International Safety Standards Compared

United States: FDA & EPA

The FDA regulates food, supplements, and cosmetics. Supplements operate under DSHEA (1994), which places the burden of proof on the FDA to demonstrate a product is unsafe rather than requiring manufacturers to prove safety before sale. The EPA sets Maximum Contaminant Levels (MCLs) for drinking water -- for example, 15 ppb for lead (action level) and 10 ppb for arsenic.

Key gap: the FDA has not established maximum limits for heavy metals in most foods. California's Proposition 65 fills some of this vacuum at the state level, requiring warnings for products containing lead above 0.5 mcg/day.

European Union: EFSA

The European Food Safety Authority applies the precautionary principle: substances are restricted until proven safe, the inverse of the US approach. The EU has banned or restricted over 1,300 chemicals in cosmetics compared to roughly 11 banned by the FDA. For food, the EU sets maximum levels for lead (0.02-0.30 mg/kg depending on category), cadmium, mercury, and tin across specific food types.

EU water standards set lead at 10 mcg/L (moving to 5 mcg/L), stricter than the US action level of 15 mcg/L. PFAS limits are being established at 0.1 mcg/L for individual compounds and 0.5 mcg/L total.

Australia: TGA

The Therapeutic Goods Administration regulates supplements as “therapeutic goods,” requiring pre-market evaluation and listing on the Australian Register of Therapeutic Goods (ARTG). This is fundamentally different from the US model. Manufacturers must provide evidence of quality, safety, and that claims are supported.

Australian drinking water guidelines set lead at 10 mcg/L and arsenic at 10 mcg/L, aligned with WHO recommendations. Pesticide residue limits generally align with Codex Alimentarius or are stricter.

Japan: MHLW

The Ministry of Health, Labour and Welfare classifies health products into “Foods with Health Claims” and “Foods for Specified Health Uses” (FOSHU). FOSHU products require clinical evidence reviewed by a government panel before approval. Japan's water quality standards set lead at 10 mcg/L and arsenic at 10 mcg/L.

Japan has historically strict limits on mercury in seafood (0.4 ppm total mercury, 0.3 ppm methylmercury) driven by the Minamata disease legacy.

Lead Limits: Side by Side

Why the EU Bans What the US Allows

The core difference is regulatory philosophy. The US requires evidence of harm before restricting a substance. The EU requires evidence of safety before allowing it. This results in the EU banning substances like titanium dioxide (E171) in food, certain azo dyes requiring warning labels, and restricting BPA in food contact materials years before the US acts.

For pesticides: the EU has banned over 70 pesticides still permitted in US agriculture, including atrazine, paraquat, and chlorpyrifos (the US eventually banned chlorpyrifos on food crops in 2022, decades after the EU).

Codex Alimentarius

The joint FAO/WHO food standards program establishes baseline international standards for food safety, quality, and labeling. Codex standards are used as reference points by the World Trade Organization for trade disputes. Individual countries can set stricter standards but cannot use food safety claims to create trade barriers that exceed Codex recommendations without scientific justification.