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EU Cosmetics

Regulatory Services

 

In order to be able to sell your products on the EU market, you must keep in mind the different steps you have to take to comply with all applicable legislation. Pharmilab simplified the process in 5 steps:

Formulation review

According to the European Cosmetics Regulation (EC) no 1223/2009, there are several forbidden ingredients as well as others that can be used under certain conditions.

Pharmilab will start the review process by reviewing all its formulas to ensure they are fully compliant with the European legislation.

Cosmetic Product Safety Report

The Cosmetic Product Safety Report (CPSR) is the main part of the Product Information File (PIF). Divided in two parts, it is a mandatory requirement from the Cosmetics Regulation 1223/2009.

 

Part A of the CPSR aims to gather all the data necessary for the safety assessment and part B is the safety assessor’s conclusion on the safety of the product.

 

The assessor must hold a diploma (e.g. pharmacy, toxicology) recognized by a Member State. Our experts are highly qualified to serve you and are used to draft CPSR on a daily basis.

Labelling and claims review

The labeling and packaging of your products must comply with the European cosmetics legislation.

 

Since the labeling and the labeling of products are fundamental elements in the marketing process it is very important that some rules are strictly observed. Depending on the country to which you will export, you will face different translation requirements.

 

Pharmilab will review all labeling and provide a helpful checklist so that its label and packaging are fully compliant. The preparation of claims on cosmetic products and the substantiation of claims are mentioned in Article 20 of Regulation 1223/2009, but also in the specific regulation on claims: EC 655/2013.

 

This regulation aims to ensure that the information transmitted to end users through the claims is useful, understandable and reliable, enabling them to make informed decisions and choose the product that best suits their needs and expectations.

Product Informations File

The Product Information File is a key element needed to put your cosmetic products on the European market.

 

The Cosmetics Regulation (EC) 1223/2009 establishes the legal framework in Article 11 and requires that all those responsible for placing cosmetic products on the market constitute a Product Information File for each cosmetic product.

 

This file must be kept by the Responsible Person for a period of 10 years after the last batch of the product has been placed on the market.

CPNP notification

The Cosmetics Regulation no. 1223/2009 requires that any company wishing to place a cosmetic product on the market notifies it online through the Cosmetic Products Notification Portal (CPNP) before doing so.

 

CPNP is a site that only responsible people and authorities can use to access product information.

 

Pharmilab as Responsible Person will handle the entire process and will notify the products to you at CPNP.

NEXT?

Do you know that every cosmetic need a Responsible Person in the EU?