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+351 259 308 214 info@cosmetek.org

The cosmetics industry is highly regulated and continually evolving to ensure the safety of use and legitimacy of label claims for a wide range of personal care products. Our expert understanding of global guidelines allow us to offer up-to-date support for all of your regulatory needs.

Compliance Assessment

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.

PIF (Product Information File)

The new EU Regulation 1223/2009 has been in force since 11 July 2013, replacing the Directive 76/768/EC with all amendments. It carries out a number of implementations and clarifications based on the experiences of the past years.

Focusing attention on some keywords which have been further elaborated and defined: in particular, the appointment of the Responsible Person, the implementation of the Product Information File (PIF) and the application of the Good Manufacturing Practice according to ISO 22716.

Product Information File is more complex and articulated: 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”.

Technical Data Sheet, MSDS and other documents

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.

CPNP (Cosmetic Products Notification Portal) Notification

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.

Monitorisation of relevant legislation, both national and european

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