销往欧盟和英国市场的个人防护产品（PPE）提供CE和UKCA两种认证服务, PETE DOUGHTY将进行说明。
world-renowned for its testing and certification services in the field of personal protective equipment (PPE) such as safety footwear. 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 now able to conduct conformity assessment work for manufacturers who want to mark their products as meeting the new ‘United Kingdom Conformity Assessment’ (UKCA) for sale in the UK after 1st January 2021.
The UK has left the EU, and is in a transition phase where EU legislation still applies until the end of December 2020. It is almost certain that after this date the UK will adopt its own legislation with regard to placing PPE goods onto the UK market. The European PPE Regulation(EU) 2016/425 will be brought into UK law to become the UK PPE Regulations. For category II and III PPE (such as safety footwear), third-party certification will be required and all categories of PPE will need to be marked with a new UKCA mark. The process will be very similar to that currently used for CE marking which will require the manufacturer to work with a UK ‘Approved Body’ for categories II and III. SATRA will have Approved Body status in the UK from 1st January 2021 and can already carry out conformity assessment work in preparation for UKCA marking.
Starting from 1st January 2021, the UK is expected to adopt its own PPE legislation. While in the first instance this will be a copy of EU law, it is expected that over time there will be a gradual divergence away from such rulings. The UK legislation will involve the use of a new UKCA mark (shown in figure 1), which will need to be placed on products as a means of showing conformance with applicable UK legislation. At this time, SATRA Technology Centre Limited in the UK will become a UK Approved Body with the reference AB0321 – the prefix ‘AB’ denoting ‘Approved Body’. SATRA will still be 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).
自2021年1月1日起，英国有望采用本国的PPE法规。尽管在最初，将仍沿用欧盟法规，但预计随着时间推移，将逐渐有所差异。英国法规将使用新的UKCA标志，该标志需要贴在产品上，以示符合适用的英国法规。对此，英国的SATRA Technology Centre Limited将成为英国认证机构，参考编号为AB0321- 前缀‘AB’表示“认证机构(Approved Body)”。SATRA仍能通过SATRA Technology Europe Limited提供CE标志服务，公司仍保留设在爱尔兰（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 will be 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将为前文提到的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）根据法规(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完全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.
In terms of the transition to the new UKCA marking system for the UK market (excluding Northern Ireland), there are several notable phases.
1st January to 31st December 2021
During this time, it will be possible to place on the UK market either products carrying the UKCA mark or a CE mark. However, where that CE mark needs to be supported by certification from a Notified Body (that is, for category II and III PPE), that Body must be based in an EU 27 member state. It will no longer be possible to place CE-marked products on the UK or EU market where the supporting CE certification is from a UK-based Notified Body. Effectively, all CE certifications issued by UK Notified Bodies will expire on 31st December 2020. During this time, the manufacturer can affix the UKCA mark to the packaging instead of the product.
1st January to 31st December 2022
During 2022, it will only be possible to place on the UK market products carrying the UKCA mark. It will no longer be possible to place on the UK market products that only carry a CE mark. During this time, the manufacturer can affix the UKCA mark to the packaging instead of the product.
From 1st January 2023
After 1stJanuary 2023, it will only be possible to place on the UK market products carrying the UKCA mark. The UKCA mark must ordinarily be affixed to the product. However, if this is not possible (for instance, due to the characteristics of the product), the UKCA mark can be placed on the packaging instead of the product.
It is important to note that the UK’s withdrawal from the EU will not affect the validity of existing or future test reports issued by SATRA’s testing facilities in the UK. These test reports will continue to be accepted for certification purposes by SATRA Technology Europe Limited and other PPE Notified Bodies. This is because testing that supports PPE certification does not need to be carried out in the EU.
值得注意的是，英国退出欧盟不会影响SATRA英国的检测机构发布的现有或未来检测报告的有效性。这些检测报告将继续为SATRA Technology Europe Limited和其他PPE公告机构所接受以用于认证。原因是支持PPE认证的检测不一定要在欧盟内进行。
The testing laboratories at SATRA are accredited by the United Kingdom Accreditation Service (UKAS) to the internationally-recognised standard ISO/IEC17025:2017 – ‘General requirements for the competence of testing and calibration laboratories’. UKAS, along with other European Accreditation Bodies, is a signatory of the International Laboratory Accreditation Cooperation (ILAC) Mutual Recognition Agreement.
SATRA的检测实验室经英国皇家认可委员会(UKAS)认可，满足国际公认标准ISO/IEC 17025:2017 -检测和校准实验室能力的通用要求。UKAS与其他欧洲认可机构共同签署了《国际实验室认可合作组织(ILAC)多边互认协议》。
The withdrawal of the UK from the European union has required new national legislation which, initially, will mirror that of the EU. This will require PPE being placed on the UK market, excluding Northern Ireland, to carry a new UKCA mark. This legislation becomes effective on 1st January 2021 and, depending on circumstances, will apply to PPE either on that date or 12 months later on 1st January 2022. SATRA is now in a position to certify PPE products for both CE marking and UKCA marking, enabling manufacturers to continue to supply PPE into both the European and UK markets.
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