How the European Union regulates Chemicals

What is REACH?

The chemical industry supplies raw materials to almost every other industry and is essential for economic competitiveness. Although essential, chemicals must be properly managed to avoid damage to human health and the environment. Each country or economic union has a specific way of regulating and controlling chemicals. Within the European Union, we have REACH

REACH stands for Registration, Evaluation, Authorization, and Restriction of Chemicals. It is a European Union regulation that addresses the production and use of chemical substances, and their potential impacts on both human health and the environment. REACH came into force on the first of June 2007 and has been described as the most complex legislation in the European Union’s history.

REACH AIM: Improve the protection of human health and the environment from the risks that can be posed by chemicals and promote alternative methods for the assessment of hazards of substances.

How does REACH work?

REACH establishes procedures for collecting and assessing information on the properties and hazards of substances. The regulation has been established by the European Chemicals Agency (ECHA), which manages the technical, scientific, and administrative aspects of REACH.

ECHA receives and evaluates individual registrations for their compliance. Further EU member states evaluate selected substances to clarify initial concerns for human health or for the environment. Authorities and ECHA’s scientific committees assess whether the risks of substances can be managed.

To comply with the regulation, companies must identify and manage the risks linked to the substances they manufacture and market in the EU. They must demonstrate how the substance can be safely used, and they must communicate the risk management measures to the users.

If the risks cannot be managed, authorities can restrict the use of substances. All legal information can be found in “REGULATION (EC) No 1907/2006 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL”.

Which companies does REACH affect?

REACH obligations are not only complied with manufacturers of chemical substances, but also to all companies which deal with preparations of the product or articles that contain those substances. For this reason, REACH has an impact on a wide range of companies across many sectors.

If you are an importer of chemical and non-chemical products (such as paints, clothes, furniture, plastic, etc.) you need to ensure that all components should be registered under REACH. Companies established outside the EU are not bound to the obligations of REACH.

The responsibility for fulfilling the requirements of REACH, lies with the importers established in the European Union, or with the only representative of a non-EU manufacturer established in the European Union. REACH applies to substances manufactured or imported in quantities of 1 tonne or more per year, per manufacturer/importer. Some substances are excluded from all or certain aspects of REACH.

Total exemptions

  • Radio-active substances
  • Substances under customs supervision
  • Substances used in the interest of defense and covered by National exemptions
  • Waste
  • Non-isolated intermediates and transported substance

Partial exemptions

  • Substances used in food
  • Medicinal products;
  • Substances included in Annex IV of the REACH Regulation which are known to be safe (such as Nitrogen)
  • Corn
  • Oil
  • Substances covered by Annex V of the REACH Regulation
  • Substances which occur in nature, if they are not chemically modified
  • Minerals
  • ores, ore concentrates
  • cement clinker
  • natural gas
  • liquefied petroleum gas
  • natural gas condensate, process gases and components thereof
  • crude oil, coal, coke
  • Substances occurring in nature other than those listed under paragraph 7, if they are not chemically modified unless they meet the criteria for classification as dangerous according to Directive 67/548/EEC. (Examples include beeswax and some fibers)
  • Polymers (however, monomer shall be registered)
  • Recycled or recovered substance already registered
  • Re-imported substance
  • Substances used for the purposes of product and process-oriented research and development (PPORD) Note: PPORD notification shall be submitted instead.  

Legislation in non-EU countries

A number of countries outside of the European Union have started to implement REACH regulations or are in the process of adopting such a regulatory framework to approach a more globalized system of chemical registration under the Globally Harmonized System of Classification and Labelling of Chemicals (GHS).  

China, the largest chemical manufacturer in the world, has also moved towards a more efficient and coherent system for the control of chemicals in compliance with GHS. Balkan countries such as Croatia and Serbia are in the process of adopting the EU REACH system under the auspices of the EU IPA program.

Switzerland has moved towards the implementation of REACH through partial revision of the Swiss Chemical Ordinance. Turkey has also paved the way to adopt REACH with the new Chemicals Management Regulation.

Transported isolated intermediates

Manufacturers or importers of transported isolated intermediates in quantities of 1 tonne or more per year need to submit a registration dossier (unless the substance is exempted from the registration provisions). The information to be submitted for standard registration purposes is listed under article 10.

However, a registrant of transported isolated intermediates can provide reduced registration information according to article 18 (2) if he confirms that he is manufacturing and/or using the substance under strictly controlled conditions and if he confirms himself or states that he has received confirmation from the user that the substance is used under strictly controlled conditions as described under article 18 (4).

In that case, both the registrant and the users are each liable for their own statement regarding the strictly controlled conditions.

Article 18 on CheMondis

As described in our Terms & Conditions, suppliers must comply with the regulations in order to sell their products on CheMondis. Next to safety and technical datasheets, users can add other relevant information about their products.

Further, suppliers are requested to tick a specific box indicating that their products are regulated by article 18, which covers the registration of transported isolated intermediates. 

Our chemical team constantly re-checks all product information, including the indications about article 18. Nevertheless, CheMondis cannot be heald liable for all information provided by third-party-sellers. 

Thank you for taking the time to read the CheMondis Blog.