Russia region - Overview on chemical control legislation (labelling, MSDS, existing and new substances, etc) and aspects of GHS Mrs. Elena Zbitneva, Dr. Dmitry Skobelev CISCENTER e.zbitneva@ciscenter.ru dskobelev@ciscenter.ru 30 October 2014
Key pre-requisites for development Draft federal law «On industrial policy in Russian Federation» Industry stimulation activities Best Available Techniques (BAT) Creation of industry federal information system Chemical management regulatory framework concept of development 2
Scope and aims Aims Scope of regulation relations Sustainable innovative development of industry Investment-attractive businesses Increase marketability of products Reduce negative impacts on human health and environment 3
Essential elements of chemical management regulatory framework 1. Regulated objects 2. Participants of regulatory system 3-4. Influences: National Priorities and International Activities Essential elements of chemical management regulatory framework 5. Parameters of regulation 6. Key procedures for control of regulated objects 7. Non-regulatory Mechanisms 8. Availability of National Data 9. Laboratory infrastructure 10. Response on emergency situations involving chemicals, including poisoning 11. Harmonization activities 4
1. Regulated objects Chemicals Industrial chemical Pesticides Chemical wastes Fertilizers Chemical market Petroleum products Consumer chemical Nanomaterials and composites Chemicals of global and/or national concern 5
2. Participants of regulatory system Ministries: Ministry of Industry and Trade, Ministry of Natural Resources and Environment, Ministry of Agriculture, etc., other Governmental Organizations/Institutions Regulator Self-regulatory organizations Russian Chemists Union, Russian Union of Industrialists and Entrepreneurs (RSPP), Industry Research Centers and Institutes GOSNIIOKHT, FMBA, Chemical market Mechanisms to facilitate stakeholder participation Government Commission on the Biological and Chemical Safety, Government Commission on the Protection of Public Health 6
3-4. Influences: National Priorities and International Activities National priorities Regulator International organizations and fora National Priorities Principles of State Policy in the Sphere of Ensuring Chemical and Biological Security of the Russian Federation for the period up to 2025 and beyond Federal Target Programme on National System of Chemical and Biological Safety for 2009-2014 Work in the International Organizations and Fora Chemical market International Organizations documents 7
5. Parameters of regulation International organizations and fora 1 Input data National priorities Regulator Chemical market IAS Monitoring 1 2 3 Input indicators 3 data on the volume of production, export and import of chemicals 2 Indicators of condition concentration of pollutants in the atmosphere of cities Governance Indicators the difference between the number of prohibited and / or restricted chemicals in a particular country and other countries 8
6. Key control procedures for control of regulated objects International organizations and fora Regulatory and legal framework National priorities Regulator IAS national interstate - State registration: first introduced in production and previously unused chemicals Customs Union Commission Decision of 28 May 2010 299, Section II - Socio-hygienic monitoring Regulation Input data Chemical market Monitoring Federal Law 52 of 30.03.1999 - ban / restriction of chemicals Rotterdam Convention, Montreal Protocol - BAT Federal Law «On protection of chemicals» (as modified by Federal Law of 21.07.2014 N 219-FZ) - 9
Draft. TR CU On the Safety of Chemical Products CU TR On Chemicals Safety requirements Register of Chemicals of the Customs Union Properties Information on their prohibition, restriction or authorization of their use Registration of chemical products Notification of new chemical substances Classification and labelling of chemicals, Russian Safety Passport (GHS) Further detalisation of existing norms and introduction of new ones in the second-tier documents and other legislative acts On the procedure of opening and maintaining the Register of Chemicals of the CU On the notification of the new chemical substances 10
On the procedure of opening and maintaining the Register of Chemicals of the CU Register of Chemicals of the CU (Register) Register of the RF Register of the RB Register of the RK It is planned that the Register will be formed of the bases of existing Registries and Data Bases of the CU Member countries, data obtained in the process of notification of the new chemical substances and registration of chemical products Inventories of chemical substances of chemical products prohibited or restricted chemicals Register will contain: Data bases Chemical properties Producers/importers Safety Passports (incl. RSP) 11
On the notification of the new chemical substances CU Technical Regulation On the Safety of Chemical Products «new chemical substances should be notified before release for circulation of chemical products containing such chemical substances» Data presented should include: Chemical Safety Report Identification data Data on phys-chemical, toxicological and ecotoxicological properties of chemical substances Intended uses and etc On the notification of the new chemical substances (under development) Procedures, deadlines, document forms used in the notification procedure List and volume of the data to be requested in the notification procedure Issues of confidentiality and rights to use the data submitted in the notifications 12
Implementation of GHS in Russia and CIS countries Draft. TR CU On the Safety of Chemical Products Interstate standards Information sharing GOST 30333-2007 «Chemical product safety passport. General requirements» GOST 31340-2013 «Labelling of chemicals. General requirements» (with GOST 2007) GHS Implementation Interstate standards OECD testing: Developed in 2013: 62 standarts Developed in 2014: 4 standarts Will be approved in Dec. 2014: 13 standarts Will be approved in 2015: 25 standarts Standartdization Plan for 2015: 3 standarts Physico-chemical property testing: 12 GOST R и 1 GOST Guidance on the composition of chemical product safety passport with GOST 30333 Guidance on the selection of precautionary statements for the labelling in accordance with GOST 31340 Interstate standards Classification GOST 32419-2013 «Classification of chemicals. General requirements» GOST 32423-2013 «Mixtures classification of hazard for health» GOST 32425-2013 «Mixtures classification of hazard for environmental» GOST 32424-2013 «Classification of chemicals for environmental hazards. General principles» 13
7. Non-regulatory mechanisms International organizations and fora RCU, CISCENTER National priorities Regulator IAS Regulation Input data Chemical market Monitoring GPS 14
8. Information resources National priorities International organizations and fora Data bases Information analysis system (IAS) Data base of regulatory and legal acts on chemical regulation Lists of existing, restricted and prohibited chemicals Regulator IAS Register of state registrations Laws Resolutions Standarts Recomendations etc Input data Regulation Chemical market Monitoring Volume of production, export, import incident data Data base on chemical properties Russian Register of Potentially Hazardous Chemical and Biological Substances, POISON, MTOX, HAZRANK Registry of Russian Safety Passports 15
Register of Russian Safety Passports (RRSP) RRSP Founded in November 1994 More than 33 000 RSPs were registered by March 2014 More than 2 000 companies applied for registration Currently RSP is a not obligatory document Expertise and Registration Expert review of RSP (Title page and 16 sections) for its compliance to the requirements, completeness and reliability of information (according to GOST 30333, GOST 31340, GOST 19433, Hygienic Normatives (GN) and other documents) Input of registration data into Register of RSP (from the Title page) Creation and Registration RSP creation in accordance with Supplier documentation, different regulatory and information Data Bases Mutual approval of Title page of RSP with Supplier Input of registration data into Register of RSP (from the Title page) 16
9. Laboratory infrastructure International organizations and fora National priorities Accredited Laboratories Regulator IAS Multiple-access Centers Laws Resolutions Standarts Recomendations etc Input data Regulation Chemical market Monitoring Volume of production, export, import incident data Distributed Testing Centers (CIS) and Innovation Centers 17
10. Response on chemical accidents International organizations and fora Russian Safety Passport (RSP - analogue SDS) (GOST 30333-2007) National priorities Regulator IAS Labeling (GOST 31340-2013) Laws Resolutions Standarts Recomendations etc Input data Regulation Chemical market Monitoring Volume of production, export, import incident data Unified State system of Emergency prevention and response Government Decision Russian Federation from 30.12.2003 794 Availability of Emergency Response Centers (ERC) and others forms of information sharing 18
Trends and tasks 1 Chemicals testing GLP standards 2 Data collection, systematization and storage 3 Hazard, exposure and risk assessment 4 Risk management 5 Support of regulatory decisions 6 Control of obligations 7 International cooperation development data bases, lists systematic investigations IAS BAT IAS ERC target indicators forecasting econometrics 19
Measures for risk management Balance the interests of regulator and businesses Technological Group of BAT Informational Support of regulatory decisions Protective PPE 20
Technological measures BAT implementation National priorities International organizations and fora Laws Financial support Environmental permits Regulation Regulator Information and analysis database (IAS) Monitoring volumes of production, export, import volumes of wastes incident data technology used Input data Optimized group of BAT for a facility 21
Informational measures Functionality Data storage (Data bases on chemicals, products and final documents) Document templates Computational methods (automatization) Search mechanisms Interaction media (regulator and industry) Software implementation IAS Information analysis system Areas of use Hazard classification Labeling SDS Risks (CSR/GPS) ERC BAT Identification Notification Registration Priority setting Volumes tracking 22
Harmonization Strategic Approach to International Chemicals Management (SAICM) Globally Harmonized System of Classification and Labelling of Chemicals (GHS) OECD Legal instruments in the field of chemicals OECD, UNEP and UNIDO Draft management scheme for industrial chemicals for the IOMC Toolbox APEC Principles for Best Practice Chemical Regulation 23