The Overall Objectives of the Project

(Biocides 2017-2018)

SAICM QSP Project “Strengthening capacities for sound management of biocides (pesticides and disinfectants) to reduce population exposure in Ukraine”
The Project Initiation Workshop
11 April 2017, Kyiv, Ukraine
1 Organizational/Background
The Project “Strengthening Capacities for Sound Management of Biocides (pesticides and disinfectants) to Reduce Population Exposure in Ukraine” (Project) was prepared with the technical expert support from WHO Euro in 2013 by the State Institution “Institute of Hygiene and Medical Ecology of the National Academy of Medical Sciences of Ukraine (currently the State Institution “OM Marzeiev Institute for Public Health of the National Academy of Medical Sciences of Ukraine” (further OM Marzeiev Institute for Public Health) for participation in the 13th round of applications of the Projects of the Strategic Approach to International Chemical Management (SAICM) Quick Start Program (GSP). Funding for the Project was awarded by letter of the Secretariat of the SAICM dated 7 February 2014; Project Implementation agreement between UNEP (the Administrative Agent, serving as administrator of QSP Trust Fund) and WHO (the Participating Organization, serving as executing agency) was signed in March 2017; the State Institute of Public Health is identified as the Applicant and will lead the implementation of Project activities. The Project initiation workshop was organized by the WHO Country Office (WHO CO) in Ukraine in cooperation with WHO European Center for Environment and Health (WHO ECEH), on 11 April 2017 in Kyiv, Ukraine. The workshop was host by the OM Marzeiev Institute for Public Health.Welcome and Self-introduction of members 

Dr Nataliya Korol, National Professional Officer WHO CO in Ukraine, opened the meeting. 
She updated participants on implementation European Environment and Health Process (EHP) in Ukraine and underlined that sound management of biocides to reduce population exposure in Ukraine is among country priorities. The objectives of the SAICM QSP Project “Strengthening capacities for sound management of biocides (pesticides and disinfectants) to reduce population exposure in Ukraine” are reflected in country Sustainable Development Goals (SDGs) nationalization process, first of all in Goal 3 in 3.9 “Substantially reduce the number of deaths and illnesses from hazardous chemicals and air, water and soil pollution and contamination”.

She provided information on the process of the Project approval. She stressed that despite of the Project was launched later that it is expected due to administrative procedures, the Project deadline can’t be changed and all planning activities should be implemented till the end of 2018. She stressed the importance of the workshop for identification of priorities, activities that require more attention and support from international experts, revision of timetable and planning of the next steps for quick start of the Project. She invited the meeting participants for fruitful discussion and wished successful workshop. 

Academician of the National Academy of Medical Sciences of Ukraine Andriy Serdjuk, Director of the OM Marzeiev Institute for Public Health, welcomed the meeting participants. He noted that the OM Marzeiev Institute for Public Health prepared the Project proposal due to importance of the Project for Ukraine given growing problems caused by unsound management of biocides. He stressed that the OM Marzeiev Institute for Public Health would create all conditions enabling successful implementation of the Project. 

Dr Koval Ruslan, Director of the Committee on hygienic regulation representing the Ministry of Health of Ukraine stressed that Ukraine has an Association Agreement with the European Union (EU) that supposed harmonization of approaches to regulation of chemicals with the best European practice. He gratitude WHO and the OM Marzeiev Institute for Public Health for the Project submission and promotion noting that it is of particular interest for the Ministry of Health of Ukraine (MoH). On behalf of the MoH he promised support for the Project implementation. 

The meeting was attended by representatives of the MoH and the Ministry of Agriculture, industry and governmental and non-governmental organizations. List of participants is in Annex 1. 

Academician of the National Academy of Medical Sciences of Ukraine Andriy Serdjuk was elected chair-person and Ms Koblyanskaya was a reporter. 

The meeting programme was adopted without amendments and is available in Annex 2. 

2 Introduction of the Project 
Short description of Project has been provided by Dr Irina Zastenskaya, Technical Officer, Chemical Safety, WHO European Centre for Environment and Health (WHO ECEH). 
The Project was submitted in the 13th round of QSP in September 2013 and accepted by the QSP Trust Fund in November 2013. Due to lack of resources in the QSP Trust Fund the Project was on hold for last three years and, finally, a contract between UNEP Chemicals and WHO has been signed in February 2017. The Project is funded by UNEP through QSP SAICM.

The main Project tasks are as following: 1) Strengthening inter-ministerial and stakeholders’ cooperation; 2) Review of current situation in biocides (pesticides and disinfectants) management including qualitative assessment their potential risks for human health and environment and identification of national priorities for sound management of biocides; 3) Development of the action plan for implementation of sound biocides (pesticides and disinfectants) management; 4) Improvement of information collection and sharing including information on hazards for environment and human health, classification and labelling (on-line information source); 5) Improvement of national legislation according to international agreements and best practices of biocides (pesticides and disinfectants) regulation. 

The Project is in-line with current political commitments including SDGs. 

Several steps has to be done both by the national experts and government to reach a progress in regulation of biocides and also WHO to provide technical support. The Project has to be implemented till the end of 2018 and appropriate planning of activities is critical to ensure its implementation in time and in full. How to organize effective Project management and works organization if supposes to be one of the main topics for the workshop discussion along with agreement on a list of stakeholders that should be involved in the Project implementation, a national implementation team and a coordinator, needs for international support. 

3 Analysis of situation with management of biocides (pesticides and disinfectants) in Ukraine 
Academician of the National Academy of Medical Sciences of Ukraine Andriy Serdjuk presented information about OM Marzeiev Institute for Public Health that demonstrated available human and technical resources for the Project implementation in cooperation with experts from other national institutions. The OM Marzeiev Institute for Public Health activities are focused on the main health determinants such as human biology, status of health system, mode of life, and the environment. To address these determinants, intersectoral programmes were developed and implemented in Ukraine, for example, the Programme “Health of the nation”. Main outcomes of the OM Marzeiev Institute for Public Health research created scientific ground for decisions of the Supreme Council of Ukraine, Cabinet of Ministers of Ukraine as well as the Ministry of Health. Currently, 223 co-workers including 160 scientific staff members have been working in 16 main laboratories. Results of studies are published in annual journal “Hygiene of populated areas” and the journal “Environment and Health”. The OM Marzeiev Institute for Public Health has an agreement with industrial associations such as the Union of Industrialists and Entrepreneurs as well as with international organizations: IAAE; WHO; UNEP-SAICM. Support of the government in harmonization of national legislation with the EU legal framework given the national realities is one of the OM Marzeiev Institute for Public Health priorities for upcoming period. 

Information on the current situation with regulation of biocides in Ukraine was provided by representatives of the OM Marzeiev Institute for Public Health Dr Valerii Stankevich (legislation, registration system), Dr Olena Surmasheva (disinfectants assessment), and Dr Vitalii Babii (disinfectants regulation, existing information). 

There are no specific legal acts regulating management of chemicals and biocides in Ukraine. The most developed area is pesticides regulation. Several laws and sub-law documents provide legal framework for pesticides management, in particular, laws “On Pesticides and Agrochemicals”, “On Plants Protection”, and “On Plants Quarantine”. The common characteristics of the laws are their objectives to Protect human health and the environment from negative impact of pesticides; state control of pesticides registration, production, storage, transportation, trade, import and export, and disposal; assessment of their hazards for human health and the environment as well as biological effectiveness; control of enterprises producing pesticide and agrochemicals; responsibilities and rights of the Cabinet of Ministries of Ukraine, governmental bodies, local governments, and industrial entities. There is an experience of regulation of chemicals including their registration and control. However, there is a gap of regulative framework for biocides management. 

Management of chemical products classified as biocides by the EU regulation (terminology biocides is missing in the Ukrainian legislation) are partly regulated by the Law “On Sanitary-Epidemiological Welfare of the Population” and relevant sub-legislative acts. Legal framework for disinfectants is more developed and includes a number of laws and sub-law documents, in particular: the Law “On Sanitary-Epidemiological Welfare of the Population”; the Law “On Protection of the Population from Infectious Diseases”; Regulations on the State Sanitary and Epidemiological Service of Ukraine; Regulations on the State Sanitary and Epidemiological Control of Ukraine; Rules of Sanitary Protection of Territory of Ukraine. The disinfectant what are used for different purposes are regulated by the legislation: disinfection of health care institutions, preschool educational institutions for disease prevention; “cold” sterilization of products for medical and special purposes; disinfection of hands of medical personnel; preventive disinfection of residential, industrial, educational, sanitary and other premises, buildings and structures, objects in the territories of settlements, in places of mass recreation and recreation zones, places of temporary residence (hotels, campsites, dormitories, etc.), at enterprises of trade, catering, transport; industrial disinfection; washing and cleaning in household and industry with disinfectant properties; disinfection of air in premises, water (except for drinking), industrial and domestic waste; destruction of carriers of pathogens of infectious diseases (insecticides); destruction of synanthropic insects in the environment of human life; scare insects; destruction of rodents, which are sources and carriers of pathogens of infectious diseases; decontamination of the hands of the personnel of the enterprises of the food and processing industry, public catering, trade; pre-sterilization treatment of medical products; control of the quality of sterilization and pre-sterilization cleaning of medical products. 

One of the problems is assessment of hazards, effectiveness and testing of disinfectants used in Ukraine. Methodological documents that are in a force don’t correspond to modern science recommendations. They are not harmonized with approached accepted in the EU. For example, only three type of microorganisms strains are used for disinfectants testing whereas, for example, in the Russian Federation 6 more specific strains are applied and in the EU the range of strains is much wider, around 15) and much more specified. There is a difference in cultivation of strains, use of nutrient media, as well as methodology of experiments themselves leading to higher uncertainties of assessments conducted in Ukraine. However, efforts were taken to harmonize approaches with recognized methodologies. Application of European standards for assessment of biological activity of disinfectants demonstrated better standardization, higher objectivity, reproducibility and statistical reliability of results. There is an urgent need for a revision of methodological documents and laboratory practice to ensure effectiveness and safety of disinfectants and quick enforcement of legislation that is planned to be developed in the Project framework. 

Available information includes data on registered disinfectants and pesticides as well as infectious diseases, poisonings caused by pesticides and disinfectants. But databases are not available on line. Harmonization of approached to data collection given needs for assessment of human health and the environment risks is needed and should be one of the purpose of the Project. 

In the discussion, participants of other sectors and institutions expressed their expectations from the Project implementation. Representative of the Ministry of Agriculture mentioned that they welcome and would support the Project implementation. There are a lot of gaps in regulation of disinfectants for use for animals. Representative of industry stressed industry expectations are liberalization of procedures with stronger control and responsibility of biocides users and producers. 

Information provided during the session benefitted to the discussion of the Project tasks later in working groups. 

4 Advanced experience in regulation of hazardous chemicals (the European Union regulation) 
Harmonization of the national legal framework with the EU requirements is one of the main tasks of the Association Agreement between Ukraine and the EU. Chemicals regulation in the EU is well developed. All chemical product including biocides are regulated by separate acts and different procedures are applied for different chemical products: medicinal product – authorization (under prescription); food or feeding stuffs – authorization; plant protection product (active substance) – authorization of a product; biocidal products (active substances) – authorization of a product; cosmetic product – notification of a product; industry chemicals – authorization only for SVHC and registration for all chemical products. REACH is the main law for chemical products regulation and include requirements to chemicals registration, evaluation, authorization and restriction. REACH also introduced definitions that can be considered by Ukraine developing proposals for biocides legislation. Another important regulation is “The Classification, Labelling and Packaging of Chemicals” adopted in 2015. All requirement of the regulation should be applied in the Project framework classifying existing biocidal products (disinfectants and pesticides). Biocidal Product Directive (BPR; EU 528/2012) has been enforced in 2013. It defines biocidal products as active substances and preparations containing one or more active substances, put up in the form in which they are supplied to the user, intended to destroy, deter, render harmless, prevent the action of, or otherwise exert a controlling effect on any harmful organism by chemical or biological means. Biocidal products are divided into four groups: disinfectants and general biocidal products; preservatives; pest control; other biocidal products. The new regulation improved the EU authorization for biocides through simplifying the approval and authorization process, reducing of animal testing, creating of on-line platform for application. 

Prioritization of chemicals to focus on in the Project given the Project objectives and national realities should predict detailed planning of the Project implementation. The EU legislation can serve as a model for improvement of biocides regulation in Ukraine. 

5 Planning of activities in the Project framework (the Project scope, stakeholders, main activities and outcomes, timeframe, required international expertise, the Project administration
The outcomes of the discussion of the Project scope and other organizations matters are described below. 

5.1.1 Main conclusions: 
– The Project is important and provides substantial support for achievement of a progress in improvement of biocides regulation in Ukraine; 
– The Project implementation is supported by the leading ministries such as the Ministry of Health and the Ministry of Agriculture as well as relevant institutions; 
– There are basic capacities for the Project implementation in Ukraine; that makes feasible the implement all tasks before the deadline; 
– Amendment to the working plan is necessary given the new timeframe;
– There is a national practice in registration and authorization of pesticides and disinfectants to build on for the Project implementation and for improvement of biocides regulation in general; 
– To ensure all stakeholders involvement an interagency coordination group should be created by the Ministry of Health and under supervision of the Professor Polka Nadiia as National Coordinator of the Project, the National Coordinator in Ukraine on Environment and Health, Deputy Director of the OM Marzeiev Institute for Public Health;
– Priority chemicals to focus on are pesticides and disinfectants as it has been agreed at the Project development stage but all types of biocides should be considered in development of legislation;
– The EU regulations and practice will serve as a model for creating a system for biocides management in Ukraine; 
– Wider involvement of industry and the private sector as well as it is critical for the Project implementation. 
– International experts support is needed for: critical analysis of the national situation assessment; social-economic impact assessment; development of a national action plan; development of legislation; classification and labelling.
5.1.2 Recommendations and the next steps: 
– Promote the Ministry of Health decision on the intersectoral steering group;
– To change the work plan given later start of the Project implementation;
– To make a contract with WHO Europe to secure activities of the implementing organization; 
– To create a national implementation team from representatives of leading institutions and other stakeholders given the new time framework for the Project implementation.
6 closure
After exchange of the usual words of courtesy, the Project initiation workshop was finished at 17:30 h.

Annex 1
Strengthening capacities for sound management 
of biocides (pesticides and disinfectants) 
to reduce population exposure in Ukraine: 
the Project initiation workshop

11 April 2017, Kyiv, Ukraine

List of participants

Representatives of organizations
Ministry of Health of Ukraine

Irina Rudenko 
Head of the sector on European integration 
Ministry of Health of Ukraine
7, Grushevskogo str.
01601 Kyiv		Tel: 
Email:		+38 050 3488973
dok7tor@ukr.net
Mykhailo Koshelnyk
Senior specialist
Department of Public Health
Ministry of Health of Ukraine
7, Grushevskogo str.
01601 Kyiv		Tel: 
Email:		+38 098 1779132
kmi@moz.gov.ua
Ruslan Koval 
Director of the “Committee on hygienic regulation”
Ministry of Health of Ukraine
7, Grushevskogo str.
01601 Kyiv		Tel: 
Email:		+38 067 4094606
rvkoval@ukr.net

State Institution “OM Marzeiev Institute for Public Health 
of the National Academy of Medical Sciences of Ukraine”

Andriy Serdjuk 
Director, Academician of the National Academy of Medical Sciences of Ukraine, Doctor of Medical Sciences, Professor 
State Institution “OM Marzeiev Institute for Public Health 
of the National Academy of Medical Sciences of Ukraine”
50, Popudrenko str. 
02660 Kyiv

Tel: +38 050 3107561
Email: usch@usch.kiev.ua

Nadiia Polka 
The National Coordinator in Ukraine 
on Environment and Health 
Deputy Director, Doctor of Medical Sciences, Professor State Institution “OM Marzeiev Institute for Public Health 
of the National Academy of Medical Sciences of Ukraine”
50, Popudrenko str. 
02660 Kyiv		Tel: 
Email:		+38 098 1779132
koblyanskaya_alla@ukr.net
Valerii Stankevich 
Head of the Laboratory of soil and waste 
Doctor of Medical Sciences 
State Institution “OM Marzeiev Institute for Public Health 
of the National Academy of Medical Sciences of Ukraine”
50, Popudrenko str. 
02660 Kyiv		Tel: 
Email:		+38 050 4450061
nakoval@i.ua
Olena Surmasheva 
Head Laboratory of Microbiology and Disinfectology 
Doctor of Medical Sciences 
State Institution “OM Marzeiev Institute for Public Health 
of the National Academy of Medical Sciences of Ukraine”
50, Popudrenko str. 
02660 Kyiv		Tel: 
Email:		+38 050 8798319
surmasheva_elena@ukr.net 
Vitalii Babii 
Head of the Laboratory of Carcinogenic Factors and Nanomaterials, Doctor of Medical Sciences 
State Institution “OM Marzeiev Institute for Public Health 
of the National Academy of Medical Sciences of Ukraine”
50, Popudrenko str. 
02660 Kyiv		Tel: 
Email:		+38 067-183-80-62
gignano@ukr.net
Alla Koblyanska 
Head of the Department of the support of state programs and international relations 
Candidate of Medical Sciences 
State Institution “OM Marzeiev Institute for Public Health 
of the National Academy of Medical Sciences of Ukraine”
50, Popudrenko str. 
02660 Kyiv		Tel: 
Email:		+38 098 4604416
koblyanskaya_alla@ukr.net
Yurii Skaletskyi 
Head of the Laboratory of the security strategies in public health, Doctor of Medical Sciences, Professor 
State Institution “OM Marzeiev Institute for Public Health 
of the National Academy of Medical Sciences of Ukraine”
50, Popudrenko str. 
02660 Kyiv		Tel: 
Email:		+38 067 3684805
yns53@i.ua
State Institution “Institute of Occupational Medicine 
of the National Academy of Medical Sciences of Ukraine”
Cherniuk Volodymyr 
Director, Doctor of Medical Sciences, Professor 
State Institution “Institute of Occupational Medicine of the National Academy of Medical Sciences of Ukraine”
75, Saksaganskogo str.
01033 Kyiv		Tel: 
Email:		+38 044 284 3427 
yik@nanu.kiev.ua
Kyiv City Administration
Mikhailo Rosada 
Director of the communal enterprise “Promdesinfection”
Kyiv City Administration
25, Dehtjarivska str. 
05010 Kyiv		Tel: 
Email:		+38 095 2740908
rosada@ukr.net
National Medical University named O.O.Bogomolets
Sergiy Omelchuk 
Head of Department of Hygiene and Ecology No. 3, Professor
National Medical University named O.O.Bogomolets 
13, Shevchenko bul. 
01010 Kyiv		Tel: +38 067 9009013
National University of Bioresources and Nature Management of Ukraine 
Nataliya Prokopenko 
Professor of the Department of Technology in Poultry, Pig and Sheep Production
Doctor of agricultural sciences 
National University of Bioresources and Nature Management of Ukraine 
15, Geroiv Oborony str. 
03041 Kyiv		Tel: 
Email:		+38 067 9685697
NatPP@meta.ua

Nongovernmental organizations
Ukrainian Association of Public Health

Olga Rudnitska 
Secretary of the Ukrainian Association of Public Health 
50, Popudrenko str. 
02660 Kyiv		Tel: 
Email:		+38 099 3489452
o.rudnytska@ukr.net

Representatives of industry
VIK-A – Ukrainian manufacture of disinfectants 

Olexander Zdrak 
Director 
VIK-A – Ukrainian manufacture of disinfectants 
3-a, Zoologichna str. 
03680 Kyiv
Tel: +38 059 4145989
Email: a.zdrak@namorn.com.ua

World Health Organization
WHO Regional Office for Europe
Dr Irina Zastenskaya
Technical Officer, Chemical Safety
WHO European Centre for Environment and Health 
Platz der Vereinten Nationen 1
D-53113 Bonn
Germany 		Email:zastenskayai@who.int

WHO Regional Office to Ukraine

Dr Nataliya Korol
National Professional Officer on NCD
WHO Country Office to Ukraine 
30, Borychiv Tik str.
04070, Kyiv		Email:koroln@who.int
Gnessoto Roberto 
National Professional Officer on NCD
WHO Country Office to Ukraine 
30, Borychiv Tik str.
04070, Kyiv

Annex 2
Strengthening capacities for sound management 
of biocides (pesticides and disinfectants) 
to reduce population exposure in Ukraine: 
the Project initiation workshop

11 April 2017, Kyiv, Ukraine

Provisional Programme 

10:00 – 10:30Registration, coffee 
10:30 – 11:00Welcome 
Head of WHO Country Office
National Academy of Medical Sciences
MoH, Department for Public Health
11:00 – 11:10Introduction of participants
11:10 – 11:40Introduction of the Project 
Ms Irina Zastenskaya, WHO Europe
11:40 – 13:00 Analysis of situation with management of biocides (pesticides and disinfectants) in Ukraine including:
– legislation, 
– existing registration system, 
– types of regulated disinfectants, 
– risk and effectiveness assessment, 
– information available, 
– available capacitiesMr Andriy Serdjuk, State Institution “OM Marzeiev Institute for Public Health of the National Academy of Medical Sciences of Ukraine”
Mr Valerii Stankevich , State Institution “OM Marzeiev Institute for Public Health of the National Academy of Medical Sciences of Ukraine”
Ms Olena Surmasheva, State Institution “OM Marzeiev Institute for Public Health of the National Academy of Medical Sciences of Ukraine”
Mr Vitalii Babii, State Institution “OM Marzeiev Institute for Public Health of the National Academy of Medical Sciences of Ukraine”
13:00 – 14:00 Lunch
14:00 – 15:00Advanced experience in regulation of hazardous chemicals (European Union regulations) 
Ms Irina Zastenskaya, WHO Europe
15:00 – 17:00Coffee break on 15:00 – 15:30Planning of activities in the Project framework (the Project scope, stakeholders, main activities and outcomes, timeframe, what international expertise is required, the Project administration, etc).
Plenary discussion and or working groups discussion 
17:00 – 17:30The workshop wrap up and closure