Possessing much of the data required by cosmetics regulations, manufacturers play a key role in ensuring the compliance of cosmetic products.
However, some manufacturers are better than others.
It might not surprise you to learn that some contract manufacturers are better equipped than others for dealing with this challenging work. This important consideration in a cosmetic product’s development could mean the difference between success or failure for your product.
BIORIUS identifies and recognizes the best performing contract manufacturers through our Preferred Manufacturer’s Program, a BIORIUS initiative whose goal is to support competent, cooperative and responsive contract manufacturers by introducing them to BIORIUS clients.
How does the program work?
BIORIUS has developed specific eligibility criteria to determine which contract manufacturers can be approved to join the program. BIORIUS evaluates companies in the context of their activities and invites them to join the program if eligibility criteria are met.
The criteria outlined below evaluates a working relationship from four different angles: trust, access to required data, responsiveness and regulatory skills. Each eligibility criterion listed below is scored as shown in the right-hand column. A contract manufacturer qualifies for the program if their total score is at least 40/50.
|1. Trust between the contract manufacturer and BIORIUS||/10|
|1a. Protected by a well-designed NDA and a highly-secure IT platform (COSMOS), the contract manufacturer places its trust in BIORIUS, an independent third party not engaged in the design, production or sale of cosmetic products. As such, the contract manufacturer agrees to share confidential information with BIORIUS for the sole purpose of evaluating cosmetic products and ensuring their introduction to the EU market.||/8|
|1b. The contract manufacturer agrees to work with BIORIUS directly if required by the cosmetics brand.||/2|
|2. Ability to provide BIORIUS with required regulatory documents||/20|
|2a. The quantitative formula of the product listed in raw materials (and, if possible, ingredients).||/3|
|2b. The MSDS, certificate of analysis, breakdown (if relevant), technical data sheet (if relevant) and non-animal testing statement for each raw material.||/3|
|2c. The IFRA certificate and allergen report for fragrances, flavors and natural extracts (with the exception of edible oil, such as sunflower seed oil).||/3|
|2d. Any purity statements that may be necessary (e.g., peroxide analysis of a natural extract containing terpenes).||/3|
|2e. Results of tests performed on the finished product (e.g., certificate of analysis, stability test, preservation efficacy test, SPF test, tests for substantiating claims). Test results are described in detail, and the test methods (protocol, reference, parameters, intermediate results) are provided.||/4|
|2f. Information specific to the product (e.g., manufacturing method).||/2|
|2g. Information specific to the contract manufacturer (e.g., GMP certificate, batch number format).||/2|
|3. Responsiveness of the contract manufacturer||/10|
|3a. The documents listed in 2a and 2b are provided within three weeks after receiving the request from BIORIUS. Documents are provided all at once (i.e., information is not submitted in batches).||/3|
|3b. All documents are submitted in a well-organized dossier or, if possible, directly via COSMOS.||/2|
|3c. The documents listed in 2c to 2e are provided within three weeks after validation of the formula by BIORIUS. A clear timeline is provided in the event that the documents cannot be provided on time.||/2|
|3d. The contract manufacturer is reesponsive and responds within two business days when a question is asked or a clarification is requested by BIORIUS.||/3|
|4. Regulatory competences of the contract manufacturer||/10|
|4a. The contract manufacturer is aware of and familiar with the Annexes of the EU Cosmetics Regulation (EC No 1223 / 2009) and formulates its products accordingly.||/5|
|4b. The contract manufacturer has a basic understanding of other legal requirements that apply to their products (e.g., IFRA Standards, Aerosol Directive, CLP Regulation).||/4|
|4c. When unaware of critical regulatory information, the contract manufacturer quickly learns and adapt for future products.||/1|
The evaluation is performed at a given time and is based on the information collected by BIORIUS. A contract manufacturer who does not meet the eligibility criteria is encouraged to provide new information that might change BIORIUS’ decision. Companies not receiving approval are invited to improve their processes and submit a new application as soon as six months after receiving the decision from BIORIUS’ first evaluation.
Manufacturers meeting the eligibility criteria can join the BIORIUS Preferred Manufacturers’ Program and are then recommended to our clients and presented as a high-quality manufacturer.
To promote continuous improvement and to ensure a long-term relationship with its partners, BIORIUS re-evaluates program members every other year.
Cosmetic product development companies: BIORIUS’ Recommendations
Manufacturing companies that BIORIUS includes as “Preferred Manufacturers”:
Join the program
BIORIUS evaluates the contract manufacturers with whom it works on a daily basis.
Contract manufacturers not yet working with BIORIUS are invited to submit their applications if interested in becoming part of this program.