Proposal for a COUNCIL REGULATION (EC) amending Annex II of Council Regulation (EEC) N 2377/90 laying down a Community procedure for the establishment of maximum residue limits of veterinary medicinal products in foodstuffs of animal origin
Date: 1996-09-24
Institutions: European Commission
Subjects: animal product, food inspection, sea fish, veterinary drug, veterinary legislation

COMMISSION  OF THE EUROPEAN  COMMUNITIES 

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Brussels, 24.09.1996 
COM(96) 34  final 

Proposal  for  a 

COUNCIL  REGULATION  (EC) 

amending Annex II of Council Regulation (EEC) N° 2377/90 
laying down a Community procedure for the establishment of maximum residue 
limits of veterinary medicinal products in foodstuffs of animal origin 

(presented  by the  Commission) 

EXPLANATORY MEMORANDUM 

A. 

Regulatory  framework 

Pursuant  to  Council  Regulation  (EEC)  No 2377/90  of  26 June  1990,l  the 
Commission  must  adopt  legally  binding  maximum  residue  limits  for  veterinary 
medicinal  products  in  foodstuffs  of  animal  origin.  These  limits  (hereinafter 
MRL)  are  established  in  accordance  with  the  regulatory  committee  procedure 
following  scientific  evaluation  by  the  Committee  for  Veterinary  Medicinal 
Products,  which then recommends classification  in one of the four  annexes to the 
Regulation: 

Annex I:  reserved  for  substances  for  which  a  MRL  can be  set  following 
evaluation of the toxicological risk they pose to human health; 

Annex II: substances for which there is no need to set a MRL; 

Annex III:  substances  for  which,  given the lack of scientific  data,  a MRL 
cannot  be  set  definitively  but  which,  without  compromising  consumer 
health,  may  be  given  a  provisional  MRL  for  a  defined  period  calculated 
according  to  the  time  needed  to  complete  the  scientific  studies.  This 
period may be extended once only in exceptional cases; 

Annex IV:  substances  for  which  it  appears  no  MRL  can  be  set  because 
they pose a risk to human health in whatever quantity. 

OJL224,  18.8.1990, p. 1. 

1 

B. 

Scientific  evaluation 

The  Commission  produced  a draft  Regulation  (HI/5425/95) amending  the  Annex 
to Regulation (EEC) No 2377/90 to include, inter alia, somatosalm.2 

This  followed  scientific  evaluation  of  this  substance  by  the  Committee  for 
Veterinary  Medicinal Products. 

The  Committee  recommended  that  somatosalm  (a  substance  produced  by  a 
biotechnological  process,  belonging  to the family  of  somatotrophins),  when used 
on young salmon, be included in Annex II on the following grounds: 

it is a protein with a very short half-life  ( < 30 min) in fish; 

the method of administration is a single injection  of the active substance  1 
or 2 years before  killing the fish. 

Along  with  five  other  substances,  viz:  azamethiphos,  streptomycin,  dihydrostreptomycin, 
gentamicin and neomycin, for which MRL were then established separately. 

C. 

1. 

2. 

Regulatory procedure and referral to the Council 

On  16 October  1995  the  Commission  sent  the  Committee  on  the  Adaptation  to 
the  Directives  on  Veterinary  Medicinal  Products 
Technical  Progress  of 
implementing  regulation  adding  (inter  alia) 
(regulatory  committee)  a  draft 
somatosalm,  on 
to  Annex II  of  Regulation  (EEC) 
No 2377/90. 

the  above  grounds, 

The draft  failed  to elicit a favourable  opinion from the Committee. 

Indeed,  claiming  that  the  moratorium  adopted  by  the  Council3  on  bovine 
somatotrophin  (BST)  would  be  "indirectly"  called  into  question  if  another 
somatotrophin  appeared  on  the  Community  market,  the  representatives  of  four 
Member States opposed the very principle of classifying  somatosalm in one of the 
annexes to Regulation (EEC) No 2377/90. 

It  should  be  noted  in  this  connection  that  (a)  the  abovementioned  Council 
moratorium  applies  only  to  bovine  somatotrophin  and  not  all  somatotrophic 
substances  and  (b)  it  emerges  from  the  assessment  report  by  the  Committee  on 
Veterinary  Medicinal Products (and from  the file submitted by the pharmaceutical 
company  concerned)  that,  unlike  BST,  somatosalm  is  used  neither  to  promote 
growth  nor  to  boost  animal  productivity,  but  solely  to  make  it  easier  for  young 
freshwater  salmon to adapt to seawater.  This single statement explains its  specific 
method  of  administration,  which  is  a  single  injection  of  active  substance  one  or 
two years before  the fish is killed. 

Following the Commission's request in April  1996 for further  information to take 
account  of  arguments  put  forward  by  the  representatives  of  certain  Member 
the  Committee  on 
States  opposed  to  the  classification  of  somatosalm, 
Veterinary  Medicinal  Products  looked  at  the  possibility  of  the  substance  being 
used fraudulently  as a growth promoter  in salmon and other species.  Its opinion, 
delivered  on 28 June  1996,  is unequivocal:  somatosalm  is only  active  in salmon, 
while  its  use  as  a  performance  enhancer  in  this  species  may  be  considered 
impossible owing to the substance's pharmacological properties and the method of 
administration,  which  guarantee  its  efficacy  (it must be  injected  directly  into  the 
stomach of each fish). 

The  Commission  would  also  stress  that  the  establishment  of  a  MRL  for  this 
substance is without prejudice  to the contents of any decision to be taken should a 
request be made for  marketing authorization,  such a decision being subject,  under 
Community  law, to autonomous assessment criteria and procedures. 

3 

Council  Decision  94/936/EEC  of  20  December  1994  amending  Decision  90/218/EEC  on  the 
marketing and administration of bovine somatotrophin (OJ L 366, 31.12.1994, p. 19). 

3. 

As the draft measures are not in accordance with the opinion of the Committee on 
the adaptation to technical progress of the Directives intended to remove technical 
barriers to trade  in  the veterinary  medicinal  products  sector,  the Commission  is 
sending the Council a proposal for a regulation under the procedure laid down in 
Article 8 of Regulation (EEC) No 2377/90. 

By  virtue  of  the  same  Article,  the  Council  is  invited  to  adopt  the  proposed 
measures within three months of the date of referral. 

PROPOSAL FOR A 

COUNCIL REGULATION (EC) 

amending Annex II of Council Regulation (EEC) N° 2377/90 
laying down a Community procedure for the establishment of maximum residue 
limits of veterinary medicinal products in foodstuffs  of animal origin 

THE COUNCIL OF THE EUROPEAN UNION, 

Having regard to the Treaty establishing the European Community, 

Having  regard  to  Council  Regulation  (EEC)  N°  2377/90  of  26  June  1990  laying  down  a 
Community  procedure  for  the  establishment  of  maximum  residue  limits  of  veterinary 
medicinal  products  in  foodstuffs  of  animal  origin'1',  as  last  amended  by  Commission 
Regulation (EC) N°  1433/96^'  and in particular Articles 6 and 8 thereof; 

Having regard to the proposal  from  the Commission 

Whereas, in accordance with Regulation (EEC) N° 2377/90, maximum residue limits must be 
established  progressively  for  all  pharmacologically  active  substances  which  are  used  within 
the  Community  in  veterinary  medicinal  products  intended  for  administration  to  food-
producing animals; 

Whereas maximum residue limits should  be established only after the examination within the 
Committee for Veterinary  Medicinal  Products of all the relevant  information  concerning  the 
safety  of residues of the substance concerned for the consumer of foodstuffs  of animal origin 
and the impact of residues on the industrial processing of  foodstuffs; 

Whereas,  in  establishing  maximum  residue  limits  for  residues  of  veterinary  medicinal 
products in foodstuffs  of animal origin, it is necessary to specify  the animal species in which 
residues may be present, the levels which may be present in each of the relevant meat tissues 

( l )O J N ° L 2 2 4,  18.08.1990, p  1 
< 2 )OJN°L  184, 24.07.1996, p 21 

^ 

obtained from the treated animal (target tissue) and the nature of the residue which is relevant 
for the monitoring of residues (marker residue); 

Whereas Somatosalm should be inserted into Annex II to Regulation (EEC) N° 2377/90 ; 
Whereas a period of 60 days should be allowed before the entry into force of this Regulation 
in  order  to  allow  Member  States  to  make  any  adjustment  which  may  be  necessary  to the 
authorisations to place the veterinary medicinal products concerned on the market which have 
been  granted  in  accordance  with  Council  Directive  81/851/EEC^',  as  last  amended  by 
Directive 93/40/EEC^' to take account of the provisions of this Regulation; 

Whereas,  in  accordance  with  the  procedure  laid  down  in  Article 8  of  Council  Regulation 
(EEC) No 2377/90, the draft of the measures to be adopted was submitted to the Committee 
for  the  Adaptation  to  Technical  Progress  of  the  Directives  on  the  Removal  of  Technical 
Barriers to Trade in the Veterinary Medicinal  Products Sector; whereas the Committee  was 
not able to deliver an opinion; whereas the Commission therefore proposed the measures to 
be adopted to the Council; 

(3> 
,4> 

OJ  N °L  317, 06.11.1981,  p 1 
O J N °L  214, 24.08.1993,  p  31 

HAS ADOPTED THE FOLLOWING REGULATION : 

Article 1 

Annex II of Regulation (EEC) N°2377/90 is hereby amended as set out in the Annex hereto. 
Article 2 
This  Regulation  shall  enter  into  force  on  the  sixtieth  day  following  its  publication  in  the 
Official  Journal of the European Communities; 

This Regulation shall be binding in its entirety and directly applicable in all Member States. 

Done at Brussels, 

For the Council 

> 

A. 
2. 

Annex II is modified as follows 
Organic chemicals 

Pharmacologically  active substances 

2.68. Somatosalm 

Salmon 

Animal species 

Other provisions 

ANNEX 

OQ 

ISSN 0254-1475 

COM(96) 34  final 

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