Mike Sargent LGC Limited, Teddington, UK

The fundamental importance of valid measurements for competitiveness and

regulatory enforcement

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Overview

1. Importance of measurements to the economy and quality of life

2. Issues and drivers for valid measurements

3. Obtaining valid measurement results

4. Achieving globally consistent chemical and biological measurements

5. Conclusions

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1. Importance of measurements to the economy and quality of life

• Sound measurement science is fundamental for scientific and medical research, production of goods and services, commerce, communications, health, environmental protection, etc.

• A measurement system creates an internationally agreed framework within which suppliers of products and services can demonstrate compliance with specifications and regulations.

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Chemical and biological measurements are all-pervasive • They underpin every aspect of everyday life, e.g.

• Health and safety

• Quality of the environment

• Research and development of new products

• Efficient agriculture and food production

• International trade in goods and services

• They are essential for social and economic activities, e.g. • Quality control of manufacturing

• Compliance with regulations

• Medical diagnostics

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Measurement for economy and trade

• 2010 world export volumes (WTO International Trade Statistics 2011): • Food products > $US 1118 billion

• Pharmaceutical products > $US 461 billion

• Growth of international trade and travel, e.g. • Food products all year round from everywhere

• Global spread of diseases from increased movement of people

• Global availability of reliable, effective pharmaceuticals

• To increase productivity and support innovation

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Measurement for quality of life

• Food safety and nutritional content

• Health care, protection and diagnostics

• Cheaper, more effective drugs and treatment of patients

• Climate change, “carbon” economy, pollution control

• Security and forensics

• Anti-doping in sport

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2. Issues and drivers for valid measurements

• International trade

• Regulation

• Contractual and accreditation requirements

• Efficiency • Avoid costs of errors and repeat

measurements

• ‘Measured once accepted everywhere’

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Examples of rejected food imports due to disagreement over contaminant analysis

• Antibiotics in pork, Japan

• Antibiotics in meat, Korea

• Antibiotics in salmon, Japan

• Crystal violet in salmon, EU

• Leucomalachite green in salmon, Chinese Taipei

• Amphenicol in salmon, Canada

• Dioxin in pig meat, South Korea

• Melamine in milk

• Carbaryl in wine

• Cd in mussels

• Hg and nitrate in swordfish

• Patulin in apple and azinphos-methyl in pears and grapes

Reasons for EU and US rejections of food

• Mycotoxins

• Microbiological contaminants

• Veterinary drug residues

• Unauthorized food additives

• Heavy metals

• Pesticide residues

• Poisonous

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UNIDO EU & US Border Rejection Analyses 2011

• Other chemical contamination

• GMOs

• Biotoxins

• Organoleptic

• Adulteration

• Allergens

• Labelling and packaging

Complexity of European food trade

• Many European countries have had extensive legislation and routine monitoring of food authenticity and adulteration since the 19th C.

• In recent years auditing the origin and authenticity of processed food has become difficult due to cross-border supply chains for ingredients

• In January 2013 the Irish Food Safety Authority reported that analysis of beef burger products had found horse DNA

• Further analyses across the EU supply chain found similar problems, with large percentages of horsemeat found in beef products

Regulation of new technology: nanoparticles

• Engineered nanomaterials used as food additives • Reduction of salt, sugar and fat without affecting taste

• Silver-modified food packaging to prevent bacterial growth

• Silicon dioxide (SiO2) at the nm range to thicken pastes, clearing of beers and wines and as anti-caking agents

• Aerosil 200F and 380F additives are nanosilica

• Titanium dioxide particles used for food whitening

• UK House of Lords Science and Technology Committee, Nanotechnologies and Food Report (2009-2010) highlighted the need for measurement protocols and nanoparticle regulation

Emerging nanoparticle regulation

• EU consultation on a European Strategic Nanotechnology Action Plan (SNAP) 2010-2015

• UK Food Standards Agency strategic plan 2010-15

• US FDA nanoparticles in food guidelines (FDA-2011-D-0489-0002)

• EU regulation 1169/2011 on food information for consumers • nanomaterials should be clearly indicated in the

list of ingredients and names should be followed by (nano)

Regulation of natural products

• EU Regulation No. 1169/2011 requires detailed allergen information for consumers of non-prepacked foods and catering sales from 13 December 2014

• In the UK this has been implemented as the Food Information Regulations 2014

• 14 allergens are subject to this legislation, plus Codex and EU legislation on foodstuffs suitable for people intolerant to gluten

• Protection of the consumer requires • accurate information on labels

• minimising unnecessary ‘may contain’ labelling

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3. Obtaining valid measurement results

• Chemical and biological measurements are difficult!

• Commercial pressures demand more complex measurements at lower concentrations • But also at ever lower cost

• Valid and consistent measurements depend on laboratories adopting a systematic approach to analytical quality assurance

Analytical quality assurance

• Documented quality system

• External assessment • accreditation • Proficiency testing

• Method validation

The VAM Principles

The quality system

• The quality system describes a series of activities aimed at ensuring that all results produced by the laboratory are reliable

• A quality system on its own achieves very little except writing a quality manual

• It needs three essential elements to be effective • Qualified and competent staff

• Organisations which strive to achieve reliable data

• Sound measurement science

External assessment

• External assessment has two functions • Independent confirmation for managers that their

systems are operating as intended

• Impartial information on the laboratory for customers, regulatory bodies, etc.

• Laboratory accreditation (ISO 17025) • Outside experts review the laboratory’s operations and

quality system

• Proficiency testing (PT) or external quality assessment (EQA) schemes (ISO 17043) • External organisations provide ‘blind samples’ to

laboratories and monitor their results

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4. Achieving globally consistent chemical and biological measurements

• Analytical chemists have adopted a basically sound approach to achieving reliable measurements which are consistent locally or within an application sector • Collaborative development and testing of methods

• Validation of methods using CRMs with a similar matrix

• Direct inter-comparisons between laboratories (proficiency testing or external quality assurance)

• But these approaches are insufficient when the requirement is for measurements to be consistent on a global basis and across different periods of time • This requires adoption of metrological traceability within an international

measurement system

The ‘metrological’ approach to traceable measurements

• Relies on the same basic principles as AQA but with two key additions: • Estimation of measurement uncertainty • Traceability to SI units

• Adopted since 19th C. for physical measurements

• Extended to chemical measurements in late 1980’s when it was clear that action was needed to facilitate international consistency of chemical measurements

• Depends on a globally maintained measurement infrastructure

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“Measured once, accepted everywhere”

• To avoid duplicating measurements

• To avoid rejection or destruction of traded products

• To avoid waste of components, energy and products

• To reproduce products precisely and at low costs

• To save money and increase profits

• To obtain reliable diagnostic and therapeutic results

• To protect lives against diseases, poisoning, pollution

• To monitor climate change

The goal of international metrology

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Drivers for traceable chemical and biological measurements

• International trade and trade agreements depend on traceability to internationally accepted standards

• New regulations in many fields now include a requirement for traceable chemical measurements

• ISO 17025 requires traceable results from accredited measurement laboratories • Accreditation bodies such as ILAC, APLAC, EA, etc promote the need for

traceability in chemical laboratories

• International organisations such as CCQM, EURACHEM and CITAC have stimulated the application of traceability and uncertainty in chemistry

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Examples of drivers for metrological traceability in chemistry and biology

• Bilateral and WTO trade requirements

• Avoidance of market distortions in a single market, e.g. EU

• Compliance with regulations, e.g. EU in-vitro diagnostics directive, FDA requirements on pharmaceuticals

• Labelling of food products, e.g. vitamins, amino and sorbic acids, fat, GMO’s, caffeine, additives, pigments

• Tariff classification (e.g. fat, sugars, caffeine, protein)

• EU TRACE project (origin of food products)

• EU REACH legislation (safety of chemicals)

The international measurement infrastructure

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Metre Convention1875

General Conference on Weights and Measures

( CGPM )

meets every four years and consistsof delegates from Member States

International Committee for Weights and Measures

( CIPM )

consists of eighteen individuals elected by the CGPM

It is charged with supervision of the BIPM and affairs of the Metre Convention

The CIPM meets annually at the BIPM

Diplomatic

Treaty

Associate Statesand Economies

of the CGPM

Governmentsof

Member States

International

organizations

Consultative Committees( CCs )

Ten CCs each chaired by a member of CIPM;to advise the CIPM; act on technical matters and

take important role in CIPM MRA; compriserepresentatives of NMIs and other experts.

Nationalmetrologyinstitutes( NMIs )

CIPM

MRA

Bureau International des Poids et Mesures( BIPM )

International centre for metrology

Laboratories and offices at Sèvres

with an international staff of about seventy

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Regional Metrology Organizations

Gulfmet

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CCQM: metrology in chemistry and biology

• CCQM established 1993 • Currently 29 member organisations and 12 observers

• President NIST, W. May

• CCQM Working Groups (>250 expert participants) • Key Comparisons and CMC Quality GLHK, D. Sin

• Organic Analysis NMIA, L. Mackay

• Inorganic Analysis LGC, M. Sargent

• Gas Analysis KRISS, J. Kim

• Electro-chemical Analysis SMU, M. Mariassy

• Surface Analysis BAM, W. Unger

• Nucleic Acid Analysis LGC, H. Parkes

• Cell Analysis NIST, A. Park

• Protein Analysis KRISS, S. Park

• Extensive CCQM stakeholder and expert cooperation • WHO, WMO, ILAC, JCTLM (IFCC and ILAC), IAEA, Codex Alimentarius Commission/IAM, IUPAC, WADA,

Pharmacopeia, IAFSI/ENFSI, Micro-biology testing, IDF, ISO

21st meeting of the CCQM (2015)

Provision of traceability by NMIs

• High level calibrants (pure substances and their solutions/mixtures)

• Matrix certified reference materials for validation

• NMI services are declared as ‘CMCs’ (Calibration and Measurement Capabilities) within the CIPM MRA • Peer reviewed by other NMIs

• Listed in the ‘KCDB’ (Key Comparison Database) a public, online database maintained by the BIPM in Paris

• The equivalence of CMCs offered by different NMIs is ensured through an extensive programme of practical measurement comparisons (‘key comparisons’) • Organised through the CCQM and its working groups

• Results and reports publicly available from the KCDB

http://kcdb.bipm.org/

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Accreditation Body

NMI

Cal. & Test Laboratories

Products & Services

Accreditation Body

NMI

Cal. & Test Laboratories

Products & Services

Consistent measurements

Free trade Safe food

Better health care Reliable climate change measurements.

Country A Country B

Traceability within an international measurement system provides an effective and efficient means to ensure global consistency of measurements

A global system of consistent measurements

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Conclusions

• Valid analytical measurements play a key role in the economy and wellbeing of a country • Sustain competitiveness, facilitate exports, strengthen the economy and improve

the quality of life • Essential for demonstrating compliance with regulations

• Valid measurements are achieved through adoption of sound measurement science, applied by competent staff within a formal quality assurance system

• There is a clear need for global consistency of measurements based on traceability to the SI (or other internationally agreed references) • Supports society and industry through international acceptance of a country’s

measurement results

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Acknowledgements

• Organisers of RESAG 2015

• The UK National Measurement Office

• Participants and colleagues who contribute to the work of the CCQM

Thank you !

Obrigado!