6 key steps to place your cosmetic product on the market.
1- Assess data gap with your manufacturer
The first step is to ensure you’ll be able to gather all the data required from your manufacturer. You can also ask your manufacturer if he knows the European Regulations and if he is aware about the requirements. You’ll need to gather (non-exhaustive list)
- Formula of the finished product
- Raw material data
- Finished data (tests, documentation, etc.)
- Good Manufacturing practice Assessment - ISO 22716
This step will allow you to save time and money!
2- List the product for export to Europe and budget your compliance
Before starting your project to export to Europe, be sure your product portfolio is ready. This crucial step will help you budget the costs of your compliance. You should therefore ask yourself:
- How many products you want to put on the market?
- How many shades you have for each product?
- What the type of products you want to export - Perfume, make-up, cream, essential oils, UV filters, aerosols, etc.?
3- Budget your compliance
The compliance process is the first step before access to the European market. It is always a good choice to schedule and budget upstream. This work can be done by a consultant. Depending on the products you want to place throughout the European market the consultant will provide you with a quote with different options.
The quote usually includes (non-exhaustive):
- Formula review
- Labeling review
- Product information File
- Safety Assessment
- CPNP notification
- Claims review
- Good Manufacturing Practice (GMP) for cosmetics
4- Designate your Responsible Person (RP)
The European Regulation 1223/2009 defines the Responsible Person (RP) in the article 4 as a legal or natural person based in the European Union who will act as the unique representative throughout the EU. The RP’s role is to ensure that each product marketed in the EU complies with the Cosmetics Regulation 1223/2009 which aims to establish that the cosmetic product is safe for use.
The Responsible Person can be:
- The manufacturer
- The importer
- The distributor
- Any person established in the European Union (a consultant for example)
5- Data collection with manufacturer(s)
To review a formula you will have to gather information available from your manufacturer as:
- Raw material breakdown formula
- INCI name
- CAS number
- Exact percentage
If you choose a consultant, his works will consist in verifying if the INCI names and CAS numbers tie in but also if the ingredients contained in your products respect the threshold imposed by the European Regulation but also he will inform you about the forbidden ingredients.
He will also check the product’s function E.G. UV filters, preservatives, Antimicrobial, Deodorant, Foaming, Solvent, Tonic, Skin protecting, Emollient, etc.
At the same time, the manufacturer must provide a dossier for each raw material which is composed of:
- Certificate of Analysis (COA)
- Impurity profile
- Safety Data Sheets (MSDS)
- Technical data Sheets
But also other information in accordance with the composition and the claims (E.g. if your product is formulated with natural ingredients)
At this stage, you must list the allergens (vegetal extract, essentials oils, and fragrance) that the raw material contains and produce an allergen statement and/or IFRA certificate. Both are required when raw material is a perfume or an essential oil. The list of ingredients must appear on the label and include the allergens.
The phase two of the data collection requires:
- Certificate of Analysis & Microbial specifications
- Stability test & DOMD conclusion
- Challenge test
- Manufacturing Method
- SOP (Standard Operating Procedures)
- Clinical tolerance test
Data collection : Brand obligations
- Exposure data
You must proceed to claim substantiation by proving the effects claimed. The test can be:
- Clinical tests
- Consumer perception test
The packaging of your product must be safe. Your packaging supplier must provide a certificate that proves that the packaging is free from SVHCs, CMRs, or other forbidden substances.
After all these steps, the Product information File and the Safety Assessment can be performed. While the Safety Assessment allows you to place your product on the European market, the Responsible Person will notify the product on the CPNP and as soon as the certificate is issued, you’re good to go!
6- Anticipate reformulations and labeling update
In order to keep your product on the shelves, be sure to frequently check the list of prohibited substances in Annex II of the regulation but also all modifications of Cosmetics Regulation 1223/2009 Annexes:
- Annex I: Cosmetic Product Safety Report
- Annex II: List of substances prohibited in cosmetics products
- Annex III: List of substance which cosmetic product must not contain except subject to the restrictions laid down
- Annex IV: List of colorant allowed in cosmetic products
- Annex V: List of preservatives allowed in cosmetics
- Annex VI: List of UV filters allowed in cosmetics products
- Annex VII: Symbol used on packaging/container
- Annex VIII: List of validated alternative methods to animal testing
There are currently more than 1,300 of them. Also, don’t forget to update as necessary when your product (formula/composition, claims, labels etc.) evolve.
- Regulation 1223/2009 services
- EU cosmetic compliance
- Responsible Person for Europe
- Formula review
- Claim review
- Cosmetic labeling services
- PIF creation
- Safety Assessment
- CPNP notification services
- Cosmetic certification for Europe
Do not hesitate to contact our expert Sylvain De Backer by phone on +33 (0)1 83 64 20 54 for Europe and for North America please dial + 1 (778) 231-1607 or send an email at [email protected].
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