Page 172 - CW E-Magazine (16-4-2024)

News from Abroad

PUSH FOR RETHINK
IFEAT and EFEO petition EU authorities on categori-

sation of tea tree oil as a reproductive toxin

On December 7, 2023, the European lation of fresh leaves and twigs of Melaleuca any known negative effect, it is warranted
Chemicals Agency (ECHA), which im- alternifolia. It has been produced com- that tea tree oil is labelled as ‘Category 2’
plements EU legislations like REACH and mercially since the beginning of the 20th as there is clearly ‘doubt on human rele-
CLP (Classification, Labelling & Packag- century. In the EU it is principally used in vance’ – the key criterion to discriminate,”
ing), announced that its Risk Assessment cosmetics and traditional pharmaceuticals. the submission stated.
Committee (RAC) had adopted eight More recently (since the mid-2000s), it has
opinions on proposals for harmonised been used as a plant protection product. Changing categorisation
classification and labelling (CLH). Three The studies used to determine Category
of these concern ingredients that may be The IFEAT-EFEO petition pointed 1B classification must be supplemented
used in cosmetic products, and include a out that if tea tree oil is classified as ‘Cate- with additional information related to
CMR (carcinogenic, mutagenic or repro- gory 1B (fertility)’, trade in this product human relevance, in part due to the fact
toxic) classification for tea tree extracts to the EU would collapse. “About 150- that para-cymene, a component of tea tree
and essential oils. 200 tonnes/year of tea tree oil is currently oil, has a different mode of action in hu-
imported to the EU. Furthermore, any mans, contrasted to that in rats.
In March this year, the International regulations against tea tree oil could have
Federation of Essential Oils and Aroma a knock-on effect for other essential oils, The Committee for Risk Assessment
Trades Ltd. (IFEAT) and the European other naturally complex substances, as (RAC), responsible for preparing opin-

Federation of Essential Oils (EFEO) well as some of the major components of ions related to the risks of substances
made a joint submission to the EU Com- tea tree oil such as para-cymene and ter- to human health and the environment,
petent Authorities for REACH and CLP pinolene,” the submission stated. noted that the mode of action of para-
(CARACAL) on ECHA’s recommenda- cymene certainly raises doubt on human
tion to classify tea tree oil as ‘Category IFEAT and EFEO emphasised the relevance. Although being only a minor
1B’ for reproductive effects. over 100 years of safe use of the oil in the component of tea tree oil, the mode of
EU, and thousands of years of exposure action of para-cymene raises enough
‘Category 1B’ covers “Presumed to humans without any reported negative doubt for the entire oil. The CLP gui-
human reproduction toxicants – largely effect. “Until there is more mechanistic dance document clearly does not require
based on animal studies.” The joint sub- data available on tea tree oil itself, we have “proof” of mode of action, but mentions
mission stressed the importance of human to rely on exposure data for human con- that as soon as mechanistic information
relevance being considered in detail before sumption. Since there is a broad human raises doubt on human relevance, a clas-
deciding on this classification. Tea tree oil exposure to all constituents contained in sification in ‘Category 2’ may be more
is an essential oil obtained by steam distil- tea tree oil from natural sources without appropriate.

172 Chemical Weekly April 16, 2024

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