Spain · Licenses & Access
Key points
- FDI screening: transposing EU Regulation 2019/452, M&A and greenfield investments affecting security or public order must be filed with the Spanish Ministry of Industry, Trade and Tourism and receive a no-objection decision.
- Sensitive areas: critical infrastructure (energy/transport/water/telecom/space), critical technology (AI/semiconductors/cybersecurity/dual-use/quantum etc.), critical inputs, sensitive data access, media pluralism.
- Non-EU/non-FTA investors: acquiring above-threshold stakes in specific strategic sectors triggers mandatory filing (including some real estate and infrastructure).
- Sectoral licenses: finance (central bank), telecom (CMNM), energy (CNMC/ecological transition ministry), pharma/health (AEMPS), etc. require permits.
- No prior approval for the company form: S.L. incorporation itself is free; access control focuses on sectoral and FDI screening levels.
Procedure
- Determine whether the investment falls within FDI sensitive areas and filing thresholds.
- When triggered, file the FDI declaration with the Ministry of Industry, Trade and Tourism and await the no-objection decision (statutory 30 working days, extendable).
- Apply for sectoral operating licenses (where applicable).
- Complete company registration (CIRCE) and then conduct restricted business.
Hard requirements
- FDI filing (sensitive areas / non-EU investors).
- Sectoral regulatory licenses.
- Filing and disclosure under tightening EU foreign-investment screening.
Costs
FDI and license legal/filing costs.Sectoral compliance and local agent fees.⏱ ⏱ Timeline:FDI screening from 30 working days; sectoral licenses 1–3 months depending on the authority.⚠ Common risks
- The EU FDI screening scope is expanding (including AI/semiconductors); high-tech Chinese M&A easily triggers it.
- Media/critical infrastructure acquisitions may be conditional or blocked.
- Closing without filing faces penalties and transaction invalidity.
📘 Step-by-Step Handbook (with owner / timeline / cost / penalties)
Applies to:Chinese investment in Spain involving FDI security screening (under RD 571/2023 transposing EU 2019/452) and sectoral operating licenses; company formation itself is free, with controls concentrated at the sectoral and FDI levels.
Prerequisites
- The investment sector and investor attributes identified (whether a non-EU entity or controlled by a third-country government)
- Whether the investment acquires at least 10% equity or control identified
- Sensitive list under Articles 15–16 of RD 571/2023 reviewed
- Sectoral license requirements initially screened
| Step | Action | Owner | Timeline | Cost | Official form / system | Notes & penalties |
|---|---|---|---|---|---|---|
| 1 | Determine whether the investment falls within FDI sensitive areas. Determine whether the investment falls within FDI sensitive areas: critical infrastructure, critical technology (AI/semiconductors/cybersecurity/dual-use/quantum etc.), critical inputs, sensitive information access, media. | Legal/Compliance | Pre-entry assessment | Internal/lawyer | Sector comparison (RD 571/2023 sensitive list) | Penalty:Misjudgment leads to no filing and invalid closing. |
| 2 | Determine whether mandatory filing applies. Determine whether mandatory filing applies: non-EU investors acquiring at least 10% equity or control of a Spanish company, where the target or investor triggers Articles 15–16 situations. | Legal | Assessment | — | Per Articles 15–16 of RD 571/2023 | Penalty:Transactions closed without filing are invalid and fined (up to the full transaction amount, minimum €30,000). |
| 3 | File the FDI declaration (when triggered). When triggered, file the FDI declaration with the General Directorate for International Trade and Investment (DGCI) of the Ministry of Industry, Trade and Tourism and await the no-objection decision (statutory maximum 3 months; below €5 million decided by the director general). | General Directorate for International Trade and Investment (DGCI) | Decision period up to 3 months (below €5 million decided by the director general) | Filing cost | AFORIX foreign-investment filing (Registro de Inversiones) | Penalty:Closing without authorization is invalid and constitutes a serious administrative violation. |
| 4 | Apply for sectoral operating licenses (where applicable). Apply for sectoral operating licenses (where applicable): finance (Banco de España), telecom (CMNM), energy (CNMC/ecological transition ministry), pharma/health (AEMPS), etc. | Corresponding authority | 1–3 months | License fees / compliance | Sectoral regulatory license application | Penalty:Operating without a license is penalized. |
| 5 | Conduct restricted business after company registration. Complete company registration (CIRCE) and then conduct restricted business; for M&A, close only after the FDI no-objection decision (recommend a 'no closing without approval' condition precedent). | Company | See incorporation dimension | — | CIRCE | Penalty:Risk of closing without the no-objection decision. |
| 6 | Annual foreign-investment filing and change reporting. Annual foreign-investment filing and major-change reporting (annual memoranda D-4/D-8 via AFORIX). | Company | Annual | — | Annual memoranda (D-4 / D-8 via AFORIX) | Penalty:Statistics penalties for failure to report. |
| 7 | Pre-M&A voluntary consultation (optional). Optional pre-M&A voluntary consultation: request a voluntary consultation from the DGCI; a binding opinion is issued within 30 working days clarifying whether approval is required. | Investor + DGCI | Opinion issued within 30 working days | — | Voluntary consultation request | Penalty:Filing directly without consultation may lead to misjudgment. |
✅ Self-check list
⚠ Common pitfalls
📅 Ongoing post-incorporation obligations
- Comply with conditions after FDI approval (conditions attached to conditional approvals)
- Annual foreign-investment memoranda filing (D-4 / D-8)
- Major change or reinvestment reporting
- Sectoral license renewals and compliance
- Cooperate with investment review and security review
🔗 Official portals
🔧 CE Marking (EU / EEA)
Benchmarked against C2P's product-compliance module: C2P gives regulatory text and catalogs, whereas this library delivers a do-it-now checklist — identify the directive, pick the conformity-assessment route, prepare the technical file, sign the DoC, affix the mark, retain records.
📘 Step-by-Step Handbook (with owner / timeline / cost / penalties)
Applies to:Physical products destined for the EU market (EEA members such as Germany / Spain / Greece) that fall under one of the EU harmonised-legislation scopes above. B2B components not placed on the EU market separately are assessed on a case-by-case basis.
Prerequisites
- Target country/market confirmed (this template covers Germany / Spain / Greece)
- Product technical spec and drawings frozen
- Non-EU manufacturer ready to appoint an EU Authorized Representative
- Qualified Notified Body identified where applicable
| Step | Action | Owner | Timeline | Cost | Official form / system | Notes & penalties |
|---|---|---|---|---|---|---|
| 1 | Identify the applicable EU directive(s) / regulation(s) Map the product type to the relevant EU harmonised legislation (e.g. radio device → RED; low-voltage appliance → LVD + EMC + RoHS). A single product often triggers several directives — list them all. | Manufacturer / compliance consultant | 1–2 weeks | — | EU directive mapping table | The directive list is the master plan for every downstream step; missing one is a violation. Penalty:Omitted applicable directive → non-conforming placement on market, market-surveillance ordered removal |
| 2 | Confirm essential requirements & harmonised standards Check each directive's 'Essential Requirements' and adopt the corresponding EU harmonised standards (EN) as the presumption-of-conformity route. | R&D / compliance | 2–4 weeks | Standard purchase fee (some free) | Harmonised standard list (EN) | Using harmonised standards gives 'presumption of conformity', reducing proof burden. Penalty:Marking before meeting essential requirements → invalid mark, penalties |
| 3 | Select conformity-assessment module Pick the route per directive: Module A (internal production control) through Module H (full quality assurance). Most products may self-declare; high-risk (e.g. medical devices, some PPE) require a Notified Body. | Manufacturer / Notified Body (if applicable) | Self-declaration immediate; Notified Body route weeks–months | Notified Body fee (high-risk categories) | Conformity-assessment module description | First decide 'whether a third party (Notified Body) is needed' — that drives lead time and cost scale. Penalty:Self-declaring when a Notified Body is required → certificate not recognised |
| 4 | Compile the Technical File Assemble product description, design drawings, circuit/structure, risk analysis, test reports, user manual, conformity calculations — proving essential requirements are met. | Manufacturer | 2–6 weeks | Testing fee (third-party lab) | Technical Documentation / Technical File | The Technical File is the core evidence of CE compliance and must be producible for market authorities on demand. Penalty:Cannot produce Technical File → presumed non-compliant, product withdrawn |
| 5 | Notified Body involvement (if applicable) For categories needing third-party assessment, submit to EU type-examination (Module B) / system audit and obtain the Notified Body certificate (e.g. NB-number certificate). | Notified Body | Weeks–months | Assessment fee (by category) | EU type-examination certificate / system certificate | Only NANDO-listed bodies with the corresponding scope are recognised. Penalty:Using a non-qualified body's certificate → treated as invalid |
| 6 | Sign the EU Declaration of Conformity (EU DoC) Draft and sign the EU DoC listing applicable directives, standards, manufacturer and representative info, NB certificate numbers — as a precondition to marking. | Manufacturer (or representative on its behalf) | 1–3 days | — | EU Declaration of Conformity | The DoC must be available with the product (paper or electronic); language per member-state requirement. Penalty:Placing on market without a DoC → unlawful, subject to penalties |
| 7 | Affix the CE mark compliantly Affix the CE mark per rules: proportions, size (height ≥5mm), visible and durable, on the same surface as the NB number (if applicable); multilingual manual with compliance info. | Manufacturer | Immediate | — | CE marking specification (Commission 2021 decision) | The CE mark is affixed by the manufacturer itself — it is not 'issued' by a third party. Penalty:Non-compliant size/position or misuse → administrative even criminal liability |
| 8 | Post-market retention & supervision cooperation Keep the Technical File and DoC for 10 years from placement on the market; cooperate with member-state market-surveillance sampling, incident and recall notifications. | Manufacturer / Authorized Representative | Ongoing (10 years) | Archive maintenance | Technical File archival | Non-EU manufacturers have files held by their EU Authorized Representative. Penalty:Destroying files before expiry → cannot prove conformity, presumed non-compliant |
✅ Self-check list
⚠ Common pitfalls
📅 Ongoing post-incorporation obligations
- Keep Technical File and DoC for 10 years from placement on market
- Product change (design/BOM/standard) triggers re-assessment
- EU Authorized Representative continuously in place and published
- Cooperate with member-state market-surveillance sampling and incident/recall notifications
- Track directive revisions (e.g. Machinery new Regulation 2023/1230 transition)
🔗 Official portals
🔧 EPR — Extended Producer Responsibility (EU)
Benchmarked against C2P's product-compliance module: C2P gives per-country EPR legal text, whereas this library delivers a do-it-now checklist — identify categories, register per target country, appoint an authorized representative, declare placed volume, pay fees, label, periodic filing. Covers Germany's LUCID/packaging, WEEE, battery and other key schemes.
📘 Step-by-Step Handbook (with owner / timeline / cost / penalties)
Applies to:Producers or importers placing physical products (including packaging) on the market of any EU member state such as Germany / Spain / Greece. Even cross-border sellers without an EU entity must fulfil EPR obligations per country of sale.
Prerequisites
- Target sales countries clarified (register per country — no EU-wide number)
- Categories involved mapped (packaging / WEEE / batteries, can stack)
- Non-EU entity ready to appoint in-country authorized representatives
- Corresponding Producer Responsibility Organisation (PRO) selected
| Step | Action | Owner | Timeline | Cost | Official form / system | Notes & penalties |
|---|---|---|---|---|---|---|
| 1 | Identify applicable EPR categories & target countries Confirm per country the EPR categories triggered: packaging (almost always), WEEE (electronics), batteries (battery-containing products). The EU has no unified registration — handle per country of sale. | Producer / compliance consultant | A few days | — | Category × country matrix | Packaging is the most overlooked 'always-triggered' item; the new Battery Regulation 2023/1542 is phased in from 2025. Penalty:Missed category/country → non-compliant sales in that country |
| 2 | Register with the target-country authority / PRO Register per country: Germany packaging → ZSVR LUCID central register + sign a PRO; WEEE → Stiftung EAR; batteries → battery-law authority. Spain/Greece connect to their respective PROs and environment ministries. | Target-country authority / PRO | Days–weeks | Registration fee / annual fee | LUCID number / EAR number / national registration number | Germany's LUCID is a mandatory central register, and the number must be uploaded to platforms. Penalty:Selling in Germany without registration → platform takedown, fines |
| 3 | Non-EU producer appoints an Authorized Representative Foreign producers must appoint an in-country Authorized Representative (AR) as the responsible entity, taking on registration, declaration and recovery obligations. | Authorized Representative (AR) | Days | Agent service fee | Authorized Representative agreement | AR info often must be published in the register. Penalty:Non-EU entity without an AR cannot register compliantly |
| 4 | Declare placed volume of products / materials Declare the expected quantity/weight placed on the market per registered category (e.g. packaging tonnes, WEEE units, battery kg) as the basis for fees and recovery quotas. | Producer / AR | At registration + periodically | — | Placed-volume declaration | Declarations must be truthful; under-reporting triggers audit. Penalty:False declared volume → fines, reputational damage |
| 5 | Pay the eco-fee Pay the eco-contribution to the PRO / authority (by category and weight), funding end-of-life recovery. | Producer / PRO | On schedule | Eco-fee (by volume) | Payment receipt | Fees vary widely by category and country. Penalty:Unpaid fees → registration lapses, sales banned |
| 6 | Fulfil labelling & recovery obligations Apply the country's recycling/sorting marks (e.g. Germany's 'Green Dot', WEEE crossed-out wheelie-bin symbol) on the product page and packaging. | Producer | Ongoing | Labelling cost | Recycling-mark spec | Platforms often require the EPR number and marks shown on the product page. Penalty:Missing marks → platform takedown |
| 7 | Periodic filing & renewal Report actual placed volume and renew fees to the PRO and authority annually/quarterly; update registration info. Multi-country sales require a per-country compliance calendar. | Producer / AR | Ongoing (annual/quarterly) | Renewal fee | Periodic filing | Multi-country sales require a multi-country compliance calendar to avoid missed filings. Penalty:Missed filing / lapsed payment → registration lapses, sales banned |
✅ Self-check list
⚠ Common pitfalls
📅 Ongoing post-incorporation obligations
- Annual / quarterly placed-volume filing and renewal
- Ongoing registration-info and AR maintenance
- Continuous display of recycling marks and platform EPR numbers
- Compliance maintained per country (no blanket exemption)
- Track national EPR legislative updates (e.g. PPWD revision, new battery rules)
🔗 Official portals
🔧 CCC Mandatory Certification (China · Source-Country Manufacturing Prerequisite)
Benchmarked against C2P's product-compliance module: C2P lists a global certification catalog, whereas this library turns China's CCC into a do-it-now checklist — determine catalog scope, pick the body, type testing, factory inspection, obtain certificate, annual surveillance. Applies to all outbound products sourced from / supplied via China.
📘 Step-by-Step Handbook (with owner / timeline / cost / penalties)
Applies to:Physical products produced or imported in mainland China that fall under the Compulsory Product Certification Catalog; includes outbound enterprises 'sourcing manufacturing/supply from China with domestic-sale or domestic-sale-linked channels'. Pure-export products that can provide export proof may apply for exemption, but the determination must be made first.
Prerequisites
- Product BOM and model frozen
- Determined against the latest CCC Catalog whether it is listed
- Domestic production plant has basic quality system in place
- Selected a CNCA-designated certification body (mainly CQC)
| Step | Action | Owner | Timeline | Cost | Official form / system | Notes & penalties |
|---|---|---|---|---|---|---|
| 1 | Determine whether the product is in the CCC mandatory catalog Cross-check against the latest CNCA Compulsory Product Certification Catalog and implementation rules to confirm the product model is listed; note the catalog is dynamically adjusted (some products have been removed). | Manufacturer / compliance consultant | A few days | — | CCC catalog cross-check | Products outside the catalog need no CCC; but 'similar names' are easily misjudged — verify against the CN sub-items in implementation rules. Penalty:Certifiable product produced/sold/imported without certification → unlawful, punished by customs and market regulator |
| 2 | Select a designated body & submit application Submit the certification application to a CNCA-designated body (mainly China Quality Certification Centre CQC), specifying the certification model. | Certification body (CQC etc.) | Acceptance in days | Application fee | CCC certification application | Only certificates from designated bodies are valid. Penalty:Certificate from a non-designated body is invalid |
| 3 | Send samples for Type Testing Per the implementation rules, send samples to a designated lab for safety, EMC and other type tests and obtain the test report. | Designated lab | Weeks | Testing fee | Type test report | Must use a production-representative sample. Penalty:Failed test cannot proceed to next step |
| 4 | Initial factory inspection The body inspects the plant's quality-assurance capability (man/machine/material/method/environment + consistency control), confirming consistency with the type-tested sample. | Body inspection team | Days–weeks | Inspection fee | Factory inspection report | Failed inspection and consistency defects are common blockers. Penalty:Factory inspection failed → no certificate issued |
| 5 | Certification decision → obtain CCC certificate + mark The body makes a certification decision combining test and inspection results; upon approval issues the CCC certificate, and the enterprise applies for and uses the CCC mark per rules. | Certification body | Decision in days | Certificate fee / mark fee | CCC certificate / CCC mark | The mark must be applied per spec; counterfeiting is prohibited. Penalty:No certificate or counterfeit mark → administrative even criminal liability |
| 6 | Post-certification supervision (annual factory inspection) During the certificate's validity, accept annual follow-up inspection and product sampling to maintain validity. | Certification body | Every year | Annual fee / supervision fee | Annual supervision report | Missed inspection or failed sampling may suspend/revoke the certificate. Penalty:Certificate revoked → product banned from sale |
| 7 | Export / domestic-sale release & exemption determination Domestic sale/import cleared against the CCC certificate; pure-export products meeting conditions may apply for exemption with export proof, but catalog determination and record retention must be done first. | Enterprise / customs | With business | — | Export proof / customs clearance | 'Export exemption from CCC' ≠ blanket exemption; determine batch by batch per customs and certification rules. Penalty:Domestic sale/import without required certificate → punished |
✅ Self-check list
⚠ Common pitfalls
📅 Ongoing post-incorporation obligations
- Annual factory-inspection and product sampling
- Certificate maintenance and change declaration (model/BOM/critical parts)
- Compliant use of the CCC mark
- Retain export-exemption records for inspection
- Track dynamic catalog adjustments
🔗 Official portals
CompliGo · Outbound Compliance Automation
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