Examining the latest information regarding changes to the UKCA and CE marking of PPE for the UK and European markets.

阐述有关英国和欧洲市场PPE的UKCA和CE标志变更的最新信息。

Now that the United Kingdom is no longer obliged to enforce EU legislation, there are new requirements for the marking of personal protective equipment (PPE) – such as safety footwear – for sale in the UK. This article outlines the latest information regarding the legal changes.

由于英国现在不再有义务执行欧盟立法,因此对在英国出售的个人防护用品(PPE)(例如安全鞋)的标志有了新的要求。本文概述了有关法律变更的最新信息。

The UK left the EU on 31st January 2020, and was in a transition phase where EU legislation still applied until the end of December 2020. Since that time, the UK has adopted its own legislation with regard to placing PPE goods onto the UK market. The European PPE Regulation (EU) 2016/425 has been brought into UK law to become the UK PPE Regulation (EU) 2016/425 (as retained in UK law and amended). For category II and III PPE (such as safety footwear), third-party certification is required and all categories of PPE need to be marked with a new UKCA mark. The process is very similar to that currently used for CE marking which requires the manufacturer to work with a UK ‘Approved Body’ for categories II and III.

英国已于2020年1月31日退出欧盟,目前处于过渡阶段,欧盟立法在2020年12月底之前仍适用。此后,英国将通过自身立法将PPE商品投放到英国市场。欧洲PPE条例(EU)2016/425已纳入到英国法律中,成为英国PPE条例(EU)2016/425(保留在英国法律中并经修订)。对于第II类和第III类PPE(如安全鞋),需要第三方认证,所有类别的PPE均需标上新的UKCA标志。这一过程与目前用于CE标志的过程非常相似,CE标志要求制造商与英国的“认证机构”就第II类和第III类PPE进行合作。

SATRA received Approved Body status in the UK on 1st January 2021 and can now carry out conformity assessment work in support of UKCA marking. Manufacturers of PPE can certify their products for sale in the European union   (EU) by working with SATRA’s notified body in Ireland (an EU 27 member state), thus enabling them to CE mark their products. SATRA is also able to conduct conformity assessment work for manufacturers who want to mark their products as being ‘United Kingdom Conformity Assessed’ (UKCA) for sale in the UK.

2021年1月1日,SATRA获得英国认证机构的地位,现在可开展支持UKCA标志的合格评定工作。PPE制造商可通过与爱尔兰(27个欧盟成员国之一)的SATRA公告机构合作,对其在欧盟(EU)销售的产品进行认证,从而使其产品能够获得CE标志。对于希望将其产品标志为符合新的“英国合格评定(UKCA)”以在英国销售的制造商,SATRA还能够为其进行合格评定工作。

While the UK PPE Regulation (EU) 2016/425 (as retained in UK law and amended) is acopy of EU law, it is expected that over time there will be a gradual divergence away from such rulings. The UK legislation involves the use of a new UKCA mark (shown in figure 1), which needs to be placed on products as a means of showing conformance with applicable UK legislation. SATRA Technology Centre Limited in the UK is now a UK Approved Body with the reference AB0321 – the prefix ‘AB’ denoting ‘Approved Body’. SATRA is still able to offer CE marking services through SATRA Technology Europe Limited, which will remain a Notified Body (number 2777) based in Ireland (an EU 27 member state).

图片尽管英国PPE条例(EU)2016/425(保留在英国法律中并经修订)仍沿用欧盟法律的规定,但预计随着时间推移,将逐渐偏离这种规定。英国立法涉及使用新的UKCA标志(如图1所示),该标志需要贴在产品上,作为显示符合适用英国立法的一种方式。英国的SATRA Technology Centre Limited现已成为英国认证机构,参考编号为AB0321 - 前缀‘AB’表示“认证机构(Approved Body)”。SATRA仍能够通过SATRA Technology Europe Limited提供CE标志服务,该公司仍将是一个总部设在爱尔兰(27个欧盟成员国之一)的公告机构(编号2777)。

The UK’s equivalent of the CE mark is the previously-mentioned UKCA mark. This means that to sell category II and III PPE in both the UK and EU 27 member states, a manufacturer will need an EU type-examination certificate under Regulation (EU)2016/425 from an EU Notified Body such as SATRA Technology Europe Limited, plus a UKCA certificate from a UK Approved Body – for instance, SATRA Technology Centre Limited. Hence, SATRA is well placed to provide both certifications in the most efficient manner, and our staff in both Ireland and the UK will be able to organise this for our customers.

CE标志的英国等效标志为前文提及的UKCA标志。这意味着,若要在英国和27个欧盟成员国销售第II类和第III类PPE,制造商将需要获得欧盟公告机构(如SATRA Technology Europe Limited)根据条例(EU)2016/425颁发的欧盟型式检验证书,以及英国认证机构(如SATRA Technology Centre Limited)颁发的UKCA证书。因此,SATRA有能力以最有效的方式提供这两种认证,我们的爱尔兰和英国员工将能够为客户安排这两种认证。

Although it is part of the UK, products being sold into Northern Ireland will still require CE marking, and not the new UKCA mark.

尽管其构成英国的一部分,但销往北爱尔兰的产品仍需要CE标志,而非新的UKCA标志。

In terms of the transition to the new UKCA marking system for the UK market (excluding Northern Ireland), there are several notable phases.

对于英国市场(不包括北爱尔兰),就向新的UKCA标志系统过渡而言,有几个值得注意的阶段。

 

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