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Agenda Item 5 CX/CF 12/6/8
January 2012
JOINT FAO/WHO FOOD STANDARDS PROGRAMME
CODEX COMMITTEE ON CONTAMINANTS IN FOODS
Sixth Session
Maastricht, The Netherlands, 26 – 30 March 2012
PROPOSED DRAFT MAXIMUM LEVELS FOR ARSENIC IN RICE
(AT STEP 3)
Codex Members and Observers wishing to submit comments at Step 3 on the proposed draft maximum levels for Arsenic
in Rice, including possible implications for their economic interests, should do so in conformity with the Uniform Procedure
for the Elaboration of Codex Standards and Related Texts (Codex Alimentarius Commission Procedural Manual) before
24 February 2012. Comments should be directed:
to:
Mrs Tanja Åkesson
Codex Contact Point
Ministry of Agriculture, Nature and Food Quality
P.O. Box 20401
2500 EK The Hague
The Netherlands
Fax.: +31 70 378 6134
E-mail: info@codexalimentarius.nl- preferably -
with a copy to:
Secretariat, Codex Alimentarius Commission,
Joint FAO/WHO Food Standards Programme,
Viale delle Terme di Caracalla,
00153 Rome, Italy
Fax: +39 (06) 5705 4593
E-mail: codex@fao.org - preferably -
BACKGROUND
1. The 5th Session of the Codex Committee on Contaminants in Foods (CCCF) agreed to initiate new work on maximum levels for
arsenic in rice subject to approval by the 34th Session of the Commission based on the information and recommendations provided in
working document CX/CF 11/5/10 presented for consideration at that session. The Committee also agreed to re-convene the electronic
Working Group, led by China, working in English only and open to all Codex members and observers, who would prepare a working
paper considering MLs for arsenic in rice based on the considerations made at plenary for deliberation at the next session of the
Committee. The electronic Working Group should specify in the paper whether the MLs apply to total and/or inorganic arsenic in rice.1
2. The Commission approved the proposal for new work on maximum levels for arsenic in rice as proposed by the Committee. In
taking this decision, it was clarified that the matter of establishing MLs for arsenic in rice matter had been thoroughly discussed in the
CCCF, including the need for further data, but that it was agreed that there was a need for work to proceed. It was also explained that
China as the lead country of the new work had been requested to develop a paper to explain whether the MLs would be for total or
inorganic arsenic. Several delegations highlighted the importance of establishing MLs for arsenic in rice for this important commodity. 2
3. The EWG focused on the following aspects: 1) The analytical methods for total and/or inorganic arsenic currently in use, and
collaborating or performance test reports at national or international level. 2) Available raw data for total and/or inorganic arsenic in rice,
used to produce the distribution curve. 3) The comments for this latest version, especially for whether ML(s) should be set on total and/or
inorganic arsenic, ML level and in what products (rice only or rice based products).
1 REP11/CF, para. 64 and Appendix IV.
2 REP11/CAC, paras. 140-142 and Appendix VI.
E
CX/CF 12/6/8 2
4. Information in support of the proposed draft maximum level recommended by the EWG for consideration by Codex members and
observers at the 6th Session of the Committee is presented in Appendix I. The information contained in this Appendix complements the
information already provided in the discussion paper presented for consideration at the 5th Session of the Committee held in March 2011
(see CX/CF 11/5/103). Therefore, information already provided in the discussion paper has not been reproduced in Appendix I. However,
in order to have an integral view of the main issues surrounding rice contamination with arsenic it is recommended to read the information
presented in Appendix I in conjunction with the information contained in CX/CF 11/5/10 that led the EWG to recommend the following
proposed draft Maximum Level for Arsenic in Rice as requested by the 5th Session of the CCCF.
REQUEST FOR COMMENTS
5. The recommendations of the EWG for comment at Step 3 and consideration by the 6th Session of the Codex Committee on
Contaminants in Foods at Step 4 are presented here after. The background information to support these recommendations is presented
in Appendix I. The list of participants is in Appendix II.
Recommendations
It is preferable to set MLs specifically for inorganic As rather than total As. However to do this further data needs to be sourced
as currently there is insufficient robust occurrence data for inorganic As in raw commodity and processed rice products to set
ML’s.
The Committee should ask the Codex Committee on Methods of Analysis and Sampling (CCMAS) to establish the method for
determination of inorganic As in rice. The sampling method for contaminants directives （EC 333/2007）should be made
available to CCMAS as potential starting point.
Consideration should be given to the value of developing a Code of Practice which could address factors which influence
inorganic As levels in rice and rice products e.g As content of soil and water, processing and cooking procedures.
If a ML is set based on the level of current knowledge then it could be set with reference to both total and inorganic As i.e draft
MLs for As in raw rice (brown) would be proposed at 0.3 mg/kg, whether for inorganic As or total As; or 0.2 mg/kg only for
inorganic As in polished rice. It might be measured for total As first, and then measured as inorganic As if the total As
measurement exceeds 0.3 mg/kg.
Raw Rice Maximum Level for Arsenic
0.3 mg/kg (whether inorganic As or total As)
6. Codex Members and Observers are kindly invited to send their comments on the proposed draft Maximum Level for Arsenic in
Rice at 0.3 mg/kg (inorganic As or total As) including the other recommendations above for consideration by the 6th Session of the Codex
Committee on Contaminants in Foods.
3 This working document is available for downloading at: ftp://ftp.fao.org/codex/meetings/cccf/cccf5/cf05_10e.pdf
CX/CF 12/6/8 3
APPENDIX I
The information contained in this Appendix complements the information provided in the discussion paper CX/CF 11/5/10
presented at the 5th Session of the CCCF which led to the recommendation to establish maximum levels for arsenic in rice by the CCCF.
Both CX/CF 11/5/10 and Appendix I to CX/CF 12/6/8 provides the technical support for the proposed draft ML for As in rice
as presented in paragraph 5 of this document.
ANALYTICAL METHODS
7. In addition to the information already presented in CX/CF 11/5/10, the Table 1 summarizes the overall information for analytical
methods collected from the EWG members.
Table 1. Summary of available methods of analysis As in rice from various countries
Country Total As Inorganic As
Australia ICP-MS – internationally validated ICP-MS – not internationally validated
Brazil ICP-MS and HG-AAS
plus graphite furnace atomic absorption None
China ICP-MS and HG-AFS –– national validation HPLC method coupled with ICP-MS or HG-AFS –
national validation
Colombia ICP-MS and HG-AAS
None
European Union Various – internationally validated Various – internationally validated
Korea No information HPLC method coupled with ICP-MS
Japan AOAC 986.15 (AAS) HPLC coupled with ICP-MS – no information on
validation status
US ICP-MS – not internationally validated HPLC coupled with ICP-MS – not internationally
validated
8. The Institute for Reference Materials and Measures (IRMM) of the European Commission Joint Research Center (JRC) issued
the Report of the seventh interlaboratory Comparison organized by the European Union- Reference Laboratory for Heavy Metals in Feed
and Food, IMEP-107: total and inorganic As in rice. The expert laboratories for total As (7) and for inorganic As (6) that participated in the
establishment of the assigned value for IMEP-107, used various methods of analysis. All results agree within a range of about 9% (95%
confidence interval), which indicates that the concentration of inorganic As is not method dependent in rice. Interestingly, the expert
laboratories found a better agreement on the concentration of inorganic As than on the total As for which a wider dispersion of results
was observed. A total 103 laboratories from 35 countries registered to participate in the performance validation exercise by their own
methods using different instruments, 98 laboratories (2 from Canada and 22 from the Asia-Pacific region) reported the result for total As
and 32 participants reported results for inorganic As. Except for EU laboratories, the countries participating laboratories were from
Canada(2), Israel (3) and the Asia-Pacific region, e.g. China (7) and Macau (1), Malaysia (4), New Zealand (2), Singapore (2), Thailand
(3).The result showed that no particular problem related to the determination of inorganic As in rice was detected in the proficiency test
and the performance of the participating laboratories was satisfactory（de la Calle et al., 2011）. The performance of the participating
laboratories was shown to be similar for total and inorganic As. Although the number of laboratories who determined inorganic As was
considerably less than the number of laboratories who determined total As, the results showed that the option of introducing possible
maximum levels for inorganic As should be considered in further discussions on risk management.
9. The U.S. Food and Drug Administration (FDA) uses ICP-MS method for measuring As in foods (CFSAN/ORS/DBC/CHCB April
25, 2011, Draft method for FDA’s Elemental Analysis Manual (EAM), and HPLC coupled with ICP-MS for inorganic As (FDA Elemental
Analysis Manual Section 4.10; Heitkemper et al., 2009). None of these methods have been directly validated through AOAC International
(AOAC) or the European Organization for Standardizations (CEN).
10. Food Standards Australia and New Zealand (FSANZ) used an ICP-MS based method for As levels in rice. The limit of reporting
for total arsenic is 0.0005-0.025 mg/kg depending on the matrix. Recently a method for testing arsenic speciation has been developed
but has not yet undergone national and international proficiency test performance evaluation due to a lack of i) suitable proficiency
providers and ii) a suitable reference standard
11. China and Korea have issued the national standard by using the HPLC method coupled with ICP-MS for measuring inorganic As
in foods, including in rice. And China also developed a cheap method by using HLPC coupled with HG-AAS (GB 5009.11).
12. In Brazil and Colombia, the laboratories are analyzing the total As detection. In Colombia, the most common techniques for
analysis are ICP-MS and HG-AAS, while in Brazil, in addition to these techniques, the graphite furnace atomic absorption is also used.
CX/CF 12/6/8 4
13. In Japan, total As in husked rice is analyzed using AOAC 986.15 (AAS), and inorganic As in husked rice is analyzed using a
method employing extraction of inorganic As with 0.15 mol/L nitric acid and determination with HPLC coupled with ICP-MS for inorganic
As in husked rice （Nagaoka et al., 2008; Maitani et al., 2010）. A recovery test with 0.2 mg/kg of total arsenic added to husked rice
resulted in a recovery range of 90–107% with the relative standard deviation (RSD) below 5.3%. The limit of quantification of the method
was 0.01 mg/kg and the limit of detection was 0.003 mg/kg. A recovery test with 0.01 or 0.02 mg/kg of inorganic arsenic added to husked
rice resulted in a recovery range of 82–106% with RSD below 8.6%. The limit of quantification of the method was 0.01 mg/kg and the limit
of detection was 0.003 mg/kg.
14. One hindrance to national and international validation is a lack of suitable proficiency test providers for As speciation
performance evaluation. Since there are no reference materials for As speciation analysis, it is needed that efforts should be paid to
develop a rice flour reference material containing both inorganic and organic As species. Such natural sample can be obtained in some
ming-impacted paddy soils in China, such as Hunan province, south central China.
15. In summary, considering that inorganic As is of more concern toxicologically than organic As it would be preferable if ML(s) was
set specifically for inorganic As. However, as currently there are a number of method(s) available for inorganic arsenic in rice, which have
undergone various levels of validation, input from CCMAS is required to provide recommendations and guidance as to which method(s)
are suitable for the analysis of arsenic in rice. In order to assist CCMAS in this objective the results from the EU validation project,
referred to in this section, and results from any other national validation projects should be provided to CCMAS.
16. CCMAS should also be requested to provide guidance on sourcing suitable reference material(s) for analysis of inorganic As in
rice and sampling methodology.
LEVEL OF TOTAL AND INORGANIC AS IN RICE COMMODITIES
17. The following information was provided to supplement that already provided in CX/CF 11/5/10. Table 2 summarizes the overall
information collected from the EWG members.
Table 2 Total and inorganic As levels in rice from various countries
Country Total As Inorganic As
Min-max mg/kg Mean mg/kg Min-max mg/kg Mean mg/kg
Australia 0.05-1.20 0.29 - -
China 0.08-5.71 0.29 <0.04-0.45 0.13
Japan 0.04-0.43 0.17 0.04-0.37 0.15
EU 0.01-1.98 0.16 0.02-1.88 0.14
UK 0.12-0.47 0.22 (median) 0.06-0.16 0.11 (median)
USA 0.04-0.41 0.21 0.025-0.157
0.091
(different study to min-max values)
Mercosur 0.05-0.13 (parboiled)
<0.02-0.03 (polished rice)
0.1 (whole grain)
Sweden 0.24 (longgrain brown rice)
0.21 (parboiled white rice)
0.1 (white rice)
0.110
Spain 0.197 0.027-0.253
Slovak Republic 0.158
18. Data from Australia: In the period 1995-98, 112 milled rice samples were collected and analyzed by a commercial producer, for
total As, 1% of these samples exceeded the current Australian New Zealand 1 mg/kg ML for total As in rice. The total As concentrations
of minimum, maximum, and average, median, 90th percentile, 95th percentile and 99th percentile were 0.05 mg/kg, 1.2 mg/kg,
0.29 mg/kg, 0.31 mg/kg, 0.40 mg/kg, 0.43 mg/kg, 1.04 mg/kg, respectively. Limited data from composite rice samples taken during
Australia’s most recent Total Diet Survey (23rd ATDS, 2008) revealed total As in rice concentration ranged from 0.07 mg/kg to
0.12 mg/kg.
CX/CF 12/6/8 5
19. Data from China: From the overall available rice data in 283 brown samples collected in 2003, 2004 and 2005, the minimum,
maximum, average, median, 90th percentile, 95th percentile and 99th percentile for total As concentration were 0.08 mg/kg, 5.41 mg/kg,
0.29 mg/kg, 0.20 mg/kg, 0.38 mg/kg, 0.48 mg/kg, 2.030 mg/kg respectively. The CDC laboratory in China analyzed 41 rice samples from
13 provinces using LC-HG-AFS, inorganic As concentrations ranged from 0.023 to 0.142 mg/kg. Samples from Hunan, Guangxi and
Sichuan provinces had higher concentrations of inorganic As, which were consistent with the distribution of As bedrock in these provinces.
In another study, 22 rice samples from 13 provinces of China were analyzed for their As content. The total As concentration ranged from
0.065-0.274 mg/kg with an average value of 0.114 mg/kg. Speciation analysis, including arsenite (As(III)), arsenate (As(V)), DMA and
MMA, was performed by using HPLC-ICP-MS for the extraction of As from milled rice powder. The inorganic As (As(III) + As(V)) species
was predominant, accounting for approximately 72% of the total As in rice, with a mean concentration of 0.082 mg/kg. The 500 samples
of peddy rice have been collected in more than 20 provinces in China, peddy, husked or polished rice on same sample in 2010 and
analyzed for total and inorganic As in order to observe the processing effect. Combining data from the partly already analyzed 400 brown
rice samples from the peddy rice collected in 2010 and 41 samples in the previous China CDC study, the overall statistical values for
inorganic As concentration were respectively <0.04 mg/kg, 0.45 mg/kg, 0.13 mg/kg, 0.12 mg/kg, 0.21 mg/kg, 0.24 mg/kg, 0.32 mg/kg in
all 441 brown samples. The analysis has been carried out in about 400 samples, concentration of inorganic As in polished rice was as
average 45.5% compared to that in brown rice (range from 12.6%~99.3%) in 400 samples analyzed, which suggested that the polished
rice can reduced the inorganic As significantly.
20. Data from Japan: Surveillance was conducted to investigate occurrence of total arsenic and inorganic arsenic in 600 husked rice
samples from 2003 to 2005 in Japan. Total As in husked rice was analyzed using AAS method, and inorganic As in husked rice was
analyzed using HPLC- ICP-MS method. The average of concentration for total arsenic and inorganic arsenic were in the range of 0.16–
0.18 mg/kg and 0.14–0.16 mg/kg, respectively. The minimum, maximum, average, median, 90th percentile, 95th percentile and 99th
percentile for total As concentration were 0.04 mg/kg, 0.43 mg/kg, 0.17 mg/kg, 0.16 mg/kg, 0.25 mg/kg, 0.27 mg/kg, 0.34 mg/kg,
respectively, the statistical values for inorganic As concentration were 0.04 mg/kg, 0.37 mg/kg, 0.15 mg/kg, 0.15 mg/kg, 0.22 mg/kg,
0.25 mg/kg, 0.31 mg/kg, respectively.
21. Data from Mercosur (Brazil, and Uraguay, etc.): At the moment only total As levels are measured. The Brazil samples were
purchased from a local market in Rio de Janeiro and analyzed by the Health Officials Laboratories with quantification graphite furnace
atomic absorption technique. The average concentrations of total As were 0.05-0.13 mg/kg for parboiled rice, <0.02-0.03 mg/kg for
polished rice and 0.10 mg/kg for whole grain（Batista et al., 2010). As in a total of 70 rice samples was determined with hydride
generation combined with electrothermal atomization absorption atomic spectrometry (FI-ETAAS) with the detection limit is 0.050 mg/kg
and the quantification limit 0.2 mg/kg in Uruguay. Some of them (n=49) were not detected and the rest (n=21) were detected but did not
exceed the level of 0.2 mg/kg.
22. Data from the EU: According to the data collected from EU member states, 1075 samples of rice were analyzed for total As by
ICP-MS ICP-AES, AFS or HG-AAS. The minimum, maximum, average, median, 90th percentile, 95th percentile and 99th percentile
concentrations were 0.01 mg/kg, 1.98 mg/kg, 0.16 mg/kg, 0.12 mg/kg, 0.29 mg/kg, 0.38 mg/kg, and 0.75 mg/kg respectively. While 132
samples of brown, white, long grain, milled or parboiled rice were collected from Italy, Spain, France or imported from Argentina, Bolivia,
Brazil, Canada, India, US, Uruguay, Thailand in 2004-2008. The inorganic As was analyzed by HPLC-ICP-MS or HG-AAS. The inorganic
As concentrations of minimum, maximum, and average, median, 90th percentile, 95th percentile and 99th percentile were 0.02 mg/kg,
1.88 mg/kg, 0.14 mg/kg, 0.11 mg/kg, 0.18 mg/kg, 0.24 mg/kg, and 0.81 mg/kg respectively. More information is available in the Scientific
Opinion on Arsenic in Food by the EFSA Panel on Contaminants in the Food Chain (CONTAM). In a UK study, total As concentrations in
pure baby rice ranged from 0.120 to 0.470 mg/kg with a median of 0.220 mg/kg while inorganic As levels ranged from 0.060 to
0.160 mg/kg, with a median of 0.110 mg/kg. The percentage of inorganic to total As ranged from 33% to 68% with a median of 57%
(Meharg et al., 2008). In a Swedish study, the mean concentration of total As in long grain brown rice of 0.240 mg/kg was similar to that
of parboiled white rice at 0.210 mg/kg, whereas the average concentration in white rice was considerably less at 0.100 mg/kg. The
concentration of inorganic As averaged 0.110 mg/kg, or 64% of the total As (Jorhem et al., 2008). As content in rice has also been
analysed in a Spanish study (Torres-Escribano et al., 2008), where the mean concentration of total As in the 31 samples of European
origin was 0.197 mg/kg. This value was close to the mean value of 0.18 mg/kg found in 7 samples of European rice in a UK study
(Williams et al, 2005). Torres-Escribano and colleagues also evaluated the inorganic As level in raw rice originating from either Europe or
Asian countries and found that it ranged from 0.027 to 0.253 mg/kg. The percentage of inorganic As over the total As varied between 27
and 93%. Williams et al. (2005) analyzed 51 samples of raw rice produced in Europe, Asia and the USA and showed a variation of
inorganic As ranging from 10 to 86%. Both studies also observed that the mean concentration of inorganic As is 1.7 or 1.8 times higher in
brown rice than in white rice. Some common food items (bread, rice, milk, pork meat, chicken meat, cabbage and potatoes) from the
Slovak Republic were collected and analysed for total As concentrations. Rice contained the highest average concentration of total As at
0.158 mg/kg. The major proportion of the As in rice seemed to be inorganic.
CX/CF 12/6/8 6
23. Data from the USA: Schoof et al. (1999) used market basket survey techniques to analyze 40 food commodities expected to
account for 90% of the dietary inorganic As intake. Consistent with earlier studies, total As concentrations were highest in the seafood
ranging from 0.160 mg/kg in freshwater fish to 2.360 mg/kg in marine fish, followed by the raw rice ranging from 0.196 mg/kg to
0.335 mg/kg. The highest inorganic As concentrations were found in raw rice at 0.074±0.010 mg/kg. Heitkemper et al. (2009) analyzed
60 rice samples collected directly from the fields in four major rice-producing states in the US, and reported an average total As content
of 0.210±0.190 mg/kg, while average inorganic As levels were 0.091±0.032 mg/kg. US rice samples with higher levels of total As have
higher levels of DMA; however, inorganic As levels, regardless of the total As content, rarely exceed 0.15 mg/kg dry weight.
24. In summary, data presented above (Table 2), provide the distribution curve (Figure 1 and Table 3), show that the maximum
values for inorganic As in rice do not generally exceed 0.2 mg/kg. However, in some cases including husked rice grown on
uncontaminated soil in Japan and rice grown on soil which is naturally high in As, values exceeded 0.3 mg/kg. It should be noted that
various analytical methods were used to measure the As (total and inorganic), various forms of rice were analysed e.g. husked, polished,
parboiled and no information was provided on the sampling techniques. Therefore before a ML is recommended further analyses of the
data is required to assess the validity of the various analysis methods used and any potential confounding effects resulting from other
variables such as sampling technique and the state of the rice analysed e.g. husked, polished, brown, white. The fraction of inorganic As
of total As showed wide variation ranging from approximately 10% to 93%. Again prior to recommending a ML and whether it should be
set for total or inorganic As further investigation is recommended to identify factors which may influence this variation. Information
provided in this paper indicates that soil type and processing stage can influence the level of inorganic As in rice.
600.0500.0400.0300.0200.0100.00.0
iAs Co n c. ng/g
500
400
300
200
100
0
Freque ncy
90th
95th
99th
97.5th
Mean = 139.1321
Std. Dev. = 65.11518
N = 1,243
Figure 1. The distribution curve of inorganic arsenic concentration in overall rice samples
(Note: line blue, green, orange and red represent the 90th, 95th, 97.5thand 99th percentage of the inorganic arsenic concentration in overall
1243 rice samples collected, in which the value is 0.21, 0.24, 0.27 and 0.34 mg/kg respectively. The average is 0.14 mg/kg)
CX/CF 12/6/8 7
Table 3 The overall frequency from concentration of inorganic and total arsenic in rice
Concentration
(mg/Kg)
Inorganic As Total As
n Ratio% Cumulative Ratio% n Ratio% Cumulative Ratio%
< 0.010 16 1.3 1.3 0 0.0 0.0
0.010 ~ 0.050 35 2.8 4.1 123 5.8 5.8
0.050 ~ 0.100 270 21.7 25.8 364 17.1 22.9
0.100 ~ 0.150 507 40.8 66.6 578 27.2 50.1
0.150 ~ 0.200 263 21.2 87.8 457 21.5 71.6
0.200 ~ 0.250 103 8.3 96.1 246 11.6 83.1
0.250 ~ 0.300 32 2.6 98.6 116 5.5 88.6
0.300 ~ 0.350 10 0.8 99.4 99 4.7 93.2
0.350 ~ 0.400 2 0.2 99.6 58 2.7 96.0
0.400 ~ 0.450 2 0.2 99.8 26 1.2 97.2
0.450 ~ 0.500 0 0.0 99.8 12 0.6 97.7
>0.500 3 0.2 100.0 48 2.3 100.0
Total 1243 100.0 2127 100.0
Note: Concentration data of inorganic and total As (iAs & tAs) of rice were provided from Japan (Total 600 rice samples
collected in 2003, 2004 and 2005 for both iAs & tAs), China (Total 441 rice samples collected in 2009, 2010 and 2011 for
iAs and 283 samples for tAs,), EU (Total 142 rice samples collected in 2004, 2006, 2007 and 2008 for iAs and 1075
samples for tAs), USA (Total 60 rice samples collected in 1980, 1981, 2001 and 2002 for iAs and 57 samples for tAs) and
Australia (Total 112 samples collected in 1998 for tAs)
DIETARY EXPOSURE
25. Based on the information provided in CX/CF 11/5/10 it can be noted that in summary, dietary exposure of total As is mainly from
rice, fish, shellfish, and seaweed, while that of inorganic As is mainly contributed from rice and fish, shellfish, excluding drinking water.
Inorganic As is toxicologically more important than total As. The dietary exposure for inorganic As from rice was calculated for 13 WHO
cluster diet by using the pooled data of the inorganic As concentration in rice provided from China, EU, Japan and USA, with the average,
90th 95th, 97.5th, and 99th percentage, i.e. 0.1 4 mg/kg, 0.21 mg/kg, 0.24 mg/kg, 0.27 mg/kg and 0.34 mg/kg respectively. Using data from
Clusters G and L which showed the highest rice consumption the average inorganic As exposure from rice will be 0.9 g/kg.bw per day if
using the body weight of 60 kg, and 90th and 99th percentiles of exposure will be 1.32-1.33 g/kg.bw per day and 2.14-2.16 g/kg.bw per
day, respectively. According to exposure assessment conducted by JECFA in 2010, BMDL0.5 is 3.0 μg/kg bw per day (with the range of
2–7 μg/kg bw per day) from lung cancer epidemiological studies. If more robust information on the concentration of inorganic As in rice
was available this would enable more robust dietary exposure assessments which would in turn provide better information for setting a
possible ML.
Table 4. Diet Exposure for Inorganic As (iAS) in Rice for Various Cluster Diets (g/kg.bw per day)
Cluster Diet A B C D E F G H I J K L M
Rice Consumption (g) 91.0 31.6 94.6 33.2 12.7 12.7 376.9 64.3 38.0 74.3 238.4 381.3 34.6
Average iAs Intake 0.21
0.07 0.22 0.08
0.03
0.03
0.88
0.15
0.09 0.17 0.56 0.89
0.08
P90 iAs Intake 0.32
0.11 0.33 0.12
0.04
0.04
1.32
0.23
0.13 0.26 0.83 1.33
0.12
P95 iAs Intake 0.36
0.13 0.38 0.13
0.05
0.05
1.51
0.26
0.15 0.30 0.95 1.53
0.14
P97.5 iAs Intake 0.41
0.14 0.43 0.15
0.06
0.06
1.70
0.29
0.17 0.33 1.07 1.72
0.16
P99 iAs Intake 0.52
0.18 0.54 0.19
0.07
0.07
2.14
0.36
0.22 0.42 1.35 2.16
0.20
CX/CF 12/6/8 8
RISK MANAGEMENT CONSIDERATION
26. In addition to the information already provided in CX/CF 11/5/10, Table 5 on maximum levels for total and inorganic As in rice for
various countries has been updated as follows:
Table 5. Maximum levels for total and inorganic As in rice for various countries
Country Regulatory Authorities Maximum Level
Australia and New Zealand Food Standards Australia New Zealand 1 mg/kg for total As (cereals)
China Ministry of Health 0.15 mg/kg inorganic As in rice and rice products *
India 1.1 mg/kg for total As (rice only?)
Mercosur Economic Block Composed by Argentina,
Brazil, Paraguay and Uruguay 0.3 mg/kg for total As (rice)
Singapore Agri-Food and Veterinary Authority 1 mg/kg for total As (other food not given ML specific)
UK Food Standard Agency 1 mg/kg for total As (all food, not given ML specific)
* G/SPS/N/CH/312: the MLs will be adjusted into 0.2 mg/kg.
27. Rice is a staple food for a large proportion of the world population and is also an important commodity in international trade. Rice
can be a significant dietary contributor to human As exposure due to its high consumption rate and its preparation. Cooking rice with As
contaminated water can actually increase the concentration in rice and further contribute to total dietary As exposure. The available
information, considered against the Codex General Standard for Contaminants and Toxins in Food and Feed and the criteria contained in
paragraph 11 of the Policy of the Codex Committee on Contaminants in Foods for Exposure Assessment of Contaminants and Toxins in
Foods or Food Groups, suggests that it would be appropriate to limit the establishment of MLs to rice and its products as they can
contribute significantly to inorganic As dietary exposure. Therefore, the MLs should be established for rice and rice-based products.
DISCUSSION
28. As Contamination of rice is a potential problem. Therefore the CCCF 5th Session agreed to establish Codex MLs for As in rice.
Inorganic As levels in rice vary due to a variety of reasons including weather conditions, soil type/contamination and rice varieties. Tools
are being developed to forecast the likelihood of contamination and/or to assist in the soil and water As contamination level. An inorganic
As exposure assessment conducted by JECFA in 2010 indicated that the PTWI of 15 μg/kg bw (equivalent to 2.1 μg/kg bw per day) is in
the region of the BMDL0.5 (3.0 μg/kg bw per day with the range of 2–7 μg/kg bw per day) from lung cancer epidemiological studies. This is
therefore no longer appropriate. The Committee withdrew the previous PTWI. This complicates establishing MLs of As in rice.
29. According to Codex criteria for establishing MLs, MLs should be set at levels necessary to protect the consumer and as low as
reasonably achievable (ALARA) but at a level that is (slightly) higher than the normal range of variation in levels in food that are produced
with current adequate technological methods, in order to avoid undue disruptions of food production and trade. However, the variability in
inorganic As content of rice and rice-based products, differences in countries’ capabilities to forecast and control inorganic As
occurrence, and the nature of the occurrence data that were provided make it challenging to determine inorganic As’s normal range of
variation in rice and rice-based food on a global scale and thereby apply the ALARA principle in establishing MLs.
30. MLs could apply to either inorganic or total As.
Inorganic As is the area of most concern for human health. However if a ML is set with respect to inorganic As in rice, as a first
step there needs to be internationally accepted validated method(s) which are widely available and not excessively expensive.
The 72nd JECFA (2010), recommended establishment of a validated method for inorganic arsenic in rice.
31. For the possible setting of ML in the future, the EWG takes into consideration from following current nationally enforced MLs:
a) Total As in rice: from 0.3 mg/kg (Mercosur) to 1 mg/kg (FSANZ)
b) Inorganic As in rice: 0.2 mg/kg (China) or 0.3 mg/kg (considering Mercosur total As)
c) Inorganic As in rice-based foods for infants (up to 12 months) and young children (12 to 36 months): 0.2 mg/kg (China).
These levels in rice products, especially for infants and young children, should be lower than the levels for inorganic As in rice.
Rice with (very) low inorganic As is available; producers should use this rice for the production of this category of food.
CX/CF 12/6/8 9
32. China and the European Commission considers it would be best to establish an ML for inorganic As in rice and rice-based
products.
It was noted that the fraction of inorganic As in rice has wide variation ranging from 10% to 93%. Therefore setting ML(s) on total
As can overestimate the risk.
The IRMM/JRC Report of IMEP-107: “total and inorganic As in rice” shows that the performance of the participating laboratories
is similar for total and inorganic As. From the analytical point of view there is no reason not to consider the option of introducing
possible maximum levels for inorganic As in further discussion on risk management.
Separate MLs could be used for vulnerable groups such as infants and young children since exposure in these groups is greater
due to the low bodyweight in relation to food intake. In addition rice is a common food base for these age groups.
Development of MLs for As in rice-based products could be established by applying processing factors calculated from inorganic
As concentrations in raw product and the corresponding processed commodity resulting from appropriate processing studies.
Setting and implementing a 0.2 mg/kg ML of inorganic As in rice is proposed according to China MLs. The previous PTWI of
15 μg/kg bw has been withdrawal by the JECFA in 2010 due to approach to BMDL 0.5. If the previous PTWI is used as the
default and assuming a body weight of 60 kg, the daily exposure is about the 128 μg inorganic As. Based on the WHO guideline
of 0.01 mg/L ML in drinking water, the daily exposure from drinking water will be 15 μg inorganic based on the consumption of
1.5 L and not considering the many areas where the ML in drinking water is likely to be exceeded. Half of remaining daily
exposure is about 50 μg inorganic As. If considering 150-250 g of rice consumption, the 0.2 mg/kg for inorganic As from China
ML or 0.3 mg/kg for total As (as currently used by from Mercosur in Economic Block Composed by Argentina, Brazil, Paraguay
and Uruguay), will use all remaining exposure minus that from drinking water and another half daily exposure from food. Limited
data provided from Australia, China, EU, Japan, US and some other countries support a possible maximum value of 0.3 mg/kg
for inorganic As in rice. However in situations where rice is grown in contaminated soil and irrigated water and in some cases in
Japan, inorganic As concentration in husked rice grown on uncontaminated soil exceeded 0.3 mg/kg. Additional data needs to
be collected from various countries and sources. In addition, it is not appropriate to refer to the PTWI which was withdrawn by
JECFA as it was not considered health protective. Second, it needs to be recognized that not everyone will be consuming 250 g
of rice at a limit of 0.2 mg/kg. This argument similarly applies to estimating exposure from water, where it is assumed that
everyone drinks 1.5 L and is exposed at the limit of 0.01 mg/L. And to add and subtract contributions from food, rice and water,
(presumably to check how it compares against a withdrawn PTWI) without any regard for ‘double counting’ makes it very difficult
to establish a limit for As on the basis of default factors, portion sizes and assumed MLs.
33. On the basis of the current status of analytical methods some countries, e.g., Australia, Brazil and Colombia, consider the ML
should be set for total As.
Draft MLs for As in raw rice should be proposed by applying the ALARA principle to available occurrence data of As from
various countries and sources.
The products to which the MLs apply, should be clearly defined.
Even on uncontaminated soil, inorganic As concentrations in husked rice grown in Japan indicated that over 10% of the
samples contained inorganic As higher than 0.2 mg/kg. The data from Japan indicate that the draft ML of 0.2 mg/kg for
inorganic As in husked rice is unlikely to be achievable.
Moreover, most occurrence data for inorganic As is based on the form and manner of aggregate data rather than distributions.
Only the limited occurrence data was available only from Australia, China, EU, Japan, USA, the working group could not
accurately assess the worldwide percentage of rice that would exceed the proposed MLs. Therefore, there is a need to
continue data collection from various countries and sources.
34. Considering the above the EWG concluded that at this stage it is inappropriate to propose ML(s) for As, especially for rice-
based products. There was a general consensus that as inorganic As is the more toxicologically relevant As species it would be most
appropriate to set MLs for inorganic As. However this is dependent on sourcing more robust data on the inorganic As content in rice and
rice products which itself is dependent on the availability of a suitable analytical method and reference source.
Combining the above two options, draft MLs for As in raw rice (brown) would be proposed at 0.3 mg/kg, whether for inorganic As
or total As, preferable for 0.2 mg/kg inorganic As. It might be measured for total As first, and then measured inorganic As if the total
As measurement exceed the 0.3 mg/kg.
RECOMMENDATIONS
35. Considering that it would be preferable if MLs were set specifically for inorganic As rather than total As, there is a need to collect
occurrence data for inorganic As in raw commodity and processed rice products from various countries and sources.
CX/CF 12/6/8 10
36. CCCF should ask the CCMAS to establish the method for determination of inorganic As in rice. The sampling method for
contaminants directives（EC 333/2007）could be considered as the start point for the sampling method for measurement of total and
inorganic As in rice.
37. Consideration should be given to the value of developing a Code of Practice which could address factors which influence
inorganic As levels in rice and rice products e.g As content of soil and water, processing and cooking procedures, before proceeding with
the establishment of MLs.
38. If a ML is set based on the level of current knowledge then it could be set with reference to both total and inorganic As i.e draft
MLs for As in raw rice (brown) would be proposed at 0.3 mg/kg, whether for inorganic As or total As; or 0.2 mg/kg only for inorganic As in
polished rice. It might be measured for total As first, and then measured as inorganic As if the total As measurement exceeds 0.3 mg/kg.
CX/CF 12/6/8 11
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CX/CF 12/6/8 14
Appendix II List of Participants
Chair
China
WU Yongning
Chief Scientist
China National Center for Food Safety Risk Assessment (CFSA)
Director and Professor
Key Lab of Chemical Safety and Health, Chinese Center for Disease Control and Prevention
Panjiayuan Nanli 7, Beijing 100050
Tel 86-10-67776790 or 83132933
Fax 86-10-67776790
e-mail: china_cdc@yahoo.cn
Participants by Country
Argentina
Lic. Daniela Rodríguez Ierace
Instituto Nacional de Tecnología Industrial
Depto. de Metrología Científica e Industrial
Teléfono (54 11) 4724 6200/300/400
Interno 6590/6323
Fax (54 11) 4713 5311
Email: dierace@inti.gob.ar
Austria
Ms Angelika Nester
Austrian Agency for Health and Food Safety
Division for Data, Statistics and Risk Assessment
Spargelfeldstr. 191
1220 Vienna, Austria
Tel: +43 50 555 25707
Email: angelika.nester@ages.at
Australia
Lynne Waterson
Food Standards Australia New Zealand
Email: Lynne.Waterson@foodstandards.gov.au
Leigh Henderson
Food Standards Australia New Zealand, Email:
Leigh.henderson@foodstandards.govt.nz
Belgium
Ms Isabel De Boosere
Federal Public Service Health, Food Chain Safety and Environment
DG Animal, Plant and Food
Service Foodstuffs, Feed and Other Products
Place Victor Hortaplein 40 box 10
1060 Brussels
Belgium
Tel + 32 2 524 73 84
Fax + 32 2 524 73 99
Email: Isabel.deboosere@health.belgium.be
Brazil
Ms. Ligia Lindner Schreiner
Expert on Regulation
Brazilian Health Surveillance Agency
General Office of Foods
Tel.: +55 61 3462 5399
E-mail: ligia.schreiner@anvisa.gov.br
China
LI Xiaowei
Associate Professor
WHO Collaborating Center for Contamination Monitoring (China)
China National Center for Food Safety Risk Assessment (CFSA)
Panjiayuan Nanli 7,
Beijing 100021,
PR China
Tel 86-10-67776790
E-mail: eveline73@vip.sina.com
LI Jinguang
Associate Professor
China CDC Key Lab of Chemical Safety and Health,
China National Center for Food Safety Risk Assessment (CFSA)
29 Nanwei Road,
Beijing 100050,
PR China
Tel 86-10-83132933
E-mail: lichrom@yahoo.com.cn
SHAO Yi
Associate Researcher
Food Safety National Standard Secretary
China National Center for Food Safety Risk Assessment (CFSA)
Panjiayuan Nanli 7,
Beijing 100021,
PR China
Tel 86-10-87720035
E-mail: sy1982bb@yahoo.com.cn
ZHU Zhiguang
Director of Standard Section
Center for Quality and Standard of Grain and Edible Oil
State Administration of Grain, PR China
A11, Guohong Building(C), Muxidi Beili. Xicheng District. Beijing
100038,
PR China
Tel.: +86 10 58523389
E-mail:lybzzzg@gmail.com
CX/CF 12/6/8 15
ZHU Yongguan
Professor of Environmental Biology and Biogeochemistry
Director General
Institute of Urban Environment
Chinese Academy of Sciences
1799 Jimei Road,
Xiamen 361021,
P R China
Tel: +86 10 592 6190997
Fax: +86 10 592 6190977
E-mail: ygzhu@iue.ac.cn
Colombia
José Álvaro Rodriguez Castañeda
Instituto Nacional de Vigilancia de Medicamentos y Alimentos –
INVIMA
E-mail: jrodriguezca@invima.gov.co
Costa Rica
Mar Elena Aguilar Solano
Technical Secretariat of the Codex in Costa Rica
Phone: (506) 2233-6922
Email: maguilar@ministeriodesalud.go.cr
Cuba
Miguel García Roch
Investigador Auxiliar, INHA
c/o Teresa Infante Frómeta
Director
International Relations
NC/ Cuba.
c.c.Dr. McS.Jorge Félix Pérez Medina
Sec. Codex National Committee
Cuban National of Standards
E-mail: tinfante@ncnorma.cu
Dominican Republic
Dr. Matilde Vasquez
Nutriciu
Ministerio de Salud Pulica (MSP)
Postal address: 10514
PCC-Dominican Republic
Tel + 1 - 809-541-0382
Email: codexsespas@yahoo.com
European Union
Mr Frank SWARTENBROUX
European Commission
Health and Consumers Directorate-General
Tel.: ++32 - 2 - 299 38 54
E-mail: frank.swartenbroux@ec.europa.eu
Ms Almut BITTERHOF
European Commission
Health and Consumers Directorate-General
Tel.: ++32 - 2 - 298 67 58
E-mail: almut.bitterhof@ec.europa.eu
Ghana
Prof. Victoria Appiah
Ghana Atomic Energy Commission
Tel: +233 243 181 003
E mail: vicappiah@yahoo.com
Mr. Kwamina Van-Ess
Kwamina Van-Ess and Associates
Tel: +1233 244 653 167
E mail: kwaminav@yahoo.com
Mr. Ebenezer Kofi Essel
Head, Food Inspectorate
Food Division
Food and Drugs Board
Accra
Tel: +0233 244 655 943
E mail: kooduntu@yahoo.co.uk
Ms. Joyce Okoree
Codex Contact Point Officer
Ghana Standards Board
Accra
Tel: +0233 244 381 351
E mail: jooko88@yahoo.com
codex@gsb.gov.gh
India
Dr. U. Venkateswarlu
Joint Secretary
Ministry of Food Processing Industries
New Delhi, India
Ph: 91-011-26494032, 9111-9868115525
Fax: 011-26492176
E-mail: venkateswarlu86@nic.in
Japan
Mr Naofumi HAMATANI
Associate Director
Plant Products Safety Division
Ministry of Agriculture, Forestry and Fisheries
1-2-1 Kasumigaseki, Chiyoda-ku, Tokyo 100-8950, JAPAN
E-mail: naofumi_hamatani@nm.maff.go.jp
Mr Masanori AOKI
Associate Director
Plant Products Safety Division
Ministry of Agriculture, Forestry and Fisheries
1-2-1 Kasumigaseki, Chiyoda-ku, Tokyo 100-8950, JAPAN
E-mail: aoki_masanori@nm.maff.go.jp
Mr Wataru IIZUKA
Section Chief
Standards and Evaluation Division
Department of Food Safety
Ministry of Health, Labour and Welfare
1-2-2 Kasumigaseki Chiyoda-ku, Tokyo 100-8916, JAPAN
E-mail: codexj@mhlw.go.jp
Dr Tomoaki TSUTSUMI
Section Chief
Division of Foods
National Institute of Health Sciences
1-18-1 Kamiyoga, Setagaya-ku, Tokyo 158-8501, JAPAN
E-mail: tutumi@nihs.go.jp
CX/CF 12/6/8 16
Malaysia
Ms Fauziah Arshad
Standard and Codex Branch
Food Safety and Quality Division
Ministry of Health Malaysia
Level 4, Plot 3C4 Building,
No. 26, Jalan Persiaran Perdana
Presint 3, 62675 Putrajaya, MALAYSIA.
Phone: +603 8885 0794
Email: fauziaharshad@moh.gov.my
Ms Raizawanis Abdul Rahman
Senior Assistant Director
Contaminant Section
Food Safety and Quality Division
Ministry of Health Malaysia
Level 4, Plot 3C4 Building,
No. 26, Jalan Persiaran Perdana
Presint 3, 62675 Putrajaya, MALAYSIA.
Phone: +603 8885 0785
Email: raizawanis@moh.gov.my
With a copy to ccp_malaysia@moh.gov.my
Sweden
Carmina Ionescu
Codex Coordinator
National Food Administration
Box 622, SE-751 26 Uppsala
Sweden
Tel. +46 709 24 56 01
Email. carmina.ionescu@slv.se
Thailand
Mr. Pisan Pongsapitch
Director, Office of Commodity and System Standard,
National Bureau of Agricultural Commodity and Food Standards,
50 Phaholyothin Road, Ladyao, Chatuchak,
Bangkok 10900 Thailand
Tel (+662) 561 2277
Fax (+662) 561 3357, (+662) 561 3373
E-mail: codex@acfs.go.th
Uruguay
Raquel Huertas
Laboratorio Technogico Del Uruguay
URUGUAY
E-mail: rhuertas@latu.org.uy
United Kingdom
Paul Jenkins
Food Standards Agency
Environmental & Process Contaminants Branch
Chemical Safety Division
3rd Floor Zone B Aviation House
125 Kingsway
London WC2B 6NH
UK
E-mail: Paul.Jenkins@foodstandards.gsi.gov.uk
United States of America
Henry Kim
On behalf of Nega Beru, U.S. Delegate to CCCF
U.S. Food and Drug Administration
Center for Food Safety and Applied Nutrition
HFS-317
5100 Paint Branch Parkway
College Park, MD 20740
E-mail: henry.kim@fda.hhs.gov
Participants by Organization
Confederation of the Food and Drink Industries of the EU (CIAA)
Lorcan O' Flaherty
Confederation of the Food and Drink Industries of the EU (CIAA)
Avenue des Arts, 43
1040 Brussels, Belgium
Telephone: +32 2 5008756;
FAX: +32 2 5112905
E-mail: l.oflaherty@ciaa.eu
Food and Agriculture Organization (FAO)
Dr Annika Wennberg
FAO JECFA Secretary
Nutrition and Consumer Protection Division
Food and Agriculture Organization of the United Nations
Viale delle Terme di Caracalla, C- 278
00153 Rome, Italy
Telephone: + 39 06 5705 3283;
FAX: + 39 06 5705 4593
E-mail: Annika.Wennberg@fao.org
Institute of Food Technologists (IFT)
Rodney Gray
Vice President Regulatory Affairs
Martek Biosciences Corporation
6480 Dobbin Road
Columbia MD 21045, USA
Telephone: +1 443 542 2327;
FAX: +1 410 740 2985
E-mail: rgray@martek.com
Rosetta Newsome
Director, Science and Policy Initiatives
Institute of Food Technologists
525 W. Van Buren Street, Suite 1000
Chicago, IL 60607-3830
Telephone: 312-604-0228;
FAX: 312-596-5628
E-mail: rnewsome@ift.org
World Health Organization (WHO)
Dr Angelika Tritscher
WHO Joint Secretary to JECFA and JMPR
Department of Food Safety and Zoonoses
World Health Organization
20, Avenue Appia, CH-1211
Geneva 27, Switzerland
Telephone: +41 22 791 3569;
FAX: +41 22 791 4807
Telephone mobile: +41 79 633 9995
E-mail: tritschera@who.int
Internet: www.who.int/ipcs/food/en
