Ensuring Export Acceptance at the Border

- Avoiding Mycotoxin RejectionElise Palmer

VICAM – A Waters Business3rd April 2019

Overview

• What are mycotoxins? Why should we care about them? Where do they form and why?

• Where do those products affected go, and what are the regulations when they get there?

• How and where are the regulations enforced?• What can be done to verify compliance and protect your product?

What are mycotoxins?

Peni

cilli

um

Aspe

rgill

us

Fusa

rium

What are mycotoxins?

Ecological parameters affecting mycotoxin production

• Moisture• Spore Load

• Temperature• Competing Microflora• Substrate

• CO2/O2

• Time

• Mechanical Damage• Insect Damage

F. Ihara

• Organic crops not treated with fungicides are especially vulnerable

Mycotoxin Economic and Health Risks

Biological FactorsSusceptible Crop +

Compatible, ToxigenicFungus

Environmental FactorsTemperature

MoistureMechanical Injury

Insect/Bird Damage

HarvestingCrop MaturityTemperature

MoistureDetection/Diversion

StorageTemperature

MoistureDetection/Diversion

Distribution-ProcessingDetection/Diversion

Factors affecting mycotoxin occurrence in the food chain (Pestka and Casale, 1989).

What mycotoxins where?

Warm to Hot Humid Conditions

Tree Nuts

A. flavus

Groundnuts

A. flavus, A. parasiticus

Cool to Warm Temperate Conditions

Grapes, wine, pistachios

A. carbonarius(A. niger)

Coffee, Cocoa

A. ochraceus,A. carbonarius

Tree Nuts, Figs

A. flavus

Aflatoxins Ochratoxin A

Adapted from: “Improving Public Health Through Mycotoxin Control, IARC Scientific Publication158, WHO Press, 2012, ISBN 978-92-2214-9

What mycotoxins are regulated in Dried Fruit and Nuts?

Aflatoxins

• Produced by Aspergillus molds

• B1, B2, G1, G2

• Grow in soil and decaying vegetation

• Severe liver damage

• IARC-class 1 human carcinogen

Ochratoxin A

• Produced by Aspergillus and Penicillium molds

• One of the most abundant

• Nephrotoxic, immune suppression, neurotoxic, teratogenic

• Humans have the longest half-life to elimination of any species studied

• Group 2B Suspect Carcinogen

by IARC, mutagenic

EC Regulation for Aflatoxin (ppb)

Commodity B1 Total M1

Processing

Almond, pistachios and apricots Kernels 12 15

Peanuts, Hazel and Brazil nuts 8 15

Other tree nuts, dried fruits, rice ,maize 5 10

Direct consumption

Cereals, rice ,maize ,peanuts, other tree nuts & dried fruit 2 4

Almond, pistachios and apricots 8 10

Hazel and Brazil nuts 5 10

Spices (capsicum, pepper, nutmeg, ginger, turmeric) 5 10

Dried Fig 6 10

Baby/Infant food, formula and dietary supplement 0.1 0.025

All Liquid milk 0.05

www.commodityregs.com

EC Regulation for Ochratoxin A (ppb)

Commodity OTA

Wine, Alcohol drinks, Grape juice 2

All Cereals for direct consumptions 3

All unprocessed Cereals, Roasted coffee 5

Wheat gluten not sold directly to the consumer 8

Dried vine fruit, Soluble coffee 10

Spices (pepper, nutmeg, ginger, turmeric) 15

Liquorice root, Capsicum (including chillies, chilli powder, cayenne and paprika), Ingredient for herbal infusion

20

Liquorice extract , for use in food in particular beverages and confectionary 80

Baby/Infant food, formula and dietary supplement 0.5

www.commodityregs.com

Regulation Summary

1 ppb (part per billion) is like looking for

a pinch of salt

in 10 tonnes of potato chips

Oakland to Hamburg

• Harvest from mid-August-October with tree-shakers• Cleaned, sorted, and possibly hulled

• 40-foot shipping containers loaded with 800 sacks weighing 25kg a piece (~22 US tons)• 8-12 containers per day per production facility• 30 days at sea

• Then what?www.hapag-lloyd.com

Port of entry

• Most non-POAO may enter through any port;

• Some products, considered to be “high risk”, from specific countries can only enter into the EU through designated ports (DPEs)

• These include products likely to be contaminated with aflatoxin

• As an example, Germany has 4 capable harbor-based DPEs

• A DPE must have availability of an accredited official laboratory for

aflatoxin analysis, situated at a place to which the samples can be

transported within a short period of time

• The laboratory must have the appropriate grinding equipment for

homogenising 10-30 kg samples

• The laboratory must be able to analyse the sample within a reasonable

period of time in order to comply with the 15 working day maximum

period of detention for consignments.

• Annex I of EC 669/2009 is updated quarterly with entries added or

removed

Import ProcessEvery consignment• Importers must notify the DPE at least one working day before

the physical arrival of the consignment

• Importer must complete Part 1 of the Common Entry Document

(CED) using TRACES

• Consignment must be accompanied by a Health Certificate with

official signature if participating in a pre-check program

• Subjected to a documentary check

• Subjected to a physical inspection

• Further checks and testing at random and at the discretion of

the inspector

• Safest to assume up to 100% may be tested

• “…ad hoc controls could be carried out at any time, even where there

is no suspicion of non-compliance.”

Imports under special control• EU 2019/35 of 8 January 2019 amending EC 669/2009 regards the

increased level of official controls on imports of certain feed and

food of non-animal origin

• Pistachios (in shell, shelled, or roasted) will be subject to 10% mandatory

checks (but could be more)

• EU 884/2014 provides legislation to introduce emergency measures for

specific import conditions for certain consignments due to contamination

by aflatoxins

• EU 2015/949 US almonds subject to successful pre-check program

(VASP):

• each lot/batch making up the consignment must have a CED, its own

official health certificate, and sampling and analytical results that are

compliant

• If health certificate missing then 100% of consignment will undergo

testing

• <1% of consignments will be randomly checked.

Physical Check Specifications

• Moisture content;

• Sizing;

• Specific cut (for certain dried fruits);

• Exceeded level of mycotoxins are banned;

• Level and types of used preservatives and pesticides;

• Quality class (defined by uniformity and tolerances).

Pre-Export Checks

• Pistaschio Export Aflatoxin Reporting program (PEAR)

• Voluntary Aflatoxin Sampling Program (VASP)

• Peanuts

What happens when a shipment fails?

Additional EU Maximum Levels for Ochratoxin A on the Horizon

• The EU has started to discuss the expansion of the

group of products subject to a maximum level for

OTA to include:

• dried figs and dried apricots or all dried fruit

• (10 μg/kg)

• sunflower and pumpkin seeds, pistachios, hazelnuts

or all tree nuts

• (5 μg/kg)

• Date: 10/20/2017• GAIN Report Number: E17070

"In God we trust, all others submit data"

Regulation is a mandate by some authority that provides harmonisation and standardisation, giving credibility, reassurance, and comfort.

Rubbish In → Rubbish Out

TestingAflatoxins and Ochratoxin A

Peanuts, tree nuts, dried fruit

Incremental Samples Representative aggregate sampleSubsample

Grinding, extraction Dissolving, Degreasing

Filtration

Immunoaffinity column (IAC) or SPE clean-up

ELISA, Quantitative or Qualitative Strip Test LC, LC/MS Fluorometer

AflatoxinsB1 B 2 G1 G2

Ochratoxin A

Pistachios Samples

Sampling Procedure

Sample Preparation

Analysis

What are the biggest challenges in mycotoxin analysis?

Total error

Sampling error

Sample preparation

error

Analytical error

Lot Sample Preparation Analysis

Invisible Imaging

Sampling foodstuffs

Lotproduct for test

Incremental Samples10-100 samples (depending on size and type of lot)

Aggregate SampleIncremental samples are mixed to give a sample

representative of the entire lot

Subsample1-10 kg is used

as the laboratory

sample

Defense

Enforcement

Reference

Prem

ixin

gSa

mpl

e di

visio

nGr

indi

ng &

Ho

mog

enisa

tion

Plac

e of

Sam

plin

g

Labo

rato

ry

Method of sampling for dried fruit including dried vine fruit and derived products but with the exception of dried figs

*Commission Regulation (EC) No 401/2006 of 23 February 2006

Method of sampling for dried figs, groundnuts, and nuts

*Commission Regulation (EC) No 401/2006 of 23 February 2006

Calculation of proportion of shell/kernel of whole nuts

• The limits for aflatoxins apply to the edible part of the nut only• samples of nuts ‘in shell’ can be shelled and the edible part tested, or;• the nuts ‘in shell’ can be taken through the sample preparation

procedure and a factor to account for the proportion of kernel applied

• Approximately 100 whole nuts shall be taken at random separately from the lot or shall be put aside from each aggregate sample.

• The ratio nut shell/kernel can vary from 25/75 (hard shell almonds), to 40/60 (soft shell almonds), 50/50 (pistachios)

*Commission Regulation (EC) No 401/2006 of 23 February 2006.

Example: 1. Analytical result in the test material is:

1.5 μg/kg (ppb) of Aflatoxin B1

2. Nut is a with kernel/shell ratio of 50/50

3. The level of aflatoxins in the edible portion:= 1.5 μg x 2

= 3 μg/kg (ppb) Almonds 0.6

Walnuts 2.34

Pistachios 2.0

Technology Pyramid

• Official Gov. & Commercial Labs

• Commercial & Gov. Laboratories • Some Transit Points & Processors

• Receiving Points• Processors• Commercial Labs• Transit Points

LC/MS 1%

LC 39%

Fluorometer, Strips,

ELISA 60%

Sample preparation and pre-concentration for LC or LC/MS

conditioning sample addition

rinsing elution

conditioning sample addition rinsing elution

Solid Phase Extraction Immunoaffinity Column Extraction

• ELISA, Strip Test, and Fluorometer test

• Lower cost per test

• Rapid

• Easy to use

• Minimal Consumables

• Consistent data

• Less precise and less sensitive.

• HPLC/UPLC or LC/MS

• Sensitive

• Accurate and confirmatory

• More expensive

• Technically well trained personnel

• More time per test

Pros and Cons

Complexity

Performance Criteria* for Aflatoxins Confirmatory Methods

*Commission Regulation (EC) No 519/2014 of 16 May 2014

Performance Criteria for Ochratoxin A Confirmatory Methods

• Fully validated confirmatory methods should be used where appropriate and available.

• Other suitable validated confirmatory methods may be used provided they fulfil the performance criteria set out.

*Commission Regulation (EC) No 519/2014 of 16 May 2014

?