Health risk assessment of chemicals - Requirements for the provision of training

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 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 the requirements, which may be delivered as a complete course programme or as a series of individual courses.

Bewertung von Gesundheitsrisiken durch Chemikalien - Anforderungen an die Ausbildung

Diese Europäische Norm legt die Mindestanforderungen an ein Kursprogramm fest, um Risikobewerter auszubilden, die zur Bewertung der gesundheitlichen Risiken durch Chemikalien befähigt sind.
Die vorliegende Europäische Norm deckt die Anforderungen an Qualifikationen zur Risikobewertung an Arbeitsplätzen nach der Richtlinie 98/24/EG nicht umfassend ab.
Die Ausbildung von Risikobewertern umfasst sowohl Kursprogramme als auch praktische Erfahrung am Arbeitsplatz. In der vorliegenden Norm wird nur das kursbasierte Programm behandelt.
In dieser Europäischen Norm werden die Anforderungen festgelegt, die in Form eines vollständigen Kursprogramms oder einer Reihe von einzelnen Kursen umgesetzt werden können.

Évaluation des risques sanitaires causés par les substances chimiques - Exigences relatives à la dispensation de formation

La présente Norme européenne spécifie les exigences minimales auxquelles doit répondre un programme de cours destiné à former des évaluateurs de risques, afin qu’ils aient les compétences nécessaires pour évaluer les risques sanitaires que présentent les produits chimiques.
La présente Norme européenne ne couvre pas les exigences relatives aux qualifications nécessaires à l'évaluation des risques sur le lieu de travail selon la Directive 98/24/CE.
La formation des évaluateurs de risques comporte à la fois des programmes de cours et une expérience pratique sur le terrain. La présente norme ne couvre que le programme des cours.
La présente Norme européenne définit les exigences de la formation qui peut être délivrée dans le cadre d'un programme de cours complet ou dans le cadre d'une série de différents cours.

Ocenjevanje tveganja za zdravje zaradi kemikalij - Zahteve za zagotavljanje usposabljanja

Ta standard opredeljuje zahteve za program usposabljanja za usposabljanje ocenjevalcev tveganj, ki bodo sposobni oceniti tveganja za zdravje, ki jih predstavljajo kemične snovi.

General Information

Status
Published
Publication Date
13-Oct-2015
Current Stage
9060 - Closure of 2 Year Review Enquiry - Review Enquiry
Due Date
04-Jun-2021
Completion Date
04-Jun-2021

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2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Ocenjevanje tveganja za zdravje zaradi kemikalij - Zahteve za zagotavljanje usposabljanjaBewertung von Gesundheitsrisiken durch Chemikalien - Anforderungen an die AusbildungÉvaluation des risques sanitaires causés par les substances chimiques - Exigences relatives à la dispensation de formationHealth risk assessment of chemicals - Requirements for the provision of training71.100.01Izdelki kemijske industrije na splošnoProducts of the chemical industry in general13.100Varnost pri delu. Industrijska higienaOccupational safety. Industrial hygieneICS:Ta slovenski standard je istoveten z:EN 16736:2015SIST EN 16736:2015en,fr,de01-december-2015SIST EN 16736:2015SLOVENSKI

STANDARD
SIST EN 16736:2015
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN 16736
October
t r s w ICS
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y sä s r rä r s English Version

Health risk assessment of chemicals æ Requirements for the provision of training Évaluation des risques sanitaires causés par les substances chimiques æ Exigences relatives à la dispensation de formation

Bewertung von Gesundheitsrisiken durch Chemikalien æ Anforderungen an die Ausbildung This European Standard was approved by CEN on

t { August
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egulations which stipulate the conditions for giving this European Standard the status of a national standard without any alterationä Upætoædate lists and bibliographical references concerning such national standards may be obtained on application to the CENæCENELEC Management Centre or to any CEN memberä

translation under the responsibility of a CEN member into its own language and notified to the CENæCENELEC Management Centre has the same status as the official versionsä

CEN members are the national standards bodies of Austriaá Belgiumá Bulgariaá Croatiaá Cyprusá Czech Republicá Denmarká Estoniaá Finlandá Former Yugoslav Republic of Macedoniaá Franceá Germanyá Greeceá Hungaryá Icelandá Irelandá Italyá Latviaá Lithuaniaá Luxembourgá Maltaá Netherlandsá Norwayá Polandá Portugalá Romaniaá Slovakiaá Sloveniaá Spainá Swedená Switzerlandá Turkey andUnited Kingdomä

EUROPEAN COMMITTEE FOR STANDARDIZATION COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre:
Avenue Marnix 17,
B-1000 Brussels

t r s w CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Membersä Refä Noä EN

s x y u xã t r s w ESIST EN 16736:2015

EN 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 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 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 Applied training programme ................................................................................................................... 12 4.5 Examination ................................................................................................................................................... 12 Bibliography ................................................................................................................................................................. 13

SIST EN 16736:2015

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 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, 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 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 implement 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, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. SIST EN 16736:2015

EN 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 regulations (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 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 agencies, 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 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 Risk Assessment Advanced Training Programme (RAAP) [2], European Toxicology Risk Assessment Training (TRISK) [3] and Risk Assessment and Management – European Training Programme (Risk Assets) [4]. SIST EN 16736:2015

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 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 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 practical 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 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 through 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 characterization 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. SIST EN 16736:2015

EN 16736:2015 (E) 6 3.2 Required knowledge and skills 3.2.1 General 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 consult 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: hazard 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; 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 risk 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 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 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 appraise 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; SIST EN 16736:2015

EN 16736:2015 (E) 7 d) critically evaluate a health risk assessment, identify its limitations and assess 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, exposure 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 human 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 end points and biomarkers of toxicity (e.g. reversible/irreversible effects, mutagenicity, carc

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