EU Market for Cosmetic Products Under 1223/2009 EU Regulation

           Manufacturers must follow a process before selling their cosmetic products in the EU market. QSE Academy has compiled the necessary steps and information to help your company enter the EU market.

Your company can do this process once you are familiar with the key aspects of venturing into the EU market.

Process of Putting Your Products in the EU Market for Cosmetic Products

• Classify Your Product

           For this part, your company must check the definition of cosmetic products in the EU.

The EU Cosmetics Regulation 1223/2009 defines cosmetic products as:

           “Any substance or mixture intended to be placed in contact with the external parts of the human body such as epidermis, hair system, nails, lips, and external genital organs.”

Furthermore, this covers cosmetic products for the teeth and the mucous membranes of the oral cavity.

Such products must clean, perfume, change appearance, protect, maintain good condition, and correct body odors.

Likewise, cosmetic products must:

• Not contain prohibited ingredients listed in the Regulation 1223/2009 Annex II.
• Follow restrictions on restricted substances in Annex III.
• Follow the requirements concerning colorants, preservatives, and UV filters.

Note that the classification is case-by-case. However, products intended to be injected, implanted, inhaled, or ingested do not come under the definition.

Hence, cosmetic products may include:

• Gels, lotions, oils, creams, and emulsions for the skin
• Make-up, hygienic, and after-bath powders
• Toilet and deodorant soaps
• Deodorants and antiperspirants
• Bath and shower preparations
• Eau de Cologne, perfumes, and toilet waters
• Face mask
• Products for fixing, straightening, and curling hair
• Hair colorants
• Hairdressing, hair-conditioning, and hair-cleansing products
• Shaving products
• Tinted bases
• Depilatories
• For care of the teeth and the mouth
• Products applied to the lips
• Products for nail care
• Products for external intimate hygiene
• Sunbathing and tanning products
• Anti-wrinkle and skin-whitening products

• Assign a Responsible Person

This applies if your company decides to designate a person, who is established in the EU, to conduct the tasks of the Responsible Person for your product.

  However, you can skip this part if you are going to act as the Responsible Person.

Note that you can reverse steps one or two. You could also combine these into one.

           According to Regulation 1223/2009 Article 4.1, “Only cosmetic products for which a legal or natural person is designated within the Community as ‘responsible person’ shall be placed on the market”.

  In other words, you cannot place a cosmetic product in the EU market without a Responsible Person<span style=”background-color: #9fe0d0;”>.

Keep in mind that the responsible person has to be designated by a written mandate, and has to accept this role in writing.

• Compile the Product Information File for Each of Your Cosmetic Products

The Product Information File (PIF) serves as the basis for the pre-market notification of cosmetic products. It includes information about a cosmetic product such as:

• Raw material specifications
• Finished product specifications
• Packaging specifications
• Product description
• Cosmetic Product Safety Report (CPSR)

• Perform the Product’s Notification

The product notification is a pre-market requirement. Hence, the product’s notification must happen before the product’s placement in the EU market.

Once the cosmetic products are compliant with the relevant legislation, you may then execute the notification.

• Put Your Product in the EU Market

After accomplishing steps one to four, you can put your cosmetic products in the EU market.

However, the Responsible Person must make the notification of your product to the Cosmetic Products Notification Portal (CPNP).

Keep in mind that you must always keep your products compliant with the regulation.

• Always Keep the Product Information File Updated

Updating the Product Information File includes keeping the cosmetic product in conformance with the relevant legislation.

Once your company has prepared and accomplished these steps, your product can successfully enter the EU market.

QSE Academy has developed toolkits and packages to help your cosmetics company begin this process and comply with the ISO 22716 standard.