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

Food business operators must ensure that establishments collecting or processing raw materials for the production of rendered animal fats and greaves comply with the following requirements.

• 1. Centres for the collection of raw materials and further transport to processing establishments must be equipped with facilities for the storage of raw materials at a temperature of not more than 7 °C.

• 1. Each processing establishment must have:
• (a) refrigeration facilities;
• (b) a dispatch room, unless the establishment dispatches rendered animal fat only in tankers; and
• (c) if appropriate, suitable equipment for the preparation of products consisting of rendered animal fats mixed with other foodstuffs and/or seasonings.

• 1. However, the refrigeration facilities required under points 1 and 2(a) are not necessary if the arrangements for the supply of raw materials ensure that they are never stored or transported without active refrigeration otherwise than as provided for in Chapter II, point 1(d).

CHAPTER II:   HYGIENE REQUIREMENTS FOR THE PREPARATION OF RENDERED ANIMAL FAT AND GREAVES

Food business operators preparing rendered animal fats and greaves must ensure compliance with the following requirements.

• 1. Raw materials must:
• (a) derive from animals which have been slaughtered in a slaughterhouse, and which have been found fit for human consumption following ante-mortem and post-mortem inspection;
• (b) consist of adipose tissues or bones, which are reasonably free from blood and impurities;
• (c) come from establishments registered or approved pursuant to Regulation (EC) No 852/2003 or in accordance with this Regulation; and
• (d) be transported, and stored until rendering, in hygienic conditions and at an internal temperature of not more than 7 °C. However, raw materials may be stored and transported without active refrigeration if rendered within 12 hours after the day on which they were obtained.

• 1. During rendering the use of solvents is prohibited.

• 1. When the fat for refining meets the standards laid down in point 4, rendered animal fat prepared in accordance with points 1 and 2 may be refined in the same establishment or in another establishment with a view to improving its physico-chemical quality.

• 1. Rendered animal fat, depending on type, must meet the following standards: Ruminants Porcine animals Other animal fat Edible tallow Tallow for refining Edible fat Lard and other fat for refining Edible For refining Premier jus [^E0037] Other Lard [^E0038] Other FFA (m/m % oleic acid) maximum 0,75 1,25 3,0 0,75 1,25 2,0 1,25 3,0 Peroxide maximum 4 meq/kg 4 meq/kg 6 meq/kg 4 meq/kg 4 meq/kg 6 meq/kg 4 meq/kg 10 meq/kg Total insoluble impurities Maximum 0,15  % Maximum 0,5  % Odour, taste, colour Normal (¹) Rendered animal fat obtained by low-temperature rendering of fresh fat from the heart, caul, kidneys and mesentery of bovine animals, and fat from cutting rooms. (²) Rendered animal fat obtained from the adipose tissues of porcine animals.

SECTION XIII:   TREATED STOMACHS, BLADDERS AND INTESTINES

Food business operators treating stomachs, bladders and intestines must ensure compliance with the following requirements.

• 1. Animal intestines, bladders and stomachs may be placed on the market only if:
• (a) they derive from animals which have been slaughtered in a slaughterhouse, and which have been found fit for human consumption following ante-mortem and post-mortem inspection;
• (b) they are salted, heated or dried; and
• (c) after the treatment referred to in (b), effective measures are taken to prevent re-contamination.

• 1. Treated stomachs, bladders and intestines that cannot be kept at ambient temperature must be stored chilled using facilities intended for that purpose until their dispatch. In particular, products that are not salted or dried must be kept at a temperature of not more than 3 °C.

SECTION XIV:   GELATINE

• 1.Food business operators manufacturing gelatine must ensure compliance with the requirements of this section.

• 2.For the purpose of this section, ‘tanning’ means the hardening of hides, using vegetable tanning agents, chromium salts or other substances such as aluminium salts, ferric salts, silicic salts, aldehydes and quinones, or other synthetic hardening agents.

CHAPTER I:   REQUIREMENTS FOR RAW MATERIALS

• 1.For the production of gelatine intended for use in food, the following raw materials may be used:

• (a) bones, other than specified risk materials as defined in Article 3(1)(g) of Regulation (EC) No 999/2001 of the European Parliament and of the Council ([^E0039]);

• (b) hides and skins of farmed ruminant animals;

• (c) pig skins;

• (d) poultry skin;

• (e) tendons and sinews;

• (f) wild game hides and skins; and

• (g) fish skin and bones.

• 2.The use of hides and skins is prohibited if they have undergone any tanning process, regardless of whether this process was completed.

• 3.Raw materials listed in point 1(a) to (e) must derive from animals which have been slaughtered in a slaughterhouse and whose carcases have been found fit for human consumption following ante-mortem and post-mortem inspection or, in the case of hides and skins from wild game, found fit for human consumption.

• 1. (a) Raw materials that have not undergone any preserving treatment other than chilling, freezing or quick-freezing must come from establishments registered or approved pursuant to Regulation (EC) No 852/2004 or in accordance with this Regulation, (b) The following treated raw materials may be used: (i) bones other than specified risk material as defined in Article 3(1)(g) of Regulation (EC) No 999/2001 coming from establishments under the control of and listed by the competent authority, and that have been subjected to one of the following treatments: — crushed to pieces of approximately 15 mm and degreased with hot water at a temperature of minimum 70 °C for at least 30 minutes, minimum 80 C for at least 15 minutes, or minimum 90 °C for at least 10 minutes, and then separated and subsequently washed and dried for at least 20 minutes in a stream of hot air with an initial temperature of minimum 350 °C, or for 15 minutes in a stream of hot air with an initial temperature of more than 700 °C, — sun-dried for a minimum of 42 days at an average temperature of at least 20 °C, — acid treatment such that the pH is maintained at less than 6 to the core for at least 1 hour before drying; (ii) hides and skins of farmed ruminant animals, pig skins, poultry skins and wild game hides and skins coming from establishments under the control of and listed by the competent authority, and that have been subjected to one of the following treatments: — treatment with alkali to establish a pH > 12 to the core followed by salting for at least 7 days, — drying for at least 42 days at a temperature of at least 20 °C, — acid treatment such that the pH is maintained at less than 5 to the core for a minimum of 1 hour, — alkali treatment throughout at a pH > 12 for at least 8 hours; (iii) bones other than specified risk material defined in Article 3(1)(g) of Regulation (EC) No 999/2001, hides and skins of farmed ruminant animals, pig skins, poultry skins, fish hides and wild game hides and skins that have undergone any other treatment than those specified in point (i) or (ii) and that come from establishments registered or approved pursuant to Regulation (EC) No 852/2004 or in accordance with this Regulation.

• For the purposes of the first 2 indents of point (b)(ii), the duration of the treatments may include the time of transportation.

• The treated raw materials referred to in points (b)(i) and (b)(ii) must be derived from:

• — domestic and farmed ruminant animals, pigs and poultry which have been slaughtered in a slaughterhouse and the carcasses of which have been found fit for human consumption following ante- and post-mortem inspection, or

• — from killed wild game whose carcasses have been found fit for human consumption following post-mortem inspection.

• 5.Collection 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.

• (a) They must have storage rooms with hard floors and smooth walls that are easy to clean and disinfect and, where appropriate, provided with refrigeration facilities.

• (b) The storage rooms must be kept in a satisfactory state of cleanliness and repair, so that they do not constitute a source of contamination for the raw materials.

• (c) If raw material not in conformity with this chapter is stored and/or processed in these premises, it must be segregated from raw material in conformity with this chapter throughout the period of receipt, storage, processing and dispatch.

CHAPTER II:   TRANSPORT AND STORAGE OF RAW MATERIALS

• 1.In place of the identification mark provided for in Annex II, Section I, a document indicating the establishment of origin and containing the information set out in the Appendix to this Annex must accompany raw materials during transport, when delivered to a collection centre or tannery and when delivered to the gelatine-processing establishment.

• 2.Raw materials must be transported and stored chilled or frozen unless they are processed within 24 hours after their departure. However, degreased and dried bones or ossein, salted, dried and limed hides, and hides and skins treated with alkali or acid may be transported and stored at ambient temperature.

• 3.After 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.

• All precautions, including safe disposal of animal by-products, waste, unused or surplus material, shall be taken to avoid risks of spreading diseases to animals.

CHAPTER III:   REQUIREMENTS FOR THE MANUFACTURE OF GELATINE

• 1.The production process for gelatine must ensure that:

• (a) all ruminant bone material derived from animals born, reared or slaughtered in countries or regions with a controlled or undetermined BSE risk in accordance with Community legislation is subjected to a process which ensures that all bone material is finely crushed and degreased with hot water and treated with dilute hydrochloric acid (at minimum concentration of 4 % and pH < 1,5) over a period of at least two days. This treatment is followed either by:
• — an alkaline treatment of saturated lime solution (pH > 12,5) for a period of at least 20 days with a heat treatment step of 138 °C minimum during at least four seconds, or
• — an acid treatment (pH < 3,5) during 10 hours minimum with a heat treatment step of 138 °C minimum during at least four seconds, or
• — a heat-and-pressure process for at least 20 minutes with saturated steam of 133 °C at more than 3 bars, or
• — any approved equivalent process;

• (b) other raw material is subjected to a treatment with acid or alkali, followed by one or more rinses. The pH must be adjusted subsequently. Gelatine must be extracted by heating one or more times in succession, followed by purification by means of filtration and heat treatment.

• 2.A food business operator may produce and store both gelatine intended for human consumption and gelatine not intended for human consumption in the same establishment provided that the raw materials and the production process comply with the requirements applying to gelatine intended for human consumption.

CHAPTER IV:   REQUIREMENTS FOR FINISHED PRODUCTS

Food business operators must ensure that gelatine complies with the residue limits set out in the following table.

Residue	Limit
As	1 ppm
Pb	5 ppm
Cd	0,5 ppm
Hg	0,15 ppm
Cr	10 ppm
Cu	30 ppm
Zn	50 ppm
SO2 (European Pharmacopoeia, latest edition)	50 ppm
H2O2 (European Pharmacopoeia, latest edition)	10 ppm

CHAPTER V:   LABELLING

Wrapping and packaging containing gelatine must bear the words ‘gelatine fit for human consumption’ and must indicate the date of minimum durability.

SECTION XV:   COLLAGEN

• 1.Food business operators manufacturing collagen must ensure compliance with the requirements of this section. Without prejudice to other provisions, products derived from collagen must be made from collagen which complies with the requirements of this section.

• 2.For the purpose of this section, ‘tanning’ means the hardening of hides, using vegetable tanning agents, chromium salts or other substances such as aluminium salts, ferric salts, silicic salts, aldehydes and quinones, or other synthetic hardening agents.

CHAPTER I:   REQUIREMENTS FOR RAW MATERIALS

• 1.For the production of collagen intended for use in food, the following raw materials may be used:

• (a) bones, other than specified risk materials as defined in Article 3(1)(g) of Regulation (EC) No 999/2001;

• (b) hides and skins of farmed ruminant animals;

• (c) pig skins;

• (d) poultry skin;

• (e) tendons and sinews;

• (f) wild game hides and skins; and

• (g) fish skin and bones.

• 2.The use of hides and skins is prohibited if they have undergone any tanning process, regardless of whether this process was completed.

• 3.Raw materials listed in point 1(a) to (d) must derive from animals which have been slaughtered in a slaughterhouse and whose carcases have been found fit for human consumption following ante-and post-mortem inspection or, in the case of hides and skins from wild game, found fit for human consumption.

• 1. (a) Raw materials that have not undergone any preserving treatment other than chilling, freezing or quick-freezing must come from establishments registered or approved pursuant to Regulation (EC) No 852/2004 or in accordance with this Regulation. (b) The following treated raw materials may be used: (i) bones other than specified risk material as defined in Article 3(1)(g) of Regulation (EC) No 999/2001 coming from establishments under the control of and listed by the competent authority, and that have been subjected to one of the following treatments: — crushed to pieces of approximately 15 mm and degreased with hot water at a temperature of minimum 70 °C for at least 30 minutes, minimum 80 °C for at least 15 minutes, or minimum 90 °C for at least 10 minutes, and then separated and subsequently washed and dried for at least 20 minutes in a stream of hot air with an initial temperature of minimum 350 °C, or for 15 minutes in a stream of hot air with an initial temperature of more than 700 °C, — sun-dried for a minimum of 42 days at an average temperature of at least 20 °C, — acid treatment such that the pH is maintained at less than 6 to the core for at least 1 hour before drying; (ii) hides and skins of farmed ruminant animals, pig skins, poultry skins and wild game hides and skins coming from establishments under the control of and listed by the competent authority, and that have been subjected to one of the following treatments: — treatment with alkali to establish a pH > 12 to the core followed by salting for at least 7 days, — drying for at least 42 days at a temperature of at least 20 °C, — acid treatment such that the pH is maintained at less than 5 to the core for a minimum of 1 hour, — alkali treatment throughout at a pH > 12 for at least 8 hours; (iii) bones other than specified risk material defined in Article 3(1)(g) of Regulation (EC) No 999/2001, hides and skins of farmed ruminant animals, pig skins, poultry skins, fish hides and wild game hides and skins that have undergone any other treatment than those specified in point (i) or (ii) and that come from establishments registered or approved pursuant to Regulation (EC) No 852/2004 or in accordance with this Regulation.

• For the purposes of the first 2 indents of point (b)(ii), the duration of the treatments may include the time of transportation.

• The treated raw materials referred to in point (b) must be derived from:

• — domestic and farmed ruminant animals, pigs and poultry which have been slaughtered in a slaughterhouse and the carcasses of which have been found fit for human consumption following ante- and post-mortem inspection, or

• — from killed wild game whose carcasses have been found fit for human consumption following post-mortem inspection.

• 5.Collection 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.

• (a) They must have storage rooms with hard floors and smooth walls that are easy to clean and disinfect and, where appropriate, provided with refrigeration facilities.

• (b) The storage rooms must be kept in a satisfactory state of cleanliness and repair, so that they do not constitute a source of contamination for the raw materials.

• (c) If raw material not in conformity with this chapter is stored and/or processed in these premises, it must be segregated from raw material in conformity with this chapter throughout the period of receipt, storage, processing and dispatch.

CHAPTER II:   TRANSPORT AND STORAGE OF RAW MATERIALS

• 1.In place of the identification mark provided for in Annex II, Section I, a document indicating the establishment of origin and containing the information set out in the Appendix to this Annex must accompany raw materials during transport, when delivered to a collection centre or tannery and when delivered to the collagen-processing establishment.

• 2.Raw materials must be transported and stored chilled or frozen unless they are processed within 24 hours after their departure. However, degreased and dried bones or ossein, salted, dried and limed hides, and hides and skins treated with alkali or acid may be transported and stored at ambient temperature.

• 3.After 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.

• All precautions, including safe disposal of animal by-products, waste, unused or surplus material, shall be taken to avoid risks of spreading diseases to animals.

CHAPTER III:   REQUIREMENTS FOR THE MANUFACTURE OF COLLAGEN

• 1.The production process for collagen must ensure that:

• (a) all ruminant bone material derived from animals born, reared or slaughtered in countries or regions with a controlled or undetermined BSE risk as determined in accordance with Article 5 of Regulation (EC) No 999/2001 is subjected to a process which ensures that all bone material is finely crushed and degreased with hot water and treated with dilute hydrochloric acid (at a minimum concentration of 4 % and pH < 1,5) over a period of at least 2 days; this treatment must be followed by pH adjustment using acid or alkali followed by:
• (i) either one or more rinses and at least one of the following processes:
• — filtration,
• — milling,
• — extrusion,
• (ii) or any approved equivalent process;

• (b) raw materials other than that referred to in point (a) must be subjected to a treatment involving washing, pH adjustment using acid or alkali followed by:
• (i) either one or more rinses and at least one of the following processes:
• — filtration,
• — milling,
• — extrusion,
• (ii) or any approved equivalent process.

• 2.After having been subjected to the process referred to in point 1, collagen may undergo a drying process.

• 3.A food business operator may produce and store both collagen intended for human consumption and collagen not intended for human consumption in the same establishment provided that the raw materials and the production process comply with the requirements applying to collagen intended for human consumption.

CHAPTER IV:   REQUIREMENTS FOR FINISHED PRODUCTS

Food business operators must ensure that collagen complies with the residue limits set out in the following table.

Residue	Limit
As	1 ppm
Pb	5 ppm
Cd	0,5 ppm
Hg	0,15 ppm
Cr	10 ppm
Cu	30 ppm
Zn	50 ppm
SO2 (European Pharmacopoeia, latest edition)	50 ppm
H2O2 (European Pharmacopoeia, latest edition)	10 ppm

CHAPTER V:   LABELLING

Wrapping and packaging containing collagen must bear the words ‘collagen fit for human consumption’ and indicate the date of preparation.

SECTION XVI:   HIGHLY REFINED PRODUCTS

• (1)Food business operators manufacturing the following highly refined products of animal origin must ensure that the treatment of the raw materials used eliminates any animal or public health risk:

• (a) chondroitin sulphate;

• (b) hyaluronic acid;

• (c) other hydrolysed cartilage products;

• (d) chitosan;

• (e) glucosamine;

• (f) rennet;

• (g) isinglass;

• (h) food additives of animal origin authorised in accordance with Article 4 of Regulation (EC) No 1333/2008 of the European Parliament and of the Council ([^E0040]) 4 straipsnį;

• (i) food flavourings that are authorised in accordance with Regulation (EC) No 1334/2008 of the European Parliament and of the Council ([^E0041]);

• (j) fat derivatives.

• (2)The raw materials used for the manufacturing of the highly refined products referred to in point 1 must be derived from:

• (a) animals, including feathers thereof, which have been slaughtered in a slaughterhouse and the meat of which have been found fit for human consumption following ante-mortem and post-mortem inspection, or

• (b) fishery products complying with Section VIII, or

• (c) rendered fats and greaves complying with Section XII, or wool, if these products are submitted to one of the following processes:
• (1) transesterification or hydrolysis at a temperature of at least 200 °C, under corresponding appropriate pressure, for at least 20 minutes (glycerol, fatty acids and esters);
• (2) saponification with NaOH 12M:
• — in a batch process at 95 °C for three hours; or
• — in a continuous process at 140 °C 2 bars (2 000 hPa) for eight minutes; or
• (3) hydrogenation at 160 °C at 12 bars (12 000 hPa) for 20 minutes;
• (4) when derived from wool grease, a heat treatment at least at 135 °C for at least 90 minutes; Human hair may not be used as a source for the manufacture of amino acids, or

• (d) insects.

Appendix to ANNEX III

MODEL DOCUMENT TO ACCOMPANY RAW MATERIAL DESTINED FOR THE PRODUCTION OF GELATINE OR COLLAGEN INTENDED FOR HUMAN CONSUMPTION

Number of the commercial document: …

I. Identification of raw material

Nature of the raw material: …

Animal species: …

Type of packaging: …

Number of packages: …

Net weight (kg): …

II.   Origin of raw material

Type, name, address and approval/registration/special authorisation number of the establishment of origin:

…

Name and address of the consignor ([^E0042]): …

III.   Destination of raw material

Type, name, address and approval/registration/special authorisation number of the production establishment of destination:

…

Name and address of the consignee ([^E0043]): …

IV.   Means of transport: …

Done at …, on …

…

(Signature of the operator of the establishment of origin or its representatives)

[^E0001]: See page 83 of this Official Journal.

[^E0002]: Council Directive 97/78/EC of 18 December 1997 laying down the principles governing the organisation of veterinary checks on products entering the Community from third countries (OJ L 24, 30.1.1998, p. 9). Directive amended by the 2003 Act of Accession.

[^E0003]: Council Directive 2002/99/EC of 16 December 2002 laying down the animal health rules governing the production, processing, distribution and introduction of products of animal origin for human consumption (OJ L 18, 23.1.2003, p. 11).

[^E0004]: Council Directive 96/23/EC of 29 April 1996 on measures to monitor certain substances and residues thereof in live animals and animal products (OJ L 125, 23.5.1996, p. 10). Directive as amended by Regulation (EC) No 806/2003 (OJ L 122, 16.5.2003, p. 1).

[^E0005]: OJ L 123, 12.5.2016, p. 1.

[^E0006]: OJ L 299, 16.11.2007, p. 1.

[^E0007]: In accordance with the Agreement on the withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union and the European Atomic Energy Community, and in particular Article 5(4) of the Protocol on Ireland/Northern Ireland in conjunction with Annex 2 to that Protocol, for the purposes of this Annex, references to Member States include the United Kingdom in respect of Northern Ireland.

[^E0008]: Regulation (EU) 2016/429 of the European Parliament and of the Council of 9 March 2016 on transmissible animal diseases and amending and repealing certain acts in the area of animal health (‘Animal Health Law’) (OJ L 84, 31.3.2016, p. 1).

[^E0009]: OJ L 338, 22.12.2005, p. 60.

[^E0010]: 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).

[^E0011]: 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).

[^E0012]: Council Regulation (EC) No 1/2005 of 22 December 2004 on the protection of animals during transport and related operations and amending Directives 64/432/EEC and 93/119/EC and Regulation (EC) No 1255/97 (OJ L 3, 5.1.2005, p. 1, ELI: http://data.europa.eu/eli/reg/2005/1/oj).

[^E0013]: Commission Implementing Regulation (EU) 2020/2235 of 16 December 2020 laying down rules for the application of Regulations (EU) 2016/429 and (EU) 2017/625 of the European Parliament and of the Council as regards model animal health certificates, model official certificates and model animal health/official certificates, for the entry into the Union and movements within the Union of consignments of certain categories of animals and goods, official certification regarding such certificates and repealing Regulation (EC) No 599/2004, Implementing Regulations (EU) No 636/2014 and (EU) 2019/628, Directive 98/68/EC and Decisions 2000/572/EC, 2003/779/EC and 2007/240/EC (OJ L 442, 30.12.2020, p. 1).

[^E0014]: Regulation (EU) 2016/429 of the European Parliament and of the Council of 9 March 2016 on transmissible animal diseases and amending and repealing certain acts in the area of animal health (‘Animal Health Law’) (OJ L 84, 31.3.2016, p. 1).

[^E0015]: Maximum time allowed from the start of loading of meat into the vehicle until the completion of the final delivery. Loading of the meat into the vehicle may be postponed beyond the maximum time allowed for chilling of the meat to its specified surface temperature. If this happens, then the maximum transport time allowed must be shortened by the same length of time by which the loading was postponed. The competent authority of the Member State of destination may limit the number of delivery points.

[^E0025]: 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).

[^E0026]: Directive 2000/13/EC of the European Parliament and of the Council of 20 March 2000 on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs (OJ L 109, 6.5.2000, p. 29). Directive as last amended by Directive 2003/89/EC (OJ L 308, 25.11.2003, p. 15).

[^E0027]: OJ L 223, 15.8.2006, p. 1.

[^E0028]: OJ L 338, 22.12.2005, p. 27.

[^E0029]: Council Directive 64/432/EEC of 26 June 1964 on animal health problems affecting intra-Community trade in bovine animals and swine (OJ 121, 29.7.1964, p. 1977/64). Directive as last amended by Regulation (EC) No 21/2004 (OJ L 5, 9.1.2004, p. 8).

[^E0030]: Council Directive 91/68/EEC of 28 January 1991 on animal health conditions governing intra-Community trade in ovine and caprine animals (OJ L 46, 19.2.1991, p. 19). Directive as last amended by Commission Decision 2005/932/EC.

[^E0031]: OJ L 123, 24.4.1998, p. 1. Directive as last amended by Commission Directive 2006/50/EC (OJ L 142, 30.5.2006, p. 6).

[^E0036]: Council Regulation (EEC) No 2377/90 of 26 June 1990 laying down a Community procedure for the establishment of maximum residue limits of veterinary medicinal products in foodstuffs of animal origin (OJ L 224, 18.8.1990, p. 1). Regulation as last amended by Commission Regulation (EC) No 1231/2006 (OJ L 225, 17.8.2006, p. 3).

[^E0039]: OJ L 147, 31.5.2001, p 1.

[^E0040]: 2008 m. gruodžio 16 d. Europos Parlamento ir Tarybos reglamentas (EB) Nr. 1333/2008 dėl maisto priedų (OL L 354, 2008 12 31, p. 16, ELI: http://data.europa.eu/eli/reg/2008/1333/oj).

[^E0041]: Regulation (EC) No 1334/2008 of the European Parliament and of the Council of 16 December 2008 on flavorings and certain food ingredients with flavoring properties for use in and on foods (OJ L 354, 31.12.2008, p. 34).

[^E0042]: Only if different from the establishment of origin.

[^E0043]: Only if different from the establishment of destination.