WRITTEN QUESTION E-2506/99

by Caroline Jackson (PPE-DE) to the Commission

(22 December 1999)

Subject: Permitted levels of aflatoxin fungus in brazil nuts imported into the EU

Could the Commission state:

1. the source of the scientific research behind its decision to allow a maximum level of aflatoxin fungus in brazil nuts at 4 parts per billion (ppb), when the US level is 20 ppb?

2. Is the EU maximum level for peanuts higher than that for brazil nuts?

3. What consultations were carried out with brazil nut producers before the EU decision was made?

4. What EU assistance has been offered to producers in order that they can take measures to ensure that fewer nuts are affected?

5. How many months advance warning of the ruling was given to producers?

6. Is the EU planning to offer compensation to producers in 2000 when they can no longer sell a large proportion of their crop to the European market?

7. Is the EU aware that the EU decision could severely reduce the income of some forest peoples, forcing them towards less eco-friendly exploitation of the forest?

8. Is the Commission prepared to withdraw this decision pending a study of the impact of it on the peoples of the rainforest?

Answer given by Mr Byrne on behalf of the Commission

(7 February 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.

1. The scientific committee for food (SCF) expressed on 23 September 1994 an opinion on aflatoxins, ochratoxin A and patulin(2). At that time the SCF 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 IARC(3) (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 ng/kg b.w./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(4) in the light of a recent JECFA evaluation(5). It recognised the great effort made by the joint FAO/WHO expert committee on foodstuffs (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 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, contributes to the protection of the consumer. These limits must be set at a level as low as reasonably achievable.

2. For groundnuts, nuts, including Brazil nuts, dried fruit, cereals and processed products thereof intended for direct human consumption or as an ingredient in foodstuffs, maximum limits are at the level of 4 microgrammes per kilogramme (µg/kg) aflatoxin total (B1 + B2 + G1 + G2) and 2 µg/kg aflatoxin B1. Sorting techniques and other 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 a sorting or other physical treatment, before their human consumption or their use as an ingredient in foodstuffs. Maximum limits for unprocessed groundnuts have been established

at 15 parts per billion (ppb) total and 8 ppb aflatoxin B1, which is in line with the limit approved in Codex Alimentarius(6) and because sufficient data exist which clearly demonstrate that, by sorting, the level of 15 ppb in unprocessed peanuts can be reduced to 4 ppb in the final consumer product. The limit of 15 ppb will also be considered for unprocessed nuts, including Brazil nuts and dried fruit if data are provided before 1 July 2001(7) proving the effectiveness of the sorting techniques or other physical treatments to reduce an aflatoxin level of 15 ppb in unprocessed nuts and dried fruit to the maximum level set for products intended for direct human consumption or use as an food ingredient. These data have not yet been submitted.

3., 5. and 6. The draft measures were notified to the World trade organisation (WTO) by notification G/SPS/N/EEC/51, dated 8 January 1998 with a deadline for comments set at 20 March 1998. Consequently, the competent authorities of WTO members were officially informed of the draft measures in January 1998. The adopted measures have been published in the Official journal(8) and a reply to the comments made during the consultation was sent to the WTO for distribution on 14 October 1998. The measures entered into force on 1 January 1999. The Commission is of the opinion that the national authorities have to ensure that the domestic producers of Brazil nuts are informed of the regulations in force in the countries whereto their products are exported.

The maximum limits established at Community level by Commission Regulation (EC) No 1525/98 replaced and harmonised the existing national maximum limits for aflatoxins of the Member States. For Brazil nuts maximum limits similar to those established at Community level were already established at national level since the beginning of the 1990's by important importing countries of Brazil nuts. It can therefore be reasonably assumed that the entry into force of the Community maximum limits on 1 January 1999, replacing the existing national maximum limits for aflatoxins, would not significantly affect the import of Brazil nuts into the Community in comparison with previous years.

Consequently, the Commission is of the opinion that on the basis of the available information, there is no reason justifying a withdrawal of the Regulation (EC) No 1525/98.

4. and 7. The Commission is fully aware of the importance of 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, including Brazil, what technical and financial assistance can be provided 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 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.

(2) Reports of the Scientific Committee for Food, 35th series.

(3) International Agency for Research on Cancer.

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

(5) Joint FAO/WHO Expert Committee on Food Additives (JECFA), Forty-ninth meeting, Rome, 17-26 June 1997, Summary and Conclusions, enclosed section.

(6) Alinorm 99/12, Report of the Thirtieth Session of the Codex Committee on Food Additives and Contaminants, The Hague, The Netherlands, 9-13 March 1998, par. 64-72 and Appendix X.

(7) Commission Regulation (EC) No 1566/1999 of 16 July 1999 amending Regulation (EC) No 194/97 setting maximum levels for certain contaminants in foodstuffs (OJ L 184, 17.7.1999, p.17).

(8) OJ L 201, 17.7.1998.