ABOUT THE STABILITY AND COMPATIBILITY TEST

The cosmetic product stability and compatibility test is required by EU Cosmetics Regulation 1223/2009. It is mentioned in part A of annex I of the regulation and is therefore a part of the cosmetic product safety information.

The primary objective of conducting stability testing is to indicate the relative stability level of a product under the various conditions that it can be subjected to from the moment it is manufactured until the end of its validity.

The purpose of the test is to evaluate whether the product will meet the prescribed physical, chemical and microbiological quality standards, and assess its functionality, safety and aesthetics over a period of time during handling, transport and storage under appropriate conditions.

Based on the stability test results, we also assign the shelf life or the period after opening to the product.

The type and quality of packaging used also affects the stability of the product, as it protects the cosmetic product from the external environment.

On the other hand, potential leaching of substances in the packaging into the product must be evaluated. For this reason, compatibility between the packaging and its contents must be investigated, in order to ensure that no quality problems are introduced by the type of packaging material used.

All cosmetic products should be subjected to the stability and compatibility test; there are no exceptions as for the preservative efficacy test. Stability and compatibility tests must be repeated every time there is a change in the formula, packaging or manufacturing process.

HOW IS THE COSMETICS STABILITY TEST PERFORMED?

The cosmetics stability test can be performed in real time or it can be accelerated. The time that it takes to complete the test and the conditions under which it is performed can vary, as can the parameters that are monitored during the stability and compatibility test.

Real-time stability tests are usually performed at room temperature and take as long as the claimed shelf life on cosmetic product labels.

Due to time constraints, most companies decide to perform the accelerated stability test, which normally includes keeping the samples at elevated temperatures (37, 40 or 45 degrees Celsius) over a period of three months.

CE.way also tests the stability in a refrigerator and performs a freeze-thaw test, which is usually used to predict the stability of the product during transport. If transparent packaging is used, we also test the stability of the product when exposed to sunlight.

Whichever stability test is chosen, it should consider the following:

• It should identify the tests that will predict the effects of normal conditions of storage and use by the consumers on the product
• It should evaluate the critical physical, chemical and microbiological properties of each product
• Variation in process conditions
• The impact of packaging on the contained product and the effect of the product on the packaging

CE.way offers a range of different cosmetics stability tests and we help you choose the right one, based on the type of your product and its desired shelf life. Our stability tests are conducted according to ISO 18811:2018. During the stability test, we monitor the following.

• Various physical and chemical specifications of the product (such as pH, viscosity and density)
• Organoleptic properties of the product
• Microbiological specifications (Candida albicans, Pseudomonas aeruginosa, Staphylococcus aureus, mould and yeast)
• Packaging compatibility

If you want to find out more, please check our blog on the stability and compatibility test.

WHY DO YOU NEED A COSMETICS CHALLENGE TEST?

The cosmetics challenge test, also known as the preservative efficacy test (PET), is an important part of the product information file, and reference to it must be made in the cosmetic product safety report (CPSR). According to ISO 29621, every cosmetic manufacturer has to ensure that the product, as purchased, is free from the numbers and types of microorganisms that could affect product quality and consumer health, as well as to ensure that microorganisms introduced during normal product use will not adversely affect the quality or safety of the product. The latter can be ensured by performing the cosmetics challenge test. Basically, the challenge test checks how effective the preservative system of the cosmetic product is and whether it is capable of withstanding various types of contamination during production, from the environment and from direct contact with the human body that the cosmetic product is exposed to, thereby guaranteeing the safety and efficacy of the product during its shelf life.

HOW IS THE COSMETICS CHALLENGE TEST PERFORMED?

CE.way checks the preservation system’s effectiveness using the international cosmetics challenge test standard ISO 11930:2019 or the United States Pharmacopeia standard USP 51. The test is based on the monitoring of the presence of various pathogens in the cosmetic product when it is produced, followed by the intentional inoculation of a cosmetic product with five different strains of microorganisms:

• Staphylococcus aureus (gram-positive bacterium)
• Pseudomonas aeruginosa (gram-negative bacterium)
• Candida albicans (fungus)
• Escherichia coli (gram-negative bacterium)
• Aspergillus brasiliensis (fungus)

The remaining concentration of these microorganisms is then determined after 7, 14 and 28 days. The product is considered to pass the preservative efficacy test if the concentrations of the fungi do not increase over the testing period and if the concentrations of the bacteria are reduced sufficiently by day 14 and do not increase from that time until the end of the test.

WHEN IS A COSMETICS CHALLENGE TEST NOT NEEDED?

A cosmetics challenge test is not required for certain types of cosmetic products. Microbiologically low-risk products can be exempt from the preservative efficacy test, because, due to the product characteristics, the likelihood of microbiological contamination for such products is very low or even non-existent. The product characteristics that define products as microbiologically low-risk products are described in ISO 29621:2017 and can be divided into characteristics due to the composition of the product, characteristics that are a consequence of the production conditions, packaging or combined factors.

These characteristics are as follows:

• Water activity of formulation: products that do not contain water
• The pH of the formulation: highly acidic (pH below 3) or highly alkaline (pH above 10) products
• Alcohol content: products with more than 20% alcohol concentration
• Formulation with raw materials that can create a hostile environment: such as strong oxidizing agents, polar organic solvents, oxidizing dyes, aluminium chlorohydrate and related salts or propellant gases
• Production conditions: if containers are filled at more than 65 degrees Celsius
• Packaging types: product packaged in pressurized containers, pump dispensers or single-dose units
• A combination of the above-mentioned factors

Any lack of challenge test, however, must be duly justified.

Notification is a pre-market requirement where the Responsible person informs the EU Commission and the EU member states that the product will be placed on the EU market. The notification has to be performed after the cosmetic products are compliant with the relevant legislation (their Product Information File is completed and compliant).

Under the Regulation 1223/2009 (fully applicable since 11th July 2013) the notification process was simplified by creating only one electronic centralized notification system (the CPNP – Cosmetic Product Notification Portal) for all the EU countries, which started operating on 11th January 2012.

Please note that there is no EU cosmetics registration. This is a notification and not a registration. A notification means that the action is only one sided, and therefore doesn’t imply any official approval for sales.

Prior to placing the cosmetic product on the market the Responsible person must submit, by electronic means, to the EU Commission the following:

Prior to placing the cosmetic product on the market the responsible person shall submit, by electronic means, the following information to the Commission… (EU Regulation 1223/2009, Article 13.1)

• The category of cosmetic product, its physical form, packaging type and its name or names, enabling its specific identification
• The name and address of the Responsible person where the Product Information File is made readily accessible
• The country of origin in case of import
• The member state in which the cosmetic product is to be placed on the market
• The contact details of a physical person to contact in case of necessity
• The presence of substances in the form of nanomaterials
• The name and the Chemical Abstracts Service (CAS) or EC number of substances classified as carcinogenic, mutagenic or toxic for reproduction (CMR), of category 1A or 1B, under part 3 of Annex VI to Regulation (EC) No 1272/2008
• The product formula or the frame formulation allowing for prompt and appropriate medical treatment in the event of difficulties
• The original labelling, and, where reasonably legible, a photograph of the corresponding packaging

It is important to know that all products placed on the EU market before July 2013, which were notified according to the old EU cosmetics Directive, have to be notified again – to the Cosmetic Product Notification Portal CPNP, in order to be able to continue to circulate in the EU market.

In order to enhance the safety of cosmetic products and strengthen the market surveillance, cosmetic products placed on the market after the date of application of this Regulation should comply with its obligations regarding safety assessment, the product information file and notification, even if similar obligations have already been fulfilled under Directive 76/768/EEC. (EU Regulation 1223/2009, 68)

 

EU COSMETICS LABELLING REQUIREMENTS

Just as attractive labelling is one of the most important features of the product when it comes to sales, so is correct labelling essential for the compliance of the cosmetic product with the cosmetics Regulation 1223/2009/EC, as labelling is an important part of the product information file.

The regulation contains various cosmetic labelling laws – requirements and very specific rules regarding labelling, which have to be followed and are described in article 19 of the regulation. The notification of cosmetic products is not possible without the compliant product labels.

Without prejudice to other provisions in this Article, cosmetic products shall be made available on the market only where the container and packaging of cosmetic products bear the following information in indelible, easily legible and visible lettering… (EU Regulation 1223/2009, Article 19.1)

According to the regulation, the container and the outer packaging of cosmetic products have to bear the following information in indelible, easily legible and visible lettering:

• The name and address of the responsible person
• The country of origin if the product is imported from countries outside of the EU
• Nominal content of the product at the time of packaging, given by weight or volume
• Date of minimum durability or period after opening
• Precautions for use
• Batch number of manufacture or the reference for identifying the cosmetic product
• Function of the cosmetic product, unless it’s clear from its presentation
• List of ingredients (which may be indicated on the outer packaging alone)

Some of these elements may also be mentioned on an enclosed or attached leaflet, label, tape, tag or card if it’s impossible to list them on the labels. In that case an open book symbol should be placed on the label, which indicates that some information about the product can be found elsewhere.

The EU consists of 28 different countries and the cosmetic labelling laws require certain information on the labels to be translated into different languages. Some countries have more than one official language, which further complicates things and requires that certain information appear in more than one language on the labels.

WHAT IS THE COSMETICS SAFETY ASSESSMENT, WHY DO YOU NEED IT AND HOW IS IT PERFORMED?

Cosmetics Regulation 1223/2009 aims to ensure the safety of cosmetic product consumers. This means that each cosmetic product must be the subject of a safety assessment performed by a qualified person, before the product can be placed on the EU market.

Safety assessment forms part B of the cosmetic product safety report (CPSR), and therefore is a vital part of the product information file. Cosmetic product safety assessment is conducted based on part A of the CPSR, which gives cosmetic product safety information and includes documents such as:

• the cosmetic product formula (the qualitative and quantitative composition of the product),
• raw material specifications and toxicological profiles of the substances used,
• physical and chemical specifications of the finished product,
• microbiological quality and the results of the preservation challenge test (if relevant),
• stability of the cosmetic product and its compatibility with the packaging,
• information about the packaging material,
• information about the normal and reasonably foreseeable use of the product,
• exposure to the cosmetic product and the substances and
• any other information on the cosmetic product that may be available to the product manufacturer.

The safety assessor reviews these documents, checks whether the ingredients used in the product are restricted or banned in the EU, checks that the other information about the cosmetic product is in order and checks that the tests were conducted properly. Based on the no observed adverse effects level (NOAEL), he or she then calculates the margins of safety (MoS) and prepares the cosmetics safety assessment report.

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. (EU Regulation 1223/2009, Article 10.1)

The cosmetic product safety assessment must include the following.

• Conclusion as to whether the product is safe and in conformity with the EU cosmetics regulation or not
• The safety assessor’s scientific reasoning that led to such a conclusion
• A list of any warnings and precautions for use that must appear on the label
• The assessor’s credentials and approval.

It is worth mentioning that the same, or very similar, cosmetic safety assessments are also required in many other countries or regions around the world. These include, among others, Turkey, Israel, the ASEAN region, some South American countries and South Africa.

SAFETY ASSESSOR REQUIREMENTS

The EU cosmetics regulation also lists requirements for the safety assessors. The safety assessor should firstly, of course, be knowledgeable about the EU cosmetics regulation, but that is not sufficient. The regulation also stipulates some additional requirements. It states that the cosmetics safety assessment must be carried out by a person in possession of a diploma or other evidence of formal qualifications awarded on completion of a university course of theoretical and practical study in pharmacy, toxicology, medicine or a similar discipline, from the EU, or a course recognized as equivalent in the EU.

CE.WAY COSMETICS SAFETY ASSESSMENT SERVICES

CE.way’s safety assessors are highly skilled and fulfil the criteria mentioned above. They have degrees in pharmacy or cosmetology, they have completed the ‘Safety Assessment of Cosmetics in the EU’ course in Brussels and have years of experience in conducting cosmetic product safety assessments. Therefore, you can be sure that their cosmetics safety assessments will be accepted by the competent authorities.

As well as the quality of our services, we are also proud of the speed at which we provide them. Due to CE.way’s extensive database of toxicological profiles of the substances commonly used in cosmetic products, together with the software that we have developed, we can guarantee that cosmetic product safety assessments will be completed in up to three days from the time when we receive all of the documents from part A of the cosmetic product safety report.

ABOUT THE COSMETICS PRODUCT INFORMATION FILE (PIF)

The product information file is a cosmetic product dossier containing all the most important information about the finished product, ingredients which the product is made from, packaging in which the product is sold, manufacturing process and product labelling, which shows the product characteristics, its safety and efficacy. Each product placed on the EU market needs to have a product information file prepared.

According to the EU Cosmetics Regulation 1223/2009, the responsible person must keep a product information file for each cosmetic product placed on the EU market, at the address specified on the product label, readily accessible for the competent authority of the EU member state where the responsible person is established. The product information file has to be available in a language easily understood by the local competent authority of the country where the responsible person is keeping the cosmetics product information file.

When a cosmetic product is placed on the market, the responsible person shall keep a product information file for it. The product information file shall be kept for a period of ten years following the date on which the last batch of the cosmetic product was placed on the market (EU Regulation 1223/2009, Article 11.1).

The responsible person shall make the product information file readily accessible in electronic or other format at his address indicated on the label to the competent authority of the Member State in which the file is kept. The information contained in the product information file shall be available in a language which can be easily understood by the competent authorities of the Member State (EU Regulation 1223/2009, Article 11.3).

The product information file must be kept at one single address within the EU, even if the cosmetic product is sold in various EU countries. This also means that there can only be one responsible person per product for the whole of the EU – there cannot, for example, be one responsible person in Germany and one in France for the same product.

WHO IS A RESPONSIBLE PERSON (RP)?

EU cosmetics responsible person is an EU based cosmetic product manufacturer, importer, distributor, or another person established within the EU who has to accept this role in writing. The role of the responsible person is to ensure that the cosmetic products placed on the EU market are safe for use and compliant with the EU Regulation 1223/2009. A responsible person is basically a legal representative of a cosmetic product in the EU.

EU Cosmetics Regulation 1223/2009, which came into effect on July 11, 2013, established the concept of a Responsible person (RP) for cosmetic products:

Only cosmetic products for which a legal or natural person is designated within the Community as ‘responsible person’ shall be placed on the market. (EU Regulation 1223/2009, Article 4.1)

It is therefore obligatory to appoint a  cosmetics Responsible person in the EU to be able to put the products on the EU market.

There has to be only one Responsible person per product for the whole EU.

In order to establish clear responsibilities, each cosmetic product should be linked to a responsible person established within the Community. (EU Regulation 1223/2009, Article 11)

For the purpose of effective market surveillance, a product information file should be made readily accessible, at one single address within the Community, to the competent authority of the Member State where the file is located. (EU Regulation 1223/2009, Article 17)

 

EU COSMETIC PRODUCT DEFINITION

Before you start digging into the EU cosmetics regulation and its requirements, it is important to determine if your product indeed falls within the scope of the cosmetic legislation.

A cosmetic product in Europe is defined in the Regulation 1223/2009 as follows:

‘cosmetic product’ means any substance or mixture intended to be placed in contact with the external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours. (EU Regulation 1223/2009, Article 2.1.a)

Based on the definition of the cosmetic products, products that may seem to be cosmetics, like nail wraps, a comb or a toothbrush, therefore aren’t cosmetics, even though they are placed in contact with the external parts of the human body, and their primary function is to change appearance, but they wouldn’t be considered a substance or a mixture.

Since products have to be placed in contact with the external parts of the human body or with the teeth and the mucous membranes of the oral cavity, any product intended to be ingested, inhaled, injected or implanted into the human body would also not be considered a cosmetic product in the EU. Breast implants then aren’t cosmetics, even though their primary function is also to change appearance.

The assessment of whether a product is a cosmetic product has to be made on the basis of a case-by-case assessment, taking into account all characteristics of the products.