The main actors in the evaluation process are:
A natural or legal person established within the European Economic Area (EEA), manufacturing or importing a substance into the EEA at quantities of one tonne or more per year or who has been appointed as an only representative according to Article 8 of the REACH Regulation, can act as a registrant.
REACH requires registrants to provide information on the intrinsic properties of a substance. The information required for each substance depends on the tonnage manufactured or imported; the higher the tonnage, the more information needs to be submitted. Submission includes a technical dossier and, for substances manufactured or imported in quantities of 10 tonnes per year or above, a chemical safety report.
Third parties are citizens, organisations, academics, companies or authorities other than a registrant. They may provide information on testing proposals involving vertebrate animals.
The ECHA Secretariat supports the Committees and the Forum by providing the best possible scientific, technical and regulatory services in an efficient and transparent way.
Member State Committee (MSC)
The task of the Member State Committee is to seek unanimous agreement on the draft evaluation decisions of ECHA to which Member States have proposed amendments. These draft decisions are discussed and agreed upon by the Member State Committee in its meetings, or alternatively, agreement may be sought via written procedure.
Once agreed by the Member State Committee, ECHA finalises the decision and provides it to the registrant. If unanimous agreement cannot be reached, the matter is referred to the European Commission for it to make a decision.
The Member State competent authorities can comment on and propose amendments to ECHA's draft decisions.
They can also propose substances for substance evaluation.
Member States will carry out this evaluation to clarify any potential risk to human health or the environment that the substance may cause. Further information may be requested through an ECHA decision.
Member States can also impose national actions on substances or registrants, or initiate the adoption of EU-wide risk management measures (e.g. occupational exposure limits, EU-wide restriction, EU-harmonised classification and labelling).
All evaluation decisions made by ECHA must be unanimously supported by the Member States. If unanimous agreement cannot be reached, the European Commission has to prepare the draft decision to be taken according to the examination procedure [under Articles 5 and 13(1)(c) of Regulation 182/2011].