|
1.
|
通报成员:
欧盟
如可能，列出涉及的地方政府名称 ( 3.2条和7.2 条)：
|
|
2.
|
负责机构：
欧盟委员会 欧盟-TBT咨询点， 传真：+ (32) 2 299 80 43， 电子邮箱：grow-eu-tbt@ec.europa.eu 网站：http://ec.europa.eu/growth/tools-databases/tbt/en/
|
|
3.
|
通报依据条款：
[X] 2.9.2
[ ] 2.10.1
[ ] 5.6.2
[ ] 5.7.1
通报依据的条款其他：
|
|
4.
|
覆盖的产品：
归类为药物前驱物的化学物质，药剂学(11.120) ，化学工业产品(71.100)
HS编码：
30
ICS编码：
|
|
5.
|
通报标题：
有关修正欧洲议会和理事会（EC）第273/2004号法规和（EC）第111/2005号理事会法规以将某些药物前体列入表列物质清单中的委员会委托监管条例草案
语言：
英文/英文
页数：
6/3
链接网址：
|
|
6.
|
内容简述：
本委员会条例草案将阿尔法苯乙酰乙酸乙酯(eapa)和3- 氧代 -2-(3,4-亚甲二氧苯基)丁酸甲酯(mamdpa)增列为第111/2005号条例中规定监测共同体与第三国之间药物贸易规则的表列物质清单的第1类。特别标签规定适用于任何包装含有这些物质根据规例第5条。
|
|
7.
|
目标与理由：
EAPA是生产苯丙胺和甲基苯丙胺的前体。 MAMDPA是3,4-亚甲二氧甲基苯丙胺（MDMA）的前体，俗称“摇头丸”。 目前，欧盟一些地区因为使用了这些药物而出现了严重的社会和公共健康问题。 由于目前法律尚不允许使用EAPA和MAMDPA，用于研究目的的除外，所以将这些药物列入（EC）第111/2005号法规中的第1类药物前体有助于应对这些风险，且任何附加贸易限制都是根据所述目标作出的； 人类健康或安全保护
|
|
8.
|
相关文件：
1988年12月19日《联合国禁止非法贩运麻醉药品和精神药物公约》第12条； 列出欧盟和第三方国家之间药物前体贸易监测规则的（EC）第111/2005号理事会条例。 http://eur-lex.europa.eu/legal-content/EN/TXT/ qid=1426599802066&uri=CELEX:32005R0111
|
|
9.
|
拟批准日期：
2022年春
拟生效日期：
这些规定将于《欧盟官方公报》上发布后20天生效并适用。鉴于法律尚不允许使用EAPA，研究目的除外，因此无过渡期。
|
|
10.
|
意见反馈截止日期：
自通报日起60天
|
|
11.
|
文本可从以下机构得到：
[ ] 国家通报机构
[ ] 国家咨询点，或其他机构的联系地址、传真及电子邮件地址(如能提供):
欧盟委员会， 欧盟-TBT查询点， 传真： + (32) 2 299 80 43, 电子邮箱： grow-eu-tbt@ec.europa.eu 文本可通过访问欧盟-TBT网站获取： http://ec.europa.eu/growth/tools-databases/tbt/en/ https://members.wto.org/crnattachments/2021/TBT/EEC/21_6559_00_e.pdf https://members.wto.org/crnattachments/2021/TBT/EEC/21_6559_01_e.pdf
|
Products covered (HS or CCCN where applicable, otherwise national tariff heading. ICS numbers may be provided in addition, where applicable): Chemical substances classified as drug precursors.; Pharmaceutics (ICS 11.120), Products of the chemical industry (ICS 71.100)
Title, number of pages and language(s) of the notified document: Draft Commission Delegated Regulation amending Regulation (EC) No 273/2004 of the European Parliament and of the Council and Council Regulation (EC) No 111/2005 as regards the inclusion of certain drug precursors in the list of scheduled substances (6 page(s), in English; 3 page(s), in English)
Description of content: This draft Commission Regulation adds ethyl alpha-phenylacetoacetate (EAPA) and methyl 3-oxo-2-(3,4-methylenedioxyphenyl)butanoate (MAMDPA) to Category 1 of the list of scheduled substances in Regulation (EC) No 111/2005 laying down rules for the monitoring of trade between the Community and third countries in drug precursors.
Operators engaged in import, export or intermediary activities involving scheduled substances listed in Category 1 of the Annex have the obligation to hold a licence. Special labelling requirements apply for any packaging containing these substances according to Article 5 of the Regulation.
Objective and rationale, including the nature of urgent problems where applicable: EAPA is a pre-precursor in the production of amphetamine and methamphetamine. MAMDPA is a pre-precursor of 3,4-methylenedioxymethamphetamine (MDMA), commonly known as 'ecstasy'. The use of these drugs is causing serious social and public health problems in some regions of the Union. As there is no known legal use for EAPA and MAMDPA except for research purposes, their inclusion in Category 1 of drug precursors in Regulation (EC) No 111/2005 is appropriate to address those risks, and any additional restriction on trade is justified by the objectives pursued. ; Protection of human health or safety
Relevant documents: Article 12 of the UN Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances of 19.12.1988;
Council Regulation (EC) No 111/2005 laying down rules for the monitoring of trade between the Union and third countries in drug precursors.
http://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1426599802066&uri=CELEX:32005R0111
