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EFSA / EMA / REACH / CBAM

Compliance Bridge

Deciphering complex EU regulations to prevent customs seizures and ensure smooth market entry

Quick Answer

Expert management of EFSA Novel Food registrations and EMA medicinal QP release. We decipher REACH and CBAM regulations to prevent customs seizures.

February 2026 Update

Regulation data updated following the India-EU FTA signing (January 27, 2026) and the India Union Budget 2026-27 (February 1, 2026). REACH registration fees increased 19.5% for large companies effective late 2025. Sources: ECHA, EFSA, PIB.

The Compliance Challenge

Unmanaged exporters face 23% higher supply chain costs due to regulatory hurdles. Customs seizures, border delays, and non-compliance penalties can derail market entry. eufta.in acts as your regulatory bridge, translating complex EU requirements into actionable compliance pathways.

F

Food, Ayush, and Wellness

Regulation (EU) 2015/2283 (Novel Foods)

The Problem

Traditional Indian ingredients (e.g., Ashwagandha) often lack a 'safe history of consumption' in the EU pre-May 1997.

eufta.in Solution

We manage the Article 4 Consultation to prove safe use or guide brands through the 9-24 month EFSA dossier approval process.

Step-by-Step Process

1Initial ingredient assessment and EU pre-1997 consumption history research
2Article 4 Consultation submission to EFSA
3Dossier preparation (9-24 months) if novel food status confirmed
4Health claims audit per Regulation EC 1924/2006
5Packaging compliance verification
M

Medicinal and Herbal Products

Annex 21 (Importation of Medicinal Products)

The Problem

Each batch of medicinal products requires EU-based Qualified Person (QP) certification before market release.

eufta.in Solution

QP-certified batch release in Rotterdam after lab testing. We assist manufacturers in maintaining EU-GMP standards through pre-inspection audits.

Step-by-Step Process

1GMP site audit preparation and gap analysis
2Batch documentation review and quality control
3Lab testing coordination in Rotterdam
4QP batch release certification
5Market release authorization
C

Chemicals and Plastics

Regulation (EC) 1907/2006 (REACH)

The Problem

Non-EU manufacturers cannot register chemicals directly with ECHA. The 19.5% registration fee increase (late 2025) adds complexity.

eufta.in Solution

eufta.in acts as your Only Representative (OR), handling all ECHA registrations and managing fee structures.

Step-by-Step Process

1Only Representative (OR) appointment and registration
2ECHA dossier preparation and submission
3Fee management (including 19.5% increase for large companies)
4Ongoing compliance monitoring and updates
5Downstream user communication
T

Textiles and Apparel

CBAM (Carbon Border Adjustment Mechanism)

The Problem

Mandatory carbon footprint reporting for textile imports. Non-compliance results in customs delays and penalties.

eufta.in Solution

We manage CBAM reporting requirements, calculate carbon footprints, and ensure timely submission to prevent border issues.

Step-by-Step Process

1Carbon footprint calculation per product category
2CBAM reporting documentation preparation
3Quarterly submission to EU authorities
4Compliance verification and audit support

Additional Regulatory Support

Comprehensive coverage across all compliance requirements

CE Certification

Technical safety file audit and CE marking for engineering goods, electronics, and machinery.

Toy Safety Directive

EN 71 standards verification for toys and sports goods entering the EU market.

Border Control Posts (BCP)

Veterinary inspection and clearance for marine products and food imports.

Origin Certification

Rules of Origin documentation and 'Change in Tariff Heading' verification for FTA benefits.

The Cost of Non-Compliance

Customs Seizures

23% Higher

Supply chain costs for unmanaged exporters

Border Delays

5-15 Days

Average delay for non-compliant shipments

Penalty Risk

Up to 10%

Of shipment value for regulatory violations

Last updated: February 15, 2026

EU Compliance FAQ for Indian Exporters

Direct answers about EFSA, REACH, CBAM, and other EU regulatory requirements

Q

What EU regulations do Indian exporters need to comply with?

Indian exporters to the EU must comply with several regulations depending on their product: EFSA Novel Food (Regulation EU 2015/2283) for food and Ayush wellness products, EMA Annex 21 for medicinal products requiring QP batch release, REACH (Regulation EC 1907/2006) for chemicals requiring an Only Representative (OR), CBAM for mandatory carbon footprint reporting on textiles, CE certification for engineering goods, and EN 71 Toy Safety Directive for toys and sports goods.

Q

What is a REACH Only Representative (OR) and why do Indian companies need one?

Non-EU manufacturers cannot register chemicals directly with ECHA (European Chemicals Agency). A REACH Only Representative (OR) is an EU-based entity that handles all ECHA registrations on behalf of the non-EU manufacturer. eufta.in acts as OR for Indian chemical and plastics exporters, managing dossier preparation, fee structures (including the 19.5% registration fee increase from late 2025), and ongoing compliance monitoring.

Q

How long does EFSA Novel Food registration take?

EFSA Novel Food registration typically takes 9-24 months. The process begins with an Article 4 Consultation to determine if the ingredient has a safe history of consumption in the EU pre-May 1997. If classified as novel, a full EFSA dossier is required. eufta.in manages the entire process including initial ingredient assessment, Article 4 submission, dossier preparation, and health claims audit per Regulation EC 1924/2006.

Q

What is CBAM and how does it affect Indian textile exports to the EU?

CBAM (Carbon Border Adjustment Mechanism) requires mandatory carbon footprint reporting for certain imports into the EU, including textiles. Indian textile exporters must calculate the carbon footprint per product category, prepare CBAM reporting documentation, and submit quarterly reports to EU authorities. Non-compliance results in customs delays and penalties of up to 10% of shipment value.

Navigate EU Regulations with Confidence

Let eufta.in be your compliance bridge. We handle the regulatory complexity so you can focus on growing your European market share.

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