1、December 2015 English price group 10No part of this translation may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).ICS 03.100.30; 71.100.01!%J-c“23910
2、64www.din.deDIN EN 16736Health risk assessment of chemicals Requirements for the provision of training;English version EN 16736:2015,English translation of DIN EN 16736:2015-12Bewertung von Gesundheitsrisiken durch Chemikalien Anforderungen an die Ausbildung;Englische Fassung EN 16736:2015,Englische
3、 bersetzung von DIN EN 16736:2015-12valuation des risques sanitaires causs par les substances chimiques Exigences pour la formation;Version anglaise EN 16736:2015,Traduction anglaise de DIN EN 16736:2015-12www.beuth.deDTranslation by DIN-Sprachendienst.In case of doubt, the German-language original
4、shall be considered authoritative.Document comprises 15 pages 11.15DIN EN 16736:2015-12 2 A comma is used as the decimal marker. National foreword This document (EN 16736:2015) has been prepared by Technical Committee CEN/TC 416 “Project Committee Health risk assessment of chemicals” (Secretariat: A
5、SI, Austria). The responsible German body involved in its preparation was DIN-Normenausschuss Sicherheitstechnische Grundstze (DIN Standards Committee Safety Design Principles), Working Committee NA 095-03-03 AA Gesundheitliche Risikobewertung von Chemikalien (SpA CEN/TC 416). EUROPEAN STANDARD NORM
6、E 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 valuation des risques sanitaires causs par les substances chimiques - Exigences la formation Bewertung von Gesundheitsrisiken du
7、rch Chemikalien - Anforderungen an die Ausbildung This European Standard was approved by CEN on 29 August 2015. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alt
8、eration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member. This European Standard exists in three official versions (English, French, German). A version in any other language ma
9、de 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 as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Esto
10、nia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey andUnited Kingdom. EUROPEAN COMMITTEE FOR STAND
11、ARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2015 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 16736:2015 Epour EN 16736:2015 (E) 2 Con
12、tents 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 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 as
13、sessment . 8 3.2.6 Risk characterization . 9 3.2.7 Ethics and quality control . 10 3.2.8 Implications for risk management and risk communication . 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 Ap
14、plied training programme . 12 4.5 Examination . 12 Bibliography . 13 DIN EN 16736:2015-12 EN 16736:2015 (E) 3 European foreword This document (EN 16736:2015) has been prepared by Technical Committee CEN/TC 416 “Project Committee - Health risk assessment of chemicals”, the secretariat of which is hel
15、d by ASI. This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at 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
16、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 all such patent rights. According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following countries are bound to i
17、mplement this European Standard: 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, Netherlands, Norway, Poland, Portugal, Roma
18、nia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. DINEN 16736:2015-12EN 16736:2015 (E) 4 Introduction Health risk assessment of chemicals is essential to prevent harmful effects of chemicals to humans. Currently risk assessment is required by different European regu
19、lations (e.g. REACH, biocidal products regulation, plant protection products regulation). To ensure consistent and high-quality assessments, it is essential to provide risk assessors with adequate education and training. The course programme specified by this document is intended for institutions th
20、at offer or intend to offer training to individuals who would like to pursue a career in human health risk assessment and work within European agencies, scientific panels and corresponding organisations within Member States, industry, consultancy or academia. Training programs exist within different
21、 European Organisations and Universities, but currently there are no agreed European Standards on the training of chemical health risk assessors. The requirements for the provision of training in the field of human health risk assessment of chemicals described below draw on the experiences gained fr
22、om many training initiatives throughout Europe, for example training qualifying for European Registered Toxicologist ERT 1, the EU-funded-projects Risk Assessment Advanced Training Programme (RAAP) 2, European Toxicology Risk Assessment Training (TRISK) 3 and Risk Assessment and Management European
23、Training Programme (Risk Assets) 4. DIN EN 16736:2015-12 EN 16736:2015 (E) 5 1 Scope This European Standard specifies the minimum requirements for a course programme to train risk assessors to be competent to assess the health risks posed by chemicals. This European Standard does not comprehensively
24、 cover requirements for qualifications for workplace risk assessment according to Directive 98/24/EC . Training of risk assessors consists of both course programs and on-the-job, practical experience. Only the course-based programme is covered in the current standard. This European Standard sets out
25、 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 this document, the following terms and definitions apply. 2.1 applied training part of the course programme containing different kinds of practic
26、al exercises in which the student actively applies the knowledge acquired in the courses EXAMPLE assignments and home-exercises, group discussions, and case studies or examples of concrete risk-assessments. 2.2 course programme taught courses as well as applied training leading to a formal assessmen
27、t 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 through instruction or practice 2.5 training programme planned series of steps to develop and improve a skill through instruction or practice 3 Objec
28、tives of the course programme 3.1 General Health risk assessment of chemicals consists of three steps: hazard assessment, exposure assessment, and risk characterization which can be provided by one or more persons with complementary skills. Health risk assessment is the first step in the risk analys
29、is process which also includes risk management and risk communication. DIN EN 16736:2015-12 N1)N1) National footnote: In Germany, the Gefahrstoffverordnung (Hazardous Substances Ordinance) specifies the knowledge necessary to carry out risk assessment at workplaces involving hazardous substances.The
30、 required knowledge as specified intheGefahrstoffverordnung, and in other relevant German technical rules, is not always the sameas that required in the present document for the health risk assessment of chemicals.EN 16736:2015 (E) 6 3.2 Required knowledge and skills 3.2.1 General The course program
31、me 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 consult and integrate ot
32、her 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: hazard assessment, exp
33、osure 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; d) the principal
34、 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 risk assessment and m
35、ethods 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 national and inte
36、rnational 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 to: a) define the
37、 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 appraise and evaluate
38、 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; DIN EN 16736:2015-12 EN 16736:2015 (E) 7 d) critically evaluate a health risk assessment, identify its limitations and assess the adequacy
39、 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, exposure assessme
40、nt 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 human body and wh
41、at 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 end points an
42、d 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-response relati
43、onships; 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 point of dep
44、arture 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 guidance values; k)
45、 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 informations, and
46、 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 different test met
47、hods for assessing health risks; o) how sensitive groups of the population and stages of development may increase susceptibility of exposure. DIN EN 16736:2015-12 EN 16736:2015 (E) 8 2) is able to: a) identify and characterize the inherent hazardous effects of a chemical substance using available to
48、xicological 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 of epid
49、emiology 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 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
