General Product Safety Directive
General Product Safety Directive
The UK's General Product Safety Directive and EU legislation, which imposes obligations on each of the players in the supply chain from manufacturer through to distributor, known as the Economic Operator have specific responsibilities that they must carry out and store the documentary evidence that proves the product meets the requirements of the regulations
While some product safety obligations can be limited and controlled contractually, the technical regulatory requirements can only be learned and managed. The price of failure in terms of recall costs, reputational damage, fines and even imprisonment mean that product quality and safety is a truly business critical issue.
In this guide, we summarise the main regulatory obligations for businesses. Please see our related guides for information on businesses' civil law duties, the work product safety regime and the food safety regime.
The General Product Safety Directive
There is now a range of EU regulations which lays down product safety and other requirements for certain products, which can include both consumer products and products for use at work. We discuss these requirements below.
The General Product Safety Directive (GPSD) provides a general safety framework that must be observed in relation to consumer products which are not covered by the EU regulations and Directives. It was also designed to supplement and fill gaps when the specific legislation did not address the product safety requirements.
The interaction of the GPSD and the Regulations and Directives can led to some confusion, and the EU has proposed simplifying and clarifying the product safety regime through a new Product Safety and Market Surveillance Package including a new Regulation on Consumer Product Safety which would replace the GPSD. The draft includes new obligations aimed at improving product identification and traceability and a greater emphasis on penalties. However, this package has been on hold since 2014 due to a disagreement over country of origin marking.
The GPSD is implemented in the UK through the 2005 General Product Safety Regulations (GPSR). Much of the approach found in the GPSR is also found in the sector-specific legislation but there are some additional requirements, specific to the economic operator, for instance with respect to the keeping of technical information for 10 years.
The General Product Safety Regulations
The GPSR provides a broad umbrella of regulation to ensure that consumer products, when marketed, are safe. It creates a series of obligations on manufacturers, importers and distributors (known as the economic operator) to help to ensure that this goal is achieved and to reduce the risk to consumers from unsafe products. The GPSR gives wide powers to Trading Standards departments, HSE and other authorities to ensure that unsafe products do not remain on the market and, if need be, are recalled.
Where a product is already subject to other existing regulations (for example, electrical goods) then those regulations will apply to that product; the GPSR do not apply to the safety of a product where there are specific provisions of UK or EU law governing all aspects of its safety. As such, they operate as a kind of 'mop-up' set of regulations.
However, the GPSR will apply where they go further than the existing regulations in terms of the specific aspects of safety covered and the extent of the obligations on economic operators. The GPSR apply to all products intended for or likely to be used by consumers (even if not intended for them) that are supplied or made available; the test would be whether a consumer can purchase the product without challenge. This includes products supplied or made available to consumers for their own use in the course of a service - for example, gym equipment for use in a gym, high chairs provided for use by diners in a restaurant and trolleys for use by shoppers.
Unlike sector-specific laws, the GPSR do not permit CE marking but do require that economic operators only supply safe products.
The following types of consumer goods would fall within the GPSR
• children's articles such as cots, prams, high chairs, bunk beds
• household goods such as crockery, cutlery, cooking utensils
• DIY tools
• furniture and soft furnishings
• candles and other ornaments
• hobby and art materials
If there are aspects of safety under GPSR that are not covered by the products' own sector-specific regulations - such as electrical equipment - then the GPSR aspects will also apply.
The Regulations also cover products that were originally designed and intended for professional use but subsequently 'migrate' on to the consumer market (such as certain power tools). Where consumers can acquire professional products, they must be treated as 'consumer goods'.
The safety requirement
A 'safe' product is one which, under normal or reasonably foreseeable conditions of use, or foreseen misuse donot present any risk or only the minimum risks compatible with the product's use and which are considered to be acceptable and consistent with a high level of protection for the safety and health of persons. 'Conditions of use' in this context also covers duration of use, putting into service, installation and maintenance. It is highly recommended that all products placed on the market undergo an initial design risk assessment against ISO 12100:2010.
As an example, an inherently dangerous product such as a power tools designed for use at home can nonetheless be regarded as a safe product provide it presents the minimum risk compatible with a high level of protection. The producer must therefore ensure that adequate instructions are provided and that appropriate safety devices, such as guarding, are fitted.
In many cases, the fact that a product is unsafe will be obvious.. As with the Consumer Protection Directive and UK Consumer Protection Act, which provide a civil remedy for consumers in relation to unsafe products, the fact that there are other products capable of providing a higher degree of safety is not by itself a reason to regard a product as an unsafe product.
The regulations provide further guidance about factors to be taken into account when deciding whether a product is unsafe, including:
• the characteristics of the product - dangerous products, the greater the protective steps that will be required;
• instructions for assembly, installation and maintenance; (if applicable)
• the effect of the product on other products – so that where it can be foreseen that the product will be used with other products those potential interactions need to be taken into account; your design risk assessment should identify the possible risks and come up with the most appropriate safety measure
• the presentation, labelling, any warnings and instructions for its use – any product which will be used by a consumer needs to come with adequate instructions for safe use unless the user will be an adult and the risks and appropriate safety measures are obvious; As the consumers are not professionals you are advised to describe the meaning of the warnings provided note: that warnings should also be large enough to read and clear visible to the operator.
• the categories of consumers at risk when using the product, in particular children and the elderly – if vulnerable groups such as these are likely to be amongst the users of the product then greater steps may be needed to take account of the increased risk of error in use or seriousness of injury resulting from error.
Where EU legislation, or UK legislation where there is no legislation, prescribes that a product must comply with certain requirements in order to be placed on the market, then the product will be presumed to be safe in respect of those matters. Where a product complies with a British Standard implementing a European Standard, then the product will be presumed to be a safe product so far as the risks covered by that national standard are concerned.
However, if a product does not in fact comply with one or more of the relevant provisions, this will not prevent the product being an unsafe product. Nor do these presumptions prevent action by the authorities to remove unsafe products from the market.
Primary duties of producers and distributors
If you affect the safety of the goods by any action - such as removing the goods from their packaging, assembling products, repairing products or not passing on instructions and warnings - then you become the 'producer' of the goods. In this case you will have to comply with the producer obligations under the GPSR.
Within the limits of his activities, a producer shall provide consumers with the relevant information to enable them to assess the risks inherent in a product throughout the normal or reasonably foreseeable period of its use, where such risks are not immediately obvious without adequate warnings, and to take precautions against those risks.
Within the limits of his activities, a producer shall adopt measures commensurate with the characteristics of the products which he supplies to enable him to be informed of the risks which the products might pose, and take appropriate action including, where necessary to avoid such risks, withdrawal, adequately and effectively warning consumers as to the risks or, as a last resort, recall.
The measures referred to in paragraph above shall include, except where it is not reasonable to do so, an indication by means of the product or its packaging of the name and address of the producer, and the product reference or where applicable the batch of products to which it belongs; and to the extent that it is reasonable to do so, sample testing of marketed products, investigating and if necessary keeping a register of complaints concerning the safety of the product, and keeping distributors informed of the results of such monitoring where a product presents a risk or may present a risk.
The main obligation on a distributor is to supply a safe product.
In particular the distributor must act with due care to help ensure only safe products are supplied and must not supply products that, as a professional, you know (or should have presumed on the basis of information in your possession) to be dangerous. For example, if a product has been subject to a recall you must not supply any you may still have in stock.
As a distributor, you must also provide consumers with relevant information to enable them to:
• assess any risk posed by the product throughout the period of its use (where such risks are not immediately obvious)
• take precautions against those risks
This means passing on all the warnings and instructions that accompany the product.
A further obligation on distributors is to be able to show traceability of the products you supply. In practice the documentation that is required to support Inland Revenue and VAT requirements should be sufficient, as long as they show from whom the goods were purchased and, if not for retail, to whom they were sold. Such records have to be kept for a minimum of six years, which should cover your GPSR obligations.
Where you discover (perhaps as a result of a consumer complaint) that a product you have supplied poses risks to the consumer and is unsafe, you must immediately notify your supplier of the issue. In some instances - for example, where it is not easy to contact your supplier - you must then inform your local trading standards service.
You must cooperate with the enforcement authorities at their request. This includes the provision of information relating to the product, the nature of the risk, the product's supply and marketing, and also in taking appropriate action to remove the risk from consumers.
It is an offence under the GPSR not to fulfil these obligations.
Powers of the enforcement authorities
The enforcement authorities, who are typically trading standards departments, have a variety of powers to obtain information and, in particular, to issue safety notices.
A safety notice can require that a producer or distributor:
• issue a notice warning about a danger with a product (warning notices);
• suspend the sale of a product (suspension notices);
• mark the product with, for example, a use warning (marking notices);
• withdraw the product from sale (withdrawal notices);
• recall product previously supplied into the market (recall notices);
There are appeal procedures available to a party aggrieved by a safety notice. If a safety notice is served it is essential to take specialist legal advice rapidly, as failure to comply with a safety notice is itself an offence.
UK Statutory Instrument and EU Legislation: scope and additional duties
There is now a suite of new sector-specific directives and regulations covering many product types including, machinery, equipment and protective systems intended for use in potentially explosive atmospheres, construction products, low voltage electrical products, toys and medical devices. The GPSD will have limited application to consumer products covered by such legislation.
Unlike the GPSD, the regulations and directives legislation applies to products for use at work or in commercial premises as well as to consumer products.
As an example, we will consider the application of the 2014 Low Voltage Directive (LVD).
The LVD imposes safety obligations on all economic operators, including producers, importers and distributors, to only place products on the market designed and manufactured in accordance with good engineering practice in safety matters and which do not endanger the health and safety of persons or property. It also sets out defined safety objectives, such as protecting against hazards caused by contact, temperature, arc or radiation, as well as any non-electrical dangers.
As can be seen from the above, the risks addressed by the legislation are much more specific than under the GPSD. Where the risk is addressed by the sector-specific legislation, the GPSD has no application in assessing safety.
As well as the obligations as to safety, traceability and marking of products found in the GPSD, manufacturers, importers and other economic operators have additional obligations under the legislation. These include:
• Certify equipment is designed and manufactured in accordance with safety objectives;
• Make sure that technical documentation is prepared and conformance assessment undertaken;
• Ensuring that procedures are in place to ensure series production results in safe products;
• Ensuring the availability of a declaration of conformity and technical documentation for 10 years after the product/equipment has been placed on the market.
All economic operators must keep their own traceability records, up and down the supply chain, for 10 years.
If the manufacture is outside the European Union he must establish a place in one of the member states to store a copy of his technical file and declaration of conformity. This will also be a requirement after BREXIT for the United Kingdom. In return, the same process is to be followed if supplying goods from outside the UK
This guide was last updated in July 2020
HOW WE CAN HELP:
Our customers contact us because they need help and advice on how to apply the UKCA or CE Mark to their products.
The CE Marking Authority has a positive attitude and approaches regulatory compliance by looking at the opportunities rather than seeing them as an inconvenience and meddling with your practices. We specialize in staying ahead of the game by using our technical knowledge (skills) conducting the necessary assessments to help our clients demonstrate their technical files meet the requirements of the regulations
Our expert team is here to help you meet the UKCA and CE Marking the requirements
• Free initial consultation to assess your requirements and plan the CE marking of your product.
• Identify the statutory instruments, the essential safety requirements, and harmonised standards, which apply to the product.
• Perform design risk assessments and clause by clause assessments against the designated standards
• Conduct a product compliance report to the applicable requirements outlining areas of non-compliance and advice on how to close out any gaps found.
• Assist in the compilation of the technical construction file, which contains the information required by the EU safety regulations.
• Provide a draft EU Declaration of Conformity and help you complete it.
• Offer follow up advice on changes in requirements for the life cycle of the product
• Act as your Authorised Representative in the UK or EU via or European office if required.
The many benefits of compliance range from brand and reputation, revenue enhancement, asset protection, higher profitability and lower costs, improved workforce performance, the provision of better data for better-made business decisions, and allows for a total harmonization of your systems