BT N 8703 (Draft Resolution BT C103/2011) Issue date : Target Date : BT - TECHNICAL BOARD 1 T O D E C I D E 2 S U B J E C T :

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1 BT N 8703 (Draft Resolution BT C103/2011) Issue date : Target Date : BT - TECHNICAL BOARD 1 T O D E C I D E 2 S U B J E C T : Creation of a new Project Committee on "Health risk assessment of chemicals" (Members are requested to state explicitly in the BT-balloting commenting field their commitment to participate) 3 B A C K G R O U N D Following the discussions at the 68 th CEN/BT meeting (see BT N 8482), with resolution BT 19/2010, CEN/BT welcomed the ASI proposal to carry out a feasibility study on the elaboration of European Standards supporting the education/training ( accreditation ) of human health risk assessors in the field of chemicals. The relevant working group met in Vienna on 14 March 2011 and agreed on the need to develop European Standards on this topic (Annex 1 to BT N 8703). The enclosed Form A (Annex 2 to BT N 8703) is the result of the discussions and it proposes the creation of a new CEN Project Committee in order to develop a European Standard on Human health risk assessment of Chemicals. In particular, the proposed European Standard aims at producing an agreed definition of the knowledge, skills and experience a risk assessor requires in order to be considered competent to assess the risks to human health from exposure to chemical substances. Additionally, it also proposed to define the minimum requirements for a training programme to train risk assessors to be competent to assess the health risks posed by chemical substances. By Resolution BT C75/2009, BT approved that both of following criteria are to be met for acceptance of such proposal for new work (in new area): A two-thirds majority of the votes cast (abstentions not counted) are in favour of the proposal (or more); Members express commitment to participate. As a consequence, BT Members are requested to state explicitly, by means of the commenting field provided in the BT-balloting tool, whether or not they are committed to participate in the work.

2 4 D R A F T R E S O L U T I O N BT, having considered - the result of the discussions on the feasibility to elaborate European Standards supporting the education/training ( accreditation ) of human health risk assessors in the field of chemicals (Annex 1 to BT N 8703); - the proposal for new work (Form A) submitted by ASI (Annex 2 to BT N 8703); considering that the following members have expressed commitment to participate: o decides, - to create a new Project Committee, CEN/TC xxx "Project Committee Health risk assessment of chemicals " in order to work on the European Standard on human health risk assessment of chemicals according to the specifications provided in BT N 8703; - to ask the new CEN/TC xxx to submit its programme of work for BT approval by April 2012; - to allocate the secretariat to ASI. This resolution is applicable as from: R E S P : CM

3 CEN Feasibility Study N 006 CEN Feasibility Study Accreditation of human health risk assessors in the field of chemicals Report 1 st meeting 14 th March ASI, Vienna Member of CEN and ISO ISO 9001:2008 certified

4 1 Opening of the meeting Mr WINKLER on behalf of ASI welcomed the attendees to the meeting. 2 Roll call of participants Delegations attended from Austria, Belgium, Croatia, Italy, Slovenia, Sweden and United Kingdom. Attendees introduced themselves in turn and the attendance sheet was circulated. 3 Adoption of the draft agenda (N 002) The draft agenda (N 002) was adopted without changes. 4 Introduction of the CEN system Mr WINKLER informed the participants about the system of European Standardization; he explained the tasks of CEN and showed the structure. He informed on the requirements for starting a standardization project and the way to finish a project with publication of a standard (see also enclosed presentation). In addition to the standardization process it is also possible to use the standard for certification. ASI can act also as an independent certification body for services and also for persons. 5 Technical discussion including presentations of participants Mr WINKLER referred to the starting point for this meeting to CEN resolution BT 19/2010 (see N 004). Mr GALLI informed about the previous projects TRISK and RAAP (see N 005); 25 people have been trained within 8 weeks in a modular programme. This was a single project a second course is asked but not planned. The aim behind the training is to find a common language and a common understanding on the tasks of risk assessors for human health in the field of chemicals. Second task is to create a model for a training course which leads to comparable results. The completion of the training should be a certification for the risk assessors but also for the training programme. Mr WINKLER underlined that it is the main task of standardization to include all the relevant stakeholders and to find together a common language and on that basis also a common understanding. Mr GALLI, Mr BURSCH and Mr CAPLETON informed about the structure, the contents and aims of the different training programmes. All these programmes are similar but not equal, they have a modular structure, and the participants need additional practical experience. It is clearly expressed that there is an urgent need for - a clear definition of risk assessor - an appointment of the preconditions for the participation in a training 2 Member of CEN and ISO ISO 9001:2008 certified

5 The experts present discussed the single training models, the tasks of a risk assessor and expressed that the training for risk assessors is an additional task for experts. It has to be seen independent from the training as toxicologist. The need to have that kind of standardization is clearly expressed on the one hand from industry and on the other hand also from the authorities. They adopted the following recommendations. Recommendations: The participants recommend the following: To ask the CEN-members for two new work items o Requirements for a training programme for risk assessors o Requirements for a risk assessor These two standards should be also basis for certification. Mr GALLI is recommended as chairman of a new project committee. Mr WINKLER and ASI are recommended as secretary of a new project committee. After a positive enquiry the members of the group will ask for financial support for the work. 6 Allocation of tasks Mr WINKLER will prepare together with Mr GALLI a proposal for an N-form (Proposal for a new work item). The participants will have three weeks time to give comments. The comments will be included and a revised version will be sent to CEN to start the enquiry for a new work item. The experts present are also asked to contact their National Standardization Bodies and to inform them on the background of the project. Even if there is a positive feedback to the enquiry there have to be at least 5 countries with active participating of experts. The experts have to be nominated by the National Standards Bodies. If the proposal for a new work item is accepted a new CEN/TC project committee should be established to start the work. 7 Any other business There is no other business. 8 Date and place of the next meeting There is no further meeting for the feasibility study planned. 9 Closure of the meeting Mr WINKLER thanked attendees for their contributions to the meeting. 3 Member of CEN and ISO ISO 9001:2008 certified

6 Convenor Secretary Name Josef Winkler Josef Winkler LIST OF PARTICIPANTS 1 st meeting in Vienna 14 th March 2010 Country Austria Belgium Croatia Italy Slovenia Sweden United Kingdom Apologies Name Werner Brüller Wilfried Bursch Maria Uhl Barbara Zemann Sylvia Jacobi Veda M. Varnai Ellaine Ferioli Corrado Galli Angelo Moretto Ester Lovsin Barle Annika Hanberg Johanna Zilliacus Alexander Capleton Odo Feenstra, Michael Rocker, Helen Hakansson, Rolf Schulte- Hermann, Bernhard Ascherl, Juhu Pyötsiä, Ruth Jiménez, Santos Huertas, Mick Maghar, Reinhard Stidl, Elisabeth Fassold, Mario Salmona, Martin Paparella, Takis Daskaleros, Karl Dobianer 4 Member of CEN and ISO ISO 9001:2008 certified

7 FORM A Proposal for a new project EUROPEAN COMMITTEE FOR STANDARDIZATION COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR NORMUNG Title of project (shortened): Health risk assessment of chemicals CEN/TC:... Other: Creation of a new CEN Project Committee (if applicable) Name and address of the proposing organization: Austrian Standards Institute Heinestraße Vienna, Austria Telephone No. : Date: Title (in full) Information to be supplied by the proposer of the new project Human health risk assessment of chemicals The title should be unambiguous and as concise as possible. Where the proposal is for a new work item, the title should specify the subject to be covered and type of standard, e.g. terminology, method of test, performance requirements, etc. 2 Scope Standardization of the knowledge, skills and experience required of a risk assessor in the area of human health risk assessment of chemicals in order to competently undertake such risk assessments, and the specifications of a training programme in order to develop such knowledge, skills and experience. The scope should define precisely the field of application. Where the new project relates to a new activity or a range of standards, the scope should begin with 'Standardization of...' or 'Standardization in the field of...' 3 Justification and purpose Why is standardization needed? Explain the economic, commercial/industrial, safety, consumer protection or other benefits of the proposal. If necessary, continue on a separate sheet. Background The health risk assessment of chemical substances is an important tool in protecting consumer and public health and often requires scientists to work in multi-disciplinary teams (for example, comprising expertise in chemistry, exposure assessment, epidemiology, modeling, socioeconomics, statistics, toxicology, etc.) to fully assess the potential health risks posed by chemical substances. Currently, there are a lack of trained risk assessors in Europe to carry out consistent, high quality assessments of the risks to human health posed by chemical substances, despite extensive

8 national and European policy and legal requirements for such assessments. This has led to inadequately trained professionals presenting themselves as risk assessors who consequently produce poor quality assessments of the health risks posed by chemicals in a range of different contexts (e.g. consumer protection, public health, etc.). This, in turn, has implications for the protection of consumers and public health from the risks posed by chemicals. As a result, a need has been identified to develop a standard specification for the knowledge, skills and experience required to adequately assess the health risks posed by chemical substances and to set out the minimum requirements necessary to ensure training programmes are adequate to train potential health risk assessors to the required standard. This need was already presented to the Technical Board of CEN during its 68 th meeting. By Resolution CEN/BT 10/2000 (Subject: Accreditation of human health risk assessors in the field of chemicals) Austrian Standards Institute was commissioned to carry out a feasibility study on this subject. This proposal is the result of this feasibility study. The information below explains in more detail the need for such a standard and the details of the standard. Public health and consumer protection Everyday, every person is exposed to chemicals through their everyday use of consumer products (e.g. cleaning products), cosmetics, from environmental pollution (both indoors and outdoors), and from the food and water we eat and drink. Whilst the levels most people are exposed to are low, it is still vitally important that the possible health risk posed by these exposures is adequately assessed to ensure there are no unwanted health effects and to ensure a high level of consumer and public health protection. As a result, there is a need to ensure there are sufficiently qualified scientists within the EU to conduct the assessments of the health risks posed by chemical substances in order to properly protect consumer and public health. European and national regulatory requirements There are a wide range of European and national regulations and legislation that require an assessment of the health risks of chemicals to be undertaken. The most substantial of these is the Registration, Evaluation, Authorisation and Restriction of Chemical Substances (REACH) regulations, which requires detailed chemical safety assessments to be conducted on all chemicals manufactured, imported or used within the European Union (approximately 143,000 substances). Additionally, other European legislation requires assessments of health risks to be undertaken in order to protect human health. For example, drinking water regulations require an assessment of health risks if there is a deviation from the prescribed standards listed in the regulations. Only in a very few pieces of legislation (e.g. the Cosmetics directive) are there provisions laid down regarding the qualifications required of those undertaking such assessments. Similarly, legislation also exists at national level where health risks posed by chemicals must be assessed (e.g. in the UK there are regulatory requirements to undertake assessments of the health risks posed by contaminated land). Furthermore, there is an on-going need in public health settings to assess health risks posed by chemicals, for example, when there is an accidental chemical release or pollution. However, there are no formal, agreed standards of competence or an agreed training programme to ensure professionals are properly qualified to undertake such assessments of the risks posed by chemical substances. This can lead to poor quality assessments being undertaken and, as a result, there is a need to agree standards of competence and the minimum requirements for a training programme. Single market context A number of training courses on various aspects of the human health risk assessment of chemicals are offered in Member States in the EU. Whilst the majority of courses have a modular structure, they are not conducted to a comparable standard and, in addition, the participants need additional practical experience in order to become competent risk assessors in the area of the human health risk assessment of chemicals. This standard proposes to define the minimum requirements of a training scheme in order that the quality of training is comparable throughout the EU, and participants are taught a common curricula in order that they are adequately equipped to assess the health risks posed by chemical substances.

9 Purpose of standard This standard proposes to produce an agreed definition of the knowledge, skills and experience a risk assessor requires in order to be considered competent to assess the risks to human health from exposure to chemical substances. Additionally, it also proposed to define the minimum requirements for a training programme to train risk assessors to be competent to assess the health risks posed by chemical substances. Such a standard will help ensure risks to human health from chemical substances are assessed by appropriately qualified and experienced professionals and ensure that professionals have a means of becoming properly qualified to an agreed standard of competence. This, in turn, will help ensure a consistent, high-level of public health protection from such risks by ensuring there are sufficient, well trained professionals available to conduct highquality assessments of the health risks posed by chemical substances, both in regulatory and public health contexts. The experience of several training courses and of two pilot projects (European Toxicology Risk Assessment Training (TRISK; and Risk Assessment and Management European Training Programme (Risk ASSETs; undertaken as part of the EC Second Programme of Community Action in the Field of Health ( ) will be taken into account in the development of the standards. Relevant stakeholders: Public health authorities Industry Universities and Educational Institutions Health Ministries Scientists involved in health risk assessment (e.g. toxicologists, epidemiologists, exposure assessors) DG SANCO, Unit C7, Risk Assessment European Chemicals Agency (ECHA) 4 Is the standard required as a reference document for use in an EU Directive? YES NO (This question should only be answered when the European Commission is responsible for the proposal) 4.1 What Directorate General is responsible? Give details If so, what is (are) the specific aim(s) of the Directive e.g.? YES NO YES NO Abolition of barriers Health What barriers to trade can be identified? Safety Do they hamper : Environment Commerce Other aims Production (please specify) Exchange of services... Free circulation of goods...

10 5 Is the proposed standard likely to be suitable for certification purposes? YES NO 6 Priority category Indicate to which, if any, of the following categories the project belongs : Category A : Subject of mandates from the Commission of the EU and/or EFTA for tasks requested by these two organizations for rapid completion Category B : Drafts relating to the harmonized application of ISO standards Category C : Existing or new subjects for which CEN offers an acceptance procedure for drafts established by European professional standardizing bodies having safeguard of constitution and effectiveness comparable with that of a CEN technical committee and where no ISO work already exists An explanation should be provided by the originator of any proposal for a new project which does not fall within the priorities defined here. 7 Programme of work 7.1 What are the objectives of the project? YES NO YES NO Safety, health, protection of the Variety control environment, energy conservation Others (specify) Interface, interchangeability Performance, function, quality 7.2 Which of the following aspects are to be standardized? YES NO YES NO 1) Terminology 3) Marketing, labelling, Symbols/Signs Designation packaging, transport 2) Characteristics : 4) Sampling Dimensions Mechanical 5) Methods of test Chemical Acoustical 6) Performance Thermal requirements Electrical* Other physical 7) Others Non-physical, i. e. logical (Please specify) * Necessary contact with CENELEC 7.3 What is your estimation of the time needed for the technical project 20 months after WI adoption up to the completion of the draft EN/HD for the CEN enquiry? 7.4 What is the proposed deadline for submission of the draft EN/HD to. 30 months after WI adoption the CEN formal vote? 7.5 What is the latest date by which the standard should be published?...

11 8 Standards or other documents on which it is intended to base the European Standard 8.1 List of standards or other documents (please give titles, reference and date): 8.2 Is there an existing International Standard? YES NO If 'YES', a) give details :..... b) is it suitable for harmonization? YES NO If 'NO', give reasons : Is any aspect detailed in 7.2 already referred to in existing : YES NO YES NO 1) International Standards* 3) Other specifications or requirements* 2) National Standards* 4) Not known * If 'YES', please identify on a separate sheet. 8.4 Is any requirement included in the documents, and detailed in 7.2 considered to be of outstanding importance by the originator? YES NO If 'YES', give details... 9 Are there any documents in the same field whose requirements must be taken into account during the technical work? YES NO Not Known If 'YES', give brief details : Will liaison with outside bodies be necessary? YES NO If 'YES', give brief details : DG SANCO, Unit C7, Risk Assessment ECHA European Chemicals Agency ( 11 Is there any existing national legislation which may be relevant to CEN Work in this area? YES NO Not Known Please specify such legislation and give details : Is any aspect governed by the requirements of inspection bodies? YES NO Not Known Give brief details : Would any aspect conflict with known patented items? YES NO (ISO Directives, Part 2 and CEN/CENELEC Guide n 8 refers) If 'YES', provide full information on a separate sheet.

12 14 Participation in work YES NO 14.1 Is the proposer prepared to participate diligently in the work? 14.2 Is the proposer, if a CEN member, prepared to undertake the Secretariat duties if a new CEN/TC is necessary? 14.3 Is the proposer prepared to undertake the preparatory work required for a new work item? 15 Documentation All documentation previously referred to should accompany this proposal and be listed below. Are any of the attached documents to be circulated to CEN members with the proposal? YES NO Please send an electronic copy of these document(s) together with the proposal to CCMC. Signed :..... Date : Name : Dr. karl Grün Position : Director Development