Regulation and development of cosmetic ranges or wellness products are key points to manage, to succeed in launch
Many entrepreneurs want to create their own cosmetic or wellness product brand and then market it in different countries. It is an exciting but complex project. Carrying out the commercial launch in countries is often subject to prior registration or declaration by country or group of countries (e.g. Zone Europe). Regulation and development points need to be well managed
STEP 1: Identify the countries or group of countries, from a regulatory point of view (Regulation and development)
- Check the conformity of the active ingredients, plant extracts, organic or conventional raw materials with the legislation in force in the country of destination.
- Validate that the packaging is in adequacy with the gestures of the consumer, and ensures the protection of the container in the country of destination. Some countries do not accept glass ampouls for example, outside temperatures can be extremely hot,…
STEP 2: Define the elements required by the authorities, for making the products on the selected export-market
- What is the status of the product in the target market? Is there a change in status?
- Do the claims comply with the applicable legislation?
- What are the customs barriers? (if any)
The set of prerequisites is now defined. Data must be collected in order to be able to respond to the authorities.
Some products may have different statuses depending on the country. For example, a sun protection product is not a cosmetic product in the USA, but an OTC product (quasi-drug), whereas it is in Europe. This therefore implies providing different elements of stability.
STEP 3 : Putting together the regulatory file (regulation and development of cosmetic ranges or wellness products are linked together)
In order to proceed with the filing of the regulatory file in the various selected markets, it must be proven that the product is not dangerous, which includes the obligation to carry out tests. These tests are subject of charge, and must be included in the launch budget. The more countries targeted, the higher the cost of the tests will be.
These tests are carried out by independent laboratories. It may include:
- challenge tests
- stability tests
- skin and eye tolerance tests
- pH and viscosity control,
- safety certificates, etc.
Let’s take the example of an launch in Europe:
According to Regulation n°1223/2009: any company must designate a Responsible Person (RP), physical or legal, within the European Community, for each cosmetic product it wishes to place on the European market. This person can be :
- The manufacturer established in the EU Community
- An importer: if the cosmetic product is manufactured outside the European Union.
- The distributor: if the product is placed on the market under his name or trademark, or if he modifies the product, already on the market.
- A person established in the Community: the manufacturer or an importer may designate a third person established in the Community.
NB: In the case where the manufacturer or importer designates a Responsible Person, the only formalism, required by Regulation 1223/2009, is in writing. You must designate your Responsible Person by written mandate.
STEP 4: Your product is ready to be marketed.
Regulation and development of cosmetic ranges or wellness brands, are now under control.
Your product has been developed, so can now be manufactured to sale in your markets.