AOAC INTERNATIONAL

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Performance Requirements for New and Modern
Methods an EU perspective

• AOAC INTERNATIONAL
• June 25-26, 2009, Rockville, MDWolf Maier,
  Counselor, Food Safety, Health, Consumer Affairs

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General Rule for Analytical Methods

• Regulation (EC) No 882/2004 of the European
  Parliament and of the Council of 29 April 2004 on
  official controls performed to ensure the
  verification of compliance with feed and food
  law, animal health and animal welfare rules
• Article 11 Sampling and analysis methods used in
  the context of official controls shall comply
  with relevant Community rules or
• If none exist, internationally recognized rules
  or protocols, for example those that the European
  Committee for standardisation (CEN) has accepted
  or those agreed in national legislation

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General Rule for Analytical Methods

• If no internationally recognized protocols exist,
  other methods may be used that are suitable for
  the intended purpose and developed in accordance
  with general scientific principles
• Validation may take place within a single
  laboratory according to an internationally
  accepted protocol

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Community Reference Laboratories

• Community reference laboratories (Article 32)
• Provide national reference laboratories with
  methods
• Organize comparative testing in accordance with
  internationally accepted protocols, when
  available
• Make technical advances in the field
• Training of staff from national reference
  laboratories and of experts from developing
  countries
• Dispute settlement where Member States contest
  the results of analyses
• Collaborate with laboratories in third countries

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Characterization

• Wherever possible, methods of analysis shall be
  characterized by the following appropriate
  criteria
• Accuracy, precision, repeatability
• Applicability (matrix and concentration range)
• Limit of detection, limit of determination
• Recovery, selectivity
• Linearity, measurement uncertainty
• Precision values (from collaborative trial
  conducted in accordance with e.g. ISO 5725 1994
  or IUPAC International Harmonised Protocol)

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Performance Criteria

• Where performance criteria for analytical methods
  are established, they must be based on criteria
  compliance tests
• Repeatability and reproducibility values must be
  expressed in an internationally recognized form
  (e.g. 95 confidence intervals)
• Methods of analysis which are applicable
  uniformly to various groups of commodities should
  be given preference over methods which apply only
  to individual commodities

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Standardization

• The Commission may lay down
• Methods of sampling and analysis, including the
  confirmatory or reference methods to be used in
  the event of a dispute
• The performance criteria, analysis parameters,
  measurement uncertainty and procedures for the
  validation of such methods
• Rules on the interpretation of the results

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Standardization

• Standardized methods of analysis are of
  importance to guarantee safety and ensure the
  free circulation of feed and food within the EU
• However, DG SANCO intends to establish methods of
  analysis only in very specific cases as regards
  safety of feed and food
• Standardization of methods is largely entrusted
  to CEN

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Putting These Principles Into Practice

• COMMISSION REGULATION (EC) No 152/2009 laying
  down the methods of sampling and analysis for the
  official control of feed
• Replaces 19 pieces of specific legislation
• Deleted 50 of the analytical methods from the EU
  books (next year 50 of the rest)
• Prescriptive only for empirical methods where
  result depends from protocol (starch, sugar)
• Performance criteria for all other methods

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Other Examples for Performance-Based Requirements
for Analytical Methods

• Mycotoxins in food (Regulation 401/206)
• Nitrates in certain foods (Reg 1882/2006)
• Dioxins in certain foods (Reg 1883/2006)
• Lead, cadmium, mercury, inorganic tin, 3-MCPD and
  benzo(a)pyrene in food (333/2007)
• Analytical methods for veterinary drugs, hormones
  and growth promotors in animals and animal
  products (Decision 2002/657)

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Sources of Information

• General Informationhttp//ec.europa.eu/food/inde
  x_en.htm
• Sampling and analysishttp//ec.europa.eu/food/fo
  od/chemicalsafety/contaminants/sampling_en.htm
• European Food Safety Authorityhttp//efsa.europa.
  eu
• And please contact our Delegationdan.rotenberg_at_e
  c.europa.eu(202) 862 9562

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