Global Trade Lexicon

Mandatory EU conformity marking indicating compliance with EU health, safety, and environmental protection standards.

Mandatory for most manufactured goods entering EU: machinery, electronics, medical devices, construction products.

Registration, Evaluation, Authorisation and Restriction of Chemicals — EU regulation governing chemicals and their safe use.

Indian chemical exporters to EU must comply with REACH. EU importers of Indian chemicals must register substances >1 tonne/year.

Substance of Very High Concern under REACH — requires authorisation for use in EU.

Indian textile and leather exporters must verify products do not contain SVHC chemicals exceeding REACH limits.

EU Medical Device Regulation 2017/745 — enhanced requirements for medical devices placed on the EU market.

Indian medical device exporters must obtain EU MDR certification. Different conformity assessment routes for Class I-III devices.

Organisation designated by an EU member state to assess conformity of regulated products before EU market placement.

Indian exporters of medical devices and machinery need Notified Body certification — TUV SUD, SGS, Bureau Veritas.

Manufacturer's declaration that a product meets requirements of relevant EU directives and regulations.

Indian exporters must have a DoC for all CE-marked goods, referencing applicable EU directives and harmonised standards.

World Health Organisation Good Manufacturing Practices — international standard for pharmaceutical production.

Indian pharma exporters must have WHO-GMP certification to export to EU, UAE, and most regulated markets.

EU standards for pharmaceutical manufacturing under Directive 2001/83/EC, enforced by national competent authorities.

Indian API and pharmaceutical manufacturers exporting to EU must have EU GMP certification — stricter than WHO-GMP.

The regulatory approval required for a pharmaceutical product to be placed on the EU market.

Indian pharma companies exporting finished dose forms to EU require EU marketing authorisation from EMA or national authorities.

Certificate issued by EDQM confirming an API meets requirements of the European Pharmacopoeia.

CEP from EDQM is mandatory for Indian API exporters supplying EU-authorised finished dose manufacturers. Takes 12-18 months.

The maximum legally permitted level of a pesticide residue in or on food and animal feed in the EU.

Indian agro-food exporters must test for EU MRL compliance. EU MRLs are often stricter than Codex Alimentarius standards.

Rapid Alert System for Food and Feed — EU's early warning network for food and feed safety risks.

AJG monitors RASFF for India-specific alerts. RASFF notifications for Indian agro-food exports are publicly available.

Certificate confirming plants or plant products meet importing country phytosanitary requirements.

Mandatory for Indian agro-food, plant, and wood exports to EU. Issued by Plant Quarantine Division.

Certificate confirming animal or animal-derived products meet importing country sanitary requirements.

Required for Indian meat, dairy, and seafood exports to EU. Issued by APEDA/MPEDA with veterinary endorsement.

Food Safety and Standards Authority of India — mandatory registration for all food businesses in India.

FSSAI certification is often required by EU buyers as baseline food safety evidence for Indian agro-food products.

Central Drugs Standard Control Organisation — India's national regulatory body for pharmaceuticals and medical devices.

CDSCO export NOC required for Indian pharma exporters. Medical device exporters need CDSCO device registration.

EU Deforestation Regulation — requires products sold in EU to be deforestation-free with due diligence documentation.

Affects Indian exporters of soya, coffee, cocoa, palm oil, timber, leather, rubber. Due diligence declarations required.

Carbon Border Adjustment Mechanism — EU carbon price on imports of steel, aluminium, cement, fertilisers, electricity, hydrogen.

Directly impacts Indian steel, aluminium, fertiliser exporters to EU. Full effect from 2026.

Corporate Sustainability Reporting Directive — EU law requiring large companies to report on sustainability impacts.

CSRD applies to EU companies and their value chains including Indian suppliers. Indian exporters must provide sustainability data.

Bureau of Indian Standards — issues IS marks and manages Quality Control Orders for India domestic market.

BIS QCOs are mandatory for specified products sold in India. Relevant for EU companies exporting to India.

Mandatory quality standards order by India requiring BIS certification for specific products imported into India.

India has issued QCOs for 600+ product categories. EU exporters to India must obtain BIS certification for QCO-covered goods.

UK Conformity Assessed marking — UK equivalent of CE marking required for goods placed on the GB market post-Brexit.

Indian exporters selling to both EU and UK need CE (for EU) and UKCA (for Great Britain) marking.

Restriction of Hazardous Substances Directive — restricts hazardous materials in electrical and electronic equipment in EU.

Indian electronics exporters to EU must comply with RoHS restrictions on lead, mercury, cadmium, and other hazardous substances.

Waste Electrical and Electronic Equipment Directive — EU law on collection, recycling, and recovery of electrical equipment.

Indian electronics exporters to EU must ensure their EU importers are registered with national WEEE take-back schemes.

EU requirement under ESPR for a digital record of a product's sustainability attributes, materials, and end-of-life instructions.

DPP mandatory for batteries (2027), textiles (2027), electronics (2028). Indian exporters must prepare product data infrastructure.

Ecodesign for Sustainable Products Regulation — new EU regulation covering all product categories with sustainability requirements.

ESPR introduces Digital Product Passport and minimum performance requirements affecting Indian exporters.