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Due to the recent COVID-19 situation in the European Union, there has been an increasing demand for protective masks and personal protective equipment (PPE). For these PPEs, including protective masks, protective glasses and face shields, protective gloves and garments and etc., to be imported into the EU, in addition to fulfilling Regulation (EU) 2016/425, relevant restricted substances requirements shall also be considered simultaneously. 

Recently, the European Safety Federation has published a notice about conformity assessment procedures for PPE.

Relevant restricted substances requirements for Protective Masks and PPEs include, but not limited to:

  • REACH Annex XVII (e.g. Azo dyes, dimethyl fumarate, chromium (VI), Phthalates and etc.)
  • POPs (SCCP, PCP and etc.)
  • Packaging requirements

Over the past years, there has been numerous recall cases on PPEs in the EU. According to statistics from the Rapid Alert System for dangerous non-food products (RAPEX), there has been over 120 recall cases on PPEs since 2005, and a lot of them are related to restricted substances requirements such as REACH and POPs.

Figure 1. Statistics on RAPEX Recall Cases for PPE

 Recall, Chart, PPE


SGS’s medical device testing, certification, audit and training services can help you navigate the complexities of international medical device regulations to bring your products to market while ensuring compliance with the required regulations and standards and providing a high level of safety to patients and healthcare professionals.


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