Packaging material means the container (or primary packaging) that is in direct contact with the formulation.
Within the Regulation (EC) 1223/2009, article 10 says: ” In order to demonstrate that a cosmetic product complies with Article 3, the responsible person shall, prior to placing a cosmetic product on the market, ensure that the cosmetic product has undergone a safety assessment on the basis of the relevant information and that a cosmetic product safety report is set up in accordance with Annex I. ”
In Annex I, section 4, requires reporting “Impurities, traces, information on packaging material” within the safety assessment.
Requests for information on packaging is more detailed in the Commission Implementing Decision 2013/674/EU, where it is indicated that the relevant characteristics of the packaging material in direct contact with the final product are important for the safety of the product and that the reference to Regulation (EC) 1935/2004 may be useful.
Therefore, packaging of cosmetic product must be safe for consumer like the product itself.
Effects of packaging on product safety
The combination of packaging material, cosmetic product formulation and contact with the environment
external effects could affect 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) migration of the substance from / to the packaging material.
Therefore, when evaluating the packaging, the evaluator must take into account the possible interactions between the components of the packaging and the finished product, the effectiveness of the packaging to isolate the product from the external environment (this also affects the duration of the product after opening) and the substances that can migrate from the packaging to the product and therefore come into contact with the final consumer.
What information is needed for packaging evaluation
As there is no specific regulation for cosmetic packaging, the European Commission recommends referring to Reg. 1935/2004 regarding materials and objects intended to come into contact with food.
This indication is taken up by Cosmetic Europe within its guidelines, where it suggests the approach to be adopted in the evaluation of packaging whether it follows the food regulation or not.
Packaging in compliance with food regulation
in the majority of cases, if the packaging is safe for a specific type of food, it should also be suitable for cosmetics that have similar physical chemical properties as this food.
If compliance has been based on migration into food/food simulants, the cosmetics assessor needs to decide whether the food/simulants and test conditions/assumptions are applicable to the cosmetics formulation.
Obviously, the evaluator will also have to take into account Annexes II and III of the cosmetic regulation (prohibited and restricted substances).
Packaging not in compliance with food regulation
A Cosmetic packaging material might not be food contact compliant because of the presence of a substance that is not authorised for food contact materials or used outside of restrictions set for such use. Non-compliance could also be linked to the material not having been manufactured according to GMP Regulation (EC) N°2023/2006. Such packaging may still be perfectly safe for use in a cosmetic application after the performance of the safety assessment. References to other standards like e.g. pharmaceutical standards or food and feed additives might be helpful in generating useful support information.