European reviewers could not finish a safety assessment in 2015
When European reviewers looked at E141 again in 2015, they found too little evidence to reach a conclusion. Studies on how the body takes it up, spreads it and gets rid of it were missing, and so were proper long-term studies of harm and cancer. They said its safety cannot be assessed, and recommended withdrawing the daily limit rather than backing it.
Reliable data on how the body absorbs, processes and gets rid of these compounds, and on DNA damage, long-term harm, cancer, and effects on reproduction and development, were missing. Reviewers could not complete their assessment of them as food additives.
2015Regulator reviewEFSA ANS Panel, Scientific Opinion on re-evaluation of copper complexes of chlorophylls (E 141(i)) and chlorophyllins (E 141(ii)) as food additives, EFSA Journal 13(6):4151
Reviewers recommended withdrawing the existing daily limit of 15mg per kg of body weight, set by the international committee, because the data behind it were not good enough.
2015Regulator reviewEFSA ANS Panel, EFSA Journal 13(6):4151
DNA damage and cancer could not be ruled out for the water-soluble form
For the water-soluble form, E141(ii), reviewers found the evidence too weak to judge whether it damages DNA. The data on cancer also contradicted itself in places. They asked for proper new studies before any conclusion could be drawn.
The data on copper chlorophyllins, E141(ii), were not good enough to judge whether they damage DNA.
2015Regulator reviewEFSA ANS Panel, EFSA Journal 13(6):4151
Because the data on cancer were contradictory and uncertain, reviewers called for further, adequate studies before any conclusion could be reached.
2015Regulator reviewEFSA ANS Panel, EFSA Journal 13(6):4151
Unlike plain chlorophyll, part of it gets into the body
The gut hardly absorbs plain chlorophyll (E140). But studies showed that at least one part of the water-soluble copper form is absorbed and carried round the body. That matters because what reaches the organs is what can do harm.
Unlike chlorophylls without copper, some parts of copper chlorophyllins were absorbed and spread through the body in animals.
2015Regulator reviewEFSA ANS Panel, EFSA Journal 13(6):4151
Rat feeding studies tracked copper chlorophyllin into the blood and organs and concluded at least one main part is absorbed. The authors said more studies are needed.
2009Animal studyGomes et al., Journal of the Science of Food and Agriculture
Copper from every part of the diet was reviewed in 2023
In 2023 European reviewers looked at copper from every part of the diet, E141 included.
Reviewers lowered the daily limit for copper to 0.07mg per kg of body weight, about 5mg a day for a 70kg adult, down from 0.15mg, because copper building up in the liver is an early sign of harm.
2023Regulator reviewEFSA Scientific Committee, EFSA Journal 2023, PMC9843535
People with Wilson's disease need to limit copper from every source
Wilson's disease is a rare inherited condition in which the body cannot get rid of copper properly, so it builds up in the liver, brain and other organs. People with it are advised to limit copper from all foods, including copper-containing additives. About 1 in 30,000 people have it.
Wilson's disease comes from faults in the ATP7B gene that stop the liver clearing copper, so it slowly builds up. Medical advice for people with it includes cutting down on high-copper foods.
2014Established medical factSchilsky, Wilson's disease and other neurological copper disorders, PMC4336199
Regulators asked industry for the missing data
After the 2015 review, the European Commission formally asked industry to send in the missing data on harm and absorption so a full review could be finished. By the mid-2020s no finished follow-up review had been published. The additive is still allowed in the EU and UK while the data are gathered.
The European Commission called for scientific and technical data on E140(i), E140(ii), E141(i) and E141(ii), to fill the gaps the 2015 reviews found.
2022Regulator actionEuropean Commission, Call for scientific and technical data on permitted food additives E140-E141 (food.ec.europa.eu)