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 Good regulatory and CA practices at UNECE projects Rio-de-Janeiro, December 2006 United Nations Good regulatory and CA practices at UNECE projects Rio-de-Janeiro, December 2006 United Nations Economic Commission for Europe

Plan of the presentation A. About UNECE B. Good Regulatory Governance – current tendencies Plan of the presentation A. About UNECE B. Good Regulatory Governance – current tendencies (good regulatory practices) C. WP. 6 and GRP D. WP. 6 and GCAP E. Market surveillance F. Conclusions United Nations Economic Commission for Europe

50 - 80 % of World Trade is between UNECE Member States (55 member 50 - 80 % of World Trade is between UNECE Member States (55 member States, Europe, North America, CIS) IS CA FI NO EE LV LT DK IE GB NL BE FR PT ES PL DE L CH US SE RU BY CZ UA SK AT HU M D SLHR RO BA YU IT BG AL MK GR TR MT KZ GE AM AZ TM KG UZ TJ CY IL United Nations Economic Commission for Europe

The UNECE’s Support to Governments and Business (since 1947) v Legal Instruments (conventions, standards, The UNECE’s Support to Governments and Business (since 1947) v Legal Instruments (conventions, standards, regulations …) v Trade & Transport Facilitation v Harmonization & Standardization United Nations Economic Commission for Europe

TRADE AND TRANSPORT FACILITATION Reducing trade transaction costs through: Ø Harmonisation and Simplification of TRADE AND TRANSPORT FACILITATION Reducing trade transaction costs through: Ø Harmonisation and Simplification of Procedures Ø Standardisation of Documentation and Information Flows United Nations Economic Commission for Europe

Trade Facilitation: Achievements A. UN layout key for trade documents B. UN/EDIFACT C. Codes Trade Facilitation: Achievements A. UN layout key for trade documents B. UN/EDIFACT C. Codes for trade locations D. UN/CEFACT supply chain reference model E. E-commerce standards F. “Single Window” United Nations Economic Commission for Europe

Jaimurzina: TIR stand for “Transport internationaux routiers” Transport Ø Regulations: Regulations on vehicles’ construction Jaimurzina: TIR stand for “Transport internationaux routiers” Transport Ø Regulations: Regulations on vehicles’ construction Transport of dangerous goods Ø Agreements: International transport of goods (transit under TIR convention) United Nations Economic Commission for Europe

HARMONIZATION & STANDARDIZATION Ø Good Regulatory Practices in Trade Ø Agricultural Quality Standards Ø HARMONIZATION & STANDARDIZATION Ø Good Regulatory Practices in Trade Ø Agricultural Quality Standards Ø Harmonization of Statistical Data Definitions and Collection United Nations Economic Commission for Europe

Quality Standards for: • • • Fresh and Dried Fruits and Vegetables Meat Potatoes Quality Standards for: • • • Fresh and Dried Fruits and Vegetables Meat Potatoes Egg & Egg products Cut flowers United Nations Economic Commission for Europe

Good Regulatory Practices 1. Working Party on Regulatory Cooperation and Standardization Policies (Working Party Good Regulatory Practices 1. Working Party on Regulatory Cooperation and Standardization Policies (Working Party 6) 1. International Model for Technical Harmonization (UNECE Recommendation “L”) 2. Promoting good practices in standardization, regulatory techniques and market surveillance United Nations Economic Commission for Europe

Good Regulatory Governance & Practices Why Good Regulatory Practices (GRP)? GRP: = = = Good Regulatory Governance & Practices Why Good Regulatory Practices (GRP)? GRP: = = = Good regulatory quality Good governance Gains for society Regulatory impact assessment Cost efficiency for society United Nations Economic Commission for Europe

Regulatory differences: possibilities to improve National (Brazil): Starting a business takes: • 19 days Regulatory differences: possibilities to improve National (Brazil): Starting a business takes: • 19 days in Minas Gerais • 152 days in São Paulo In international context, based on an OECD study of 155 States, at a world level: • Minas Gerais is ranked 30 • São Paolo is ranked 149 (Source "Doing Business in Brazil", IFC/World Bank publication, 2006) International GRP context: • Work at OECD, APEC, US, EC and EU countries, etc. • GRP training (on RIA-College of Europe) United Nations Economic Commission for Europe

From « culture of control » to « culture of shared responsibilities » “Traditional” From « culture of control » to « culture of shared responsibilities » “Traditional” regulatory approach: v Control inspect punish “Smart” regulatory approach: v v Focus on outcome (not on tools/means) Cost/benefit assessment through consultation, balance of interests United Nations Economic Commission for Europe

Regulatory approaches « culture » “Traditional” “Smart” Sectoral Coordinated One time Systematic/monitored Conventional means Regulatory approaches « culture » “Traditional” “Smart” Sectoral Coordinated One time Systematic/monitored Conventional means Tailored Impose on market Use market Procedure – focus Outcome/objective Top – down Bottom-up Authorian Transparent/Consultation United Nations Economic Commission for Europe

 « Smart » regulation provides: Ø Problem definition/risks profile/scenarios Ø Objective of regulation/incentives « Smart » regulation provides: Ø Problem definition/risks profile/scenarios Ø Objective of regulation/incentives Ø Solution justification (alternatives) Ø Effectivness to reach the outcome Ø Benefits/costs calculation Ø Proportionality of chosen measures Ø Consistent/simple (versus legislation) Ø Overall social net effect cost-efficienct outcome for society United Nations Economic Commission for Europe

Consulation with civil society -WHY ? Ø Transparency = understanding = compliance Ø Reduce Consulation with civil society -WHY ? Ø Transparency = understanding = compliance Ø Reduce regulatory failures ( problem or its "shadow" ? ) Ø Best solution = technological or structural ? Ø Result: « Smart" regulation, partnerships, good governance United Nations Economic Commission for Europe

GRP & WP. 6 Ø Technical regulations – where to start? Ø Should you GRP & WP. 6 Ø Technical regulations – where to start? Ø Should you regulate? Ø If yes, what is the potential impact? Ø Based on impact assessment, how you shall regulate? United Nations Economic Commission for Europe

International UNECE Forum on Common Regulatory Language for Global Trade, Geneva, 20 -21 June International UNECE Forum on Common Regulatory Language for Global Trade, Geneva, 20 -21 June 2006 v “UNECE region plus…” event v Good regulatory practices (WTO, OECD, ISO, UNECE) v Regional experiences (EU, North America, ASEAN, MERCOSUR, CIS) v To regulate or not to regulate… United Nations Economic Commission for Europe

Regulatory Method - « self-regulation » (examples) v Information awareness (by/for industry and consumers/users). Regulatory Method - « self-regulation » (examples) v Information awareness (by/for industry and consumers/users). standards, voluntary certification, quality/environment management schemes, industry codes (company; sectoral; multi (uni) lateral; "recognized", etc. ), customer charters, official codes/guidelines… v Need for regional/international convergence? United Nations Economic Commission for Europe

Regulatory Method - Binding Regulation (examples) v Performance regulations; mandatory information/labelling; economic incentives (taxes, Regulatory Method - Binding Regulation (examples) v Performance regulations; mandatory information/labelling; economic incentives (taxes, subsidies, "user pay" charges, loans/loan guarantees, insurance, public expenditure, public ownership, etc. ); certification; … v Need for regional/international convergence ? United Nations Economic Commission for Europe

Promoting Good Practices v The Team of Specialists on Standardization and Regulatory Techniques (“START”) Promoting Good Practices v The Team of Specialists on Standardization and Regulatory Techniques (“START”) v The Advisory Group on Market Surveillance (“MARS” Group) v Promoting Good Governance including dialogue and cooperation with the private sector and NGOs United Nations Economic Commission for Europe

International Model for Technical Harmonization (REC. L) PRINCIPLES 1. National technical regulations on the International Model for Technical Harmonization (REC. L) PRINCIPLES 1. National technical regulations on the basis of international (regional) standards 2. "Common regulatory objectives" on the basis of mutually agreed safety and other legitimate requirements 3. Regulators should not harmonize existing regulations, but rather should try to agree on what safety (etc. ) levels they would like to achieve United Nations Economic Commission for Europe

International Model for Technical Harmonization 1. Regional application: CIS technical harmonization agreement on 2. International Model for Technical Harmonization 1. Regional application: CIS technical harmonization agreement on 2. Balkan project: training of officials on good regulatory practices 3. Sectoral application: 1. The TELECOM initiative 2. Earth-Moving Machinery 3. Safety of Pipelines Initiative (2005) 4. Equipment for explosive environment. (June 2006) United Nations Economic Commission for Europe

UNECE/SIDA Southeast Europe Regulatory Project Ø Identify regulatory-related obstacles to regional trade Ø Agree UNECE/SIDA Southeast Europe Regulatory Project Ø Identify regulatory-related obstacles to regional trade Ø Agree on national and regional regulatory priorities Ø Propose solutions for regulatory convergence Ø Promote good regulatory practices United Nations Economic Commission for Europe

Good Practices for Conformity Assessment (GPCA) WTO principles transformed in GPCA: v SDo. C Good Practices for Conformity Assessment (GPCA) WTO principles transformed in GPCA: v SDo. C (pre-requisite: liability laws for manufacturers and efficient market surveillance) v Acceptance of CA results ( «one test-one certificateaccepted worldwide» ) v Less certification (voluntary compliance means? ) United Nations Economic Commission for Europe

Conformity Assessment at WP. 6 A. National and regional developments (laws, procedures, changes in Conformity Assessment at WP. 6 A. National and regional developments (laws, procedures, changes in infrastructure) B. Accreditation developments C. Quality and environmental schemes (quality national policies, awards, integrated schemes, public governance, etc. ) D. Definitions (support to ISO work ) E. Market surveillance United Nations Economic Commission for Europe

Market Surveillance (MS) at WP. 6 v UN General Assembly decision 54/449 of 22 Market Surveillance (MS) at WP. 6 v UN General Assembly decision 54/449 of 22 December 1999 (United Nations Guidelines for Consumer Protection) v International MS Forums (2002 & 2005) v Etablishing «MARS» Group in 2003 United Nations Economic Commission for Europe

Control of Safety (at which stage and how? ) Design Production Placing on market Control of Safety (at which stage and how? ) Design Production Placing on market 1. Certification Market surveilance v From certification to MS (& maybe to SDo. C) United Nations Economic Commission for Europe

Market Surveillance (MS) v Common feature- no (few) common features v Differencies in institutional Market Surveillance (MS) v Common feature- no (few) common features v Differencies in institutional structure (number of bodies, to whom repport), v Scope of work (safety or plus quality, IPR), legal basis, … v Less certification more market surveilance? United Nations Economic Commission for Europe

EU (EC) requirements for national MS organization v organize communication and national coordination between EU (EC) requirements for national MS organization v organize communication and national coordination between relevant authorities (incl. labour inspectorates and customs) v establish necesary procedures (for non-compliant products) in order to: ü ü ü Record of complaints/reports and follow-up Monitor accidents and damage to health, public interest Establish/implement MS programmes for specific categories of products or risks United Nations Economic Commission for Europe

EU (EC) requirements for MS measures (authorities shall: ) Ø Perform checks on safety EU (EC) requirements for MS measures (authorities shall: ) Ø Perform checks on safety (and other issues) on adequate scale through appropriate controls (documentary, or physical, laboratory checks) Ø Apply best practices and sound resources Ø Take necessary representative samples of products for controls Ø Require that necessary documentation/information is available by economic operators (manufacturer, importer, distributor) …/… United Nations Economic Commission for Europe

Ø Take appropriate necessary national measures to alert/inform users of the risks from dangerous Ø Take appropriate necessary national measures to alert/inform users of the risks from dangerous products placed on the market Ø Cooperate with economic operators on actions to avoid or reduce risks caused by their product Ø Carry out other duties with due independence and observe confidentiality and professional secrecy Ø Take appropriate measures when a dangerous product is detected (or sufficient reason to believe it) on the basis of a risk analysis (taking into account the precautionary principle) Ø Contribute to and use EU integrated information system on MS United Nations Economic Commission for Europe

EC Proposals for EU MS Electonic Information System v Archiving of data v Information EC Proposals for EU MS Electonic Information System v Archiving of data v Information exchange on MS activities in general v Particular MS information (MS statistics, information by sector, by product, . . . ) v Risk analysis methodlogies and results v Anaylsis of accidents with comparative data to exchange/adopt best practices v Information on counterfeits that could have impact on health, or other issues of public interest v Accessible to public (with safegurad of confidentiality and professional secrecy) United Nations Economic Commission for Europe

MS problems and solutions (examples from “MARS” Group) v Legal representation on the market MS problems and solutions (examples from “MARS” Group) v Legal representation on the market v Intellectual property rights (IPRs) and MS v Sampling, misleading labelling , success criteria, etc. v Who needs MS (state, companies)? Coordination … United Nations Economic Commission for Europe

“Disappearing” companies v Who “represents” the product on the market? v Slovakia: Control by “Disappearing” companies v Who “represents” the product on the market? v Slovakia: Control by authorities (of legal papers and of premises) which grant permissions to sell on markets v Israel: Regime for imported goods based on risks of products and their use United Nations Economic Commission for Europe

Israel – four imported products’ groups 1. High danger (207 products; toys, electrical home Israel – four imported products’ groups 1. High danger (207 products; toys, electrical home appliances …): certification of each shipment 2. Medium (120 ; carpets, bottles. . . ): type approval 3. Low (39; ceramic tiles. . . ) : importer’s declaration. 4. For industrial use (11): SDo. C United Nations Economic Commission for Europe

IPR & UNECE Recommendation “M” v Counterfeits = 5 -7 % of international trade IPR & UNECE Recommendation “M” v Counterfeits = 5 -7 % of international trade (in Russia: up to 1/3 in some sectors) v Counterfeit conformity assessment marks v Use of market surveillance against counterfeit goods (under preparation - adoption in 2007? ) v Need for coordination on national level (IPR & other matters with customs, consumer protection, etc. ) United Nations Economic Commission for Europe

 Sampling in MS: Who pays? v Brazil: - manufacturer replaces product to retailer Sampling in MS: Who pays? v Brazil: - manufacturer replaces product to retailer v Russia, Belarus: retailer pays (restrictions on inspections to avoid abuse) v Czech Republic: MS body takes a product for inspection (charged when product meets requirements) v EU, Indonesia, Turkey, etc. : MS body buys the product from its budget United Nations Economic Commission for Europe

New problems - new experiences v Misleading labelling (fresh orange juice, cholesterol free, only New problems - new experiences v Misleading labelling (fresh orange juice, cholesterol free, only 1% salt, etc. ) v Choice of laboratories to inspect products (through tender? ) v Criteria of MS success (0% or 100% of inspected products are safe? ) United Nations Economic Commission for Europe

Conclusions & Way forward v GRPs and GPCA: no «one size-fit all » recipe Conclusions & Way forward v GRPs and GPCA: no «one size-fit all » recipe v “Think globally - act locally”: “tailor” your own solutions on the basis of national and international experiences v UNECE welcomes you to join its work United Nations Economic Commission for Europe

Thank you ! OBRIGADO ! For more information, please contact: Mr. (Dr. ) Serguei Thank you ! OBRIGADO ! For more information, please contact: Mr. (Dr. ) Serguei Kouzmine Secretary to UNECE Working Party on Regulatory Cooperation and Standardization Policies (WP. 6) Tel. (+41 22) 917 2771; Fax (41 22) 917 0479/0037 e-mail : Serguei. Kouzmine@unece. org United Nations Economic Commission for Europe