The New CE Marking Regulation for Personal Protective Equipment (EU) 2016/425 will replace 89/686/EEC from 21^st April 2018.

PPE has been required to be CE Marked since 1989, however as of April this year, a new regulation will come into place. In the meantime, Manufacturers will still be able to CE Mark PPE against the existing Directive until April 2019 and in addition, EC Type Examination Certificates issued against the old Directive will remain valid until April 2023.

The purpose of the new regulation is to bring PPE in line with the New Legislative Framework (NLF) under which many common Directives such as Low Voltage and Electro-Magnetic Compatibility (EMC) now fall. The NLF more directly outlines the responsibilities of Economic Operators and makes Risk Assessments an explicit legal requirement as well as introducing a common approach to the structure of the legislation. However there have been some subtle changes to the detail of the PPE Regulations which Manufacturers should be aware of.

Whereas certain types of equipment have moved categories, one of the more interesting changes is that equipment for private use to protect against excessive heat now falls within the scope of the Regulations – hence as of April, oven gloves for private use will need to be CE Marked.

Other changes include a compulsory maximum period for certification validity, the requirement to issue a Declaration of Conformity for each item (or at the least an internet addresses where one can be obtained) and a derogation for ‘bespoke’ PPE.

If you need any help and support with CE Marking under the new PPE Regulation, then please call us on 01564 792349.

Over 150 people attended the three CE Marking Seminars given at the Southern Manufacturing Show earlier this month which looked at the CE Marking process in general as well as exploring recent or imminent changes to legislation.

Members of our Technical Team were on hand to help and advise both before and after the seminars. If you are interested in ongoing support for your CE Marking requirements, we offer membership of the CE Marking Association, details of which can be found here.

We look forward to welcoming you at similar events in the future, please keep an eye on our website for details of future seminars.

A copy of the presentation delivered is available to download here (.pdf 4.4Mb)

The CE Marking Association is once again attending the Southern Manufacturing & Electronics Show (at FIVE in Farnborough) providing CE marking seminars. This year, Representatives of the CE Marking Association will give an overview of the CE marking process, discuss the implications of BREXIT and look forward to any changes in product and machine safety legislation. At the end of the presentation, there will be an opportunity to ask our team any questions on CE Marking.

The show runs from the 6th – 8th February 2018 and our seminar times are:

The show and our seminars are free to attend and there is free parking on-site. It is not too late to register your attendance; visit the industrysouth.co.uk website or register on the day.

Click here to find a copy of our presentation (.pdf – 4.4Mb)

We hope to see you at the show.

If you would like to follow up any CE Marking questions, then please feel free to get in contact.

UPDATE: On the 15^th December, leaders of the 27 remaining EU nations agreed that negotiations regarding the UK’s exit from the European Union should move onto the next phase. So how does this further development affect your CE Marking obligations?

The first phase of negotiations centred around the UK’s existing obligations to the EU; the rights of EU citizens in the UK, border issues and the financial commitments undertaken as a Member State. Negotiators have now agreed that sufficient progress has been made on these matters to move to the second phase of talks; pertaining to the UK’s future relationship with the EU.

Both the EU and the UK have agreed that a ‘Transition’ or ‘Implementation’ period be agreed during which the UK would still be subject to EU law after it leaves the EU; the UK have suggested that this should be for two years following the UK’s departure in March 2019, however the EU have strongly urged that this period should end on 31^st December 2020 to coincide with their seven year financial cycle.

In terms of CE Marking, products placed on the market in the 27 remaining EU member states will continue to be subject to CE Marking legislation after Brexit and into the future. Both parties appear to favour the UK remaining within the Single Market during the transition period and as such it could be assumed that products placed on the market in the UK will also fall under the scope of CE Marking legislation.

The CE Marking Association will continue to follow the Brexit process and consider its effects on CE Marking for UK Manufacturers; we will publish updates as they become available however if you wish to discuss any topics related to CE Marking, then please get in contact.

This is a very common question that we get asked on our CE Marking training courses and it can often be linked to another question; ‘why should we CE mark?’

First it is easy to answer the ‘why bother’ question; simply put, it is a legal requirement to affix the CE mark to products covered by CE Marking Legislation. There are some exceptions to this rule and it is important to note that not everything can be CE marked. However, if we look at when it is required, the CE mark should illustrate that the product is compliant to the relevant Legislation and therefo

re can be made available on the market. The process is intended to give a level playing field, with everyone following the same process. The question about enforcement often appears when manufacturers are concerned that some people in the market place are cutting corners and maybe trying to gain an unfair advantage by doing so. The answer will depend upon various factors, so let’s focus on the basics.

The enforcement of the CE mark is down to individual countries, which have their own ‘Market Surveillance Authorities’. In the UK, there are many bodies doing this job, who will investigate non-conformities, with Trading Standards and the Health and Safety Executive (HSE) being two examples. The GOV.UK website says that an enforcement body will often provide an opportunity to ensure a product is correctly CE marked, should it be found not to meet the requirements. It goes on to say that failure to comply could lead to a product recalls, prohibition notices, fines or imprisonment.

We are not aware of any cases where someone has received a custodial sentence, but it is possible to see the other types of enforcement measures that have been taken, by visiting the European Commission’s ‘Rapid Alert System’ (formerly known as RAPEX) website. This website produces weekly overview reports of dangerous products that have been found by the national authorities. By searching the reports, you can quickly find items where there is a risk of electric shock, fire, cuts and other injuries and action taken for each ‘alert’, which is typically a recall, withdrawal and ban of the product.

The HSE in the UK, maintains a public register of convictions, where is possible to see examples of companies successfully prosecuted under the ‘Supply of Machinery (Safety) Regulation’ (the UK Statutory Instrument for the EU Machinery Directive) and other Regulations policed by the HSE. The level of information for each breach is limited and can it can vary on each record, but does show that all we

re given fines. It is understood that the enforcement measure is proportionate to the level of risk.

Two Examples of Enforcement Measures Taken:

1. Prosecution of a company following an accident where a person got their hand trapped in a roller and suffered multiple fractures. The company was fined £4000.00 after being found to be non-compliant with the Supply of Machinery (Safety) Regulations.
2. An imported LED wall light posed the risk of an electric shock, because the electrical insulation of the power supply unit was found to be inadequate. The report states that the item was recalled from the end users, after being found to be non-compliant with the Low Voltage Directive and EN 60598 (European Standard for Luminaires).

The CE Marking Association can assist you to meet your own CE Marking requirements, but should you be concerned about non-compliant items, then make sure you raise your concern with the relevant enforcement body. Further details about enforcing the CE Mark can be found at the links below.

https://www.gov.uk/guidance/ce-marking#ce-marking-enforcement

https://ec.europa.eu/consumers/consumers_safety/safety_products/rapex/alerts/?event=main.listNotifications

http://www.hse.gov.uk/prosecutions/