During the official visit to the Security Control Agency in Esbjerg, an introductory presentation was held on the Danish Security Control Agency, which is an organizational part of the Danish Ministry of Industry and Finance. Within the determined policy of action of the EU member states and in accordance with the projects signed by the Minister, guidelines for work are determined, which the competent authorities implement as a priority in their work. Accordingly, the Security Control Agency, with 190 employees and three areas of work, is focused on achieving its basic task of providing consumers and businesses with security (products) in the way that is most acceptable / easiest for them. three areas: market surveillance, inspection and permits. Presenting the tasks and activities in the period from 2018 to 2020, it was pointed out that in that period a significant increase in inspections and market surveillance activities for products was achieved with a smaller increase in operating costs. In the structure of cases related to products (market surveillance), inspection, permits and the total number of cases in the period, statistics are presented through categories of cases that include the application of guidelines in the period COVID-19, tobacco control, permits, electronic cigarettes, health aspects, safety of consumer products, inspections in the field of electrical installations and systems, explosives, machinery, pressure vessels, tattoo parlors, traffic, inspections of facilities, supply of electricity, gas and cases of market surveillance, inspections and other activities in the field of metrology, accreditation and of precious metals. A detailed organizational scheme and a new Strategy for the period from 2021 to 2024 were presented, which should ensure security. As part of its mission, this agency creates a framework of action that enables citizens and businesses to participate in safe choices, in cooperation with others and strives to continuously develop its activities / businesses to be a relevant partner in its field of work, to achieve security, using the data at its disposal for the benefit of society as a whole. A strategic approach in data aggregation, analysis, processes, exchange and use of data to guide development, create new products, methods and positive changes was presented. Access to communication, exchange of information and knowledge through digital platforms is of special value based on the new Strategy.
After the introductory presentation of the Danish Security Control Agency, a presentation was held by the Ministry of Trade, Tourism and Telecommunications – Market Inspection Sector. In addition to the organization and presentation of internal units within the Ministry and the Sector, the organization of the Market Inspection Sector and cross-sectoral cooperation, including cooperation with the Consumer Protection Sector, were presented in more detail. The manner of cooperation with the Sanitary Inspection in the Ministry of Health, within the National System for Rapid Exchange of Information on Dangerous Products, which was established in Serbia (NEPRO) and functions as the equivalent of RAPEX, was pointed out. Representing the Departments at the Headquarters of the Market Inspection Sector in the context of the implementation of the Twinning Project – Protection and Enforcement of Intellectual Property Rights, the manner of mutual cooperation and coordination in the field of traffic control, prevention of unfair competition and consumer protection was explained. and the quality management system being developed in the field of market surveillance, the role of the Reporting and Education Department and the Internal Control Department, from the aspect of unifying the overall activities of the Sector and coordinating the work of 24 operational market inspection departments in Serbia. , through a comparative analysis of overall statistics in the field of enforcement of intellectual property rights and market surveillance. The key activities of the Twinning Project-IPA 2016-Protection and Enforcement of Intellectual Property Rights were presented, namely: capacity building of IPR enforcement bodies, workshops, including e-commerce seminars for prosecutors and judges, IT mechanisms such as information exchange platform and electronic module for submitting requests for taking measures within the competence of the Market Inspection Sector. The most important activities of the regional project in the field of market surveillance, as well as the project of quality infrastructure development with the basic directions of further development of this field of work and cooperation of the competent authorities of the Western Balkans / CEFTA parties are briefly listed. The connection between counterfeiting and piracy with product safety control was presented in terms of cooperation and coordination that is being developed with the support of this twinning project, in partnership with the Intellectual Property Office and all law enforcement agencies in the field. The work of the Expert Group for Monitoring Trends and Extent of Counterfeiting in Serbia was especially emphasized, as well as the cooperation with the Inspectorate for Medicines and Medical Devices, which is also the body responsible for enforcing intellectual property rights and market surveillance in the medicines and medical devices sector. From the aspect of implementation of this and other development projects, the importance of cooperation with the Sector for Administrative, Normative and European Integration Affairs in the Ministry of Trade, Tourism and Telecommunications was stated.
In the continuation of the paper, the experiences of the Danish Safety Control Agency in organizing and conducting risk-based market surveillance are presented. An approach to control planning where there is a high risk or where compliance is low is presented. For this purpose, the Danish market surveillance authorities use their own databases, ISCMS / RAPEX data as well as statistics on accidents that are challenging as a result of the use of certain products. In addition to the importance of professional experience, checklists for compliance control and databases, the importance of risk management methods and standardized market surveillance processes, which provide a unified approach across all product groups and rapid transition to new areas, was emphasized. With regard to sampling, a risk-based approach to sampling is also presented, so that this sampling process focuses on products that are suspected to be non-compliant. “Online sampling” using “AIME” software and using “anonymous shopping” are listed. Regarding the control of product labeling, it is stated that the control of labeling and packaging is performed, which is focused on SE labeling and traceability, where the control of data on packaging, etc. is of great importance. It was emphasized that there is currently a high level of non-compliance identified in traceability controls. It is stated that in the control of documentation, the declaration of conformity, certificates, if necessary in accordance with the relevant directive / regulation, other technical documentation, instructions for use and other relevant documentation are checked. For product testing, it was emphasized that accredited laboratories are used, that controls are performed through a dynamic purchasing process, that testing is mainly performed on the basis of harmonized standards, at the choice of inspectors depending on the type of product. With regard to sanctions, it is stated that, according to the Law on Products and Market Surveillance, there are seven levels of sanctions: notification to consumers – warning of the risks posed by the product; prohibition of misleading marketing; elimination of discrepancies; sales ban; withdrawal of products from the market; recall of products from consumers; destruction of products. As for fines, they amount to a minimum of 50,000 DKk-6,700 EUR, which are increased in case of repeated violations. There is also a measure to block online distribution, especially in the case of resale of dangerous products. All non-compliant products are published through www.produkter.dk. “Market surveillance-based” companies mean audits based on controls, which are discussed with economic entities, with a focus on internal procedures related to product compliance. When there is a positive response from economic operators and audits based on inspections, ie harmonization of internal procedures for product compliance, market surveillance supports the market for compliant and safe products.
A tour of the office building was organized, followed by a presentation of procedures for the use of space and equipment.
In the further course of work, digital tools for online market surveillance / use of artificial intelligence were presented: “AIME” and “SAFE”. In the context of the e-commerce challenge for market surveillance, the Danish Security Control Agency (DSTA) together with the market surveillance authorities of the Netherlands and Estonia, successfully tested in 2019 the AIME digital tool that was ready for use in 2020. The characteristics of this digital tool and how it is used in online market surveillance are presented. It automatically researches specific products that pose a risk and checks the market. SAFE – the common European market surveillance tools – was presented and how this system works on the basis of the exchange of information reported by market surveillance authorities to the ICSMS database and Safety Gate, where notifications on dangerous products are submitted. The joint IT tool “SAFE” performs online checks for non-compliant products, for each country, sends notifications to the competent authorities of the Member State where the product is marketed and regularly checks whether non-compliant / unsafe products reappear for further response through competent authorities. The 15 EU member states that are currently participating in this system with the possibility of access to other partners are listed. In addition to the above common IT tools at EU level, used by the Danish market surveillance authorities, the Danish product safety platform: producter.dk was presented, which supports the implementation of the strategy and the achievement of market surveillance objectives. In addition to the structure and operation of this platform, it is explained in particular how the notification of dangerous products and reporting of dangerous and defective products, how to determine the product category or the scope of a particular regulation. On practical examples, it is explained how the mentioned IT alti are used and how they are integrated and interconnected, including integration with ICSMS. Examples of published unsafe and non-compliant products are presented. Future directions of development, user needs, ideas were also presented, such as the proposal for the establishment of the European Platform for Product Safety (Project 2022-2023) – the Danish Security Control Agency has the role of a key coordinator in the project team.
The Communication Strategy and a comprehensive approach in the application of communication mechanisms with companies, citizens, access to information through the press, magazines, social networks and in other ways were also presented.
The Danish Veterinary and Food Administration presented a way to control food in terms of the application of EU legislation relating to general principles and requirements for food and official controls to verify compliance. Representing the organization and competence of this Administration, the control of food traceability was especially emphasized, which is an obligation arising from the European legislation. Namely, it is prescribed that subjects in the business of food and feed should be able to identify when and to whom their products were delivered and to have systems and procedures that enable this information to be available to the competent authorities when they request it. Transparency in the work of this administration is reflected in the fact that all control results are available on the Internet. If they find any problem, the media and service users / consumers find out immediately. An inspection report for consumers must be visibly available in retail stores and restaurants. An internal audit of the work of inspectors is also organized, as well as an audit by the competent EU bodies. The control of imports of food of non-animal origin is performed in accordance with the new strategy, where the principles of responsibility of importers and not exporters are applied – imported products must be in accordance with the requirements set by Danish and EU regulations. Namely, the importer is the one who orders the product, makes the specification of the products they order and must check the delivery whether it is in accordance with the specification he requested. An importer is one who knows the manufacturer or at least the exporter and knows the business chain, prices and product quality. After the general presentation of this administration, its role and competencies at the national and international level, the work of the Operational Group of the Food Inspection, which works on the prevention of criminal fraud in the food sector, was presented in detail.
During this official visit to the Danish Patent and Trademark Office, the organization, mission and vision of the Office, as well as its role in the enforcement of intellectual property rights, were presented in cooperation with the European Observatory for Intellectual Property Infringements. Presenting the status and tasks it performs in the field of protection of intellectual property rights (patents, trademarks, design), general information on the role of this Office in coordinating the implementation of intellectual property rights and establishing a network of competent authorities at the national level. Also, information on international projects implemented by DKPTO is given. In addition to the EU Twinning project in Serbia, the DKPTO is currently implementing projects in Indonesia, Argentina, Brazil, Egypt and India. Considering that one of the activities implemented within the Twinning Project in Serbia is related to the further development of coordination of the work of competent bodies, experiences and practices in this area were exchanged, primarily regarding the role of the Intellectual Property Office in Serbia. work of the Coordination Commission and expert / operational groups that were established in order to implement and consolidate the planned activities. Special attention is paid to the comprehensive presentation of the activities of the DKPTO in raising awareness about the harmfulness of piracy and counterfeiting. In this regard, the experiences of Serbia were discussed, given that the DKPTO supports the implementation of activities carried out by the Serbian authorities in the field of raising public awareness, within the Twinning project – Protection and Enforcement of Intellectual Property Rights in Serbia.
At the Danish Medicines Agency, the presentations focused on three important segments related to supervision in the medicines and medical devices sector, which relate to: challenges related to the illegal trade in “non-standard” medicines outside official supply chains; challenges when the Internet and social networks are used for trade and challenges related to counterfeit products in official supply chains. Transmitting experiences related to electronic investigations, the IT tools used in investigations are listed, namely: Search-Google, DuckDuckGo, Bing, etc .; Google Earth and Streetview to identify addresses, databases from national company registries; Webshop reviews (Trust Pilot); website hosting identification tools (www.whoishostingthis.com); WHOIS databases (Domaintools, Godaddy, EURID). Cooperation between the Danish State Prosecutor for Serious Crime in International and International Forms of Crime, the Customs Administration, the network of competent ministries, the Ministry of the Environment-Food and Veterinary Administration and the Danish non-profit e-market organization for certification of safe and reliable web stores was presented. Specific examples of cooperation at the international and national level are given. Representatives of the Serbian Ministry of Health presented their experiences regarding the seizures of illegal drugs and international cooperation in that sector, and representatives of the market inspection showed interest in online investigation techniques and presented their experience in developing these procedures within the current Twinning project.
The budget to cover the costs of this study visit was provided within the mentioned EU Twinning project.
Ministry of Trade, Tourism and Telecommunications