M
Manufacturer
Definition
Under REACH Article 3(9), a manufacturer is any natural or legal person established within the EU who manufactures a substance within the EU. EU manufacturers of substances above 1 tonne per year must register those substances with ECHA before placing them on the EU market. Manufacturers are primary duty holders for registration, Chemical Safety Assessment, Safety Data Sheet preparation, and supply chain communication obligations.
Source
REACH Regulation (EC) No 1907/2006, Article 3(9) and Articles 6–14.
Practical Explanation (Compliance Context)
EU manufacturers initiating production of a new substance must register before manufacture commences above 1 t/year. Manufacturers must ensure IUCLID dossiers are kept current with updated data and use patterns. They are responsible for deriving DNELs, PNECs, and exposure scenarios that form the basis of the eSDS communicated to downstream users. Non-EU manufacturers exporting to the EU must appoint an Only Representative to fulfil registration obligations.