by Richard McPartland
Placing a CE Marking on a product means it has been declared as complying with all applicable regulations. The CE Marking of gas appliances is currently regulated by the EU Gas Appliances Directive (GAD) (2009/142/EC). This will be replaced as the Gas Appliances Regulation (GAR) (EU 2016/426) comes into effect from 21 April 2018.
Who will be impacted?
The change will impact everybody in the gas appliances and fittings supply chain within the EU including manufacturers (supplying to the EU), importers and distributors and even retailers.
Will other CE Marking directives change?
While the Gas Appliances Directive will be replaced, other CE Marking directives (such as the EMC Directive, Low Voltage Directive, or Construction Products Regulations) that may also apply to gas appliances are unaffected and will continue to apply (if they did previously).
Will things change post-Brexit?
The new regulation comes into force at least a year before the UK leaves the EU. Current understanding is that EU regulations will be subsumed into UK law with little evidence that the Gas Appliances Regulation would not be included in this approach.
The current regulations
What is the Gas Appliances Directive (GAD)?
The GAD was published in 1993 and came into force on 1 January 1996. The GAD introduced CE Marking of gas equipment, a mandatory independent certification, and essential safety requirements for gas appliances. At the heart of the GAD was a two-stage approach to ensuring product safety - product type testing and ongoing factory surveillance. Notified Bodies were certified to undertake third-party certification of appliances.
It is important to remember that a CE Mark is a promise of compliance with the minimum legal requirements, nothing more. They key issue is whether or not you trust the person making that promise, as you may be accountable for the product you are putting on the market. Our guide to to CE Marking explains in more detail.
What impact has the GAD had?
The GAD had the effect of ensuring new safety devices were introduced across a range of equipment - overheat thermostats on gas fires or frying ranges, for example.
Over the last two decades the number of fatalities in the UK that could be attributed to unsafe gas products has followed a downward trend (bar a rise in 2008/9 where cookers with enclosed grills that did not have automatic shut-off valves were responsible for seven deaths even though they complied with European Standard EN 30).
Why has the GAD been replaced?
After two decades in use, review is desirable to ensure the regulations are fit for purpose. In a modern world the GAD has some particular shortcomings in terms of how it deals with standards, regulations and the role of Notified Bodies. We expand on some of these issues below:
- The production of standards is difficult as it relies on volunteers and contributions from 30+ countries. It can often be hard to find relevant experts. The process can be geared around organisations' self-interest and typically favours the status quo.
- Standards are not mandatory so there's little incentive for manufacturers to add new safety features - such as a flame failure device - despite the obvious benefits. The regulations rely on the idea that if something was safe and appropriate at a given point in time it continues to be so in the here and now.
- 'Reasonably foreseeable use' of products often falls short. It seems reasonable to expect that people might use bigger pans on a portable cooker, for example, yet often all too little is done to mitigate or warn of the dangers.
- Warnings can be favoured over design solutions. There's an assumption of a working knowledge of the rules and standards that apply to installation and therefore rather than preventing or mitigating an effect by design a warning is often deemed sufficient. In the case of mobile products, more likely to be installed by a layperson, these may not be clearly understood.
- It focuses too squarely on piped gas and the notion of a 'competent installer' ensuring safety. This will not be the case when it comes to, say, mobile catering equipment. Here the "technical instructions needed for the installer" (Essential Requirement 1.2.1) are likely to be interpreted by a layperson who would take on the responsibility of ensuring devices are "correctly installed and serviced according to their instructions".
- It places responsibility for compliance on the manufacturer which can be difficult to enforce as production has increasingly shifted outside of the EU.
- It fails to ensure annual production surveillance and product audit testing. Where this does occur the focus is squarely on changes made to product(s) rather than what's happening in the external environment, such as changes to standards.
3. Notified Bodies
There now approaching 60 notified bodies (up from 30 on launch) and competition has brought industry benefits in terms of cost and time to market products but some would say the expertise is diminishing as competition increases.
There can be pressure for notified bodies to become little more than 'box-tickers', applying minimum standards and interpretations to the testing of products. Indeed, there's nothing to stop manufacturers shopping around to pick a notified body who only suggest testing to standards that are out there, rather than adding in additional tests and checks to deal more effectively with new features.
The new regulations
What is Gas Appliances Regulation?
The 2011 EU Commission Report into the functioning of the GAD highlighted a number of areas for improvement. One of the key outcomes of the report was the Gas Appliances Regulation that was published in March 2016. As a regulation (as opposed to a directive) no new national laws were needed to put the new Gas Appliances Regulation into place.
When does Gas Appliances Regulation come into effect?
Under the Gas Appliances Regulation products are required to comply with existing legislation (including the GAD) up to and including 20 April 2018.
Products already in the supply chain or on the market before 21 April 2018 are not affected.
Once the regulation is in effect the GAD and UK regulation in this area will eventually be repealed.
What's changed in the Gas Appliances Regulation?
- The scope is now much broader - Alternative fuel sources (such as hydrogen cells), cooking implements (a chef's blow torch), air conditioning, and the entire laundry process (including drying) all now fall under GAR. So too do high-temperature water boilers (above 105 degrees Celsius) that had been excluded under the assumption these would be dealt with under the Pressure Equipment Directive.
- There are clearer definitions for manufacturers, importers and distributors - There's a clearer understanding of who is the manufacturer and therefore responsible for assessment conformity. The duties of importers and distributors are much clearer particularly in relation to 'own brand' appliance suppliers.
- Importers must co-operate with the authorities and ensure the GAR process has been followed, appliances are compliant and instructions adequate. Importers must also ensure complaints are investigated and take any action needed to ensure product safety.
- Gas fittings, such as safety and controlling devices, will require the CE Mark and must meet the same conformity assessments as gas appliances.
- A maximum certificate validity period of a decade will be introduced (where previously there was no expiry). At the end of the validity period a manufacturer must apply to a notified body for an extension and a new Type Examination Certificate is issued with a new 10 year expiry.
- Significant changes to the Notified Body rules will be made to ensure these bodies are competent across the whole of the EU to deliver the work they are appointed to deliver. The technical competence of a Notified Body is important and the regulations now ensure a commitment to training and knowledge sharing. Already some Notified Bodies opt not to take up work under the GAR, presumably over fears that they cannot meet this level of competence.
- EU Member states have to provide much more detail on gas quality and supply pressure. Information here has traditionally been sketchy and acted as a barrier to cross-border trade - making it hard for manufacturers to design and develop appliances. The information required here is similar to the UK Gas Management Regulations and will continue to evolve to take into account a new generation of gas technologies (such as biomass).
What changes have been made to Essential Requirements?
Changes here are generally minor though there are a few new important requirements for manufacturers - including taking the 'state of the art' into account and performing a risk assessment for all products placed on the market. There's also a greater focus on foreseeable misuse and implementing hazard/risk reduction techniques (removing, guarding and warning against hazards - in that prescribed order).
- Essential Requirement 1.2 - Risk assessment must be performed by the manufacturer with a view to finding and mitigating risks. "The manufacturer is under an obligation to analyse the risks in order to identify those which apply to his appliance of fitting. He shall then design and construct it taking into account its analysis". It is important to note that other applicable standards must be complied with outside of this process and also that complying with standards is not necessarily enough to mitigate all risks.The Notified Body has a responsibility to check the risk assessment has been carried out and is reasonable.
- Essential Requirement 1.3 - Risk reduction techniques must be applied when designing the product. "In selecting the most appropriate solutions, the manufacturer shall apply the principles set out in the following order: Eliminate or reduce risks as far as possible (inherently safe design and construction), Take the necessary protection measures in relation to risks that cannot be eliminated, Inform users of the residual risks due to any shortcomings of the protection measures adopted and indicate whether any particular precautions are required".
- Essential Requirement 1.4 - The manufacturer must consider unintended use of the product. "When designing and constructing the appliance, and when drafting the instructions, the manufacturer shall envisage not only the intended use of the appliance, but also the reasonably foreseeable uses."
What does this mean for the risk management process?
The risk management model is not prescribed and manufacturers are free to use any that they feel appropriate and comfortable in using. Your own management process and the relevant standards are at the heart of the process. In summary you should seek to identify the risk factors, establish who can be harmed (and how), evaluate and record these risks, and continually monitor and review. Documentation is important in order to show due diligence has been observed and this should be reviewed in conjunction with your Notified Body.
The risks to consider will vary from product to product but you are likely to focus on:
- Assembly and production errors - Your Quality Management System (such as ISO 9000) will cover much but you should also consider what's required on a product-by-product basis. In-process and end-of-line-tests need to be designed to ensure they detect all likely significant production faults. A Quality Plan should be produced to document the quality standards, practices, specifications and activities relevant to a particular product or project.
- Installation errors - Most territories require gas appliances to be installed by a 'competent' person but reasonable mistakes can and do occur and designs should allow a degree of tolerance for this. A safety margin should be built into all settings to allow for small mistakes or accuracy of the competent installer. Instructions should be clear (particularly where an installer is not required) with jargon and unfamiliar terms removed and knowledge not necessarily assumed. Designs should be 'foolproof', protecting users from their mistakes.
- User or operator error (foreseeable use) - The manufacturer must consider 'reasonably foreseeable' use as part of the risk assessment. This isn't about solving every conceivable problem - rather what might be expected and is within the realms of possibility. Instructions should also be reasonable in their scope, coverage and clarity. Design solutions may also be required to protect users from their own mistakes. For example, a cooker is obviously intended to heat food but may reasonably foreseen to be used as a space heater. In finding the most appropriate solutions a manufacturer should seek to eliminate, protect or inform users of risks (and preventative measures required) in that order. A gas cooker with a glass lid might be mitigated with a warning label, a cut-off-device as a safety solution, use of shatter-proof lid, for example.
- Component failure - Many component faults are already covered by testing required by existing standards. However, new technologies may present risks that are not covered by standards. Some kind of Failure Mode and Effects Analysis (FMEA) is advisable. For example, adding a remote control to a fire increases risks around accidental operation, children being potentially able to operate the fire, and faults or interference causing the fire to become operational.
- State of the art - As part of your monitoring and review process you should be ensuring compliance with the latest harmonised standards then, you should be in compliance with this Essential Requirement. The world is changing apace so awareness is key - standards and requirements change. Manufacturers and Notified Bodies have an obligation to ensure that they are aware of changes to the "generally acknowledged state of the art" and whether changes require further investigation.
What obligations are placed on importers?
Under Article 9 importers must only place compliant products on the market and must ensure that the manufacturer has undertaken the correct conformity assessment procedure. The importer must ensure their name and trademark is placed on packaging or accompanying documents.
Quality evidence is more important than huge swathes of documentation when it comes to compliance. This will include the Declaration of Conformity, the Type Examination Certificate, the Surveillance Certificate, and evidence of conformity with other directives and instructions. Records should be kept for 10 years and evidence of conformity provided when requested.
In terms of documentation:
- Declaration of Conformity is the most important legal document and is the manufacturer's statement of compliance and must cover the model being bought (not a similar one). It should show which EU directives apply and be signed by the correct person. It should list the standards applied (these need to be the correct ones) and be dated.
- Two separate documents are needed under the GAR:
- A Type Examination Certificate to show the one-off type testing has shown the product to be compliant, and:
- The EC Surveillance Certificate to show ongoing production conformity.
These documents must cover the actual products someone will be buying - not similar ones. You can check the certificates were produced by a Notified Body via the Nando(New Approach Notified and Designated Organisations) website.
Importers also have duties in terms of:
- Product Testing - The regulations state "where deemed appropriate... importers shall.. carry out sample testing of appliances..." - the onus here is on the importer to decide. The best testing will obviously be independent of the manufacturer and Notified Body. In considering testing process it's worth considering complaints and foreseeable use of products. You might also consider keeping a 'golden sample' for comparison or routine batch audit testing allowing you to check for design change
- Instructions - These must be provided and there is an opportunity to make a real difference when it comes to the safe installation and operation of products. Most Notified Bodies check instructions against lists of information required under the EN Standard and give little thought to presentation or context of this information. Design of Instruction Manuals ISO/IEC Guide 37: 2012 establishes principles and gives recommendations on the design and formulation of instructions for use of products by consumers. Good instruction sets should use fonts and subheadings to aid navigation and legibility. Warning and restriction information need to be reasonable and appropriate. The good use of pictures and symbols will help.
- Storage and transport - Long-term exposure to low temperatures in storage, vibration from road transport and mishandling all have the potential to make your product unsafe. There is an obligation on the importer to ensure that storage and transport do not affect the product's safety and sample testing may be necessary to ensure this is the case and take action where there are doubts.
The key takeaways
Why change was needed
The Gas Appliance Directive delivered a solid model of type testing and surveillance that has generally worked well. That said, over 20 years after its introduction, it is apparent that there are operational issues which the Gas Appliances Regulation aims to address.
The Gas Appliances Regulation makes economic operators accountable, ensures the two-stage safety process is always followed and compliance with 'state of the art' requirements with mandatory risk assessment is now included.
- Review all current products that you plan to carry on supplying (ie. won't be obsolete) after 21 April 2018.
- Ensure all current products are updated to 'state of the art' (based on the latest EN standards) where technically and economically feasible.
- Complete your own risk assessment as required by the GAR and take account of how people might reasonably use your products. You should start early as design changes may be required.
A reminder of key dates
- March 2016 - Gas Appliance Regulation published
- 21 October 2016 - Notified Bodies can be appointed
- 21 October 2017 - Gas supply data submitted
- 21 April 2018 - GAR applies and GAD is repealed
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