VETERINARY RESIDUES COMMITTEE ANNOUNCEMENT OF THE

VETERINARY RESIDUES COMMITTEE ANNOUNCEMENT OF THE
RESULTS
OF
THE
BRAND
NAMING
SURVEY
OF
CHLORAMPHENICOL IN CERTAIN ROYAL JELLY NUTRITIONAL
SUPPLEMENTS
A survey carried out by the Veterinary Medicines Directorate (VMD) on behalf
of the Veterinary Residues Committee (VRC) found residues of
chloramphenicol in 18 samples of royal jelly nutritional supplements sold in
the form of capsules, tablets or fresh royal jelly out of 71 samples analysed.
The VRC is concerned about the findings of the survey, which show a high
rate of non-compliance in the samples tested. This survey focused on
products containing high concentrations of royal jelly and the Committee is
aware that other products are available which contain lower concentrations of
royal jelly which have not been the subject of this survey.
The Committee recommended that royal jelly in nutritional supplements form
should be tested for this antibiotic following a series of Rapid Alert Reports
from the European Commission on residues of chloramphenicol detected in
royal jelly. Whilst the Committee recognised that it is not a widely consumed
product, it was concerned that those who do take it are likely to consume it
every day and are therefore high level consumers.
Previous brand naming surveys were based on sample collection at Border
Inspection Posts (BIPs) and retail outlets.
However the number of
consignments of royal jelly entering the UK at BIPs is limited. The Committee
therefore recommended that this survey focused on retailers and internet
suppliers.
A total of 71 samples were analysed in the survey which was carried out
between September and November 2007. Eighteen samples contained
confirmed residues of chloramphenicol. Concentrations ranged between
0.33μg/kg and 21μg/kg. Following the confirmation of these residues the
Food Standards Agency (FSA) was informed of the results and trade
withdrawals were carried out by the FSA in collaboration with local authorities.
The FSA contacted the eleven UK retailers/suppliers of products that tested
positive. These companies have informed customers who bought the
implicated products of the reasons for the withdrawal and asked them not to
consume the product and return it to the company.
Chloramphenicol is not authorised for use in the treatment of animals for
food production in the EU and may not be used in the production of food of
animal origin which is exported to the EU. Chloramphenicol is considered to
be a potential genotoxic carcinogen, though the risks from the levels of intake
arising from the consumption of royal jelly would be extremely small,
especially if exposure were relatively short-term.
Medical use of
chloramphenicol has also been associated with a rare idiosyncratic aplastic
anaemia which can be fatal. However, intakes of chloramphenicol from royal
jelly would be seven orders of magnitude lower than medical exposures and
any incidence of aplastic anaemia would be expected to be extremely low and
unlikely to be distinguishable from a low background incidence in the
population.
1
Results of the brand naming survey for chloramphenicol in royal
jelly nutritional supplements
Summary
A survey of chloramphenicol in royal jelly nutritional supplements was carried
out by the Veterinary Medicines Directorate (VMD) between September and
November 2007. The purpose of the survey was to assess the incidence of
residues of this antibiotic in high concentration royal jelly food supplements
available from retail outlets and internet sites. The use of chloramphenicol in
the treatment of food producing animals is prohibited in the EU and residues
should not be present in food products or supplements intended for human
consumption.
A total of 71 samples of royal jelly were analysed for residues of
chloramphenicol. Samples for the survey were purchased from a range of
internet sites and retailers by shoppers employed by the market research
organisation Mintel International Group Ltd. All the samples were analysed
by the Central Science Laboratory (CSL) using a validated method of
analysis.
Chloramphenicol residues were confirmed in 18 samples. Three samples of
‘pure royal jelly’ purchased from different internet sites were found to be from
the same supplier and the same batch of royal jelly. Two samples of
capsules purchased from one internet site were identical samples.
The Decision Limit (CCα) for the analysis of chloramphenicol in royal jelly is
0.11µg/kg. This limit is in line with the EU Minimum Required Performance
Limit (MRPL) of 0.3µg/kg for this substance. Any results at or above the
MRPL for chloramphenicol are non-compliant under European legislation.
In each case where non-compliant results for chloramphenicol were
confirmed, the Food Standards Agency (FSA) was informed. The FSA took
consistent risk management action in all cases. Trade withdrawals were
carried out in collaboration with local authorities. The FSA contacted all the
UK retailers/suppliers of the non-compliant products. These companies have
informed customers who bought the implicated products of the reasons for
the withdrawal and asked them not to consume the product and return it to
the company. In one case a point of sale notice was put up by a retail outlet
as they had been supplying the product in store.
Where royal jelly products were purchased directly from a non-EU country
and EU legislation does not apply, the VMD has contacted the relevant
authorities in the non-EU countries concerned, requesting them to take further
action.
Annex 1 gives details of all the samples collected as part of the survey.
Annex 2 gives details of sample preparation and the method of analysis. The
results show a high incidence of residues of chloramphenicol in high
2
concentration royal jelly nutritional supplements sold as capsules or fresh
product.
Background
Royal jelly is a product made by bees for the nourishment of larvae
developing into queen honey bees. It is sold as a nutritional supplement
normally in the form of capsules. Since 2004, the European Commission has
reported evidence of residues of chloramphenicol in royal jelly imported into
the EU. Eighteen notifications were sent out to Member States under the
Commission’s Rapid Alert System for Feed and Food between 2004 and
2006. The concentrations of chloramphenicol detected ranged from 0.6μg/kg
to more than 5000μg/kg. Prior to this survey no notifications had been issued
in 2007.
Legislation
EC legislation requires that all active substances used in veterinary medicines
for food producing animals must be assessed so that a Maximum Residue
Limit can be set. Due to the lack of adequate studies, evidence of
genotoxicity in a number of in-vivo and in-vitro tests and the inability to
identify a “threshold” level for the induction of aplastic anaemia in humans, no
Acceptable Daily Intake or Maximum Residue Limit could be set for
chloramphenicol. Chloramphenicol is therefore in Annex IV of Council
Regulation 2377/90 and its use in the treatment of food producing animals,
including bees, is prohibited in the EU. Countries that wish to export food of
animal origin to the EU must respect the requirements of this legislation thus
should not contain residues of Annex IV substances.
Commission Decision 2002/657 introduced the concept of Minimum Required
Performance Limits (MRPLs).
This recognises the need for EU
harmonisation of analytical detection limits, particularly for banned
substances, and is the concentration at which regulatory laboratories should
be able to detect and confirm the presence of particular substances. In
March 2003 Commission Decision 2003/181/EC set an MRPL of 0.3µg/kg for
chloramphenicol in meat, milk, eggs, aquaculture products and honey. Article
2 of Commission Decision 2005/34/EC, states that the MRPLs laid down in
Annex II to Decision 2002/657/EC shall be used as reference points for action
irrespective of the matrix tested. In practise this means that the MRPL of
0.3µg/kg for chloramphenicol applies to royal jelly and any results at or above
the MRPL are non-compliant.
Selection of products for testing
Royal jelly is a constituent in a number of products including topical creams
and nutritional supplements. In deciding the type of product to be analysed
as part of this survey there were a number of considerations, in particular, the
concentration of royal jelly in the product. Shoppers were instructed to
purchase either capsules containing 500mg of royal jelly or fresh royal jelly.
The overall sample size was 50g of royal jelly. This sample size ensured
3
sufficient material to complete screening analysis, and confirmatory analysis,
should it be required, and to provide sufficient sensitivity to meet the required
MRPL for each portion tested. Whilst royal jelly was the main constituent in
the products purchased, other minor constituents are likely to have been
present including honey and beeswax.
Sampling
The original intention was to purchase and analyse 100 samples. Sourcing
these products at the retail level proved particularly difficult. Shoppers from
the market research organisation were unable to find sufficient retailers
selling these products to fulfil all the sampling requests because most
products on sale had less than the target level of royal jelly per capsule. Out
of 50 requested retail samples, shoppers were only able to obtain 27. The
majority of these were from health food shops and two chemists, one of which
specialises in complementary medicine. Three samples were obtained from
two department stores in London.
Of these, there were three sets of samples (seven samples in total) where the
batch number was duplicated. This was a result of shoppers buying the same
product from the same outlet in different parts of the country. At retail level
the majority of samples were two brands, Holland and Barrett and Power
Health Bumbles.
Where capsules/fresh royal jelly were on sale, shoppers also experienced
difficulties in obtaining sufficient quantity with the same batch number to meet
the 50g requirement. Six of the samples purchased were made up of
capsules with more than one batch code.
The shoppers who purchased samples from internet sites were more
successful in obtaining suitable samples. They were provided with a list of
pre-selected sites and the quantity of product required. Out of 50 samples
requested 45 samples were purchased. One sample was not analysed
because the capsule contained a very highly concentrated form of royal jelly
which made it unassayable by the Central Science Laboratory (CSL) method.
Of the samples purchased, there were three sets of samples (8 samples in
total) where the batch number was duplicated. Details of all samples
collected for the survey are given in Annex 1.
Results
Full results of the survey are detailed in Annex 1. Details of the analytical
methods are set out in Annex 2.
Eighteen samples were confirmed as non-compliant. The countries of origin
were Australia (2 duplicate samples), China (8 samples (3 duplicates)) and
the USA (5 samples). In the case of three samples, the country of origin of the
raw product is unknown. The VMD wrote to all retailers and suppliers of the
products sampled as part of the survey, requesting information on the country
of origin of the raw material.
4
In accordance with the FSA survey guidelines, the importers or wholesalers of
the contaminated product were asked if they wished to comment on the
confirmed results. Comments received are detailed in Annex 3.
Risk assessment
Chloramphenicol is listed in Annex IV of Council Regulation 2377/90 and
therefore is not authorised for use in the EU. Chloramphenicol is genotoxic
and therefore assumed to be potentially carcinogenic, but the risk from the
levels of intake arising from consumption of the royal jelly cannot be
quantified, especially if the exposure were relatively short-term.
Medical, oral and intravenous use of chloramphenicol is associated with a
rare idiosyncratic aplastic anaemia which can be fatal. The mechanism for
this is not fully understood and there is no identified dose-response
relationship or threshold for this effect. Therefore, although intakes from royal
jelly would be approximately seven orders of magnitude lower than oral
medicinal exposures, the risk is uncertain.
Chloramphenicol is also used in some eye drops and topical creams and
results in levels in the body which are lower than other therapeutic uses but
approximately two orders of magnitude higher than potential intakes from the
royal jelly. Epidemiological data indicates that the use of chloramphenicol
eye drops is unlikely to be associated with aplastic anaemia. Therefore, any
incidence of aplastic anaemia from such intakes of chloramphenicol would be
expected to be extremely low and is unlikely to be distinguishable from a low
background incidence of aplastic anaemia in the population.
An MRPL of 0.3µg/kg has been set for chloramphenicol by Commission
Decision 2003/181/EC amending 2002/657/EC. (MRPLs are agreed EU
laboratory standards to detect a substance or its residues and are not safety
limits. Food should not contain any traces of chloramphenicol).
Action taken on residue findings
i)
Samples purchased from UK internet sites/retailers

Of the 11 samples purchased from within the UK and found to contain
residues of chloramphenicol ten were from internet sites and one was
purchased from a retail outlet.

The concentrations detected were between 0.93µg/kg and 21µg/kg.

For the retail sample, the country of origin is not known. There was no
product left and the retailer agreed to display a point of sale notice.

The remaining ten samples originated from the USA (three samples),
China (five samples (three were duplicates)), Turkey (one sample),
with the country of origin of one sample being unknown.
5

Following action from the FSA in association with local authorities, the
remaining stock for eight of the samples was withdrawn and for six of
these the customers were notified. For the remaining two samples,
one was dealt with by the States of Guernsey and for the other the
company was no longer trading from the advertised address and all
efforts to contact them have failed.

Rapid Alerts have been issued for five samples. Three of these
originated from the USA, one from China and one sample where the
country of origin is unknown. Rapid Alerts were not issued for the
other non-compliant samples where information on the supplier of the
product is lacking. The Commission will be sent a copy of the report
including all the results.

The Acting Chief Veterinary Officer has written to the authorities in the
USA regarding their three samples and to the authorities in China
regarding three of their five samples asking to be kept informed of the
outcome of any action that is taken.
ii) Samples purchased from foreign internet sites

These samples were purchased directly from internet sites without a
UK base. As no risk management action could be taken in this
country, the VMD has contacted the relevant authorities in the
countries concerned for them to take further action.

Seven samples purchased from foreign internet sites were found to
contain residues of chloramphenicol.

The concentrations detected were between 0.33µg/kg and 5.5µg/kg

Three samples were purchased from sites based in the USA with one
of the samples originating from China and the other two originating
from the USA. The American authorities have been notified by the
VMD and are investigating these results.

Two samples were purchased from sites in New Zealand (NZ) and
following investigations by the NZ authorities there we understand that
the two internet suppliers obtain their supplies from two different NZ
manufacturers. Each manufacturer obtains royal jelly from China and
one manufacturer’s supplies go via their Australian parent company
before arriving in NZ. Investigations by the NZ authorities are ongoing.

Two samples were purchased from a site based in Australia. They
were duplicate samples with the same best before dates, production
dates and batch numbers. The authorities in Australia have confirmed
that the royal jelly was of Chinese origin.
6
Conclusions
The VRC is concerned about the findings of the survey which show a high
rate of non-compliance in the samples tested. This survey focused on
products containing high concentrations of royal jelly and the Committee is
aware that other products are available which contain lower concentrations of
royal jelly which have not been the subject of this survey. The presence of
chloramphenicol, which is not authorised for use as a veterinary medicine in
the EU, in products that are available for purchase by UK consumers is a
serious concern. The Committee welcomes the risk management action
taken by the FSA and hopes that equivalent action will be taken by those nonEU countries that were selling royal jelly food supplements that were
contaminated with chloramphenicol.
7
ANNEX 1
Royal Jelly Brand Survey 2007 Results
NSR No
Web Address
Power Health
Bumbles
07N0881
Holland &
Barrett
07N0883
07N0896
07N0897
Brand
www.yourhealthfoodstore.co.uk
www.swsupplements.co.uk
Labelling Details
Country of
(as appears on
Origin
product)
Royal gellee
30 x 500mg
capsules
Royal Jelly
60 x 500mg
capsules
China
England
Date of
Purchase
26/11/2007
26/11/2007
Best Before
Date
Jun-09
Jul-10
Fresh Royal
Chorley Health
Jelly 500mg x 60 Unknown 18/09/2007 19/09/2009
Food Store
capsules
Seventh Wave
100% Pure
Royal Jelly
1500mg
capsules
Unknown 21/09/2007 07/04/2008
8
Batch
81352
A07264
Q3680
Retail Address
Supplier /
Manufacturer
Address
Result/
confirmed
value
μg/kg
Dennis Gore
Chemist
26 Whittaker Lane
Prestwich
Manchester
M25 1FX
Power Health
Products Ltd
Pocklington
York
YO2 1NR
Holland & Barrett
25 The Haymarket
Bury
BL9 0BX
Holland & Barrett
Retail Ltd
Nuneaton
Compliant
Warwickshire
CV11 6XW
Chorley Health Food
Store
c/o Abrams Ashton
41 St Thomas Road
Chorley
Lancashire
PR7 1JE
Gemini Health
Care
PO Box 92
Keighley
BD20 6EW
Seventh Wave
Supplements
Suite 78
151060407 792 Wilmslow Road
Manchester
M20 6UG
Compliant
Compliant
Compliant
NSR No
07N0898
07N0900
07N0901
07N0902
07N0903
Web Address
www.power-health.co.uk
www.althealth.co.uk
www.good4you.co.uk
www.bodykind.com
www.purelyforyou.com
Brand
Labelling Details
Country of
(as appears on
Origin
product)
Power Health
Royal gellee
Bumbles
500mg capsules
Venus Health
Royal Jelly
Now Royal
Jelly
Apitherapy
Apitherapy
Made with fresh
Royal Jelly
500mg x
30capsules
High Potency
Royal Jelly
1500mg x 60
capsules
Pure Royal Jelly
50g
Pure Royal Jelly
50g
China
China
USA
China
China
Date of
Purchase
19/09/2007
19/09/2007
18/09/2007
18/09/2007
18/09/2007
9
Best Before
Date
Aug-10
May-09
Feb-10
Feb-08
Feb-08
Batch
88642
60500
Retail Address
Power Health
Products
Airfield Estate
Pocklington
York
YO42 1NR
302/07
Power Health
Products Ltd
Pocklington
York
YO2 1NR
Althealth
11 Market Way
Wakefield
WF1 1QJ
Good 4 You
Nutrition Gateway
Ltd
8538070825 PO Box 34
Wrexham
LL14 5YG
302/07
Supplier /
Manufacturer
Address
Result/
confirmed
value
μg/kg
Compliant
Compliant
Now Foods
Bloomingdale
IL 60108
USA
Bodykind
Boxblack Trading Ltd
Unit 4
Whitegate Business
Centre
Oldham
OL9 9JT
Apitherapy
Health Ltd
28 The Street
Sustead
Norwich
NR11 8RU
Purely for You
PO Box 589
Timperley
Altrincham
WA15 7ZA
Apitherapy
Health Ltd
28 The Street
Sustead
Norwich
NR11 8RU
Noncompliant
1.4
Noncompliant
7.5
Noncompliant
1.4
NSR No
07N0905
07N0906
07N0907
07N0908
07N0909
07N0910
Web Address
Brand
Labelling Details
Country of
(as appears on
Origin
product)
www.healthmonthly.co.uk
Made with fresh
Royal Jelly
Health Monthly
500mg x
60capsules
www.bioceuticals.co.uk
Made with fresh
Royal Jelly.
Each jar
Biobees Royal
contains 25g of
Jelly
Fresh Royal
Jelly
www.healthydirect.com
www.auravita.com
www.pinkgoods.co.uk
www.justvitamins.co.uk
Healthy Direct
Summer Bee
Royal Jelly
600mg x 90
capsules
Royal Jelly
500mg x 50
capsules
Now Royal
Jelly
Royal Jelly
1000mg x 60
softgel capsules
Just Vitamins
Royal Jelly
500mg x 90
capsules
Date of
Purchase
Best Before
Date
Batch
Retail Address
Supplier /
Manufacturer
Address
Health Monthly
91-93 Great Union
5026143987 Road
Unknown 18/09/2007 01/03/2009
St Helier
706
Jersey
JE2 3WA
Italy
Australia
USA
USA
19/09/2007
19/09/2007
20/09/2007
18/09/2007
Unknown 19/09/2007
10
Aug-09
Apr-09
Jan-09
May-09
Apr-10
609041
00014
Bioceuticals Ltd
Brandon House
1 Balham Road
London
SW12 9PH
Healthy Direct
PO Box 325
Guernsey
GY1 3TT
Manufactured in
the EU
Pinkgoods
Unit 2
Cooper Drive
7711710422 Braintree
Essex
CM7 2RF
GO1
Compliant
Bioceuticals Ltd
Nutri House
26 Zennor Road
Balham
London
SW1L 0PS
Auravita Ltd
140 Cricklewood
Lane
BH021606 London
NW2 2DT
Just Vitamins
PO Box 4112
Coventry
CU4 0BA
Result/
confirmed
value
μg/kg
Compliant
Compliant
Summerbee
Products
PO Box 213
Torquay
TQ1
Now Foods
Bloomingdale
IL 60108
USA
Noncompliant
3.1
Noncompliant
3.4
Compliant
NSR No
07N0911
07N0912
07N0913
07N0914
07N0915
Web Address
www.healthy.co.uk
www.hollandandbarrett.com
www.naturesremedy.co.uk
www.bodysmart.co.uk
www.summerbee.co.uk
Brand
Cornucopia
Fresh Live
Royal Jelly
Holland &
Barrett
Natures
Remedy
Labelling Details
Country of
(as appears on
Origin
product)
100% Royal
Jelly 20gm
Date of
Purchase
Best Before
Date
Unknown 19/09/2007 Not known
Royal Jelly
Unknown 26/09/2007
500mg capsules
Jul-10
Fresh Royal
Jelly 500mg x 60 Unknown 18/09/2007 06/09/2009
capsules
Life Source
Royal Jelly
60 capsules
Summer Bee
Pure Fresh
Royal Jelly.
Tested and
completely free
from
chloramphenicol
50gms take 1/4
tsp on bread or
neat
China
China
19/09/2007
18/09/2007
11
Feb-09
Feb 08
Batch
Unknown
AO7264
Q3680
25147
100906
Retail Address
Supplier /
Manufacturer
Address
The Really Healthy
Company
4 Tanner Street
Unit 1
London
SE1 3LD
Result/
confirmed
value
μg/kg
Compliant
Holland & Barrett
PO Box 5736
Burton upon Trent
DE14 1BR
Holland & Barrett
Retail Ltd
Warwickshire
Compliant
CV11 6XW
Natures Remedy
Barley Castle
Bank Street
Hayfield
SK22 2EQ
Gemini Health
Care
PO Box 92
Keighley
BD20 6EW
Life Source
Supplements Ltd
Camp Hill Industrial
Estate
Ripon
North Yorkshire
HG4 1QY
Summerbee
Products
PO Box 213
Torquay
TQ1
Compliant
Compliant
Wuhan Musen
Ltd
Wuhan
Hubei
China 430017
Compliant
NSR No
07N0916
07N0917
07N0918
07N0919
07N0920
07N0921
Web Address
www.healthspan.co.uk
www.apitherapy.eu.com
www.wellbeing-nutrition.com
www.healthypulses.co.uk
www.simplyhealthy.co.uk
www.cgcmall.com
Brand
Healthspan
Apitherapy
Wellbeing
Labelling Details
Country of
(as appears on
Origin
product)
200mg capsules
Pure Royal Jelly
50g
Fresh Royal
Jelly 500mg x 30
capsules
Made from fresh
Royal Jelly
Power Health
Bumbles
500mg x 60
capsules
USA
China
China
China
Date of
Purchase
18/09/2007
18/09/2007
Best Before
Date
Sep-08
Feb-08
26/09/2007 19/09/2007
19/09/2007
Aug-08
Fresh Royal
Simply Healthy Jelly 500mg x 60 Unknown 18/09/2007 26/09/2009
softgel capsules
Golden Lily
High Strength
Royal Jelly
486mg x100
capsules
China
28/10/2007
12
Jan-09
Batch
5546
302/07
W3680
75154
810560
01/2005
Retail Address
Supplier /
Manufacturer
Address
Healthspan
PO Box 64
Guernsey
GY1 3BT
Apitherapy Health
Ltd
28 The Street
Sustead
Norwich
NR11 8RU
Result/
confirmed
value
μg/kg
Compliant
Apitherapy
Health Ltd
28 The Street
Sustead
Norwich
NR11 8RU
Elizabeth Harfleet
Wellbeing
12 Gwendor Avenue
Manchester
M8 4LE
Noncompliant
1.5
Compliant
Healthy Pulses
95 Cornwall Street
Plymouth
Devon
PL1 1NX
Power Health
Products Ltd
Pocklington
York
YO2 1NR
Simply Healthy
The Health Store
8 Skirvving Street
Shawlanos
Glasgow
G41 3AA
Logical Health
Care
PO Box 5717
Derbyshire
DE56 2YW
CGC Mall
FL 1
13736 Laburnum
Ave
Flushing, NY
USA 11355-4138
Imported into
USA by:
NonKingsway
compliant
Trading Inc
0.33
Corona
New York 11368
Compliant
Compliant
NSR No
07N0922
07N0923
07N0924
07N0925
07N0926
Web Address
www.foodsforhealth.co.uk
www.nzpurehealth.com
www.aroma-blast.co.uk
www.westons.com
www.dixiehealth.com
Brand
Power Health
Bumbles
Labelling Details
Country of
(as appears on
Origin
product)
Made from fresh
Royal Jelly
500mg x 30
capsules
Deep Blue
Health
Royal Jelly
1000mg x 100
capsules
Summer Bee
Products
Pure Fresh
Royal Jelly.
Tested and
completely free
from
chloramphenicol
50gms take 1/4
tsp on bread or
neat
Valupak
Royal Jelly
capsules
Royal Jelly
30 capsules
Royal Jelly
500mg x 60
capsules
China
China
China
Date of
Purchase
28/10/2007
28/10/2007
28/10/2007
Unknown 28/10/2007
USA
28/10/2007
13
Best Before
Date
July 2010
(x 2)
Aug 2010
(x 1)
June-10
Feb 08
Jun-10
Oct-08
Batch
88256
(x 2)
F 7025
100906
L 07137
362122
Retail Address
14 Bank Street
Teignmouth
Devon
TQ14 8AW
Supplier /
Manufacturer
Address
Power Health
Products Ltd
Pocklington
York
YO2 1NR
New Zealand Pure
Health
PO Box 40718
Glenfield
Auckland
New Zealand
Result/
confirmed
value
μg/kg
Compliant
Noncompliant
1.5
Aroma Blast
21 Elizabeth Avenue
Newbury
Berks
RG14 6HA
Wuhan Musen
Ltd
Wuhan
Hubei
China 430017
Westons Internet
PO Box 1646
Hassocks
West Sussex
BN6 9GS
BR
Pharmaceuticals
Ltd
Compliant
Leeds
LS16 6QE
Dixie Health Inc
2161 Newmarket
Parkway
Suite 222
Marietta
GA 30067
USA
Compliant
Noncompliant
3.2
NSR No
07N0927
07N0928
07N0929
07N0930
07N0931
Web Address
www.giftsofnz.com
www.goodnessdirect.co.uk
www.dancingbeeacres.com
www.lifetimehealth.com.au
www.nutrisun.co.uk
Brand
HNZ New
Zealand
Power Health
Bumbles
Dancing Bee
Acres
Natural Life
Natures Aid
Labelling Details
Country of
(as appears on
Origin
product)
Royal Jelly
1000mg x 180
capsules
Royal Gellee
500mg x 60
capsules
Royal Jelly
500mg x 60
capsules
Royal Jelly
1000mg x 60
capsules
Royal Jelly
150mg x 90
capsules
China
China
USA
China
Australia
Date of
Purchase
28/10/2007
28/10/2007
28/10/2007
28/10/2007
28/10/2007
14
Best Before
Date
Sep-10
Aug-10
Jun-10
Feb-10
Apr-10
Batch
AL 0093
Retail Address
Gifts of New Zealand
16 Learn Mouth
Avenue
Auckland
New Zealand 1310
Goodness Direct
South March
Daventry
B/N 90064 NN11 4PH
51807
EO 195
31A1074
Supplier /
Manufacturer
Address
Honey New
Zealand
8 Short Street
Te Awamutu
New Zealand
Power Health
Products Ltd
Pocklington
York
YO42 1NR
Dancing Bee Acres
198 W. Wyoming
Avenue
Irrigon
Oregon
OR 97844
USA
Noncompliant
1.2
Compliant
Noncompliant
3
Lifetime Health
Products Pty Ltd
1/111 Old Pittwater
Road
Brookvale
NSW 2100
Australia
Nutrisun Ltd (The
Good Life)
207 High Street
Sutton
SN11 1JU
Result/
confirmed
value
μg/kg
Noncompliant
5.4
Natures Aid
Kirkham
Preston
PR4 2DQ
Compliant
NSR No
07N0932
07N0933
07N0934
07N0935
07N0936
Web Address
www.simplysupplements.co.uk
www.flynnsbeefarm.co.uk
www.ldb.co.uk
www.reginahealthcare.com
www.panaxginseng.co.uk
Brand
Labelling Details
Country of
(as appears on
Origin
product)
Date of
Purchase
Royal Jelly
Simply
Tablets 100mg x Unknown 28/10/2007
Supplements
180 tabs
The Food of
Queens
Fresh Royal
Jelly 100g
Zip Vit
Royal Jelly
500mg x 30
capsules
Regina
Premium Fresh
Royal Jelly
150mg x 90
capsules
Pine Brand
High Strength
Royal Jelly
200mg x 100
capsules
China
28/10/2007
Unknown 28/10/2007
Turkey
China
28/10/2007
28/10/2007
15
Best Before
Date
May-2009
Feb-08
Jun-09
Aug-09
N/A
Batch
Retail Address
333102
Simply Supplements
PO Box 206
Guernsey
GY1 3NB
892510
8071
1H06
Flynns Bee Farm Ltd
Elmley Road
Bramble Down
Minster-On-Sea
Isle Of Sheppey
Kent ME12 3SS
Zip Vit Ltd
The Towers
Business Park
Rugeley
Walsall
Staffs
WS15 1BR
Regina Health Care
PO Box 789
Thornton Heath
Croydon
CR7 7WY
Panax Ginseng UK
504 Wallisdown
Road
CP 03105D Bournemouth
Dorset
BH11 8PT
Supplier /
Manufacturer
Address
Result/
confirmed
value
μg/kg
Noncompliant
21
Importer: Bee
Well Products
Ltd
Laurel Cottage
Apiaries
Hockley Lane
Wingerworth
Derbyshire
S42 6QQ
Noncompliant
13
Compliant
Bentley
Laboratories Ltd
NonStandard House
compliant
1-2 Church Way
1
Edgware
Middlesex
The Central
Pharmaceutical
Co Ltd
NonTianjin
compliant
China
0.93
NSR No
07N0937
Web Address
www.healthreaction.com
07N0938
www.lifetimehealth.com.au
07N0939
www.burstingwithhealth.co.uk
07N0940
07N0941
www.armstrongshealth.com
www.theultimatecatalogue.co.uk
Brand
Natures Aid
Natural Life
Labelling Details
Country of
(as appears on
Origin
product)
Royal Jelly
150mg x 90
capsules
Royal Jelly
1000mg x 60
capsules
Australia
28/10/2007
Best Before
Date
Apr-10
Batch
31A 1074
28/10/2007
01-Feb
E 0195
Fresh Royal
Bursting With
Jelly 500mg x 60 Unknown 28/10/2007
Health
capsules
03/2009
08/2009
50710
Armstrongs
Royal Jelly
Royal Jelly
150mg x 90
capsules
China
Date of
Purchase
Australia
28/10/2007
Made from fresh
Royal Jelly.
Royal Jelly
Unknown 28/10/2007
500mg x 60
capsules
16
Sep-08
Mar-09
314407
F01
Retail Address
Health Reaction
PO Box 241
Stockport
SK4 3FZ
Supplier /
Manufacturer
Address
Natures Aid
Kirkham
Preston
PR4 2DQ
Lifetime Health
Products Pty Ltd
1/111 Old Pittwater
Road
Brookvale
NSW 2100
Australia
Bursting With Health
27 Vance Road
Blackpool
Lancashire
L11 4QD
Armstrongs Herbal
Store
22 Town Road
Hanley
Stoke-On-Trent
ST1 2JQ
Result/
confirmed
value
μg/kg
Compliant
Noncompliant
5.5
Compliant
Natures Aid Ltd
PR4 2DQ
The Ultimate
Premier Health
Catalogue
Products
76 Philadelphia Lane CV4 9UP
Norwich
Norfolk
NR3 3JU
Compliant
Compliant
NSR No
07N0946
07N0947
07N0948
07N0949
07N0951
07N0952
Web Address
Brand
Power Health
Bumbles
Holland &
Barrett
ISO
Power Health
Bumbles
GNC
Holland &
Barrett
Labelling Details
Country of
(as appears on
Origin
product)
Royal gellee
500mg x 60
capsules
Royal Jelly
500mg x 60
capsules
Royal Jelly
500mg x 60
capsules
Royal gellee
500mg x 30
capsules
Royal Jelly
500mg x 30
capsules
Royal Jelly
500 mg x 60
capsules
China
China
Date of
Purchase
24/09/2007
24/09/2007
Unknown 24/09/2007
China
USA
China
24/09/2007
24/09/2007
24/09/2007
17
Best Before
Date
Aug-10
Apr-10
Aug-08
1/3/2010
3/7/2010
Jun-10
Feb-10
Batch
88642
6324
20207
88233
AO7192
5736
Retail Address
Supplier /
Manufacturer
Address
Hanover Health
Foods
40 Hanover Street
Edinburgh
EH2 2DR
Result/
confirmed
value
μg/kg
Compliant
Holland & Barrett
Hanover Buildings
Rose Street
Edinburgh
EH2 2NN
Holland & Barrett
Retail Ltd
Nuneaton
Compliant
Warwickshire
CV11 6XW
ISO Edinburgh
57-59 South Clerk
Street
Edinburgh
EH8 9PP
Ecovit
Grey Cottage
Hardings Green
Cookham Dean
Berkshire
SL6 9NX
Holland & Barrett
124 Nicolson Street
Edinburgh
EH8 9EH
Power Health
Products Ltd
Pocklington
York
YO2 1NR
GNC
16 Laurie Walk
Romford
Essex
RM1 3RT
Health and Diet
Ltd
Hucknall
Notts
NG13 7HQ
Holland & Barrett
27 Laurie Walk
Romford
Essex
RM1 3RT
Holland & Barrett
Retail Ltd
Nuneaton
Compliant
Warwickshire
CV11 6XW
Noncompliant
3
Compliant
Compliant
NSR No
07N0953
07N0956
07N0957
07N0958
07N0961
07N0962
Web Address
Brand
Power Health
Bumbles
Holland &
Barrett
Power Health
Bumbles
Power Health
Bumbles
Power Health
Bumbles
Premier Health
Food Products
Labelling Details
Country of
(as appears on
Origin
product)
Royal gellee
500mg x 30
capsules
Royal Jelly
500mg x 60
capsules
Royal gellee
500mg x 30
capsules
Royal gellee
500mg x 30
capsules
Royal gellee
500mg x 30
capsules
China
China
China
China
China
Date of
Purchase
24/09/2007
25/09/2007
25/09/2007
24/09/2007
24/09/2007
Made from Fresh
Royal Jelly
Unknown 24/09/2007
500mg x 60
capsules
18
Best Before
Date
22/07/2010
22/03/2010
Batch
87590
88230
88233
Apr-10
6324
March 2010
July 2010
85893
86502
88264
87078
May 2010
Feb 2010
Aug 2010
July 2010,
March 2010
Mar-09
86865
88264
85437
88230
88256
86502
Unknown
Retail Address
Supplier /
Manufacturer
Address
Result/
confirmed
value
μg/kg
Holland & Barrett
27 Laurie Walk
Romford
Essex
RM1 3RT
Power Health
Products Ltd
Pocklington
York
YO2 1NR
Holland & Barrett
Cornwall Street
Plymouth
PL1 1LR
Holland & Barrett
Retail Ltd
Nuneaton
Compliant
Warwickshire
CV11 6XW
Holland & Barrett
Cornwall Street
Plymouth
PL1 1LR
Power Health
Products Ltd
Pocklington
York
YO2 1NR
Kilworthy Kapers
11 King Street
Tavistock
PL19 0DS
Power Health
Products Ltd
Pocklington
York
YO2 1NR
Holland & Barrett
Brunswick Pavillion
West Borough
Scarborough
YO11 2PA
Power Health
Products Ltd
Pocklington
York
YO2 1NR
Victoria Health Food
Centre
91 Victoria Road
Scarborough
YO11 1SL
Compliant
Compliant
Compliant
Compliant
Compliant
NSR No
07N0966
07N0967
07N1552
07N1604
07N1605
07N1607
Web Address
Brand
Holland &
Barrett
Power Health
Bumbles
Holland &
Barrett
Power Health
Bumbles
Power Health
Bumbles
Power Health
Bumbles
Labelling Details
Country of
(as appears on
Origin
product)
Royal Jelly
500mg x 60
capsules
Royal gellee
500mg x 30
capsules
Royal Jelly
500mg x 60
capsules
Royal gellee
500mg x 30
capsules
Royal gellee
500mg x 60
capsules
Royal gellee
500mg x 60
capsules
China
China
England
China
China
China
Date of
Purchase
22/09/2007
24/09/2007
22/11/2007
21/11/2007
21/11/2007
28/11/2007
19
Best Before
Date
Jun-10
Mar-10
Sep-10
Apr-07
Jul-10
Mar-10
Batch
6864
87078
86042
86274
BO7264
Retail Address
Supplier /
Manufacturer
Address
Result/
confirmed
value
μg/kg
Holland & Barrett
53/54 Mander
Square
Mander Centre
Wolverhampton
WV1 3NL
Holland & Barrett
Retail Ltd
Nuneaton
Compliant
Warwickshire
CV11 6XW
Holland & Barrett
98 Church Street
Bilstow
West Midlands
WV14 0AX
Power Health
Products Ltd
Pocklington
York
YO2 1NR
Holland & Barrett
2 Globe Lane
The Lanes
Carlisle
CA3 8NX
Holland & Barrett
Retail Ltd
Nuneaton
Compliant
Warwickshire
CV11 6XW
Gordon's Chemist
66 Main Street
Bushmills
B/N 71751 Co Antrim
BT57 8QD
Power Health
Products Ltd
Pocklington
York
YO2 1NR
The Health Food
Store NI
B/N 88234 62 The Promenade
Portstewart
Northern Ireland
Power Health
Products Ltd
Pocklington
York
YO2 1NR
Iona Shop
27 Church Road
Holywood
B/N 85917 Co Down
BT18 9BU
Power Health
Products Ltd
Pocklington
York
YO2 1NR
Compliant
Compliant
Compliant
Compliant
NSR No
07N1609
07N1610
07N1614
07N1615
07N1616
07N1617
Web Address
Brand
Holland &
Barrett
Power Health
Bumbles
Biobees Royal
Jelly
Queen Bee
Labelling Details
Country of
(as appears on
Origin
product)
Royal Jelly
500mg x 60
capsules
Royal gellee
500mg x 60
capsules
Royal Jelly
750mg x 30
capsules
Fresh Royal
Jelly 60g
Royal Jelly Biobees Royal
Made from fresh
Jelly
Royal Jelly 25g
Holland &
Barrett
Royal Jelly
500mg x 60
capsules
England
China
Italy
Australia
Date of
Purchase
25/11/2007
26/11/2007
20/11/2007
Best Before
Date
Sep-10
Jul-10
Jan-09
20/11/2007 06/03/2009
Batch
B07264
Holland & Barrett
Unit 6
St David's Way
St David's Centre
Cardiff
CF10 2DP
Health With Herbs
Cowbridge Road
B/N 88234 East Canton
Cardiff
CF11 9DX
501044
Unknown
Italy
20/11/2007
Aug-09
609041
England
20/11/2007
Sep-10
B07264
20
Retail Address
Supplier /
Manufacturer
Address
Result/
confirmed
value
μg/kg
Holland & Barrett
Retail Ltd
Nuneaton
Warwickshire
Compliant
CV11 6XW
Power Health
Products Ltd
Pocklington
York
YO2 1NR
Compliant
Selfridges
Oxford Street
London
W1A 1AB
Bioceuticals Ltd
Brandon House
1 Balham New
Road
London
SW12 9PH
Harrods
87-135 Brompton
Road
Knightsbridge
London
SW1X 7XL
Health World
(King & Gardiner
Ltd)
7 Falcon Court
Compliant
St Martins Way
London
SW17 0JH
Harrods
87-135 Brompton
Road
Knightsbridge
London
SW1X 7XL
Holland & Barrett
Oxford Street
London
W1R 1FE
Bioceuticals Ltd
Brandon House
1 Balham New
Compliant
Road
London
SW12 9PH
Holland & Barrett
Retail Ltd
Nuneaton
Compliant
Warwickshire
CV11 6XW
Compliant
NSR No
07N1618
Web Address
Brand
Power Health
Bumbles
Labelling Details
Country of
(as appears on
Origin
product)
Royal gellee
500mg x 60
capsules
China
Date of
Purchase
21/11/2007
21
Best Before
Date
Aug-10
Batch
90064
Retail Address
Planta Health Shop
32 Weston Hill
Upper Norwood
London
SE19 1RX
Supplier /
Manufacturer
Address
Power Health
Products Ltd
Pocklington
York
YO2 1NR
Result/
confirmed
value
μg/kg
Compliant
ANNEX 2
ANALYTICAL METHODOLOGY
Approach
All royal jelly samples were transported to the Central Science Laboratory
(CSL) at ambient temperature and maintained at ambient temperature during
the survey. For samples in capsule form, a sub-sample for screening analysis
was prepared by mechanically extracting and combining the capsule contents.
A portion of each sample was retained as intact capsules, and stored
separately for confirmatory analysis should this be necessary. Where
samples in capsule form were subject to confirmatory analysis, confirmation
aliquots were prepared by mechanical extraction (as above). For samples
consisting of royal jelly in pots, a portion of each sample was removed for the
screening analysis. The remainder was retained in the original container, and
stored separately for confirmatory analysis should this be necessary. For
samples in tablet form a portion of each sample was removed and crushed to
a powder. A portion of each sample was retained as intact tablets, stored
separately for confirmatory analysis should this be necessary. Where
samples in tablet form were subject to confirmatory analysis, confirmation
aliquots were prepared by crushing (as above).
Samples were analysed in accordance with the quality criteria defined in EU
Legislationa and ISO17025 accredited methodology. An overview of the
analytical method is as follows:
Chloramphenicol (CAP) was extracted from the royal jelly using
acetonitrile/water at 45-50ºC. The cooled extract was applied to a disposable
cartridge packed with a specially cleaned diatomaceous earth and eluted with
dichloromethane. The eluent was reduced to dryness under a stream of
nitrogen, resuspended in hexane/ethyl acetate and loaded onto a preconditioned amino (NH2) Solid Phase Extraction cartridge. After washing, the
sample extract was eluted from the cartridge with ethyl acetate/methanol. The
cleaned-up sample extract was reduced to dryness under nitrogen and
reconstituted with water. Samples were analysed using LiquidChromatography-Mass Spectrometry/Mass Spectrometry (LC-MS/MS).
Identification of CAP residues in a sample was made via two LC-MS/MS
transitions. A deuterated internal standard was used in the quantification of
CAP residues.
All samples were screened and confirmed at CSL using LC-MS/MS.
a
Commission Decision 2002/657/EC of 12 August 2002 implementing Council
Directive 96/23/EC concerning the performance of analytical methods and the
interpretation of results
22
Quality assurance
All screening batches included known blank samples, a matrix matched
standard (i.e. a known amount of analyte added to a known blank sample
after extraction), an extracted matrix matched standard (i.e. a known amount
of analyte added to a known blank sample prior to extraction) and multi-level
solvent standards. Suspect “positive” (non-compliant) samples from these
initial screening analyses were subject to confirmatory tests.
All confirmatory analyses were conducted in duplicate using test portions
taken from the retained sample, along with the Quality Assurance samples
and multilevel solvent standards included for screening (see above).
Any detectable CAP residues were implicitly corrected for recovery via the use
of d5-Chloramphenicol as an internal standard.
Quality assurance was also demonstrated by regular participation in both UK
and EU–wide proficiency schemes and collaborative studies.
Decision limit(CC) and Detection capability(CC)
The LC-MS/MS method for determining CAP was validated at CSL according
to the requirements of Commission Decision 2002/657/EC. This required the
determination of a number of key parameters including “CC” (Decision limit)
and “CC” (Detection capability):
CC
CC
CAP in Royal Jelly (µg/kg)
0.11
0.19
23
ANNEX 3
Comments from suppliers/retailers of confirmed samples
Note from Summerbee Products:
“These capsules were imported from USA using a recognised
registered supplier of long standing. Summerbee has a record of clean
and analytically sound royal jelly products dating back to 1991”.
24