What is EU REACH and Why Does it Matter?
EU REACH (EC No 1907/2006) — short for Registration, Evaluation, Authorisation, and Restriction of Chemicals — is the cornerstone of the EU’s chemical safety framework. Enforced by the European Chemicals Agency (ECHA) since June 1, 2007, its core goal is to safeguard human health, workers, and the environment from chemical risks while ensuring full supply chain transparency.
Under EU REACH, chemical substances—whether standalone, in mixtures, or in articles—must be registered with ECHA if manufactured or imported into the EU at 1 tonne or more per year. Failure to register results in a ban on manufacturing the substance in, or importing it to, the EU.
Beyond registration, substances may also be subject to REACH’s other key obligations: evaluation, authorisation, restriction, and notification—all designed to mitigate long-term chemical risks.
What Does EU REACH Apply To?
EU REACH scope covers three primary categories of chemical-related products. For businesses selling into the EU, clarifying which category your products fall into is the first step to compliance:
Substances
Pure chemicals (e.g., sodium chloride, ethanol) with an annual manufacturing or importing volume of ≥ 1 ton. Split into two types:
Phase-in Substances (“Existing Substances”): Listed in the EINECS (European Inventory of Existing Commercial Chemical Substances) or NLP (No-Longer Polymers) lists, or manufactured but not placed on the EU market before May 31, 1992.
Non-Phase-in Substances (“New Substances”): Not meeting the criteria for phase-in substances (e.g., newly developed chemicals post-1992).
Mixtures
Blends of two or more substances (e.g., cleaning products, paints). Registration applies if the total quantity of a single substance in the mixture is ≥1 t/a.
Articles
Products where chemicals are part of a physical object (e.g., electronics, textiles). REACH registration is required only if:
A substance in the article is deliberately released (e.g., air fresheners, where fragrance is released for a specific function), and
The released substance is manufactured/imported >1 t/a.
Substances Exempt from EU REACH
EU REACH clearly defines comprehensive total and partial exemptions from registration obligations, which are fully aligned with ECHA’s official regulatory guidelines.
Fully Exempt from the EU REACH Regulation
Radioactive substances
Substances in temporary storage under customs supervision, provided they are not being transformed or processed in any way
Substances used in the interest of defence when (these are) covered by specific national exemptions
The transport of hazardous substances on their own or in mixtures
Non-isolated intermediates – these are substances that appear between two successive chemical reactions and that are not removed from the system, except for sampling
Waste is exempt from REACH, but a product recovered from waste is not. REACH applies to any substance, mixture, or article you recover from waste that meets the end-of-waste criteria. However, sometimes it's possible to get an exemption for a recovered substance that has already been registered by someone else.
Exemptions from EU REACH Registration
Exempt from both registration and authorisation:
Scientific research and development
Food and feedstuffs
Medicinal products
Exempt from registration only:
That present minimum risk because of their basic properties (e.g. water, nitrogen) listed in Annex IV of REACH
Occurring in nature (e.g. minerals, ores and ore concentrates that are not chemically modified) where registration is deemed inappropriate or unnecessary.
Already registered, then exported from and re-imported into the EEA, by an actor in the supply chain
- Already registered and recovered through a waste recovery process
Deemed Registered Substances
Active substances in plant protection products and biocidal products
Substances notified under the Notification of New Substances (NONS) scheme of Directive 67/548/EEC – that was in place before REACH – are considered as registered.
Who is Responsible for EU REACH Registration?
REACH assigns obligations based on your role in the EU supply chain—no ambiguity. Here’s exactly who is legally responsible for registration:
EU-Based Manufacturers/Importers: Legally responsible for registering all substances, mixtures, and applicable articles produced in or imported into the EU that meet the ≥1 t/a threshold.
EU-Based Article Producers/Importers: Only required to register when articles containing deliberately released substances exceeding the 1 t/a annual threshold.
Only Representatives (ORs): Appointed by non-EU manufacturers to act as their legal representative in the EU. ORs handle registration, notification, and compliance on behalf of non-EU companies—protecting confidential business information (CBI) from importers/public.
EU-Based Downstream Users (DUs): Companies that use chemicals. DUs must follow safety guidelines from eSDS, report adverse effects, and comply with restrictions/authorizations.
How Non-EU Manufacturers Can Comply with EU REACH
Non-EU manufacturers are prohibited from directly registering substances with the European Chemicals Agency (ECHA). To legally place chemicals on the EU market, they must select one of three compliant pathways:
Establish an EU Branch Office: Establish a legal entity in the EU to handle registration, compliance, and reporting. This option gives full control but requires significant investment in EU-based resources.
Partner with an EU-Based Importer: Partner with an EU-based importer who registers the substance on your behalf. Note: This arrangement typically requires sharing confidential business information (CBI) with the importer, which may expose sensitive commercial data.
Appoint an Only Representative (OR): The most secure and widely adopted pathway for non-EU manufacturers. An OR acts as the non-EU manufacturer's legal proxy in the EU, assuming full responsibility for registration, notification, and CBI protection. This structure ensures sensitive commercial and technical data is not disclosed to importers, competitors, or the public, while maintaining full compliance with REACH's legal requirements.
For professional, fully REACH-compliant OR services tailored to your regulatory needs, contact REACH24H.
EU REACH Registration Procedure
Special Registration Types under EU REACH
Polymers Registration
Polymers that meet the REACH definition of a polymer—namely, substances in which more than 50% (w/w) of the components consist of molecules with a degree of polymerisation (n) ≥ 3, and no more than 50% (w/w) of the components consist of molecules of the same degree of polymerisation—are exempt from EU REACH registration as such.
However, the monomers and other reactants used to manufacture the polymer must be registered under EU REACH, where:
they are present in the polymer structure at ≥ 2% (w/w); and
their quantity reaches 1 tonne or more per year.
Intermediate Registration
On-site isolated intermediates and transported isolated intermediates may be registered as intermediates where they are used under Strictly Controlled Conditions (SCC).
In such cases, reduced information requirements apply in accordance with the intermediate registration provisions under EU REACH.
PPORD Registration
Substances used for Product and Process Oriented Research and Development (PPORD) purposes—such as the development or improvement of products or processes, including scale-up activities in pilot plants or industrial production—may be exempt from EU REACH registration for a period of five years upon submission of a PPORD notification.
This exemption may be extended once, for a maximum additional period of five years.
Key Compliance Obligations Beyond Registration
EU REACH is an ongoing process. After registration, substances may be subject to further controls.
Obligations | Details |
Evaluation |
|
Notification |
|
Authorisation |
|
Restriction |
|
FAQs: Common EU REACH Questions
Q1: What is a Lead Registrant (LR) under EU REACH?
A Lead Registrant (LR) is a registrant designated to coordinate the joint registration of a single substance under EU REACH, adhering to the "one substance, one dossier" principle. The LR submits the core data section of the registration dossier (including classification & labeling, physical-chemical properties, toxicological data, and ecotoxicological data) on behalf of other co-registrants, who have consented to their role.
Typically, an LR is the company that registers first, owns key substance data, or has a large annual registered tonnage of the substance.
Q2: Can non-EU distributors/trading companies appoint an Only Representative (OR) for EU REACH registration?
No, according to EU REACH Regulation (EC) No 1907/2006, non-EU distributors cannot appoint an Only Representative (OR) to register substances. Non-EU manufacturers are allowed to appoint an OR to handle their REACH registration obligations.
Q3: What documents must a company share with downstream partners after completing REACH registration?
After obtaining REACH registration, companies must promptly provide the following documents to downstream partners:
REACH registration number
Tonnage coverage certificate
Extended Safety Data Sheet (eSDS)
Q4: Do cosmetics and cosmetic ingredients require EU REACH registration?
Yes. EU REACH does not exempt cosmetics or cosmetic ingredients. Any cosmetic ingredient (or substance in a finished cosmetic product) that is manufactured in or imported into the EU at a quantity of ≥1 tonne per year (t/a) is subject to EU REACH registration obligations.
Our Services
Only Representative (OR) Service
Inquiry Service
EU REACH Registration Service
Lead Registrant Service
Exemption Declaration Service
OR Change Service
SIEF Management
Exposure Scenario (ES) Development
Chemical Safety Assessment and Chemical Safety Report (CSR) Preparation
Extended Safety Data Sheet (eSDS) Preparation
Third Party Technical Support
Compliance Check of Qualified Suppliers
PPORD Notification Service
Authorization Application Service
Testing Monitoring Service
REACH Training
EU Authorities Inspection Assistance
Consortium Supporting Service
Why REACH24H?
Technical Strength
Our team of seasoned regulatory experts, chemists, and compliance specialists brings over a decade of experience navigating EU chemical regulations.
We maintain strong, long-standing relationships with ECHA and regulatory authorities across EU member states, ensuring efficient resolution of compliance challenges.
We have extensive risk assessment capabilities and a global network of accredited testing laboratories to support data generation for registration dossiers.
Business Achievements
We serve as the trusted REACH compliance partner for approximately 3,000 enterprises worldwide.
We have successfully completed nearly 10,000 substance registrations (including pre-registration, late pre-registration, and full registration) with a 100% dossier acceptance rate from ECHA.
We deliver tailored compliance solutions for diverse industries, including rubber, flavor & fragrance, specialty chemicals, inorganic salts, pharmaceuticals, and agrochemicals.
If you have any questions on EU REACH, please feel free to contact us at customer@reach24h.com.
