Cosmetics >> Regulatory affairs >> Monitoring of regulations

Monitoring of regulations

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Chemical and physical analysis

According to Directive 76/768/EEC, respectively regulation (EC) No. 1223/2009, a cosmetic product that is put on the market within the Community must not cause damage to human health when applied under normal or reasonably foreseeable conditions of use. The directive also protects for misguidance. A number of substances are banned and elements of labelling (e.g. INCI-declaration of the ingredients) are regulated. Furthermore, it imposes the duty of notification and reporting on manufacturers and requires them to hold certain documents e.g. safety assessments that are at the ready for authorities. In order to prevent damage and public condemnation, effective quality control of cosmetic products is essential for commercial success.

In addition, the cosmetics directive 76/768/EEC limits the total content of furocoumarines to less than 1 mg/kg when using natural essential oils in sun protection and bronzing products.

However, the SCCS' (Scientific Committee on Consumer Safety) statement dated from December 12, 2005 recommended the extension to all cosmetic products, as human skin is exposed to sunlight not only after the application of sunscreen. Implementation under European law is expected.

Microbiology

Council Directive 76/768/EEC respectively regulation (EC) No. 1223/2009 stipulates that "cosmetic products put on the market within the Community must not cause damage to human health when applied under normal or foreseeable conditions of us." By virtue of this disposition cosmetic products must be harmless for consumers. In order to prevent any damages or risk manufacturers are obliged to guarantee their product's safety in order to meet the regulatory requirements. The analysis of the microbiological status is the first step in the assessment of safety for both cosmetic products and their raw materials.

Safety

Council Directive 76/768/EEC respectively regulation (EC) No. 1223/2009 stipulates that "cosmetic products put on the market within the Community must not cause damage to human health when applied under normal or foreseeable conditions of use." Therefore, the manufacturer is obliged to check his product's safety in order to meet the regulatory requirements.

Efficacy

The Directive 93/95/EEC mentions in article 7 that, the manufacturer, or his agent, or the person to whose order a cosmetic product is manufactured or the person responsible for placing an imported product on the Community Market shall for control purposes keep the following information ready accessible to the competent authorities of the Member State concerned at the address specified on the label in accordance with article 6 §1.a: proof of the effect claimed for the cosmetic product, where justified by the nature of the effect or product." Therefore, efficacy testing is essential in order to confirm the efficiency of a certain cosmetic product before launching it on the market.

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