COSMETICS PIF

Cosmetic product safety assessment according to Regulation (EC) No 1223/2009:

from data of the cosmetic product ingredients (part A of the Product Information File (PIF)), is assessed the impact on human health in the safety report (PART B of PIF).

Audits of PIFs

Material Safety data Sheets (MSDS)

Risk analysis to incorporate a cosmetic product in share facilities with drugs, under cross-contamination point of view

 

Cosmetics are complex mixtures, frequently containing natural ingredients themselves, multi components, polymers and nanomaterials.

For cosmetics marketed within the European Union, under Regulation (EC) No 1223/2009

are required Cosmetic Product Safety Reports (CPSR)

Effective May 1, 2020 Regulation (EU) 2019/1966  adds around 30 CMR substances to the annex II (prohibited substances)

The following information is assessed by our qualified safety assessor:

  1.  Quantitative and qualitative composition of the cosmetic product
  2.  Physical/chemical characteristics and stability of the cosmetic product
  3.  Microbiological quality
  4.  Impurities, traces, information about the packaging material
  5.  Normal and reasonably foreseeable use: Label specifications
  6.  Exposure to the cosmetic product: Exposure assessment
  7.  Exposure to the substances: Margin of safety (MoS) calculation
  8.  Toxicological profile of the ingredients
  9.  Undesirable effects and serious undesirable effects
  10.  Information on the cosmetic product

As animal testing for cosmetics is banned in Europe and India, we use a new approach to consumer safety. ‘Next Generation Risk Assessment’ (NGRA), defined as an exposure-led, hypothesis driven risk assessment approach that integrates in silico, in chemico and in vitro approaches. 

The four main principles of the ‘next generation’ risk assessment state that the methods used for safety evaluation need to be relevant to assess the effect on human health and the overall goal should be the prevention of harm.

A hypothesis on the biological mechanisms of the effects should lead the evaluation, as well as considerations of the way, duration and frequency of the exposure to the substance. 

 

Socosur cosmetics safety assessments are certified by a qualified safety assessor.

Our Cosmetics Safety Assessors prepare the Product Safety Information and a Safety Assessment before products can be marketed within EU according to EC 1223/2009. 

Latest news

Back to physical CPhI 2021

SOCOSUR WILL BE BACK TO CPHI WITH BOOTH LOCATED 14B61   CPhI Worldwide houses six...(...)

A3P Cosmetics Symposium 2021

Back to face to face events for Socosur. We will attend A3P Cosmetics symposium 2021 with a...(...)

A3P Cleaning Validation Symposium

Next June 29th and 30th 2021, Socosur Tox will exhibit at the second edition of the A3P Cleaning...(...)

HydroxyChloroquine Sulfate free of charge PDE and OEL monographs to support the fight versus Covid-19

As responsible player in the European healthcare system, we have organized ourselves to meet our...(...)

Stay in touch

Contact us