Summary of status of the GHS regional implementation Regional Project “Evaluating and Strengthening National and Sub-regional Capacities for Implementing the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) and Supporting SAICM Implementation in Central and Eastern Europe (CEE)” Dr. Suzana Andonova Regional GHS CEE Project Consultant

Introduction This report presents the results of a survey conducted to assess the status of implementation of Globally Harmonized System of Classification and Labelling of Chemicals (GHS) in the CEE countries and the needs of each country in the Region for prompt introduction and better implementation of GHS. The results of the assessment will serve as a basis for drafting the strategy for GHS implementation in the CEE Region.

Material and methods A questionnaire comprised of 28 questions was prepared. All the questions were relevant to the issues related to GHS implementation in the countries. All the National Focal points were contacted and were invited to respond to the questions. A cross tabulation and data results dispersion methods were used to analyse and summarise the responded questionnaires. Personal communication and desk research for other countries.

General Feedback Among 24 countries invited to fill in the questionnaires, in total 12 responses were received: Invited countries Responding Countries Albania Armenia   Azerbaijan Belarus Bosnia and Herzegovina Bulgaria Croatia Czech Republic Estonia Georgia Invited countries Responding countries Hungary Kosovo Latvia   Lithuania Republic of Macedonia Montenegro Republic of Moldova Poland Romania Russia Serbia Slovakia Slovenia Ukraine

List of the contact points in the respondent countries Country Contact Point Name Title/ Responsible Institution Kosovo Violeta Lajqi-Makolle Senior Officer for chemical management/ Ministry of Environment and Spatial Planning-MESP Moldova Liudmila Marduhaeva Main Advisory Officer /Ministry of Environment Serbia Aleksandra Zujic International Cooperation and Projects Coordinator/ Serbian Chemicals Agency Croatia Biserka Bastijančić-Kokić/ Nenad Lamer Ministry of Health, Directorate for Sanitary Inspection Albania Lindita Tafaj SAICM Focal Point/ Institute of Public Health Macedonia  Marin Kocov SAICM National Focal Point/POPs&Ozone Unit/MoEPP Belarus Irina Ilyukova Liliya Najaran Republican Scientific Practical Centre of Hygiene Russia Makarova Anna Sergeevna Institute of Chemistry and Sustainable development( РХТУ им.Д.И.Менделеева) Bulgaria Hristina Filipova Chief Expert/Ministry of environment and water Poland Mariusz Godala Szymon Domagalski Bureau for Chemical Substances Hungary Gabriella Füle Ministry of Rural Development Romania Liliana Luminita Tirchila SAICM National Focal Point/MINISTRY OF ENVIRONMENT and FORESTS

Survey findings Q1 Level of development of chemical industry Q1.Status of development of chemical industry in CEE countries Q2.Source of chemical products Country Q1 Level of development of chemical industry Q2 Source of chemical products developed Least Needs additional development Well Highly advanced level Domestic production Imported products Manufacture /processing of imported bulk/raw chemicals Kosovo   Moldova Serbia Croatia Albania Macedonia Belarus Russia Bulgaria Poland Hungary Romania

Q3. Current legal and policy frameworks assessment Among 12 countries, 4 Countries assessed the current legal and policy frameworks 4 did not do so and the remaining 4 are in process of assessment of the legal policy framework.

Q4. Status of implementation of the MEAs Stockholm Convention Yes -Albania, Belarus, Bulgaria, Croatia, Hungary,, Republic of Macedonia, Republic of Moldova, Poland, Romania, Russia and Serbia /Armenia, Ukraine, Georgia, EU member states in CEE Region No – Kosovo, Montenegro and Bosnia and Herzegovina (at initial phase) Basel Convention Yes-Belarus, Bulgaria, Croatia, Hungary,, Republic of Macedonia, Republic of Moldova, Poland, Romania, Russia and Serbia/Armenia, Ukraine, Georgia, EU member states in CEE Region, Montenegro and Bosnia and Herzegovina (at initial phase) No- Kosovo, Albania (not implemented) Rotterdam Convention Yes-Albania, Belarus, Bulgaria, Croatia, Hungary,, Republic of Macedonia, Republic of Moldova, Poland, Romania, Russia and Serbia/Armenia, Ukraine, Georgia, EU member states in CEE Region No-Kosovo, Azerbaijan, SAICM Yes-Albania (initial phase), Belarus, Bulgaria, Croatia, Hungary,, Republic of Macedonia, Republic of Moldova, Poland, Romania, Russia and Serbia/Armenia, Ukraine, Georgia, EU member states in CEE Region No-Kosovo, Azerbaijan,Montenegro, Bosnia and Herzegovina

  Q5. Integrated SAICM objectives in relevant programs, plans and/or strategies at various levels Out of total 12 countries, only Kosovo and Belarus have not integrated the SAICM objectives into a country relevant strategic program, plan or strategy. SAICM objectives are integrated into the EU Regulations REACH and CLP and are acting into all EU Countries.

Q6. Status of GHS implementation in CEE countries

Inter-ministerial or inter-institutional coordination body Q7a. Inter-ministerial or inter-institutional coordination arrangements to facilitate the sound management of chemicals / GHS implementation in CEE Region Country Inter-ministerial or inter-institutional coordination body Albania Committee for pesticide registration, committee for biocides. ToR have been prepared for an Inter-sectorial Committee for Chemicals Management (Safety) Belarus Yes Bulgaria Croatia Hungary Kosovo No Macedonia National Inter-ministerial Working Group for chemical management comprised by the representatives from the Ministry of Environment, Finance-Customs Administration, Health, Agriculture, Crisis management Centre, Poisoning Centre Moldova National Inter-ministerial Working Group, mandated to implement the Chemical MEAs, SAICM and National Programme on Sound Management of Chemicals Poland Romania Russia Yes/CIS Serbia Serbian Chemicals Agency, Ministry of infrastructure and energy and Ministry of Agriculture, Trade, Forestry and Water Management *

Q7b,c&d National Governmental authority/agency responsible for the GHS implementation Government agencies that should be involved for GHS implementation in the country Ministries/agencies in the country ready to implement and maintain the GHS All listed in the Annex 1 of the report.

Q8.Level of awareness on GHS Level of awareness on GHS in CEE Region Country Very low Medium High Kosovo   Moldova Serbia Croatia Albania Macedonia Belarus Russia Bulgaria Poland Hungary Romania

Q9. What are the obstacles to implement the GHS in countries? No sufficient human resources/capacities and expertise. Lack of financial resources to properly implement GHS. Lack of system for integrated chemicals and hazardous substances information was very common for the twelve surveyed CEE countries.

Q10. GHS Implementation in the transportation sector All the CEE countries have relevant Law on transportation for dangerous goods that are in accordance with the based on the UN Recommendations for the Transport of Dangerous Goods(Model Regulations which is in accordance with GHS). Some of the countries stated some additional regulation concerning the transportation (Albania)

Q11. Has your country already conducted any basic/initial training course for GHS introduction/ implementation

Q12. How will stakeholder cooperation and support for implementing the GHS be managed Many different views and approaches as well as understandings. …To be discussed during the workshop/working groups…

Q13A. Current status of GHS implementation- Sector transportation Country Current status of GHS implementation- Sector transport No action taken Situation analysis prepared or under preparation Preparing for revising related legislation/ administrative procedures Preparing for establishing new legislation/ administrative procedures Already implementing GHS Other Kosovo   Moldova Serbia Croatia Albania Macedonia Belarus Russia Bulgaria Poland Hungary Romania

Q13B/C Current status of GHS implementation- Sector Industry & Consumer products Country Current status of GHS implementation- Sector Industry & Consumer products No action taken Situation analysis prepared or under preparation Preparing for revising related legislation/ administrative procedures Preparing for establishing new legislation/ administrative procedures Already implementing GHS Other Kosovo   Moldova Serbia Croatia Albania Macedonia Belarus Russia Bulgaria Poland Hungary Romania

Q13D Current status of GHS implementation- Sector Agriculture/Pesticides Country Current status of GHS implementation- Sector Agriculture/Pesticides No action taken Situation analysis prepared or under preparation Preparing for revising related legislation/ administrative procedures Preparing for establishing new legislation/ administrative procedures Already implementing GHS Other Kosovo   Moldova Serbia Croatia Albania Macedonia Belarus Russia Bulgaria Poland Hungary Romania

Q14. Is there a mandatory requirement to translate GHS into the national language(s)?

Q 15 a. Interesting topics to be discussed during the Regional workshop, according to the country needs Country Interesting topics to be discussed during the Regional workshop Organizational structure needed for implementation of GHS/CLP Needs for Capacity building to be prepared for GHS introduction Full introduction of GHS or by sectors (Building Block Approach) Introduction of GHS Versus CLP in some countries Kosovo   Moldova Serbia Croatia Albania Macedonia Belarus Russia Bulgaria Poland Hungary Romania

Additional topics of interests: Information on related activities under Agreements on Association with EU(Moldova); Cooperation among countries in the Region for proper implementation of GHS/CLP (Macedonia); Training of population and other relevant stakeholders (Russia); Small and medium-sized enterprise involvement and difficulties by introducing GHS (Hungary).

Q16. Availability of financial resources for national/regional capacity building activities towards GHS implementation

Q17. Activities completed or planned for GHS implementation   Situation/ Gap Analysis Comprehensibility Testing Impact Study and/or Cost Benefit Analysis First Draft of the Implementation Instrument Consultation with Stakeholders Development of a GHS National Implementation strategy Final Adoption of the Implementation Instrument Training courses for GHS implementation Kosovo / Moldova Serbia Yes No Croatia Albania Macedonia Belarus Yes/ 2008 Yes/2011 Yes/2010-11 Yes/2008-11 Russia Bulgaria Poland Hungary Romania

Industrial / Workplace Agriculture / pesticides Q18. Sectors covered by the National regulation regarding GHS, Edition used (Rev, 2, 3,4)   Transport Industrial / Workplace Consumer products Agriculture / pesticides Other Kosovo / Moldova Serbia Yes/Rev 3 Croatia Albania Macedonia Yes No Belarus Yes/ SMGS Yes/ GOST 12.1.007-76 Yes/GOST 12.1.007-76 Russia Bulgaria Yes/Rev2 Yes/Rev 2 Poland ADR Hungary Romania

Q20. Transitional period in place for GHS implementation

Q21. Are all GHS hazard classes implemented for the sectors that are covered Only Serbia, Bulgaria, Poland, Hungary and Romania answered to this question. “According to CLP only hazard categories that are not part of CLP are : •“flammable liquids category 4”, •“acute toxicity category 5”, •“skin corrosion/irritation category 3”, •“aspiration hazard category 2” • “acute aquatic toxicity category 2 and 3”

Q22. Are GHS safety data sheets (SDS) accepted in your country today? Safety Data Sheets accepted Yes No In process Kosovo / Moldova Serbia   Croatia Albania Macedonia Belarus Russia Bulgaria Poland Hungary Romania

Q23. Difficulties encountered in preparing the SDS due to lack of facilities and capabilities Belarus: Lack of trained specialists, Absence of GLP laboratories, Legislation gaps. Russia: Lack of data. Different interpretation of existing data, Problems of reliability and Data inconsistencies. Serbia: One of the biggest problems is lack of data for classification of substances which are not in the List of classified substances or are not classified for all hazard classes. Very important problem for the downstream users (formulators) is the bad quality of SDS of imported substances. Also, there is a lack of capabilities for preparing SDS, especially in small and medium enterprises.

Q24. Support the cooperation and information exchange among the countries in the region for better implementation of GHS All countries support the cooperation and exchange of information in the frames of the CEE Region. Hungary: HelpNet Steering Group Bulgaria: The country is open to provide expertise and take part in CLP training seminars Poland: In 2011 Inspector for Chemical Substances implements three projects co-financed by the Polish aid program of the Ministry of Foreign Affairs (Armenia, Georgia and Moldova). Russia: Through TAIEX instruments

Accredited GLP laboratories Q25. Existing accredited laboratories on GLP and cooperation with any relevant (Q26)   Accredited GLP laboratories Cooperation with GLP Croatia Developing such practice Macedonia 1. Public health Institute-State owned 2. Tehnolab-Private / Poland http://www.chemikalia.gov.pl/list_of_polish_labs_glp_certified.html Hungary National Institute of Chemical Safety, state owned http://www.okbi.hu/images/reach/laborlista_201002.pdf Every GLP laboratory develops collaboration with other laboratories on their own Romania Private institution It is not necessary, proposals for testing are controlled by ECHA and tests methods are governed by Regulation 440/2008 under REACH, indirectly OECD methods

Q27. Regional institution that coordinates the GHS implementation at regional level Slovenian Chemicals Bureau Swedish Chemical Agency GOST Standard European Chemical Agency(ECHA)

Q28. Specific problems indicated in implementing the GHS Country Indicated specific problems Belarus Lack of political will, Legislation gaps, No Register of chemicals, No Law on chemicals Croatia Lack of staff and time Georgia: Inconsistent approach to classification of chemicals and distribution of the information on hazards; Necessity of introduction of GHS (Ref. National Chemical profile, 2009) Hungary Lack of human resource, quantitative and in expertise; Financial needs; Particularly small and medium-sized enterprises have the above mentioned difficulties Poland In European Union GHS is implemented by CLP Regulation. According to the CLP Regulation each country has to establish: Competent Authority, Enforcement authority, National Helpdesk to provide advice to manufacturers, distributors, downstream users and other interested parties, Body responsible for receiving information relating to emergency health response. The main problem usually is concerning with division of responsibilities and preparing some changes in national law (very long process in Poland) Serbia In certain cases where there is no other way to have access to data necessary for classification, and when it will be necessary to perform experimental testing in compliance with GLP principles, the problem for our industry will be where to perform those tests and the cost of these testing

Thank you for participating to this survey Dr. Suzana Andonova Regional GHS CEE Project Consultant