1994L0065 — EN — 05.06.2003 — 001.001 — 1
This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents
►B COUNCILDIRECTIVE94/65/EC
of14December 1994
laying downthe requirements for the productionandplacing onthe market of minced meat and
meatpreparations
(OJ L 368, 31.12.1994, p. 10)
Amended by:
Official Journal
No page date
►M1Council Regulation (EC) No 806/2003 of 14 April 2003 L 122 1 16.5.2003
Corrected by:
►C1Corrigendum, OJ L 127, 29.4.1998, p. 34 (94/65/EC)
▼B
COUNCILDIRECTIVE94/65/EC
of14December 1994
laying down the requirements for the production and placing on
themarketofmincedmeatandmeatpreparations
THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty establishing the European Community, andin particular Article 43 thereof,
Having regard to the proposal from the Commission (
1),
Having regard to the Opinion of the European Parliament (2),
Having regard to the Opinion of the Economic and Social
Committee (3),
Whereasminced meat and meat preparationsare included in the lis t of
productsin Annex II to the Treaty; whereasthe production of and tradein minced meat and meat preparations constitute an important source ofincome for part of the farming population;
Whereas in order to ensure the rational development of the industry
producing such meat and to increase productivity, public health rulesfor the production and placing on the market of such meat must belaid down at Community level;
Whereasthe laying down of s uch rulesimprovesthe protection of
public health and consequently facilitates the completion of the internal
market;
Whereas, to achieve this purpose, it is necessary to repeal Council
Directive 88/657/EEC of 14 December 1988 laying down the require-
mentsfor the production of, and trade in, minced meat, meat in piecesof less than 100 grams and meat preparations and amending Directives64/433/EEC, 71/118/EEC and 72/462/EEC (
4), and to replace it by this
Directive;
Whereasmeat which hasnot undergone any treatment — other than
cold treatment — iss ubject to the requirementsof Directives64/433/
EEC (5) and 71/118/EEC (6); whereasproductswhich have undergone
treatment modifying the characteristics of fresh meat are regulated byDirective 77/99/EEC (
7); whereasthe production of other products ,
whether they are presented in the form of minced meat or meatpreparations, should as a result be subject to the requirements of thisDirective;
Whereas to take account of consumption habits in some Member
States, and of the risk presented by some of those products if they are
eaten lightly cooked, very strict requirements should be maintained
►
C1for minced meat and meat preparationswhich may be traded; ◄
Whereasthe fundamental criterion which the Community mus t adopt
asregardsthe functioning of the internal market isthat of a high s tan-dard of consumer protection;
WhereasCouncil Directive 79/112/EEC of 18 December 1978 on the
approximation of the lawsof the Member Statesrelating to the label-ling, presentation and advertising of foodstuffs (
8) and Council
Directive 89/396/EEC of 14 June 1989 on indicationsor marksidenti-fying the lot to which a foodstuff belongs (
9) are applicable;1994L0065 — EN — 05.06.2003 — 001.001 — 2
(1) OJ No C 84, 2. 4. 1990, p. 120 and OJ No C 288, 6. 11. 1991, p. 3.
(2) OJ No C 183, 15. 7. 1991, p. 59.
(3) OJ No C 225, 10. 9. 1990, p. 1.
(4) OJ No L 382, 31. 12. 1988, p. 3.
(5) OJ No L 121, 29. 7. 1964, p. 2012/64.
(6) OJ No L 55, 8. 3. 1971, p. 23.
(7) OJ No L 26, 31. 1. 1977, p. 85.
(8) OJ No L 33, 8. 2. 1979, p. 1.
(9) OJ No L 186, 30. 6. 1989, p. 21.
▼B
Whereas a system of approval should be introduced for the establish-
mentswhich meet the health requirementslaid down by thisDirective, together with a Community inspection procedure to ensure
that the conditions for such approval are observed;
Whereas that system should be based on the principle of self-moni-
toring by the establishments;
Whereas health marking of meat products is the best way of satisfying
the competent authority of the place of destination that a consignmentcomplieswith the provis ionsof thisDirective; whereasthe health certi-ficate should be maintained for the purposes of verifying the
destination of certain products;
Whereas the rules, principles and safeguard measures established by
Council Directive 90/675/EEC of 10 December 1990 laying down theprinciplesgoverning the organization of veterinary checkson products
entering 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 (2) should also be applied;
Whereasthe rulesapplicable to importsfrom third countriess hould be
defined;
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,
HAS ADOPTED THIS DIRECTIVE:
CHAPTER I
Article 1
1. ThisDirective laysdown rulesfor the production, placing on the
market in the Union and importing of meat preparationsand mincedmeat.
2. ThisDirective s hall not apply to meat preparationsand minced
meat which are produced in retail shops or in premises adjacent tosales points, with a view to sale there directly to the final consumer,such operations remaining subject to the health checks required by
national rules governing supervision of the retail trade.
3. ThisDirective s hall not apply to mechanically recovered meat for
industrial use which undergoes heat treatment in establishmentsapproved in accordance with Directive 77/99/EEC.
4. National rulesapplicable to the production and placing on the
market of minced meat intended for use as raw material for the manu-facture of the productsreferred to in Article 21 (a) s hall be unaffectedby thisDirective.
Article 2
For the purposes of this Directive:
1. the definitionscontained in Article 2 of Directives64/433/EEC, 71/
118/EEC and 72/462/EEC (
3) shall apply as necessary;
2. the following definitionss hall apply;
(a) minced meat: meat which hasbeen minced into fragmentsor
passed through a spiral-screw mincer;1994L0065 — EN — 05.06.2003 — 001.001 — 3
(1) OJ No L 373, 31. 12. 1990, p. 1.
(2) OJ No L 395, 30. 12. 1989, p. 13.
(3) OJ No L 302, 31. 12. 1972, p. 28.
▼B
(b) meat preparations: meat within the meaning of Article 2 of
Directives64/433/EEC, 71/118/EEC and 92/45/EEC (1), and
meat satisfying the requirements of Articles 3, 6 and 8 of Direc-
tive 91/495/EEC (2) which has had foodstuffs, seasonings or
additivesadded to it or which hasundergone a treatment ins uffi-cient to modify the internal cellular structure of the meat andthus to cause the characteristics of the fresh meat to disappear;
(c) seasonings: salt intended for human consumption, mustard,
spices and aromatic spice extracts, aromatic herbs and aromaticextractsthereof;
(d) production plant: any plant in which minced meat or meat
preparationsare produced:
— which is located in a cutting plant and satisfies the require-
mentsof Chapter I of Annex I to thisDirective,
— which in the case of the production of meat preparations, is
located in an establishment fulfilling the requirements ofChapter III of Annex I to thisDirective,
— which, if it isnot located on the premis esof, or in an annex
to, an establishment approved under Directives 64/433/EEC,
71/118/EEC or 77/99/EEC, fulfilsthe requirementsof point2 of Chapter I or point 2 of Chapter III of Annex I to thisDirective;
(e) trade: trade between Member Stateswithin the meaning of
Article 9 (2) of the Treaty;
(f) competent authority: the central authority of a Member State
competent to carry out veterinary checksor any authority towhich it hasdelegated that power.
CHAPTER II
Placingonthemarketofmincedmeat
Article 3
1. Each Member State shall ensure that only fresh meat obtained
from bovine animals, pigs, sheep or goats and presented in the form
of minced meat, which meetsthe following requirementsistraded:
(a) it must have been prepared from striated muscle (a) — except heart
muscle — which meets the requirements of:
(i) Article 3 of Directive 64/433/EEC; or
(ii) Directive 72/462/EEC;
and hasbeen ins pected in accordance with Directive 90/675/EEC.
In the case of fresh pigmeat, it must furthermore have been exam-
ined for trichinae in accordance with Article 2 of Directive 77/96/EEC (
3) or have undergone cold treatment asreferred to in Annex
IV to that Directive;
(b) it must have been prepared, in accordance with the requirements of
Chapter II of Annex I in a plant which:
(i) meetsthe requirementsof points1, 2 and 3 of Chapter I of
Annex I, and
(ii) has been approved and is included on the list(s) drawn up in
accordance with Article 8 (1);
(c) it must have been inspected in accordance with Chapter V of
Annex I and with Article 8;
d) it must be marked and labelled in accordance with Chapter VI of
Annex I;1994L0065 — EN — 05.06.2003 — 001.001 — 4
(1) OJ No L 268, 14. 9. 1992, p. 35.
(2) OJ No L 268, 24. 9. 1991, p. 41.
(a) Including the adjoining fatty tissues.
(3) OJ No L 26, 31. 1. 1977, p. 67.
▼B
(e) it must have been wrapped, packaged and stored in accordance
with the respective provisions of Chapters VII and VIII of Annex I;
(f) it must be transported in accordance with Chapter IX of Annex I;(g) it must, during transport, be accompanied by:
(i) an accompanying commercial document which must:
— be drawn up by the dispatching establishment,
— bear the veterinary approval number of the approved
production plant and in the case of frozen minced meat,the month and year of freezing in clear,
— for minced meat intended for Finland and Sweden, bear one
of the indicationsprovided for in the third indent ►
C1of
Part IV of Annex IV to Directive 64/433/EEC, ◄
— be kept by the consignee so that it can be produced at the
request of the competent authority. Computer data must beprinted out at the request of the aforesaid authority.
However, at the request of the competent authority in the
Member State of destination, ►
C1a health certificate must
be provided ◄when meat isintended for export to a third
country after mincing. The cost of such certification shall beborne by the operators:
(ii) a health certificate ►
C1in accordance with Annex III, ◄in
the case of minced meat from a production plant situated in arestricted region or area or minced meat to be sent to anotherMember State, after transit through a third country in a sealedlorry.
2. Minced meat must meet the following requirements in addition to
those listed in paragraph 1:
(a) the fresh meat from which it is obtained must:
(i) where it hasbeen frozen or deep-frozen, be obtained from fres h
boned meat which hasbeen s tored for no longer than 18monthsfor beef and veal, 12 monthsfor s heepmeat and s ix
monthsfor pigmeat, after freezing or deep-freezing, in a cold
store approved in accordance with Article 10 of Directive 64/433/EEC. However, the competent authority may authorize theboning of pigmeat and sheepmeat on the spot immediatelybefore mincing where this operation is carried out in satisfac-
tory conditionsof hygiene and quality;
(ii) where it hasbeen chilled, be us ed:
— within no more than six days after slaughter of the animals,
or
— within no more than 15 daysafter s laughter of the animals
in the case of boned, vacuum-packed beef and veal;
(b) the minced meat must have undergone cold treatment within a
period of not more than one hour after portioning and wrapping,except where processes requiring the lowering of the internal
temperature of the meat during production are used;
(c) the minced meat must be packaged and presented in one of the
following forms:
(i) chilled and in this case obtained from meat as described in (a)
(ii) and cooled to an internal temperature below + 2ºC in theshortest time possible.
However, the addition of a limited quantity of frozen meat
satisfying the conditions laid down in (a) (i) shall be authorizedto accelerate the refrigeration proces sprovided that thisaddi-tion is mentioned on the label. In such cases, the periodreferred to above must not exceed one hour;1994L0065 — EN — 05.06.2003 — 001.001 — 5
▼B
(ii) deep-frozen, and in this case obtained from meat as described
in (a) and cooled to an internal temperature below − 18ºC asquickly as possible, in accordance with Article 1 (2) of Direc-
tive 89/108/EEC (
a);
(d) the minced meat must not have been subjected to ionizing radiation
or ultraviolet treatment;
(e) the designations in Section 1 of Annex II, possibly combined with
the name of the species of animal from which the meat wasobtained, may be used on packages only if the requirements setout in Section 1 of Annex II are met for those designations.
3. Minced meat to which not more than 1 % salt has been added
shall be subject to the requirements of paragraphs 1 and 2.
Article 4
1. In order to take account of particular habitsof cons umption and
while ensuring that the health requirements of this Directive are
observed, Member States may authorize the production and placing on
the market of minced meat to be sold in their territory only obtained:
a) from meat ►
C1referred to in Article 2(2)(b); ◄
b) from production plantswhich are approved or regis tered and have
the premises referred to in Annex I;
c) by derogation from
i) point 4 of Chapter VI of Annex I;
ii) Article 3 (1) (f) and (g) and Article 3 (2), except for the first,
second and third indents of Annex II, point 1;
2. Minced meat obtained in accordance with thisArticle mus t not
bear the health mark provided for in Chapter VI of Annex I.
3. A Member State which wishes to make use of the provisions of
paragraph 1 shall notify the Commission of the nature of the deroga-tionsit intendsto grant.
Should the Commission, after consulting the Member State concerned,
consider that the derogations fail to guarantee the health standardprovided for by the Directive, appropriate steps shall be taken in accor-dance with the procedure laid down in Article 20.
Otherwise, the Commission shall inform the other Member States of
the measures notified to it.
CHAPTER III
Placing onthemarketofmeatpreparations
Article 5
1. Meat preparationswithin the meaning of Article 2 (2) (b) may be
traded only if:
(a) they have been prepared from fresh meat, other than meat from
solipeds, which:
(i) complieswith Article 3 of the Directivesreferred to in Article
2 (2) (b);
(ii) in the case of imported meat, complies with Directive 72/462/
EEC or Chapter III of Directives71/118/EEC and 92/45/EECand the requirementslaid down in Articles3, 6 and 8 of Direc-tive 91/495/EEC, or Chapter 11 of Annex I to Directive 92/
118/EEC (
1) and be inspected in accordance with Directive 90/
675/EEC. In the case of fresh meat from pigs, it must havebeen examined for trichinae in accordance with Article 2 of1994L0065 — EN — 05.06.2003 — 001.001 — 6
(a) OJ No L 40, 11. 2. 1989, p. 34.
(1) OJ No L 62, 15. 3. 1993, p. 46.
▼B
Directive 77/96/EEC or have undergone cold treatment in
accordance with Annex IV to that Directive;
(b) they have been prepared in one of the establishments referred to in
Article 2 (2) (d) which:
(i) meetsthe requirementsof Chapter III of Annex I; and
(ii) has been approved and is included on the list(s) drawn up in
accordance with Article 8 (1).
(c) they have been obtained from meat which, if it hasbeen deep-
frozen, must be used within a maximum period after slaughter of18 monthsfor beef and veal, 12 monthsfor s heepmeat and goat-meat, poultrymeat, rabbit meat and farmed game meat and sixmonths for meat from other species;
However, the competent authority may authorize boning of pigmeat
and sheepmeat on the spot immediately before preparation,
provided this operation is carried out in satisfactory conditions of
hygiene and quality.
(d) they have been packaged and where they are to be placed on the
market:
(i) chilled, they must be cooled as quickly as possible to an
internal temperature below + 2ºC for meat preparationsobtained from minced meat, + 7ºC for preparationsobtainedfrom fresh meat, + 4ºC for preparations of poultry meat and+ 3ºC for preparationscontaining offal;
►
C1(ii) deep-frozen ◄, they must be cooled to an internal
temperature below − 18ºC asquickly aspos s ible, in accordancewith Article 1 (2) of Directive 89/108/EEC.
2. Meat preparationsmus t fulfil the following requirementsin addi-
tion to those laid down in paragraph 1:
(a) they must have been prepared in accordance with Chapter IV of
Annex I;
(b) they must have been inspected in accordance with Article 8 and
Chapter V of Annex I;
(c) they must be marked and labelled in accordance with Chapter VI of
Annex I;
(d) they must be wrapped and packaged in accordance with the
requirementsof Chapter VII of Annex I and s tored in accordance
with Chapter VIII of Annex I;
(e) they must be transported in accordance with Chapter IX of Annex
I;
(f) they must during transport be accompanied by a health certificate
in accordance with Annex V, which must be kept by the consigneefor a period of not less than one year for presentation on request tothe competent authority.
3. With the exception of fresh sausages and sausage meat, meat
preparationsobtained from minced meat of s laughter animalsmay betraded only if they fulfil the requirementsof Article 3.
4. Pending the possible introduction of Community rules on ioniza-
tion, meat preparations must not have been subjected to ionizingradiation. This provision shall not affect national rules applicable toionization for medical purposes.
5. Member Statesmay, for the purpos e of their approval, grant
manufacturing plantsmanufacturing meat preparationswithout anindustrial structure or production capacity derogations from the require-mentsof Chapter I of Annex I to thisDirective and from thos e ofChapter I of Annex B to Directive 77/99/EEC and of Chapter I (2) (a)
(asregardstaps ) and point 11 (asregardslockers ) of ►
C1Annex I to
Directive 64/433/EEC. ◄
Moreover, derogationsmay be granted from point 7 of Chapter I of
Annex B to Directive 77/99/EEC asregardsroomswhere raw materials1994L0065 — EN — 05.06.2003 — 001.001 — 7
▼B
and finished products are stored. However, in this case, the establish-
ment must have at least:
(i) a room or secure place for the storage of raw materials, if such
storage takes place;
(ii) a refrigerated room or secure place for the storage of finished
products, if such storage takes place.
Article 6
1. In order to take account of particular habitsof cons umption and
while ensuring that the health requirements of this Directive are
observed, Member States may authorize the production and►
C1placing on the market of meat preparationsto be s old ◄in their
territory only obtained:
(a) from meat ►C1referred to in Article 2(2)(b); ◄
(b) from production plantswhich are approved or regis tered and have
the premises ►C1referred to in Chapter III of Annex I; ◄
(c) by derogation from:
— points(b) and (d) of Chapter IV of Annex I,
— Article 5 (1) (c) and (d),
— point 4 of Chapter VI of Annex I,— Article 5 (2) (e) and (f) and Article 5 (3).
2. Meat preparationsobtained in accordance with paragraph 1 mus t
not bear the health mark provided for in Chapter VI of Annex I.
3. A Member State which wishes to make use of the provisions of
paragraph 1 shall notify the Commission of the nature of the deroga-tionsit intendsto grant.
Should the Commission, after consulting the Member State concerned,
consider that the derogations fail to guarantee the health standardprovided for by the Directive, appropriate steps shall be taken in accor-
dance with the procedure laid down in Article 20.
Otherwise, the Commission shall inform the other Member States of
the measures notified to it.
CHAPTER IV
Commonprovisions
Article 7
1. Member States shall ensure that the operator or manager of the
production plant takes all necessary measure to ensure that, at all stages
of production, the provisions of this Directive are complied with.
To that end, the said persons must comply with the requirements of
Articles3 and 6 of Directive 93/43/EEC (1) and, in addition, constantly
carry out their own checksin compliance with the following principles :
— checking raw materials entering the establishment to ensure compli-
ance with the criteria in AnnexesII and IV in res pect of the finalproduct,
— checking cleaning and disinfection methods,
— taking samples for analysis in a laboratory recognized by the
competent authority,
— keeping written or recorded track of the information required in
accordance with the preceding indent with a view to submitting it
to the competent authority. The results of the different checks andtests shall in particular be kept for a period of at least two years,save in the case of chilled products for which this period may bereduced to six months after the use-by date of the product,1994L0065 — EN — 05.06.2003 — 001.001 — 8
(1) OJ No L 175, 19. 7. 1993, p. 2.
▼B
— providing guaranteesfor the competent authority asregardsthe
administration of the health marking, particularly the labels bearingthe health mark,
— when the laboratory examination or any other information at their
disposal reveals that there is a health risk, informing the competentauthority thereof,
— in the event of an immediate human health risk, withdrawing from
the market the quantity of productsobtained in technologicallysimilar conditions and likely to present the same risk. This with-drawn quantity must stay under the supervision and control of thecompetent authority until it is destroyed, used for purposes other
than human consumption or, after authorization by the competent
authority, reprocessed in an appropriate manner to ensure its safety.
2. For inspection purposes, the operator or manager of the establish-
ment must ensure that the packaging of the products bears a clear andlegible indication of the temperature at which the productsmus t betransported and stored, as well as the use-by date for deep-frozenproducts or the minimum conservation date for chilled products.
The operator or manager of the establishment must arrange or establish
a staff training programme enabling workers to comply with conditionsof hygienic production adapted to the production structure, unless suchstaff already have adequate qualifications attested by diplomas.
The competent authority responsible for the establishment must be
involved in the planning and implementation of the programme.
3. Microbiological tests must be carried out on minced meat as
referred to in Article 3 and minced-meat preparationsasreferred to inArticle 5 on a daily basis and at least weekly on other minced meat and
meat preparations. These tests must be carried out either in the produc-
tion plant, if it isrecognized by the competent authority, or in anapproved laboratory.
The sample taken for analysis must comprise five units and be repre-
sentative of daily production. Samples of meat preparations must betaken from deep in the muscle after the skin has been cauterized.
The microbiological checksmus t be carried out in accordance with
proven methods which are scientifically recognized, in particular thoselaid down in Community directives or other international standards.
The results of the microbiological checks must be assessed using the
criteria for interpretation laid down in Annex II in the case of mincedmeat and meat preparationsobtained from minced meat of s laughteranimals, except for fresh sausages and sausage meat, in accordancewith the criteria in Annex IV in the case of other meat preparations.
In the event of disputes arising in trade, Member States shall recognize
the EN methodsasreference methods .
4. The requirements as regards self-monitoring must have been
drawn up in conjunction with the competent authority, which mustregularly monitor compliance therewith.
5. The arrangementsfor implementing thisArticle, in particular in
cases where paragraph 1 applies, shall be detailed in accordance withthe procedure laid down in Article 20.
Article 8
1. Each Member State shall draw up a list of establishments produ-
cing minced meat or meat preparations, making a distinction betweenthose approved under Articles 3 and 5 and those registered under Arti-cles 4 and 6. It shall send a list of the production plants approved underArticles 3 and 5 to the other Member States and to the Commission.
It shall assign to each production plant the approval number of the
establishment approved in accordance with Directives 64/433/EEC,71/118/EEC, 77/99/EEC, 91/495/EEC or 92/45/EEC with an indicationthat it hasbeen approved for the production of minced meat or meat1994L0065 — EN — 05.06.2003 — 001.001 — 9
▼B
preparations, and to each independent production unit an individual
approval number.
A single approval number ma be given to:
(i) an establishment making preparations obtained from or with raw
materialscovered by more than one of the Directivesreferred to
in the following subparagraph:
(ii) an establishment located on the same site as an establishment
approved in accordance with Article 2 of one of the above Direc-tives.
Production plantsthusapproved s hall be entered either for the produc-
tion of minced meat or for that of meat preparationsin a s eparatecolumn in the list of establishments referred to in Article 10 of Direc-tive 64/433/EEC, Article 6 of Directive 71/118/EEC, Article 8 ofDirective 77/99/EEC or that referred to in Article 7 of Directive 92/
45/EEC and, in the case of an independent production unit, on a sepa-
rate list drawn up according to the same criteria.
The competent authority shall not approve an establishment unless it is
satisfied that it complies with this Directive with respect to the natureof its activities. However, if an establishment seeking approval
pursuant to this Directive forms an integral part of an establishment
approved under Directives64/433/EEC, 71/118/EEC, 79/99/EEC or92/45/EEC, the premises, equipment and installations for staff and,generally, all premises where there is no risk of contamination of rawmaterials or unwrapped products may be common to both establish-ments.
2. Production plantsmus t remain under the control of the competent
authority, which shall inspect and monitor them with the followingfrequency:
— for production plants attached to cutting plants: same frequency as
for the said cutting plants,
— for approved production plantsproducing the productsreferred to in
Article 3: at least once a day during the production of minced meat,
— for other production plants: the need for permanent or periodic
presence of the competent authority in a given establishment willdepend on the size of the establishment, the type of product manu-factured, risk assessment and the guarantees offered in accordancewith the second subparagraph of Article 7 (1).
The competent authority must at all times have free access to all parts
of establishments in order to ensure that this Directive is beingcomplied with and, where there isdoubt asto the origin of meat, toaccounting documents which enable the slaughterhouse or establish-ment of origin of the raw material to be traced and, asregards
compliance with the criteria laid down in Annexed II and IV, to the
results of the self-monitoring provided for in Article 7, including theresult of checks on raw materials. In the case of computer data, theymust be printed out at the request of the competent authority.
The competent authority must regularly analyse the results of the
checks provided for in Article 7. It may, on the basis of these analyses,
conduct further examinationsat all s tagesof production or on theproducts.
The nature of these checks, their frequency and the methods of
sampling and of carrying out microbiological examinations shall be
established under the procedure laid down in Article 20.
The results of these analyses shall be set out in a report, the conclu-
sions or recommendations of which shall be notified to the operator ormanager of the establishment, who shall be obliged to rectify the short-
comingsnoted with a view to improving hygiene.
The competent authority may, when carrying out the said checks, be
helped by assistants who hold the professional qualifications specifiedin Annex III to Directive 64/433/EEC or in Annex III to Directive 71/118/EEC.1994L0065 — EN — 05.06.2003 — 001.001 — 10
▼B
3. Where the competent authority finds, in the course of checks
carried out in accordance with Chapter V of Annex I, that there isrepeated non-compliance during self-monitoring with the criteria laid
down in Annexes II and IV, it shall intensify the measures for moni-
toring the production of the establishment in question, and may seizethe labelsand other itemsbearing the health mark referred to inChapter VI of Annex I.
If, after the expiry of 15 days, the output from production plants still
fails to meet the above standards, the competent authority shall take
all appropriate measures to make good the shortcomings noted and
shall if necessary require products from the establishment in questionto undergo heat treatment. If these measures are not adequate, theestablishment's approval shall be suspended.
4. Where the competent authority findsan obviousfailure to comply
with the hygiene ruleslaid down by thisDirective or obs taclesto anadequate health inspection:
(i) it shall be empowered to act in respect of the use of equipment or
premises and to take any requisite measures which may go as far asreducing the rate of production or temporarily suspending theproduction process;
(ii) where these measures or the measures provided for in the final
indent of Article 7 (1) have proved insufficient to remedy the situa-
tion, it shall temporarily suspend approval, if appropriate, for the
type of production in question.
If the operator or manager of the establishment does not make good the
shortcomings noted within the period fixed by the competent authority,the latter shall withdraw approval.
The competent authority in question shall in particular be obliged to
comply with the conclusions of any check carried out in accordancewith Article 9.
The other Member States and the Commission shall be informed of the
suspension or withdrawal of approval.
5. In the event of repeated shortcomings, checks shall be increased
and, where appropriate, labels, seals or other items bearing the healthmark shall be removed.
6. The arrangementsfor implementing thisArticle, in particular
details of help by assistants, shall be adopted in accordance with theprocedure laid down in Article 20.
Article 9
Experts from the Commission may, in so far as is necessary for the
uniform application of thisDirective and in cooperation with thecompetent authorities, make on-site checks. To do this, they may
verify, by checking a representative percentage of production plants,
whether the competent authoritiesare, in a uniform manner, ens uringthat such plants are complying with the provisions of this Directive,and in particular with Article 7 (self-monitoring).
These checks may be carried out when other checks are being made by
Commission experts pursuant to Community legislation.
The Commission shall inform the Member States of the results of the
checkscarried out.
A Member State in whose territory a check is being carried out shall
give all the necessary assistance to the experts in carrying out theirduties.
The general provisions for applying this Article — in particular those
aimed at regulating proceduresfor cooperation with national authorities— shall be adopted in accordance with the procedure laid down inArticle 20.1994L0065 — EN — 05.06.2003 — 001.001 — 11
▼B
Article 10
The provisions of Council Directive 89/662/EEC of 11 December 1989
concerning veterinary checksin intra-Community trade with a view to
the completion of the internal market shall apply, in particular withrespect to the organization of and the action to be taken on the checkscarried out by the Member State of destination and the safeguardmeasures to be applied.
Article 11
Any addition of additivesto the minced meat or meat preparations
covered by thisDirective s hall take place in compliance with Directive94/36/EEC (
1).
Article 12
1. Without prejudice to the specific provisions of this Directive, the
competent authority shall, where it is suspected that the provisions of
thisDirective have not been complied with or there isdoubt astowhether the productsreferred to in Article 1 are fit for cons umption,carry out any checksit deemsappropriate.
2. Each Member State shall determine the penalties to be applied in
the event of infringement of the provisions of this Directive.
CHAPTER V
Provisions applicable to imports into the Community of meat
preparationsandmincedmeat
Article 13
I. Member States shall ensure that imports of minced meat satisfying
the requirementsof Article 3 which hasbeen deep-frozen at theproduction plant of origin ►
C1and meat preparations
satisfying ◄the requirementsof Article 5 which have been deep-
frozen at the production plant of origin are not authorized unless
they meet the requirementsof thischapter.
A. The guaranteesprovided by the production plant of origin and
confirmed by the competent authority of the third countryregarding compliance with the requirementslaid down for the
placing on the market of productsof Community origin obtained
in accordance with Articles3 and 5 mus t be approved in accor-dance with the procedure laid down in Article 20.
B. For the purposes of uniform application of A, the provisions of
the following paragraphss hall apply.
1. In order to be imported into the Community, deep-frozen
minced meat asreferred to in Article 3 and deep-frozen
meat preparationsasreferred to in Article 5 mus t:
(a) come from third countriesor partsof third countriesfrom
which importsare not prohibited on animal healthgroundsin accordance with Directive 91/494/EEC (
2),
92/118/EEC, 72/462/EEC and 92/45/EEC;
(b) come from a third country on the lists drawn up in accor-
dance with the Directivesgoverning health and animalhealth aspects to be complied with for imports of meat
used in meat preparations and offering the guarantees
provided for in thisDirective;
(c) be accompanied by the animal and public health certifi-
cate which isto be drawn up in accordance with the
procedure laid down in Article 20 supplemented by adeclaration signed by the official veterinarian to the effect1994L0065 — EN — 05.06.2003 — 001.001 — 12
(1) OJ No L 22, 27. 1. 1994, p. 43.
(2) OJ No L 268, 24. 9. 1991, p. 35.
▼B
that thisminced meat ►C1and these meat
preparations ◄fulfil respectively the requirements laid
down in Articles 3 and 5, come from establishments
offering the guaranteesprovided for in Annex I, and
have been deep-frozen at the production plant of origin.
2. The following shall be established in accordance with the
procedure laid down in Article 20:
(a) a Community list of establishments which satisfy the
requirementsin (b). Pending the compilation of that lis t,
Member Statesare authorized to maintain the controls
provided for in Article 11 (2) of Directive 90/675/EECand the national health certificate required for establish-mentswhich have been the s ubject of national approval;
(b) the specific conditions relating to the requirements of this
Directive, other than those enabling meat to be excludedfrom human consumption in accordance with Directive64/433/EEC and 71/118/EEC. Such conditionsand guar-
antees may not be less stringent than those laid down in
Articles3 and 5.
Pending the decisions referred to in (a) and (b), imports from
establishments approved under Directive 72/462/EEC withrespect to which the competent authorities are able to guar-antee that the requirementsof thisDirective are compliedwith, may be authorized asfrom the date laid down in Article
22.
3. Experts from the Commission shall, in cooperation with the
competent authoritiesof the Member States , carry out on-
the-spot inspections to check:
(a) the guaranteesgiven by the third country regarding the
conditionsof production and placing on the market;
(b) whether the conditionsof paragraphs1 and 2 are fulfilled.The experts from the Member States responsible for these
inspections shall be appointed by the Commission, acting ona proposal from the Member States.
These inspections shall be made on behalf of the Community,
which shall bear the cost of any expenditure in this connec-tion. The frequency of and procedure for these inspections
shall be determined in accordance with the procedure laid
down in Article 20.
4. Pending the organization of the inspections referred to in
paragraph 3, national rulesapplicable to ins pection in thirdcountries shall continue to apply, subject to notificationthrough the Standing Veterinary Committee of any failure tocomply with hygiene rules found during these inspections.
II. Under the procedure laid down in Article 19, derogationsmay be
made from the requirementsof thisArticle.
Article 14
The lists provided for in Article 13 (I) (B) (2) may include only third
countriesor partsof third countries :
(a) from which importsare not prohibited purs uant to Articles9 to 12
of Directive 91/494/EEC and Articles14, 17 and 20 of Directive72/462/EEC;
(b) which, in view of their legislation and the organization of their
veterinary services and of their inspection services, the powers ofsuch services and the supervision to which they are subject, have
been recognized, in accordance with Article 3 (2) of Directive 72/
462(EEC) of Article 9 (2) of Directive 91/494/EEC, ascapable ofguaranteeing and supervising the implementation of their legisla-tion in force, or the veterinary services of which are able toguarantee that health requirements at least equivalent to those laiddown in Articles3 and 5 are being complied with.1994L0065 — EN — 05.06.2003 — 001.001 — 13
▼B
Article 15
1. Member States shall ensure that deep-frozen minced meat as
referred to in Article 3 and deep-frozen meat preparationsasreferred
to in Article 5 are imported into the Community only if they:
— are accompanied by the certificate provided for in Article 13 (1)
(B) (1) (c),
— have satisfied the checks required by Directive 90/675/EEC.
2. Pending the establishment of detailed rules for implementing this
chapter:
— the import of minced meat remainsprohibited,
— the national rulesapplicable to importsof meat preparationsfrom
third countriesfor which s uch requirementshave not been adopted
at Community level shall continue to apply, provided that they arenot more favourable than those laid down in Article 5,
— importsmus t take place under the conditionslaid down in Article
11 of Directive 90/675/EEC.
Article 16
The principlesand ruleslaid down in Directive 90/675/EEC s hall
apply, with particular reference to the organization of and follow-upto the inspections to be carried out by the Member States and the safe-guard measures to be implemented.
Pending implementation of the decisions provided for in Article 8 (3)
of Directive 90/675/EEC, importsmus t take place in accordance withArticle 11 (2) that Directive.
CHAPTER VI
Finalprovisions
Article 17
►C11. The following paragraph 5 shall be added to Article 5 of
Directive 71/118/EEC:
‘5. Member States ◄shall ensure that mechanically recovered
meat may be traded only if it hasprevious ly undergone heat treat-
ment in accordance with Directive 77/99/EEC in the establishment
of origin or any other establishment designated by the competentauthority.’
2. The following paragraph 4 shall be added to Article 6 of Direc-
tive 91/495/EEC:
‘4. Member States shall ensure that mechanically recovered
meat may be traded only if it hasprevious ly undergone heat treat-
ment in accordance with Directive 77/99/EEC in the establishment
of origin or any other establishment designated by the competentauthority.’
Article 18
1. The provisions of the Annexes shall not apply to production
plants situated on certain islands of the Hellenic Republic or in certainFrench Overseas Departments and territories where the production ofsuch establishments remains exclusively reserved for local consump-
tion.
2. The arrangementsfor applying paragraph 1 s hall be adopted in
accordance with the procedure provided for in Article 20.
Under the same procedure it may be decided to amend paragraph 1
with a view to the progressive extension of Community standards toall production plants situated in the abovementioned islands and partsof territories.1994L0065 — EN — 05.06.2003 — 001.001 — 14
▼B
Article 19
The Annexess hall be amended by the Council acting by a qualified
majority on a proposal from the Commission, in particular to adapt
them to technological and scientific progress.
Article 20
1. The Commission shall be assisted by the Standing Committee on
the Food Chain and Animal Health set up pursuant to Article 58 ofRegulation (EC) No 178/2002 (
1).
2. Where reference ismade to thisArticle, Articles5 and 7 of Deci-
sion 1999/468/EC (2) shall apply.
The period laid down in Article 5(6) of Decision 1999/468/EC shall be
set at three months.
3. The Committee shall adopt its Rules of Procedure.
Article 21
The Council, acting by a qualified majority on a proposal from the
Commission, shall before 1 January 1996 lay down the health rules
applicable to:
(a) the production and placing on the market of sausage meat intended
for the subsequent production of a meat-based product;
(b) the production and use of mechanically recovered meat.
Article 22
Member States shall bring into force the laws, regulations and admin-
istrative provisions necessary to comply with this Directive before 1
January 1996. They shall forthwith inform the Commission thereof.
When Member States adopt these measures, they shall contain a refer-
ence to this Directive or shall be accompanied by such reference on theoccasion of their official publication. The methods of making suchreference shall be laid down by Member States.
The Member States shall communicate to the Commission the main
provisions of national law which they adopt in the field covered bythisDirective.
Article 23
Directive 88/657/EEC shall be repealed with effect from 1 January
1996.
Article 24
This Directive is addressed to the Member States.1994L0065 — EN — 05.06.2003 — 001.001 — 15
(1) OJ L 31, 1.2.2002, p. 1.
(2) OJ L 184, 17.7.1999, p. 23.▼M1
▼B
▼B
ANNEX I
CHAPTER I
Special conditions for the approval of establishments producing minced
meat
1. Producion plantswithin the meaning of Article 2 (2) (d).
Over and above compliance with the conditionslaid down in Annex I, Chap-
ters I and III, to Directive 64/433/EC, production plants must have at least:
(a) a room for mincing and wrapping separate from the cutting room and
equipped with a recording thermometer or recording telethermometer.
However, the competent authority may authorize the mincing of meat in
the cutting room provided that the mincing iscarried out in s pecific area
that isclearly s eparate;
(b) a room for packaging, unless the conditions laid down in point 63 of
Chapter XII of Annex I to Directive 64/433/EEC are fulfilled;
(c) a room or cabinets for storing salt;
(d) refrigeration equipment enabling the temperatureslaid down in this
Directive to be adhered to.
2. Over and above the general conditionslaid down in Chapter I of Annex A to
Directive 77/99/EEC, independent production units must have at least:
(a) roomsin accordance with point 1 of Chapter I of Annex B to Directive
77/99/EEC; and
(b) roomsasdes cribed in point 1.a of thischapter.
3. The ruleslaid down in Chapter V of Annex I to Directive 64/433/EEC s hall
apply as regards the hygiene of the staff, premises and equipment in the
establishments.
Staff engaged in the manual preparation of minced meat must in addition
wear masks covering the mouth and nose. The competent authority may
also oblige staff to wear smooth, moisture-proof gloves, either for once-only
use or capable of being cleaned and disinfected.
CHAPTER II
Conditionsfortheproductionofmincedmeat
1. Meat must be examined before mincing or cutting up, in accordance with
Article 7. All soiled and suspect parts shall be removed and condemned
before the meat isminced.
2. Minced meat may not be obtained from scrap cuttings, scrap trimmings or
from mechanically recovered meat.
In particular, it may not be prepared from the meat referred to in Article 5 of
Directive 64/433/EEC or from meat from the following partsof bovine
animals, pigs, sheep or goats: muscles from the head, with the exception of
the masseters, and the non-muscular part of the linea alba, the carpus and
tarsus region and bone scrapings. The muscles of the diaphragm — after
removal of serosa — and of the masseters may be used only after an investi-
gation for cysticercosis has been carried out. The fresh meat must not contain
any bone fragments.
Where the operationscarried out from the time when the meat entersthe
room referred to in Chapter I to the time when the finished product under-
goesthe chilling or deep-freezing proces sare performed within a maximum
period of one hour, the internal temperature of the meat must be no higher
than +7 ºC and the temperature of the production premises must be no higher
than +12 ºC. The competent authority may authorize a longer time limit in
individual cases where the addition of salt justifies this on technical grounds,
provided that health rulesare not affected by that derogation.
Where the duration of these operations is over one hour or over the period
authorized by the competent authority in accordance with the preceding
subparagraph, the fresh meat may not be used until the internal temperature
of the meat hasbeen reduced to a maximum of +4 ºC.
3. Minced meat may be deep-frozen only once.4. Immediately after production the minced meat must be hygienically wrapped
and, after packaging, be cooled to and stored at the temperatures laid down
in Article 3 (2) (c).1994L0065 — EN — 05.06.2003 — 001.001 — 16
▼B
CHAPTER III
Special conditions for the approval of establishments producing meat
preparations
1. Production plants within the meaning of Article 2 (2) (d) must have premises
which at least meet the requirements of:
(a) ChaptersI and III of Annex I to Directive 64/433/EEC; or
(b) ChaptersI and III of Annex I to Directive 71/118/EEC; or
(c) ChaptersI and IV, point 1, of Annex I to Directive 92/45/EEC;
aswell ashaving:
— a room separate from the cutting room for the production of meat
preparations, the addition of other foodstuffs and wrapping, equipped
with a recording thermometer or recording telethermometer.
However, the competent authority may authorize the production of meat
preparationsin the cutting room provided that the production iscarried
out on a specific area that is clearly separate. The addition of seasonings
to whole poultry carcasses may be authorized in a specific room that is
clearly separate from the slaughter premises,
— a room for packaging, unless the conditions laid down in point 63 of
Chapter XII of Annex I to Directive 64/433/EEC or point 74 of Chapter
XIV of Annex I to Directive 71/118/EEC or point 5 of Chapter VIII of
Annex I to Directive 92/45/EEC are fulfilled,
— a room for storing seasonings and other cleaned foodstuffs ready for use,— refrigerated roomsfor the s torage of:
— fresh meat as referred to in Article 5 (1) (a),
— meat preparations,
— refrigeration equipment enabling the temperatureslaid down in this
Directive to be adhered to.
2. Independent production unitsmus t meet the requirementsof Chapter I of
Annex A and Chapter I of Annex B to Directive 77/99/EEC.
3. The ruleslaid down in Chapter V of Annex I to Directives64/433/EEC or
71/118/EEC or those of Chapter II of Directive 92/45/EEC shall apply by
analogy as regards the hygiene of the staff, premises and equipment in the
establishments.
Staff engaged in the manual production of meat preparations must also wear
masks covering their noses and mouths. The competent authority may also
require such staff to wear smooth, moisture-proof gloves, either or once-
only use or capable of being cleaned and disinfected.
CHAPTER IV
Specialrequirementsfortheproductionofmeatpreparations
Over and above compliance with the general requirementsof Chapter III, and
depending on the type of production concerned:
(a) the production of meat preparationsmus t take place under conditionsof
temperature control;
(b) meat preparations must be wrapped in dispatch units in such a way as to
obviate any risk of contamination;
(c) meat preparationsmay be deep-frozen only once and may be traded only
within a period not exceeding 18 months;
(d) meat preparations must, immediately after the production process, be
wrapped in accordance with Chapter VII and, after packaging, be cooled to
the relevant temperature laid down in Article 5 (1) (d).
CHAPTER V
Inspection
1. Production plantswhich produce minced meat and meat preparationss hall be
subject to monitoring by the competent authority, which must ensure that the
requirementsof thisDirective are met and in particular mus t:
(a) check:
(i) the cleanliness of the premises and equipment and staff hygiene;
(ii) the efficacy of the checks carried out by the establishment, in accor-
dance with Article of thisDirective, in particular by examining the
results and taking samples;1994L0065 — EN — 05.06.2003 — 001.001 — 17
▼B
(iii) the microbiological and hygienic condition of the minced meat and
the meat preparations;
(iv) the appropriate health marking of the minced meat and the meat
preparations;
(v) storage and transport conditions;
(b) within the framework of the official checks, take any samples required
for laboratory tests to confirm the results of the self-monitoring;
(c) make any other checks it considers necessary to ensure compliance with
this Directive, it being understood that the results of the microbiological
tests must be evaluated by the competent authority on the basis of the
criteria laid down in Annex II for minced meat and in Annex IV for
meat preparations.
2. The competent authority must have free access at all times to the cold stores
and all working premises to check that these provisions are being strictly
complied with.
CHAPTER VI
Markingandlabelling
1. Minced meat and meat preparationsmus t be marked on the wrapping or
packaging with a health mark.
2. Only minced meat obtained in accordance with Article 3 and meat prepara-
tionsobtained in accordance with Article 5 and produced in a production
plant approved in accordance with Article 8, may be given the Community
health mark. That health mark must correspond:
(a) to point 50 of Chapter XI of Annex I to Directive 64/433/EEC for
minced meat;
(b) for meat preparations:
(i) of fresh meat of slaughter animals or farmed game meat, to point 50
of Chapter XI of Annex I to Directive 64/433/EEC;
(ii) of poultrymeat or small feathered or furred farmed game, to point
66 of Chapter XII of Annex I to Directive 71/118/EEC;
(iii) of killed game, to point 2 of Chapter VII of Annex I to Directive
92/45/EEC.
3. Where minced meat or meat preparationsare produced in an independent
production unit, the health mark must include the approval number assigned
by the competent authority pursuant to Article 8 (1).
4. Without prejudice to Directive 79/112/EEC, in the case of meat preparations
the following information must be visibly and legibly displayed for inspec-
tion purposes on the packaging, where it is not clear from the sales
description or from the list of ingredients in accordance with Directive 79/
112/EEC: the species from which the meat was obtained and, in the case of
a mixture, the percentage of each species and, for packaging not intended for
the final consumer, the date of preparation.
In the case of minced meat and meat preparations made from minced meat
except for fresh sausages and sausage meat bearing the healthmark provided
for in this chapter, the labelling must also display the following words:
— ‘percentage of fat under …’,
— ‘Collagen: meat protein ratio under …’.
CHAPTER VII
Wrappingandpackaging
1. Packaging (for example packing cases, paperboard boxes) must fulfil all rules
of hygiene, and in particular:
— must not alter the organoleptic characteristics of the minced meat or meat
preparations,
— must not be capable of transmitting to the minced meat or meat prepara-
tions substances harmful to human health,
— must be strong enough to ensure effective protection of the minced meat
or meat preparationsduring trans port and handling.
2. Packaging must not be reused for minced meat or meat preparations unless it
is made of corrosion-resistant materials which are easy to clean and has been
previously cleaned and disinfected.
3. Wrapped minced meat or meat preparationsmus t be packaged.1994L0065 — EN — 05.06.2003 — 001.001 — 18
▼B
4. However, when wrapping fulfilsall the protective conditionsof packaging it
need not be transparent and colourless and placing in a second container is
not necessary provided that the other conditions of point 1 above are
fulfilled.
CHAPTER VIII
Storage
1. Minced meat and meat preparationsmus t be chilled immediately after wrap-
ping and/or packaging. Minced meat must be stored at the temperatures
indicated in Article 3 (2) (c) and meat preparationsat the temperaturesindi-
cated in Article 5 (1) (d).
2. Minced meat and meat preparationsmay be deep-frozen only in roomsof the
production establishment or independent production unit or in approved cold
stores.
3. In cold stores, minced meat and meat preparations may be stored together
with other foodstuffs only if it is ensured by means of packaging that the
minced meat or meat preparationscannot be affected unfavourably.
CHAPTER IX
Transport
1. Minced meat and meat preparations must be dispatched in such a way that
during transport they are protected from anything liable to contaminate
them or to affect them unfavourably, having regard to the duration and
conditions of transport and to the means of transport employed. In particular,
vehicles used to transport minced meat and meat preparations must be
equipped in such a way as to ensure that the temperatures laid down in this
Directive are not exceeded during transport and they must be equipped with a
recording thermometer to record that the latter requirement isfulfilled.
2. Member Statesmay, by way of derogation from paragraph 1, authorize the
transport of meat preparations originating in the establishments referred to
in Article 5 (5) at temperatureshigher than thos e laid down in thisDirective
from a production plant or independent production unit to nearby retail
premises or local communities, provided that such transportation takes not
more than one hour.
3. In the case of transit through a third country and where the production plant
is situated in an area subject to restrictions for animal health reasons, the
means of transport must remain sealed.1994L0065 — EN — 05.06.2003 — 001.001 — 19
▼B
ANNEX II
COMPOSITIONCRITERIAANDMICROBIOLOGICALCRITERIA
I.Compositioncriteria checkedonthebasisofadailyaverage
Fat contentCollagen: meat protein
ratio
— lean minced meat ≤7% ≤12
— minced pure beef ≤20 % ≤15
— minced meat containing pigmeat ≤30 % ≤18
— minced meat of other species ≤25 % ≤15
II.Microbiological criteria
Production plants and independent production units must ensure that, during
the checksprovided for in Article 7 (3) and in accordance with the methods
of interpretation set out below, minced meat complies with the following
criteria:
M(a)m (b)
Aerobic mesophile bacteria 5 × 106/g 5 × 105/g
n(c)=5 ;c(d)=2
Escherichia coli 5×1 02/g 50/g
n = 5; c = 2
Salmonella absence in 10 g
n = 5; c = 0
Staphylococcus aureus 5×1 03/g 102/g
n = 5; c = 2
(a) M = acceptability threshold, above which results are no longer considered satisfactory where M equals 10 m
where the count ismade in a s olid medium and M equals30 M where the count ismade in a liquid medium.
(b) m = threshold below which all results are considered satisfactory.
(c) n = number of unitsmaking up the s ample.
(d) c = number of unitsin the s ample giving valuesbetween m and M.
The results of the microbiological analyses must be interpreted according to:
A. Three categoriesof contamination for aerobic mes ophile bacteria,
Escherichia coli andStaphylococcus aureus, viz.:
— up to and including the criterion m,
— between the criterion m and the threshold M,— above the threshold M.
1. The quality of the consignment shall be considered:
(a) satisfactory, where all the values observed are equal to or less
than 3 m where a solid medium has been used or 10 m where a
liquid medium hasbeen us ed;
(b) acceptable, where all the valuesobs erved are between:
(i) 3 m and 10 m (= M) in a solid medium;
(ii) 10 m and 30 m (= M) in a liquid medium;
and where c/n isequal to or les sthan ⅖where n = 5 and c = 2 or
any other figuresof equivalent or greater reliability to be recog-
nized by the Council, acting in accordance with the procedure
laid down in Article 19.
2. The quality of the consignment shall be considered unsatisfactory;
— in all cases where values in excess of M are observed,
— when c/n is> ⅖.1994L0065 — EN — 05.06.2003 — 001.001 — 20
▼B
However, where thislatter thres hold hasbeen exceeded for aerobic
micro-organisms at + 30 ºC while all the other criteria have been
fulfilled, this exceeding of the threshold must be the subject of a
further interpretation, in particular in the case of raw products.
In any event, the product must be considered toxic or tainted when
contamination reachesthe microbic limit value S, which for general
purposes is set at 103m.
In the case of Staphylococcus aureus, the value of S must never be
allowed to exceed 5 × 104.
Tolerancesrelated to analytical techniquess hall not apply to the
valuesM and S.
B. Two categoriesfor s almonella, with no category tolerance permitted:
— ‘Absence in’: the result is considered satisfactory.
— ‘Presence in’: the result is considered unsatisfactory.1994L0065 — EN — 05.06.2003 — 001.001 — 21
▼B
ANNEX III
1994L0065 — EN — 05.06.2003 — 001.001 — 22
▼B
1994L0065 — EN — 05.06.2003 — 001.001 — 23
▼B
ANNEX IV
MICROBIOLOGICALCRITERIA
Production plants and independent production units must ensure that, during the
checksprovided for in Article 7 (3) and in accordance with the methodsof
interpretation specified in Annex II, meat preparations comply with the
following criteria:
Meat preparationsM (1)m (2)
Escherichia coli 5×1 03/g 5 × 102/g
n = 5; c = 2
Staphylococci aurei 5×1 03/g 5 × 102/g
n = 5; c = 1
Salmonella absence in 1 g
n = 5; c = 0
(1) M = acceptability threshold, above which results are no longer considered satisfactory where M equals 10 m
where the count ismade in a s olid medium and M equals30 m where the count ismade in a liquid medium.
(2) m = threshold below which all results are considered satisfactory.
The Council acting on a Commission proposal shall, before 31 December 1995,
review the criteria applicable to meat preparationsasregardsthe abs ence of
salmonella.1994L0065 — EN — 05.06.2003 — 001.001 — 24
▼B
ANNEX V
1994L0065 — EN — 05.06.2003 — 001.001 — 25
▼B
1994L0065 — EN — 05.06.2003 — 001.001 — 26