Proposal for a COUNCIL DIRECTIVE amending Directive 92/46/EEC laying down the health rules for the production and placing on the market of raw milk, heat-trated milk and milk-based products
Date: 1994-01-10
Institutions: European Commission
Subjects: Luxembourg, VAT, basis of tax assessment, own resources, tax exemption, tax harmonisation

COMMISSION OF THE EUROPEAN  COMMUNITIES 

C0M(93) 715 final 

Brussels, 10 January 1994 

Proposal  for a 

COUNCIL PI RECTI YE 

amending  Directive 92/46/EEC  laying down the health  rules 

for the production and placing on the market of raw milk, 

heat-treated milk and milk-based  products 

(presented by the Commission) 

I 

EXPLANATORY  MEMORANDUM 

In June  1992  the  Community  adopted  measures  on  the  production  and  placing  of  the 

market  of  raw  milk,  heat-treated  drinking  milk,  milk  for  the  manufacture  of 

milk-based  products  and milk-based  products. 

In  the  light  of  the  experience  gained,  it  has  been  found  necessary  to  make 

certain  technical  adjustments  and  additional  specifications  in  the  annexes  to 

Directive  92/46/EEC. 

The  amendments, which  are  presented  in the  form of  a proposal  for  a Directive,  do 

not  concern  the body  of  the Directive  but  only  its annexes. 

They  concern,  in particular: 

-  the  temperatures  for  collection  and  transport  of  raw  milk  from  the  production 

holding  to the  treatment  or  processing  establishment. 

These  amendments  must  take  account  of  the  fact  that  several  species  of 

milk-producing  animals  are  covered  by  the Directive  and  uniform  treatment  would 

compromise  certain  traditional  industrial  practices; 

-  the  rules  concerning  equipment  in  treatment  or  processing  establishments. 

Amendments  are  needed  because  of  the  very  wide  diversity  in  the  size  of 

industrial  establishments.  The  need  to adapt  the  rules  to  take  account  of  this 

.  diversity  has  lead  to  greater  flexibility  for  small  establishments,  without 

Jeopardizing  the  hygiene  of  products or  compromising  consumer  protection; 

3 

-  lastly,  hygiene  and  standardization  requirements  for  the  production  of 

heat-treated  drinking  milk  and  milk-based  products  in  order  to  improve  checks 

by  the  competent  authorities  and  to  facilitate  greater  harmonization  of  the 

rules when  these  are  transposed  into national  law. 

These  amendments  are  simply  technical  adjustments  to  the  annexes  with  a  view  to 

improving  the  application  of  Community  legislation,  particularly  the  measures 

establishing  the  single  market  and  free movement  of  foodstuffs  of  animal  origin; 

the  amendments  in  no  way  call  into  question  the  high  level  of  public  health 

protection;  they  adjust  the  requirements  so  as  to  take  better  account  of  the 

different  species  of  animal  concerned  and  the  differences  in  the  initial 

situations  in  the  Member  States.  It, too  is  in  the  form  of  a  Directive,  which 

Member  States  are  required  to  implement  under  Commission  supervision. 

The  proposal  has no  implications  for  the Community  budget. 

Proposal  for a 

COUNCIL  DIRECTIVE 

amending  Directive 92/46/EEC  laying down  the health  rules 

for  the production  and placing on  the market  of  raw milk, 

heat-treated  milk and milk-based  products 

THE COUNCIL OF THE EUROPEAN  UNION, 

Having  regard  to the Treaty establishing  the European  Community, 

Having  regard  to Council  Directive 92/46/EEC  laying down  the health  rules  for  the 

production  and  placing  on  the  market  of  raw  milk,  heat-treated  milk  and 
milk-based  products*1*, and  in particular  Article  21  thereof, 

Having  regard  to the proposal  from  the  Commission^2), 

Whereas,  following  a  detailed  study  of  certain  provisions  In  the  Annexes  to 

Directive 92/46/EEC,  it  has  been  found  necessary  to  make  certain  technical 

adjustments  in  order  to  ensure  better  application;  whereas  such  amendments 

concern,  in  particular,  the  collection  temperatures  for  raw  milk,  the  rules  on 

equipment  in  treatment  or  processing  establishments  and  the  manufacture  of 

heat-treated  milk and milk-based products, 

(1) OJ  No L 268, 14.09.1992, p. 1 
(2) OJ No L 

J" 

HAS ADOPTED  THIS  DIRECTIVE: 

Article 1 

Directive  92/46/EEC  is hereby  amended  as  follows: 

1.  In  Annex  A,  the  second  subparagraph  of  Chapter  II1(A)(2)  is  replaced  by  the 

fo11owIng: 

2.  "Immediately  after  milking,  the milk  must  be placed  in a clean  place  which 

is so equipped  as  to avoid  adverse  effects  on  the milk.  If  the milk  is not 

collected  within  two  hours  of  milking,  it must  be  cooled  to  a  temperature 

of  8"C  or  lower  in  the  case  of  daily  collection  or  6"C  if  collection  is 

not  daily.  While  the  milk  is  being  transported  to  the  treatment  and/or 

processing  establishment  its  temperature  must  not  exceed  10'C  unless  the 

milk  has  been  collected  within  two  hours of  milking." 

For  technological  reasons  concerning  the  manufacture  of  certain  products 

based  on  goat's  or  ewe's  milk,  the  competent  authorities  may  authorize 

derogations  to  the  temperatures  laid  down  in  the  preceding  subparagraph 

provided  the  end  product  meets  the  standards  set  out  in  Chapter  II  of 

Annex  C." 

2.  In Annex  B, Chapter  I, the  first  sentence  of  (3)  is replaced  by  the  following: 

"in  rooms  where  the  raw  materials  and  the  products  covered  by  this  Directive 

are  stored,  the  same  conditions as  those  at  2(a)  to  (f), except:" 

G 

3.  in Annex  B, Chapter  11(A)(3)  is replaced  by  the  following: 

"3. Working  areas,  instruments  and  working  equipment  must  be  used  only  for 

work  on  products  for  which  approval  has been  granted. 

However,  following  authorization  by  the  competent  authority,  they  may  be 

used  at  the same  time or  other  times  for  work  on  other  foodstuffs  fit  for 

human  consumption  or other  milk-based  products  intended  for  use other  than 

human  consumption,  provided  they  do  not  create  contamination  of  the 

products  for which  agreement  has been  given." 

4.  In Annex  B,  the  title of  Chapter  III  is replaced  by: 

"Special  requirements  for  approval  of  collection centres". 

5.  In Annex  B,  the  title of  Chapter  IV  is replaced  by: 

"Special  requirements  for  approval  of  standardization  centres". 

6.  In Annex  B, Chapter  V(a)  is replaced  by  the  following: 

"(a)  equipment  for  the  mechanical  filling  and  proper  automatic  sealing  of 

containers which  are  to be used  for  packaging  heat-treated  drinking  milk 

and milk-based  products  in  liquid  form,  after  filling, excluding  churns, 

tanks  and  bulk  packaging  of  more  than  5  litres,  insofar  as  such 

operations  are carried  out  there; 

However,  in  the  case  of  limited  production,  the  competent  authorities 

may  authorize  alternative  non-automatic  sealing  methods  provided  that 

such  methods  carry  equal  assurances with  regard  to hygiene". 

7.  In Annex  B, Chapter  V(f)  is replaced  by  the  following: 

"(f)  In  the  case  of  treatment  establishments,  heat-treatment  equipment 

approved  or  authorized  by  the competent  authority,  fitted  with: 

-  an automatic  temperature  control, 

-  a  recording  thermometer, 

-  an  automatic  safety  device  preventing  insufficient  heating, 

9 

-  an  adequate  safety  system  preventing  the mixture  of  heat-treated  milk 

with  incompletely  heated milk; 

-  an automatic  recording  device  for  the safety  system  referred  to  in the 

preceding  indent. 

However,  the  competent  authorities  may  authorize  different  equipment 

with  equivalent  performance  guarantees  and  equal  assurances  with 

regard  to hygiene. 

In the case of processing  establishments,  insofar  as such operations are 

carried  out  there,  equipment  and  methods  for  heating,  thermization  or 

heat-treatment, meeting  the hygiene  requirements". 

8.  In Annex  B, Chapter  VI(3)  is replaced  by  the following: 

"3. Equipment, containers  and  installations which  come  into contact  with milk 

or  milk-based  products  or  other  perishable  raw  materials  during 

production  must  be  cleaned  and  if  necessary  disinfected  according  to a 

frequency  and  procedures  consistent  with  the  principles  referred  to  in 

Article  14(1)". 

9.  In Annex  V, Chapter  VI(4)  is replaced  by  the following: 

"4. The  treatment  premises  must  in  principle  be  cleaned  according  to  a 

frequency  and  procedures  consistent  in  accordance  with  the  principles 

referred  to  in Article  14(1)." 

10.  In  Annex  C,  in  the  first  sentence  of  the  second  subparagraph  of 

Chapter  1(A)(2),  the word  "cow's"  is  inserted  between  "raw" and  "milk". 

11.  In  Annex  C,  the  first  indent  of  Chapter  1(A)(3)(a)  is  replaced  by  the 

fol Iow i ng: 

"-  raw  milk,  if  it  is  not  treated  within  36 hours  of  acceptance,  does  not 

exceed  immediately  before heat  treatment  a plate count  at  30*C of  300 000 

per  ml  in  the  case  of  cow's  milk  or  1 000 000 per  ml  in  the  case  of 

sheep's, ewe's or  buffalo's milk". 

? 

12.  In Annex  C,  the  following  is added  to Chapter  1(A)(4)(d): 

"Pasteurized  milk  may  be  produced  in  the  same  conditions  from  raw  milk  which 

has undergone  only  initial  thermization". 

13.  In Annex  C, Chapter  1(B)(1)  is replaced  by  the  following: 

"1.  The  operator  or  manager  of  the  processing  establishment  must  take  all 

necessary  steps  to ensure  that  the  raw milk  is heat-treated,  or  used,  in 

the case of  products  "made with  raw milk", 

-  as  soon  as  possible  after  acceptance  if  the  milk  has  not  been 

refrigerated, 

-  within  36  hours of  acceptance  if  the milk  is kept  at  a  temperature  not 

exceeding  6*C, 

-  within  48  hours  of  acceptance  if  the miik  is kept  at  a  temperature  not 

exceeding  4'C. 

However,  for  technological  reasons  concerning  the  manufacture  of  certain 

milk-based  products,  the  competent  authorities  may  authorize  the  times 

and  temperatures  referred  to  in  the  above  three  indents  to  be  exceeded. 

They  shall  inform  the Commission  of  such  derogations,  and  their  technical 

Just ification. 

14.  In Annex  C, Chapter  I(B)(3)(a)(i)  is replaced  by  the  following: 

"(i)  have  been  obtained  from  raw  milk  which,  if  it  is  not  treated  within 

36 hours  of  acceptance  by  the  establishment,  has  a  plate  count  at  30'C 

which  does  not  exceed  300 000  per  ml  in  the  case  of  cow's  milk  and 

1 000 000 per  ml  in the case of  buffalo's, goat's or  ewe's  milk". 

15.  In Annex  C, Chapter  I (B)(3)(a)(iii)  is replaced  by  the  following: 

"If  it  is  used  for  the  production  of  pasteurized,  UHT  or  sterilized  milk 

intended  for  the  manufacture  of  milk-based  products,  meet  the  following 

standards  before  treatment:  plate  count  at  30'C  equal  to  or  less  than 

100 000 per  ml". 

3 

16.  In  Annex  C,  the  last  two  subparagraphs  of  Chapter  11(A)(2)  are  replaced  by 

the  fol lowing: 

"In  addition,  whenever  the  standard  M  is exceeded  in  the  case  of  cheese  made 

from  raw milk  and  from  thermized  milk  and  soft  cheese, either  testing  must  be 

carried  out  for  the  possible  presence  of  toxins  in such  products, or  strains 

of  enterotoxinogenic  Staphylococcus  aureus  or  strains  of  Escherichia  coli 

that  are  presumed  to  be  pathogenic  must  be  identified  by  means  of  methods  to 

be  determined  in  accordance  with  the  procedure  laid  down  in  Article  31  of 

this  Directive.  If  toxins  are  found  or  the  above-mentioned  strains  are 

identified,  all  the  batches  involved  shall  be  withdrawn  from  the  market.  In 

this case  the competent  authority  shall  be  informed  of  the  findings,  pursuant 

to  the  fifth  indent  of  Article  14(1)  of  this  Directive,  and  of  the  action 

taken  to  withdraw  the  suspect  batches  and  the  corrective  procedures 

introduced  into  the production monitoring  system." 

17.  "In  Annex  C,  the  first  sentence  of  Chapter  11(A)(4)  is  replaced  by  the 

fol lowing: 

"In  addition,  milk-based  products  which  have  undergone  UHT  treatment  or 

sterilization  which  are  intended  for  conservation  at  room  temperature  must 

meet  the  following  standards  after  incubation  for  15 days at  30'C:" 

18.  In Annex  C,  the  following  is added  to Chapter  lll(3): 

"However,  in  the  case  of  limited  production,  the  competent  authorities  may 

authorize  non-automatic  sealing  methods  provided  that  these  provide  equal 

assurances with  regard  to hygiene". 

19.  In  Annex  C,  the  second  subparagraph  of  Chapter  lll(4)  is  replaced  by  the 

foI Iow i ng: 

"Sealing  must  be  carried  out  in  the  establishment  in  which  the  last  heat 

treatment  of  drinking milk  and/or  milk-based  products  in  liquid  form  has  been 

carried  out,  immediately  after  filling,  by  means  of  sealing  devices  which 

ensure  that  the milk  is protected  from  any  adverse  effects of  external  origin 

on  its  characteristics.  The  sealing  system  must  be  so  designed  that  once  the 

container  has  been  opened,  the evidence  that  it has been  opened  remains  clear 

and  easy  to check." 

1o 

20.  In Annex  C, Chapter  lll(5)  is replaced  by  the  following: 

"5.  The  operator  or  manager  of  the  establishment  must  ensure  for  control 

purposes  that  in  addition  to  the  information  required  by  Chapter  IV  the 

following  information  is  visibly  and  legibly  displayed  on  the  packaging 

of  the  heat-treated  milk  and milk-based  products  in  liquid  form: 

-  the nature*of  the heat  treatment  which  the milk  has  undergone, 

-  an  indication,  in  code  or  not,  whereby  the  date  of  the  last  heat 

treatment  may  be  established  and,  in  the  case  of  pasteurized  milk,  the 

temperature  at  which  the product  must  be  stored". 

21.  In  Annex  C,  the  last  sentence  of  Chapter  IV(A)(1)  is  replaced  by  the 

following: 

"However,  where  a  product  is  individually  wrapped  and  packaged  or  split  into 

small  packaged  units  to be  supplied  to  the  final  consumer  by  an  institution, 

it will  suffice  for  the health mark  to be  applied  to  the  packaging." 

22.  In Annex  C,  the  following  is added  to Chapter  IV(A)(3)(a): 

"In  the  case  of  the  bottles,  packaging  and  recipients  referred  to  in 

Article  11(4)  and  (6) of  Directive  79/112/EEC,  the  health  mark  may  indicate 

only  the  initials  of  the  consigning  country  and  the  approval  number  of  the 

establishment". 

23.  In Annex  C,  the  last  sentence of Chapter  IV(A)(3)(b)  is deleted. 

24.  In Annex  C,  the  following  is added  to Chapter  IV(A): 

"4.  To  take  account  of  the disposal  of  existing  packaging,  application  of  the 

health  mark  on  packaging  shall  be  compulsory  only  from  1 January  1995. 

However,  the  health  mark  must  be  shown  on  the  accompanying  commercial 

document  provided  for  in  Article  5(8)  and  the  last  subparagraph  of 

Article  7(A)(9) of  this  Directive". 

41 

25.  In Annex  C,  the  following  is added  to Chapter V(7): 

"and 

authorize 

a  tolerance  of 

+2'C  during 

deliveries 

to  retail 

establishments". 

Article  Z 

Member  States  shall  bring  into  force  the  laws,  regulations  and  administrative 

provisions  necessary  to comply  with  this Directive before  1 July  1994. They  shall 

forthwith  inform  the Commission  thereof. 

When  these  measures  are  adopted  by  the  Member  States,  they  shall  contain  a 

reference  to  this  Directive  or  shall  be  accompanied  by  such  reference  on  the 

occasion  of  their  official  publication.  The  methods  of  making  such  a  reference 

shall  be  laid down by  the Member  States. 

This Directive  is addressed  to the Member  States. 

Article  3 

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