Actors
The main actors in the evaluation process are:
1. Registrant
A natural or legal person established within the European Economic Area (EEA), manufacturing or importing a substance into the EEA at quantities of 1 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 is dependant 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 p.a. or above, a chemical safety report.
Registration under REACH [PDF]
Guidance on registration [PDF]
- Guidance on Information Requirements and Chemical Safety Assessment PATHFINDER
2. Third parties
Third parties are citizens, organisations, academics, companies as well as authorities other than the registrant. They may provide information on a testing proposal involving vertebrate animals.
Consultations on testing proposals
3. ECHA
3.1 Secretariat
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.
Evaluation Directorate and Units
3.2 Committees
3.2.1 Member State Committee (MSC)
The task of the Member State Committee is to seek unanimous agreement on 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. In cases where unanimous agreement cannot be reached, the matter is referred to the European Commission for it to make a decision.
4. Member States
The Competent Authorities of the Member States can comment on and propose amendments to ECHA's draft decisions.
The Competent Authorities of the Member States can propose substances for substance evaluation. The Member States will carry out this evaluation to clarify any potential risk to human health or the environment the substance may cause. Further information may be requested through an ECHA decision.
The 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).
5. European Commission
All evaluation decisions made by ECHA must be unanimously supported by EU Member States. If unanimous agreement cannot be reached, the European Commission shall prepare the draft decision to be taken according to the comitology procedure.