Documenti di Didattica
Documenti di Professioni
Documenti di Cultura
TABLE OF CONTENTS
Table of contents
Introduction to project
Overview of activities
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12
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Project achievements
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Key facts
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LETTER FROM
EU HEAD OF OPERATIONS II
I am delighted to congratulate Serbia in the progress it has made over the past 2.5
years to meet the EUs requirements and procedures for product safety.
Preparing to transpose the directives for product safety into national legislation may
feel like a Sisyphean task. But you have laid very important foundation stones, working
together with EU experts from this project to develop strategies, models and methodologies that are vital to carrying out that task efficiently and effectively.
This will give your businesses greater access to the EUs 500 million consumers. And it
will also do more to protect your own consumers at home against the risks posed by
sub-standard, non-compliant and dangerous products. One of the reasons consumers
enjoy more safety, is that under the new system, all suppliers be they retailers, wholesalers, importers or manufacturers - are responsible for the safety of their products. No
longer will they be able to shirk responsibility by pointing the finger of blame at others.
So they pay more attention to making sure that their products comply with legislation.
And the legislation is extensive. In order to fully comply and access the market, member states, and those wanting to become members, must ensure their national legislation is compliant with the essential requirements that are laid down in the EU Directives governing product safety. Its a huge body of legislation that must be checked,
and where necessary, adapted. It takes years to adopt.
To succeed, it also needs to be understood by both businesses and inspectors. And the
CE marking needs to be known and recognised by consumers.
That is what makes its introduction so challenging and why the EU funded the two and
a half year MSS project to support Serbian institutions to adopt the EUs market surveillance system.
We are happy to be associated with this effort and look forward to seeing more Serbian products on the EUs markets.
LETTER FROM
STATE SECRETARY
Vesna Kovac
State Secretary
Ministry of Trade, Tourism
and Telecommunications
Serbia is a strong trading partner with the EU, and we look forward to making it even
stronger, in particular as we increase exports by complying with EU Directives and
adapting our market surveillance system and legislation to that of the EU.
That is why the task of the Market Inspectorate in particular is so important for everyone: for the Serbian economy as it gains access to EU markets; for Serbias consumers
because it provides better coordinated and hence more effective protection; and
hence for Serbias manufacturers and exporters and importers.
The new system allows businesses more freedoms, which is good, because this allows
for more innovation. But it is also their responsibility to ensure that their innovations
comply with the EUs product safety standards.
But first our legislation must be compliant with the relevant EU legislation for the product in question. For some, that legislation is already in place, for others the work is still
underway. For it is a huge task that means reviewing our standards on all products
and ensuring that they are at least equivalent in terms of safety standards. Thousands
of pages of regulations must be checked, revised, approved. A data base must be developed that is easy to use and can be accessed by all relevant bodies. Hundreds of
inspectors, customs officials and laboratory staff must be trained to understand their
new role and how it works.
It is that task that the MSS project has helped our Market inspectorate with, and for
that help we are truly grateful. Thanks to the project we have developed roadmaps
and methodologies that can be used quickly and effectively for other products. And
thanks to the project activities, our market inspectors are now much better trained to
apply the EUs approach to market surveillance.
Lidija Stojanovic
Assistant Minister and Chief MS Inspector
Ministry of Trade, Tourism and Telecommunications
Two and a half years ago, the Sector for Market Inspection in cooperation with other market
surveillance authorities, Customs Administration and the Sector for Quality Infrastructure and
technical regulations started a lengthy process of reforms, which should end with the full adoption and implementation of the new legislative framework for product safety.
The challenges that this developing new legal framework presents to inspectors is considerable
and the reason why the activities undertaken by the Market Surveillance System project have
been designed to increase the administrative capacity of market surveillance authorities whose
activities provide high level of consumer protection and fair competition without unnecessary
trade limitations. Technical subject training has been undertaken on EU directives covering low
voltage, machinery and electromagnetic compatibility, complemented by training on the risk
assessment of potentially dangerous products and its use when deciding to alert the public
of a dangerous product through the NEPRO rapid alert system. In addition, training has been
provided on the efficient use of sampling methods as a tool to undertake surveillance on unsafe products on the market.
So that as many inspectors as possible gain from the training performed by the project, one
group of inspectors has been trained as trainers so that they can repeat the training to other
inspectors across Serbia. Such training will form the basis of a personal and professional development programme for inspectors which has been established as part of the on-going development of a new quality management system.
The development and implementation of a management information system, which with joint
funding from both the Ministry of Trade, Tourism and Telecommunications and EU will support
market surveillance coordination and information management in order to obtain more efficient performance of market surveillance activities and to monitor the impact of undertaken
measures. For instance, data that will inform us of what the market surveillance priorities are,
and on the outcomes that result from our interventions. Information that will form the basis of
the future development of inspectorate based on a new market surveillance system.
From the project training it is clear that coordination and cooperation is a vital component of
a market surveillance. The legal obligations based on the transposed EU market surveillance
regulations and product safety regulations, as well as the MSS projects contribution to the
Serbian market surveillance development require exchange of information and effective communication, while the right priority is given to unsafe products which should be dealt with in
a substantial and coordinated way. Certainly the project outcomes made it clear that mutual
cooperation was most important if we want to increase efficiency and efficacy of market surveillance.
The professional training and development received by inspectors, the adoption of Quality
manual and procedures, and the creation of a management information system will be the basis for functioning and further development of Serbian market inspection surveillance system.
INTRODUCTION TO PROJECT
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Train management staff to
understand the New Legislation
Framework and Quality
Management system
a) C
ollectionand preparation of
inspection data that needs to be
migrated from the old inspection
database,
b) C
ollection and preparation of
legislation and checklist data
needed for MIS operation
c) Design of management reports.
1.
LEGAL FRAMEWORK
FOR PRODUCT SAFETY
The Challenge
The EU has a huge body of legislation called the Acquis Communataire. This comprisesthe directives and regulations all products must comply with in order to be freely traded on the market. Countries wishing to join the EU, or gain access to its markets, must
ensure their products conform. They do this by making their own national legislation
compliant.
Given that the entire Acquis Communautaire covers some 65,000 items of legislation,
this is a task that takes many years.
Food products
Cosmetics
Eggs
Crystal glass
Honey
Footwear
Textiles
Organic food
Toys
Example:
The Directive for Electromagnetic Compatibility (EMC-D) states that too much
electromagnetic radiation should not be emitted.
But neither the 765/2008 regulation nor the relevant product standards specify
HOW market surveillance activities should be carried out.
Hence procedures had to be created for a non-homogenous sampling procedure
to be used for Market Surveillance (MS) activities in different technical fields.
The strategy also sets out the objectives, activities and communications that will
be used to apply these MS procedures.
Case study: The implications of the EUs Approach to ensuring product safety for
different stakeholders
The Low Voltage Directive (LVD), the Electro-Magnetic Compatibility Directive (EMCD)
and the Machinery Directive (MD) have now been fully transposed and come into effect. This will have implications for all household appliances. Below we set out how the
new system will have implications for everyone, from manufacturer to consumer, using
a kettle as an example.
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MANUFACTURER identifies
whether independent
conformity assessment
needs to be obtained from
Notified body
MANUFACTURER applies
the CE mark to the kettle
and places the product
on the market- selling to
distributors
CUSTOMS ADMINISTRATION
allow exported kettle
into the EU because it
is CE marked and has a
declaration of conformity
CONSUMERS
purchase CE
marked Kettle.
MANUFACTURER
identifies Directive +
Harmonised standards relevant
to kettles
MANUFACTURER tests
the kettle to check
that it conforms with
requirements
MANUFACTURER
Verifies the
products
essential safety
requirements
MANUFACTURER
prepares Technical
Documentation,
+ undertakes Risk
Assessment
Manufacturer
exports to the
EU CE marked
kettles
Products on the
market. Kettles
distrubuted to
RETAILERS and
displayed for sale
If CONSUMER experiences a
problem during use-matter referred
to Market surveillance inspectors
MARKET SURVEILLANCE
INSPECTORS
send samples/product for
testing
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2.
MARKET SURVEILLANCE
PROCEDURES
The challenge
Once a system of legislation is based on the Acquis Communautaire, the second challenge is to prepare the market surveillance authorities to discharge their responsibilities in line with its principles.
It is a considerable task. In addition to familiarizing staff with new standards and legislation that products must comply with, the approach to market surveillance has also
changed, as defined by Regulation (EC) 765/2008, which is part of the EUs New Legislative Framework (NLF) 2008/765. The Regulation establishes the requirements for
accreditation and market surveillance. It also calls for the establishment of a new Quality Management System and procedures that will be critical to the implementation of
Serbias Law on Market Surveillance.
The changes that the new system heralds must be planned and coordinated at managerial and district level. They must be understood and implemented by surveillance
authorities, legislators and businesses alike.
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2. Human resources
3. Continuous improvement
4. Information and
communication
5. Preparation
Proactive
5.1 Planning of market surveillance for nonfood products
5.2 Planned market surveillance activities
5.3 System level sampling
5.6 Development of test plan for conformity assessment
Reactive
5.4 Extraordinary inspection
5.7 Handling of standards
5.8 Legislation information management
6. Execution
6. Market surveillance
6.1 Inspection of non-food products
6.2 Sampling
6.3 Selection of CABs and subcontracting
6.4 Risk assessment
7. Reporting
7.1 Reporting
The system is now ready for implementation. For the sustainability of the quality management system, a management representative has been nominated who will continue to monitor its further development to include possible further MTTT-MI responsibilities. In particular, over the next few years it is anticipated that the QMS and the MIS
will need further coordinated integration, in order to optimize the support provided to
the Quality Management System by the Management Information System.
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SLAVISA PETKOVIC
Since the disintegration of the Federal State, in Serbia market inspectors have been responsible for enforcing legislation to ensure the safety of industrial non-food products.
And this role continues today. We used to do this using rulebook, which contained a
lot of detailed safety requirements. This was because there was not a lot of confidence
that manufacturers and retailers would adequately protect the consumer.
But this situation has now changed, or rather, is changing.
The change started in 2009 when we began to implement the EUs product safety rules.
Now, manufacturers, retailers etc are liable for meeting the essential harmonized safety
requirements if they want to be able to operate. If they fail to comply, they can all be
responsible for the consequences and will be fined. No one can pass the buck. Its much
more clear-cut. This makes us as inspectors feel less like police, and more like advisors. If
anyone on the supply chain is found to be non-compliant, there will be consequences.
Having said that, the process of change is still ongoing, as the new harmonized legal
framework continues to be developed. So we are in a period of transition. Sometimes
we will still undertake compliance checks based on the old style declaration, rather
than the newer certificate of conformity that effectively guarantees suppliers to EU
markets.
The challenge this new legal framework represents to inspectors is considerable, and
thats why the Market Surveillance System projects efforts to help us has been vital.
Weve had training on EU directives covering products involving low voltage, machinery and electromagnetic compatibility. This was complemented by training on the risk
assessment of potentially dangerous products and their use. Weve learned when it
might be necessary to alert the public about a dangerous product through the NEPRO
rapid alert system. In addition, weve learned about efficient sampling methods to
check on unsafe products on the market.
Weve also had a number of our team trained as trainers, so that they can train more
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MD training
inspectors. This was good for their own personal development programme, as well as
for the organization.
In future our work as Inspectors will provide valuable data when it comes to setting
priorities for future inspections. Here the Management Information System will be critical. Our findings will help determine what kinds of products or companies might be a
risk, as well as documenting what activities have been carried out, and what the results
were. In turn this kind of information can help inform future Ministry decisions and priorities.
Its also important to say that the new framework presents a greater opportunity to cooperate with businesses.
Our main aim is to protect consumers from unsafe products. And this works much better if we have the flexibility to avoid court action as long as they cooperate. Obviously,
to ensure it is applied correctly and fairly, and to eliminate corruption, strictly defined
limits are imposed. Nonetheless, in future if they cooperate it will be possible using
simplified procedures for some matters to be resolved without the need to take court
action.
Finally, thanks to this project, we truly came to appreciate that through coordination
and cooperation the role of a market inspection service becomes much easier. Now
that relations between different institutions are improving, and because the new legislation demands better cooperation between ministries and institutions, we get the
information we need. There are mechanisms in place to ensure a quick and effective
sharing and exchange of information about unsafe products.
In my view this is a very positive time for market inspectors. The new training and procedures will help us do our job to protect consumers well. And this will be good for
both Serbian businesses and consumers.
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3.
INSPECTION
AND SURVEILLANCE
The challenge
Under the old system, producers applied for mandatory certification before placing
their products on the market. That certification showed that their products complied
with precisely defined requirements. The new approach places more responsibility on
the shoulders of manufacturers and/or importers but also allows manufacturers greater freedom. They are free to design their products as they wish provided essential
safety, health and other requirements of public interest are met.
This means a much more challenging role for inspectors, who must have an in-depth
knowledge, understanding and capacity to apply the standards and procedures to individual cases.
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4.
MANAGEMENT
INFORMATION SYSTEM
The challenge
Currently the various authorities and agencies involved in market surveillance in Serbia
operate with little coordination or exchange of information. The information systems
themselves are often paper-based and fragmented. Consequently, they are inefficient.
They were also designed to meet the needs of inspectors under the old system and do
not meet the implicit and explicit information requirements of the new system, and
hence hamper its implementation.
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MIMIS will become the memory and nerve centre of the MTTT Market Inspection
Department. It will support the planning, preparation, execution and follow-up of the
market inspection activities by providing extensive information about inspections and
economic operators. Comprehensive information about the inspection results and outcome will facilitate the monitoring and evaluation of policy implementation.
The NIMIS architecture:
a. Introduces the inspection case concept, which will enable a comprehensive linking
of inspections with possible follow-ups and court case(s).
b. Introduces inspection checklists, based on legislative requirements, that will help
standardize inspection practices and facilitate extensive recording of, and thus reporting on, inspection results.
c. Links centrally developed pro-active Inspection plans with actual inspections, thus
facilitating the monitoring and evaluation of progress and outcome of these plans
d. Assesses risk as part of the inspections, which will facilitate risk base planning of future inspections.
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MS System training
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PROJECT ACHIEVEMENTS
LEGAL FRAMEWORK
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REGULATIONS
AND DIRECTIVES
PREPARED FOR
TRANSPOSITION INTO
SERBIAN LAW
EU APPROACH
management
staff of MTTT
trained on Market
Surveillance System
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METHODOLOGY
FOR CORRECT
TRANSPOSITION OF
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REGULATIONS
AND DIRECTIVES
PROVIDED
18
members
of Product
Safety Council
trained
29 trainings/workshops in
10 fields
57 trainers trained on the eu
approach to market surveillance
CAPACITY BUILDING
9 members of MDI (MIS development and implementation team) enhanced their information management skills in 18 sessions covering 6
modules
24 regional department managers prepared for their role
23 information managers designated to implement the MIS
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SOFTWARE
DEVELOPMENT
Specifications
evaluated
KEY FACTS
Duration
Value
EUR 2.85 million, EU contribution: EUR 2.5 m. The Serbian 350,000 contribution mostly was used to invest in software for the Management
Information System
Beneficiaries
Implemented by
EMCD training
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