Communication of the European Agency for the Evaluation of Medicinal Products pursuant to Article 1 of Council Regulation (EC) No 434/97

(97/C165/03)

(OJ N°C 165, 31.5.1997)

 

Pursuant to Article 1 of Council Regulation (EC) No 434/97 (1) amending Council Regulation (EEC) No 2377/90 (2), the European Agency for the Evaluation of Medicinal Products shall publish the list of those substances, the use of which was authorized on the day of entry into force of Regulation (EEC) No 2377/90, and in respect of which documented applications for the establishment of maximum residue limits were lodged with the Commission or with the European Agency for the Evaluation of Medicinal Products before 1 January 1996. This list, which is presented in the Annex to this communication does not include those substances, which are mentioned in Annexes, I, II, III and IV to Regulation (EEC) No 2377/90 as amended (3) (Part A).

 

Part B of the Annex lists those substances, the use of which was authorized on the day of entry into force of Regulation (EEC) No 2377/90, and which are already included in Annex III to Regulation (EEC) No 2377/90 as amended, but for which the applications received before 1 January 1996 cover additional species and/or target tissues to those already published in the aforementioned Annex and are yet to be assessed.


(1) OJ No L67, 7.3.1997
(2) OJ No L224, 18.8.1990
(3)
Commission Regulation (EEC) No 675/92 (0J No L73, 19.3.1992)
Commission Regulation (EEC) No 3093/92 (0J No L311, 28.10.1992)
Commission Regulation (EEC) No 895/93 (0J No L93, 17.4.1993)
Commission Regulation (EEC) No 2901/93 (OJ No L264, 23.10.1993)
Commission Regulation (EEC) No 3425/93 (0J No L312, 15.12.1993)
Commission Regulation (EEC) No 3426/93 (0J No L312, 15.12.1993)
Commission Regulation (EC) No 955/94 (0J No L108, 29.4.1994)
Commission Regulation (EC) No 1430/94 (OJ No L156, 23.6.1994)
Commission Regulation (EC) No 2703/94 (0J No L287, 8.11.1994)
Commission Regulation (EC) No 3059/94 (0J No L323, 16.12.1994)
Commission Regulation (EC) No 1102/95 (0J No L110, 17.5.1995)
Commission Regulation (EC) No 1441/95 (OJ No L143, 27.6.1995)
Commission Regulation (EC) No 1442/95 (0J No L143, 27.6.1995)
Commission Regulation (EC) No 1798/95 (0J No L174, 26.7.1995)
Commission Regulation (EC) No 2796/95 (0J No L290, 5.12.1995)
Commission Regulation (EC) No 2804/95 (0J No L291, 6.12.1995)
Commission Regulation (EC) No 281/96 (0J No L37, 15.2.1996)
Commission Regulation (EC) No 282/96 (0J No L37, 15.2.1996)
Commission Regulation (EC) No 1140/96 (OJ No L151, 26.6.1996)
Commission Regulation (EC) No 1147/96 (0J No L151, 26.6.1996)
Commission Regulation (EC) No 1311/96 (0J No L170, 9.7.1996)
Commission Regulation (EC) No 1312/96 (0J No L170, 9.7.1996)
Commission Regulation (EC) No 1433/96 (0J No L184, 24. 7.1996)
Commission Regulation (EC) No 1742/96 (OJ No L226, 7.9.1996)
Commission Regulation (EC) No 1798/96 (0J No L236, 18.9.1996)
Commission Regulation (EC) No 2010/96 (0J No L269, 22.10.1996)
Commission Regulation (EC) No 2017/96 (0J No L270, 23.10.1996)
Commission Regulation (EC) No 2034/96 (0J No L272, 25.10.1996)
Commission Regulation (EC) No 17/97 (0J No L5, 9.1.1997)
Commission Regulation (EC) No 211/97 (0J No L35, 5.2.1997)
Commission Regulation (EC) No 270/97 (0J No L45, 15.2.1997)
Commission Regulation (EC) No 716/97 (0J No L106, 24.4.1997)
Commission Regulation (EC) No 748/97 (0J No L110, 26.4.1997)
Commission Regulation (EC) No 749/97 (0J No L110, 26.4.1997)


ANNEX

Part A

Substance

1 Acepromazine
2 Acetylsalicylic acid
3 Activated attapulgite (*)
4
Aesculus hippocastanum
5 Alfacalcidol
6 Aloe (*)
7 Altrenogest
8 Aluminium and compounds:

Aluminium
Aluminium distearate
Aluminium hydroxide acetate
Aluminium phosphate
Aluminium potassium sulphate
Aluminium tristearate
Aluminium salicylate, basic

9 Amino acids (*)
10 Ammonia solution
11 Ammonium bituminsulfonate
12 Ammonium chloride
13 Ammonium phtalamate
14 Amperozide hydrochloride
15 Amprolium
16
Angelicae radix aetheroleum
17
Anisi aetheroleum
18 Apramycin
19 Argobase
20 Arnica
21
Arnicae flos
22 Atropine
23 Bacitracin
24
Balsamum peruvianum
25 Benzalkonium chloride
26 Benzetimide hydrochloride
27 Benzocaine
28 Benzoic opium tincture
29 Benzonaphtol
30 Benzylideneacetone
31 Betaine
32 Betamethasone sodium phosphate
33 Biotin (*)
34 Bismuth subnitrate
35 Bithionol sulphoxid
36
Bolus alba
37 Bromhexine
38 Butanilicaine
39 Butaphosphan
40 Butorphanol
41 N-Butylscopolamine
42 Calcium-urea acerylsalicylate
43 Calcium compounds:

Calcium glucoheptonate
Calcium glutamate
Calcium glucono glucoheptonate

44 Calendulae flos
45 Camylofin
46
Capsici fructus
47 Carbaril
48 Carboxymethylcellulose (*)
49 Carboxypolymethylene
50
Carlina acaulis (*)
51
Carvi aetheroleum
52
Caryophylli actheroleum
53
Cascara sagrada
54 Cefacetrile sodium
55 Cefalexin
56 Cefalexin sodium
57 Cefoperazone
58 Cefuroxime sadium
59
Centella asiatica
60 Cephalonium
61
Chamomillae flos
62
Chelidonii herta
63 Chloral hydrate
64 Chlormadinone acetate
65 Chlorobutanol
66 Chlorpheniramine
67 Choline (*)
68
Chrysanthemi cinerarifolii flos
69 Chymotrypsin (*)
70
Cimicifugae rhizoma
71
Cinnamomi cassiae aetheroleum
72
Cinnamomi ceylanci aetheroleum
73
Citri aetheroleum
74
Citronella aetheroleum
75 Clanobutin
76 Clazuril
77 Cloprostenol
78 Cobalt compounds:

Cobalt gluconate
Cobalt sulphate
Cobalt sulphate heptahydrate

79 Coconut oil (*)
80
Coffeae arabicae semen
81 Copper compounds:

Copper calcium ethylenediaminetetraacetate
Copper gluconate
Copper heptonate
Copper napthenate
Copper oxide
Copper oxinate
Copper sulphate
Cupric oxide
Diahylamine copper oxyquinolone sulphonate (cuproxoline)
Methionine copper complex

82 Coriandri aetheroleum
83 Corticotrophin
84 Coumafos
85 Cronolone
86
Cupressus officinalis (*)
87 Cyfluthrin
88 Cyhalothrin
89 Cypermethrin
90 a-cypermethrin
91 Cyromazine
92 Deltamethrin
93 Denaverine hydrochloride
94 Dexamethasone-21-(3-sulfabenzoate)
95 Dextromorphan hydrobromide
96 Dichlorvos
97 Diclofenac
98 3,5-Diiod-L-tyrosin
99 Diminazene
100 Diphenhydramine dihydrochloride
101 Diphenhydramine hydrochloride
102 Diprophylline
103 Doxapram
104
Echinacea
105 Emulgade F (rnixture of cetylstearylalcohol, sodium stearylsulphate and non-ionogene emulgators)
106 Enilconazole
107 Ephedrine hydrochloride
108 Epoxidized soybean oil (*)
109 Ergometrine maleate
110 Etamsylate
111 Ethanolamine
112 Ethanol-2-aminophosphoric acid
113 Ethoxyquin
114 2-Ethyl-l,3-hexanediol
115 Etilefrine hydrochloride
116 Eucalptus oil (*)
117
Extractum Pini
118
Extractum secalis cornuti fluidem
119 Fatty acid polyethylene glycol esters
120 Fenpipramide hydrochloride
121 Fenprostalene
122 Fenthion
123 Flumetasone
124 Flunixin Meglumine
125
Foeniculi aetheroleum
126 Folic acid
127 Fumagillin
128 Furosemide
129 Glucan (*)
130 Glycerol (*)
131 Glycerol dimethylketal
132 Glycofurol
133 Guaifenesin
134
Hamamelidis folium
135 Heptenophos
136 Hexetidine
137 Honey (*)
138 Humic acid (*)
139 Hyaluronic acid (*)
140 Hydrochlorothiazide
141 Hydrocortisone
142 8-Hydroxyquinoline
143
Hyperici oleum
144 Imidocarb dipropionate
145 Immunoglobuline (*)
146 Inositol (*)
147 Iron compounds:

Iron gluconate
Iron sulphate

148 Isoflupredone
149
Juniperi fructus
150 Kanamycin sulphate
151 Kaolin (*)
152 Ketamine hydrochloride
153 Kitasamycin
154
Lauri folium actheroleum
155
Lauri fructus
156 Lauryl amino dimethylaceto betain (Dehyton AB 30)
157
Lespezeda capita
158 Levomethadone
159 Levothyroxine
160 Lidocaine hydrochloride
161 Lincomycin
162
Lini oleum
163 Luprostiol
164 Lyophylised ruminal fluid
165 Lysine acetylsalicylate
166
Majorana herba
167 Manganese compounds:

Manganese chloride
Manganese gluconate
Manganese glycerophosphate
Manganese pidolate
Manganese ribonucleate
Manganese sulphate

168 Matricariae flos
169 Mebendazole
170 Meclofenamic acid
171 Meclofenate sodium
172
Medicago sativa
173 Meglumine
174
Melissae folium
175 Menadione
176 Mepivacaine
177 Mercaptamine hydrochloride
178 Metamizole
179 Methyl nicotinate
180 1-Methyl-2-pyrrolidone
181 Methyl salicylate
182 Methylprednisolone
183 Metrifonat
184 Metronidazol
185
Millefolii herba
186 Molybdenum
187 Morantel citrate
188 Morantel tartrate
189
Myristicae aetheroleum
190 Nafcillin
191 Narcobarbital
192 Natamycin
193 Niauli oil (*)
194 Nickel gluconate
195 Niclosamide
196 Nicoboxil
197 Nitroxynil
198 Nonivamide
199 Norgestomet
200 Novobiocin sodium
201 Nucleotides (*)
202
Nux vomica
203 Nystatin
204 Oil of thyme (*)
205 Oleyloleat
206 Olive oil (*)
207 Organ autolysates (*)
208 Orotic acid (*)
209 Oxolinic acid
210 Oxyclozanide
211 Paracetamol-
212 Parconazole
213 Peanut oil
214 Pectin (*)
215 Penicillin V
216 Pentetrazol
217 Pentoxyverine
218 Peppermint oil (*)
219 Peptides (*)
220 Permethol
221 Permethrin
222 Phenazone
223 Phenylbutazone
224 Phenylethyl alcohol
225 Phosmet
226 Phosphor compounds:

Magnesium hypophosphite
Sodium hypophosphite

227 Phoxim
228 Piperazine citrate
229 Piperazine hydrochloride
230 Piperonyl butoxide
231 Polyethylene glycol esters
232 Polyethylene glycol-7-glyceryl-cocoate (Cetiol HE)
233 Polyethylene terephthalates
234 Polyhexamethylene biguanide hydrochloride
235 Polyoxyl-l5-hydroxystearate (Solutol HS 15)
236 Populeum ointment
237 Porcine pituitary gonadotrophin
238 Potassium compounds:

Potassium aspartate
Potassium bromide
Potassium glocuronate
Potassium glycerophosphate
Potassium guaiacol sulfonate
Potassium nitrate

239 Prednisolone
240 Prednisolone-21-acetate
241 Prednisolone-21-(3-sulfobenzoate)
242 Prethcamide
243 Procaine
244 Progesterone
245 Propetamphos
246 Propionic acid (*)
247 Propionylpromazine
248 Proteins (including gelatin and pepsin)(*)
249 Pyrantel pamoate
250 Pyrethrum extract
251 Pyridoxine (*)
252 2-Pyrrolidone
253
Quercus cortex
254 Rafoxanide
255 Ramifenazone
256
Ricini oleum
257 Rosemary oil (*)
258
Rosmarini folium
259
Rosmarini folium actheroleum
260 Roxarsone
261
Ruscus aculeatus
262 Saccharides (*)
263 Salicylic acid
264
Salviae folium
265
Sambuci flos
266 Selenium
267 Sesame oil
263
Sinapis semen
269 Smectite (*)
270 Sodium acetylsalicylate
271 Sodium bromide
272 Sodium salicylate
273 Sodium selenite
274 Soybean oil (*)
275 Strychnine
276 Suxibuzone
277
Symphyti radix
278 Tanninum
279
Terebinthinae aetheroleum rectificatum
280
Teretinthinae laricina
281
Terehinthinae oleum (*)
282 Terpin hydrate
283 Testosterone.
284 Tetracaine
285 Tetrachlorvinphos
286 Thenoic acid
287 Thiamylal
288 Thiopental sodium
289 Thiophanate
290
Thymi aetheroleum
291 Tiamulin hydrogen fumarate
292 Tiaprost
293
Tiliae flos
294 Toldimfos sodium
295 Tolfenamic acid
296 Toltrazuril
297 Tricaine methane sulphonate
298 Trichlormethiazide
299 Trypsin (*)
300
Urticae herta
301 Vetrabutine hydrochloride
302 Vincamine
303 Vitamin A
304 Vitamin Bl, B2, B3, B5, B6, B12 (*)
305 Vitamin C (*)
306 Vitamin E (*)
307 Vitamin D
308 Xylazine
309 Cetain homeopathic substances at concentrations greater than 1 part per 10 000 (**)

 

(*) The Committee for Veterinary Medicinal Products, having examined the documentation provided, considered the substance as not falling within the scope of Regulation (EEC) No 2377/90.

(**) Applications for homeopathic substances used in veterinary medicine were submitted by the European Coalition on Veterinary Homeopathy and those whose concentration in the product does not exceed 1 part per 10 000 are included in Annex II to Regulation (EEC) No 2377/90. Of the remaining substances at concentrations greater than 1 part per 10000, those defended by the companies DHU, Heel, Intervet, PlantaVet and Reckeg are yet to be assessed in the time remaining to 1 January 2000.

 

Part B

Substance

1 Aminosidine
2 Amitraz
3 Cephapirin
4 Colistin
5 Decoquinate
6 Dihydrostreptomycin
7 Erythromycin
8 Flumequine
9 Gentamycin
10 Josamycin
11 Spectinomycin
12 Streptomycin
13 Thiamphenicol


[Legislation]