欧盟认为没有证据证明婴儿尿布中的化学物质存在风险

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来源:ECHA | 作者:沐睿环境-莉哥 | 发布时间: 2021-09-13 | 1713 次浏览 | 分享到:

Risks from chemicals in baby diapers not demonstrated

ECHA/NR/21/21

ECHA’s Committee for Risk Assessment (RAC) considers that there is not enough scientific evidence to conclude that certain chemicals found in single-use diapers or nappies pose a risk. This conclusion follows an evaluation of a proposal to restrict formaldehyde, PAHs, dioxins, furans and PCBs in baby diapers throughout the EU.

Helsinki, 10 September 2021 – RAC has adopted its opinion on the French authority ANSES’s proposal to restrict substances in single-use baby diapers under the EU’s chemicals legislation, REACH. RAC evaluated the information related to the identified risks and the options proposed to reduce them, as presented in the restriction proposal. The committee also assessed the information received during a six-month stakeholder consultation.

RAC’s evaluation concluded that the available scientific data and risk assessment do not demonstrate that the substances included in the proposal are present in diapers at levels that pose a risk. RAC found that the data on the amount of some of the substances in diapers was inconclusive – particularly for polycyclic aromatic hydrocarbons (PAHs). In addition, the methodology likely overestimated any exposure. The committee also provided advice on what kind of information would be necessary to address the identified shortcomings.

Tim Bowmer, Chair of RAC says: “RAC takes the health of small children very seriously. The restriction proposal does not provide sufficient scientific evidence of a risk at EU level. However, it also does not allow the committee to completely rule out risks from some of the substances. It is important to note that none of the chemicals seem to be deliberately added during the manufacture of diapers but are rather background residues from raw materials or contaminants from ambient air. We highlight that, in any case, these chemicals should be kept to the lowest possible levels in diapers.”

The Committee for Socio-Economic Assessment (SEAC) has also agreed on its draft opinion on the costs and benefits of the proposal for society. The committee considers that the evidence available does not demonstrate that the proposed restriction would be proportionate to the risk.

The opinion of RAC and draft opinion of SEAC will be available on ECHA’s website shortly after administrative checks have been completed. The key points from the opinions are in the Q&A document.

Next steps

A 60-day consultation of SEAC’s draft opinion will start on 15 September 2021. The combined opinion of both committees is expected to be ready by the end of 2021 and will be sent to the European Commission for decision making in early 2022.

Background

In October 2020, ANSES proposed a REACH restriction concerning hazardous substances such as formaldehyde, PAHs, dioxins, furans and polychlorinated biphenyls (PCBs) found in baby diapers. The proposed restriction would limit these chemicals to very low levels in diapers placed on the EU/EEA market.

The REACH restriction process relies on EU Member States to make proposals for EU-wide restrictions. Recently, the European Commission adopted a restriction introduced by Germany and Sweden to limit uses of a subgroup of PFAS, perfluorinated carboxylic acids (C9-14 PFCAs). In September 2020, ECHA’s committees supported a proposal by the French and Swedish authorities to restrict over 1 000 skin sensitising chemicals in clothing and other articles, including single-use baby diapers. This proposal is currently in the Commission for decision making.

婴儿尿布中的化学物质的风险没有被证明

欧洲卫生安全委员会的风险评估委员会(RAC)认为，没有足够的科学证据得出结论，认为一次性尿布或尿布中发现的某些化学物质构成风险。这一结论是在对欧盟范围内限制婴儿尿布中甲醛、多环芳烃、二恶英、呋喃和多氯联苯的建议进行评估后得出的。
赫尔辛基，2021年9月10日消息——根据欧盟化学品法规REACH，法国权威机构ANSES提出的限制一次性婴儿纸尿裤中的物质的建议，RAC通过了其意见。RAC评估了与已识别风险相关的信息，以及限制建议中提出的减少风险的选项。委员会还评估了在6个月的利益攸关方磋商期间收到的信息。
RAC的评估结论是，现有的科学数据和风险评估并不能证明该建议中所含的物质在尿布中存在的水平会构成风险。RAC发现，尿布中某些物质的含量数据是不确定的，尤其是多环芳烃(PAHs)。此外，该方法可能高估了任何风险敞口。委员会还就解决已查明的缺点所需的资料提供了咨询意见。
英国皇家飞行俱乐部主席蒂姆·鲍默说:“英国飞行俱乐部非常重视幼儿的健康。该限制建议没有提供足够的科学证据证明该风险处于欧盟水平。然而，它也不允许委员会完全排除某些物质的风险。值得注意的是，这些化学物质似乎都不是在生产尿布的过程中故意添加的，而是来自原材料的背景残留物或环境空气的污染物。我们强调，无论如何，尿布中的这些化学物质应该保持在尽可能低的水平。”
社会经济评估委员会(SEAC)也就该建议对社会的成本和效益的意见草案达成一致。委员会认为，现有证据并不能证明拟议的限制将与风险成比例。
在完成行政检查后不久，RAC的意见和谘询委员会的意见草案将会在ECHA的网站上公布。意见的要点都在问答文件中。
下一个步骤
将于2021年9月15日开始对东盟咨询委员会的意见草案进行为期60天的磋商。两个委员会的联合意见预计将在2021年底准备好，并将在2022年初提交给欧盟委员会(European Commission)进行决策。
背景
2020年10月，ANSES提出了一项REACH限制，涉及婴儿尿布中发现的甲醛、多环芳烃、二恶英、呋喃和多氯联苯等有害物质。这项拟议的限制将把这些化学物质限制在欧盟/欧洲经济区市场上的尿布中非常低的水平。
REACH限制程序依赖于欧盟成员国对欧盟范围内的限制提出建议。最近，欧洲委员会通过了德国和瑞典提出的一项限制措施，以限制全氟化羧酸(C9-14全氟化羧酸)的一个亚组的使用。2020年9月，ECHA各委员会支持法国和瑞典当局的一项提议，限制服装和其他物品(包括一次性婴儿尿布)中超过1000种皮肤敏感化学品。这项建议目前由委员会作出决定。