Obelis partner regulatory training: takeaways from Chemron FDA Korea
An interview with Sarah You about her experience in following one of our expert’s professional trainings on EU Regulations and the insights she gained from it.
The EU Market is the largest and most desired export market in the world for cosmetic and personal care products. In 2017 alone, personal care product sales accounted for 77.6 billion euros. The complexity of the regulatory framework in Europe and the ongoing updates related especially to ingredients used in cosmetic products might challenge Brand Owners in having their products effectively placed on the EU Market without the support and assistance of a professional EU Responsible Person. From July 11, 2013, the Cosmetic Regulation EC 1223/2009 became fully applicable in the EU as the main legal framework for cosmetic products.
Working with Obelis will allow cosmetics brand owners to not only successfully navigate the complexities of EU product compliance but also to ensure longevity of their brand in the EU Market. Not to mention, once you have complied under the advisement of a professional EU Responsible Person / EU Consultant, success in other global markets is far more attainable.
From July 11, 2013, the Cosmetic Regulation EC 1223/2009 became fully applicable in the EU as the main legal framework for cosmetic products.
From January 1, 2021, the UK Cosmetic Products Regulation is applicable on the Great Britain Market. Learn more here.
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:
General Considerations
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.
Test Method
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:
Conclusion Report
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.
General Considerations
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:
Test Method
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.
Acceptance Criteria
The antimicrobial properties of the product are acceptable if a significant decrease or no increase in viable count of micro-organisms is seen:
Conclusion Report
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.
General Considerations
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:
Test Method
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):
Temperature | Humidity | Duration | |
Control | 4°C | Shelf life | |
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”)
Room temperature: | 24-25°C |
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.
Acceptance Criteria
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.
Conclusion Report
The Conclusion report on stability study shall contain
On November 3, 2021, the European Commission published the Omnibus Act IV. Regulation (EU) 2021/1902 aims at including in Annex II to the EU Cosmetics Regulation those substances that have been classified as CMR in the latest amendment of the CLP Regulation, dated May 19, 2020.
The bans will apply as of March 1, 2022. They will affect not only new products but also cosmetics already on shelves on the EU market that will need to be withdrawn. Banned ingredients are:
Did you know that by importing or distributing cosmetics from manufacturers based outside the European Union, you automatically assume the role of Responsible Person?
This means that you are fully responsible & liable to ensure the compliance of those products with the regulatory requirements!
Remember, you can always designate another European company as your Responsible Person.
As Responsible Person for the manufacturer, Obelis will:
Explore the services we offer to manufacturers, producers and distributors of Cosmetics products in the European Union. Contact us for inquiries.
COSlaw.eu is Obelis’s subscription service which informs about the latest Cosmetics regulation, and explains how to comply.