As the good ship Brexit sets sail next month, the replacement of two letters – CE (Conformité Européenne) – with four – UKCA (UK Conformity Assessed) – will commence on 1 January for machine tools in respect of supply to Great Britain. It’s not an abrupt change, there’s a transition period and some qualifications, but from 1 January 2022, the UKCA regime becomes the requirement for machine tools placed on the GB market. Northern Ireland retains the CE marking regime, although Howard Wheeler, senior consultant at Finch Consulting ( www.finch-consulting.com ), says there is talk of a UKNI mark but that the situation is fluid and there is no detail.
Government guidance on placing goods onto the Northern Ireland market ( www.is.gd/sugoto ) indicates that the question of regulatory alignment can be revisited every four years by “elected institutions in Northern Ireland”, with the first date being 2024.
Products to be sold in the EU (including the larger European Economic Area, EEA, that includes Iceland, Liechtenstein and Norway, and which shares EU internal market rules) will still need CE marking. UKCA will have no legitimacy in the EU (or Northern Ireland) and, importantly, there are no transition arrangements in the EU as is the case for Great Britain’s move to UKCA.
Just as a recap, the Machinery Directive 2006/42/EC ( www.is.gd/vihope ) is part of the EU’s economic legislation. It applies to products designed to be sold (or enabled) in the European Union for the first time.
It addresses manufacturers, importers and dealers of machinery and safety components, and applies to new equipment (except in one particular circumstance – see box item on second-hand machinery, p14). This directive harmonised the level of safety of products designed and produced by different manufacturers. Already installed machines were outside the scope of the Directive, but all machinery employed in factories, regardless of how it is obtained, falls within the UK’s national safety regime – Provision and Use of Work Equipment Regulations (PUWER) introduced in 1992 and subsequently updated in 1998 (and itself derived from another European Directive, 2009/104/EC). To be clear, PUWER applies whether a machine is CE marked or not, while the responsibility of companies using machinery and equipment stretches further than merely asking for CE, or UKCA, marking.
For many end users of new machinery it is, perhaps, enough to know that UKCA=CE, in the sense that a machine marked as such has been deemed safe, either by a Notified Body or via a self-certification process (but PUWER also applies, as already stated). However, an appreciation of the subject is likely to be of interest to end users wishing to understand why they see three possible marking combinations – CE alone, UKCA alone, or CE and UKCA together – on machines they buy at various times. For those manufacturing, distributing, importing and/or exporting, the subject is more involved, of course.
To help explain the situation, the Engineering And Machinery Alliance (EAMA) put on a webinar recently ( www.is.gd/diyena ), with representatives from the Department for Business, Energy and Industrial Strategy (BEIS) in attendance. EAMA is a non-sectoral organisation whose members work across multiple industrial areas. MACH exhibition organiser and representative body the Manufacturing Technologies Association (MTA) is an EAMA member, for example, and many of the MTA’s members supply metalcutting or metalworking machine tools, which fall within scope of this new safety compliance/marking regime.
“The webinar is part of a programme to get business ready for what’s going to happen at the end of the Brexit transition period at the end of this year,” explained Jack Semple, EAMA president, as he opened the online gathering, adding: “Firms need to be considering both what’s going to be happening immediately and what they’re being given a bit of time to prepare for past January .”
Speaking for BEIS, Terry Boniface, assistant director of electronics and machinery, opened with: “I think the biggest risk, really, to the end of the transition period is lack of preparedness by traders, either in the UK or in the EU. There are a few misconceptions about what will be amended by the EU Free Trade Agreement, if that’s actually landed by the UK government. UKCA marking will come into force, regardless of a deal with the European Union.” So, there will be no last-minute change, clearly.
The government’s website ( www.is.gd/uwipac ) on matters UKCA dryly states what will be required under the new regime. “You will need to use the new UKCA marking immediately after 1 January 2021, if all of the following apply to your product: it is for the GB market; it is covered by legislation that requires the UKCA marking; it requires mandatory third-party conformity assessment [by a Notified Body]; and where conformity assessment has been carried out by a UK conformity assessment body and you haven’t transferred your conformity assessment files from your UK body to an EU-recognised body before 1 January 2021.”
Since most machine tools do not require mandatory third-party conformity assessment, this requirement won’t apply to many. Self-certification is permitted for all machinery, except those types listed in the so-called Annex IV of the EU Machinery Safety Directive. Companies not making such machinery may choose to voluntarily engage a third-party to support their conformance activities, however.
The government website adds that the UKCA regime does not apply to existing stock, for example if the good was fully manufactured and ready to place on the market before 1 January 2021.
Government advice on the acceptance criteria for continued use of CE marking for Great Britain is as follows: “You will be able to use the CE marking until 31 December 2021, if any of the following apply: you currently apply CE marking to your good on the basis of self-declaration; any mandatory third-party conformity assessment was carried out by an EU-recognised Notified Body (including a body in a country with which the EU has a relevant mutual recognition agreement); or if the certificate of conformity previously held by a UK-approved body has been transferred to an EU-recognised notified body.”
BEIS higher executive officer Abigail Gambell confirms that a company in Great Britain could continue to manufacture a machine tool in the EU, using an EU Notified Body for CE marking and place it on the market throughout 2021. After that, UKCA marking would be required, however.
|Quote from Yamazaki Mazak: "Mazak has the authority to self-certify all machines in Japan and UK HQ. In the present state of Brexit negotiations, with what we know now, there will be no change to our processes between now and December 2021.|
In Jan 2022, under the current guidelines, we will dual-mark all machines with CE and UKCA certification to ensure the safety of all machines, regardless of where they are being produced (Japan, UK) and where they will be sold (GB or Europe)."
DIVERGENCE IS A TWO-WAY STREET
There’s one further qualification for continued use of the CE mark. Says official guidance: “You can only place CE-marked goods that meet EU requirements in Great Britain while UK and EU requirements are the same. This will be the case on 1 January 2021 and there are no UK plans to diverge at this time. Nonetheless you are encouraged to be ready as soon as possible, and by 1 January 2022 at the latest.”
So, any divergence of UKCA from CE requirements on the UK’s part is not seen until that latter date, it would appear to be heavily implied. But the EU could diverge/change, as is made clear, and then things are different.
“If the EU changes their rules and you CE mark your goods based on new EU rules that are different from the requirements in the UK, you will no longer be able to use the CE marking in the UK. This will be the case even if the change happens before 1 January 2022.”
Boniface highlights that while UKCA and CE start off the same, the move to UKCA “gives us the ability to shape product regulation in the UK, which is obviously a key ambition for the government”.
So, what happens on 1 January 2021 is that “conformance will be against UK regulations, but the UK regulations will essentially be the EU Directive brought onto the UK statute”, he encapsulates. The harmonised technical standards underpinning assessment will become BS prefix standards, but again will be a port of existing standards used in CE marking, he further adds.
“Instead of EU harmonised standards, the UK will identify UK-designated standards and this will provide presumption of conformity in a similar way EU ones do now,” says Finch Consulting’s Wheeler. (Manufacturers need not use harmonised standards, but automatic presumption of conformity then vanishes.) And he goes on: “Manufacturers will need to produce a dedicated declaration of conformity and/or incorporation for UKCA marking. So, if the product is also CE marked, there will be at least two versions of these declarations. I say at least two, because of the Northern Ireland situation.”
Now, there are more subtleties within all of this, as BEIS’ Gambell points out. For example, importers have a stronger duty to ensure goods are compliant than do distributors. And a company within Great Britain that was a distributor for EU goods, or of those imported by an EU country-based company, will now become an importer, if it is the first to place a machine tool on the GB market. (That also operates the other way, too.) So, such companies will need to make sure, for example, that goods are labelled with details that include the company name and a contact address, although until 31 December 2022 these details can be on the accompanying documentation, rather than on the manufactured good itself.
Finch Consulting’s Wheeler adds some more detail on the change from distributor to importer. While he says there should be no reason why companies would need two separate Technical Files (the technical documentation that demonstrates that the product meets the regulatory requirements) since the same one could be used for both CE and UKCA, holding two files is a choice they may make because of this change from distributor to importer. “Many companies that either import into GB or into the EU, not forgetting Northern Ireland, will, in most cases, have significantly more responsibilities. And they will need to be able to provide the Technical File to authorities, if asked.
If the manufacturer undertakes the importing, then that makes it simpler, but third-party importers may be asking for copies of the manufacturer’s Technical File, as their responsibilities can last for 10 years after supply.”
He additionally makes clear that unlike for other EU directives such as The Electrical Equipment (Safety) Regulations 2016, The Pressure Equipment (Safety) Regulations 2016, The Dangerous Substances and Explosive Atmosphere Regulations, The Electromagnetic Compatibility Regulations 2016, for example, in the case of the Machinery Directive and machine tools, end users do not become importers when buying directly from EU-based companies.
Moving onto Notified Bodies that offer third-party compliance services for so-called Annex IV machinery and Gambell advises that all such current UK-based organisations will automatically become UK-approved bodies (for UKCA conformance services) from the first of January 2021 (UKAS website list:
www.is.gd/epabaz ), but for UK companies placing goods on the EU market from that same date, such UK bodies will no longer be recognised in the EU. (There is a potential muddying of the waters in that mutual recognition could still be part of any UK-EU deal.) Emphasises Gambell: “So companies do need to be making sure you’re taking steps to ensure compliance with the EU requirements by the end of this year, ready for the first of January.”
She adds: “Voluntary testing by conformity assessment bodies and self-declaration of conformity to the EU market will continue where legislation currently allows, and that is for both markets.”
UK companies not producing Annex IV equipment and self-certifying can still voluntarily engage with organisations that previously had EU Notified status for their CE marking services, advises Finch Consulting’s Wheeler.
On the UK regime, Gambell says: “The test that the UK bodies will be doing to ensure goods are compliant will be the same as they are required to do under the existing [CE] regime. But, just to reiterate, we really do encourage you to reach out and speak to your UK-based body as soon as possible, because it’s ultimately down to them to guide you on exactly what they will require from the 1 January, but their requirements will be detailed in letters sent before the end of this year.”
LOCATION, LOCATION, LOCATION
A related issue concerns Authorised Representatives (AR)and Responsible Persons (RP). These keep the declaration of conformity and the technical documentation, including the Technical File, on behalf of others, which must contain all information necessary to demonstrate conformity of the product to the applicable requirements. The AR/RP must make this information available to national surveillance authorities and cooperate with them at their request. Any organisation in the UK that offers AR services will no longer be able to meet the requirement for being based in the EU, so requiring an EU-based one for products being placed on the EU market. MTA guidance (10 November, V2) for firms exporting to the EU/NI is to appoint an AR there as a CE mark/GB address combination will not be acceptable, as well as to provide an EU or NI address on the CE mark. Vice versa, of course, those based in the EU will no longer be recognised in Great Britain from 1 January 2021, so one would need to be based in the UK for products being placed on the GB market.
As regards the actual manner of marking the new four-letter acronym on products, as is required for CE, there is leeway being given for 24 months from 1 January 2021 such that an indelible mark on the product is not being requested; it can be a label affixed to the product or even on documentation, Gambell highlights. There are rules as to the dimensions and proportions of the mark, of course.
It’s all very clear, then? Sadly not, as BEIS’ Boniface was candid enough to admit in the EAMA webinar. “The main idea of these seminars is to try to make sure you aware of the policy and of those, for a better word, soft-landing measures we’re trying to introduce. We don’t know all the answers. And I think also we’re trying to understand what the implementation challenges will be from companies. Because I know you probably think government knows everything; we obviously don’t know everything and there is a myriad of business models out there, so we need to actually make sure that we know how these policies are landing with different types and shapes of companies up and down the country.”
So, it is no surprise that during the webinar companies were encouraged to “keep their eye on the government website”, while points arose that could not be definitively answered. What you read here gives a current-at-the-time, top-level overview. It does not cover all the detailed points that will no doubt arise in coming months, nor does it preclude the potential for change to the areas discussed above.
All Machinery would observe is that the official online Machinery Directive ( www.is.gd/omeriq ) runs to some 28,000 words and that strict adherence to it might be expected during border checks made as goods pass from Great Britain into the EU/EEA. Perhaps the ‘Guide to application of the Machinery Directive 2006/42/EC – Edition 2.2’ ( www.is.gd/vijudo ) will become a more interesting read for some; that’s over 180,000 words, however – a good Christmas read, then.
On the border
Wording in ‘Guidance to the Machinery Directive’ ( www.is.gd/vijudo ):
The authorities in charge of the external border controls shall suspend release of machinery for free circulation within the EU in the following cases:
■ If complete machinery does not bear the CE marking and the other markings required by the Machinery Directive or has been affixed with the CE marking in a false or misleading manner, or is not accompanied by the EC Declaration of Conformity signed by the manufacturer or his Authorised Representative
■ If there is cause to believe that the machinery presents a serious risk to health and safety
Extended box item
Guidance to the Machinery Directive ( www.is.gd/vijudo ) states that, in general, the directive “does not apply to the placing on the market of used or second-hand machinery”. It continues: “In some Member States, the placing on the market of used or second-hand machinery is subject to specific national regulations. Otherwise, the putting into service and use of second-hand machinery for professional use is subject to the national regulations on the use of work equipment implementing the provisions of Directive 2009/104/EC.” The UK’s ‘The Provision and Use of Work Equipment Regulations (PUWER) 1998’ derives from that very directive.
A qualification to what this means is given in Machinery Directive Article 15, which the guidance document explains as this: “[This] indicates that Member States remain free to regulate the installation and use of machinery in accordance with the relevant provisions of EU law, providing these regulations do not have the effect of restricting the free movement of machinery that complies with the provisions of the Machinery Directive.”
The guidance notes an exception to exclusion from the Machinery Directive: “The one exception is for used or second-hand machinery that was first made available with a view to distribution or use outside the EU when it is subsequently placed on the market or put into service for the first time in the EU. In this case, the person responsible for placing on the market or putting into service such used machinery for the first time in the EU, whether he is the manufacturer of the machinery, an importer, a distributor or the user himself, must fulfil all the obligations set out in Article 5 of the Machinery Directive.” And that includes affixing the CE mark (or now the UKCA mark – Machinery requested clarification from BEIS, none was received).
The wording on the HSE website covering this exception is: “Where the second-hand equipment is in scope of one of the European product supply Directives and has not previously been put into service in the European Economic Area (EEA – includes EU countries and also Iceland, Liechtenstein and Norway), or placed on the market of the EEA, the person importing it into the EEA must meet the conformity assessment requirements of the relevant European Directives, including CE marking [UKCA in future, presumably].”
In this specific case, then, the movement across borders of second-hand equipment could potentially become rather more complex, as Finch Consulting's Howard Wheeler details.
Circumstance A - UK purchaser buying second-hand machinery from the EEA after the end of the transition period but before the end of 2021 (assuming no divergence between EU and UK law).
During this period, CE-marked equipment is allowed onto the UK market, hence it is likely that second-hand CE-marked machinery will be allowed into the UK in a similar way as present and in a similar way to new machinery.
Circumstance B - A UK purchaser buying second-hand machinery from the EEA (machinery that has never been ‘placed on the UK market’) after the end of 2021.
After the end of 2021, machinery will be required to be UKCA marked when it ‘is placed on the UK market’. CE (only) marked machinery will not be sufficient.
If it is not, then the importer (who could also be the end user) will need to take responsibility for it, UKCA mark it and undertake all the roles of the manufacturer as dictated by The Supply of Machinery (Safety) Regulations.
Machinery coming in from the EEA and being ‘placed on the UK market for the first time’ after the end of 2021, will be treated in the same way as new machinery coming in from abroad.
If machinery is both CE and UKCA marked, the importer (who could also be the end user) will need to check that it is suitably UKCA marked, ensure that the UK Declaration of Conformity is correct (and in English), that the versions of the standards listed are appropriate to meet the Essential Health and Safety Requirements of the UK Machinery Regulations and that the instructions are available in English. Basically, due diligence will be needed.
Old second-hand UKCA marked equipment that was never previously ‘placed on the UK market’ may not comply with relevant UK designated standards at the date of import and hence due diligence checks should disallow import unless a highly technical evaluation can show the older standards are still suitable for that particular machine.
Circumstance C - A UK purchaser buying second-hand machinery from the EEA (machinery that has previously been ‘placed on the UK market’ but subsequently sold to into the EEA and now being re-sold back into the UK) after the end of 2021.
If the machinery is UKCA marked, there could be a case to be made that the machinery was previously ‘placed on the UK market’ and hence can be considered as other second-hand machinery from within the UK. However, this may not be acceptable and the simpler case of treating all machinery the same may be applied. It is unlikely that guidance will cover this particular option and such a case may need to be tested in UK law.
There could be a similar case for machinery that was CE marked prior to the end of 2021 and used initially in the UK before being sold originally into the EEA and subsequently re-sold back into the UK, again this may have to be tested in law.
Circumstance D - An EEA purchaser buying second-hand machinery from the UK after the end of the transition period.
After the end of 2020, machinery will be required to be CE marked when it ‘is placed on the EEA market’. UKCA (only) marked machinery will not be sufficient.
If it is not, then the importer (who could also be the end user) into the EEA will need to take responsibility for it, CE mark it and undertake all the roles of the manufacturer as dictated by The Machinery Directive.
Machinery coming in from the UK and being ‘placed on the EEA market for the first time’ after the end of 2020, will be treated in the same way as new machinery coming in from abroad.
Circumstance E - An EEA purchaser buying second-hand machinery from the UK (machinery that has previously been ‘placed on the EEA market’ but subsequently sold to into the UK and now being re-sold back into the EEA) after the end of 2020.
If the machinery is CE marked, there could be a case to be made that the machinery was previously ‘placed on the EU market’ and hence can be considered as other second-hand machinery from within the EEA. However, this may not be acceptable and the simpler case of treating all machinery the same may be applied. No known guidance covers this particular option and such a case may need to be tested in EU law.
Reasoning - Both the UK Regulations and the EU Directive use the same fundamental approach to requiring machinery to be marked. ‘Placing on the market’ for the first time means being placed on that particular market. If the machinery was placed on the market outside that region, that placing is not relevant and such goods will be treated as other new goods will be on entering that market.