What is CE Marking?
A definitive guide to CE marking in Europe. Discover what a CE marking is, what products require a CE mark, and why a CE mark is required on the EU market.
The EU market is one of the largest and most sought-after in the world for cosmetic brand owners. However, the complexity of the regulatory framework in Europe presents significant challenges to manufacturers who wish to place their products without the support of a professional regulatory partner.
Learn more about the legal requirements applicable to your products, the steps you need to take to become and stay compliant, and how Obelis Group can assist you in this process.
As clearly indicated by the EC 1223/2009, designating a Responsible Person is a mandatory requirement: “Responsible persons shall ensure compliance with Articles 3, 8, 10, 11, 12, 13, 14, 15, 16, 17, 18, Article 19(1),(2)and (5), as well as Articles 20, 21, 23 and 24” (Art.5, p.1).
The RP is responsible to ensure that all the obligations related to product conformity have been carried out prior to placing the product onto the European Market and then to act as the Cosmeto-Vigilance contact point in Europe towards the cosmetic product responsible for. In supporting any brand owners in gaining EU Compliance, a professional EU Responsible Person should act as a consultant providing:
Once products have been registered (notified), the EU Responsible Person should also provide:
Provide information and documentation to demonstrate conformity as per requests by national authorities. Keep the PIF readily accessible to the Competent Authorities for a period of 10 years after the last batch was placed on the market.
One of the main requirements of the Regulation EC 1223/2009 is the pre-market notification. The Notification can only be completed by the designated Responsible Person and only after the Product Information File encloses all evidence of conformity. The Notification of a Cosmetic product indicates that:
A cosmetic product notified in the CPNP – one time notification, may be placed on any of the EU markets provided that the labelling is in conformity with the language requirements of the respective country. As such, no national notifications are necessary anymore. The information to be submitted to the CPNP includes but is not limited to:
At the completion of the Notification procedure, each product is assigned a CPNP reference code.
The Safety Report, identified in Annex I of the EC 1223/2009, is one of the essential elements when building the Product Information File of a cosmetic product. The Safety Report always includes two parts:
Part A: Safety Information
The Safety Information, identified in the Annex I of the Regulation, is Part A of the Safety Report within the Product Information File of a cosmetic product. The safety information is to be obtained from the suppliers of the raw materials and the producers of the finished product (easily accessible when producing according to Good Manufacturing Practices) and with the support of laboratory tests. The Safety Information includes but is not limited to:
Part B: EU Safety Assessment
The Safety Assessment, identified in the Annex I of the Regulation, is Part B of the Safety Report within the Product Information File of a cosmetic product. The Safety Assessment includes but is not limited to:
The safety assessment is to be completed by the “Safety Assessor”, a qualified person with a European degree in pharmacy, medicine, toxicology or a related discipline. When the qualification degree diploma is not obtained from a European university, the Safety Assessor must have it recognized by the appointed national bodies within one of the EU Member States. A special safety assessment needs to be issued in case the products are:
You might also find interesting: Mandatory Safety Testing
The Cosmetics Regulation EC 1223/2009 clarifies requirements for safety of a cosmetic product and includes clearer requirements for manufacturers to compile the Product Information File prior to placing a cosmetics product on the European market. Part of the requirements of EC 1223/2009 are listed in the Safety Report (which includes the Safety Information & Safety Assessment). Among these requirements are the safety tests. The main safety tests are stability tests, compatibility tests, and challenge tests.
The purpose of the compatibility test is to evaluate the migration of chemicals between the cosmetic product and its container – primary packaging. Packaging can directly affect finished product stability and safety because of the possible physical and chemical interactions between the product, the package, and the external environment. The Compatibility test may include:
Several aspects are checked for both the container and the product:
There are no standard protocols for the compatibility testing of the cosmetic products. An appropriate assessment may be made based on the knowledge of the formulation and primary packaging materials and experienced expert judgment.
Why: to test the potential migration of small amounts of substances from the primary packaging material to the formulation.
When: before the placing on the market of the cosmetic product and while development or Good Manufacturing Practices or GMP random controls.
How: The environmental conditions and the periodicity of the analysis can be the same as those mentioned for the formulation Stability Studies.
In this test, several alternative container materials may be analyzed to determine which is most suitable for the product.
Types of container material and main evaluations:
The conclusion on compatibility report should contain:
As an Obelis client, you can take advantage of our network for pre-approved Safety Testing facilities to obtain any tests you may be missing in parallel to the EU Compliance process.
Challenge testing is mandatory for all cosmetic products for which a risk of microbial growth during normal conditions of storage or use is identified. Preservatives are included in most cosmetic product formulations to protect them from microbiological contamination during normal consumer use. The purpose of the challenge test is to verify the reliability of the preservative system during the shelf and usage life of the cosmetic product.
While there are different challenge tests protocols, similar methods are described in the EU Pharmacopeia and US Pharmacopeia. These protocols differ one from the other in the detailed procedures, test organisms, criteria for passing the test and the requirements for validation. Concerning microbiological susceptibility there are differences between three product categories:
When: The test should be done in at least two phases:
How: The product is inoculated with a known quantity of different microbial pathogens (bacteria, molds, yeasts, etc).
The microbial activity of preservatives or any other compound in the finished cosmetic must be ruled out in the challenge test by dilution, filtration, neutralizers or any other means. The experimental performance of the microbial controls and the challenge tests must be laid down and validated by a microbiologist.
The antimicrobial properties of the product are acceptable if a significant decrease or no increase in viable count of micro-organisms is seen:
The conclusions report of Challenge Test shall contain:
As an Obelis client, you can take advantage of our network of pre-approved Safety Testing facilities to fulfill any missing safety testing in parallel with the rest of the EU Compliance process.
The purpose of stability testing is to ensure that the cosmetic product maintains its intended physical, chemical and microbiological quality, as well as functionality and aesthetics when stored under appropriate conditions.
Due to the different nature of each cosmetic product, no mandatory Stability Test was established. Each manufacturer given its knowledge on the formulation and the product intended use, may draft and argue the best suited conditions to evaluate the stability of the product. The elements to be considered when drafting the protocol of a stability test:
Why: To ensure that the cosmetic product maintains its intended physical, chemical and microbiological quality, as well as functionality and aesthetics when stored under appropriate conditions.
When: The most common conditions for stability testing of cosmetic products are listed in several published references:
(✓) International Federation of Societies of Cosmetic Chemists, IFSCC Monograph, Number 2 (The Fundamentals of Stability Testing):
|Room Temp||20 – 25° C||–||Shelf life|
|Accelerated||37° C||–||3-6 months|
|Accelerated||37° C||80%||1 month|
|Accelerated||45° C||1-3 months|
(✓) Cosmetic Regulation in a Competitive Environment (Ch 11 “Stability Testing of Cosmetic Products”)
|Accelerated testing:||37, 45 and 50°C|
|Freeze-thaw cycling:||0 or -5°C|
|Elevated humidity:||80% RH|
How: Stability testing is an experiment in which samples of the formula are put at different environmental/ storage conditions for a set period of time to simulate what will happen to the product during its life cycle. At selected intervals, samples are evaluated for various physical, chemical and performance characteristics to see if and how they have changed.
A preliminary test recommended is the centrifugation test. This test predicts emulsion creaming (for powder, liquid/cream products).
• A sample heated to 50°C is centrifuged at 3,000rpm for 30 minutes.
(✓) The product must remain stable and any sign of instability shows the need for reformulation.
If approved in this test, the product can then be submitted to the stability tests.
This test is also known as screening test, accelerated stability test or short-term test.
Why: help in the screening of the formulation.
When: is carried out in the initial phase of product development.
How: the samples can be submitted to:
Duration of the study: 15 days
The parameters to be evaluated:
An accelerated stability test is also a possibility, none the less, the product will be required to be submitted to more-severe-than-usual conditions. The accelerated stability is also known as normal or exploratory stability test. This test is a predictive study that can be used to estimate the expiry date of the product. Duration of the study: generally 90 days.
The samples are evaluated against the standard sample (must remain unchanged during the whole life cycle of the product) and with products that are considered as ‘’references’’ submitted to the same test conditions. Generally limits of acceptance are defined for the evaluated parameters. The interpretation of the data obtained during the Stability Test depends on criteria established in accordance with the formulator’s experience.
|Criteria||Limits of acceptability|
|Appearance||The product must, maintain its initial appearance under all the conditions except high temperatures, freezer conditions or cycles in which small alterations are acceptable.|
|Color and odor||Must remain stable for at least 15 days when exposed to sunlight. Small alterations are acceptable at high temperatures.|
|Viscosity||The limits of acceptability must be defined by the formulator, considering the visual and sensorial perceptions caused by alterations. The possibility of the consumers also noticing them must be considered.|
|Compatibility with the primary packaging material||The integrity of the package and the formulation must be considered, evaluating the weight, the sealing and the functionality|
In cases where the monitoring of the active ingredient percentage is necessary, the quality and performance parameters of the product must be considered. Other parameters can be established according to the formulator and the products’ specifications.
The Conclusion report on stability study shall contain:
In addition, the following should also be provided:
The EU requirements for cosmetic products are frequently being updated: in particular, several new substances are banned or restricted for use in cosmetic products every year.
Such changes may require beauty brands to quickly reformulate their products to remain compliant. Our role as Responsible Person includes informing our clients about ingredient updates as early as possible so they can act promptly.
Timely communication is essential to avoid issues when selling in the EU market. For this reason, we have created the online COSlaw Watch-out database: an overview of substances that have been recently banned or restricted or that will soon face some restrictions.
In 2022, the updates concerned more than 20 ingredients. As of March 1, 2022, the ban on 24 substances, including the commonly used Butylphenyl Methylpropional (Lilial) and Zinc Pyrithione, applies in the EU (Omnibus Act IV).
Furthermore, as of December 17, 2022, 14 additional substances are prohibited for use in cosmetic products marketed in the EU and Methyl Salicylate is restricted per categories (Omnibus Act V).
In 2023, the European Commission will publish Omnibus Act VI, which will apply from December 1, 2023. According to the draft, it will ban 30 new substances, including Benzophenone!
What is the role of EU importers and distributors of cosmetic products?
Are you an importer of cosmetic products? Do you know that by importing cosmetic products from outside the European Union, you automatically assume the role of their Responsible Person?
It is stated in Article 4(5) of the EU Cosmetics Regulation. When you become the Responsible Person, you are fully responsible for ensuring the products meet the requirements set by the law.
However, you can designate by written mandate another EU-based company as the Responsible Person for the products you import.
Are you a distributor of cosmetic products? Do you know that you become the Responsible Person for those products:
It is established in Article 4(6) of the EU Cosmetics Regulation. In such cases, you will be fully responsible for ensuring the products’ compliance with the regulatory framework. If you want to avoid it.
Explore our cosmetic regulatory services & learn more about how we can assist you. Contact us for inquiries.