Written question WQ85535

The regulation of medicines in the UK is a reserved matter and is the responsibility of the Medicines and Healthcare products Regulatory Agency (MHRA). This means the power to act rests with the UK Government and not with the Welsh Government. This includes collecting and analysing data regarding the safety and effectiveness of all medicines both before they are licensed and after they come into use.

Colours permitted in medicines in Wales are determined by UK medicines legislation (the Human Medicines Regulations 2012 as amended). This legislation continues to apply EU standards for the quality, safety and efficacy for medicines and cross refers to permitted colours in EU food legislation (as it was at the end of the Transition Period following EU Exit). These lists include carmoisine (E122), permitting it in UK medicines.

Scandinavian countries are members of the EU and /or EEA, and as such EU medicines legislation applies in those countries including the lists of colours permitted by EU food legislation. As carmoisine is a listed permitted food additive it is also permitted in medicines in those countries.

An extensive evaluation of carmoisine was carried out by the European Food Safety Authority (EFSA) in 2009 (https://www.efsa.europa.eu/en/efsajournal/pub/1332) following which there was no recommendation to revise the acceptable daily intake (ADI) although it was noted that the results of a UK study (McCann 2007) found that exposure to mixtures of certain artificial colours including carmoisine, resulted in increased hyperactivity in children. The amount of colouring in a tablet or capsule coating is quite small and would result in exposures well below the ADI.

The situation in the USA is different; carmoisine has been permitted for use in externally applied drugs and cosmetics until 1939. It was delisted in 1963 because safety studies were not provided by interested parties. There is no evidence of a safety signal leading to the delisting. Carmoisine has never been approved for use in internal medicines in the USA.

In 2008 the UK government encouraged food manufacturers to work towards finding alternatives to certain artificial colours, including carmoisine, in foods, due to concerns regarding hyperactivity in children. Food and medicines manufacturers can still legally use these colours as they are not banned, but MHRA requires robust justification if they are proposed for use in medicines for children.