If you manufacture or import one tonne or more per year of a chemical substance in the EEA, you must record this in the REACH database. REACH stands for the Registration, Evaluation, Authorisation and Restriction of Chemicals.
REACH applies to all chemical substances, both those needed for industrial processes and those we use in our everyday lives, in paints, cleaning products, clothes, furniture and electrical appliances, for example. It thus affects most businesses in the European Economic Area (EEA).
Non-registered substances must not be marketed or used.
REACH applies to you if your business is:
- a manufacturer - you make chemicals for sale by your company or for supply to others.
- an importer - you buy individual chemicals, mixtures of chemicals or products such as clothes, furniture or plastic goods from outside the EU.
- a distributor - you store and place on the market chemicals or mixtures of chemicals.
- a downstream user - you use chemicals or mixtures of chemicals in your industry or occupation.
To comply with the regulation, you must identify and manage the risks associated with the substances you manufacture and market in the EU/EEA.
As a manufacturer or importer registering such substances, you must show the European Chemicals Agency (ECHA) how they can be used safely and use a safety data sheet to inform potential users in the supply chain of any risk management measures they may need to take.
If your business is a downstream user, you have different obligations to meet. The main one is to take any risk management measures detailed in the safety data sheets. Check that your uses are covered in the registration dossiers and make contact with your suppliers and users in the supply chain.
Browse the SME support section on ECHA to learn about the issues relevant to small businesses.
How REACH works
REACH has introduced marketing rules on covering substances in isolation, mixtures and substances used in goods. It ensures that the industry takes responsibility for:
- managing any risks that chemicals may pose to health and the environment
- providing users in the supply chain with appropriate safety information.
It also enables the European Union to take additional measures if complementary action at EU level is needed. The European Chemicals Agency (ECHA) helps coordinate and implement all the necessary steps:
- Registration is compulsory where a company intends to manufacture or import a tonne or more per year of a particular substance.
- As part of the evaluation, the European Chemicals Agency (ECHA) examines information in the registration dossiers and all testing proposals to avoid unnecessary testing, especially on animals. National authorities assess substances in the light of specific concerns about human health and the environment.
- An authorisation is required for certain substances that raise particular concerns, to ensure that any risks they pose are properly controlled, and such substances are gradually replaced by safer alternatives once these are economically and technically viable.
- Restriction can limit or ban the production, marketing or use of certain substances if they pose an unacceptable risk to health or the environment.
Fees and charges
REACH requires fees and charges to be paid. The amounts charged and deadlines for payment depend on the type of submission concerned. Small and medium-sized enterprises pay reduced fees. Your business will also need to take into account other costs associated with REACH, including:
- data sharing
- chemical safety assessments
- research into substitutes for particular substances
You can reduce your costs significantly through close cooperation with the other parties involved, including preparing in good time.
See also:
FAQs
The Regulation on the registration, evaluation, authorisation and restriction of chemicals (REACH) is the main EU law to protect human health and the environment from the risks that can be posed by chemicals.
What is EU REACH registration? ›
REACH is the EU regulation governing the manufacture and import of chemical substances. REACH is an acronym for the “registration, evaluation and authorization of chemicals” and has been in force in all EU Member States since June 1, 2007. It also applies in Iceland, Lichtenstein, and Norway.
Is registration of REACH mandatory for all chemical substances that are imported in the EU? ›
Registering chemicals (REACH) If you manufacture or import one tonne or more per year of a chemical substance in the EEA, you must record this in the REACH database.
Do I need to register my product with REACH? ›
If you use, supply or manufacture chemical substances, or import them from outside the European Union (EU), you must comply with the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Regulation.
How many chemicals are banned in the US vs Europe? ›
In cosmetics alone, the EU has banned or restricted more than 1,300 chemicals while the US has outlawed or curbed just 11. It's possible to find formaldehyde, a known carcinogen banned in EU-sold cosmetics, in US hair-straightening treatments and nail polish.
What is the EU Regulation for contaminants? ›
Maximum levels for certain contaminants in food are set in Commission Regulation (EU) 2023/915. Maximum levels in certain foods are set for the following contaminants: mycotoxins (aflatoxins, ochratoxin A, patulin, deoxynivalenol, zearalenone, fumonisins, citrinine, ergot sclerotia and ergot alkaloids)
What are the requirements of REACH regulations? ›
The REACH Regulation:
- requires manufacturers and importers of chemical substances to gather hazard information and assess risks;
- can require the use of some particularly high-risk substances to be authorised;
- restricts the marketing and use of certain hazardous chemicals and mixtures.
The best way to verify the validity of a REACH registration number is to look at the original submission report issued by ECHA. On the report, you can find registration number, registered tonnage band and registrant's name.
How do I register a product in Europe? ›
How to register. To register the name of a product, EU producers or producer groups need to lay down the product's specifications and link to the geographical area, if applicable. The application is sent to national authorities for scrutiny and then forwarded to the European Commission, who will examine the request.
Do US companies have to comply with REACH? ›
American and other non-EU companies selling products into the European Union must comply with an EU regulatory program known as Registration, Evaluation, Authorisation & Restriction of Chemicals, more commonly known by its acronym "REACH." EU REACH is a complex system of regulations that can severely impede the ability ...
Substances Exempted from REACH Registration
Substances used in food stuffs; Medicinal products; Substances included in Annex IV of the REACH Regulation (68 substances known to be safe such as Nitrogen, Corn Oil); Substances covered by Annex V of the REACH Regulation.
How to get a REACH certificate? ›
EU REACH Compliance Requirements
- Step 1: Product Information Collection and Analysis. ...
- Step 2: Registration of Substances. ...
- Step 3: ECHA Registration Evaluation. ...
- Step 4: Ruling on Substances by ECHA. ...
- Step 5: REACH Certification.
The inquiry process takes 1-2 months and the whole registration process might take up to 12 months.
How many chemicals are registered under REACH? ›
Making REACH work the chemical industry's priority
More than 20,000 substances have been registered with ECHA, with corresponding physico-chemical, toxicological, ecotoxicological and use data, thereby creating the largest and most comprehensive database on substances, their properties and behaviour in the world.
How do I know if my product is REACH compliant? ›
If you product is a chemical product (substance or mixture), you need to ensure that every substance in it has been registered under EU REACH when the volume of that substance exceeds 1t/y. The best way to show compliance is to obtain a REACH registration number issued by the European Chemicals Agency (ECHA).
What is the EU GMP Regulation? ›
GMP requires that medicines: are of consistent high quality; are appropriate for their intended use; meet the requirements of the marketing authorisation or clinical trial authorisation.
What is the Regulation of chemicals? ›
EPA regulates the production and distribution of commercial and industrial chemicals, in order to ensure that chemicals for sale and use in the United States do not harm human health or the environment. Read more at Pollution Prevention and Toxics. On this page: Chemicals and Hazardous Substances.
What is the TSCA chemical Regulation? ›
The Toxic Substances Control Act of 1976 provides EPA with authority to require reporting, record-keeping and testing requirements, and restrictions relating to chemical substances and/or mixtures. Certain substances are generally excluded from TSCA, including, among others, food, drugs, cosmetics and pesticides.
What is the chemical ban in Europe? ›
The EU decided on March 23, 2023 to ban two very toxic chemicals Ipconazole and Oxamyl. They are banned because they have been proven to be too dangerous. So they were not substituted, but banned.
