1999 Annual Report of the Committees on Toxicity
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74513-DOH-Ann Report 1999 5/4/00 10:11 am Page fci 1999 Annual Report of the Committees on Toxicity Mutagenicity Carcinogenicity of Chemicals in Food, Consumer Products and the Environment 74513-DOH-Ann Report 1999 5/4/00 10:11 am Page ifc2 74513-DOH-Ann Report 1999 5/4/00 10:11 am Page ibc1 74513-DOH-Ann Report 1999 5/4/00 10:11 am Page i 1999 Annual Report of the Committees on Toxicity Mutagenicity Carcinogenicity of Chemicals in Food, Consumer Products and the Environment Department of Health 74513-DOH-Ann Report 1999 5/4/00 10:11 am Page ii 74513-DOH-Ann Report 1999 5/4/00 10:11 am Page 1 Contents About the Committees 3 Committee on Toxicity of Chemicals in Food, Consumer Products and the Environment 5 Preface 6 Alitame 7 Breast Implants 7 2-Chlorobenzylidene Malononitrile (CS) and CS Spray 7 Epoxidised Soya Bean Oil 16 Food Intolerance 16 French Maritime Pine Bark Extract 16 Hemicellulase Enzyme in Bread-Making 19 Hypospadias and Maternal Nutrition 19 Iodine in Milk 20 Malachite Green and Leucomalachite Green in Farmed Fish 23 Mathematical Modelling 27 Metals and Other Elements in Infant Foods 27 Methylcyclopentadienyl Manganese Tricarbonyl 28 Multielement Survey of Wild Fungi and Blackberries 28 Multiple Chemical Sensitivity 30 Openness 30 Organophosphates 30 PCDDs, PCDFs and PCBs in Marine Fish and Fish Products 31 Phytoestrogens 34 Potatoes Genetically Modified to Produce Galanthus nivalis Lectin 34 Short and Long Chain Triacyl Glycerol Molecules (Salatrims) 36 1999 Membership of the Committee on Toxicity of Chemicals in Food, Consumer Products and the Environment 40 Committee on Mutagenicity of Chemicals in Food, Consumer Products and the Environment 45 Preface 46 Malachite Green 47 MCPD (3-Monochloro-propane 1,2-Diol) 48 1 74513-DOH-Ann Report 1999 5/4/00 10:11 am Page 2 TCDD (2,3,7,8-tetrachlorodibenzo-p-dioxin) 49 Ozone 50 2-Chlorobenzylidene Malononitrile and CS Spray 51 Test Strategies and Evaluation 51 Topics Under Consideration 52 1999 Membership of the Committee on Mutagenicity of Chemicals in Food, Consumer Products and the Environment 53 Committee on Carcinogenicity of Chemicals in Food, Consumer Products and the Environment 57 Preface 58 Drinking Water 59 Organochlorine Insecticides and Breast Cancer 62 Ozone (Review of Animal carcinogenicity data) 71 Test Strategies and Evaluation 72 Presentation on Validation of Short-term Carcinogenicity Tests Using Transgenic Animals 73 Topics Under Consideration 75 1999 Membership of the Committee on Carcinogenicity of Chemicals in Food, Consumer Products and the Environment 76 Annexes 54 Annex 1 – Terms of Reference 54 Annex 2 – Declaration of Interests: a Code of Practice for Members 55 Annex 3 – Glossary of Terms 58 Annex 4 – Index to Subjects and Substances Considered in Previous Annual Reports of the Committees on Toxicity, Mutagenicity and Carcinogenicity of Chemicals in Food, Consumer Products and the Environment 66 Annex 5 – Index of Considerations by the Committee on Toxicity of Chemicals in Food, Consumer Products and the Environment of MAFF Food Surveillance Papers 74 Annex 6 – Publications Produced by the Committees on Toxicity, Mutagenicity and Carcinogenicity of Chemicals in Food, Consumer Products and the Environment 76 Annex 7 – Improved Arrangements for Openness 77 Annex 8 – References 81 2 74513-DOH-Ann Report 1999 5/4/00 10:11 am Page 3 About the Committees This is the ninth joint annual report of the Committee on Toxicity of Chemicals in Food, Consumer Products and the Environment (COT), the Committee on Mutagenicity of Chemicals in Food, Consumer Products and the Environment (COM) and the Committee on Carcinogenicity of Chemicals in Food, Consumer Products and the Environment (COC). The aim of these reports is to provide the toxicological background to the Committees’ deci- sions for the concerned professional. Those seeking further information on a particular subject can obtain relevant references from the Committee’s administrative secretary. Members of the COT, COM and COC are appointed by the Chief Medical Officer (CMO). The Committees advise the CMO and, through the CMO, the Government. Committee members are appointed as independent scientific and medical experts on the basis of their special skills and knowledge. They are appointed for fixed time periods, generally three years, and are eligible for reappointment at the end of their terms. The terms of reference are at Annex 1. The report also contains the commercial interests of committee members. Members are required to declare any commercial interests on appointment and, again, during meetings if a topic arises in which they have an interest. If a member declares a specific interest in a topic under discussion, he or she may, at the Chairman’s discretion, be allowed to take part in the discussion, but they are excluded from decision making. Guidance on this is at Annex 2. The report contains, at Annex 4, an alphabetical index to subjects and substances considered in previous reports. A second index, at Annex 5, contains details of the subjects on which the COT has given advice since 1988 as part of its consideration of the results of surveillance for chemicals in the UK diet. These considerations were published formerly in the Food Surveillance Papers which report this surveillance work, rather than in the Committee’s annual reports. The usual way in which committee reviews are conducted is that the relevant Secretariat critically assesses all the relevant data and prepares papers for the committee. These normally consist of appendices giving detailed sum- maries of the studies reviewed – methodology and results – and a covering paper in which the available data are briefly summarised, the most important points highlighted and recommendations presented for discussion by the Committee. Although original study reports are not routinely circulated to members, they are made available on request and are circulated if the study is particularly complex. Definitive summaries are necessary because docu- mentation on any one chemical can amount to many hundreds of pages. The Committees cannot undertake to review information provided by individuals, industry or other organisations that has not been forwarded through, or discussed with, the appropriate Secretariat. Many of the reviews conducted by the Committees are done so at the request of other Government Departments and the Committee Secretariats liaise closely with colleagues in these Departments. The Committees offer advice independent of each other in their area of expertise but will, if need be, work closely together. This is helped by the close working relationship of the Secretariats. If, for example, during a review of a particular chemical by the COT, it becomes clear that there is need for expert advice on mutagenicity or carcinogenicity aspects, it will be referred to COM or COC as appropriate. These three Committees also provide expert advice to other advisory committees, such as the Advisory Committee on Novel Foods and Processes and the Food Advisory Committee. There are also links with the Veterinary Products Committee and the Advisory Committee on Pesticides. 3 74513-DOH-Ann Report 1999 5/4/00 10:11 am Page 4 During 1999 the CMO announced changes to the procedures of the three Committees. These changes will result in greater openness of committee business and include the publication of agendas, finalised minutes, agreed con- clusions and statements. It was also announced that some meetings could be open to members of interest groups, consumer organisations and professional societies to attend. The first of these meetings was held during February in Bath. More information on the changes can be found in a paper at Annex 7. 4 Committee on Toxicity of Chemicals in Food, Consumer Products and the Environment 74513-DOH-Ann Report 1999 5/4/00 10:11 am Page 5 Committee on Toxicity of Chemicals in Food, Consumer Products and the Environment 74513-DOH-Ann Report 1999 5/4/00 10:11 am Page 6 Preface In keeping with the experience in previous years, the Committee has been fully engaged in the consideration of a wide range of toxicological problems. Whereas these are described in detail in the text, consideration of the topics points to a number of general matters which are important to the overall function of the Committee. Together with its sister Committees, the COT has adopted new principles of working in order to increase openness, it is our intention to further increase the degree of openness, through a process of evolution. During the year we held an Open Meeting to discuss mathematical modelling in toxicology. This brought together a number of experts and provided a forum for discussion which will inform future methodology applied to toxi- cological assessment in man. The section on the toxicology of breast implants illustrates how the Committee can act rapidly to provide an opinion. The rapidity of response is dependent upon the willingness of members of the Committee to act at short notice and also upon our being able to call upon a wide range of toxicological expertise from within the member- ship of the Committee. During the year two Working Groups were meeting, one considering Food Intolerance and the other Organophosphates. The Report on Organophosphates was published in November 1999 and provided the basis for discussion of this topic by other Committees which advise Ministers in relation to policy so far as Organophosphates are concerned. It is the intention to publish the Food Intolerance report in the year 2000. The report contains information on our consideration of the toxicology of a group of novel molecules (the Salatrims). This work underlines the importance of there being well-conducted human studies which inform the formulation of advice about the inclusion of novel foods within the human diet. A further important general point was raised by our consideration of potatoes genetically modified to produce Galanthus nivalis lectins.