It's quite striking! Judging from this "B6 overdose → neuropathy" controversy, Germany (and indeed the entire EU) is generally more conservative and proactively controls dosage and labeling/claims than Australia and the US . But let's be honest: most products in Germany are still regulated by food law, not pharmaceutical-grade products that undergo individual pre-market approval.
The key comparisons are as follows:
1) Dosage perspective: Germany and the EU are more conservative
• In 2023, the EU EFSA lowered the "tolerable upper intake UL" of vitamin B6 to 12 mg per day for adults ; this is the upper limit of overall daily intake (including diet + all supplements).
• The German Agency for Risk Assessment (BfR) further recommends that the maximum recommended amount of B6 in a single health supplement is 3.5 mg per day (leaving a portion of the “safety limit” for daily diet and other fortified foods).
2) Listing procedures and labeling: Germany requires "pre-notification + submission of bids"
•In Germany, if you want to put health products (Nahrungsergänzungsmittel) on the market, you must notify the BVL (Federal Office of Consumer Protection and Food Safety) at the latest when you first put them on the market and submit a German label sample; after that, the state governments will conduct market supervision.
• Health claims are also strictly controlled by EU Directive 1924/2006 and List of Authorised Claims 432/2012. For example, claims that can be made about B6 (such as “contributes to the normal functioning of the nervous system”) must meet the nutrient source threshold and terminology standards. Any claims that exceed these standards will be disallowed.
3) Australia: Historically high doses are common, and risk management is being strengthened
• Most “AUST L-listed” complementary medical products do not undergo pre-market efficacy review (management of ingredient and claim lists + post-marketing inspections), which has created space for high-dose B6 on the market.
• Starting from 2022, B6 doses greater than 10 mg/day must be accompanied by a warning that it may cause peripheral neuropathy; A tentative resolution in June 2025 proposed that B6 doses greater than 50 mg/day be reclassified as a pharmacist-indicated drug (Schedule 3), with the target implementation starting in February 2027 (still in the decision-making process).
• At the same time, Blackmores was involved in a potential class action lawsuit related to B6 (the legal team claimed that the B6 dosage in the product in the case was far higher than the recommended daily intake).
4) United States: Regulations are relatively loose, but UL is still high
• According to DSHEA (1994), most dietary supplements do not require pre-market safety and effectiveness approval; the FDA mainly performs post-market supervision.
• The adult UL of B6 in the United States is still 100 mg/day (FNB/IOM) ; the NIH ODS page also mentions that EFSA will adjust the EU UL to 12 mg in 2023, highlighting the gap between Europe and the United States.
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Why is "Germany relatively rigorous"?
• Dosage: The EU's overall UL is low (12 mg/day), while Germany imposes an even lower recommended upper limit (3.5 mg/day) for individual products, implementing total dosage control at the product level. This directly limits the market for high-dose B6 products.
• Labeling/claims: First notify + strictly follow the claim list to clearly define “what to write on the packaging” and “where to write” to reduce misleading high-dose marketing.
• But you should also know: German health products are still regulated by food law and are not pre-screened one by one (not drug grade approval). It is just a combination of "conservative dosage + strict claims + notification mechanism" that makes the average risk low.
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Three practical product selection methods recommended to consumers:
1. Look at the total amount, not individual products : Add up the B6 in various products (comprehensive B complex, magnesium, energy drinks, etc.) and try to keep it within the EU UL of 12 mg/day; if it exceeds this value for a long time, the risk increases.
2. Read the labels and claims: German/EU products will strictly adhere to the claims; be careful of over-promises or ridiculously high dosages.
3. Stop use and seek medical attention if you experience symptoms: tingling in the hands and feet, unsteady gait, blurred vision, etc. may be warning signs of B6 neurotoxicity. Cases in Australia have increased in recent years, and the competent authorities have also strengthened warnings.
Compared to Australia (with its history of high-dose use and tightening regulations) and the US (a relaxed market under DSHEA), Germany and the EU are tightening the screws on dosage and claims. If you're choosing products in Taiwan, choose German or EU-branded products with dosages that are close to physiological needs, claims of restraint, and complete labeling. This generally reduces the risk of falling into the "high-dose trap."