Since the publication of Regulation 1223/2009 EC rules on cosmetic products and communication through the European portal CPNP, companies have been developing the safety dossiers to the expert report, the dossier of product information, etc. In these times and in application of Law 10/2013, all manufacturers know they should present the "Responsible Declaration" start of activity, a step that is important to be aware of all its implications, and how efficiently to not pass continuously pay fees.

With the entry into force of the regulation, it must meet several aspects:

  • Address the restriction of substances.
  • It is mandatory to adopt good practices (GMP, GDP, etc).
  • Labeling, claims and notifications.

In general, one can say, that all this can be integrated into the second point, tending to the implementation of a complete quality system, ie further from ISO 9001 and very close to the ISO 22716, in some respects needless to reach it and in others, it is exceeded.
Sistema Calidad Fabricación de Cosméticos

Regulation 655/2013 has also involved major changes in claims, in particular about:

  • Sunscreen products.
  • Dyes.
  • Aerosols.
  • The "Made in ...", when imported substances.
  • If a distributor modifies the claims, it assumes responsibility.

Especially we highlight Annex I of this regulation because under the concept of Truth, three important aspects, which can determine the activity of technical/laboratory and Marketing departments, are introduced:

  • Show claims: The claims shall be demonstrated, ie not contain a "hydrating substance", the resulting cosmetic is.
  • The "representative sample": this issue is important and can be a great opportunity to improve processes and products through statistical methods. This concept can be interpreted in various ways, it is related to the sample size, but distinct, we determine how samples are selected. It is a matter of precision, risk tolerance and cost.
  • justification of opinions: Expert opinions assumptions are no longer valid if they are not justified based on scientific evidence.

The claims shall be demonstrated, ie not contain a "hydrating substance", the resulting cosmetic is. In addition a significant change occurs, the claims become an integral part of the product.

In all this we can help your company.