EU-Project: Trade and Private Sector Development (TPSD) Standards Landscape Achim Seiler, Trade Consultant and Capacity Building Specialist, Kathmandu EU-Project: Trade and Private Sector Development (TPSD) TPSD is implemented by in cooperation with and

Coverage TBT Measures necessary to ensure the quality of exports, or for the protection of human, animal or plant life and health, of the environment, or for the prevention of deceptive practices, at the levels considered appropriate (…) necessary for the protection of essential security interests (preamble)

Coverage SPS Measures to protect human, animal or plant life or health, subject to the requirement that these measures are not applied in a manner which would constitute a means of arbitrary or unjustifiable discrimination between Members where the same conditions prevail or a disguised restriction on international trade (preamble)

Interface between SPS and TBT TBT: The provisions of the Agreement do not apply to sanitary and phytosanitary measures as defined in Annex A of the Agreement on the Application of Sanitary and Phytosanitary Measures (Art. 1.5) SPS: Nothing in this Agreement shall affect the rights of Members under the Agreement on Technical Barriers to Trade with respect to measures not within the scope of the Agreement (Art. 1.4)

SPS-Measures Protection of: Against risks arising from: Diseases carried by animals, plants or their products Additives, contaminants, toxins or disease-causing organisms in food, beverages or feedstuffs Diseases, disease-carrying organisms or disease-causing organisms Entry, establishment or spread of pests Human Life or Health Animal Life Plant Life Member’s Territory

Against risks arising from: Protection of: Against risks arising from: Diseases carried by animals, plants or their products Additives, contaminants, toxins or disease-causing organisms in food, beverages or feedstuffs Diseases, disease-carrying organisms or disease-causing organisms Entry, establishment or spread of pests Human Life or Health Animal Life Plant Life Member’s Territory

Against risks arising from: Protection of: Against risks arising from: Diseases carried by animals, plants or their products Additives, contaminants, toxins or disease-causing organisms in food, beverages or feedstuffs Diseases, disease-carrying organisms or disease-causing organisms Entry, establishment or spread of pests Human Life or Health Animal Life Plant Life Member’s Territory

SPS and/or TBT Source: Codex

Commonalities Harmonization Establishment, recognition and application of common measures by different Members Equivalence Acceptance of another country’s procedures as equivalent whenever the same level of protection is achieved Transparency Designation of a national notification point, establishing one or more enquiry points Technical Assistance Assistance to Developing Country Members to enable their compliance with the stipulations of the SPS and TBT agreements. S+D Longer transitional period, DCs not expected to use int. standards as a basis for their technical regulations or standards, incl. testing methods (TBT) Dispute Settlement Unified WTO dispute settlement procedure (additional options under SPS)

Main (Formal) Difference Mandatory or voluntary voluntary VC Operators mandatory ‚SHALL‘ ‚SHALL‘ Regulators/ Legislators SPS TBT

Private, commercial Standards (EU-TPSD) Private, commercial Standards Mandatory Standards SPS/TBT, CAC, OIE, IPPC

Standards and Regulations from the Perspective of VC Operators Private voluntary standards Regional requirements National requirements: standards or regulations SPS TBT CAC OIE IPPC FPs, PBRs TPSD RoO, IPR

Conceptual issues I Standard Regulation Technical Regulation Measure Mandatory Voluntary Horizontal Vertical Testing Inspection Certification Registration

Conceptual issues II Conformity Assessment Accreditation Calibration Metrology Assessment Auditing Guides Recommendations Due diligence Food supply chain operators Food supply chain supporters Food supply chain enablers

Conceptual issues III Good agricultural practice Good hygiene practice Good manufacturing practice Good distribution practice Good laboratory practice Preparatory programs Risk assessment Risk management Risk communication Proficiency testing Certification mark

Conceptual issues IV Certificate of origin Geographical indication First, second, third party Label Norm NTM NTB Notification point Enquiry point Competent authority REC MRA, MLA

How to categorize standards and regulations Horizontal versus vertical Mandatory versus voluntary Public versus private Individual versus collective National versus international B-to-B versus B-to-C Result orientation versus means orientation Product versus process attributes Standard setters versus standard takers Reactive versus proactive Regulating versus self-regulating

Public mandatory versus private commercial requirements Mandatory requirements Commercial requirements Fresh apples should be… …free of pesticide residues, pests and diseases that might establish themselves in the importing country. …of a specific variety, colour, size, flavour, sweetness, freshness, organically or conventionally grown, free of blemishes, washed, waxed, etc.

Standard-Setting Levels Private Voluntary GlobalGAP, BRC, QS, SQF, etc. Multilateral CAC, OIE, IPPC, ISO supranational Mandatory and/or voluntary EU Regional SAARC National NBSM, DFTQC

Food Supply Chain …to Fork From Farm….. Consumers Agricultural Production Sale of Commodities, raw materials, etc. Manufacturing, packaging etc. Sale of food products, im- and export

Food Supply Chain II Consumers Authority Operators Service Providers Competent Authorities (regulations and controls) Growers Producers of fertilisers, soil amendments, biocides, pesticides Producers of additives and processing aids Equipment manufacturers Service providers Trainers, Experts Laboratories Animal feed producers Transport operators, local buyers… Processors Exporters/Importers Wholesalers/Distributors Retailers, Restaurants Consumers Source: ColeACP/EDES

Private Voluntary Standards: Vertical and Horizontal jjnnn Consumtion Horizontal Standards Retail Trade Good Practice Models GHP, HACCP Vertical Standards ISO 14000 family ISO 9000 family ISO 22000 family QF, SQF GRP Trade and Logistics BRC IOP, COCERAL, FPA-Safe, IFS Logistics GDP Processing and Packaging BRC Food, BRC Packaging, Dutch HACCP, FPA Safe, IFS, Label Rouge GMP Production EuropGAP & approved schemes AMAGAP, ChileGAP, Mais Doux, etc.n GAP Input Suppliers GMP EuropGAP Propagation Material Standard, Feed Manufacturer Standard Source: Guenther

Food Safety Management Systems How is HACCP implemented? Assemble HACCP team (Pre-Step 1) Describe the product (Pre-Step 2) Identify intended use (Pre-Step 3) Construct the flow diagram Pre-Step 4) On-site confirmation of flow diagram (Pre-Step 5) List all potential hazards associated with each step, conduct a hazard analysis, and consider any measure to control hazards (Codex: Principle 1) Determine critical control points (CCP) (Principle 2) Establish critical limits for each CCP (Principle 3) Establish a monitoring system for each CCP (Prcpl.4) Establish corrective actions (Principle 5) Establish verification procedures (Principle 6) Establish documentation and record keeping (Prcpl.7)

Integration of HACCP into ISO 22 000 Plus interactive communication, system management Plus prerequisite programs GAP, GMP etc. GAP, GMP etc. Plus Principles Pre-Steps Pre-Steps Pre-Steps Pre-Steps HACCP ISO 22 000

Common Features across all ISO Management Standards For all concerned, including the management representative, defining responsibilities and designating authorities Resource management Control of documents Control of records Internal audit Corrective action Preventive action Continual improvement of the system Periodic review of the system by top management

Quality Infrastructure Market/ Client/ Consumer Product quality recognized through certification Value Chain: Regional and International System SAARC, CAC, OIE, IPPC, ISO, IAF, ILAC, etc Certification Bodies Product Certificate Standards, Testing Analysis Research Inspections Calibrations Reference Materials Accreditation Bodies Inspection Bodies Standardisation Bodies Testing Bodies Metrology Bodies Calibration Bodies Political, legal, regulatory framework Source: PTB

Conformity Assessment Hierarchy Accreditation Body ISO/IEC 17011 Testing and Calibration Laboratories ISO/IEC 17025 Inspection Bodies ISO/IEC 17020 Certification Bodies ISO/IEC Guide 65 ISO/IEC 17021 etc. Clients Various product and technical requirements Clients Various product and regulatory requirements Clients ISO 9001 ISO 14001 etc. Source: Gilmour

First, Second and Third Party Second Party First Party Third Party

First, Second and Third Party Second Party Third Party First Party

First, Second and Third Party Second Party First Party Third Party

First, Second and Third Party Second Party Tested once, inspected once, certified once, accepted everywhere First Party Third Party

Does accreditation automatically lead to the recognition of test reports and certification? A regulatory body or commercial buyer may: Accept any test report Accept a test report from a laboratory that has established a good reputation with a particular regulatory authority or customer Accept a test report from a laboratory accredited by the national accreditation body in the importing market, provided the test report is endorsed by that accreditation body Accept a test report from a laboratory accredited by one of the mutual recognition partners where mutual recognition arrangements exist between accreditation bodies Accept test reports only from the laboratory operated by the relevant regulatory authority Source: ITC/PTB

Thank You Seiler.achim@yahoo.de