STC Number - 198

Regulation on aflatoxins and Ocratoxin A in foods for infants and young children

Maintained by: European Union
Raised by: China
Supported by:
First date raised: October 2004 G/SPS/R/35, paras. 68-69
Dates subsequently raised:
Number of times subsequently raised: 0
Relevant documents: Raised orally
Products covered: 21 Miscellaneous edible preparations; 2106 Food preparations not elsewhere specified or included.
Primary subject keyword: Food safety
Keywords: Food safety; Human health; International Standards / Harmonization
Status: Not reported
Date reported as resolved:

Extracts from SPS Committee meeting summary reports

China raised concerns over EC notification G/SPS/N/EEC/223 and addendum on aflatoxins and OTA in foods for infants and young children. Studies conducted by JEFCA concluded that the acceptable level of risk was the same when the level of aflatoxin B1 was reduced from 20 to 10 mg/kg and when the level of aflatoxin M1 was reduced from 0.5 to 0.05 mg/kg. Any further reductions of the levels of aflatoxins B1 and M1 would have no significant impact on public health safety. Furthermore, JECFA, in its 37th Session, had established a weekly intake of OTA of 112 mg/kg. This minimum intake was subsequently lowered to 100 mg/kg at the 44th Session of JECFA and remained unchanged in the 56th Session based on results of risk assessments carried out on OTA levels in cereals and cereal based products. The European Communities was requested to provide scientific justification for its measures and to consider the impact of the measures on international trade.
The European Communities stated that the EC regulation amending Commission regulation 466/2001 concerning aflatoxins and OTA in foods for infants and young children applied to products placed in EC markets and was effective from 1 November 2004. Although China had not submitted comments during the comment period, China's comments would be taken into account and a written response would be provided. The JECFA studies referenced above were based on intake levels of adults, rather then on intake levels of infants. The European Communities had therefore considered it necessary to establish maximum levels of aflatoxins of B1, M1 and OTA for infants and young children. These maximum levels were achievable and substantiated by data. Furthermore, they had little trade implications, as finished foods for infants and young children were not traded in significant amounts.