10. 3. 89 Official Journal of the European Communities No C 61/5 
II 
(Preparatory Acts) 
COMMISSION 
Proposal for a Council Regulation (EEC) laying down a Community procedure for the 
establishment of tolerances for residues of veterinary medicinal products 
COM(88) 779 final 
(Submitted by the Commission on 10 January 1989) 
(89/C 61/07) 
THE COUNCIL OF THE EUROPEAN COMMUNITIES, 
Having regard to the Treaty establishing the European 
Economic Community, and in particular Article 43 
thereof, 
Having regard to the proposal from the Commission, 
Having regard to the opinion of the European 
Parliament, 
Having regard to the opinion of the Economic and 
Social Committee, 
Whereas the use of veterinary medicinal products in 
food-producing animals may result in the presence of 
residues in foodstuffs obtained from treated animals; 
Whereas, in accordance with the principles laid down by 
Council Directive 81/851/EEC (*), it is necessary to 
ensure that the withdrawal period between the last 
administration of a veterinary medicinal product to food-
producing animals and the production of foodstuffs from 
such animals is long enough to ensure that such food­
stuffs do not contain any residues which might constitute 
a health hazard to the consumer; 
Whereas, as a result of scientific and technical progress, 
it is possible to detect the presence of residues of 
veterinary medicines in foodstuffs at ever lower levels; 
Whereas, therefore, it is necessary to establish tolerances 
for the maximum levels of residues which may be 
accepted in foodstuffs of animal origin in accordance 
with generally recognized principles of safety assessment: 
Whereas the establishment of different tolerances by 
Member States may hinder the free movement of 
veterinary medicinal products and of foodstuffs of 
animal origin: Whereas, therefore, it is necessary to lay down a 
procedure for the establishment of tolerances for 
residues of veterinary medicinal products by the 
Community, following a single scientific assessment of 
the highest possible quality; 
Whereas the need for the establishment of tolerances by 
the Community is recognized in the Community rules 
relating to trade in foodstuffs of animal origin: 
Whereas, therefore, no new veterinary medicinal product 
containing a new active substance not previously used in 
food-producing animals should be authorized for use in 
the Community unless a tolerance for residues of that 
substance has been established by the Community; 
whereas the person responsible for marketing a new. 
veterinary medicinal product of this nature should be 
permitted to avail himself of the procedures established 
by Council Directive 87/22/EEC of 22 December 1986 
on the approximation of national measures relating to 
the placing on the market of high-technology medicinal 
products, particularly those derived from biotech­
nology O; 
Whereas arrangements must also be made for the 
establishment of tolerances for substances which are 
currently used in veterinary medicines administered to 
food-producing animals; whereas, however, in view of 
the complexity of this matter and the large number of 
substances involved, long transitional arrangements are 
required; 
Whereas the tolerances should be adopted by a rapid 
procedure which ensures close cooperation between the 
Commission and the Member States through the 
Committee for Veterinary Medicinal Products estab­
lished by Directive 81/851/EEC; whereas an urgent 
procedure is also required to ensure the swift review of 
any tolerance which may not be sufficient to protect 
public health; 
(*) OJ No L 317, 6. 11. 1981, p. 1. (2) OJ No L 15, 17. 1. 1987, p. 38. 
No C 61/6 Official Journal of the European Communities 10. 3. 89 
Whereas the information necessary to assess the safety of 
residues should be presented in accordance with the 
principles laid down by Council Directive 81/852/EEC 
of 28 September 1981 on the approximation of the laws 
of the Member States relating to analytical, pharmaco-
toxicological and clinical standards and protocols in 
respect of the testing of veterinary medicinal 
products ('), as amended by Directive 87/20/EEC (2), 
HAS ADOPTED THIS REGULATION: 
Article 1 
For the purposes of this Regulation, the following 
definitions shall apply: 
1. 'Residues of veterinary medicinal products', all active 
ingredients of veterinary medicinal products or 
metabolites thereof which remain in meat or other 
foodstuffs originating from the animal to which the 
medicinal product in question has been administered. 
2. 'Tolerance', the maximum level or residues of 
veterinary medicinal products which may be accepted 
by the Community and which do not present a hazard 
for the health of the consumer of foodstuffs of animal 
origin. 
Article 2 
A tolerance shall be established in accordance with the 
provisions of this Regulation, having regard to all the 
information available, and in accordance with generally 
recognized principles of safety assessment. A tolerance 
may be reduced to take account of the level of residues 
which is expected to result from the correct adminis­
tration of the veterinary medicinal product to the animal 
species concerned. It may also be reduced where it 
appears that residues may cause difficulties for the 
industrial processing of foodstuffs. A tolerance shall be 
expressed in terms of micrograms per kilogram (parts per 
billion) on a fresh weight basis. Where necessary, a 
separate tolerance shall be established for each foodstuff 
of animal origin (muscle tissue, liver, kidney, fat, skin, 
milk, eggs, honey, ect.). 
The list of substances used as active ingredients in 
verterinary medicinal products in respect of which 
tolerances have been established shall be contained in 
Annex I to this Regulation, which shall be adopted in 
accordance with the procedure laid down in Article 9. 
Except as provided for in Article 10, any amendments to 
Annex I shall be adopted in accordance with the same 
procedure. 
O OJ No L 317, 6. 11. 1981, p. 16. 
O OJ No L 15, 17. 1. 1987, p. 34. Article 3 
Where, having regard to the nature and pattern of use of 
a substance used as an active ingredient in veterinary 
medicinal products, it is not necessary to establish a 
tolerance for residues of that constituent or its metab­
olites, that substance shall be included in a list in Annex 
II to this Regulation. Annex II shall be adopted in 
accordance with the procedure laid down in Article 9. 
Except as provided for in Article 10, any amendments to 
Annex II shall be adopted in accordance with the same 
procedure. 
Article 4 
A provisional tolerance may be adopted for a substance 
used as an active ingredient in veterinary medicinal 
products provided that there are no grounds for 
supposing that residues of the substance concerned at the 
level proposed present a hazard for the health of the 
consumer. A provisional tolerance shall apply for a 
defined period of time, which shall not exceed three 
years, and shall not be renewed more than once. 
The list of substances used as active ingredients in 
veterinary medicinal products in respect of which 
provisional tolerances have been established shall be 
contained in Annex III to this Regulation, which shall be 
adopted in accordance with the procedure laid down in 
Article 9. Except as provided for in Article 10, any 
amendments to Annex III shall be adopted in accordance 
with the same procedure. 
Article 5 
Where it appears that a tolerance cannot be established 
in respect of a substance used as an active ingredient in 
veterinary medicinal products because residues of the 
substances concerned, at whatever level, in foodstuffs of 
animal origin constitute a hazard to the health of the 
consumer, that substance shall be included in a list in 
Annex IV to this Regulation. Annex IV shall be adopted 
in accordance with the procedure laid down in Article 9. 
Except as provided for in Article 10, any amendements 
to Annex IV shall be adopted in accordance with the 
same procedure. 
The administration of the substances listed in Annex IV 
to food-producing animals shall be prohibited 
throughout the Community. 
Article 6 
A Member State shall not authorize the marketing of a 
veterinary medicinal product intended for administration 
to food-producing animals containing an active 
substance which was not authorized for use in veterinary 
medicinal products intended for administration to food-
producing animals in the Member State concerned on 
the date of entry into force of this Regulation unless the 
substance concerned has been included in Annex I, II or 
III. 
10. 3. 89 Official Journal of the European Communities No C 61/7 
Unless it is developed by one of the biotechnological 
processes listed in Part A of the Annex to Directive 
87/22/EEC, a veterinary medicinal product covered by 
the provisions of the preceding paragraph shall be 
regarded as a high-technology medicinal product to 
which Part B of the Annex to Directive 87/22/EEC 
applies. 
Article 7 
1. In order to obtain the inclusion of an active 
substance referred to in Article 6 in Annex I, II or III to 
this Regulation, the person responsible for marketing 
shall submit an application to the Commission. The 
application shall contain the information and particulars 
referred to in Annex V and shall conform to the prin­
ciples laid down in Directive 81/852/EEC. 
2. After verifying that the application is submitted in 
correct form, the Commission shall forthwith submit the 
application for examination by the Committee for 
Veterinary Medicinal Products established by Article 16 
of Directive 81/851/EEC (hereinafter referred to as 'the 
Committee'). The Committee may request one of its 
Members to act as rapporteur and to undertake an initial 
evaluation of the application. 
3. Within 120 days of referral of the application to the 
Committee, and having regard to the observations 
formulated by the members of the Committee, the 
Commission shall prepare a draft of the measures to be 
taken. However if, after consulting the Committee, the 
Commission considers that the information submitted by 
the person responsible for marketing is insufficient to 
enable such a draft to be prepared, the Commission may 
request that person to provide additional information. If 
the person responsible for marketing agrees to provide 
such information, the Commission will prepare a draft of 
the measures to be taken within 90 days of its receipt. 
4. The draft of the measures to be taken shall be 
communicated forthwith by the Commission to the 
Member States and to the person responsible for 
marketing. Within a further 60 days the person 
responsible for marketing may, at his request, explain 
himself orally or in writing before the Committee. The 
Commission may, at the request of the applicant, extend 
this time limit. 
5. Within a further 60 days the Commission shall 
submit the draft measures to the Committee for adoption 
in accordance with the procedure laid down in Article 9. 
Article 8 
The following provisions shall apply in respect 
of substances which are authorized for use as active 
ingredients in veterinary medicinal products on the date 
of entry into force of this Regulation: 
1. After consulting the Committee, the Commission shall 
publish a timetable for the consideration of these substances, including time limits for submission of the 
information referred to in Annex V. The Member 
States and persons responsible for marketing the 
veterinary medicinal products concerned shall ensure 
that all relevant information is submitted to the 
Commission in accordance with the requirements of 
Annex V and in conformity with the principles laid 
down in Directive 81/852/EEC before the relevant 
time limits. 
2. After verifying that the information is submitted in 
correct form, the Commission shall forthwith submit 
the information to the Committee for examination. 
The Committee may request one of its members to 
act as rapporteur and to undertake an initial 
evaluation of information. 
3. Having regard to the observations formulated by the 
members of the Committee, the Commission shall 
prepare a draft of the measures to be taken. However 
if, after consulting the Committee, the Commission 
considers that the information submitted by the 
person responsible for marketing is insufficient to 
enable such a draft to be prepared, the Commission 
may request that person to provide additional infor­
mation, within a specified period. 
4. The draft of the measures to be taken shall be 
communicated forthwith by the Commission to the 
Member States and those persons responsible for 
marketing who have submitted information to the 
Commission. These persons may, at their request, 
explain themselves orally or in writing before the 
Committee. 
5. The Commission shall forthwith submit the draft 
measures to the Committee for adoption in 
accordance with the procedure laid down in Article 9. 
Article 9 
1. Where the procedure laid down in this Article is to 
be followed, matters shall be referred to the Committee 
by the chairman either on his own initiative or at the 
request of a Member State. 
2. The representative of the Commission shall submit 
to the Committee a draft of the measures to be adopted. 
The Committee shall deliver its opinion on the draft 
within a time limit set by the chairman, having regard to 
the urgency of the matter. It shall act by a qualified 
majority, the votes of the Member States being weighted 
as provided for in Article 148 (2) of the Treaty. The 
chairman shall not vote. 
3. (a) The Commission shall adopt the measures 
envisaged where they are in accordance with the 
opinion of the Committee. 
No C 61/8 Official Journal of the European Communities 10. 3. 89 
(b) Where the measures envisaged are not in 
accordance with the opinion of the Committee, or 
if no opinion is adopted, the Commission shall 
without delay propose to the Council the 
measures to be adopted. The Council shall act by 
a qualified majority. 
(c) If within three months of the proposal being 
submitted to it, the Council has not acted, the 
proposed measures shall be adopted by the 
Commission. 
Article 10 
1. Where a Member State, as a result of new infor­
mation or a reassessment of existing information, 
considers that the urgent amendment of a provision 
contained in Annexes I to IV is necessary in order to 
protect human or animal health, and therefore requires 
swift action to be taken, that Member State may tempo­
rarily suspend the operation of the provision concerned 
in its own territory. In that case, it shall immediately 
notify the other Member States and the Commission of 
the measures, attaching a statement of the reasons 
therefor. 
2. The Commission shall as soon as possible examine 
the grounds given by the Member State concerned and 
shall consult the Member States within the Committee 
and shall then deliver its opinion forthwith and take 
appropriate measures. The Commission shall immediately 
notify the Council and the Member States of any 
measures taken. Any Member State may refer the 
Commission's measures to the Council within 15 days of 
such notification. The Council, acting by a qualified 
majority may take a different decision within 15 days of 
the date on which the matter was referred to it. 
3. If the Commission considers that it is necessary to 
amend the provision of Annexes I to IV concerned in 
order to resolve the difficulties referred to in paragraph 1 
and to ensure the protection of human health, it shall 
initiate the procedure laid down in Article 11 with a view 
to adopting those amendments; the Member State which 
has taken measures under paragraph 1 may maintain 
them until the Council or the Commission has taken a 
decision in accordance with the abovementioned 
procedure. 
Article 11 
1. Where the procedure laid down in this Article is to 
be followed, matters shall be referred to the Committee 
by the chairman either on his own initiative or at the 
request of a Member State. 2. The representative of the Commission shall submit 
to the Committee a draft of the measures to be adopted. 
The Committee shall deliver its opinion on the draft 
within a time limit set by the chairman, having regard to 
the urgency of the matter. It shall act by a qualified 
majority, the votes of the Member States being weighted 
as provided for in Article 148 (2) of the Treaty. The 
chairman shall not vote. 
3. (a) The Commission shall adopt the measures 
envisaged, where they are in accordance with the 
opinion of the Committee. 
(b) Where the measures envisaged are not in 
accordance with the opinion of the Committee, or 
if no opinion is • adopted, the Commission shall 
without delay propose to the Council the 
measures to be adopted. The Council shall act by 
a qualified majority. 
(c) If within 15 days of the proposals being submitted 
to it, the Council has not acted, the proposed 
measures shall be adopted by the Commission. 
Article 12 
Any changes which are necessary to adapt Annex V to 
take account of scientific and technical progress shall be 
adopted in accordance with the procedure laid down in 
Article 2c of Directive 81/852/EEC. 
Article 13 
As soon as possible after the amendment to Annex I, II, 
III or IV, the Commission shall publish a summary 
assessment of the safety of the substances concerned. 
The confidential nature of any proprietary data shall be 
respected. 
Article 14 
Member States shall ensure that the withdrawal periods 
between the last administration of a veterinary medicinal 
product to animals and the production of foodstuffs 
from such animals are established in such a manner as to 
ensure that the tolerances provided for in accordance 
with this Regulation are not exceeded. 
Article 15 
Member States may not prohibit or impede the putting 
into circulation within their territories of foodstuffs of 
animal origin on the ground that they contain residues of 
10. 3. 89 Official Journal of the European Communities No C 61/9 
veterinary medicinal products if the quantity of residue Article 17 
does not exceed the tolerance provided for in Annex I or ,_,,._,.. . „ . . .. . ^ . 
Ill, or if the substance concerned is listed in Annex II. Trhl* ReSulatlon sh*} ln no way prejudice the application 
or Community legislation prohibiting the use in livestock 
Article 16 farming of certain substances having a hormonal action. 
With effect from 1 January 1997, the administration to 
food-producing animals of veterinary medicinal products Article 18 
containing active substances which are not mentioned in T, • D , . • n » • . r 1 T 1flQ1 T TT TTT i ii L i •!_• J • L- i_ This Regulation shall enter into torce on 1 January 1992. Annex I, II or III shall be prohibited within the ° J J 
Community, except in the case of clinical trials which 
have been notified to or approved by the competent This Regulation shall be binding in its entirety and 
authorities. directly applicable in all Member States. 
ANNEX V 
Information and particulars to be included in an application for the establishment of a tolerance for 
residues of a veterinary medicinal product 
1. Administrative particulars 
1.1. Name or corporate name and permanent address of the person responsible for placing the veterinary 
medicinal product on the market. 
1.2. Name of the veterinary medicinal product. 
1.3. Qualitative and quantitative composition in terms of active principles, with mention of the interna­
tional non-proprietary name recommended by the World Health Organization where such name 
exists. 
1.4. Manufacturing authorization. 
1.5. Marketing authorizations. 
1.6. Summary of the characteristics of the veterinary medicinal product prepared in accordance with 
Article 5a of Directive 81/851/EEC. 
2. Identity 
2.1. International non-proprietary name. 
2.2. IUPAC name. 
2.3. ' CAS name. 
2.4. Classification: 
— therapeutic, 
— pharmacological. 
2.5. Synonyms and abbreviations. 
2.6. Structural formula. 
2.7. Molecular formula. 
2.8. Molecular weight. 
2.9. Degree of impurity. 
2.10. Qualitative and quantitative composition of impurities. 
No C 61/10 Official Journal of the European Communities 10. 3. 89 
2.11. Description of physical properties: 
— fusion point, 
— boiling point, 
— vapour pressure, 
— solubility in water and organic solvents expressed in grams per litre with indication of 
temperature, 
— density, 
— spectra of refraction, rotation, etc. 
3. Toxicological studies 
3.1. Short term toxicological studies. 
3.2. Long-term studies. 
3.3. Studies on reproduction. 
3.4. Studies on teratogenicity. 
3.5. Studies on mutagenicity. 
3.6. Studies for carcinogenicity. 
3.7. Studies of immunological effects. 
3.8. Studies of microbiological effects. 
3.9. Observations in humans. 
3.10. Other biological effects. 
4. Metabolic and residue studies 
4.1. Absorption, distribution, excretion and biotransformations. 
4.2. Determination of residues. 
4.3. Methods of residue analysis. 
4.4. National maximum residue limits. 
5. Recommendations 
. 5.1. Level causing no toxicological effect. 
5.2. Estimate of temporary acceptable daily intake for man. 
5.3. Estimate of maximum residue levels in food with the specification of the residue of concern. 
5.4. Methods of residue analysis. 
5.5. Further work or information: 
— required, 
— desirable. 
6. References