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Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific hygiene rules for food of animal origin

EU Regulation No 853/2004 · Adopted 29 April 2004 · Extends to United Kingdom

Original text. legislation.gov.uk does not revise this item, so later amendments are not shown here. Changes made to it are listed under each provision when known.

X1Regulation (EC) No 853/2004 of the European Parliament and of the Council

of 29 April 2004

laying down specific hygiene rules for food of animal origin

C1

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Article 152(4)(b) thereof,

Having regard to the proposal from the Commission f1 ,

Having regard to the opinion of the European Economic and Social Committee f2 ,

Having consulted the Committee of the Regions,

Acting in accordance with the procedure laid down in Article 251 of the Treaty f3 ,

Whereas:

(1)

Pursuant to Regulation (EC) No 852/2004 f4 , the European Parliament and the Council laid down general rules for food business operators on the hygiene of foodstuffs.

(2)

Certain foodstuffs may present specific hazards to human health, requiring the setting of specific hygiene rules. This is particularly the case for food of animal origin, in which microbiological and chemical hazards have frequently been reported.

(3)

In the context of the common agricultural policy, many Directives have been adopted to establish specific health rules for the production and placing on the market of the products listed in Annex I to the Treaty. These health rules have reduced trade barriers for the products concerned, contributing to the creation of the internal market while ensuring a high level of protection of public health.

(4)

With regard to public health, these rules contain common principles, in particular in relation to the manufacturers ‘ and competent authorities ’ responsibilities, structural, operational and hygiene requirements for establishments, procedures for the approval of establishments, requirements for storage and transport and health marks.

(5)

These principles constitute a common basis for the hygienic production of food of animal origin, permitting the simplification of the existing directives.

(6)

It is desirable to achieve further simplification by applying the same rules wherever appropriate to all products of animal origin.

(7)

The requirement in Regulation (EC) No 852/2004 whereby food business operators carrying out any stage of production, processing and distribution of food after primary production and associated operations must put in place, implement and maintain procedures based on hazard analysis and critical control point (HACCP) principles also permits simplification.

(8)

Taken together, these elements justify a recasting of the specific hygiene rules contained in existing directives.

(9)

The principal objectives of the recasting are to secure a high level of consumer protection with regard to food safety, in particular by making food business operators throughout the Community subject to the same rules, and to ensure the proper functioning of the internal market in products of animal origin, thus contributing to the achievement of the objectives of the common agricultural policy.

(10)

It is necessary to maintain and, where required to ensure consumer protection, to tighten detailed hygiene rules for products of animal origin.

(11)

Community rules should not apply either to primary production for private domestic use or to the domestic preparation, handling or storage of food for private domestic consumption. Moreover, where small quantities of primary products or of certain types of meat are supplied directly by the food business operator producing them to the final consumer or to a local retail establishment, it is appropriate to protect public health through national law, in particular because of the close relationship between the producer and the consumer.

(12)

The requirements of Regulation (EC) No 852/2004 are generally sufficient to ensure food safety in establishments carrying out retail activities involving the direct sale or supply of food of animal origin to the final consumer. This Regulation should generally apply to wholesale activities (that is, when a retail establishment carries out operations with a view to supplying food of animal origin to another establishment). Nevertheless, with the exception of the specific temperature requirements laid down in this Regulation, the requirements of Regulation (EC) No 852/2004 should suffice for wholesale activities consisting only of storage or transport.

(13)

Member States should have some discretion to extend or to limit the application of the requirements of this Regulation to retail under national law. However, they may limit their application only if they consider that the requirements of Regulation (EC) No 852/2004 are sufficient to achieve food hygiene objectives and when the supply of food of animal origin from a retail establishment to another establishment is a marginal, localised and restricted activity. Such supply should therefore be only a small part of the establishment's business; the establishments supplied should be situated in its immediate vicinity; and the supply should concern only certain types of products or establishments.

(14)

In accordance with Article 10 of the Treaty, Member States are to take all appropriate measures to ensure that food business operators comply with the obligations laid down in this Regulation.

(15)

The traceability of food is an essential element in ensuring food safety. In addition to complying with the general rules of Regulation (EC) No 178/2002 f5 , food business operators responsible for establishments that are subject to approval in accordance with this Regulation should ensure that all products of animal origin that they place on the market bear either a health mark or an identification mark.

(16)

Food imported into the Community is to comply with the general requirements laid down in Regulation (EC) No 178/2002 or to satisfy rules that are equivalent to Community rules. This Regulation defines specific hygiene requirements for food of animal origin imported into the Community.

(17)

The adoption of this Regulation should not reduce the level of protection provided by the additional guarantees agreed for Finland and Sweden on their accession to the Community and confirmed by Commission Decisions 94/968/EC f6 , 95/50/EC f7 , 95/160/EC f8 , 95/161/E f9 and 95/168/EC f10 , and Council Decisions 95/409/EC f11 , 95/410/EC f12 and 95/411/EC f13 . It should establish a procedure for the granting, for a transitional period, of guarantees to any Member State that has an approved national control programme which, for the food of animal origin concerned, is equivalent to those approved for Finland and Sweden. Regulation (EC) No 2160/2003 of the European Parliament and of the Council of 17 November 2003 on the control of salmonella and other specified food-borne zoonotic agents f14 provides for a similar procedure in respect of live animals and hatching eggs.

(18)

It is appropriate for the structural and hygiene requirements laid down in this Regulation to apply to all types of establishments, including small businesses and mobile slaughterhouses.

(19)

Flexibility is appropriate to enable the continued use of traditional methods at any of the stages of production, processing or distribution of food and in relation to structural requirements for establishments. Flexibility is particularly important for regions that are subject to special geographical constraints, including the outermost regions referred to in Article 299(2) of the Treaty. However, flexibility should not compromise food hygiene objectives. Moreover, since all food produced in accordance with the hygiene rules will normally be in free circulation throughout the Community, the procedure allowing Member States to exercise flexibility should be fully transparent. It should provide, where necessary to resolve disagreements, for discussion within the Standing Committee on the Food Chain and Animal Health established by Regulation (EC) No 178/2002 and for the Commission to coordinate the process and take appropriate measures.

(20)

The definition of mechanically separated meat (MSM) should be a generic one covering all methods of mechanical separation. Rapid technological developments in this area mean that a flexible definition is appropriate. The technical requirements for MSM should differ, however, depending on a risk assessment of the product resulting from different methods.

(21)

There are interactions between food business operators, including the animal feed sector, and connections between animal health, animal welfare and public health considerations at all stages of production, processing and distribution. This requires adequate communication between the different stakeholders along the food chain from primary production to retail.

(22)

In order to ensure proper inspection of hunted wild game placed on the Community market, bodies of hunted animals and their viscera should be presented for official post-mortem inspection at a game-handling establishment. However, to preserve certain hunting traditions without prejudicing food safety, it is appropriate to provide for training for hunters who place wild game on the market for human consumption. This should enable hunters to undertake an initial examination of wild game on the spot. In these circumstances, it is not necessary to require trained hunters to deliver all viscera to the game-handling establishment for post-mortem examination, if they carry out this initial examination and identify no anomalies or hazards. However, Member States should be allowed to establish stricter rules within their territories to take account of specific risks.

(23)

This Regulation should establish criteria for raw milk pending the adoption of new requirements for its placing on the market. These criteria should be trigger values, implying that, in the event of any overshooting, food business operators are to take corrective action and to notify the competent authority. The criteria should not be maximum figures beyond which raw milk cannot be placed on the market. This implies that, in certain circumstances, raw milk not fully meeting the criteria can safely be used for human consumption, if appropriate measures are taken. As regards raw milk and raw cream intended for direct human consumption, it is appropriate to enable each Member State to maintain or establish appropriate health measures to ensure the achievement of the objectives of this Regulation on its territory.

(24)

It is appropriate for the criterion for raw milk used to manufacture dairy products to be three times as high as the criterion for raw milk collected from the farm. The criterion for milk used to manufacture processed dairy products is an absolute value, whereas for raw milk collected from the farm it is an average. Compliance with the temperature requirements laid down in this Regulation will not halt all bacterial growth during transport and storage.

(25)

The present recasting means that the existing hygiene rules can be repealed. Directive 2004/41/EC of the European Parliament and of the Council of 21 April 2004 repealing certain directives on food hygiene and health conditions for the production and placing on the market of certain products of animal origin intended for human consumption f15 achieves this.

(26)

In addition, the rules of this Regulation on eggs replace those of Council Decision 94/371/EC of 20 June 1994 laying down specific public health conditions for the putting on the market of certain types of eggs f16 , which the repeal of Annex II to Council Directive 92/118/EEC f17 renders void.

(27)

Scientific advice should underpin Community legislation on food hygiene. To this end, the European Food Safety Authority should be consulted whenever necessary.

(28)

To take account of technical and scientific progress, close and effective cooperation should be ensured between the Commission and the Member States within the Standing Committee on the Food Chain and Animal Health.

(29)

The requirements of this Regulation should not apply until all parts of the new legislation on food hygiene have entered into force. It is also appropriate to provide for at least 18 months to elapse between entry into force and the application of the new rules, to allow the industries affected time to adapt.

(30)

The measures necessary for the implementation of this Regulation should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission f18 ,

HAVE ADOPTED THIS REGULATION:

Annotations to the whole text

Modifications

C1

Regulation applied (with modifications) (N.I.) (1.10.2023) by The Windsor Framework (Retail Movement Scheme: Public Health, Marketing and Organic Product Standards and Miscellaneous Provisions) Regulations 2023 (S.I. 2023/959), regs. 1(2), 4(a), Sch. 1 (with regs. 7, 8)

Editorial notes

X1

Substituted by Corrigendum to Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific hygiene rules for food of animal origin (Official Journal of the European Union L 139 of 30 April 2004).

Footnotes

f1

OJ C 365 E, 19.12.2000, p. 58 .

f2

OJ C 155, 29.5.2001, p. 39 .

f3

Opinion of the European Parliament of 15 May 2002 ( OJ C 180 E, 31.7.2003, p. 288 ), Council Common Position of 27 October 2003 ( OJ C 48 E, 24.2.2004, p. 23 ), Position of the European Parliament of 30 March 2004 (not yet published in the Official Journal) and Council Decision of 16 April 2004 .

f4

See page 3 of this Official Journal.

f5

Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety ( OJ L 31, 1.2.2002, p. 1 ). Regulation as amended by Regulation (EC) No 1642/2003 ( OJ L 245, 29.9.2003, p. 4 ).

f6

OJ L 371, 31.12.1994, p. 36 .

f7

OJ L 53, 9.3.1995, p. 31 .

f8

OJ L 105 9.5.1995, p. 40 .

f9

OJ L 105, 9.5.1995, p. 44 .

f10

OJ L 109, 16.5.1995, p. 44 .

f11

OJ L 243, 11.10.1995, p. 21 .

f12

OJ L 243, 11.10.1995, p. 25 .

f13

OJ L 243, 11.10.1995, p. 29 .

f14

OJ L 325, 12.12.2003, p. 1 .

f15

OJ L 157, 30.4.2004, p. 33 .

f16

OJ L 168, 2.7.1994, p. 34 .

f17

Council Directive 92/118/EEC of 17 December 1992 laying down animal health and public health requirements governing trade in and imports into the Community of products not subject to the said requirements laid down in specific Community rules referred to in Annex A (I) to Directive 89/662/EEC and, as regards pathogens, to Directive 90/425/EEC ( OJ L 62, 15.3.1993, p. 49 ). Directive as last amended by Commission Regulation (EC) No 445/2004 ( OJ L 72, 11.3.2004, p. 60 ).

f18

OJ L 184, 17.7.1999, p. 23 .

Contents

  1. Chapter I: GENERAL PROVISIONS
  2. 1Scope
  3. 2Definitions
  4. Chapter II: FOOD BUSINESS OPERATORS' OBLIGATIONS
  5. 3General obligations
  6. 4Registration and approval of establishments
  7. 5Health and identification marking
  8. 6Products of animal origin from outside Great Britain
  9. Chapter III: TRADE
  10. 7Documents
  11. 8Special guarantees Repealed
  12. Chapter IV: FINAL PROVISIONS
  13. 9Article 9 Repealed
  14. 10Amendment and adaptation of Annexes II and III
  15. 11Specific decisions
  16. 11aExercise of the delegation Repealed
  17. 12Regulations and devolved powers
  18. 13Consultation of the ... Food Safety Authority
  19. 14Report to the European Parliament and to the Council Repealed
  20. 15Article 15
  21. Signature
  22. Annex IDEFINITIONS
  23. MEAT
  24. 1.1Division 1.1
  25. 1.2Division 1.2
  26. 1.3Division 1.3
  27. 1.4Division 1.4
  28. 1.5‘Wild game’ means:
  29. 1.6Division 1.6
  30. 1.7Division 1.7
  31. 1.8Division 1.8
  32. 1.9Division 1.9
  33. 1.10Division 1.10
  34. 1.11Division 1.11
  35. 1.12Division 1.12
  36. 1.13Division 1.13
  37. 1.14Division 1.14
  38. 1.15Division 1.15
  39. 1.16Division 1.16
  40. 1.17Division 1.17
  41. 1.18Division 1.18
  42. LIVE BIVALVE MOLLUSCS
  43. 2.1Division 2.1
  44. 2.2Division 2.2
  45. 2.3Division 2.3
  46. 2.4Division 2.4
  47. 2.5Division 2.5
  48. 2.6Division 2.6
  49. 2.7Division 2.7
  50. 2.8Division 2.8
  51. 2.9Division 2.9
  52. FISHERY PRODUCTS
  53. 3.1Division 3.1
  54. 3.2Division 3.2
  55. 3.3Division 3.3
  56. 3.4Division 3.4
  57. 3.5Division 3.5
  58. 3.6Division 3.6
  59. MILK
  60. 4.1Division 4.1
  61. 4.2Division 4.2
  62. EGGS
  63. 5.1Division 5.1
  64. 5.2Division 5.2
  65. 5.3Division 5.3
  66. 5.4Division 5.4
  67. FROGS' LEGS AND SNAILS
  68. 6.1Division 6.1
  69. 6.2Division 6.2
  70. PROCESSED PRODUCTS
  71. 7.1Division 7.1
  72. 7.2Division 7.2
  73. 7.3Division 7.3
  74. 7.4Division 7.4
  75. 7.5Division 7.5
  76. 7.6Division 7.6
  77. 7.7Division 7.7
  78. 7.8Division 7.8
  79. 7.9Division 7.9
  80. OTHER DEFINITIONS
  81. 8.1‘Products of animal origin’ means:
  82. 8.2Division 8.2
  83. Annex II: REQUIREMENTS CONCERNING SEVERAL PRODUCTS OF ANIMAL ORIGIN
  84. I:IDENTIFICATION MARKING
  85. APPLICATION OF THE IDENTIFICATION MARK
  86. 1Division 1
  87. 2Division 2
  88. 3Division 3
  89. 4Division 4
  90. FORM OF THE IDENTIFICATION MARK
  91. 5Division 5
  92. 6Division 6
  93. 7Division 7
  94. 8Division 8
  95. 9Division 9
  96. METHOD OF MARKING
  97. 9Division 9
  98. 10Division 10
  99. 11Division 11
  100. 12Division 12
  101. 13Division 13
  102. 14Division 14
  103. OBJECTIVES OF HACCP-BASED PROCEDURES
  104. 1Division 1
  105. 2The procedures must guarantee that each animal or, where appropriate, each lot of animals accepted onto the slaughterhouse premises:
  106. 3Division 3
  107. III:FOOD CHAIN INFORMATION
  108. 1Division 1
  109. 2Division 2
  110. 3The relevant food chain information referred to in point 1 is to cover, in particular:
  111. 4Division 4
  112. 5Division 5
  113. 6Division 6
  114. 7If the competent authority so permits and provided it does not jeopardise the objectives of this Regulation, food chain information may arrive less than 24 hours before the arrival of the animals of all species to which it relates at the slaughterhouse or accompany these animals to the slaughterhouse.
  115. 8Division 8
  116. REQUIREMENTS APPLICABLE TO FROZEN FOOD OF ANIMAL ORIGIN
  117. 1For the purposes of this Section, ‘ date of production ’ means:
  118. 2Until the stage at which a food is labelled in accordance with Regulation (EU) 1169/2011 or used for further processing, food business operators must ensure that in the case of frozen food of animal origin intended for human consumption, the following information is made available to the food business operator to whom the food is supplied and, upon request, to the competent authority:
  119. 3Division 3
  120. Annex III: SPECIFIC REQUIREMENTS
  121. MEAT OF DOMESTIC UNGULATES
  122. I:TRANSPORT OF LIVE ANIMALS TO THE SLAUGHTERHOUSE
  123. II:REQUIREMENTS FOR SLAUGHTERHOUSES
  124. III:REQUIREMENTS FOR CUTTING PLANTS
  125. IV:SLAUGHTER HYGIENE
  126. V:HYGIENE DURING CUTTING AND BONING
  127. VI:EMERGENCY SLAUGHTER OUTSIDE THE SLAUGHTERHOUSE
  128. VII:STORAGE AND TRANSPORT
  129. MEAT FROM POULTRY AND LAGOMORPHS
  130. I:TRANSPORT OF LIVE ANIMALS TO THE SLAUGHTERHOUSE
  131. II:REQUIREMENTS FOR SLAUGHTERHOUSES
  132. Chapter III:: REQUIREMENTS FOR CUTTING PLANTS
  133. 1Food business operators must ensure that cutting plants handling meat from poultry or lagomorphs:
  134. 2If the following operations are undertaken in a cutting plant:
  135. IV:SLAUGHTER HYGIENE
  136. V:HYGIENE DURING AND AFTER CUTTING AND BONING
  137. VI:SLAUGHTER ON THE FARM
  138. VII:WATER RETENTION AGENTS
  139. MEAT OF FARMED GAME
  140. 1Division 1
  141. 2Division 2
  142. 3Notwithstanding points 1 and 2, food business operators may slaughter farmed ratites and farmed ungulates referred to in point 1 at the place of origin with the authorisation of the competent authority if:
  143. 3aBy way of derogation from point 3(j), the competent authority may authorise that the attestation of the correct slaughter and bleeding and of the date and time of slaughter be included only in the declaration by the food business operator referred to in point 3(i), provided that:
  144. 3bIn paragraph 3a, “region” means that part of a constituent territory of Great Britain which is at least 2000km2 in area and which is subject to inspection by the competent authorities and includes at least one of the following administrative regions—
  145. 4Division 4
  146. WILD GAME MEAT
  147. Chapter I:: TRAINING OF HUNTERS IN HEALTH AND HYGIENE
  148. 1Division 1
  149. 2Division 2
  150. 3Division 3
  151. 4Training must be provided to the satisfaction of the competent authority to enable hunters to become trained persons. It should cover at least the following subjects:
  152. 5Division 5
  153. Chapter II:: HANDLING OF LARGE WILD GAME
  154. 1Division 1
  155. 2Division 2
  156. 3Division 3
  157. 4Division 4
  158. 5Division 5
  159. 6Division 6
  160. 7Division 7
  161. 8In addition, unskinned large wild game:
  162. 9Division 9
  163. Chapter III:: HANDLING OF SMALL WILD GAME
  164. 1Division 1
  165. 2Division 2
  166. 3Division 3
  167. 4Division 4
  168. 5Division 5
  169. 6Division 6
  170. 7Division 7
  171. MINCED MEAT, MEAT PREPARATIONS AND MECHANICALLY SEPARATED MEAT (MSM)
  172. I:REQUIREMENTS FOR PRODUCTION ESTABLISHMENTS
  173. II:REQUIREMENTS FOR RAW MATERIAL
  174. III:HYGIENE DURING AND AFTER PRODUCTION
  175. Chapter IV:: LABELLING
  176. 1Division 1
  177. 2Division 2
  178. MEAT PRODUCTS
  179. 1Food business operators must ensure that the following items are not used in the preparation of meat products:
  180. 2Division 2
  181. LIVE BIVALVE MOLLUSCS
  182. 1Division 1
  183. 2Division 2
  184. 3Division 3
  185. 4The requirements of this Section supplement those laid down in Regulation (EC) No 852/2004:
  186. Chapter I:: GENERAL REQUIREMENTS FOR THE PLACING ON THE MARKET OF LIVE BIVALVE MOLLUSCS
  187. 1Division 1
  188. 2Division 2
  189. 3Division 3
  190. 4The registration document must be in English or in English and Welsh and contain at least the information specified below.
  191. 5Division 5
  192. 6Division 6
  193. 7However, if:
  194. Chapter II:: HYGIENE REQUIREMENTS FOR THE PRODUCTION AND HARVESTING OF LIVE BIVALVE MOLLUSCS
  195. REQUIREMENTS FOR PRODUCTION AREAS
  196. 1Division 1
  197. 2Division 2
  198. 3Division 3
  199. 4Division 4
  200. 5After purification or relaying, live bivalve molluscs from class B or C production areas must meet all of the requirements of Chapter V. However, live bivalve molluscs from such areas that have not been submitted for purification or relaying may be sent to a processing establishment, where they must undergo treatment to eliminate pathogenic micro-organisms (where appropriate, after removal of sand, mud or slime in the same or another establishment). The permitted treatment methods are:
  201. 6Division 6
  202. BREQUIREMENTS FOR HARVESTING AND HANDLING FOLLOWING HARVESTING
  203. CREQUIREMENTS FOR RELAYING LIVE BIVALVE MOLLUSCS
  204. Chapter III:: STRUCTURAL REQUIREMENTS FOR DISPATCH AND PURIFICATION CENTRES
  205. 1Division 1
  206. 2Tanks and water storage containers must meet the following requirements:
  207. 3Division 3
  208. Chapter IV:: HYGIENE REQUIREMENTS FOR PURIFICATION AND DISPATCH CENTRES
  209. AREQUIREMENTS FOR PURIFICATION CENTRES
  210. BREQUIREMENTS FOR DISPATCH CENTRES
  211. V:HEALTH STANDARDS FOR LIVE BIVALVE MOLLUSCS
  212. Chapter VI:: WRAPPING AND PACKAGING OF LIVE BIVALVE MOLLUSCS
  213. 1Division 1
  214. 2Division 2
  215. Chapter VII:: IDENTIFICATION MARKING AND LABELLING
  216. 1Division 1
  217. 2In addition to the general requirements for identification marks contained in Annex II, Section I, the following information must be present on the label:
  218. 3Division 3
  219. Chapter VIII:: OTHER REQUIREMENTS
  220. 1Division 1
  221. 2Division 2
  222. IX:SPECIFIC REQUIREMENTS FOR PECTINIDAE, MARINE GASTROPODS AND ECHINODERMS WHICH ARE NOT FILTER FEEDERS HARVESTED OUTSIDE CLASSIFIED PRODUCTION AREAS
  223. FISHERY PRODUCTS
  224. 1This Section does not apply to bivalve molluscs, echinoderms, tunicates and marine gastropods if they are still alive when placed on the market. With the exception of Chapters I and II, it applies to such animals when not placed on the market live, in which case they must have been obtained in accordance with Section VII.
  225. 2Division 2
  226. 3The requirements of this Section supplement those laid down in Regulation (EC) No 852/2004:
  227. 4In relation to fishery products:
  228. I:REQUIREMENTS FOR VESSELS
  229. STRUCTURAL AND EQUIPMENT REQUIREMENTS
  230. Requirements for all vessels
  231. 1Division 1
  232. 2Division 2
  233. 3Division 3
  234. 4Division 4
  235. Requirements for vessels designed and equipped to preserve fresh fishery products for more than 24 hours
  236. 1Division 1
  237. 2Division 2
  238. 3Division 3
  239. CRequirements for freezer vessels
  240. Requirements for factory vessels
  241. 1Factory vessels must have at least:
  242. 2Division 2
  243. 3Division 3
  244. HYGIENE REQUIREMENTS
  245. 1Division 1
  246. 2Division 2
  247. 3Division 3
  248. 4Division 4
  249. 5Division 5 Repealed
  250. 6Division 6
  251. 7Division 7
  252. Chapter II:: REQUIREMENTS DURING AND AFTER LANDING
  253. 1Food business operators responsible for the unloading and landing of fishery products must:
  254. 2Food business operators responsible for auction and wholesale markets or parts thereof where fishery products are displayed for sale must ensure compliance with the following requirements.
  255. 3Division 3
  256. 4Division 4
  257. III:REQUIREMENTS FOR ESTABLISHMENTS, INCLUDING VESSELS, HANDLING FISHERY PRODUCTS
  258. REQUIREMENTS FOR FRESH FISHERY PRODUCTS
  259. 1Division 1
  260. 2Division 2
  261. 3Division 3
  262. 4Division 4
  263. 5Division 5
  264. BREQUIREMENTS FOR FROZEN PRODUCTS
  265. CREQUIREMENTS FOR MECHANICALLY SEPARATED FISHERY PRODUCTS
  266. DREQUIREMENTS CONCERNING PARASITES
  267. EREQUIREMENTS FOR FISH OIL FOR HUMAN CONSUMPTION Repealed
  268. IV:REQUIREMENTS FOR CERTAIN PROCESSED FISHERY PRODUCTS
  269. REQUIREMENTS FOR COOKING OF CRUSTACEANS AND MOLLUSCS
  270. 1Division 1
  271. 2Division 2
  272. 3Division 3
  273. REQUIREMENTS FOR FISH OIL INTENDED FOR HUMAN CONSUMPTION
  274. 1Raw materials used in the preparation of fish oil for human consumption must:
  275. 2Division 2
  276. 3Division 3
  277. 4Division 4
  278. V:HEALTH STANDARDS FOR FISHERY PRODUCTS
  279. AORGANOLEPTIC PROPERTIES OF FISHERY PRODUCTS
  280. BHISTAMINE
  281. CTOTAL VOLATILE NITROGEN
  282. DPARASITES
  283. TOXINS HARMFUL TO HUMAN HEALTH
  284. 1Fishery products derived from poisonous fish of the following families must not be placed on the market: Tetraodontidae, Molidae, Diodontidae and Canthigasteridae.
  285. 2Division 2
  286. Chapter VI:: WRAPPING AND PACKAGING OF FISHERY PRODUCTS
  287. 1Division 1
  288. 2Division 2
  289. 3When fishery products are wrapped on board fishing vessels, food business operators must ensure that wrapping material:
  290. VII:STORAGE OF FISHERY PRODUCTS
  291. VIII:TRANSPORT OF FISHERY PRODUCTS
  292. IX:RAW MILK, COLOSTRUM, DAIRY PRODUCTS AND COLOSTRUM-BASED PRODUCTS
  293. I:RAW MILK AND COLOSTRUM — PRIMARY PRODUCTION
  294. HEALTH REQUIREMENTS FOR RAW MILK AND COLOSTRUM PRODUCTION
  295. 1Raw milk and colostrum must come from animals:
  296. 2Division 2
  297. 3However, raw milk from animals that does not meet the requirements of point 2 may be used with the authorisation of the competent authority:
  298. 4Division 4
  299. 5Division 5
  300. HYGIENE ON MILK AND COLOSTRUM PRODUCTION HOLDINGS
  301. Requirements for premises and equipment
  302. 1Division 1
  303. 2Division 2
  304. 3Division 3
  305. 4Division 4
  306. Hygiene during milking, collection and transport
  307. 1Milking must be carried out hygienically, ensuring in particular:
  308. 2Immediately after milking, milk and colostrum must be held in a clean place designed and equipped to avoid contamination.
  309. 3Division 3
  310. 4Food business operators need not comply with the temperature requirements laid down in points 2 and 3 if the milk meets the criteria provided for in Part III and either:
  311. Staff hygiene
  312. 1Division 1
  313. 2Division 2
  314. CRITERIA FOR RAW MILK AND COLOSTRUM
  315. 1Division 1
  316. 2A representative number of samples of raw milk and colostrum collected from milk production holdings taken by random sampling must be checked for compliance with points 3 and 4 in case of raw milk .... The checks may be carried out by, or on behalf of:
  317. 3Division 3
  318. 4Without prejudice to Directive 96/23/EC, food business operators must initiate procedures to ensure that raw milk is not placed on the market if either:
  319. 5Division 5
  320. Chapter II:: REQUIREMENTS CONCERNING DAIRY AND COLOSTRUM-BASED PRODUCTS
  321. TEMPERATURE REQUIREMENTS
  322. 1Food business operators must ensure that, upon acceptance at a processing establishment,
  323. 2However, food business operators may keep milk and colostrum at a higher temperature if:
  324. REQUIREMENTS FOR HEAT TREATMENT
  325. 1When raw milk, colostrum, dairy or colostrum-based products undergo heat treatment, food business operators must ensure that this satisfies the requirements laid down in Chapter XI of Annex II to Regulation (EC) No 852/2004. In particular, they shall ensure, when using the following processes, that they comply with the specifications mentioned:
  326. 2When considering whether to subject raw milk and colostrum to heat treatment, food business operators must:
  327. CRITERIA FOR RAW COWS' MILK
  328. 1Food business operators manufacturing dairy products must initiate procedures to ensure that, immediately before being heat treated and if its period of acceptance specified in the HACCP-based procedures is exceeded:
  329. 2Division 2
  330. III:WRAPPING AND PACKAGING
  331. Chapter IV:: LABELLING
  332. 1In addition to the requirements of Regulation (EU) No. 1169/2011, except in the cases envisaged in Article 16(1) and (2) of that Regulation, labelling must clearly show—
  333. 2Division 2
  334. V:IDENTIFICATION MARKING
  335. EGGS AND EGG PRODUCTS
  336. Chapter I:: EGGS
  337. 1Division 1
  338. 2Division 2
  339. 3Division 3
  340. Chapter II:: EGG PRODUCTS
  341. IREQUIREMENTS FOR ESTABLISHMENTS
  342. IIRAW MATERIALS FOR THE MANUFACTURE OF EGG PRODUCTS
  343. IIISPECIAL HYGIENE REQUIREMENTS FOR THE MANUFACTURE OF EGG PRODUCTS
  344. ANALYTICAL SPECIFICATIONS
  345. 1Division 1
  346. 2Division 2
  347. 3Division 3
  348. LABELLING AND IDENTIFICATION MARKING
  349. 1Division 1
  350. 2Division 2
  351. XI:FROGS' LEGS AND SNAILS
  352. RENDERED ANIMAL FATS AND GREAVES
  353. I:REQUIREMENTS APPLICABLE TO ESTABLISHMENTS COLLECTING OR PROCESSING RAW MATERIALS
  354. II:HYGIENE REQUIREMENTS FOR THE PREPARATION OF RENDERED ANIMAL FAT AND GREAVES
  355. XIII:TREATED STOMACHS, BLADDERS AND INTESTINES
  356. GELATINE
  357. 1Division 1
  358. 2Division 2
  359. Chapter I:: REQUIREMENTS FOR RAW MATERIALS
  360. 1For the production of gelatine intended for use in food, the following raw materials may be used:
  361. 2Division 2
  362. 3Division 3
  363. 4Division 4
  364. 5Collection centres and tanneries may also supply raw material for the production of gelatine intended for human consumption if the competent authority specifically authorises them for this purpose and they fulfil the following requirements.
  365. Chapter II:: TRANSPORT AND STORAGE OF RAW MATERIALS
  366. 1Division 1
  367. 2Division 2
  368. 3After the veterinary checks provided for in Directive 97/78/EC, and without prejudice to the conditions laid down in Article 8(4) of that Directive, raw materials for the production of gelatine for human consumption, for which animal health certification is required, must be transported directly to the establishment at the place of destination.
  369. Chapter III:: REQUIREMENTS FOR THE MANUFACTURE OF GELATINE
  370. 1The production process for gelatine must ensure that:
  371. 2Division 2
  372. IV:REQUIREMENTS FOR FINISHED PRODUCTS
  373. V:LABELLING
  374. COLLAGEN
  375. 1Division 1
  376. 2Division 2
  377. Chapter I:: REQUIREMENTS FOR RAW MATERIALS
  378. 1For the production of collagen intended for use in food, the following raw materials may be used:
  379. 2Division 2
  380. 3Division 3
  381. 4Division 4
  382. 5Collection centres and tanneries may also supply raw material for the production of collagen intended for human consumption if the competent authority specifically authorises them for this purpose and they fulfil the following requirements.
  383. Chapter II:: TRANSPORT AND STORAGE OF RAW MATERIALS
  384. 1Division 1
  385. 2Division 2
  386. 3After the veterinary checks provided for in Directive 97/78/EC, and without prejudice to the conditions laid down in Article 8(4) of that Directive, raw materials for the production of collagen for human consumption, for which animal health certification is required, must be transported directly to the establishment at the place of destination.
  387. Chapter III:: REQUIREMENTS FOR THE MANUFACTURE OF COLLAGEN
  388. 1The production process for collagen must ensure that:
  389. 2Division 2
  390. 3Division 3
  391. IV:REQUIREMENTS FOR FINISHED PRODUCTS
  392. V:LABELLING
  393. XVI:HIGHLY REFINED CHONDROITIN SULPHATE, HYALURONIC ACID, OTHER HYDROLYSED CARTILAGE PRODUCTS, CHITOSAN, GLUCOSAMINE, RENNET, ISINGLASS AND AMINO ACIDS
  394. to ANNEX IIIAppendix to ANNEX III