What are impurities?

What is the legislation on impurities?

EU legislation on impurities is regulated in EC No 1223/2009, articles 3 and 17.

Briefly, this legislation states that the unintended presence of a trace amount of an impurity is permitted, if it is technically impossible to avoid in accordance with good manufacturing practices. It must also be determined to pose no danger to the consumer's health.

What are trace impurities?
Impurities are substances that are not intentionally added to a raw material, but are often naturally present from the start of the process. They only exist in the product in trace (small) amounts, commonly given in parts per million (ppm). 

For example, Titanium Dioxide has a mineral form that is often used as a UV filter in sunscreen or a pigment. In this instance, trace levels of heavy metals could be found in the substances derived from minerals. They are naturally a component of the raw material. Consequently, it is not unique to find impurities from the raw materials in the final cosmetic product.


What is the difference between impurities and contaminants?
Contaminants are traces of substances that have accidentally and in extremely small amounts entered the product. Contrary to impurities, contaminants are not found in the raw materials used to create the product. They could be introduced as a result of a manufacturing process, contact with a substance, or chemical reactions that could leave traces of compounds in the raw material or completed product. As a result, these manufacturing and storage processes are strictly monitored in the industrial setting in accordance with quality control plans and adhere to good manufacturing practises. 

For example, if you are using an Lavandula angustifolia flower (essential) oil, it is likely that the plants have been exposed to pesticides during the farming process. In the EC No 1223/2009 legislation it states that only a certain amount of pesticides can be present in the final cosmetic product for the safety of the consumer. Therefore, this information on the pesticides must be checked. 

How does SkinConsult check for impurities or contaminants?
As it is essential for consumer health and safety, SkinConsult is very strict about checking for impurities. 
For each raw material in your product, your supplier must provide a statement or analysis on impurities. These impurities can differ per raw material, for example it is unlikely to find heavy metals in an essential oil, so your supplier may choose to give a statement/analysis on pesticides and CMR substances. However, each raw material must have their own impurities statement or analysis, otherwise we cannot accept the raw material documentation as complete.

What are some common impurities?

• Heavy metals
• Pesticides
• Formaldehyde
• 1,4-Dioxane
• Ethylene oxide
• Nitrosamines
• Volatile Organic Compounds (VOCs)
• CMR substances
• Pesticide residues
  
  However, many other impurities exist and raw material suppliers do have a responsibility to check for impurities.

Essential Impurities
There are certain raw materials that are required by law to have a specific impurities statement. These are:

• Polymers require monomer statement
• Phenoxyethanol requies phenol statement
• Alcohol requires methanol analysis
• Aloe Vera requires an aloin analysis
• Natural and mineral raw materials require heavy metal statement
• Synthetic raw materials require residual solvents

Impurities in Parfums and Essential Oils
It may be more challenging to get ahold of impurities statements from parfum suppliers, as perfume composition is a trade secret. Therefore, we accept allergen statements as impurity statements for perfumes. For essential oils, we accept allergen statements as impurity statements unless they are produced by cold-pressing.

This allergen statement is a list of 82 high-frequency contact allergens such as Limonene and Linalool. This list shows the concentration of these 82 allergens in the fragrance. It is necessary to provide a document listing not only the allergens that are present but also the allergens that are not present.

Please check this page to check exactly what documentation we need for your specific Raw Material. 

We hope to have informed you of the impurities in raw materials for cosmetics. If you have any other questions, please don’t hesitate to contact us at office@skinconsult.com.

Remember: safety first!