For more than 25 years, machines, including injection units, have been subject to the CE (Conformité Européenne) marking process when they were put into use in the European market (EU and the European Economic Area). The mark aims to simplify the free movement of the machine and demonstrate compliance with one or more European product safety directives, but it becomes more complicated. 

After Brexit, from January 1, 2021, the UKCA (UK Compliance Assessment) mark will replace the long-term CE mark for goods sold in England, Wales and Scotland. Since Ireland has no hard borders, the free movement of people and goods continues to apply, as does the CE marking. To make matters more complicated, in Northern Ireland, when goods subject to the CE marking are implemented by a GB authorized agency (according to Article 7(3) of the Northern Ireland Protocol), the third mark-UKNI will be used. In addition, the notified body recognized by the EU can also certify products in the NI market.

So, what do all these certification changes mean for European machinery manufacturers such as Sumitomo (SHI) Demag, which provide molding systems, peripherals and robotics to customers located in the UK or Ireland? As the UKCA transition period expires on January 1, 2022, British companies are quickly trying to crack the certification responsibilities, commercial risks and legal liabilities. 

Managing Director Nigel Flowers worked with CE expert Derek Coulson to ensure and check the future prospects of UKCA machinery certification and how to avoid sleepwalking into the risky minefield. As the first step after the split is reached, both parties will review the gray areas, new rules related to the role of importers, and how future safety certifications will align with the national sovereignty aspects of Brexit and international safety standards.

From plastic toys to medical equipment, from light bulbs to robots, the CE mark has been regarded by many companies and consumers as a recognized cornerstone of safety. Nigel pointed out that the introduction of the UKCA logo has not changed this. "Except for some minor changes to the text in the document to reflect the requirements of UK legislation, the current transition to UKCA is mainly an administrative change. The biggest impact will depend on the location of the manufacturer."

Any UK company exporting to the European Union must now appoint a responsible person or entity as the person who edits the CE marking technical file. The entity—any EU individual or company—must be physically located in the EU. 

This requirement has been removed from UK legislation. There is no requirement for non-UK suppliers to identify a British person to compile technical documents. It can now be borne by the original manufacturer in any country. Derek emphasized that what is worrying is that the British health and safety authorities will not be able to obtain technical documents. "This means that the end user must ensure that any equipment provided meets all requirements and is safe before it is put into use," Derek said. 

In July 2021, EU regulations 2019/1020 will require all non-EU CE marked commodity suppliers to supply through importers or fulfillment centers. Importers or fulfillment centers must hold technical documents, or they must have an EU Authorized Representative (AR) To fulfill their tasks. This EU AR must be marked in the declaration and in some cases must also be marked on the manufacturer's nameplate. This requirement does not apply to England, Scotland or Wales, but it applies to suppliers in Northern Ireland. If British, Welsh or Scottish manufacturers want to supply Northern Ireland, they must obtain EU AR from July 16, 2021.

For the UK CA mark, when the “harmonized standard” with the EN prefix is ​​mentioned before the declaration of conformity (DoC) or the declaration of company (DoI), these must now refer to the “designated standard”. Standard numbers should be prefixed with BS to indicate that they are British standards.

The CE mark requires that the machine description be written in the language used by each machine, while the UKCA mark insists on writing the manual in English.

The change with the greatest risk impact is related to the state. British distributors who import equipment manufactured in the UK are now defined as "importers". The compliance responsibility for complying with the UKCA system lies here. "If a security-related matter occurs, the party located in the jurisdiction-in this case the British importer-bears responsibility," Derek emphasized. 

"It all sounds pretty simple. It is true, as long as the EU and UK safety certification standards are fully consistent," Nigel said. Although no disagreement is currently expected, it may happen in the future. This is why most global companies, including Sumitomo (SHI) Demag, advocate working towards international ISO safety standards rather than national standards. 

Ireland is where the situation has become more chaotic. Because Northern Ireland’s rules allow people and goods to move freely within Ireland, most of the rules are consistent with the European Union’s CE marking. 

Derek explained: "Machine manufacturers exporting to Ireland from the EU, as Sumitomo (SHI) Demag has done, will continue to use technical documents compiled by EU personnel to CE mark their machines exactly as before. If a subsidiary, importer, representative or distributor located in the European Union is ready to assume this role, it only needs to update the file accordingly. The manufacturer must trust any importer because the technical file contains intellectual property rights."

If the EU machine manufacturer previously used the UK Notified Body to assess the compliance of Annex IV machines, it should be transferred to the EU Notified Body. Most UK notified bodies now have EU subsidiaries or parent companies. However, if a product with the CE mark is put into use in Northern Ireland, if it has been evaluated by a British authorized agency, the UKNI mark must also be used with the CE mark. 

Nigel serves a large and expanding customer base for injection molding in Northern and Southern Ireland. He clarified that setting up a new registered office in Ireland would help. In addition, having a designated signatory in Germany can reassure Sumitomo (SHI) Demag customers that all future DoC or DoI documents will comply with all these new certification systems.

For most of the new injection molding systems commissioned for UK customers, Sumitomo (SHI) Demag will focus on importing the entire unit from Germany or Japan, including robots and peripheral equipment such as runners and cooling systems. As an importer, the British team assumes the responsibility of technical documents, so that the issuance of the UKCA mark can be seamlessly connected. 

Combining robots and other equipment from different machinery suppliers does increase the complexity of certification, and the responsibility may be transferred to the end user-the molding company or integrator. Nigel explained: “Within the scope of the Machinery Supply (Safety) Regulations 2008 and its amendments, the complete robot cell must bear the CE mark. If it is added to a safety machine, a company statement can be issued. However, even Before Brexit, the responsibility for certification lies with the customer or integrator. This still applies."

In addition, the creation of complex mechanical components may bring other safety hazards. A new cell is actually created. "Just assuming that the CE or UKCA mark is affixed to each device means that the entire battery is certified, which is not enough," Derek said. 

The 1998 "Work Equipment Regulations and Use Regulations" (PUWER) will continue to cover the sale of second-hand or second-hand molding machinery in the UK.

Currently, the process is shifting from compliance with EU directives to almost the same system under British regulations. However, compared with distributors, it does bring greater responsibilities to importers, especially in terms of compliance. "Although these changes are subtle, some clear changes in legal liability are about to happen," Nigel concluded.

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