WRITTEN QUESTION E-2343/99

by Robert Evans (PSE) to the Commission

(13 December 1999)

Subject: Aflatoxin fungus

Would the Commission inform me of recent actin taken by the Commission concerning permissible levels of aflatoxin fungus and Brazil nuts?

I have been approached about the possible impact of this action on forest people in the Amazon region. I would like further information on the scientific basis for this action and any assistance that the EU is giving to producers.

Answer given by Mr Byrne on behalf of the Commission

(19 January 2000)

Commission Regulation (EC) No 1525/98 of 16 July 1998 amending Regulation (EC) No 194/97 of 31 January 1997 setting maximum levels for certain contaminants in foodstuffs(1) establishes maximum limits for aflatoxin B1 and aflatoxin total for groundnuts, nuts, including brazil nuts, dried fruit, cereals and derived products of these commodities and for aflatoxin M1 in milk. For nuts, including brazil nuts, and processed products thereof intended for direct human consumption or as an ingredient in foodstuffs, maximum limits are at the level of 4 microgram per kilogram (µg/kg) aflatoxin total and 2 µg/kg aflatoxin B1. Sorting techniques and other possible physical treatments which reduce the aflatoxin content can be carried out on unprocessed nuts to obtain the final consumer product. Taking these techniques into account, higher maximum limits have been established for nuts, including brazil nuts (10 µg/kg aflatoxin total and 5 µg/kg aflatoxin B1) to be subjected to sorting or other physical treatment, before their human consumption or their use as an ingredient in foodstuffs.

The scientific committee for food (SCF) expressed on 23 September 1994 an opinion on aflatoxins, ochratoxin A and patulin(2). At that time the Committee concluded for aflatoxins: Aflatoxins are genotoxic carcinogens. For this type of carcinogen, it is generally felt that there is no threshold dose below which no tumour formation would occur. In other words, only a zero level of exposure will result in no risk. It agreed with the recent evaluations of the International agency for research on cancer (IARC) (1993) with respect to the carcinogenicity and genotoxicity of the aflatoxins. From the many reports on risk assessment, it can be concluded that even very low levels of exposure to aflatoxins, i.e. 1 nanogram per kilogram (ng/kg) body weight per day or less contribute to the risk of liver cancer.

The SCF re-discussed the toxicology of aflatoxins at its 108th plenary session in September 1997(3) in the light of a joint FAO/WHO expert committee on food additives (JECFA) evaluation(4). The SCF recognised the great effort made by JECFA to perform a quantitative risk assessment by combining carcinogenic potencies and human exposure data, but noted also the several limitations and assumptions inherent in this approach, which were clearly set out in the report. The SCF noted that the toxicology of the aflatoxins is not questioned by JECFA Aflatoxins are amongst the most potent mutagenic and carcinogenic substances known and that several statements of the JECFA are not incompatible with the SCF opinion on aflatoxins expressed in 1994 and concluded that this opinion remains valid. On the basis of this assessment it is considered that fixing maximum levels, besides preventive measures to avoid contamination, contribute to the protection of the consumer. These limits must be set at a level as low as reasonably achievable.

The Commission is fully aware of the importance of the brazil nut production for the social conditions of the local producers and for the preservation of the Amazon forest. The Commission is therefore currently examining under the technical co-operation programmes with the countries involved which technical and financial assistance can be provided for in order to maintain brazil nut production as a way of preservation of the bio-diversity of the Amazon rainforest, to improve the quality of the brazil nut with regard to aflatoxin content and to improve the social conditions of the small, local growers. However, these objectives are secondary to the protection of European consumers from the dangers to public health from aflatoxin contamination.

(1) OJ L 201, 17.7.1998, p. 43 and p. 93.

(2) Reports of the scientific committee for food, 35th series.

(3) Minutes of the 108th meeting of the Scientific Committee for Food held on 18-19 September 1997 in Brussels.

(4) Forty-ninth meeting, Rome, 17-26 June 1997, Summary and Conclusions, enclosed section.