3rd Party Testing Overview

The US (FDA) does not have standards regarding 3rd Party Testing. However, there are certain types of testing required for cosmetic products in the EU before products can go to market. There are three  (3) main types of testing for cosmetic products in the EU and it is very time consuming – the basic tests are as follows: 

1. Stability and Compatibility tests 

2. Challenge test (Preservative Efficacy Test, abbreviated PET) 

3. Microbiological Quality Analysis 

These are the EU governing articles for cosmetics, of importance Article 16, Article 17, and Annex I shows an example of the  required Cosmetic Product Safety Report: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX%3A32009R1223 &fbclid=PAAaaj-h_rySeAY9-plnrbCupNXRC2y88Y45Wd6dzRuUYK0VI9-WcM-1OPqkA_aem_AdBQIRMBmDuEUOwW2OR1cZ 25BLwgaRtrfkdxmD-1TgjnA5YS8SBSh4H4Hz0TuH_SQO8 

Heavy Metals: It is important to understand that it is impossible to remove all trace heavy metals from products and formulations. The UK and EU Cosmetics Regulations allow for the fact that products may contain ‘unavoidable traces’ and crucially this  doesn’t indicate that the raw ingredient or finished product is unsafe. Rather than specifying exactly what constitutes an ‘unavoidable trace’, they state instead that each impurity must be assessed on an individual basis to ensure its presence does not pose  any risk to human health. This of course requires accurate analyses of both raw materials and finished products, as well as the  production of any necessary paperwork to prove safety. (This process forms part of the safety assessment as required under  Article 10 and Annex I of the EU and UK Cosmetics Regulations.) 

The CTPA, or Cosmetic, Toiletry & Perfumery Association represents all types of companies involved in making and selling cosmetic and personal care products. It effectively acts as a voice to the industry, offering advice and training to help ensure regulations are understood and met. The CTPA have made various statements about trace heavy metals in products, including one on  Heavy Metals in general, and more specifically about Antimony, Chromium, Lead and Mercury. 

German guidance goes further than the rest of the EU. The German authorities, Federal Office of Consumer Protection and  Food Safety, have issued guidance recommending specific limits for heavy metals in cosmetic products. The aim of providing  these, rather than defining an acceptable safety threshold, was to analyze the state of the market and to have an idea of the  technically unavoidable. If the trace levels of Heavy Metals are above the recommended levels, they will then request the  Responsible Person to justify and include the reasoning in the safety assessment.