Do your products have CE markings? You have to do something now, says FBC Manby Bowdler Brexit Director Peter Wilding
The CE mark is gone.
If you have industrial products which are subject to CE Marking requirements when placed on the European Union (EU) market you will now have to have re-certify them. The CE mark is to be replaced with a UK mark. The trouble is the UK government has given no indication about what the process will be to ensure frictionless compliance with the EU. So, producers of toys, electrical equipment, the verification of weighing and measuring equipment and a whole host of other sectors will now have to change labels, equipment and stamps to cope. Production lines will have to be altered to allow for UK marking separate to CE marking, increasing costs.
The problem is that the European Commission has clearly confirmed that, in order to demonstrate compliance with the CE Marking requirements for products “economic operators are advised to take the necessary steps to ensure that, where the applicable conformity assessment procedures require the intervention of a Notified Body, they will hold certificates issued by an EU-27 Notified Body”.
In practice, this means that, as from Brexit Day, companies that wish to continue placing products (see below) on the EU market and that previously relied on conformity assessments carried out by a UK Notified Body, can no longer rely on them.
Anxiety has emerged because the UK government tabled a proposed law only on January 24th setting out plans to alter the certification scheme for the UK only. The problem is that it does not make clear how compliance with the EU regime happens. Worse still, there is no chance that it will be passed through Parliament before Brexit day.
As we stand, the loss of the CE mark and the effective replacement of CE certification and type approval with UK only systems mean certain sectors will see duplication of certification costs. This will make the UK an unattractive market for certain products, especially fast moving consumer goods with tight margins. It will apply to both exporters and importers.
For example, take a look at organic food. The Organic Products Regulations are clear that current certifications lapse and UK producers will no longer be able sell into the EU as they can no longer use the green leaf logo.
Or what about the CE Mark which applies to medical devices such as hip replacements? If unsafe devices are imported into the UK after Brexit day, there is no regulator with authority to take action.
This is an issue not only confined to importers. When selling into the EU market, companies will not be able to go through UK Notified Bodies when a conformity assessment by a Notified Body is required, but will rather have to request EU Notified Bodies to carry out these conformity assessments. This will take time and money.
The reason is that manufacturers currently operating from the UK will no longer be considered to have an establishment in the EU after the UK withdrawal. Consequently, companies have to anticipate that their designation will change under CE Marking legislation, as well as their relevant obligations. That means companies will become importers under CE Marking legislation in relation to products that they want to place on the EU market as from the UK withdrawal date.
You should, therefore, make sure that you are aware of all your conformity obligations post-Brexit. To anticipate these changes and ensure full access of your products to the EU market, it is recommended that you start reviewing your CE Marking conformity assessment procedures and, where you require the intervention of a Notified Body, initiate EU Notified Body assessment procedures or negotiate the transfer of your file from a UK Notified Body to an EU Notified Body.
For more information or to get in touch with our Brexit advisory team contact Peter Wilding on 01694 724440, 07901 008220 or email p.wilding@fbcmb.co.uk.
What Products Are Covered by CE Marking Requirements?
- 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