As evidenced by the efforts of the relevant authorities, the cosmetics sector, packaging makers, and industry groups, people are becoming increasingly demanding when purchasing new goods.

When it comes to the safety of cosmetic packaging, we must consider existing regulation, and in this regard, Regulation 1223/2009 on cosmetic goods exists inside the European framework. The Cosmetic Product Safety Report must include details on impurities, traces, and information about the packaging material, including the purity of substances and mixtures, evidence of their technical unavoidability in the case of traces of prohibited substances, and relevant packaging material characteristics, such as purity and stability, according to Annex I of the Regulation.

Packaging safety regulations

Decision 2013/674/EU, for example, sets recommendations to make it simpler for businesses to comply with the requirements of Annex I of Regulation (EC) No. 1223/2009. This Decision outlines the data that should be gathered on the packaging material as well as the possibility of chemicals migrating from the container to the cosmetic product. 

Cosmetics Europe issued a non-binding document in June 2019 with the goal of assisting and facilitating the evaluation of packaging’s influence on product safety when the cosmetic product is in direct contact with the packaging.

Primary packaging is that which comes into direct touch with the cosmetic product. In terms of cosmetic product safety, the properties of the materials in close touch with the product are crucial. Any potential dangers should be able to be estimated using information on the properties of these packing materials. The composition of the packaging material, including technical compounds such as additives, technically unavoidable impurities, and substance migration from the packaging, are all relevant features.

Because one of the industry’s most generally recognized techniques is based on checking compliance with food contact laws, one of the most extensively developed and approved methodologies is based on confirming compliance with food contact legislation.

Plastics, adhesives, metals, alloys, paper, cardboard, printing inks, varnishes, rubber, silicones, glass, and ceramics are among the materials used in cosmetic product packaging. These materials and publications are governed by Regulation 1935/2004, often known as the Framework Regulation, which governs the regulatory framework for food contact. These materials and items should also be produced in line with good manufacturing practice (GMP), with quality assurance, quality control, and documentation procedures in place.  Regulation 2023/2006 explains this need (5). The Framework Regulation also allows for the establishment of particular measures for each type of material in order to verify that the basic principles are followed. Plastic, as defined by Regulation 10/2011(6) and later revisions, is the material for which the most detailed measures have been developed.

Regulation 10/2011 specifies the standards for raw materials and final goods to be met. Appendix IV lists the information that must be included in the Declaration of Compliance (this annex is supplemented by the Union Guidance on information in the supply chain). The Union Guidance seeks to offer important information on the transmission of information in the supply chain necessary to comply with Regulation 10/2011).

In terms of laboratory analysis, the following laboratory measures must be conducted to ensure compliance with the particular migration limitations set forth in Regulation 10/2011: 

1. Based on Annex IV of Regulation 10/2011, the package maker must have a Declaration of Compliance (DoC) for every plastic raw materials used. This supporting document allows users to determine if a material is formed for food contact, that is, if all of the ingredients used in the formulation are mentioned in Annex I and II of Regulation 10/2011 and later amendments (unless for justified exceptions).

2. Conducting comprehensive migration tests in order to confirm a material’s inertness (if applicable). The entire quantity of non-volatile chemicals that can migrate into food is assessed in overall migration, which does not identify the individual substances. Overall migration tests are performed in line with the UNE EN-1186 standard. The number of tests with the simulant and the type of contact varies (e.g. immersion, one-sided contact, filling). The total migration limit is ten milligrams per square meter of contact surface area. The limit is 60 mg/kg of food simulant for plastic materials in contact with food for breast-feeding babies and young children.

​​3. If required, conducting quantitative tests on residual content and/or particular migration with the goal of ensuring that each substance is within the legal limitations set forth in the legislation.

Specific migration tests, as well as internal testing techniques established in laboratories for chromatographic analysis, are performed in line with the UNE-CEN/TS 13130 standard series. Following a review of the DoC, a judgment is made as to whether this type of testing is required. Only a few of the allowed chemicals have limits and/or requirements. The ones that have specifications must be specified in the DoC so that compliance with the relevant limitations in the material or end product may be verified.

Simulants: Test simulants are chosen based on the foods/cosmetics that may come into contact with the substance, as specified in Annex III of Regulation 10/2011.

It is important to consider the simulants to be used while conducting migration testing on cosmetic product packaging. Cosmetics are generally pH neutral or slightly acidic water/oil mixes that are chemically inert. The physical and chemical characteristics of most cosmetic formulations that are significant for migration correspond to the qualities of the foodstuffs listed above. As a result, a strategy similar to that used with foodstuffs can be used. However, the simulants listed cannot represent some alkaline preparations, such as haircare products.

Conditions of exposure: 

The time and temperature of interaction between the packaging and the foodstuff/cosmetic from packing to expiry date should be considered when choosing exposure settings. This guarantees that test circumstances reflect the worst-case scenarios that may occur in actual use. The overall and specific migration conditions are chosen independently. They are sometimes the same, although they are specified differently in different chapters of Regulation 10/2011.

Compliance with packaging regulations must be specified in the relevant DoC, which must contain information on the uses for which it is safe to bring the material or item into contact with foodstuffs/cosmetics (after verification of any applicable limitations) (e.g. types of food, time and temperature of use). The cosmetic product safety specialist then assesses the DoC.

Plastic packaging designed for cosmetic goods is not required to comply with Regulation 10/2011, but the most practical solution is probably to use the same approach as with foodstuffs and presume that the raw materials must be appropriate for food contact during the package design process. It will be able to ensure the safety of packaged products only when all agents in the supply chain are participating in accordance with regulatory standards.