EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/10432/2020 ANNEX feedback 
(POOL/G4/2020/10432/10432 -EN 
ANNEX feedback.docx)  
[…](2020) XXX  draft  
ANNEX  
 
ANNEX  
to the  
Commission Delegated Regulation  
amending Annex III to Regulation (EC) No 853/2004 of the European Parliament and of 
the Council on specific hygiene requirements for food of animal origin   EN 1  EN ANNEX  
Annex III to Regulation (EC) No 853/2004 is amended as follows:  
(1) Section I is amended as follows:  
(a) Chapter IV is amended as follows:  
(i) point 2(b)(ii) is replaced by the following:  
‘(ii) animals slaughtered at the holding of provenance in accordance with 
Chapter VIa of this Section or  in accordance with point 3 of Section III ;’ 
(ii) point 18 is replaced by the following:  
‘18. Unless intend ed for use as animal by -product in accordance with 
Regulation ( EC) No 1069/2009  of the European Parliament and of the 
Council* : 
(a) stomachs must be scalded or cleaned; however, when intended for 
rennet production, the stomachs:  
(i) are only required  to be emptied in the case of young bovine 
animals  
(ii) are not required to be emptied, scalded or cleaned in the case 
of young ovine and caprine animals;  
(b) intestines must be emptied and cleaned;  
(c) heads and feet must be skinned or scalded and depilate d; however, 
when authorised by the competent authority, visibly clean heads, 
not containing specified risk materials in accordance with Article 8 
of Regulation (EC) No 999/2001 of the European Parliament and of 
the Council* *, and visibly clean feet, intend ed for processing into 
food, may be transported to and skinned or scalded and depilated in 
an approved establishment.  
* Regulation (EC) No 1069/2009 of the European Parliament and of the 
Council of 21 October 2009 laying down health rules as regards animal  by-
products and derived products not intended for human consumption and 
repealing Regulation (EC) No 1774/2002 (Animal by -products Regulation)  
(OJ L 300, 14.11.2009, p. 1).  
** Regulation (EC) No 999/2001 of the European Parliament and of the 
Council of 22  May 2001 laying down rules for the prevention, control and 
eradication of certain transmissible spongiform encephalopathies (OJ L 147, 
31.5.2001, p. 1 ).’ 
(b) Chapter VI is amended as follows:  
(i) points 2 and 3 are replaced by the following:  
‘2. The offic ial veterinarian must carry out an ante -mortem inspection of the 
animal.  
3. The slaughtered and bled animal must be transported to the slaughterhouse 
hygienically and without undue delay. Removal of the stomach and intestines, 
but no other dressing, may ta ke place on the spot, under the supervision of the EN 2  EN official veterinarian. Any viscera removed must accompany the slaughtered 
animal to the slaughterhouse and be identified as belonging to that animal.’  
(ii) point 6 is replaced by the following:  
’The offici al certificate set out  in Chapter 5 of Annex IV to Commission 
Implementing Re gulation (EU) [ C(2020)8100 ]* shall accompany the 
slaughtered animal to the slaughterhouse or be sent in advance in any format.  
* Commission Implementing Regulation of … concerning  model official 
certificates for certain categories of animals and goods and repealing Directive 
98/68/EC, Decisions 2000/572/EC, 2003/779/EC and 2007/240/EC, Regulation 
(EC) No 599/2004, Implementing Regulations (EU) No 636/2014 and (EU) 
2019/628  (OJ L …,  ../../…., p. ..)  [C(2020)8100 ].’ 
(c) The following Chapter VIa is inserted after Chapter VI:  
‘CHAPTER VIa: SLAUGHTER AT THE HOLDING OF PROVENANCE OF 
DOMESTIC BOVINE , OTHERS THAN BISONS,  AND  PORCINE ANIMALS 
AND  DOMESTIC  SOLIPEDS OTHER THAN EMERGENCY SLAUGHTER  
Up to three  domestic bovine , others than bisons,  or up to six domestic porcine  
animal s or up to three domestic soliped s may be slaughtered at the same occasion at 
the holding of provenance, when authorised by the competent authority in 
accordance  with the following requirements:  
(a) the animal s cannot be transported  to the slaughterhouse , to avoid any risk 
for the handler and to prevent any injuries to the animal s during transport;  
(b) there is an agreement between the slaughterhouse and the owner of the 
animal  intended for slaughter ; the owner must inform the competent 
authority in writing of such an agreement;  
(c) the slaughterhouse or the owner of the animal s intended for slaughter  must 
inform the official veterinarian at least three days in advance of the date and 
time of intended slaughter of the animal s; 
(d) the official veterinarian that carries out the ante-mortem inspection of the 
animal intended for slaughter must also be pres ent at the time of slaughter.  
(e) the mobile unit  to be used for the slaughter, bleeding and transport  of the 
slaughtered animal s to the slaughterhouse must allow  the hygienic handling, 
slaughtering, bleeding of the animal, and the proper disposal of blood  and 
must be part of a slaughterhouse  approved by the competent authority in 
accordance with Article 4(2) ; 
(f) the slaughtered and bled animal s must be transported directly to the 
slaughterhouse hygienically and without undue delay; removal of the 
stomach and intestines, but no other dressing, may take place on the spot, 
under the supervision of the official veterinarian; any viscera removed must 
accompany the slaughtered ani mal to the slaughterhouse and be identified as 
belonging to each individual  animal;  
(g) if more than two hours elapse between the time of slaughter of the first  
animal and the time of arrival at the slaughterhouse  of the slaughtered 
animal s, the slaughter ed animal s must be refrigerated; where climatic 
conditions so permit, active chilling is not necessary;  EN 3  EN (h) the owner of the animal must inform the slaughterhouse in advance of the 
intended time of arrival of the slaughtered animal s, which must be handled 
without undue delay after arrival at the slaughterhouse;  
(i) in addition to the food chain information to be submitted in accordance with 
Section III of Annex II to this Regulation, the official certificate set out  in 
Chapter 3 of Annex IV to Implementing Regulation [ C(2020)8100 ] must 
accompany the slaughtered animal s to the slaughterhouse or be sent in 
advance in any format .’ 
(d) In Chapter VII, point 4 is replaced by the following:  
‘4  Meat intended for freezing must be frozen without undue delay, taking into 
account where necessary a stabilisation period before freezing.  
However, food business operators carrying out a retail activity may freeze meat in 
view of its redistribution fo r the purpose of food donations  in accordance with the 
following conditions : 
(i) in the case of meat for which a ‘use by’ date is applied in accordance with 
Article 24 of Regulation (EU) No 1169/2011  of the European Parliament and 
of the Council* , before the expiry of that date;  
(ii) without undue delay to a temperature of -18°C  or lower;  
(iii) ensuring that the date of freezing is documented and provided either on the 
label or by other means; and,  
(iv) excluding meat that has been frozen before (defrosted meat)  
(v) in accordance with any condition laid down by the competent aut horities 
for freezing and further use as food . 
* Regulation (EU) No 1169/2011 of the European Parliament and of the 
Council of 25 October 2011 on the provision of food information to 
consumers, amending Regulations (EC) No 1924/2006 and (EC) No 1925/2006 
of the European Parliament and of the Council, and repealing Commission 
Directive 87/250/EEC, Council Directive 90/496/EEC, Commission Directive 
1999/10/EC, Directive 2000/13/EC of the European Parliament and of the 
Council, Commission Directives 2002/67/EC  and 2008/5/EC and Commission 
Regulation (EC) No 608/2004 (OJ L 304, 22.11.2011, p. 18) .’ 
(2) Section II is amended as follows:  
(a) In Chapter V, point 5 is replaced by the following:  
‘5 Meat intended for freezing must be frozen without undue delay.  
Howeve r, food business operators carrying out a retail activity may freeze meat in 
view of its redistribution for the purpose of food donations  in accordance with the 
following conditions : 
(i) in the case of meat for which a ‘use by’ date is applied in accordanc e with 
Article 24 of Regulation (EU) No 1169/2011, before the expiry of that date;  
(ii) without undue delay to a temperature of -18°C or lower;  
(iii) ensuring that the date of freezing is documented and provided either on the 
label or by other means; and,  
(iv) excluding meat that has been frozen before (defrosted meat)  EN 4  EN (v) in accordance with any condition laid down by the competent authorities 
for freezing and further use as food .’ 
(b) Chapter VI  is amended as follows:   
(i) point 6 is deleted;  
(ii) point 7  is replaced by the following:  
‘7 In addition to the food chain information to be submitted in accordance 
with Section III of Annex II to this Regulation, the official certificate set out  in 
Chapter 3 of Annex IV to Implementing Regulation [ C(2020)8100 ] mu st 
accompany the slaughtered animal to the slaughterhouse or cutting plant, or be 
sent in advance in any format .’ 
(3) Section III  is amended as follows:   
a) point 1 is replaced by the following:  
‘1. The provisions of Section I apply to the production and p lacing on the 
market of meat from even -toed farmed game mammals , unless the 
competent authority considers them inappropriate. ’ 
b) point 3(j) is replaced by the following:  
‘(j) the official certificate set out in Chapter 3 of Annex IV to Commission 
Implemen ting Regulation (EU) [C(2020)8100], issued and signed by the 
official veterinarian, attesting to a favourable result  of the ante -mortem 
inspection, correct slaughter and bleeding and the date and time of 
slaughter, accompanies the slaughtered animal to the  slaughterhouse or 
was sent in advanc e in any format .’  
 (4) Section IV  is amended as follows:   
(a) the following introductory sentence is added:  
’For the purpose of this Chapter, ‘collection centre’ means an establishment 
used to store the bodies and viscera of wild game before their transport to a 
game handling establishment .’ 
(b) Chapter II is amended as follows:  
(i) point 4(c) is replaced by the following:  
‘(c) If no trained person is available to carry out the examination 
referred to in point 2 in a particular case, the head , except for tusks, 
antlers and horn s, and all the viscera , except for the stomach and 
the intestines , must accompany the body which must  be transported 
to a game handling -establishment as soon as possible after killing .’ 
(ii) in point 8(b) , the first subparagraph  is replaced by the following:  
‘(b) may be sent to a game establishment in another Member State only 
if, during transport to that game -handling establishment, it is 
accompanied by a n official certificate set out in Chapte r 2 of Annex II 
to Implementing Regulation [ C(2020)8100 ] issued and signed by an 
official veterinarian, attesting that the requirements set out in point 4 of 
this Chapter as regards the availability of a declaration, when relevant, 
and the accompaniment of  relevant parts of the body, have been 
complied with. ’ EN 5  EN (iii) the following point 10 is added:  
‘10. The bodies and viscera of large wild game may be transported to 
and stored in a collection centre before being sent to a game 
handling establishment provided  that: 
(a) the collection centre is  either:  
 (1) registered with the competent authority as a food 
business carrying out primary production as referred to 
in Article 4(2)(a) when only receiving bodies as first 
collection centre , or 
 (2) approved by the com petent authority as a food business 
in accordance with Article 4(2) when receiving bodies 
from other collection centres ; 
(b) the temperature conditions laid down in point 5 are complied 
with;  
(c) storage time is kept to the minimum possible;  
(d) no other handling takes place on the bodies and viscera of the 
large wild game; however the examination by a trained 
person and the removal of viscera may take place under the 
conditions laid down in points 2 , 3 and  4.’ 
(c) Chapter III is amended as follows:  
(i) point 3 is replaced by the following:  
‘3 Meat of small wild game may be placed on the market only if the body 
is transported to a game -handling establishment as soon as possible after 
the examination referred to in point 1 or, if no trained person is availab le 
to carry out that examination  in a particular case, as soon as possible 
after killing ’. 
(ii) the following point 8 is added :  
‘8. The bodies, including viscera, of small wild game may be 
transported to and stored in a collection centre before being sen t to 
a game handling establishment provided that : 
(a) the collection centre is  either:  
 (1) registered with the competent authority as a food 
business carrying out primary production as referred to 
in Article 4(2)(a) when only receiving bodies as first 
collection centre , or 
 (2) approved by the competent authority as a food business 
in accordance with Article 4(2) when receiving bodies 
from other collection centres ; 
 (b) the temperature conditions laid down in point 4 are complied 
with;  
(c) storage time is kept to the minimum possible;  
(d) no other handling takes place on the bodies, including 
viscera, of the small wild game; however the  examination by EN 6  EN a trained person and the removal of viscera may take place 
under the conditions laid down in points 1 and 2.’ 
(5) Section VII is amended as follows:  
(a) In the introductory part, the following point 1a is inserted:  
‘1a. For the purpose of this Section, ‘intermediary operator’ means a food 
business operator , including traders , other than the first supplier, with or 
without premises, who carries out its activities between production  areas  or 
relaying areas, or establishments, and the dispatch centre .’  
(b) Chapter I is amended as follows:  
(i) point 3 is replaced by the following:  
‘3. Whenever a food business o perator moves a batch of live bivalve molluscs 
from a production area or relaying area or between establishments, up to 
and including the arrival of the batch at a dispatch centre or processing 
establishment, a registration document must accompany the batc h.’ 
(ii) in point 4, the following point (d) is added:  
‘ (d) Where a batch of live bivalve molluscs is sent to an intermediary 
operator, a new registration document, filled -in by the intermediary 
operator, must accompany the batch. The registration documen t must 
contain at least the information referred to in points (a), (b) and (c) and 
the following information:  
(i) the intermediary’s name  and address  
(ii) in the case of conditioning , the duration of the conditioning and the 
place where the conditioning  took place. If a conditioning in a 
natural si te was carried out, the intermediary operator must confirm 
that the natural si te where the conditioning took place was 
classified as an A area  open for harvest , the date when the 
conditioning started and the dat e of the end of the conditioning .’ 
(iii) in the case of grouping, the species, the date when the grouping 
started, the date of the end of the grouping, the status of the area 
where the live bivalve mollusc s were harvested, and the batch of 
the grouping, th at always consists of the same species, captured on 
the same date, and in the same production area.  
 (iii) the following points 8 and 9 are added :  
‘8. Intermediary operators must be:  
(a) registered with the competent authority as a food business carrying 
out primary production  as referred to in Article 4(2)(a)  if they don’t 
have premises or if they have premises where they only handle, 
wash and store at ambient temperature live bivalve molluscs, 
without grouping nor conditioning , or 
(b) approved by the com petent authority as a food business operator in 
accordance with Article 4(2) if, in addition to carrying out the 
activities referred to in point (a), they have a cold store or they 
group or split batches of live biva lve molluscs or they carry out 
conditioning . EN 7  EN 9. Intermediary operators may receive live bivalve molluscs from class A 
and B production areas or from another intermediate operators .’ 
(c) In  Chapter V, point 2 (c) is replaced by the following:  
‘(c) for okadaic acid and dinophysistoxins  together  160 micrograms of okadaic acid 
equivalents per kilogram ;’ 
(d)  Chapter IX is replaced by the following:  
‘CHAPTER IX: SPECIFIC REQUIREMENTS FOR PECTINIDAE, MARINE 
GASTROPODS AND HOLOTHUROIDEA WHICH ARE NOT FILTER FEEDERS 
HARVESTED OUTSIDE CLASSIFIED  PRODUCTION AREAS  
Food business operators harvesting pectinidae, marine gastropods and holothuroidea which 
are not filter feeders, outside classified production areas or handling such pectinidae, and/or 
such marine gastropods and/or holothuroidea must comp ly with the following requirements:  
1. Pectinidae, marine gastropods and holothuroidea which are not filter feeders, must not be 
placed on the market unless they are harvested and handled in accordance with Part B of 
Chapter II and meet the standards laid down in Chapter V, as demonstrated by a system of 
own-checks  by the food business operators operating a fish auction, a dispatch centre or a 
processing establishment ; 
2. In addition to point 1, where data from official monitoring programmes enable the 
competent authority to classify fishing grounds — where appropriate, in cooperation with 
food business operators — the provisions of Part A of Chapter II apply by analogy to 
pectinidae;  
3. Pectinidae, marine gastropods and holothuroidea which are not filte r feeders, must not be 
placed on the market for human consumption otherwise than via a fish auction, a dispatch 
centre or a processing establishment. When they handle pectinidae and/or such marine 
gastropods, and/or holothuroidea food business operators op erating such establishments must 
inform the competent authority and, as regards dispatch centres, comply with the relevant 
requirements of Chapters III and IV;  
4. Food business operators handling pectinidae, marine gastropods and holothuroidea which 
are no t filter feeders, must comply with the following requirements:  
(a) with the documentary requirements of points 3 to 7 of Chapter I, where applicable. In this 
case, the registration document must clearly indicate the location of the area , indicating the 
system used to describe the coordinates , where the live pectinidae and/or live marine 
gastropods and/or live holothuroidea were harvested; or  
(b) with the requirements of point 2 of Chapter VI concerning the closing of all packages of 
live pectinidae, live ma rine gastropods and live holothuroidea dispatched for retail sale and 
Chapter VII concerning identification marking and labelling.’  
 
(d) The following  Chapter X is added:  
‘CHAPTER X  
MODEL OF REGISTRATION DOCUMENT OF LIVE BIVALVE MOLLUSCS, 
LIVE ECHINODERM S, LIVE TUNICATES AND LIVE MARINE 
GASTROPODS   
REGISTRATION DOCUMENT OF LIVE BIVALVE MOLLUSCS, LIVE ECHINODERMS , 
LIVE TUNICATES AND LIVE MARINE GASTROPODS  EN 8  EN      Part I – Supplier   I.1 IMSOC Reference number  I.2 Internal reference number  
 
I.3 Supplier  
 
Name  
Address  
Registration or Approval No  
Country                               ISO Country 
code  
Activity  I.4 Receiving food business operator  
 
Name  
Address  
Registration or Approval No  
Country                                  ISO Country code  
Activity  
 
I.5 Description of goods  
 
Aquaculture ? ?  Natural Banks ? ? 
 
 
 CN code | species | quantity | package | batch | date of starting of conditioning | date of end 
of conditioning | date of starting of grouping | date of end of grouping | production area | 
health status  
 
I.6 From relaying area            Yes?   No? 
Relaying area                          
Duration of relaying  I.7 From purification/dispatch centre  
Auction hall         Yes ?   No? 
Purification/dispatch centre/auction hall 
approval  number                       
Date of entry                                    Date of 
exit 
Duration of purification  
 
1.8 Intermediary operator  
 
Name  
Address  
Registration or Approval No  
Country                               ISO Country 
code  
 Activity  
Date of arrival   
Date of exit  
  
 
  
I.9Declaration of the supplier  
 
I, the undersigned food business operator responsible for dispatching the consignment declare 
that, to the best of my knowledge and belief, the information provided in Part I of this 
document is true and complete.  
 
Date                                        Name of signatory                                  Signature  
 
 Part 
II – 
Recei
ving 
oper
ator II.1 Internal reference number (receiving)  
 
 EN 9  EN II.2 Declaration of the receiving food business operator  
 
I, the undersigned  food business  operator responsible for receiving the consignment declare that 
the consignment has arrived on [DATE] in my premises.  
 
 
Name of signatory                                Signature  
 
 
 
 
  EN 10  EN Explanatory notes  
Box Description  
Part I – Supplier  
 
This part of the document shall be filled by the food business operator dispatching a batch of live 
bivalve molluscs.  
 
I.1 IMSOC reference number  
 
This is the unique alpha -numeric code assigned by the IMSOC  
 
I.2 Local reference number  
 
This box may be used by the dispatching  food business operator to indicate an internal 
reference number.  
 
I.3  Supplier  
 
Indicate the name and address street, city and region/province/state, as appropriate), 
country and ISO country code of the establishment of origin. In the case of production 
areas, please indicate the area as authorised by the competent authorities( CAs). In the case 
of live pectinidae, marine gastropods or holothuroidea, indicate the location of the 
harvesting area.  
Where applicable, indicate the registration or approval number  of the establishment . 
Indicate the activity (gatherer, purification centre, disp atch centre, auction hall or  
intermediary activities)  
 
I.4 Receiving food business operator  
 
Indicate the name and address (street, city and region/province/state, as appropriate), 
country and ISO country code of the establishment of destination.  In the case of production 
or relaying areas please indicate the area as authorised by the CAs.  
Where applicable, indicate the registration or approval number  of the establishment  
Indicate the activity (gatherer, purification centre, dispatch centre or intermediary  
activities)  
 
I.5 Description of goods  
 
Indicate as required, the Common Nomenclature code, species, quantity, type of packaging 
(bags, bulk, etc), batch, date of starting and end of conditioning (when applicable), date of 
starting and end of grouping (wh en applicable), production area and its health status 
(classification of the production area when applicable).  
When grouping of live bivalve molluscs is performed, the batch must refer to bivalves of 
the same species, harvested on the same day and coming from the same production area.  
Delete as appropriate  
 
 
I.6 From relaying area  
 
Where  the batch of live bivalve molluscs is sent from a relaying area, indicate the relaying 
area, as authorised by the CAs, and the duration of the relaying.  
 
I.7 From purification  centre /dispatch centre or fish auction  
 EN 11  EN Where  the batch of live bivalve molluscs is sent from a purification  centre /dispatch centre, 
or, in case of pectinidae, marine gastropods and holothuroidea which are not filter feeders 
harvested outside classified production areas , from a fish auction , indicate the approval 
number and the address of the purification  centre /dispatch centre or fish auction . 
If sent from a purification centre the duration of the purification and the dates on which the 
batch  entered and left the purification centre. Delete as appropriate  
 
I.8 Intermediary operator  
 
Indicate the name and address street, city and region/province/state, as appropriate), 
country and ISO country code of the intermediary operator.  
Where applicable, indicate the registration or approval number and the activity (splitting, 
conditioning or other activities ) 
 
  
  
  
1.9 Declaration of the dispatching  food business operator  
 
Include the date, name of the signatory and the signature.  
 
 
Part II – Receiving food business operator  
 
This part of the document shall be filled by the food business operator receiving a batch of live 
bivalve molluscs.  
 
II.1 Local reference number (receiving)  
 
This box may be used by the food business operator receiving the batch to indicate an 
internal reference number.  
 
II.2 Declaration of the receiving food business operator  
 
Indicate the date of arrival of the batch of live bivalve molluscs at the premises of the 
receiving food business operator. In  the case of an intermediary operator without premises 
indicate the date of purchase of the batch.  
 
Include the name of the signatory and the signature.  
 
 
‘ 
(6) Section VIII is amended as follows:  
(a) Chapter I is amended as follows:  
(i) Point 1 is replaced b y the following : 
‘Food business operators must ensure that:  
1. vessels used to harvest fishery products from their natural 
environment, or to handle or process them after harvesti ng, and 
reefer vessels comply with the structural and equipment 
requirements laid down in Part I ;’ 
(ii) In Part I.A, the following point 5 is added:  EN 12  EN ‘5. Vessels must be designed and constructed so as not to cause 
contamination of the fishery products with bilge -water, sewage, 
smoke, fuel, oil, grease or other objectionable substan ces. Holds, 
tanks, or containers used for storing, cooling or freezing 
unprotected  fishery products including those destined  for the 
production of feed, shall not be used for other purposes than the 
storing, cooling or freezing those  products, as well as ice or brine  
used for such purposes . In the case of reefer vessels, the provisions 
applicable to unprotected  fishery products apply to all  the products 
transported .’ 
(iii) In Part I.C, points 1 and 2 are replaced by the following:  
‘1. have freezing equipment with sufficient capacity to freeze as 
quick ly as possible in a continuous process and with a thermal 
arrest period as short as possible, so as to achieve a core 
temperature of not more than -18 °C;  
2. have refrigeration equipment with sufficient capacity to maintain 
fishery products in the storage holds at not more than -18 °C. 
Storage holds must not be used for freezing unless they fulfil the 
conditions laid down in point  1, and must be equipped with a 
temperature -recording device in a place wher e it can be easily read. 
The temperature sensor of the reader must be situated in the area 
where the temperature in the hold is the highest ;’ 
(iv) In Part I, the following point E is added:  
‘E. Requirements for reefer vessels  
Reefer vessels transporting an d/or storing frozen fishery products 
in bulk must have equipment meeting the requirements for freezer 
vessels laid down in point 2 of part C  concerning their capacity to 
maintain the temperature .’ 
(v) In Part II, point 6 is replaced by the following  
‘6. Where fish are headed and/or gutted on board, such operations 
must be carried out hygienically as soon as possible after capture, 
and the  fishery  products must be washed immediately . The viscera 
and parts that may constitute a danger to public health must be  
removed as soon as possible and kept apart from fishery products 
intended for human consumption. Livers and roes intended for 
human consumption must be refrigerated or preserved under ice, at 
a temperature approaching that of melting ice , or be frozen .’ 
(vi) in Part II , point 7 is replaced by the following : 
‘7. Where freezing in brine of the whole fish intended for canning is 
practiced, a temperature of not more than -9 °C must be achieved 
for the fishery product. Even if it is subsequently frozen at a 
temperature of -18ºC , the w hole fish initially frozen in brine at a 
temperature of not more than -9 °C must be destined for canning. 
The brine must not be a source  of contamination for the fish .’ 
(b) Chapter III is amended as follows:  EN 13  EN (i) In Part A, point 4.i s replaced by the following:  
‘4. Containers used for the dispatch or storage of unpackaged prepared 
fresh fishery products stored under ice must ensure that melt water 
is drained away and does not remain in contact with any fishery 
products .’ 
(ii) Part B is replaced by the following:  
‘B. REQUIREMENTS FOR FROZEN PRODUCTS  
Establishments on land that freeze or store frozen fishery products 
must have equipment that satisfies the requirements for freezer 
vessels laid down in points 1 and 2 of Chapter 1 .’ 
(7) In Section XI, the following points 7 and 8 are added:  
‘7. The requirements laid down in points 1, 3, 4 and 6, also apply to any other 
snails of the Family of Helicidae, Hygromiidae  or Sphincterochilidae , when 
intended for human consumption.  
8. The requirements laid down in points 1 to 5 also apply to frogs’ legs of the 
genus Pelophylax  from the Family of Ranidae , and the genus Fejervarya,  
Limnonectes  and Hoplobatrachus  from the Family of Dicroglossidae , when 
intended for human consumption .’ 
(8) In Section XII, in Chapter II , point 5  is deleted.