# Commission Implementing Decision of 25 November 2013 on Guidelines on Annex I to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products (Text with EEA relevance) (2013/674/EU), Division 3.4.3: The relevant characteristics of packaging material

Extent: E+W+S+N.I.

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. Reference to Regulation (EC) No 1935/2004 of the European Parliament and of the Council could be useful.
Experience with similar formulation/packaging combinations already on the market provides useful indications. Materials that have been developed for food packaging have often already been tested, so relevant information on stability and migration may be available. Additional testing may not be required. However, more evaluation may be needed for new or novel packaging.
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.
This information only indicates the hazard. It is up to the safety assessor to evaluate the risk.
Studies on interactions/suitability between formulation and packaging allow testing of the potential migration of small amounts of substances from the primary packaging material to the product. These tests are performed under specific and relevant test conditions. There are, however, no standard procedures for cosmetic products. An appropriate assessment may be made based on knowledge of the formulation and primary packaging materials and experienced expert judgment.
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.

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Source: https://www.legislation.gov.uk/eudn/2013/674/annex/division/3/division/3.4/division/3.4.3 (the official version)
Page: https://openlegislation.uk/eu-decision-2013-674/annex/division-3/division-3.4/division-3.4.3
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.