The European Safety Federation highlighted the issue of counterfeit CE certificates for PPE in a recent article. This applied to protective masks (FFP2/FFP3), protective glasses, face shields, protective gloves and protective garments etc. Therefore, compliance with C&K testing requirements under EU REACH Regulations as well as CE certification is necessary to ensure legitimate PPE.

Under EU REACH, PPE products are defined as articles and therefore must adhere to the requirements of articles set out under EU REACH Regulations. The obligations must be fulfilled by the manufacturer or importer of articles whereby:

  • The total substances present in the article exceeds 1 ton/year per manufacturer/importer
  • The substance is intended to be released under normal or reasonably foreseeable conditions of use

Substances of Very High Concern (SVHC)

SVHCs refer to those substances which have an adverse effect on human health and the environment. According to Article 57 of the EU REACH Regulation, substances containing one or more of the following hazardous properties are considered SVHCs:

  • Substances in Class 1 or Class 2 for carcinogenicity, teratogenicity or reproductive toxicity (CMR 1 or 2 substances)
  • Substances which are persistent and bio-accumulative (PvB substances)
  • Substances which are persistent and highly bio-accumulative (vPvB substances)
  • Substances which do not meet items 2 or 3 but are supported by scientific evidence to be hazardous to human health and/or the environment

If the conditions mentioned above for articles are not met, then the following items must be considered:

  • If articles contain SVHCs in a concentration of less than 0.1 % (w/w), notification to ECHA is not required. However, information shall be communicated to the recipient of the article and relevant information shall be provided at the request of the importer or consumer
  • If articles contain SVCHs in a concentration of greater than 0.1 % (w/w) + the sum of the SVHCs present in those articles is less than 1 ton/year per manufacturer/importer, notification to downstream users and the passing on of information with relevant certifications shall be required
  • If articles contain SVCHs in a concentration of greater than 0.1% (w/w) + the sum of SVHCs present in those articles is 1 ton/year per manufacturer/importer, notification to ECHA and information communication shall be required
  • The manufacturer of such articles shall provide relevant information to the consumer within 45 days of receipt of the request to ensure safe use of the article

The Test Items for PPE

  1. SVHCs: all articles are required
  2. Restricted substances RSL: cadmium, hexavalent chromium, arsenic, lead, formaldehyde, triacridyl phosphorus oxide, polybrominated biphenyls, azo, nonylphenol (polyoxyethylene ether), polycyclic aromatic hydrocarbons, phthalates, rich dimethyl maleate, dimethyl formamide etc.

The testing items are determined by the products materials and usage
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CIRS Europe provides EU REACH Registration service and SVHC testing service.
www.cirs-reach.com

Further information please contact:
Julie Harrington — Regulatory Consultant (CIRS Europe)
Email：julie@cirs-reach.com      Tel: +353 1477 3710

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