Marknadskontroll butikskedjor

Rapport
2008:20
Market surveillance
of store chains
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Market surveillance of store chains
Project leader: Maria Lindstedt
Participant: Helena Nilsson
Konsumentverket 2008
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Contents Summary .......................................................................................................... 4
Introduction .................................................................................................. 6
Background .................................................................................................. 7
Aim............................................................................................................... 9
Methods ........................................................................................................ 9
Documentation requirements ..................................................................... 10
Analysis and results ................................................................................... 12
Questions to the store chains .................................................................. 12
Internal controls ..................................................................................... 13
Technical documentation on purchased products .................................. 15
Feedback to the store chains visited ........................................................... 19
Conclusions ................................................................................................ 19
Appendices ................................................................................................. 20
Appendix 1.
Rules for safe toys in brief ............................................. 22
Appendix 2. Act on Personal Protective Equipment (PSU) and
the CE mark ........................................................................................ 23
Appendix 3.
EC Type test certificate. ................................................. 24
Appendix 4.
Result and summary of purchased products .................. 25
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Summary
Each year, around 1,500 products with safety defects are reported in the EU’s
warning system for dangerous products. In many cases, the defects have been
judged to be so serious that selling has ceased and the products have been
recalled from shops. The responsibility for ensuring that products sold to
consumers are safe lies with all the businesses involved in the supply chain
selling the products. The chief responsibility for product safety lies with the
manufacturers and importers in the EU who have placed the product on the
European market.
Preventing dangerous products from reaching consumers requires that the
businesses are aware of current regulations in the area of product safety. This
also requires that they undertake preventive and systematic product safety
work. This includes having procedures for risk assessment, and checking the
products they manufacture or import.
Against this background, Konsumentverket (the Swedish Consumer Agency)
carried out during 2008 a supervisory project targeting a number of major
store chains. The aim of the project was to check what sort of preventive
action these businesses took on product safety and product risk analysis. The
Consumer Agency has also allowed these companies themselves to
demonstrate, with technical documentation, that the products they sell are
safe.
The store chains selected were Clas Ohlson, Överskottsbolaget, Åhléns,
Barnens Hus, ICA Maxi, COOP Forum, Biltema and Intersport.
The results showed that there were deficiencies in preventive product safety
work at several of these companies. Above all, in many cases there was no
documented risk assessment. There were also defects in the companies’ own
checks of the technical documentation for various product types.
The Consumer Agency purchased and checked 16 articles of personal
protective equipment and 17 toys.
9 Nine of the test reports/certificates could not be linked to the
purchased product with any certainty.
9 Ten articles of personal protective equipment did not have any
instructions for use in Swedish.
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9 The CE mark was missing on four articles of personal protective
equipment.
9 Three articles of toy-like products with a catapult function were
wrongly CE marked.
One positive outcome of the market surveillance was that all the store chains
were making efforts to improve their product safety procedures. In addition,
all the businesses had taken action when the Consumer Agency pointed out
defects relating to product safety, marking, information or instructions for
use.
None of the products has been sent off for testing, but the surveillance had in
any case resulted in the businesses ceasing to manufacture or sell some
products, because of safety defects or faulty marking.
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Introduction
The responsibility for ensuring that products sold on the Swedish market are
safe lies with the business that manufactured the product in Sweden, or if
manufactured outside the EU, with the business that imported the product.
One requirement therefore is that the businesses are aware of current
regulations, have sound procedures and good preventive safety work. The
Consumer Agency’s experience is that many of the businesses rely to an
excessive extent on the companies manufacturing the products (usually in
Asia) being aware of the regulations and requirements inside the EU. One
possible consequence is that the companies’ own risk assessments and
checking of the products may be insufficient.
Each year, 1,500-2,000 products are reported in the EU’s RAPEX reporting
system 1 . Up to and including September 2008, 1,600 notifications were
made. Of these, 615 related to toys, 14 to personal protective equipment, and
16 to hobby and sports articles. 56% of the products notified had China as
their country of origin. This suggests that a large number of products with
safety defects are placed on the EU and the Swedish market each year. The
number of notifications varies, and depends to some extent on how efficiently
and comprehensively the authorities in each country carry out their
supervision and market surveillance. One reason why toys feature so
prominently is because toys are a priority area for the EU supervisory
authorities.
Diagram 1. The number of notifications in Rapex between 1 Jan 2008 and 30 Sep 2008.
1
The EU’s rapid alert system for the exchange of information between member states
regarding products posing a serious risk to consumers. See also link:
http://ec.europa.eu/consumers/dyna/rapex/rapex_archives_en.cfm
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Background
The Consumer Agency’s responsibilities include supervision of and
compliance with the Product Safety Act, the Act on Personal Protective
Equipment for Private Use, and the Toy Safety Act. See appendix 1-2.
The purpose of the Product Safety Act is to ensure that goods and services
offered to consumers do not cause any injuries to persons. The Act on
Personal Protective Equipment for Private Use and the Toy Safety Act
impose health and safety requirements, as well as requirements on the design,
marking and product information of each product type.
The Consumer Agency is responsible for supervising the safety of toys, and
also personal protective equipment for private use. Examples of this sort of
protective equipment are bicycle helmets, life jackets, reflectors and various
types of sports protection, but also includes respiratory protection equipment
and eye protectors for private use. For personal protective equipment, the
requirements in Arbetsmiljöverket’s (the Swedish Work Environment
Authority) regulations on the performance of personal protective equipment
must be fulfilled.
Toys and personal protective equipment must be CE marked in order to be
sold. With the CE mark, the manufacturer certifies that the safety
requirements have been fulfilled. The CE mark means that the product can be
freely sold within the EU. For toys and for some types of personal protective
equipment, the manufacturer can self-certify the product, while for more
advanced safety equipment, an EC Type test certificate from an accredited
notified laboratory is required, appendix 3.
In order to place a product on the market, the business must first ensure that
the product meets the safety requirements. In practice, this means that a risk
analysis needs to be made for each product type. There are various methods
for making risk assessments, and in the current state of play, there are no
clear requirements about how the risk analysis should be documented. A risk
analysis must always take into account intended or foreseeable uses of the
product. A good example is a chair. A chair is clearly intended for sitting, but
it is foreseeable that the chair will be used for climbing up and standing on.
The chair must therefore have sufficient stability to cope with this sort of use.
Preventive product safety work should include risk analyses, product
inspections/function inspections, checks of the documentation, and there
should also be procedures prepared for dealing with complaints and product
recalls. A risk analysis should also take account of and assess the risks during
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the product's entire service life. The precautionary principle must always
apply.
The following points should be covered in a risk analysis:
1. Identification of the product. Name, article number, country of origin,
manufacturer, plus a photograph of the product.
2. Account of which requirements are imposed on the product in
legislation and other regulations.
3. An assessment whether the product should be CE marked.
4. The product's target group and intended area of use, for example
whether the product is aimed at small children, elderly persons or
people with disabilities.
5. A statement as to whether there are current and applicable standards.
6. An account of assessed risks in the product. The risks can be split up
into different areas, such as mechanical, chemical, physical,
combustibility, electrical and microbiological.
7. Document what changes can be made to reduce the risks. For
example, changes in the product, warning marks and instructions for
use.
8. Document internal checks such as for example that functional
inspections of products have been carried out.
9. Report whether a business and market analysis has been carried out in
order to discover whether there are similar products on the market in
which safety defects have been noted. For example, by looking at the
EU’s Rapex list.
10. Report whether technical documentation from the manufacturer has
been requested and reviewed, or whether random samples of the
product have been tested in a laboratory.
11. Is there any assurance that mass production will conform to the
approved prototype.
The Consumer Agency may utilise various different methods for supervision
and for carrying out market surveillance. Traditional market surveillance, in
which random samples are purchased and the products are then tested at
accredited laboratories, has only a limited effect on the market. Requirements
for action are then only imposed on the product types that have not passed the
test. In this project, the Consumer Agency has used a different supervisory
method. The Consumer Agency has used on-site inspections to check how a
number of store chains have set up their preventive safety work. During these
inspections, the Consumer Agency has explained the companies’ obligations
under the Product Safety Act, and the companies have had to describe their
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preventive procedures in the area of product safety – “self-inspection
controls/checks”. The Consumer Agency also asked these companies to
demonstrate themselves, with technical documentation, that the products they
sell are safe.
As the market surveillance authority, the Consumer Agency has the power to
issue injunctions and prohibitions in order to prevent products with safety
defects from reaching consumers. The Product Safety Act is an Act
permitting negotiations, which means that in the majority of cases the
Consumer Agency reaches a voluntary agreement with the business
concerned. The Consumer Agency can also apply for injunctions for
sanctions charges in the event that a business places a dangerous product on
the market.
Aim
The aim of the project has been to check that only safe products in the form
of toys and personal protective equipment are sold to consumers, by the
following means:
•
Make on-site inspections at a number of store chains, and check the
procedures for the companies’ preventive product safety work.
•
Impose requirements on the store chains to provide technical
documentation certifying that the products they sell are safe.
•
Provide information and thereby increase the store chains’
understanding of their obligations under the Product Safety Act.
•
Develop industry contacts and gain a better understanding of how the
businesses carry out their preventive product safety work.
Methods
The project commenced in April 2008 with visits to eight stores. The criterion
for selecting the stores was that they should belong to a chain with several
stores spread across the country. Their product range should include either
toys or personal protective equipment. The store chains selected were Clas
Ohlson, Överskottsbolaget, Åhléns, Barnens Hus, ICA Maxi, COOP Forum,
Biltema and Intersport.
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One store from each store chain was visited. The project was explained to the
store manager, who then described the procedures relating to product safety.
During the visit, some samples of toys and personal protective equipment
were purchased. The selection of products was by random sample, but
focusing on products where the Consumer Agency had already discovered
during the store visit that the marking was defective. The products purchased
were then checked for complete marking and instructions for use. No
products were sent for testing. Instead, the Consumer Agency requested the
store chains to produce technical documentation demonstrating that the
products are safe.
Subsequently, each store chain's head office was visited. At these meetings,
the companies were required to hand over the technical documentation, and
account for their preventive safety work by answering a number of questions.
The Consumer Agency has laid down requirements for the action required
where products with safety or marking defects are discovered. In some cases,
the actions have not been aimed at the store chains, but at the businesses that
were responsible for placing the product on the Swedish market.
Documentation requirements
In the Consumer Agency’s regulations about the safety of toys (1993:9) and
in Arbetsmiljöverket’s regulations (1996:6) about the performance of
personal protective equipment, there are requirements on the manufacturer or
his authorised representative in the EU to present technical documentation to
the supervisory authority confirming that the product is safe.
For personal protective equipment, the following documentation must be
available:
• EC Type certificate: The manufacturer shall submit the equipment to
a Notified Body 2 in order to test the product and issue an EC Type
certificate. The Notified Body tests and approves the equipment
according to harmonised standards or against the fundamental safety
requirements in the Directive for personal protective equipment.
Personal protective equipment of a simple nature is exempt from the
requirement for an EC Type test certificate.
•
2
Declaration of conformity: The manufacturer, or his representative in
the EU, shall prepare a Declaration of Conformity in line with
By Notified Body is meant an accredited laboratory that has been notified to the EU and is
permitted to issue Type test certificates.
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Arbetsmiljöverket’s regulations. The declaration shall certify that the
personal equipment meets the general safety requirements under the
Directive for Personal Protective Equipment, and that other specimens
of the product conform to the specimen submitted for a Type
examination.
•
Instructions for use in Swedish: The personal protective equipment
must be accompanied by information, namely instructions for use in
the language where the product is sold.
For toys the following applies:
• Technical documentation: For toys manufactured in conformity with
standards, the manufacturer must be in a position to provide technical
documentation in the form of a test report or similar, demonstrating
that the toy complies with the standards for toys. If the toy is not
manufactured in conformity with standards, or where the toy carries a
risk not covered by a standard, the toy shall be submitted to a Notified
Body for an EC Type certificate. The EC Type certificate shall certify
that the toy fulfils the essential safety requirements in the Directive on
toys, which in Sweden has been implemented in the Toy Safety Act.
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Analysis and results
Questions to the store chains
Below is a summary of the answers to the questions put by the Consumer
Agency to the product safety managers at each store chain. All the store
chains sell both toys and personal protective equipment. Intersport has a very
limited range of toys, and Åhléns has an insignificant range of personal
protective equipment.
The number of stores in each chain is shown below:
CLAS OHLSON
93 stores in the group, of which about 60 in
Sweden. Several new stores are opened each
year.
ÖVERSKOTTSBOLAGET
79 stores
COOP FORUM
61 COOP Forum stores. 43 are owned by
COOP Sverige, the rest by societies with
contracts with the chain
ICA MAXI
60 stores in Sweden
BILTEMA
51 stores in the Nordic countries, of which
20 in Sweden.
INTERSPORT
145 stores in Sweden. The stores are
operated by franchise holders. Intersport is
present in 33 countries, with a total of 5,000
stores.
ÅHLÉNS
79 department stores in Sweden
BARNENS HUS
18 Barnens Hus. 14 of these are franchise
holders
All the chains have substantial imports of their own, primarily from Asia. For
certain types of products, above all personal protective equipment, a great
deal of the trade is conducted with well-established major players in the EU.
Many of the chains have their own purchasing companies who do all the
purchasing.
The companies’ head offices and purchasing companies acquire a good
understanding of the legislation and the rules for the products sold in various
different ways. Many of the chains are members of various industrial
organisations, and some participate actively in standards setting for toys. One
chain subscribes to SIS 3 and thereby has access to around 100 standards. It is
3
Sveriges tekniska standardiseringsinstitut (Swedish Standards Institute)
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standard practice to search for information on websites, particularly websites
run by various official bodies.
Most of the chains permit the stores only to purchase products from the
organisation's own product range. There are some exceptions for stores run as
franchises 4 or as societies in the COOP. What happens there is a degree of
pressure to use the internal product range, though the store may also make its
own local purchases. Know-how about regulations and product safety is built
up at the head offices and purchasing companies. The training and knowledge
transfer about product safety to the individual stores is in many cases judged
by the store chains themselves to be deficient.
Internal controls
One aspect of internal controls is imposing requirements on suppliers. The
store chains do this in various different ways. Clas Ohlson has a checklist
with detailed requirements that must be fulfilled before the product is released
on the market. Biltema has recently worked out a system in which each
product must be approved and signed off by the product manager. COOP
sends all toys to be imported for testing, and Åhléns imposes requirements,
and checks test reports, on each toy they purchase in. Other chains sign
contracts with suppliers with more or less detailed product specifications.
Each store chain has its own procedures for carrying out risk analysis before
the products are placed on the market, though documentation about this is
often missing. The responsibility for acquiring knowledge about various
product groups, and for making risk assessments, in many cases lies with the
individual buyer for a particular store chain.
Before a product is imported, sample products are sent for functional
inspections to the purchasing manager for each company. Documentation
about the function inspections is missing. Acceptance inspection is not done
in Sweden. It is more usual to make checks on site in Asia before the products
are shipped. The checks that the store chains carry out on test reports they
have requested from the manufacturers for various products are sometimes
deficient. The companies often rely on the test certificates sent by the
manufacturers for the product for which they have requested test certificates –
even though the test reports sometimes do not actually relate to the product.
4
A franchise can be regarded as a privilege granted by a brand owner to a company to use the
business model for selling products and services under the brand name – albeit at a price.
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The store chains carry out their own tests using random samples. The COOP
and Biltema send all imported toys for testing.
One defects noted is that none of the chains has a system for ongoing checks
of product safety. Products that have at some time “been approved” for
importing may have undergone changes or manufacturing methods which
may have given rise to safety defects. The store chains often sign contracts
with suppliers which mean that they may not switch sub-suppliers, or change
the manufacturing methods, without the importer's approval. One store chain
has stated that it intends to impose a requirement that test certificates from
manufacturers for different products may not be more than two years old.
As for own brands (in Swedish EMV) there are more thorough systematic
control procedures which also involve audits at manufacturers. At several of
the chains there is also work being done to build up an inspection
organisation in Asia.
The store chains have procedures for complaints, sales stops, and product
recalls. Some of the store chains also have facilities for blocking products at
the head office so that the products cannot be sold at their stores. In the case
of customer complaints directly to individual department stores, there are in
some chains defects in the feedback to the head office and the purchasing
department. The handling of complaints and follow-ups form an important
part of systematic work on quality. By discovering defects at an early stage,
products can be stopped before incidents and personal injuries can occur.
All the store chains have issued recalls because of safety defects in the
products. With one exception, the store chains recognised their obligation to
inform the appropriate supervisory authority and to report on what action had
been taken. Six out of eight chains check the Rapex list of stopped and
recalled products on a weekly basis. In several cases they have discovered
products they had on sale, and thereby prevented further sales of these
products. On the other hand, there was a lack of awareness that there should
be some sort of response 5 and to inform the Consumer Agency that action
had been taken to stop a Rapex-notified product.
On the positive side, the chains visited are working actively to improve
preventive procedures for product safety, particularly by setting up
purchasing and quality control offices on site in Asia.
5
Submitting a response to a Rapex notification means informing the Consumer Agency that
the product is in Sweden, and disclosing what action has been taken to stop further sales.
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Technical documentation on purchased products
In conjunction with a visit to the local stores, the Consumer Agency
purchased 16 articles of personal protective equipment and 17 toys. The head
office for each store chain was then tasked with producing technical
documentation demonstrating that the products are safe.
A summary of results and actions taken for all the purchased products is
given in appendix 4.
9 The summary shows that nine of the test reports/certificates cannot be
connected to purchased products with any certainty.
9 Ten articles of personal protective equipment did not have any
instructions for use in Swedish.
9 The CE mark was missing on four articles of personal protective
equipment: rollerblade protection, floorball goggles, mouth guards,
and a skating helmet. Three “toy” articles with a catapult function
were wrongly CE marked.
Of the purchased products, it turned out that several of them were defective in
terms of CE markings and instructions for use in Swedish. As regards
technical documentation submitted to the Consumer Agency, it has
sometimes been difficult to connect test certificates or other certificates to the
product. The reason for this may be that the article number from the
manufacturer does not always match the article number that the store chain
applies to the product, though it may also arise because of deficient technical
documentation. Photographs and descriptions of the products are often
lacking. In some cases, certificates have been in French, without a translation.
The store chains’ own checks that test certificates match purchased products
are often deficient.
In several of the store chains, toys with a catapult function were found. By an
EU decision and within toy standardisation, all types of catapults such as
slingshots, as well as other types of products involving shooting with a rubber
band, are not classified as toys in the Toy Safety Directive, nor within the
meaning of the toy standards. The reason is that the speed when shooting can
be very high, with a great risk of damage to eyes. It is not considered possible
to eliminate the risk of damage through standards at the EU level. Instead, the
national authorities should intervene against the sale of dangerous catapult
toys. This means that toy aeroplanes driven by a rubber band may not carry
CE markings, nor may they be sold as a toy. None of the store chains that had
catapult aeroplanes on sale were aware that the product was not covered by
the requirements of the toy standard EN 71:1.
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The Consumer Agency has not submitted any products for testing, but market
surveillance has resulted in the sale of a number of products ceasing. Several
companies have also had to take further action in the form of new instructions
for use and changes in the marking of the products.
Examples of actions taken are reported below:
• Ear protectors and protective goggles from Gisle-Krigsvoll lacked
Swedish instructions. This has now been fixed.
• Cycling and skating helmets from Biltema have had their instructions
for use translated into Swedish..
• Rollerblade protection from Biltema lacked markings and instructions
for use. This has now been fixed.
• Biltema has changed its markings for toys so that only toys for
children over 3 with small parts are marked with ”Warning! Not for
children under 3 years– contains small parts”.
• Biltema has removed the defective CE marking on a catapult
aeroplane.
• Skating helmets imported by Toyman lacked CE markings and
instructions for use. The helmets were judged not to fulfil the safety
requirements and were withdrawn from the stores. Illustration 1
• The manufacture of bandy mouth guards from JOFA that did not meet
the safety requirements has ceased. Furthermore, the mouth guard
lacked markings and instructions for use. Illustration 2
• Floorball goggles from Intersport, Pro Touch, lacked CE markings
and test reports. Intersport has stopped selling them and recalled the
remaining goggles from the stores. Illustration 3
• At ICA Maxi, ear protectors and respiratory protection equipment
from Hall-Miba were purchased. Instructions for use in Swedish were
lacking. This has now been fixed.
• The selling of a “catapult toy”, Finger Flickers, at COOP has ceased.
Illustration 4
• A catapult aeroplane with the wrong CE marking was purchased at
Barnens Hus. The importer was Suntoy, Sunne. Sales have ceased.
Illustration 5
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Illustration 1. Helmet purchased at Barnens Hus, importer Toyman. Sales
have ceased and the helmet has been recalled from the stores.
Illustration 2. Mouth guard purchased from Intersport, manufactured by
JOFA. Does not meet the safety requirements. Manufacturing has ceased.
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Illustration 3. Floorball goggles, Pro Touch from Intersport. Sales have
ceased and the product has been recalled from the stores.
Illustration 4. Finger Flickers from COOP. Sales have ceased and the
product has been recalled from the stores.
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Illustration 5. Catapult aeroplane purchased at Barnens Hus, importer Sun
Toy. Sales have ceased and the product has been recalled from the stores.
Feedback to the store chains visited
All the store chains visited have received feedback in writing with the
minutes from the Consumer Agency’s on-site inspection. Action requirements
have been sent to each store chain or to the company responsible for placing
the product on the Swedish market.
Conclusions
In order to assure themselves that only safe products are sold to consumers,
businesses that manufacture or import products to Sweden must carry out
preventive product safety work. Before a product is placed on the market,
businesses must carry out a risk analysis. How this should be done, and what
documentation needs to exist, is not clear from current regulations. However,
it is not sufficient to rely on the manufacturers in Asia being aware of the
requirements and regulations in the area of product safety in the EU.
When an importer imposes requirements on suppliers, there must also be
sound procedures for checking that the requirements are met. A precondition
for effective and functioning preventive product safety is that the
requirements imposed are product-specific. When requirements are imposed
that products must be tested, then there must also be a check that the test
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certificates received are in agreement and can be connected to the correct
product.
In the case of own manufacture, or imports from third countries, selfinspection controls/checks in the form of risk assessments and ongoing
checking of production and marking are a precondition for products offered to
consumers being safe. The functional inspections and risk analysis that
companies carry out today are in many cases considered to be insufficient, as
documentation is often lacking.
The Consumer Agency is one of several authorities supervising the market.
Supervision and market surveillance can be done in various different ways.
Through information, on-site inspections and regular checks of random
samples, the Consumer Agency can combat the sale of products with safety
defects to consumers. Nevertheless, the responsibility for ensuring that the
products are safe lies with the businesses. Several of the store chains look for
information on the websites of the various authorities. The Consumer Agency
should therefore take active steps to systematically set out important and upto-date information on its website www.konsumentverket.se .
For consumers, it is important to remember to complain and report products
with serious safety defects. Such reports should initially be made to the
company where the product was sold, but the report should also be sent to the
authority with supervisory responsibilities.
Appendices
Appendix 1. Rules for safe toys in brief
Appendix 2. Act on Personal Protective Equipment (PSU) and the CE
mark
Appendix 3. EC Type test certificate.
Appendix 4. Result and summary of purchased products
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Appendix 1. Rules for safe toys in brief
The basic rules for product safety are set out in the Product Safety Act. In
addition there is the Toy Safety Act (1992:1327) setting out special
legislation in this field, as well as the Consumer Agency’s regulations about
toy safety (KOVFS 1993:9), in the regulations identified below.
The Toy Safety Act and the regulations specify that a toy may not be
designed in such a way that it constitutes a risk for the user's safety, or the
safety and health of any other person, when the toy is used in a foreseeable
way, bearing in mind a child's normal behaviour. Toys are presumed to be
safe if they comply with a European standard, Toys – Safety Rules EN 71:1EN 71:11, or have been designed to comply with an approved toy prototype.
Toys must be CE marked in order to be sold. If a toy has a CE mark even
though it does not fulfil the requirements laid down for CE marking, the
supervisory authority may order the manufacturer, the importer, or whoever
sells the product, to cease to sell product or to recall the product. The order
may be combined with a fine.
It is the business which has to provide the evidence that a product is safe.
Anyone who has supplied a dangerous product shall without delay take
whatever action is required to prevent injuries. From the preparatory work
done for the Product Safety Act it is clear, for example, that children should
be considered to have a particularly strict need for protection. This means that
an action may be justified even though the risk of injury is small. When
assessing whether a product should be considered to be acceptable, special
regard should be paid to the risks that the product can carry for children. If a
business supplies a dangerous product, intervention may be justified. Under
the Act, a business can be prohibited from supplying a product, enjoined to
submit safety or warning information, and enjoined to recall the product. A
business that deliberately or negligently breaches its obligations runs the risk
of being ordered to pay a penalty charge.
Anyone who has supplied a dangerous product shall without delay take
whatever action is required to prevent injuries. If a business is made aware
that a product they supply or have supplied is dangerous, the supervisory
authority must be informed. On the Consumer Agency’s website,
www.konsumentverket.se, under the headings “Safety” and “For companies”
there are notification forms and guidance about recalls and other corrective
action. On the website, the legislation can be studied in its entirety.
Appendix 2. Act on Personal Protective Equipment
(PPE) and the CE mark
As of 1 July 1995, there is a special Act applicable to Personal Protective
Equipment for Private Use (SFS 1992:1326) with a requirement for
marking. The Act means that businesses may only supply personal protective
equipment that fulfils certain requirements for the protection of health and
safety, marking and information. Supplying a product means selling, hiring or
lending out the product. The Act is supplemented by a government ordinance
(SFS 1993:972) and by regulations from Arbetsmiljöverket (the Swedish
Work Environment Authority) (AFS 1996:7) who have produced these
following consultations with the Consumer Agency.
The Act on Personal Protective Equipment for Private Use applies to products
that consumers use or might use for private use. The regulations are a
consequence of the EEA Agreement and of EU membership. The EU
regulations can be found in the Directive on Personal Protective Equipment,
89/686/EEC.
It is assumed that the requirements have been fulfilled if the equipment has
markings, and the manufacturer or its representative in the EEA has made
a declaration that the equipment complies with the provisions in the Directive
on Personal Protective Equipment. In simple terms, the marking can be
described as a “passport”. If an item of personal protective equipment is
considered to fulfil the safety requirements and has been
marked in one
EEA country, it can accordingly be freely sold in other EEA countries.
Life jackets are an example of personal protective equipment, category II,
which means that the manufacturer must submit the equipment to what is
known as a Notified Body in order to receive an EC Type test certificate.
Testing of the equipment is normally done using the harmonised standards
that are common to the whole EU, all using the basic safety requirements in
the legislation. Once the manufacturer has an EC Type test certificate,
technical documentation for the product and also instructions for use, the
marking is applied to each individual product. The instructions for use shall
be the language where the product is intended to be sold.
The technical documentation must contain all relevant facts about the steps
taken by the manufacturer to ensure that the equipment meets the basic safety
requirements. Businesses are under an obligation to provide the technical
documentation to the authority, following a request from that supervisory
authority.
Appendix 3. EC Type test certificate, EC Type approval, EC Type certificate
Personal protective equipment Cat 1
(simple protective equipment, such as gardening gloves, sunglasses) Toys
Personal protective equipment Cat 2
(the commonest type of protective equipment, such as helmets, sports protection) Personal protective equipment Cat 3 (Complex equipment. Protection against mortal danger, such as diving apparatus, safety harness Technical documentation that confirms that the toy or personal protective equipment fulfils the safety requirements in the appropriate Directive. (May be a test report or other descriptions of the manufacturing process and product design) Self‐certification NOTE! Toys with risks that are not covered by the standards, and toys that have not been manufactured in compliance with standards, require an EC type certificate which shows that the toy fulfils the essential safety requirements under the Directive on toys Self‐certification An EC type certificate must be issued to before quantity production can start. A Notified Body certifies that a test sample of the equipment fulfils the general safety requirements in the PPE Directive. Quality and Production control. The Notified Body has responsibility Declaration of conformity (must certify that other examples of the protective equipment besides the one being tested also fulfil the requirements. Name, address and “number” of the Notified Body must be included in the declaration nnnn (=number of the Notified Body) Appendix 4. Result
Store chain
Clas Ohlson
Överskotts‐
bolaget
Biltema
PPE, toy
Bicycle helmet,
Bell sports
Ear protector,
child protector
Protective goggles,
worksafe
Protective goggles,
CAT yellow lenses
Moon sand,
toy
Electric motor,
Core
Picture book baby joker,
Playmix
Revolverset Wild West
Playbox
Ear protector,
Gisle-krigsvoll
Protective goggles
Gisle-krigsvoll
Breathing mask,
Biltema
Cycling/skating helmet
Biltema
Rollerblade protection,
Biltema
Catapult aeroplane,
Biltema
Technical documentation
Assessment
Certificate in German
Hard to link the certificate to the product
Certificate in French
Hard to understand the certificate in French
Art nr in declaration does not fully match
the product marking
Declaration of conformity
Declaration of conformity
test report
Declaration of conformity
Instructions for use missing
test report
OK
Test report cannot be linked to the
product
test report
Action taken
New procedure when repackaging
products at the central warehouse.
OK
test report from year 2000
EC certificate
Instructions for use in Swedish missing
EC certificate
EC certificate
Declaration of conformity
Instructions for use in Swedish missing
Gisle‐Krigsvoll have produced Instructions for use in Swedish
Gisle‐Krigsvoll have produced Instructions for use in Swedish
tested as a toy
OK
Hard to link the protocol to the product
Instructions for use missing
Hard to link the test report to the product.
CE mark and instructions for use missing
Biltema have produced Instructions for use Marking and instructions for use fixed. New test carried out.
test report
Defective CE marking. Catapult function
CE marking removed
Bath toys,
Biltema
test report,
Declaration of conformity
Wrongly marked with warning "Not for
children aged below 3 – contains small parts”. Marking fixed
Wooden building blocks,
Biltema
Test report 10 mths.
Wrongly marked with warning "Not for
children aged below 3 – contains small parts”. Marking fixed
test report
Barnens Hus
Intersport
ICA AB
COOP
Åhléns
Skateboard helmet,
Toyman
Catapult aeroplane,
Suntoy
Bath toys,
Suntoy
Rollerblade protection,
Crazy Creek
Mouth guard,
JOFA
Floorball goggles,
Pro Touch
Ear protector,
Hall-Miba
Breathing
Brea
thing mask,
Hall-Miba
Plastic car
GOWI
Plastic toy,
Fischer Prize
Catapult.
Finger Flickers, COOP
Glider plane
Foam gliders, COOP
Child's rattle
Turtle Rattle, COOP
Particulate filtering mask
KOYOTE, 3 M
Wooden helicopter
Minifriends, Åhléns
Flying disc, Åhléns
test report
CE mark and instructions for use missing.
Test report does not match the product.
Considered to have safety defects
Voluntary sales stop and recall
test report
Defective CE marking. Tested according to
American standard
Voluntary sales stop
test report
OK
test report
EC certificate in French
OK
CE mark and instructions for use missing
Considered to have safety defects
CE mark and instructions for use missing
Declaration does not match the product.
Hard to understand the certificate.
Instructions for use missing
EC certificate
Instructions for use missing
Voluntary sales stop and recall
Hall-Miba have produced
Instructions for use
Hallll‐Mib
Ha
Mibaa have have produced
produced Instructions for use CE mark difficult to see
Marking changed by manufacturer
missing
Declaration
test report
OK
test report
CE mark despite catapult function
test report
OK
test report
OK
EC certificate
Declaration of conformity+C5 OK
test certificate
OK
test certificate
OK
Sales stopped
Voluntary sales stop and recall
Konsumentverket
Box 48
651 02 Karlstad
Telefon: 0771-42 33 00
Webbplats: www.konsumentverket.se
E-post: [email protected]