R
4 Posts in this encyclopedia categoryREACH Regulation (EC) 1907/2006
REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) is EU chemicals Regulation (EC) 1907/2006, administered by the European Chemicals Agency (ECHA) in Helsinki. For gloves and PPE the key provisions are the Annex XVII restrictions (e.g. phthalates and PAHs in plasticised PVC and elastomers, chromium(VI) in leather) and the duty to communicate information on substances of very high concern (SVHC) on the Candidate List from 0.1 % in an article.
Regulation
A Regulation in EU law is a binding legal act that applies directly in all Member States without requiring national implementing legislation. Key regulations for medical devices and PPE: MDR (EU) 2017/745, PPE Regulation (EU) 2016/425, REACH (EC) 1907/2006. To be distinguished from EU Directives, which must be transposed into national law.