How is the Harmonization Project managed and organized?
The Project is overseen by the Harmonization Steering Committee (HSC), a group of about 20 individuals with relevant expertise in risk assessment, from different geographical regions and countries at different stages of development.
The HSC includes members representing countries from Africa, South and North America, Asia/Pacific, Europe, the Middle-East and international organizations (EFSA, European Commission, and OECD), and NGOs in official relations with WHO and working in support of the Project (ECETOC and ILSI).
The Committee meets approximately every 2 years and elects a Chair, and a Core Group which meets regularly by teleconference. The Committee establishes Working Groups or convenes Workshops to carry out the individual activities of the Project Workplan.
The Harmonization Secretariat, which is located at IPCS (WHO, Geneva, Switzerland) is responsible for the daily management of the Project and associated activities.
Health and Safety Guides (HSG)
Provide concise information in non-technical language, for decision-makers on risks from exposure to chemicals, with practical advice on medical and administrative issues.
The Health and Safety Guide series are published by the World Health Organization and hard copies can be obtained from the Office of Distribution and Sales, World Health Organization, 1211 Geneva 27, Switzerland.
International Agency for Research on Cancer (IARC) - Summaries and Evaluations
In 1969, the International Agency for Research on Cancer (IARC) initiated a programme on the evaluation of the carcinogenic risk of chemicals to humans involving the production of critically evaluated monographs on individual chemicals. In 1980 and 1986, the programme was expanded to include evaluations of carcinogenic risks associated with exposures to complex mixtures and other agents.
The objective of the programme is to elaborate and publish in the form of monographs critical reviews of data on carcinogenicity for agents to which humans are known to be exposed and on specific exposure situations; to evaluate these data in terms of human risk with the help of international working groups of experts in chemical carcinogenesis and related fields;and to indicate where additional research efforts are needed.
International Chemical Safety Cards (ICSC)
Summarize essential information on chemical substances; developed cooperatively by the IPCS and the Commission of the European Union (EC).
The International Chemical Safety Cards summarize essential health and safety information on chemical substances in a clear way, and are not only intended to be used at the "shop floor" level by workers, but also by other interested parties in factories, agriculture, construction and other places of work.
Draft versions of the card containing a summary of health and safety information are prepared by cooperating scientific institutions. These institutions have the task of collecting and validating the relevant information. The cards are then peer-reviewed by a committee consisting of internationally- recognized experts who take into account advice given by manufacturers, workers' representatives and poisons centres.
The International Chemical Safety Cards are published by the Commission of the European Union, and hard copies can be obtained from the Office for Official Publications of the European Union, 2 rue Mercier, L-2985 Luxembourg.
IPCS/EC Evaluation of Antidotes Series
Provides definitive and authoritative guidance on the use of antidotes to treat poisoning. The International Programme on Chemical Safety (IPCS) and the Commission of the European Union (EC) are jointly undertaking a major project to evaluate antidotes used clinically in the treatment of poisoning. The aim of this project is to identify and evaluate for the first time in a scientific and rigorous way the efficacy and use of a wide range of antidotes. This series summarises and assesses, on an antidote-by-antidote basis, their clinical use, mode of action and efficacy. The aim is to provide an authoritative consensus statement which will greatly assist in the selection and administration of an appropriate antidote. This scientific assessment is complemented by detailed clinical information on routes of administration, contra-indications and precautions. The series collates a wealth of useful information which will be of immense practical use to clinical toxicologists and all those involved in the treatment and management of poisoning.
The IPCS/EC Antidotes Series are published by Cambridge University Press and hard copies can be obtained from Cambridge University Press, Cambridge CB2 2RU, England.
JECFA (Joint Expert Committee on Food Additives) - Monographs and evaluations
Toxicological evaluations of food additives and contaminants and of residues of veterinary drugs in food, produced by the Joint WHO/FAO Expert Committee on Food Additives JECFA, are used by the Codex Alimentarius Commission and national governments to set international food standards and safe levels for protection of the consumer.
The monographs provide the toxicological information upon which the JECFA makes its evaluations. These monographs are prepared by scientific experts and peer reviewed at the JECFA meetings.
JMPR (Joint Meeting on Pesticide Residues) - monographs and evaluations.
Toxicological evaluations of pesticides, produced by the WHO/FAO Joint Meeting on Pesticide Residues JMPR, are used by the Codex Alimentarius Commission and national governments to set international food standards and safe levels for protection of the consumer.
The monographs provide the toxicological information upon which the JMPR makes its evaluations. These monographs are prepared by scientific experts and peer reviewed at the JMPR meetings.
These documents are produced by the Swedish Criteria Group (SCG) and the Nordic Expert Group (NEG).
The Swedish Criteria Group for Occupational Standards – consensus reports and criteria documents
The Swedish Criteria Group for Occupational Standards (SCG) consists of about 15 scientific experts representing different fields of science, such as toxicology, occupational hygiene and occupational medicine. The main task is to produce consensus reports and criteria documents to be used by the Swedish Work Environment Authority (SWEA) as the scientific basis for setting occupational exposure limits (OELs) for chemical substances in Sweden. The secretariat of the group is run by the SWEA and is located at Karolinska Institutet in Stockholm, Sweden.
In most cases, a document is produced on request to the group from the SWEA. Evaluations are made of all relevant published original papers for a substance found in searches in relevant databases. Consensus reports are concise documents that summarize and evaluate scientific data relevant for setting an occupational exposure limit. They do not give a summary of all available data on a particular chemical, but studies, important for establishing dose-effect/dose-response relationships and critical effect(s), are described in detail. A draft consensus report (or sometimes a more comprehensive criteria document) is written by the secretariat or by a scientist appointed by the secretariat. A qualified evaluation is made of the information in the references. After discussions in the Criteria
Group, the draft is approved and accepted as a consensus report from the group. The Criteria Group does not propose a numerical occupational exposure limit value for a substance, but, as far as possible, give a dose-response/dose-effect relationship and the critical effect of occupational exposure. The documents are published in English, as well as in Swedish, by the University of Gothenburg in the scientific serial Arbete och Hälsa.
The Nordic Expert Group criteria documents The main task of the Nordic Expert Group for Criteria Documentation of Health Risks from Chemicals (NEG) is to produce criteria documents to be used by the regulatory authorities of the Nordic countries as the scientific basis for setting occupational exposure limits (OELs) for chemical substances. NEG consists of scientific experts from the
Nordic countries (Denmark, Finland, Norway and Sweden) representing different fields of science, such as toxicology, epidemiology and occupational medicine.
The documents are risk evaluation reports, and constitute comprehensive reviews based on a thorough search of the scientific literature. The documents comprise data on physical and chemical properties, occurrence and use, analytical methods, occupational exposure, toxicokinetics, biological monitoring, and effects in animals and man. Finally, an evaluation of human health risks based on dose-effect/dose-response relationships and the identification
of the critical effect(s) is made. No numerical values on OELs are given, as this is done at the national level, according to country-specific procedures. No information on environmental fate and effects is included.
The documents are published by the University of Gothenburg in the scientific serial Arbete och Hälsa. More information about NEG including all documents is available via the web site:www.nordicexpertgroup.org.
The scientific serial Arbete och Hälsa is also available in the KemI-Riskline database . Please note however that this database is no longer being updated.