1、BSI Standards PublicationBS EN 16736:2015Health risk assessment ofchemicals Requirements forthe provision of trainingBS EN 16736:2015 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN 16736:2015.The UK participation in its preparation was entrusted to TechnicalCom
2、mittee HCM/1, Health risk assessment of chemicals.A list of organizations represented on this committee can beobtained on request to its secretary.This publication does not purport to include all the necessaryprovisions of a contract. Users are responsible for its correctapplication. The British Sta
3、ndards Institution 2015.Published by BSI Standards Limited 2015ISBN 978 0 580 85758 4ICS 03.100.30; 71.100.01Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of theStandards Policy and Strategy Committee on 31 Oct
4、ober 2015.Amendments/corrigenda issued since publicationDate T e x t a f f e c t e dBS EN 16736:2015EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 16736 October 2015 ICS 03.100.30; 71.100.01 English Version Health risk assessment of chemicals - Requirements for the provision of training valuat
5、ion des risques sanitaires causs par les substances chimiques - Exigences relatives la dispensation de formation Bewertung von Gesundheitsrisiken durch Chemikalien - Anforderungen an die Ausbildung This European Standard was approved by CEN on 29 August 2015. CEN members are bound to comply with the
6、 CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC Management
7、 Centre or to any CEN member. This European Standard exists in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same status a
8、s the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Ne
9、therlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey andUnited Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2015 CEN All r
10、ights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 16736:2015 EBS EN 16736:2015EN 16736:2015 (E) 2 Contents Page European foreword . 3 Introduction 4 1 Scope 5 2 Terms and definitions . 5 3 Objectives of the course programme . 5 3.1 General 5
11、3.2 Required knowledge and skills 6 3.2.1 General 6 3.2.2 General health risk assessment principles 6 3.2.3 Toxicology 7 3.2.4 Epidemiology 8 3.2.5 Exposure assessment . 8 3.2.6 Risk characterization . 9 3.2.7 Ethics and quality control . 10 3.2.8 Implications for risk management and risk communicat
12、ion . 10 4 Course programme 11 4.1 Teaching level for the course programme 11 4.2 Requirements for the course programme. 11 4.3 Programme structure . 12 4.4 Applied training programme . 12 4.5 Examination . 12 Bibliography . 13 BS EN 16736:2015EN 16736:2015 (E) 3 European foreword This document (EN
13、16736:2015) has been prepared by Technical Committee CEN/TC 416 “Project Committee - Health risk assessment of chemicals”, the secretariat of which is held by ASI. This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, a
14、t the latest by April 2016, and conflicting national standards shall be withdrawn at the latest by April 2016. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN and/or CENELEC shall not be held responsible for identifying any or
15、 all such patent rights. According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic
16、of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. BS EN 16736:2015EN 16736:2015 (E) 4 Introduction Health risk a
17、ssessment of chemicals is essential to prevent harmful effects of chemicals to humans. Currently risk assessment is required by different European regulations (e.g. REACH, biocidal products regulation, plant protection products regulation). To ensure consistent and high-quality assessments, it is es
18、sential to provide risk assessors with adequate education and training. The course programme specified by this document is intended for institutions that offer or intend to offer training to individuals who would like to pursue a career in human health risk assessment and work within European agenci
19、es, scientific panels and corresponding organisations within Member States, industry, consultancy or academia. Training programs exist within different European Organisations and Universities, but currently there are no agreed European Standards on the training of chemical health risk assessors. The
20、 requirements for the provision of training in the field of human health risk assessment of chemicals described below draw on the experiences gained from many training initiatives throughout Europe, for example training qualifying for European Registered Toxicologist ERT 1, the EU-funded-projects Ri
21、sk Assessment Advanced Training Programme (RAAP) 2, European Toxicology Risk Assessment Training (TRISK) 3 and Risk Assessment and Management European Training Programme (Risk Assets) 4. BS EN 16736:2015EN 16736:2015 (E) 5 1 Scope This European Standard specifies the minimum requirements for a cours
22、e programme to train risk assessors to be competent to assess the health risks posed by chemicals. This European Standard does not comprehensively cover requirements for qualifications for workplace risk assessment according to Directive 98/24/EC. Training of risk assessors consists of both course p
23、rograms and on-the-job, practical experience. Only the course-based programme is covered in the current standard. This European Standard sets out the requirements, which may be delivered as a complete course programme or as a series of individual courses. 2 Terms and definitions For the purposes of
24、this document, the following terms and definitions apply. 2.1 applied training part of the course programme containing different kinds of practical exercises in which the student actively applies the knowledge acquired in the courses EXAMPLE assignments and home-exercises, group discussions, and cas
25、e studies or examples of concrete risk-assessments. 2.2 course programme taught courses as well as applied training leading to a formal assessment 2.3 taught courses formal lecture to give information about or instruction in a subject or skill 2.4 training development and improvement of a skill thro
26、ugh instruction or practice 2.5 training programme planned series of steps to develop and improve a skill through instruction or practice 3 Objectives of the course programme 3.1 General Health risk assessment of chemicals consists of three steps: hazard assessment, exposure assessment, and risk cha
27、racterization which can be provided by one or more persons with complementary skills. Health risk assessment is the first step in the risk analysis process which also includes risk management and risk communication. BS EN 16736:2015EN 16736:2015 (E) 6 3.2 Required knowledge and skills 3.2.1 General
28、The course programme shall cover the knowledge and skills described below. The domains reflect the intended learning outcomes, not necessarily the structure of the course. A risk assessor shall appreciate the complexities and inter-disciplinary nature of health risk assessment and the need to consul
29、t and integrate other expertise in the process when required. 3.2.2 General health risk assessment principles The course programme shall ensure that a future risk assessor 1) knows and understands: a) health risk assessment principles, terminology and methodology, including the following steps: haza
30、rd assessment, exposure assessment and risk characterization; b) the basic principles of statistics of relevance to health risk assessment; c) the application of health risk assessment in EU regulatory and public health contexts, including how these regulations differ for specific groups of products
31、; d) the principal physico-chemical properties of chemicals of relevance to health risk assessment; e) the principles of deriving a health-based guidance and guideline values, as well as standards, and the use of such values; f) principal sources of data and information; g) uncertainty in health ris
32、k assessment and methods of characterizing and reducing uncertainty; h) the overarching principles of strategies used in health risk assessment when considering aggregate and cumulative risks; i) test methods in toxicology including computational toxicology, in vitro and in vivo testing methods, and
33、 national and international guidelines for testing of chemicals; j) factors that influence the susceptibility of different population sub-groups and how health risk assessment approaches differ for population sub-groups; k) priority setting and tiered approaches in health risk assessment. 2) is able
34、 to: a) define the scope, boundaries and purpose of a health risk assessment to address the practical needs of decision making; b) conduct comprehensive literature searches and query relevant databases to identify and obtain relevant information for use in a health risk assessment; c) critically app
35、raise and evaluate the quality of data for use in health risk assessment applying, where applicable, approaches such as weight of evidence, grouping of substances and read-across; BS EN 16736:2015EN 16736:2015 (E) 7 d) critically evaluate a health risk assessment, identify its limitations and assess
36、 the adequacy of its conclusions in a regulatory or public health context; e) contribute to a documented health risk assessment, clearly setting out and demonstrating a good understanding of health risk assessment methodology and principles, including hazard identification and characterization, expo
37、sure assessment and risk characterization. 3.2.3 Toxicology The course programme shall ensure that a future risk assessor 1) knows and understands: a) the principles of toxicology in order to be able to communicate effectively with specialists in toxicology; b) how chemical substances reach the huma
38、n body and what is their fate in the body, including the major kinetic determinants and the major pathways of metabolism; c) the relationship between external dose and internal dose at target site; d) different types of toxicity (e.g. local/systemic, acute/chronic, single/repeat dose); e) different
39、end points and biomarkers of toxicity (e.g. reversible/irreversible effects, mutagenicity, carcinogenicity); f) factors influencing toxicity, including chemical properties, biological systems, routes and patterns of exposure, individual susceptibility and interaction with other chemicals; g) dose-re
40、sponse relationships; h) concepts of threshold and non-threshold effects and the differences in health based guidance values for each and their derivation; i) point of departure (such as benchmark dose or no observed adverse effect level) and how to identify suitable toxicity end points on which the
41、 point of departure is based; j) the principles of dose extrapolation, of route-route extrapolation, and the application of assessment/uncertainty factors to account for intra- and inter-species variability, including sensitive groups as well as uncertainties in the derivation of health based guidan
42、ce values; k) different types of health based guidance values and how regulatory and health-based guideline levels/standards are derived from health-based guidance values; l) major toxicological databases and other information sources of relevance to health risk assessment, and how to use these info
43、rmations, and how to assess their reliability; m) the toxicity of mixtures, and that substances may interact in a way that affects their overall level of toxicity, and be aware of methods of assessing the health risk of mixtures; n) the strengths and limitations of toxicological approaches and diffe
44、rent test methods for assessing health risks; o) how sensitive groups of the population and stages of development may increase susceptibility of exposure. BS EN 16736:2015EN 16736:2015 (E) 8 2) is able to: a) identify and characterize the inherent hazardous effects of a chemical substance using avai
45、lable toxicological data sources; b) critically evaluate the quality of and interpret toxicity studies and reports; c) evaluate the derivation of health based guidance values. 3.2.4 Epidemiology The course programme shall ensure that a future risk assessor 1) knows and understands: a) the principles
46、 of epidemiology in order to be able to communicate effectively with specialists in epidemiology; b) the role of epidemiology in regulatory and public health risk assessment; c) measures of health and disease and the main measures of association; d) the basic principles, structure of, and advantages
47、 and disadvantages of the different epidemiological study designs and issues concerning data quality, exposure misclassification, confounding, bias, power/chance; e) the principles of systematic review, meta- and pooled analyses; f) the relevance of disease clusters, small area statistics and diseas
48、e burden calculations and their use in health risk assessment. 2) is able to: a) read and interpret an epidemiological study with understanding and critically evaluate its quality with a view to contributing to the health risk assessment process; b) apply epidemiological data in identifying and char
49、acterizing health outcomes and exposure response relationships for health risk assessment. 3.2.5 Exposure assessment The course programme shall ensure that a future risk assessor 1) knows and understands: a) the principal physico-chemical properties of chemical substances and how they influence the chemical fate and behaviour pathways of chemicals in indoor and outdoor environments; b) the principal sources, pathways and routes of exposure and their relative significance in different exposure settings, and different types and patterns of exposure; c) sampling princip
