No C 131/14 Official Journal of the European Communities 30. 5. 90 
II 
(Preparatory Acts) 
COMMISSION 
Amendment to the proposal for a Council Regulation (EEC) laying down a Community 
procedure for the establishment of tolerances for residues of veterinary medicinal products (') 
COM(90) 135 final 
(Submitted by the Commission pursuant to Article 149 (3) of the EEC Treaty on 4 May 1990) 
(90/C 131/05) 
(*) OJ No C 61, 10. 3. 1989, p. 5 (COM(88) 779 final). 
ORIGINAL TEXT AMENDED TEXT 
Visas and recitals 1 td 9 unchanged 
Tenth Recital Tenth Recital 
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; 
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 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 HI 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. Whereas the tolerances must 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; 
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 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 and only 
under exceptional circumstances and for the same 
maximum period. 
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. Medicinal products which 
contain active substances included in Annex III shall be 
authorized only for the period for which a provisional 
tolerance has been established; this authorization may be 
extended if the provisional tolerance is renewed. Last recital and Articles 1 to 3 unchanged 
Article 4 Article 4 
30. 5. 90 Official Journal of the European Communities No C 131/15 
ORIGINAL TEXT AMENDED TEXT 
Articles 5 and 6 unchanged 
Article 7 Article 7 
Paragraph 1 unchanged 
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. 2. After verifying that the application is submitted in 
correct form within 30 days, the Commission shall 
forthwith submit the application for examination by the 
Committee for Veterinary Medicinal Products estab­
lished by Article 16 of Directive 81/851/EEC (herein­
after 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. 
The rest of Article 7 is unchanged 
Article 8 Article 8 
Paragraph 1 unchanged 
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 the application. After verifying that the information is submitted in 
correct form within 30 days, the Commission shall 
forthwith submit the information for examination by 
the Committee, which shall deliver its opinion within 
a period which may be extended to 120 days. The 
Committee may request one of its members to act as 
rapporteur and undertake an initial evaluation of the 
information. 
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. Having regard to the observations formulated by the 
members of the Committee, the Commission shall 
prepare a draft with the measures to be taken, within 
30 days at the latest. However if, after consulting the 
Committee, the Commission considers that the infor­
mation 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, within a specified 
period. 
The rest of Article 8 is unchanged 
Articles 9 to 1 8 unchanged 
NoC 131/16 Official Journal of the European Communities 30. 5. 90 
ORIGINAL TEXT AMENDED TEXT 
4.4. National maximum residue limits. ANNEX V 
Points 1 to 4.3 unchanged 
4.4. Maximum residue limits. 
The rest is unchanged 
Proposal for a Council Directive amending Directive 81/851/EEC on the approximation of the 
laws of the Member States relating to veterinary medicinal products (') 
COM(90) 135 final — SYN 189 
(Submitted by the Commission pursuant to Article 149 (3) of the EEC Treaty on 4 May 1990) 
(90/C 131/06) 
(') OJ No C 61, 10. 3. 1989, p. 11 (COM(88) 779 final — SYN 189). 
ORIGINAL TEXT AMENDED TEXT 
Visas and recitals unchanged 
Article 1 Article 1 
Paragraph 1 unchanged 
Paragraph 2 (Directive 81/851/EEC, Article 1 (5)) subparagraphs 1 and 2 
unchanged 
2. Before the date of implementation of this Directive, 
Member States shall communicate to the Commission a 
list of the veterinary medicinal products which are 
available without veterinary prescription. 2. Before the date of implementation of this Directive, 
Member States shall communicate to the Commission a 
list of the veterinary medicinal products which are 
available without veterinary prescription. 
When the Commission has received the communication 
from the Member States, it shall examine whether to 
propose appropriate measures for drawing up lists of 
medicinal products which may be administered without 
prescription within the Community. 
Paragraph 3 unchanged 
Paragraph 4 (Directive 81/851/EEC, Article 4) subparagraph 1 unchanged