Exposure to sulfur dioxide–sulfites (E 220–228) as food additives

were not included, and four food categories were included in the exposure assessment without considering these restrictions/specifications.

The use of sulfur dioxide–sulfites (E 220–228) in ‘14.2.7.1 Aromatised wines’, ‘14.2.7.2 Aromatised wine-based drinks’ and ‘14.2.7.3 Aromatised wine-product cocktails’ is authorised under Annex II to Regulation (EC) No 1333/2008 (Table 1), whereas maximum levels of sulfur dioxide–sulfites (E 220–

228) are defined in Annex IB to Regulation (EC) No 606/2009 for red, white and rosé wine, liqueur wine and sparkling wine (Section 1.1). As no specific food entries are present in FoodEx for aromatised wines, wine-based drinks and wine/product cocktails, the consumption of these products are all coded as wine. Therefore, a unique food category was considered for wine, including also red, white and rosé wine and sparkling wine, when assessing the exposure.

228) is not authorised and whose presence cannot be explained via carry-over (dataset 2).

This dataset consisted of a total of 24,956 analytical values, after excluding the analytical results expressed as qualitative results (n = 2), analytical results of food categories not listed in Annex II to Regulation (EC) No 1333/2008 and Annex IB to Regulation (EC) No 606/2009, where all analytical results were below the LOQ and of food categories not listed in Annex II to Regulation (EC) No 1333/2008 nor in Annex IB to Regulation (EC) No 606/2009 composed of only one analytical sample (n = 84) and analytical results of food categories not referenced in FoodEx (n = 337). Overall, 43 food categories were considered for the exposure assessment (Appendix C and D).

In order to evaluate the impact of the relatively high number of analytical results found to exceed the MPL (n = 516), the exposure to sulfur dioxide–sulfites (E 220–228) was as well assessed under a scenario including use levels and analytical data for food categories for which direct addition of sulfur dioxide–sulfites (E 220–228) is authorised and, in addition, the available analytical data for foods categories which may contain sulfur dioxide–sulfites (E 220–228) due to carry-over and for food categories for which the direct addition of sulfur dioxide–sulfites (E 220–228) is not authorised and whose presence cannot be explained via carry-over.

2.9.2.1. Regulatory maximum level exposure assessment scenario

The regulatory maximum level exposure assessment scenario is based on the MPLs as set in the Annex II to Regulation (EC) No 1333/2008 and Annex IB to Regulation (EC) No 606/2009 and listed in Section 2.6.

A MPL of 250 mg/L as established for white and rosé wines with more than 5 g of glucose/L by Annex IB to Regulation (EC) No 606/2009 (Section 2.6) was assigned to the food category ‘Wine’

(Appendix C).

The exposure estimates derived following this scenario should be considered as the most conservative as it is assumed that the consumer will be continuously (over a lifetime) exposed to sulfur dioxide–

sulfites (E 220–228) present in the food at a MPL.

2.9.2.2. Refined exposure assessment scenario

The refined exposure assessment scenarios are based on reported use levels from industry and analytical results submitted to EFSA by the Member States. The refined exposure assessment scenarios were carried out twice, based on the dataset 1 and dataset 2 (Section 2.9.2). Appendix C and D summarise the concentration levels of sulfur dioxide–sulfites (E 220–228) used in the refined exposure assessment scenarios per dataset.

Per dataset, the Panel calculated two estimates based on different model populations:

1. The brand-loyal consumer scenario: It was assumed that a consumer is exposed long term to sulfur dioxide–sulfites (E 220–228) at the maximum reported use/analytical level for one food category. This exposure estimate is calculated as follows:

a. Food consumption is combined with the maximum of the reported use levels or the maximum of the analytical results, whichever was highest or available, for the main contributing food category at the individual level.

b. Food consumption is combined with the mean of the typical reported use levels or the mean of analytical results, whichever was highest or available, for the remaining food categories.

2. The non-brand-loyal consumer scenario: It was assumed that a consumer is exposed long term to sulfur dioxide–sulfites (E 220–228) present at the mean reported use/analytical results in

food, whichever was highest or available. This exposure estimate is calculated using the mean of the typical reported use levels or the mean of analytical levels for all food categories.

In the brand-loyal consumer scenario, including values above the MPL, the 95th percentile level of a food category was used instead of the maximum value in order to minimise the impact of possible outliers. However, for food categories listed in Annex II to Regulation (EC) No 1333/2008, in case the 95th percentile level was below the MPL, the maximum value below the MPL as reported in dataset 1, was used also in dataset 2.

To consider left-censored analytical data (i.e. analytical results < LOD or < LOQ) in both refined exposure assessment scenarios, the substitution method as recommended in the ‘Principles and Methods for the Risk Assessment of Chemicals in Food’ (WHO, 2009) and the EFSA scientific report

‘Management of left-censored data in dietary exposure assessment of chemical substances’ (EFSA, 2010) was used. In the present opinion, analytical data below LOD or LOQ were assigned half of LOD or LOQ, respectively (medium-bound (MB)). Subsequently, per food category the mean or median, as appropriate, MB concentration was calculated.

For all food categories, except 06.2.2 ‘Starches’, analytical data were used to estimate the exposure according to the refined exposure scenarios for both datasets. For 06.2.2, use levels were used.

2.9.2.3. Estimated exposure to sulfur dioxide–sulfites (E 220–228)

Table 12 summarises the estimated exposure to sulfur dioxide–sulfites (E 220–228) from their use as food additives in six population groups. Detailed results per population group and survey are presented in Appendix F and summary results related to the exposure to sulfur dioxide–sulfites (E 220–228) under the scenario including also concentration levels above the MPLs are reported in Appendix E.

Table 12: Summary of estimated exposure to sulfur dioxide–sulfites (E 220–228) from their use as food additives in the regulatory maximum level exposure assessment scenario and in the refined exposure scenarios in six population groups (min–max across the dietary surveys in mg/kg bw per day).

Infants (4–11 months)

Toddlers (12–35 months)

Children (3–9 years)

Adolescents (10–17 years)

Adults (18–64 years)

The elderly (> 65 years) Regulatory maximum level exposure assessment scenario

Mean 0.23–1.10 0.75–2.21 0.63–1.86 0.35–1.02 0.42–0.85 0.37–0.97

High level 1.33–3.95 2.34–6.92 1.55–5.11 0.85–2.31 1.11–2.02 1.03–2.01

Refined exposure scenario considering concentration levels not exceeding the MPLs for food categories listed in Annex II to Regulation (EC) No 1333/2008 and Annex IB to Regulation (EC) No 606/2009 (dataset 1)

Brand-loyal scenario

Mean 0.13–0.91 0.41–1.22 0.25–1.16 0.16–0.63 0.3–0.67 0.28–0.89

High level 0.68–3.48 1.55–4.5 0.70–3.63 0.42–1.63 0.97–1.97 0.78–2.41

Non-brand-loyal scenario

Mean 0.03–0.23 0.14–0.56 0.10–0.53 0.06–0.31 0.12–0.26 0.11–0.30

High level 0.16–0.70 0.61–2.26 0.34–1.65 0.15–0.79 0.42–0.76 0.39–0.69

Refined exposure scenario considering in addition to dataset 1, the available analytical data for foods categories which may contain sulfur dioxide–sulfites (E 220–228) due to carry-over and for food categories for which the direct addition of sulfur dioxide–sulfites (E 220–228) is not authorised and whose presence cannot be explained via carry- over (dataset 2)

Brand-loyal scenario

Mean 0.25–0.99 0.74–1.6 0.57–1.45 0.37–0.88 0.48–0.75 0.45–0.95

High level 1.4–3.61 1.98–4.64 1.18–3.78 0.74–2.09 1.16–2.06 0.94–2.46

Non-brand-loyal scenario

Mean 0.08–0.31 0.26–0.74 0.25–0.69 0.14–0.4 0.19–0.34 0.2–0.34

High level 0.45–0.85 0.79–2.4 0.55–1.83 0.3–0.9 0.51–0.87 0.48–0.74

MPL: maximum permitted level.