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PT1 3Rd 18/5/04 12:14 Page I 7566 COT Cover 3rd 18/5/04 12:31 Page fc2 Committees on: Toxicity Mutagenicity Carcinogenicity of Chemicals in Food, Consumer Products and the Environment COT/COM/COC Annual Report 2003 If you require any further information about the work of the committees, or the contents of this report, please write to the committee’s administrative secretary at the following Committee on address: TOXICITY COT Secretariat Food Standards Agency Room 511C Annual Report 2003 Aviation House Committee on Kingsway London WC2B 6NH MUTAGENICITY Tel 020 7276 8522 Fax 020 7276 8513 E-mail [email protected] http://www.food.gov.uk/science/ouradvisors/toxicity/ Committee on COC/COM Secretariat CARCINOGENICITY Department of Health Room 692D Skipton House 80 London Road Elephant and Castle London SE1 6LH Tel 020 7972 5020 Fax 020 7972 5156 E-mail [email protected] http://www.advisorybodies.doh.gov.uk/com/index.htm http://www.advisorybodies.doh.gov.uk/coc/index.htm © Crown copyright Published by Food Standards Agency/Department of Health May 2004 FSA/0900/0504 PT1 3rd 18/5/04 12:14 Page i Committees on Toxicity Mutagenicity Carcinogenicity of Chemicals in Food, Consumer Products and the Environment Annual Report 2003 PT1 3rd 18/5/04 12:14 Page ii PT1 3rd 18/5/04 12:14 Page 1 Annual Report 2003 Contents Page About the Committees 4 COMMITTEE ON THE TOXICITY OF CHEMICALS IN FOOD, CONSUMER PRODUCTS AND THE ENVIRONMENT Preface 6 COT evaluations 7 Arsenic in food: results of the 1999 Total Diet Study 7 Brominated flame retardants in fish from the Skerne-Tees rivers system 7 Enzyme submission – Chymosin preparation derived from GM Aspergillus niger var. awamori 8 Erythritol 8 Fluorine in the 1997 Total Diet Study 9 Hexachlorobutadiene contamination at Weston Quarries 9 Iodine in cows’ milk 10 Mercury in fish and shellfish – reconsideration of 2002 COT opinion 11 Metals and other elements in infant foods 12 Metals and other elements in the 2000 Total Diet Study 12 Nickel leaching from kettle elements into boiled water 13 Terephthalic acid 13 Urgent advice provided by COT 14 2,4-Dinitrophenol 14 Fumonisins in maize meal 15 Sudan I found in chilli powder 16 Committee procedures and working groups 16 Horizon scanning 16 Phytoestrogens and health 17 Procedure for holding COT meetings in open session 17 Variability and uncertainty in toxicology 18 Risk assessment strategies 19 Guidelines for Exposure Assessment Practice for Human Health 19 Physiologically-based pharmacokinetic modelling 19 Uncertainty factors: their use in human health risk assessment by UK government 20 Ongoing work 21 Adverse trends in the development of the male reproductive system 21 Phosphorus, parathyroid hormone and bone metabolism 21 Tryptophan and eosinophilia myalgia syndrome 21 1 PT1 3rd 18/5/04 12:14 Page 2 Annual Report 2003 Statements of the COT 23 Statement on arsenic in food: results of the 1999 Total Diet Study 24 Statement on brominated flame retardants in fish from the Skerne-Tees rivers system 33 Statement on fluorine in the 1997 Total Diet Study 50 Updated statement on a survey of mercury in fish and shellfish 64 Statement on a survey of metals in infant food 80 Statement on twelve metals and other elements in the 2000 Total Diet Study 94 Statement on physiologically based pharmacokinetic modelling 105 Urgent Opinions Requested Of The COT 110 Fumonisins in maize meal: risk assessment 110 Nickel leaching from kettle elements into boiled water 114 Sudan I found in chilli powder 117 2003 Membership of the Committee on Toxicity of Chemicals in Food, Consumer Products and the Environment 121 Declaration of COT members’ interests during the period of this report 123 COMMITTEE ON THE MUTAGENICITY OF CHEMICALS IN FOOD CONSUMER PRODUCTS AND THE ENVIRONMENT Preface 127 1,3-Dichloropropan-2-ol 128 Diethyl-m-toluamide (DEET) 128 Flunixin, meglumine and flunixin-meglumine 129 Malachite green 130 Malathion 132 Phenol 132 2-Phenylphenol 133 Polycyclic aromatic hydrocarbons in air pollution 135 Review of Committee Procedures 137 Horizon scanning 137 Test Strategies and Evaluation 137 In-vitro mammalian cell mutation assays 137 Strategy for investigation germ cell mutagens 138 Significance of in-vivo mutagenicity at high doses 139 Ongoing reviews 141 Chromium picolinate 141 Statements of the COM 142 1,3-Dichloropropan-2-ol 143 Flunixin, meglumine, and flunixin-meglumine 148 Joint statement on review of malathion 154 2-Phenylphenol 173 Significance of in-vivo mutagenicity at high doses 178 2003 Membership of the Committee on Mutagenicity of Chemicals in Pools, Consumer Products and the Environment 183 Declaration of COM members’ interests during the period of this report 184 2 PT1 3rd 18/5/04 12:14 Page 3 COMMITTEE ON THE CARCINOGENICITY OF CHEMICALS IN FOOD, CONSUMER PRODUCTS AND THE ENVIRONMENT Preface 188 Dibenzo(a,l)pyrene in air pollution 189 1,3-Dichloropropan-2-ol 190 Environmental tobacco smoke and lung cancer (Consideration of paper by Enstrom JE and Kabat GC. British Medical Journal, volume 326, 1057-1066, 2003) 191 Impurities in the pesticide 1-methylcyclopropene 191 Polycyclic aromatic hydrocarbons in air pollution 192 Update on intrahepatic cholangiocarcinoma 192 Update on risks associated with exposure to low levels of air pollution 193 Review of Committee Procedures 193 Horizon Scanning 193 Further discussions on openness of Committee business 194 Test Strategies and Evaluation 194 Biobank project 194 EPA risk assessment guideline; supplemental data for assessing susceptibility from early life exposure to carcinogens 195 Hormesis (the occurrence of “U” shaped dose-response curves) 196 Ongoing Reviews 196 Alcohol and breast cancer 196 Organochlorines and risk of breast cancer 196 Olfactory neuroblastomas: possible association in dentists and dental nurses 197 Prostate cancer 197 Revised guidance on risk assessment of carcinogens 197 Statements of the COC 198 Carcinogenicity of dibenzo(a,I) pyrene 199 Statement on environmental tobacco smoke (ETS): consideration of a paper by Engstron JE and Kabat GC (2003). British Medical Journal, Volume 326, 1057-1066 205 Carcinogenic impurities in the pesticide 1-methylcyclopropene 208 Risk associated with exposure to low levels of carcinogenic air pollutants 211 2003 Membership of the Committee on Carcinogenicity of Chemicals in Food, Consumer Products and the Environment 214 Declaration of COC members’ interests during the period of this report 216 ANNEXES Annex 1 – Terms of reference 218 Annex 2 – Code of conduct for Members of Advisory committees 220 Annex 3 – Openness 226 Annex 4 – Glossary of terms 231 Annex 5 – Index of Subjects and Substances Considered in Previous Annual Reports 248 Annex 6 – Previous Publications 261 3 PT1 3rd 18/5/04 12:14 Page 4 Annual Report 2003 About the Committees This is the thirteenth 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 a brief toxicological background to the Committees’ decisions. Those seeking further information on a particular subject can obtain relevant references from the Committee’s administrative secretary. The year 2003 has seen a number of changes in the membership of the committees and these are shown in the membership lists at the end of each committee’s report. In common with other independent advisory committees the members are required to follow a Code of Conduct which also gives guidance on how their commercial interests should be declared. 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. The Code of Conduct is at Annex 2 and Annex 3 describes the Committees’ policy on openness. Annex 4 contains a glossary of technical terms used in the text. Annex 5 is an alphabetical index to subjects and substances considered in previous reports. Previous publications of the Committees are listed in Annex 6. These three Committees also provide expert advice to other advisory committees, such as the Advisory Committee on Novel Foods and Processes and there are also links with the Veterinary Products Committee and the Advisory Committee on Pesticides. The Committees procedures for openness include the publication of agendas, finalised minutes, agreed conclusions and statements. These are now published on the internet at the following addresses: COT: http:www.food.gov.uk/science/ouradvisors/toxicity COM: http://www.advisorybodies.doh.gov.uk/com/index.htm COC: http://www.advisorybodies.doh.gov.uk/coc/index.htm This report contains summaries of the discussions and includes the Committees’ published statements in full in order to fulfil the obligation to publish statements both electronically and in hard copy. 4 PT1 3rd 18/5/04 12:14 Page 5 Committee on Toxicity of Chemicals in Food, Consumer Products and the Environment 5 PT1 3rd 18/5/04 12:14 Page 6 Annual Report 2003 Preface In 2003 the Committee took another major step forward in improving the openness and transparency of its working by permitting observers to attend committee meetings. So far, the numbers attending have been very small, but an important principle has been established. I welcome this decision, which has allowed interested parties to more fully understand the Committee’s deliberations. More information on this process is described elsewhere in this report. The Committee has provided advice on a number of chemicals that may be present in various foods, including metals such as arsenic, mercury and nickel, fluorine, iodine, brominated flame retardants, terphthalic acid, the enzyme chymosin and the bulk sweetener erythritol.
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