Proposal for a Council Regulation amending Annex II of Council Regulation (EEC) No 2377/90 laying down a Community procedure for the establishment of maximum residue limits of veterinary medicinal products in foodstuffs of animal origin
Date: 2000-07-12
Institutions: European Commission
Subjects: animal product, food inspection, human nutrition, marketing, veterinary drug

COMMISSION OF THE EUROPEAN COMMUNITIES

Brussels, 12.07.2000
COM(2000) 435 final

Proposal for a

COUNCIL REGULATION

amending Annex II of Council Regulation (EEC) No 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) N° 2377/90 of 26 June 19901, binding maximum
residue limits for veterinary medicinal products in foodstuffs of animal origin are established
at a Community level. These limits (hereinafter MRL) are established in accordance with the
regulatory committee procedure, laid down in article 8, following scientific evaluation by the
Committee for Veterinary Medicinal Products. The pharmacologically active substances are
then classified 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.

B.

SCIENTIFIC ELEMENTS

BST is a substance with hormonal effect which is used to increase lactation in cows. The
Committee for Veterinary Medicinal Products recommended that
recombinant bovine
somatotropins (rBST) (substances produced by a biotechnological process, which are proteins
closely related to the four variants of natural bovine somatotropin), when used on bovine, be
included in Annex II on the following grounds:

–

–

–

–

–

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rBST are biologically active analogues of endogenous bovine somatotropin which is
a normal component of the bovine milk;

rBST are degrated in the gastrointestinal tract;

rBST stimulate the production of insulin growth factor I (IGF-I) (for which
production is stimulated by rBST and possible factor that may be involved in the
development of insulin-dependent diabetes and suggested as a marker of ongoing
breast cancer) but may be absorbed to a low degree from the gastrointestinal tract;

Levels of both bovine somatotropin and IGF-I after treatment with rBST have been
shown to be at or within physiological limits in milk and tissues;

The additional intake of IGF-I through ingestion of cow’s milk from rBST-treated
cows is regarded as biologically insignificant compared to the endogenous amount

OJ L 224, 18.8.1990, p. 1.

2

C.

1.

2.

3.

4.

produced daily in the human gastrointestinal tract and therefore does not constitute a
health hazard for the consumer.

REGULATORY PROCEDURE AND REFERRAL TO THE COUNCIL

Despite of the existing marketing ban2 two companies3 have maintained their
application to obtain the fixing of MRLs for rBST in accordance with Regulation
(EEC) n°2377/90. The Court of First instance ruled in that context that the existence
of a marketing ban does not justify to refuse the granting of an MRL (cases T-
120/964 and T-112/975) but that decision is now subject to appeal before the Court of
Justice (Case C-298/99 P).

In the light of new scientific findings and information available since the original
recommendation issued by the former Committee for Veterinary Medicinal Products
in November 1994, which recommended that rBST be included in Annex II of
Council Regulation (EEC) No 2377/90 and taking into account the judgement of the
Court of First Instance in the case T-120/96, the European Commission requested the
EMEA to re-examine its previous recommendation on 1 February 1999.

After this re-evaluation the Committee of Veterinary Medicinal Products confirmed
on 14 July 1999 his previous recommendation to include recombinant bovine
somatotropin (rBST) in annex II. The Commission decided on 8 December 1999 to
submit the draft proposal for establishing MLRs for rBST to the Standing Committee
on Veterinary Medicinal Products.

The Commission sent to the Standing Committee a draft implementing regulation
adding (inter alia) rBST, on the above grounds, to Annex II of Regulation (EEC) N°
2377/90. The draft failed to elicit a favourable opinion from the Committee on 4
February 2000 where 10 Member States (73 votes) voted against, 4 Member States
(13 votes) in favour and 1 Member State (4 votes) abstained.

Indeed, the representatives of the ten Member States opposed the very principle of
classifying rBST in one of the annexes to Regulation (EEC) N° 2377/90, because of
the existing marketing ban (despite the judgements of the CFI) and because of the
remaining scientific uncertainty concerning the human health implications of
residues of IGF I in milk and milk products.

It should be noted in this connection that (a) no scientific evidence of a risk
concerning a likely initiation of cancer linked to IGF-I has been demonstrated so far
(b) it emerges from the scientific assessment carried out by the Committee on
Veterinary Medicinal Products that both rBST and IGF-I (for which production is
stimulated by rBST) are either degraded or absorbed at very low and physiological
level. However, the Commission is aware of the remaining scientific uncertainty
concerning the human health implications of residues of IGF I in milk and milk
products.

2

3

4

5

Council Decision 1999/879/EC of 17.12.1999.
Eli Lilly and Monsanto Company.
Judgement of the Court of First Instance of 25 June 1998, EC Reports 1998 page II-2571.
Judgement of the Court of First Instance of 22 April 1996, EC Reports 1999.

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From a general point of view, it should be stressed that because of the existing
prohibition concerning the placing on the market and administration of BST, any
marketing authorisation application for rBST would be rejected.

5.

As the proposed measures are not in accordance with the opinion of the Standing
Committee, the Commission is sending to the Council a proposal for a regulation to
be adopted 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.

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Proposal for a

COUNCIL REGULATION

amending Annex II of Council Regulation (EEC) No 2377/90 laying down a Community
procedure for the establishment of maximum residue limits of veterinary medicinal
products in foodstuffs of animal origin

(Text with EEA relevance)

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community,

Having regard to Council Regulation (EEC) No 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 origin6, as last amended by Commission
Regulation (EC) No 2758/997 and in particular Articles 6 and 8 thereof,

Having regard to the proposal from the Commission,

Whereas:

(1)

(2)

(3)

(4)

(5)

In accordance with Regulation (EEC) No 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.

Maximum residue limits should be established only after the examination within the
Committee for Veterinary Medicinal Products of all
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.

the relevant

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

Recombinant Bovine Somatotropins should be inserted into Annex II to Regulation
(EEC) No 2377/90.

The Commission is aware that there remains scientific uncertainty concerning the
human health implications of residues of IGF I in milk and milk products and that its
intention is to pursue these matters through further scientific studies and research and

6

7

OJ L 224, 18.8.1990, p. 1.
OJ L 331, 23.12.1999.

5

by requesting at
Committees.

the appropriate time a new opinion from one of its Scientific

The Council has adopted decision 1999/879/EC8 of 17 December 1999 concerning the
placing on the market and administration of bovine somatotrophin (BST) and
repealing Decision 90/218/EEC9 in such a way that it permanently prohibits the use of
BST in the Community for reasons of animal health and welfare.

The Standing Committee on Veterinary Medicinal Products referred to in Article 8 of
Regulation (EEC) No 2377/90 and consulted by the Commission has not delivered a
favourable opinion on the Commission proposed measures.

(6)

(7)

HAS ADOPTED THIS REGULATION:

Annex II of Regulation (EEC) No 2377/90 is hereby amended as set out in the Annex hereto.

Article 1

This Regulation shall enter into force on the twentieth day following that of its publication in
the Official Journal of the European Communities.

Article 2

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

Done at Brussels,

For the Council
The President

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9

OJ L 331, 23.12.1999, p. 71–72.
OJ L 116, 8.5.1990, p. 27.

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The following substance is inserted in Annex II to Regulation (EEC) No 2377/90 (List of substances not subject to maximum residue limits)

ANNEX

2. Organic compounds

Pharmacologically active substance(s)

Animal species

Other provisions

Recombinant Bovine Somatotropins

Bovine

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