Regulation 5 Amendment of Regulation (EC) 273/2004 of the European Parliament and Council
Council Regulation (EC) No. 273/2004 of the European Parliament and of the Council dated 11th February 2004 on drug precursors is amended as follows.
In Article 1 (scope and objectives) for “the United Kingdom” substitute “Great Britain”.
In Article 2 (definitions)—
in paragraph (c) for “the United Kingdom” in each place it occurs substitute “Great Britain”;
for paragraph (i) substitute—
“(i)‘natural product’ means—
(i)an organism or a part thereof, in any form; or
(ii)a naturally occurring substance which is unprocessed or processed only by manual, mechanical or gravitational means, by dissolution in water, by flotation, by extraction with water, by steam distillation or by heating solely to remove water, or which is extracted from air by any means.”.
In Article 3 (requirements for the placing on the market of scheduled substances), in paragraph 8—
after “the requirements and conditions” insert “(including, in the case of a licence or registration, the payment of a prescribed fee)”;
omit the last sentence.
In Article 4 (customer declaration) in paragraphs 1 and 3 for “the United Kingdom” substitute “Great Britain”.
In Article 15 (adaptation of annexes) after “III” insert “to adapt”.
In Annex I (list of schedule substances)—
for the table headed “Category 1” substitute—
| Substance | CN designation (if different) | CN code (1) | CAS No (2) |
|---|---|---|---|
| 1-phenyl-2-propanone | Phenylacetone | 2914 31 00 | 103-79-7 |
| Diethyl (phenylacetyl) propanedioate (also referred to as DEPAPD) | 2918 30 00 | 20320-59-6 | |
| Methyl alpha-phenylacetoacetate (also referred to as MAPA) | 2918 30 00 | 16648-44-5 | |
| Ethyl alpha-phenylacetoacetate (also referred to as EAPA) (4) | Ex 2918 30 00 | 5413-05-8 | |
| 2-methyl-3-phenyloxirane-2-carboxylic acid (also referred to as BMK glycidic acid) (6) | 2918 99 90 | 25547-51-7 | |
| N-acetylanthranilic acid | 2-Acetamidobenzoic acid | 2924 23 00 | 89-52-1 |
| Alpha-phenylacetoacetamide (also referred to as APAA) | 2924 29 70 | 4433-77-6 | |
| Alpha-phenylacetoacetonitrile (also referred to as APAAN) | 2926 40 00 | 4468-48-8 | |
| Isosafrol (cis + trans) | 2932 91 00 | 120-58-1 | |
| 3,4-methylenedioxyphenylpropan-2-one | 1-(1,3-Benzodioxol-5-yl)propan-2-one | 2932 92 00 | 4676-39-5 |
| Piperonal | 2932 93 00 | 120-57-0 | |
| Safrole | 2932 94 00 | 94-59-7 | |
| Methyl 3-oxo-2-(3,4-methylenedioxyphenyl)butanoate (also referred to as MAMDPA)(5) | Methyl 3-oxo-2-(3,4-methylenedioxyphenyl)butanoate | Ex 2932 99 00 | 1369021-80-6 |
| 3-(1,3-benzodioxol-5-yl)-2-methyl-oxirane-2-carboxylic acid (also referred to as PMK glycidic acid) (7) | 2932 99 00 | 2167189-50-4 | |
| Isopropylidene (2-(3,4-methylenedioxyphenyl)acetyl)malonate (also referred to as IMDPAM) (8) | IMDPAM | 2932 99 00 | |
| N-phenyl-1-(2-phenylethyl)piperidin-4-amine | 4-anilino-N-phenethylpiperidine (ANPP) | 2933 36 00 | 21409-26-7 |
| 1-(2-phenylethyl)piperidin-4-one | N-phenethyl-4-piperidone (NPP) | 2933 37 00 | 39742-60-4 |
| N-phenylpiperidin-4-amine (also referred to as 4-AP) | 2933 39 99 | 23056-29-3 | |
| Tert-butyl 4-anilinopiperidine-1-carboxylate (also referred to as 1-boc-4-AP) | 2933 39 99 | 125541-22-2 | |
| N-phenyl-N-(piperidin-4-yl)propanamide (also referred to as norfentanyl) | 2933 39 99 | 1609-66-1 | |
| 4-piperidone | Piperidin-4-one | 2933 39 99 | 41661-47-6 |
| 1-boc-4-piperidone | tert-butyl 4-oxopiperidine-1-carboxylate | 2933 39 99 | 79099-07-3 |
| Ephedrine | 2939 41 00 | 299-42-3 | |
| Pseudoephedrine | 2939 42 00 | 90-82-4 | |
| Norephedrine | 2939 44 00 | 14838-15-4 | |
| Ergometrine | 2939 61 00 | 60-79-7 | |
| Ergotamine | 2939 62 00 | 113-15-5 | |
| Lysergic acid | 2939 63 00 | 82-58-6 | |
| The stereoisomeric forms of the substances listed in this category not being cathine (3), whenever the existence of such forms is possible. | |||
| The salts of the substances listed in this category, whenever the existence of such salts is possible and not being the salts of cathine. | |||
| (1R,2S)-(-)-chloroephedrine | 2939 79 90 | 110925-64-9 | |
| (1S,2R)-(+)-chloroephedrine | 2939 79 90 | 1384199-95-4 | |
| (1S,2S)-(+)-chloropseudoephedrine | 2939 79 90 | 73393-61-0 | |
| (1R,2R)-(-)-chloropseudoephedrine | 2939 79 90 | 771434-80-1 | |
| (1) OJ No. L 290, 28.10.2002, p. 1. | |||
| (2) The CAS No is the ‘chemical abstracts service registry number’, which is a unique numeric identifier specific to each substance and its structure. The CAS No is specific to each isomer and to each salt of each isomer. The CAS Nos for the salts of the substances listed above will be different to those given. | |||
| (3) Also named (+)-norpseudoephedrine, CN code 2939 43 00, CAS No 492-39-7. | |||
| (4)Also known as ethyl 3-oxo-2-phenylbutanoate, according to The International Union of Pure and Applied Chemistry (IUPAC). | |||
| (5) Also known as methyl 2-(2H-1,3-benzodioxol-5-yl)-3-oxobutanoate, according to IUPAC. | |||
| (6) And its ethyl, methyl (CAS No 80532-66-7), propyl, isopropyl, butyl, isobutyl, sec-butyl and tert-butyl esters, with the same CN code as BMK glycidic acid. | |||
| (7) And its ethyl (CAS No 28578-16-7), methyl (CAS No 13605-48-6), propyl, isopropyl, butyl, isobutyl, sec-butyl and tert-butyl esters, with the same CN code as PMK glycidic acid. | |||
| (8) Also known as 5-[2-(1,3-benzodioxol-5-yl)acetyl]–2,2-dimethyl–1,3-dioxane–4,6-dione, according to IUPAC. | |||
for the table headed “Category 2” and “Subcategory 2A” substitute—
| Substance | CN designation (if different) | CN code | CAS No |
|---|---|---|---|
| Red phosphorus | 2804 70 10 | 7723-14-0 | |
| Acetic anhydride | 2915 24 00 | 108-24-7 | |
| The salts of the substances listed in this category, whenever the existence of such salts is possible. | |||
In Annex II, for the table substitute—
| Substance | Threshold |
|---|---|
| Acetic anhydride | 100 L |
| Potassium permanganate | 100 kg |
| Anthranilic acid and its salts | 1 kg |
| Phenylacetic acid and its salts | 1 kg |
| Piperidine and its salts | 0.5 kg |
| Red phosphorus | 0.1kg |