食品・経口薬への「赤色３号」使用禁止 米ＦＤＡ

【ワシントンＡＦＰ＝時事】米食品医薬品局（ＦＤＡ）は、合成着色料の「赤色３号（エリスロシン）」の食品と経口薬への使用を禁止する措置を決定した。米保健福祉省が１５日付の連邦官報で明らかにした。赤色３号をめぐっては、動物実験で発がん性が認められるとして以前から物議を醸していた。（写真はスーパーマーケットの棚に並べられた赤色３号〈エリスロシン〉が使われた商品）
　今回の決定は、２０２２年１１月に米国のＮＰＯ、公益科学センター（ＣＳＰＩ）などが提出した請願を受けて下された。同請願が引き合いに出している「デラニー条項」では、人または動物への発がん性が認められる着色料の使用を禁じている。
　ＦＤＡは赤色３号について、１９９０年には既に、雄のラットで甲状腺がんの誘発が認められたとして、化粧品への使用を禁止すべきと判断していた。
　しかし、主に食品業界からの抵抗を受け、食品での使用は続けられてきた。一例として、マラスキーノ・チェリーは特徴的な真っ赤な色を保つために赤色３号で着色されてきた。
　米政府運営のデータベース「ＤａｉｌｙＭｅｄ」の検索によると、赤色３号は数千種類のキャンディーやスナック、果物製品、さらに数千種類の薬剤にも使用されている。
　ＦＤＡは、食品メーカーは２０２７年１月１５日、経口薬メーカーは２０２８年１月１８日までに同着色料の使用を改めるよう指示している。
　一方で、ラットでの発がん性は認められたものの、人に対する発がん性は立証できていないとし、人の場合はラットとはホルモン機能に差があり、また、ばく露レベルも著しく低いと指摘している。【翻訳編集ＡＦＰＢＢＮｅｗｓ】
〔ＡＦＰ＝時事〕（2025/01/16-17:46）

Outgoing US President Joe Biden's administration on Wednesday announced a ban on Red Dye No 3, a controversial food and drug coloring long known to cause cancer in animals.
Decades after scientific evidence first raised alarm, Red 3, as it is also called, is currently used in nearly 3,000 food products in the United States, according to the nonprofit Environmental Working Group.
FDA is revoking the authorized uses in food and ingested drugs of FD&C Red No 3 in the color additive regulations, said a document from the Department of Health and Human Services, published in the Federal Register on Wednesday.
The decision stems from a petition filed in November 2022 by the Center for Science in the Public Interest (CSPI) and other advocacy groups, which cited the Delaney Clause -- a provision mandating the prohibition of any color additive shown to cause cancer in humans or animals.
Notably, the FDA determined as early as 1990 that Red 3, whose chemical name is erythrosine, should be banned in cosmetics because of its link to thyroid cancer in male rats.
However, the additive continued to be used in foods, largely due to resistance from the food industry. Manufacturers of maraschino cherries, for example, relied on Red 3 to maintain the iconic red hue of their products.
It's also present in thousands of candies, snacks and fruit products -- and thousands of medicines, according to a search of a government-run database, DailyMed.
Manufacturers who use FD&C Red No 3 in food and ingested drugs will have until January 15, 2027, or January 18, 2028, respectively, to reformulate their product, the FDA said.
Although the agency acknowledged a cancer link in rats, it maintained that the available evidence does not support such a link in humans, citing differences in hormonal mechanisms between the species and significantly lower exposure levels in people.
- US lags behind -
While the FDA determination focused on carcinogenicity, other research has also found potential neurobehavioral effects of synthetic food dyes on children, notably Attention-Deficit/Hyperactivity Disorder (ADHD).
The body of evidence from human studies indicates that synthetic food dyes are associated with adverse neurobehavioral outcomes in children, and that children vary in their sensitivity to synthetic food dyes, a California government report found in 2021.
Animal studies indicated that synthetic food dyes caused changes in neurotransmitter systems in the brain and produced microscopic changes in brain structure, affecting activity, memory and learning.
The United States has been slow to act on Red 3 compared to other major economies. The European Union banned its use in 1994, with similar prohibitions enacted in Japan, China, the UK, Australia, and New Zealand.
Carl Tobias, a former FDA legal consultant and now a professor at the University of Richmond, told AFP it was hard to square the agency's mission of protecting American health with the prolonged delay in reaching the decision.
There's pretty extensive lobbying, there always has been, and some of it is sometimes effective, he said, calling the ban a step in the right direction.
CSPI also hailed the FDA's decision as long overdue, and expressed hope that it would pave the way for broader action on other harmful chemicals in food.
They don't add any nutritional value, they don't preserve the food -- they're just there to make food look pretty, Thomas Galligan, a scientist with CSPI, told AFP.
The nonprofit called on the incoming administration of President-elect Donald Trump to take further steps to protect consumers, including setting stricter limits on heavy metals like lead, arsenic and cadmium in foods consumed by children.