REACH is Regulation (EC) No 1907/2006, a European regulation introduced to protect human health and the environment from the risks associated with the manufacture, placing on the market and use of chemical substances.
The acronym REACH stands for Registration, Evaluation, Authorisation and Restriction of Chemicals.
Exposure to substances during their use can have adverse effects on both human health and the environment. The purpose of REACH is therefore to establish the measures necessary to control the risks arising from the manufacture and use of chemical substances.
To comply with REACH requirements, companies must identify the hazards associated with the substances they manufacture and market within the European Union, determine how these substances can be used safely, and communicate information about their properties and hazards to users throughout the supply chain.
Who must comply with the REACH Regulation?
REACH is a cross-sectoral regulation that affects virtually all industries, including companies that may not initially consider themselves part of the chemical sector.
Depending on a company’s activities, REACH defines the following roles:
- Manufacturer – A company established in the EU that manufactures chemical substances.
- Importer – A company established in the EU that imports chemical products from outside the European Union.
- Downstream User – A company established in the EU that uses chemical products as part of its industrial or professional activities.
- Distributor – A company established in the EU that stores and places chemical products on the market without using them.
- Article Producer – A company established in the EU that manufactures or assembles an article within the European Union.
- Only Representative (OR) – A company established in the EU that has been appointed by a non-EU manufacturer, formulator or article producer to fulfil the obligations that would otherwise apply to importers under REACH.
Which chemical products are covered by REACH?
REACH applies to all substances, whether on their own, in mixtures or contained in articles, that are manufactured or imported into the European Union. However, certain substances are exempt under Article 2 of REACH, including: radioactive substances, substances under customs supervision, non-isolated intermediates,the transport of dangerous substances by rail, road, inland waterway, sea or air, and waste.
What does the REACH Regulation require?
To comply with REACH, companies must identify the hazards associated with the substances they manufacture and market in the European Union, determine how these substances can be used safely, and communicate relevant information on their properties and hazards to users.
To achieve this, REACH establishes a number of obligations for companies placing chemical products on the European market, including:
- REACH Registration
- Communication within the supply chain (Title IV), such as Safety Data Sheets (SDSs) and information on SVHCs in articles.
- Restrictions on substances
- Substances subject to authorisation
- Notification of substances contained in articles
Not all companies have the same obligations. The specific requirements applicable to a company depend on its role or roles within the supply chain.
What is REACH registration?
Companies are required to submit a registration to ECHA (the European Chemicals Agency) for substances that they manufacture and/or import in quantities of one tonne or more per year. The registration must include information on: hazardous properties, uses of the substance and recommendations for safe use.
REACH registration is based on the principle of “one substance, one registration”, meaning that manufacturers and importers of the same substance are required to submit certain information jointly.
The registration package consists of a technical dossier and, for hazardous substances manufactured or imported in quantities of 10 tonnes or more per year, a Chemical Safety Report (CSR) must also be included.
Who is the competent authority?
ECHA (European Chemicals Agency), established in 2007 and headquartered in Helsinki, is the body responsible for implementing EU chemicals legislation. Its mission is to promote the safe use of chemicals and ensure a high level of protection for human health and the environment.
ECHA supports companies by providing information on chemical substances and their uses, managing registration dossiers submitted by industry and evaluating information and focusing on substances of greatest concern.
While ECHA manages the regulatory framework, enforcement responsibilities lie with the competent authorities designated by each Member State, typically ministries or governmental departments responsible for environmental or public health matters.
Would you like to download the REACH Regulation in PDF format? Click here
Would you like to know which REACH obligations apply to your company?
Through its REACH consulting services, ServiREACH provides the support companies need to comply with REACH requirements across all European Union Member States.
Our services include:
- REACH compliance assessment
- REACH Registration
- Registration cost analysis
- Only Representative (OR) services
- Safety Data Sheet (SDS)
If you are a non-EU manufacturer exporting chemical products to Europe, you can appoint ServiREACH as your Only Representative, allowing your products to be placed on the EU market without requiring your customers to register the substances themselves.
