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COSMETIC AND PERSONAL CARE PRODUCTS
PREPARATION OF PRODUCT INFORMATION FILE
One of the requirements to be able to manufacture and place a cosmetic product on the European market, according to Regulation (UE) 1223/2009, is the elaboration of the information file of your products. This file should include items such as:
- Product description
- Cosmetic Product Safety Report
- Description of the manufacturing method and GMP declaration of conformity
- Justification of the effect of the product, when appropriate
- Information on animal experiments
- substance restrictions
- Labelled
- Qualitative and quantitative composition
- Toxicological profile Communication file, product safety information and assessment
In BUROTEC We can help you prepare the information file for your product in accordance with the requirements established by the applicable Regulations, advising you, at the same time, on all the items you will need, such as essays or analysis, for the preparation of technical documentation.
PRODUCT REGISTRATION ON THE EUROPEAN PORTAL
Prior to placing on the market, It is necessary to register through the Cosmetic Product Notification Portal (CPNP). It is a virtual registry launched by the European Commission, whose purpose is to provide said body with information on the products that are placed on the European market.
Our experts they can help you in this process, ensuring the correct and complete registration of your cosmetic products on the mentioned platform.
IMPLEMENTATION OF GOOD MANUFACTURING PRACTICES
A requirement demanded by the Spanish Medicines Agency to be able to carry out the manufacture of cosmetic products is compliance with the Good manufacturing practices (BPF), as established in article 8 of the European Regulation 1223/2009, for this kind of products:
The manufacture of cosmetic products will be carried out in accordance with good manufacturing practices in order to ensure the achievement of the objectives of the article 1 of this Regulation.
Thus, It will be necessary to implement a Quality Management System according to the activity of the company that ensures that the products are safe for human health..
From Burotec we can carry out the comprehensive implementation of this Quality Management System, for full compliance with the required Good Manufacturing Practices.
RESPONSIBLE TECHNICIAN
All those companies that carry out manufacturing or import processes of cosmetic products must have the Responsible Person service. Some of its functions to fulfill will be the following:
Directly supervise the activities of the company that fall under cosmetic regulations.
Verify that the products meet the requirements of the regulations that apply to them
Supervise the documentary file of the devices.
Market surveillance.
Review and evaluate incidents related to the products for the surveillance system and have the means to communicate them to the health authorities.
Being an interlocutor with the health authorities and collaborating with them in the execution of the measures that proceed, such as the withdrawal of the product from the market.
Provide health authorities, whenever it is required, the documentation that guarantees the conformity of the products with what is established in the legislation.
Supervision of messages aimed at advertising and promoting devices.
Being an interlocutor with the health authorities and collaborating with them in the execution of the appropriate measures, such as the withdrawal of the device from the market
BUROTEC offers periodic technical assistance by one of our experts, with a university degree admitted by the Spanish Agency for Drugs and Medical Devices to provide the service of Technical Responsible for the commercialization of cosmetics, or to train the Technical Responsible of your company
RESPONSIBLE DECLARATION OF ACTIVITIES OF MANUFACTURING / IMPORTING OF COSMETICS
To be able to carry out both the manufacture and the importation of cosmetic products, It will be necessary for companies to carry out the Responsible Declaration of activity before the Spanish Drugs Agency.
The presentation of the Responsible Declaration will allow the start of activities, After subsequent verification by the AEMPS, through documentary verification and, in your case, inspection, of the elements and circumstances revealed by the interested party in the Responsible Declaration.
REGISTRATION OF COSMETIC PRODUCTS BEFORE the FDA
For its introduction into the US market, the FDA is the body responsible for the control of cosmetic products.
Last 29 from December to 2022 new cosmetic regulation was published “MoCRA”, that introduces Changes and new demands for economic agents in the cosmetics sector.
Thus, as of December 2024 will be mandatory both registration of facilities such as the list of cosmetic products put on the market. From Burotec, We can help you with the necessary procedures to be able to set up your companies in the face of these new demands, both in the registration of the company and in the registration of the cosmetics to be introduced into the US market.