REACH regulation: what it is, importer obligations, restrictions and penalties

THURSDAY, 5 NOVEMBER 2026

Who must register above one tonne, what applies at 0.1% in articles, the Annex XVII limits on phthalates and azo dyes, Italian penalties and an example with an order of PVC bags.

The REACH regulation is the European law that decides which chemical substances may enter the EU market and on what terms. For importers it applies twice: substances and mixtures above one tonne a year must be registered, and every finished product must meet composition limits that do not depend on volumes.

REACH regulation: what it is and who it applies to

REACH is Regulation (EC) No 1907/2006 of 18 December 2006. The name sums up its four functions: registration, evaluation, authorisation and restriction of chemicals. Technical management lies with the European Chemicals Agency, ECHA, which receives registrations and publishes the lists.

The principle behind everything is set out in Article 5 and has an easy name to remember: no data, no market. A substance that should have been registered and was not cannot be manufactured or placed on the European market.

The regulation is not only about the chemical industry. It covers substances on their own, mixtures (paints, glues, detergents, inks) and articles, meaning objects whose function depends on shape more than on composition: a bag, a toy, a cable, a shoe. Most companies buying in Asia import articles, and many assume REACH does not concern them. It is the most common mistake.

Who the importer is under REACH

Under the regulation the importer is the natural or legal person established in the Union who is responsible for import, meaning the physical introduction of goods into the customs territory. What matters is not who negotiated with the supplier or who paid for freight, but who appears as importer. The Chinese, Vietnamese or Turkish supplier has no direct obligations, because the regulation does not reach outside the Union.

There is a useful exception. Article 8 lets a non-EU manufacturer appoint an only representative, a person established in the Union who takes on the registration obligations in place of importers. In that case importers in the same supply chain are regarded as downstream users. It is worth asking the supplier whether it has an only representative before ordering a substance or mixture in significant quantities: the answer changes who has to register.

Substances and mixtures: the one-tonne threshold

Article 6 requires manufacturers and importers to register with ECHA every substance, on its own or in mixtures, in quantities of one tonne or more a year. The calculation is per substance and per importer, adding up all purchases over the year.

The key point is that a mixture breaks down into its substances. If a company imports a glue, what counts is the quantity of each component, not the total weight of the product. Two tonnes of adhesive with one component at 60% bring that component to 1.2 tonnes, above the threshold.

For polymers, the monomers and other substances not yet registered by someone further up the chain must be registered, under the conditions of Article 6(3). In practice, anyone importing plastic granules needs to know whether the monomers are already covered by a registration.

Imported articles: what applies and when

For articles the regulation sets three separate obligations, with different thresholds.

Registration, under Article 7(1), applies only to substances intended to be released during normal use, such as the scent of a scented eraser or the ink of a marker, and only above one tonne a year per importer. It is a rare case.

Notification to ECHA, under Article 7(2), concerns substances of very high concern on the Candidate List: it is required when the substance exceeds 0.1% by weight in the article and, at the same time, one tonne a year across all imported articles. No notification is needed if exposure of people and the environment can be ruled out under normal conditions of use, including disposal.

The duty to inform, under Article 33, is the one that affects almost everyone. If an article contains a Candidate List substance above 0.1% by weight, the supplier must pass on to the customer the information needed for safe use, at minimum the name of the substance. Consumers who ask must receive the same information free of charge within 45 days. There is no tonnage threshold here: a single piece is enough. The list and notification to the SCIP database are covered in a separate article on SVHC substances.

The REACH regulation in figures

• Registration of a substance or mixture component: from 1 tonne a year per importer
• Concentration threshold for article obligations: 0.1% by weight of the listed substance
• Time to answer a consumer request: 45 days, free of charge
• Entries on the Candidate List after the 4 February 2026 update: 253
• Penalty for failure to register in Italy: from 15,000 to 90,000 euro

Annex XVII restrictions: the limits that apply to every piece

Restrictions are the part of the REACH regulation that most often blocks consumer goods. Annex XVII lists substances banned or limited in certain uses, and the limits apply regardless of volumes: a single non-compliant article cannot be sold.

Two of the most frequent examples for goods imported from Asia. The four phthalates DEHP, DBP, BBP and DIBP may not exceed 0.1% by weight, even combined, in plasticised materials: the typical problems are soft PVC, faux leather coatings, cables and toys. Aromatic amines released by azo dyes may not exceed 30 mg/kg in dyed textiles and leather intended for prolonged contact with the skin. The annex also sets limits for nickel in items in contact with the skin, for hexavalent chromium in tanned leather, for polycyclic aromatic hydrocarbons in rubber and plastics, and for lead.

Authorisation is different: it concerns Annex XIV substances, which may not be used or placed on the market without a specific authorisation, except in the cases of Article 56.

Penalties in Italy: what importers risk

Penalties are set by Legislative Decree No 133 of 14 September 2009. Failing to register a substance above one tonne carries an administrative fine of 15,000 to 90,000 euro. For breaches of Annex XVII restrictions, Article 16 provides for a criminal offence: arrest of up to three months or a fine of 40,000 to 150,000 euro, for the manufacturer, importer, only representative or downstream user. The same penalty applies, under Article 14, to using or placing on the market a substance subject to authorisation without one.

The Italian Court of Cassation, in ruling No 1454 of 12 January 2024, clarified that Article 16 punishes only the parties it lists: a mere distributor is not liable. This suggests where the risk is concentrated: on the importer, not the reseller.

Worked example: an order of faux leather bags

A hypothetical example, with figures chosen to keep the maths readable. An Italian company imports from China 12,000 bags with a soft PVC coating weighing 150 grams each, plus 2 tonnes of adhesive for an in-house workshop.

The bags are articles. Suppose a lab test finds DEHP at 0.3% in the coating: 0.45 grams per bag, 5.4 kilos across the whole order. Notification to ECHA is not triggered, because 5.4 kilos is far below one tonne. But DEHP above 0.1% in a plasticised material breaches the Annex XVII restriction: those bags cannot be sold, and compliance with the Candidate List rules would not save them.

The adhesive is a mixture. If its main component accounts for 60%, the company imports 1.2 tonnes of it in a year and must register it, unless the manufacturer has an only representative in the Union covering it. Without registration the fine starts at 15,000 euro.

How to manage REACH in purchasing

The useful steps happen before the order, not after unloading. A banned substance cannot be removed from a product already in the warehouse.

The first step is to classify what you buy: substance, mixture or article. For substances and mixtures, ask for the safety data sheet, the registration status of the components and any only representative. For articles, ask for a declaration that cites the Annex XVII restrictions relevant to the product and the current version of the Candidate List.

The second is to test the risky materials, at least on the first batch and whenever the supplier or material changes: soft plastics, rubber, leather, dyed textiles, metals in contact with the skin. The third is to write the obligation into the supply contract, with the right to reject non-compliant goods.

With La Merce, managing the REACH regulation means knowing before the order whether the adhesive exceeds one tonne and who registers it, and having the PVC of the bags tested in China against the 0.1% phthalate limit while the goods can still be corrected.

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