European Union Certification
EUROPEAN UNION CERTIFIED
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.
This certification is one of the highest cosmetic standards in the world!
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.
Requirements to obtain European certification:
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:
- In case there is no substance for substitution that is appropriate after the analysis of alternative solutions.
- If a request has been made for a particular use of the products’ category, with a determined exposition.
- When the substances have been assessed and judged safe by the SCCS for a use in cosmetic products (sole condition for category CMR 2).
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.
- Allowed colorants: they are listed in the Annex IV of Cosmetic Regulation (153 of them)
- Allowed conservative agents: they are listed in the Annex V (59 of them)
- Allowed UV filters: they are listed in the Annex VI (29 of them )
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:
- Kept for 10 years (from the date when the last batch of the cosmetic product is placed on the market) by the Responsible Person.
- Kept under electronic or paper format.
- Written in an easily understandable language for the authorities of the member states where it is archived.
- It contains "a description of the cosmetic product which enables the product information file to be clearly attributed to the cosmetic product”.
- The Product Safety Report.
- A description of the method of manufacturing and a statement of compliance with the Good Manufacturing Practices.
- The proof of the effect claimed for the cosmetic product.
- Data on any animal testing performed by the manufacturer, its agents or suppliers, related to the development or safety assessment of the cosmetic product or its ingredients, including any animal testing performed to meet the legislative or regulatory requirements of third countries.
Information about the safety of the cosmetic product
The following data must be included in the PIF:
- Quantitative and qualitative composition of the cosmetic product
- Chemical / physical characteristics and stability data of the cosmetic product
- Microbiological quality
- Impurity, traces, and information regarding the packaging material
- Normal and reasonably predictable use
- Exposures to chemicals
- Exposures to substances
- The toxicological profile of the substances
- Adverse effects and serious adverse effects
- Information on the cosmetic product
- Microbiology specifications for each raw material.
- Safety Data Sheets for each raw material.
- Toxicological data for each raw material.
- Certificates of Analysis Sheets for each raw material.
- Tests of stability and microbiological quality.
- The conclusion of the evaluation: an indication regarding the safety of the cosmetic product.
- The warnings and instructions of use on the label.
- The scientific rationale: made on a case-by-case basis for each cosmetic product, verification of the presence of all required data, assessment of these data by an expert who analyses the relevance of the data.
- The references of the person in charge of the assessment and approval: name and address of the person in charge of the safety assessment, date and signature, etc.
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:
- Name and address of the Responsible Person
- Country of origin
- Nominal content
- Date of minimum durability or period-after-opening
- Precautions & warnings*
- Batch number
- Product function*
- Ingredients list
*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
- Name and category of the product.
- The name and address of the Responsible Person, plus contact details.
- In case of import, the country of origin.
- The first country where the product will be placed on the market.
- The presence of nanomaterials and CMR substances.
- The cosmetic product’s formulation.
- A compliant label with photo of the external packaging.
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