Because we are committed to making our products the safest and healthiest line available,
we have been working for over a year and a half to certify our products through the European Union.
The United States cosmetic regulations allow for many known toxins, carcinogens, and allergens to be used in cosmetic and personal care products. This industry is one of the least regulated in the U.S. The Food and Drug Administration has no authority to require companies to test cosmetics products for safety, nor does not review or approve the vast majority of products or ingredients before they go on the market.
1. Every cosmetic brand must appoint a Responsible Person (RP).
This must be a natural or legal person within the European Union that is responsible for each and every cosmetic product placed on the European market.
2. Cosmetic products must be validated before being placed on the market.
The composition or formula of the cosmetic product must be reviewed on a regulatory perspective, i.e against the Annexes of the EU Regulation.
3. Ingredients susceptible to provoke an allergic reaction to certain subjects must be disclosed.
Currently there are 26 recognized allergens and those must be labelled if their concentration exceeds the 0.01% threshold in rinse-off cosmetic products, and 0.0001% in leave-on products.
Regulation 1223/2009 features several annexes that list some of the regulated substances susceptible to be harmful to human health. There are three categories of ingredients:A. Prohibited ingredients
Prohibited substances are classified in Annex II of the Regulation 1223/2009.
The CMR substances (Carcinogenic, Mutagen, Reprotoxic) are listed in Annex VI of the CLP Regulation (EC No 1272/2008), and when they are of 2, 1A, 1B categories, they are prohibited.
These substances can be authorized in finished cosmetics products under the following conditions:
B. Restricted Ingredients
These substances are listed in Annex III of the Cosmetic Regulation, which counts about 300 substances. These ingredients can be used in cosmetic products only under the conditions described in the annex (product type, purity criteria, percentage of maximal use,etc.).C. Allowed Ingredients
Three functions of ingredients are listed by the Regulation: colorants, conservative agents and UV filters.
These ingredients are authorized if they respect the Regulation's restrictions and depending type of products in which they are contained, the part of the body that is concerned, as well as the concentration of the ingredient in the product.
This work must be done on a regular basis. These annexes are updated several times a year (on an average of three months). It is crucial to conduct a continuous regulatory watch.
4. A Product Information File (PIF) must be created which can be consulted at any time by authorities.
The PIF (Product Information File) is a regulatory file which must be:
Information about the safety of the cosmetic product
The following data must be included in the PIF:
6. Good Manufacturing Practices (GMP) must be used for production.
These come from the ISO standard 22716 published in 2007, providing the guidelines for the production, the storage, and the shipping of cosmetic products.
The PIF must contain a description of the manufacturing conditions and the declaration of compliance with the ISO 22716 Good Manufacturing Practices.
7. Animal experimentation is prohibited.
The testing ban on finished products applies since September 2004. Since this date products and ingredients can no longer be tested on animals on the EU market.
8. Labeling must be EU compliant. Mandatory requirements for labeling include:
*Translation in the language of the export country is mandatory. Note that Austria, Bulgaria, France, Poland, Portugal and Slovakia, request full translation of the label, i.e. even the marketing content and claims.
Statements must appear visibly, legibly and indelibly on the label.
9. Products must be added to the Cosmetics Products Notification Portal (CPNP): CPNP is the online notification portal created for the enforcement of Regulation (CE) No 1223/2009 by the European Parliament and the Council of Cosmetic Products. It is a website that Responsible Persons and Authorities can use to access products’ information
For a full description of the REGULATION (EC) No 1223/2009 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 30 November 2009 on cosmetic products CLICK HERE