REACH Regulation

REACH (Registration, Evaluation, Authorization and Restriction of Chemicals) is a European Union regulation adopted to improve the protection of human health and the environment from the risks posed by chemicals.

REACH Process Overview

Key Elements of REACH

Registration: Companies must register substances manufactured or imported in quantities of 1 tonne or more per year
Evaluation: ECHA and Member States evaluate information submitted by companies
Authorization: Substances of Very High Concern (SVHC) require specific authorization
Restriction: Certain substances may be restricted if they pose unacceptable risks

Registration Process

Registration Process

Pre-registration or inquiry
Data gathering and sharing
Hazard assessment
Chemical safety assessment (for substances >10 tonnes/year)
Preparation and submission of registration dossier

Information Requirements by Tonnage Band

Tonnage Band (tonnes/year)	Key Requirements	Additional Information
1-10	Physicochemical properties Available toxicological data Basic environmental data	Reduced requirements for phase-in substances meeting Annex III criteria
10-100	Additional toxicological testing Environmental fate and behavior Chemical Safety Report	Exposure scenarios required for hazardous substances
100-1000	Extended toxicological testing Long-term aquatic toxicity Developmental toxicity	Testing proposals may be required
>1000	Comprehensive testing package Carcinogenicity studies Long-term reproductive toxicity	Highest level of scrutiny and data requirements

Authorization Process

Authorization Process

Identification of SVHCs
Prioritization and inclusion in Annex XIV
Application for authorization
Analysis of alternatives
Socio-economic analysis

Important Updates and Changes:

Increased focus on nanomaterials
Enhanced requirements for polymers
Integration with circular economy objectives
Improved information requirements for low-tonnage substances
Better alignment with other EU chemical legislation