ANNEX 1: GUIDANCE FOR THE OFFICIAL CONTROL SAMPLING OF
PECTINIDAE HARVESTED OUTSIDE OF CLASSIFIED PRODUCTION AREAS
FOR BIOTOXINS
Background
Marine biotoxins produced by phytoplankton can accumulate in the tissues of
shellfish. If these species are consumed by humans, toxin related illness can
occur. The health standards applicable to Pectinidae harvested outside
classified areas are the same as those used for live bivalve molluscs
harvested in classified production areas.
Chapter III of Annex II to Regulation (EC) 854/2004 outlines the legal
requirements for Official Controls (OC) on Pectinidae harvested outside of
classified production areas:
‘Official controls on Pectinidae harvested outside classified production areas
are to be carried out in fish auctions, dispatch centres and processing
establishments. Such official controls are to verify compliance with the health
standards for live bivalve molluscs laid down in Annex III, Section VII, Chapter
V, to Regulation (EC) 853/2004 as well as compliance with other requirements
of Annex III, Section VII, Chapter IX, to that Regulation.’
FSA has central competency for functions under this Regulation. Enforcement
of the regime for OC of Pectinidae has been delegated to Local Authorities.
These OC checks are therefore verification checks on food businesses.
Sampling frequency
In general terms LAs should follow guidance on inspection and sampling
detailed within the enforcement code and associated good practice guidance.
The frequency of testing official control samples of Pectinidae is not specified
within Regulation (EC) No 854/2004. The frequency of checks (including
sampling) will be appropriate to the individual business and should be riskbased. For example factors such as the time of the year, the volume of
product being placed on the market, current level of end-product testing etc.
should be considered. The range of OC checks will include the need to check
documentation in relation to sampling and verification.
Sample submission
The Agency is funding biotoxin analysis of Local Authority Official Control
samples of Pectinidae, harvested outside classified production areas,
collected from fish auctions, dispatch centres and processing establishments.
Local authorities should liaise with their appointed Public Analyst Laboratory
to check whether they have the appropriate accreditation to undertake the
analysis. If your Public Analysts are able to carry out testing then please
contact the Agency so that funding support can be arranged.
Samples which cannot be tested by your Public Analyst can be sent direct to
Cefas for analysis with the agreement and under the supervision of your
Public Analyst. Cefas can be contacted on: 01305 206696, fax 01305 206601
biotoxinmonitoring@cefas.co.uk. If submitting through Cefas, the scallops
submitted for analysis must be in the form that the product is placed on the
market i.e. either in whole (unshucked) or shucked form. Please note the
species of scallops which can be tested at Cefas – anything submitted other
than those listed in the sample submission form will be rejected (see Annex
3).
Where possible, details of official control samples are to be entered on
UKFSS by the Local Authority and submitted electronically to the Public
Analyst. The UKFSS code 2014/EW/OCP should be entered on the UKFSS
database under the COP tab.
Communication and notification arrangements for OC results
For samples submitted to Cefas, OC sample results will be reported by email
to the Public Analyst, and copied to the Local Authority and the FSA using the
attached reporting template (see attachment in email).
Template Results
Biotoxins C5667 EW Scallops v1.xlsx
The Public Analyst will issue certificates of analysis to the Local Authority as
appropriate, and upload results and outcomes onto UKFSS. Results of
analyses may be made available to the business where the sample was
taken.
The legal marketing standards in relation to biotoxins contained in Regulation
EC 853/2004, Section VII, Chapter V 2 indicates that Live Bivalve Molluscs
(LBM) must not contain marine biotoxins in total quantities (measured in the
whole body or any part edible separately) that exceed the following statutory
limits:
Toxin
Paralytic Shellfish Poisoning (PSP)
Amnesic Shellfish Poisoning (ASP)
Okadaic acid (OA), dinophysistoxins
and pectenotoxins together
Yessotoxins (YTX)
Azaspiracids (AZA)
Regulatory limit
800 μg [STX eq.]/kg shellfish
20 mg/kg shellfish
160 μg [OA eq.]/kg shellfish
3.75 mg [YTX eq.]/kg shellfish
160 μg [AZA eq.]/kg shellfish
Invoicing


For samples submitted to Cefas, there will be no need to submit
invoices for testing costs to the Agency
For any analysis undertaken by Public Analysts please contact the
Agency so funding arrangements can be made.
The Agency will directly fund costs of the following:

Laboratory analysis of samples of Pectinidae, harvested outside
classified production areas, collected from fish auctions, dispatch
centres and processing establishments1 for the three biotoxin groups
(ASP, PSP, and DSP including lipophilic toxins).
If you have any queries regarding this funding please contact:
shellfishtoxins@foodstandards.gsi.gov.uk.
1
OC samples of Pectinidae collected at all other stages of production, processing and
distribution in order to verify FBO compliance with the requirements of end product will not be
funded by the Agency.
ANNEX 2: OFFICIAL CONTROL PECTINIDAE SAMPLE COLLECTION
PROTOCOL – For samples being sent to Cefas ONLY
Samples which cannot be tested by your Public Analyst can be sent direct to
Cefas for analysis with the agreement and under the supervision of your Public
Analyst. The following protocol indicates how the OC sample should be gathered
and details the method, amount and equipment required to fulfil this. The sample
submission form (Annex 3) must accompany the samples to the Cefas
laboratory.
The relevant equipment to facilitate the taking of these samples i.e. cool box, ice
packs, bags and labels will be provided to the LA on request from the laboratory
If you are intending to submit verification samples, a minimum notice of 5
working days is required to allow for lab preparation and any arrangement
for delivery of equipment. Sampling officers will be responsible for
contacting the laboratory and checking that they do have sufficient
capacity
to
undertake
the
required
tests.
Please
email
biotoxinmonitoring@cefas.co.uk to place a request.
1
Shellfish samples should be collected from identified processors/dispatch
centre/auction markets at a frequency determined by risk assessment.
2
Ideally samples should be collected Monday to Wednesday and posted to
Cefas Weymouth using the boxes provided 2. For this financial year the
last day for samples to be received by Cefas is Friday 28th March 2014.
3
The sample should contain the minimum number of individual shellfish
shown on the submission form (or more if required, in order to yield
minimum 100g of meat).
4
Shellfish must be placed inside a strong food grade plastic bag and the
bag tied leaving some air space. A second bag may be used if required (in
particular if the sample is likely to puncture the first plastic bag).
5
A sample submission form must also be completed for every sample. The
bagged sample and form should then be placed in a second/third bag and
resealed, then placed in the container provided along with frozen cool
packs and foam/spacers.
6
Once correctly assembled and the relevant sample submission forms have
been included, the box lid must be secured with adhesive tape to prevent
leakage and a prepaid postage label attached before posting to the
relevant laboratory. Shellfish samples sent using Royal Mail must be
labelled as “perishable”, This is for compliance with new Royal Mail
labelling instructions in force since 15/07/13. Please note that Royal Mail
has defined specific restrictions to the transport of live creatures/animals.
These are not suitable for shellfish samples destined to testing. Sampling
officers are therefore advised not to log/describe the samples as live
creatures for the purpose of Royal Mail. “Perishable” labels should be
affixed to the tape used to secure the transport box. Alternatively please
write on the tape using a marker pen.
2
Posting on the day of collection would always be preferable.
7
Samples submitted to the Cefas laboratory should be sent to Cefas,
Weymouth Laboratory, BTX Dept, Barrack Road, The Nothe, Weymouth,
Dorset, DT4 8UB.
Any queries or problems relating to Cefas samples should be referred to:Lewis
Coates
on:
01305
206744,
fax
01305
206601
biotoxinmonitoring@cefas.co.uk
ANNEX 3 - ENGLAND AND WALES PECTINIDAE
CEFAS SAMPLE SUBMISSION FORM FOR BIOTOXIN TESTING
Please ensure that samples are accompanied by this sheet and that all sections have
been completed – thank you
Local Authority:
Name of Collector:
Tel:
Email address to which results should be reported:
Appointed Public Analyst: Name:
Tel:
Email address to which results should be reported:
Name and Address of Premises:
Type of establishment (i.e. Auction Hall, Dispatch Centre or Processor):
Premises Approval No.:
Date of Collection from Premises:
Time:
Origin of Sample i.e. sea box no./area – information should be available on registration document
accompanying batch:
Date of Harvesting:
Date of Landing of Catch:
Where Landed:
Sample details (please tick all relevant boxes for sample submitted to indicate species and toxin tests
required). Please note that samples consisting of other scallop species or submitted in a different form will
be rejected – if unclear please contact Cefas):
Please ASP
PSP
DSP
tick
(Lipop Minimum number of
Sample
hilic
individual animals to
Toxins be submitted
)
Whole King Scallop (in shell)
15
Shucked King Scallop (adductor & roe)
15
King Scallop White Meat Only (adductor)
15
Whole Queen Scallop (in shell)
Number of sample boxes remaining (please circle)
To be completed by Laboratory
Date of arrival:
Laboratory Sample ID:
35
1
2
3
4
5+
Time of arrival:
PLEASE ENSURE THAT COOL-PACKS ARE FROZEN BEFORE PUTTING IN SAMPLE
BOX.