Module 3 - Strategic case studies in practice

German samples: TNA <10- 660μg/kg (up to 1.4μg per unit) including NDMA, NDBA and NDEA (range 3.8-31ng/g). Chinese samples (saliva): TNA range 5.3- 1289.8μg/kg with NDMA N.D. to 36.5μg/kg, NDEA N.D. to 277.8μg/kg and NDBA 3.49 - 556.3μg/kg. Chinese sample (sweat): TNA range 15.6- 792.9μg/kg with NDMA N.D. to 14.5μg/kg, NDEA 7.3- 648.9μg/kg and NDBA N.D. to 299.1μg/kg.

Biaudet et al. 1997

Feng et al. 2010

Balloon release to artificial saliva:

German samples: TNA <10- 380μg/kg (up to 0.46μg per unit) including NDMA, NDBA and NDEA.

*Cosmetic products containing nitrosamines including NDELA are no longer allowed on the EU/EEA market under the Cosmetics Directive 76/768/EEC ( limit of 50 μg/kg (50 ppb) for nitrosamines). Food and water : Nitrosamines, primarily NDMA, can be introduced into drinking water supplies when chloramine/chlorine disinfection of DW is used, but also to some extent by ozonisation. Generally, the average or median NDMA levels in drinking water seem to be around or below 10-20 ng/L. Based on the literature overview for all food-nitrosamine studies before 2017 by Gushgari & Halden (2018), the food groups with the highest average total nitrosamine (TNA) concentrations are:

• Fats, oils and sweets (n=21 studies): TNA average 8.92 µ g/kg

• Meats (n=118 studies): TNA average 8.10 µ g/kg

• Fish (n=59 studies): TNA average 5.55 µ g/kg

• Vegetables (n=21 studies): TNA average 5.35 µ g/kg

The most commonly measured nitrosamines in food products according to Gushgari & Halden (2018) were NDBA, NDEA, NDMA, NDPA, NMEA, NMOR, NPIP and NPYR. NDMA was the most common nitrosamine across food groups with an average of 2.2 µ g/kg whereas NDEA had an average of 0.9 µ g/kg. A similar literature overview on nitrosamines focused on meat products and was published by Lee (2019), covering 25 studies reported between 1985 and 2018 (where the nitrosamine levels reported were also adjusted for the number of samples). The nitrosamines NDBA, NDEA NDMA, NPIP and NPYR were the most commonly ones present in nitrite/nitrate treated meat and poultry products (although at different proportions in different meat products). In most cases (i.e. food samples measured in studies), the average or median levels of TNA are around or <10 µ g/kg in foods with the exceptions of fried foods such as fried bacon (average 35.6 µ g/kg), fried pork (average 25.9 µ g/kg) and fried chicken (average 22.4 µ g/kg). Heat-treatment generally increases nitrosamine levels (especially frying, grilling and less so boiled cooking) – in particular in processed meat products. It can be noted that volatile N- nitrosamines in cured meat seem to be present at lower amounts than non- volatile N- nitrosamines. The level depends on the market e.g. higher levels have been observed in Belgium than in Denmark [Herrmann et al. (2015a], study (period of time) and products (cured meat, smoked meat, etc.). Some non-volatile N- nitrosamines may also be formed in raw cooked sausage depending on nitrite added such as N- nitrosohydroxyproline (NHPRO), N- nitrosoproline (NPRO), N-

EMA/369136/2020

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