# Toxic Metals Migration from Plastic Food Contact Materials in Romania: A Health Risk Assessment
## 3 Results  
### Heavy Metals Migration  
In accordance with Regulation EC no. 1935/2004 (Regulation 1935) [36], materials and articles must be obtained in accordance with good manufacturing practices [37] to ensure that, under normal or foreseeable conditions of use, packaging materials do not release their constituents into food in quantities that could: (a) present a risk to human health, \begin{table}
\begin{tabular}{c c c} \hline
**Element** & **TDI (mg/kg bw/day)** & **RfD Ingestion** & **CSF Ingestion** \\  & & **(mg/kg bw/day)** & **(mg/kg bw/day)** \\ \hline Cu & 7.0 \(\times\) 10\({}^{-2.\,\mathrm{c}}\) & - & - \\ Zn & - & 3.0 \(\times\) 10\({}^{-1.\,\mathrm{d}}\),e & - \\ Mn & - & 4.60 \(\times\) 10\({}^{-2.\,\mathrm{e}}\) & - \\ Ni & 1.30 \(\times\) 10\({}^{-2.\,\mathrm{f}}\) & - & 90 \(\times\) 10\({}^{-1.\,\mathrm{h}}\) \\ Li & 2.0 \(\times\) 10\({}^{-2.\,\mathrm{g}}\) & - & - \\ Fe & 7.0 \(\times\) 10\({}^{-1.\,\mathrm{g}}\) & - & - \\ Pb & - & 3.50 \(\times\) 10\({}^{-3.\,\mathrm{d}}\),e & 8.50 \(\times\) 10\({}^{-3.\,\mathrm{h}}\),ij \\ Cd & - & 1.0 \(\times\) 10\({}^{-3.\,\mathrm{d}}\),e & 1.5 \(\times\) 10\({}^{0.\,\mathrm{h}}\) \\ Cr & - & 3.0 \(\times\) 10\({}^{-3.\,\mathrm{d}}\),e & 4.2 \(\times\) 10\({}^{-1.\,\mathrm{h}}\) \\ Sb & 4.0 \(\times\) 10\({}^{-4.\,\mathrm{g}}\) & - & - \\ \hline \end{tabular}  
*–SCHER 2012 [22]; \({}^{\mathrm{b}}\)–AFSSA 2010 [23]; \({}^{\mathrm{c}}\)–EFSA 2023 [24]; \({}^{\mathrm{d}}\)–[PERSON] et al., 2019 [25]; \({}^{\mathrm{e}}\)–[PERSON] et al., 2023 [26]; \({}^{\mathrm{f}}\)–EFSA 2020 [27]; \({}^{\mathrm{g}}\)–EPA 2007 [28]; \({}^{\mathrm{b}}\)–OEHHA, 2020 [29]; \({}^{\mathrm{i}}\)–[PERSON] et al., 2015 [30]; \({}^{\mathrm{j}}\)–[PERSON] et al., 2023 [31].  
\end{table} 
Table 4: _Cont._(b) cause an unacceptable change in the composition of the food, or (c) lead to a decrease in its organoleptic properties [36]. The regulations on good manufacturing practices should be applicable to all groups of materials and articles intended to come into contact with foodstuffs, listed in Annex I of Regulation 1935 [36]. In addition, good manufacturing practice must apply to those materials already in contact with food and intended for that purpose as well as those that can reasonably be expected to come into contact with food or transfer their constituents to food in normal or foreseeable conditions of use [37]. For plastic materials, EU Regulation no. 10/2011 (Regulation 10) [11] establishes quality standards for packaging materials in contact with food and emphasizes that these materials must not present a risk to human health [8]. According to this regulation, plastic materials and articles will not transfer their constituents to food in quantities that exceed the overall migration limit (OML) and specific migration limits (SML) established by Regulation 10 [11]. Overall migration represents all the compounds that can migrate from a packaging material into a food product or food simulant, having an overall migration limit of 10 mg/dm\({}^{2}\) or 60 mg/kg. Specific migration is the maximum allowable amount of a given substance released from a material or article into food or food simulants. In Regulation 10 [11] are presented the SMLs of various non-intentionally and intentionally added substances (NIAS) from plastic materials. The SMLs of all investigated trace and toxic metals from this study are presented in Table 5.  
As can be seen, the measured concentrations of tested elements in the food simulant are significantly lower than the specific migration limits set by Regulation 10 [11] and subsequent changes and presented in Table 5. All tested plastic films released relatively low concentrations of heavy metals, with a maximum concentration of 4.38 mg/kg in the case of Fe, indicating minimal contamination of food products packaged in these materials during real use conditions. The results of heavy metal migration from all tested samples are presented in Table S1.