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SAFETY REGULATIONS
The General Product
This document provides a guide
to the General Product Safety Regulations 2005 (SI 2005 No 1803). Its purpose
is to help users of the Regulations understand their main features and the
circumstances in which they apply. Those affected by the Regulations should refer to
them for a full statement of the legal requirements, and in case of doubt seek
legal advice on questions of interpretation. This guide has no legal force. While
every effort has been made to ensure that it is correct the Department of Trade and
Industry cannot accept liability for any errors, omissions or misleading
statements in it.
The Regulations can be
obtained from The Stationery Office, Publications Centre, PO Box 29, Norwich NR3
1GN
Purpose
The purpose of the General
Product Safety Directive is to ensure that all products intended for or
likely to be used by consumers under normal or reasonably foreseeable
conditions are safe. The Directive pursues its principal objective of
ensuring consumer product safety by:
* specifying
that products placed on the market or supplied by producers and
distributors must be safe;
* defining
a safe product;
* imposing
obligations on producers and distributors consistent with marketing safe
products;
* laying
down a framework for assessing safety;
* requiring
enforcement authorities to be empowered to take the action necessary to protect consumers
from unsafe products.
Responsibility
The Department of Trade
and Industry has overall policy responsibility for the General Product Safety
Regulations, but responsibility for the safety of some consumer products rests with
other Departments. For example, the Medicines and Healthcare Products
Regulatory Agency have the lead on medical devices and licensed medicines for
human use, while the Vehicle Operator Services Agency (VOSA) leads on motor
vehicles safety. For some products covered by specific product Regulations
(e.g. machinery) the Health and Safety Executive (HSE) lead.
It is recognised that most
businesses in the UK are responsible and comply with the law, and that
generally speaking product safety levels in this country are high. When safety problems
are identified UK businesses are usually very quick to voluntarily remove
risks to the consumer. Nothing in the Regulations prevents that; indeed
voluntary action is specifically encouraged as an alternative to formal
enforcement. Nevertheless the
Regulations provide powers to the enforcement
authorities to take appropriate action against those businesses that fail to
fulfill their responsibilities and, as a last resort, enable enforcement authorities to
order the recall of dangerous products.
Product Coverage
The Regulations apply to
the supply of all new and second-hand products, excluding products supplied
for repair or reconditioning prior to being used (provided the supplier clearly
informs the person to whom he supplies the product to that effect), and
excluding the sale of antiques.
“Products” within the
meaning of the Regulations can best be described as all
goods that are (or could be)
placed on the market, or supplied or made available (including in the
course of providing a service) to consumers for their private use. Products covered
include, but are not restricted to, clothing, medicines, machinery, tools
and equipment, fireworks supplied to consumers, household goods, nursery
goods, gym equipment, chemicals and pesticides, and motor vehicles.
Borderlines
Where a product is already
subject to other existing Regulations (e.g. toys) then those Regulations will
still apply to that product. The GPS Regulations will also apply where they go
further than the existing Regulations in terms of the specific aspects of safety
covered, the extent of the obligations on producers and distributors, and the
powers available to enforcement officers. As an example, the Toys (Safety)
Regulations 1995 do not (among other things) require producers or
distributors to notify the enforcement authorities of problems associated with their
products and the steps they have taken to remove the risk to consumers.
Neither do they give the enforcement authorities the powers to
order mandatory recall of the product from consumers. The GPS Regulations
will therefore apply to toys in these areas. Similar considerations apply
in respect of all other products covered by specific legislation made under the
Consumer Protection Act (CPA) 1987.
Meaning of Supply/Make
Available/Place on the Market
These terms are used
variously throughout the Regulations. The European Commission’s guidance on New
Approach Directives says that “placing on the market” means making a
product available for the first time when it is transferred from the
manufacturer to be distributed. Further, that this applies to each individual product and
not to a type of product. Hence placing on the market generally refers to
what producers do, while distributors supply products. The definition of “supply”
in the Regulations extends to hire and making a product available for use by
consumers in the course of providing a service.
Placing a product on the
market, making it available or supplying can happen in many ways, for example:
* Selling,
leasing, hiring it out or lending it;
* Entering
into a hire purchase or other credit agreement for it;
* Exchanging
it for any consideration other than money;
* Giving
it as a prize or otherwise making a gift; and
* Providing
it in the course of the delivery of a service.
The extension of these
Regulations to products made available to consumers in the course of the delivery
of a service is a new departure. An example of such a supply would be the
provision in a hotel room of a hairdryer for the guest’s own use. In
contrast, a hairdryer in a salon is used by the hairdresser rather than
the client and not covered by this provision.
The Regulations only
apply to the commercial placing on the market or supply i.e. in the course of a
business or trade. They apply irrespective of the marketing methods employed and
include distance and electronic selling. Each time a product is
made available for use, loaned, hired or leased etc to a consumer this will be a
separate supply.
The Regulations also
extend to the preparatory acts of agreeing to place a product on the market and
exposing or possessing any product for placing on the market.
Possessing an unsafe
product that has been returned whether as part of a recall or otherwise, or the
fact of having possession of a product for further assembly or re-working in
order to make the product safe, would not constitute possession with the
intent to supply.
Where a construction
product is incorporated into a permanent structure (e.g. a concrete lintel) it is
doubtful that the product remains a distinguishable product to which the
Regulations can apply. However DIY products used in buildings, such as light
fittings, switches, showers etc, which are intended for or may be used by consumers
are covered by the Regulations.
Products used in the workplace
The Regulations do not
apply to products used in the workplace by workers. Products that are used in the
provision of a service, even if they are used for (but not by) consumers
are also outside the scope of the Regulations. An example is a cleaning product
used as part of a car valet service that is not supplied to the consumer. The
safety of such products is controlled by the Heath and Safety Executive (HSE)
using specific Health and Safety at Work legislation. “Products”
that consumers ride or travel on and which are operated by a service provider are also
excluded. In this instance “operation” has a wide definition and includes
transport vehicles and devices such as escalators and lifts whether manned or not.
Products for Export
The Regulations do not
apply to:
* Products
which are not placed on the market or supplied in the UK or intended for placing on the
market or intended for supply in the UK, e.g. those which are exported
or are for export to a country outside the Community3. An exception is
where there is a Commission decision which imposes an export ban on them;
or
* Products
used or intended only for display at exhibitions or trade fairs. However, such products are
subject to the Regulations if they are subsequently placed on the
market in the UK or made available for supply to consumers. Guidance for businesses,
consumers and enforcement authorities
Community is used in this
note to refer to the European Community and the three additional members
of the European Economic Area – Iceland, Norway and
Lichtenstein.
Meaning of a Safe Product
A “safe product” is
any product which under normal or reasonably foreseeable conditions of use presents no
risk or only the minimum risk compatible with the product’s use and which
is consistent with a high level of protection for consumers.
While the Regulations do
not apply to the safety of services per se, the safety of some products (e.g. certain
machinery and gas appliances etc) is dependent on how they have been
installed and maintained. These services are an essential feature of the
safety of the product and may form part of the contract to supply the product. As such
they will be taken into account when judging whether the product is a safe
product.
The safety of a product
will be assessed having regard to a number of matters and, in particular:
* the
product’s characteristics;
* packaging;
* instructions
for assembly and maintenance, use and disposal;
* the
effect on other products with which it might be used;
* labelling
and other information provided for the consumer; and
* the
categories of consumers at risk when using the product, particularly children and the elderly.
The existence of higher
levels of safety, or availability of products presenting lesser risk, will not in
itself mean that a product is unsafe
Specific Product Regulations
Where specific product
legislation covers exactly the same ground as the GPS Regulations the specific
legislation will apply.
Where the specific
legislation deals only with certain aspects of safety, only those aspects of safety that
fall outside the scope of the specific legislation but within the scope of the GPS
Regulations will be subject to the GPS Regulations.
Where there is no relevant
specific product legislation, safety will be assessed by one or other of the methods
in the GPS Regulations set out in paragraphs below.
National Regulations
Since the coverage is
wide, some products will be subject to national safety regulations made under s11 of
the CPA (e.g. The Furniture and Furnishings (Fire) (Safety) Regulations
1988) as well as these Regulations. In the absence of Community provisions
governing the safety of the product in question, the product will be deemed safe if
it conforms to the specific rules of national law so long as those rules cover
the specific risk under consideration. In cases where specific national safety
regulations apply only to new products the General Product Safety
Regulations will apply when those products are supplied second-hand.
Voluntary European Standards
The Regulations introduce
for the first time a presumption of conformity with the general safety requirement
if a product conforms with the UK transposition of a voluntary European
standard that has had its references published in the Official Journal of the
European Union, but only as far as the risks are covered by that standard. A list of
the standards so far published in the Official Journal may be found on the European
Commission’s website
Where neither a specific
Regulation nor national safety law applies, safety will be assessed taking each of the
following into account in turn:
* voluntary
European standards;
* Community
technical specifications;
* national
standards (i.e. British standards which are not UK versions of European standards);
* industry
codes of good practice; and
* state
of the art and technology, and the safety which consumers may reasonable expect.
It should be noted that
compliance with one or more of the above will not necessarily mean that the
product is a safe product if it does not provide an acceptable level of safety.
There will be instances where, for example, a European standard exists for
the product in question but does not deal with a particular aspect of safety
or does so inadequately. In such cases other provisions in the list, if
applicable, may be used – e.g. aspects of a national standard or reference to the
state of the art and technology. In the case of Balding v Lew Ways Ltd the
court found that a “Tipper Trike” toy conformed with EN71 but it was still
found to be unsafe for the purposes of the Toys (Safety) Regulations 1995.
Standards of the International
Standards Organisations
Standards published by the
ISO (International Standards Organisation) and the IEC (International Electro technical
Commission) are given no special status in the Regulations in assessing
the safety of products unless they are embodied as European or national
standards. However, they should be taken as falling within the general provisions
in the last 3 bulleted points above.
Reputable
Conformity with the
criteria designed to ensure product safety (e.g. national legislation, standards
referenced in the Official Journal of the European Union etc) will not bar the
enforcement authorities from taking appropriate measures where there is evidence that
despite such conformity the product is dangerous.
Suppliers Affected
The Regulations apply to
all UK suppliers of products used by consumers, whether intended for them or
not, and whether the goods were intended for use in the UK or another
Member State. Suppliers in the Regulations may be either ”producers” or ”distributors”.
It should be noted that both terms have particular meanings for the
purpose of the General Product Safety Directive – and hence the Regulations –
and do not correspond with their normal everyday usage. Thus, it should not be
presumed that a wholesaler or a retailer will in every case be a ”distributor”
for the purpose of the Regulations, nor that ”producer” refers solely
to a manufacturer. We consider that a person who finances the sale of products
on hire purchase, or an insurer who provides products to a consumer under
an obligation in an insurance policy, is generally not a distributor under the
terms of the Regulations so the person from whom the products are actually
obtained (the effective supplier) or the producer will normally be responsible for
the safety of those products.
A consumer who sells his
surplus personal possessions at a car boot sale is outside of the scope of the
Regulations unless the consumer is doing this as a commercial activity. A
consumer, who as part of the sale of his permanent dwelling includes in the sale
existing furnishings and fittings (including domestic appliances), is also
outside the scope of the Regulations.
Producers
For practical purposes,
”producer” is defined in two ways – either as the first placer of the product on the
Community market or as someone whose activities may affect the safety of the
product.
”Producer” in relation
to a particular product means:
* the
manufacturer (where he is established in the Community);
* any
person who presents himself as the manufacturer by putting his name or trademark on the product
(the brand owner);
* any
person who repairs or reconditions the product; or
* other
professionals (see Annex A) in the supply chain if their activities may affect the safety properties
of a product after it has been supplied to them.
If the manufacturer is not
established in the Community, the producer will be:
* either
the manufacturer’s representative in the Community, or;
* where
there is no Community representative, the importer of the product into the Community.
In practice, the
requirements of the Regulations, as they relate to producers, apply to any of the above
persons who are established in the UK.
A producer is not
necessarily just the person who manufactures something. It includes any professional
in the supply chain whose activities affect the safety of the product. For
example a person who reconditions, works, re-works or customises a product will
place a different product on the market to that which he started out with and
hence be responsible under the Regulations in so far as his activities may
have affected the safety properties of the product. The corollary of this is that
to the extent that this person’s activities did not affect the safety properties
of the product, the original producer will continue to be responsible for its
safety.
Distributors
Distributor”, in
contrast, is any professional in the supply chain whose activities do not affect the
safety of a product. This can include wholesalers, retailers (shops), agents and
auctioneers. However, auctioneers are neither producers nor distributors for the purposes
of the Regulations when they are merely acting under instructions to conduct
the sale (i.e. controlling the bidding and knocking down to the highest bidder) of
an item for the owner, and it is the owner who is the seller. But, an auctioneer
who had purchased the contents of a house on a clearance basis would be a
distributor and subject to the Regulations when he subsequently auctioned the
contents. Similarly, an individual who buys goods to sell on a bidding basis
(whether from a temporary site or established premises) will come within the ambit of
the Regulations.
A person who makes a
product available for the use of a consumer in the course of delivering a service
will for the most part also be considered a distributor. However, if the
product carries the service supplier’s own brand, or if he has in any way
altered the characteristic of the product so as to affect its safety properties, he will
be considered to be a producer.
Responsibilities of Producers and Distributors
Just as with the General
Product Safety Regulations 1994, the 2005 Regulations place an
obligation on producers and distributors to supply only products that are safe, and to
undertake relevant activities (where appropriate) to help ensure that a product
remains safe throughout its reasonably foreseeable period of use.
Producers and distributors
are required to provide consumers with all relevant information and warnings, and
to keep themselves informed about possible risks. However, it is accepted
that the nature and extent of action necessary will vary considerably
depending on the product, the risks inherent in its use, and the type of consumer at
which it is aimed. In addition, the Regulations recognise that a supplier is
only required to act within the limits of his activity.
Producer and Distributor
Notifications
A new obligation
introduced by the 2005 Regulations requires producers and distributors who discover that
they have placed an unsafe product on the market, or distributed such a
product, to notify the competent authorities of the fact and what action they
have taken to remove the risks to consumers. The Regulations require that
such notifications should also be transmitted to the enforcement authorities of
all the Member States in which they believe the product has been marketed.
In general in the UK, producers and distributors will make these notifications
to their Local Authorities, who will then pass the information on to the
Department of Trade and Industry for onward transmission to other Member
States. However, the first point of contact for certain product types will be
different. It will be MHRA for medical devices and medicines for humans, VOSA
for motor vehicles and HSE for products used in the workplace.
Separate guidance for producers and distributors on these notification obligations
will be made available on the DTI website
The authorities will
advise on actions aimed at removal of the risk and work with the producer or
distributor on completing the notification. The authorities will then forward this to the
appropriate national contact point for further action, and to the DTI where
there is a serious risk requiring notification under the rapid exchange of
information scheme (RAPEX). Medicinal products and medical devices have their own
notification systems and are therefore excluded from the RAPEX
system.
The information provided
in the notification must include that required to precisely identify the
product, all information relating to tracing the product, and a description of the risks
the products presents and the actions taken to remove those risks from the
market. The form to use when doing this will be available from local Trading
Standards and from the DTI website.
In practice, we expect
that distributors in the supply chain will want to make the producer (especially if
located within the Community) aware of problems they perceive (as the
Regulations require them to do) before making a notification in case it
relates to isolated circumstances or products (in which case notification is not
required). Communication within the supply chain should also help agreement to
be reached on who should make the notification for the product
in question. Where the producer is in the UK our general expectation is that
the producer will make the notification. However, a distributor who has become
aware of a problem should make a notification under regulation 9 if he
understands that on one else is doing so.
Isolated Circumstances or
Products
It is not necessary to
make a notification where it is clear that the risk is related to a limited number of
specifically identifiable products or batches, and the producer or distributor has
solid evidence to conclude that the risk has been fully controlled and its cause
contained and dealt with. Such problems might include the malfunctioning of a
production line, errors in handling and/or packing etc.
Further guidance on
notifications can be found on the European Commission website
Cooperation
There is a specific
requirement for producers and distributors, within the limits of their activities, to
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.
Information on Risks and
Safety Instructions
Producers and
distributors have for many years been obliged by product safety legislation to provide
information and warnings as to the risks their products posed where those risks were
not obvious and, where necessary, to provide instructions adequate to
consumers’ needs as to the safe operation/use of the product. These Regulations
maintain that requirement.
Obligations on Producers
A producer has a primary
duty to place on the market only safe products but he also has more specific
duties:
* to
provide relevant information to enable consumers 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 to the user. This should include
information on the precautions to be taken to avoid those risks (for example, the
need to wear protective gloves); and
* to
adopt measures commensurate with the characteristics of the products which he supplies, to enable
him to be informed of the risks which these products might present and to
take appropriate action, including, where necessary, withdrawing the
product in question from the distribution chain.
Examples of such measures
include:
* marking
the products, their packaging or other materials supplied with the product (e.g. instruction
booklets) with the name and address of the producer (name and postcode is
acceptable), product reference, and batch number where appropriate, so
that they can be identified (in many cases the manufacturer’s normal
quality control procedures will mean that batch marking is already in place);
* sample
testing of products on the market;
* investigating
complaints relating to safety, and keeping a register of such complaints; and/or
* informing
distributors of the monitoring work and the results.
The above are not
mandatory requirements in every case and which of them will be appropriate to a
particular product will be determined by the nature of the product, the group of
consumers for whom it is intended and the type of activity in which the producer
is engaged. In the case of producers, monitoring may, for a low risk product,
consist largely of assessing complaints from consumers. More complex and
higher risk products may involve a higher level of vigilance and attention
from the producer involving an ongoing sampling programme. There may be
advantage in seeking the advice of your local Trading Standards Department in each
case and prior to the placing of a new product on the market.
Obligations on Distributors
A distributor is required
to act with due care to help ensure that the products he supplies are safe. In
particular, he must not supply products which as a professional he knows or
should have presumed, on the basis of information in his possession, to be
dangerous.
Guidance for businesses,
consumers and enforcement authorities
A distributor is also
required to keep and provide documentation necessary to trace the origin of unsafe
products. For the most part producers mark their products with a product
reference (which may be its name) and/or its production batch to ease
traceability, but there may be issues with very small products and products where it
is impracticable for them to do so, or simply where the producer is not
obvious. In these instances distributors’ records can be used to trace an unsafe
product back to its source and thereby allow the enforcement authorities an
opportunity to resolve the problem at source. Even where a producer cannot be
identified (e.g. at the end of a long supply chain), keeping records of where the
product was sourced should ensure that a producer can be traced back
through the supply chain.
Producers and larger
distributors often maintain product files that contain all manner of information relating
to the products that they sell. It would be overly burdensome to suggest that all
distributors, especially the smallest, should adopt such procedures. In these
circumstances the documentation that is required to support Inland Revenue and VAT
requirements should be sufficient so long as they show from whom the goods
were purchased and, if not for retail, to whom they were sold. We appreciate
that such records have to be kept for a minimum of 6 years. For most products
we believe that will be sufficient to cover the life cycle of the product in normal
or reasonably foreseeable consumer use. Where there is evidence that a
particular product is normally or often in consumer use for a longer period the
records should be retained for that longer period. These records may be electronic.
A distributor is also
required, within the limits of his activity, to participate in monitoring the safety of
products that he supplies and pass on information on the product risks. In practice
this will mean:
* passing
on to consumers information provided by producers about product risks;
* passing
back to producers safety complaints and information and experiences on safety related
matters which he obtains from customers;
* co-operating
with the authorities and others in the supply chain in taking action to avoid or remove
those risks.
The monitoring
requirement placed on distributors should not be viewed in isolation. It clearly must be
taken as part of the overall requirement for the distributor to supply safe
products and, in general, it is anticipated that action by an enforcement authority
would only be contemplated where the safety of a product is at issue.
Responsibilities of Producers
and Distributors
Enforcement of the
Regulations is the responsibility of the Vehicle Operator Services Agency (VOSA) so far
as safety problems with vehicles are concerned, and in the case of
medicines and medical devices the enforcement authority will be the
Medicines and Healthcare Products Regulatory Agency. Otherwise the principal
responsibility for day-to-day enforcement of the Regulations, including in
respect of individual unsafe vehicles on dealers’ forecourts, rests with Local
Authorities, primarily local Trading Standards Authorities in England, Wales
and Scotland, and in Northern Ireland District Council Environmental Health
Officers (EHOs). EHOs also have responsibilities under the regulations in
England, Wales and Scotland. This responsibility largely manifests itself in
respect of products used by consumers in the course of the delivery of a service
on work premises such as restaurants, hotels and in leisure facilities. In most
cases EHOs will find that their existing powers under health and safety at
work legislation will be sufficient to resolve the risk that has been identified. But
in some circumstances EHOs may be required to enforce under these
Regulations. For example:
* a
kettle in a hotel room with a frayed cord would clearly be for EHOs to deal under their existing
powers;
* an
unsafe child’s booster seat not available on general sale but in wide
use by restaurants across the
country is an example of a product where EHOs might need recourse to these
Regulations;
* a
kettle that was in a hotel bedroom but found to be inherently unsafe and on general sale would be an
example of a situation where it would be more appropriate for EHOs to pass
information about the product to their trading standards colleagues for wider
enforcement activity.
HSE are the sole enforcers
in respect of some product-specific Regulations (for example on machinery
safety) where the products concerned are used by the trade in the workplace.
However, where and to the extent that a particular product is a dual-use product,
or where it has migrated from the professional to the consumer market, HSE will
be required to coordinate and cooperate with other appropriate enforcement
authorities (principally Local Authority Trading Standards Departments) to
ensure that there is safety coverage for consumers as necessary at the
borderlines under the provisions of these Regulations.
Enforcement should take
due account of Service Delivery Plans drawn up under the National Performance
Framework (particularly in England, Scotland and Wales) and should also,
wherever possible, follow the principles of the Enforcement Concordat. The
Government is currently consulting on the “Better Regulation Bill”
and this consultation includes proposals for the future of the Concordat. One proposal
is to change the Concordat to a statutory basis.
The General Product Safety
Regulations highlight the importance of enforcement authorities
reaching voluntary agreement with producers and distributors on action to
remove risk to consumers, and this should be the principal objective for
enforcement authorities as long as this is compatible with protecting consumer
safety.
Cross Border Investigation,
Seizure and Prosecution
Local Authorities are
given the power under the Regulations to:
* enter
premises (including by warrant if necessary);
* make
test purchases and undertake testing; and
* seize
records and products from producers and distributors in the supply chain whether they are in its
own Local Authority area or another area.
For the purposes of
efficient enforcement, a Local Authority in England and Wales may investigate and
prosecute for an alleged contravention of the Regulations that was committed
outside its Local Authority area but within England and Wales. Similar
arrangements apply for district councils within Northern Ireland. In Scotland
prosecutions are the responsibility of the Lord Advocate and Part 1 of
the Criminal Procedure (Scotland) Act 1995 applies. Identical offences
committed by the same offender across several Sheriffdoms may be prosecuted
in any one of them. Similar provisions apply to the District Courts.
The Home Authority Principle
The Local Authorities
Coordinators of Regulatory Services (LACORS) promotes the “Home Authority”
principle, under which the Local Authority for the area where the decision-making
function of a business is located (usually a business’s headquarters or main place of
business) accepts the primary responsibility for offering advice and
preventative guidance on a regular basis on safety (and other related matters) to the
business. Other Local Authorities should liaise with the relevant home authority on any
safety matters arising from the products supplied by that business and before
implementing any measures. Businesses are encouraged to make contact
with, and seek advice on any particular matter from their home Local
Authority.
Enforcement
The Home Authority
principle is aimed at promoting uniformity of approach to regulatory services reducing
duplication and assisting businesses to comply with the law. LACORS monitors
the effectiveness of the principle and fulfils a role in resolving any
differences of interpretation in appropriate cases. Guidance on the Home Authority
principle can be found on the LACORS website.
Products originating from
outside the United Kingdom
As under the 1994
Regulations, enforcement authorities will continue to have the power to take action in
the UK to safeguard the health and safety of UK consumers in cases where a
product is first placed on the market in another Member State and is then found
to be unsafe when supplied in the UK.
Measures available to
enforcement authorities
Dialogue and the
encouragement of voluntary action is specifically encouraged as an alternative to formal
enforcement. However, enforcement authorities have access to a range of
measures that can be employed in removing risk to consumer safety where
producers and distributors have not fulfilled their obligations under these
Regulations.
Generally, it is assumed
that where the producer or distributor is already taking the action necessary to remove
the risk to consumers it will not be necessary for the enforcement
authorities to serve a safety notice.
Other than in the case of
urgency resulting from the identification of a serious risk the parties concerned
must, whenever feasible, be given an opportunity to submit their views before the
adoption of a measure. In other cases they must be given the opportunity to
comment following implementation of the measure.
The measure chosen must
be proportionate to the seriousness of the risk:
* Suspension Notices
Suspension Notices Suspension Notices –
Where there may have been a breach of the Regulations, these notices
temporarily ban the placing on the market or the supply of a product while
tests are undertaken and the results are being waited for;
* Requirement to Mark and
Requirement to Warn – these
powers allow an enforcement authority to
order the marking of a product with suitable warnings where it could pose
risks in certain conditions, or require that specific warnings be given to
certain persons considered to be at particular risk from a product (e.g.
young children, the elderly etc);
* Withdrawal Notices –
enforcement authorities can issue a Withdrawal Notice to permanently prevent
a person from further supplying a product that is believed to be dangerous
where it is already on the market (if the voluntary action taken by producers and
distributors is insufficient or unsatisfactory) or from placing it on the market
if it has not yet been so placed; Guidance for businesses,
consumers and enforcement authorities
* Recall Notices –
where an enforcement authority has reasonable grounds for believing that a dangerous
product has already been made available to consumers and voluntary action
falls short of that considered necessary and sufficient to remove the risk,
a last resort (i.e. no other measure available to the authority will suffice)
power to serve a Recall Notice exists. This will require the person on whom it
is served to take such steps as are identified in the notice to organise the
return of the product from consumers. We understand though that in the
case of high volumes of small, low-value, unsafe products, disposal by
consumers could well serve the purpose of a recall as an alternative to
the return of the product. Where a disagreement exists
between the authority and the producer/distributor over
whether recall is necessary, business may require the authority to seek a
reasoned opinion on the case for recall under a scheme operated by the
Chartered Institute of Arbitrators set up by the DTI specifically for the purpose.
The cost of the scheme is to be met by the business that requested its
use. The total cost should be no more than around £5,500. Enforcement
authorities are expected to take account of the advice received when coming to
a final decision on whether or not to serve a Recall Notice. Detailed
rules for the use of the Product Recall Advisory Scheme are at Annex B of this
Guidance. Where a person on whom a
Recall Notice is served fails, fully or in part, to abide by its terms of that
notice the enforcement authority may undertake the recall itself and bring
civil proceedings for the recovery of its costs. The authority is also required
to act where no producer or distributor can be identified on whom to serve
a Recall Notice. In such circumstances recall remains a measure of
last resort. The Regulations recognise that
Codes of Practice on Recall may be valuable in determining the nature and
scope of a recall action. The European Guide to Corrective Actions
including Recall is available from the European Commission’s website6. The
Guide, produced with DTI support, is aimed at improving the effectiveness
of recalls of unsafe products from the Community market;
* Forfeiture and Destruction –
where products are dangerous the enforcement authority may
apply to the court for an order for their forfeiture and destruction. However as an
alternative to destruction the court may, on condition that any order to
pay the costs and expenses of the proceedings is complied with, permit the
supply of the product to a person for repair or reconditioning or for scrap.
Confidentiality of information
An enforcement authority
has an obligation under these Regulations to make available to the public
information about the nature of risks that specific products pose to consumer
health and safety and the measures taken to remove those risks.
However, to the extent that the information is professionally secret and/or
the disclosure of which the authority thinks might significantly harm the
legitimate business interests of the business to which it relates, or relates to the
private affairs of an individual whose disclosure the authority thinks might
significantly harm the individual’s interests, that information shall not be
disclosed while the business continues in existence or during the lifetime of the
individual, other than by consent, or in connection with any criminal proceedings
or the investigation of, or decision to take any criminal proceedings, or
unless such disclosure is necessary to protect the health and safety of
consumers. Other than as specified disclosure is an offence under s245 of Part 9
of the Enterprise Act 2002.
Penalties
For the more serious
offences of a breach of the general safety requirement or the breach of a safety
notice the maximum penalty is a fine of £20,000 or 12 months imprisonment. For
other offences the penalty is a maximum fine of £5,000 or 3 months
imprisonment.
Liability of persons other
than the principal offender
Where a person (the ”principal
offender”) has committed an offence under the Regulations and this was
due to the act or default of another person, proceedings may be brought
against that other person whether or
not
proceedings are also brought
against the principal offender.
Activities affecting the
safety properties of a product placed on the market
1. Examples of such activities
may include:
* assembly
of different components, complete in themselves, received, for example, from different
manufacturers;
* damage
or loss of instructions when part of the supplier’s operation is repackaging of the product;
* commercial
activity.
Trade and business
activities whether or not they are carried on for the purpose of profit are covered.
Charities and Voluntary
Organisations
There is no special
exemption for charities or voluntary organisations that sell goods on a regular basis, and
are for practical purposes engaged in a business activity, from the
requirements imposed by the general safety requirement. Charities could not however be
expected to have documentation that would help trace the origin of
products that are donated free of charge by members of the public, often
anonymously. It is not unreasonable though for charities to be subject to the Regulations
and expected to keep records in respect of any other product obtained through
commercial channels that they may from time to time supply or make
available.
In cases where products are
given away free those supplies will generally be subject to the Regulations
where the act of supply is part of a commercial activity. However voluntary
organisations that exist solely to provide goods free of charge to the needy
are probably not engaging in a commercial activity and are not therefore subject
to the Regulations. Similar considerations apply to village fetes and jumble
sales (e.g. organised by youth organisations) apart from in respect of stands
taken by commercial operations where the activity is clearly commercial even
though the profit, or a proportion of it, is to be donated to charity.
Labelling/information
It is not expected that
products will be labeled with a warning about every conceivable potential hazard.
It will be for the producer to assess the risks and hazards. Whether a warning
should be given must depend on a variety of factors, including:
* the
severity of the hazard;
* the
risk of that hazard being realised;
* the
degree to which the risk is obvious;
* the
type of consumer likely to be at particularly risk.
The considerations set out
under ”Minimum risk compatible with the product’s use” below also apply to an
assessment of the labelling needs.
Antiques
In the absence of any
guidance in the Directive as to what constitutes an antique, the Department is not
able to include a definition of an antique in the Regulations. However, as a
working assumption an antique may be taken to be a product which is more
than 100 years old, or which is of a type that has long gone out of circulation,
is recognised as a collectible item and as such is unlikely (although there are
some exceptions such as furniture) to be used by a consumer for its original
purpose. If there is any doubt about whether or not the product is an antique then
it must be safe, as defined in the Regulations.
Products for Repair or
Reconditioning
It should be noted that it
is not sufficient for a trader to make or display a general statement that goods
are supplied for repair or reconditioning. Purchasers should be clearly
informed of this fact in each case unless, for example, the goods on sale are
in a separate area of the sales premises or trading area and the status of
the goods is made clear in a general notice of such prominence and
proportions that prospective purchasers cannot overlook it.
Minimum risk compatible with
the product’s use which is consistent with a high level
of protection for consumers
It must be recognised that
it is not always possible to eliminate all risk from products. Certain products, by
the very nature of their intended purpose, carry an inherent safety risk
and consumers must accept that they have a responsibility to exercise due
care in using such products. Examples are knives and scissors, which must have
sharp edges to perform their function but where reasonable precautions can be
taken to ensure that handles are sturdy and hands are kept away from the
functional edges when such items are in use. In other cases, it could be
argued that consumers should be aware of the potential risks of misuse
through general knowledge, education and experience. Thus, a balanced view must be
taken based on the nature of the product and the acceptability of the risk
to consumers based on the characteristics of the product and its use. The range
of potential hazards which may need to be drawn to consumers’
attention will depend on a number of factors (referred to in the section above on ”Labelling”).
CE markings
The Directive (and hence
the Regulations) imposes no CE marking requirement. CE marking a product which
does not require this is likely to
“Professional” in
these Regulations is considered to refer:
* to
a person carrying on a commercial activity; or
* the
knowledge and expertise which a distributor could reasonably be expected to have available to
him, either alone or with others, having regard to the nature of business
activity and to other relevant factors (e.g. whether he is required to have
specialist education, knowledge or training in order to enter that business).
Risk
Risk – the probable rate
of occurrence of a hazard causing harm and the degree of severity of the harm.
(Hazard is defined as a potential source of harm).
Serious Risk
Serious risk means any
serious risk, including those the effects of which are not immediate, requiring
rapid intervention by the public authorities. The Commission has produced a
methodology for determining the severity of a risk and this is attached to its
non-binding Guidance on Notifications. We are aware though that there are
also a number of risk analysis models in normal use such as the Nomograph and
others. Neither the Directive nor these Regulations prescribe the use
of any one particular model; however it is possible that there may be
further work in the future on developing a consistent approach at the
Community level.
Normal or reasonably
foreseeable conditions of use including duration
Normal conditions of
use can be taken to be the general usage intended by the producer without him
placing unreasonable restrictions on such use by consumers.
Reasonably foreseeable use
should, it is considered, where appropriate, take account of the intended
and potential types of user (i.e. the elderly, the unpredictable behaviour of
children) and how a reasonable person might use a product in the absence of
any indications to the contrary.
Duration means the
normally expected or actual life of the product, whichever is longer
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