Compliance

Manufacturing Compliance for EU Brands: What You Need to Check

In short

Manufacturing compliance for EU brands has two separate layers. Legal market-access obligations — chemical restrictions, product safety, labelling — apply whether or not anyone certifies them. Voluntary certification schemes such as GOTS, OEKO-TEX or amfori BSCI are chosen by a buyer, and holding one never discharges a legal obligation.

Published 10 min read

What you must check before importing into the EU depends heavily on what the product is. A cotton t-shirt, a scented candle, a Bluetooth speaker and a children’s toy sit under different legislation and carry different testing. There is no universal list, and any article offering one is misleading you. This page maps the territory instead: the categories of obligation that exist, who carries them, and how to tell an obligation from a certificate.

The distinction to get right first

Most compliance confusion in sourcing comes from one conflation: treating a certification scheme as though it were the law. They are different kinds of thing, and they fail differently.

Legal market-access obligation
A requirement in EU or national law applying to a product placed on the market, whether or not anyone certified anything. Failure is an enforcement matter — market surveillance, withdrawal, recall, penalties — and it falls on a named economic operator.
Voluntary certification scheme
A standard owned by a private organisation, which a buyer or supplier chooses to be assessed against. It can be commercially essential and still discharge no legal obligation. The consequence of failure is losing the certificate.
Obligation or voluntary scheme
Instrument or schemeWhich is itWhat it governs
REACH — Regulation (EC) No 1907/2006Legal obligationRegistration, evaluation, authorisation and restriction of chemicals, including substances in articles such as clothes
Regulation (EU) 2023/988 on general product safetyLegal obligationEssential rules on the safety of consumer products placed or made available on the market
Regulation (EU) No 1007/2011Legal obligationTextile fibre names, and the labelling and marking of fibre composition
Regulation (EU) 2019/1020, Article 4Legal obligationFor the instruments that article lists, a responsible economic operator established in the Union
amfori BSCIVoluntary schemeSocial performance at a production site, audited against amfori’s criteria and graded
OEKO-TEX STANDARD 100Voluntary schemeTextile components tested against OEKO-TEX’s own harmful-substance limits
GOTSVoluntary schemeOrganic fibre processing, certified at every processing stage
Global Recycled StandardVoluntary schemeRecycled content and chain of custody, plus processing criteria

A voluntary certificate can be a hard commercial requirement and still not be law.

Who carries the obligation when you import

This is the part most often assumed away. ECHA states it directly for REACH: a company established outside the EU is not bound by the obligations of REACH, and responsibility for requirements such as registration lies with the importer established in the European Union, or the only representative of a non-EU manufacturer established in the EU.

Read that commercially. Your supplier in Asia sits outside the obligation; you sit inside it. A purchase-agreement clause can allocate cost, but it does not move the obligation off the importer, and an enforcement authority will not be interested in your contract.

Regulation (EU) 2019/1020 on market surveillance adds a related requirement. Article 4(1) provides that a product subject to the legislation listed in Article 4(5) may be placed on the market only if an economic operator established in the Union is responsible for the Article 4(3) tasks — holding the declaration of conformity and technical documentation, answering authorities, flagging a product that may present a risk, cooperating on corrective action. Article 4(2) lists who that can be, including an importer where the manufacturer is not established in the Union, and Article 4(4) puts their name and contact details on the product, its packaging, the parcel or an accompanying document.

Substance restrictions: the layer that catches everyone

REACH — Regulation (EC) No 1907/2006 of 18 December 2006, in force since 1 June 2007 — is the obligation brands least expect to touch them, because they sell clothing rather than chemicals. ECHA is explicit that REACH applies in principle to all chemical substances, including those in everyday articles such as clothes, furniture and electrical appliances, and that it places the burden of proof on companies. Three mechanisms reach an importer of finished goods.

  1. Restrictions. ECHA publishes the substances restricted under REACH — those whose manufacture, placing on the market or use is limited or banned in the EU, in Annex XVII. It is amended over time, so check it against your bill of materials at the date you order.
  2. The Candidate List of substances of very high concern. Published under Article 59(10), and ECHA states that inclusion brings immediate legal obligations, including under Articles 7, 31 and 33.
  3. Notification. ECHA sets the trigger at a Candidate List substance in imported articles above 0.1% weight by weight, where the total exceeds one tonne per importer per year, within six months of inclusion.

The communication obligation reaches your customer service inbox. Above 0.1% weight by weight, ECHA states that suppliers must give recipients enough information for safe use — as a minimum the substance name — and must answer a consumer request within 45 days, free of charge, with information also going to ECHA’s SCIP database under the Waste Framework Directive. None of which you can answer without material-level data from your supplier, so it is a vetting question first: see how to vet an overseas manufacturer.

General product safety

Regulation (EU) 2023/988 of 10 May 2023 on general product safety repealed Directive 2001/95/EC and, in its own words, lays down essential rules on the safety of consumer products placed or made available on the market. It is the backstop: where no sector-specific EU legislation governs a consumer product’s safety, this does.

Two recitals show how obligations sit across a chain. Recital 32 describes obligations proportionate to each operator’s role — a distributor performing factual verifications rather than assessing the product. Recital 33 describes the manufacturer preparing technical documentation from an internal risk analysis. If you specify a product and have it made to your design, read the manufacturer-shaped obligations closely: that is often the role you occupy.

Labelling, with textiles as the worked example

Labelling rules are category-specific, prescriptive, and cheap to fix only at the artwork stage. Textiles show the shape of the problem. Regulation (EU) No 1007/2011 of 27 September 2011 governs textile fibre names and the labelling of fibre composition, precisely:

  • Only the fibre names in Annex I may be used, and "100 %", "pure" or "all" only for a product made exclusively of one fibre (Articles 5(1), 7(1)).
  • Name and percentage by weight of all fibres, in descending order (Article 9(1)) — with a derogation allowing "other fibres" up to 5% individually or 15% collectively (Article 9(2)).
  • Non-textile parts of animal origin must be declared as "Contains non-textile parts of animal origin" (Article 12(1)).
  • Descriptions must be easily legible and clearly visible before purchase, including where the purchase is made by electronic means (Article 16(1)), in the official language or languages of the member state (Article 16(3)).
  • A 3% manufacturing tolerance applies between stated and actual composition, on the conditions set (Article 20(3)).

Nothing there is exotic, and all of it is decided upstream — by the fibre content your factory actually uses, the languages on the label, and whether your product page repeats the composition. Other categories have their own equivalents. That is the point: check yours.

Voluntary schemes: what each one actually says

amfori BSCI

A social performance scheme, launched in 2003 and aligned with the OECD guidelines, the UN Guiding Principles and ILO conventions. amfori describes an audit of eighty-one questions, via on-site observation, interviews and document review, graded A to E on a two-year cycle — with a follow-up audit between two and twelve months where the grade is below B. So "BSCI audited" means little without the grade, the date and the cycle position.

OEKO-TEX STANDARD 100

A product-level test for harmful substances, applied to textile components against a list of over a thousand substances, with limit values OEKO-TEX states are reviewed at least once a year. Certification is by product class — strictest is class 1, babies and children up to three years — and a certificate runs for one year. That annual validity is why a certificate on file evidences nothing unless you check it.

GOTS and the Global Recycled Standard

GOTS describes itself as the leading textile processing standard for organic fibres, including environmental criteria and backed by third-party certification of all processing stages. Textile Exchange describes the Recycled Claim Standard and the Global Recycled Standard as setting criteria for third-party certification of recycled content and chain of custody, GRS adding a higher 50% minimum recycled content plus social and environmental processing requirements. One live change to plan around: Textile Exchange has published a transition to its Materials Matter Standard, criteria released 12 December 2025, effective 31 December 2026 and mandatory from 31 December 2027. If a certification claim sits on your packaging artwork, that timeline belongs in your product calendar.

Verifying that a given certificate names your supplier, is current, and covers your product rather than the site in general is a mechanical exercise, and the same one in every scheme. It is set out step by step in how to vet an overseas manufacturer.

Customs and product documentation

The compliance file and the customs file overlap without being the same. Classification, declared value and origin are declarations the importer is responsible for, technical enough to be worth advice on the first shipment of a new product rather than the fifth — and they drive your duty, so they belong in the cost model too: see landed cost.

The discipline is being able to produce, on request and without a scramble: what the product is made of, who made it and where, what testing was done and by whom, what supports the claims on the label and the product page, and which EU-established operator is answerable. Assemble it during development, while the factory still needs something from you.

What does not transfer by contract

You can and should require compliance in your purchase terms: named standards, test reports before shipment, notice of material substitution, a right to reject and to recover costs. None of it changes who an EU authority holds responsible for a product on the EU market, and none of it helps if the supplier has no assets you can reach and has already been paid. Contract terms allocate cost; they do not relocate the obligation.

How Library of Trade approaches it

Compliance is treated as part of the specification rather than a document chase at the end: naming the requirements and the evidence while the product is still being defined, checking certificates against site and scope rather than filing the PDF, and keeping the material and test record attached to the product. AI structures the documentation; people judge whether it covers the product. Where a category needs specialist regulatory advice, that is what we say.

  • Before you place a first EU order
  • Product category identified, and the legislation reaching it confirmed with an adviser
  • Every requirement classified as either a legal obligation or a voluntary scheme
  • The EU-established operator answerable for the product named
  • Full material and component declaration obtained from the supplier
  • Restrictions and Candidate List screened against that declaration, at the date of order
  • Testing scope agreed: who pays, which laboratory, at what stage
  • Label artwork checked against the category’s rules, in every market language
  • Product pages carry the same mandatory information as the physical label
  • Certificates verified at the issuing body — holder, site, validity, scope
  • Technical documentation and test reports producible on request
  • Classification, value and origin reviewed before the first shipment

Frequently asked questions

  • Is a GOTS or OEKO-TEX certificate enough to sell in the EU?

    No. Both are voluntary schemes owned by private organisations, and holding a certificate discharges no legal obligation. Chemical restrictions, product safety and labelling rules apply independently of any certification, and are enforced against a named economic operator.

  • Does my supplier outside the EU have to comply with REACH?

    ECHA states that a company established outside the EU is not bound by REACH obligations, and that responsibility for requirements such as registration lies with the importer established in the EU or an only representative established in the EU. Your contract can allocate cost, not the obligation.

  • When should we get specialist advice rather than reading guidance?

    Before the first order of any new product category, and again before any change of material, component or supplier. Advice costs little against a shipment that cannot be sold, and category-specific questions are exactly where general guidance stops being useful.

Sources

  1. ECHA — Understanding REACH echa.europa.eu
  2. ECHA — REACH legislation (Regulation (EC) No 1907/2006) echa.europa.eu
  3. ECHA — Substances restricted under REACH (Annex XVII) echa.europa.eu
  4. ECHA — Candidate List of substances of very high concern echa.europa.eu
  5. ECHA — Candidate List obligations echa.europa.eu
  6. ECHA — Communication in the supply chain echa.europa.eu
  7. EUR-Lex — Regulation (EU) 2023/988 on general product safety eur-lex.europa.eu
  8. EUR-Lex — Regulation (EU) No 1007/2011 on textile fibre names and labelling eur-lex.europa.eu
  9. EUR-Lex — Regulation (EU) 2019/1020 on market surveillance, consolidated text eur-lex.europa.eu
  10. amfori — amfori BSCI amfori.org
  11. OEKO-TEX® — STANDARD 100 oeko-tex.com
  12. GOTS — The Standard global-standard.org
  13. GOTS — Certified Suppliers Database global-standard.org
  14. Textile Exchange — Recycled Claim Standard and Global Recycled Standard textileexchange.org

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