R11 Xi; R36 R66 R67 |
| t-Butyl alcohol |
0.35 |
F; R11 Xn; R20 |
| Ethanol |
14.00 |
F; R11 |
| Product classification |
None |
The flashpoint of product C was measured to be between 45-50°C. This means that the product should be labelled with R10. However, a product having a flash point equal to or greater than 21° C and less than or equal to 55° C need not be classified as flammable if the product could not in any way support combustion and only so long as there is no reason to fear risks to those handling these products or to other persons. Due to this it is assessed that product C do not have to labelled with R10.
Table 4.11 Classification for sports product number E
| Sample number: E |
| Substance |
Amount (w%) |
Classification |
| α-Pinene |
3.30 |
N;R50/53* |
| d-Limonene |
0.23 |
R10 Xi;R38 R43 N;R50/53 |
| Linalool |
0.17 |
Potential R43 |
| Methyl salicylate |
6.70 |
None |
| Product classification |
None |
| To be labelled for allergens |
Contains d-limonene. May cause allergic reactions. |
The product contains substances which may be hazardous to the environment. This aspect is not covered by the project.
Table 4.12 Classification for sports product number H
| Sample number: 2 |
| Substance |
Amount (w%) |
Classification |
| α-Pinene |
2.20 |
N;R50/53* |
| d-Limonene |
0.09 |
R10 Xi;R38 R43 N;R50/53 |
| Linalool |
0.18 |
Potential R43 |
| Methyl salicylate |
7.60 |
None |
| Product classification |
None |
The product contains substances which may be hazardous to the environment. This aspect is not covered by the project.
According to the Statutory Order on classification of chemicals the above tables show that products nos. 2 and 12 should have been labelled. The products no. 4, 8 and E have to be labelled for allergens and with warning of allergic reactions.
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Version 1.0 Decmeber 2006, © Danish Environmental Protection Agency
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