CELEX: 51990PC0671
Language: en
Date: 1990-12-17
Title: AMENDMENT TO THE PROPOSAL FOR A COUNCIL REGULATION ( EEC ) ON THE OPERATION OF AIR CARGO SERVICES

COMMISSION OF THE EUROPEAN COMMUNITIES
                                             C0MC89) 671 final
                                             Brussels, 1 Febraury 1990
                           Proposal for a
                      COUNCIL REGULATION (EEC)
   laying down the health rules for the production and placing
       on the market of minced meat, meat preparations and
                comminuted meat for industrial use
                   (presented by the Commission)
 ---pagebreak---                                       - 2 -                 COM(89)671 final-EN
                             EXPLANATORY MEMORANDUM
The Community must adopt, before 31 December 1992, the measures aimed at
establishing the internal market.  The need of assuring the free circulation
of products of animal origin must be reconciled with the need of protection of
the public health.
The objective of the present proposal is to harmonize the health rules
applying to minced meat, meat preparations and other comminuted meat.
The Council has adopted Directive 88/657/EEC laying down the requirements for
the production of, and trade in minced meat, meat in pieces of less than
100 grams and meat preparations and amending Directives 64/433/EEC, 71/118/EEC
and 72/462/EEC.
The present proposal extends to all the Communitory production the principles
established in the above referred Directive.  In this framework it is however
necessary to amend some technical rules.
It is opportune to regulate the case of establishments that will not be in
position to comply with the envisaged rules by 1.1.1993 in a general framework.
The proposal envisages also some derogations for small establishments.   In any
case, the general hygienic rules laid down in Council Regulation (EEC)
No       of                laying down general health rules for the production
and placing on the market of products of animal origin and specific health
rules for certain products of animal origin will apply.
The Commission proposes, for certain applicatory measures, the Regulatory
Committee procedures.
This choice is justified in this case by a desire not to disrupt the
management process in the veterinary field.  It is without prejudice to the
Commission*s preference for the Consultative Committee formula.
This proposal appears in the timetable in the Annex to the White Paper on
completing the internal market.
 ---pagebreak---                                        - 3 -
                                  PROPOSAL FOR A
                            COUNCIL REGULATION (EEC)
    laying down the health rules for the production and placing on the market
    of minced meat, meat preparations and comminuted meat for industrial use
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 proposal from the Commission;
Having regard to the opinion of the European Parliament;
Having regard to the opinion of the Economic and Social Committee;
Whereas minced meat, meat preparations and comminuted meat for induatiral use
are included in the list of products in Annex II to the Treaty;  whereas the
production of and trade in minced meat, meat preparations and comminuted meat
for industrial use constitute an important source of income 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 rules for the production
and placing on the market of such meat must be laid down at Community level;
Whereas the Community must adopt the measures intended to progressively
establish the internal market over a period expiring on 31 December 1992;
 ---pagebreak---                                         - 4 -
Whereas the laying down of such rules improves the protection of public health and
consequently facilitates the completion of internal market;
Whereas, to achieve this purpose, it is necessary to extend the principal health
rules laid down in Council Directive 88/657/EEC of 16 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 and amending Directives 64/433/EEC,
71/118/EEC and 72/462/EECCL) to all production and placing on the market of minced
meat and meat preparations in the Community;
Whereas it is possible that, due to certain particular circumstances, some
establishment operating prior to 1 January 1992 will not be able to comply with
all the rules laid down in this regulation;   whereas the question of whether
limited and temporary derogations may be granted to such establishments within the
general framework laid down in Council Decision .../.../EEC [on the granting of
temporary and limited derogations from specific Community health rules on the
production and marketing of products of animal origin](2) should be resolved;
Whereas it should be stressed that the granting of derogations from the health
rules laid down in this Regulation is without prejudice to the submission of all
operations of production and placing on the market of minced meat, meat
preparations and comminuted meat for industrial use to the general health rules
laid down by Council Regulation (EEC) N*.../... [laying down general health rules
applicable to the production and placing on the market of products of animal
origin and specific health rules applicable to certain products of animal
origin] (3);
Whereas Council Directive 79/112/EEC of 18 December 1978 on the approximation of
the laws of the Member States relating to the labelling, preservation and
advertising of foodstuffs (4) as last amended by Council Directive 89/395/EEC, (5)
and Council Directive 89/396/EEC of 14 June 1989 on indications or marks
identifying the lot to which a foodstuff belongs (6) are applicable;
Whereas the Commission should be entrusted with the task of adopting certain
measures for implementing this Regulation;  whereas, to that end, procedures
should be laid down establishing close and effective cooperation between the
Commission and the Member States within the Standing Veterinary Committee,
(1) O.J. No L 382, 31.12.1988, p.  3
(2) O.J. No
(3) O.J. No L                , p.
(4) O.J. No L 33, 08.02.1979, p. 1
(5) O.J. No L 186, 30.06.1989, p. 17
(6) O.J. No L 186, 30.06.1989, p. 21
 ---pagebreak---                                       - 5
HAS ADOPTED THIS REGULATION :
                                    Article 1
1. This Regulation lays down health rules for the production and placing on
   the market in the Community of minced meat, meat preparations and
   comminuted meat for industrial use.
2. This Regulation shall not apply to minced meat and meat preparations
   obtained in retail shops or in premises adjacent to sale points, prepared
   on the spot at the request of the purchaser or to such meat obtained in
   establishments selling directly to the consumer where transport and
   packaging are not involved.
3. This Regulation shall not apply to comminuted meat for industrial use
   produced in establishments approved according to Regulation
   (EEC) No .../... (1) [or health conditions for the production and placing
   on the market of meat products] where the transformation into meat products
   is performed in the establishment of production.
4. If necessary, the Commission, shall adopt appropriate rules for a uniform
   application of paragraph 2 and 3, in accordance with the procedure referred
   to in Article 9.
                                    Article 2
For the purposes of this Regulation:
1) "minced meat" means preparations obtained by mincing into fragments or
   passing through a spiral-screw mincer fresh meat as defined in Regulation
   (EEC) No .../... (2) [laying down the health rules for production and
   placing on the market of fresh meat].
(1) OJ No L    ,          , p,
(2) OJ No L    ,          , p.
 ---pagebreak---                                         - 6 -
2) **meat preparations** means preparations made wholly or partly from fresh
   meat as defined in
    (a) Regulation (EEC) No .../... [laying down the health rules for
        production and placing on the market of fresh meat]
    (b) Regulation (EEC) No .../... (1) [laying down the health rules for
        production and placing on the market of fresh poultry meat]
   or from minced meat.
   Meat preparations are preparations which have undergone
      - either a treatment other than those referred to in Regulation
        (EEC) No .../... [laying down health rules for the production and
        placing on the market of meat products];
      - or been prepared by addition of foodstuffs, seasoning or additives;
      - or undergone a combination of the above.
   The preparation must be such that the cellular structure of the meat is
   unaffected and the finished product contains no fragments of bone.
   Minced meat and fresh meat which have undergone only cold treatment shall
   not be regarded as meat preparations.
3) "Seasoning" means salt intended for human consumption, mustard, spices and
   spice extracts, aromatic herbs and extracts thereof.
4) **Food8tuffs** means any product of animal or vegetable origin considered fit
   for human consumption.
5) "Products for direct consumption** means minced meat or meat preparations
   intended to be consumed directly without undergoing any further treatment.
(1) OJ No L      ,          , p.
 ---pagebreak---                                        - 7 -
6) "comminuted meat for industrial use** means minced meat or mechanically
   recovered meat intended to undergo one of the treatments referred to in
   Regulation (EEC) No .../... [laying down the health rules for production
   and placing on the market of meat products].
7) "Establishment" means a processing plant for production of minced meat
   and/or meat preparations and/or comminuted meat for industrial use.
The definitions given in Articles 2 of
- Regulation (EEC) No .../... [laying down the health rules for production and
  placing on the market of fresh meat]
- Regulation (EEC) No .../... [laying down the health rules for production and
  placing on the market of fresh poultry meat]
- Regulation (EEC) No .../... [laying down the health rules for production and
  placing on the market of meat products]
shall apply where necessary.
                                     Article 3
Minced meat, meat preparations and comminuted meat for industrial use must
meet the following conditions:
A. Minced meat must
   (a) have been prepared from fresh meat
        i) either in compliance with Regulation (EEC) No .../... [laying down
            the health rules for producion and placing on the market of fresh
           meat]
       ii) or in compliance with Directive 72/462/BEC (1) and coming from a
            third country either directly or via another Member State.  In the
            case of fresh pigmeat it must have been examined for trichinae in
            accordance with Article 2 of Directive 77/96/BEC (2).
(1) OJ No L 302, 31.12.1972, p. 28
(2) OJ NO L   26, 31.01.1977, p. 67
 ---pagebreak---                                            8 -
   (b) have been prepared in
         i) either a cutting plant approved according to Regulation
              (EEC) No .../... [laying down the health rules for production and
             placing on the market of fresh meat]
       ii) or an establishment approved according to Article 5 for this
             purpose ;
   (c) have been prepared, packaged and stored in accordance with Chapter III
       of Annex I;
   (d) have been inspected in accordance with Chapters V and VI of Annex I;
   (e) have been marked in accordance with Chapter VII of Annex I;
   (f) have been transported in accordance with Chapter VIII of Annex I;
   (g) comply with the microbiological standards referred to in Annex II, in
       case of products for direct consumption or as ingredient for meat
       preparations.
B. Meat preparations must
   (a) have been prepared from fresh meat
          (i) either in compliance with point A;
        (ii) or in compliance with Regulation (EEC) No       /... [laying down
                the health rules for production and placing on the market of
                fresh meat];
       ( H i ) or in compliance with Directive 72/462/EEC and coming from a
               third country either directly or via another Member State.
                In the case of fresh pigmeat it must have been examined for
               trichinae in accordance with Article 2 of Directive 77/96/EEC;
        (iv) or in compliance with Regulation (EEC) N* .../... [laying down
               the health rules of producton and placing on the market of fresh
               poultry meat].   In this case the mincing of poultry meat shall be
               performed in the establishment of production of meat preparations,
 ---pagebreak---                                      - 9-
  (b) have been prepared in an establishment approved according to Article 5
      for this purpose;
  (c) have been prepared, packaged and stored in accordance with Chapter II
      of Annex I;
  (d) have been inspected in accordance with Chapters V and VI of Annex I;
  (e) have been marked in accordance with Chapter VII of Annex I;
  (f) have been transported in accordance with Chapter VIII of Annex I;
  (g) comply with the microbiological standards referred to in Annex II in
      case of products for direct consumption.  However, derogations can be
      established according to the procedure referred to in Article 9 for
      some products not obtained from minced meat or for some products
      obtained from poultry meat.
C Comminuted meat for industrial use must
  (a) have come from fresh meat
        i) either in compliance with Regulation (BBC) No .../... [laying down
           the health rules for producion and placing on the market of fresh
           meat];
       ii) or in compliance with Directive 72/462/BBC and coming from a third
           country either directly or via another Member State;
      iii) or in compliance with Regulation (BBC) No .../... [laying down the
           health rules for production and placing on the market of fresh
           poultry meat];
 ---pagebreak---                                       - 10 -
   (b) have been prepared, as appropriate, in
         i) either a cutting plant approved according to Regulation (EEC)
            No .../... [laying down the health rules for production and
            placing on the market of fresh meat];
        ii) or a cutting plant approved according to Regulation (EEC)
            No .../... [laying down the health rules for production and
            placing on the market of fresh poultry meat];
       iii) or an establishment approved according to Regulation (EEC)
            No .../... [laying down the health rules for production and
            placing on the market of meat products];
        iv) or an establishment approved according to Article 5 for this
            purpose;
   (c) have been prepared, packaged and stored in accordance with Chapter IV
       of Annex I;
   (d) have been inspected in accordance with Chapters V and VI of Annex I;
   (e) have been marked in accordance with Chapter VII of Annex I;
   (f) have been transported in accordance with Chapter VIII of Annex I;
                                    Article 4
1. In addition to the general conditions laid down in Article 3, minced meat
   and, insofar they contain such meat, meat preparations must
   (a)  (i) either be obtained from chilled fresh meat, within a maximum of
            six days after the slaughter of the animal of origin, compliance
            with this requirement being guaranteed by a method of
            identification to be specified by the competent authority
       (ii) or be obtained from frozen or quick frozen boneless meat.
 ---pagebreak---                                        - 11 -
    (b) undergo cold treatment referred in subparagraph (c) within a maximum of
        one hour after cutting into portions and wrapping except where
        processes requiring the lowering of internal temperature of the meat
        during preparation are used;
    (c) be placed on the market
         (i) either chilled and wrapped for the final consumer and cooled at an
             internal temperature below +2*C in a period of not more than one
             hour.
             In this case they must be obtained from the meat referred to in
             subparagraph (a)(i).
        (ii) or quick frozen and wrapped for the final consumer, in this case
             they must conform with the Council Directive 89/108/EEC (1);
2. The additives used must be in conformity with Community rules.
                                     Article 5
1. Each Member State shall draw up a list of the establishments manufacturing
   - minced meat
   - meat preparations
   - comminuted meat for industrial use
   approved by it.
   This list shall be forwarded to the other Member States and the Commission,
   stating whether these establishments are connected to establishments
   approved according to the Regulations referred to in (a), (b) or (c) or are
   independent establishments.
(1) O.J. No. L   40, 11.02.1989, p. 43
 ---pagebreak---                                          12 -
   Each establishment shall receive an approval number, which in the first
   case shall be that of the establishment that has been approved, indicating
   that it has been approved for the production of minced meat, meat
   preparations and comminuted meat for industrial use.
   Establishments thus approved shall be entered in a separate column either
   on the list of establishments referred to in
   (a) Regulation (EEC) No . . . / — [laying down the health rules for
       production and placing on the market of fresh meat] or
   (b) Regulation (EEC) No .../... [laying down the health rules for
       production and placing on the market of fresh poultry meat] or
   (c) Regulation (EEC) No .../... [laying down the health rules for
       production and placing on the market of meat products]
   (d) or, in case of independent establishments, on a separate list drawn up
       according to the same criteria.
2. A Member State shall not include an establishment on the list referred to
   in paragraph 1 unless it is sure that the establishment satisfies the
   conditions laid down in this Regulation.
   Member States shall withdraw the approval if the conditions cease to be met.
   If a check has been made in accordance with Article 6, the Member State
   concerned shall take account of the conclusions thereof.    The other Member
   States and the Commission shall be informed in the event of approval being
   withdrawn.
 ---pagebreak---                                        - 13 -
 3. The inspection and supervision of establishments shall be carried out under
    the responsibility of the competent authority which may be assisted in
    purely practical tasks by staff specially trained for the purpose.   The
    competent authority must at all times have free access to all parts of the
    establishments in order to ensure that this Regulation is being complied
    with.
    The detailed rules governing this assistance shall be determined in
    accordance with the procedure laid down in Article 10.
4. The production of the health mark and sealing material referred to in
    Chapter VII of Annex I must be authorized by the authorities of the Member
    State which supervise their use.
                                     Article 6
1. Veterinary experts from the Commission may, in so far as is necessary to
    ensure uniform application of this Regulation, make on-the-spot checks;
    they may verify whether establishments are actually complying with this
    Regulation.  The Commission shall inform the Member States of the results
    of the investigation.
    A Member State in whose territory a check is being carried out shall give
    all the necessary assistance to the experts in carrying out their duties.
2. If necessary, the general provisions for implementing this Article shall be
    determined in accordance with the procedure laid down in Article 10.   In
    accordance with the same procedure, a code containing the rules to be
    followed for the purpose of the checks provided for in paragraph 1 may be
    established.
                                     Article 7
The rules laid down in Council Regulation (EEC) No       (1) [concerning
veterinary checks on intra-Community trade in view of completing the internal
market], shall apply in particular with respect to the organization of and the
action to be taken following the checks carried out by the country of
destination and the safeguard measures to be applied in relation to health
problems affecting production and distribution of fresh meat in the territory
of the Community.
 ---pagebreak---                                          14
                                     Article 8
The Annexes in particular to adapt them to advances in science and technology,
shall be amended by the Commission in accordance with the procedure referred
to in Article 9.
                                     Article 9
1. The Commission shall be assisted by the Standing Veterinary Committee, set
   up by the Council Decision 68/361/EEC (1), hereinafter referred to as "the
   Committee**.
2. Where the procedure laid down in this Article is to be followed, the
   following provisions shall apply.
   The representative of the Commission shall submit to the Committee a draft
   of the measures to be taken.   The Committee shall deliver its opinion on
   the draft within a time limit which the Chairman may lay down according to
   the urgency of the matter.   The opinion shall be delivered by the majority
   laid down in Article 148(2) of the Treaty in the case of decisions which
   the Council is required to adopt on a proposal from the Commission.   The
   votes of the representatives of the Member States within the Committee
   shall be weighted in the manner set out in that Article.   The Chairman
   shall not vote.
   The Commission shall adopt the measures envisaged if they are in accordance
   with the opinion of the Committee.
   If the measures envisaged are not in accordance with the opinion of the
   Committee, or if no opinion is delivered, the Commission shall, without
   delay, submit to the Council a proposal relating to the measures to be
   taken.   The Council shall act by a qualified majority.
(1) OJ No L 255, 18.10.1968, p. 23
 ---pagebreak---                                       - 15 -
    If, on the expiry of a period of three months from the date of referral to
    the Council, the Council has not acted, the proposed measures shall be
    adopted by the Commission.
                                    Article 10
Where the procedure laid down in this Article is to be followed, the following
provisions shall apply.
The representative of the Commission shall submit to the Committee a draft of
the measures to be taken.   The Committee shall deliver its opinion on the
draft within a time-limit which the Chairman may lay down according to the
urgency of the matter, if necessary by taking a vote.
The opinion shall be recorded in the minutes;   in addition, each Member State
shall have the right to ask to have its position recorded in the minutes.
The Commission shall take the utmost account of the opinion delivered by the
Committee.   It shall inform the Committee of the manner in which its opinion
has been taken into account.
                                    Article 11
1. In accordance with the procedure referred to in Article 9, derogations from
   the rules referred to in the Annexes may be granted in favour of
   establishments which have small production.
2. When examing the derogations referred to in paragraph 1, the Commission
   shall take into account the information and the criteria referred to in
   Articles 2 and 3 of Council Decision .../.../EEC [on the granting of
   temporary and limited derogations from specific Community health rules on
   the production and marketing of products of animal origin].
 ---pagebreak---                                       - 16 -
3. When granting the derogations referred to in paragraph 1, the Commission
    shall establish in accordance with the procedure referred to in Article 9,
   the general and particular conditions applicable to the enforcement of each
   derogation.
                                    Article 12
The Commission may in accordance with the procedure referred to in Article 10,
draw up recommendations containing guidelines concerning good manufacturing
practices applicable to different stages of production and placing on the
market.
                                    Article 13
1. Directive 88/657/EEC is hereby repealed with effect from 1 January 1993.
2. However, the implementing provisions adopted under Directive 88/657/EEC
   shall remain valid for the purposes of this Regulation.
                                    Article 14
This Regulation shall enter into force on the thirtieth day following its
publication in the Official Journal of the European Communities.
It shall apply with effect from 1 January.
This Regulation shall be binding in its entirety and directly applicable in
all Member States.
Done at Brussels,                               For the Council
 ---pagebreak---                                       - 17 -
                                     ANNEX I
                                    CHAPTER I
         SPECIAL CONDITIONS FOR THE APPROVAL OF ESTABLISHMENTS PRODUCING
       MINCED MEAT. MEAT PREPARATIONS. COMMINUTED MEAT FOR INDUSTRIAL USE
1. Over and above the general conditions laid down in, respectively Annex I,
   points 1 to 12 and points 14, 15 and 16 of Regulation (EEC) No        /
   (laying down the health rules for production and placing on the market of
   fresh meat and repealing Directive 64/433/EEC) and Chapter I of Annex A to
   Regulation (EEC) No      /      [laying down the health rules for the
   production and placing on the market of meat products and repealing
   Directive 77/99/EEC] and points 1 to 12 and points 14, 15 and 16 of
   Regulation (EEC) No .../... [laying down the health rules for production
   and placing on the market of fresh poultry meat and repealing Directive
   71/118/EBC], production plants or independent production units shall have
   at least :
   (a) a room separate from the cutting room for mincing, wrapping and for the
       addition of other foodstuffs, 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 is carried out in a separate
       area and does not involve the addition of seasonings and other
       foodstuffs;
   (b) a room for packaging, unless the conditions laid down in point 62 of
       Chapter XI of Annex I to Regulation (EEC) No      /       [laying down
       the health rules for production and placing on the market of fresh meat
       and repealing Directive 64/433/EEC] are fulfilled;
   (c) a room for storing seasonings and other cleaned foodstuffs ready for
       use;
   (d) refrigeration equipment enabling the temperatures laid down in this
       Regulation to be adhered to.
 ---pagebreak---                                       - 18 -
   Establishments producing meat preparations shall also comply with the
   relevant requirements of Chapter I of Annex B to Regulation (EEC)
   No      /.... [laying down the health rules for the production and placing
   on the market of meat products and repealing Directive 77/99/EEC].
2. The rules laid down in Chapter IV of Annex I to Regulation (EEC)
   No      /       [laying down the health rules for production and placing on
   the market of fresh meat and repealing Directive 64/433/EEC] shall apply as
   regards the hygiene of the staff, premises and equipment in the
   establishments.
   Staff engaged in the manual preparation of minced meat shall also wear
   masks covering their noses and mouths and surgical-type gloves.
                                    CHAPTER II
                CONDITIONS FOR THE PRODUCTION OF COMMUNITED MEAT
                                FOR INDUSTRIAL USB
3. Meat shall be examined before cutting.   All soiled or suspect parts shall
   be removed and condemned before the meat is cut up.
4. Communited meat for industrial use shall not be obtained from contaminated
   meat.  In particular, mechanically recovered meat shall be obtained from
   flesh bearing bones apart from the bones of the head, extremities of the
   limbs below the carpal and tarsal joints and, in case of swine, the
   coccydeal vertebrae.
5. Where the operations carried out from the time when the meat enters the
   room referred to in Chapter I, point 1(a) to the time when the finished
   product undergoes the chilling or freezing process, the internal
   temperature of the meat shall be no higher than + 7°C for fresh meat and
   + 4°C for fresh poultry meat and the temperature of the production premises
   shall be no higher than + 12*C.
 ---pagebreak---                                        - 19 -
6. Immediately after production, comminuted meat shall be hygienically wrapped
    and packaged and stored at a temperature of not more than + 2°C in the case
    of chilled meat and not more than - 12*C in the case of frozen meat.
                                    CHAPTER III
                     CONDITIONS FOR PRODUCTION OF MINCED MEAT
7. Meat shall be examined before mincing.    All soiled and suspect parts shall
   be removed and condemned before the meat is minced.
8. Minced meat shall not be obtained from scrap cuttings or scrap trimmings.
   In particular, it shall not be prepared from meat from the following parts
   of bovine animals, pigs, sheep or goats : fragments of muscles from the
   head, boned shin meat, the point at which the sticking of the animal took
   place, injection areas, diaphragm and the central part of the belly muscles
   and bone scrapings.   It shall not contain any bone fragments.
9. Where the operations carried out from the time when the meat enters the
   room referred to in Chapter I, point 1(a) to the time when the finished
   product undergoes the chilling or freezing process are performed within a
   maximum period of one hour, the internal temperature of the meat shall be
   no higher than + 7°C and the temperature of the production premises shall
   be no higher than + 12°C.   The competent authority may authorize a longer
   time limit in individual cases where the addition of seasonings or
   foodstuffs justifies this on technical grounds, provided hygiene rules are
   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 has been reduced to a maximum of + 4*C.
   Immediately after production the minced meat shall be hygienically wrapped
   and packaged and stored at the temperatures prescribed in Article 4(1)(c).
 ---pagebreak---                                       - 20 -
                                   CHAPTER IV
          SPECIAL REQUIREMENTS FOR THE PRODUCTION OF MEAT PREPARATIONS
10. Over and above the general requirements of Chapter I, and depending on the
    type of production concerned :
    (a) the production of meat preparations shall take place under conditions
        of temperature control.  Immediately after production, meat
        preparations must be forthwith cooled to a temperature below + 2°C; if
        they contain minced meat, they shall be cooled to the temperatures
        provided for in Article 4(1)(c);
    (b) meat preparations intended for direct sale to the final consumer shall
        be wrapped in indivisible commercial portions;
    (c) refreezing of meat preparations shall be prohibited.
                                    CHAPTER V
                                   INSPECTION
11. Establishments which produce the minced meat or meat preparations or
    comminuted meat for industrial use shall be subject to inspection by the
    official service.  The official service shall be present when work is
    undertaken.
12. Inspection by the official service shall include the following tasks :
    - inspecting the entries of fresh meat,
    - inspecting the outgoing products,
    - hygiene inspection of the premises, facilities and instruments,
    - taking of any necessary samples and in particular those required for the
      microbiological tests referred to in Chapter VI.
 ---pagebreak---                                      - 21 -
                                   CHAPTER VI
                              MICROBIOLOGICAL TESTS
13. The production of minced meat, comminuted meat for industrial use and meat
    preparations shall be monitored by means of daily microbiological tests in
    the production establishment or in an approved laboratory.
    To that end, the operator or proprietor of the establishment or his
    representative shall conduct a regular check on the general hygiene of
    conditions of production in his establishment, in particular by micro-
    biological controls.
    These controls shall cover utensils, fittings and machinery at all stages
    of production and, according to the type of production concerned, products,
    He shall be in a position, upon request from the official service, to
    inform the competent authority or the Commission*s veterinary experts of
    the nature, frequency and results of the controls conducted to this end,
    together with the name of the investigating laboratory if need be.
    The competent authority shall regularly analyse the results of the
    monitoring provided for in the first subparagraph.   It may, on the basis
    of this analysis, conduct further microbiological examinations at all
    stages of production or on the products.
    The results of these analyses shall be written up in a report, the
    conclusions and recommendations of which shall be notified to the
    operator, who shall see to the rectification of shortcomings noted with a
    view to improving hygiene.
14. The sample taken for analysis shall comprise five units weighing 100 grams
    each.  Where minced meat is being produced in portions intended for the
    final consumer, the sample shall be taken from wrapped products.   The
    samples shall be representative of daily production.
 ---pagebreak---                                       - 22 -
15. According to the type of production concerned, samples shall be examined
    every day for aerobic mesophile bacteria and salmonella and every week for
    staphylococci, Escherichia coli and sulphite-reducing anaerobes.
    However,
    - for comminuted meat for industrial use, the competent authority, taking
      into account the intended utilization of the product, may require only
      the examination for aerobic mesophile bacteria,
    - where the standards for salmonella have been adhered to over a
      three-month period, the competent authority may authorize weekly
      examinations,
    - in the case of products to be placed on the market frozen or deep-
      frozen, the competent authority may waive the test for staphylococci.
16. In spot checks carried out by production plants or independent production
    units, production of the minced meat and meat preparations shall,
    depending on the type of meat used, comply with the standards laid down in
    Annex II.
17. The results of the microbiological tests shall be at the official
    veterinarian*s disposal.
    The establishment shall inform the official veterinarian when the
    standards laid down in Annex II are reached.  The official veterinarian
    shall take the appropriate measures.
    If, after the expiry of 15 days starting from the time of sampling, the
    output from production plants or independent production units does not
    meet the standards prescribed, products from such establishments shall be
    excluded from human consumption.
                                   CHAPTER VII
                              MARKING AND LABELLING
18. - Minced meat shall be marked on the packaging with the health mark of the
      establishment as defined in Chapter X of Annex I to Regulation (EEC)
      No      /        [laying down the health rules for production and
      placing on the market of fresh meat and repealing Directive 64/433/EEC].
 ---pagebreak---                                        - 23 -
     - Meat preparations shall be marked on the packaging with the health mark
       of the establishment as defined in Chapter V of Annex A to Regulation
       (EEC) No       /        [laying down the health rules for the production
       and placing on the market of meat products and repealing Directive
       77/99/EEC].
    - Comminuted meat for industrial use shall be marked on the packaging with
       the health mark of the establishment of production.
19. Without prejudice to Directive 79/112/EEC, for inspection purposes that
    the following information is visibly and legibly displayed on the
    packaging of minced meat, meat preparations and comminuted meat for
    industrial preparation,
    - 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,
    - for packaging not intended for the final consumer, the date of
       preparation,
20. Without prejudice to points 18 and 19, for minced meat or meat prepara-
    tions wrapped in commercial portions intended for direct sale to the
    consumer, a printed reproduction of the informations referred to in
    point 19 and of the mark provided for in paragraph 18 shall appear on the
    wrapping or on a label applied to the wrapping.    The mark shall include
    the establishment's approval number.    The dimensions laid down in
    Regulation (BBC) No       /.... [laying down the health rules for
    production and placing on the market of fresh meat and repealing Directive
    64/433/BRC] and Regulation (BBC) No .../       [laying down the health rules
    for production and placing on the market of fresh poultry meat and
    repealing Directive 71/118/EEC] and Regulation (BBC) No        /
    [laying down the health rules for the production and placing on the market
    of meat products and repealing Directive 77/99/EEC], shall not apply to
    the marking referred to in this paragraph, provided that the required
    information is legible.
 ---pagebreak---                                      - 24 -
                                  CHAPTER VIII
                                    TRANSPORT
21. The minced meat, meat preparations and comminuted meat for industrial use
    must be dispatched in such a way that during transport it is protected
    from anything liable to contaminate it or to affect it 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, meat preparations and comminuted meat for industrial use, shall be
    equipped in such a way as to ensure that the temperatures laid down in
    this Regulation are not exceeded and for long-distance trade they must be
    equipped with a recording thermometer to ensure that the latter
    requirement is fulfilled.
 ---pagebreak---                                       - 25 -
                                    ANNEX II
                            MICROBIOLOGICAL STANDARDS
1. MICROBIOLOGICAL STANDARDS
   Establishments must ensure that, in accordance with Chapter VI of Annex I
   and with the methods of interpretation set out below, minced meat intended
   to be marketed without further processing or as an ingredient in meat
   preparations, comply with the following standards :
   :                                           M (1)        :        m (2)    :
   : Aerobic mesophile bacteria              5 x 106/g             5 x 105/g
   : n (3) » 5      c (4) * 2        :                      :                 :
   : Escherichia coli                        5 x 102/g      :         50/g
   : n = 5          c = 2            :                      :                 :
   : Sulphite-reducing anaerobes               102/g                  10/g
   : n * 5          c = 1            :                      :                 :
   : Staphylococci                           5 x 102/g      :         50/g    :
   : n = 5          c * 1            :                      :                 :
   : Salmonella
   : n = 5          c * 0                            absence in 25 g
   : (1) M * acceptability threshold, above which results are no longer
             considered satisfactory where M equals 10 m where the count is
             made in a solid medium and M equals 30 m where the count is
             made in a liquid medium.
   : (2) m = threshold below which all results are considered satisfactory.
   : (3) Number of units making up the sample.
   : (4) Number of units in the sample giving values between m and M.
   A. Three categories of contamination for aerobic mesophile bacteria,
      Escherichia coli, sulphite-reducing anaerobes and staphylococci, viz,
      - up to and including the criterion m,
      - between the criterion m and the threshold M,
      - above the threshold M.
 ---pagebreak---                                 - 26 -
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 has been used;
   (o) acceptable, where all the values observed 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 is equal to or less than 2/5 where n * 5 und c * 2
       or any other figures of equivalent or greater reliability to be
       recognized according to the procedure referred to in Article 9.
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 > 2/5.
   However, where this latter threshold has been exceeded for aerobic
   micro-organisms at + 30°C 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 reaches the microbic limit value S, which for general
                         3
   purposes is set at 10 m.
   In the case of Staphylococcus aureus, the value of S must never be
                            A
   allowed to exceed 5 x 10 .
   Tolerances related to analytical techniques shall not apply to the
   values M and S.
 ---pagebreak---                                       - 27 -
   B. Two categories for salmonella, with no category tolerance permitted :
      - "Absence in** : the result is considered satisfactory,
      - "Presence in** : the result is considered unsatisfactory.
2. The microbiological methods for examination will be established according
   to the procedure referred to in Article 9.
 ---pagebreak---                                                    - 28 -
 'FINANCIAL STATEMENT           concerning:
 Draft proposal for a Council Regulation laying down the health rules for the production and
 piocing on the market of minced meat and meat preparations
 and repealing Directive 88/657/EEC.
1.   Budget heading:            Item:                           Title:
       HI B                     382 (1)                         Controls in agriculture
2.   Legal basis:
       Article 43 of the Treaty
3.  Classification:                    Non-compulsory expenditure
4.  Purpose/description of the measure:
       -Verification of the implementation of the Regulation
          (Article 6)
5. Method of calculation
5.1 Form of expenditure:        Mission expenses
5.2 Community contribution:     100 X
5.3 Calculation:                100 days of mission per year at 170 ECU per day
                                (actual cost of inspections)
                                - 17.000 ECU
6.   Financial implication as regards operating appropriations
$.1 Schedule of appropriations (m ECU)
                                Year
                                1991                     0.017
                                1992                     0.017
                                1993                     0.017
                                1994                     0.017
                                1995                     0.017
                                Total                    0.085
6.2 Financing during current year:      None
7.   Observations:
        (1) When the preliminary draft budget is prepared, an examination wi11 be made to see where
            this category of expenditure is to be charged in the budget.
       This proposal also calls for 1 addtlonal A7/6 post.
       Staff requirements set out above must be met either by redeployment within the Commission
        or by the budget procedure for the year concerned
 ---pagebreak---                                                           Task Force PME
                                  - 29 -
              COMPETITIVENESS AND EMPLOYMENT IMPACT STATEMENT
I.   What is the main reason for Introducing the measure?
     To have a uniform level of healthy and hygienic guarantees for minced
     meat and meat preparation produced In the Community In order to allow
     the free trade between Member States.
II.  Features of the businesses in question. In particular:
     a) Are they many SMEs?
        Yes
     b) Are they concentrated In regions which are:
         I.  eligible for regional atd In the Member States?
             No
         II. eligible under the ERDF?
             No
III. What direct obligations does this measure Impose on businesses?
     Respect hygiene rules and in particular control measures established
     at Community level.
IV.  What indirect obligations are local authorities     likely to  impose on
     businesses?
     Being this text a regulation,       all  the  requirements  are   imposed
     directly at Community level.
V.   Are there any special measures In respect of SMEs? Please specify.
     Yes. derogations can be established according to the proposed Council
     Decision on the granting of derogations from specific Community health
     rules on the production and marketing of products of animal origin.
VI.  What is the likely effect on:
     a) the competitiveness of businesses?
        PosItIve
     b) employment?
        Positive
VII. Have both   sides of   industry been consulted?   Please  indicate  their
     opinions                                                            '
     Yes. Favourable.
 ---pagebreak---  ---pagebreak---                                           - 30 -                     ISSN 0254-1475
                                                              COM (89) 671 final
                                                      DOCUMENTS
EN                                                                              03
                                 Catalogue number : CB-CO-90-006-EN-C
                                                             ISBN 92-77-56524-1
Office for Official Publications of the European Communities
L-2985 Luxembourg