ChemicalScan ChemicalScan

Understanding REACH: The EU Chemical Regulation

What is REACH?

REACH stands for Registration, Evaluation, Authorisation and Restriction of Chemicals. It is a regulation of the European Union, adopted to improve the protection of human health and the environment from the risks that can be posed by chemicals. REACH entered into force on 1 June 2007 and replaced a number of European Directives and Regulations with a single system.

Key Principles of REACH

REACH is based on the principle that manufacturers, importers, and downstream users of chemicals must ensure that the substances they manufacture or place on the market do not adversely affect human health or the environment. Its key principles include:

  • No data, no market: Substances manufactured or imported in quantities of 1 tonne or more per year must be registered with the European Chemicals Agency (ECHA).
  • Burden of proof on industry: Companies must identify and manage risks linked to the substances they manufacture and market in the EU.
  • Substitution of hazardous chemicals: The most dangerous substances should be progressively replaced by less dangerous ones where suitable alternatives exist.

The Four Pillars of REACH

1. Registration

Manufacturers and importers of chemical substances must register them with ECHA if they produce or import 1 tonne or more per year. Registration requires submitting a technical dossier containing information on the properties, uses, and safe handling of the substance. For substances manufactured or imported in quantities of 10 tonnes or more per year, a Chemical Safety Report (CSR) must also be submitted.

2. Evaluation

ECHA and EU Member States evaluate the information submitted by companies to examine the quality of the registration dossiers and testing proposals, and to clarify whether a substance poses a risk to human health or the environment. There are three types of evaluation:

  • Dossier evaluation: ECHA checks compliance and examines testing proposals.
  • Substance evaluation: Member States conduct in-depth evaluations of substances of concern.
  • Testing proposals: ECHA examines proposals for tests on vertebrate animals.

3. Authorisation

The authorisation process aims to ensure that substances of very high concern (SVHCs) are progressively replaced by less dangerous substances or technologies where technically and economically feasible alternatives are available. Companies must apply for authorisation to continue using SVHCs that have been included in the Authorisation List (Annex XIV of REACH).

Substances of Very High Concern include those that are:

  • Carcinogenic, mutagenic, or toxic for reproduction (CMR Category 1A or 1B)
  • Persistent, bioaccumulative, and toxic (PBT)
  • Very persistent and very bioaccumulative (vPvB)
  • Identified as causing an equivalent level of concern (e.g., endocrine disruptors)

4. Restriction

Restrictions are a tool to protect human health and the environment from unacceptable risks posed by chemicals. Restrictions may limit or ban the manufacture, placing on the market, or use of a substance. A restriction applies to any substance on its own, in a mixture, or in an article. Restrictions are listed in Annex XVII of REACH.

Who Does REACH Affect?

REACH affects a wide range of companies across many sectors, not just those in the chemical industry. In general, REACH may apply to your company if you:

  • Manufacture chemicals in the EU/EEA
  • Import chemicals into the EU/EEA
  • Use chemicals in your industrial or professional activities
  • Sell chemicals or products containing chemicals

The Candidate List and SVHC

The Candidate List identifies Substances of Very High Concern (SVHCs). Companies may have immediate legal obligations when a substance is placed on the Candidate List. These obligations relate to:

  • Safety Data Sheets
  • Communication of information on substances in articles
  • Notification to ECHA of substances in articles
  • Waste framework directive obligations

ECHA's Role

The European Chemicals Agency (ECHA) is central to the REACH process. ECHA manages the registration, evaluation, authorisation, and restriction processes. It provides guidance to companies, maintains databases of chemical information, and makes certain information publicly available to help promote the safe use of chemicals.