REACH Compliance: A Practical Guide for Importers

Key Takeaways

* REACH is for Everyone: The EU's primary chemical safety law, Regulation (EC) No 1907/2006 (REACH), applies to nearly all physical products sold in the EU, not just chemicals. If you sell finished goods, you have obligations.

* Focus on SVHCs: Your main responsibility as an importer of goods is to identify and manage Substances of Very High Concern (SVHCs) within your products.

* The 0.1% Rule is Key: If your product contains an SVHC above a concentration of 0.1% by weight, specific legal duties are triggered, including communication and database notifications.

* Supplier Collaboration is Non-Negotiable: You cannot achieve REACH compliance alone. You must work closely with your non-EU manufacturers to gather the necessary chemical data and test reports for your products.

* SCIP Database is a Major Hurdle: If your products contain SVHCs above the threshold, you are legally required to notify the ECHA SCIP database, a complex process that waste operators use to handle hazardous materials.

* Penalties are Real: Non-compliance can result in market withdrawal orders, significant fines from EU member state authorities, and account or listing suspensions on marketplaces like Amazon.

* Compliance is a Process, Not a Project: The SVHC list is updated twice a year. Your compliance efforts must be ongoing to keep pace with these regulatory changes.

If you import physical products into the European Union for sale on Amazon, Shopify, or your own website, you are subject to a complex web of regulations. Among the most far-reaching and frequently misunderstood is the REACH compliance framework. REACH stands for Registration, Evaluation, Authorisation and Restriction of Chemicals, established by Regulation (EC) No 1907/2006. While it sounds like it only applies to chemical factories, it has profound implications for anyone placing finished goods on the EU market. This guide provides a practical, no-nonsense roadmap to navigating your obligations under the REACH EU rules.

What is the REACH Regulation? (And Why It Matters to You)

The core purpose of the REACH regulation is to ensure a high level of protection for human health and the environment from the risks posed by chemicals. It is managed by the European Chemicals Agency (ECHA) and places the burden of proof on companies. As an importer, you are responsible for ensuring the products you bring into the EU are safe and compliant.

Forgetting REACH is not an option. Market surveillance authorities in countries like Germany and France are active, and online marketplaces are increasingly demanding proof of compliance. An Amazon request for a "REACH Declaration of Conformity" can shut down your best-selling ASIN overnight if you're unprepared.

Substances, Mixtures, and Articles: Know Your Product Type

REACH classifies products into three categories. For ecommerce sellers, understanding which category your product falls into is the first critical step.

* Substance: A single chemical element or compound. Think pure ethanol or sodium chloride. Most online sellers do not deal with pure substances.

* Mixture: A deliberate blend of two or more substances, where the components are not chemically bonded. Examples include paint, essential oil blends, or cleaning fluids.

* Article: An object given a special shape, surface, or design during production which determines its function to a greater degree than its chemical composition. This category covers almost everything sold on ecommerce platforms: a phone case, a pair of headphones, a child's toy, a t-shirt, a screwdriver.

This guide focuses on "articles," as this is the category relevant to the vast majority of online sellers importing finished goods. Your obligations for articles are very different—and generally less intensive—than those for substances and mixtures.

Your Core REACH Compliance Obligations as an Importer

For importers of articles, REACH compliance boils down to one central concept: identifying and managing a specific group of chemicals known as Substances of Very High Concern.

The Heart of the Matter: Substances of Very High Concern (SVHCs)

SVHCs are chemicals that have been identified as having serious and often irreversible effects on human health or the environment. This includes substances that are:

* Carcinogenic, Mutagenic, or toxic to Reproduction (CMRs)

* Persistent, Bioaccumulative, and Toxic (PBTs)

* Very Persistent and very Bioaccumulative (vPvBs)

* Identified as causing probable serious effects (e.g., endocrine disruptors) on a case-by-case basis.

ECHA maintains an official list of these substances called the Candidate List. This list is the foundation of your compliance work.

Your primary duty is triggered by a specific threshold: 0.1% weight by weight (w/w). If any article you import contains a substance from the Candidate List in a concentration above 0.1% w/w, you have legal obligations.

A common and costly mistake is to apply this 0.1% to the total weight of the product. The threshold applies to each individual component article that makes up your final product. For example, in a child's raincoat, the PVC coat is an article, each plastic button is an article, and the zipper is an article. If the plastic in a single button contains an SVHC (like a phthalate plasticiser) at 0.2%, your obligations are triggered, even if that button is only a tiny fraction of the raincoat's total weight.

Article 33: Your Duty to Communicate

If your product contains an SVHC above the 0.1% w/w threshold, Article 33 of the REACH regulation requires you to communicate this information down the supply chain.

* For Business Customers (B2B): You must automatically provide your professional customers with sufficient information to allow for the safe use of the article. At a minimum, this includes the name of the SVHC.

* For Consumers (B2C): You must provide the same information to a consumer, free of charge, within 45 days of receiving a request. Any customer who buys your product has the "right to know" and can email you asking about SVHCs. You are legally required to respond accurately within the deadline.

The SCIP Database Notification

The duty to communicate was expanded by the Waste Framework Directive (Directive (EU) 2018/851), which created the SCIP database. SCIP stands for Substances of Concern In articles as such or in complex objects (Products).

If you are an EU importer placing an article containing an SVHC from the Candidate List (>0.1% w/w) on the market, you must submit a notification to the SCIP database.

The purpose of this database is to provide information to waste operators, allowing them to identify and safely handle products containing hazardous substances during recycling or disposal. This is a significant administrative task that requires creating a detailed technical dossier in a specific format (IUCLID) and submitting it to ECHA. Failure to notify is a compliance breach.

Building Your REACH Compliance Checklist: A Step-by-Step Process

Theoretical knowledge is one thing; practical application is another. Follow these steps to build a robust system for managing REACH.

Step 1: Map Your Products and Supply Chain

You cannot ensure compliance for products you don't fully understand. For each product you sell, create a simple Bill of Materials (BOM) that breaks it down into its constituent components.

* Product: Bluetooth Headphones

* Component Articles:

* ABS plastic outer casing

* Polyurethane foam earpads

* PVC-coated cable

* Metal connectors

* Printed circuit board (PCB)

* Lithium-ion battery

This map tells you exactly what materials you need to investigate for the presence of SVHCs.

Step 2: Engage Your Suppliers

REACH compliance is a collaborative effort. As the importer, you are legally responsible in the EU, but you depend entirely on your non-EU manufacturer for information. You must ask them for the right data.

Do not simply ask, "Is the product REACH compliant?" This question is too vague. Instead, send a formal declaration request that is specific and references the current regulation.

Sample Supplier Request:

> "In accordance with our obligations under EU Regulation (EC) No 1907/2006 (REACH), please provide a declaration for all products supplied to [Your Company Name]. Specifically, please confirm whether any of these products contain substances listed on the ECHA Candidate List of Substances of Very High Concern (SVHCs), last updated on [insert date of latest update], in a concentration above 0.1% weight by weight (w/w) in any component article."

Always reference the date of the latest Candidate List update to ensure your data is current.

Step 3: Gather and Review Documentation

A supplier's word is not enough. You need evidence. There are three main types of documents you should request and keep on file.

1. Supplier's Declaration of Conformity: This is a formal statement from your supplier declaring that the products meet the requirements of REACH, specifically concerning the absence of SVHCs above the 0.1% threshold. It's a good start, but it has its limits.
2. Third-Party Laboratory Test Reports: This is the gold standard of due diligence. A report from a reputable lab (like SGS, Intertek, TÜV, or Bureau Veritas) that screens your product's materials for the full list of SVHCs provides objective proof of compliance. While it costs money, a test report is the strongest evidence you can have if challenged by authorities or Amazon.
3. Full Material Disclosures (FMDs): This is a complete breakdown of all substances present in a material, down to the chemical level. While common in industries like electronics and automotive, it can be difficult to obtain for simpler consumer goods.

For most ecommerce sellers, a combination of a supplier declaration backed by representative lab testing is the most practical and defensible approach.

Step 4: Assess Your Obligations Based on the Data

Once you have the data from your supplier, your path is clear. Use this simple decision tree:

* IF your documentation confirms no SVHCs are present above 0.1% w/w in any component...

* THEN your primary due diligence is complete. File the documentation securely. Your main ongoing task is to monitor the Candidate List for updates.

* IF your documentation reveals an SVHC is present above 0.1% w/w...

* THEN you have active obligations. Proceed to the next step.

Step 5: Fulfill Communication and Notification Duties

If your product contains an SVHC over the limit, you must act.

1. Prepare for Consumer Requests: Set up a process to handle customer inquiries under Article 33. Create a template response that includes the required information (at least the substance name) so you can reply within the 45-day deadline.
2. Submit a SCIP Notification: This is the most complex task. You will need to gather detailed information about the product, the component containing the SVHC, its location, and safe use information. This data must be compiled into a dossier using ECHA's IUCLID software and submitted to the SCIP portal. Many businesses choose to use a compliance consultant for this process due to its technical nature.
3. Inform B2B Customers: If you sell to other businesses, ensure your product information and invoices clearly communicate the presence of the SVHC as required.

Common Pitfalls and How to Avoid Them

Navigating the REACH regulation can be tricky. Here are some of the most common mistakes importers make.

"My Supplier Said It's Compliant"

Blindly trusting a supplier's verbal or emailed assurance is one of the biggest risks. There can be misunderstandings due to language barriers, or the supplier may not fully grasp the complexities of the EU REACH rules (like the 0.1% component article rule). Always insist on formal declarations and, for your key products, invest in third-party testing to verify their claims.

Forgetting the Candidate List is Dynamic

REACH compliance is not a one-time check. ECHA typically updates the SVHC Candidate List twice a year, usually in January and June/July. A substance that was not on the list when you first sourced your product could be added later, instantly making your product non-compliant if it's present above the threshold. You must have a process to review your product portfolio against every new list update.

Misunderstanding the 0.1% Threshold

As mentioned before, but worth repeating: the 0.1% limit applies to each homogeneous material or component article, not the product as a whole. A leather watch strap may contain Chromium VI, a plastic cable may contain phthalates, and a metal component may be plated with cadmium. You must assess each part. This is where a detailed Bill of Materials becomes invaluable.

Ignoring Marketplace Requirements

Marketplaces are gatekeepers. Amazon's compliance teams regularly conduct checks and will not hesitate to suspend listings or even entire accounts for sellers who cannot provide satisfactory evidence of REACH compliance. Having your test reports and declarations organised and ready to submit is crucial for business continuity. Being proactive is far better than being reactive when your revenue is on the line.

Achieving and maintaining REACH compliance is a fundamental requirement for selling in the EU. It demands a systematic approach that integrates supply chain communication, rigorous documentation, and continuous monitoring. By treating it as an essential business process, you not only protect yourself from enforcement action but also build a more resilient and trustworthy brand.

Stay Ahead of EU Compliance Changes

Delphian Compliance monitors regulations like Regulation (EC) No 1907/2006 at the legislative source and alerts you when the rules change. Join the waitlist at delphian.eu/compliance to get early access.