Proposal for a European Parliament and Council Directive amending Council Directive 93/74/EEC on feedingstuffs intended for particular nutritional purposes and amending Directives 74/63/EEC, 79/373/EEC and 82/471/EEC
Date: 1997-07-25
Institutions: European Commission
Subjects: animal feedingstuffs, animal nutrition, dietary product, manufactured feedingstuffs, marketing

COMMISSION  OF THE  EUROPEAN  COMMUNITIES 

Brussels, 25.07.1997 
COM(97)  408  final 

97/0208  (COD) 

Proposal for a 

EUROPEAN PARLIAMENT AND COUNCIL DIRECTIVE 

amending Council Directive 93/74/EEC on feedingstuffs  intended for particular 

nutritional purposes and amending Directives 74/63/EEC. 79/373/EEC and 

82/471/EEC 

(presented by the Commission) 

Note  : The modifications  made to Directive 93/74/EEC are underlined 

EXPLANATORY MEMORANDUM 

On  13  September  1993  the  Council  adopted  Directive  93/74/EEC  of  13 
September  1993 on feedingstuffs  intended for particular nutritional purposes1, the 
use of which has expanded considerably over the past few years. 

Applying  solely  dietary  principles  (the  use  of  medicines  being  excluded),  those 
feedingstuffs  were able to cover the specific  needs of certain categories of animal 
in  particular  situations  and  thus  prevent  physiological  imbalances  at  critical 
periods  which could  entail  significant  production  losses  (for  example:  to  reduce 
the risk  of  calving  fever  in dairy  cows,  stress  in pigs,  or urinary  concretions  in 
ruminants). 

In accordance with the provisions of Directive 94/39/EC the Commission adopted 
on 25 July  1994 the list of  intended uses  of  feedingstuffs  intended  for  particular 
nutritional purposes . 

That  list  contains  the  nutritional  purposes  both  for  productive  livestock  and  for 
pets; feedingstuffs  intended for particular nutritional purposes can also be used to 
help pets suffering  from a chronic metabolic disorder such as renal  insufficiency. 

It now appears necessary to expand the scope of Directive 93/74/EEC  to include 
a new generation of products called  "nutritional supplements for animals". 

Like  feedingstuffs 
intended  for  particular  nutritional  purposes,  nutritional 
supplements  for  animals  are  intended  to  meet  the  requirements  of  animals  in 
certain physiological conditions or in particular environmental conditions. 

However,  because  of  their  nature,  concentration  and  method  of  administration 
they cannot be likened to complementary feedingstuffs  or additive premixes. 

OJ No L 237, 22.9.1993, p. 23. 
OJ No L 207,  10.8.1994, p. 20. 

(X 

In  fact,  they  are  preparations  likely  to  contain  high  levels  of  minerals,  trace 
elements,  vitamins, amino acids, etc., which are administered  orally  over an  often 
very  short  period  in the form  of an individual  dose  in drinking  water  or  via  daily 
feed. 

For example,  nutritional  supplements  are very useful  in coping with  unforeseeable 
situations  such  as  heat-stroke  which  affects  pig  and  poultry  farms  in  summer;  in 
that case,  the animals need the rapid administration of a multi-vitamin  supplement 
over a short period to offset  a reduction in, or even the ceasing of,  feed  intake. 

Individual  supplements  to feedingstuffs  may also be needed  in the case of calving, 
weaning or large litters where the mother  is not lactating  sufficiently. 

To  prevent  nutritional  supplements  from  evading  any  form  of  regulation,  it  is 
proposed  to extend  the principles  applying  to feedingstuffs  intended  for  particular 
nutritional purposes  to this new generation of products. 

This  approach  is justified  for  safety  reasons:  the  administration  of  high  doses  of 
vitamins,  trace  elements  or  minerals  may  have an adverse effect  on animal  health 
or  on  public  health  if  residues  are  left  in  animal  products.  Like  feedingstuffs 
intended  for  particular  nutritional  purposes,  nutritional  supplements  will  be 
their 
registration  procedure 
subject 
effectiveness  and  safety  vis-à-vis  the  purpose  claimed  for  them.  Authorisations 
will  also  be  granted  by  the  Commission  after  consulting  the  Standing  Committee 
for  Feedingstuffs. 

to  a  Community 

to  verify 

intended 

Just  as  for  feedingstuffs 
the 
Commission  will draw up the list of approved  supplements,  indicating  for  each its 
precise  use,  particular  nutritional  characteristics,  obligatory  and  optional 
declarations  and conditions of use. 

intended  for  particular  nutritional  purposes, 

The  general  rules  applying  to  feedingstuffs  intended  for  particular  nutritional 
purposes  with  regard  to  controls,  safeguard  clauses,  free  circulation,  etc.,  will 
also be extended to nutritional  supplements. 

ib 

DIRECTIVE  OF THE  EUROPEAN  PARLIAMENT  AND  OF THE  COUNCIL 

of 

amending  Council  Directive  93/74/EEC  on feedingstuffs  intended  for  particular 

nutritional  purposes  and amending  Directives  74/63/EEC,  79/373/EEC  and 

82/471/EEC 

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, 

Having  regard  to the Treaty  establishing  the European  Community,  and  in particular 

Article  100a  thereof, 

Having  regard  to the proposal  from  the  Commission1, 

Having  regard  to the opinion of the Economic and  Social  Committee2, 

Acting  in accordance  with the procedure  laid down  in Article  189b of the  Treaty3 

Whereas,  since  the  adoption  of  Council  Directive  93/74/EEC  of  13  September  1993  on 

feedingstuffs 

intended  for  particular  nutritional  purposes  and  Commission  Directive 

94/39/EC  of  25 July  1994 establishing  a list of  intended  uses  of  animal  feedingstuffs  for 
particular  nutritional  purposes5,  a  new  category  of  products  called  "nutritional 
particular  nutritional  purposes5,  a  new  category 

supplements  for  animals" has appeared  on the market; 

-

OJNo 
OJNo 
OJNo 
OJ No L 237,  22.9.1993, p. 23. 
O J N o L 2 0 7,  10.8.1994, p. 20. 

Whereas  while  nutritional  supplements  are  similarly  intended  to  satisfy  the  particular 

nutritional requirements of animals, they cannot be considered feedingstuffs  for particular 

nutritional  purposes  within  the  meaning  of  Directive  93/74/EEC  because  of  their 

composition,  method  of  administration  and,  in  certain  cases,  their  specific  purpose; 

whereas  the scope of  Directive  93/74/EEC  should  therefore  be extended  to  include this 

new category of products and provisions similar to those laid down for  the authorisation 

and  marketing  of  feedingstuffs  intended  for  particular  nutritional  purposes  should  be 

introduced for the new category; 

Whereas  it  will  also be necessary  to amend  Directive  94/39/EC  to  take  account  of  the 

extension  of  the  scope  of  Directive  93/74/EEC  to  include  nutritional  supplements  for-

animals; 

Whereas  nutritional  supplements  for  animals  cannot  be  deemed  to  be  compound 

feedingstuffs;  whereas they are not therefore  subject to the general provisions of Council 
Directive  79/373/EEC  of  2  April  1979 on the marketing  of  compound  feedingstuffs6; 

whereas labelling and packaging rules applicable to those products must therefore  be laid 

down; 

Whereas  any  authorisation .of  a  new  type  of  feedingstuff  intended  for  a  particular 

nutritional purpose  implies the need for prior verification  of the composition,  method of 

administration  and  intended use of the product  so as to ensure that  it actually  meets the 

nutritional requirements of the categories of animals for  which it is intended;  whereas to 

aid  that  verification  Member  States  and  the  Commission  should  possess  a  dossier 

containing all the scientific  and technical  information  demonstrating  the beneficial  effect 

of  the" product  on  the  category  of  animal  concerned;  whereas  the  Commission  will,  if 

necessary, have to lay down guidelines for the presentation of the dossiers; 

OJN0L86,  6.4.1979, p. 30. 

Whereas the other provisions of Community legislation apply where necessary  to animal 

feedingstuffs  for  particular  nutritional  purposes  and  to  nutritional  supplements  for 

animals,  in  particular  with  regard  to  the  use  of  additives;  whereas,  however,  those 

provisions will have to be inserted  into Council Directive 70/524/EEC  of 23 November 

1970 concerning additives in feedingstuffs  , to take account of the  special requirements of 

the animals receiving the products in question; whereas establishments manufacturing  the 

nutritional supplements for animals should also be subject to the provisions governing the 

approval  of  manufacturers  of premixes in Council  Directive  95/69/EC  of  22 December 

1995 laying down the conditions and arrangements  for  approving and registering certain 

establishments  and  intermediaries  operating  in  the  animal  feed  sector  and  amending 
Directives 70/524/EEC, 74/63/EEC, 79/373/EEC and 82/471/EEC8; 

Whereas,  in  view  of  the  large  number  of  amendments  to  be  made  to  Directive 

93/74/EEC, for the sake of clarity and rationality the current text of that Directive should 

be replaced by a new text, 

HAVE ADOPTED THIS DIRECTIVE: 

Article 1 

Directive 93/74/EEC is hereby amended as follows: 

1. 

The title of the Directive is replaced by the following; 

"Council  Directive  93/74/EEC  of  13 September  1993 on  feedingstuffs  intended 

-  for particular nutritional purposes and nutritional supplements for animals." 

OJNoL270,  14.12.1970, p. 1. 
OJ No L 332, 30.12.1995, p. 15. 

Articles  1 to  13 are replaced by the following: 

"Article 1 

1. 

This  Directive  concerns  feedingstuffs  intended  for  particular  nutritional 

purposes and nutritional supplements for animals. 

2. 

Member States shall prescribe that: 

(a) 

feedingstuffs  intended  for  particular  nutritional  purposes  may  be 

marketed only  if: 

— 

— 

they fulfil  the conditions referred to in Article 3, 

they  are  labelled  in  accordance  with  the  provisions  laid 

down in Article 6, and 

— 

their  intended uses  are  included  in the list  in Part B of the 

Annex  to  Directive  94/39/EC  and  they  fulfil  the  other 

provisions laid down in that list. 

QÙ 

nutritional supplements for animals may only marketed if: 

— 

— 

they  fulfil  the conditions  referred  to in Article 3. 

they  are  labelled  in  accordance  with  the  provisions  laid 

down  in Article 7. and 

— 

their  intended  uses  are  included  in  the  list  drawn  up 

pursuant  to  Article  8  and  they  fulfil  the  other  provisions 

laid down  in that list, 

Article 2 

L. 

For  the purposes  of this Directive, the following  definitions  shall  apply: 

(a) 

'feedingstuffs'  shall  mean  products  of  vegetable  or  animal  origin 

in  their  natural  state,  fresh  or  preserved,  and  products  derived 

from  the  industrial  processing  thereof,  and  organic  or  inorganic 

substances,  used  singly  or  in  mixtures,  whether  or  not  containing 

additives,  for  oral animal  feeding; 

(b) 

'compound  feedingstuffs'  shall  mean  mixtures  of  products  of 

vegetable  or  animal  origin 

in  their  natural  state,  fresh  or 

preserved,  and  products  derived  from  the  industrial  processing 

thereof,  or  of  organic  or  inorganic  substances,  whether  or  not 

containing  additives,  for  oral  animal  feeding  in  the  form  of 

complete feedingstuffs  or complementary  feedingstuffs; 

(c) 

'feedingstuffs  intended for  particular  nutritional  purposes'  shall 

mean  compound  feedingstuffs  which,  by  virtue  of  their  particular 

composition  or  method  of  manufacture, 

can  be  clearly 

distinguished  from  both  ordinary  feedingstuffs  and  the  products 

defined  in Council  Directive 90/167/EEC of 26 March  1990 laying 

down  the  conditions  governing  the  preparation,  placing  on  the 

market  and  use of medicated  feedingstuffs  in the  Community  , and 

are presented  as intended  to meet specific  nutritional  requirements; 

OJ No L92,  7.4.1990,  p. 42. 

(d) 

'nutritional  supplements  for  animals'  shall  mean  preparations 

made up by  the mixture  of  additives  or  bv  the mixture  of  additives 

and  products  authorised  bv  Council  Directive  82/471/EEC  of  30 

June  1982  concerning  certain  products  used  in  animal  nutrition1^ 

whether  or  not  containing  basic  materials  for  feedingsmffs.  which 

are  intended  to be  administered  orailv  so as  to  meet  the  temporary 

and'specific  nutritional  needs  of  animals  in  special  breeding  or 

^  living  conditions  or  to  achieve  specific  nutritional  purposes,  and 

which,  because  of  their  nature,  concentration  or  method  of 

administration 
feedingstuffs: 

cannot 

be 

considered 

as 

complementary 
-  -

(e) 

'particular  nutritional  purpose'  shall  mean  the  purpose  of 

satisfying 

the  specific  nutritional  needs  of  certain  pets  or 

productive  livestock  whose  process  of  assimilation,  absorption  or 

metabolism  could  be  temporarily  impaired  or  is  temporarily  or 

irreversibly  impaired  and  are  therefore  able  to  derive  benefit  from 

ingestion of feedingstuffs  appropriate  to their  condition. 

2. 

The  other  definitions  laid  down  in  Community  legislation  in  the  animal 

feed  sector  shall apply  wherever  necessary. 

Article 3 

The  Member  States  shall  require  that  the  nature  or  composition  of  the 

feedingstuffs  and  nutritional  supplements  for  animals  referred  to  in  Article  1(1) 

shall  be  such  that  the  products  are  appropriate  for  their  intended  particular 

nutritional  purpose. 

10 

O J N o L 2 1 3,  21.7.1982,  p.  8. 

Article 4 

This  Directive  shall  apply,  subject  to  the  specific  provisions  laid  down  therein, 

without prejudice to the Community provisions on: 

(a) 

(b) 

(c) 

(d) 

(e) 

(f) 

compound  feedingstuffs; 

additives used in, feedingstuffs; 

undesirable substances and products in animal nutrition; 

certain products used in animal nutrition; 

basic materials for animal  feedingstuffs; 

the  approval  and registration  of  certain  establishments  and  intermediaries 

operating in the animal feed sector. 

Article 5 

Member  States  shall  prescribe  that  nutritional  supplements  for  animals  may  be 

marketed only  in sealed packages or containers.  They shall also prescribe that the 

packages  or  containers  be  sealed  in  such  a  way  that,  when  the  package  or 

container is opened, the seal is damaged and cannot be re-used. 

Article 6 

In  addition  to  the  labelling  provisions  in  Article  5  of  Directive  79/373/EEC  of 

2 April  1979  on  the  marketing  of  compound  feedingstuffs,  the  Member  States 

shall require that: 

1. 

the  following  additional  indications  appear  in  the  space  provided  for  the 

purpose  on  the  packaging,  on  the  container  or  on  the  label  of  the 

feedingstuffs  referred  to in Article  1(1): 

(a) 

the  qualifying  expression  'dietetic'  together  with  the  description  of 

the  feedingstuff; 

(b) 

(c) 

the precise use,  i.e.  the particular  nutritional  purpose; 

indication  of 

the  essential  nutritional  characteristics  of 

the 

feedingstuffs; 

(d) 

the  declarations  prescribed  in  column  4  and,  where  applicable-

column  6  of  the  Annex  to  Directive  94/39/EC  concerning  the 

particular  nutritional purpose; 

(e) 

the recommended  length of time for use of the  feedingstuff. 

The  indications  referred  to  in  points  (a)  to  (e)  must  comply  with  the 

content  of  the  list  of  intended  uses  in  the  Annex  to  Directive  94/39/EC 

and the general provisions  laid down in accordance with Article 8(3): 

2. 

indications  other  than  those  referred  to  in point  1 may  be  supplied  in  the 

space  provided  for  the  purpose,  insofar  as  they  are  covered  by  Article 

3. 

without  prejudice  to  Article  5e  of  Directive  79/373/EEC,  the  labelling  of 

feedingstuffs  as  referred  to  in  Article  1(1)  may  make  reference  to  a 

specific  pathological  condition  insofar  as that condition  corresponds  to  the 

nutritional  purpose  laid  down  in  the  list  of  intended  uses  drawn  up  in 

accordance  with Article  8d): 

4. 

the label  or the directions  for  use of the feedingstuffs  referred  to  in Article 

1(1) must bear the indication  'It  is recommended  that a specialist's  opinion 

be sought before  use.' 

It may,  however,  be provided  in the  list  of  intended  uses  in  the  Annex  to 

Directive  94/39/EC  that  this  declaration  shall  be  replaced  for  specific 

dietetic  feedingstuffs  with  a  recommendation  to  request  the  prior  opinion 

of a  veterinarian; 

5. 

the  provisions  of  Article  5c(5)  of  Directive  79/373/EEC  shall  also  apply 

to  the  feedingstuffs  referred  to  in  Article  1(1)  and  intended  for  animals 

other  than pets; 

6. 

the  labelling  of  the  feedingstuffs  referred  to  in  Article  1(1)  may  also 

highlight  the  presence  or  the  low  level  of  one  or  more  analytical 

constituents  which  are  essential  for  the  description  of  the  feedingstuff.  In 

such  cases,- the  minimum  or  maximum  level  of  the  analytical  constituents 

expressed  as  a  percentage  by  weight  of  the  feedingstuff  must  be  clearly 

indicated  in the list of declared analytical  constituents; 

7. 

the  qualifying  expression 

'dietetic' 

shall  be 

reserved 

solely 

for 

feedingstuffs  as referred  to in Article  1(1). 

Qualifying  expressions  other  than  'dietetic'  shall  be  prohibited  in  the 

labelling  and presentation of these  feedingstuffs; 

8. 

notwithstanding  the  provisions  of  Article  5c(3)  of  Directive  79/373/EEC, 

the  declaration  of  ingredients  may  be  made  in  the  form  of  categories 

grouping  several  ingredients,  even  where  the  declaration  of  certain 

ingredients  by  their  specific  name  is  required  to  justify  the  nutritional 

characteristics  of the  feedingstuff. 

10 

Article 7 

1. 

Member  States  shall  prescribe  that  nutritional  supplements  for  animals 

mav  be  marketed  only  if  the  indications  listed  below,  which  shall  be 

clearly  visible,  legible  and  indelible  and  for  which  the  producer,  packer, 

importer,  seller  or  distributer  established  within  the  Community  shall  he 

held  responsible,  are  set  out  in  the  package  or  container  or  on  a  label 

attached thereto; 

(a) 

(b) 

the description  'nutritional  supplement  for  animals': 

the  precise  intended  use,  i.e.  the  particular  nutritional  purpose  of 

the  supplement  and  the  species  or  category  of  animals  for  which 

the supplement  is intended: 

(c) 

the  description  of  the  main  nutritional  characteristics  of  the 

supplement: 

(d) 

the  declarations  listed  in column  4  and,  where  applicable,  column 

(e) 

(f) 

(g) 

6 of the Annex: 

the duration of use of the  supplement: 

directions  for  use permitting  appropriate use of the  supplement: 

the  name  or  trade  name  and  the  address  or  registered  office  of  the 

person responsible for  the indications  referred  to in this paragraph: 

11 

(h) 

the  net  weight  as a unit  of mass  for  solids  and  a unit  of  volume  or 

(i) 

(j) 

(k) 

(1) 

mass for  liquids: 

the date of  manufacture: 

the  expiry  date  or  the  final  date  for  keeping  the  product  starting 

from  the date of  manufacture: 

the batch reference  number: 

the  approval  number  allocated  to  the  establishment  in  accordance 

with Article 5 of Council  Directive 95/69/EC. 

The  indications  in  points  (a)  to  (e)  must  satisfy  the  contents  of  the  list  of 

intended  uses  to  be  drawn  up  in  accordance  with  the  Annex  and  the 

general  provisions  to be laid down in accordance with Article  8(2): 

2. 

Where  other provisions  of Community  legislation  require  the  indication of 

a minimum conservation  date,  a single date must be indicated,  i.e.  the  first 

date  to expire. 

3. 

Indications  other  than  those  referred  to  in point  1 may  be  supplied  in  the 

space  provided  for  the  purpose,  insofar  as  they  are  covered  by  Article 

4. 

The  label  or  the  directions  for  use  of  the  nutritional  supplements  for 

animals  referred  to  in  Article  1(1)  must  bear  the  indication 

'It  is 

recommended  that a specialist's  opinion be sought before  use'. 

12 

It mav.  however,  be provided  in the  list of  intended  uses  to he drawn up 

in  accordance  with  the  Annex  that  this  declaration  shall  he  replaced  for 

nutritional  supplements  for  specific  animals  with  a  recommendation  to 

request the prior opinion of a veterinarian. 

5. 

Information  other than that laid down  in this  Article  may  be  supplied hy 

the  person  responsible  for  the  labelling  indications  for  the  nutritional 

supplement  for animals provided that such  information: 

is not intended to declare the presence  or the content of  analytical 

constituents  other than those  the  declaration  of  which  "is  provided 

for in point 1(d): 

does  not  mislead  the  user,  particularly  by  attributing  to  the 

supplement  effects  or  properties  which  it  does  not  possess  or  by 

suggesting  that  the  nutritional  supplement  possesses  special 

characteristics  when  all  similar  products  possess  those  same 

characteristics; 

does not refer to properties for the prevention, treatment or cure of 

a  disease:  however,  the  information  may  make  reference  to  a 

specific pathological  condition where that condition corresponds to 

the  nutritional  purpose  defined  in  the  list  of  intended  uses  drawn 

up pursuant to Article 8(2): 

relates to objective or measurable aspects that can be justified: 

is quite separate from all the indications referred to in this Article. 

13 

Article  8 

Pursuant  to  the  procedure  laid  down  in  Article  12  a  list  of  intended  uses 

concerning  feedingsmffs  intended  for  particular  nutritional  purposes  and  a  list  of 

intended  uses  for  nutritional  supplements  for  animals  shall  be  drawn  up  in 

accordance  with  the  models  included  in part  A  or  part  B of  the  Annex  and  with 

the following  provisions; 

1. 

For 

feedingstuffs  having  particular  nutritional  purposes,  the  list  of 

intended  uses  established  by  Directive  94/39/EC  shall  apply.  That  list 

— 

— 

the indications referred  to in Article £(l)(b),  (c), (d) and  (e), and 

where  appropriate,  the  indications  referred  to  in  Article  6(2)  and 

the second  subparagraph  of Article 6(4); 

2. 

The  list  of  intended  uses  for  nutritional  supplements  for  animals  shall  be 

adopted  by no later than 30 June  1999. It shall  contain: 

— 

— 

the indications  referred  to in Article  7(l)(b).  (c). (d) and  (e). and 

where applicable, the indications  referred  to in Article  7(2) and  the 

second  subparagraph  of Article 7(4); 

3. 

general  provisions  regarding  the  application  of  the  indications  referred  to 

in points. 1 and 2.  including applicable tolerances,  may be  established; 

4. 

the  measures  adopted  in  accordance  with  this  Article  may  be  modified, 

following  developments  in scientific  and technical  knowledge. 

14 

Article 9 

1. 

With  a  view  to  establishing  the  lists  provided  for  in  Article  8.  Member 

States  shall  ensure  that  an  application  accompanied  by  a  dossier  is 

officially  sent  to  the  Member  States  and  the  Commission  to  justify  the 

intended uses of the animal  feedingstuffs  intended  for  particular  nutritional 

purposes and the nutritional  supplements for animals. 

2- 

The  Commission,  in  accordance  with  the  procedure  laid  down  in  Article 

12.  may  adopt  guidelines  in  accordance  with  which  the  dossiers  referred 

to in paragraph  1 are to be established. 

Article  10 

The Member  States  shall ensure  that feedingsmffs  and  nutritional  supplements  for 

animals  as  referred  to  in  Article  1(1\  are  not,  for  reasons  concerning  the 

provisions  of  this  Directive,  subject  to  marketing  restrictions  other  than  those 

provided  for  in this Directive. 

Article  11 

1. 

Where  a  Member  State  establishes  that  the  use  of  a  feedingstuff  or  a 

nutritional  supplement  for  animals  as  referred  to  in Article  1(1)  or  its  use 

in the  prescribed  conditions  presents  a hazard  for  animal  or  human  health 

or  for  the  environment,  it  shall  immediately  inform  the  Commission, 

giving  the reasons for  its decision. 

2. 

The  Commission  shall  initiate  as soon as possible  the procedure  laid  down 

in Article 12 with a view to adopting  any appropriate  measures. 

15 

Article  12 

JL  Where  the  procedure  laid  down  in  this  Article  is  to  be  followed,  the 

Commission  shall  he  assisted 

in  an  advisory  capacity  bv  the  Standing 

Committee  for  Feedingsmffs.  set  up  bv  Council  Decision  70/372/EEC. 

hereinafter  referred to as  "the Committee". 

I* 

The  Chairman  shall  submit  to  the  Committee  a  draft  of  the  measures  to  he 

taken.  The  Committee  shall  deliver  its  opinion  on the  draft  within  a time  limit 

which  the  Chairman  may  set  according  to  rhe  urgency  of  the  matter,  where 
necessary  taking a vote. 

1. 

The  opinion  shall  be  entered  in  the  minutes:  in  addition,  each  Member  State 

shall  have the right to request that its position be entered in the minutes. 

4u 

The  Commission  shall  take  the  fullest  account  of  all  aspects  of  the  opinion 

delivered  by the Committee.  It shall  inform the Committee of  the way  in which 

it has taken account of its opinion. 

16 

Article 13 

To  allow  effective  official  inspection  of  feedingstuffs  and  nutritional  supplements 

for  animals  as  referred  to  in  Article  1(1),  the  following  specific  provisions  shall 

apply: 

1. 

Member  States  shall  make  all  necessary  arrangements  for  official 

inspection during manufacture  or marketing,  at least by Sampling,  in order 

to ensure compliance with the requirements of this Directive; 

2. 

Where appropriate,  the competent authority  shall be empowered to require, 

the  person  responsible  for  placing  the  product  on  the  market  to  produce 

data  and  information  establishing  the  conformity  of  the  feedingstuffs  and 

the nutritional  supplements for  animals with this Directive. 

If  such data have been published  in readily  accessible  form,  a reference  to 

the publication shall  suffice." 

17 

iL 

The Annex  to the Directive  is replaced  by the  following: 

"ANNEX 

Part A 

(model of the list of  intended  uses  for  feedingstuffs  intended  for particular  nutritional  purposes  to be drawn up in accordance  with Article 8) 

Particular  nutritional 

Essential  nutritional 

Animal  species or 

Labelling 

Recommended 

Other  provisions 

purpose 

characteristics 

category 

declarations 

length of time of use 

1 

2 

3 

4 

5 

6 

™=r= 

= 

rr 

18 

ANNEX 

PartB 

(model  of the list of  intended uses for  nutritional  supplements  for animals to be drawn up in accordance with Article 8) 

Particular  nutritional 

Essential  nutritional 

Animal  species or 

Labelling 

Length  of time of 

Other  provisions 

purpose 

characteristics 

category 

declarations 

use 

1 

2 

3 

4 

5 

6 

19 

Article 2 

The following  Directives are hereby amended as follows: 

1. 

The following  is added to Article  1(2) of Council Directive 74/63/EEC of 

17  December  1973  on  the  fixing  of  maximum  permitted  levels  for 
undesirable substances and products in  feedingstuffs11: 

"(f) 

feedingstuffs  for  particular  nutritional  purposes  and  nutritional 

supplements for animals." 

2. 

In Directive 79/373/EEC: 

(a) 

the following  is added to Article 1(2): 

"(h) 

feedingsmffs 

for  particular  nutritional  purposes  and 

nutritional supplements for animals." 

(b) 

the first indent of the second subparagraph of Article 5e is replaced 

by the following: 

u 

OJNoL38,  11.2.1974, p. 31. 

20 

"—  may not be designed  to indicate the presence or content of 

analytical  constituents  other  than  those  the  declaration  of 

which  is  provided  for  in  Article  5  of  this  Directive  or 

Article  5(2)  of  Council  Directive  93/74/EEC  of 

13 September  1993 on feedingstuffs  intended  for  particular 

nutritional  purposes  and  nutritional  supplements  for 

animais  ;" 

3. 

the following  is added to Article 1(2) of Council Directive 82/471/EEC: 

"(f) 

feedingsmffs  for  particular  nutritional  purposes  and' nutritional 

supplements for animals." 

Article 3 

1. 

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

administrative provisions necessary for them to comply' with this Directive 

no later than 30 June  1999. They shall forthwith  inform  the Commission 

thereof. 

When Member States adopt those provisions, they shall include  references 

to  this  Directive  or  shall  accompany  them  with  such  references  on their 

official  publication.  The  Member  States  shall  lay  down  the  manner  in 

which such references  shall be made. 

- 2. 

Member  States shall  forward  to the Commission the texts of the essential 

national  provisions  which  thev  shall  adopt  in  the field governed  bv  this 

Directive. 

12 

OJNoL237,  22.9.1993, p. 23. 

21 

Article 4 

This Directive  shall  enter into force  on the twentieth dav following  its publication  in the 

Official  Journal of the  European Communities. 

This Directive is addressed to the Member States. 

Article 5 

» 

Done at Brussels, 

For the European Parliament 

The President 

For the Council 

The President 

22 

TABLE OF CONCORDANCE 

Directive 93/74/EEC 

Directive 93/74/EEC as amended 

Article  1(1) 

Article  1(2) 

Article 2(a) 

Article 2(b) 

Article 2(c) 

Article 2(d) 

Article 3 

Article 4 

Article 5 

Article 6(a) 

Article 6(b) 

Article 6(c) 

Article 7 

Article  8 

Article 9 

Article  10 

Article  1(1) 

Article  l(2)(a) 

Article  l(2)(b) 

Article  2(l)(a) 

Article 2(1 )(b) 

Article  2(l)(c) 

Article 2(l)(d) 

Article 2(l)(e) 

Article 2(2) 

Article 3 

Article 4 

Article 5 (new) 

Article 6 

Article 7 (new) 

Article 8(1) 

Article 8(2) 

Article 8(3) 

Article 8(4) 

Article 9 

Article  10 

Article  11 

Article  12 

Article  13 

23 

ISSN 0254-1475 

COM(97) 408 final 

DOCUMENTS 

EN 

03  15  10 

Catalogue  number  :  CB-CO-97-413-EN-C 

ISBN  92-78-23623-3 

Office  for  Official  Publications of the European  Communities 

L-2985  Luxembourg 

-2-Lr