EU REACH Registration

What is EU REACH?

REACH stands for Registration, Evaluation, Authorization and Restriction of Chemicals. It was implemented on June 1, 2008. According to the REACH regulation, companies that are importing or manufacturing chemicals within the European Union (EU) — whether standalone, in mixtures, or intentionally released from products — are responsible for registering these substances if they are manufactured or imported in annual quantities exceeding 1 ton. On completion of registration, an 18-digit registration code will be issued to the registrant. Now that the last registration deadline has passed, companies must complete full registration prior to manufacturing or importing chemicals into the EU. Additionally, certain registered substances are subject to post-registration obligations, including evaluation, notification/authorization, and restrictions.

The enforcement of REACH has significantly impacted exports to the EU, particularly in industries such as chemicals, electromechanical goods, textiles, printing and dyeing, rubber, plastics, toys, and furniture.

Four Core Pillars of REACH Regulation

Registration: This is the primary obligation under REACH. It requires all companies manufacturing or placing a substance on the EU market in quantities greater than one ton per year (1t/y) to register that substance with the European Chemicals Agency (ECHA). For legal reasons, only companies with a legal entity in Europe are allowed to submit a registration under REACH. However, non-EU companies can submit a REACH registration by appointing an Only Representative (OR) to register on their behalf, in which case their importers will be regarded as downstream users and do not need to do registrations.

Evaluation: ECHA and the competent authority of member states review the submitted dossier, including the quality of the data and the source, the reasons for the exemption, and the quality of the risk assessment report. Following the evaluation of the dossier, the registrants may be required to generate additional data and update their dossiers or reports accordingly.

Authorisation: REACH considers that the registration and evaluation cannot address the risks of all chemicals, and therefore it has set up a strict authorization system for the use of some chemicals in Annex XIV. Substances included in the authorization list can only be manufactured, imported or used after authorization by the European Commission. Authorization is required even if the annual manufacturing or import volume does not exceed 1 ton.

Restriction: REACH also includes a restriction mechanism. If the risks to human health or the environment from the manufacture, use, or placing on the market of a substance cannot be effectively controlled, the EU may list the substance in Annex XVII to limit or prohibit its use and sale within the EU market.

REACH Registration

The Scope of a REACH Registration

• A substance manufactured or imported above 1t/y on its own or in preparations; (Note: some substances are exempted).

• Substances in articles if present above 1 t/y and intended for release (for example, ink in a pen);

• Monomer substances if present at a concentration above 2% in a polymer (for polymers, monomers shall be registered);

• Intermediates – reduced requirements and lower costs;

• Substances subject to Product and Process Oriented Research and Development (PPORD) – are exempted from registration for five years. However, a PPORD notification must be submitted. 

Who Shall Submit REACH Registrations

• Manufacturers/Importers in EU;

• REACH only representative appointed by non-EU manufacturers; 

The Deadline for REACH Registration

Substances can be categorized into two groups under REACH:

• phase-in substances and
• none phase-in substances.

Each group has a different REACH registration deadline.

Phase-in substances (existing substances) enjoy the benefits of extended registration deadlines if pre-registered before December 2008. The principle is that the higher the tonnage, the earlier the registration deadline.

None phase-in substances (new substances not covered by the definition of a phase-in substance) need to be registered immediately before being placed in the EU market.

Definition of a Phase-in Substance

A substance that meets at least one of the following criteria:

• It is listed in the European Inventory of Existing Commercial Chemical Substances (EINECS).

• It was manufactured in the Community, or in the countries accepted to the European Union on January 1, 1995, or on May 1, 2004, but not placed on the market by the manufacturer or importer, at least once in the 15 years before the entry into force of this Regulation, provided the manufacturer or importer has documentary evidence of this.

• It was placed on the market in the Community, or in the countries accepted to the European Union on January 1, 1995, or on May 1, 2004, before entry into force of this Regulation by the manufacturer or importer and was considered as having notified in accordance with the first indent of Article 8(1) of Directive  67/548/EEC but does not meet the definition of a polymer as set out in this Regulation, provided the manufacturer or importer has documentary evidence of this.

Phase-in substances that missed pre-registration cannot enjoy the benefits of the extended registration deadline and must be registered immediately. 

Registration Process

Only Representative (OR)

Non-EU companies may submit registration by appointing an EU-based OR to register on their behalf. An OR must be an EU-based legal entity that has a sufficient background in the practical handling of substances and the information related to them required by the REACH regulation. Importers will be exempt from REACH registration if their non-EU suppliers have registered. However, importers need to confirm with their suppliers' OR that they are included in the importer list and that their tonnage and uses are covered by the OR. 

More about REACH Only Representative

Why Choose CIRS

Established in 2007, CIRS has branch offices in the Republic of Ireland, South Korea, the United States, the United Kingdom, Japan and China. CIRS Group utilizes its technical expertise, various resources, and international network to provide one-stop compliance services, from regulatory compliance, laboratory testing, R&D to data services across multiple industries, to help clients gain a competitive advantage by reducing business risks associated with regulatory affairs and removing barriers to entry. 

We have:

• 3000+ global clients;
• 10+ years of experience as a stable OR for EU REACH;
• 2000+ full registration dossiers submitted;
• 10000+ pre-registration dossiers submitted;
• 200+ lead registrant dossiers submitted;

Our Services

• Only Representative (OR) Service;
• Lead Registrant;
• Joint Submission;
• Dossier Evaluation/Updating;
• Chemical Safety Report (CSR) Compilation;
• Testing Coordination/Supervision;
• Alternative methods (QSAR, Read-Across, In-vitro, Grouping, and more);
• SIEF Management Service;
• Development of Exposure Scenario (ES);
• REACH Technical Training Services.

EU REACH Compliance: Frequently Asked Questions for Industry

Q1: Which substances within the polymer qualify for intermediate registration under EU REACH?

A1: While polymer monomers technically satisfy the definition of an intermediate, they are explicitly excluded from the regulatory provisions governing intermediate registration.

However, substances that are not incorporated into the monomer units—such as initiators, chain-terminating agents, and modifiers—may qualify for registration as intermediates under Strictly Controlled Conditions (SCC), provided that analytical testing confirms zero analytical residue of these substances within the final polymer matrix.

Q2: If substance A has already been registered, does the hydrochloride salt of substance A still require REACH registration?

A2: Yes, they must be registered separately. Generally speaking, a parent substance and its hydrochloride salt are considered different substances; therefore, registration must be considered for both.

Q3: The supply chain flow is: Registered EU Supplier → Domestic Distributor → Domestic Processor. Is it available for the processor to use the EU supplier's registration number? Does the processor need to finish REACH registration as well?

A3: Within a single supply chain, once the upstream supplier has completed the REACH registration, other actors in that chain do not need to register.

In this case, the topmost EU supplier has already completed the registration. If the downstream actors re-export the substance to the EU in the form of a substance or a mixture without any chemical transformation, there is no need to complete EU REACH registration again.

Q4: If a substance is used as both a general substance and an intermediate, do we need to register it both ways?

A4: Yes. You can opt to submit a standard (full) registration and an intermediate registration concurrently. This approach ensures that the volumes allocated for intermediate use do not count against or impact the tonnage thresholds of your standard registration.

While both use-cases are submitted within a single registration dossier and will share the same registration number, ECHA treats them as separate actions financially. This means you will need to pay individual administrative fees for each type, and your Tonnage Coverage Certificates (TCC) will be issued separately to keep your compliance tracking clear.

Q5: One company has registered a substance through an Only Representative (OR), but now plans to transfer the entire production line to a different company. What documentation and steps are required for a Legal Entity Change?

A5: To process a Legal Entity Change, you will need to prepare the following materials:

• Proof of the asset transfer: An asset purchase agreement, merger/acquisition documentation, or a formal statement confirming the production line transfer. This must be in English and signed by both legal entities.
• A new Power of Attorney (POA): A fresh agreement officially appointing the OR to represent the new company.

Once these documents are in order, your OR can submit the update directly through REACH-IT. Keep in mind that ECHA charges an administrative fee to process legal entity updates, which must be paid during the legal entity change process.

Q6: Does a successful ECHA Inquiry confirm that our substance is a 100% match with the Lead Registrant's (LR) substance?

A6: Yes, during the inquiry process, ECHA evaluates the analytical and spectral data you submit to verify substance identity and ensure a match. Passing the inquiry is a formal confirmation from ECHA that your substance is considered identical to the one registered by the LR.

Additionally, once your inquiry is approved, ECHA will grant you access to the relevant joint submission details in REACH-IT. This allows you to view contact information for the LR and other co-registrants so you can initiate data-sharing and join the submission.

Q7: What kind of registrant can become a Lead Registrant (LR)?

A7: Under the REACH regulation, a Lead Registrant (LR) plays a specific role when multiple registrants register the same substance. To adhere to the "one substance, one dossier" principle, one registrant—agreed upon by and representing the other registrants—must submit the core data part of the dossier. This includes classification and labeling, physical and chemical properties, toxicological data, and ecotoxicological data. The registrant acting in this capacity is the Lead Registrant.

In theory, there are no strict regulatory restrictions on who can become an LR. However, based on CIRS Group's experience in contacting thousands of LRs, the following types of registrants are generally well-suited to act as the LR:

• Companies holding substance data: Renowned international corporations like BASF, Clariant, IFF, and Firmenich produce a vast array of products and possess extensive data. Consequently, they naturally take on the role of LR, which is widely recognized by other registrants.
• Registration Consortia: Some large consortia (e.g., the Iron Oxide Consortium, Fluorocarbon Consortium) consist of major companies with a strong intent to register. They usually elect one company to act as the LR, and the consortium drives the registration process forward.
• Enterprises with large tonnages within the industry: Due to their high registration tonnages, these companies need to address REACH compliance as early as possible—typically needing to complete registration before the first or second registration deadlines. Therefore, if no other data holders are willing to act as the LR, these enterprises should proactively step up.

How to apply: An enterprise can entrust an Only Representative (OR) or utilize an EU affiliate to conduct a SIEF (Substance Information Exchange Forum) election. Once successfully elected, the OR/affiliate will report to ECHA via REACH-IT. After passing the ECHA review period, the enterprise officially becomes the Lead Registrant and can commence LR work.