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【分享】关于欧盟通过禁止含有富马酸二甲酯的消费品投放市场决议草案(中文)

其他消费品检测

  • 欧洲委员会决议
    布鲁塞尔,
    C(2009)最终法规
    欧委会
    要求各成员国保证不将含有生物杀灭剂富马酸二甲酯的产品投放到市场上
    或销售该产品的草案
    (全文具EEA 关联性)

    欧盟欧洲议会和理事会:
      遵照《成立欧共体的条约》,
      遵照2001年12月3日欧洲议会和理事会有关一般产品安全的第2001/95/EC号指令 ,特别是其中第13条,
      在与各成员国协商以后,
    鉴于:
    (1)按照第2001/95/EC号指令,生产商有义务仅将安全的消费品投放到市场上。
    (2)在几个成员国市场上出售的家具和鞋类产品已经被确定为损害法国、波兰、芬兰、瑞典和英国消费者健康的原因。
    (3)根据临床试验,这种健康损害是由化学品富马酸二甲酯(DMF)造成的,这是一种抑制霉菌的生物杀灭剂,这种霉菌在潮湿环境下保存或运输过程中会导致皮革家具或鞋类产品变质。
    (4)富马酸二甲酯多数包在固定在家具内部的小袋中,或加在鞋盒里。从而保持产品干燥和防潮,防止产品生霉。但是,接触到该产品的消费者也受到了伤害。富马酸二甲酯通过衣服渗透到消费者的皮肤上 ,引起皮肤接触型皮炎痛楚,包括发痒、刺激、发红和灼伤;在某些情况下,也有报告说出现急性呼吸疾病。皮炎特别不容易治疗。因此富马酸二甲酯的存在成为一种严重的危险。
    (5)根据第2001/95/EC号指令第13条,如果欧委会知道某些产品对消费者健康和安全存在严重的危险,可以根据具体的情况采用一项决议,要求各成员国采取措施,特别限制出售这种产品或为此设定具体条件。
    (6)如果(a)各成员国在采用或要采用来应对相关风险的方法有很大差别;(b)由于该安全问题的性质,无法按照共同体适用于相关产品具体立法所规定其他程序以与符合情况紧急程度的方式来处理该风险;和(c)只有通过采用在共同体层面适用的适当措施才能有效地消除风险,则可以采用这种决议,以保证消费者健康和安全得到一致和高水平的保障,同时保证内部市场的正当运作。
    (7)一项用皮革家具和纯富马酸二甲酯补片的人体临床研究 (斑贴试验)显示,在最严重的情况下(到1毫克/公斤),出现强烈反应。根据这项研究,法国采用了一项法令 ,法令规定,禁止含有富马酸二甲酯的座椅及鞋类产品的进口及投放市场。法国法令还要求,凡产品或包装中含有含量可感知的富马酸二甲酯的座椅及鞋类产品,一律回收。该项法令的限期是一年。比利时基于相同研究也发布的一项法令 ,禁止所有含有富马酸二甲酯的物品和产品进口及投放市场。西班牙颁布措施 ,禁止所有消费品中的富马酸二甲酯接触到皮肤。
    (8)比利时、西班牙和法国是唯一已经针对生物杀灭剂富马酸二甲酯引起消费者健康严重风险采取具体法规措施的成员国。
    (9)根据1998年2月16日关于生物杀灭产品投放市场的欧洲议会和理事会第98/8/EC号指令第2(1)(a)条(“生物杀灭指令”) ,生物杀灭的定义是活性物质和含有一种或多种活性物质的制品,其目的是通过化学或者生物手段破坏、阻止有害生物体,使之无害,防止其发生反应,或采取治理措施。生物杀灭指令第3(1)条要求各成员国规定,除非是根据该指令得到授权,否则不得在其领土范围内上市和使用生物杀灭产品;该指令第(l)(b)(iii)规定,只有在生物杀灭产品本身或者其残渣对人类健康没有直接或者间接不可接受的影响时,才能授权此生物杀灭产品。因此,在授权某种生物杀灭产品以后,必须满足非常高的安全标准。
    (10)根据生物杀灭指令,共同体没有对含有富马酸二甲酯的生物杀灭产品进行授权。因此,共同体内含有富马酸二甲酯的生物杀灭产品不能合法用于产品防霉,也因此在欧盟内制造的产品如含有富马酸二甲酯均是不合法的。但是,当进口到共同体的产品(或产品原材料)中存在富马酸二甲酯时,则没有任何限制。
    (11)根据2006年12月18日欧洲议会和理事会关于化学品注册、评估、许可和限制制度(REACH),成立欧洲化学品管理局,修订第1999/45/EC号指令,取缔第793/93号理事会法规以及第1488/94号委员会法规和第76/769/EEC号理事会指令和第91/155/EEC号、第93/67/EEC号、第93/105/EC号和第2000/21/EC号委员会指令的第1907/2006号欧盟法规(OJ L 396,2006年12月30日) 落实富马酸二甲酯限制短期内可能无法实现,因而在存在风险管理需要的紧迫性方面不足。
    (12)在这些情况下,应要求各成员国保证市场上不销售含有富马酸二甲酯的产品,以防止这些产品对消费者造成严重的风险,直到有一个永久性的解决方案。
    (13)产品中富马酸二甲酯的含量最大限量为每公斤产品或产品零件0.1毫克富马酸二甲酯。这个限量足以低于1毫克/公斤的浓度,这个浓度在上面所说的斑贴试验中显示出强烈的反应。因此0.1毫克/公斤的最大限量适当地解决了产品中富马酸二甲酯引起的严重风险。
    (14)因此,所使用的分析方法应该能够可靠确定每公斤产品或产品零件0.1毫克富马酸二甲酯的数量。这表示该方法的量化限值应是0.1毫克/公斤或低于0.1毫克/公斤。
    (15)各成员国必须实施市场监管和强制执行措施,来防止不安全产品对消费者健康和安全造成的风险。
    (16)对于必须保证该指令实施的各成员国以及有义务只销售安全产品的生产商和经销商,都需要有一个不长的过渡期。过渡期越短越好,要符合防止进一步损害消费者健康和安全以及保证比例性的需要。
    (17)本指令规定的措施符合第2001/95/EC号指令第15条所制定的委员会意见。


    已采用本指令:

    第1条
    定义
    在本指令中,下列定义应适用:
    (1)“DMF”指化学品富马酸二甲酯,IUPAC(国际纯化学与应用化学联盟)名称为Dimethyl (E)-butenedioate,CAS(化学物质登记号)编号:624-49-7,EINECS(欧洲现有商用化学物质目录信息系统)编号:210-849-0。
    (2)“产品”指第2001/95/EC号指令第2(a)条中定义的任何产品;
    (3)“含有富马酸二甲酯的产品”指如下产品或产品零件:
    (i)声明了富马酸二甲酯的存在率,如在一个或多个小袋子上;或
    (ii)富马酸二甲酯的浓度大于每公斤该产品或产品零件重量0.1毫克;
    (4)“投放市场”指第一次在共同体市场销售;
    (5)“在市场上销售”指在商业活动过程中提供用于在共同体市场上经销、消费或使用,不管是有偿还是无偿。

    第2条
    实施
    1.到2009年5月1日以前,各成员国应保证禁止含有富马酸二甲酯的产品投放市场或在市场上销售。
    2.到2009年5月1日以前,各成员国应保证,已经投放市场或在市场上销售,含有富马酸二甲酯的产品从市场和消费者那里收回,并且保证消费者已充分了解这种产品的危险性。
    3.各成员国应根据第2001/95/EC号指令第12条将根据本条采取的措施立刻通知委员会。

    第3条
    信息
    各成员国应采取必要措施达到本指令要求,公布这些措施,并据此通知委员会。

    第4条
    实施期
    本指令应于[委员会采用日期]适用。

    第5条
    接收人
    本指令发送给各成员国。

    完成地点:布鲁塞尔,2009年[  ]

    委员会
    梅格莱纳•库尼娃(Meglena KUNEVA)
    委员会委员
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  • 智慧的弟弟

    第1楼2009/03/05

    IP/09/190
    Brussels, 29 January 2009

    Consumers: EU to ban dimethylfumarate (DMF) in consumer products, such as sofas and shoes

    The use of the biocide (DMF) dimethylfumarate - which has caused severe allergic reactions in hundreds of consumers, because of its use in every day consumer products such as couches and shoes - looks set to be banned across the EU. Today, Member States voted in favour of a draft European Commission Decision to ensure that consumer products, such as leather furniture or footwear, containing the strongly sensitising (DMF) are not placed on the market in the EU. If already on the market, these products will have to be recalled and withdrawn without delay. In countries such as France, Finland, Poland, Sweden and the UK, consumers exposed to products containing DMF, have experienced serious health problems including skin itching, irritation, redness, burns and, in some cases, acute respiratory difficult. The draft Commission decision is for an emergency EU wide measure, pending the adoption of a more permanent regulatory solution. Following today's vote, the draft Commission decision will be submitted for consultation to the European Parliament before going before the College of Commissioners for final approval.

    EU Consumer Affairs Commissioner Meglena Kuneva, said: "There can be no compromise on safety. I am pleased to see that that the RAPEX system has been functioning well to ensure dangerous goods containing DMF are quickly removed from the market. But we need to go further with urgent EU action to tackle the problem at source. An EU wide ban on the use of DMF in all consumer goods is designed to eliminate the serious health risks and in particular the severe allergic reactions suffered by some consumers when they are exposed to this chemical simply by using everyday leather goods."

    The risk from DMF
    Dimethylfumarate (DMF) is used by producers as a biocide to kill moulds that may cause furniture or shoe leather to deteriorate during storage and transportation in a humid climate. Placed in sachets, which are fixed inside the furniture or added to the footwear boxes, DMF evaporates and impregnates the leather, protecting it from moulds. However, it has been found to seriously affect consumers who were in contact with the products. DMF penetrated through the clothes onto the skin of many consumers[1], where it caused painful dermatitis. The fact that in serious cases it is particularly difficult to treat adds to the damage. The presence of DMF is thus a serious risk.
    The dangerous chemical initially raised concerns when notified by a number of Member State authorities through the EU rapid alert system for dangerous non-food consumer products (RAPEX).

    The notifications related to sofas, armchairs and shoes, and clinical tests confirmed that the dermatitis suffered by consumers in contact with these produtcs was caused by DMF[2]. France and Belgium subsequently put national bans in place and Spain is also preparing to do so. The new Decision which was agreed today will cover all Member States.
    The existing rules
    DMF is already banned for use in the manufacture of goods in the EU, since biocidal products containing DMF are not authorised under the Biocides Directive (98/8/EC). However, manufacturers outside the EU may use these unauthorised biocides and then export their products to the EU. Today's Decision therefore protects EU consumers from the risk of DMF in imported products in the same way as they are protected at home.

    Recent measures introduced by Member States
    In December 2008, France adopted a decree[3] which bans the importation and placing on the market of seating and footwear containing DMF for 1 year. The French decree also requires the recall of all seating and footwear which visibly contains, or the packaging of which visibly contains, DMF. In January 2009, Belgium issued a decree[4], which bans the placing on the market of all articles and products containing DMF. Spain is considering introducing a measure.

    Background - RAPEX
    RAPEX is the EU rapid alert system for dangerous non-food consumer products, providing a rapid exchange of information between Member States and the Commission to prevent marketing or use of products posing a serious risk to the health and safety of consumers.

    For further information see:
    http://ec.europa.eu/consumers/safety/rapex/index_en.htm


    [1] Williams JDL, et al (2008) An outbreak of furniture dermatitis in the U.K. . British Journal of Dermatology 159: 233-234.
    [2] Rantanen T (2008) The cause of the Chinese sofa/chair dermatitis epidemic is likely to be contact allergy to dimethylfumarate, a novel potent contact sensitizer. Concise communication. British Journal of Dermatology 159: 218-221.
    [3] Ministry for the Economy, Industry and Employment, Decree of 4 December 2008 suspending the placing on the market of seats and footwear containing DMF from the market. French Official Journal , 10 December 2008, Text 17 of 108.
    [4] The Minister for Public Health and the Minister for Consumer Protection, The Minister for Public Health and the Minister for Consumer Protection, Ministerial Decree concerning the prohibition of placing articles and products containing DMF on the market. Belgian Official Journal , 12.1.2009

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  • sarge

    第3楼2009/03/06

    这个严令家具类的,幸好医药类产品有溶剂残留量限制,DMF、DMSO这个在化工里可是被称为万能溶剂的

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