All you need to know for the marketing authorisation of a cosmetic aerosol
In this article, we want to highlight a not so visible part of the development cycle of an aerosol. This week we are talking about the imperatives linked with the marketing of a new cosmetic product. How to be sure that you are complying with the rules ?
Our framework of study will be contained among the European Union, with the European cosmetic regulation 1223/2009. This regulation has multiple goals. It makes sure that any new product on the market is safe for consumers in all 31 countries of European Union. It also verifies that marketing claims, written on the packaging, are justified.
Typically, we receive a lot of demands for new aerosols, but this bit remains dark or unknown for a majority of our contacts. It is a binding key step for any company from a financial and legal perspective. A new product with an incomplete product file exposes itself to the withdrawal from the market.
This article is particularly relevant for people looking after new products, or modifying existing formulas.
What are the steps in this process ?
Firstly, the responsible person for the marketing authorisation has to make a notification on the CPNP portal ( i.e. CPNP = Cosmetic Products Notification Portal). This is a must before going any further on the marketing authorisation. This allows the relevant authorities the surveillance and analysis of the market, the evaluation of the products and its information to consumers.
Then, a big part of the work comes with the next step. The security of a cosmetic product is evaluated and proven thanks to the Product Information File or PIF.
One of the PIF critical point is the checking of the following materials: CMRs (cancerogen, mutagen, reprotoxical), nanomaterials. (They have to be declared also in the CPNP notification).
Tests in laboratory are done specifically for marketing authorisation of the product. The analysis and restitution of these tests is very detailed.
In the facts, these are the regulatory essentials for launching and for the marketing authorisation of a new product.
What’s the structure for the PIF ?
There is an expected structure to respect, and it looks like that:
- Decription of the cosmetic product
- Product Safety report
- Quantitative and qualitative composition of the cosmetic product
- Physical/chemical properties and data on product’s stability
- Microbiological quality
- Impurities, traces, and information on the packaging material
- Normal use and predictable reasoning
- Exposure to the cosmetic product
- Exposure to the substances
- Toxicological profile of the substances
- Adverse effects and serious adverse effect
- Information on the cosmetic product
- Description of manufacturing method and conformity declaration with good manufacturing practices ( GMP – EN norm ISO22716)
- Proof of the effect claimed
- Data relative to the development or evaluation of the safety of the cosmtic product and its ingredients
How can Proersa simplify this process for you ?
The PIF process has obviously a cost for the company making the marketing authorisation. Depending on the complexity of the product, the PIF has a cost between 1.000€ and 2.000€. Moreover, by observation from our recent projects, the lead time to deliver a PIF is around 4 to 5 months.
To be closer to its clients’ demands, Proersa proposes to centralize and lead all the necessary work to be done to write this file. For all the laboratory studies and the testing of the product, we have partnered up with a professional laboratory, specialist in this field.
We take care after of the writing of the file. A toxicologist is doing the writing of this file. It is time consuming because there are a lot of things to check. It is necessary to obtain all the elements about the raw material present in the formula. The packaging needs to be also documented with all the relevant technical information.
We help you as well on the labelling of the product. For example, what security pictograms do you need for a bag-on-valve product ? If so, which one ? Inflamable aerosol or extremely inflammable aerosol ? The precaution for use sentences for aerosols are also regulated. We bring you our experience in this field.
Last few words on us
In conclusion, the regulatory work for launching a new cosmetic product in aerosol is a key step. Although not fully understood or known, it is a necessary one. It allows to ensure there is no risk to consumer’s health. We hope this reading has allowed you to understand the issues of this process.
If you are looking for an aerosol manufacturer that can commit itself for you, one that can do all the heavy lifting for you with regulatory steps, then Proersa might be a good option. We have all the necessary experience to formulate and to bring to market products compliant with European regulations.
PROERSA AEROSOLES, S.A.U. is a European market leader for aerosol filling. Since 1969, we dedicate ourselves exclusively to private label.
We make the aerosol manufacturing process easy for you. We can offer you a turn-key solution ( Full-service) or just help you on specific operations. Our services include R&D, formulation, manufacturing of concentrate, filling and assembling of the components.
If you want to develop a new aerosol product, but have no idea where to start, you will find with the following link an article explaining you all the key steps for aerosol development. You will discover also how to put together an efficient retroplanning. The 5 key steps of an aerosol development and efficient retroplanning.
If you have an unstoppable curiosity for aerosol filling, we will release soon an ebook with all the information, techniques and tips. To be among the first to receive it, please subscribe to the newsletter and we will make sure you receive it in preview.
If this article has been helpful and/or you wish to receive more information, please don’t hesitate to get in touch with us at firstname.lastname@example.org . It will be our pleasure to help you.
The PROERSA Team.