1992L0118 — EN — 01.05.2004 — 014.001 — 1
This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents
►B COUNCILDIRECTIVE92/118/EEC
of17December 1992
laying down animal health and public health requirements governing trade in and imports into
theCommunityofproductsnotsubjecttothesaidrequirementslaiddowninspecificCommunityrules 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)
Amended by:
Official Journal
No page date
►M1Commission Decision 94/466/EC of 13 July 1994 L 190 26 26.7.1994
►M2Commission Decision 94/723/EC of 26 October 1994 L 288 48 9.11.1994
►M3Commission Decision 95/338/EC of 26 July 1995 L 200 35 24.8.1995
►M4Commission Decision 95/339/EC of 27 July 1995 L 200 36 24.8.1995
►M5Commission Decision 96/103/EC of 25 January 1996 L 24 28 31.1.1996
►M6Commission Decision 96/340/EC of 10 May 1996 L 129 35 30.5.1996
►M7Commission Decision 96/405/EC of 21 June 1996 L 165 40 4.7.1996
►M8Council Directive 96/90/EC of 17 December 1996 L 13 24 16.1.1997
►M9Council Directive 97/79/EC of 18 December 1997 L 24 31 30.1.1998
►M10Commission Decision 1999/724/EC of 28 October 1999 L 290 32 12.11.1999
►M11Commission Decision 2001/7/EC of 19 December 2000 L 2 27 5.1.2001
►M12Directive 2002/33/EC of the European Parliament and of the Council of
21 October 2002L 315 14 19.11.2002
►M13Commission Decision 2003/42/EC of 10 January 2003 L 13 24 18.1.2003
►M14amended by Commission Decision 2003/503/EC of 7 July 2003 L 170 30 9.7.2003
►M15Commission Decision 2003/721/EC of 29 September 2003 L 260 21 11.10.2003
►M16Commission Regulation (EC) No 445/2004 of 10 March2004 L 72 60 11.3.2004
Amended by:
►A1Act of Accession of Austria, Sweden and Finland C241 21 29.8.1994
(adapted by Council Decision 95/1/EC, Euratom, ECSC) L 1 1 1.1.1995
►A2Act concerning the conditions of accession of the Czech Republic, the
Republic of Estonia, the Republic of Cyprus, the Republic of Latvia,the Republic of Lithuania, the Republic of Hungary, the Republic ofMalta, the Republic of Poland, the Republic of Slovenia and the SlovakRepublic and the adjustments to the Treaties on which the European
Union is foundedL 236 33 23.9.2003
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COUNCILDIRECTIVE92/118/EEC
of17December 1992
laying down animal health and public health requirements
governing trade in and imports into the Community of productsnotsubjecttothesaidrequirements laid downinspecific Commu-nity rules referred to in AnnexA (I) to Directive 89/662/EEC and,
asregardspathogens,toDirective 90/425/EEC
THE COUNCIL OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Economic
Community, and in particular Article 43 thereof,
Having regard to the proposals from the Commission (1),
Having regard to the opinions of the European Parliament (2),
Having regard to the opinions of the Economic and Social
Committee (3),
Whereas products of animal origin are included in the list of products
in Annex II to the Treaty; whereas the placing on the market of such
products constitutes an important source of income for part of the
farming population;
Whereas in order to ensure rational development in this sector and
increase productivity, animal health and public health rules for theproducts in question should be laid down at Community level;
Whereas the Community must adopt the measures intended progres-
sively to establish the internal market consisting of an area withoutinternal frontiers, over a period expiring on 31 December 1992;
Whereas in view of the abovementioned objectives the Council has laid
down animal health rules applicable to fresh meat, poultrymeat, meatproducts, game meat, rabbit meat and milk products;
Whereas, save where otherwise provided, trade in products of animal
origin must be liberalized, without prejudice to recourse to possible
safeguard measures;
Whereas, given the significant risk of the spread of diseases to which
animals are exposed, for certain products of animal origin particular
requirements should be specified to be imposed when they are placedon the market for the purposes of trade, particularly when intended forregions witha h ighh ealthstatus;
Whereas, when Directive 92/65/EEC was adopted, the Commission
agreed to disassociate the animal health aspects applicable to animalsfrom those applicable to products;
Whereas, so as to allow checks at borders between Member States to
be abolished on 1 January 1993, animal health and public health rulesshould be fixed to apply to all products subject to such checks trade in
and imports of which have not yet been harmonized at Community
level;
Whereas, to achieve this objective, certain existing rules should be
adapted for the adoption of the aforesaid measures;
Whereas a system of approval should be introduced for the third coun-
tries and establishments which meet the requirements laid down by thisDirective, together with a Community inspection procedure to ensurethat the conditions for such approval are observed;
Whereas the accompanying document for products is the best way of
satisfying the competent authority of the place of destination that aconsignment complies with the provisions of this Directive; whereas1992L0118 — EN — 01.05.2004 — 014.001 — 2
(1) OJ No C 327, 30. 12. 1989, p. 29; and OJ No C 84, 2.4. 1990, p 102.
(2) OJ No C 113, 7. 5. 1990, p. 205; and OJ No C 149, 18. 6. 1990, p. 259.
(3) OJ No C 124, 21. 5. 1990, p. 15; and OJ No C 182, 23. 7. 1990, p. 250.
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the public health or animal health certificate should be maintained for
the purposes of verifying the destination of certain imported products;
Whereas the rules, principles and safeguard measures established by
Council Directive 90/675/EEC of 10 December 1990 laying down the
principles governing the organization of veterinary checks on productsentering the Community from third countries (
1) should apply here;
Whereas, in the context of intra-Community trade, the rules laid down
in Directive 89/662/EEC should also be applied;
Whereas the Commission should be entrusted with the task of adopting
certain measures for implementing this Directive; whereas, to that end,
procedures should be laid down establishing close and effective coop-
eration between the Commission and the Member States within theStanding Veterinary Committee;
Whereas, in view of the particular supply difficulties arising from its
geographical situation, special derogations should be permitted for theHellenic Republic;
Whereas the adoption of specific rules for the products covered by this
Directive is without prejudice to the adoption of rules on food hygiene
and safety in general, on which the Commission has submitted aproposal for a framework Directive,
HAS ADOPTED THIS DIRECTIVE:
CHAPTER I
General provisions
Article 1
This Directive lays down the animal health and public health require-
ments governing trade in and imports into the Community of productsof animal origin (including trade samples taken from suchproducts)
not subject to the said requirements laid down in specific Community
rules referred to in Annex A (I) to Directive 89/662/EEC (
2) and, as
regards pathogenic agents, to Directive 90/425/EEC.
This Directive shall be without prejudice to the adoption of more
detailed rules on animal health in the framework of the aforesaidspecific rules nor the maintenance of restrictions on trade or imports
of products covered by the specific rules referred to in the first para-
graph based on the rules of public health.
Article 2
1. For the purposes of this Directive:
(a)trade means trade as defined by Article 2 (2) of Directive 89/
662/EEC;
(b)trade sample means a sample of no commercial value, taken on
behalf of the owner or the person responsible for an establish-
ment, which is representative of a given product of animalorigin produced by that establishment, or constitutes aspecimen of a product of animal origin the manufacture ofwhich is contemplated, and which, for the purposes of subse-quent examination, must bear a reference to the type of
product, its composition and the species of animal from which
it was obtained;
(c)serious transmissible disease means all diseases covered by
Directive 82/894/EEC (
3)1992L0118 — EN — 01.05.2004 — 014.001 — 3
(1) OJ No L 373, 31. 12. 1990, p. 1.
(2) OJ No L 395, 30. 12. 1989, p. 13. Directive as last amended by Directive
91/496/EEC (OJ No L 268, 24. 9. 1991, p. 56).
(3) OJ No L 378, 31. 12. 1982, p. 58. Directive as last amended by Decision 90/
134/EEC (OJ No L 76, 22. 3. 1990, p. 23).
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(d)pathogenic agents jmeans any collection or culture of organ-
isms or any derivative, present either alone or in the form ofa manipulated combination of such a collection or culture of
organisms capable of causing disease in any living being (other
than man) and any modified derivatives of these organisms,which can carry or transmit an animal pathogen, or the tissue,cell culture, secretions or excreta by which or by means ofwhich an animal pathogen can be carried or transmitted; this
definition does not include the immunological veterinary
medicinal products authorized pursuant to Directive 90/677/EEC(
1);
(f)processed animal protein intended for human consumption
means greaves, meatmeal and pork-rind powder referred to in
Article 2 (b) of Directive 77/99/EEC (2).
2. In addition, the definitions contained in Article 2 of Directives
89/662/EEC, 90/425/EEC and 90/675/EEC shall apply mutatis
mutandis.
Article 3
Member States shall ensure that:
— trade in and imports of products of animal origin referred to in
Article 1 ►M12 ◄are not prohibited or restricted
for animal health or public health reasons other than those arising
from the application of this Directive or from Community legisla-tion, and in particular any safeguard measures taken,
— any new product of animal origin intended for human consumption
whose placing on the market in a Member State is authorised afterthe date provided for in Article 20 may not be the subject of tradeor importation until a decision has been taken in accordance withthe first paragraph of Article 15 after evaluation, if appropriate in
the light of the opinion of the Scientific Veterinary Committee set
up by Decision 81/651/EEC, of the real risk of the spread of serioustransmissible diseases which could result from movement of theproduct, not only for the species from which the product originatesbut also for other species which could carry the disease, become afocus of disease or a risk to human health,
— the other products of animal origin referred to in Article 2 (b) of
Directive 77/99/EEC may not be the subject of trade or importation
from third countries unless they meet the requirements of that
Directive and the relevant requirements of this Directive.
CHAPTER II
Provisionsapplicabletotrade
Article 4
Member States shall take the necessary measures to ensure that, for the
purposes of applying Article 4 (1) of Directive 89/662/EEC and Article
4 (1) (a) of Directive 90/425/EEC, the products of animal originreferred to in Annexes I and II and the second and third indents of1992L0118 — EN — 01.05.2004 — 014.001 — 4
(1) OJ No L 373, 31. 12. 1990, p. 26
(2) OJ No L 26, 31. 1. 1977, p. 85. Directive updated by Directive 92/5/EEC
(OJ No L 57, 2. 3. 1992, p. 1), and last amended by Directive 92/45/EEC
(OJ No L 268, 14. 9. 1992, p. 35)▼M12
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Article 3 of this Directive may, without prejudice to the particular
provisions to be adopted in implementation of Articles 10 (3) and 11,be the subject of trade only if they satisfy the following requirements:
1. they must meet the requirements of Article 5 and the specific
requirements laid down in Annex I as regards animal health aspectsand Annex II as regards public health aspects,
2. they must come from establishments which:
(a) undertake, in the light of the specific requirements laid down in
Annexes I and II for the products the establishment produces, to:
— comply withth e specific production requirements set out in
this Directive,
— establishand implement meth ods of monitoring and
checking the critical points on the basis of the processesused,
— depending on the products, take samples for analysis in a
laboratory recognized by the competent authority for thepurpose of checking compliance with the standards estab-lished by this Directive,
— keep a record, whether written or otherwise recorded, of the
information obtained pursuant to the preceding indents for
presentation to the competent authority. The results of thevarious checks and tests in particular shall be kept for atleast two years,
— guarantee the administration of marking and labelling,
— should the result of the laboratory examination or any other
information available to them reveal the existence of aserious animal health or public health hazard, inform thecompetent authority,
— consign, for purposes of trade, only products accompanied
by a commercial document indicating the nature of the
product, the name and, where appropriate, the veterinaryapproval number of the establishment of production;
(b) they are under supervision by the competent authority to ensure
that the operator or manager of the establishment complies withthe requirements of this Directive;
(c) they were registered by the competent authority on the basis of
assurances from the establishment guaranteeing compliance withthe requirements of this Directive.
Article 5
Member States shall ensure that every necessary measure is taken to
guarantee that products of animal origin referred to in Annexes I andII are not dispatched for purposes of trade from any holding, situated
in a zone subject to restrictions because of the occurrence of a disease
to which the species from which the product is derived is susceptible orfrom any establishment or zone from which movements or trade wouldconstitute a risk to the animal health status of the Member Statesexcept where products are heat-treated in accordance with Community
legislation.
Particular assurances permitting, by way of derogation from the first
paragraph, the movement of certain products may be adopted underthe procedure laid down in Article 18 within the framework of safe-
guard measures.
Article 6
Member States shall ensure that trade in pathogenic agents is subject to
strict rules to be defined under the procedure laid down in Article 18.
Article 7
1. The rules on checks established by Directive 89/662/EEC and, as
regards pathogenic agents, by Directive 90/425/EEC shall apply, in1992L0118 — EN — 01.05.2004 — 014.001 — 5
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particular as regards the organization of and follow-up to the checks to
be carried out, to the products covered by this Directive.
2. Article 10 of Directive 90/425/EEC shall apply to the products
covered by this Directive.
3. For the purposes of trade, the provisions of Article 12 of Direc-
tive 90/425/EEC shall be extended to establishments supplying
products of animal origin covered by this Directive.
4. Without prejudice to the specific provisions of this Directive, the
competent authority shall carry out any checks it may deem appropriatewhere it is suspected that this Directive is not being complied with.
5. Member States shall take the appropriate administrative or penal
measures to penalize any infringement of this Directive, in particularwhere it is found that the certificates or documents drawn up do not
correspond to the actual state of the products referred to in Annexes I
and II, or that the products in question do not satisfy the requirementsof this Directive or have not undergone the checks provided for therein.
Article 8
In Chapter 1 (1) of Annex A to Directive 92/46/EEC (
1) the following
subparagraphis added:
‘Milk and milk products must not come from a surveillance zone
defined in accordance withDirective 85/511/EEC unless th e milkhas undergone pasteurization (71,7 ºC for 15 seconds) under the
supervision of the competent authority.’
CHAPTER III
ProvisionsapplicabletoimportsintotheCommunity
Article 9
The requirements applicable to imports of products covered by this
Directive must offer at least the guarantees provided for in Chapter II,
including those established in implementation of Article 6, and thoselaid down in the second and third indents of Article 3.
Article 10
1. For the purposes of uniform application of Article 9, the
following provisions shall apply.
2. The products referred to in Annexes I and II and in the second
and third indents of Article 3 may be imported into the Communityonly if they satisfy the following requirements:
(a) unless otherwise specified in Annexes I and II, they must come
from a third country or part of a third country on a list to be drawn
up and updated in accordance withth e procedure provided for in
Article 18;
(b) unless otherwise specified in Annex II, products must come from
establishments on a Community list to be drawn up in accordance
withth e procedure laid down in Article 18;
(c) in the cases specifically provided for in Annexes I and II and in the
second and third indents of Article 3, they must be accompanied by
an animal health or public health certificate corresponding to aspecimen to be drawn up under the procedure provided for inArticle 18, certifying that the products meet the additional condi-tions or offer the equivalent guarantees referred to in paragraph 3(a) and come from establishments offering such guarantees, and1992L0118 — EN — 01.05.2004 — 014.001 — 6
(1) OJ No L 268, 14. 9. 1992, p. 1.▼M12
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signed by an official veterinarian or, as appropriate, by any other
competent authority recognized under the same procedure.
3. Under the procedure provided for in Article 18:
(a) specific requirements shall be established — in particular for the
protection of the Community from certain exotic diseases ordiseases transmissible to man — or guarantees equivalent to thoseconditions.
The specific requirements and equivalent guarantees established for
third countries may not be more favourable than those laid down inAnnexes I and II and in the second and third indents of Article 3.
Pending the fixing of the detailed rules of application provided for
in the fourth and fifth indents of Chapter 2 of Annex II, Member
States shall ensure that imports of products referred to therein aresubject to compliance withth e minimum guarantees laid down inthe said indents;
(c) the nature of any treatment or the measures to be taken to avoid
recontamination of animal casings, eggs and egg products shall beestablished.
4. The decisions provided for in paragraphs 2 and 3 must be taken
on the basis of evaluation and, if appropriate, the opinion of the Scien-
tific Veterinary Committee, of the real risk of the spread of serioustransmissible diseases or of diseases transmissible to man which couldresult from movement of the product, not only for the species fromwhich the product originates but also for other species which could
carry the disease or become a focus of disease or a risk to public
health.
5. Experts from the Commission and the Member States shall carry
out on-the-spot inspections to verify whether the guarantees given bythe third country regarding the conditions of production and placing
on the market can be considered equivalent to those applied in the
Community.
The experts from the Member States responsible for these inspections
shall be appointed by the Commission, acting on proposals from theMember States.
These inspections shall be made on behalf of the Community, which
shall bear the cost of any expenditure involved.
Pending organization of the inspections referred to in the first subpara-
graph, national rules applicable to inspection in third countries shallcontinue to apply, subject to notification, through the Standing Veter-inary Committee, of any failure to comply withth e guarantees offered
in accordance withparagraph3 found during th ese inspections.
6. Pending compilation of the lists provided for ►
M8in paragraph
2 (a) and (b) second indent ◄, Member States are authorized to main-
tain the controls provided for in Article 11 (2) of Directive 90/675/EECand the national certificate required by products imported under
existing national rules.
Article 11
The procedure provided for in Article 18 shall be used to stipulate
specific animal health requirements for imports into the Communityand the nature and content of accompanying documents for productsreferred to in Annex I intended for experimental laboratories.1992L0118 — EN — 01.05.2004 — 014.001 — 7
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Article 12
1. The principles and rules laid down in Directives 90/675/EEC and
91/496/EEC (1) shall apply, with particular reference to the organiza-
tion of and follow-up to the inspections to be carried out by the
Member States and the safeguard measures to be implemented.
However, for certain types of product of animal origin, derogations
may be adopted in accordance withth e procedure laid down in Article18, from the physical check provided for in ►
M9Article 4(4)(b) of
Directive 97/78/EC ◄.
Article 13
1. Member States may, by issuing an appropriate licence, permit the
importation from third countries of products of animal origin referred
to in Annexes I and II in the form of trade samples.
2. The licence mentioned in paragraph 1 must accompany the
consignment and contain full details of the specific conditions underwhich the consignment may be imported, including any derogationsfrom the checks provided for by Directive 90/675/EEC.
3. Where the consignment enters one Member State for onward
transmission to a second Member State, the first Member State shall
ensure that the consignment is accompanied by the appropriate licence.Movement shall take place in accordance with the provisions of Article11 (2) of Directive 90/675/EEC. The responsibility for ensuring that theconsignment complies with the conditions of the licence (and whetherentry into its territory should be permitted) shall rest with the Member
State which issues the licence.
CHAPTER IV
Commonfinalprovisions
Article 14
1. Article 3 (d) of Directive 72/461/EEC (2) shall be deleted.
Commission Decisions 92/183/EEC (3) and 92/187/EEC (4) shall
continue to apply for the requirements of this Directive, without preju-dice to any amendments to be made to them under the procedure
provided for in Article 18.
2. Directive 90/667/EEC is hereby amended as follows:
(a) in Article 13 the following paragraph shall be added:
‘2. With a view to ensuring that the controls provided for in
paragraph1 are followed up:
(a) processed products obtained from low-risk or high-risk mate-
rials must satisfy the requirements of Chapter 6 of Annex I to
Directive 92/118/EEC (*);
(b) low-risk materials, high-risk materials intended for processing
in a plant designated in another Member State in accordancewithth e second sentence of Article 4 (1) and processed1992L0118 — EN — 01.05.2004 — 014.001 — 8
(1) OJ No L 268, 24. 9. 1991, p. 56.
(2) OJ No L 302, 31. 12. 1972, p. 24. Directive as last amended by Directive
91/687/EEC (OJ No L 377, 31. 12. 1991, p. 16).
(3) OJ No L 84, 31. 3. 1992, p. 33.
(4) OJ No L 87, 2. 4. 1992, p. 20.▼M9
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products obtained from high-risk or low-risk materials must be
accompanied:
— if they come from a plant approved in accordance with
Article 4 or 5, by a commercial document specifying;
— if appropriate, the nature of the treatment,
— whether the product contains ruminant proteins,
— if they come from another plant, by a certificate issued and
signed by an official veterinarian indicating:
— the methods of treatment used on the consignment,
— the result of the salmonella tests,
— — whether the product contains ruminant proteins.
(*) OJ No L 62, 15. 3. 1993, p. 49.’;
(b) in Article 6, ‘shall be established under the procedure laid down in
Article 19’ shall be replaced by ‘are laid down under Chapter 10 ofAnnex I to Directive 92/118/EEC’;
(c) in Article 14 the first paragraph shall be deleted.
Article 15
The Council, acting by a qualified majority on a proposal from the
Commission, shall adopt any new Annex laying down specific require-
ments for other products capable of presenting a real risk of spreadingserious transmissible diseases or a real risk to human health.
The Annexes shall, where the need arises, be amended under the proce-
dure provided for in Article 18 in compliance withth e generalprinciples set out in the second indent of Article 3.
Article 16
1. Member States shall be authorized to make the entry into their
territory of products of animal origin referred to in Annexes I and II
and in the second and third indents of Article 3 which were produced
in the territory of a Member State and have passed through the territoryof a third country subject to production of an animal health or publichealth certificate certifying compliance with the requirements of thisDirective.
2. Member States which have recourse to the possibility laid down
in paragraph 1 shall so inform the Commission and the other MemberStates within the Standing Veterinary Committee set up by Decision
68/361/EEC (
1).
Article 17
1. Annexes A and B to Directives 89/662/EEC and 90/425/EEC
shall be replaced by the texts set out in Annex III to this Directive.
2. Directive 77/99/EEC is hereby amended as follows:
— in Article 2 (b), point (iv) shall be deleted and points (v) and (vi)
shall become (iv) and (v) respectively;
— Article 6 (2) shall read:
‘2. Under the procedure laid down in Article 20, additional
conditions may be set for the other products of animal origin so as
to ensure the protection of public health.’
Article 18
Where reference is made to the procedure provided for in this Article,
the Standing Veterinary Committee shall act in accordance with therules laid down in Article 17 of Directive 89/662/EEC.1992L0118 — EN — 01.05.2004 — 014.001 — 9
(1) OJ No L 255, 18. 10. 1968, p. 23.
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Article 19
Under the procedure provided for in Article 18, transitional measures
may be adopted for a period of up to three years beginning on 1 July
1993 to facilitate the transition to the new arrangements established by
this Directive.
Article 20
1. Member States shall bring into force the laws, regulations and
administrative provisions necessary to comply withArticles 12 (2) and17 by 1 January 1993 and with the other requirements of this Directivebefore 1 January 1994. They shall forthwith inform the Commissionthereof.
When these measures are adopted by the Member States, they shall
contain a reference to this Directive or shall be accompanied by such
reference on the occasion of their official publication. The methods of
making such a reference shall be laid down by the Member States.
2. Member States shall communicate to the Commission the texts of
the main provisions of national law which they adopt in the fieldgoverned by this Directive.
3. The setting of the deadline for transposition into national law at 1
January 1994 shall be without prejudice to the abolition of veterinary
checks at frontiers provided for by Directives 89/662/EEC and 90/425/
EEC.
Article 21
This Directive is addressed to the Member States.1992L0118 — EN — 01.05.2004 — 014.001 — 10
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ANNEX I
SPECIFICANIMALHEALTHREQUIREMENTS
CHAPTER 2
Animalcasingsintendedforhumanconsumption
A.Trade
Trade in animal casings is subject to production of a document specifying
the plant of origin which must be:
— where the casings are salted or dried at the point of origin and where
salted or dried casings are subsequently handled for other purposes, a
plant approved by the competent authority,
— in other cases, a plant approved in accordance with Directive 64/433/
EEC (1), provided the casings are transported in such a way as to avoid
contamination.
B.Imports from third countries
Imports of animal casings from any third country are subject to production
of the certificate referred to in Article 10 (2) (c), issued and signed by an
official veterinarian of the exporting third country, stating that:
(i) the casings come from plants approved by the competent authority of
the exporting country;
(ii) the casings have been cleaned, scraped and then either salted or
bleached (or as an alternative to salting or bleaching, that they have
been dried after scraping);
(iii) after the treatment in (ii), effective steps were taken to prevent the
recontamination of the casings.
CHAPTER 5
Bones and bone products (excluding bone meal), horns and horn products
(excluding hornmeal) andhooves andhoofproducts(excluding hoofmeal)
►M12 intendedforhumanconsumption ◄
Trade in and imports of the products in question are subject to the following
conditions:
1. where trade is concerned, bones, horns and hooves are subject to the
animal health requirements laid down in Directive 72/461/EEC;
2. where trade is concerned, bone products, horn products and hoof products
are subject to the animal health requirements provided for in Directive
80/215/EEC (2);
3. where imports are concerned, bones, bone products, horns, horn products,
hooves and hoof products are subject to the requirements of Directive 72/
462/EEC (3).1992L0118 — EN — 01.05.2004 — 014.001 — 11
(1) OJ No 121, 29. 7. 1964, p. 2012/64. Directive as last amended by Directive 91/497/
EEC (OJ No L 268, 24. 9. 1991, p. 69).
(2) OJ No L 47, 21. 2. 1980, p. 4. Directive as last amended by Directive 91/687/EEC (OJ
No L 377, 31. 12. 1991, p. 16).
(3) OJ No L 302, 31. 12. 1972, p. 28. Directive as last amended by Directive 91/688/EEC
(OJ No L 377, 31. 12. 1991, p. 18).▼M12
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CHAPTER 6
Processedanimalprotein ►M12 intendedforhumanconsumption ◄
I. Without prejudice to any restrictions imposed as regards BSE or to the
restrictions on the feedings of ruminant protein to ruminants, trade in and
imports of processed animal protein are subject:
A. as regards trade, to the production of the document or certificate
provided for in Directive 77/99/EEC, stating that the requirements of
that Directive have been complied with;
B. as regards imports:
1. to production of a health certificate as provided for in Article 10 (2)
(c), signed by the official veterinarian of the country of origin and
stating that:
a) the products fulfil the requirements of Directive 80/215/EEC;
(b) every precaution has been taken after treatment to prevent
contamination of the product treated;
(c) samples have been taken and tested for salmonella when the
consignment left the country of origin;
(d) the results of these tests are negative;
2. following document checks of the certificate referred to in 1, to
sampling by the competent authority at the border inspection post
without prejudice to point II:
(i) of eachconsignment of products submitted in bulk;
(ii) at random of consignments of products packaged in the manufac-
turing plant;
3. for release for free circulation in Community territory of consign-
ments of processed animal protein, to prove that the results of the
sampling carried out pursuant to B (1) (c) have proved negative, if
necessary after reprocessing;
C. national rules existing on the date of notification of this Directive
concerning the requirements applicable as regards BSE and scrapie for
animal proteins may be maintained pending a decision on the type of
heat treatment capable of destroying the agent responsible.
Trade in and imports of meat meal and bone meal remain subject to
Article 5 (2) of Directive 89/662/EEC and Article 11 (2) of Directive
90/675/EEC.
II. Member States may carry out random sampling of bulk consignments origi-
nating in a third country from which the last six consecutive tests have
proved negative. Where during one of these checks a result has proved posi-
tive, the competent authority of the country of origin must be informed so
that it can take appropriate measures to remedy the situation. These
measures must be brought to the attention of thecompetent authority respon-
sible for the import checks. In the event of a further positive result from the
same source, further tests must be carried out on all consignments from the
same source until the requirements laid down in the first sentence are again
satisfied.
III. Member States must keep records of the results of sampling carried out on
all consignments which have undergone sampling.
IV. In accordance withArticle 3 (3) of Directive 89/662/EEC, transh ipment of
consignments is permitted only through ports which have been approved
under the procedure laid down in Article 18, provided that a bilateral agree-
ment has been reached between Member States to allow checking of the
consignments to be deferred until they reach the border inspection post of
the Member State of final destination.
V. Where a consignment proves to be positive for salmonella, it is either:
(a) re-exported from the Community;
(b) used for purposes other than animal feeds. In this case, the consignment
may leave the port or storage depot only on condition that it is not
incorporated into animal feedingstuffs;1992L0118 — EN — 01.05.2004 — 014.001 — 12
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(c) re-processed in a treatment plant approved pursuant to Directive 90/
667/EEC or any plant approved for decontamination. Movement from
the port or storage depot shall be controlled by permit from the compe-
tent authority and the consignment shall not be released until it has
been treated, tested for salmonella by the competent authority in accor-
dance withAnnex II, Ch apter III, to Directive 90/667/EEC and a
negative result obtained.
CHAPTER 7
Bloodandbloodproductsofungulatesandpoultry
(withth e exception of serum from equidae)
I.Fresh blood and blood products intended for human consumption
A. Trade
1. Trade in freshblood of ungulates and poultry intended for h uman consump-
tion is subject to the animal health conditions applicable to trade in fresh
meat pursuant to Council Directives 72/461/EEC (1), 91/494/EEC (2) or 91/
495/EEC (3).
2. Trade in blood products intended for human consumption is subject to the
animal health conditions laid down in Chapter 11 of this Directive.
B. Imports
1. Imports of freshblood of domestic ungulates intended for h uman consump-
tion are prohibited pursuant to Council Directive 72/462/EEC (4).
Imports of freshblood of domestic poultry intended for h uman consumption
are subject to the animal health conditions laid down in Directive 91/494/
EEC.
Imports of freshblood of reared game intended for h uman consumption are
subject to the animal health conditions laid down in Chapter 11 of this
Annex.
2. Imports of blood products for human consumption, including those referred
to in Council Directive 77/99/EEC (5), are subject to the animal health condi-
tions applicable to meat products pursuant to Directive 72/462/EEC and this
Directive, without prejudice to the rules on blood-based processed animal
protein products referred to in Chapter 6 of this Annex.
III.General provisions
The detailed rules for the application of this Chapter are to be adopted,
where necessary, in accordance with the procedure laid down in Article 18.
CHAPTER 9
Lardandrenderedfatsintendedforhumanconsumption
1. Member States shall authorize the importation into the Community of lard
and rendered fats from third countries appearing on the list annexed to Deci-
sion 79/542/EEC from which the importation of fresh meat of the species
concerned is permitted.
2. Where there has been an outbreak of a serious transmissible disease in the
previous 12 months before export in a country mentioned in paragraph 1,1992L0118 — EN — 01.05.2004 — 014.001 — 13
(1) OJ No L 302, 31. 12. 1972, p. 24.
(2) OJ No L 268, 24. 9. 1991, p. 35.
(3) OJ No L 268, 24. 9. 1991, p. 41.
(4) OJ No L 302, 31. 12. 1972, p. 28.
(5) OJ No L 26, 31. 1. 1977, p. 85.▼M7
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eachconsignment of lard or rendered fats must be accompanied by a certifi-
cate referred to in Article 10 (2) of this Directive stating that:
A. the lard or rendered fats have been subjected to one of the following heat
treatment processes:
(i) at least 70 ºC for at least 30 minutes; or
(ii) at least 90 ºC for at least 15 minutes; or
(iii) a minimum temperature of 80 ºC in a continuous rendering system;
B. where the lard of rendered fats are packaged, they have been packed in
new containers and all precautions have been taken to prevent their
recontamination;
C. where bulk transport of the product is intended, the pipes, pumps and
bulk tank and any other bulk container tanks or bulk road tanker used in
the transportation of the products from the manufacturing plant either
directly on to the ship or into shore tanks or direct to establishments
were inspected and found to be clean before use.
CHAPTER 11
Rabbitmeatandfarmedgamemeatintendedforhumanconsumption
Member States shall ensure that rabbit meat and farmed game meat are imported
only if:
(a) they come from third countries included:
(i) for furred farm game, on the list of countries from which fresh meat of
the corresponding species may be imported pursuant to Directive 72/
462/EEC;
(ii) for feather farmed game, on the list of countries from which fresh poul-
trymeat may be imported pursuant to Directive 91/494/EEC (1);
(iii) for rabbit meat, on a list to be drawn up under the procedure laid down
in Article 18;
(b) they satisfy at least the requirements laid down in Chapters II and III
respectively of Directive 91/495/EEC (2);
(c) they come from establishments offering the guarantees provided for in (b)
and recognized under the procedure provided for in Article 18 or, pending
the list referred to in (a) (iii), from establishments approved by the compe-
tent authorities;
(d) each batch of meat is accompanied by the health certificate provided for in
Article 10 (2) (c).1992L0118 — EN — 01.05.2004 — 014.001 — 14
(1) OJ No L 268, 24. 9. 1991, p. 25.
(2) OJ No L 268, 24. 9. 1991, p. 41.▼M12
▼B
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ANNEX II
SPECIFICPUBLICHEALTHCONDITIONS
CHAPTER 1
Importsfrom third countries of meat productsobtainedfrom poultrymeat,
farmedgamemeat,wildgamemeatandrabbitmeat
Member States shall ensure that meat products obtained from poultrymeat,
farmed game meat, wild game meat and rabbit meat are not imported unless:
(a) either they come from a third country listed in accordance with:
(i) Article 9 of Directive 91/494/EEC for poultrymeat;
(ii) Article 16 of Directive 92/45/EEC for wild game meat;
(iii) Chapter 2 of Annex I to this Directive for rabbit meat and farmed game
meat,
either they come from a third country listed in the Annex, Part I of Decision
79/542/EEC. In this case they must have undergone a heat treatment in a
sealed container, the Fovalue being equal or over 3,00. However for meat
products made from species other than swine, this treatment may be
replaced by a heat treatment which brings the internal temperature to at least
70 ºC.
(b) the fresh meat used meets the appropriate requirements of Article 14 of
Directive 71/118/EEC for poultrymeat, Article 16 of Directive 92/45/EEC
for wild game meat, Article 3 of Directive 91/495/EEC for rabbit meat and
Article 6 of that Directive for farmed-game meat;
(c) they come from an establishment offering the same guarantees as those
referred to in Directive 77/99/EEC and approved in accordance withth e
procedure provided for in Article 18 or, pending the adoption of such adecision, by the competent authority of the Member State with imports of
these products remaining subject to the rules in Article 11 (2) of Directive
90/675/EEC;
(d) they are prepared, checked and handled in accordance with the appropriate
requirements provided for in Directive 77/99/EEC;
(e) eachconsignment of meat products is accompanied by a h ealthcertificate
established in accordance with the procedure provided for in Article 18.
CHAPTER 2
►
M8Before 1 July 1997 ◄, the health conditions applicable to the following
shall be established in accordance with the procedure laid down in Article 18:
— putting on the market in and imports of eggs and imports of egg products
intended for human consumption, without prejudice to the rules laid down
within the framework of the common organization of the market.
In respect of salmonella and pending the adoption of Community provisions,
the following rules shall apply for eggs intended for Finland and Sweden:
(a) consignments of eggs may be subject to additional general or limited
guarantees defined by the Commission following the procedure provided
for in Article 18;
(b) the guarantees provided for in (a) shall not be carried out for eggs origi-
nating in an establishment subject to a programme recognized as
equivalent to that referred to in (c), pursuant to the procedure provided
for in Article 18;
(c) the guarantees provided for in (a) shall apply only after approval by the
Commission of an operational programme to be presented by Finland
and Sweden. The Commission decisions must be taken before the date
of entry into force of the Accession Treaty in order for the operational
programmes and the guarantees provided for in (a) to be applicable as
from the date of entry into force of the Accession Treaty,
— trade in and import of honey ►M6 ◄intended for human
consumption,1992L0118 — EN — 01.05.2004 — 014.001 — 15
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— trade in and imports of milk and milk-based products intended for human
consumption, obtained from species not covered by Directive 92/46/EEC;
depending on the species, specific requirements may be laid down as
regards:
— animal health and the health status of dairy herds, in particular with
regard to tuberculosis and brucellosis;
— hygiene in respect of
— milking,
— the collection, transport, treatment and processing of milk,— staff,
— testing for residues of pharmacologically and/or hormonally active
substances, antibiotics, pesticides or other harmful substances in milk or
milk products,
— criteria applicable to raw milk as a raw material,— microbiological criteria applicable to finished products,
— the production, placing on the market and importation of meat of species not
covered by specific requirements, and in particular reptile meat and products
thereof, intended for human consumption.
Depending on the species, specific requirements may be laid down as
regards:
— microbiological and parasitological criteria,
— hygiene during slaughter,
— testing for residues.
CHAPTER 3
I.Specific public health conditions applicable to trade in and imports of
snailsintendedforhumanconsumption
A. Without prejudice to Community, national or international provisions on
the protection of wildlife, for the purpose of this Chapter, ‘snails’ means
terrestrial gastropods of the species Helix pomatia Linné, Helix aspersa
Muller, Helix lucorum and species of the family of Achatinidae .
B. Member States must ensure that shelled, cooked and prepared or
preserved snails are traded for human consumption only if they meet
the following conditions:
(1) They must come from establishments:
— which meet the requirements of Article 4 (2) of this Directive,
— which are approved by the competent authority in accordance
with the requirements of Chapters III and IV of the Annex to
Directive 91/493/EEC,
— which undergo monitoring by the competent authority of produc-
tion conditions and health checks in accordance with Chapter V
(I) (3) and (5) and (II), (3) and (4) of Directive 91/493/EEC,
— which conduct own checks in accordance with the provisions of
Commission Decision 94/356/EC.
(2) They must be subjected to organoleptic checks carried out by
sampling. If the organoleptic examination reveals that the snails are
not fit for human consumption, measures must be taken to withdraw
them from the market and denature in such a way that they cannot be
re-used for human consumption.
(3) For the preparation of shelled snailmeat,
(a) depending on the scale of the operation, establishments must set
aside special rooms or areas for:
— the storage of packaging and wrapping materials,
— the reception and storage of live snails,
— washing, blanching or boiling, shelling and trimming,
— the storage and, where necessary, cleaning and treatment of
shells,
— the heat treatment of the snailmeat, where necessary,— the wrapping or packaging of the snailmeat,
— the storage of the finished product in cold stores;
(b) the snails must be checked before being boiled. Dead snails must
not be prepared for human consumption;
(c) following shelling, the hepatopancreas removed during trimming
must not be used for human consumption.1992L0118 — EN — 01.05.2004 — 014.001 — 16
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(4)Canned snails
Establishments must satisfy the conditions laid down in Chapter IV
(IV) (4) of the Annex to Directive 91/493/EEC.
(5)Cooked and prepared snails
(a) Depending on the scale of the operation, establishments must set
aside special rooms or areas for:
— the storage of shelled snailmeat in cold stores,
— the storage of clean shells,— the storage of breading products,
— the preparation of stuffing,
— cooking and cooling,— the filling of the shells with snailmeat and stuffing, and
packaging in a controlled-temperature room,
— where applicable, freezing,— the storage of finished products in cold stores;
Products must satisfy the relevant conditions set out in Chapter
IX of Annex B to Directive 77/99/EEC.
(b) Snailmeat used to fill shells prior to cooking must satisfy the
conditions laid down in respect of shelled snailmeat.
(6) In accordance with the procedure laid down in Article 18 of this
Directive, microbiological criteria, including sampling plans and
methods of analysis, may be laid down when there is a need to
protect public health.
(7) The snails must be put up, packaged, stored and transported under
the appropriate hygiene conditions laid down in Chapters VI and
VIII of the Annex to Directive 91/493/EEC.
(8) The packaging and wrapping of snails must bear an identification
mark containing the following particulars:
the name of the consigning country in capitals, or the initial letter or
letters of the consigning country in printed capitals, i.e.: B, CZ, DK,
D, EE, EL, E, F, IRL, I, CY, LV, LT, L, HU, MT, NL, AT, PL, P,
SI, SK, FI, SE, UK followed by the approval number of the estab-
lishment, and one of the following sets of initials: CE, EC, EF, EG,
EK, EY, ES, EÜ, EB, KE, WE.
C. For imports:
(1) the packaging and wrapping of shelled, cooked and prepared or
preserved snails must carry the name or ISO code of the country of
origin and the approval number of the production establishment in
indelible print;
(2) the following is an example of the specimen health certificate laid
down in Article 10 (2) (c) of this Directive, which must accompany
every consignment of shelled, cooked and prepared or preserved
snails originating in third countries.1992L0118 — EN — 01.05.2004 — 014.001 — 17
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SPECIMEN HEALTH CERTIFICATE FOR SHELLED, COOKED, PREPARED OR PRESERVED
SNAILS ORIGINATING IN THIRD COUNTRIES AND INTENDED FOR THE EUROPEAN
COMMUNITY
Note to the importer: this certificate is for veterinary purposes only and must accompany the consign-
ment until it reaches the border inspection point.
1992L0118 — EN — 01.05.2004 — 014.001 — 18
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1992L0118 — EN — 01.05.2004 — 014.001 — 19
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II.Specific public health conditions applicable to trade in and imports of
frogs'legsintendedforhumanconsumption
A. Without prejudice to Community, national or international provisions on
the protection of wildlife, for the purposes of this Chapter, ‘Frogs' legs’
means the back part of the body divided by a transversal cut behind the
front limbs, eviscerated and skinned, of the species Ranaspp. (family
Ranidae), presented fresh, frozen or processed.
B. Member States must ensure that frogs' legs are traded for human
consumption only if they meet the following conditions:
(1) The frogs must have been slaughtered, bled, prepared and, where
appropriate, chilled, frozen, processed, packaged and stored in estab-
lishments which:
— meet the requirements of Article 4, point 2 of this Directive,
— are approved by the competent authority in accordance with the
requirements of Chapters III and IV of the Annex to Directive
91/493/EEC,
— undergo monitoring by the competent authority of production
conditions and health checks in accordance with Chapter V (I)
(3) and (5) and (II) (3) and (4) of the Annex to Directive 91/
493/EEC,
— conduct own checks in accordance with the provisions of Deci-
sion 94/356/EC.
(2) The frogs legs must be subjected to organoleptic checks carried out
by sampling. If the organoleptic examination reveals that the frogs
legs are not fit for human consumption, measures must be taken to
withdraw them from the market and denature in such a way that
they cannot be re-used for human consumption.
(3) In addition, a special room must be set aside for the storage and
washing of live frogs, and for their slaughter and bleeding. The death
of frogs must only be carried out by slaughter in an approved estab-
lishment. Frogs which are found to be dead prior to slaughter must
not be prepared for human consumption. The special room must
meet the requirements of Chapter III, paragraph I, point 2 of the
Annex to Directive 91/493/EEC and must be physically separated
from the preparation room.
(4) Immediately following preparation, the frogs' legs must be washed
very fully in running drinking water and immediately chilled at the
temperature of melting ice, frozen at a temperature of at least
− 18 ºC or processed.
(5) Where the frogs' legs are processed, this must be carried out in
accordance with the rules laid down in Chapter IV of the Annex toDirective 91/493/EEC.
(6)Microbiological controls
In accordance with the procedure laid down in Article 18 of this
Directive, microbiological criteria, including sampling plans and
methods of analysis, may be laid down when there is a need to
protect public health.
(7) The frogs' legs must be put up, packaged, stored and transported
under the appropriate hygiene conditions laid down in Chapters VI
and VIII of Directive 91/493/EEC.
(8) The packaging and containers of frogs' legs must bear an identifica-
tion mark containing the following particulars:
The name of the consigning country in capitals, or the initial letter or
letters of the consigning country in printed capitals, i.e.: B, CZ, DK,
D, EE, EL, E, F, IRL, I, CY, LV, LT, L, HU, MT, NL, AT, PL, P,
SI, SK, FI, SE, UK followed by the approval number of the estab-
lishment, and, one of the following sets of initials: CE, EC, EF, EG,
EK, EY, ES, EÜ, EB, KE, WE.
C. For imports:
(1) The packaging and wrapping of frogs' legs must carry the name or
ISO code of the country of origin and the approval number of the
production establishment in indelible print.
(2) The following is an example of the specimen health certificate laid
down in Article 10 (2) (c) of this Directive, which must accompany
every consignment of frogs' legs originating in third countries:1992L0118 — EN — 01.05.2004 — 014.001 — 20
▼A2
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▼M6
SPECIMEN HEALTH CERTIFICATE FOR CHILLED, FROZEN OR PREPARED FROGS' LEGS
ORIGINATING IN THIRD COUNTRIES AND INTENDED FOR THE EUROPEAN COMMUNITY
Note to the importer: This certificate is for veterinary purposes only and must accompany the consign-
ment until it reaches the border inspection point.
1992L0118 — EN — 01.05.2004 — 014.001 — 21
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1992L0118 — EN — 01.05.2004 — 014.001 — 22
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CHAPTER 4
Section A
SPECIFIC HEALTH CONDITIONS FOR THE GELATINE INTENDED
FORHUMANCONSUMPTION
This chapter lays down the health conditions applicable to putting on the market
and for imports of gelatine intended for human consumption, but excluding
gelatine destined to pharmaceutical, cosmetic or other technical use and medical
devices.
For the purpose of this chapter, the following definitions apply:
— gelatine: natural, soluble protein, gelling or non-gelling, obtained by the
partial hydrolysis of collagen produced from bones, hides and skins, tendons
and sinews of animals (including fishand poultry),
— hides and skins: all cutaneous and subcutaneous tissues,
— tanning: 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,
— category 1 country or region: country or region classified as BSE free in
accordance withCommunity legislation,
— category 2 country or region: country or region classified as provisionally
BSE free withaccordance to Community legislation,
— category 3 country or region: country or region classified as low BSE risk in
accordance withCommunity legislation,
— category 4 country or region: country or region classified as high BSE risk
in accordance withCommunity legislation.
Gelatine intended for human consumption shall comply with the following
conditions:
I.Conditionsforestablishmentsproducinggelatine
Gelatine intended for human consumption shall come from establishments
which:
1. comply with the conditions laid down in Chapters I, II, V, VI, VII, VIII, IX
and X of the Annex to Directive 93/43/EEC;
2. are authorised and registered in accordance with Article 11 of Directive 77/
99/EEC;
3. are subject to supervision of production conditions by the competent
authority in accordance with Chapter IV of Annex B to Directive 77/99/
EEC as appropriate;
4. carry out an own-checks programme in accordance with Article 7(1) and (3)
of Directive 77/99/EEC;
5. keep records for two years on the sources of all incoming raw material and
on all outgoing products;
6. introduce and implement a system that makes it possible to link each produc-
tion batch dispatched, the incoming raw material consignments, the
production conditions and the time of production.
II.Requirementsforrawmaterialstobeusedfortheproductionofgelatine
1. For the production of gelatine intended for human consumption, the
following raw materials may be used:
— bones,
— hides and skins of farmed ruminant animals,
— pig skins,— poultry skin,
— tendons and sinews,
— wild game hides and skins,
— fishskin and bones.
2. The use of bones obtained from ruminant animals born, reared or slaughtered
in category 4 countries or regions is prohibited.
3. The use of hides and skins submitted to tanning processes is prohibited.
4. Raw materials listed in the first five indents of paragraph 1 shall be derived
from animals which have been slaughtered in a slaughterhouse and whose1992L0118 — EN — 01.05.2004 — 014.001 — 23
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carcases have been found fit for human consumption following ante and post
mortem inspection.
5. Raw material listed in the sixth indent of paragraph 1 shall be derived from
killed animals whose carcases have been found fit for human consumption
following the inspections laid down in Article 3 of Council Directive 92/45/
EEC (1).
6. Raw materials listed in the first six indents of paragraph 1 shall come from
slaughterhouses, cutting plants, meat processing establishments, wild game
processing plants, bone degreasing plants, tanneries, collection centres, retail
shops, or premises adjacent to sales points where the cutting and the storage
of meat and poultrymeat is performed for the sole purpose of supplying the
final consumer directly.
7. Raw material listed in the last indent of paragraph 1 shall come from plants
manufacturing fishproducts for h uman consumption approved or registered
in accordance withCouncil Directive 91/493/EEC (2).
8. The collection centres and tanneries which intend to supply raw material for
the production of gelatine intended for human consumption shal be specifi-
cally authorised for this purpose and registered by the competent authorities
and fulfil the following requirements:
(a) they must have storage rooms with hard floors and smooth walls which
are easy to clean and disinfect;
(b) where appropriate, they must be provided with refrigeration facilities;
(c) the storage rooms must be kept in a satisfactory state of cleanliness and
repair, so that they do not consitute a source of contamination for the raw
materials;
(d) if raw material not in conformity to this part is stored and/or processed in
these premises, it must be segregated throughout the period of receipt,
storage, processing and dispatchfrom raw material in conformity to th is
part;
(e) they must be inspected by the competent authority at regular intervals in
order to ensure that this chapter is being complied with and to check
accounting documents and/or health certificates which enable the origin
of the raw material to be traced.
9. Imports into the Community of raw material destined to the production of
gelatine intended for human consumption are subject to the following provi-
sions:
— Member States shall authorise the importation of this raw material only
from third countries which appear on the list laid down in Council Deci-
sion 79/542/EEC (3) or in Commission Decision 94/85/EC (4)o ri n
Commission Decision 97/296/EC (5) or in Decision 94/86/EC (6), as
appropriate,
— each consignment is accompanied by a certificate that conforms to the
model laid down in accordance withth e procedure provided for in Article
18 of this Directive.
III.Transportandstorageofrawmaterials
1. Transports of raw materials destined to the production of gelatine must be
carried out under clean conditions using appropriate means of transport.
During transportation, at the time of delivery in the collection centre and in
the tannery and in the gelatine processing establishment, raw materials must
be accompanied by a commercial document in conformity withth e model
laid down in Part VIII of this chapter.
2. Raw materials must be transported and stored chilled or frozen, unless they
are processed within 24 hours after their departure.
By way of derogation from the preceding subparagraph, degreased and dried
bones or ossein, salted, dried and limed hides and skins and hides and skins
treated withalkali or acid may be transported and stored at ambient tempera-
ture.1992L0118 — EN — 01.05.2004 — 014.001 — 24
(1) OJ L 268, 14.9.1992, p. 35.
(2) OJ L 268, 24.9.1991, p. 15.
(3) OJ L 146, 14.6.1979, p. 15.
(4) OJ L 44, 17.2.1994, p. 31.
(5) OJ L 122, 14.5.1997, p. 21.
(6) OJ L 44, 17.2.1994, p. 33.
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3. 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.
IV.Conditionstobecompliedwithforthemanufactureofgelatine
1. Gelatine must be produced by a process which ensures that:
— all ruminant bone material which is derived from animals born, reared
and slaughtered in category 3 countries or regions 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, followed by an alkaline treatment of saturated lime solution
(pH > 12,5) for a period of at least 20 days witha sterilisation step of
138-140 ºC during four seconds or by an equivalent process approved
by the Commission after consultation of the appropriate Scientific
Committee,
— 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 several times in succession,
followed by purification by means of filtration and sterilisation.
2. After having been subjected to the processes listed in paragraph 1, gelatine
may undergo a drying process and, where appropriate, a process of pulverisa-
tion or lamination.
3. The use of preservatives, other than sulphur dioxide and hydrogen peroxide,
is prohibited.
4. Provided the requirements for gelatine not intended for human consumption
are exactly the same as for gelatine intended for human consumption,
production and storage may be undertaken in the same establishment.
V.Requirementsforfinishedproducts
Each production batch of gelatine shall be subjected to tests to ensure that it
meets the following criteria:
1.Microbiological criteria
Microbiological parameters Limit
Total aerobic bacteria 103/g
Coliforms (30 ºC) 0/g
Coliforms (44,5 ºC) 0/10 g
Anaerobic sulphite-reducing bacteria (no gas
production)10/g
Clostridium perfringens 0/g
Staphylococcus aureus 0/g
Salmonella 0/25 g
2.Residues
Elements Limit
As 1 ppm
Pb 5 ppm
Cd 0,5 ppm
Hg 0,15 ppm
Cr 10 ppm
Cu 30 ppmZn 50 ppm
Moisture (105 ºC) 15 %1992L0118 — EN — 01.05.2004 — 014.001 — 25
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Elements Limit
Ash(550 ºC) 2 %
SO2(ReithWilliems) 50 ppm
H2O2(European Pharmacopia 1986 (V2O2)) 10 ppm
VI.Packaging,storageandtransport
1. Gelatine intended for human consumption must be wrapped, packaged, stored
and transported under satisfactory hygiene conditions, in particular:
— a room must be provided for storing, wrapping and packaging materials,
— wrapping and packaging must take place in a room or in a place intended
for that purpose.
2. Wrappings and packages containing gelatine must:
— bear an identification mark giving the following particulars:
the name or initial letter or letters of the consigning country in printed
capitals, i.e.: B-CZ-DK-D-EE-EL-E-F-IRL-I-CY-LV-LT-L-HU-MT-NL-
AT-PL-P-SI-SK-FI-SE-UK, followed by the registration number of the
establishment and one of the following sets of initials: CE-EC-EF-EG-
EK-EY-ES-EÜ-EB-KE-WE
and
— carry the words ‘Gelatine for human consumption’.
3. Gelatine must be accompanied during transportation by a commercial docu-
ment, in accordance withArticle 3(A)(9)(a) of Directive 77/99/EEC, wh ich
must bear the words ‘Gelatine for human consumption’ and the date of
preparation.
VII.Importationofgelatinefromthirdcountries
A. Member States shall ensure that gelatine destined to human consumption is
imported only if:
— it comes from third countries which appear on the list of Part XIII of the
Annex to Commission Decision 94/278/EC (1),
— it comes from establishments meeting the conditions laid down in Part I
of this chapter,
— it has been produced from raw material which met the requirements of
Parts II and III of this chapter,
— it has been manufactured in compliance with the conditions set out in
Part IV of this chapter,
— it satisfies the criteria of Part V and the requirements of part VI.1 of this
chapter,
— it bears on its wrappings and packages an identification mark giving the
following particulars:
the ISO Code reference of the country of origin followed by the registra-
tion number of the establishment
and
— it is accompanied by a certificate that conforms to the model laid down
in accordance with the procedure provided for in Article 18 of this
Directive.
B. In accordance with the procedure of Article 18 of this Directive, the
Commission may recognise the health measures applied by a third country
to the production of gelatine for human consumption, as offering guarantees
equivalent to those applied for putting on the market in the Community, if
the third country supplies objective proof in this respect.
When the Commission recognises such equivalence of the health measures
of a third country, it shall adopt in accordance with the same procedure,
the conditions governing the importation of gelatine for human consumption
including the health certificate which must accompany the product.1992L0118 — EN — 01.05.2004 — 014.001 — 26
(1) OJ L 120, 11.5.1994, p. 44.▼A2
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VIII.Modelofcommercialdocumentforrawmaterialdestinedtotheproductionofgelatinefor
humanconsumption
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Section B
SPECIFIC HEALTH CONDITIONS FOR THE COLLAGEN INTENDED
FORHUMANCONSUMPTION
I.General
1. This Section lays down the health conditions for putting on the market and
imports of collagen intended for human consumption.
2. For the purposes of this Section, the definitions of ‘hides and skins’ and
‘tanning’ in section A shall apply.
The following definitions shall also apply:
(a) ‘collagen’ means protein-based product derived from hides, skins and
tendons of animals, including bones in the case of pigs, poultry and fish
only, manufactured using the method set in Part V below.
(b) ‘collagen intended for human consumption’ means collagen intended for
consumption either as food or incorporated into or wrapped around food
or product to be consumed by humans.
3. Collagen intended for human consumption shall comply with the conditions
in Parts II to X below.
II.Establishmentsproducingcollagen
Collagen intended for human consumption shall come from establishments that
fulfil the conditions in Part I of Section A.
III.Rawmaterials andestablishmentssupplyingthem
1. The following raw materials may be used for the production of collagen
intended for human consumption:
(a) hides and skins of farmed ruminant animals;
(b) pig skins, bones and intestines;
(c) poultry skin and bones;
(d) tendons;
(e) wild game hides and skins; and
(f) fishskin and bones.
2. The use of hides and skins submitted to tanning processes is prohibited.
3. The raw materials shall meet the following requirements:
— for the raw materials listed in paragraph 1(a) to (d) above, the require-
ments set in Paragraph4 of Part II of Section A apply;
— for the raw material referred to in paragraph 1(e) above, the requirements
set in Paragraph5 of Part II of Section A apply;
— for the raw materials listed in paragraph 1(a) to (e) above, the require-
ments set in Paragraph6 of Part II of Section A apply, except th at no
raw material shall come from plants degreasing ruminant bones; and
— for the raw material referred to in paragraph 1(f) above, the requirements
set in Paragraph7 of Part II of Section A apply.
4. The collection centres and tanneries supplying the raw material for the
production of collagen intended for human consumption shall be specifically
authorised for the purpose and registered by the competent authorities and
fulfil the requirements set in Paragraph 8 of Part II of Section A.
IV.Transportandstorageoftherawmaterial
1. Transport and storage of the raw material destined for the production of
collagen shall be done in accordance with Part III of Section A.
2. During transportation and at the time of delivery at the collection centres,
tanneries and collagen processing plants, raw materials must be accompanied
by a commercial document in conformity withth e model laid down in Part
IX of this Section.
V.Manufactureofcollagen
1. Collagen must be produced by a process that ensures that the raw material is
subjected to a treatment involving washing, pH adjustment using acid or
alkali followed by one or more rinses, filtration and extrusion; or by an
equivalent process approved by the Commission after consultation of the
appropriate Scientific Committee.1992L0118 — EN — 01.05.2004 — 014.001 — 29
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2. After having been subjected to the process referred to at paragraph 1 above,
collagen may undergo a drying process.
3. Collagen not intended for human consumption may be produced and stored
in the same establishment as collagen intended for human consumption only
if it is produced and stored using exactly the same conditions set in this
Section.
4. The use of preservatives other than those permitted under Community legis-
lation is prohibited.
VI.Finishedproducts
Appropriate measures, including tests shall be carried out to ensure that each
production batchof collagen meets th e microbiological and residues criteria set
in Part V of Section A, but where necessary to achieve desired products such as
collagen-based casings, no moisture and ashlimit sh all apply.
VII.Packaging,storageandtransport
1. Collagen intended for human consumption must be wrapped, packaged,
stored and transported under satisfactory hygiene conditions and, in parti-
cular, fulfil the conditions set in Paragraph 1 of Part VI of Section A.
2. Wrappings and packages containing collagen must bear an identification
mark giving the particulars listed in the first indent of Paragraph 2 of Part
VI of Section A, and carry the words ‘Collagen fit for human consumption’
and the date of preparation and the batch number.
3. During transportation collagen must be accompanied by a commercial docu-
ment, in accordance withArticle 3(A)(9)(a) of Directive 77/99/EEC, bearing
the words ‘Collagen fit for human consumption’ and the date of preparation
and the batch number.
VIII.Import from third countries of collagen and raw materials intended
fortheproductionofcollagenforhumanconsumption
1. Member States shall authorise import into the Community of collagen
intended for human consumption only if it:
(a) comes from third countries listed in Part XIII of the Annex to Commis-
sion Decision 94/278/EC (1);
(b) comes from establishments meeting the conditions laid down in Part II of
this Section;
(c) has been produced from raw material that met the requirements of Parts
III and IV of this Section;
(d) has been manufactured in compliance with the conditions set out in Part
V of this Section;
(e) satisfies the criteria in Part VI and the wrapping, packaging, storage and
transport conditions in Part VII(1) of this Section;
(f) bears on its wrappings and packages an identification mark giving the
particulars specified in the sixth indent of Part VII(A) of Section A; and
(g) is accompanied by a health certificate that conforms to the model laid
down in Part X(a) of this Section.
2. Member States shall authorise import into the Community of the raw mate-
rial listed in Part III(1) of this Section for the production of collagen intended
for human consumption only if:
(a) it comes from third countries listed in Council Decision 79/542/EEC (2)
or in Commission Decision 94/85/EC (3) or in Decision 94/86/EC (4)o r
in Commission Decision 97/296/EC (5), as appropriate; and
(b) a health certificate conforming to the model laid down in Part X(b) of
this Section accompanies each consignment of the raw material.
3. The health certificates referred to in paragraphs 1(g) and 2(b) above shall
consist of one sheet, and shall be completed in at least one official language
of the Member State through which the consignment first enters the Commu-
nity, and in at least one official language of the Member State of destination.1992L0118 — EN — 01.05.2004 — 014.001 — 30
(1) OJ L 120, 11.5.1994, p. 44.
(2) OJ L 146, 14.6.1979, p. 15.
(3) OJ L 44, 17.2.1994, p. 31.
(4) OJ L 44, 17.2.1994, p. 33.
(5) OJ L 122, 14.5.1997, p. 21.
▼M15
4. The Commission may recognise, in accordance with the procedure of Article
18, the health measures applied by a third country for the production of
collagen intended for human consumption as offering guarantees equivalent
to those offered for putting collagen on the market in the Community, if the
third country concerned supplies objective proof in this respect. When the
Commission recognises suchequivalence, it sh all adopt in accordance with
the same procedure, the conditions governing the importation of collagen
for human consumption.1992L0118 — EN — 01.05.2004 — 014.001 — 31
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▼B
ANNEX III
I
CONSOLIDATED VERSION OF ANNEXES A AND B TO DIRECTIVE
89/662/EEC
‘ANNEX A
VETERINARYLEGISLATION
CHAPTER I
— Council Directive 64/433/EEC of 26 June 1964 on health problems affecting
intra-Community trade in freshmeat (OJ No 121, 29. 7. 1964, p. 2012/64).
— Council Directive 71/118/EEC of 15 February 1971 on health problems
affecting trade in freshpoultrymeat (OJ No L 55, 8. 3. 1971, p. 23).
— Council Directive 72/461/EEC of 12 December 1972 on health problems
affecting intra-Community trade in freshmeat (OJ No L 302, 31. 12. 1972,
p. 24).
— Council Directive 77/99/EEC of 21 December 1976 on health problems
affecting intra-Community trade in meat products (OJ No L 26, 31. 1.
1977, p. 85).
— Council Directive 80/215/EEC of 22 January 1980 on animal health
problems affecting intra-Community trade in meat products (OJ No L 47,
21. 2. 1980, p. 4).
— Council Directive 88/657/EEC of 14 December 1988 laying down the
requirements for the production of, and trade in, minced meat, meat in
pieces of less than 100 grams and meat preparations (OJ No L 382, 31. 12.
1988, p. 3).
— Council Directive 89/437/EEC of 20 June 1989 on hygiene and health
problems affecting the production and the placing on the market of egg
products (OJ No L 212, 22. 7. 1989, p. 87).
— Council Directive 91/67/EEC of 28 January 1991 concerning the animal
health conditions governing the placing on the market of aquaculture
animals and products (OJ No L 46, 19. 2. 1991, p. 1).
— Council Directive 91/492/EEC of 15 July 1991 laying down the health
conditions for the production and the placing on the market of live bivalve
molluscs (OJ No L 268, 24. 9. 1991, p. 1).
— Council Directive 91/493/EEC of 22 July 1991 laying down the health
conditions for the production and the placing on the market of fishery
products (OJ No L 268, 24. 9. 1991, p. 15).
— Council Directive 91/494/EEC of 26 June 1991 on animal health conditions
governing intra-Community trade in and imports from third countries of
freshpoultrymeat (OJ No L 268, 24. 9. 1991, p. 35).
— Council Directive 91/495/EEC of 27 November 1991 concerning public
health and animal health problems affecting the production and placing on
the market of rabbit meat and farmed game meat (OJ No L 268, 24. 9.
1991, p. 41).
— Council Directive 92/45/EEC of 16 June 1992 on public health and animal
health problems relating to the killing of wild game and the placing on the
market of wild-game meat (OJ No L 268, 14. 9. 1992, p. 35).
— Council Directive 92/46/EEC of 16 June 1992 laying down the health rules
for the production and placing on the market of raw milk, heat-treated milk
and milk-based products (OJ No L 268, 14. 9. 1992, p. 1).
CHAPTER II
— 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 (with the
exception of pathogens).1992L0118 — EN — 01.05.2004 — 014.001 — 38
▼B
ANNEX B
PRODUCTS NOT SUBJECT TO COMMUNITY HARMONIZATION,
BUT TRADE IN WHICH WOULD BE SUBJECT TO THE CHECKS
PROVIDEDFORBYTHISDIRECTIVE
Other products of animal origin included neither in Annex B to this Directive
nor in the Annex to Directive 90/425/EEC: these products will be defined under
the procedure laid down in Article 18.’
II
CONSOLIDATED VERSION OF ANNEXES A AND B TO DIRECTIVE
90/425/EEC
‘ANNEX A
CHAPTER I
VETERINARYLEGISLATION
Section 1
— Council Directive 64/432/EEC of 26 June 1964 on animal health problems
affecting intra-Community trade in bovine animals and swine (OJ No 121,
29. 7. 1964, p. 1977/64).
— Council Directive 88/407/EEC of 14 June 1988 laying down the animal
health requirements applicable to intra-Community trade in and imports of
deep-frozen semen of domestic animals of the bovine species (OJ No L
194, 22. 7. 1988, p. 10).
— Council Directive 89/556/EEC of 25 September 1989 on animal health
conditions governing intra-Community trade in and importation from third
countries of embyros of domestic animals of the bovine species (OJ No L
302, 19. 10. 1989, p. 1).
— Council Directive 90/426/EEC of 26 June 1990 on the health policy condi-
tions governing the movement of equidae and their import from third
countries (OJ No L 224, 18. 8. 1990, p. 42).
— Council Directive 90/429/EEC of 26 June 1990 laying down the animal
health requirements applicable to intra-Community trade in and imports of
semen of domestic animals of the porcine species (OJ No L 224, 18. 8.1990, p. 62).
— Council Directive 90/539/EEC of 15 October 1990 on animal health condi-
tions governing intra-Community trade in, and imports from third countries
of, poultry and hatching eggs (OJ No L 303, 31. 10. 1990, p. 6).
— Council Directive 90/667/EEC of 27 November 1990 laying down the veter-
inary rules for the disposal and processing of animal waste, for its placing on
the market and for the prevention of pathogens in feedstuffs of animal or
fishorigin and amending Directive 90/425/EEC (OJ No L 363, 27. 12.
1990, p. 51).
— Council Directive 91/67/EEC of 28 January 1991 concerning the animal
health conditions governing the placing on the market of aquaculture
animals and products (OJ No L 46, 19. 2. 1991, p. 1).
— Council Directive 91/68/EEC of 28 January 1991 on animal health condi-
tions governing intra-Community trade in ovine and caprine animals (OJ
No L 46, 19. 2. 1991, p. 19).
— Council Directive 91/628/EEC of 19 November 1991 on the protection of
animals during transport and amending Directives 90/425/EEC and 91/496/
EEC (OJ No L 340, 11. 12. 1991, p. 17).
Section 2
Council Directive 92/65/EEC of 13 July 1992 laying down animal health
requirements governing trade in and imports into the Community of animals,
semen, ova and embryos not subject to animal health requirements laid down
in specific Community rules referred to in Annex A (I) (1) to Directive 90/
425/EEC (OJ No L 268, 14. 9. 1992, p. 54).
— For pathogens:
Council Directive 92/118/EEC of 17 December 1992 laying down animal health
and public health requirements governing trade in and imports into the Commu-
nity of products not subject to the said requirements laid down in specific1992L0118 — EN — 01.05.2004 — 014.001 — 39
▼B
Community rules referred to in Annex A (I) to Directive 89/662/EEC and, as
regards pathogens, to Directive 90/425/EEC.
CHAPTER II
ZOOTECHNICALLEGISLATION
— Council Directive 77/504/EEC of 25 July 1977 on pure-bred breeding
animals of the bovine species (OJ No L 206, 12. 8. 1977, p. 8).
— Council Directive 88/661/EEC of 19 December 1988 on the zootechnical
standards applicable to breeding animals of the porcine species (OJ No L
382, 31. 12. 1988, p. 36).
— Council Directive 89/361/EEC of 30 May 1989 concerning pure-bred
breeding sheep and goats (OJ No L 153, 8. 6. 1989, p. 30).
— Council Directive 90/427/EEC of 26 June 1990 on the zootechnical and
genealogical conditions governing intra-Community trade in equidae (OJ
No L 224, 18. 8. 1990, p. 55).
— Council Directive 91/174/EEC of 25 March1991 laying down zootech nical
and pedigree requirements for the marketing of pure-bred animals (OJ No L
85, 5. 4. 1991, p. 37).1992L0118 — EN — 01.05.2004 — 014.001 — 40
▼B
ANNEX B
ANIMALS ANDPROD UCTS NOT SUBJECT TO HARMONIZATION
BUT TRADE IN WHICH WILL BE SUBJECT TO THE CHECKS
PROVIDEDFORINTHISDIRECTIVE
CHAPTER I
Veterinary legislation — other live animals not listed in Annex A, Chapter I.
CHAPTER II
Veterinary legislation — semen, ova and embryos not listed in Annex A,
Chapter I.’1992L0118 — EN — 01.05.2004 — 014.001 — 41