An analytical instrument manufacturer's perspective; - JIFSAN: IFSTL

35 Pages·2013·2.04 MB·English

An analytical instrument
manufacturer’s perspective;
supporting the accreditation and training
needs of food testing laboratories

Sara Stead PhD
[email protected]
Fera-JIFSAN Annual Symposium
13th June 2013
©2013 Waters Corporation 1
Overview
 Food testing analysis requirements & challenges – “the
big five”

 The regulatory perspective?

 Technology solutions to solve real world challenges
– Case study 1; ASAP for rapid testing of export samples

 Demonstrating “fitness for purpose”
– Case study 2; Validation of a multi-residue method
accordance with regulatory criteria

 Making the customer successful
– Supporting capacity building & training priorities

©2013 Waters Corporation 2
Food analysis – requirements?
the “big five”
Robust
Rapid multi-class
quantitative
screening
analytical tools
Simplified
“Ease of
extraction
operation”
protocols
Identification
of
“unknowns”
©2013 Waters Corporation 3
Quantitative trace residue analysis
What challenges do our customers face?
Matrix &
analyte
complexity
Validation & Sample type &
AQC extract
requirements preparation
Compliance with
Ease of use &
regulatory
implementation
performance
criteria
©2013 Waters Corporation 4
Complying with the regulatory
framework the “day-to-day” challenges
 Regulated market sector
 Regulations vary with geography
 Trade barriers?
 Permitted residue levels
 Authorised compounds, e.g. ractopamine
 Requirement to validate method performance & monitoring
ongoing AQC

 Drive to harmonise the regulations globally (CODEX,
WHO FAO)
 International standards for food safety
 Many countries choose to implement the criteria of the countries
they export to
• EU has criteria for “third countries”

©2013 Waters Corporation 5
Regulations may define the choice of
analytical method employed
Suitable for use as confirmatory assays

)
y
for BANNED compounds
t
i
Techniques Suitable for use as v
I i
t
n
suitable for confirmatory assays c
c e
re screening for permitted el
a s
s assays MS/MS compounds (
in e
t
g
a
p LC/GC-MS n
o i
m
t
e i
r
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c
t LC-F s
i
a i
d
l

f o
o
t
r
y
in LC-UV t
i
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i
e b
r a
f
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g
r
e ELISA n
n i
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e Microbiological e
s r
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©2013 Waters Corporation 6
Instrument manufacturers role?

Meeting the ne eds of the industry

Regulatory Current analytical

challenges?
Requirements?

Sample complexity
Permitted limits
Sensitivity
Banned residues
Informed product Selectivity
Validation and AQC
development via Speed of analysis

effective

communication

Emerging risks?
Future directions
Residue scares
and trends?
Consumer safety
Horizon scanning
Toxicological assessments

©2013 Waters Corporation 7
Deployment of technology solutions
to solve complex analytical
challenges

©2013 Waters Corporation 8
Case Study -1
Strategy for rapid analysis
2011 plasticizer incident in food
exports from Taiwan

©2013 Waters Corporation 9
Background
2011 plasticiser incident in Taiwan
 Di(2-ethylhexyl) phthalate (DEHP): general purpose plasticizer used to make soft / pliable
plastics
 Toxicity
– 20 times more toxic than melamine!
– Classified as class B2 (probable human carcinogen)
 Regulations
– Dissolved DEHP maximum level must not exceed 1.5 ppm
– International TDI between 1.2 - 8.4 mg /60 kg adult
 May 2011 Taiwan FDA found DEHP in powdered probiotics
– Product recall, traced back “clouding agent” food additive
– Rigorous tests were carried out on six categories of food & beverages including:
Sports, fruit and tea drinks
o
Jam and jellies
o
Food powders
o
Health supplement tablets
o
 Rapid screen for the presence of DEHP using a simple technique with minimal
sample preparation and no chromatographic separation was required…
©2013 Waters Corporation 10