There are many questions that need to be answered regarding the placement of your products on the European market and REGULATION (EC) NO 1223/2009 on cosmetic products.
We will try to help you answering to the most important questions through the following text.
Many cosmetic companies worldwide, especially from China, Russia, The United Arab Emirates, Maroco, The United States of America, etc. are interested for placing their products on the EU market. They want to know are there some additional requests and documents for placing Chinese, Russian, Arabian, American... cosmetic products on the EU market?
NO, the rules are identical for everyone. European regulation on cosmetic products sets requirements that are same for all manufacturers of cosmetic products, regardless of where they are from.
How to start, what we need to know first?
REGULATION (EC) NO 1223/2009 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCILS implemented in full from July 2013 is establishing standards for cosmetic products that are available on the EU market and providing a high-level of protection for the safety and health of EU citizens.
Based on the regulation, in order to place your product to the EU market, you need to prepare supporting documentation for each individual cosmetic product.
This documentation is called PIF (Product Information File).
What is a PIF (Product Information File) and what it consists of?
On this site you'll find all about it...
Who should prepare the cosmetic PIF?
PIF documentation should be prepared by the Safety Assessor, Manufacturer, or Responsible Person. Often all together.
The most important part of PIF is Cosmetic Product Safety Report (CPSR). Cosmetic Product Safety Report (CPSR) MUST be prepared by Safety Assessor.
Safety Assessor by definition is a qualified person "in possession of a diploma or other evidence of formal qualifications awarded on completion of a university course of theoretical and practical study in pharmacy, toxicology, medicine or a similar discipline, or a course recognized as equivalent by a Member State" (EC 1223/2009, Art. 10).
The Safety Assessor must be a professional who possesses the necessary experience in analysis, evaluation and interpretation of toxicological data.
What does the Safety Assessor do and what are his/her responsibilities?
The Safety Assessor performs safety assessment based on a knowledge of cosmetic product ingredients and their properties.
The Safety Assessor has access to the toxicological and analytical information relevant to the assessment.
The Safety Assessor should carry out the safety assessment of each cosmetic product, i.e., risk assessment based on a thorough analysis of all available data, conditions of exposure and appropriate consideration of weight of evidence.
The Safety Assessor is responsible ONLY for safety assessment, i.e., CPSR and is not responsible for other parts of the PIF.
The Safety Assessor is independent and signs the CPSR.
Do you need a Safety Assessor?
When we prepare all the necessary documentation for the cosmetic product, what then?
Finally, the cosmetic product manufacturer out of the EU have to designate a legal or natural person within the community as "Responsible Person".
Who is "Responsible Person"?
The Responsible Person is responsible for the placing cosmetic products on the EU market and should ensure that each cosmetic product marketed in the EU countries complies with the Cosmetics Regulation (EC) N┬░1223/2009.
Who may be a "Responsible Person"?
The Responsible Person may be: - Manufacturer (established within the EU) - Importer - Distributor - Any person established in the European Union which is designated by written mandate by the manufacturer (from EU or non-EU countries) or the importer.
We tried to put a general description placing cosmetic products on the European market.
This is just general, we are aware that every product is a story unto itself.
Some other questions regarding placing cosmetic products on EU market:
Do you want to know all procedures and costs involved in the cosmetic products registration in Europe, including lab test, documents, certification, etc. contact us!
If you have a question about placing a cosmetic product on the EU market and could not find an answer contact us!