Traceability and Labeling: A Global Perspective

Bobby RicheyForeign Agricultural Service/USDADecember 5, 2003

Traceability and Labeling: A Global Perspective

Key PointsMotivationGlobal ViewSpecific examplesImplications

Key Points

Mandatory biotech traceability and labeling regimes vary widely Countries rapidly adopting or considering a variety of biotech labeling regimesMany labeling regimes fail to acknowledge practical implications

Why traceability and labeling?

Traceability: Market drivenMandatory

Labeling:Market drivenMandatory

Why traceability and labeling?

Economic InterestsDeveloping countries want to maintain market access to the EU

Consumer ConcernsEU response to consumer concernsJapan/Korea respond to consumer demand but opt for less stringent thresholds, more practical measures than EU.

Why traceability and labeling?

Environmental ProtectionAustralia/New Zealand respond to consumer and environmental concerns

Market Driven vs. MandatoryU.S. opts for voluntary, market-driven labeling while EU responds to consumer demand for mandatory biotech labeling

Sometimes the reasons and policies are unclear…

ChinaIndia Brazil

Traceability and Labeling Requirements Worldwide

Country Mandatory Biotech Labeling?

Threshold

Enforced?

Mandatory Biotech Documentation Required?

Argentina No No (n/a) No

Australia/NZ

Yes 1% Yes Yes – to maintain integrity of labeling regime

Bolivia Yes No No No

Brazil Yes 1% No No

Canada No No (n/a) No

China Yes No Yes, but uneven

No

Colombia Yes No Yes No

Croatia Yes No Yes Yes

Estonia Yes 1% Yes No

EU Yes 1% (0.9% as of 4/04)

Yes Yes – as of 4/04

India No, but considering

1% (n/a) No

Indonesia Yes 5% No No, but considering

Japan Yes 5% Yes Yes – documentation required for non-biotech labeling

Korea Yes 3% Yes Yes – documentation required for non-biotech products (exemption from labeling)

Country Mandatory Biotech Labeling?

Threshold

Enforced?

Mandatory Biotech Documentation Required?

Malaysia No, but considering

No (n/a) No

Mauritius No No (n/a) No, but considering

Poland Yes, to harmonize w/EU

1% Yes No, but considering – to harmonize w/EU

Romania Yes, to harmonize w/EU

No (unclear) Yes – to harmonize w/EU

Russia Yes 5% No No

Saudi Arabia

Yes 1% Yes No

Serbia & Montenegro

Yes, to harmonize w/EU

0.9% No Yes - “May contain” documentation req. for imports

Slovakia Yes, to harmonize w/EU

1% Yes No, but will harmonize w/EU regs in future

Sudan No, but considering

No (n/a) No, but considering

Taiwan Yes – beginning 1/1/03

5% (n/a) No

Thailand Yes 5% No No

U.S. No No (n/a) No

Vietnam Yes No No No

Zambia No, but considering

No (n/a) No

Traceability and Labeling: A Closer Look

European Union and Accession CountriesDeveloping Countries Japan and KoreaAustralia and New ZealandCanada and Argentina

European Union:Traceability and Labeling Regulations

Mandatory biotech labeling regardless of detectability, unless identity preservedMandatory biotech traceability throughout the commercial chain

Products CoveredAll products produced from biotechnology including whole grains, food, and feed but excluding enzymes and processing aids used in the production.

EU Accession Countries:

Must adopt EU policies as a condition of entryCountries entering the EU in May 2004 include Cyprus, Czech Republic, Estonia, Hungary, Latvia, Lithuania, Malta, Poland, Slovakia, and SloveniaPotential future members, such as Romania, Croatia, and Serbia & Montenegro, have or are planning to harmonize biotech regulations with the EU.

Developing Countries:Traceability and Labeling Regulations

Rudimentary or no regulatory systemsProducts Covered

Generally unclear what’s coveredWhy?

Policies in response to general misinformation/lack of knowledge about biotechLack of ownership of the technologyLack of risk assessment systems/capacityExternal pressures weighing on decision makers

Japan and Korea:

Traceability and Labeling RegulationsMandatory biotech labeling3-5 percent labeling thresholdDocumentation requirement for non-biotech

Products CoveredPositive product list

Why?Pressure from consumers

Australia and New Zealand:

Traceability and Labeling RegulationsMandatory biotech labeling for 1% or moreUse of existing IP/QA system permitted

Products CoveredAcross the board – no products specified

Why?Documentation requirement to maintain integrity of labeling regime

Canada and Argentina:

Traceability and Labeling RegulationsMandatory labeling for all products containing allergens, nutritional changes, or special handling requirementsNo special labeling or product tracing requirements for biotech products

Products CoveredAll products

Why?General trust in the regulatory system

Codex Discussions of Traceability or Product Tracing:

Committee on General PrinciplesCommittee on Food Import and Export Inspection and Certification SystemsCommittee on Food LabelingAd Hoc Intergovernmental Task Force on Foods Derived from BiotechnologyCodex Ad Hoc Task Force on Animal FeedCodex Committee on Methods of Analysis and Sampling

Effects of Mandatory Biotech Labeling & Traceability:

Consumer perception potentially skewedMarket uncertaintyLoss of markets Industry reformulates or re-sourcesIncreased demands on regulatory systemsIncreased producer costsMay force changes in marketing systemsReduced investment in R&D