•it it 
it ir 
it if COMMISSION OF THE EUROPEAN COMMUNITIES 
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. Regulatory procedure and referral to the Council 
1. On 16 October 1995 the Commission sent the Committee on the Adaptation to 
Technical Progress of the Directives on Veterinary Medicinal Products 
(regulatory committee) a draft implementing regulation adding (inter alia) 
somatosalm, on the above grounds, to Annex II of Regulation (EEC) 
No 2377/90. 
The draft failed to elicit a favourable opinion from the Committee. 
2. 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 
States opposed to the classification of somatosalm, the Committee on 
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)OJN°L224, 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> OJ N°L 317, 06.11.1981, p 1 
,4> OJN°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 
> 
ANNEX 
A. Annex II is modified as follows 
2. Organic chemicals 
Pharmacologically active substances Animal species Other provisions 
2.68. Somatosalm Salmon 
OQ 

ISSN 0254-1475 
COM(96) 34 final 
DOCUMENTS 
EN 05 03 
Catalogue number : CB-CO-96-039-EN-C 
ISBN 92-77-99947-0 
Office for Official Publications of the European Communities 
L-2985 Luxembourg