英文_OIV_葡萄栽培领域的De_Minimis理念_14页_3mb

Summary of the De Minimis Notion in the Vitivinicultural Sector

Core Content

The document explores the concept of de minimis in the vitivinicultural industry, focusing on its definition, relevance, and application across analytical, technological, health, legal, environmental, and societal dimensions. It outlines the need for a standardized analytical threshold to address the practical and interpretative challenges associated with detecting substances at trace levels, especially in the context of regulatory compliance, consumer expectations, and scientific advancements.

Main Points

• Origin of the Concept:
  The term "de minimis" originates from Roman law, meaning "the judge does not deal with that which is insignificant." It is primarily used to translate regulatory criteria into analytical ones.

• Analytical Challenges:

  • "0" is not achievable in analysis due to inherent measurement uncertainties.
  • The concept of de minimis is distinct from the limit of quantification (LOQ), which varies by laboratory and is not stable over time.
  • A de minimis value should be set at a level where the analytical result is no longer relevant, not as a regulatory or toxicological limit.

• Technological Relevance:

  • De minimis is relevant to the classification of additives and processing aids.
  • It allows for the exemption of trace amounts of substances from labelling requirements, provided they are not contaminants.
  • Examples include sulphites, pesticides, and ethanol in dealcoholised wines.

• Health Considerations:

  • De minimis values are not related to toxicological thresholds (e.g., ADI, TDI) but are instead based on regulatory and environmental considerations.
  • They should not be used in uncontrolled toxicological contexts.
  • The concept is not a safety issue but a question of relevance in reporting.

• Legal Framework:

  • The legal definition of "0" is ambiguous and often depends on expert interpretation.
  • De minimis values must be based on scientific and legal consensus, not on unilateral decisions by certification bodies or private laboratories.
  • Legal interpretations of trace substances can lead to disputes, highlighting the need for harmonization.

• Environmental Context:

  • Some substances may be present due to environmental background noise or unintentional exposure.
  • De minimis values help differentiate between analytically detectable residues from environmental sources and those from intentional technological processes.

• Societal and Consumer Expectations:

  • Consumers expect to know whether a substance is "absent" in a product.
  • The de minimis value serves as a practical indicator of "irrelevant" levels, helping to avoid unnecessary concern or litigation.
  • Public education is necessary to clarify the meaning and application of de minimis thresholds.

Key Objectives

• To define de minimis as an analytical threshold that is not a regulatory or toxicological limit but a value indicating non-relevance in reporting.
• To establish a common interpretative framework for trace analysis across all stakeholders.
• To ensure consensus among scientific, legal, and societal actors in defining and applying de minimis values.
• To regularly review de minimis values in light of new scientific data, legal developments, and societal expectations.

Conclusion

The de minimis notion is a crucial tool for managing trace substances in wine, particularly those that are not contaminants but may be unintentionally present. It aims to balance the need for accurate analytical reporting with the practical realities of detection limits and consumer perception. The OIV task force is working to harmonize its interpretation and application across the vitivinicultural sector, ensuring consistency and reducing potential disputes.