Frequently Asked Questions

CE marking is the mandatory EU product safety marking for goods placed on the EU market. Products requiring CE: machinery, electrical/electronic equipment, personal protective equipment, medical devices, construction products, pressure vessels, toys, radio equipment. CE marking requires: (1) identify applicable EU directives, (2) conduct conformity assessment (self-declaration or Notified Body), (3) compile technical documentation, (4) issue Declaration of Conformity, (5) affix CE mark. Indian manufacturers must CE-mark before shipping to EU.

REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) is the EU regulation governing chemicals. Impact on Indian exporters: (1) EU importers of Indian chemicals must register substances in amounts >1 tonne/year with ECHA, (2) Indian chemical exporters should appoint an Only Representative (OR) in the EU to handle REACH registration on behalf of EU importers, (3) Indian textile and leather exporters must ensure products don't contain SVHC (Substances of Very High Concern) above REACH limits. Non-compliance: product ban from EU market.

EU Good Manufacturing Practice (GMP) is the EU standard for pharmaceutical manufacturing. Indian API and finished dose manufacturers must have EU GMP certification to sell to EU pharmaceutical companies or patients. Process: (1) implement EU GMP (Annex 1-16) in your facility, (2) an EU national competent authority (MHRA, ANSM, BfArM, etc.) or EMA conducts an inspection, (3) if compliant, a GMP certificate is issued, valid 3 years. PHARMEXCIL coordinates EU GMP audit preparation for Indian pharma companies.

CEP (Certificate of Suitability) is issued by EDQM (European Directorate for the Quality of Medicines) confirming that an API complies with the European Pharmacopoeia (Ph. Eur.) monograph. EU pharmaceutical manufacturers require CEP from their API suppliers. CEP application: submit an EDQM application with full dossier of your manufacturing process, impurity profile, and quality specifications. CEP process takes 12-18 months. CEP is the primary market access credential for Indian API exporters to EU.

EU MDR (Regulation 2017/745) is the EU regulatory framework for medical devices placed on the EU market. It replaced the MDD (Medical Device Directive) with stricter requirements: (1) All devices need a Unique Device Identifier (UDI), (2) Higher risk Class II-III devices require Notified Body assessment, (3) EUDAMED (European Medical Device database) registration required, (4) Post-market surveillance and clinical evidence requirements are stricter. Indian medical device manufacturers must comply with EU MDR before EU market entry.

For Indian food exporters to EU: (1) FSSAI registration (India mandatory), (2) EU food hygiene compliance (EU Regulation 852/2004 — HACCP implementation), (3) EU MRL compliance for pesticide residues (tested by EU-accredited laboratory), (4) Labelling compliance (EU Regulation 1169/2011 — allergen declaration, nutrition labelling, country of origin), (5) For organic products: EU organic certification from an EU-recognised control body. Seafood additionally requires EU-approved processing facility listing.

EU Deforestation Regulation (EUDR) requires operators and traders placing products on the EU market to ensure they are deforestation-free and comply with laws of the country of production. Covered products: soya, beef, palm oil, wood, cocoa, coffee, rubber, and their derived products. Indian exporters of coffee, rubber, leather, and wood products must: (1) establish geo-location of production plots, (2) conduct due diligence on deforestation-free status, (3) file due diligence statements in EU TRACES system. Full enforcement began 2025.

The Digital Product Passport (DPP) is an EU requirement under the Ecodesign for Sustainable Products Regulation (ESPR) for a digital record of a product' sustainability attributes, materials, recycled content, and end-of-life instructions. DPP will be mandatory for: batteries (2027), textiles and garments (2027), electronics (2028). Indian exporters of batteries, textiles, and electronics must prepare data infrastructure to generate and attach DPPs to their products.

RoHS (Restriction of Hazardous Substances) Directive restricts 10 substances including lead, mercury, cadmium, hexavalent chromium, and certain flame retardants in electrical and electronic equipment (EEE). Indian electronics, LED lights, solar panels, medical devices, and industrial equipment exported to EU must comply with RoHS. Test your products at an accredited laboratory and include RoHS compliance in your CE marking Declaration of Conformity.

Not all products require a Notified Body. Self-declaration of conformity is sufficient for lower-risk products. Notified Body assessment is required for: Class II-III medical devices, high-risk machinery (e.g., lifts, pressure vessels), PPE Category III, construction products needing Type Examination, radio equipment with new spectrum. Search for NANDO (New Approach Notified and Designated Organisations) database for EU Notified Bodies — TUV SUD, Bureau Veritas, SGS are the most commonly used by Indian exporters.

Post-Brexit, Great Britain (England, Scotland, Wales) requires UKCA (UK Conformity Assessed) marking instead of CE marking. CE marking is still accepted in Northern Ireland (under Windsor Framework). For Indian exporters selling to both EU and UK: you need both CE (EU) and UKCA (GB). Most UKCA requirements mirror CE, but UKCA requires UK-registered approved bodies and UK Declaration of Conformity. Note: UK accepted CE marking until December 2024 — from 2025, UKCA is mandatory for most products.

EU labelling requirements: (1) Language: labelling must be in the official language(s) of the country of sale — multi-country EU products need multi-language labels, (2) Country of origin: 'Made in India' required for textile, food, and some other products, (3) Food labelling: nutrition declaration, allergens in bold, net quantity, best before/use by date (Reg 1169/2011), (4) CE marking: where applicable, (5) Recycling symbols: where required. Non-compliant labelling causes products to be refused at EU customs or withdrawn from shelves.