Explanatory Memorandum to COM(1980)614 - - Main contents
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This page contains a limited version of this dossier in the EU Monitor.
| dossier | COM(1980)614 - . |
|---|---|
| source | COM(1980)614  |
| date | 29-10-1980 |
COLLECTION RELIEE DES DOCUMENTS 'COM'
COM (80)614
Contents
- Vol. 1980/0193
- Brussels, 31st October 1980
- PROPOSAL
- Having regard to the Opinion of the European Parliament/
- Whereas, moreover, if the use of natural substances may be authorised for therapeutic
- . and of fresh meat containing residues in excess of the tolerance is prohibited*
- 2. However, the examination of the fresh meat may
- Domestic animals covered by this Regulation must be registered or identified to permit investigation where necessary at the holding of origin or transit. ’
- All costs for the controls and examinations provided for in Article 5 shall be
- , Article 9
Disclaimer
Conformement au reglement (CEE, Euratom) n° 354/83 du Conseil du ler fevrier 1983 concernant I’ouverture au public des archives historiques de la Communaute economique europeenne et de la Communaute europeenne de I’energie atomique (JO L 43 du 15.2.1983, p.
1), tel que modifie par le reglement (CE, Euratom) n° 1700/2003 du 22 septembre 2003 (JO L 243 du 27.9.2003, p.
1), ce dossier est ouvert au public. Le cas echeant, les documents classifies presents dans ce dossier ont ete declassifies conformement a I’article 5 dudit reglement.
In accordance with Council Regulation (EEC, Euratom) No 354/83 of 1 February 1983 concerning the opening to the public of the historical archives of the European Economic Community and the European Atomic Energy Community (OJ L 43, 15.2.1983, p.
1), as amended by Regulation (EC, Euratom) No 1700/2003 of 22 September 2003 (OJ L 243, 27.9.2003, p.
1), this file is open to the public. Where necessary, classified documents in this file have been declassified in conformity with Article 5 of the aforementioned regulation.
In Obereinstimmung mit der Verordnung (EWG, Euratom) Nr. 354/83 des Rates vom 1. Februar 1983 uber die Freigabe der historischen Archive der Europaischen Wirtschaftsgemeinschaft und der Europaischen Atomgemeinschaft (ABI. L 43 vom 15.2.1983, S.
1), geandert durch die Verordnung (EG, Euratom) Nr. 1700/2003 vom 22. September 2003 (ABI. L 243 vom 27.9.2003, S.
1), ist diese Datei der Offentlichkeit zuganglich. Soweit erforderlich, wurden die Verschlusssachen in dieser Datei in Obereinstimmung mit Artikel 5 der genannten Verordnung freigegeben.
COMMISSION OF THE EUROPEAN COMMUNITIES
COCKS*? *14 final
PROPOSAL FOR A COUNCIL REGULATION (EEC)
CONCERNING THE USE OF SUBSTANCES WITH A HORMONAL ACTION AND THOSE HAVING A THYROSTATIC ACTION IN DOMESTIC ANIMALS
C0M(80) 614 final
EXPLANATORY NOTE
At its meeting of 30th September ■ , . ' ■ , ,
the Council invited the Commission to submit urgent proposals concerning substances with hormonal effect in animal production following its recent favourable orientation : ,
- envisaging the prohibition of the use of all hormonal substances for rearing
animals and in consequence their presence in meat produced or imported into the Community, . ' ■ . .
- recognising the necessity to accelerate the work of harmonisation in this .
. field, in order to provide uniform and reinforced controls not only at the level of the final product (by fixing levels for residues and methods of analysis) but also upstream at the level of production and distribution of hormones (rules concerning distribution of veterinary medicines) and at _
the place of livestock rearing and at the abattoirs. . -
The Commission has examined the subject of the use of hormones in animal production, the presence of these substances in meat and meat products, their, possible effects on human health and the quality of the products0 This '
' ' ' • ' ■ J ' ■
examination has included both natural and artificial hormones* ...
The Commission considers that rapid action must be taken to prohibit the use of these substances for rearing animals* This is necessary in particular in ; respect of the artificial substances in view of the effects of these substances in relation to carcinogenicity, physiological effects and meat quality* The latter aspect is also important as regards use of natural substances" since physiological effects may also occur when exposure to exceptional levels accidentally takes place* The need for control is.obvious*
-Although Member States already have national measures in force* .it is clear.that no control system will be fully effective unUst it ia developed end spoiled on a Community basis* These rules are needed so that trade of animals and fresh meat can flow unimpeded within the Community,, ' . .
, These controls .need- to be, applied at the level,of distribution of the products* . at the level, of the place of production in respect of livestock*' and at the - .
abbatoirs producing fresh meat* As regards the production and distribution of x
hormones existing initiatives at Community level must be completed and where necessary extended* The Commission recalls that it made a proposal in respect of - veterinary medicines in 1976. As a result of discussion of this proposal* the Commission considers that it should also include a,provision that-hormonal substances • which can be used in the preparation of'veterinary medicines" should be supplied ■ only to authorised persons;. The .Commission urges the Council to resolve this question ancf take an early decision. . ' . ’
A related initiative which the Commission is urgently considering' concerns a ' ■
, draft, proposal - on medicated feedings.tuffs* It -is already necessary* however* ■ r to provide for controls on the distribution and use of hormones for veterinary therapeutic purposes* ■ . „ '
To' support this primary control* -measures must be adopted to -monitor live, animals ;on'the. farm for illicit use of these substances*. This action will need .
. appropriate sampling procedures adopted to the different animal categories,- and . suitable sanctions in case of inf-rinaements' , - - 1 ■
A further strategic point where control must be considered is at the slaughterhouse, in the form of screening fresh meat for residues as part of the post™mortem examination* ' . . • The extension of this examination-to- ante-mortem
inspection of the live animal either at the slaughterhouse or. farm of origin will probably.provide a moreeffective control* In all cases it is essential to ' provide a common regulation for laboratory methods which must be used for these examinations* In addition* to enable tracing of the origin of animals when positive results are found* the establishment' of a system to permit the -. identification of animals in-the Community is important* . , ■ .
The work already dene by the Commission in respeet of the preBlfms of control has concentrated particularly on methods of analysis. Good methods which are suitable both qualitatively and quantitatively are not easily^developed but recent progress should enable the Commission to take appropriate action shortly in this respect particularly as regards artificial substances which are of special, concern. This question is more difficult in respect of nature1 hormones as there is always a certain level of these hormones naturally present in meat animals. In consequence the development of checks on the use of these substance is more difficult.
In order to avoid distortion of competition it is necessary to provide for , the harmonisation of the means of financing these controls. To this effec" provision is included so that these costs must be borne by the product its If.
The proposal of the Commission lays doun the basis for these controls. .
The introduction of a ban at the Community level, and of the necessary control measures, wi ll involve additional costs of production which m-,y ’ eventually’be reflected in the long term on the price of meat. But at the ^ time consumers will be assured of better protection and a 'better quality prodt. -
for a
COUNCIL REGULATION
concerning the use of substances with a hormonal action and those having a thyrostatic action in domestic animals •
THE COUNCIL OF THE EUROPEAN COMMUNITIES : .
Having regard to the Treaty establishing the European Economi^ Community and in particular Article 43 thereof; , .. , . j . ,
- - . - •}
Having regard to the proposal from the Commission/ j '
Having regard to the Opinion of the Economic and Social Committee/
Whereas due to the residues that they leave in meat, substances with a hormonal
action or thyrostatic action may be dangerous to human health; whereas these •
substances may also affect the quality of the meat; *
Whereas for these reasons, their use for fattening purposes must be banned, in the ' interest of the consumer; -
purposes, this must be at the same time strictly controlled, both by the
establishment of a list of authorised products and by the establishment of the
conditions under which they may be used; whereas the particular danger of artificial substances does not permit their inclusion under this autorisation;
Whereas the present Regulation calls for means of application in particular concerning the fixing of tolerances, frequency of sampling and methods used to detect the presence of residues;
5
- ■ ; - 2 - ._ . ■ -
• ■ • v - .
Whereas means permitting the assurance of an effective control of Community provisions and of the application of the necessary sanctions must be established;
Whereas it is suitable, in order to avoid distortion of competition, to provide that the costs resulting from this control must be borne by the product itself V in conformity with the current practice generally followed in the Community,
HAS ADOPTED THIS REGULATION : ’ ,
; Article 1 . . ' "• .
This Regulation shall apply to the use of substances with a hormonal action and those having a thyrostatic action in domestic animals' and to the presence of residues of these substances in domestic animals, fresh meat and fresh poultry meat* . - . • . ■ •'
■ ' . Article 2 . . ■
For the purposes of this Regulation the following definitions shall apply : 1
' \ \ .
(a) Domestic animals : animals of the following species : bovine, swine, sheep,
goats, domestic solipeds and poultry* '
(b) Fresh meat : fresh meat as defined in Article 1 of Directive 64/433/EEC and in
Article 2 of Directive 72/462/EEC, . , ...
(c) Fresh poultrymeat : fresh poultrymeat as defined in Article 1 of Directive
71/118/EEC* , • : ' ' " . ’ ...
(d) Residue : detectable quantities of a substance with a hormonal or thyrostatic
action and their metabolites* . ,
(e) Examination for residues : the examination for detection of residues* ,
(f) Tolerance : the maximum permitted quantity of residue in domestic animals or
in fresh meat * - -
(g) Holding : an officially supervised agricultural, industrial or commercial
undertaking in which domestic animals are regularly kept*- ,
. ■ ■ ' . ■■ . r
. ■ • . • . - t . . ■ - • • .
■ " : ■ -*-■ . £> "
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Article 3 • |
Notwithstanding Article 4, • |
■ . , . - - • . ; ■ ■ ■ V ' ■ - i
(a) The use on domestic animals of substances with oestrogenic, .
androgenic and gestagenic effect and of substances having a thyrostatic ;
effect is prohibited* < i,
(b) The putting into trade in the territory of the Community of domestic animals ?
. Article 4 >,
1* The use of natural hormonal substances with actions or effects referred to • in Article 3(a) is authorised to treat domestic animals therapeutically including synchronisation of oestrus provided that ;
- the competent authority has approved the product for therapeutic use and its . conditions of manufacture in accordance with Council Directive , on
the approximation of the laws of Member States on medicinal veterinary . products, and has specified the conditions of use including a withdrawal period . during which the domestic animal cannot be delivered for slaughter, '
, - the product is administered by a veterinarian, who shall keep a record of the use of the product, including quantity date and identification of the treated . domestic animal, ,
- manufacturers and all handlers of these substances shall keep a record of
production and sales* . -
- . . • . . . / .
2* Additional provisions concerning the application of paragraph .1, in particular -the establishment of a Community list of natural hormonal substances, shall be . adopted by the Council acting by a qualified majority on a Proposal from the Commission* This list may be amended in accordance with the procedure of Article 9* ,
Article 5 • "
1. Fresh meat put into trade, in the Community must be subject to examination for residues of the substances referred to in Article 3.
be replaced or supplemented by an examination of the domestic animal either at the place of slaughter or at the holding of origin or transit.
3. The Council, acting by a qualified majority on Proposal from the Commission,
. • . ' \ \ -shall decide the general rules for the application of paragraphs 1 and 2 in
particular : .
•- the frequency of sampling, ■ . .
- the tolerances for residues.
4. The methods and procedures required for detecting the presence of residues of the substances shall be decided in accordance with the procedure laid down in Artiple 9. - - . ’
Article 6 .
Domestic animals covered by this Regulation must be registered or identified to permit investigation where necessary at the holding of origin or transit. ’
- • . Article 7 ' ' ■ ■
’ ' . ‘ / • /
borne by a tax on the..product at the slaughterhouse without reimbursement from public funds. ^ ,
Article 8 ^ '
Member States shall ensure that, in case of contravention of the present Regulation:
- domestic animals and fresh meat concerned are confiscated and destroyed;
- sanctions are Applied to all persons contravening the present Regulation.
f
This Regulation shall not apply to the use of substances for the purposes of Pfeseahah* ,
‘ . Article 10
1*.Where the procedure laid down in this Article is to be used, the matter shall - be referred without delay to the Standing Veterinary Committee (hereinafter referred to as the Committee), set up by the Council Decision of 15 October 1968, by the chairman, either oh his own initiative or at the request of a ‘ Member State* . > • - .
2* Within the Committee, the votes of the Member States shall be weighted as provided in Article 148(2) of the Treaty* The chairman shall not vote* •
3* The Commission representative shall submit a draft of the measures to be • adopted* The Committee shall deliver its opinion on the measures within a period to be determined by the chairman in keeping with the urgency of the ) question submitted for examination* Opinions shall be delivered by a majority of 41 votes*
4* The Commission shall adopt the measures and shall implement them immediately,' ' where they are in accordance with the opinion of the Committee* Where they are not in accordance with the opinion of the Committee or if no opinion is . delivered, the Commission shall without delay submit to the Council a proposal : on the measures to be adopted* The Council shall adopt the measures by a
qualified majority* , ' '
If the Council has not adopted any measures within three months from the date on which the proposal was submitted to it, the Commission shall adopt the proposed measures and apply them immediately* , .
. "\ Article 11
This Regulation shall enter into force on 1 January 1981.
’ . ■ • ' ^ . ■
This Regulation shall be binding in its entirety and directly applicable in all Member States. . 1