Posted by Khetika Team
on June 22, 2026
The same bread additive that's legal in an American bakery is banned in Europe. The same synthetic food dye that colours a British snack before export gets removed for the European market. The same preservative that a US food company uses freely requires special justification in France.
These aren't minor technical discrepancies. They represent genuinely different answers to the same question: how much evidence of harm do you need before you remove a substance from the food supply?
That question has three different answers depending on where you are — and India's answer is worth understanding on its own terms, not just as a comparison point between the US and EU.
The case that started the conversation: ADA in bread
Azodicarbonamide — ADA — is a chemical used in commercial bread-making to condition dough, improve texture, and create the even crumb structure that makes commercially baked bread soft and consistent. It's also used in the manufacture of rubber and foam plastics, including yoga mats.
The issue with ADA is not the compound itself but what happens when it's heated. During baking, ADA breaks down into two byproducts: semicarbazide and urethane. The US Department of Health and Human Services classifies urethane as a probable human carcinogen. Semicarbazide has shown toxicity in animal studies, with less conclusive evidence for humans.
Faced with the same evidence, the FDA and the European Food Safety Authority (EFSA) reached different conclusions:
The FDA determined that at permitted levels, the breakdown products pose negligible risk and allowed ADA to remain in use. The reasoning is risk-proportionate: unless harm is demonstrated at realistic exposure levels, the substance stays.
The EFSA decided the potential risk outweighs the functional benefit — the bread-conditioning effect can be achieved through alternatives — and applied what's called the precautionary principle: when scientific uncertainty exists about a substance's safety, the burden of proof falls on demonstrating safety, not on demonstrating harm.
India's position: ADA is not on FSSAI's approved list of food additives. It was never explicitly cleared for use in Indian food, which means it's effectively unavailable to Indian food manufacturers by default rather than by a specific ban. The outcome is the same as the EU — Indian bread doesn't contain ADA — but the regulatory pathway is different. FSSAI didn't evaluate and reject ADA; it simply never approved it.
How the US and EU regulatory philosophies diverge
Understanding why the US and EU reach different conclusions on the same additives requires understanding the architecture of their regulatory systems.
The US approach: demonstrate harm
The FDA's framework for food additives is shaped significantly by a 1958 law that introduced "Generally Recognized as Safe" — GRAS — status. GRAS was originally intended for common ingredients like salt, vinegar, and sugar that had long histories of safe use. Over decades, it expanded into a mechanism by which food manufacturers can self-determine that a new additive is safe, convene their own expert panel, and begin using the substance — with only voluntary notification to the FDA.
The practical consequence is significant. As food writer Chris Van Tulleken documented, only ten applications were made to the FDA for full approval of new food substances between 2000 and the mid-2010s. In the same period, 766 new food chemicals entered the US market — meaning roughly 98.7 percent of new food chemicals were self-determined as safe by the companies producing them, with no mandatory regulatory review.
The baseline assumption in this system is that a substance is safe unless proven otherwise. The burden of proof rests with regulators to demonstrate harm, not with manufacturers to demonstrate safety.
The EU approach: demonstrate safety
Europe's more cautious regulatory posture was shaped significantly by a public health crisis. In the 1980s and 1990s, Bovine Spongiform Encephalopathy — BSE, or mad cow disease — spread across British cattle herds. Authorities initially assured the public that the disease posed no risk to humans through meat consumption. That assurance proved wrong. By the late 1990s, people were dying of variant Creutzfeldt-Jakob disease, the human form of BSE. Over 150 deaths were eventually attributed to it.
The crisis wasn't just a public health failure — it was a regulatory credibility failure. European governments had trusted industry and moved slowly on the available evidence. The response was institutional: the European Food Safety Authority was created in 2002, and the EU adopted a General Food Law built around the precautionary principle.
Under this principle, the baseline assumption runs in the opposite direction from the US system: where there is scientific uncertainty about a substance's safety, regulatory action doesn't require proof of harm. The burden falls on demonstrating safety. If the evidence is genuinely inconclusive, the default is caution.
This is why ADA, potassium bromate, titanium dioxide, and several synthetic food dyes are banned in the EU but permitted in the US. It's not that European scientists have access to different evidence. It's that the system is calibrated to treat uncertain evidence differently.
Potassium bromate: where India made a clear call
Potassium bromate is a flour improver used in commercial baking to strengthen gluten structure and improve bread volume. The International Agency for Research on Cancer classified it as a possible human carcinogen in 1999. It has been banned in the EU, Canada, China, Brazil, and most major economies for decades.
In the US, potassium bromate remains permitted under FDA regulations. The FDA's position is that when used correctly, it converts to potassium bromide during baking and is not present at harmful levels in the finished product — though this depends on baking conditions that are not always consistent across commercial operations. As of 2024, the FDA has opened a review of potassium bromate's status, and California has passed a law banning it effective 2027.
India moved earlier and more decisively. In 2016, a Centre for Science and Environment study tested 38 brands of commercially available bread and found that roughly 84 percent tested positive for potassium bromate and potassium iodate residues. FSSAI banned potassium bromate that same year — acting relatively quickly after the evidence became public, and aligning with the international consensus rather than the US position.
This is one of the clearer examples of FSSAI taking a more precautionary stance than the FDA on a specific additive — and getting there before the US regulatory system caught up with the evidence.
Artificial colours: where India is more restrictive than many expect
FSSAI permits only eight synthetic food colours for use in food, drugs, and cosmetics in India. The US FDA permits a broader list. Several synthetic dyes that are permitted under FDA rules have been banned by FSSAI.
The colours FSSAI permits include Tartrazine, Carmoisine, Sunset Yellow FCF, Brilliant Blue FCF, Ponceau 4R, Allura Red, Erythrosine, and Indigo Carmine — all at product-specific concentration limits. This is a notably restricted list compared to the US, where a larger number of certified colours are permitted across a wider range of product categories.
Several colours permitted in the US but not in India have been the subject of ongoing regulatory debate. Certain dyes linked in observational studies to hyperactivity in children — Red 40, Yellow 5, Yellow 6 — are still permitted in the US, though the FDA is conducting ongoing reviews. The EU requires warning labels on products containing these dyes, stating that consumption "may have an adverse effect on activity and attention in children." India's approach of simply not permitting them is arguably more precautionary than the EU's label-and-permit approach.
The enforcement gap is a separate problem. Prohibited colours like Rhodamine B — a textile dye with documented carcinogenicity — continue to appear in food products, particularly in street food and regional confectionery, because FSSAI's enforcement infrastructure does not reach all food business operators consistently. This is the distinction between what the regulations say and what the market reflects.
Titanium dioxide: a case study in divergence
Titanium dioxide (E171) is a white pigment used in hundreds of food products — confectionery, chewing gum, sauces, processed cheese, icing — to produce brightness and opacity. It's what makes certain white foods look white rather than off-white.
In 2022, the EFSA concluded that titanium dioxide could no longer be considered safe as a food additive, citing concerns about genotoxicity — the potential to damage genetic material — based on accumulated evidence that couldn't rule out this effect. The EU banned it as a food additive shortly after.
The FDA's current position is that titanium dioxide is permitted as a food additive at up to 1 percent by weight of the finished product, citing the long history of use and existing safety studies. The FDA has not conducted an updated formal review applying the same evidentiary standards as the EFSA's 2022 assessment.
FSSAI's status on titanium dioxide is ambiguous. It is not listed as a permitted food additive in FSSAI's approved additive list for most food categories, which means it is effectively unavailable to Indian food manufacturers in those categories — the same outcome as the EU ban, reached through a different regulatory mechanism.
Where FSSAI sits in this framework
FSSAI's regulatory philosophy is harder to characterise as simply as the US or EU approaches, partly because it's younger as an institution — FSSAI was established in 2006, consolidating seven earlier food safety laws — and partly because it operates with a different resourcing and enforcement context.
In approach, FSSAI broadly follows the Codex Alimentarius — the international food standards body — rather than anchoring to either the FDA or EFSA framework. Codex itself sits between the US and EU approaches: it requires evidence-based safety assessment but doesn't apply the EU's formal precautionary principle. This positions FSSAI as more demanding than the US system (which allows significant self-regulation through GRAS) but less systematically precautionary than the EU.
In practice, FSSAI's standards on specific additives are sometimes more restrictive than the US (synthetic colours, potassium bromate), sometimes less restrictive than the EU (certain contaminant limits), and sometimes simply unaddressed — gaps where no standard exists because the regulatory capacity hasn't reached that question yet.
The more significant constraint is enforcement. A regulatory standard only protects consumers if it's consistently enforced. FSSAI's inspection and testing infrastructure covers the organised food sector with reasonable effectiveness — large manufacturers, packaged food brands, and products in formal retail. It covers informal food production, street food, and small regional manufacturers with much less consistency. The additives that appear most often in Indian foods in violation of FSSAI standards are not the ones used by major food companies — they're the ones used where enforcement is weakest.
What this means in practical terms
Three takeaways worth keeping in mind when reading food labels:
The Indian regulatory baseline is not as weak as it's sometimes characterised. On synthetic colours, potassium bromate, and several other specific additives, FSSAI's permitted list is more restrictive than the FDA's. India banned potassium bromate before the US began reviewing it. The eight-colour restriction on synthetic food dyes is a narrower permitted list than most consumers realise.
The gap between the standard and the market is real. The formal permitted additive list is what large manufacturers in organised retail follow. Products sold in informal markets, regional confectionery, and unpackaged food operate outside consistent oversight. The regulatory protection applies where enforcement reaches — which is not everywhere.
The burden of proof question matters for how you shop. The fundamental difference between the US and EU approaches — demonstrate harm versus demonstrate safety — shapes what's on shelves before evidence accumulates. For substances where long-term effects are uncertain and study periods short, the precautionary approach offers protection the harm-demonstration approach doesn't. Reading labels with this in mind, and preferring ingredients with longer histories of use over newer additives regardless of regulatory status, is a reasonable consumer heuristic regardless of which system you're buying in.
This is also, incidentally, the argument for minimal ingredient lists — not because long lists are inherently dangerous, but because every additional additive is a separate question about where on the evidence spectrum its safety assessment sits.
FAQ
Is FSSAI equivalent to the FDA or the EFSA? FSSAI occupies a different position from both. It follows Codex Alimentarius standards as a baseline, which sit between the FDA's harm-demonstration approach and the EFSA's precautionary principle. FSSAI's permitted lists for specific additives are sometimes more restrictive than the FDA's and sometimes less restrictive than the EFSA's. Its enforcement capacity is the more significant differentiator — both the FDA and EFSA operate with substantially more resourcing relative to their regulated markets.
Why does the EU ban things the US doesn't? The EU's regulatory framework operates on the precautionary principle — where scientific uncertainty exists, the default is caution rather than continued use. The FDA's framework requires demonstrated harm at realistic exposure levels before removing a substance. The same evidence base produces different outcomes because the threshold for regulatory action is calibrated differently.
Is food in India less safe than in Europe? The comparison isn't straightforward. On specific additives, FSSAI's permitted lists are often more conservative than the US and comparable to the EU. The more meaningful gap is enforcement: FSSAI's standards apply most reliably to the organised, packaged food sector. Informal food production and small manufacturers operate with less consistent oversight. The risk profile of food in India depends significantly on where in the food system it's coming from.
What does "no permitted additives" mean on a food label? It means the product doesn't contain substances from FSSAI's approved additives list — preservatives, synthetic colours, emulsifiers, stabilisers, and similar. It doesn't mean no processing at all; it means the processing hasn't added regulated additives. For genuinely minimally processed foods, the absence of additives is verifiable through the ingredient list — which should read as a list of recognisable ingredients rather than a list of E-numbers and chemical names.
Should I be worried about food additives in Indian packaged food? The organised packaged food sector in India is subject to FSSAI regulation, which covers the main categories of additives with specific permitted lists. The more relevant concern for most consumers isn't the additives that major food companies use — which are typically within permitted limits — but the broader processing question: what does regular consumption of heavily processed food, with its combined load of multiple permitted additives, do over time? That's a question the regulatory system answers for individual substances at individual doses, not for combined long-term exposure to dozens of substances simultaneously. Minimising total additive load, rather than focusing on any single additive, is a more durable approach than tracking individual ingredient bans.
