EC regulation 1223/2009 and the role of cosmetics packaging

In 2009 the regulation of EU 1223 which specifies the new regulations concerning the distribution of cosmetics in the European market was issued, to ensure the protection of consumers' health. The materials of the packaging are refereed in the annex I, where the general requirements of the safety study that should accompany the cosmetic products are mentioned. Concrete information should be included in the report concerning the material of the packaging, the purity of the raw materials used and the stability of the packaging during the whole lifetime of the product.

This general reference to the packaging materials of the cosmetics is specified in the executive decision 2013/674/EU where the main definition of the cosmetics' packaging as well as some useful tools of reference are given:
Packaging material means the container (or primary packaging) that is in direct contact with the formulation. The relevant characteristics of packaging materials in direct contact with the final product are important for the safety of the cosmetic product.
The combination of packaging material, formulation of the cosmetic product and contact with the external environment may have an impact on the safety of the finished product, due to the following factors:

a interaction between the product and the packaging material;
b barrier properties of the packaging material;
c substance migration from/to the packaging material.

The information on relevant characteristics of the packaging materials in direct contact with the product should allow an estimation of potential risks. Relevant characteristics could include, for example, the following:

a composition of the packaging material, including technical substances such as additives;
b technically unavoidable impurities;
c possible migration from the packaging.

Special reference is done to the traces – impurities of raw materials used for the packaging materials. The meaning of purity of the materials used is highlighted; however no specific restrictions are adopted, or positive reports listed.
The Scientific Committee for Consumers Safety (SCCS), has recommended that 'relevant stability tests, adapted to the type of cosmetic product and its intended use, should be carried out. To make sure that no stability problems are induced by the type of container and packaging used, physical stability tests are currently carried out with inert containers and those intended to be used on the market If migration is dependent on storage conditions, the correct conditions should be indicated on the product labelling. If the formulation is sensitive to light or air, and would degrade in a way that impacts product safety or product efficacy, appropriate packaging should be used.

A Committee of the European organization Cosmetics Europe tried to particularize the requirements of the new legislations concerning the packaging materials of the cosmetics by editing a document with guidelines entitled: safety evaluation of packaging under the cosmetics regulation 1223/2009, guidance on information exchange along the value chain. This document was studied and its main points are the following:

- During the evaluation of the usage safety of a cosmetic packaging the transfer of substances from the packaging to the packaged product is evaluated. The primal packaging does not ensure an effective barrier to potential migration and integration of substances, traces, casual contaminations. All the materials of the packaging (primary and secondary) that can be integrated to the cosmetics must be recognized and identified.

- The materials of cosmetic packaging must be certified for usage for direct contact with food. If this is not possible the manufacturer of the materials must prepare a special file with the necessary information about the safe usage of the packaging materials.

- The file must contain enough information about the substances that have been banned or placed under restrictions: annexes II and III of the legislation 1223/2007, CMR substances (categories 1A, 1B, 2), compounds signalized for the sensitization of the skin and finally compounds that have a special limit of migration according to the existing European directives.

- Specially for the substances that have been classified as CMR of category 1A, 1B, 2 (carcinogenic, mutagenic or toxic to reproduction) the manufacturer of the packaging material must declare that the content of the packaging does not exceed the limit of 1 ppm or must provide enough data proving that the maximum migration to the cosmetic will be less than the limit of 10 ppb.

- Concerning the substances included in the annexes II and III of the legislation 1223/2007 the respective limits are 10 ppm and 100 ppb respectively. For the substances that have been identified as sensitizers of the skin of class 1, 1A, 1B, 2 per CLP the limits are the following: maximum content 0.1% for the substances 1, 1B, 2 and 0.01% for the substances 1A or calculation of the maximum authorized migration by 100 ppb.

- In the cases that the packaging material contains non evaluated substances (i.e. with special limit of migration) according to the applicable legislation of EU (non EU food contact authorized substances) and they are not subject to the restrictions mentioned in the above paragraphs, the approach TTC (Threshold of toxicological concern) and the classification according to the categories Crammer I, II, III can be applied.

- In the cosmetics packaging materials we cannot apply the axiomatic definitions applied to the food packaging: the consumer is nourished on a daily basis with an average of 1 kilo of nutrition for which is used packaging of surface 6 dm². For the cosmetics the following principles are valid: the consumer is using on a daily basis an average of 17,4 gr of cosmetics for which is used 4.9 dm² of packaging surface. In special cases the packaging surface can be accurately calculated according to the exact dimensions of the container. By studying the directives of the document which is under discussion, we notice the non distinct definition of the methods and simulators of the migration trials. Indicatively we report that for the hair dye (product with pH) there is no suggestion of an appropriate test method.

We are waiting with extreme interest the improved modifications of the existing directive that will follow as well as the new legislative regulations concerning the cosmetics' packaging. We believe that with the right equipment and the complete report lists the evaluation of the cosmetic packaging will become safer and quicker without the obstruction of induction of new innovating materials in the market.

For any further information you can contact the association's secretariat via its site .

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