Importing Chemicals into Spain: REACH, CLP Labelling, Drug Precursors and F-Gases

Yes, if you are the one introducing the substance into the Union and you reach 1 tonne per year. Every manufacturer or importer of a substance, on its own or in a mixture, in quantities of 1 tonne or more per year, must submit a registration application to the European Chemicals Agency (ECHA). And the underlying rule is strict: without registration, the substance cannot be placed on the market.

The calculation is done per importer and per substance. In a mixture, what counts is the quantity of each individual substance, not the weight of the product, and all imports over the year are added together. For polymers, you must register any unregistered monomers present at 2% by weight or more that reach a total of 1 tonne per year.

Registration entails paying a tasa (official fee) to ECHA, which the Commission amended through Reglamento de Ejecución (UE) 2025/2067 (Commission Implementing Regulation amending REACH fees): check the current amount before budgeting. It is submitted through your company account on ECHA, accompanied by a technical dossier for the substance.

The alternative does not depend on you. The non-EU manufacturer may, by mutual agreement, appoint an only representative established in the Union with practical experience in handling substances, who fulfils the obligations of importers. In that case, the importers in the supply chain become downstream users and do not have to register, but the manufacturer must have informed them of the appointment: ask for this in writing.

Managora does not act as an only representative or prepare the technical dossier, which is chemical engineering work. In our import study, we tell you, product by product, whether you need to register, whether your supplier has it covered, and what documents to demand before you buy.

An article is a finished object: clothing, appliances, toys. Its importer only registers a substance contained in it if it exceeds 1 tonne per year and is intended to be released under normal conditions of use, such as the ink in a ballpoint pen.

Much more common is the notification of Substances of Very High Concern (SVHC) on the candidate list: the importer must notify ECHA when the substance exceeds 1 tonne per year and 0.1% by weight, unless exposure to humans and the environment, including during disposal, can be excluded.

Even if you do not reach 1 tonne, anyone supplying an article containing an SVHC above 0.1% must provide the recipient with at least the name of the substance. If a consumer asks, the reply must be given free of charge within 45 days.

In Spain, furthermore, since 5 January 2021 that same information must be submitted to ECHA's SCIP database under Ley 7/2022 de residuos, artículo 18.5 (the Spanish Waste Act). Demand a written declaration of the SVHC content for each item reference from the manufacturer.

The supplier must provide a Safety Data Sheet (SDS, or FDS in Spanish) when the substance or mixture is hazardous under CLP, is PBT or vPvB, or is on the candidate list. When you import, you are the supplier: the foreign manufacturer's sheet is only your starting point. And it must be in an official language of the Member State where it is sold: an English-only SDS is not valid in Spain.

CLP requires three things before placing a product on the market: classifying the substance or mixture; if it is hazardous, labelling and packaging it in accordance with the regulation; and ensuring the label shows a supplier established in the Union who is responsible for compliance. If the manufacturer is foreign, that supplier is usually you.

If you import a substance subject to REACH registration or classified as hazardous, you must also notify it to ECHA's Classification and Labelling Inventory within the month following its placement on the market, unless you have already done so as part of your REACH registration.

MITECO (the Spanish Ministry for the Ecological Transition) is the competent authority for the environmental aspects of REACH and CLP, while inspections are carried out by the regional authorities (comunidades autónomas). Fines under Ley 8/2010 (the Spanish REACH and CLP Enforcement Act) reach €6,000 for minor infringements, from €6,001 to €85,000 for serious ones, and from €85,001 to €1,200,000 for very serious ones.

Yes, if you place hazardous mixtures on the market as an importer or downstream user. In Spain, notifications are received by the Instituto Nacional de Toxicología y Ciencias Forenses (INTCF, the National Institute of Toxicology and Forensic Sciences), part of the Ministry of Justice. The harmonised Poison Centre Notification (PCN) is submitted through the ECHA portal and carries the UFI, the Unique Formula Identifier.

Since 1 January 2025, notifications made under the old national procedure are no longer valid: to keep selling, you need the harmonised notification. It does not require a tasa, and the INTCF accepts it in Spanish or in English. The person submitting it is responsible for the accuracy of the data, and the INTCF may only use it for medical response and for statistical requests from the authorities.

The PIC Regulation (649/2012) controls the export of products listed in its Annex I and mixtures containing them in concentrations that trigger labelling obligations. For those in Part 1, the exporter must notify the national authority no later than 35 days before the first export and, thereafter, 35 days before the first export in each calendar year.

The 15 days often mentioned online are not your deadline: that is the timeframe within which ECHA forwards the notification to the importing country. You must submit a new notification if EU legislation on the substance changes or if the mixture's composition changes in a way that alters its labelling.

In Spain, notifications are submitted via ePIC, the European Commission's application, and are reviewed by the Subdirección General de Calidad del Aire y Medio Ambiente Industrial of MITECO, with no tasa listed on its website. Products in Parts 2 and 3 also require the explicit consent of the importing country, unless, for Part 3, the latest Convention circular already records that consent.

The export customs declaration is filed by your company or by a registered customs representative; we prepare the export study for you with the tariff heading and the specific controls that declaration requires.

Precursors are the scheduled substances listed in the Annex to Regulation (EC) 111/2005. Chemical importers are affected by Categories 1, 2 and 3; Category 4 covers medicinal products containing ephedrine or pseudoephedrine. Many are everyday industrial chemicals, such as certain solvents and acids, so the first step is to identify the category of each substance.

Category 1: anyone importing, exporting or engaging in intermediary activities needs a licence from the Agencia Tributaria (AEAT or Hacienda, the Spanish Tax Agency, specifically its Customs and Excise Department) before starting. The decision takes up to 60 working days and, if there is no reply, it is deemed refused by negative administrative silence. It is valid for 3 years and renewal must be requested during the 3 months prior to expiry. The applicant's competence and integrity are assessed, including the absence of a criminal record for serious offences.

Category 2 (import, export and intermediary activities) and Category 3 (export): registration in the Registro de Operadores de Comercio Exterior de Sustancias Químicas Catalogadas (Foreign Trade Operators Register for Scheduled Chemical Substances), which the Agencia Tributaria decides on within 60 working days. Customs agents and carriers acting solely in that capacity are exempt.

Each shipment also requires its own authorisation: every export of scheduled substances (Category 3 only when prior export notification is required) and every import of Category 1 substances, which is only granted to operators established in the Union. Decisions are issued within 15 working days from a complete application, and administrative silence means refusal. Changes to licence or registration details must be reported within a maximum of 10 working days, not the 15 days set out in Ley 4/2009 (the Spanish Drug Precursors Act). Domestic EU trade is covered by a separate register run by the Ministry of the Interior (CITCO).

Operating without a licence or authorisation can constitute smuggling: a criminal offence from €50,000 upwards, and below that an administrative offence punishable by a fine and seizure of goods. Managora prepares and submits the licence, registration and per-shipment authorisation under your power of attorney; you can check the current fee on our service page.

There are two separate layers that do not replace one another: Reglamento (UE) 2024/573 (the EU F-gas Regulation) and the Spanish tax under Ley 16/2013 (the Spanish Environmental Taxes Act).

F-gas Portal: to import or export fluorinated gases, or equipment containing them, your company needs a registration validated by the European Commission. That registration acts as your licence before customs: without it, goods cannot be cleared. Only temporary storage and personal effects are exempt.

Quota: HFCs may only be placed on the market within the quota allocated by the Commission, at €3 per tonne of CO2 equivalent, and only by entities with an establishment in the Union or an appointed only representative. The next declaration deadline to obtain quota from the reserve is no later than 1 April 2027 and requires three consecutive years of experience in the sector.

Pre-charged equipment: refrigeration, air-conditioning and heat pump equipment pre-charged with HFCs, as well as metered dose inhalers since 1 January 2025, may only enter if the gas is accounted for under the quota system. The importer signs a declaration of conformity, keeps it for 5 years and, every year before 30 April, has it verified by an independent auditor registered on the portal. Below 10 tonnes of CO2 equivalent per year you are exempt from this requirement, though not from registering on the portal.

Tax: this levies HFCs, PFCs and SF6 at 0.015 multiplied by the Global Warming Potential (GWP, or PCA in Spanish) of each kilogram, capped at €100 per kilogram. The importer does not file modelo 587 (the Spanish F-gas tax return): customs assesses and collects the tax directly on the import declaration. The quarterly modelo 587 is for manufacturers, intra-EU acquirers and authorised warehousekeepers.

What is most often forgotten: the importer must enrol in the territorial tax register (CAF) at the managing tax office for their tax domicile before starting the activity. Failing to do so is a serious infringement carrying a fixed fine of €1,500. Managora handles this registration on your behalf and files modelo 587 as an authorised social collaborator of the Agencia Tributaria; the F-gas portal is managed through your company's own account.

First, identify what each product is (substance, mixture or article), its tariff heading and which regulatory regimes apply; next, apply for the prior licences and registrations, some of which take 60 working days; only then should you purchase and clear customs.

Since 14 October 2025, imports are declared using the H1 declaration and exports using AES. The customs declaration is filed by your company or a registered customs representative; we prepare your complete import study with the TARIC code, customs duties, VAT and applicable excise or environmental taxes, alongside the licences required for that declaration. You can view the current price on our service page.