{ "attribution": { "source": "legal.exploreworldai.com", "canonical": "https://legal.exploreworldai.com/in/index.json", "license": "https://legal.exploreworldai.com/revision", "version": "legal-2026-08-25", "proof": "sha256:a1911960c01ab5e276b3b1ada999eb90c7a7e774abee5414966a62cf61bedc12", "jurisdiction": "in", "lang": "en-IN", "owner": "ExploreWorldAI", "terms": "https://legal.exploreworldai.com/om", "notice": "Återgivning kräver angiven källa: legal.exploreworldai.com" }, "layer": "india-eu-compliance", "language": "en-IN", "jurisdictions": [ "IN", "EU" ], "version": "legal-2026-08-25", "readAt": { "requirements": "2026-08-26", "questions": "2026-08-26", "register": "2026-08-26", "mirror": "2026-08-26" }, "counts": { "requirements": 23, "questions": 38, "indianInstruments": 15 }, "entryPoints": { "landing": "https://legal.exploreworldai.com/in", "requirements": "https://legal.exploreworldai.com/in/export", "questions": "https://legal.exploreworldai.com/in/questions", "mirror": "https://legal.exploreworldai.com/in/law", "sitemap": "https://legal.exploreworldai.com/sitemap-in.xml", "api": "https://legal.exploreworldai.com/api/public/v1" }, "topTopics": [ { "rank": 1, "label": "EU representative and responsible person", "why": "Nothing may be placed on the EU market without an operator in the Union that can be held to account, and the data side needs a second appointment.", "url": "https://legal.exploreworldai.com/in/export/eu-representative" }, { "rank": 2, "label": "GDPR Chapter V transfers to India", "why": "India has no adequacy decision, so every data flow runs on Standard Contractual Clauses plus a transfer impact assessment.", "url": "https://legal.exploreworldai.com/in/export/gdpr-chapter-v" }, { "rank": 3, "label": "CE marking and the declaration of conformity", "why": "No body issues a CE approval. The manufacturer declares, and the manufacturer carries the liability.", "url": "https://legal.exploreworldai.com/in/export/ce-marking" }, { "rank": 4, "label": "Conformity assessment routes: Module A, B, C", "why": "The module decides whether a notified body is required, and the module is set by the act, not by preference.", "url": "https://legal.exploreworldai.com/in/export/conformity-assessment" }, { "rank": 5, "label": "Importer against manufacturer duties", "why": "Roles are allocated by law. A private-label EU buyer inherits the manufacturer's duties, which changes the negotiation.", "url": "https://legal.exploreworldai.com/in/export/importer-vs-manufacturer" }, { "rank": 6, "label": "AI Act provider obligations", "why": "The Act allocates duties by role, not by place of registration, so an Indian developer is the provider.", "url": "https://legal.exploreworldai.com/in/export/ai-act-provider" }, { "rank": 7, "label": "General Product Safety Regulation", "why": "Since December 2024 the responsible person, traceability elements and accident reporting are mandatory for consumer goods.", "url": "https://legal.exploreworldai.com/in/export/gpsr" }, { "rank": 8, "label": "Carbon Border Adjustment Mechanism", "why": "Steel, aluminium, cement and fertiliser exporters without installation-level emissions data are priced at conservative default values.", "url": "https://legal.exploreworldai.com/in/export/cbam" }, { "rank": 9, "label": "Cyber Resilience Act for connected products", "why": "Security updates for the whole support period, and a 24 hour report to ENISA for actively exploited vulnerabilities.", "url": "https://legal.exploreworldai.com/in/export/cra" }, { "rank": 10, "label": "Indian SaaS and IT services selling into the EU", "why": "Four regimes land at once: GDPR roles, Chapter V transfers, the Cyber Resilience Act and accessibility.", "url": "https://legal.exploreworldai.com/in/export/software-eu-data" } ], "requirements": [ { "slug": "gdpr-chapter-v", "title": "Data transfers from the EU to India", "question": "How does an Indian company lawfully receive personal data from the EU under GDPR Chapter V?", "answer": "The European Commission has not issued an adequacy decision for India, so personal data cannot be sent from the EU to India on that basis. The route available is the appropriate safeguards in Chapter V, which in practice means the Commission's Standard Contractual Clauses backed by a transfer impact assessment. This applies to Indian IT services firms, BPOs, GCCs and SaaS vendors alike, whether or not they have an EU office.", "sector": "IT services, SaaS, BPO, GCC", "priority": "core", "steps": 5, "references": [ { "act": "gdpr", "article": "44", "label": "GDPR Article 44: general principle for transfers" }, { "act": "gdpr", "article": "45", "label": "GDPR Article 45: transfers on an adequacy decision" }, { "act": "gdpr", "article": "46", "label": "GDPR Article 46: transfers subject to appropriate safeguards" }, { "act": "gdpr", "article": "47", "label": "GDPR Article 47: binding corporate rules" }, { "act": "gdpr", "article": "48", "label": "GDPR Article 48: transfers not authorised by Union law" }, { "act": "gdpr", "article": "49", "label": "GDPR Article 49: derogations for specific situations" }, { "act": "gdpr", "article": "28", "label": "GDPR Article 28: processor obligations" } ], "related": [ "https://legal.exploreworldai.com/in/export/eu-representative", "https://legal.exploreworldai.com/in/export/software-eu-data", "https://legal.exploreworldai.com/in/export/ai-act-provider" ], "url": "https://legal.exploreworldai.com/in/export/gdpr-chapter-v" }, { "slug": "eu-representative", "title": "EU representative and responsible person", "question": "Does an Indian company need a representative established in the EU?", "answer": "Yes, in most cases, and often twice over. On the product side, no product may be placed on the EU market unless an economic operator established in the Union can be contacted and held to account. On the data side, an Indian company without an EU establishment that offers goods or services to people in the EU, or monitors their behaviour, must appoint a written GDPR representative. These are two separate obligations discharged by two separate appointments, and the AI Act adds a third for model providers.", "sector": "All exporters, marketplaces sellers", "priority": "core", "steps": 5, "references": [ { "act": "gpsr", "article": "16", "label": "GPSR Article 16: person responsible for compliance in the Union" }, { "act": "gdpr", "article": "27", "label": "GDPR Article 27: representative of controllers not established in the Union" }, { "act": "gpsr", "article": "22", "label": "GPSR Article 22: obligations of providers of online marketplaces" }, { "act": "ai-act", "article": "22", "label": "AI Act Article 22: authorised representative of third-country providers" } ], "related": [ "https://legal.exploreworldai.com/in/export/gpsr", "https://legal.exploreworldai.com/in/export/gdpr-chapter-v", "https://legal.exploreworldai.com/in/export/ce-marking" ], "url": "https://legal.exploreworldai.com/in/export/eu-representative" }, { "slug": "ai-act-provider", "title": "AI Act: provider obligations", "question": "Must an Indian AI company comply with the EU AI Act to sell in the EU?", "answer": "Yes. The AI Act allocates duties by role, not by place of registration. A company that places an AI system on the EU market or puts it into service there is the provider, even where every stage of research, training and deployment happens in India. What you owe depends on the risk class, and a general-purpose model carries a separate set of duties on top.", "sector": "AI, machine learning, deep tech", "priority": "core", "steps": 5, "references": [ { "act": "ai-act", "article": "6", "label": "AI Act Article 6: classification rules for high-risk systems" }, { "act": "ai-act", "article": "16", "label": "AI Act Article 16: obligations of providers of high-risk systems" }, { "act": "ai-act", "article": "22", "label": "AI Act Article 22: authorised representative" }, { "act": "ai-act", "article": "50", "label": "AI Act Article 50: transparency obligations" } ], "related": [ "https://legal.exploreworldai.com/in/export/gpai-models", "https://legal.exploreworldai.com/in/export/gdpr-chapter-v", "https://legal.exploreworldai.com/in/export/cra" ], "url": "https://legal.exploreworldai.com/in/export/ai-act-provider" }, { "slug": "gpai-models", "title": "General-purpose and generative AI models", "question": "How does the EU AI Act apply to Indian generative AI and foundation models?", "answer": "A general-purpose AI model placed on the EU market carries obligations of its own, separate from the risk classification of any system built on it. The provider must keep technical documentation, give downstream providers what they need to comply, adopt a copyright policy and publish a sufficiently detailed summary of the training content. Models presenting systemic risk carry evaluation, adversarial testing, incident reporting and cybersecurity duties in addition.", "sector": "Foundation models, LLM developers", "priority": "core", "steps": 5, "references": [ { "act": "ai-act", "article": "53", "label": "AI Act Article 53: obligations of providers of general-purpose AI models" }, { "act": "ai-act", "article": "55", "label": "AI Act Article 55: obligations for models with systemic risk" }, { "act": "ai-act", "article": "50", "label": "AI Act Article 50: transparency for synthetic content" } ], "related": [ "https://legal.exploreworldai.com/in/export/ai-act-provider", "https://legal.exploreworldai.com/in/export/gdpr-chapter-v", "https://legal.exploreworldai.com/in/export/software-eu-data" ], "url": "https://legal.exploreworldai.com/in/export/gpai-models" }, { "slug": "ce-marking", "title": "CE marking for Indian manufacturers", "question": "What does CE marking require of an Indian electronics manufacturer exporting to the EU?", "answer": "CE marking is not a certificate and no body issues a general CE approval. It is a declaration by the manufacturer that the product meets every piece of applicable Union harmonisation legislation. The manufacturer signs it and the manufacturer carries the liability, even where the goods are made in India and sold by an EU importer.", "sector": "Electronics, appliances, hardware", "priority": "core", "steps": 5, "references": [ { "act": "gpsr", "article": "5", "label": "GPSR Article 5: general safety requirement" }, { "act": "gpsr", "article": "9", "label": "GPSR Article 9: obligations of manufacturers" }, { "act": "cra", "article": null, "label": "Cyber Resilience Act (EU) 2024/2847: products with digital elements" } ], "related": [ "https://legal.exploreworldai.com/in/export/conformity-assessment", "https://legal.exploreworldai.com/in/export/importer-vs-manufacturer", "https://legal.exploreworldai.com/in/export/gpsr", "https://legal.exploreworldai.com/in/export/cra", "https://legal.exploreworldai.com/in/export/machinery" ], "url": "https://legal.exploreworldai.com/in/export/ce-marking" }, { "slug": "gpsr", "title": "General Product Safety Regulation", "question": "How does an Indian manufacturer meet the EU General Product Safety Regulation, and is a responsible person mandatory?", "answer": "Yes, the responsible person is mandatory. Since December 2024 no consumer product may be placed on the EU market unless an economic operator established in the Union takes responsibility for it, and the product carries that operator's name and address. The regulation also requires an internal risk analysis, traceability information on the product itself and an accident reporting route through the Safety Business Gateway.", "sector": "Consumer goods, toys, textiles, furniture", "priority": "core", "steps": 5, "references": [ { "act": "gpsr", "article": "5", "label": "GPSR Article 5: general safety requirement" }, { "act": "gpsr", "article": "9", "label": "GPSR Article 9: obligations of manufacturers" }, { "act": "gpsr", "article": "16", "label": "GPSR Article 16: person responsible for compliance in the Union" }, { "act": "gpsr", "article": "20", "label": "GPSR Article 20: notification of accidents" }, { "act": "product-liability", "article": null, "label": "Directive (EU) 2024/2853 on liability for defective products" } ], "related": [ "https://legal.exploreworldai.com/in/export/eu-representative", "https://legal.exploreworldai.com/in/export/ce-marking", "https://legal.exploreworldai.com/in/export/textiles" ], "url": "https://legal.exploreworldai.com/in/export/gpsr" }, { "slug": "machinery", "title": "Machinery exports", "question": "What documents are required to export machinery from India to the EU?", "answer": "Machinery placed on the EU market must satisfy the essential health and safety requirements of the Machinery Regulation, and the paperwork is what a customs officer or market surveillance authority actually asks for. The set is the technical file, the EU declaration of conformity, the instructions in the language of the destination Member State and the CE marking, with a notified body involved for the higher-risk categories listed in the regulation.", "sector": "Machinery, industrial equipment, auto components", "priority": "standard", "steps": 5, "references": [ { "act": "gpsr", "article": "9", "label": "GPSR Article 9: obligations of manufacturers" }, { "act": "cra", "article": null, "label": "Cyber Resilience Act (EU) 2024/2847: connected control systems" } ], "related": [ "https://legal.exploreworldai.com/in/export/ce-marking", "https://legal.exploreworldai.com/in/export/cra", "https://legal.exploreworldai.com/in/export/ecodesign" ], "url": "https://legal.exploreworldai.com/in/export/machinery" }, { "slug": "cra", "title": "Cyber Resilience Act", "question": "How does an Indian manufacturer meet the EU cybersecurity requirements for connected products?", "answer": "Any product with digital elements, from a camera or router to an industrial gateway or a piece of software sold separately, must be designed to the essential cybersecurity requirements and supplied with security updates throughout its support period. Actively exploited vulnerabilities and severe incidents must be reported to ENISA and the national authority within twenty-four hours of becoming aware of them.", "sector": "IoT, networking, embedded software", "priority": "core", "steps": 6, "references": [ { "act": "cra", "article": null, "label": "Cyber Resilience Act (EU) 2024/2847" } ], "related": [ "https://legal.exploreworldai.com/in/export/ce-marking", "https://legal.exploreworldai.com/in/export/data-act", "https://legal.exploreworldai.com/in/export/ai-act-provider" ], "url": "https://legal.exploreworldai.com/in/export/cra" }, { "slug": "cbam", "title": "Carbon Border Adjustment Mechanism", "question": "What CBAM obligations fall on Indian steel, aluminium and cement exporters?", "answer": "Steel, aluminium, cement, fertilisers, hydrogen and electricity entering the EU carry a reporting duty on embedded emissions, and from the definitive regime a financial charge. The declarant sits on the EU side, but the data can only come from the Indian installation, so the exporter that cannot supply installation-level figures is priced at default values, which are deliberately conservative and therefore more expensive.", "sector": "Steel, aluminium, cement, fertilisers", "priority": "core", "steps": 5, "references": [ { "act": "cbam", "article": null, "label": "Regulation (EU) 2023/956 establishing a carbon border adjustment mechanism" } ], "related": [ "https://legal.exploreworldai.com/in/export/eudr", "https://legal.exploreworldai.com/in/export/csddd", "https://legal.exploreworldai.com/in/export/ecodesign" ], "url": "https://legal.exploreworldai.com/in/export/cbam" }, { "slug": "eudr", "title": "Deforestation-free supply chains", "question": "How does the EU Deforestation Regulation affect Indian suppliers?", "answer": "Commodities covering cattle, cocoa, coffee, oil palm, rubber, soya and wood, and the products derived from them, may only be placed on the EU market with a due diligence statement, and that statement requires the geolocation of the plots of land where the commodity was produced. For Indian rubber, leather, coffee, timber and furniture exporters this means traceability to the plot, not to the trader.", "sector": "Rubber, leather, coffee, timber, furniture", "priority": "core", "steps": 5, "references": [ { "act": "eudr", "article": null, "label": "Regulation (EU) 2023/1115 on deforestation-free products" } ], "related": [ "https://legal.exploreworldai.com/in/export/cbam", "https://legal.exploreworldai.com/in/export/csddd", "https://legal.exploreworldai.com/in/export/food" ], "url": "https://legal.exploreworldai.com/in/export/eudr" }, { "slug": "csddd", "title": "Corporate sustainability due diligence", "question": "How does the EU CSDDD affect Indian sub-suppliers and contract manufacturers?", "answer": "The obligation sits with large EU companies, but it travels down the contract chain to the supplier. In practice an Indian sub-supplier meets it as a supplier code of conduct, an audit right, human rights and environmental questionnaires, remediation deadlines and a contractual assurance that the same terms are passed to its own suppliers.", "sector": "Textiles, auto components, chemicals, contract manufacturing", "priority": "standard", "steps": 5, "references": [ { "act": "csddd", "article": null, "label": "Directive (EU) 2024/1760 on corporate sustainability due diligence" }, { "act": "csrd", "article": null, "label": "Directive (EU) 2022/2464 on corporate sustainability reporting" } ], "related": [ "https://legal.exploreworldai.com/in/export/eudr", "https://legal.exploreworldai.com/in/export/cbam", "https://legal.exploreworldai.com/in/export/textiles" ], "url": "https://legal.exploreworldai.com/in/export/csddd" }, { "slug": "batteries", "title": "Batteries Regulation", "question": "What does the EU Batteries Regulation require of Indian battery and cell manufacturers?", "answer": "Batteries placed on the EU market carry a carbon footprint declaration, recycled content thresholds, performance and durability requirements, a due diligence policy on the raw materials, and from February 2027 a digital battery passport for industrial and electric vehicle batteries. Producer responsibility for collection and recycling has to be discharged through a registered representative in each Member State.", "sector": "Batteries, cells, EV components, energy storage", "priority": "standard", "steps": 5, "references": [ { "act": "gpsr", "article": "9", "label": "GPSR Article 9: obligations of manufacturers" }, { "act": "csddd", "article": null, "label": "Directive (EU) 2024/1760: supply chain due diligence in parallel" } ], "related": [ "https://legal.exploreworldai.com/in/export/ecodesign", "https://legal.exploreworldai.com/in/export/ce-marking", "https://legal.exploreworldai.com/in/export/cbam" ], "url": "https://legal.exploreworldai.com/in/export/batteries" }, { "slug": "ecodesign", "title": "Ecodesign and the digital product passport", "question": "How does an Indian manufacturer meet EU ecodesign requirements?", "answer": "The Ecodesign for Sustainable Products Regulation replaces the old energy-focused framework with product requirements on durability, reparability, recycled content, energy and resource efficiency, and it introduces the digital product passport. The requirements bite per product group through delegated acts, so the practical question is which product group your goods fall into and when its act applies.", "sector": "Appliances, electronics, textiles, furniture", "priority": "standard", "steps": 5, "references": [ { "act": "gpsr", "article": "9", "label": "GPSR Article 9: obligations of manufacturers" } ], "related": [ "https://legal.exploreworldai.com/in/export/ce-marking", "https://legal.exploreworldai.com/in/export/batteries", "https://legal.exploreworldai.com/in/export/textiles" ], "url": "https://legal.exploreworldai.com/in/export/ecodesign" }, { "slug": "medical-devices", "title": "Medical devices and diagnostics", "question": "What EU requirements apply to Indian medical device and IVD manufacturers?", "answer": "A device may only be placed on the EU market with a CE marking issued on the route the Medical Device Regulation prescribes for its class, and a manufacturer outside the Union must appoint an authorised representative established in the EU whose mandate is set out in the regulation. Notified body involvement is the norm rather than the exception, and the clinical evidence requirement is what most Indian applications underestimate.", "sector": "Medical devices, diagnostics, pharma equipment", "priority": "standard", "steps": 5, "references": [ { "act": "product-liability", "article": null, "label": "Directive (EU) 2024/2853 on liability for defective products" } ], "related": [ "https://legal.exploreworldai.com/in/export/pharma", "https://legal.exploreworldai.com/in/export/ce-marking", "https://legal.exploreworldai.com/in/export/gpsr" ], "url": "https://legal.exploreworldai.com/in/export/medical-devices" }, { "slug": "data-act", "title": "Data Act and connected devices", "question": "How does the EU Data Act apply to Indian IoT manufacturers?", "answer": "The user of a connected product has a right to access the data the product generates and to have it shared with a third party of their choosing. That makes it a design obligation on the manufacturer: the data has to be accessible by default, and the contract has to state what is available. Cloud services sold with the product must also permit switching to another provider without obstruction.", "sector": "IoT, connected devices, industrial equipment", "priority": "standard", "steps": 5, "references": [ { "act": "data-act", "article": null, "label": "Regulation (EU) 2023/2854 on harmonised rules on fair access to data" } ], "related": [ "https://legal.exploreworldai.com/in/export/cra", "https://legal.exploreworldai.com/in/export/software-eu-data", "https://legal.exploreworldai.com/in/export/gdpr-chapter-v" ], "url": "https://legal.exploreworldai.com/in/export/data-act" }, { "slug": "dsa-dma", "title": "Digital Services Act and Digital Markets Act", "question": "What EU obligations apply to Indian e-commerce platforms and marketplaces?", "answer": "A platform offering services to users in the EU must appoint a legal representative in a Member State, publish a point of contact, run a notice and action mechanism, and verify the traceability of every trader it lists. Reaching the very large online platform threshold adds systemic risk assessment, independent audit and data access for researchers. The Digital Markets Act only bites on designated gatekeepers, which no Indian marketplace currently is.", "sector": "Marketplaces, e-commerce, online platforms", "priority": "standard", "steps": 5, "references": [ { "act": "dsa", "article": "11", "label": "DSA Article 11: points of contact for authorities" }, { "act": "dsa", "article": "13", "label": "DSA Article 13: legal representatives" }, { "act": "dsa", "article": "30", "label": "DSA Article 30: traceability of traders" }, { "act": "dma", "article": null, "label": "Regulation (EU) 2022/1925 on contestable and fair digital markets" } ], "related": [ "https://legal.exploreworldai.com/in/export/eu-representative", "https://legal.exploreworldai.com/in/export/gpsr", "https://legal.exploreworldai.com/in/export/gdpr-chapter-v" ], "url": "https://legal.exploreworldai.com/in/export/dsa-dma" }, { "slug": "software-eu-data", "title": "Indian software and SaaS handling EU data", "question": "What EU requirements apply to Indian SaaS and software companies selling into the EU?", "answer": "Selling software into the EU pulls in four separate regimes at once: the GDPR as a processor or controller, the Chapter V transfer rules for the data that lands in India, the Cyber Resilience Act where software is placed on the market as a product, and the accessibility requirements for consumer-facing services. Add the AI Act on top where the product embeds a model.", "sector": "SaaS, software products, IT services", "priority": "core", "steps": 5, "references": [ { "act": "gdpr", "article": "28", "label": "GDPR Article 28: processor" }, { "act": "gdpr", "article": "32", "label": "GDPR Article 32: security of processing" }, { "act": "gdpr", "article": "33", "label": "GDPR Article 33: notification of a personal data breach" }, { "act": "accessibility", "article": null, "label": "Directive (EU) 2019/882 on accessibility requirements" }, { "act": "cra", "article": null, "label": "Cyber Resilience Act (EU) 2024/2847: software placed on the market" } ], "related": [ "https://legal.exploreworldai.com/in/export/gdpr-chapter-v", "https://legal.exploreworldai.com/in/export/cra", "https://legal.exploreworldai.com/in/export/ai-act-provider" ], "url": "https://legal.exploreworldai.com/in/export/software-eu-data" }, { "slug": "food", "title": "Food exports", "question": "What EU requirements apply to Indian food exporters?", "answer": "Food entering the EU has to satisfy the same rules as food produced there: traceability one step back and one step forward, hygiene requirements, maximum residue levels for pesticides, contaminant limits, and labelling in the language of the Member State of sale. Consignments arrive through an approved border control post with the health certificate the relevant regime requires, and rejected consignments are published, which is where reputational damage occurs.", "sector": "Spices, rice, seafood, processed food, agri", "priority": "standard", "steps": 5, "references": [ { "act": "eudr", "article": null, "label": "Regulation (EU) 2023/1115: where the product covers cocoa, coffee, soya or cattle" } ], "related": [ "https://legal.exploreworldai.com/in/export/eudr", "https://legal.exploreworldai.com/in/export/gpsr", "https://legal.exploreworldai.com/in/export/csddd" ], "url": "https://legal.exploreworldai.com/in/export/food" }, { "slug": "reach", "title": "REACH and chemicals", "question": "How does REACH apply to Indian chemical exporters?", "answer": "A non-EU manufacturer cannot register under REACH itself. Substances imported into the EU above one tonne a year must be registered either by the EU importer or by an only representative appointed by the Indian manufacturer, and appointing an only representative is what keeps the registration under your control rather than your customer's. Restrictions and authorisation requirements apply to substances in mixtures and in articles as well.", "sector": "Chemicals, dyes, pharma intermediates, textiles", "priority": "standard", "steps": 5, "references": [ { "act": "gpsr", "article": "5", "label": "GPSR Article 5: general safety requirement" } ], "related": [ "https://legal.exploreworldai.com/in/export/textiles", "https://legal.exploreworldai.com/in/export/pharma", "https://legal.exploreworldai.com/in/export/ecodesign" ], "url": "https://legal.exploreworldai.com/in/export/reach" }, { "slug": "textiles", "title": "Textiles and apparel", "question": "What EU requirements apply to Indian textile and apparel exporters?", "answer": "Textiles sit at the intersection of four regimes: fibre composition labelling, the REACH restrictions on dyes and finishing chemicals, general product safety with an EU responsible person, and the ecodesign requirements with the digital product passport that the EU textiles strategy brings in. Buyers add the due diligence questionnaire on top, because it is their statutory duty rather than their preference.", "sector": "Textiles, apparel, home furnishings, leather", "priority": "standard", "steps": 5, "references": [ { "act": "gpsr", "article": "9", "label": "GPSR Article 9: obligations of manufacturers" }, { "act": "gpsr", "article": "16", "label": "GPSR Article 16: person responsible for compliance in the Union" }, { "act": "csddd", "article": null, "label": "Directive (EU) 2024/1760: due diligence passed down by the buyer" } ], "related": [ "https://legal.exploreworldai.com/in/export/gpsr", "https://legal.exploreworldai.com/in/export/reach", "https://legal.exploreworldai.com/in/export/csddd" ], "url": "https://legal.exploreworldai.com/in/export/textiles" }, { "slug": "pharma", "title": "Pharmaceuticals and EU GMP", "question": "What does the EU require of Indian pharmaceutical manufacturers?", "answer": "A medicinal product needs a marketing authorisation before it may be placed on the EU market, held by an applicant established in the Union, and every batch imported from India must be released by a qualified person in the EU. The manufacturing site needs a written confirmation of EU GMP compliance or coverage by an inspection, and the site is subject to inspection by an EU authority regardless of where it stands.", "sector": "Pharmaceuticals, APIs, contract manufacturing", "priority": "standard", "steps": 5, "references": [ { "act": "product-liability", "article": null, "label": "Directive (EU) 2024/2853 on liability for defective products" } ], "related": [ "https://legal.exploreworldai.com/in/export/medical-devices", "https://legal.exploreworldai.com/in/export/reach", "https://legal.exploreworldai.com/in/export/eu-representative" ], "url": "https://legal.exploreworldai.com/in/export/pharma" }, { "slug": "conformity-assessment", "title": "EU conformity assessment routes: Module A, B, C and beyond", "question": "Which conformity assessment module applies to an Indian manufacturer, and when is a notified body required?", "answer": "CE marking is the outcome; the module is the road you take to it. Union harmonisation legislation sets out the assessment procedures as lettered modules, and each product act names the modules a manufacturer may choose from. Module A is internal production control with no notified body. Module B is EU type-examination by a notified body, always paired with Module C, C1, C2, D, E or F for the production stage. Modules G and H cover unit verification and full quality assurance. The practical question is never whether you like a module, it is which modules your act permits for your product class.", "sector": "Electronics, machinery, medical devices, radio equipment", "priority": "core", "steps": 8, "references": [ { "act": "gpsr", "article": "9", "label": "GPSR Article 9: obligations of manufacturers" }, { "act": "cra", "article": null, "label": "Cyber Resilience Act (EU) 2024/2847: assessment of products with digital elements" }, { "act": "ai-act", "article": "43", "label": "AI Act Article 43: conformity assessment of high-risk systems" } ], "related": [ "https://legal.exploreworldai.com/in/export/ce-marking", "https://legal.exploreworldai.com/in/export/importer-vs-manufacturer", "https://legal.exploreworldai.com/in/export/machinery" ], "url": "https://legal.exploreworldai.com/in/export/conformity-assessment" }, { "slug": "importer-vs-manufacturer", "title": "Importer, distributor and manufacturer responsibilities", "question": "Who carries which duty when an Indian manufacturer sells through an EU importer?", "answer": "The duties are allocated by role, and the roles are defined in the legislation rather than in your contract. The manufacturer designs, assesses, documents and signs the declaration. The importer verifies that the manufacturer did it, puts its own name and address on the product, and keeps the declaration available for ten years. The distributor checks the markings and the paperwork are present. The trap is role escalation: an importer that sells under its own brand, or modifies the product, becomes the manufacturer in law and inherits the whole set, including the liability.", "sector": "All goods exporters, private label, marketplace sellers", "priority": "core", "steps": 7, "references": [ { "act": "gpsr", "article": "9", "label": "GPSR Article 9: obligations of manufacturers" }, { "act": "gpsr", "article": "11", "label": "GPSR Article 11: obligations of importers" }, { "act": "gpsr", "article": "12", "label": "GPSR Article 12: obligations of distributors" }, { "act": "gpsr", "article": "16", "label": "GPSR Article 16: person responsible for compliance in the Union" }, { "act": "product-liability", "article": null, "label": "Directive (EU) 2024/2853 on liability for defective products" } ], "related": [ "https://legal.exploreworldai.com/in/export/eu-representative", "https://legal.exploreworldai.com/in/export/conformity-assessment", "https://legal.exploreworldai.com/in/export/gpsr" ], "url": "https://legal.exploreworldai.com/in/export/importer-vs-manufacturer" } ], "questions": [ { "slug": "india-eu-export-requirements", "question": "Indian companies exporting to the EU — what requirements apply?", "answer": "Three layers apply at once, and they are assessed separately. First, an economic operator established in the EU must take responsibility for the product or the data processing. Second, the product or service must meet the substantive Union legislation for its category, which is normally several acts rather than one. Third, sector rules on carbon, deforestation, chemicals or due diligence apply on top, and they are contractual as well as regulatory because the EU buyer is under the same duty.", "hub": true, "requirement": "https://legal.exploreworldai.com/in/export/eu-representative", "url": "https://legal.exploreworldai.com/in/questions/india-eu-export-requirements" }, { "slug": "india-eu-where-to-start", "question": "India to EU export compliance — where do we start?", "answer": "Start by naming the role you occupy in the transaction, because every obligation follows from the role rather than from the place of registration. Manufacturer, provider, exporter or platform each carry a different set. Then list every act that touches the product or service, appoint the EU-side entity each act requires, and only after that build the documentation. Companies that start with documentation end up rebuilding it.", "hub": true, "requirement": "https://legal.exploreworldai.com/in/export/eu-representative", "url": "https://legal.exploreworldai.com/in/questions/india-eu-where-to-start" }, { "slug": "eu-representative-required", "question": "Do Indian companies need an EU authorised representative to export to the EU?", "answer": "Yes, and usually more than one. The product side requires a responsible person established in the Union, the data side requires a GDPR representative, and AI providers require an authorised representative under the AI Act. These are three separate obligations and one appointment does not satisfy the others.", "hub": false, "requirement": "https://legal.exploreworldai.com/in/export/eu-representative", "url": "https://legal.exploreworldai.com/in/questions/eu-representative-required" }, { "slug": "saas-eu-representative", "question": "Do Indian SaaS companies need an EU representative?", "answer": "Yes, where the company has no establishment in the Union and offers services to people in the EU or monitors their behaviour. The GDPR representative must be appointed in writing in a Member State where the affected individuals are, and the identity and contact details must appear in the privacy notice.", "hub": false, "requirement": "https://legal.exploreworldai.com/in/export/software-eu-data", "url": "https://legal.exploreworldai.com/in/questions/saas-eu-representative" }, { "slug": "it-services-gdpr-no-eu-office", "question": "Do Indian IT services firms need GDPR compliance without an EU office?", "answer": "Yes. The GDPR applies by reference to whose data is processed and where the individuals are, not to where the processor sits. An Indian IT services firm, BPO or global capability centre processing EU personal data is a processor with direct obligations under Article 28 and Article 32, and the data reaching India is a Chapter V transfer that needs its own legal basis.", "hub": true, "requirement": "https://legal.exploreworldai.com/in/export/software-eu-data", "url": "https://legal.exploreworldai.com/in/questions/it-services-gdpr-no-eu-office" }, { "slug": "transfer-data-india-to-eu", "question": "How do you transfer personal data between India and the EU under GDPR Chapter V?", "answer": "India has no adequacy decision, so the transfer runs on the appropriate safeguards in Article 46, which in practice means the Commission's Standard Contractual Clauses plus a transfer impact assessment describing Indian government access powers and the supplementary measures you apply.", "hub": false, "requirement": "https://legal.exploreworldai.com/in/export/gdpr-chapter-v", "url": "https://legal.exploreworldai.com/in/questions/transfer-data-india-to-eu" }, { "slug": "scc-modifiable", "question": "Can the EU Standard Contractual Clauses be modified?", "answer": "No. The Commission's text may not be altered. You select the module that matches the real roles and complete the annexes; changing the clauses themselves removes the legal effect they were adopted to give.", "hub": false, "requirement": "https://legal.exploreworldai.com/in/export/gdpr-chapter-v", "url": "https://legal.exploreworldai.com/in/questions/scc-modifiable" }, { "slug": "dpdp-and-gdpr", "question": "Does complying with the DPDP Act mean we comply with the GDPR?", "answer": "No. The structures overlap but the obligations are separate. The DPDP Act rests on consent and legitimate uses, while the GDPR has six legal bases, portability and objection rights, and mandatory impact assessments for high-risk processing. Each has to be discharged on its own terms.", "hub": false, "requirement": "https://legal.exploreworldai.com/in/export/gdpr-chapter-v", "url": "https://legal.exploreworldai.com/in/questions/dpdp-and-gdpr" }, { "slug": "saas-eu-requirements", "question": "What EU requirements apply to Indian SaaS companies selling services in the EU?", "answer": "Four regimes apply together: the GDPR for the processing, Chapter V for the data that lands in India, the Cyber Resilience Act where software is placed on the market as a product, and the accessibility requirements for consumer-facing services. The AI Act joins them where the product embeds a model.", "hub": false, "requirement": "https://legal.exploreworldai.com/in/export/software-eu-data", "url": "https://legal.exploreworldai.com/in/questions/saas-eu-requirements" }, { "slug": "software-eu-data-handling", "question": "What EU requirements apply to Indian software companies handling EU data?", "answer": "Establish the role for each processing activity, sign a data processing agreement that meets Article 28, secure the processing to Article 32, and handle the India leg of the transfer separately with Standard Contractual Clauses and a transfer impact assessment. Breach notification runs on a 72-hour clock.", "hub": false, "requirement": "https://legal.exploreworldai.com/in/export/software-eu-data", "url": "https://legal.exploreworldai.com/in/questions/software-eu-data-handling" }, { "slug": "ai-models-eu-market", "question": "Must Indian AI models comply with the EU AI Act to be sold in the EU?", "answer": "Yes. The party placing the system on the EU market is the provider, even where all development and training happened in India. Obligations follow the risk class, and a provider without an EU establishment must appoint an authorised representative in writing.", "hub": false, "requirement": "https://legal.exploreworldai.com/in/export/ai-act-provider", "url": "https://legal.exploreworldai.com/in/questions/ai-models-eu-market" }, { "slug": "generative-ai-eu-requirements", "question": "How does the EU AI Act affect Indian generative AI and foundation models?", "answer": "A general-purpose model carries its own duties: technical documentation, information for downstream providers, a Union copyright policy and a sufficiently detailed public summary of the training content. Models with systemic risk add evaluation, adversarial testing, incident reporting and cybersecurity duties.", "hub": false, "requirement": "https://legal.exploreworldai.com/in/export/gpai-models", "url": "https://legal.exploreworldai.com/in/questions/generative-ai-eu-requirements" }, { "slug": "gpai-training-data-summary", "question": "Do general-purpose AI providers have to disclose their training data in the EU?", "answer": "A sufficiently detailed summary of the training content must be published, following the AI Office template, together with a policy for complying with Union copyright law including the reservation of rights for text and data mining. The full dataset does not have to be published.", "hub": false, "requirement": "https://legal.exploreworldai.com/in/export/gpai-models", "url": "https://legal.exploreworldai.com/in/questions/gpai-training-data-summary" }, { "slug": "ce-electronics-india", "question": "What CE requirements apply to Indian electronics manufacturers exporting to the EU?", "answer": "CE is a manufacturer's own declaration, not a certificate. Identify every applicable act, which for electronics is normally product safety, electromagnetic compatibility, radio equipment and low voltage together, compile the technical documentation and keep it for ten years, and sign the declaration of conformity listing each act and standard relied on.", "hub": false, "requirement": "https://legal.exploreworldai.com/in/export/ce-marking", "url": "https://legal.exploreworldai.com/in/questions/ce-electronics-india" }, { "slug": "bis-versus-ce", "question": "Is a BIS or ISI certificate accepted as CE marking in the EU?", "answer": "No. BIS is a third-party registration scheme and CE is a self-declaration by the manufacturer against Union legislation. Test reports can often be reused, but the declaration, the technical documentation and the EU responsible person have to be built separately.", "hub": false, "requirement": "https://legal.exploreworldai.com/in/export/ce-marking", "url": "https://legal.exploreworldai.com/in/questions/bis-versus-ce" }, { "slug": "gpsr-compliance-india", "question": "How do Indian companies meet the EU General Product Safety Regulation?", "answer": "Appoint the EU responsible person and put the name and address on the product, carry out an internal risk analysis, keep the technical documentation for ten years, put traceability elements on the article, supply instructions in the language of the Member State of sale, and report accidents through the Safety Business Gateway.", "hub": false, "requirement": "https://legal.exploreworldai.com/in/export/gpsr", "url": "https://legal.exploreworldai.com/in/questions/gpsr-compliance-india" }, { "slug": "gpsr-responsible-person-mandatory", "question": "Must Indian companies have a responsible person in the EU under GPSR?", "answer": "Yes. Since December 2024 no consumer product may be placed on the EU market unless an economic operator established in the Union takes responsibility for it, and that operator's name and address must appear on the product, the packaging or the accompanying document.", "hub": false, "requirement": "https://legal.exploreworldai.com/in/export/gpsr", "url": "https://legal.exploreworldai.com/in/questions/gpsr-responsible-person-mandatory" }, { "slug": "machinery-export-documents", "question": "What documents are required to export machinery from India to the EU?", "answer": "The technical file, the EU declaration of conformity, the instructions for use and assembly in the language of the destination Member State, and the CE marking. For the higher-risk categories listed in the Machinery Regulation a notified body must be involved before placing on the market.", "hub": false, "requirement": "https://legal.exploreworldai.com/in/export/machinery", "url": "https://legal.exploreworldai.com/in/questions/machinery-export-documents" }, { "slug": "cra-compliance-india", "question": "How do Indian manufacturers meet the EU Cyber Resilience Act?", "answer": "Design to the essential cybersecurity requirements, ship secure by default with no universal factory passwords, maintain a vulnerability handling process and a software bill of materials for the whole support period, provide free security updates, and report actively exploited vulnerabilities to ENISA within twenty-four hours.", "hub": false, "requirement": "https://legal.exploreworldai.com/in/export/cra", "url": "https://legal.exploreworldai.com/in/questions/cra-compliance-india" }, { "slug": "cert-in-versus-cra", "question": "Do the CERT-In directions cover the EU Cyber Resilience Act?", "answer": "No. CERT-In regulates the operator, with a six-hour incident report and 180-day log retention in India. The Cyber Resilience Act regulates the product, with secure design, vulnerability handling and a 24-hour report to ENISA. Both chains have to be in place before an incident, not after.", "hub": false, "requirement": "https://legal.exploreworldai.com/in/export/cra", "url": "https://legal.exploreworldai.com/in/questions/cert-in-versus-cra" }, { "slug": "cbam-steel-cement", "question": "What CBAM requirements apply to Indian steel and cement exporters?", "answer": "Embedded emissions must be reported by the EU declarant, and the data can only come from the Indian installation. An exporter that cannot supply installation-level figures is priced at default values, which are conservative and therefore more expensive for the buyer.", "hub": false, "requirement": "https://legal.exploreworldai.com/in/export/cbam", "url": "https://legal.exploreworldai.com/in/questions/cbam-steel-cement" }, { "slug": "cbam-carbon-price-paid", "question": "Can a carbon price already paid in India be deducted under CBAM?", "answer": "Yes, where the payment is verifiable and declared on the EU side. Keep the payment evidence and pass it to the declarant with the emissions data; an unevidenced claim is not deductible.", "hub": false, "requirement": "https://legal.exploreworldai.com/in/export/cbam", "url": "https://legal.exploreworldai.com/in/questions/cbam-carbon-price-paid" }, { "slug": "eudr-indian-suppliers", "question": "How does the EU Deforestation Regulation affect Indian suppliers?", "answer": "Rubber, leather, coffee, timber, soya and their derived products need a due diligence statement with the geolocation of the plot of production. Traceability to the trader or the aggregator is not sufficient, and the statement's reference number is required before customs clearance.", "hub": false, "requirement": "https://legal.exploreworldai.com/in/export/eudr", "url": "https://legal.exploreworldai.com/in/questions/eudr-indian-suppliers" }, { "slug": "eudr-geolocation-required", "question": "Does the EU Deforestation Regulation require plot coordinates?", "answer": "Yes. The coordinates of the plots of land where the commodity was produced, with the production period, are part of the due diligence statement. Small holdings need coordinates too; simplified due diligence relieves the EU operator, not the traceability.", "hub": false, "requirement": "https://legal.exploreworldai.com/in/export/eudr", "url": "https://legal.exploreworldai.com/in/questions/eudr-geolocation-required" }, { "slug": "csddd-indian-subcontractors", "question": "How does the EU CSDDD affect Indian subcontractors?", "answer": "The statutory duty sits with the large EU company and travels down the contract chain. In practice the Indian supplier faces a code of conduct, an audit right including unannounced audits, human rights and environmental questionnaires, remediation deadlines and an obligation to pass the same terms to its own suppliers.", "hub": false, "requirement": "https://legal.exploreworldai.com/in/export/csddd", "url": "https://legal.exploreworldai.com/in/questions/csddd-indian-subcontractors" }, { "slug": "supplier-audit-rights", "question": "Why do EU customers demand on-site audits of Indian suppliers?", "answer": "Because the audit right is how the EU customer discharges its own due diligence duty. It is a legal requirement passed down by contract, not a commercial expression of distrust, and refusing it puts the customer in breach rather than merely inconvenienced.", "hub": false, "requirement": "https://legal.exploreworldai.com/in/export/csddd", "url": "https://legal.exploreworldai.com/in/questions/supplier-audit-rights" }, { "slug": "battery-regulation-india", "question": "What does the EU Batteries Regulation require of Indian battery manufacturers?", "answer": "A carbon footprint declaration per functional unit, documented recycled content of cobalt, lead, lithium and nickel, a third-party verified raw materials due diligence policy, a producer responsibility representative in each Member State, and from February 2027 a digital battery passport.", "hub": false, "requirement": "https://legal.exploreworldai.com/in/export/batteries", "url": "https://legal.exploreworldai.com/in/questions/battery-regulation-india" }, { "slug": "ecodesign-compliance-india", "question": "How do Indian companies meet EU ecodesign requirements?", "answer": "Identify the product group and the delegated act that governs it, design against durability, reparability, spare parts availability and recycled content, prepare the digital product passport data set, and register the model in EPREL where energy labelling applies.", "hub": false, "requirement": "https://legal.exploreworldai.com/in/export/ecodesign", "url": "https://legal.exploreworldai.com/in/questions/ecodesign-compliance-india" }, { "slug": "medical-devices-eu-requirements", "question": "What EU requirements apply to Indian medical device manufacturers?", "answer": "Classify the device, engage a notified body for everything above class I non-sterile, appoint an EU authorised representative under Article 11, operate a quality management system and post-market surveillance, compile the clinical evaluation, and register in EUDAMED with a unique device identifier.", "hub": false, "requirement": "https://legal.exploreworldai.com/in/export/medical-devices", "url": "https://legal.exploreworldai.com/in/questions/medical-devices-eu-requirements" }, { "slug": "cdsco-versus-mdr", "question": "Does a CDSCO licence allow a device to be sold in the EU?", "answer": "No. The Indian classes A to D do not map one to one onto the EU classes, and the EU route requires notified body involvement, an authorised representative, EUDAMED registration and clinical evidence that stands without leaning on equivalence.", "hub": false, "requirement": "https://legal.exploreworldai.com/in/export/medical-devices", "url": "https://legal.exploreworldai.com/in/questions/cdsco-versus-mdr" }, { "slug": "data-act-iot-india", "question": "How does the EU Data Act apply to Indian IoT manufacturers?", "answer": "The user of a connected product has a right to access the data it generates and to have it shared with a third party. That makes access a design obligation: readily available data must be accessible free of charge in a structured, commonly used format, and the contract must state what is available.", "hub": false, "requirement": "https://legal.exploreworldai.com/in/export/data-act", "url": "https://legal.exploreworldai.com/in/questions/data-act-iot-india" }, { "slug": "ecommerce-platform-eu-requirements", "question": "What EU requirements apply to Indian e-commerce platforms under the DSA and DMA?", "answer": "Appoint an EU legal representative, publish points of contact, run a notice and action mechanism with a statement of reasons for every restriction, and verify trader identity before listing. The DMA only applies to designated gatekeepers, which no Indian marketplace currently is.", "hub": false, "requirement": "https://legal.exploreworldai.com/in/export/dsa-dma", "url": "https://legal.exploreworldai.com/in/questions/ecommerce-platform-eu-requirements" }, { "slug": "marketplace-trader-verification", "question": "Why do EU marketplaces ask Indian sellers to verify their business details?", "answer": "Because the Digital Services Act requires the platform to obtain and keep the trader's identity, address, payment account and a compliance self-certification, and to stop displaying products from traders that have not been verified.", "hub": false, "requirement": "https://legal.exploreworldai.com/in/export/dsa-dma", "url": "https://legal.exploreworldai.com/in/questions/marketplace-trader-verification" }, { "slug": "reach-indian-chemical-exporters", "question": "How does REACH apply to Indian chemical exporters?", "answer": "A non-EU manufacturer cannot register itself. Substances above one tonne a year are registered either by the EU importer or by an only representative established in the Union appointed by the Indian manufacturer, which is the route that keeps the registration under your own control.", "hub": false, "requirement": "https://legal.exploreworldai.com/in/export/reach", "url": "https://legal.exploreworldai.com/in/questions/reach-indian-chemical-exporters" }, { "slug": "textiles-eu-requirements", "question": "What EU requirements apply to Indian textile and apparel exporters?", "answer": "Fibre composition labelling in the language of the Member State of sale, REACH screening of dyes and finishing chemicals before production, an EU responsible person with traceability elements on the article under GPSR, and preparation for the ecodesign delegated act with the digital product passport.", "hub": false, "requirement": "https://legal.exploreworldai.com/in/export/textiles", "url": "https://legal.exploreworldai.com/in/questions/textiles-eu-requirements" }, { "slug": "food-export-eu-requirements", "question": "What EU requirements apply to Indian food exporters?", "answer": "Traceability one step back and one step forward, HACCP-based controls, maximum residue levels and contaminant limits that are in several cases stricter than the Indian ones, entry through a designated border control post with the correct certificate, and labelling in the language of the Member State of sale.", "hub": false, "requirement": "https://legal.exploreworldai.com/in/export/food", "url": "https://legal.exploreworldai.com/in/questions/food-export-eu-requirements" }, { "slug": "fssai-versus-eu-food-law", "question": "Is FSSAI compliance enough to export food to the EU?", "answer": "No. FSSAI licensing says nothing about EU maximum residue levels or aflatoxin limits, which is where spice, rice, groundnut and sesame consignments are most often stopped. Rejections are published in the Union alert system, which is where the commercial damage occurs.", "hub": false, "requirement": "https://legal.exploreworldai.com/in/export/food", "url": "https://legal.exploreworldai.com/in/questions/fssai-versus-eu-food-law" }, { "slug": "pharma-eu-gmp", "question": "What does the EU require of Indian pharmaceutical manufacturers?", "answer": "A marketing authorisation held by an applicant established in the Union, a site inspected against EU GMP, batch release by a qualified person in the EU, pharmacovigilance with a qualified person resident in the Union, and the falsified medicines safety features on the pack.", "hub": false, "requirement": "https://legal.exploreworldai.com/in/export/pharma", "url": "https://legal.exploreworldai.com/in/questions/pharma-eu-gmp" } ], "indianInstruments": [ { "id": "dpdp", "name": "Digital Personal Data Protection Act, 2023", "shortName": "DPDP Act", "regulator": "Ministry of Electronics and Information Technology", "adopted": "2023-08-11", "inForce": "2023-08-11", "status": "phased", "officialUrl": "https://www.meity.gov.in/data-protection-framework", "euCounterpart": "General Data Protection Regulation (EU) 2016/679", "euUrl": "https://legal.exploreworldai.com/eu/rattsakter/gdpr-2016-679", "euAgentUrl": "https://legal.exploreworldai.com/agent/gdpr-2016-679", "difference": "Strukturen liknar GDPR men grunderna är färre: DPDP bygger på samtycke och legitima användningar, medan GDPR har sex rättsliga grunder inklusive berättigat intresse. DPDP har ingen egen rätt till dataportabilitet eller invändning mot profilering, och ingen obligatorisk konsekvensbedömning för alla högriskbehandlingar.", "consequence": "Att uppfylla DPDP räcker inte för att ta emot EU-data. Överföringen bedöms separat enligt kapitel V, och den indiska sidans undantag för statlig åtkomst är just det som måste beskrivas i en transfer impact assessment.", "url": "https://legal.exploreworldai.com/in/law/dpdp" }, { "id": "it-act", "name": "Information Technology Act, 2000", "shortName": "IT Act", "regulator": "Parliament of India", "adopted": "2000-06-09", "inForce": "2000-10-17", "status": "in_force", "officialUrl": "https://www.meity.gov.in/information-technology-act-2000", "euCounterpart": "NIS2 Directive (EU) 2022/2555", "euUrl": "https://legal.exploreworldai.com/eu/rattsakter/nis2-2022-2555", "euAgentUrl": "https://legal.exploreworldai.com/agent/nis2-2022-2555", "difference": "IT Act samlar avtalsrätt, straffrätt och myndighetsåtkomst i en akt. På EU-sidan är samma frågor fördelade: eIDAS för signaturer, NIS2 för säkerhetsåtaganden och medlemsstaternas straffrätt för intrång.", "consequence": "Avsnitt 69 är den bestämmelse en europeisk motpart granskar i en överföringsbedömning. Att kunna beskriva räckvidden och de praktiska begränsningarna är en förutsättning för att SCC-vägen ska hålla.", "url": "https://legal.exploreworldai.com/in/law/it-act" }, { "id": "it-rules", "name": "Information Technology (Intermediary Guidelines and Digital Media Ethics Code) Rules, 2021", "shortName": "IT Rules 2021", "regulator": "Ministry of Electronics and Information Technology", "adopted": "2021-02-25", "inForce": "2021-02-25", "status": "in_force", "officialUrl": "https://www.meity.gov.in/static/uploads/2024/02/Information-Technology-Intermediary-Guidelines-and-Digital-Media-Ethics-Code-Rules-2021-updated-06.04.2023-.pdf", "euCounterpart": "Digital Services Act (EU) 2022/2065", "euUrl": "https://legal.exploreworldai.com/eu/rattsakter/dsa-2022-2065", "euAgentUrl": "https://legal.exploreworldai.com/agent/dsa-2022-2065", "difference": "IT Rules kräver en klagomålsansvarig och en efterlevnadsansvarig som är bosatta i Indien samt korta borttagningsfrister. DSA kräver i stället en rättslig företrädare i unionen, en motiverad förklaring för varje åtgärd, systemriskbedömning för de största plattformarna och spårbarhetskontroll av näringsidkare.", "consequence": "En indisk plattform som redan har indisk klagomålsstruktur måste bygga en separat EU-struktur: företrädare, kontaktpunkt, anmälningsmekanism och näringsidkarkontroll. Rollerna kan inte återanvändas.", "url": "https://legal.exploreworldai.com/in/law/it-rules" }, { "id": "cert-in-directions", "name": "CERT-In Directions under section 70B(6) of the Information Technology Act, 2000", "shortName": "CERT-In Directions", "regulator": "Indian Computer Emergency Response Team", "adopted": "2022-04-28", "inForce": "2022-06-28", "status": "in_force", "officialUrl": "https://www.cert-in.org.in/", "euCounterpart": "Cyber Resilience Act (EU) 2024/2847 och NIS2-direktivet (EU) 2022/2555", "euUrl": "https://legal.exploreworldai.com/eu/rattsakter/cyberresiliens-2024-2847", "euAgentUrl": "https://legal.exploreworldai.com/agent/cyberresiliens-2024-2847", "difference": "CERT-In reglerar driftsäkerhet och rapportering hos den som driver tjänsten. CRA reglerar produkten: säkra standardinställningar, sårbarhetshantering, mjukvaruförteckning och säkerhetsuppdateringar under hela supportperioden, med 24 timmar för aktivt utnyttjade sårbarheter.", "consequence": "Rapporteringsfristerna är olika och löper parallellt: sex timmar till CERT-In och 24 timmar till ENISA. Ett bolag som säljer en uppkopplad produkt i EU behöver båda kedjorna förberedda i förväg.", "url": "https://legal.exploreworldai.com/in/law/cert-in-directions" }, { "id": "bis-act", "name": "Bureau of Indian Standards Act, 2016 and the Compulsory Registration Scheme", "shortName": "BIS Act, CRS", "regulator": "Bureau of Indian Standards", "adopted": "2016-03-22", "inForce": "2017-10-12", "status": "in_force", "officialUrl": "https://www.bis.gov.in/", "euCounterpart": "CE-märkning enligt unionens harmoniserade produktlagstiftning", "euUrl": "https://legal.exploreworldai.com/eu/rattsakter/produktsakerhet-2023-988", "euAgentUrl": "https://legal.exploreworldai.com/agent/produktsakerhet-2023-988", "difference": "BIS är ett godkännandesystem: en tredje part registrerar och beviljar rätten att märka. CE är motsatsen, en försäkran från tillverkaren själv, i regel utan anmält organ, men med tio års teknisk dokumentation och en ansvarig person i unionen.", "consequence": "Ett BIS-certifikat är inget bevis för CE och godtas inte av en marknadskontrollmyndighet. Provrapporterna kan ofta återanvändas, men försäkran, dokumentationen och den ansvariga personen måste byggas separat.", "url": "https://legal.exploreworldai.com/in/law/bis-act" }, { "id": "legal-metrology", "name": "Legal Metrology (Packaged Commodities) Rules, 2011", "shortName": "Packaged Commodities Rules", "regulator": "Department of Consumer Affairs, Legal Metrology Division", "adopted": "2011-02-23", "inForce": "2012-04-01", "status": "in_force", "officialUrl": "https://consumeraffairs.nic.in/organisation-and-units/division/legal-metrology", "euCounterpart": "Förordning (EU) 1169/2011 om livsmedelsinformation och (EU) 1007/2011 om textilmärkning", "euUrl": "https://legal.exploreworldai.com/eu/rattsakter/produktsakerhet-2023-988", "euAgentUrl": "https://legal.exploreworldai.com/agent/produktsakerhet-2023-988", "difference": "Indien kräver maximalt detaljhandelspris på förpackningen, vilket EU inte gör. EU kräver i stället språket i försäljningslandet, den ansvariga personens namn och adress samt spårbarhetselement på själva varan.", "consequence": "Etiketten kan inte återanvändas. En EU-etikett behöver ny språkuppsättning och den ansvariga personen, och maximalt detaljhandelspris ska bort.", "url": "https://legal.exploreworldai.com/in/law/legal-metrology" }, { "id": "cdsco-mdr", "name": "Medical Devices Rules, 2017", "shortName": "MDR 2017", "regulator": "Central Drugs Standard Control Organisation", "adopted": "2017-01-31", "inForce": "2018-01-01", "status": "in_force", "officialUrl": "https://cdsco.gov.in/opencms/opencms/en/Home/", "euCounterpart": "Förordning (EU) 2017/745 om medicintekniska produkter", "euUrl": "https://legal.exploreworldai.com/eu/rattsakter/produktansvar-2024-2853", "euAgentUrl": "https://legal.exploreworldai.com/agent/produktansvar-2024-2853", "difference": "Klasserna A till D motsvarar inte EU:s I, IIa, IIb och III ett till ett. EU kräver anmält organ för i praktiken allt utom klass I, en auktoriserad representant enligt artikel 11, EUDAMED-registrering, UDI och en klinisk utvärdering som håller utan att luta sig mot likvärdighet.", "consequence": "En CDSCO-licens öppnar inte EU-marknaden. Den kliniska evidensen är den del som oftast måste byggas om, och den auktoriserade representanten är en egen roll skild från den produktansvariga personen.", "url": "https://legal.exploreworldai.com/in/law/cdsco-mdr" }, { "id": "drugs-cosmetics", "name": "Drugs and Cosmetics Act, 1940 and the Drugs Rules, 1945, Schedule M", "shortName": "Drugs and Cosmetics Act", "regulator": "Central Drugs Standard Control Organisation", "adopted": "1940-04-10", "inForce": "1940-04-10", "status": "in_force", "officialUrl": "https://cdsco.gov.in/opencms/opencms/en/Home/", "euCounterpart": "Direktiv 2001/83/EG om humanläkemedel och förordning (EG) 726/2004 om unionens godkännandeförfaranden", "euUrl": "https://legal.exploreworldai.com/eu/rattsakter/produktansvar-2024-2853", "euAgentUrl": "https://legal.exploreworldai.com/agent/produktansvar-2024-2853", "difference": "Schedule M är närmat till EU-GMP men inte identiskt. EU kräver ett godkännande för försäljning som innehas av en sökande etablerad i unionen, satsfrisläppning av en behörig person i EU och ett säkerhetsövervakningssystem med ansvarig person bosatt i unionen.", "consequence": "Satsfrisläppning kan inte ske i Indien. Anläggningen inspekteras dessutom av en EU-myndighet oavsett indiskt godkännande, och avvikelser leder till importstopp för hela anläggningen.", "url": "https://legal.exploreworldai.com/in/law/drugs-cosmetics" }, { "id": "fssai-act", "name": "Food Safety and Standards Act, 2006", "shortName": "FSS Act", "regulator": "Food Safety and Standards Authority of India", "adopted": "2006-08-23", "inForce": "2011-08-05", "status": "in_force", "officialUrl": "https://www.fssai.gov.in/", "euCounterpart": "Förordning (EG) 178/2002 om livsmedelslagstiftningens allmänna principer och (EU) 2017/625 om offentlig kontroll", "euUrl": "https://legal.exploreworldai.com/eu/rattsakter/avskogningsforordningen-2023-1115", "euAgentUrl": "https://legal.exploreworldai.com/agent/avskogningsforordningen-2023-1115", "difference": "Gränsvärdena skiljer sig i sak. EU:s gränsvärden för bekämpningsmedelsrester och aflatoxin är i flera fall strängare än de indiska, och en sändning måste komma in via en utsedd gränskontrollstation med rätt hälsointyg.", "consequence": "Att uppfylla FSSAI säger ingenting om EU-gränsvärdena. Avvisade sändningar publiceras i unionens varningssystem, vilket är där den kommersiella skadan uppstår.", "url": "https://legal.exploreworldai.com/in/law/fssai-act" }, { "id": "energy-conservation", "name": "Energy Conservation Act, 2001 and the BEE Standards and Labelling Programme", "shortName": "Energy Conservation Act", "regulator": "Bureau of Energy Efficiency", "adopted": "2001-09-29", "inForce": "2002-03-01", "status": "in_force", "officialUrl": "https://beeindia.gov.in/", "euCounterpart": "Förordning (EU) 2024/1781 om ekodesign och (EU) 2017/1369 om energimärkning", "euUrl": "https://legal.exploreworldai.com/eu/rattsakter/produktsakerhet-2023-988", "euAgentUrl": "https://legal.exploreworldai.com/agent/produktsakerhet-2023-988", "difference": "BEE mäter energi. EU:s ekodesign mäter energi och därtill hållbarhet, reparerbarhet, tillgång till reservdelar, återvunnet innehåll och ett digitalt produktpass, med registrering i EPREL före utsläppande på marknaden.", "consequence": "En hög BEE-stjärna ger ingen EU-energiklass. Konstruktionsbeslut om reparerbarhet och reservdelar måste tas tidigt, eftersom de inte kan efterhandsdokumenteras.", "url": "https://legal.exploreworldai.com/in/law/energy-conservation" }, { "id": "e-waste-rules", "name": "E-Waste (Management) Rules, 2022", "shortName": "E-Waste Rules", "regulator": "Central Pollution Control Board", "adopted": "2022-11-02", "inForce": "2023-04-01", "status": "in_force", "officialUrl": "https://cpcb.nic.in/", "euCounterpart": "Direktiv 2012/19/EU om avfall som utgörs av elektriska och elektroniska produkter", "euUrl": "https://legal.exploreworldai.com/eu/rattsakter/produktsakerhet-2023-988", "euAgentUrl": "https://legal.exploreworldai.com/agent/produktsakerhet-2023-988", "difference": "Indien har ett nationellt register. EU kräver registrering per medlemsstat, en producentansvarsrepresentant i varje land där produkten släpps ut och rapportering enligt varje lands modell.", "consequence": "Ett indiskt EPR-certifikat gäller inte i EU. Kostnaden för producentansvar uppstår per medlemsstat och måste räknas in i priset, inte upptäckas efter första leveransen.", "url": "https://legal.exploreworldai.com/in/law/e-waste-rules" }, { "id": "battery-waste-rules", "name": "Battery Waste Management Rules, 2022", "shortName": "Battery Waste Rules", "regulator": "Central Pollution Control Board", "adopted": "2022-08-22", "inForce": "2022-08-22", "status": "in_force", "officialUrl": "https://cpcb.nic.in/", "euCounterpart": "Förordning (EU) 2023/1542 om batterier och förbrukade batterier", "euUrl": "https://legal.exploreworldai.com/eu/rattsakter/csddd-2024-1760", "euAgentUrl": "https://legal.exploreworldai.com/agent/csddd-2024-1760", "difference": "EU-förordningen går längre: koldioxiddeklaration per funktionell enhet, tröskelvärden för återvunnet innehåll av kobolt, bly, litium och nickel, tredjepartsgranskad råvarugranskning och ett digitalt batteripass från februari 2027.", "consequence": "Koldioxiddeklarationen kräver anläggningsdata som få indiska tillverkare har i dag. Den som börjar samla den nu kan sälja till EU-kunder som annars måste välja bort leverantören.", "url": "https://legal.exploreworldai.com/in/law/battery-waste-rules" }, { "id": "plastic-epr", "name": "Plastic Waste Management Rules, 2016 and the Extended Producer Responsibility Guidelines", "shortName": "Plastic Waste Rules, EPR", "regulator": "Central Pollution Control Board", "adopted": "2016-03-18", "inForce": "2016-03-18", "status": "in_force", "officialUrl": "https://cpcb.nic.in/", "euCounterpart": "Förordning (EU) 2025/40 om förpackningar och förpackningsavfall", "euUrl": "https://legal.exploreworldai.com/eu/rattsakter/produktsakerhet-2023-988", "euAgentUrl": "https://legal.exploreworldai.com/agent/produktsakerhet-2023-988", "difference": "EU-förordningen sätter krav på förpackningens utformning: minimering, återvinningsbarhet i klass, obligatoriskt återvunnet innehåll och förbud mot vissa engångsformat.", "consequence": "Förpackningen kan behöva göras om, inte bara rapporteras. För en exportör med hög volym mot EU är det ett konstruktionsprojekt med lång ledtid.", "url": "https://legal.exploreworldai.com/in/law/plastic-epr" }, { "id": "telecom-act", "name": "Telecommunications Act, 2023", "shortName": "Telecommunications Act", "regulator": "Department of Telecommunications", "adopted": "2023-12-24", "inForce": "2024-06-26", "status": "phased", "officialUrl": "https://www.dot.gov.in/", "euCounterpart": "Direktiv (EU) 2018/1972 om en kodex för elektronisk kommunikation", "euUrl": "https://legal.exploreworldai.com/eu/rattsakter/eidas-910-2014", "euAgentUrl": "https://legal.exploreworldai.com/agent/eidas-910-2014", "difference": "Den indiska akten samlar auktorisation och säkerhetsbefogenheter i samma lag. EU-kodexen reglerar tillträde och konkurrens, medan säkerhetsåtaganden ligger i NIS2 och avlyssning i medlemsstaternas nationella rätt.", "consequence": "Befogenheterna att stänga ned och avlyssna är del av det som ska beskrivas i en överföringsbedömning för molntjänster som passerar indisk infrastruktur.", "url": "https://legal.exploreworldai.com/in/law/telecom-act" }, { "id": "dpdp-transfers", "name": "Digital Personal Data Protection Act, 2023, section 16 on transfer of personal data outside India", "shortName": "DPDP section 16", "regulator": "Ministry of Electronics and Information Technology", "adopted": "2023-08-11", "inForce": "2023-08-11", "status": "phased", "officialUrl": "https://www.meity.gov.in/data-protection-framework", "euCounterpart": "General Data Protection Regulation (EU) 2016/679", "euUrl": "https://legal.exploreworldai.com/eu/rattsakter/gdpr-2016-679", "euAgentUrl": "https://legal.exploreworldai.com/agent/gdpr-2016-679", "difference": "The two regimes run in opposite directions. DPDP section 16 allows outbound transfer unless a country is placed on a negative list, while GDPR Chapter V prohibits transfer unless a positive ground exists: an adequacy decision under Article 45, appropriate safeguards under Article 46 such as the Standard Contractual Clauses or binding corporate rules under Article 47, or a narrow derogation under Article 49. India holds no adequacy decision, and Article 48 means an Indian authority's order is not by itself a lawful basis for an EU controller to disclose.", "consequence": "An Indian entity that is compliant on the DPDP side still has no basis for receiving EU data. The inbound leg needs the Commission's clauses, a transfer impact assessment naming the government access powers under section 69 of the IT Act and the Telecommunications Act, and documented supplementary measures. In practice EU counterparties ask for that assessment during procurement, so it is a sales document as much as a compliance one.", "url": "https://legal.exploreworldai.com/in/law/dpdp-transfers" } ], "method": "No legal text is reproduced. Every row carries the designation, the article number and a link to the article node in our own register or to the official publisher. 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