Food Law News - EU - 2001

FSA Scotland Letter, 9 August 2001

CONTAMINANTS - Update on Chloropropanols

Since a letter of 10 April 2001 (not given on this site - but see
15 June 2001) matters have progressed in a number of areas related to chloropropanols. This letter provides an update on these.

1. Toxicological consideration of chloropropanols

The UK Committee on Mutagenicity of Chemicals in Food, Consumer Products and the Environment (COM) and Committee on Carcinogenicity of Chemicals in Food, Consumer Products and the Environment (COC), have considered 1 ,3-dichloropropanol (1 ,3-DCP) and its isomer 2,3-dichloropropanol (2,3-DCP). The COM concluded that it would be prudent to regard 1,3-DCP and 2,3-DCP as potentially genotoxic in-vivo and agreed that both compounds should be tested for genotoxicity in-vivo using the approach set out in the COM guidelines. Following this the COC concluded, "it is prudent to assume that 1,3-DCP is a genotoxic carcinogen and that exposure to 1,3-DCP should be reduced to as low a level as technologically feasible."

The European Commission Scientific Committee on Food (SCF) re-examined its 1994 opinion on 3-MCPD in May and set a tolerable daily intake (TDI) at 2 mg/kg bw/day. The Joint FAO/WHO Expert Committee on Food Additives (JECFA) considered chloropropanols 3-MCPD and 1,3-DCP in June. They recommended a provisional maximum tolerable daily intake (PMTDI) of 3-MCPD of 2 mg/kg bw. JECFA's evaluated the currently available 1 ,3- DCP toxicity studies and concluded that they 'clearly indicated that 1,3-dichloro-2-propanol was genotoxic in vitro'. The committee thus concluded that the establishment of a tolerable intake for 1 ,3-DCP was inappropriate because of the nature of toxicity, i.e. since 1 ,3-DCP is thought to directly damage genetic material it is not possible to establish a safe level of consumption.

2. New EC Regulation

An EC Regulation setting maximum limits for certain contaminants including 3-MCPD, in foodstuffs, an allied Directive on sampling and analysis, and a related Decision were formally adopted on the 8 March 2001. The maximum limit for the processing contaminant 3-MCPD introduced for both hydrolysed vegetable protein (HVP) and soy sauce is 0.02mg/kg. The Commission has decided that the Regulation, Directive and Decision will apply from 5 April 2002 as published. The 3-MCPD component of this regulation was reviewed at a meeting of the EU Working Group in July in light of the recent SCF opinion on 3-MCPD. No changes are to be made to the limit of 0.02 mg/kg for 3-MCPD in soy sauce and HVP (based on 40% dry matter content) at this stage. The group will meet later in the year to review the limit once information has been submitted by the HVP industry.

3. Standing Committee for Foodstuffs

The committee met in July and chloropropanols were briefly discussed. In particular the findings of the recent Food and Veterinary Office (FVO) mission to China were presented. The report from this FVO mission has now been approved by the Commission Directors and has been transmitted to the Chinese Authorities who have 25 working days to respond. The mission looked at the problem of 3-MCPD in soy sauce and found poor official control and internal co-ordination resulting in a system which is open to abuse. Certificates of analysis are provided for export but little reliance can be placed upon them. The recommendations to China include the introduction of robust methodology with adequate quality control procedures and the improvement of the certification to include lot identification. The problems of counterfeiting also need to be addressed. The meeting was asked to consider a measure which would require China to certify all exports to Europe and all Member States to control each consignment on import. The control authorities in Member States were asked to take action to test imports against the currently agreed level of 0.02 mg/kg. The Commission is to write to the Chinese authorities to ask them to provide certificates. They will also write to all third countries whose soy sauce products have been identified by Member States as containing unacceptable levels of 3-MCPD. An FVO mission to investigate 3-MCPD in soy sauce in Thailand will take place in the autumn.

4. Surveys of 3-MCPD and 1,3-DCP in soy sauce and related products

The Agency published surveys of 3-MCPD and 1,.3-DCP in soy sauce and related products in June. The Food Survey Information Sheets for these surveys are available on the Agency's website. Consumers were advised to avoid products identified in the 3-MCPD survey as containing levels above the agreed EU limit. A leaflet explaining the results of this survey is available in English and Chinese.

5. SCOOP task

Work has begun on a scientific co-operation (SCOOP) task 'Collection and collation of data on levels of 3-MCPD and related substances in foodstuffs' for which the UK is acting as a joint co-ordinator with Sweden. SCOOP tasks involve co-ordination amongst Member States to provide pooled data from across the EU on particular issues of concern regarding food safety. These data are used to assist the Commission in developing EU legislation to increase protection of consumers. The primary objective of this task is to gather information on the levels of 3-MCPD in a wide range of foods and then utilise this to develop consumption information. These will then be used as a basis for further discussion of limits.

6. Project to investigate Factors Affecting the Formation of 3-MCPD in Foods

The Agency has recently commissioned a R&D project to discover the major factors causing or affecting the formation of 3-MCPD in foods. Despite its widespread occurrence, mechanisms of 3-MCPD formation have not been studied in foods other than acid-HVP. A successful outcome of this work will allow the Agency to formulate advice and recommend strategies which can be used to reduce 3-MCPD formation in food. The information will also assist the Agency in discussions regarding domestic and EC legislation for 3-MCPD in foods and ingredients. An outline of the project is available on request.

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