What happens to British manufacturers using the CE mark after "Brexit day"?

What happens to British manufacturers using the CE mark after "Brexit day"?

by Nick Paul

Since 1985 UK manufacturers, distributors, and suppliers have enjoyed the ability to sell their products in all EU member states without any impediment caused by national safety standards. One set of standards meant safe products and fair access everywhere. After “Brexit day” on March 29th 2019, UK manufacturers – and UK consumers – fall out of the system of the now-famous 'CE mark'.

Before the advent of the Council Directive 85/374/EEC (liability for defective products) there was no CE mark and EU member states could reject the sale of any product that did not meet their own safety standards. This meant that manufacturers had to create different products for each of the different national requirements if they wanted to sell their products there. These national safety standards were effectively import barriers as they were often established around home-produced products rather than ‘foreign’ competition.

The UK believed this was unfair and along with other members lobbied for common standards. This eventually resulted in the EU Machinery Directive in 1989 (Directive 89/392 EEC) featuring common harmonised safety standards across the EU. Thus a level playing field was created and the passport to this was the CE mark. The application of the CE mark is simply the outward sign that the product meets with ALL the required safety standards. Accompanying this is a declaration to that effect signed by the manufacturer’s representative which, if subsequently found to be in breach, the product can be removed from sale in all EU states and fines or imprisonment for those concerned. The key to all this is the requirement that either the manufacturer or their representative (known as the responsible person) is resident within an EU member state so that they are in fact subject to EU law, liability and potential prosecution. Third Countries (those countries who are not members of the EU) are not subject to EU law and so cannot be part of the CE process.

On the 22nd. January 2018 the European Commission published an important document (Titled Notice to stakeholders), outlining the consequences that Brexit will have on UK manufactured products which are subject to CE marking requirements when placed on the European Union (EU) market following 19th March 2019 ("Brexit day").

Product types include:

  • - Electrical and electronic equipment
  • - Batteries and waste batteries
  • - Appliances burning gaseous fuels
  • - Eco-design requirements for energy-related products
  • - Simple pressure vessels
  • - Toys
  • - Machinery
  • - Measuring instruments
  • - Non-automatic weighing instruments
  • - Cableway installations designed to carry persons
  • - Radio equipment
  • - Medical devices and active implantable medical devices
  • - In vitro diagnostic medical devices
  • - Cosmetics
  • - Pressure equipment
  • - Aerosol dispensers
  • - Lifts and safety components for lifts
  • - Recreational craft and personal watercraft
  • - Equipment and protective systems intended for use in potentially explosive atmospheres
  • - Explosives for civil uses
  • - Construction products
  • - Pyrotechnics
  • - Regulation on the labelling of tyres
  • - Personal protective equipment
  • - Marine equipment
  • - Noise emission in the environment by equipment for use outdoors
  • - Energy labelling
  • - Textile products
  • - Metrology
  • - Pre-packaged products
  • - Hot-water boilers fired with liquid or gaseous fuels
  • - Rail system
  • - Electronic road toll systems
  • - Tachographs in road transport

Following "Brexit day" any UK based company that currently manufactures and directly distributes CE marked products into the EU will no longer be able to do so as the UK will become a Third Country.

CE marking is not something that can be fudged over within a trade deal as it is embedded in EU law. The HSE in their guidance notes for CE compliance responsibility state:

“The manufacturer, or the manufacturer's authorised (in writing) representative in Europe (in the UK they are known as the Responsible Person), carry the full responsibility for the safety and conformity of the product. This duty must be met before the product is placed on the market or put into service.”

Those concerned with worker safety, such as trade unions, might consider whether UK safety legislation will always mirror that of the EU or gradually fall behind? Will companies, given a choice, buy cheaper manufacturing tools which fall short of CE safety requirements?

Consumers may also wish to consider the items that they buy in the UK would no longer be covered by EU liability law, regardless if it had CE stamped on it or not. Do they know, care, or trust what will replace that? Are they happy that future products available in the UK may also fall short of the safety level currently expected under the CE mark?

Our government’s rhetoric will undoubtedly be that our safety standards will always be second to none, but there is a real danger that the UK will gradually lag behind the ever improving standards required by the CE mark. This is simply because the pressure to reduce manufacturing costs will be immense as the UK attempts to ‘go global’ again from a lone precarious position rather than continuing to expand globally from the secure base of EU standards.

As with so many other aspects of how our businesses work, there is a lot of Britishness woven into the EU. Our famous CE mark is no exception. It would be a real shame to have those years of work jettisoned and UK manufacturers left out in the cold by our own national volition.

Eur-Ing Nicholas Paul MSc CEng FIAgrE IOSH

Nick Paul is a qualified mechanical engineer, lecturer and safety advisor. He has designed and developed specialist agricultural machinery, taught engineering and IT at colleges and worked as a safety advisor to a major UK manufacturing company.

Specialising in CE marking and the machinery directive, Nick was part of a ‘road show’ team organised by the HSE to help introduce CE to UK industry. He is now retired.

Showing 12 reactions

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  • Bernard McEwen
    commented 2019-06-25 16:51:44 +0100
    The house means indoor use only. The double square means double insulated, and the the CE Mark means that the manu factturer declares that the product meets the requirements for use throughout the EU. Obviously no UK 13A mains plug can meet the last of these as only two countries in the EU use this type of mains plug. CE marking on a mains plug is a sure sign that it is an illegal and unsafe product. Also, a notified body (ASTI, BSI Kitemark or NEMKO N Mark) are required but not visible in the picture.
  • Michael Wheeler Wheeler
    commented 2019-05-11 02:25:19 +0100
    Donato Jara, the double square means double insulation or reinforced insulation, and is a symbol identified in many IEC (and EN) standards (eg EN 61010-1:2010 Safety requirements for electrical equipment for measurement, control and laboratory use – but also many other similar standards). Such symbols are defined in IEC 60417 and this particular one is numbered IEC 60417-5172
  • Andrew Chapman
    commented 2019-04-16 13:28:07 +0100
    The regulations are the same for all manufacturers whether in or out of the EU. The thing that changes is that UK notified bodies lose their notified status. But this doesn’t just affect UK manufacturers, since a very high % of manufacturers worldwide – including many in EU-27 – use UK NBs. The larger UK NBs have been migrating their certificates to subsidiaries/parents etc in EU-27 at minimal cost to the client. Quite a slow process and not completed in some cases, from a quick look at medical devices as an example. But BSI medical devices – which accounts for most UK NB certified devices – gained notified status in the Netherlands in 2018 under the relevant directives, and the certificates were being migrated from January 2019.
  • Donato Jara
    commented 2018-11-20 01:02:07 +0000
    Hi. What does the “double square” symbol mean? What’s it used for? What country or area? I can find no references to it on Google. Here’s the image I’m referring to:
  • Michael Wheeler Wheeler
    commented 2018-08-26 21:23:38 +0100
    Eric Worrall, the main issue for those that can self certify is that the importer and EU customs will now check the relevant docs thoroughly. Prior to that they did not, as I said before 90% of such docs are incorrect, UK manf exporting to the EU will have to get their act together pretty quickly. There is also a need for now finding an EU address to ‘lodge’ their technical file with. If a notified body is involved, the UK ones previously used could well be no good and new EU ones may need to be found with significant time delay issues as well as costs
  • Michael Wheeler Wheeler
    commented 2018-08-26 21:01:49 +0100
    This is terrible for manf of Medical Devices and any other equipment that needs Notified Body involvement. Bad as it is, for Machinery and Electrical goods they can be self certified if you know what you are doing. Most dont. After brexit the docs will be much more seriously checked at the EU border – 90% of the docs I check are WRONG! P.S. the lead post photo is also WRONG, UK mains plugs are exempt and MUST NOT be CE marked, they just need to meet the relevant British Standard – shame Scientists for EU got this basic bit wrong!
  • Eric Worrall
    commented 2018-08-25 19:50:05 +0100
    It sounds like it’s the importer of goods that’s responsible for the CE mark. They need to issue a declaration of conformance and have a technical file that demonstrates the product is conformant. I don’t see this will involve any more money or time than is required to self certify products at the moment. Or is this site incorrect?

  • Cyndy Hodgson
    commented 2018-08-25 14:59:28 +0100
    Jarrod Hunt did you read the article. Non-EU countries can get the CE mark but they must do so through a responsible person who is within the EU and who will be held responsible under EU laws. This will cost money, of course, thereby increasing costs, but as the first poster points out, it will also cost a great deal of time. A timescale which will only increase after Brexit as there will be more work for them to do as UK firms lose the right to self certify. But at least we will have got control back of our country. and this doesn’t just apply in the case of No deal. The requirement is absolute and cannot be negotiated away as part of trade negotiations.
  • Nicky Sutton
    commented 2018-08-25 14:50:10 +0100
    Goods bearing the CE mark may be manufactured all over the world but they need the CE mark to demonstrate they comply with EU regulations. Goods bearing the CE mark need to be “certified” against the standards ratified by the EU. It’s a short-hand way of assuring consumers of safety and breaking down trade barriers. It includes things that we have learned by grim experience need regulation in order to be safe. I have taken a couple of products through the process so I can assure readers this is not scaremongering. This is the way we eliminated lead paint in toys, and it is the structure that underpins all of the regulatory testing of medical devices. You need to prove that the product will be safe, that is is fit for purpose, that it can be manufactured to a consistent standard and that there are effective inspection and recall procedures. It’s all deathly dull to do and to talk about, but we did see this coming, and we did speak out. By the way, if UK companies want to sell in the EU, they will still have to go through the process, otherwise they will not be able to sell, because they will need the CE mark. They will have all of the red tape, and none of the benefits. There are just over six months – if you need a new hip I suggest you get moving because you’re about to lose the guarantee that it will be sterile.
  • Jarrod Hart
    commented 2018-08-25 09:32:02 +0100
    In fact I thibk even my statement below is still overstating, you can self-certify as CE compliant, just as tons of chinese equipment is, though I guess you need some representation in Europe in order for enforcement to have any teeth.
  • Jarrod Hart
    commented 2018-08-25 09:26:44 +0100
    Err, I think it’s a bit of an overstatement to say UK manufacturers won’t be able to ‘make CE marked equipment’… what they lose is the ability to CE mark equipment. They will still be able to make and sell equipment, they will just need to fork out for someone in Europe to test it and CE mark it assuming it passes. This is of course still a total disaster but not quite as the article portrays.
  • Dave Seaward
    commented 2018-08-25 09:03:24 +0100
    I suspect folks don’t understand just how completely and utterly shit this is for any UK business that exports physical products anywhere in the world. I run a business that exports high value added, one of a kind, custom machines. Our machines typically make the next generation of medical devices. Even our big corporate American customers demand CE marks on machinery as a badge of safety along with their own UL certs. The Chinese and most other countries also request it. Currently my business has invested in the systems to carry out the required checks and, being in Europe, we currently have the legal authority to self certificate. Because we know what we are doing and because our machines are designed from the ground up to the relevant standards it takes a few days and costs a few £1000s to CE one of our machines. As a third country we would need a notified body based in the EU to do it for us. There is currently around a 3-4 month waiting list and a cost of £30k to get a notified body in from Europe for our kind of equipment. I know because occasionally we go down this route for imported machines that we haven’t designed. We build one off custom machines so EVERY machine we build needs this. Get your head around a 4 month delay and an extra £30k of cost on contracts which normally takes 5 months and cost around £200k. This is typical for my business. There is a massive shortage of trained inspectors so I suspect the delay will get longer. If we cant CE mark our own machines then we simply cant export, and not just to Europe. This isn’t project fear this is the reality businesses up and down the land have to deal with. ANY deal is better than a no deal and staying in Europe is better than any deal: this is one of the very many reasons why I support the #peoplesvote (please share).