REACH Compliance Guide

If you import into the EU any product that touches a consumer, a toy, a candle, a phone case, a lipstick tube, a wooden chair, a t-shirt, a set of earbuds, REACH applies to you. Not to your supplier in Shenzhen, not to your freight forwarder in Rotterdam, but to you, the legal entity that places the goods on the EU market. This guide covers what REACH is, who exactly it applies to, the two lists that matter most in practice, what a REACH certificate actually is and is not, how testing works with ISO 17025 accredited labs across Asia, how REACH compares to California's Prop 65 for importers selling on both markets, the failure patterns we see recurring at factories, and how AQF fits into the picture as the QC partner that verifies REACH conformity at the factory before your container leaves the port.

What Is REACH? (EU Regulation 1907/2006, In Force Since 2007)

REACH is the EU regulation, EC 1907/2006, that governs the registration, evaluation, authorisation and restriction of chemical substances in products placed on the EU market. It entered into force on 1 June 2007 and applied to articles from 1 June 2008. Its scope covers substances on their own, in mixtures, and in finished articles.

REACH is a regulation, not a directive, so it applies directly in all 27 Member States without any national transposition. There is no separate "French REACH" or "German REACH" to satisfy. Since 1 January 2021, the UK operates a parallel regime, UK REACH, which is administered separately by the Health and Safety Executive. This guide focuses on EU REACH; UK-bound shipments should be checked against UK REACH independently, as the two lists have diverged since the split.

Who Does REACH Apply To?

Three roles carry REACH obligations: the manufacturer established in the EU, the importer established in the EU, and the downstream user established in the EU who further processes a substance or mixture. For AQF's clients, the importer role is the one that matters.

Here is the point that causes the most confusion on the factory floor: your supplier in China is not the REACH duty holder. You are. Under REACH, an "importer" is any legal entity established in the EU that brings a substance, mixture, or article into the EU from a non-EU country. The obligation to register, communicate, and restrict sits with the EU-based company, not the overseas factory that manufactures the goods.

A quick note on terms: a substance is a single chemical element or compound. A mixture is a combination of substances, such as a paint or an adhesive. An article is an object given a shape, surface, or design that determines its function more than its chemical composition, a chair, a toy, a phone case.

The Four REACH Obligations: Registration, Evaluation, Authorisation, Restriction

REACH rests on four pillars.

Registration requires manufacturers and importers of substances above one tonne per year to register with ECHA and submit safety data. Evaluation is the process by which ECHA and Member State authorities check registration dossiers and, where needed, request further testing. Authorisation applies to substances on Annex XIV, the Authorisation List: once listed, a substance cannot be used past its sunset date without a positive authorisation decision from the European Commission for that specific use. Restriction applies to substances on Annex XVII: these substances cannot be manufactured, placed on the market, or used in the EU except under the conditions written into the restriction entry.

For an importer of finished articles, such as toys, furniture, packaging, or cosmetics, Registration and Authorisation mostly sit upstream with your raw material and chemical suppliers. What touches you directly is Restriction under Annex XVII, the communication duty for Substances of Very High Concern under Article 33, and the SCIP notification duty. These three are the ones your sourcing and QC teams need to manage actively.

The SVHC Candidate List: 256 Substances of Very High Concern (June 2026)

The Candidate List of Substances of Very High Concern currently contains 256 substances, following the update of 3 June 2026, which added three substances, a fluorinated resin curing agent and two nano-scale coupling agents. This followed the 4 February 2026 update, which added n-hexane and a bisphenol AF group, bringing the list to 253. ECHA updates the Candidate List at least twice a year, typically in February and June.

A substance is added to the Candidate List when it meets one of the Article 57 criteria: carcinogenic, mutagenic, or toxic for reproduction (category 1A or 1B), persistent, bioaccumulative and toxic (PBT), very persistent and very bioaccumulative (vPvB), or of equivalent concern, such as an endocrine disruptor.

Once a substance is on the Candidate List, several obligations activate immediately. Article 33(1) requires the supplier to communicate the presence of the SVHC to the next actor in the supply chain, without being asked, once the concentration exceeds 0.1% weight by weight. Article 33(2) requires a response to a consumer request within 45 days. Article 7(2) requires notification to ECHA within six months of the substance's inclusion, if the SVHC exceeds 0.1% w/w and the total quantity across all articles exceeds one tonne per producer or importer per year. Since 5 January 2021, the SCIP database has required notification for any article placed on the EU market that contains an SVHC above 0.1% w/w, regardless of tonnage.

The 0.1% threshold is where most confusion happens, and where the Court of Justice of the European Union stepped in. In its 2015 ruling in Case C-106/14, the Court confirmed that the threshold must be calculated per component article, not diluted across the finished product. A chair made of a cushion, a metal frame, a textile cover, and screws is assessed component by component, not as a single averaged weight. This is sometimes called the "once an article, always an article" principle: a part that qualified as an article before assembly keeps that status inside the finished product.

Annex XVII: Restricted Substances You Cannot Place on the EU Market

Annex XVII currently contains 79 active restrictions, numbered up to Entry 83 (several historical entry numbers, including 22, 33, 39, 42, 44, 53 and 67, have been deleted or merged into other entries over the years, most often when a substance moved to a different regulatory instrument such as the POPs Regulation). The most recent addition is Entry 83, covering 2,4-dinitrotoluene, added by Commission Regulation (EU) 2026/859, published in the Official Journal on 21 April 2026, with general application from 11 May 2027.

Each entry sets out a substance or group of substances in column one and the conditions of the restriction, limits, exempted uses, effective dates, in column two. For AQF's product categories, the entries that come up most often are:

Textiles: azo dyes and aromatic amines (Entry 43), and 33 CMR category 1A/1B substances in clothing, related accessories, other skin-contact textiles, and footwear (Entry 72, from Regulation (EU) 2018/1513, applicable since 1 November 2020).

Toys and childcare articles: phthalates DEHP, DBP, BBP and DIBP (Entry 51), and phthalates DINP, DIDP and DNOP specifically in mouthable toys and childcare articles (Entry 52). Lead and its compounds are separately restricted under Entry 63.

Furniture and wood-based articles: formaldehyde and formaldehyde-releasing substances (Entry 77, added in 2023), with emission limits for furniture and wood-based articles applying from August 2026.

Cosmetics packaging and plastics: cadmium (Entry 23) and lead (Entry 63) in various forms and uses.

Jewellery and metal accessories: nickel release (Entry 27), alongside cadmium and lead where relevant.

Electronics and coatings: long-chain C9-C14 perfluorocarboxylic acids, PFCAs (Entry 68, restricting what was previously the PFOA-specific entry, PFOA itself having moved to the POPs Regulation in 2020), and undecafluorohexanoic acid, PFHxA (Entry 79, added in 2024). A broader, cross-sector restriction covering PFAS as a chemical class has completed its scientific committee review at ECHA but had not been adopted by the European Commission as of mid-2026; importers of electronics, coatings, and textile-treated goods should treat this as a confirmed direction of travel rather than a current requirement, and plan reformulation timelines accordingly.

Rubber, footwear and plastic components with skin or mouth contact: polycyclic aromatic hydrocarbons, PAHs (Entry 50).

If your products span several of these categories, toys with textile elements, furniture with metal fittings, cosmetics in plastic packaging, treat Annex XVII as a checklist to run against every material and component, not just the finished product as a whole.

REACH Certificate and Statement of Compliance: What Buyers Actually Need

There is no official "REACH certificate" issued by ECHA. The confusion usually comes from comparing REACH to CE marking, which does have a formal declaration and, in some cases, a notified body certificate. REACH works differently.

In practice, what a buyer needs is a combination of documents. A Statement or Declaration of REACH Compliance, signed by the supplier, in a free format but with standardised content, stating that the product does not contain Annex XVII restricted substances above their limits and does not contain Candidate List SVHCs above 0.1% w/w (or listing which ones it does, and at what concentration). One or more test reports from an ISO 17025 accredited laboratory, covering the relevant substance groups for the product category. Where relevant, a Safety Data Sheet, which applies to substances and mixtures rather than to finished articles.

Amazon EU sellers should expect a similar pattern in practice: no visible "REACH badge" on the listing, but a Statement of Compliance and supporting lab test report that can be uploaded through Seller Central if a product is audited or flagged.

REACH Testing: Methods, Accredited Labs and Sample Selection

Common test methods for REACH-relevant substances include GC-MS, LC-MS/MS, or ICP-MS for SVHC screening depending on the substance; EN 14372 or EN 62321-8 for phthalates; AfPS GS 2019:01 PAK for polycyclic aromatic hydrocarbons; ISO 14184-1 for formaldehyde in textiles and EN 717-1 for wood-based panels; EN 14362-1 for azo dyes and aromatic amines; and ICP-MS or EN 71-3 migration testing for heavy metals in toys.

ISO 17025 accredited laboratories across major sourcing hubs in China, including Shenzhen, Shanghai, Guangzhou and Hong Kong, run these tests to EU-recognised methods. What labs do not typically manage, and what causes the most costly compliance failures, is sample selection. A sample tested to REACH standard is only meaningful if it represents the batch that actually ships. A pre-production sample handed to a lab by the supplier's sales team is not the same thing as a sample pulled from the production line at the end of a run, and the gap between the two is where non-compliance most often hides.

AQF's approach starts on the line, not at the courier drop-off point: an inspector selects the sample directly from production, at the point in the run that best represents the finished batch, and documents the chain of custody from there to the lab.

REACH vs Prop 65: EU and US Chemistry Regimes Side by Side

Importers selling into both the EU and California often assume the two chemistry regimes overlap more than they do. They do not.

REACH is a regulation, EC 1907/2006, in force since 1 June 2007, enforced by ECHA and Member State authorities, covering 256 SVHCs and 79 active Annex XVII restrictions as of mid-2026. Its mechanism is restriction: certain substances cannot be placed on the market above defined limits.

Prop 65 is a California right-to-know statute, in force since 1986, administered by OEHHA for the substance list and enforced through the California Attorney General and private plaintiffs. It covers over 900 listed chemicals. Its mechanism is disclosure: a warning label is required above defined safe harbour levels, rather than an outright restriction.

The practical consequence for an importer selling on both markets: REACH tells you what you cannot put in the product, or above what concentration. Prop 65 tells you what you must warn about if it is there. The two lists do not match substance for substance, and thresholds for the same chemical, lead or formaldehyde, for example, can differ between the two frameworks. A product cleared for the EU market under REACH is not automatically Prop 65 compliant, and vice versa; each requires its own screening.

A related but distinct EU framework worth a one-line mention here is RoHS, Directive 2011/65/EU, which restricts ten substances specifically in electrical and electronic equipment. RoHS and REACH work in parallel rather than as substitutes: RoHS is narrow and sector-specific, REACH is broad and applies across all product categories.

Common REACH Compliance Failures at China Factories

Test reports fail less often because a supplier deliberately cheats, and more often because of a gap between what was tested and what was shipped. Patterns AQF inspectors see recurring on the factory floor include:

An undeclared raw material change between the pre-production sample and mass production, where a resin or compound swapped for cost reasons introduces an SVHC or restricted substance above the threshold that the original sample did not contain.

A subcontracted process, such as injection moulding or dyeing, carried out at a workshop the buyer was never told about, using inputs the main factory does not track.

Cross-contamination from a material used elsewhere on the same production floor, wood-based panels or packaging picking up formaldehyde from an unrelated batch stored or produced nearby.

A lower-cost metal alloy substituted on a secondary production run, affecting nickel release or lead content in jewellery and metal fittings.

Recycled plastic or rubber content introduced without re-testing, which can carry PAH levels the virgin material did not have.

Residue from an industrial cleaning product left on cosmetic packaging surfaces that come into skin contact.

A decorative paint or coating, applied to a logo or trim detail, sourced separately from the main body finish and never included in the original test scope.

A flexible PVC power cord or cable sheath tested for other properties but not screened for phthalates, while attention stayed on the main plastic housing.

Each of these illustrates the same underlying problem: a test result is only as good as its connection to what actually ships. This is the gap factory-side verification is built to close, and it is largely invisible from a lab's side of the relationship, since a lab tests whatever sample arrives at its door.

AQF's REACH Compliance Workflow

AQF is not the testing laboratory. AQF is the QC partner working inside the factory that makes lab results meaningful for your specific shipment. The workflow runs in five steps.

Pre-production review: mapping which substances are relevant to the product category, checking raw material sources and subcontractor disclosure against what the factory has stated, and confirming batch traceability is in place.

Sampling on the production line: an inspector pulls samples directly from the line, at the stage of the run that best represents the shipped batch, following an appropriate sampling plan, and seals and documents the chain of custody.

Coordination with an ISO 17025 accredited laboratory: AQF arranges transfer of the sealed sample to an appropriate accredited lab based on scope and location, and tracks turnaround.

Report review: AQF reads the lab report against the relevant Annex XVII and SVHC thresholds for the product category and flags any values close to or over the limit.

Pre-shipment verification: before the container is sealed, AQF checks that the batch being shipped corresponds to the batch that was sampled and tested, cross-checking visual details, markings, and batch codes.

Frequently Asked Questions

What is REACH compliance?

REACH compliance means meeting the requirements of EU Regulation EC 1907/2006, which governs the registration, evaluation, authorisation and restriction of chemical substances placed on the EU market. For most importers of finished goods, this means checking products against the Annex XVII restriction list and the SVHC Candidate List.

Does REACH apply to me if I import from China into the EU?

Yes. Under REACH, any legal entity established in the EU that brings substances, mixtures or articles in from a non-EU country is the importer, and carries the compliance obligations. Your supplier in China is not the duty holder; you are.

How many substances are on the REACH SVHC list?

As of the update on 3 June 2026, the Candidate List contains 256 substances. It is updated by ECHA at least twice a year, typically in February and June.

What is the 0.1% SVHC threshold and how is it calculated?

An article containing an SVHC above 0.1% weight by weight triggers a communication duty, and above one tonne per year in total, a notification duty. Following the 2015 Court of Justice ruling in Case C-106/14, the threshold is calculated per component article, not averaged across the finished product.

What is Annex XVII of REACH?

Annex XVII lists substances whose manufacture, sale, or use is restricted or banned in the EU. It currently contains 79 active restrictions, with entry numbers running up to 83 as of mid-2026.

Do I need a REACH certificate?

There is no single official REACH certificate issued by ECHA. In practice, buyers and marketplaces such as Amazon EU expect a signed Statement of Compliance from the supplier, supported by test reports from an ISO 17025 accredited laboratory.

Can I test my product for REACH in China?

Yes. ISO 17025 accredited laboratories in major sourcing hubs including Shenzhen, Shanghai, Guangzhou and Hong Kong run SVHC screening, Annex XVII parameter testing, phthalates, PAHs, and heavy metals testing to EU-recognised methods.

How much does REACH testing cost?

Cost depends on the scope tested, the number of substance groups screened, the analytical methods required, and the number of separate materials in the product, since each distinct component is its own test scope. AQF can put together a scope-based quote once we have your bill of materials.

How is REACH different from Prop 65?

REACH is an EU regulation restricting chemicals in products placed on the EU market. Prop 65 is a California right-to-know law requiring a warning label above defined thresholds. REACH restricts; Prop 65 mostly requires disclosure, and an importer selling into both markets needs to check compliance against each separately.

What happens if my product fails REACH?

Consequences can include the shipment being held at EU customs, the product being withdrawn from the market, a fine from the relevant Member State authority, disposal costs falling to the importer, and suspension of an Amazon EU listing pending resolution.