欧盟口罩CE最新的REACH要求

近日，欧洲安全联盟在其上发文明确：防护口罩等个人防护用品（PPE）需满足REACH法规等要求。

原文如下：

conformity assessment procedure for PPE

remark : this article is valid for Personal Protective Equipment (PPE), such as protective masks (type FFP2 or FFP3), protective glasses and face shields, protective gloves and garments, etc. The conformity assessment procedures for medical devices (e.g. medical or surgical masks) are different and for those you should seek information from the relevant trade associations or authorities. The manufacturer must also check of other legislation is simultaneously applicable to the product (e.g. REACH is always applicable).

Compliance with the EU legislation on PPE (Regulation (EU) 2016/425) ensures that PPE are safe to be used by the wearer and at the same time offer the necessary and claimed protection. Having the same legislation in the EU (+EFTA/EEA and some other European countries) is obviously a key element for the single market.

The COVID-19 crisis does not change the fact that PPE must be safe for the wearer, nor that the PPE must protect the wearer as claimed by the manufacturer. Even if some deviations of the conformity assessment procedures are made possible with the Commission Recommendation 2020/403, the essential health and safety requirements for PPE can under no condition be ignored. These exceptions are in any case limited for PPE used by healthcare workers. For more information on this specific aspect, see the page “exceptions to the conformity assessment rules for PPE”.

The conformity assessment procedure is the responsibility of the manufacturer of the PPE. First step is to make a risk analysis, defining what protection is offered by the product and what the foreseeable use (and misuse) is. Based on this, the category of the PPE is defined (for instance for respiratory protection that is always category III).

The technical file must contain this risk analysis but also all information about the product, the production control, the user instructions etc. The file must also contain information on how the manufacturer proves compliance with the applicable Essential Health and Safety Requirements (annex II of the PPE Regulation). The most common way to demonstrate compliance is by using harmonised European standards, but also other technical specifications can be acceptable.

In the case of category II and III PPE (which are the vast majority of PPE), the manufacturer must apply for a type examination by a Notified Body which results in an EU Type Examination Certificate. For category III PPE (such as protective masks), this also needs to be completed with a follow-up of the production by a Notified Body. See the NANDO database of the EU Commission to find a Notified Body competent for your product.

Once this completed, the manufacturer has to mark the product with the CE mark (in case of category III followed by the number of the Notified Body responsible for the production follow-up) together with his name (and address), the reference of the product and reference of the standard used (for full list of what needs to be included in the marking, see the Regulation, e.g. article 8 (obligations of manufacturers) and also the (European) standards).

The manufacturer must prepare the Declaration of Conformity which needs to be included with each product (or at least a link to the document must be available with the product) and ensure that procedures to remain in conformity are in place for the series production of the PPE. This Declaration of Conformity is the only document that needs to accompany the PPE and that the manufacturer needs to share with his customers.

All PPE have to be accompanied by the instructions for the user in the language of the country where the PPE will be sold (see annex II paragraph 1.4 of the PPE Regulation for the minimal content).

翻译：

PPE的合格评定程序

注:本品适用于个人防护用品(PPE)，如防护面罩(FFP2或FFP3型)、防护眼镜和面罩、防护手套和服装等。医疗仪器(例如医用或外科口罩)的合格评定程序有所不同，你应向有关行业协会或当局查询有关资料。制造商还必须检查同时适用于产品的其他法规(例如REACH始终适用)。

遵守欧盟关于个人防护装备(条例(EU) 2016/425)的法规，确保穿戴者使用个人防护装备是安全的，同时提供必要的和要求的保护。在欧盟(+EFTA/EEA和其他一些欧洲国家)有同样的立法显然是单一市场的关键因素。

COVID-19危机并没有改变这样一个事实，即PPE对穿戴者来说必须是安全的，也没有改变PPE必须像制造商所声称的那样保护穿戴者。即使委员会的建议2020/403使得合格评定程序的一些偏差成为可能，但在任何情况下都不能忽视PPE的基本健康和安全要求。这些例外情况在任何情况下都仅限于卫生保健工作者使用的PPE。有关这方面的详细信息，请参阅“PPE合格评定规则的例外情况”页面。

合格评定程序是PPE制造商的责任。第一步是进行风险分析，定义产品提供了什么保护，以及可预见的使用(和误用)是什么。在此基础上，定义了PPE的类别(例如，用于呼吸保护的总是第III类)。

技术文件不仅要包含风险分析，还要包含产品、生产控制、用户使用说明等所有信息。该文件还必须包含有关制造商如何证明符合适用的基本卫生和安全要求的信息(PPE条例附件二)。证明合规的最常见方式是使用统一的欧洲标准，但也可以接受其它技术规范。

对于第二类和第三类PPE(它们占PPE的绝大部分)，制造商必须向公告机构申请类型检验，并获得欧盟类型检验证书。对于第III类PPE(如防护面罩)，还需要由一个通知机构对生产进行跟踪。请参阅欧盟委员会的NANDO数据库，以查找适合您的产品的公告机构。

一旦完成,制造商与CE标志产品标志(三级紧随其后的公告机构负责的数量生产后续)连同他的名字(地址),产品的参考和引用标准的使用(完整列表的需要包含在标记,看到监管,如第八条(制造商的义务)和(欧洲)标准)。

制造商必须准备符合要求的声明，该声明必须包含在每个产品中(或至少与该产品有文件链接)，并确保在PPE的系列生产中保持符合要求的程序已经就位。这份符合性声明是唯一需要与PPE一起提供的文件，制造商需要与客户共享这份符合性声明。

所有的个人防护装备都必须以将出售个人防护装备的国家的语言为用户提供说明(最低限度内容见个人防护装备条例附件二第1.4段)。

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