Module 3 - Strategic case studies in practice

of this referral to cover all non-nitrosamine substances, only N -nitrosamines are covered in this section. There exist various estimates on the background exposure to exogenous N -nitrosamines (either for specific or the sum of n>1 N -nitrosamines in various sample types). The N -nitrosamine sources of exposure include endogenous generation from nitrite present in water and foods (e.g. drinking water contaminated with nitrite, eating processed foods), processed drinking water, drinking water from drinking water treatment plants (DWTPs) that use chlorination or chloramination processes, direct and indirect tobacco product exposure (e.g. smoking), contact with some latex and rubber products etc (see table below for estimates in some of these sources). Overall, it is considered likely that food is a major if not the dominant source of human exposure to exogenous N -nitrosamines, but the sum of the other exposure sources may also be substantial (at least for some N -nitrosamines). Table 2.4.1.1-1 Some estimates in academic reports on exogenous N -nitrosamine-levels (specific and total levels, TNA) in various samples (some of which may exceed current EU limits).

Source

Nitrosamine range detected

References (PubMed ID)

Processed foods (cured, cooked, smoked)

Across food groups:

Lee 2019

TNA: range 0.4- 35.6μg/kg

PMID: 30208538

NDMA: mean 2.2μg/kg

Gushgari & Halden 2018

NDBA: mean 1.5μg/kg

NPYR: mean 1.5μg/kg

NDEA: mean 0.9- 1.5μg/kg

NPIP: mean 0.5μg/kg

NMOR: mean 0.05μg/kg

Personal care products (cosmetics, hair products, lotions, shampoos, soaps)*

Hair gel (NDELA): 7644μg/kg

Lotions (NDELA): 22- 230μg/kg

Joo et al. 2015

Soap (NDELA): 26- 75μg/kg

Schothorst & Stephany 2001

Shampoo (NDELA): 46- 1287μg/kg

Schothorst & Somers 2005

Shower gel (NDELA): 46- 3746μg/kg

Tobacco product exposure (cigarettes,

Cigarettes:

NNN: 0.306-7. 4μg/g tobacco

Gushgari & Halden 2018

cigars, chewing tobacco, snuff)

NNK: 0.194- 3.2μg/g tobacco

Edwards et al. 2017

NAT: 0.32- 4.6μg/g tobacco

NAB: 0.021- 0.95μg/g tobacco

Rubber and latex products 9

Condoms release to artificial sweat or saliva :

Altkofer et al. 2005

EMA/369136/2020

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