In addition to removing methylene chloride from the food additive regulations, the petition includes removing ethylene dichloride, benzene and trichloroethylene, which “have been found to induce cancer in humans or animals and, therefore, are not safe pursuant to … the Delaney Clause.”
The Delaney Clause, which is part of FDA’s Federal Food, Drug and Cosmetic Act, bans any food additive that shows signs of causing cancer in humans or animals during safety testing.
In 2023, the US Environmental Protection Agency (EPA) proposed to ban “most uses” of methylene chloride that are regulated under the Toxic Substances Control Act (TSCA) due to health risks like cancer and liver problems; however, its regulated use in food remains under FDA’s Federal Food, Drug and Cosmetic Act.
Along with Environmental Defense Fund’s petition, Clean Label Project (CLP) is also lobbying to the California State Assembly to ban European Method decaf in A.B. 2066. The bill proposes to ban methylene chloride from human consumption in California beginning Jan. 1, 2027.
Clean Label Project’s studies show trace levels of methylene chloride in decaf coffee
In the petition, EDF refers to results from a 2022 Clean Label Project study that tested 17 decaf coffee samples and found methylene chloride traces to be 10% to 99.5% or more below the safe level set by the FDA. Even though the levels are considered safe by FDA, CLP argues the agency should re-evaluate the ingredient’s safety, a process that the agency has not done since 1985.
CLP cites “overlapping jurisdiction to regulate the advertising and labeling of foods” between the FDA and Federal Trade Commission which both prohibit false advertising.
“One would argue that a decaffeinated product with the active ingredient in paint stripper and still has residual levels left in the finished product is far from ‘pure’ or natural,'” CLP wrote in a statement.
Similarly, CLP tested and found levels of acrylamide below FDA safe levels in popular coffee brands. Classified as a “probable carcinogen,” by the International Agency for Research on Cancer (IARC), acrylamide was the center of the Prop 65 in Cali.
In 2020, an accredited analytical chemistry lab analyzed the samples, and in 2022, Eurofins, an ISO 17025-accredited lab, confirmed the presence of methylene chloride in several popular decaf brands.
NCA: EDF and CLP do not have enough evidence
According to the National Coffee Association’s 2023 data trends, approximately 10% of Americans consume decaffeinated coffee mostly through the European Method. The method is done outside of the US in Germany, Italy and Switzerland, according to NCA, per data by the US International Trade Commission.
“Banning European Method decaf would defy science and harm American’s health. … Neither EDF nor CLP have presented anything resembling compelling evidence to the contrary, so FDA and the California legislature must reject these baseless proposed bans, ” Bill Murray, CEO and president of NCA, wrote in a statement.
NCA affirmed that the safety of the European Method has been verified by FDA and international authorities, including the European Food Safety Authority and Food Standards Australia New Zealand.
In the US, methylene chloride is safe to use up to 10 parts per million (ppm), which NCA explained is equivalent to 10 drops of water in 10 gallons. According to FDA, these levels present an “essentially non-existent” risk.
Public comments support the removal of methylene chloride and other proposed additives
As of press, the petition received 50 public comments, with most commenters supporting the ban. The comment period ends March 11, 2024.
Life Time Foundation, a non-profit organization created by Time Life, Inc., that supports social, health and environmental initiatives, supports the petition filed by EDF, et al, and proposed the use of safer alternatives to the additives in question.
Megan Flynn, nutrition program manager, Life Time Foundation stated, “FDA amending the food additive and color additive regulations to remove uses in food is in line with the EPA’s proposed actions to eliminate or restrict the use of … methylene chloride under the TSCA because of their cancer non-cancer risks. The risks resulting from the use of these cancer-causing solvents in food is likely to be small, but it is completely unnecessary as there are safe alternatives which can be used.”
Linda Birnbaum, scientist emeritus and former director, National Institute of Environmental Health Sciences and National Toxicology Program, wrote that the proposed chemicals are “listed in [the US Report on Carcinogens] on cancer-causing chemicals,” citing that authorities like the American Cancer Society, California state, EPA, the International Agency for Research on Cancer of the World Health Organization and the National Toxicology Program have recognized the carcinogenicity of these materials.
“EPA recently announced plans to ban nearly all uses under its jurisdiction, such as cleaners and automobile products, for two of the four chemicals, TCE and methylene chloride. But uses in food, like the use of methylene chloride in decaffeinated coffee, fall under FDA’s jurisdiction, and remain allowed. A full ban on these cancer-causing chemicals in food is long past due,” Birnbaum added.