Cosmetics packaging regulations in Europe

Packaging can be described as a vital system for transporting, distributing, storing, and eventually, ensuring the use of the product by the end consumer. Essentially, it serves as a means of ensuring the safe delivery of a product that must adhere to certain quality standards.

The functions of packaging can be condensed into the following key roles:

• Containing the product;

• Preventing product loss and leakage;

• Shielding the product from mechanical and environmental harm;

• Serving as a platform for displaying mandatory information as dictated by Regulation (EC) 1223/2009;

• Enhancing the product’s appeal through sophisticated graphics on the packaging itself.

The packaging for cosmetics products may comprise various components. Some are in direct contact with the cosmetic formulation, while others are not or only do so briefly during the product’s use. Each component can in turn be made up of different raw materials. As such, packaging is not only an indispensable marketing tool but also a complex system that needs to be assessed to ensure that it does not negatively impact the safety of the cosmetic product.

If you are interested specifically in the Italian market we recommend you read this article on labelling and packaging regulations in Italy.

Cosmetic package safety evaluation in Europe

In accordance with Regulation (EC) 1223/2009, every cosmetic product placed on the market must be safe for human health if used under normal or reasonably foreseeable conditions of use.

Cosmetic products, as indicated in Article 10 of Regulation (EC) 1223/2009, must undergo a Safety Assessment before being marketed:

“In order to demonstrate compliance of a cosmetic product with Article 3, the responsible person shall ensure that the cosmetic products, prior to being placed on the market, have undergone a safety assessment on the basis of relevant information and that a Cosmetic Product Safety Report pursuant to Annex I.”

Annex I of Regulation (EC) 1223/2009 specifies all the elements included in the Safety Assessment. Specifically, point 4, which concerns impurities, traces, and information on packaging material, indicates that the following factors must be taken into consideration in the Safety Assessment:

• The purity of substances and mixtures;

• If traces of prohibited substances are present, proof of their technical unavoidability;

• The relevant characteristics of the packaging material, especially purity and stability.

Therefore, Regulation (EC) 1223/2009, requires that the evaluation of the packaging is carried out to ensure the safety of cosmetic products. The safety assessment of a cosmetic is therefore considered complete only if the potential risk associated with the packaging is also assessed.

The Commission’s guidance on Annex I of the Regulation provides further guidance regarding information on packaging material and the potential release of substances from the packaging:

“Packaging material means the container (or primary packaging) which is in direct contact with the formulation. The relevant characteristics of the packaging material 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 may be helpful; in particular, experience gained with similar formulation/packaging combinations already on the market provides useful insights. Materials that have been developed for packaging have often already been tested and therefore relevant information on stability and migration may be available. As a result, further tests may not be necessary. However further assessments may be required for new packaging.”

The safety of the product could in fact be influenced by the following aspects:

• Interaction between the product and the packaging material;

• Barrier properties of the packing material;

• Migration of the substance from/to the packaging material

Information relating to packaging material in direct contact with the product should include:

• Technically unavoidable impurities;

• Composition of the packaging material, including technical substances such as additives;

• Possible migration from packaging

From Cosmetic Packaging to the Specifics of Labelling in Europe

While understanding the nuances of cosmetic packaging in Europe provides a broad overview, diving into the specifics of labelling offers a more detailed insight into one of its most crucial aspects. Labelling isn’t just about branding; in the European context, it’s an essential component that conveys safety information, ingredient lists, and origin details to the consumer. The European Union has set forth stringent guidelines to ensure transparency and trustworthiness in this domain. To gain a deeper understanding of these labelling intricacies, we encourage you to explore our comprehensive article on cosmetics labelling in Europe.

Who is responsible for evaluating the safety of packaging for cosmetics products?

The Safety Assessor carries the responsibility of analysing risks associated with the packaging. For instance, they must consider the potential migration of small quantities of substances from the packaging material into the cosmetic product, as well as the formulation and primary packaging materials.

Consequently, the assessment of product safety and evaluation of packaging safety are compulsory. However, there is no specific regulation governing the use of cosmetics packaging in the cosmetics industry. As a result, the documentation provided by the supplier becomes of utmost importance.

With this in mind, several industrial associations representing the cosmetics packaging distribution chain have developed guidelines. These guidelines delineate the information about packaging that must be furnished to the Safety Evaluator.

The purpose of the guidelines from Cosmetics Europe

The meticulously developed guideline seeks to isolate essential packaging information critical to the safety evaluation of cosmetic products. In fact, it constitutes a shared and harmonised strategy for the dissemination of information within the distribution network.

The development of packaging for cosmetic products must take into consideration a number of factors including:

• The technical performance required of the packaging, such as product protection, compatibility with the product itself and performance in the filling line;

• Compliance with the requirements of the Cosmetics Regulation regarding product safety, ie it must not have a negative impact on the safety of the cosmetic formulation;

• Requirements regarding REACH, the Packaging Waste Directive 94/62/EC and other legislation.

Concerning product safety, as previously highlighted, the most significant issue revolves around the potential transfer of substances from the packaging to the cosmetic product contained within. Depending on the mix of materials utilized, such migration might be unavoidable. This is precisely what Article 17 of Regulation (EC) 1223/2009 takes into consideration, stating:

“The unintended presence of a small amount of a prohibited substance, resulting from impurities in the natural or synthetic ingredients, the manufacturing process, storage, migration from the packaging and which is technically unavoidable despite the observance of good manufacturing practices, is permitted provided that such presence is in accordance with Article 3.”

Essentially, given that substance migration to the product can occasionally be unavoidable, the Regulation allows for it. However, it’s critical that this transfer doesn’t jeopardize product safety. This highlights the importance of the Safety Assessor receiving comprehensive information about the composition of the packaging material and any potential substance migration.

General approach to information exchange

Regulation (EC) 1935/2004, which pertains to materials in contact with food, outlines the fundamental principles on the safety and inertness of such materials. Notably, it mandates that these materials are produced in compliance with Good Manufacturing Practices (GMP) and ensures they don’t release substances into food at levels detrimental to human health.

The information on food packaging can also be leveraged for the safety assessment of cosmetics packaging, based on the following rationales:

• Chemical-physical similarities between many cosmetic formulations and food materials;

• Production standards based on GMP;

• Evaluation of the safety of food packaging based on its composition and its potential release of substances into the food.

Useful information related to the Safety Assessment of Packaging Cosmetics

1. For all items, the general chemical composition must be provided.

The Safety Assessment of a cosmetic product must take into account the potential impact stemming from the transfer of substances from the packaging to the cosmetic formulation. Thus, it’s crucial to scrutinise the documentation relating to the components and materials of the primary packaging. Furthermore, if the primary packaging doesn’t provide a functional barrier, the potential transfer of substances from secondary packaging to the product should also be considered.

It is also important to receive the following information about each material or component of the packaging:

• REACH: it is mandatory to indicate the presence of Candidate list Substances of Very High Concern (SVHC substances) when present in quantities equal to or greater than 0.1% w/w (i.e. ≥ 1000 mg/kg) and provide the identity of such substances or indicate the absence of the same substances;

• Heavy metals: it is necessary to confirm that the product complies with the 100ppm limit set out in Directive 94/62/EC on packaging and packaging waste for the sum of the concentration levels of lead, cadmium, mercury and hexavalent chromium.

2. All those components/materials that are potentially capable of transferring chemicals in the formulation of cosmetics should be identified.

3. After identifying the components/materials that may have a potential impact on the safety of the cosmetic product, adequate information needs to be communicated to enable the cosmetic product safety assessor to assess their impact on the safety of the cosmetic formulation.

Compliance with regulations and standards relating to food contact

A common principle is adopted which suggests that, in most instances, if packaging is safe for a particular type of food, it should also be suitable for cosmetics that exhibit chemical-physical properties akin to those of the food.

For each component, whenever possible, the supplier should therefore declare and document: 

• Compliance with the general requirements of Regulation (EC) no. 1935/2004 of the EU on materials in contact with food;

• Compliance with GMP (Regulation (EC) No. 2023/2006);

• Compliance with EU or national legislation requirements applicable to the specific type of food material;

• Indication of the type of food simulants for which the declaration of conformity is valid. This allows the cosmetic product safety assessor to determine whether the food packaging safety information is relevant for its specific cosmetic formulation.

An important mechanism for ensuring the safety of food contact materials is the use of migration limits which specify the maximum amount of a substance allowed to migrate to food.

• Overall Migration Limit (OML), i.e. the global migration limit, is a limit for the migration into food of all substances taken together. It is an index of the inertia of the material;

• Specific Migration Limits (SML), are the specific migration limits established in EU or national regulations on the basis of toxicity data for specific substances.

For example, for plastic materials in contact with food, the rules for migration tests are established in Regulation (EU) 10/2011 with the Overall Migration Limit set at 60 mg/kg of food or 10 mg/dm2 of the plastic material contact.

The Safety Assessor has to decide if the food simulants and test conditions are applicable to the cosmetic formulation. Regulation (EU) no. 10/2011 relating to plastics and articles defines 5 food simulants representing the main food categories:

• A. Ethanol 10% (v/v)

• B. Acetic acid 3% (w/v)

• C. Ethanol 20% (v/v)

• Q1. Ethanol 50% (v/v)

• Q2. Any vegetable oil containing less than 1% unsaponifiable matter

• E. Poly(2,6-diphenyl-p-phenylene oxide), particle size 60-80 mesh, pore size 200 nm

Cosmetics are generally chemically inert, water-based (or oil-based) mixtures with a neutral or slightly acidic pH therefore, in most cases, the chemical-physical properties of the cosmetic formulations correspond to the properties of the previously indicated food simulants.

When food contact compliance is not provided

Cosmetic packaging may not be compliant for food contact due to the presence of a substance not approved for materials in contact with food, or used beyond the restrictions set for such use. Non-compliance could also stem from materials not manufactured in line with the Good Manufacturing Practices (GMP) as per Regulation (EC) No. 2023/2006. Nevertheless, such packaging could still be deemed safe for cosmetic use and a cosmetics package, provided it passes the safety assessment. Referencing other standards, such as pharmaceutical standards or food and feed additives standards, could prove helpful as supporting information.

First of all, it is important to demonstrate that the cosmetic packaging is produced in an adequate way and the presence of ISO 9001 certification or another equivalent quality system can be useful.

Secondly, it is important to pay attention to the presence of unauthorized substances. It should be emphasized that the presence of such substances renders the packaging non-compliant for food, but does not necessarily indicate that the packaging is less safe for cosmetic use. For those non-conforming materials or components, the supplier shall inform the safety assessor stating the reasons for the non-conformity: 

• Presence of unapproved substances;

• Presence of approved substances that do not meet the purity criteria of the food contact legislation;

• No assessment of potential migration (by testing or other means of assessment);

• Presence of substance(s) above the SML / OML migration limits;

• Material/article not manufactured according to GMP

How is it possible to protect oneself in this maze of regulations, directives and guidelines for the packaging of cosmetics?

Without a doubt, the most reliable approach to achieving compliance in this extensive field is to engage a trusted partner, who can provide declarations of compliance in line with the legislative requirements discussed in this article. As such, the information provided by the supplier must be evaluated by the Safety Evaluator (as discussed earlier). This is of paramount importance for all Responsible Persons who introduce a cosmetic product under their brand in the market. Taobè can assist you in evaluating all these facets. Reach out to us, and we will ensure that your cosmetic product adheres to all the requirements outlined today.