Cosmetic Packaging Safety: Key Considerations and Insights

Cosmetics

Cosmetic products constitute an extremely broad and heterogeneous category of consumer goods that, in accordance with current regulations, must ensure their safety. This applies to both the product itself and its packaging, ensuring that the latter does not alter the safety characteristics of the cosmetic.

In the cosmetic sector and various consumer goods sectors, packaging plays a fundamental role by fulfilling multiple functions:

  • Containment of the product throughout its life cycle;
  • Protection of the cosmetic during various phases of transport, storage, and preservation;
  • Maintenance of adequate storage conditions;
  • Support for indicating information required by current regulations;
  • Enhancement of the product’s attractiveness through design, materials, and graphics used.

The packaging of a cosmetic includes various components, some of which come into direct contact with the cosmetic formulation, while others only temporarily during use. Each component can be made from different raw materials. Therefore, packaging is not only crucial for the product’s presentation but also represents a complex system that requires accurate evaluation to ensure the safety of the cosmetic.

Regulatory References

The safety of cosmetic products marketed in the EU has been mandatory since 1976. Formal safety assessment was introduced in 1993 with Directive 93/35/EEC, which amended Directive 76/768/EEC. This amendment made the safety assessment of products mandatory before marketing but did not explicitly mention the evaluation of packaging characteristics.

Recently, there has been a significant increase in consumer and company awareness regarding cosmetic product safety and a greater interest in the impact of packaging on the safety of the contained product. In the food sector, attention is already high, supported by legislation that obliges manufacturers of packaging intended for food contact to perform specific tests and generate related documentation.

Significant changes are also occurring in the cosmetic sector. With Regulation (EC) No 1223/2009, the legislator introduced the obligation to also pay attention to the packaging used. However, details on how to comply with this new requirement are not sufficiently specified in the legislative text.

In Regulation 1223/2009, the points that refer to packaging and must be considered are:

  • Article 17: Traces of prohibited substances

” The non-intended presence of a small quantity of a prohibited substance, stemming from impurities of natural or synthetic ingredients, the manufacturing process, storage, migration from packaging, which is technically unavoidable in good manufacturing practice, shall be permitted provided that such presence is in conformity with Article 3.”

  • ANNEX I – Part A: Impurities, traces, information about packaging material
    • The purity of substances and mixtures.
    • If the case of traces of prohibited substance, evidence for their technical unavoidability.
    • The relevant characteristics of the packaging material, in particular purity and stability.

The Commission’s Implementing Decision of 25 November 2013 on guidelines on Annex I of Regulation (EC) No 1223/2009 concerning the safety report on cosmetic products delves into the topic of impurities, traces, and information on packaging material in point 3.4 of the annex. Specifically, at point 3.4.3. on the characteristics of packaging material, it states:

“Reference to Regulation (EC) No 1935/2004 of the European Parliament and of the Council may be useful. Experience gained with similar formulation/packaging combinations already on the market provides useful indications. Materials developed for food packaging have often been tested, and therefore information on stability and migration may be available.”

Point 3.4.3 also states:

  • “The combination of packaging material, cosmetic product formulation, and contact with the external environment could affect the safety of the finished product due to the following factors:
    • Interaction between the product and the packaging material;
    • Barrier properties of the packaging material;
    • Migration of substances from/to the packaging material.

The relevant characteristics for estimating potential risks could include, for example, the following elements:

  • Composition of the packaging material, including technical substances such as additives;
  • Technically unavoidable impurities;
  • Possible migration from the packaging”.

These information points indicate the associated hazards, but risk assessment is the responsibility of the safety assessor, who must consider both the hazard and exposure. Regulation (EC) 1223/2009, therefore, imposes the evaluation of packaging to ensure the safety of cosmetic products, establishing that the safety assessment is complete only if it also includes the potential risk deriving from the packaging.

With the introduction of these provisions in Regulation 1223/2009, although in general terms, cosmetic companies have begun to require suppliers to comply with food contact requirements for packaging. This compliance can be considered a first step to facilitate the work of the safety assessor.

Additionally, it is essential that the safety assessor has access to detailed information on substances of particular interest present in cosmetics:

  • Migration of substances present in Annex II and III of the cosmetic regulation or classified as CMR, although usually present in traces, could affect the compliance of the cosmetic;
  • Migration of sensitizing and/or irritating substances that could affect product safety;
  • The need to inform of the presence of such substances if present above a certain threshold.

Framework of legislation concerning materials in contact with food

There are two framework provisions, two European regulations, and one national DPR. The legislator has divided the specific provisions for various materials of use as illustrated in the following table:

Cosmetics Packaging

In the cosmetic field, the safety assessor does not mandatorily require anything on packaging other than conducting investigations to ensure the safety of the packaging, even if these are not technically detailed.

The Materials and Articles in Contact with Food legislation provides:

  • Compliance with the compositional conformity to positive lists of substances permitted for the production of packaging.
    • The lists are binding and specific to each material.
    • The lists are open, subject to continuous updating.
    • The lists can be harmonized at the European level (only for some materials) or valid only in certain member states.
  • Respect of limits through the required tests.
  • Verification of sensory inertia.
  • Assessment of technological suitability.

The core of food contact discipline is understanding what passes from the packaging to the product, and this is what the legislator also refers to in the cosmetic regulation. Indeed, 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 into the food.

  • Overall Migration Limit (OML): Indicates the maximum amount of substances that can be released from the packaging material and represents only a limit (expressed in 60 ppm or 10 mg/dm2) to the possible interaction between food and packaging, regardless of the potential health risk to the consumer.
  • Specific Migration Limits (SML): Indicate the maximum amount of a specific migrating substance and depend on its toxicological properties. The SML is defined as the maximum value that provides a migrating amount lower than the tolerable daily intake (TDI), expressed in mg/kg body weight/day.

Analyzing food products can be difficult, due to their complex matrix. However, in the sector of plastic materials in contact with food, the regulations for migration tests are established by Regulation (EU) 10/2011, which sets an overall migration limit of 60 mg/kg of food or 10 mg/dm² of the contact material.

Regarding cosmetics, which are generally chemically inert mixtures based on water or oil, with a neutral or slightly acidic pH, their chemical-physical properties often correspond to those of the food simulants defined in Regulation (EU) 10/2011. These simulants include:

  • 10% Ethanol (v/v)
  • 3% Acetic acid (w/v)
  • 20% Ethanol (v/v)
  • 50% Ethanol (v/v)
  • Vegetable oils
  • Poly(2,6-diphenyl-p-phenylene oxide), particle size 60-80 mesh, pore size 200 nm

The Safety Assessor must evaluate whether these food simulants and the related test conditions are applicable to cosmetic formulations.

As regards the glass sector in contact with food, the regulations for migration tests are established by Ministerial Decree 21/3/73. In addition to global migration, where the simulant is distilled water, lead migration is also evaluated. The global migration limit is 50 ppm or 8 mg/dm2, while the lead release limit is < 0.3 ppm.

Another very common packaging material in the cosmetics sector is aluminum. The regulatory system governing materials and objects made of aluminum and aluminum alloys intended to come into contact with food is Decree 76/2007. Aluminum must be approached differently from other materials. Migrations do not need to be considered, only the composition and purity requirements. There is no evidence of migration in aluminum. It must be evaluated exclusively for the composition and purity of the alloy compared to the percentage of some permitted metals. There are specific tables indicating the maximum allowed percentage for each alloy.

Comparison between Food and Cosmetics

  • The Materials and Articles in Contact with Food legislation is one of the most structured and comprehensive.
  • Materials used in cosmetics are also used in Materials and Articles in Contact with Food.
  • Information on material performance is available from the Materials and Articles in Contact with Food sector.
  • Information on Materials and Articles in Contact with Food constituents is available from the Declarations of Conformity (DoC).
  • From the DoC, one should deduce compositional and “migration” compliance.

The parallel between food and cosmetics is not so critical, but when we look at global and specific migration limits, the exposure scenario changes. EFSA has assumed limits for calculating the exposure of food packaging. The limit expressed in mg/kg (amount of migrating substance per kilogram of food product) is equivalent to the limit expressed in mg/dm2 (amount per surface area of the material or object) as the legislation assumes that 1 kg of food is in contact with about 6 dm2 of packaging material. Furthermore, for defining the limits, it assumes that each person consumes daily, for their entire life, 1 kg of food packaged in the material containing the migrating substance; that the average body weight of the consumer is 60 kg, and that there are no other significant sources of exposure.

These assumptions are used to calculate exposure and define safety limits for substances migrating from packaging materials to food.

Cosmetic packaging tends to be much smaller than food packaging, and therefore the surface/volume ratio can exceed 6 dm2/kg. However, cosmetic usage is much lower, with the generally accepted model being 17.4 g of cosmetic instead of 1 kg of food consumed per day. The worst-case scenario of a high surface/volume ratio is that of a sample sachet measuring 40 mm x 70 mm that could contain 2 g of product (considering both sides of the sachet), giving a surface/volume ratio of ~300 dm2/kg. A consumer using ~17 g of this product would theoretically be exposed to migration from 280 x 0.0174 = 4.9 dm2 of packaging. This value of 4.9 dm2 is less than the standard surface of 6 dm2 for food packaging, confirming that the exposure is still below the standard limit.

For estimating exposure from packaging vs. cosmetics, a reasonable and conservative approach has been taken based on the simplest risk assessment: if something can be ingested, it can also be absorbed through skin contact.

When compliance with food contact is not provided

Cosmetic packaging may not comply with food contact due to the use of unauthorized substances or those used outside the prescribed restrictions. This non-compliance may also be associated with the failure to manufacture the material according to GMP Regulation (EC) No 2023/2006. However, despite this, the packaging could be considered safe for cosmetic use after completing an appropriate safety assessment. It is useful to refer to other standards, such as those for pharmaceuticals or related to food additives and feed, to support this assessment. It is crucial to demonstrate that the cosmetic packaging has been produced in a compliant manner, and ISO 9001 certification or an equivalent quality system can be a useful indicator in this regard.

Additionally, it is essential to monitor the presence of unauthorized substances. Although this makes the packaging non-compliant for food use, it does not necessarily make it less safe for cosmetic use. In the case of non-compliant materials or components, the supplier must inform the safety assessor, clearly indicating the reasons for non-compliance, for example:

  • Presence of unapproved substances;
  • Use of approved substances that do not meet purity criteria for food contact;
  • Lack of evaluation of potential migration (through testing or other assessments);
  • Presence of substances beyond the SML/OML migration limits;
  • Material/article not manufactured according to GMP.

 

Article Issued by Maria Labianca 

Bibliography

Commission Regulation (EU) No 10/2011 of 14 January 2011 on plastic materials and articles intended to come into contact with food Text with EEA relevance.

https://www.efsa.europa.eu/en/topics/topic/food-contact-materials

Regulation (EC) No 1223/2009 of the European Parliament and of the council of 30 November 2009 on cosmetic products (recast).

Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC

SCCS (Scientific Committee on Consumer Safety) THE SCCS NOTES OF GUIDANCE FOR THE TESTING OF COSMETIC INGREDIENTS AND THEIR SAFETY EVALUATION 12TH REVISION, 2023.