Why Export Packaging Regulations Matter to Indian Manufacturers

India's domestic packaging regulations, primarily governed by FSSAI (food), CDSCO (pharmaceuticals), BIS (standards), and the Plastic Waste Management Rules (EPR), apply to products sold within India. The moment an Indian-manufactured product crosses an international border in its packaging, it enters the regulatory jurisdiction of the destination market. The importing country's packaging regulations apply, and ignorance of them is not a defence at customs.

The consequences of non-compliant export packaging:

  • Shipment refused entry at port of destination and returned to origin (at exporter's cost)
  • Product recalled from market if non-compliance is discovered after entry
  • Financial penalties imposed on the importer of record
  • Loss of supplier approval status with the importing brand or retailer
  • Reputational damage that affects future export opportunities

The good news: export packaging compliance, while complex, is manageable with advance planning. The key is to understand what each market requires before packaging is designed and printed, not after.

Regulations change, verify current requirements

Packaging regulations are updated regularly. The EU's PPWR (Packaging and Packaging Waste Regulation) was being finalised through 2024–2025 with phased implementation timelines. UK regulations have been evolving post-Brexit. Always verify current requirements with a compliance specialist or the relevant regulatory authority before final packaging approval. This article is a practical orientation guide, it does not substitute for regulatory advice on specific products.

🇪🇺
European Union
PPWR · REACH · Food Contact Regulation (EC) 1935/2004 · Recycling targets

EU Packaging and Packaging Waste Regulation (PPWR)

The PPWR (Regulation (EU) 2025/40, the successor to the 1994 Directive 94/62/EC) is the EU's comprehensive packaging regulation, covering all packaging placed on the EU market. For Indian exporters, the key requirements include:

  • Recyclability: All packaging placed on the EU market must be recyclable by 2030, with progressively tighter recyclability criteria. Multi-material packaging structures (plastic + aluminium + paper laminate) that cannot be separated for recycling are being phased out.
  • Recycled content: Minimum recycled content requirements for plastic packaging, phased in from 2030 (30% recycled content in plastic packaging generally; higher for specific applications).
  • Packaging minimisation: Unnecessary packaging and excessive void fill are regulated. Packaging must use the minimum amount of material that safely protects the product.
  • Reusable packaging targets: Specific product categories (beverages, takeaway, transport) must offer reusable packaging options by defined deadlines.
  • Labelling: Standardised EU recyclability labelling must appear on all packaging, indicating which components are recyclable and in which recycling stream.

REACH regulation, restricted substances in inks and coatings

REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals, Regulation (EC) 1907/2006) restricts the use of specific hazardous substances in products placed on the EU market, including printing inks and packaging coatings. Key REACH restrictions affecting Indian packaging exporters:

  • Restricted substances in inks: Certain aromatic amines (from azo dyes), heavy metals (lead, cadmium, chromium VI, mercury), and phthalates are restricted or prohibited in inks on packaging that contacts food or is handled by consumers
  • SVHCs (Substances of Very High Concern): The SVHC candidate list (updated regularly) includes substances that may be restricted. Indian exporters must ensure inks, coatings, and adhesives in their packaging do not contain SVHCs above threshold concentrations
  • EuPIA (European Printing Ink Association) guidelines: The de facto industry standard for ink compliance in European packaging, Indian packaging ink suppliers should provide EuPIA compliance declarations for inks used in EU-destined packaging

Food contact materials, Regulation (EC) 1935/2004

All materials and articles intended to contact food (packaging, containers, utensils) must comply with EC 1935/2004 and its specific implementing measures. For Indian exporters of food products:

  • Packaging must not transfer substances to food in quantities that could endanger human health or change the food's characteristics
  • Paper and board food contact materials must comply with overall migration limits, typically tested to confirm no unacceptable transfer of substances from packaging to food simulants
  • Printing inks on food packaging must be on the non-food-contact side with appropriate barrier coatings, or, if on the food-contact side, must use food-grade inks only
  • A Declaration of Compliance (DoC) from the packaging supplier confirming EC 1935/2004 compliance must be available for inspection
India to EU, key practical steps

Request REACH compliance declarations from all ink, coating, and adhesive suppliers used in EU-destined packaging. Obtain a Declaration of Compliance (DoC) for food contact packaging under EC 1935/2004. Ensure packaging structure meets recyclability requirements, avoid laminate structures that cannot be separated. Have packaging recyclability assessed against the EU's recyclability criteria before finalising the structure for new EU-destined product launches.

🇺🇸
United States
FDA 21 CFR · CONEG · FTC Green Guides · California Prop 65

FDA 21 CFR, Food contact packaging

The US Food and Drug Administration (FDA) regulates food contact materials under Title 21 of the Code of Federal Regulations (21 CFR). Parts 170–189 cover indirect food additives, substances that may migrate from packaging into food. For Indian exporters of food products to the USA:

  • Packaging materials (paper, board, plastics, adhesives, coatings, inks) must use only FDA-cleared substances as defined in 21 CFR
  • The manufacturer must be able to demonstrate that all components of the packaging system are either on the FDA's list of approved substances or have received a Food Contact Notification (FCN)
  • Migration testing may be required to demonstrate that substances do not migrate into food above safe thresholds
  • For pharmaceuticals, additional requirements under FDA 21 CFR Part 211 (GMP for finished pharmaceuticals) and Part 610 apply

CONEG, heavy metals in packaging

The Coalition of Northeastern Governors (CONEG) model legislation (now adopted by 19+ US states) limits the total concentration of four heavy metals, lead, cadmium, mercury, and hexavalent chromium, in packaging and packaging components to 100 ppm (0.01%) combined. This applies to packaging inks, dyes, pigments, and coatings. Indian ink suppliers must provide certification that inks for US-destined packaging comply with CONEG limits.

California Proposition 65

California's Prop 65 (Safe Drinking Water and Toxic Enforcement Act) requires businesses to provide warnings before knowingly exposing Californians to substances listed as known carcinogens or reproductive toxins. For packaging, this is most relevant for:

  • Lead in printing inks (lead chromate yellow, for example, is a Prop 65 substance)
  • Di(2-ethylhexyl)phthalate (DEHP) and other phthalates used as plasticisers in flexible packaging
  • Bisphenol A (BPA) in certain plastic packaging

Products sold in California that contain listed substances must carry specific Prop 65 warning text on the packaging. Avoid using materials containing Prop 65-listed substances in packaging for the US market.

FTC Green Guides

The US Federal Trade Commission's Green Guides govern environmental marketing claims on packaging. Claims like "recyclable," "recycled content," "compostable," and "biodegradable" must be substantiated and accurate. Indian exporters making green claims on US-market packaging must ensure those claims can withstand FTC scrutiny, unsubstantiated green claims expose the brand to enforcement action.

India to USA, key practical steps

Obtain 21 CFR compliance letters from all packaging material suppliers (paper, board, plastics, adhesives, inks, coatings) confirming the materials are FDA-cleared for their intended food contact application. Obtain CONEG heavy metals certifications from ink suppliers. Verify no Prop 65-listed substances are present above threshold levels if selling to California. Review any environmental claims against FTC Green Guide standards before printing.

🇬🇧
United Kingdom (Post-Brexit)
UK PPWR · UK REACH · UKCA marking · Separate regulatory regime since January 2021

UK's separate regulatory regime post-Brexit

Since 1 January 2021, Great Britain (England, Scotland, Wales) operates its own regulatory regime for packaging, largely mirroring EU requirements but as separate UK law. Northern Ireland has a different arrangement with continued alignment to EU rules in some areas. Indian exporters selling to GB and selling to the EU now need to comply with two separate regulatory frameworks.

UK Packaging and Packaging Waste regulations

The UK Packaging and Packaging Waste Regulations (updated through the Producer Responsibility Obligations scheme) set UK-specific recycling targets and packaging compliance requirements. The UK government has been developing its own Extended Producer Responsibility (UK EPR) scheme for packaging, which places responsibility on UK brand owners and importers for the cost of packaging waste collection and recycling. Indian exporters need to understand that their UK importer/brand owner bears EPR obligations, and that packaging must meet UK recyclability criteria.

UK REACH

UK REACH (the UK's retained version of EU REACH under the Chemicals and Substances (Registration, Evaluation, Authorisation and Restriction) Act) mirrors EU REACH in scope but is maintained independently. Substances restricted under EU REACH are typically also restricted under UK REACH, but the lists may diverge over time. Indian packaging exporters should confirm REACH compliance under both EU and UK frameworks for dual-market packaging.

UKCA marking

The UKCA (UK Conformity Assessed) marking has replaced the CE marking for products placed on the GB market in categories requiring conformity marking. While not all packaging requires UKCA marking (most consumer packaging does not), certain packaging types in regulated categories (medical device packaging, certain electrical product packaging) may require UKCA assessment. Verify with your UK importer whether UKCA marking applies to your specific packaging.

EU and UK, can you use one packaging design for both markets?

For most FMCG and consumer goods, yes, EU-compliant packaging will also satisfy UK requirements in the near term since both regimes broadly mirror each other. However, as UK and EU regulations diverge over time, dual-market packaging will require either a common-denominator approach or separate packaging designs. Track regulatory developments in both markets if your product sells significantly in both.

🇯🇵
Japan
Food Sanitation Act · JHPA guidelines · Positive list system · High compliance bar

Japan's Food Sanitation Act

Japan's Food Sanitation Act regulates food contact materials including packaging. Japan operates a positive list system for food contact plastics (from June 2020), only substances on the positive list may be used in plastic food contact materials. This is more restrictive than the EU or US approach, which have negative lists (substances not on the restricted list are generally permitted). For Indian exporters:

  • Plastic food contact packaging must use only positive-listed substances
  • Paper and board food contact materials are not yet covered by the positive list system but are regulated under the Food Sanitation Act's general provisions
  • Migration testing against Japanese food simulants and at Japanese test conditions may be required

JHPA (Japan Hygienic Olefin and Styrene Plastics Association) guidelines

JHPA and sister organisations publish technical guidelines for food contact materials that are the industry standard in Japan. JHPA compliance is typically required or strongly preferred by Japanese food importers for plastic food contact packaging. Equivalent organisations cover other materials, JHOSPA (polyolefins), JFPA (paper and board).

Japan's high compliance standards in practice

Japan has some of the strictest food contact packaging standards in the world. Japanese importers of food products typically require extensive documentation from Indian suppliers, test reports from accredited Japanese or internationally recognised testing laboratories, declarations of compliance referencing specific Japanese standards, and often factory audits. Budget significant lead time for Japan compliance documentation, typically 3–6 months before first shipment to obtain all required certifications.

India to Japan, approach

Engage a specialist Japanese food contact compliance testing laboratory (accredited by JNLA, Japan National Laboratory Accreditation, or internationally recognised) early in the packaging development process. Request positive list compliance confirmation from all plastic material suppliers. Prepare Japanese-language technical documentation as most Japanese importers require documentation in Japanese. Expect the Japan compliance process to be the most demanding of any export market.

🌙
GCC, Gulf Cooperation Council
GSO standards · UAE, Saudi Arabia, Kuwait, Qatar, Bahrain, Oman · Halal compliance

GCC standardisation

The Gulf Cooperation Council (UAE, Saudi Arabia, Kuwait, Qatar, Bahrain, and Oman) operates a harmonised standards system through the GSO (GCC Standardisation Organisation). GSO standards cover many product categories including food, pharmaceuticals, and general consumer goods packaging. Indian exports to GCC countries must meet GSO standards where applicable.

Food packaging requirements in GCC markets

  • GSO 24 (Food Labelling Standard): General food labelling requirements including mandatory Arabic language on all food packaging sold in GCC markets
  • Halal compliance: For food products, packaging materials must not use any animal-derived substances that are not halal. This affects inks (some contain animal-based ingredients), adhesives, and coatings. Halal certification of packaging materials may be requested by GCC buyers
  • Migration limits: GCC food contact packaging standards generally align with EU or US standards, Codex Alimentarius guidelines are often referenced

Arabic language labelling, mandatory

All food products sold in GCC markets must have Arabic language text on the label. This is not optional and is enforced at customs. For Indian exporters who design their packaging without Arabic text, either a separate Arabic overlay label must be applied (common for smaller exporters) or the primary packaging must include Arabic. Arabic is a right-to-left script requiring specific typographic setup, see the India-Specific Printing article for Urdu/Arabic script workflow guidance.

Saudi Arabia, SABER certification

Saudi Arabia operates the SABER (Saudi Product Safety Program) electronic platform for importing regulated products. Certain product categories require pre-shipment certification through SABER, the product and its packaging must be registered and certified before the shipment departs India. Check whether your specific product category falls under SABER mandatory certification requirements.

India to GCC, key practical steps

Ensure Arabic language text is on the primary packaging or arrange for Arabic overlay labels. For food products, obtain halal certification for packaging materials if required by the importer. Register on SABER for Saudi Arabia-destined shipments if your product category requires it. Most Indian exporters to the GCC work with a local GCC agent who handles regulatory compliance, ensure your agent is familiar with current GSO standards for your category.

Export Packaging Compliance Documentation

The documentation requirements for export packaging compliance vary by market and product category. The following is a general framework, specific requirements for your product and market must be verified with a compliance specialist.

Core documents for food contact packaging exports

Declaration of Compliance (DoC), from the packaging manufacturer confirming the packaging complies with applicable food contact regulations of the destination market (EC 1935/2004 for EU, 21 CFR for USA, etc.)
Ink and coating REACH / CONEG / EuPIA compliance certificates, from the ink and coating supplier, confirming restricted substances are within limits
Migration test reports, from an accredited testing laboratory confirming migration from packaging into food simulants is within acceptable limits
Material composition data, full list of all materials, coatings, inks, and adhesives used in the packaging with CAS numbers for chemical substances
Recycled content certification, if recycled materials are used, certification of recycled content percentage from the material supplier
FSC / PEFC certification (if making sustainability claims), chain of custody certificate from the packaging manufacturer
Heavy metals test certificate, for inks and pigments, confirming CONEG (USA) or EU limits on lead, cadmium, mercury, and chromium VI

Additional documents for pharmaceutical export packaging

GMP (Good Manufacturing Practice) compliance certificate for the packaging supplier, required for EU FMD, US FDA drug packaging
Braille translation validation, for EU-destined prescription medicines, a validated Braille translation certificate
Serialisation compliance documentation, for EU FMD and US DSCSA, documentation of serialisation system implementation
Child-resistant closure certification, if required for the pharmaceutical form
Drug master file (DMF) references, for packaging components of regulated drug products

Who to contact for compliance documentation

Document typeSource
REACH / EuPIA compliance certificatesInk and coating supplier's technical or regulatory department
FDA 21 CFR compliance lettersPackaging material supplier (paper, board, plastic, adhesive)
Migration test reportsAccredited testing laboratories, SGS, Intertek, Bureau Veritas, TÜV SÜD all operate in India
GMP certificatesIssued by regulatory authority of the manufacturing country, CDSCO for Indian packaging manufacturers
FSC chain of custodyFSC India, the Indian affiliate of the international FSC system
Halal packaging certificatesHalal certification bodies, HFCI (Halal Food Council of India), Jamiat Ulama-i-Hind Halal Trust

Practical Action Plan for Indian Exporters

Export packaging compliance is easiest to manage at the design stage, before materials are specified and printing has begun. Retroactive compliance (trying to make existing packaging compliant after it has been designed and printed) is expensive, slow, and sometimes impossible without redesigning the packaging entirely.

The compliance-first approach

  1. Identify destination markets before packaging design begins. Different markets have different requirements. Design packaging to meet the most demanding market's requirements, or design market-specific variants.
  2. Engage a packaging compliance specialist or regulatory consultant familiar with your destination markets and product category. This is not a cost to avoid, a compliance failure costs far more than the consultant's fee.
  3. Request compliance documentation from all packaging suppliers upfront. Do not assume compliance, require written declarations from paper mills, board suppliers, ink manufacturers, coating suppliers, and adhesive manufacturers before approving packaging materials for production.
  4. Commission migration testing from an accredited laboratory for food contact packaging intended for regulated markets. Testing typically takes 4–8 weeks, build this into the product launch timeline.
  5. Create a compliance file for each packaging SKU. Maintain all compliance documents (DoC, test reports, supplier certificates) in a single file per packaging item. This file is what you present to customs or regulatory authority if compliance is challenged.
  6. Review compliance annually. Regulations change. Set a calendar reminder to verify that compliance documents are still current and that no new restrictions have been added that affect your packaging.
Related articles in The Print Codex
Print Buyer's Guide, briefing and managing print suppliers · Sustainability & FSC, FSC certification and sustainable packaging · Flexible Packaging · Security Printing, pharma serialisation for EU FMD and US DSCSA