Cosmetic Packaging in European Union
Packaging material is defined as the container (or primary packaging) that is in direct contact with the formulation. According to the European Cosmetic Regulation No. 1223/2009, packaging evaluation is mandatory to guarantee cosmetic product safety. To meet this Regulation requirements, the European Commission issued the Decision 2013/674/EU, establishing guidelines on the practical application of such requirements and identifying information that should be collected on the packaging materials and the potential migration of substances from packaging.
Marta Pinto

Marta Pinto

Regulatory Affairs Associate

IMPACT OF PACKAGING ON COSMETICSAFETY 

Annex I of the EU Cosmetics Regulation (EC) No. 1223/2009 describes the information that needs to be considered for the Cosmetic Product Safety Report. Section 4 from this Annex provides details concerning impurities, traces and information about the packaging material. According to this Regulation, the packaging must not negatively impact the safety of the cosmetic formulation. 

The combination of the packaging material, formulation of the cosmetic product and contact with external environment may impact the safety of the finished product. Since substances may migrate from the packaging into the formulation, there is the need to consider relevant characteristics of the packaging material as well as the interaction between the product and the packaging material and barrier properties of the packaging material.  

Relevant characteristics of the packaging material may include the composition of the packaging material (including additives), technically unavoidable impurities and possible migration from packaging. These characteristics should make it possible to estimate any potential hazards.  

There are several types of packaging materials used on cosmetic products: plastics, adhesives, metals, alloys, paper, board, printing, inks, varnishes, rubber, silicones, glass and ceramics. 

Similar formulation/packaging combinations that are already available on the market as well as materials that have been developed for food packaging may provide useful indications.  

Different factors need to be taken into consideration when developing a packaging for a cosmetic product: 

  • Requirements of the EU Cosmetics Regulation (EC) No. 1223/2009 for safety assessment; 
  • Requirements regarding REACH, the Packaging and Packaging Waste Directive 94/62/EC and other legislation; 
  • Technical performance of the packaging (compatibility with the products, product protection, and others). 

COSMETICS EUROPE GUIDELINES 

In 2019, Cosmetics Europe – the European trade association for the cosmetics and personal care industry – issued an advisory document regarding the information exchange on cosmetic packaging materials along the value chain in the context of the EU Cosmetics Regulation EC 1223/2009. In sum, it identifies which information regarding the packaging is relevant for conducting the safety assessment of the cosmetic product, where the main concern is the possible migration of packaging substances into the cosmetics formulation. 

General principles of safety and inertness for all Food Contact Materials are set out in the EU Framework for food contact materials (Regulation (EC) No 1935/2004). Overall, this Framework requires that materials be manufactured according to Good Manufacturing Practices and do not release their constituents into food at levels harmful to human health. It also establishes rules for compliance documentation and traceability. In principle, food packaging legislation provides information that could be useful for the safety assessment of cosmetic products packaging. This is a strategy widely used in the cosmetic industry. 

Migration limits (i.e. maximum amount of a substance allowed to migrate to food) are an important mechanism to safeguard the safety of food contact materials. The EU or national regulations can set out Specific Migration Limits (SML), based on the toxicity of specific substances. An Overall Migration Limit (OML) means a limit for the migration into food of all substances together (measure for the inertness of the material). Rules for migration testing have been established in national regulations or industry guidelines for many materials. 

Commission Regulation (EU) No. 10/2011 on plastic materials and articles lists 6 different food simulants representing the main food characteristics that influence migration. Since cosmetics are typically chemically inert, water based/oil-based mixtures with a neutral or slightly acidic pH, the physical/chemical properties relevant for migration correspond to the properties of those 6 food simulants (except for some cases).  

Cosmetics Europe suggest the following methodology/approach: 

  • If possible, the supplier declares and documents compliance with food contact legislation/standards. 
  • When food contact compliance cannot be claimed, the supplier provides relevant information for the safety evaluation of the packaging by other means. 
  • In either case, the supplier addresses substances that are of specific concern to the cosmetic product safety assessor (i.e. banned or restricted under the Cosmetic Regulation Annex II, Annex III and CMR substances as well as substances classified as skin sensitizers). 

If a packaging material/component is not food contact compliant due to the presence of a specific substance, the Threshold of Toxicological Concern (TTC) approach can be valuable.  

References: 

  1. Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products. 
  1. 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. 
  1. Scientific Committee on Consumer Safety (SCCS) – The SCCS’S Notes of Guidance For The Testing Of Cosmetic Ingredients and Their Safety Evaluation, 10th Revision, 2018. 
  1. Cosmetics Europe – Advisory Document – Information Exchange On Cosmetic Packaging Materials Along the Value Chain In The Context Of The EU Cosmetics Regulation EC 1223/2009, 2019. 
  1. 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. 
  1. Commission Regulation (EU) No 10/2011 of 14 January 2011 on plastic materials and articles intended to come into contact with food.  

further
reading

cosmetic products

Creating a “Zero Waste” Cosmetic Industry. Is it possible?

Climate changes, pollution, waste management, recycling are some of the terms we see frequently on the news and tabloids. Consumers are concerned with the planet and are demanding more innovative and sustainability ideas (“eco-friendly”). Cosmetic and personal care products have been the target of some criticism by its users. Both the cosmetic industry and governments are starting to adapt and take action with the ultimate goal of reducing plastic waste. New ingredient and packaging alternatives are being developed and more sustainable products are starting to appear on the market.

Read More »
cosmetic products

Cannabis-Derived Ingredients in Cosmetic Products

Cannabis-derived ingredients are popular and interesting compounds. There is specific EU and national legislation regarding cannabis-derived ingredients, identifying which extracts and derivatives may be used in cosmetic products. There are several aspects to consider to ensure compliance when adding these compounds to your cosmetics and personal care products.

Read More »
cosmetic products

Cosmetic Claims in the European Union

Claims are an important part of a cosmetic and represent a powerful and essential tool of marketing. It is crucial to know which claims are allowed in cosmetic products in the EU and also how can they be substantiated.

Read More »
cosmetic products

Cosmetic companies obligations under REACH Regulation

REACH is a regulation of the European Union (EU) that stands for Registration, Evaluation, Authorisation and Restriction of Chemicals. All chemical substances manufactured and market in the EU, whether used in our daily lives (e.g. clothes, cleaning products, cosmetics) or industrial processes, are regulated by REACH.

Read More »
cosmetic products

May Butylphenyl Methylpropional be used in my Cosmetic Products?

Butylphenyl Methylpropional, also known as Lilial, is a fragrance ingredient that has been used for years in several cosmetic and non-cosmetic products. Nevertheless, some concerns have been expressed regarding the use of this ingredient and its risk to consumers. The use of Butylphenyl Methylpropional shall be prohibited in cosmetic products from 1st March 2022.

Read More »
cosmetic products

RAPEX System 2020 Report

The rapid alert system (RAPEX) for dangerous non-food products enables national authorities to quickly exchange information about dangerous products. The European Union Safety Gate European RAPEX 2020 annual report was published in March this year. It lists the alerts and follow-up actions taken, per country, product category and risk notified.

Read More »
cosmetic products

Silica – a nanomaterial?

Notification of a cosmetic product containing nano-form ingredients can be complex and involves more costs for the company (cosmetic product owner). The best way to simplify the notification process is to make sure that the Silica and related ingredients used do not fall to the nanomaterial category.

Read More »
cosmetic products

Screening Assessment of Talc by Health Canada

In Canada, Talc was identified as a priority substance for assessment, so the Minister of the Environment and the Minister of Health performed a screening assessment of this compound. Regarding inhalation and perineal exposure, Talc may constitute a potential danger to human life or health.

Read More »
cosmetic products

New Revision of the SCCS Notes of Guidance

The SCCS has issued a new revision of its notes of guidance for the testing of cosmetic ingredients and their safety evaluation. This 11th revision was adopted at its plenary meeting on 30-31 March this year, and it updates the 10th revision that was published in 2018.

Read More »
cosmetic products

Is Propylparaben still considered Safe by the SCCS?

Propylparaben has been assessed several times by the European Commission’s Scientific Committee on Consumer Safety (SCCS). Last year there was a request for scientific opinion concerning the evaluation of a list of ingredients, including Propylparaben. On March, this year (2021), the SCCS issued the requested opinion on this ingredient.

Read More »
cosmetic products

China – the end of Animal Testing Requirements for Cosmetics?

Animal testing of cosmetics is already prohibited in the European Union for several years but, until now, it was mandatory to perform animal testing when making available a cosmetic product in the Chinese market. From 1st May (2021), animal testing will no longer be a requirement for ‘general’ cosmetics imported to China.

Read More »