EU REACH Compliance for Small Sellers

1. What Is REACH?

REACH stands for Registration, Evaluation, Authorisation and Restriction of Chemicals. It is established by Regulation (EC) No 1907/2006 and is widely regarded as the most comprehensive chemicals regulation in the world. REACH entered into force on 1 June 2007 and is administered by the European Chemicals Agency (ECHA), headquartered in Helsinki, Finland.

REACH applies to all chemical substances manufactured in or imported into the European Union in quantities of 1 tonne or more per year per registrant. This includes substances on their own, in mixtures (such as fragrance oils, cleaning products, and paints), and in some cases substances contained in articles (such as textiles, electronics, and packaging).

The Four Pillars of REACH

• Registration: Manufacturers and importers must register chemical substances with ECHA, providing data on properties, hazards, and safe use conditions.
• Evaluation: ECHA and Member State authorities evaluate registration dossiers and testing proposals to ensure data quality and assess potential risks.
• Authorisation: Substances of Very High Concern (SVHCs) may be placed on the Authorisation List (Annex XIV), requiring companies to obtain specific authorisation before using them.
• Restriction: Where unacceptable risks exist, restrictions are imposed on the manufacture, placing on the market, or use of certain substances (Annex XVII).

Core Objectives

• Protect human health and the environment from the risks posed by chemicals.
• Promote alternative methods for the assessment of chemical hazards (reducing animal testing).
• Ensure the free circulation of chemical substances on the EU internal market.
• Enhance competitiveness and innovation in the EU chemicals industry.

The foundational principle of REACH is "no data, no market" — a chemical substance cannot be manufactured in or imported into the EU unless it has been registered with ECHA. This shifts the burden of proof from public authorities to industry: companies must demonstrate that the substances they produce or import can be used safely.

2. Does REACH Apply to Small Sellers?

This is the most common question from small consumer-product sellers — and the answer is nuanced. REACH primarily regulates chemical substances and mixtures, not finished articles (with important exceptions). Understanding where your product fits in this framework is critical.

Articles vs. Substances vs. Mixtures

The classification depends on your product type. Articles are objects whose function is determined by their shape, surface, or design rather than by their chemical composition (e.g., a t-shirt, a ceramic mug, jewellery, textiles).

However, many consumer products in the ClearShip space are mixtures, not articles.Candles and wax melts are typically classified as mixtures because their function (releasing fragrance when heated) depends on chemical composition. Soaps intended for cleansing the body are cosmetic products under Regulation (EC) No 1223/2009 and are therefore mixtures. Liquid soaps, cleaning products, essential oils, and perfumes are also clearly mixtures. Cosmetic products are mixtures under REACH but benefit from partial exemptions under REACH Article 2(6) — their human health effects are regulated by the Cosmetics Regulation instead. They are still subject to REACH for environmental endpoints and SVHC obligations.

What Does This Mean for You?

• If you sell articles: You generally do not need to register substances under REACH yourself. However, you have obligations related to Substances of Very High Concern (SVHCs) — specifically the communication and notification duties described in Sections 4 and 5 below.
• If you sell mixtures: The individual substances in your mixture must be REACH-registered. Typically, your ingredient suppliers or fragrance houses handle this registration. You are a "downstream user" under REACH and have specific obligations.
• If you manufacture or import substances: You must register those substances with ECHA if volumes exceed 1 tonne per year. This applies even to small businesses.

Downstream User Obligations

As a downstream user (someone who uses chemicals supplied by others), your key REACH obligations are:

• Use substances only in accordance with the conditions described in the Safety Data Sheet (SDS) and exposure scenarios provided by your supplier.
• Communicate information up and down the supply chain — inform suppliers of your uses, and pass safety information to your customers.
• Check that the substances you use are registered (look for the REACH registration number on the SDS, formatted as XX-XXXXXXXXXX-XX-XXXX).
• Comply with any restrictions (Annex XVII) and authorisation requirements (Annex XIV) that apply to substances in your products.

3. Key REACH Concepts

Understanding REACH starts with its core terminology. The regulation distinguishes between three categories of chemicals, each subject to different obligations.

Registration Thresholds

REACH registration requirements scale with the volume of substance manufactured or imported per year. The data requirements increase at each threshold:

For substances that have not yet been registered and are newly manufactured or imported, registration must occur before the substance is placed on the market. The "no data, no market" principle is absolute.

The Only Representative (OR)

Non-EU manufacturers can appoint an EU-based Only Representative to fulfil REACH registration obligations on their behalf. When an OR is appointed, the EU importers of that substance become "downstream users" rather than "importers" under REACH, relieving them of registration duties. This concept is covered in detail in Section 7.

Safety Data Sheets (SDS)

The Safety Data Sheet is the primary vehicle for communicating chemical safety information in the supply chain. Under REACH Article 31, suppliers must provide an SDS for any substance or mixture classified as hazardous, any mixture containing substances above certain concentration thresholds, or any substance on the Candidate List. As a small seller, you should always have current SDS documents for every chemical input in your products.

4. SVHC and the Candidate List

Substances of Very High Concern (SVHCs) are chemicals that may have serious and often irreversible effects on human health or the environment. ECHA maintains the Candidate List of SVHCs, which currently contains over 240 substances (as of early 2026). The Candidate List is updated twice per year, typically in January and July.

What Makes a Substance an SVHC?

A substance can be identified as an SVHC if it meets any of the following criteria under REACH Article 57:

• CMR: Carcinogenic, mutagenic, or toxic to reproduction (Category 1A or 1B).
• PBT: Persistent, bioaccumulative, and toxic.
• vPvB: Very persistent and very bioaccumulative.
• Equivalent concern: Substances for which there is scientific evidence of probable serious effects (e.g., endocrine disruptors).

The 0.1% Threshold

The critical threshold for SVHCs in articles is 0.1% weight by weight (w/w). When an article contains a Candidate List substance above this concentration, two obligations are triggered:

Obligation 1: Communication (REACH Article 33)

You must provide sufficient information to allow safe use of the article to any recipient (whether a business customer or a consumer). At minimum, you must communicate the name of the SVHC. This information must be provided automatically to professional recipients and within 45 days of a consumer request.

Obligation 2: Notification (REACH Article 7(2))

Producers and importers of articles must notify ECHA if their article contains a Candidate List substance above 0.1% w/w and the total quantity of that substance exceeds 1 tonne per year per producer/importer. Since January 5, 2021, this notification must be submitted via the SCIP database (see Section 5).

Common SVHCs in Consumer Products

The Candidate List is publicly available on the ECHA website. You should check it regularly — especially when a new update is published — against the substances present in your supply chain. Your suppliers' Safety Data Sheets are the primary source for determining whether SVHCs are present in your products.

5. The SCIP Database

SCIP stands for Substances of Concern In articles as such or in complex objects (Products). The SCIP database is maintained by ECHA and was established under the Waste Framework Directive (EU) 2018/851. Notification has been mandatory since 5 January 2021.

Who Must Notify?

Any EU producer or importer of articles that contain a Candidate List substance above 0.1% w/w must submit a SCIP notification. This applies regardless of the total annual volume of the substance — unlike the 1-tonne threshold for REACH Article 7(2) notification.

• EU manufacturers: Companies that produce articles within the EU.
• EU importers: Companies that bring articles into the EU from outside the EU/EEA.
• EU assemblers: Companies that assemble or combine imported articles into complex objects.

Practical Impact for Non-EU Sellers

If you are a non-EU seller shipping products to EU consumers via marketplaces or your own website, the SCIP notification obligation falls on the entity that acts as the importer of record within the EU. This is typically your EU-based Authorised Representative, fulfillment partner, or the marketplace itself (depending on the fulfilment model).

However, even if the notification duty falls on your EU importer, you are responsible for providing the information needed to make the notification. You must know whether your products contain Candidate List substances above 0.1% w/w and communicate this clearly to your EU partners.

Key Facts About SCIP

• SCIP notifications are public — anyone can search the database and see which articles contain SVHCs.
• Notifications are permanent and cannot be deleted.
• Each notification must include: article identification, the SVHC name and concentration range, the article category, and instructions for safe use and disposal.
• The SCIP database is designed to support the circular economy by tracking hazardous substances through a product's lifecycle into the waste phase.

6. REACH Annex XVII Restrictions

While the SVHC/Candidate List system operates on a notification-and-authorisation model, REACH Annex XVII imposes outright restrictions on specific substances. These restrictions limit or prohibit the manufacture, placing on the market, or use of certain substances — regardless of volume. Annex XVII restrictions are legally binding and directly enforceable.

Key Restrictions Relevant to Consumer Products

The Proposed PFAS Universal Restriction

In February 2023, five EU/EEA Member States submitted the largest restriction proposal in REACH history: a near-universal ban on per- and polyfluoroalkyl substances (PFAS) — a group of approximately 10,000 substances. PFAS are used in waterproof textiles, non-stick coatings, food packaging, cosmetics, and many other consumer products.

• The proposal covers virtually all PFAS, with limited time-bound derogations for critical uses.
• ECHA's committees are evaluating the proposal; a final decision is expected in 2025-2027.
• If adopted, transition periods will vary by sector (typically 18 months to 12 years).
• Small sellers should begin auditing their supply chains for PFAS-containing materials and identify alternatives.

To check whether a specific restriction applies to your product, consult the full text of REACH Annex XVII on the EUR-Lex portal or use ECHA's searchable database of restricted substances.

7. The Only Representative (OR)

Under REACH Article 8, a non-EU manufacturer of a substance (on its own or in a mixture) can appoint an Only Representative (OR) established in the EU to fulfil the REACH registration and related obligations on their behalf. This mechanism is essential for non-EU companies that export chemical substances or mixtures to the EU market.

What Does an OR Do?

• Submits REACH registration dossiers to ECHA on behalf of the non-EU manufacturer.
• Keeps records of imported quantities and the identity of EU importers who become downstream users.
• Provides updated Safety Data Sheets to downstream users.
• Ensures compliance with authorisation and restriction requirements.
• Participates in Substance Information Exchange Forums (SIEFs) and data-sharing arrangements.

When Do You Need an OR?

You need to consider appointing an OR (or verifying that your supplier has one) in the following scenarios:

• You manufacture chemical substances outside the EU and export them directly to EU customers in quantities of 1 tonne or more per year.
• You formulate mixtures outside the EU (e.g., fragrance blends, cleaning products) and sell directly into the EU. The individual substances in your mixture need registration.
• Your non-EU supplier does not have an OR: In this case, the EU importer becomes the "importer" under REACH and must handle registration themselves — a costly and complex obligation.

When Do You NOT Need an OR?

• You buy ingredients from EU-based suppliers who have already registered the substances. You are simply a downstream user.
• You sell finished articles (not substances or mixtures) into the EU. Articles do not require REACH registration (though SVHC/SCIP obligations may still apply).
• Your non-EU supplier already has an OR appointed. Confirm this with your supplier and request the OR's contact details for your records.

The OR must be a legal entity established in the EU. Many compliance consultancies, law firms, and specialized service providers offer OR services. Costs vary depending on substance complexity and volume, but typically range from EUR 2,000 to EUR 15,000+ per year per substance.

8. REACH and Product-Specific Regulations

REACH does not exist in isolation. It interacts with several other EU regulations that apply to specific product categories. Understanding these intersections helps you avoid gaps in compliance.

REACH and CLP

Regulation (EC) No 1272/2008 — the Classification, Labelling and Packaging of substances and mixtures (CLP) — is the sister regulation to REACH. While REACH governs registration, evaluation, authorisation, and restriction, CLP governs how chemical hazards are communicated to users through labels and Safety Data Sheets.

• CLP classification determines the hazard pictograms, signal words, and H/P statements on your labels.
• REACH registration data feeds into CLP classification — the two systems are interdependent.
• A substance that is REACH-registered may still require CLP labeling if it is classified as hazardous.
• Confusing REACH registration status with CLP classification is a common compliance error (see Section 10).

REACH and the Cosmetics Regulation

Regulation (EC) No 1223/2009 — the EU Cosmetics Regulation — requires that all cosmetic ingredients be REACH-registered. However, finished cosmetic products benefit from certain REACH exemptions:

• Finished cosmetic products are mixtures under REACH, but benefit from partial exemptions under REACH Article 2(6) — human health effects are regulated by the Cosmetics Regulation instead of REACH Titles II, V, VI, and VII.
• The individual substances (ingredients) used in cosmetics must be REACH-registered by their manufacturers or importers. The finished cosmetic product itself does not need separate registration.
• The Cosmetics Regulation imposes its own restrictions on specific substances (Annexes II-VI) which may be stricter than REACH restrictions.
• Finished cosmetics are exempt from CLP labeling (per CLP Article 1(5)(c)) but must comply with cosmetics-specific labeling (INCI, PAO, batch code, etc.). SVHC obligations still apply.

REACH and GPSR

Regulation (EU) 2023/988 — the General Product Safety Regulation (GPSR) — applies to all consumer products placed on the EU market. GPSR interacts with REACH in several ways:

• GPSR requires products to be safe — this includes chemical safety. Compliance with REACH restrictions is a key part of demonstrating product safety under GPSR.
• GPSR requires traceability (manufacturer details, Authorised Representative, batch/serial identification) for all consumer products, including articles subject to REACH SVHC obligations.
• Non-EU sellers must appoint an EU Authorised Representative under GPSR. This is a separate role from the REACH Only Representative, though the same entity can sometimes serve both functions.
• GPSR's Authorised Representative obligation applies to all products, while REACH's OR obligation applies only to substances/mixtures above 1 tonne/year.

9. Compliance Checklist

Before Selling in the EU

• Classify your product: Is it a substance, mixture, or article under REACH?
• Obtain Safety Data Sheets (SDS) for all chemical inputs (fragrances, dyes, additives, raw materials).
• Verify REACH registration numbers on each SDS — ensure all substances are registered.
• Check the ECHA Candidate List for SVHCs present in your products above 0.1% w/w.
• Check REACH Annex XVII for applicable restrictions on substances in your product category.
• If your product is a mixture: confirm your supplier handles REACH registration for all constituent substances.
• If you import substances/mixtures above 1 tonne/year: ensure REACH registration is in place (either directly or via an Only Representative).
• Appoint an EU Authorised Representative under GPSR (separate from REACH obligations but often handled together).

Ongoing Obligations

• Monitor the ECHA Candidate List for updates (published twice yearly, January and July).
• Monitor REACH Annex XVII for new or amended restrictions.
• Maintain current SDS for all chemical inputs — request updated versions from suppliers at least annually.
• Communicate SVHC information to customers (Article 33) if any article contains a Candidate List substance above 0.1% w/w.
• Ensure SCIP notifications are submitted by your EU importer for articles containing SVHCs above 0.1% w/w.
• Keep records of substance quantities, supplier information, and SDS documents for at least 10 years after last use.
• Report any new information on hazardous properties of substances to your supplier and/or ECHA.

If You Manufacture or Import Substances

• Register all substances manufactured or imported above 1 tonne/year with ECHA.
• Prepare and maintain a Chemical Safety Report (CSR) for substances above 10 tonnes/year.
• Provide downstream users with exposure scenarios as annexes to the SDS.
• If manufacturing outside the EU: appoint an Only Representative (OR) or ensure your EU importers are aware of their registration obligations.
• Participate in data-sharing (SIEF/consortium) to avoid unnecessary animal testing and reduce costs.
• Apply for authorisation if you use any Annex XIV (Authorisation List) substances.

10. Common Mistakes

Even well-intentioned sellers frequently stumble on REACH compliance. Here are the most common errors — and how to avoid them.

1. Assuming REACH Does Not Apply to Finished Products

Many small sellers believe that because they sell finished articles — not raw chemicals — REACH is irrelevant to them. This is incorrect. Even if your product is an article, you are subject to SVHC communication obligations (Article 33), SCIP notification requirements, and Annex XVII restrictions. A jewellery maker using nickel-containing alloys, a textile seller using PFAS-treated fabrics, or a candle maker using phthalate-containing fragrances all have direct REACH obligations.

2. Confusing REACH Registration with CLP Classification

REACH registration and CLP classification are distinct processes. A substance can be REACH-registered (meaning it has a dossier with ECHA) and still be classified as hazardous under CLP (requiring warning labels). Registration does not mean a substance is safe or exempt from labeling. Conversely, a substance may not be classified as hazardous but still require REACH registration based on volume.

3. Not Checking the Candidate List

The Candidate List is updated twice per year. A substance that was not an SVHC when you started selling may be added in a subsequent update. You must proactively monitor the list and reassess your products whenever it changes. Setting a calendar reminder for each ECHA update cycle (January and July) is a simple but effective practice.

4. Ignoring the SCIP Database Obligation

Many sellers — particularly non-EU sellers — are unaware of the SCIP notification requirement. Even though the notification is typically submitted by the EU importer, the information originates with you. If you cannot tell your EU importer whether your product contains Candidate List substances above 0.1% w/w, the notification cannot be made, and your products may be blocked at the border or removed from the market.

5. Assuming Your Supplier's Registration Covers You

A supplier's REACH registration covers their manufacture or import of a substance — not your downstream use. As a downstream user, you must verify that your specific use is covered by the exposure scenarios in the supplier's registration. If your use is not covered, you must notify ECHA or adapt your process. Additionally, if you import a substance from a non-EU supplier who has no Only Representative, you become the importer under REACH and must register the substance yourself.

6. Failing to Keep Records

REACH requires that records of substance information, SDS documents, and compliance actions be kept for at least 10 years after the last manufacture, import, or use. Market surveillance authorities can request this documentation at any time. Small sellers who rely on informal record-keeping or discard supplier documentation after a product change are at risk of non-compliance.