12 October 2017 [28-17] Supporting document 3



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4.3 Risk characterisation and conclusion


The highly conservative theoretical exposure estimates calculated in Phase 2 of the 24th ATDS suggested a potential that dietary exposures to DEHP and DINP may exceed their respective TDIs. However, the more refined exposure estimates derived from the present survey indicate that estimated dietary exposures to all the plasticisers included in the survey are below the respective TDIs for all age groups, for both mean and 90th percentile dietary exposures.

Based on these data, current dietary exposures of Australian consumers to the seven plasticisers included in this study are not considered to be of health concern.


5 Mineral oils

5.1 Mineral oil hydrocarbons survey

5.2.1 Introduction


An analytical survey was undertaken to investigate whether mineral oil hydrocarbons (MOH) migrate from food packaging to food. This was done with a view to determine whether current food packaging regulatory measures in Australia and New Zealand are appropriate to protect public health and safety. This work was conducted to inform the FSANZ Proposal, P1034- Chemical Migration from Packaging into Food.

5.2.2 Hazard summary


Mineral oils are complex mixtures that are generally comprised of two main forms, mineral oil saturated hydrocarbons (MOSH) and mineral oil aromatic hydrocarbons (MOAH). The composition of mineral oils varies depending on the source, but technical grades generally contain 15-35% MOAH, whereas food grade mineral oils are treated to minimise the presence of MOAH.

MOSH and MOAH are both of low acute toxicity, however in sub-chronic toxicity studies in rats MOSH exposure has been found to result in the formation of microgranulomas and inflammation in the liver. Some forms of MOAH are genotoxic and carcinogenic (EFSA 2012). No internationally agreed HBGVs are currently available for MOH, however EFSA has identified toxicological points of departure for MOSH that can be used as reference points in a margin of exposure evaluation. These reference points are based on NOAELs for liver effects in rats.

It is desirable that exposures to MOAH should be as low as reasonably achievable.

5.2.3 Methods


The analytical survey was conducted in two phases; the first phase established a method for the detection and quantification of MOH in paperboard packaging. Analytical methods were developed for the two main groups of MOH, MOSH and MOAH, in accordance with the method published by the German Institute for risk assessment (BfR 2012). Phase two of this project undertook a small scale analytical survey, measuring MOSH and MOAH levels in the paperboard packaging and corresponding food samples.

Following the establishment of a robust, reliable method, a total of 61 paperboard packaging samples were analysed as part of the first phase using gas chromatography, coupled with flame ionisation detection. Phase two of the survey analysed 56 dried unprepared food samples and the associated packaging for total MOSH and MOAH. The Limit of Quantification (LOQ) for all MOHs analysed in paperboard and food was 10 mg/kg and the Limit of Detection (LOD) was 5 mg/kg. Given white mineral oil is also a permitted processing aid as a lubricant, release and anti-sticking agent, foods were selected where detections were more likely to be a result of chemical migration from packaging, rather than from use as a processing aid or food additive.


5.2.4 Summary of analytical survey results

5.2.4.1 Phase 1 – Quantification of MOH in paperboard packaging only


The results from the first phase of this study indicate a strong correlation between the level of MOH detected and the proportion of recycled material used in the packaging construction (Table 6). These findings are consistent with the control packaging samples containing recycled materials. In addition, in most cases, packaging which contained recycled materials also used an inner lining as a physical barrier between the package and the food.

5.2.4.2 Phase 2 – Quantification of MOH in food and paperboard packaging


Over 98% of the 56 food samples tested for total MOSH in phase two of the survey had concentration levels at or below the LOQ of 10 mg/kg (Table 7). One sample of dry chocolate cake mix was found to have a total MOSH level of 71 mg/kg.

For the food packaging analysed in phase two, MOSH was detected in over 90% of the 56 samples tested. Levels ranged from 12 to 2,900 mg/kg. Generally, higher levels of MOSH were found in packaging which was derived from recycled materials, with highest concentrations detected in packaging that used 100% recycled products.



The same 56 food samples and packaging were also analysed for total MOAH, with over 92% of food samples found to contain MOAH at or below the LOQ of 10 mg/kg. Detections above the LOQ were found in dry unprepared cous cous (85 mg/kg) and three samples of chocolate cake mix (17, 77, 150 mg/kg). Total MOAH was detected in approximately 90% of the corresponding food packaging, with concentration levels ranging from 11 to 9600 mg/kg. The composition of the packaging which had the highest concentration of MOAH detected, was not indicated.

Table 6 – Total MOAH and MOSH concentrations in food packaging available in Australia

Food Packaging Type

(n=x)

Packaging Type used

Individual Food Packaging Concentration (mg/kg)

Paperboard

Internal bag

Total MOSH

Total MOAH

Risoni (5)

Not indicated

No

350, 380, 170, 360, 140

190; 230; 60, 370, 560

Pasta/Spelt (4)

Not indicated

No

170, 120, 3900

500, 330, 710

Not indicated

Yes

540

320

Cous Cous (6)

Not indicated

No

790, 330, 500, 180, 400, 200

280, 120, 20, 290, 120, <10

Oats (5)

Not indicated

No

<10, 170, 120, 220, 810

30, 30, 80, 60, 210

Breakfast cereal, multiple grain (5)

95% recycled

Yes

970, 970, 2400, 600, 1100

460, 360, 1100, 780, 670

Breakfast cereal, single grain (5)

100% recycled

Yes

2400, 4900, 3800, 4000, 3400

210, 870, 880, 1100, 490

Bread crumbs (5)

Not indicated

No

220, 490, 60, 390, 560

200, <10, <10, 164, 110

Sugar (5)

Not indicated

No

880, 1000, 520, 730, 960

70, 10, 10, 100, 460

Custard powder (5)

Not indicated

Yes

200, 380, <10, 400, 300

90, 70, 10, 300, 910

Cake mix, chocolate (3)

Not indicated (1)

Yes

310

250

95% recycled (2)

Yes

3200, 7000

440, 3200

Cake mix, vanilla (2)

95% recycled

Yes

6400

560

Not indicated

Yes

5300

710

Nuts/dried fruit mix (5)

Not indicated

No

210, 110, 500, 160

20, <10, 130, 310, 230

Tea (1)

95% recycled

No

7300

540

Fish, battered/ frozen (3)

Not indicated

No

290, 320, 430

120, 200, 70

Chicken, battered/ frozen (2)

Not indicated

No

320, 270

110, 70

CONTROL PAPERBOARD SAMPLES

Kraft + 25% recycled (5)

N/A

N/A

1500, 570, 1800, 860

290, 90, 260, 870, 210

100% recycled cardboard (5)

N/A

N/A

5700, 4200, 5400, 4900, 4600

1200, 1500, 1000, 530, 1600

100% virgin cardboard (5)

N/A

N/A

110, 120, 100, 110, 90

<10, 240, 410, 610, 260

Total values are for detects of the C10 – C35 forms; ‘X’ denotes the number of samples tested;

LOQ= 10 mg/kg; LOD= 5 mg/kg. One sample was not tested by the analytical laboratory for total MOSH


Table 7 – Total MOSH and MOAH concentrations in food and packaging available in Australia*


Food Type (n=X)

Sample Type

MOSH

MOAH

Number of Detects >LOQ

Total Food and/or Packaging Concentration Range

(mg/kg)

Number of Detects >LOQ

Total Food and/or Packaging Concentration Range

(mg/kg)

Pasta (n=5)


Food

0

-

0

-

Packaging

5

44-420

2

54-150

Cous Cous (n=3)

Food

0

-

1

85

Packaging

3

29-720

3

78-300

Oats (n=3)

Food

0

-

0

-

Packaging

1

34

2

11-12

Breakfast cereal, multiple grain (n=3)

Food

0

-

0

-

Packaging

3

61-630

3

250-660

Breakfast cereal, single grain (n=9)

Food

0

-

0

-

Packaging

9

23-1000

9

110-9600

Bread crumbs (n=3)

Food

0

-

0

-

Packaging

2

18-88

2

39-120

Sugar (n=3)

Food

0

-

0

-

Packaging

3

55-160

3

100-190

Flour, Plain (n=3)

Food

0

-

0

-

Packaging

3

54-92

3

150-180

Cake mix, chocolate (n=3)

Food

1

71

3

17-150

Packaging

3

12-2200

3

20-320

Chicken, battered/frozen (n=3)

Food

0

-

0

-

Packaging

1

14

3

14-47

Fish, battered/frozen (n=3)

Food

0

-

0

-

Packaging

3

26-120

3

130-270

Sausage rolls (n=3)

Food

0

-

0

-

Packaging

3

25-75

3

64-81

Box, Pizza, take away (n=6)

Food

0

-

0

-

Packaging

6

110-2900

5

280-920

Eggs (n=2)

Food

0

-

0

-

Packaging

2

180-630

2

220-370

Infant cereal (n=4)

Food

0

-

0

-

Packaging

4

400-1400

4

430-680

Total values are for detects of the C10 – C35 forms; ‘X’ denotes the number of samples tested; - indicates that there is no range as there were no detections above the LOQ; LOQ= 10 mg/kg & LOD= 5 mg/kg for all samples analysed.* All foods were analysed raw, uncooked, dry or unprepared.

5.2.5 Risk characterisation and conclusion


The survey indicated that the levels of MOSH and MOAH from food packaging in Australian foods are very low and unlikely to be of public health concern. Given the low incidence of detections in sampled foods a quantitative risk assessment was not carried out.

Levels of MOAH should be kept as low as reasonably achievable. FSANZ is aware of industry efforts to minimise the migration of these substances from food packaging into food8 and will continue to monitor this issue.


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