Regulatory Services

We can advise you on specific safety regulations regarding:

• Raw material.
• Cosmetic packaging materials.
• Symbols used on packaging and containers.
• Label review.
• Prohibited and restricted substances .
• Approved colorants, preservatives and UV filters.
• Animal testing and validated alternative safety testing methods.
• Regulatory requirements.

The new EU Regulation 1223/2009 has been in force since 11 July 2013, replacing the Directive 76/768/EC with all amendments.

This new regulation involves many changes and the clarification of various aspects, based on the experience of recent years, focusing on a few key factors that have thus been created and described, namely:

• The appointment of the Responsible Person.
• The implementation of the Product Information File (PIF).
• The application of the Good Manufacturing Practice according to ISO 22716.

The PIF is a complex document which combines and articulates the following documents:

• Product Information File
• Cosmetic Product Safety Report
• Cosmetic Product Safety Information
• Cosmetic Product Safety Assessment.

At Cosmetek we build and keep up to date your product’s PIF, in compliance with European Regulation as well as “Colipa Guidelines on de Product Information File (PIF) requirement”.

• Global import/export support.
• Placement cosmetics in the EU from third countries.
• Ensure compliance with Regulation (EU) 1223/2009.
• Material Safety Data Sheets (MSDS) for transportation.
• CPNP notification

Exclusively for cosmetic products imported into Portugal:

• Conformity Document for INFARMED.
• Responsible Technician and Safety Assessor for your company (DL 189/2008 – Portugal).

Both raw materials and finished products are covered by European regulation 453/2010, with respect to the Registration, Evaluation, Authorisation and Restrictions of Chemicals (REACH).
According to regulations, all chemical substances and mixtures must have a Material Safety Data Sheet (MSDS), elaborated in compliance with ISO 11014.

Raw material and finished products must have a Technical Data Sheet were all their characteristics are described, in order to assess, later, their compliance with specifications.

As European Regulation came into force, all cosmetic products placed in the European market, produced in Europe or imported from any other third country, must be notified by the Responsible Person, at the Cosmetic Product Notification Portal, CPNP. This notification system replaces all other notification procedures individually previewed in each European country.